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## Protocol Section
### Identification Module
**NCT ID:** NCT04415879
**Brief Title:** Effects of a N95 Respirator vs Cloth Mask on Exercise Capacity During Treadmill Exercise.
**Official Title:** Effects of a N95 Respirator vs Cloth Mask on Exercise Capacity During Treadmill Exercise.
#### Organization Study ID Info
**ID:** 20-538
#### Organization
**Class:** OTHER
**Full Name:** The Cleveland Clinic
### Status Module
#### Completion Date
**Date:** 2020-08-01
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2020-08-13
**Type:** ACTUAL
**Last Update Submit Date:** 2020-08-12
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2020-08-01
**Type:** ACTUAL
#### Start Date
**Date:** 2020-06-01
**Type:** ACTUAL
**Status Verified Date:** 2020-08
#### Study First Post Date
**Date:** 2020-06-04
**Type:** ACTUAL
**Study First Submit Date:** 2020-06-01
**Study First Submit QC Date:** 2020-06-01
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** The Cleveland Clinic
#### Responsible Party
**Investigator Affiliation:** The Cleveland Clinic
**Investigator Full Name:** Debasis Sahoo
**Investigator Title:** Staff Physician
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This study intends to find out how a cloth mask may impact exercise capacity, to provide guidance for exercisers to adjust their expectations and training accordingly. The investigators plan to asses exercise capacity through estimated peak oxygen consumption (eVO2peak), oxygen saturation and level of perceived exertion during treadmill based exercise while wearing a cloth mask compared to exercising without a cloth mask. The potential significance of this study is to determine if subjects can exercise safely and if their exercise training needs to be adjusted while following the current recommendations of wearing a cloth mask in public. The degree of airflow limitation experienced will depend on the type and fit of the mask being worn, and inadequeate airflow could possibly result in CO2 re-breathing if all air was not fully discharged from the mask with each breath. This re-breathing of CO2 could potentially limit the workload leading to a detriment in performance, and increase in adverse symptoms such as dizziness, lightheadedness, chest pain or shortness of breath that does not improve with rest.
**Detailed Description:** If healthcare providers are going to recommend that individuals exercise with cloth masks, it is imperative that future research is conducted to evaluate the degree to which airflow can be limited during exercise by wearing a cloth mask. At the completion of the study, the investigators will have further understanding of the effects of face masks during treadmill based running. To the investigators knowledge this is the first study to assess the effects of wearing protective cloth mask on exercise capacity.
Hypothesis The null hypothesis HO states that exercising with a cloth mask will be inferior to the current standard of exercising without a facemask, limiting peak exercise when non-inferiority margin is 1 estimated metabolic equivalent ( eMET 3.5 mlO2\*kg-1\*min-1).
The alternative hypothesis H1 states that exercising with a mask will not be inferior to the current standard of exercising without a facemask, limiting peak exercise when non-inferiority margin is 1 eMET.
EXPERIMENTAL DESIGN \& METHODS Subject Recruitment: The investigators will recruit 20 subjects though the Cleveland Clinic. Inclusion Criteria: Healthy subjects age \> 18, Exclusion Criteria: Any long-term disease that would interfere with their ability to exercise safely, fever \>100.4 F, or pregnancy. Informed consent will be obtained by the CoPI, and need for medical clearance determined based on ACSM's 2015 preparticipation guidelines. To remain compliant with enterprise guidelines we will not be recruiting healthy subjects outside of the Cleveland Clinic staff at this time to avoid increase COVID-19 exposure risk. However, if the enterprise changes the guidelines we will expand our enrollment to include non Cleveland Clinic employees. Employees will not be solicited by direct initiation. Recruitment will involve only posted notice or general advertising that does not pressure employees into participating for fear of job loss, delayed promotion, or other influences from their superior.
Study Design: The study design is a prospective crossover non-inferiority trial where subjects will complete 3 separate graded exercise treadmill tests each time wearing either No Mask, N-95 Mask (3M), or Cloth Mask (Boco). The order of the mask worn will be randomly assign to minimize familiarization or training effect. All testing will be performed in a Cleveland Clinic facility following standardized COVID-19 screening precautions. The investigators will compare the data collected from each test to asses for differences between subject comfort, peak exercise capacity (eMET), heart rate response during exercise and recovery.
Testing: After completing the informed consent and being medically cleared, subjects will then perform a symptom limited graded exercise treadmill test using a modified Balke protocol with continuous 12-lead EKG monitoring. Exercise tests will be stopped if any significant cardiac arrhythmias occur or significant ST segment depressions develops. The test will be terminated if ST elevation (\> 1.0 mm), marked ST displacement (horizontal or downsloping of \> 2mm, measured 60 to 80 ms after the J point), moderate to severe angina, Signs of poor perfusion (cyanosis or pallor), Sustained ventricular tachycardia or other arrhythmia, including second or third decree AV block, that interferes with normal maintenance of cardiac output during exercise, or development of bunle-branch block that cnannot be distinguished from bentricular tachycardia. The modified Balke, which is a well-accepted treadmill protocol that keeps the speed constant and increases workload by grade. Subjects will rest for 3 minutes and resting heart rate, blood pressure, subjective perceptions of the face mask will be measured. Subjects then will walk at 0% grade at 3 miles per hour for 2 minutes. Elevation will be increased by 2% after the initial 2 minutes and by 1% each minute thereafter until the test is terminated. Heart rate, RPEand oxygen saturation will be measured with a pulse oximeter at baseline, last 5-10 seconds of each stage and the investigators will continue to monitor heart rate during recovery at 1, 3 and 5 minutes post exercise. The investigators will monitor each stage for perceived exertion, feelings of light headedness, anxiety, and discomfort. The test will also be terminated at the request of the subject or if any chest pain develops. The scale of measuring subjective perceptions instrument will be adminstereted after collecting 5 minutes of resting, end of the exercise test, and at 5 minutes post recovery. The graded exercise test will be performed once with No Mask, once with a 3M 8200 N-95 Respirator, and once with a Cloth Mask (Boco). Subjects will be randomized by a random number generater (1= No Mask, 2= N-95, 3= Cloth Mask) to determine the order the perform each exercise test No Mask, N-95 or Cloth Mask and will complete the other tests 2 atleast 1 day apart. Subjects will be instructed to abstain from exercise for 2 days before the test.
Mask:
3M 8200 N-95 Respirator obtain from a third party provider. N-95 Respirators have been purchased outside the Cleveland Clinic supply chain. Cloth Face Mask manufactured by Boco is a custom designed two-layer face masks are built with a tightly woven polyester outer shell fabric and a soft, breathable performance knit mesh inner linig. Includes a slit pocket where a filter can be added.
### Conditions Module
**Conditions:**
- COVID-19
**Keywords:**
- Exercise
- Face Mask
- COVID-19
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
##### Masking Info
**Masking:** NONE
**Primary Purpose:** HEALTH_SERVICES_RESEARCH
#### Enrollment Info
**Count:** 20
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Individuals will perform a Modified Balke Treadmill test with no mask and their estimated VO2 peak will be calculated based off of peak workload.
**Intervention Names:**
- Device: N-95 Respirator
- Device: Cloth Face Mask
- Diagnostic Test: Graded exercise test
**Label:** No Mask
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** Individuals will perform a Modified Balke Treadmill test while wearing a N-95 Respirator and their estimated VO2 peak will be calculated based off of peak workload.
**Intervention Names:**
- Device: N-95 Respirator
- Device: Cloth Face Mask
- Diagnostic Test: Graded exercise test
**Label:** N-95 Respirator
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Individuals will perform a Modified Balke Treadmill test while wearing a cloth mask and their estimated VO2 peak will be calculated based off of peak workload.
**Intervention Names:**
- Device: N-95 Respirator
- Device: Cloth Face Mask
- Diagnostic Test: Graded exercise test
**Label:** Cloth Mask
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Cloth Mask
- N-95 Respirator
- No Mask
**Description:** N-95 mask will be worn as personal protective equipment during a graded exercise test
**Name:** N-95 Respirator
**Type:** DEVICE
#### Intervention 2
**Arm Group Labels:**
- Cloth Mask
- N-95 Respirator
- No Mask
**Description:** A cloth mask will be worn as personal protective equipment during a graded exercise test
**Name:** Cloth Face Mask
**Type:** DEVICE
#### Intervention 3
**Arm Group Labels:**
- Cloth Mask
- N-95 Respirator
- No Mask
**Description:** No personal protective equipment during a graded exercise test
**Name:** Graded exercise test
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** To gain further understanding on effects exercising with a cloth mask has on exercise capacity. Our working hypothesis is that wearing a face mask will limit exercise capacity by a minimal clinically important difference (MCID) of 1 estimated Metabolic Equivalent (eMET 3.5 O2 ml/kg/min).
**Measure:** Exercise Capacity
**Time Frame:** 4 Weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age 18 years or older
* Cleveland Clinic Employee
* Must not be pregnant
Exclusion Criteria:
* Medical condition that would interfere with ability to exercise safely
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Cleveland
**Country:** United States
**Facility:** Cleveland Clinic
**State:** Ohio
**Zip:** 44195
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000011024
- Term: Pneumonia, Viral
- ID: D000011014
- Term: Pneumonia
- ID: D000012141
- Term: Respiratory Tract Infections
- ID: D000007239
- Term: Infections
- ID: D000014777
- Term: Virus Diseases
- ID: D000018352
- Term: Coronavirus Infections
- ID: D000003333
- Term: Coronaviridae Infections
- ID: D000030341
- Term: Nidovirales Infections
- ID: D000012327
- Term: RNA Virus Infections
- ID: D000008171
- Term: Lung Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC01
- Name: Infections
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M2561
- Name: COVID-19
- Relevance: HIGH
- As Found: COVID-19
- ID: M21089
- Name: Facies
- Relevance: LOW
- As Found: Unknown
- ID: M13904
- Name: Pneumonia
- Relevance: LOW
- As Found: Unknown
- ID: M13914
- Name: Pneumonia, Viral
- Relevance: LOW
- As Found: Unknown
- ID: M10283
- Name: Infections
- Relevance: LOW
- As Found: Unknown
- ID: M6368
- Name: Communicable Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14978
- Name: Respiratory Tract Infections
- Relevance: LOW
- As Found: Unknown
- ID: M17522
- Name: Virus Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M20490
- Name: Coronavirus Infections
- Relevance: LOW
- As Found: Unknown
- ID: M6555
- Name: Coronaviridae Infections
- Relevance: LOW
- As Found: Unknown
- ID: M23685
- Name: Nidovirales Infections
- Relevance: LOW
- As Found: Unknown
- ID: M15149
- Name: RNA Virus Infections
- Relevance: LOW
- As Found: Unknown
- ID: M11168
- Name: Lung Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000086382
- Term: COVID-19
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT01705379
**Brief Title:** Safety of One Dose of Meningococcal ACWY Conjugate Vaccine in Subjects 2 Years of Age and Older
**Official Title:** A Multicenter, Single Arm, Post Marketing Surveillance Study to Monitor the Safety of Novartis Meningococcal ACWY Conjugate Vaccine (MenACWY-CRM) Administered According to the Prescribing Information to Healthy Subjects 2 Years of Age and Older in the Philippines
#### Organization Study ID Info
**ID:** V59_45OB
#### Organization
**Class:** INDUSTRY
**Full Name:** Novartis
### Status Module
#### Completion Date
**Date:** 2016-04
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2016-12-01
**Type:** ESTIMATED
**Last Update Submit Date:** 2016-11-30
**Overall Status:** WITHDRAWN
#### Primary Completion Date
**Date:** 2016-04
**Type:** ESTIMATED
#### Start Date
**Date:** 2013-03
**Status Verified Date:** 2016-11
#### Study First Post Date
**Date:** 2012-10-12
**Type:** ESTIMATED
**Study First Submit Date:** 2012-10-09
**Study First Submit QC Date:** 2012-10-09
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Novartis Vaccines
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** A multicenter, single arm, postmarketing surveillance study. This study is a postlicensure requirement of the Philippine Food and Drug Administration (FDA) to provide continued safety evaluation of MenACWY-CRM in Philippine individuals 2 years of age and older, receiving MenACWY-CRM vaccination according to routine clinical practice and prescribing information.
### Conditions Module
**Conditions:**
- Meningococcal Disease
**Keywords:**
- Neisseria meningitidis, conjugate vaccine, phase IV clinical trial
### Design Module
#### Enrollment Info
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** 2 years of age and older
**Intervention Names:**
- Biological: Novartis Meningococcal ACWY Conjugate Vaccine
**Label:** MenACWY-CRM
### Interventions
#### Intervention 1
**Arm Group Labels:**
- MenACWY-CRM
**Description:** Immunization
**Name:** Novartis Meningococcal ACWY Conjugate Vaccine
**Type:** BIOLOGICAL
### Outcomes Module
#### Primary Outcomes
**Measure:** All adverse events
**Time Frame:** Day 29
**Measure:** All serious adverse events
**Time Frame:** Day 29
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
Individuals eligible for enrolment in this study are those:
1. who are of any gender, from the age of 2 and older, and to whom/whose parents or legally acceptable representatives the nature of the study has been described and the subject/subject's parent/legally acceptable representative has provided written informed consent.
2. who the investigator believes that the subject and/or his or her parent/legal representative can and will comply with the requirements of the protocol.
3. who are in good health as determined by clinical judgment of the investigator.
Exclusion Criteria:
Individuals not eligible to be enrolled in the study are those:
1. who are unwilling or unable to give written informed consent or assent to participate in the study.
2. who are perceived to be unreliable or unavailable for the duration of the study period.
3. who have previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s) (licensed or investigational).
4. who have received any investigational or non-registered product (drug or vaccine) within 30 days prior to enrolment or who expect to receive an investigational drug or vaccine prior to the completion of the study.
5. who have received or who are planning to receive any vaccines (other than routine childhood vaccines) within 30 days before and after administration of study vaccine.
(Exception: Influenza vaccine may be administered up to 15 days prior to study vaccination and at least 15 days after study vaccination)
6. who have behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject's ability to participate in the study.
7. who are pregnant or breast feeding (female subjects of appropriate age) or who plan to become pregnant during the course of the study.
8. who have any serious acute, chronic or progressive disease (e.g., any history of neoplasm, cancer, diabetes, cardiac disease, autoimmune disease, HIV infection or AIDS, or blood dyscrasias, with signs of cardiac or renal failure or severe malnutrition), who have epilepsy or any progressive neurological disease or history of Guillain-Barre syndrome.
9. who have a history of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine components.
10. who are known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
11. who are included in study personnel or close family members of personnel conducting this study.
**Healthy Volunteers:** True
**Minimum Age:** 2 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
**Study Population:** Healthy male and female subjects 2 years of age and older
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000016870
- Term: Neisseriaceae Infections
- ID: D000016905
- Term: Gram-Negative Bacterial Infections
- ID: D000001424
- Term: Bacterial Infections
- ID: D000001423
- Term: Bacterial Infections and Mycoses
- ID: D000007239
- Term: Infections
### Condition Browse Module - Browse Branches
- Abbrev: BC01
- Name: Infections
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M11572
- Name: Meningococcal Infections
- Relevance: HIGH
- As Found: Meningococcal Disease
- ID: M10283
- Name: Infections
- Relevance: LOW
- As Found: Unknown
- ID: M6368
- Name: Communicable Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M19218
- Name: Neisseriaceae Infections
- Relevance: LOW
- As Found: Unknown
- ID: M4722
- Name: Bacterial Infections
- Relevance: LOW
- As Found: Unknown
- ID: M19249
- Name: Gram-Negative Bacterial Infections
- Relevance: LOW
- As Found: Unknown
- ID: M12136
- Name: Mycoses
- Relevance: LOW
- As Found: Unknown
- ID: M4721
- Name: Bacterial Infections and Mycoses
- Relevance: LOW
- As Found: Unknown
- ID: T3709
- Name: Meningococcal Infection
- Relevance: HIGH
- As Found: Meningococcal Disease
- ID: T4057
- Name: Neisseria Meningitidis Infection
- Relevance: HIGH
- As Found: Meningococcal Disease
### Condition Browse Module - Meshes
- ID: D000008589
- Term: Meningococcal Infections
### Intervention Browse Module - Ancestors
- ID: D000002400
- Term: Cathartics
- ID: D000005765
- Term: Gastrointestinal Agents
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Gast
- Name: Gastrointestinal Agents
### Intervention Browse Module - Browse Leaves
- ID: M17360
- Name: Vaccines
- Relevance: LOW
- As Found: Unknown
- ID: M239062
- Name: Lactitol
- Relevance: HIGH
- As Found: Cruciate Ligament
- ID: M27664
- Name: Laxatives
- Relevance: LOW
- As Found: Unknown
- ID: M5651
- Name: Cathartics
- Relevance: LOW
- As Found: Unknown
- ID: M8881
- Name: Gastrointestinal Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: C000014635
- Term: Lactitol
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT03088579
**Brief Title:** Intraoperative Brachytherapy for Central Nervous System Lesions: A Validation Study of a Radioactive Seed Loading Device
**Official Title:** Intraoperative Brachytherapy for Central Nervous System Lesions: A Validation Study of a Radioactive Seed Loading Device
#### Organization Study ID Info
**ID:** 13RT022
#### Organization
**Class:** OTHER
**Full Name:** St. Joseph's Hospital and Medical Center, Phoenix
### Status Module
#### Completion Date
**Date:** 2020-08-11
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-04-12
**Type:** ACTUAL
**Last Update Submit Date:** 2023-04-11
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2018-02-28
**Type:** ACTUAL
#### Start Date
**Date:** 2013-04-02
**Type:** ACTUAL
**Status Verified Date:** 2023-03
#### Study First Post Date
**Date:** 2017-03-23
**Type:** ACTUAL
**Study First Submit Date:** 2017-03-01
**Study First Submit QC Date:** 2017-03-16
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** Arizona Commerce Commission, Phoenix AZ
**Class:** INDUSTRY
**Name:** GT Medical Technologies, Inc.
#### Lead Sponsor
**Class:** OTHER
**Name:** St. Joseph's Hospital and Medical Center, Phoenix
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The researchers recognized the possible clinical usefulness of a shielded device or jig to help increase the accuracy but decrease the time of loading the seeds into the biocompatible material used intra-operatively. Therefore, the researchers created a prototype of a device called the GammaTile (GT) loader (design patent pending). The reusable device will be made of surgical quality stainless steel of sufficient thickness (greater than 10 half-value layers (HVL) to provide significant staff and user shielding as well as allowing it to be sterilized. It is utilized intraoperatively but off of the operative field and has no direct patient contact. Currently two sizes are planned. The first will accommodate a 2 inch x 2 inch collagen square and the second will accommodate a 1 inch x 1 inch collagen square. These are the most commonly used sizes of lyophilized collagen used in the Barrow Neurosurgical Institute (BNI) operating rooms (OR).
**Detailed Description:** This is a 100 patient observational-design study for the purpose of testing the seed loader device as a method of arranging and securing the seeds in a carrier in a set pattern for the convenient use of the neurosurgeon against the backdrop of a hodgepodge of currently available techniques (seed in suture, seed in mesh, loose seeds), all of which currently need to be secondarily secured with some additional, not currently standardized material, in a cumbersome, time-consuming, and not assuredly accurate manner. An additional primary objective will be an assessment of the loader device as a radiation protection tool for the user and staff during seed placement in the carrier and prior to intracranial carrier placement. Secondary objectives will be conformality of pre- and post-implant dosimetry (expected vs achieved) and post implant stability (seed shift) over time as judged on a routine follow up MRI. An additional proposed endpoint is an economic (cost) comparison to other modalities.
Eligible patients are those deemed appropriate for and scheduled to undergo adjuvant brachytherapy of the central nervous system as determined by the radiation oncologist and neurosurgeon. Potential candidates will have a lesion(s) that may be newly diagnosed or recurrent, in need of gross total or near gross total resection, and such that in the opinion of the operating surgeon it would be both amenable to and in need of the proposed treatment. Informed consent will be obtained. Radiation oncologist and neurosurgeon will determine appropriateness of the proposed procedure and the radiation oncologist and neurosurgeon will determine the volume and configuration of the area to be implanted.
A carrier using currently available material (lyophilized bovine-derived collagen, Duraform or similar) stocked in the BNI OR. The isotope (seeds) are also already approved for use anywhere in the body, are in use and on the hospital's radioactive materials license (RML). Patients will have pre- and post-operative computerized tomography (CT) or magnetic resonance imaging (MRI) as routine care, and post-operative CT's as per routine implant case dosimetry. All applicable radiation safety procedures will continue to be followed. The sterilizable loader(s) will be provided as a non-charge-item, and are anticipated to be classified as a "Class 1" device by the FDA as they are not implanted and have no direct patient contact.
### Conditions Module
**Conditions:**
- Central Nervous System Lesion
**Keywords:**
- radiation shielding
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 120
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
### Interventions
#### Intervention 1
**Description:** Patients are chosen based on symptomatic tumor/radiographic finding of a surgically accessible mass. Surgery will be done in usual fashion. A cavity will be left where the tumor was. Size of operative bed will be measured using a surgical dissector and standard operating room ruler. A sheet of surgical fabric may be used to estimate size of cavity. If pathology is positive the study treatment will continue. If not, patient will not be on trial. If patient is eligible, radiation oncologist will form custom implants using a seed(s) of Cesium-131, with other biocompatible materials used to achieve maximum dosimetric conformality. Surgeon will place constructs into cavity until the operative bed is fully addressed. Implant is not expected to migrate. Surgicel, bioglue or similar material may be used to secure seeds. Wound will be closed in standard fashion. The last 10 patients will be asked to participate in an effort to gauge costs related to radiation portion of treatment.
**Name:** GammaTile seed loader
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Analyze users' (radiation oncologists and neurosurgeons) experience with the loader methodology by utilizing a standardized questionnaire recording 1) time added to case, 2) the size and size range of implants utilized, 3) conformality to operative bed, and 4) ease of use. Both perceptual (subjective) and numerical (objective) data will be obtained.
**Measure:** User's Experience
**Time Frame:** Immediately post-operatively
**Description:** Evaluate shielding (radiation protection ability) of shielded loader through mRm measurements while seeds are in loader prior to implantation: surface of loader (mRm/hour), at 1 meter (mRm/hour), and at 3 meter (mRm/hour).
**Measure:** Shielding
**Time Frame:** Immediately post-operatively
#### Secondary Outcomes
**Description:** Using Advisory Committee on the Medical Uses of Isotopes (ACMUI) guidelines, analyze the post-implant dosimetry and compare with the pre-plan dosimetry (expected vs achieved dosimetry) both of which are standard procedures for brachytherapy.
**Measure:** Post-Implant Dosimetric Analysis
**Time Frame:** Post-operative Day 1
**Description:** Presence or absence of source (seed) migration on subsequent scans ordered for routine follow-up.
**Measure:** Seed Migration
**Time Frame:** Post-operative Day 1
**Description:** For all study patients obtain sufficiently detailed, global costs for treatment to be able to analyze the overall cost of this modality compared to existing literature data for other forms of adjuvant therapies where available.
**Measure:** Economic Impact
**Time Frame:** Post-Operative Day 1, at follow-up per routine care (up to 5 years)
**Description:** The length of time during and after treatment that the participant lives with the disease but it does not get worse.
**Measure:** Progression Free Survival (PFS)
**Time Frame:** Pre-Operative and at follow-up per routine care (up to 5 year)
**Description:** The length of time from when consent is signed that participants are still alive.
**Measure:** Overall Survival (OS)
**Time Frame:** Pre-Operative and at follow-up per routine care (up to 5 year)
**Description:** Participants ability to carry out activities of daily living will be scored per the following scale:
0 Fully active, able to carry on all predisease activities without restriction (Karnofsky 90-100);
1. Restricted in physically strenuous activity but ambulatory and able to carry work of a light or sedentary nature. For example, light housework, office work (Karnofsky 70-80);
2. Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours (Karnofsky 50-60);
3. Capable of only limited self-care, confined to bed or chair 50% or more of waking hours (Karnofsky 30-40);
4. Completely disabled. Cannot carry on self-care. Totally confined to bed or (Karnofsky 10-20);
5. Death (Karnofsky 0).
**Measure:** Zubrod Performance Scale
**Time Frame:** Pre-Operative, Post-Operative Day 1, at follow-up per routine care (up to 5 years)
**Description:** Participants' neurologic status will be scored per the following scale:
0 No neurologic symptoms - fully active at home/work without assistance;
1. Minor neurologic symptoms - fully active at home/work without assistance;
2. Moderate neurologic symptoms - fully active at home/work but requires assistance;
3. Moderate neurologic symptoms - less than fully active at home/work and requires assistance;
4. Severe neurologic symptoms - totally inactive requiring complete assistance at home or in institution--unable to work.
**Measure:** Neurologic Function Status Scale
**Time Frame:** Pre-Operative, Post-Operative Day 1, at follow-up per routine care (up to 5 years)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Planned for resection of aggressive primary or metastatic brain tumor and appropriate for adjuvant radiotherapy.
* Zubrod Performance Score of 0-2.
* 18 years of age or older.
* Pre-operative stereotactic CT or MRI.
* Life expectancy \>26 weeks.
* History and physical for all patients and detailed neurological exams.
* Signed study-specific informed consent form prior to study entry.
Exclusion Criteria:
* Negative biopsy if presumed diagnosis on imaging.
* External beam therapy is allowed if the implant is being used instead of a boost or cone down treatment.
* Life expectancy \< 26 weeks.
* Inability to undergo post-operative CT for implant assessment, or postoperative follow-up imaging.
* Major medical or psychiatric illness, which, in the investigator's opinion, would prevent completion of treatment and/or interfere with follow-up.
* Inability or refusal to provide informed consent.
* Prior radiation therapy in excess of 100Gy to site of implant.
* Patients in which there is no cranium in place (for example, bone flap removed for infection).
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Adults of either gender having a central nervous system lesion (high grade primary brain tumor and electing intra-operative brachytherapy. Participants will be patients of Barrow Brain and Spine neurosurgery group located in Phoenix AZ.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Phoenix
**Country:** United States
**Facility:** Barrow Brain and Spine
**State:** Arizona
**Zip:** 85013
**Location 2:**
**City:** Phoenix
**Country:** United States
**Facility:** Barrow Neurological Institute at St. Joseph's Hospital and Medical Center
**State:** Arizona
**Zip:** 85013
#### Overall Officials
**Official 1:**
**Affiliation:** Barrow Neurological Institute
**Name:** David G Brachman, MD
**Role:** STUDY_CHAIR
**Official 2:**
**Affiliation:** Barrow Neurological Institute
**Name:** Peter Nakaji, MD
**Role:** STUDY_CHAIR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Pinnaduwage DS, Srivastava SP, Yan X, Jani S, Brachman DG, Sorensen SP. Dosimetric Impacts of Source Migration, Radioisotope Type, and Decay with Permanent Implantable Collagen Tile Brachytherapy for Brain Tumors. Technol Cancer Res Treat. 2022 Jan-Dec;21:15330338221106852. doi: 10.1177/15330338221106852.
**PMID:** 35712977
## Derived Section
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT05903079
**Brief Title:** Impact of the Placebo Effect on the Effects of Trancranial Direct Current Stimulation in Fibromyalgia
**Official Title:** Impact of the Placebo Effect on the Effects of Trancranial Direct Current Stimulation in Fibromyalgia:A Randomized Clinical Trial
#### Organization Study ID Info
**ID:** 20220596
#### Organization
**Class:** OTHER
**Full Name:** Hospital de Clinicas de Porto Alegre
### Status Module
#### Completion Date
**Date:** 2025-01-10
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-06-15
**Type:** ACTUAL
**Last Update Submit Date:** 2023-06-05
**Overall Status:** ACTIVE_NOT_RECRUITING
#### Primary Completion Date
**Date:** 2024-06-10
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-06-05
**Type:** ACTUAL
**Status Verified Date:** 2023-06
#### Study First Post Date
**Date:** 2023-06-15
**Type:** ACTUAL
**Study First Submit Date:** 2023-06-05
**Study First Submit QC Date:** 2023-06-05
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Hospital de Clinicas de Porto Alegre
#### Responsible Party
**Investigator Affiliation:** Hospital de Clinicas de Porto Alegre
**Investigator Full Name:** Wolnei Caumo
**Investigator Title:** Professor, surgery departament
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Fibromyalgia (FM) is a syndrome characterized by generalized musculoskeletal pain, fatigue, non-restorative sleep, cognitive alterations, depressive and neurovegetative symptoms. Conventional pharmacological therapies are known to produce responses with little clinical impact in more than 50% of patients. Functional alterations of the motor cortex and its connections with subcortical structures have also been demonstrated in FM. Based on the above, the objective of this research is to identify subgroups of patients with greater potential for response to treatment with a view to advancing diagnosis and treatment. In this study, the therapeutic target will be transcranial direct current stimulation (tDCS) according to the potential of responsiveness to the placebo effect, with the precise location of the stimulation area by a neuronavigation system, with the objective of counter-regulating the processes dysfunctional factors responsible for triggering and maintaining FM symptoms. Therefore, this clinical trial aims to compare the effectiveness of anodic tDCS applied in the left dorsolateral prefrontal cortex (DLPFC) compared to sham tDCS in FM, according to susceptibility to the placebo effect and serum endorphin levels.
**Detailed Description:** Fibromyalgia (FM) is a chronic disease that affects more than five million people annually in the US. The population prevalence ranges from 2% to 5.4% according to the 2010 American Society of Rheumatology diagnostic criteria. The female: male ratio has changed according to the diagnostic criteria. When applying the 1990 diagnostic criteria (ACR 1990) it is 7:1 and according to the 2010 criteria (ACR 2010) and revised in 2016, this ratio is 2.3:1. Regardless of the variation in prevalence between the sexes, it is a syndrome characterized by generalized musculoskeletal pain, fatigue, non-restorative sleep, cognitive changes, depressive symptoms and other correlates of autonomic dysfunction, such as colon syndrome. irritability and bladder tenesmus. In addition, FM has a level of psychological distress associated with catastrophism and depressive symptoms, which can worsen the prognosis and reinforce disability more markedly than is observed in other chronic pain conditions. FM is the prototype of dysfunction syndromes that course with pain by processes mediated by the central and peripheral nervous system. Patients with FM have been associated with an increased risk of stroke. In fact, it is a syndrome with great social impact, which demands advances in the understanding of diagnostic and therapeutic processes. In this direction, an attempt has been made to identify factors associated with the potential for response to treatment: potential for response to placebo, clinical, psychological, neurophysiological factors, levels of endorphins and neurotrophins associated with clinical response. The quest to understand the effects of these markers aims to personalize therapy and identify factors that can modify the clinical effect of treatments and the organization of neurobiological systems.
Although the results with the use of tDCS have been promising in the treatment of several chronic pain conditions, as demonstrated in a recent meta-analysis conducted by the Pain and Neuromodulation research group at Hospital de Clínicas de Porto Alegre (Zortea et al., 2019). ) it is necessary to consider that expectations about pain can directly affect nociceptive processing. Such expectations contribute to the placebo effect that has been shown to be mediated by opioids. The study by Eippert et al. (2009) showed that naloxone administration reduces the neural and behavioral effects of placebo, as well as placebo-induced responses in several cortical and subcortical areas that constitute the descending pain modulatory system (e.g., rACC, PAG, RVM, and hypothalamus). ). Furthermore, it abolished the rACC-PAG coupling induced by the placebo intervention. The expectation of placebo-induced analgesia is positively correlated with the availability of MOR. On the contrary, negative suggestion reduces the analgesic effects of synthetic opiates. All these findings support the close association between opioids and expectations that drive placebo-mediated analgesia.
Therefore, this clinical trial aims to compare the effectiveness of anodic tDCS applied to the left dorsolateral prefrontal cortex (DLPFC) compared to sham tDCS in FM, according to susceptibility to the placebo effect and serum endorphin levels, in the following results ( 1) treatment efficacy, which includes daily measurements recorded in a Brief Pain Inventory (BPI) application, which allows assessing pain from a multidimensional perspective (pain intensity and interference with general activities, mood, mobility, work, personal relationships, sleep and enjoyment of life, etc.) (primary outcome), the primary outcome will be the Brief Pain Inventory (BPI) score, which assesses pain levels, sleep quality, mood, fatigue, disability, use of analgesics, etc. Secondary outcomes are the impact of pain on quality of life, depressive symptoms. Predictors of the placebo effect will also be evaluated, through the Verbal Numerical Pain Scale (NPS, 0-10) scores in the last week and through the BPI scores, using a multiple hierarchical model. Among potential predictors, there is disability due to pain, psychological profile, drugs in use. In addition to these, the index of inflammatory markers (serum interleukins IL1-, IL-6, IL-10; TNF-alpha and C-reactive protein); serum levels of endorphins, brain-derived neurotrophic factor (BDNF), S-100B protein and the polymorphisms Val66Met of the BDNF gene and Val158Met of the COMT enzyme gene. Will be included 100 women with FM, randomized to receive active (n=50) or sham (n=50) tDCS, aged between 18 and 65 years. Randomization will be stratified according to the placebo effect response potential, determined after a simulated tDCS session. A variation in NPS (0-10) equal to or greater than 30% after a simulated tDCS session will classify them as high responders to the placebo effect. The follow-up time will be four weeks after a single treatment session. In this way, it is intended to produce consistent evidence for the use of this low-cost technique in the treatment of patients of the Unified Health System, which will be directed to patients with chronic pain at the same time, which will provide data to subsidize the feasibility of studying the effect of this complementary therapy in other conditions, such as refractory depression and neurorehabilitation. In addition, to provide data to better understand tDCS response predictors in outcomes that are related to the impact of pain on the quality of life of conditions that generate a lot of suffering and high costs to the health system.
### Conditions Module
**Conditions:**
- Fibromyalgia
**Keywords:**
- Fibromyalgia, tDCS, Placebo effect
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Double-Blind, Randomized, Parallel Group, Sham-Controlled Clinical Trial
##### Masking Info
**Masking:** QUADRUPLE
**Masking Description:** The researcher will receive equipment already programmed by a research assistant, so the researcher who will deliver the tDCS to perform stimulation will not know the programed stimulation. Patients will be instructed to discuss aspects of treatment with the respective investigator. Two independent evaluators who will not participate in the consultations where guidance on the use of tDCS will be provided will be trained to make outcome assessments in follow-up. Patients will not be aware of the type of intervention received, since the sham condition produces a stimulus, but no expected effects. In order to study the level of the blinding, at each moment of evaluation, the patient will be asked about the type of intervention that he / she believes to have received (active or simulated), and about the degree of safety in the response, using a standardized questionnaire. The blinding will be evaluated at the end of each treatment week by means of a standardized instrument.
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 100
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Braço: Comparador de placebo: responde ao efeito placebo Intervenção: 'Estimulação Transcraniana por Corrente Contínua - tDCS
Os pacientes receberão tratamento de estimulação tDCS córtex pré-frontal dorso lateral De acordo com o sistema 10-20 EEG, o ânodo será colocado no F3 esquerdo e o cátodo no F4 contralateral.
A estimulação placebo utiliza uma corrente de 2 miliamperes durante os primeiros minutos, nos 10 min e nos 19 minutos.
**Intervention Names:**
- Device: s-Tdcs
**Label:** Respondres placebo effect
**Type:** PLACEBO_COMPARATOR
#### Arm Group 2
**Description:** Braço: Comparador de placebo: responde ao efeito placebo Intervenção: 'Estimulação Transcraniana por Corrente Contínua - tDCS
Os pacientes receberão tratamento de estimulação tDCS córtex pré-frontal dorso lateral De acordo com o sistema 10-20 EEG, o ânodo será colocado no F3 esquerdo e o cátodo no F4 contralateral.
A estimulação placebo utiliza uma corrente de 2 miliamperes durante os primeiros minutos, nos 10 min e nos 19 minutos
**Intervention Names:**
- Device: s-Tdcs
**Label:** No Respondres placebo effect
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- No Respondres placebo effect
- Respondres placebo effect
**Description:** Intervention: tDCS is a therapeutic method that modulates the membrane potential, where anodic stimuli induce cortical excitability and cathodic stimuli reduce it
**Name:** s-Tdcs
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Change from before and after the First phase of treatment on Pain scores assessed by a Numerical Pain Scale (NPS 0 to 10) (0 means no pain - 10 means the worst pain imaginable)
**Measure:** Change in pain level - first phase
**Time Frame:** Time Frame: 1 month
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Women aged 18 to 65 years; who can read and write, with a confirmed diagnosis of FM according to the American College of Rheumatology criteria (2010-2016). Pain score equal to or greater than six on the Numerical Pain Scale (NPS 0-10) on most days of the last 3 months.
Exclusion Criteria:
* Residing outside the greater Porto Alegre area and pregnancy. Contraindications to TMS and tDCS: metallic implant in the brain; medical devices implanted in the brain, cardiac pacemakers; cochlear implant; history of alcohol or drug abuse in the last 6 months; neurological pathologies; hx of head trauma or neurosurgery; decompensated systemic diseases and chronic inflammatory diseases (lupus, rheumatoid arthritis, Reiter's syndrome); uncompensated hypothyroidism; personal history of cancer, past or undergoing treatment.
**Maximum Age:** 65 Years
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Porto Alegre
**Country:** Brazil
**Facility:** Hospital de Clinicas de Porto Alegre
**State:** Rio Grande Do Sul
**Zip:** 90.450-120
#### Overall Officials
**Official 1:**
**Affiliation:** Hospital de Clinicas de Porto Alegre
**Name:** Wolnei Caumo, PhD
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009135
- Term: Muscular Diseases
- ID: D000009140
- Term: Musculoskeletal Diseases
- ID: D000012216
- Term: Rheumatic Diseases
- ID: D000009468
- Term: Neuromuscular Diseases
- ID: D000009422
- Term: Nervous System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC05
- Name: Musculoskeletal Diseases
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
### Condition Browse Module - Browse Leaves
- ID: M8486
- Name: Fibromyalgia
- Relevance: HIGH
- As Found: Fibromyalgia
- ID: M12161
- Name: Myofascial Pain Syndromes
- Relevance: HIGH
- As Found: Fibromyalgia
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M12092
- Name: Muscular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12097
- Name: Musculoskeletal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15045
- Name: Rheumatic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6323
- Name: Collagen Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12411
- Name: Neuromuscular Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000005356
- Term: Fibromyalgia
- ID: D000009209
- Term: Myofascial Pain Syndromes
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT01610479
**Brief Title:** A Study of TAS-114 in Combination With S-1 in Patients With Advanced Solid Tumors
**Official Title:** A Phase 1 Study of TAS-114 in Combination With S-1 in Patients With Advanced Solid Tumors
#### Organization Study ID Info
**ID:** Taiho10050020
#### Organization
**Class:** INDUSTRY
**Full Name:** Taiho Pharmaceutical Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2017-02
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-08-04
**Type:** ACTUAL
**Last Update Submit Date:** 2017-08-02
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2017-02
**Type:** ACTUAL
#### Start Date
**Date:** 2012-06
**Status Verified Date:** 2017-08
#### Study First Post Date
**Date:** 2012-06-04
**Type:** ESTIMATED
**Study First Submit Date:** 2012-05-25
**Study First Submit QC Date:** 2012-05-30
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Taiho Pharmaceutical Co., Ltd.
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This is a phase 1 study of TAS-114 in combination with S-1 in patients with advanced solid tumors.
**Detailed Description:** This is a phase 1, open-label, non-randomized, dose-escalating safety, tolerability, and pharmacokinetic study of TAS-114 in combination with S-1 in patients with advanced solid tumors.
### Conditions Module
**Conditions:**
- Advanced Solid Tumors
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 120
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** TAS-114 plus S-1
**Intervention Names:**
- Drug: TAS-114 + S-1
**Label:** TAS-114/S-1
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- TAS-114/S-1
**Name:** TAS-114 + S-1
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Measure:** Maximum tolerated dose of TAS-114 when used in combination with S-1
**Time Frame:** 4 years
#### Secondary Outcomes
**Measure:** Pharmacokinetic profiles (peak plasma concentration (Cmax) and area under the plasma concentration versus time curve (AUC) of TAS-114, S-1 components and its metabolite)
**Time Frame:** 4 years
**Measure:** Response rate
**Time Frame:** 4 years
**Measure:** Disease control rate
**Time Frame:** 4 years
**Measure:** Progression free survival
**Time Frame:** 4 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Life expectancy of at least 3 months
* Histological or cytological documentation of advanced solid tumors
* ECOG Performance Status of ≤ 1 (ECOG: Eastern Cooperative Oncology Group)
* Adequate bone marrow, liver and renal function
* Women of childbearing potential and men must agree to use adequate contraception
**Minimum Age:** 20 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Kashiwanoha, Kashiwa-shi
**Country:** Japan
**Facility:** Site 01
**State:** Chiba
**Zip:** 277-8577
### References Module
#### References
**Citation:** Doi T, Yoh K, Shitara K, Takahashi H, Ueno M, Kobayashi S, Morimoto M, Okusaka T, Ueno H, Morizane C, Okano N, Nagashima F, Furuse J. First-in-human phase 1 study of novel dUTPase inhibitor TAS-114 in combination with S-1 in Japanese patients with advanced solid tumors. Invest New Drugs. 2019 Jun;37(3):507-518. doi: 10.1007/s10637-018-0697-3. Epub 2018 Dec 4.
**PMID:** 30511200
## Derived Section
### Condition Browse Module - Meshes
- ID: D000009369
- Term: Neoplasms
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT01113879
**Brief Title:** Exercise as an Adjuvant to Aphasia Therapy
**Official Title:** Exercise as an Adjuvant to Aphasia Therapy
#### Organization Study ID Info
**ID:** C7175-M
#### Organization
**Class:** FED
**Full Name:** VA Office of Research and Development
### Status Module
#### Completion Date
**Date:** 2012-08
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-07-22
**Type:** ACTUAL
**Last Update Submit Date:** 2019-05-03
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2012-07
**Type:** ACTUAL
#### Results First Post Date
**Date:** 2019-07-22
**Type:** ACTUAL
**Results First Submit Date:** 2019-05-03
**Results First Submit QC Date:** 2019-05-03
#### Start Date
**Date:** 2009-07
**Type:** ACTUAL
**Status Verified Date:** 2019-05
#### Study First Post Date
**Date:** 2010-04-30
**Type:** ESTIMATED
**Study First Submit Date:** 2010-04-28
**Study First Submit QC Date:** 2010-04-28
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Brooks Rehabilitation
#### Lead Sponsor
**Class:** FED
**Name:** VA Office of Research and Development
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The purpose of the study is to reveal if individuals who participate in aerobic activity demonstrate greater improvement in language abilities than patients who do not participate in aerobic activity.
**Detailed Description:** The objective of this research project is to reveal if individuals who participate in aerobic activity demonstrate greater improvement in language abilities with treatment than patients who do not participate in aerobic activity. As secondary objectives, we will determine if there is a direct relationship between either brain efficiency or increases in Brain Derived Neurotrophic Factor (BDNF) after exercise and higher learning rates in aphasia.
### Conditions Module
**Conditions:**
- Aphasia
**Keywords:**
- rehabilitation
- aphasia
- exercise
- BDNF
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** The study used a single-subject, multiple-baseline design across behaviors. Following assessment and baseline procedures, participants completed 2 therapy periods: Block 1 was aphasia therapy alone, and Block 2 was aphasia therapy plus aerobic exercise or stretching.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 9
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Aphasia therapy for anomia: The treatment is a traditional lexical/semantic stimulation approach during which subjects will attempt to name drawings of objects.
Aerobic exercise: An aerobic exercise intervention will target cardiorespiratory fitness by progressing from 50-70% of the participants' maximum heart rate.
**Intervention Names:**
- Behavioral: Aerobic exercise
**Label:** Aphasia therapy with an exercise adjuvant
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Aphasia therapy for anomia: The treatment is a traditional lexical/semantic stimulation approach during which subjects will attempt to name drawings of objects.
Stretching: Stretching will occur for 50 minutes a day, three days/week for 12 weeks.
**Intervention Names:**
- Behavioral: Stretching
**Label:** Aphasia therapy with a stretching adjuvant
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Aphasia therapy with an exercise adjuvant
**Description:** An aerobic exercise intervention will target cardiorespiratory fitness by progressing from 50-70% of the participants' maximum heart rate.
**Name:** Aerobic exercise
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- Aphasia therapy with a stretching adjuvant
**Description:** Stretching will occur for 50 minutes a day, three days/week for 12 weeks.
**Name:** Stretching
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** Tau-U effect sizes of \<0.20 were considered small; 0.20 to \<0.60 moderate; 0.60 to \<0.80 large, and \>=0.80 very large. Weighted Tau-U averages in exercise participants and stretching participants were calculated in each block using an online web-based calculator (http://www.singleresearch.org/calculators/tau-u). In the present analysis, any baseline trends over 0.10 were adjusted.
**Measure:** Change in Picture Naming Abilities as Measured by Tau U Effect Size Weighted Means
**Time Frame:** administered before and after each of two, two week aphasia therapy blocks
#### Secondary Outcomes
**Description:** The baseline BDNF levels in participants (ie, the 2 measures prior to the exercise or stretching interventions) showed a great deal of intraparticipant variation. Hence, in an attempt to minimize the intraparticipant variability, we calculated the mean values from samples 1 and 2 to obtain a baseline BDNF measure, samples 3 and 4 to obtain a BDNF measure in the first 6 weeks of aerobic exercise or stretching, and samples 5 and 6 to obtain a measure in the last 6 weeks of the exercise or stretching intervention.
**Measure:** Change in Serum Brain-derived Neurotrophic Factor (BDNF) Levels With Exercise
**Time Frame:** six samples collected over a 16 week period
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Post-stroke aphasia
* at least 6 months post-stroke
* at least minimally intact auditory verbal comprehension
* pre-morbidly right handed
* native English speaker
Exclusion Criteria:
* contraindications for fMRI (metal implants, claustrophobia)
* inability to pass an exercise tolerance test
* significant depression
* uncorrected hearing or vision problems
* severe apraxia of speech
* regularly perform 20 minutes of cardiovascular exercise 3 times per week
**Maximum Age:** 95 Years
**Minimum Age:** 20 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Gainesville
**Country:** United States
**Facility:** North Florida/South Georgia Veterans Health System
**State:** Florida
**Zip:** 32608
**Location 2:**
**City:** Jacksonville
**Country:** United States
**Facility:** Brooks Rehabilitation Clinical Research Center
**State:** Florida
**Zip:** 32216
#### Overall Officials
**Official 1:**
**Affiliation:** North Florida/South Georgia Veterans Health System
**Name:** Stacy M. Harnish, PhD CCC/SLP
**Role:** PRINCIPAL_INVESTIGATOR
### References Module
#### References
**Citation:** Harnish SM, Rodriguez AD, Blackett DS, Gregory C, Seeds L, Boatright JH, Crosson B. Aerobic Exercise as an Adjuvant to Aphasia Therapy: Theory, Preliminary Findings, and Future Directions. Clin Ther. 2018 Jan;40(1):35-48.e6. doi: 10.1016/j.clinthera.2017.12.002. Epub 2017 Dec 23.
**PMID:** 29277374
#### See Also Links
**Label:** Click here for more information about this study: Exercise as an Adjuvant to Aphasia Therapy
**URL:** http://www.brrc.research.va.gov
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000013064
- Term: Speech Disorders
- ID: D000007806
- Term: Language Disorders
- ID: D000003147
- Term: Communication Disorders
- ID: D000019954
- Term: Neurobehavioral Manifestations
- ID: D000009461
- Term: Neurologic Manifestations
- ID: D000009422
- Term: Nervous System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
### Condition Browse Module - Browse Leaves
- ID: M4352
- Name: Aphasia
- Relevance: HIGH
- As Found: Aphasia
- ID: M15864
- Name: Speech Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M10823
- Name: Language Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M6374
- Name: Communication Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M21826
- Name: Neurobehavioral Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001037
- Term: Aphasia
### Misc Info Module
- Version Holder: 2024-05-24
## Results Section
### Adverse Events Module
#### Event Groups
**Group ID:** EG000
**Title:** Aphasia Therapy With an Exercise Adjuvant
**Deaths Num At Risk:** 5
**Description:** Aphasia therapy for anomia: The treatment is a traditional lexical/semantic stimulation approach during which subjects will attempt to name drawings of objects.
Aerobic exercise: An aerobic exercise intervention will target cardiorespiratory fitness by progressing from 50-70% of the participants' maximum heart rate.
**ID:** EG000
**Other Num at Risk:** 5
**Serious Number At Risk:** 5
**Title:** Aphasia Therapy With an Exercise Adjuvant
**Group ID:** EG001
**Title:** Aphasia Therapy With a Stretching Adjuvant
**Deaths Num At Risk:** 2
**Description:** Aphasia therapy for anomia: The treatment is a traditional lexical/semantic stimulation approach during which subjects will attempt to name drawings of objects.
Stretching: Stretching will occur for 50 minutes a day, three days/week for 12 weeks.
**ID:** EG001
**Other Num at Risk:** 2
**Serious Number At Risk:** 2
**Title:** Aphasia Therapy With a Stretching Adjuvant
**Frequency Threshold:** 0
## Results Section - Baseline Characteristics Module
### Denomination Counts
**Group ID:** BG000
**Value:** 7
**Group ID:** BG001
**Value:** 2
**Group ID:** BG002
**Value:** 9
**Units:** Participants
### Group
**ID:** BG000
**Title:** Aphasia Therapy With an Exercise Adjuvant
**Description:** Aphasia therapy for anomia: The treatment is a traditional lexical/semantic stimulation approach during which subjects will attempt to name drawings of objects.
Aerobic exercise: An aerobic exercise intervention will target cardiorespiratory fitness by progressing from 50-70% of the participants' maximum heart rate.
### Group
**ID:** BG001
**Title:** Aphasia Therapy With a Stretching Adjuvant
**Description:** Aphasia therapy for anomia: The treatment is a traditional lexical/semantic stimulation approach during which subjects will attempt to name drawings of objects.
Stretching: Stretching will occur for 50 minutes a day, three days/week for 12 weeks.
### Group
**ID:** BG002
**Title:** Total
**Description:** Total of all reporting groups
### Measure
#### Measurement
**Group ID:** BG000
**Value:** 0
#### Measurement
**Group ID:** BG001
**Value:** 0
#### Measurement
**Group ID:** BG002
**Value:** 0
**Category Title:** <=18 years
#### Measurement
**Group ID:** BG000
**Value:** 6
#### Measurement
**Group ID:** BG001
**Value:** 2
#### Measurement
**Group ID:** BG002
**Value:** 8
**Category Title:** Between 18 and 65 years
#### Measurement
**Group ID:** BG000
**Value:** 1
#### Measurement
**Group ID:** BG001
**Value:** 0
#### Measurement
**Group ID:** BG002
**Value:** 1
**Category Title:** >=65 years
**Class Title:**
### Measure
#### Measurement
**Group ID:** BG000
**Spread:** 12.5
**Value:** 63.2
#### Measurement
**Group ID:** BG001
**Spread:** 10.6
**Value:** 44.5
#### Measurement
**Group ID:** BG002
**Spread:** 14.4
**Value:** 57.9
**Class Title:**
### Measure
#### Measurement
**Group ID:** BG000
**Value:** 3
#### Measurement
**Group ID:** BG001
**Value:** 2
#### Measurement
**Group ID:** BG002
**Value:** 5
**Category Title:** Female
#### Measurement
**Group ID:** BG000
**Value:** 4
#### Measurement
**Group ID:** BG001
**Value:** 0
#### Measurement
**Group ID:** BG002
**Value:** 4
**Category Title:** Male
**Class Title:**
### Measure
#### Measurement
**Group ID:** BG000
**Value:** 7
#### Measurement
**Group ID:** BG001
**Value:** 2
#### Measurement
**Group ID:** BG002
**Value:** 9
**Class Title:** United States
### Measure
#### Measurement
**Group ID:** BG000
**Lower Limit:** 10
**Upper Limit:** 43
**Value:** 20.6
#### Measurement
**Group ID:** BG001
**Lower Limit:** 4
**Upper Limit:** 39
**Value:** 21.5
#### Measurement
**Group ID:** BG002
**Lower Limit:** 4
**Upper Limit:** 43
**Value:** 20.9
**Class Title:**
### Measure
#### Measurement
**Group ID:** BG000
**Lower Limit:** 43.5
**Upper Limit:** 80.7
**Value:** 58.6
#### Measurement
**Group ID:** BG001
**Lower Limit:** 35.8
**Upper Limit:** 84.4
**Value:** 60.1
#### Measurement
**Group ID:** BG002
**Lower Limit:** 35.8
**Upper Limit:** 80.7
**Value:** 59
**Class Title:**
**Denomination Units Selected:**
## Results Section - Baseline Characteristics Module
### Measure 1
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Age, Categorical
**Unit of Measure:** Participants
### Measure 2
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Region of Enrollment
**Unit of Measure:** Participants
### Measure 5
**Description:** The Boston Naming Test measures picture naming abilities. The range is 0-60 with higher scores corresponding with better naming abilities.
**Dispersion Type:** FULL_RANGE
**Parameter Type:** MEAN
**Title:** Boston Naming Test
**Unit of Measure:** units on a scale
### Measure 6
**Description:** The Western Aphasia Battery Aphasia Quotient range is 0-100 with higher scores demonstrating better language abilities. A score of less than 93.8 is the clinical cutoff for the diagnosis of aphasia.
**Dispersion Type:** FULL_RANGE
**Parameter Type:** MEAN
**Title:** Western Aphasia Battery
**Unit of Measure:** units on a scale
## Results Section - More Information Module
### Certain Agreement
### Point of Contact
**Email:** [email protected]
**Organization:** The Ohio State University
**Phone:** 614-688-1471
**Title:** Stacy Harnish
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:**
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 85
**CI Upper Limit:**
**CI Upper Limit Comment:**
**Dispersion Type:**
**Dispersion Value:**
**Estimate Comment:**
**Group Description:** Weighted Tau U effect size mean values in Block 1 of treatment (no aerobic exercise or stretching) were compared to weighted Tau U mean values in Block 2 of treatment (aerobic exercise or stretching adjuvant).
**Non-Inferiority Comment:**
**Non-Inferiority Type:** OTHER
**Other Analysis Description:**
**P-Value:** < 0.001
**P-Value Comment:**
**Parameter Type:**
**Parameter Value:**
**Statistical Comment:**
**Statistical Method:** Weighted Tau U
**Tested Non-Inferiority:**
### Outcome Measure 2
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:** 0.67
- **Spread:**
- **Upper Limit:** 1.00
- **Value:** 0.83
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:** 0.49
- **Spread:**
- **Upper Limit:** 1.00
- **Value:** 0.75
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:** 0.71
- **Spread:**
- **Upper Limit:** 1.00
- **Value:** 0.88
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:** 0.50
- **Spread:**
- **Upper Limit:** 1.00
- **Value:** 0.77
**Title:**
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 0
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 1
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 4
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 0
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 4
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 0
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 0
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 1
**Title:**
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Tau-U effect sizes of \<0.20 were considered small; 0.20 to \<0.60 moderate; 0.60 to \<0.80 large, and \>=0.80 very large. Weighted Tau-U averages in exercise participants and stretching participants were calculated in each block using an online web-based calculator (http://www.singleresearch.org/calculators/tau-u). In the present analysis, any baseline trends over 0.10 were adjusted.
**Dispersion Type:** 80% Confidence Interval
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** administered before and after each of two, two week aphasia therapy blocks
**Title:** Change in Picture Naming Abilities as Measured by Tau U Effect Size Weighted Means
**Type:** PRIMARY
**Unit of Measure:** Tau U effect size weighted mean
##### Group
**Description:** Aerobic exercise: An aerobic exercise intervention will target cardiorespiratory fitness by progressing from 50-70% of the participants' maximum heart rate.
**ID:** OG000
**Title:** Aphasia Therapy With an Exercise Adjuvant
##### Group
**Description:** Stretching: Stretching will occur for 50 minutes a day, three days/week for 12 weeks.
**ID:** OG001
**Title:** Aphasia Therapy With a Stretching Adjuvant
#### Outcome Measure 2
**Description:** The baseline BDNF levels in participants (ie, the 2 measures prior to the exercise or stretching interventions) showed a great deal of intraparticipant variation. Hence, in an attempt to minimize the intraparticipant variability, we calculated the mean values from samples 1 and 2 to obtain a baseline BDNF measure, samples 3 and 4 to obtain a BDNF measure in the first 6 weeks of aerobic exercise or stretching, and samples 5 and 6 to obtain a measure in the last 6 weeks of the exercise or stretching intervention.
**Parameter Type:** NUMBER
**Population Description:** Complete BDNF datasets from 5 of the 7 participants who completed the study were available. BDNF data from the remaining two participants were not collected due to the PI and study team moving locations and no longer having access to the facilities.
**Reporting Status:** POSTED
**Time Frame:** six samples collected over a 16 week period
**Title:** Change in Serum Brain-derived Neurotrophic Factor (BDNF) Levels With Exercise
**Type:** SECONDARY
**Unit of Measure:** participants
##### Group
**Description:** Aphasia therapy for anomia: The treatment is a traditional lexical/semantic stimulation approach during which subjects will attempt to name drawings of objects.
Aerobic exercise: An aerobic exercise intervention will target cardiorespiratory fitness by progressing from 50-70% of the participants' maximum heart rate.
**ID:** OG000
**Title:** Aphasia Therapy With an Exercise Adjuvant
##### Group
**Description:** Aphasia therapy for anomia: The treatment is a traditional lexical/semantic stimulation approach during which subjects will attempt to name drawings of objects.
Stretching: Stretching will occur for 50 minutes a day, three days/week for 12 weeks.
**ID:** OG001
**Title:** Aphasia Therapy With a Stretching Adjuvant
### Participant Flow Module
#### Group
**Description:** Aphasia therapy for anomia: The treatment is a traditional lexical/semantic stimulation approach during which subjects will attempt to name drawings of objects.
Aerobic exercise: An aerobic exercise intervention will target cardiorespiratory fitness by progressing from 50-70% of the participants' maximum heart rate.
Following assessment and baseline procedures, participants completed 2 therapy periods: Block 1 was aphasia therapy alone, and Block 2 was aphasia therapy plus an aerobic exercise or stretching adjuvant.
**ID:** FG000
**Title:** Aphasia Therapy Alone, Then With Exercise
#### Group
**Description:** Aphasia therapy for anomia: The treatment is a traditional lexical/semantic stimulation approach during which subjects will attempt to name drawings of objects.
Stretching: Stretching will occur for 50 minutes a day, three days/week for 12 weeks.
**ID:** FG001
**Title:** Aphasia Therapy Alone, Then With Stretching
#### Period
**Title:** Period 1: Block 1
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 7
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 2
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 5
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 2
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 2
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
#### Period
**Title:** Period 2: Block 2
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 5
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 2
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 5
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 2
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
**Has Results:** True |
## Protocol Section
### Identification Module
**NCT ID:** NCT00141479
**Brief Title:** To Evaluate the Impact of Treatment Interruption on Re-initiation of Bifeprunox
**Official Title:** A Single-center Safety and Tolerability Study to Evaluate the Impact of Treatment Interruption on Re-initiation of Bifeprunox in Subjects With Schizophrenia or Schizoaffective Disorder
#### Organization Study ID Info
**ID:** S154.2.013
#### Organization
**Class:** INDUSTRY
**Full Name:** Solvay Pharmaceuticals
### Status Module
#### Completion Date
**Date:** 2006-11
**Type:** ACTUAL
#### Last Update Post Date
**Date:** 2015-01-16
**Type:** ESTIMATED
**Last Update Submit Date:** 2015-01-15
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2006-11
**Type:** ACTUAL
#### Start Date
**Date:** 2005-05
**Status Verified Date:** 2006-05
#### Study First Post Date
**Date:** 2005-09-01
**Type:** ESTIMATED
**Study First Submit Date:** 2005-08-30
**Study First Submit QC Date:** 2005-08-30
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** H. Lundbeck A/S
**Class:** INDUSTRY
**Name:** Wyeth is now a wholly owned subsidiary of Pfizer
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Solvay Pharmaceuticals
### Description Module
**Brief Summary:** The purpose of this study is to investigate a safe treatment interruption interval(s) for re-initiation of bifeprunox at a therapeutic dose. The study duration is approximately 7 to 10 weeks.
### Conditions Module
**Conditions:**
- Schizophrenia
- Schizoaffective Disorder
**Keywords:**
- Treatment interruption on reinitiation
- Schizophrenia
- Schizoaffective disorder
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** DOUBLE
**Primary Purpose:** TREATMENT
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
### Interventions
#### Intervention 1
**Name:** Bifeprunox
**Type:** DRUG
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Diagnosis of Schizophrenia or Schizoaffective disorder
* 18-55 years
Exclusion Criteria:
* Subjects who are acutely psychotic
* Subjects with current Axis I primary psychiatric diagnosis other than schizophrenia
* Subjects at significant risk of suicide
* Subjects with a seizure disorder
**Maximum Age:** 55 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Wichita
**Country:** United States
**Facility:** Site 1
**State:** Kansas
#### Overall Officials
**Official 1:**
**Affiliation:** Solvay Pharmaceuticals
**Name:** Global Clinical Director Solvay
**Role:** STUDY_DIRECTOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000019967
- Term: Schizophrenia Spectrum and Other Psychotic Disorders
- ID: D000001523
- Term: Mental Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M15376
- Name: Schizophrenia
- Relevance: HIGH
- As Found: Schizophrenia
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: HIGH
- As Found: Schizoaffective Disorder
- ID: M21838
- Name: Schizophrenia Spectrum and Other Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000012559
- Term: Schizophrenia
- ID: D000011618
- Term: Psychotic Disorders
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT05500079
**Brief Title:** Transctunaous Pulsed Radiofrequency Therapy in Carpal Tunnel Syndrome
**Official Title:** Efficacy of Transctunaous Pulsed Radiofrequency Therapy in Carpal Tunnel Syndrome
#### Organization Study ID Info
**ID:** Carpal Tunnel Syndrome
#### Organization
**Class:** OTHER
**Full Name:** Diskapi Teaching and Research Hospital
### Status Module
#### Completion Date
**Date:** 2023-06-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-05-16
**Type:** ACTUAL
**Last Update Submit Date:** 2023-05-15
**Overall Status:** ACTIVE_NOT_RECRUITING
#### Primary Completion Date
**Date:** 2023-05-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2021-08-01
**Type:** ACTUAL
**Status Verified Date:** 2023-05
#### Study First Post Date
**Date:** 2022-08-12
**Type:** ACTUAL
**Study First Submit Date:** 2022-08-11
**Study First Submit QC Date:** 2022-08-11
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Diskapi Teaching and Research Hospital
#### Responsible Party
**Investigator Affiliation:** Diskapi Teaching and Research Hospital
**Investigator Full Name:** Damla Yürük
**Investigator Title:** Director, medical doctor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The aim of this study is to examine the effect of transcutaneous pulsed radiofrequency current in the treatment of carpal tunnel syndrome.
**Detailed Description:** Carpal tunnel syndrome (CTS) is the most common peripheral neuropathy. Wrist splint is the first-line treatment option for CTS. Pulsed radiofrequency therapy is used in the treatment of chronic pain.
60 carpal tunnel syndrome patients diagnosed with electroneuromyelography will be included in the study. 30 patients will wear wrist splints for 1 month. In the other 30 patients, pulsed radiofrequency current will be given through the wrist median nerve trace. RF current will be applied through transcutaneous pads. It will be applied once a week for a total of 2 sessions, 8 minutes each. Boston carpal tunnel syndrome questionnaire with visual analog scale (VAS) will be applied to all patients before and after the treatment at 1 week and 1 month.
Our aim is to compare the effectiveness of wrist splint and pulsed rf therapy.
### Conditions Module
**Conditions:**
- Peripheral Neuropathy
- Chronic Pain
**Keywords:**
- carpal tunnel syndrome
- pulsed radiofrequency treatment
- transcutaneous pulsed radiofrequency
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** QUADRUPLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The group to be treated with a wrist splint
**Intervention Names:**
- Device: Wrist splint
**Label:** Wrist splint group
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** The group to be treated with transcutaneous pulsed RF
**Intervention Names:**
- Other: Pulsed radiofrequency current
**Label:** Transcutaneous pulsed RF group
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Wrist splint group
**Description:** A wrist splint is a It stabilizes your wrist. Wearing a wrist splint minimizes pressure on the median nerve.
**Name:** Wrist splint
**Type:** DEVICE
#### Intervention 2
**Arm Group Labels:**
- Transcutaneous pulsed RF group
**Description:** Pulsed rf current is delivered to the median nerve trace via transcutaneous pads. Pain expression is suppressed in the dorsal horn of the spinal cord.
**Name:** Pulsed radiofrequency current
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "0=no pain" and "10=worst pain.
**Measure:** Change From Baseline in Pain on the Visual Analog Scale (VAS) at Week 2 and 4
**Time Frame:** Baseline, Week 2 and 4
**Description:** The Boston Carpal Tunnel Questionnaire (BCTQ) is a disease-specific measure of self-reported symptom severity and functional status. It is frequently used in the reporting of outcomes from trials into interventions for carpal tunnel syndrome.
ıncluding Symptom Severity Scale is 11: no symptoms, 55: worst symptoms and Functional Disability Scale (FDS) no difficulties:8, worst difficulties: 40
**Measure:** Boston Carpal Tunnel Syndrome Questionnaire before treatment
**Time Frame:** Before treatment
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Carpal tunnel syndrome detected by electroneuromyography
* Positive Tinel sign
Exclusion Criteria:
* Thenar muscle atrophy
* Weakness in the abductor pollicis brevis muscle
**Maximum Age:** 65 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Ankara
**Country:** Turkey
**Facility:** Diskapi Yildirim Beyazıt Teaching and Research Hospital
**State:** Dişkapi
#### Overall Officials
**Official 1:**
**Affiliation:** Diskapi TRH
**Name:** mehlika panpallı ateş
**Role:** STUDY_CHAIR
**Official 2:**
**Affiliation:** Diskapi TRH
**Name:** ömer taylan akkaya
**Role:** STUDY_DIRECTOR
**Official 3:**
**Affiliation:** Diskapi TRH
**Name:** Hüseyin Alp Alptekin
**Role:** STUDY_CHAIR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010146
- Term: Pain
- ID: D000009461
- Term: Neurologic Manifestations
- ID: D000009468
- Term: Neuromuscular Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000020423
- Term: Median Neuropathy
- ID: D000020422
- Term: Mononeuropathies
- ID: D000009408
- Term: Nerve Compression Syndromes
- ID: D000012090
- Term: Cumulative Trauma Disorders
- ID: D000013180
- Term: Sprains and Strains
- ID: D000014947
- Term: Wounds and Injuries
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: BC16
- Name: Diseases and Abnormalities at or Before Birth
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M29442
- Name: Chronic Pain
- Relevance: HIGH
- As Found: Chronic Pain
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M13432
- Name: Peripheral Nervous System Diseases
- Relevance: HIGH
- As Found: Peripheral Neuropathy
- ID: M5603
- Name: Carpal Tunnel Syndrome
- Relevance: HIGH
- As Found: Carpal Tunnel Syndrome
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: M12411
- Name: Neuromuscular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M22219
- Name: Median Neuropathy
- Relevance: LOW
- As Found: Unknown
- ID: M22218
- Name: Mononeuropathies
- Relevance: LOW
- As Found: Unknown
- ID: M12352
- Name: Nerve Compression Syndromes
- Relevance: LOW
- As Found: Unknown
- ID: M5853
- Name: Charcot-Marie-Tooth Disease
- Relevance: LOW
- As Found: Unknown
- ID: M18092
- Name: Hereditary Sensory and Motor Neuropathy
- Relevance: LOW
- As Found: Unknown
- ID: M17685
- Name: Wounds and Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M14930
- Name: Cumulative Trauma Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M15974
- Name: Sprains and Strains
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
- ID: T1081
- Name: Charcot-Marie-Tooth Disease
- Relevance: LOW
- As Found: Unknown
- ID: T2761
- Name: Hereditary Motor and Sensory Neuropathy
- Relevance: LOW
- As Found: Unknown
- ID: T2766
- Name: Hereditary Neuropathy With Liability to Pressure Palsies
- Relevance: LOW
- As Found: Unknown
- ID: T5067
- Name: Roussy Levy Syndrome
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000010523
- Term: Peripheral Nervous System Diseases
- ID: D000002349
- Term: Carpal Tunnel Syndrome
- ID: D000059350
- Term: Chronic Pain
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT05099679
**Brief Title:** Pilot Study for Black Men With Prostate Cancer: Optimization Of Mental and Heart Health, the BOOM-Heart Study
**Official Title:** A Pilot Study for Optimizing Mental Wellbeing and Heart Health for Black Patients With Prostate Cancer
#### Organization Study ID Info
**ID:** IRB-60375
#### Organization
**Class:** OTHER
**Full Name:** Stanford University
#### Secondary ID Infos
**Domain:** Stanford
**ID:** PROS0109
**Type:** OTHER
**Domain:** Clinical Trials Reporting Program
**ID:** NCI-2022-02832
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2024-11
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-01-10
**Type:** ACTUAL
**Last Update Submit Date:** 2024-01-08
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-11
**Type:** ESTIMATED
#### Start Date
**Date:** 2021-11-18
**Type:** ACTUAL
**Status Verified Date:** 2024-01
#### Study First Post Date
**Date:** 2021-10-29
**Type:** ACTUAL
**Study First Submit Date:** 2021-10-11
**Study First Submit QC Date:** 2021-10-27
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Stanford University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Pilot study to determine the feasibility of providing psychosocial and cardiac rehabilitation services to address socioeconomic health disparities and improve wellbeing for black men with prostate cancer.
**Detailed Description:** Subjects will see an oncology Associate Clinical Social Worker at Stanford's Cancer Center for a two hour psychosocial assessment. Subsequently participants will complete the psychosocial intake support session and elective additional counseling sessions (Part A) at the end of up to 8 counseling sessions (maximum sessions possible) or 20 weeks (+/- 4 weeks), whichever comes first. For participants who continue onto cardiac services (Part B), the participant will complete the cardiac rehabilitation exercise program within 12 weeks (+/- 2 weeks) of the first day of exercise start. The end of study will occur after the last cardiac rehabilitation exercise session (+ 2 weeks).
### Conditions Module
**Conditions:**
- Prostate Cancer
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 30
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Cognitive Behavioral Therapy + Cardiac Rehab
**Intervention Names:**
- Behavioral: Cognitive behavioral therapy (supportive counseling)
- Behavioral: Virtual Cardiac Rehabilitation
**Label:** Psychosocial intervention + Cardiac Rehab Services
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Psychosocial intervention + Cardiac Rehab Services
**Description:** Patients will complete a psychosocial intake that generally takes up to 2 hours, but the time required for the intake varies per patient. Subsequently they will be offered up to 7 optional counseling sessions with a clinical social worker
**Name:** Cognitive behavioral therapy (supportive counseling)
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- Psychosocial intervention + Cardiac Rehab Services
**Description:** If eligible, patients will be referred to Movn Health Virtual Cardiac Rehabilitation to provide approximately 3 exercise sessions per week, with approximately eight coaching sessions over a 12 week period
**Name:** Virtual Cardiac Rehabilitation
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** Proportion of screened eligible participants who complete the initial 2-hour psychosocial support session intake.
The pilot study is considered feasible if the primary endpoint is met in at least 50% of patients. We will evaluate the 95% CI of the feasibility rate.
**Measure:** Proportion of Completers
**Time Frame:** 12 weeks
#### Secondary Outcomes
**Measure:** Difference in Patient Health Questionnaire-9 (PHQ-9)
**Time Frame:** 12 weeks
**Measure:** Difference of General Anxiety Disorder-7 (GAD-7) score
**Time Frame:** 12 weeks
**Measure:** Difference of Functional Assessment of Cancer Therapy-Prostate (FACT-P) score
**Time Frame:** 12 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria for Part A (Mental Health Services)
* Self-Identify as Black and/or African American.
* Diagnosed with prostate cancer currently or any time in the past (per medical history; pathology not required, active prostate cancer at time of enrollment is not required).
* Males \>= age 18.
* All participants must have a life expectancy of \> 6 months.
* Participants must have the ability to understand and the willingness to sign a written informed consent document in English, and the willingness/ability to comply with the protocol activities.
* Ability to wear a face mask during all in-person sessions (when required).
Participants must complete the psychosocial intake (Part A, Visit A1) in order to enroll in a cardiac rehabilitation program (Part B).
Additional Inclusion Criteria for Part B (Cardiac Services)
* Have completed the psychosocial intake portion of Visit A1 (as documented by clinical social worker).
* Meets at least one of the following (\[a\] or \[b\]):
1. planning to receive androgen deprivation on Day 1, or is currently, or was formerly, on androgen deprivation therapy. It is acceptable for participant to switch/transition to another form of androgen deprivation therapy while in the study. Participant may be receiving or planning to receive additional systemic therapy concurrent with androgen deprivation.
\^ treatment with single agent testosterone-blocking agents (such as, but not limited to bicalutamide) will also be eligible
OR
2. patients with a cardiac risk factor may enroll. Cardiac risk factors include, but are not restricted to: pre-hypertension, hypertension, metabolic syndrome, tobacco history, coronary artery disease, CVA/TIA, peripheral vascular disease, obesity, hypercholesterolemia, hyperglycemia, heart failure, or any other cardiac condition based on the discretion of the investigators.
* Participants must have an ECOG Performance Status of \<= 2 or at the investigator's discretion, will have the ability to participate in a cardiac rehab program.
* Participants must be able and willing to follow the cardiac rehabilitation activities.
* Participant must have a smartphone or tablet to use for the cardiac rehabilitation app.
Exclusion Criterion for Part A (Mental Health Services)
\* Actively engaging in self harm, or currently on a 5150 or 5250.
Exclusion Criteria for Part B (Cardiac Services)
* Uncontrolled angina, active acute coronary syndrome (e.g., unstable angina or acute MI) or poorly controlled arrhythmias.
* In the opinion of the Principal Investigator, have a clinically significant comorbid disease that is likely to affect the ability of the patient to complete the trial, interfere with their ability with measurement of self-reported outcomes.
**Gender Based:** True
**Gender Description:** Self-Identify as Black and/or African American
**Minimum Age:** 18 Years
**Sex:** MALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Sneha Mohile
**Phone:** (650) 725-5459
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Palo Alto
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Sneha Mohile
- **Role:** CONTACT
***Contact 2:***
- **Name:** Alice C Fan, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Stanford University
**State:** California
**Status:** RECRUITING
**Zip:** 94305
#### Overall Officials
**Official 1:**
**Affiliation:** Stanford University
**Name:** Alice Fan, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000005834
- Term: Genital Neoplasms, Male
- ID: D000014565
- Term: Urogenital Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000005832
- Term: Genital Diseases, Male
- ID: D000091662
- Term: Genital Diseases
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000011469
- Term: Prostatic Diseases
- ID: D000052801
- Term: Male Urogenital Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M14335
- Name: Prostatic Neoplasms
- Relevance: HIGH
- As Found: Prostate Cancer
- ID: M8946
- Name: Genital Neoplasms, Male
- Relevance: LOW
- As Found: Unknown
- ID: M17315
- Name: Urogenital Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M2876
- Name: Genital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8944
- Name: Genital Diseases, Male
- Relevance: LOW
- As Found: Unknown
- ID: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14333
- Name: Prostatic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27095
- Name: Male Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000011471
- Term: Prostatic Neoplasms
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT02095379
**Brief Title:** Oligosecretary Myeloma: Prevalence and Its Clinical Significance
**Official Title:** Oligosecretary Myeloma: Prevalence and Its Clinical Significance
#### Organization Study ID Info
**ID:** 2014-02-055
#### Organization
**Class:** OTHER
**Full Name:** Samsung Medical Center
### Status Module
#### Completion Date
**Date:** 2014-02
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2014-03-24
**Type:** ESTIMATED
**Last Update Submit Date:** 2014-03-20
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2013-12
**Type:** ACTUAL
#### Start Date
**Date:** 2013-10
**Status Verified Date:** 2014-03
#### Study First Post Date
**Date:** 2014-03-24
**Type:** ESTIMATED
**Study First Submit Date:** 2014-02-13
**Study First Submit QC Date:** 2014-03-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Samsung Medical Center
#### Responsible Party
**Investigator Affiliation:** Samsung Medical Center
**Investigator Full Name:** Kihyun Kim
**Investigator Title:** Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** In this study, the investigators aim to investigate the prevalence and clinical course of oligosecretary myeloma.
**Detailed Description:** Oligosecretary myeloma is a subgroup of multiple myeloma (MM) characterized by low levels of serum and urine monoclonal (M) protein below thresholds of measurable disease (a serum M protein ≥ 1g/dL, a urine M protein ≥ 200mg/day). Patients with oligosecretary myeloma do not have established methods for disease monitoring and clinical informations regarding oligosecretary myeloma are still largely unknown.
In this study, we aimed to investigate the prevalence and clinical course of oligosecretary myeloma.
### Conditions Module
**Conditions:**
- Multiple Myeloma
**Keywords:**
- oligosecretary multiple myeloma
### Design Module
#### Design Info
**Observational Model:** CASE_ONLY
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 390
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Multiple myeloma (MM) characterized by low levels of serum and urine monoclonal (M) protein below thresholds of measurable disease (a serum M protein ≥ 1g/dL, a urine M protein ≥ 200mg/day)
**Intervention Names:**
- Other: oligosecretary
**Label:** oligosecretary
### Interventions
#### Intervention 1
**Arm Group Labels:**
- oligosecretary
**Description:** not abvailable
**Name:** oligosecretary
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Measure:** Number of patients with oligosecretary myeloma among multiple myeloma patients
**Time Frame:** up to 1 year
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* a subgroup of multiple myeloma (MM) characterized by low levels of serum and urine monoclonal (M) protein below thresholds of measurable disease (a serum M protein ≥ 1g/dL, a urine M protein ≥ 200mg/day)
* available clinical data
Exclusion Criteria:
* patients without available clinical data
**Maximum Age:** 90 Years
**Minimum Age:** 17 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
**Study Population:** a subgroup of multiple myeloma (MM) characterized by low levels of serum and urine monoclonal (M) protein below thresholds of measurable disease (a serum M protein ≥ 1g/dL, a urine M protein ≥ 200mg/day)
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Seoul
**Country:** Korea, Republic of
**Facility:** Samsung Medical Center
#### Overall Officials
**Official 1:**
**Affiliation:** Samsung Medical Center
**Name:** Kihyun Kim
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000009369
- Term: Neoplasms
- ID: D000020141
- Term: Hemostatic Disorders
- ID: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000010265
- Term: Paraproteinemias
- ID: D000001796
- Term: Blood Protein Disorders
- ID: D000006402
- Term: Hematologic Diseases
- ID: D000006474
- Term: Hemorrhagic Disorders
- ID: D000008232
- Term: Lymphoproliferative Disorders
- ID: D000007160
- Term: Immunoproliferative Disorders
- ID: D000007154
- Term: Immune System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: BC15
- Name: Blood and Lymph Conditions
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M12058
- Name: Multiple Myeloma
- Relevance: HIGH
- As Found: Multiple Myeloma
- ID: M27588
- Name: Neoplasms, Plasma Cell
- Relevance: HIGH
- As Found: Myeloma
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
- ID: M21977
- Name: Hemostatic Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M5059
- Name: Blood Coagulation Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M13178
- Name: Paraproteinemias
- Relevance: LOW
- As Found: Unknown
- ID: M5077
- Name: Blood Protein Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M9490
- Name: Hematologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M9560
- Name: Hemorrhagic Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M11225
- Name: Lymphoproliferative Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M10206
- Name: Immunoproliferative Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T3947
- Name: Multiple Myeloma
- Relevance: HIGH
- As Found: Multiple Myeloma
### Condition Browse Module - Meshes
- ID: D000009101
- Term: Multiple Myeloma
- ID: D000054219
- Term: Neoplasms, Plasma Cell
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M12147
- Name: Myeloma Proteins
- Relevance: LOW
- As Found: Unknown
- ID: M13179
- Name: Paraproteins
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06090279
**Brief Title:** Feasibility of the Gamification of Incentive Spirometry in Trauma Patients
**Official Title:** Feasibility of the Gamification of Incentive Spirometry in Trauma Patients
#### Organization Study ID Info
**ID:** IRB00097144
#### Organization
**Class:** OTHER
**Full Name:** Wake Forest University Health Sciences
### Status Module
#### Completion Date
**Date:** 2025-07
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-01
**Type:** ACTUAL
**Last Update Submit Date:** 2024-04-29
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-07
**Type:** ESTIMATED
#### Start Date
**Date:** 2025-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-04
#### Study First Post Date
**Date:** 2023-10-19
**Type:** ACTUAL
**Study First Submit Date:** 2023-10-13
**Study First Submit QC Date:** 2023-10-13
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Wake Forest University Health Sciences
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** True
**Is FDA Regulated Drug:** False
**Is US Export:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Gamification may be one solution that can increase the compliance in the use of devices like incentive spirometry.
**Detailed Description:** Recently, there has been much interest in the gamification of healthcare, such as virtual incentive spirometry gaming. Several studies have examined the addition of gamification e.g. virtual incentive spirometry devices. There is a paucity of data regarding the gamification of incentive spirometry, and there is no data involving trauma patients. Previous studies have enrolled either healthy volunteers or patients with specific lung pathology. This study to assess the safety, feasibility and efficacy of respiratory interventions in chest trauma patients using a therapeutic gamification platform.
### Conditions Module
**Conditions:**
- Thoracic Trauma
**Keywords:**
- pulmonary therapies
- incentive spirometry
- pulmonary complications
- pulmonary function
- gamification
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** a minimum of 3 rounds of game usage in the Trauma Intensive Care Unit (TICU). Each patient will receive at least 2 sessions per day.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 20
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** This system is a FDA approved healthcare gaming system that is used for patients who have difficulty breathing and allows the patients to participate in breathing exercises for pulmonary rehab.
**Intervention Names:**
- Device: OmniFlow Breathing Therapy BioFeeback System
**Label:** OmniFlow Breathing Therapy BioFeeback System
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- OmniFlow Breathing Therapy BioFeeback System
**Description:** FDA approved healthcare gaming system that is used for patients who have difficulty breathing and allows the patients to participate in breathing exercises for pulmonary rehab. Each game usage itself is expected to last 15-20 minutes.
**Name:** OmniFlow Breathing Therapy BioFeeback System
**Other Names:**
- healthcare gaming
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Number screened and eligible compared to patient that consented to project
**Measure:** Number screened and eligible compared to patient that consented to project
**Time Frame:** up to 6 months
**Description:** Number of sessions attempted, completed and aborted including the time spent in successful intervention
**Measure:** Number of sessions attempted, completed and aborted including the time spent in successful intervention
**Time Frame:** up to 6 months
**Description:** Enter the results according to the reason
The Session will be terminated if one or more of the following occurs:
* Sustained Pain Score \>8/10
* Increase in oxygen requirements by more than 2L/min or hypoxia to less than 92% during the intervention or need for escalation of an oxygen supplementation device
* Sustained Heart Rate \>110 beats per minute, new cardiac arrhythmia or respiratory rate \>30 per minute
* Cyanosis, pallor, or new onset confusion
* Refusal to continue by choice, reduced engagement in game, adverse symptoms related to dyspnea, pain or discomfort related to the intervention
* These safety measures are vital sign derangements or signs/symptoms that predict threat to the patient's health
* Sessions unable to be performed after enrollment due to lack of personnel
* Failure of intervention device to work, failure of accompanying gamification platform to work
**Measure:** Reasons for aborting a session related to patient factors, staffing factors, technology factors
**Time Frame:** up to 6 months
**Description:** Number of days spent in Intensive Care Unit (ICU)
**Measure:** Number of days spent in Intensive Care Unit (ICU)
**Time Frame:** up to 6 months
**Description:** Number of Subjects readmitted to the ICU for pulmonary complications
**Measure:** Number of Subjects readmitted to the ICU for pulmonary complications
**Time Frame:** up to 6 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients will be included if informed consent can be obtained from patient themselves and first session of incentive spirometry gamification can be performed within 48 hours of Trauma Intensive Care Unit (TICU) admission
* Adult patients (≥ 18 years of age) in the TICU with rib fractures or flail segment or a sternal fracture
Exclusion Criteria:
* Trauma patients in the TICU who are mechanically ventilated or requiring bilevel positive airway pressure (BiPAP)
* Glasgow Coma Scale (GCS) \< 15, at the time of enrollment
* Facial fractures precluding the use of incentive spirometry
* Any organ injury that precludes use of respiratory therapies in the clinical judgement of the clinical team
* Patients who are expected to be transferred out of the TICU or discharged from the TICU in the next 24 hours based on treating physicians judgment
* Patients who are transitioning to palliative care or expected to die in the next 48 hours based on treating physician's judgment will not be included
* Patients unable to consent for themselves
* Patients unable to use the mouthpiece of the Omniflow system, and those who have visual or hearing impairments that could limit their ability to evaluate the games
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Areen AL-Dhoon, MBBS
**Phone:** 336-405-0740
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Winston-Salem
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Areen AL-Dhoon, MBBS
- **Phone:** 336-405-0740
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Arthur Grimes, MD
- **Role:** CONTACT
***Contact 3:***
- **Name:** Aarti Sarwal, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Wake Forest University Health Sciences
**State:** North Carolina
**Zip:** 27157
#### Overall Officials
**Official 1:**
**Affiliation:** Wake Forest University Health Sciences
**Name:** Aarti Sarwal, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M17685
- Name: Wounds and Injuries
- Relevance: HIGH
- As Found: Trauma
### Condition Browse Module - Meshes
- ID: D000014947
- Term: Wounds and Injuries
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT02780479
**Brief Title:** Steroids in Children Hospitalized With Asthma
**Official Title:** Oral Dexamethasone Versus Oral Prednisone in Children Hospitalized With Asthma: A Randomized Control Study
#### Organization Study ID Info
**ID:** UFJ 2016-24
#### Organization
**Class:** OTHER
**Full Name:** University of Florida
### Status Module
#### Completion Date
**Date:** 2017-08-29
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-06-21
**Type:** ACTUAL
**Last Update Submit Date:** 2019-06-20
**Overall Status:** TERMINATED
#### Primary Completion Date
**Date:** 2017-08-29
**Type:** ACTUAL
#### Start Date
**Date:** 2017-03-20
**Type:** ACTUAL
**Status Verified Date:** 2019-06
#### Study First Post Date
**Date:** 2016-05-23
**Type:** ESTIMATED
**Study First Submit Date:** 2016-05-19
**Study First Submit QC Date:** 2016-05-19
**Why Stopped:** insufficient number of participants met the enrollment criteria.
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Florida
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Asthma is the most common chronic disease of children. A short (3-5 day) course of a short-acting steroid such as Prednisone or Prednisolone has long been the standard of care for asthma exacerbation. Dexamethasone efficacy in asthma exacerbation has been studied in the outpatient setting and was found to be as effective as Prednisone. Dexamethasone has the advantage of shorter course, more compliance, and more tolerable. This has led many emergency departments to provide a 1-2 dose course of Dexamethasone on discharge. Thus, many inpatients have received a first dose of Dexamethasone prior to reaching the inpatient unit, leading to confusion about the best plan for these patients. Many hospitalist pediatricians continue to give a 5-day total course with Prednisone, but some patients have begun to receive a second dose of Dexamethasone 24 hours after the first dose. To our knowledge, no studies have been done to compare the efficacy of these two protocols in pediatric patients requiring hospitalization. The hypothesis is that a second dose of Dexamethasone is as effective as four additional days of Prednisone in hospitalized children with asthma exacerbation. This is an open label, randomized control study comparing these treatments in children age 2-18 hospitalized with asthma exacerbation who have received a first dose of Dexamethasone.
**Detailed Description:** Corticosteroids are the first-line therapy for managing acute asthma exacerbations. Studies have shown that systemic steroids effect decrease relapse and hospital admission. Due to its short half-life, Prednisone is usually given daily or twice daily for 3-5 days. It has been associated with poor compliance due it the prolonged course. Dexamethasone half-life is 36 - 72 hours.
Several studies have shown no difference in outcomes between 3-5 days of prednisone and different forms of dexamethasone, including single intramuscular dose or single oral dose or two oral doses 1 day apart. However, those studies were done in the emergency department (ED). Lack of response to initial asthma treatment in ED results in admission to the hospital, implying more severe exacerbation than those able to be discharged. Some clinician shift to oral prednisone once admitted to the floor for patients who have received Dexamethasone or not. Others have begin to complete the Dexamethasone course with one more dose of Dexamethasone 24 hour after the first dose. Dexamethasone has the advantage of compliance and tolerability, however, no studies investigated its efficacy in hospitalized patients. Such knowledge will improve patient's compliance and outcomes.
* Sample size calculation: Primary outcome of return to normal activities within 3 days of discharge. Based on previous studies, it is estimated that 70% of the control group will achieve this goal. Based on a minimum absolute difference of 15%, and a power of 0.80, the sample size calculated to be 117 in each arm. Assuming 20% lost to follow up, it is intended to recruit 150 in each arm (total 300 subjects).
* Statistical Analysis: Demographics will be analyzed to ensure the experimental and control groups are equivalent at baseline. All proportions will be tested with Chi-square or Fisher exact test and two-sample T-test will be used for continuous variables. α = 0.05 will be used for all hypothesis tests. Interim analysis will be performed monthly and the study will be halted if any safety concerns arise. The Center for Health Equity and Quality Research (CHEQR) will help with statistical analysis
* Data Safety and Monitoring Plan: The study PI and co-investigator will meet and review the collected data on a monthly basis and identify any interim results that may require a change of study protocol. Information that may affect subjects' safety will be communicated to appropriate parties in a timely fashion.
### Conditions Module
**Conditions:**
- Asthma
- Status Asthmaticus
- Wheezes
**Keywords:**
- Prednisone
- Dexamethasone
- Asthma exacerbation
- Hospitalized
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 6
**Type:** ACTUAL
**Phases:**
- PHASE4
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Dexamethasone arm: will receive second dose of oral Dexamethasone 0.6 mg/kg/dose max of 16 mg, 24 hour from the first dose given in emergency department.
**Intervention Names:**
- Drug: Dexamethasone
**Label:** Dexamethasone
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Prednisone arm: will receive oral Prednisone 1mg/kg with max of 30 mg twice daily starting 24 hours after the Dexamethasone dose given in emergency department for 8 additional doses.
**Intervention Names:**
- Drug: Prednisone
**Label:** Prednisone
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Dexamethasone
**Description:** at 24 hours from the first Dexamethasone dose given in ED.
**Name:** Dexamethasone
**Other Names:**
- Decadron
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Prednisone
**Description:** at 24 hours from the first Dexamethasone dose given in ED.
**Name:** Prednisone
**Other Names:**
- Orapred
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Proportion of patients who have returned to normal activity
**Measure:** Return to normal activity (Patient Self-Assessment Score)
**Time Frame:** 3 days after discharge
#### Secondary Outcomes
**Description:** Proportion of patients with unscheduled primary care physician visits, emergency department or hospital admission
**Measure:** Relapse ( ED visit or unscheduled physician visit)
**Time Frame:** 2 weeks after discharge
**Description:** Proportion of patients with of ongoing albuterol use (based on validated self-reporting tool)
**Measure:** Albuterol use (Patient Self-Assessment Score)
**Time Frame:** 2 weeks after discharge
**Description:** Patient self assessment score at 2 weeks after discharge
**Measure:** Asthma symptoms (Patient Self-Assessment Score)
**Time Frame:** 2 weeks after discharge
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Signed informed consent by legal guardian
* Age 2 to 18 years old
* Admission to the floor with acute asthma exacerbation.
* Received single dose of oral Dexamethasone
* Initial Pediatric Asthma Score (PAS) of 8 or higher.
Exclusion Criteria:
* Admission to PICU
* Recent steroid use (within 1 month)
* Cardiac disorder, chronic respiratory illness (BPD or CF)
* Stridor
* Bacterial Pneumonia
**Maximum Age:** 18 Years
**Minimum Age:** 2 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Jacksonville
**Country:** United States
**Facility:** Wolfson Children Hospital
**State:** Florida
**Zip:** 32207
#### Overall Officials
**Official 1:**
**Affiliation:** Universiry of Florida, College of Medicine Jacksonville
**Name:** Jeffrey C Winer, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
### References Module
#### References
**Citation:** National Asthma Education and Prevention Program. Expert Panel Report 3 (EPR-3): Guidelines for the Diagnosis and Management of Asthma-Summary Report 2007. J Allergy Clin Immunol. 2007 Nov;120(5 Suppl):S94-138. doi: 10.1016/j.jaci.2007.09.043. Erratum In: J Allergy Clin Immunol. 2008 Jun;121(6):1330.
**PMID:** 17983880
**Citation:** Keeney GE, Gray MP, Morrison AK, Levas MN, Kessler EA, Hill GD, Gorelick MH, Jackson JL. Dexamethasone for acute asthma exacerbations in children: a meta-analysis. Pediatrics. 2014 Mar;133(3):493-9. doi: 10.1542/peds.2013-2273. Epub 2014 Feb 10.
**PMID:** 24515516
**Citation:** Qureshi F, Zaritsky A, Poirier MP. Comparative efficacy of oral dexamethasone versus oral prednisone in acute pediatric asthma. J Pediatr. 2001 Jul;139(1):20-6. doi: 10.1067/mpd.2001.115021.
**PMID:** 11445789
**Citation:** Rowe BH, Spooner CH, Ducharme FM, Bretzlaff JA, Bota GW. Corticosteroids for preventing relapse following acute exacerbations of asthma. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD000195. doi: 10.1002/14651858.CD000195.pub2.
**PMID:** 17636617
**Citation:** Butler K, Cooper WO. Adherence of pediatric asthma patients with oral corticosteroid prescriptions following pediatric emergency department visit or hospitalization. Pediatr Emerg Care. 2004 Nov;20(11):730-5. doi: 10.1097/01.pec.0000144914.78124.6f.
**PMID:** 15502653
**Citation:** Czock D, Keller F, Rasche FM, Haussler U. Pharmacokinetics and pharmacodynamics of systemically administered glucocorticoids. Clin Pharmacokinet. 2005;44(1):61-98. doi: 10.2165/00003088-200544010-00003.
**PMID:** 15634032
**Citation:** Gries DM, Moffitt DR, Pulos E, Carter ER. A single dose of intramuscularly administered dexamethasone acetate is as effective as oral prednisone to treat asthma exacerbations in young children. J Pediatr. 2000 Mar;136(3):298-303. doi: 10.1067/mpd.2000.103353.
**PMID:** 10700684
**Citation:** Klig JE, Hodge D 3rd, Rutherford MW. Symptomatic improvement following emergency department management of asthma: a pilot study of intramuscular dexamethasone versus oral prednisone. J Asthma. 1997;34(5):419-25. doi: 10.3109/02770909709055384.
**PMID:** 9350159
**Citation:** Gordon S, Tompkins T, Dayan PS. Randomized trial of single-dose intramuscular dexamethasone compared with prednisolone for children with acute asthma. Pediatr Emerg Care. 2007 Aug;23(8):521-7. doi: 10.1097/PEC.0b013e318128f821.
**PMID:** 17726409
**Citation:** Altamimi S, Robertson G, Jastaniah W, Davey A, Dehghani N, Chen R, Leung K, Colbourne M. Single-dose oral dexamethasone in the emergency management of children with exacerbations of mild to moderate asthma. Pediatr Emerg Care. 2006 Dec;22(12):786-93. doi: 10.1097/01.pec.0000248683.09895.08.
**PMID:** 17198210
**Citation:** Greenberg RA, Kerby G, Roosevelt GE. A comparison of oral dexamethasone with oral prednisone in pediatric asthma exacerbations treated in the emergency department. Clin Pediatr (Phila). 2008 Oct;47(8):817-23. doi: 10.1177/0009922808316988. Epub 2008 May 8.
**PMID:** 18467673
**Citation:** National Asthma Education and Prevention Program. National Asthma Education and Prevention Program. Expert Panel Report: Guidelines for the Diagnosis and Management of Asthma Update on Selected Topics--2002. J Allergy Clin Immunol. 2002 Nov;110(5 Suppl):S141-219. No abstract available. Erratum In: J Allergy Clin Immunol. 2003 Mar;111(3):466.
**PMID:** 12542074
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001982
- Term: Bronchial Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
- ID: D000008173
- Term: Lung Diseases, Obstructive
- ID: D000008171
- Term: Lung Diseases
- ID: D000012130
- Term: Respiratory Hypersensitivity
- ID: D000006969
- Term: Hypersensitivity, Immediate
- ID: D000006967
- Term: Hypersensitivity
- ID: D000007154
- Term: Immune System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M4556
- Name: Asthma
- Relevance: HIGH
- As Found: Asthma
- ID: M16017
- Name: Status Asthmaticus
- Relevance: HIGH
- As Found: Status Asthmaticus
- ID: M5258
- Name: Bronchial Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M11168
- Name: Lung Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M11170
- Name: Lung Diseases, Obstructive
- Relevance: LOW
- As Found: Unknown
- ID: M10018
- Name: Hypersensitivity
- Relevance: LOW
- As Found: Unknown
- ID: M14967
- Name: Respiratory Hypersensitivity
- Relevance: LOW
- As Found: Unknown
- ID: M10020
- Name: Hypersensitivity, Immediate
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001249
- Term: Asthma
- ID: D000013224
- Term: Status Asthmaticus
### Intervention Browse Module - Ancestors
- ID: D000000893
- Term: Anti-Inflammatory Agents
- ID: D000000932
- Term: Antiemetics
- ID: D000001337
- Term: Autonomic Agents
- ID: D000018373
- Term: Peripheral Nervous System Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000005765
- Term: Gastrointestinal Agents
- ID: D000005938
- Term: Glucocorticoids
- ID: D000006728
- Term: Hormones
- ID: D000006730
- Term: Hormones, Hormone Substitutes, and Hormone Antagonists
- ID: D000018931
- Term: Antineoplastic Agents, Hormonal
- ID: D000000970
- Term: Antineoplastic Agents
### Intervention Browse Module - Browse Branches
- Abbrev: Infl
- Name: Anti-Inflammatory Agents
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: AnEm
- Name: Antiemetics
- Abbrev: Gast
- Name: Gastrointestinal Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: NeuroAg
- Name: Neuroprotective Agents
### Intervention Browse Module - Browse Leaves
- ID: M7102
- Name: Dexamethasone
- Relevance: HIGH
- As Found: Children
- ID: M14121
- Name: Prednisone
- Relevance: HIGH
- As Found: Min
- ID: M14120
- Name: Prednisolone
- Relevance: LOW
- As Found: Unknown
- ID: M235549
- Name: Dexamethasone acetate
- Relevance: LOW
- As Found: Unknown
- ID: M199152
- Name: BB 1101
- Relevance: LOW
- As Found: Unknown
- ID: M11749
- Name: Methylprednisolone
- Relevance: LOW
- As Found: Unknown
- ID: M1833
- Name: Methylprednisolone Acetate
- Relevance: LOW
- As Found: Unknown
- ID: M11750
- Name: Methylprednisolone Hemisuccinate
- Relevance: LOW
- As Found: Unknown
- ID: M229449
- Name: Prednisolone acetate
- Relevance: LOW
- As Found: Unknown
- ID: M211887
- Name: Prednisolone hemisuccinate
- Relevance: LOW
- As Found: Unknown
- ID: M248881
- Name: Prednisolone phosphate
- Relevance: LOW
- As Found: Unknown
- ID: M4217
- Name: Anti-Inflammatory Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4251
- Name: Antiemetics
- Relevance: LOW
- As Found: Unknown
- ID: M8881
- Name: Gastrointestinal Agents
- Relevance: LOW
- As Found: Unknown
- ID: M9047
- Name: Glucocorticoids
- Relevance: LOW
- As Found: Unknown
- ID: M9789
- Name: Hormones
- Relevance: LOW
- As Found: Unknown
- ID: M9788
- Name: Hormone Antagonists
- Relevance: LOW
- As Found: Unknown
- ID: M20966
- Name: Antineoplastic Agents, Hormonal
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000003907
- Term: Dexamethasone
- ID: D000011241
- Term: Prednisone
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT02281279
**Brief Title:** Rituximab, Romidepsin, and Lenalidomide in Treating Patients With Recurrent or Refractory B-cell Non-Hodgkin Lymphoma
**Official Title:** A Phase I/II Trial of Romidepsin, Rituximab and Lenalidomide (R3) in Relapsed/Refractory B Cell Lymphomas Including Transformed Follicular Lymphoma
#### Organization Study ID Info
**ID:** MC1288
#### Organization
**Class:** OTHER
**Full Name:** Mayo Clinic
#### Secondary ID Infos
**Domain:** CTRP (Clinical Trial Reporting Program)
**ID:** NCI-2014-02186
**Type:** REGISTRY
**ID:** RM-FOL-PI-0034
**Domain:** Mayo Clinic
**ID:** MC1288
**Type:** OTHER
**ID:** P30CA015083
**Link:** https://reporter.nih.gov/quickSearch/P30CA015083
**Type:** NIH
### Status Module
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2016-08-11
**Type:** ESTIMATED
**Last Update Submit Date:** 2016-08-09
**Overall Status:** WITHDRAWN
#### Primary Completion Date
**Date:** 2020-10
**Type:** ESTIMATED
#### Start Date
**Date:** 2016-10
**Status Verified Date:** 2016-08
#### Study First Post Date
**Date:** 2014-11-02
**Type:** ESTIMATED
**Study First Submit Date:** 2014-10-30
**Study First Submit QC Date:** 2014-10-30
### Sponsor Collaborators Module
#### Collaborators
**Class:** NIH
**Name:** National Cancer Institute (NCI)
#### Lead Sponsor
**Class:** OTHER
**Name:** Mayo Clinic
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** This phase I/II trial studies the side effects and best dose of romidepsin and lenalidomide when combined with rituximab and to see how well this combination works in treating patients with B-cell non-Hodgkin lymphoma that has returned (recurrent) or did not respond to treatment (refractory). Monoclonal antibodies, such as rituximab, may block cancer growth in different ways by targeting certain cells. Romidepsin and lenalidomide may stop the growth of cancer cells by blocking enzymes needed for cell growth. Giving rituximab together with romidepsin and lenalidomide may be a better treatment for B-cell non-Hodgkin lymphoma.
**Detailed Description:** PRIMARY OBJECTIVES:
I. To establish the maximum tolerated dose (MTD) of the combination of romidepsin, rituximab and lenalidomide in patients with relapsed/refractory B-cell non-Hodgkin lymphoma (NHL). (Phase I) II. To assess the overall response rate (ORR) of this combination in patients with transformed follicular lymphoma (FL). (Phase II)
SECONDARY OBJECTIVES:
I. To assess the toxicity and safety of romidepsin in combination with lenalidomide and rituximab.
II. To assess complete response rate (CR), progression free survival (PFS), and overall survival (OS) of this combination in patients with transformed FL.
TERTIARY OBJECTIVES:
I. To assess the impact of B-cell leukemia/lymphoma 2 (BCL2) mutations on ORR among patients treated with this combination.
II. To assess the impact of BCL2 mutations on PFS among patients treated with this combination.
OUTLINE: This is a phase I, dose-escalation study of romidepsin and lenalidomide followed by a phase II study.
Patients receive rituximab intravenously (IV) over 90 minutes on day 1; romidepsin IV over 4 hours on either day 1, days 1 and 8, or days 1, 8, and 15; and lenalidomide orally (PO) on days 1-21. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
### Conditions Module
**Conditions:**
- B-cell Adult Acute Lymphoblastic Leukemia
- Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
- Intraocular Lymphoma
- Nodal Marginal Zone B-cell Lymphoma
- Recurrent Adult Acute Lymphoblastic Leukemia
- Recurrent Adult Burkitt Lymphoma
- Recurrent Adult Diffuse Large Cell Lymphoma
- Recurrent Adult Diffuse Mixed Cell Lymphoma
- Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
- Recurrent Adult Grade III Lymphomatoid Granulomatosis
- Recurrent Adult Immunoblastic Large Cell Lymphoma
- Recurrent Adult Lymphoblastic Lymphoma
- Recurrent Grade 1 Follicular Lymphoma
- Recurrent Grade 2 Follicular Lymphoma
- Recurrent Grade 3 Follicular Lymphoma
- Recurrent Mantle Cell Lymphoma
- Recurrent Marginal Zone Lymphoma
- Recurrent Small Lymphocytic Lymphoma
- Refractory Hairy Cell Leukemia
- Small Intestine Lymphoma
- Splenic Marginal Zone Lymphoma
- Testicular Lymphoma
- Waldenström Macroglobulinemia
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Type:** ACTUAL
**Phases:**
- PHASE1
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients receive rituximab IV over 90 minutes on day 1; romidepsin IV over 4 hours on either day 1, days 1 and 8, or days 1, 8, and 15; and lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
**Intervention Names:**
- Biological: rituximab
- Drug: lenalidomide
- Drug: romidepsin
- Other: laboratory biomarker analysis
**Label:** Treatment (rituximab, romidepsin, lenalidomide)
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Treatment (rituximab, romidepsin, lenalidomide)
**Description:** Given IV
**Name:** rituximab
**Other Names:**
- IDEC-C2B8
- IDEC-C2B8 monoclonal antibody
- Mabthera
- MOAB IDEC-C2B8
- Rituxan
**Type:** BIOLOGICAL
#### Intervention 2
**Arm Group Labels:**
- Treatment (rituximab, romidepsin, lenalidomide)
**Description:** Given PO
**Name:** lenalidomide
**Other Names:**
- CC-5013
- IMiD-1
- Revlimid
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- Treatment (rituximab, romidepsin, lenalidomide)
**Description:** Given IV
**Name:** romidepsin
**Other Names:**
- FK228
- FR901228
- Istodax
**Type:** DRUG
#### Intervention 4
**Arm Group Labels:**
- Treatment (rituximab, romidepsin, lenalidomide)
**Description:** Correlative studies
**Name:** laboratory biomarker analysis
**Type:** OTHER
### Outcomes Module
#### Other Outcomes
**Description:** Will be assessed as mutation present vs. absent. The correlation between overall response (responder vs. non-responder) and mutation status will be evaluated using Fisher's exact test. The PFS in each group will be estimated using the Kaplan-Meier method. The differences in PFS between the two mutation groups will be assessed using the log-rank test.
**Measure:** BCL-2 sequence
**Time Frame:** Baseline
#### Primary Outcomes
**Measure:** MTD, defined as the dose level below the lowest dose that induces dose-limiting toxicity in at least one-third of patients (at least 2 of a maximum of 6 new patients) (Phase I)
**Time Frame:** 28 days
**Description:** A success is defined as a CR or partial response (PR) noted as the objective status. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true success proportion will be calculated.
**Measure:** Overall response rate (Phase II)
**Time Frame:** Up to 5 years
#### Secondary Outcomes
**Description:** The number and severity of all adverse events (overall and by dose-level) will be tabulated and summarized in this patient population. The grade 3+ adverse events will also be described and summarized in a similar fashion.
**Measure:** Adverse events profile, graded according to the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase I)
**Time Frame:** Up to 30 days post-treatment
**Description:** Non-hematologic toxicities will be evaluated via the ordinal Common Terminology Criteria (CTC) standard toxicity grading. Hematologic toxicity measures of thrombocytopenia, neutropenia, and leukopenia will be assessed using continuous variables as the outcome measures (primarily nadir) as well as categorization via CTC standard toxicity grading. Overall toxicity incidence as well as toxicity profiles by dose level, patient and tumor site will be explored and summarized. Frequency distributions, graphical techniques and other descriptive measures will form the basis of these analyses.
**Measure:** Toxicity profile, defined as adverse events that are classified as either possibly, probably, or definitely related to study treatment (Phase I)
**Time Frame:** Up to 30 days post-treatment
**Description:** Responses will be summarized by simple descriptive summary statistics delineating complete and partial responses as well as stable and progressive disease in this patient population.
**Measure:** Response profile, defined to be a CR or PR noted as the objective status (Phase I)
**Time Frame:** Up to 5 years
**Description:** Will be estimated by the number of patients who achieve a CR divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true complete response rate will be calculated.
**Measure:** CR rate (Phase II)
**Time Frame:** Up to 5 years
**Description:** The distribution of survival time will be estimated using the method of Kaplan-Meier.
**Measure:** Survival time (Phase II)
**Time Frame:** Time from registration to death due to any cause, assessed up to 5 years
**Description:** The distribution of PFS will be estimated using the method of Kaplan-Meier.
**Measure:** PFS (Phase II)
**Time Frame:** Time from registration to the earliest date of documentation of disease progression or death due to any cause, assessed up to 5 years
**Description:** The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration.
**Measure:** Incidence of adverse events, graded according to the revised NCI CTCAE version 4.0 (Phase II)
**Time Frame:** Up to 30 days post-treatment
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* PHASE I: Histological confirmation of relapsed (recurrent after previous therapy\[ies\]) or refractory (no response to previous therapy\[ies\]) B-cell NHL; note: patients with small lymphocytic lymphoma (SLL) are eligible however patients with chronic lymphocytic leukemia (CLL) are not eligible
* PHASE II: Histological confirmation of transformation of FL lymphoma to diffuse large B cell lymphoma or aggressive lymphoma
* The biopsy confirming diagnosis can be up to 12 weeks prior to registration as long as there is no intervening therapy; note: if patient has had lymphoma treatment since previous biopsy, a biopsy should be repeated
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
* Measurable disease (at least 1 lesion of \>= 1.5 cm in diameter) as detected by computed tomography (CT) or the CT images of the positron emission tomography (PET)/CT
* Absolute neutrophil count (ANC) \>= 1500/mm\^3
* Platelet count \>= 75,000/mm\^3
* Total bilirubin =\< 1.5 x upper limit of normal (ULN) or if total bilirubin is \> 1.5 x ULN, the direct bilirubin =\< ULN
* Alkaline phosphatase =\< 3 x ULN unless due to direct lymphoma involvement, and then =\< 5 x ULN
* Aspartate transaminase (AST) =\< 3 x ULN unless due to direct lymphoma involvement, and then =\< 5x ULN
* Calculated creatinine clearance \>= 50 mL/min using the Cockcroft-Gault formula
* Magnesium \>= 1.6 mg/dL
* Potassium \>= 3.5 mg/dL
* Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid Risk Evaluation and Mitigation Strategy (REMS)® program
* Willing to be registered into the mandatory Revlimid REMS® program, and willing and able to comply with the requirements of the REMS® program
* If currently not on anticoagulation medication, willing and able to take aspirin (325 mg) daily; note: if aspirin is contraindicated, the patient may be considered for the study after if on therapeutic dose warfarin or low molecular weight heparin; patients unable to take any prophylaxis are not eligible
* Life expectancy \>= 3 months
* Ability to complete medication diary by themselves or with assistance
* Ability to provide informed written consent
* Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
* Note: during the active monitoring phase of a study (i.e., active treatment and observation), participants must be willing to return to the consenting institution for follow-up
* Willing to provide tissue for central review and blood samples for correlative research purposes
Exclusion Criteria:
* Prior therapy with histone deacetylase (HDAC) inhibitors or immunomodulatory drugs (IMDs) (lenalidomide or thalidomide)
* Any of the following:
* Pregnant women
* Nursing women
* Men or women of childbearing potential who are unwilling to employ adequate contraception
* Active central nervous system (CNS) lymphoma or cerebrospinal fluid involvement with malignant lymphoma cells that requires therapy
* Prolongation of corrected QT interval of \> 480 ms
* Receiving any medications that prolong the corrected QT (QTc) and have a known risk for Torsades de pointes; note: providers should use caution with drugs with possible increased risk for Torsades de pointes; patient will be eligible if they can be taken off these medications prior to initiation of therapy and no less than 4 half-life of the medication
* Receiving any medications or substances that are strong inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4/5 (CYP3A4/5)
* Use of the following strong inhibitors are prohibited =\< 7 days prior to registration
* Boceprevir (Victrelis™)
* Clarithromycin (Biaxin®, Biaxin XL®)
* Conivaptan (Vaprisol®)
* Grapefruit juice
* Indinavir (Crixivan®)
* Itraconazole (Sporanox®)
* Ketoconazole (Nizoral®)
* Lopinavir/ritonavir (Kaletra®)
* Mibefradil
* Nefazodone (Serzone®)
* Nelfinavir (Viracept®)
* Posaconazole (Noxafil®)
* Ritonavir (Norvir®)
* Saquinavir (Invirase®)
* Telaprevir (Incivek®)
* Telithromycin (Ketek®)
* Receiving any medications or substances that are inducers of CYP3A4
* Use of the following inducers are prohibited =\< 12 days prior to registration
* Avasimibe
* Bosentan (Tracleer®)
* Carbamazepine (Carbatrol®, Epitol®, Equetro™, Tegretol®, Tegretol-XR®)
* Efavirenz (Sustiva®)
* Modafinil (Provigil®)
* Phenobarbital (Luminal®)
* Phenytoin (Dilantin®, Phenytek®)
* Rifabutin (Mycobutin®)
* Rifampin (Rifadin®)
* St. John's wort
* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
* Known positivity for human immunodeficiency virus (HIV); note: baseline testing for HIV is not required
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements; note: patients with hepatitis B and C are eligible at the discretion of the treating physician; appropriate counseling regarding the risks of rituximab should be provided
* Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
* Other active malignancy requiring therapy; exceptions: non-melanotic skin cancer or any cancer that in the judgment of the investigator will not interfere with treatment plan and response assessment; patients with \>= 25% of the bone marrow radiated for other diseases are not eligible
* History of myocardial infarction =\< 6 months prior to registration, unstable angina, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
* History of life threatening or recurrent thrombosis/embolism; patients may participate if they are on anticoagulation during the treatment
* Receiving erythroid stimulating agents (erythropoietin \[EPO\]: Procrit, Aranesp)
* History of allogeneic bone marrow or stem cell transplantation
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Overall Officials
**Official 1:**
**Affiliation:** Mayo Clinic
**Name:** Grzegorz Nowakowski
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000009369
- Term: Neoplasms
- ID: D000008232
- Term: Lymphoproliferative Disorders
- ID: D000008206
- Term: Lymphatic Diseases
- ID: D000007160
- Term: Immunoproliferative Disorders
- ID: D000007154
- Term: Immune System Diseases
- ID: D000006402
- Term: Hematologic Diseases
- ID: D000020969
- Term: Disease Attributes
- ID: D000010335
- Term: Pathologic Processes
- ID: D000015448
- Term: Leukemia, B-Cell
- ID: D000002908
- Term: Chronic Disease
- ID: D000020031
- Term: Epstein-Barr Virus Infections
- ID: D000006566
- Term: Herpesviridae Infections
- ID: D000004266
- Term: DNA Virus Infections
- ID: D000014777
- Term: Virus Diseases
- ID: D000007239
- Term: Infections
- ID: D000014412
- Term: Tumor Virus Infections
- ID: D000054219
- Term: Neoplasms, Plasma Cell
- ID: D000020141
- Term: Hemostatic Disorders
- ID: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000010265
- Term: Paraproteinemias
- ID: D000001796
- Term: Blood Protein Disorders
- ID: D000006474
- Term: Hemorrhagic Disorders
- ID: D000011230
- Term: Precancerous Conditions
- ID: D000005134
- Term: Eye Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC15
- Name: Blood and Lymph Conditions
- Abbrev: All
- Name: All Conditions
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BC01
- Name: Infections
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: BC11
- Name: Eye Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M10945
- Name: Leukemia
- Relevance: HIGH
- As Found: Leukemia
- ID: M10951
- Name: Leukemia, Lymphoid
- Relevance: HIGH
- As Found: Lymphoblastic Leukemia
- ID: M18116
- Name: Leukemia, Lymphocytic, Chronic, B-Cell
- Relevance: HIGH
- As Found: Small lymphocytic lymphoma
- ID: M27585
- Name: Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Relevance: HIGH
- As Found: Acute Lymphoblastic Leukemia
- ID: M11220
- Name: Lymphoma
- Relevance: HIGH
- As Found: Lymphoma
- ID: M22307
- Name: Lymphoma, Mantle-Cell
- Relevance: HIGH
- As Found: Mantle Cell Lymphoma
- ID: M11222
- Name: Lymphoma, Non-Hodgkin
- Relevance: HIGH
- As Found: Diffuse small cleaved cell lymphoma
- ID: M11221
- Name: Lymphoma, Follicular
- Relevance: HIGH
- As Found: Follicular lymphoma
- ID: M18831
- Name: Lymphoma, Large B-Cell, Diffuse
- Relevance: HIGH
- As Found: Diffuse large cell lymphoma
- ID: M20554
- Name: Lymphoma, B-Cell, Marginal Zone
- Relevance: HIGH
- As Found: Marginal zone B-cell lymphoma
- ID: M14850
- Name: Recurrence
- Relevance: HIGH
- As Found: Recurrent
- ID: M18828
- Name: Lymphoma, B-Cell
- Relevance: HIGH
- As Found: B-cell Lymphoma
- ID: M5321
- Name: Burkitt Lymphoma
- Relevance: HIGH
- As Found: Burkitt lymphoma
- ID: M11251
- Name: Waldenstrom Macroglobulinemia
- Relevance: HIGH
- As Found: Waldenstrom Macroglobulinemia
- ID: M10950
- Name: Leukemia, Hairy Cell
- Relevance: HIGH
- As Found: Hairy cell leukemia
- ID: M30199
- Name: Intraocular Lymphoma
- Relevance: HIGH
- As Found: Intraocular lymphoma
- ID: M381
- Name: Plasmablastic Lymphoma
- Relevance: HIGH
- As Found: Immunoblastic large cell lymphoma
- ID: M18830
- Name: Lymphoma, Large-Cell, Immunoblastic
- Relevance: HIGH
- As Found: Immunoblastic large cell lymphoma
- ID: M11223
- Name: Lymphomatoid Granulomatosis
- Relevance: HIGH
- As Found: Lymphomatoid granulomatosis
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
- ID: M11225
- Name: Lymphoproliferative Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M11203
- Name: Lymphatic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10206
- Name: Immunoproliferative Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M9490
- Name: Hematologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
- ID: M18115
- Name: Leukemia, B-Cell
- Relevance: LOW
- As Found: Unknown
- ID: M6147
- Name: Chronic Disease
- Relevance: LOW
- As Found: Unknown
- ID: M10283
- Name: Infections
- Relevance: LOW
- As Found: Unknown
- ID: M6368
- Name: Communicable Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M21881
- Name: Epstein-Barr Virus Infections
- Relevance: LOW
- As Found: Unknown
- ID: M17522
- Name: Virus Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M9643
- Name: Herpesviridae Infections
- Relevance: LOW
- As Found: Unknown
- ID: M7442
- Name: DNA Virus Infections
- Relevance: LOW
- As Found: Unknown
- ID: M17162
- Name: Tumor Virus Infections
- Relevance: LOW
- As Found: Unknown
- ID: M27588
- Name: Neoplasms, Plasma Cell
- Relevance: LOW
- As Found: Unknown
- ID: M21977
- Name: Hemostatic Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M5059
- Name: Blood Coagulation Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M13178
- Name: Paraproteinemias
- Relevance: LOW
- As Found: Unknown
- ID: M5077
- Name: Blood Protein Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M9560
- Name: Hemorrhagic Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14111
- Name: Precancerous Conditions
- Relevance: LOW
- As Found: Unknown
- ID: M8277
- Name: Eye Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: T1308
- Name: Chronic Lymphocytic Leukemia
- Relevance: HIGH
- As Found: Small lymphocytic lymphoma
- ID: T175
- Name: Acute Lymphoblastic Leukemia
- Relevance: HIGH
- As Found: Acute Lymphoblastic Leukemia
- ID: T3533
- Name: Lymphoblastic Lymphoma
- Relevance: HIGH
- As Found: Acute Lymphoblastic Leukemia
- ID: T3543
- Name: Lymphosarcoma
- Relevance: HIGH
- As Found: Lymphoma
- ID: T3601
- Name: Mantle Cell Lymphoma
- Relevance: HIGH
- As Found: Mantle Cell Lymphoma
- ID: T2361
- Name: Follicular Lymphoma
- Relevance: HIGH
- As Found: Follicular lymphoma
- ID: T640
- Name: B-cell Lymphoma
- Relevance: HIGH
- As Found: B-cell Lymphoma
- ID: T1866
- Name: Diffuse Large B-Cell Lymphoma
- Relevance: HIGH
- As Found: Diffuse large cell lymphoma
- ID: T3612
- Name: Marginal Zone Lymphoma
- Relevance: HIGH
- As Found: Marginal zone lymphoma
- ID: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
- ID: T892
- Name: Burkitt Lymphoma
- Relevance: HIGH
- As Found: Burkitt lymphoma
- ID: T5887
- Name: Waldenstrom Macroglobulinemia
- Relevance: HIGH
- As Found: Waldenstrom Macroglobulinemia
- ID: T2650
- Name: Hairy Cell Leukemia
- Relevance: HIGH
- As Found: Hairy cell leukemia
- ID: T4586
- Name: Plasmablastic Lymphoma
- Relevance: HIGH
- As Found: Immunoblastic large cell lymphoma
- ID: T3539
- Name: Lymphoma, Large-cell, Immunoblastic
- Relevance: HIGH
- As Found: Immunoblastic large cell lymphoma
- ID: T3540
- Name: Lymphomatoid Granulomatosis
- Relevance: HIGH
- As Found: Lymphomatoid granulomatosis
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000002051
- Term: Burkitt Lymphoma
- ID: D000008223
- Term: Lymphoma
- ID: D000007938
- Term: Leukemia
- ID: D000008224
- Term: Lymphoma, Follicular
- ID: D000054198
- Term: Precursor Cell Lymphoblastic Leukemia-Lymphoma
- ID: D000007945
- Term: Leukemia, Lymphoid
- ID: D000016393
- Term: Lymphoma, B-Cell
- ID: D000008228
- Term: Lymphoma, Non-Hodgkin
- ID: D000020522
- Term: Lymphoma, Mantle-Cell
- ID: D000018442
- Term: Lymphoma, B-Cell, Marginal Zone
- ID: D000015451
- Term: Leukemia, Lymphocytic, Chronic, B-Cell
- ID: D000016403
- Term: Lymphoma, Large B-Cell, Diffuse
- ID: D000016400
- Term: Lymphoma, Large-Cell, Immunoblastic
- ID: D000069293
- Term: Plasmablastic Lymphoma
- ID: D000008258
- Term: Waldenstrom Macroglobulinemia
- ID: D000007943
- Term: Leukemia, Hairy Cell
- ID: D000008230
- Term: Lymphomatoid Granulomatosis
- ID: D000064090
- Term: Intraocular Lymphoma
- ID: D000012008
- Term: Recurrence
### Intervention Browse Module - Ancestors
- ID: D000074322
- Term: Antineoplastic Agents, Immunological
- ID: D000000970
- Term: Antineoplastic Agents
- ID: D000007155
- Term: Immunologic Factors
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000018501
- Term: Antirheumatic Agents
- ID: D000020533
- Term: Angiogenesis Inhibitors
- ID: D000043924
- Term: Angiogenesis Modulating Agents
- ID: D000006133
- Term: Growth Substances
- ID: D000006131
- Term: Growth Inhibitors
- ID: D000000903
- Term: Antibiotics, Antineoplastic
- ID: D000056572
- Term: Histone Deacetylase Inhibitors
- ID: D000004791
- Term: Enzyme Inhibitors
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: ARhu
- Name: Antirheumatic Agents
- Abbrev: Infe
- Name: Anti-Infective Agents
### Intervention Browse Module - Browse Leaves
- ID: M4225
- Name: Antibodies
- Relevance: LOW
- As Found: Unknown
- ID: M4230
- Name: Antibodies, Monoclonal
- Relevance: LOW
- As Found: Unknown
- ID: M373
- Name: Rituximab
- Relevance: HIGH
- As Found: Sclerosis
- ID: M1725
- Name: Lenalidomide
- Relevance: HIGH
- As Found: Respiratory
- ID: M10184
- Name: Immunoglobulins
- Relevance: LOW
- As Found: Unknown
- ID: M109562
- Name: Romidepsin
- Relevance: HIGH
- As Found: Health behavior
- ID: M1346
- Name: Antineoplastic Agents, Immunological
- Relevance: LOW
- As Found: Unknown
- ID: M10201
- Name: Immunologic Factors
- Relevance: LOW
- As Found: Unknown
- ID: M20604
- Name: Antirheumatic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M22318
- Name: Angiogenesis Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M9231
- Name: Growth Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M4222
- Name: Anti-Bacterial Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4224
- Name: Antibiotics, Antitubercular
- Relevance: LOW
- As Found: Unknown
- ID: M28511
- Name: Histone Deacetylase Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M7951
- Name: Enzyme Inhibitors
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000069283
- Term: Rituximab
- ID: D000077269
- Term: Lenalidomide
- ID: C000087123
- Term: Romidepsin
### Misc Info Module
#### Removed Countries
- Country: United States
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT05446779
**Acronym:** SuddenDeath
**Brief Title:** Postmortem Evaluation of Adrenal and Other Endocrine Tumors in Patients With Sudden Death
**Official Title:** Postmortem Evaluation of Adrenal and Other Endocrine Tumors in Patients With Sudden Death Without Definitive Causative Diagnosis (PEA-SuddenDeath)
#### Organization Study ID Info
**ID:** THL/5008/5.05.00/2021
#### Organization
**Class:** OTHER
**Full Name:** Helsinki University Central Hospital
### Status Module
#### Completion Date
**Date:** 2026-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-04-16
**Type:** ACTUAL
**Last Update Submit Date:** 2024-04-14
**Overall Status:** ACTIVE_NOT_RECRUITING
#### Primary Completion Date
**Date:** 2023-01-31
**Type:** ACTUAL
#### Start Date
**Date:** 2022-02-03
**Type:** ACTUAL
**Status Verified Date:** 2024-04
#### Study First Post Date
**Date:** 2022-07-07
**Type:** ACTUAL
**Study First Submit Date:** 2022-06-22
**Study First Submit QC Date:** 2022-07-04
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER_GOV
**Name:** Finnish Institute for Health and Welfare
**Class:** OTHER
**Name:** University of Helsinki
**Class:** OTHER
**Name:** Tampere University Hospital
**Class:** OTHER
**Name:** Tampere University
#### Lead Sponsor
**Class:** OTHER
**Name:** Helsinki University Central Hospital
#### Responsible Party
**Investigator Affiliation:** Helsinki University Central Hospital
**Investigator Full Name:** Niina Matikainen
**Investigator Title:** M.D., Ph.D, , Assoc. Prof.
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Sudden Cardiac Death is a leading cause of mortality and remains a major public health burden worldwide. Cardiac arrest due to coronary heart disease explains a large proportion of the cases, but if autopsy is not performed the exact underlying cause remains obscure in many adults who face sudden death outside heath care organizations. The investigators aim to find proof that primary aldosteronism is a risk factor for sudden death and to characterize the prevalence of adrenal pathology in sudden death of undetermined cause in a case-control study. In addition, the study aims to characterize the prevalence of other adrenal pathology i.e. silent adenomas, cortisol-producing adenomas and pheochromocytomas in sudden death. The investigators also seek evidence that other endocrine hormone overproduction-causing diseases are more prevalent in persons with sudden death compared with those experiencing traumatic or suicidal death sudden death.
### Conditions Module
**Conditions:**
- Primary Aldosteronism
- Adrenal Cushing Syndrome
- Pheochromocytoma
- Endocrine Neoplasia
### Design Module
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** CROSS_SECTIONAL
#### Enrollment Info
**Count:** 400
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Unexpected witnessed death occurring within an hour of the onset of symptoms in a person with or without previously known cardiac disease without an extra-cardiac cause, or unexpected unwitnessed death without extra-cardiac cause occurring in the previous 24 hours
**Intervention Names:**
- Diagnostic Test: Adrenal aldosterone synthase (CYP11B2) staining
- Diagnostic Test: Adrenal cortisol synthase (CYP11B1) staining
- Diagnostic Test: Histopathological analysis
**Label:** Sudden death
#### Arm Group 2
**Description:** Death because of an exogenic reason for sudden death such as trauma or suicide as a control group i.e. non-disease-induced sudden death
**Intervention Names:**
- Diagnostic Test: Adrenal aldosterone synthase (CYP11B2) staining
- Diagnostic Test: Adrenal cortisol synthase (CYP11B1) staining
- Diagnostic Test: Histopathological analysis
**Label:** Control
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Control
- Sudden death
**Description:** Immunoshistochemical diagnosis of primary aldosteronism
**Name:** Adrenal aldosterone synthase (CYP11B2) staining
**Type:** DIAGNOSTIC_TEST
#### Intervention 2
**Arm Group Labels:**
- Control
- Sudden death
**Description:** Immunoshistochemical diagnosis of adrenal hypercortisolism
**Name:** Adrenal cortisol synthase (CYP11B1) staining
**Type:** DIAGNOSTIC_TEST
#### Intervention 3
**Arm Group Labels:**
- Control
- Sudden death
**Description:** Diagnosis of any endocrine neoplasia other than primary aldosteronism or adrenal hypercortisolism
**Name:** Histopathological analysis
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** Histopathological diagnosis of the autopsy
**Measure:** CYP11B2 staining in adrenal glands
**Time Frame:** Through study completion, an average of 2 years
**Description:** Histopathological diagnosis of the autopsy
**Measure:** CYP11B1 staining in adrenal glands
**Time Frame:** Through study completion, an average of 2 years
#### Secondary Outcomes
**Description:** Histopathological diagnosis of the autopsy
**Measure:** CYP11B2 staining in adrenal glands
**Time Frame:** Through study completion, an average of 2 years
**Description:** Histopathological diagnosis of the autopsy
**Measure:** Pheochromocytoma or paraganglioma
**Time Frame:** Through study completion, an average of 2 years
**Description:** Histopathological diagnosis of the autopsy
**Measure:** Neuroendocrine tumor
**Time Frame:** Through study completion, an average of 2 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
Consecutive patients with out-of-hospital, sudden death
Exclusion Criteria:
1. Estimated time from death to refrigerator more than 24-48 hours and in the refrigerator time more than 7 days (susceptibility to excessive tissue breakdown)
2. Terminal disease
3. Institutionalized patients
**Maximum Age:** 70 Years
**Minimum Age:** 35 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** We enroll aproximately 200 consecutive patients with out-of-hospital, sudden death to both groups.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Helsinki
**Country:** Finland
**Facility:** Endocrinology, Helsinki University Hospital and University of Helsinki
#### Overall Officials
**Official 1:**
**Affiliation:** Helsinki University Central Hospital
**Name:** Niina Matikainen, MD, PhD, Assoc Prof
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009369
- Term: Neoplasms
- ID: D000010235
- Term: Paraganglioma
- ID: D000018358
- Term: Neuroendocrine Tumors
- ID: D000017599
- Term: Neuroectodermal Tumors
- ID: D000009373
- Term: Neoplasms, Germ Cell and Embryonal
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000009380
- Term: Neoplasms, Nerve Tissue
- ID: D000000308
- Term: Adrenocortical Hyperfunction
- ID: D000000307
- Term: Adrenal Gland Diseases
- ID: D000004700
- Term: Endocrine System Diseases
- ID: D000003643
- Term: Death
- ID: D000010335
- Term: Pathologic Processes
- ID: D000009371
- Term: Neoplasms by Site
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M13578
- Name: Pheochromocytoma
- Relevance: HIGH
- As Found: Pheochromocytoma
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M6845
- Name: Death
- Relevance: LOW
- As Found: Unknown
- ID: M7863
- Name: Endocrine Gland Neoplasms
- Relevance: HIGH
- As Found: Endocrine Neoplasia
- ID: M9980
- Name: Hyperaldosteronism
- Relevance: HIGH
- As Found: Aldosteronism
- ID: M6689
- Name: Cushing Syndrome
- Relevance: HIGH
- As Found: Cushing's Syndrome
- ID: M6847
- Name: Death, Sudden
- Relevance: HIGH
- As Found: Sudden Death
- ID: M13149
- Name: Paraganglioma
- Relevance: LOW
- As Found: Unknown
- ID: M20495
- Name: Neuroendocrine Tumors
- Relevance: LOW
- As Found: Unknown
- ID: M19845
- Name: Neuroectodermal Tumors
- Relevance: LOW
- As Found: Unknown
- ID: M20388
- Name: Neuroectodermal Tumors, Primitive
- Relevance: LOW
- As Found: Unknown
- ID: M12318
- Name: Neoplasms, Germ Cell and Embryonal
- Relevance: LOW
- As Found: Unknown
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
- ID: M12325
- Name: Neoplasms, Nerve Tissue
- Relevance: LOW
- As Found: Unknown
- ID: M3660
- Name: Adrenocortical Hyperfunction
- Relevance: LOW
- As Found: Unknown
- ID: M3659
- Name: Adrenal Gland Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7862
- Name: Endocrine System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T4530
- Name: Pheochromocytoma
- Relevance: HIGH
- As Found: Pheochromocytoma
- ID: T1679
- Name: Cushing's Syndrome
- Relevance: HIGH
- As Found: Cushing's Syndrome
- ID: T4409
- Name: Paragangliomas 1
- Relevance: LOW
- As Found: Unknown
- ID: T4091
- Name: Neuroendocrine Tumor
- Relevance: LOW
- As Found: Unknown
- ID: T4092
- Name: Neuroepithelioma
- Relevance: LOW
- As Found: Unknown
- ID: T2879
- Name: Hyperadrenalism
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000010673
- Term: Pheochromocytoma
- ID: D000004701
- Term: Endocrine Gland Neoplasms
- ID: D000006929
- Term: Hyperaldosteronism
- ID: D000003480
- Term: Cushing Syndrome
- ID: D000003645
- Term: Death, Sudden
### Intervention Browse Module - Ancestors
- ID: D000000893
- Term: Anti-Inflammatory Agents
- ID: D000000316
- Term: Adrenergic alpha-Agonists
- ID: D000000322
- Term: Adrenergic Agonists
- ID: D000018663
- Term: Adrenergic Agents
- ID: D000018377
- Term: Neurotransmitter Agents
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000000318
- Term: Adrenergic beta-Agonists
- ID: D000001993
- Term: Bronchodilator Agents
- ID: D000001337
- Term: Autonomic Agents
- ID: D000018373
- Term: Peripheral Nervous System Agents
- ID: D000018927
- Term: Anti-Asthmatic Agents
- ID: D000019141
- Term: Respiratory System Agents
- ID: D000009184
- Term: Mydriatics
- ID: D000013566
- Term: Sympathomimetics
- ID: D000014662
- Term: Vasoconstrictor Agents
### Intervention Browse Module - Browse Branches
- Abbrev: VaCoAg
- Name: Vasoconstrictor Agents
- Abbrev: Resp
- Name: Respiratory System Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Infl
- Name: Anti-Inflammatory Agents
### Intervention Browse Module - Browse Leaves
- ID: M7992
- Name: Epinephrine
- Relevance: HIGH
- As Found: Subdural
- ID: M9912
- Name: Hydrocortisone
- Relevance: HIGH
- As Found: 4 years
- ID: M155245
- Name: Hydrocortisone 17-butyrate 21-propionate
- Relevance: LOW
- As Found: Unknown
- ID: M228609
- Name: Hydrocortisone acetate
- Relevance: LOW
- As Found: Unknown
- ID: M263259
- Name: Hydrocortisone hemisuccinate
- Relevance: LOW
- As Found: Unknown
- ID: M30371
- Name: Racepinephrine
- Relevance: HIGH
- As Found: Subdural
- ID: M211043
- Name: Epinephryl borate
- Relevance: HIGH
- As Found: Subdural
- ID: M4217
- Name: Anti-Inflammatory Agents
- Relevance: LOW
- As Found: Unknown
- ID: M20746
- Name: Adrenergic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M3668
- Name: Adrenergic alpha-Agonists
- Relevance: LOW
- As Found: Unknown
- ID: M3673
- Name: Adrenergic Agonists
- Relevance: LOW
- As Found: Unknown
- ID: M20504
- Name: Neurotransmitter Agents
- Relevance: LOW
- As Found: Unknown
- ID: M3670
- Name: Adrenergic beta-Agonists
- Relevance: LOW
- As Found: Unknown
- ID: M5269
- Name: Bronchodilator Agents
- Relevance: LOW
- As Found: Unknown
- ID: M20963
- Name: Anti-Asthmatic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M21137
- Name: Respiratory System Agents
- Relevance: LOW
- As Found: Unknown
- ID: M12139
- Name: Mydriatics
- Relevance: LOW
- As Found: Unknown
- ID: M16345
- Name: Sympathomimetics
- Relevance: LOW
- As Found: Unknown
- ID: M17409
- Name: Vasoconstrictor Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000006854
- Term: Hydrocortisone
- ID: D000004837
- Term: Epinephrine
- ID: D000064705
- Term: Racepinephrine
- ID: C000018285
- Term: Epinephryl borate
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT04530279
**Brief Title:** Clinical Assessment of Burns in Norway
**Official Title:** Accordance of Clinical Assessment of Burn Depth and %TBSA Between Referring Hospitals and the National Norwegian Burn Centre
#### Organization Study ID Info
**ID:** 2014/1627, Rek-Vest
#### Organization
**Class:** OTHER
**Full Name:** Haukeland University Hospital
### Status Module
#### Completion Date
**Date:** 2023-06-30
**Type:** ESTIMATED
#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2022-03-21
**Type:** ACTUAL
**Last Update Submit Date:** 2022-03-18
**Overall Status:** UNKNOWN
#### Primary Completion Date
**Date:** 2022-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2018-01-01
**Type:** ACTUAL
**Status Verified Date:** 2022-03
#### Study First Post Date
**Date:** 2020-08-28
**Type:** ACTUAL
**Study First Submit Date:** 2020-08-25
**Study First Submit QC Date:** 2020-08-25
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Haukeland University Hospital
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Clinical assessment of burn depth and area can be challenging even for experienced surgeons. Still, the assessment is fundamental for the treatment, as it determines the fluid treatment and indication for escharotomy and need for referral to a burn centre.There are few studies comparing the initial evaluation of burn depth and surface with that of a specialist burn centre. The aim of this study was to make such a comparison for a cohort of patients admitted to a specialist burn centre during one year.The cohort was defined as patients transferred to the burn unit at Haukeland university hospital during 2014.
### Conditions Module
**Conditions:**
- Burns
**Keywords:**
- clinical assessment
- TBSA
- national burn centre
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 100
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Burn assessments performed in referring hospitals
**Intervention Names:**
- Procedure: Clinical assessment
**Label:** Referring hospital
#### Arm Group 2
**Description:** Burn assessments performed in the national burn centre
**Intervention Names:**
- Procedure: Clinical assessment
**Label:** Burn centre
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Burn centre
- Referring hospital
**Description:** Clinical assessment of burn depth and the percentage of total body surface area (TBSA) burnt with any method
**Name:** Clinical assessment
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** Burn depth measured with any described clinical method.Clinical assessment of depth is a subjective evaluation based on visual and tactile characteristics, that is, wound appearance, capillary refill and wound sensibility to touch and pin prick.
**Measure:** Burn depth
**Time Frame:** 1 year
**Description:** TBSA measured with any described clinical method, for example, Wallace's Rule of Nines, Lund and Browder charts, and Palmar Surface Measurement ('rule of palm')
**Measure:** The percentage of total body surface area (TBSA) burnt
**Time Frame:** 1 year
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients transferred to the burn unit at Haukeland university hospital during 2014
Exclusion Criteria:
* Readmissions
* Patients transported to Haukeland directly from the site of the accident
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
**Study Population:** The cohort was defined as patients transferred to the burn unit at Haukeland university hospital during 2014.The incidence of burns in Norway is 15.5 /100 000/ year (pop.
5.2 mill), and 70-100 patients a year is treated at the national burn centre. The
Australian and New Zealand Burn Association (ANZBA) referral criteria are used:
* Burns \> 10% Total Body Surface Area (TBSA)
* Burns \> 5% TBSA in children
* Full Thickness burns \> 5% TBSA
* Burns of Special Areas - Face, Hands, Feet, Genitalia, Perineum, Major Joints and circumferential limb or chest burns
* Burns with inhalation injury
* Electrical burns
* Chemical burns
* Burns with pre-existing illness
* Burns associated with major trauma
* Burns at the extremes of age - young children and the elderly
* Burn injury in pregnant women
* Non-accidental burns
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Ragnvald L Brekke, MD
**Phone:** +4740874208
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Bergen
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Ragnvald L Brekke, MD
- **Phone:** +47 40874208
- **Role:** CONTACT
**Country:** Norway
**Facility:** Haukeland University Hospital
**State:** Vestland
**Status:** RECRUITING
**Zip:** 5021
#### Overall Officials
**Official 1:**
**Affiliation:** Haukeland University Hospital
**Name:** Ragnvald L Brekke, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000014947
- Term: Wounds and Injuries
### Condition Browse Module - Browse Branches
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M5326
- Name: Burns
- Relevance: HIGH
- As Found: Burn
- ID: M17685
- Name: Wounds and Injuries
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000002056
- Term: Burns
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT00385879
**Brief Title:** The Effects of Case Management in a Medicaid Managed Care Plan
**Official Title:** The Effects of Case Management in a Medicaid Managed Care Plan
#### Organization Study ID Info
**ID:** Health Plus at Home
#### Organization
**Class:** OTHER
**Full Name:** Metropolitan Jewish Health System
### Status Module
#### Completion Date
**Date:** 2008-01
#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2006-10-11
**Type:** ESTIMATED
**Last Update Submit Date:** 2006-10-10
**Overall Status:** UNKNOWN
#### Start Date
**Date:** 2006-05
**Status Verified Date:** 2006-10
#### Study First Post Date
**Date:** 2006-10-11
**Type:** ESTIMATED
**Study First Submit Date:** 2006-10-09
**Study First Submit QC Date:** 2006-10-10
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Metropolitan Jewish Health System
### Description Module
**Brief Summary:** The purpose of this study is to evaluate whether or not case management by a social worker and nurse can decrease the number of emergency room visits, increase the number of primary care doctor visits, and increase quality of life of people in a Medicaid managed care plan.
**Detailed Description:** This study will assign participants based on Zip Code to one of two conditions: control and experimental. In the control group, participants will receive telephonic assessments at baseline, three months, and six months. These assessments will be conducted by a member of the Medical Center's Department of Geriatrics under the supervision of the Principal Investigator. Participants in the experimental group will receive medical case management provided by a nurse and social worker in the homecare setting including an in-home assessment. Assessments will be conducted at baseline, three months, and six months during routine homecare visits. Dependent variables being measured include: access to primary care physicians, emergent hospitalizations/admissions, articulation of advance directives, and quality of life. Data will be collected through the participants' medical claims and records to analyze the number of emergent hospitalizations/admissions, documentation of advance directives, and number of visits to primary care physicians. To measure participants' quality of life, the Depression Self-Rating Scale and the Clinical Anxiety Scale will be utilized. Data will be compared between and within the groups via statistical analyses. The researcher will conduct pre-post comparisons of utilization and other database-derived outcomes for both groups, comparing the 12 months prior to and up to 20 months following enrollment.
### Conditions Module
**Conditions:**
- Neoplasms
- Heart Diseases
- Adrenal Cortex Diseases
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** CROSSOVER
##### Masking Info
**Masking:** NONE
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 500
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
### Interventions
#### Intervention 1
**Name:** Case management
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Measure:** The outcome measure for the number of emergency room visits will be calculated from the medical record counting the number of hospital emergency room visits; for access to primary physicians, the medical record will be reviewed as well.
#### Secondary Outcomes
**Measure:** The outcomes for quality of life will be evaluated from the McGill Quality of Life Questionnaire.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* participation in a Medicaid managed care plan
* resident of identified zip codes in Brooklyn, NY
* frequent hospitalizations and low frequency of primary doctor visits
Exclusion Criteria:
* residents outside the catchment area
* patients not being managed in a Medicaid managed care plan
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Russell E Hilliard, PhD, LCSW
**Phone:** 718-491-7214
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Eliot Fishman, PhD
**Phone:** 718-491-7134
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Brooklyn
**Contacts:**
***Contact 1:***
- **Name:** Eliot Fishman, PhD
- **Role:** SUB_INVESTIGATOR
**Country:** United States
**Facility:** Metropolitan Jewish Health System
**State:** New York
**Status:** RECRUITING
**Zip:** 11220
#### Overall Officials
**Official 1:**
**Affiliation:** Maimonides Medical Center
**Name:** Barbara Paris, MD
**Role:** PRINCIPAL_INVESTIGATOR
### References Module
#### References
**Citation:** Chattopadhyay A, Bindman AB. The contribution of Medicaid managed care to the increasing undercount of Medicaid beneficiaries in the Current Population Survey. Med Care. 2006 Sep;44(9):822-6. doi: 10.1097/01.mlr.0000218835.78953.53.
**PMID:** 16932133
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000000307
- Term: Adrenal Gland Diseases
- ID: D000004700
- Term: Endocrine System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
### Condition Browse Module - Browse Leaves
- ID: M9419
- Name: Heart Diseases
- Relevance: HIGH
- As Found: Heart Disease
- ID: M3655
- Name: Adrenal Cortex Diseases
- Relevance: HIGH
- As Found: Adrenal Cortex Diseases
- ID: M3659
- Name: Adrenal Gland Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7862
- Name: Endocrine System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000006331
- Term: Heart Diseases
- ID: D000000303
- Term: Adrenal Cortex Diseases
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT02396979
**Acronym:** Harapan
**Brief Title:** Intervention of HIV, Drug Use and the Criminal Justice System in Malaysia
**Official Title:** Intervention of HIV, Drug Use and the Criminal Justice System in Malaysia
#### Organization Study ID Info
**ID:** 0908005646
#### Organization
**Class:** OTHER
**Full Name:** Yale University
#### Secondary ID Infos
**ID:** R01DA025943
**Link:** https://reporter.nih.gov/quickSearch/R01DA025943
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2014-12
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-02-26
**Type:** ACTUAL
**Last Update Submit Date:** 2024-02-23
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2014-12
**Type:** ACTUAL
#### Start Date
**Date:** 2010-01
**Status Verified Date:** 2024-02
#### Study First Post Date
**Date:** 2015-03-24
**Type:** ESTIMATED
**Study First Submit Date:** 2015-02-23
**Study First Submit QC Date:** 2015-03-17
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** University of Malaya
**Class:** NIH
**Name:** National Institute on Drug Abuse (NIDA)
#### Lead Sponsor
**Class:** OTHER
**Name:** Yale University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Is US Export:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The purpose of this study is to evaluate the relative impact a medical drug (methadone) or behavioral counseling program (Holistic Health Recovery Program) or both (methadone and Holistic Health Recovery Program) has on reducing HIV-related risk behaviors and illicit drug use among opioid-dependent, HIV-infected individuals in prison when given 90 to 180 days prior to leaving prison.
### Conditions Module
**Conditions:**
- Human Immunodeficiency Virus
- Acquired Immunodeficiency Syndrome
- Opiate Addiction
- Drug Dependence
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** FACTORIAL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 300
**Type:** ACTUAL
**Phases:**
- PHASE4
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Methadone induction and management provided
**Intervention Names:**
- Drug: Methadone
**Label:** Methadone Maintenance
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Administration of the Holistic Health Recovery Program (HHRP-M), which is an eight-session substance abuse relapse prevention and harm reduction program administered by a trained substance abuse counselor.
**Intervention Names:**
- Behavioral: Holistic Health Recovery Program
**Label:** Holistic Health Recovery Program
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Methadone induction and management provided in combination with the Holistic Health Recovery Program (HHRP-M).
**Intervention Names:**
- Drug: Methadone
- Behavioral: Holistic Health Recovery Program
**Label:** Methadone Maintenance and Holistic Health Recovery Prorgram
**Type:** EXPERIMENTAL
#### Arm Group 4
**Description:** Standard of care provided for substance abuse treatment. No methadone maintenance or holistic health recovery program intervention provided.
**Label:** Standard of Care
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Methadone Maintenance
- Methadone Maintenance and Holistic Health Recovery Prorgram
**Name:** Methadone
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Holistic Health Recovery Program
- Methadone Maintenance and Holistic Health Recovery Prorgram
**Name:** Holistic Health Recovery Program
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** The primary outcome is the number of HIV high risk events. This outcome will be constructed from a composite measure counting the number of unprotected vaginal and anal insertive events and needle-or-syringe-sharing events with an HIV- or HIV-status-unknown partner that might result in HIV transmission to an uninfected partner. As such, the primary outcome will be the number of high-risk events during the period of observation in the intervention. All data will be self-reported by the participant.
**Measure:** HIV Risk Events
**Time Frame:** Change from Baseline in HIV Risk Events at Months 3, 6, 9 and 12
#### Secondary Outcomes
**Description:** This outcome will be measured by a series of questions that will be used to produce a composite score that will indicate the participant's overall quality of life as it relates to their HIV status. These questions will ask about your general health and your ability to perform daily activities in your life. All data will be self-reported by the participant.
**Measure:** HIV Quality of Life
**Time Frame:** Change from Baseline in HIV Quality of Life at Months 3, 6, 9 and 12
**Description:** This outcome will be measured as any opioid drug use after release from prison. This outcome will be measured in two ways. First, participants will provide a monthly urine sample that will be tested for the presence of opioids. Second, participants will answer questions about their drug use since the time of their last interview.
**Measure:** Relapse to Drug Use
**Time Frame:** Change from Baseline in Relapse to Drug Use at Months 3, 6, 9 and 12
**Description:** This outcome will be measured by a series of questions about the participant's drug use. These questions will be used to produce a composite score which indicates the severity of the participant's addiction.
**Measure:** Addiction Severity
**Time Frame:** Change from Baseline in Addiction Severity at Months 3, 6, 9 and 12
**Description:** This outcome will be measured by both self-report and objective data from the Malaysian Ministry of Prisons. Self-report questions will be used to ask participants if they have been arrested by police (placed in jail) or incarcerated in prison during the time since the last interview. Objective data will also be obtained from the Ministry of Prisons which will indicate if the participant has been reincarcerated in one of Malaysia's prison during the 12 months since they were initially released from prison.
**Measure:** Reincarceration
**Time Frame:** Any reincarceration to prison during the 12 month post-release follow-up period
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* HIV-infected
* Clinical Diagnosis of Opioid Dependence
* Fluent in Bahasa Malaysia or English
* Within 90 to 180 days of release from prison
* Planning to live in Klang Valley region after release from prison
* Able to provide informed consent
Exclusion Criteria:
* Pregnancy or planning to become pregnant (female only)
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Overall Officials
**Official 1:**
**Affiliation:** Yale University
**Name:** Frederick L Altice, M.D.
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** University of Malaya
**Name:** Adeeba Kamarulzaman, M.D.
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
### References Module
#### References
**Citation:** Bazazi AR, Culbert GJ, Wegman MP, Heimer R, Kamarulzaman A, Altice FL. Impact of prerelease methadone on mortality among people with HIV and opioid use disorder after prison release: results from a randomized and participant choice open-label trial in Malaysia. BMC Infect Dis. 2022 Nov 11;22(1):837. doi: 10.1186/s12879-022-07804-6.
**PMID:** 36368939
**Citation:** Chandra DK, Bazazi AR, Nahaboo Solim MA, Kamarulzaman A, Altice FL, Culbert GJ. Retention in clinical trials after prison release: results from a clinical trial with incarcerated men with HIV and opioid dependence in Malaysia. HIV Res Clin Pract. 2019 Feb;20(1):12-23. doi: 10.1080/15284336.2019.1603433. Epub 2019 May 1.
**PMID:** 31303149
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007154
- Term: Immune System Diseases
- ID: D000086982
- Term: Blood-Borne Infections
- ID: D000003141
- Term: Communicable Diseases
- ID: D000007239
- Term: Infections
- ID: D000015229
- Term: Sexually Transmitted Diseases, Viral
- ID: D000012749
- Term: Sexually Transmitted Diseases
- ID: D000016180
- Term: Lentivirus Infections
- ID: D000012192
- Term: Retroviridae Infections
- ID: D000012327
- Term: RNA Virus Infections
- ID: D000014777
- Term: Virus Diseases
- ID: D000012897
- Term: Slow Virus Diseases
- ID: D000091662
- Term: Genital Diseases
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000064419
- Term: Chemically-Induced Disorders
- ID: D000001523
- Term: Mental Disorders
- ID: D000079524
- Term: Narcotic-Related Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC01
- Name: Infections
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: BC25
- Name: Substance Related Disorders
### Condition Browse Module - Browse Leaves
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M3522
- Name: Acquired Immunodeficiency Syndrome
- Relevance: HIGH
- As Found: Acquired Immunodeficiency Syndrome
- ID: M18250
- Name: HIV Infections
- Relevance: HIGH
- As Found: Acquired Immunodeficiency Syndrome
- ID: M19100
- Name: Behavior, Addictive
- Relevance: LOW
- As Found: Unknown
- ID: M17522
- Name: Virus Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10199
- Name: Immunologic Deficiency Syndromes
- Relevance: HIGH
- As Found: Immunodeficiency
- ID: M10283
- Name: Infections
- Relevance: LOW
- As Found: Unknown
- ID: M6368
- Name: Communicable Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M21837
- Name: Substance-Related Disorders
- Relevance: HIGH
- As Found: Drug Dependence
- ID: M12244
- Name: Opioid-Related Disorders
- Relevance: HIGH
- As Found: Opiate Addiction
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M2593
- Name: Blood-Borne Infections
- Relevance: LOW
- As Found: Unknown
- ID: M15558
- Name: Sexually Transmitted Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17933
- Name: Sexually Transmitted Diseases, Viral
- Relevance: LOW
- As Found: Unknown
- ID: M18640
- Name: Lentivirus Infections
- Relevance: LOW
- As Found: Unknown
- ID: M15026
- Name: Retroviridae Infections
- Relevance: LOW
- As Found: Unknown
- ID: M15149
- Name: RNA Virus Infections
- Relevance: LOW
- As Found: Unknown
- ID: M15700
- Name: Slow Virus Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M2876
- Name: Genital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M30302
- Name: Chemically-Induced Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M2057
- Name: Narcotic-Related Disorders
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000000163
- Term: Acquired Immunodeficiency Syndrome
- ID: D000015658
- Term: HIV Infections
- ID: D000007153
- Term: Immunologic Deficiency Syndromes
- ID: D000019966
- Term: Substance-Related Disorders
- ID: D000009293
- Term: Opioid-Related Disorders
### Intervention Browse Module - Ancestors
- ID: D000000701
- Term: Analgesics, Opioid
- ID: D000009294
- Term: Narcotics
- ID: D000002492
- Term: Central Nervous System Depressants
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000000700
- Term: Analgesics
- ID: D000018689
- Term: Sensory System Agents
- ID: D000018373
- Term: Peripheral Nervous System Agents
- ID: D000000996
- Term: Antitussive Agents
- ID: D000019141
- Term: Respiratory System Agents
### Intervention Browse Module - Browse Branches
- Abbrev: Analg
- Name: Analgesics
- Abbrev: AnTuAg
- Name: Antitussive Agents
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: Resp
- Name: Respiratory System Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: AnObAg
- Name: Anti-Obesity Agents
- Abbrev: VaCoAg
- Name: Vasoconstrictor Agents
### Intervention Browse Module - Browse Leaves
- ID: M11671
- Name: Methadone
- Relevance: HIGH
- As Found: Of Children
- ID: M4032
- Name: Analgesics
- Relevance: LOW
- As Found: Unknown
- ID: M4033
- Name: Analgesics, Opioid
- Relevance: LOW
- As Found: Unknown
- ID: M12245
- Name: Narcotics
- Relevance: LOW
- As Found: Unknown
- ID: M13570
- Name: Phenylpropanolamine
- Relevance: LOW
- As Found: Unknown
- ID: M9238
- Name: Guaifenesin
- Relevance: LOW
- As Found: Unknown
- ID: M186319
- Name: Chlorpheniramine, phenylpropanolamine drug combination
- Relevance: LOW
- As Found: Unknown
- ID: M4312
- Name: Antitussive Agents
- Relevance: LOW
- As Found: Unknown
- ID: M21137
- Name: Respiratory System Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000008691
- Term: Methadone
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT01806779
**Acronym:** ConNic5
**Brief Title:** Combination Bupropion / Varenicline for Smoking Cessation in Male Smokers
**Official Title:** Combination Bupropion / Varenicline for Smoking Cessation in Male Smokers
#### Organization Study ID Info
**ID:** Pro00042699
#### Organization
**Class:** OTHER
**Full Name:** Duke University
#### Secondary ID Infos
**ID:** 1P50DA027840-01A1
**Link:** https://reporter.nih.gov/quickSearch/1P50DA027840-01A1
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2015-03
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2016-01-18
**Type:** ESTIMATED
**Last Update Submit Date:** 2015-12-14
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2014-12
**Type:** ACTUAL
#### Results First Post Date
**Date:** 2015-10-08
**Type:** ESTIMATED
**Results First Submit Date:** 2015-09-03
**Results First Submit QC Date:** 2015-09-03
#### Start Date
**Date:** 2013-03
**Status Verified Date:** 2015-10
#### Study First Post Date
**Date:** 2013-03-07
**Type:** ESTIMATED
**Study First Submit Date:** 2013-03-06
**Study First Submit QC Date:** 2013-03-06
### Sponsor Collaborators Module
#### Collaborators
**Class:** NIH
**Name:** National Institute on Drug Abuse (NIDA)
**Class:** INDUSTRY
**Name:** Philip Morris USA, Inc.
#### Lead Sponsor
**Class:** OTHER
**Name:** Duke University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Previous results from the investigators' Center have shown that combination treatment with Chantix and Zyban is more successful in helping men quit smoking. The investigators hope to replicate these findings with this study.
### Conditions Module
**Conditions:**
- Nicotine Dependence
**Keywords:**
- Nicotine addiction
- Cigarette smoking
- Smoking cessation
- Zyban
- Chantix
- Nicotine patches
- varenicline
- bupropion
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 376
**Type:** ACTUAL
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** For the first 3 days after being switched from Nicotine Replacement Therapy (NRT) (occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12-week active treatment duration.
**Intervention Names:**
- Drug: Chantix
- Drug: Nicotine patches
**Label:** Chantix
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** For the first 3 days after being switched from NRT (occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus Zyban at a dose of 150mg once per day. Subsequently, the dose of Chantix will be 1 mg twice per day and the dose of Zyban will be 150 mg twice per day for the remainder of the 12-week active treatment duration.
**Intervention Names:**
- Drug: Chantix
- Drug: Zyban
- Drug: Nicotine patches
**Label:** Chantix + Zyban
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Chantix
- Chantix + Zyban
**Name:** Chantix
**Other Names:**
- Varenicline
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Chantix + Zyban
**Name:** Zyban
**Other Names:**
- Bupropion
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- Chantix
- Chantix + Zyban
**Description:** All participants will receive 21 mg/24 h dose nicotine (nic.) patches for 1 week.
**Name:** Nicotine patches
**Other Names:**
- NRT
**Type:** DRUG
### Outcomes Module
#### Other Outcomes
**Description:** Withdrawal symptoms will be assessed by questionnaire on Quit Day, Week 1, Week 3, Week 7 and Week 11 post target quit date and 6 months post quit Follow-Up (if applicable) using the Shiffman-Jarvik questionnaire, which consists of 33-items rated from 1 to 7, where 1= not at all, 2= very little, 3= a little, 4= moderately, 5= a lot, 6= quite a lot, and 7= extremely. The 33 items are grouped into 8 subscales: Craving, Negative Affect, Appetite, Arousal, Somatic - Anxiety, Somatic - G.I., Somatic - Respiratory Tract, and Habit Withdrawal. The range of scores for each subscale will be 1-7, with higher scores indicating more of the withdrawal symptom having been experienced.
**Measure:** Change in Smoking Withdrawal Symptoms
**Time Frame:** Quit Day and 1 week, 3 weeks, 7 Weeks, 11 Weeks and 6 months post Quit Day
#### Primary Outcomes
**Description:** This will be determined by a composite of self-report at the 11-week study visit of no smoking between the 8-week and 11-week visits and expired air carbon monoxide (CO) \<10 ppm (measured at the 11-week study visit). An intent-to-treat criterion will be used, whereby drop-outs are considered to be non-abstinent.
**Measure:** Number of Participants Completing Continuous Four-week Abstinence From Smoking Between the 8-week and 11-week Post Quit Day Visits
**Time Frame:** Period between 8-week and 11-week visits post target Quit Day
#### Secondary Outcomes
**Description:** This will be determined by a self-report of no smoking for the previous seven days when called for 6-month follow-up confirmed by expired air CO.
**Measure:** Number of Participants Completing Seven-day Point Abstinence From Smoking at 6 Months Post Quit Day
**Time Frame:** 6 months post Quit Day
**Description:** This will be determined by a composite of self-report of no smoking between study visits at the 1-week, 3-week, 7-week and 11-week post Quit Day study visits and expired air carbon monoxide (CO) \<10 ppm (measured at those study visits). An intent-to-treat criterion will be used, whereby drop-outs are considered to be non-abstinent.
**Measure:** Number of Participants Completing Continuous Abstinence From Smoking Between Quit Day and 11-week Post Quit Day Visit
**Time Frame:** Quit Day to 11-week post Quit Day study visit
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Have no known serious medical conditions;
* Male;
* Are 18-65 years old;
* Smoke an average of at least 10 cigarettes per day;
* Have smoked at least one cumulative year;
* Have an expired air carbon monoxide (CO) reading of at least 10ppm;
* Able to read and understand English;
* Express a desire to quit smoking in the next thirty days.
Potential subjects must agree to use acceptable contraception.
Potential subjects must agree to avoid the following:
* participation in any other nicotine-related modification strategy outside of this protocol;
* use of tobacco products other than cigarettes, including pipe tobacco, cigars, e-cigarettes, snuff, and chewing tobacco;
* use of experimental (investigational) drugs or devices;
* use of illegal drugs;
* use of opiate medications.
Exclusion Criteria:
* Hypertension;
* Hypotension with symptoms;
* Coronary heart disease;
* Lifetime history of heart attack;
* Cardiac rhythm disorder (irregular heart rhythm);
* Chest pains (unless history, exam, and electrocardiogram (ECG) clearly indicate a non-cardiac source);
* Cardiac (heart) disorder (including but not limited to valvular heart disease, heart murmur, heart failure);
* History of skin allergy;
* Active skin disorder (e.g., psoriasis) within the last five years;
* Liver or kidney disorder (except kidney stones, gallstones);
* Gastrointestinal problems or disease other than gastroesophageal reflux or heartburn;
* Active ulcers in the past 30 days;
* Currently symptomatic lung disorder/disease (including but not limited to Chronic obstructive pulmonary disease (COPD), emphysema, and asthma);
* Brain abnormality (including but not limited to stroke, brain tumor, and seizure disorder);
* Migraine headaches that occur more frequently than once per week;
* Recent, unexplained fainting spells;
* Problems giving blood samples;
* Diabetes treated with insulin; non-insulin treated diabetes (unless glucose is less than 180mg/dcl and HbA1c is less than 7%);
* Current cancer or treatment for cancer in the past six months (except basal or squamous cell skin cancer);
* Other major medical condition;
* Current psychiatric disease (with the exception of anxiety disorders, Obsessive Compulsive Disorder (OCD) and ADHD);
* Suicidal ideation (within the past 10 years) or lifetime occurrence of attempted suicide;
* Current depression;
* Bulimia or anorexia;
* Use of opiate medications for pain or sleep (non-opiate medication for pain or sleep will be allowed) within the past 14 days;
* Smoking more than one cigar a month.
* Alcohol abuse;
* Significant adverse reaction to nicotine patches, bupropion / Wellbutrin / Zyban or Chantix / varenicline in the past.
* Current participation or recent participation (in the past 30 days) in another smoking study at our Center or another research facility.
* Current participation in another research study.
Use (within the past 30 days) of:
* Illegal drugs (or if the urine drug screen is positive for tetrahydrocannabinol (THC), Cocaine, Amphetamine, Opiates, Methamphetamines, phencyclidine (PCP), Benzodiazepines, or Barbiturates),
* Experimental (investigational) drugs;
* Psychiatric medications including antidepressants, anti-psychotics or any other medications that are known to affect smoking cessation (e.g. clonidine);
* Smokeless tobacco (chewing tobacco, snuff), pipes or e-cigarettes;
* Wellbutrin, bupropion, Zyban, Chantix, varenicline, nicotine replacement therapy or any other smoking cessation aid.
**Maximum Age:** 65 Years
**Minimum Age:** 18 Years
**Sex:** MALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Charlotte
**Country:** United States
**Facility:** Duke Center for Smoking Cessation
**State:** North Carolina
**Zip:** 28210
**Location 2:**
**City:** Durham
**Country:** United States
**Facility:** Duke Center for Smoking Cessation
**State:** North Carolina
**Zip:** 27705
**Location 3:**
**City:** Raleigh
**Country:** United States
**Facility:** Duke Center for Smoking Cessation
**State:** North Carolina
**Zip:** 27609
**Location 4:**
**City:** Winston-Salem
**Country:** United States
**Facility:** Duke Center for Smoking Cessation
**State:** North Carolina
**Zip:** 27103
#### Overall Officials
**Official 1:**
**Affiliation:** Duke University
**Name:** Jed E Rose, Ph.D.
**Role:** PRINCIPAL_INVESTIGATOR
### References Module
#### References
**Citation:** Rose JE, Behm FM. Combination Varenicline/Bupropion Treatment Benefits Highly Dependent Smokers in an Adaptive Smoking Cessation Paradigm. Nicotine Tob Res. 2017 Aug 1;19(8):999-1002. doi: 10.1093/ntr/ntw283.
**PMID:** 29054128
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000019966
- Term: Substance-Related Disorders
- ID: D000064419
- Term: Chemically-Induced Disorders
- ID: D000001523
- Term: Mental Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
- Abbrev: BC25
- Name: Substance Related Disorders
### Condition Browse Module - Browse Leaves
- ID: M19100
- Name: Behavior, Addictive
- Relevance: LOW
- As Found: Unknown
- ID: M16785
- Name: Tobacco Use Disorder
- Relevance: HIGH
- As Found: Nicotine Dependence
- ID: M21837
- Name: Substance-Related Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M30302
- Name: Chemically-Induced Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000014029
- Term: Tobacco Use Disorder
### Intervention Browse Module - Ancestors
- ID: D000005731
- Term: Ganglionic Stimulants
- ID: D000001337
- Term: Autonomic Agents
- ID: D000018373
- Term: Peripheral Nervous System Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000018722
- Term: Nicotinic Agonists
- ID: D000018679
- Term: Cholinergic Agonists
- ID: D000018678
- Term: Cholinergic Agents
- ID: D000018377
- Term: Neurotransmitter Agents
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000018687
- Term: Antidepressive Agents, Second-Generation
- ID: D000000928
- Term: Antidepressive Agents
- ID: D000011619
- Term: Psychotropic Drugs
- ID: D000018765
- Term: Dopamine Uptake Inhibitors
- ID: D000014179
- Term: Neurotransmitter Uptake Inhibitors
- ID: D000049990
- Term: Membrane Transport Modulators
- ID: D000015259
- Term: Dopamine Agents
- ID: D000065690
- Term: Cytochrome P-450 CYP2D6 Inhibitors
- ID: D000065607
- Term: Cytochrome P-450 Enzyme Inhibitors
- ID: D000004791
- Term: Enzyme Inhibitors
### Intervention Browse Module - Browse Branches
- Abbrev: PsychDr
- Name: Psychotropic Drugs
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: CNSSti
- Name: Central Nervous System Stimulants
- Abbrev: CaAg
- Name: Cardiotonic Agents
### Intervention Browse Module - Browse Leaves
- ID: M19013
- Name: Bupropion
- Relevance: HIGH
- As Found: 10 days
- ID: M12478
- Name: Nicotine
- Relevance: HIGH
- As Found: Prior to
- ID: M278
- Name: Varenicline
- Relevance: HIGH
- As Found: Option
- ID: M4029
- Name: Central Nervous System Stimulants
- Relevance: LOW
- As Found: Unknown
- ID: M20796
- Name: Nicotinic Agonists
- Relevance: LOW
- As Found: Unknown
- ID: M20758
- Name: Cholinergic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M20504
- Name: Neurotransmitter Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4247
- Name: Antidepressive Agents
- Relevance: LOW
- As Found: Unknown
- ID: M14474
- Name: Psychotropic Drugs
- Relevance: LOW
- As Found: Unknown
- ID: M7473
- Name: Dopamine
- Relevance: LOW
- As Found: Unknown
- ID: M20832
- Name: Dopamine Uptake Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M17962
- Name: Dopamine Agents
- Relevance: LOW
- As Found: Unknown
- ID: M7951
- Name: Enzyme Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M30537
- Name: Cytochrome P-450 Enzyme Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: T482
- Name: Varenicline
- Relevance: HIGH
- As Found: Option
### Intervention Browse Module - Meshes
- ID: D000016642
- Term: Bupropion
- ID: D000009538
- Term: Nicotine
- ID: D000068580
- Term: Varenicline
### Misc Info Module
- Version Holder: 2024-05-24
## Results Section
### Adverse Events Module
**Description:** Serious Adverse Events (AE) were evaluated for all subjs. who rcvd. nic. patches at Visit (V) 1 (197), \& subjs. randomized to receive Chantix (90) or Chantix+Zyban (84) at V2. Other AEs were evaluated for all subjs. receiving nic. patches \& completing V2 SE quest. (176), \& randomized subjs. completing SE quest. at V3 (170) \& at subsequent visits.
#### Event Groups
**Group ID:** EG000
**Title:** Chantix
**Description:** For the first 3 days after being switched from Nicotine Replacement Therapy (NRT, occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12-week active treatment duration.
Chantix
Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week.
**ID:** EG000
**Other Num Affected:** 39
**Other Num at Risk:** 87
**Serious Number Affected:** 3
**Serious Number At Risk:** 90
**Title:** Chantix
**Group ID:** EG001
**Title:** Chantix + Zyban
**Description:** For the first 3 days after being switched from Nicotine Replacement Therapy (NRT, occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus Zyban at a dose of 150mg once per day. Subsequently, the dose of Chantix will be 1 mg twice per day and the dose of Zyban will be 150 mg twice per day for the remainder of the 12-week active treatment duration.
Chantix
Zyban
Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week.
**ID:** EG001
**Other Num Affected:** 53
**Other Num at Risk:** 83
**Serious Number Affected:** 2
**Serious Number At Risk:** 84
**Title:** Chantix + Zyban
**Group ID:** EG002
**Title:** Nicotine Patch
**Description:** All participants will receive Nicotine Replacement Therapy (NRT) in the form of 21 mg/24 h dose nicotine patches for 1 week prior to randomization to treatment with Chantix alone or Chantix + Zyban.
**ID:** EG002
**Other Num Affected:** 57
**Other Num at Risk:** 176
**Serious Number At Risk:** 197
**Title:** Nicotine Patch
**Frequency Threshold:** 5
#### Other Events
**Term:** Headache
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
**Source Vocabulary:**
**Term:** Excessive Sweating
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
**Source Vocabulary:**
**Term:** Change in Taste
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
**Source Vocabulary:**
**Term:** Dry Mouth
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:**
**Term:** Thirst
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:**
**Term:** Joint/Muscle/Back Pain
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Musculoskeletal and connective tissue disorders
**Source Vocabulary:**
**Term:** Irritability
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
**Source Vocabulary:**
**Term:** Vivid Dreams
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
**Source Vocabulary:**
**Term:** Insomnia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
**Source Vocabulary:**
**Term:** Anxiety
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Psychiatric disorders
**Source Vocabulary:**
**Term:** Decreased Libido
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:**
**Term:** Itching/Burning at Patch Site
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
**Source Vocabulary:**
#### Serious Events
**Term:** Allergic Reaction to Chantix or Zyban
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 90
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 84
**Num Events:** 1
**Group ID:** EG002
**Num At Risk:** 197
**Term:** Non-cardiac Chest Pain & Right Ventricular Hypertrophy
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 90
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 84
**Group ID:** EG002
**Num At Risk:** 197
**Term:** Jaw & upper extremity fracture due to an accident
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Injury, poisoning and procedural complications
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 90
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 84
**Group ID:** EG002
**Num At Risk:** 197
**Term:** COPD and reactive airway disease
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 90
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 84
**Group ID:** EG002
**Num At Risk:** 197
**Term:** Left sided weakness, headache, blurred vision
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 90
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 84
**Num Events:** 1
**Group ID:** EG002
**Num At Risk:** 197
**Time Frame:** Subjects (subjs.) received (rcvd.) study drugs for 13 weeks. At each study session during this period subjs. completed a questionnaire about side effects (SE). Subjs. were also told to contact study staff between study sessions if SE were bothersome.
## Results Section - Baseline Characteristics Module
### Denomination Counts
**Group ID:** BG000
**Value:** 90
**Group ID:** BG001
**Value:** 84
**Group ID:** BG002
**Value:** 174
**Units:** Participants
### Group
**ID:** BG000
**Title:** Chantix
**Description:** For the first 3 days after being switched from Nicotine Replacement Therapy (NRT, occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12-week active treatment duration.
Chantix
Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week.
### Group
**ID:** BG001
**Title:** Chantix + Zyban
**Description:** For the first 3 days after being switched from NRT (occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus Zyban at a dose of 150mg once per day. Subsequently, the dose of Chantix will be 1 mg twice per day and the dose of Zyban will be 150 mg twice per day for the remainder of the 12-week active treatment duration.
Chantix
Zyban
Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week.
### Group
**ID:** BG002
**Title:** Total
**Description:** Total of all reporting groups
### Measure
#### Measurement
**Group ID:** BG000
**Value:** 0
#### Measurement
**Group ID:** BG001
**Value:** 0
#### Measurement
**Group ID:** BG002
**Value:** 0
**Category Title:** <=18 years
#### Measurement
**Group ID:** BG000
**Value:** 90
#### Measurement
**Group ID:** BG001
**Value:** 84
#### Measurement
**Group ID:** BG002
**Value:** 174
**Category Title:** Between 18 and 65 years
#### Measurement
**Group ID:** BG000
**Value:** 0
#### Measurement
**Group ID:** BG001
**Value:** 0
#### Measurement
**Group ID:** BG002
**Value:** 0
**Category Title:** >=65 years
**Class Title:**
### Measure
#### Measurement
**Group ID:** BG000
**Spread:** 11.381
**Value:** 44.75
#### Measurement
**Group ID:** BG001
**Spread:** 10.562
**Value:** 43.12
#### Measurement
**Group ID:** BG002
**Spread:** 10.992
**Value:** 43.96
**Class Title:**
### Measure
#### Measurement
**Group ID:** BG000
**Value:** 0
#### Measurement
**Group ID:** BG001
**Value:** 0
#### Measurement
**Group ID:** BG002
**Value:** 0
**Category Title:** Female
#### Measurement
**Group ID:** BG000
**Value:** 90
#### Measurement
**Group ID:** BG001
**Value:** 84
#### Measurement
**Group ID:** BG002
**Value:** 174
**Category Title:** Male
**Class Title:**
### Measure
#### Measurement
**Group ID:** BG000
**Value:** 2
#### Measurement
**Group ID:** BG001
**Value:** 1
#### Measurement
**Group ID:** BG002
**Value:** 3
**Category Title:** Hispanic or Latino
#### Measurement
**Group ID:** BG000
**Value:** 88
#### Measurement
**Group ID:** BG001
**Value:** 83
#### Measurement
**Group ID:** BG002
**Value:** 171
**Category Title:** Not Hispanic or Latino
#### Measurement
**Group ID:** BG000
**Value:** 0
#### Measurement
**Group ID:** BG001
**Value:** 0
#### Measurement
**Group ID:** BG002
**Value:** 0
**Category Title:** Unknown or Not Reported
**Class Title:**
### Measure
#### Measurement
**Group ID:** BG000
**Value:** 0
#### Measurement
**Group ID:** BG001
**Value:** 0
#### Measurement
**Group ID:** BG002
**Value:** 0
**Category Title:** American Indian or Alaska Native
#### Measurement
**Group ID:** BG000
**Value:** 0
#### Measurement
**Group ID:** BG001
**Value:** 1
#### Measurement
**Group ID:** BG002
**Value:** 1
**Category Title:** Asian
#### Measurement
**Group ID:** BG000
**Value:** 0
#### Measurement
**Group ID:** BG001
**Value:** 0
#### Measurement
**Group ID:** BG002
**Value:** 0
**Category Title:** Native Hawaiian or Other Pacific Islander
#### Measurement
**Group ID:** BG000
**Value:** 20
#### Measurement
**Group ID:** BG001
**Value:** 26
#### Measurement
**Group ID:** BG002
**Value:** 46
**Category Title:** Black or African American
#### Measurement
**Group ID:** BG000
**Value:** 66
#### Measurement
**Group ID:** BG001
**Value:** 57
#### Measurement
**Group ID:** BG002
**Value:** 123
**Category Title:** White
#### Measurement
**Group ID:** BG000
**Value:** 1
#### Measurement
**Group ID:** BG001
**Value:** 0
#### Measurement
**Group ID:** BG002
**Value:** 1
**Category Title:** More than one race
#### Measurement
**Group ID:** BG000
**Value:** 3
#### Measurement
**Group ID:** BG001
**Value:** 0
#### Measurement
**Group ID:** BG002
**Value:** 3
**Category Title:** Unknown or Not Reported
**Class Title:**
### Measure
#### Measurement
**Group ID:** BG000
**Value:** 90
#### Measurement
**Group ID:** BG001
**Value:** 84
#### Measurement
**Group ID:** BG002
**Value:** 174
**Class Title:** United States
**Denomination Units Selected:**
## Results Section - Baseline Characteristics Module
### Measure 1
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Age, Categorical
**Unit of Measure:** Participants
### Measure 2
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Ethnicity (NIH/OMB)
**Unit of Measure:** Participants
### Measure 5
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race (NIH/OMB)
**Unit of Measure:** Participants
### Measure 6
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
## Results Section - More Information Module
### Certain Agreement
**PI Sponsor Employee:** True
### Point of Contact
**Email:** [email protected]
**Organization:** Duke Center for Smoking Cessation
**Phone:** 919-668-5055
**Title:** Dr. Jed E. Rose
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 41
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 38
**Title:**
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 21
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 19
**Title:**
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 21
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 15
**Title:**
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 2.354
- **Upper Limit:**
- **Value:** -18.15
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 3.117
- **Upper Limit:**
- **Value:** -15.49
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 3.520
- **Upper Limit:**
- **Value:** -27.06
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 4.439
- **Upper Limit:**
- **Value:** -28.64
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 3.124
- **Upper Limit:**
- **Value:** -30.94
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 5.104
- **Upper Limit:**
- **Value:** -28.75
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 4.471
- **Upper Limit:**
- **Value:** -26.97
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 5.201
- **Upper Limit:**
- **Value:** -30.82
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 6.563
- **Upper Limit:**
- **Value:** -42.96
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 9.020
- **Upper Limit:**
- **Value:** -33.52
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 2.551
- **Upper Limit:**
- **Value:** -11.45
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 2.791
- **Upper Limit:**
- **Value:** -7.15
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 2.494
- **Upper Limit:**
- **Value:** -9.74
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 4.230
- **Upper Limit:**
- **Value:** -4.72
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 2.885
- **Upper Limit:**
- **Value:** -10.16
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 4.177
- **Upper Limit:**
- **Value:** -10.88
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 3.396
- **Upper Limit:**
- **Value:** -15.06
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 4.567
- **Upper Limit:**
- **Value:** -8.52
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 10.707
- **Upper Limit:**
- **Value:** -8.55
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 19.660
- **Upper Limit:**
- **Value:** 21.96
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 3.148
- **Upper Limit:**
- **Value:** -10.53
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 3.224
- **Upper Limit:**
- **Value:** -4.40
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 5.065
- **Upper Limit:**
- **Value:** -11.04
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 5.553
- **Upper Limit:**
- **Value:** -4.42
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 5.981
- **Upper Limit:**
- **Value:** -9.30
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 6.403
- **Upper Limit:**
- **Value:** -11.66
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 7.153
- **Upper Limit:**
- **Value:** -16.20
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 8.199
- **Upper Limit:**
- **Value:** -8.64
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 10.872
- **Upper Limit:**
- **Value:** -33.88
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 15.819
- **Upper Limit:**
- **Value:** -35.44
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 5.620
- **Upper Limit:**
- **Value:** 8.03
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 3.716
- **Upper Limit:**
- **Value:** 10.72
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 5.675
- **Upper Limit:**
- **Value:** 5.87
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 3.643
- **Upper Limit:**
- **Value:** -4.40
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 6.763
- **Upper Limit:**
- **Value:** 6.94
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 3.950
- **Upper Limit:**
- **Value:** -4.03
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 6.117
- **Upper Limit:**
- **Value:** 7.33
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 3.928
- **Upper Limit:**
- **Value:** -1.56
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 15.516
- **Upper Limit:**
- **Value:** 19.80
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 32.352
- **Upper Limit:**
- **Value:** 49.01
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 3.480
- **Upper Limit:**
- **Value:** -8.22
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 2.780
- **Upper Limit:**
- **Value:** -12.26
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 4.001
- **Upper Limit:**
- **Value:** -8.66
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 3.517
- **Upper Limit:**
- **Value:** -14.40
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 3.25
- **Upper Limit:**
- **Value:** -11.82
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 5.000
- **Upper Limit:**
- **Value:** -12.50
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 3.526
- **Upper Limit:**
- **Value:** -9.34
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 3.768
- **Upper Limit:**
- **Value:** -19.83
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 3.269
- **Upper Limit:**
- **Value:** -66.77
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 6.064
- **Upper Limit:**
- **Value:** -57.15
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 3.720
- **Upper Limit:**
- **Value:** -0.69
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 2.692
- **Upper Limit:**
- **Value:** -7.78
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 2.994
- **Upper Limit:**
- **Value:** -5.14
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 2.791
- **Upper Limit:**
- **Value:** -10.07
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 3.231
- **Upper Limit:**
- **Value:** -7.67
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 4.777
- **Upper Limit:**
- **Value:** -8.44
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 3.357
- **Upper Limit:**
- **Value:** -8.05
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 3.897
- **Upper Limit:**
- **Value:** -9.60
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 3.245
- **Upper Limit:**
- **Value:** -67.72
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 6.026
- **Upper Limit:**
- **Value:** -56.61
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 3.113
- **Upper Limit:**
- **Value:** 1.41
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 2.887
- **Upper Limit:**
- **Value:** -7.47
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 4.694
- **Upper Limit:**
- **Value:** -1.12
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 3.697
- **Upper Limit:**
- **Value:** -8.81
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 6.534
- **Upper Limit:**
- **Value:** 0.92
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 4.120
- **Upper Limit:**
- **Value:** -18.04
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 6.014
- **Upper Limit:**
- **Value:** -4.36
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 4.507
- **Upper Limit:**
- **Value:** -19.67
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 3.293
- **Upper Limit:**
- **Value:** -65.87
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 6.618
- **Upper Limit:**
- **Value:** -55.77
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 4.878
- **Upper Limit:**
- **Value:** -5.15
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 5.120
- **Upper Limit:**
- **Value:** 1.64
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 4.959
- **Upper Limit:**
- **Value:** -17.67
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 3.735
- **Upper Limit:**
- **Value:** -16.07
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 6.666
- **Upper Limit:**
- **Value:** -14.46
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 4.868
- **Upper Limit:**
- **Value:** -20.55
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 6.601
- **Upper Limit:**
- **Value:** -16.61
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 6.085
- **Upper Limit:**
- **Value:** -24.78
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 4.807
- **Upper Limit:**
- **Value:** -56.97
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 5.905
- **Upper Limit:**
- **Value:** -53.40
**Title:**
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** This will be determined by a composite of self-report at the 11-week study visit of no smoking between the 8-week and 11-week visits and expired air carbon monoxide (CO) \<10 ppm (measured at the 11-week study visit). An intent-to-treat criterion will be used, whereby drop-outs are considered to be non-abstinent.
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** Period between 8-week and 11-week visits post target Quit Day
**Title:** Number of Participants Completing Continuous Four-week Abstinence From Smoking Between the 8-week and 11-week Post Quit Day Visits
**Type:** PRIMARY
**Unit of Measure:** participants
##### Group
**Description:** For the first 3 days after being switched from Nicotine Replacement Therapy (NRT, occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12-week active treatment duration.
Chantix
Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week.
**ID:** OG000
**Title:** Chantix
##### Group
**Description:** For the first 3 days after being switched from NRT (occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus Zyban at a dose of 150mg once per day. Subsequently, the dose of Chantix will be 1 mg twice per day and the dose of Zyban will be 150 mg twice per day for the remainder of the 12-week active treatment duration.
Chantix
Zyban
Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week.
**ID:** OG001
**Title:** Chantix + Zyban
#### Outcome Measure 2
**Description:** This will be determined by a self-report of no smoking for the previous seven days when called for 6-month follow-up confirmed by expired air CO.
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** 6 months post Quit Day
**Title:** Number of Participants Completing Seven-day Point Abstinence From Smoking at 6 Months Post Quit Day
**Type:** SECONDARY
**Unit of Measure:** participants
##### Group
**Description:** For the first 3 days after being switched from Nicotine Replacement Therapy (NRT, occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12-week active treatment duration.
Chantix
Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week.
**ID:** OG000
**Title:** Chantix
##### Group
**Description:** For the first 3 days after being switched from NRT (occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus Zyban at a dose of 150mg once per day. Subsequently, the dose of Chantix will be 1 mg twice per day and the dose of Zyban will be 150 mg twice per day for the remainder of the 12-week active treatment duration.
Chantix
Zyban
Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week.
**ID:** OG001
**Title:** Chantix + Zyban
#### Outcome Measure 3
**Description:** This will be determined by a composite of self-report of no smoking between study visits at the 1-week, 3-week, 7-week and 11-week post Quit Day study visits and expired air carbon monoxide (CO) \<10 ppm (measured at those study visits). An intent-to-treat criterion will be used, whereby drop-outs are considered to be non-abstinent.
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** Quit Day to 11-week post Quit Day study visit
**Title:** Number of Participants Completing Continuous Abstinence From Smoking Between Quit Day and 11-week Post Quit Day Visit
**Type:** SECONDARY
**Unit of Measure:** participants
##### Group
**Description:** For the first 3 days after being switched from Nicotine Replacement Therapy (NRT, occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12-week active treatment duration.
Chantix
Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week.
**ID:** OG000
**Title:** Chantix
##### Group
**Description:** For the first 3 days after being switched from NRT (occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus Zyban at a dose of 150mg once per day. Subsequently, the dose of Chantix will be 1 mg twice per day and the dose of Zyban will be 150 mg twice per day for the remainder of the 12-week active treatment duration.
Chantix
Zyban
Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week.
**ID:** OG001
**Title:** Chantix + Zyban
#### Outcome Measure 4
**Description:** Withdrawal symptoms will be assessed by questionnaire on Quit Day, Week 1, Week 3, Week 7 and Week 11 post target quit date and 6 months post quit Follow-Up (if applicable) using the Shiffman-Jarvik questionnaire, which consists of 33-items rated from 1 to 7, where 1= not at all, 2= very little, 3= a little, 4= moderately, 5= a lot, 6= quite a lot, and 7= extremely. The 33 items are grouped into 8 subscales: Craving, Negative Affect, Appetite, Arousal, Somatic - Anxiety, Somatic - G.I., Somatic - Respiratory Tract, and Habit Withdrawal. The range of scores for each subscale will be 1-7, with higher scores indicating more of the withdrawal symptom having been experienced.
**Dispersion Type:** Standard Error
**Parameter Type:** MEAN
**Population Description:** A total of 163 subjects (Chantix n=82, Chantix+Zyban n=81) attended the first post-quit visit. However, ten subjects (5 in each condition) failed to complete or return their Quit Day withdrawal questionnaires; therefore change scores could only be calculated for 153 subjects (Chantix n=77, Chantix+Zyban n=76).
**Reporting Status:** POSTED
**Time Frame:** Quit Day and 1 week, 3 weeks, 7 Weeks, 11 Weeks and 6 months post Quit Day
**Title:** Change in Smoking Withdrawal Symptoms
**Type:** OTHER_PRE_SPECIFIED
**Unit of Measure:** percentage of change
##### Group
**Description:** For the first 3 days after being switched from Nicotine Replacement Therapy (NRT, occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12-week active treatment duration.
Chantix
Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week.
**ID:** OG000
**Title:** Chantix
##### Group
**Description:** For the first 3 days after being switched from NRT (occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus Zyban at a dose of 150mg once per day. Subsequently, the dose of Chantix will be 1 mg twice per day and the dose of Zyban will be 150 mg twice per day for the remainder of the 12-week active treatment duration.
Chantix
Zyban
Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week.
**ID:** OG001
**Title:** Chantix + Zyban
### Participant Flow Module
#### Group
**Description:** For the first 3 days after being switched from Nicotine Replacement Therapy (NRT, occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12-week active treatment duration.
Chantix
Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week.
**ID:** FG000
**Title:** Chantix
#### Group
**Description:** For the first 3 days after being switched from NRT (occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus Zyban at a dose of 150mg once per day. Subsequently, the dose of Chantix will be 1 mg twice per day and the dose of Zyban will be 150 mg twice per day for the remainder of the 12-week active treatment duration.
Chantix
Zyban
Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week.
**ID:** FG001
**Title:** Chantix + Zyban
#### Group
**Description:** These subjects received nicotine patches at the first study visit but dropped out before randomization. 176 subjects attended the second study visit and provided side effects (SE) data. Two of these subjects dropped out during that visit (after providing SE data but prior to randomization). So, out of the initial 197 subjects receiving nicotine patches, 174 went on to receive Chantix or Chantix+Zyban; 23 subjects only received nicotine patches before dropping out.
**ID:** FG002
**Title:** Nicotine Patches Only
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Physician Decision
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 1
##### Withdraw
**Type:** Lack of Efficacy
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 19
###### Reason
**Group ID:** FG001
**Number of Subjects:** 20
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 20
###### Reason
**Group ID:** FG001
**Number of Subjects:** 23
###### Reason
**Group ID:** FG002
**Number of Subjects:** 22
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 90
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 84
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 23
##### Milestone
**Type:** Completed SE Quest. After Using Patches
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 90
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 84
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 2
##### Milestone
**Type:** Randomized at Visit 2
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 90
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 84
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 0
##### Milestone
**Type:** Completed SE Quest. After Randomization
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 87
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 83
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 0
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 48
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 40
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 0
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 42
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 44
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 23
**Pre-Assignment Details:** Of the 376 subjs. enrolled, 179 were withdrawn by study staff or withdrew voluntarily from further participation prior to the 1st study visit (V1). 197 subjs. met all study criteria, attended V1 \& given NRT for 1 week; 176 subjs. attended V2 \& completed SE quest.; 2 subjs. dropped out during this visit before randomization; 174 subjs. randomized.
**Recruitment Details:** Recruitment began on 3/4/2013 and ended on 9/7/2014. Of the 376 subjects (subjs.) consented during this period, 197 subjects met all study criteria.
**Has Results:** True |
## Protocol Section
### Identification Module
**NCT ID:** NCT03132779
**Brief Title:** Intralipid Related Effect on NKcells in Patients With Unexplained Recurrent Spontaneous Abortion
**Official Title:** Intralipid Related Effect on NKcells in Patients With Unexplained Recurrent Spontaneous Abortions
#### Organization Study ID Info
**ID:** Intralipid
#### Organization
**Class:** OTHER
**Full Name:** Ain Shams Maternity Hospital
### Status Module
#### Completion Date
**Date:** 2018-02-20
**Type:** ESTIMATED
#### Expanded Access Info
**Last Known Status:** NOT_YET_RECRUITING
#### Last Update Post Date
**Date:** 2017-04-28
**Type:** ACTUAL
**Last Update Submit Date:** 2017-04-25
**Overall Status:** UNKNOWN
#### Primary Completion Date
**Date:** 2018-01-20
**Type:** ESTIMATED
#### Start Date
**Date:** 2017-05-01
**Type:** ESTIMATED
**Status Verified Date:** 2017-04
#### Study First Post Date
**Date:** 2017-04-28
**Type:** ACTUAL
**Study First Submit Date:** 2017-04-16
**Study First Submit QC Date:** 2017-04-25
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Ain Shams Maternity Hospital
#### Lead Sponsor
**Class:** OTHER
**Name:** Ahmed Mohamed Bahaa Eldin Ahmed
#### Responsible Party
**Investigator Affiliation:** Ain Shams Maternity Hospital
**Investigator Full Name:** Ahmed Mohamed Bahaa Eldin Ahmed
**Investigator Title:** Clinical professor
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Is US Export:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Evaluating the effect of intralipid on the natural killer cells
**Detailed Description:** This study will done on women with recurrent spontaneous abortions having increased NKCELLS activity and evaluate the effect of Intralipid on them after re-estimation of NKcells activity again after one week of Intralipid adminstration
### Conditions Module
**Conditions:**
- Recurrent Miscarriage
**Keywords:**
- Intralipid
- NK cells
- Recurrent miscarriage
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** Women with unexplained recurrent spontaneous abortions having increased NKcells activity
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 34
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** One group of patient will take Intralipid for all
**Intervention Names:**
- Drug: Intralipid
**Label:** One armed
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- One armed
**Description:** Adose of intralipid given and rechecking NKcells activity
**Name:** Intralipid
**Other Names:**
- Intralipid 18 mg
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** NK cells is measured before and after injection of intralipid and is noticed for change in activity
**Measure:** Change in NK cells activity after injection of intralipid
**Time Frame:** One week
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* All women icluded having recurrent spontaneous abortions equal or more than twice.
* Alittle women having increased NKCELLS activity.
Exclusion Criteria:
* Any other diseases causing miscarriage as autoimmune (lupus erythematosus or antiphospholipid antibodies syndrome )or endocrinopathy (diabetes mellitus, thyroid disorders and hyperprolactinaemia)or thrombophilia (factor v leiden mutation, protein c or s deficiency, prothrombin G20210A mutation, antithrombin III deficiency ) or abnormal karyotyping to one or both of parents or previous history of hormonal contraception or intrauterine device usage at last 3 months or any contraindications for intralipid usage.
**Gender Based:** True
**Gender Description:** Women with recurrent spontaneous abortions
**Healthy Volunteers:** True
**Maximum Age:** 38 Years
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Sobhy R Mohammed, MBBCH
**Phone:** 01003815460
**Phone Ext:** 002
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Ahmed M BahaaEldin, MD
**Phone:** 01111700556
**Phone Ext:** 002
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Hassan Tawfik office
**Name:** Hassan T Khairy, Professor
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000020969
- Term: Disease Attributes
- ID: D000010335
- Term: Pathologic Processes
- ID: D000011248
- Term: Pregnancy Complications
- ID: D000005261
- Term: Female Urogenital Diseases and Pregnancy Complications
- ID: D000091642
- Term: Urogenital Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
### Condition Browse Module - Browse Leaves
- ID: M14850
- Name: Recurrence
- Relevance: HIGH
- As Found: Recurrent
- ID: M21
- Name: Abortion, Spontaneous
- Relevance: HIGH
- As Found: Miscarriage
- ID: M25
- Name: Abortion, Habitual
- Relevance: HIGH
- As Found: Recurrent Miscarriage
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
- ID: M14127
- Name: Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27093
- Name: Female Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8399
- Name: Female Urogenital Diseases and Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000000022
- Term: Abortion, Spontaneous
- ID: D000000026
- Term: Abortion, Habitual
- ID: D000012008
- Term: Recurrence
### Intervention Browse Module - Ancestors
- ID: D000005217
- Term: Fat Emulsions, Intravenous
- ID: D000057947
- Term: Parenteral Nutrition Solutions
- ID: D000019999
- Term: Pharmaceutical Solutions
### Intervention Browse Module - Browse Branches
- Abbrev: PhSol
- Name: Pharmaceutical Solutions
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: HB
- Name: Herbal and Botanical
### Intervention Browse Module - Browse Leaves
- ID: M223889
- Name: Soybean oil, phospholipid emulsion
- Relevance: HIGH
- As Found: Mimic
- ID: M8360
- Name: Fat Emulsions, Intravenous
- Relevance: LOW
- As Found: Unknown
- ID: M21860
- Name: Pharmaceutical Solutions
- Relevance: LOW
- As Found: Unknown
- ID: M28934
- Name: Parenteral Nutrition Solutions
- Relevance: LOW
- As Found: Unknown
- ID: T294
- Name: Soy Bean
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: C000545823
- Term: Soybean oil, phospholipid emulsion
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06311279
**Brief Title:** End to End Versus Side to End Anastomosis After Anterior Resection of Cancer Rectum
**Official Title:** End to End Versus Side to End Anastomosis After Anterior Resection of Cancer Rectum
#### Organization Study ID Info
**ID:** Soh-Med-24-03-01MD
#### Organization
**Class:** OTHER
**Full Name:** Sohag University
### Status Module
#### Completion Date
**Date:** 2025-03-20
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-03-15
**Type:** ACTUAL
**Last Update Submit Date:** 2024-03-08
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-01-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-03-05
**Type:** ACTUAL
**Status Verified Date:** 2024-03
#### Study First Post Date
**Date:** 2024-03-15
**Type:** ACTUAL
**Study First Submit Date:** 2024-03-08
**Study First Submit QC Date:** 2024-03-08
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Sohag University
#### Responsible Party
**Investigator Affiliation:** Sohag University
**Investigator Full Name:** Nabil Abdelnaser Al-ameer
**Investigator Title:** assistant lecturer, physician and MD candidate
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Comparison between end to end and side to end anastomosis after anterior resection of cancer rectum and compare the outcomes of both surgical techniques. The main outcomes were bowel functional outcomes and QoL. Bowel functional outcomes mainly included three indexes: stool frequency, urgency, incomplete defecation, and incontinence. The secondary outcomes were surgical outcomes including operative time, postoperative hospital stay, postoperative complications, reoperation, and mortality.
**Detailed Description:** During the past two decades, remarkable progress has been made in the treatment of rectal cancer. The main goal of rectal surgery for malignancy is oncologic radicality in an effort to achieve the preservation of sphincters and sexual-urinary function.The introduction of circular stapling devices is largely responsible for their increasing popularity and utilization. Sphincter-saving procedures associated to partial or total mesorectal excision (TME) for the treatment of mid and distal rectal cancer have become increasingly prevalent as their safety and efficacy have been proved. Total mesorectal excision (TME) is the best available treatment for rectal cancer. With the advancement of surgical techniques, the majority of patients with mid and upper rectal cancer can undergo a sphincter-saving TME procedure. After TME, the most widely used reconstructive technique is straight coloanal anastomosis. With the advancement of surgical technique, the local recurrence rate after rectal cancer surgery has been decreased from 25-50% to 3-8%. Naturally, it is time to focus on how to improve bowel functional outcomes and quality of life (QoL) for rectal cancer patients. However, because the sigmoid colon is usually excised during surgery which decreases the storage volume of stool, there is a common problem seriously influencing the life quality of patients, including increased tool frequency, urgency and incontinence, which is termed as anterior resection syndrome (ARS). About 19-56% of patients would suffer from ARS. Thus, the demand for a technique with better functional outcomes made surgeons modify the straight anastomotic technique. Thus, another modified anastomotic technique, side-to-end anastomosis, which has been used since 1966, has gained attention. Side-to-end anastomosis usually needs a 3-5 cm-long colonic segment. Multiple studies on the literature have shown that compared with straight anastomosis, side-to-end anastomosis has advantages in bowel functional and operative outcomes.
### Conditions Module
**Conditions:**
- Rectum Cancer
**Keywords:**
- cancer rectum
- Anastomosis
- End to end
- side to end
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** Comparison between end to end and side to end anastomosis after anterior resection of cancer rectum and compare the outcomes of both surgical techniques. The main outcomes were bowel functional outcomes and QoL. Bowel functional outcomes mainly included three indexes: stool frequency, urgency, incomplete defecation, and incontinence. The secondary outcomes were surgical outcomes including operative time, postoperative hospital stay, postoperative complications, reoperation, and mortality
##### Masking Info
**Masking:** DOUBLE
**Masking Description:** randomized comparative clinical trial
**Who Masked:**
- PARTICIPANT
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 20
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** the first group included patients who will have anterior resection with end-to-end anastomosis
**Intervention Names:**
- Procedure: Anterior resection of Rectal cancer
**Label:** Group A
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** the second group included patients will have anterior resection with side to end anastomosis.
**Intervention Names:**
- Procedure: Anterior resection of Rectal cancer
**Label:** Group B
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Group A
- Group B
**Description:** Anterior resection of cancer rectum and type of anastomosis (End to end or side to end)
**Name:** Anterior resection of Rectal cancer
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** in minutes
**Measure:** Operative time
**Time Frame:** Immediate postoperative
**Description:** yes or No
**Measure:** Anastomotic leakage
**Time Frame:** 2 weeks postoperative
**Description:** in days
**Measure:** hospital stay
**Time Frame:** 2 weeks postoperative
**Description:** yes or no
**Measure:** Mortality
**Time Frame:** 4 weeks postoperative
**Description:** in cubic centimeters
**Measure:** Anastomotic leak amount
**Time Frame:** 2 weeks postoperative
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* 18 years of age to 80 years.
* Laparoscopic or open anterior resection of cancer rectum.
Exclusion Criteria:
* synchronous colorectal carcinoma
* emergency surgery
* history of colon or rectal segmental resections
* fixed rectal carcinoma who received preoperative radiotherapy
**Maximum Age:** 80 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Nabil A Al-Ameer, MD
**Phone:** 1118416290
**Phone Ext:** 0020
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Nabil A Al-Ameer, MD
**Phone:** 1067833019
**Phone Ext:** 0020
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Sohag
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Nabil A Al-Ameer, MD
- **Phone:** 1118416290
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Ahmed G Hassanein, MD
- **Phone:** 1552538300
- **Phone Ext:** 0020
- **Role:** CONTACT
**Country:** Egypt
**Facility:** Sohag university
**Status:** RECRUITING
**Zip:** 82511
#### Overall Officials
**Official 1:**
**Affiliation:** Sohag University
**Name:** AbdElhafez H Mohamed, MD
**Role:** STUDY_CHAIR
**Official 2:**
**Affiliation:** Ain Shams University
**Name:** Ahmed A Ahmed, MD
**Role:** STUDY_DIRECTOR
**Official 3:**
**Affiliation:** Sohag University
**Name:** Nabil A Al-Ameer, MD
**Role:** PRINCIPAL_INVESTIGATOR
**Official 4:**
**Affiliation:** Sohag University
**Name:** Emad G Mohamed, MD
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000015179
- Term: Colorectal Neoplasms
- ID: D000007414
- Term: Intestinal Neoplasms
- ID: D000005770
- Term: Gastrointestinal Neoplasms
- ID: D000004067
- Term: Digestive System Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000005767
- Term: Gastrointestinal Diseases
- ID: D000007410
- Term: Intestinal Diseases
- ID: D000012002
- Term: Rectal Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M14846
- Name: Rectal Neoplasms
- Relevance: HIGH
- As Found: Rectum Cancer
- ID: M17890
- Name: Colorectal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M10448
- Name: Intestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8886
- Name: Gastrointestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M7256
- Name: Digestive System Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10444
- Name: Intestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14844
- Name: Rectal Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000012004
- Term: Rectal Neoplasms
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT04495179
**Acronym:** AARDVARC
**Brief Title:** A Study of AZD4635 With Durvalumab and With Cabazitaxel and Durvalumab in Patients With mCRPC.
**Official Title:** A Phase II, Open-label, Study to Assess the Efficacy, Safety, and Tolerability of AZD4635 in Combination With Durvalumab and in Combination With Cabazitaxel and Durvalumab in Patients Who Have Progressive Metastatic Castrate-Resistant Prostate Cancer (AARDVARC)
#### Organization Study ID Info
**ID:** D8731C00002
#### Organization
**Class:** INDUSTRY
**Full Name:** AstraZeneca
#### Secondary ID Infos
**ID:** 2020-000209-10
**Type:** EUDRACT_NUMBER
### Status Module
#### Completion Date
**Date:** 2022-08-08
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-08-09
**Type:** ACTUAL
**Last Update Submit Date:** 2023-07-21
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2021-11-01
**Type:** ACTUAL
#### Results First Post Date
**Date:** 2023-08-09
**Type:** ACTUAL
**Results First Submit Date:** 2022-10-27
**Results First Submit QC Date:** 2023-07-21
#### Start Date
**Date:** 2020-08-04
**Type:** ACTUAL
**Status Verified Date:** 2023-07
#### Study First Post Date
**Date:** 2020-07-31
**Type:** ACTUAL
**Study First Submit Date:** 2020-07-23
**Study First Submit QC Date:** 2020-07-30
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** Parexel
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** AstraZeneca
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This is a Phase II, international, open-label, two-arm, non-randomised study of AZD4635 in participants with metastatic castration-resistant prostate cancer (mCRPC).
**Detailed Description:** This is a Phase II, international, open-label, two-arm, non-randomised study of AZD4635 in participants with mCRPC. Participants in each arm will be stratified by the presence of measurable soft tissue metastasis (per Response Evaluation Criteria in Solid Tumours \[RECIST v1.1\]) or bone-only metastasis (per Prostate Cancer Working Group 3 \[PCWG3 criteria\]). There will be no formal comparisons between treatment arms.
AZD4635 plus durvalumab (Arm A) will consist of 80 participants with mCRPC previously treated with one or more approved new hormonal agent(s) (NHAs) and one or more taxanes or participants who are taxane ineligible.
AZD4635 plus durvalumab plus cabazitaxel (Arm B) will consist of 80 participants mCRPC previously treated with docetaxel and one prior NHA.
As of November 2020, the Sponsor stopped enrolment in Arm A following decisions at the program level, not related to any safety issues. Ongoing participants in Arm A may continue treatment as planned.
### Conditions Module
**Conditions:**
- Progressive Metastatic Castrate-Resistant Prostate Cancer
**Keywords:**
- Prostate Cancer
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 30
**Type:** ACTUAL
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** AZD4635 plus durvalumab (Arm A) will consist of participants with mCRPC previously treated with one or more approved NHAs (eg, abiraterone acetate, enzalutamide, apalutamide and/or darolutamide), and one or more taxanes, or participants who are taxane ineligible.
**Intervention Names:**
- Drug: AZD4635
- Drug: Durvalumab
**Label:** Arm A: AZD4635 + durvalumab
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** AZD4635 plus durvalumab plus cabazitaxel (Arm B) will consist of participants with mCRPC previously treated with docetaxel and one prior NHA (either abiraterone acetate or enzalutamide but not both (prior apalutamide is not allowed in Arm B).
**Intervention Names:**
- Drug: AZD4635
- Drug: Durvalumab
- Drug: Cabazitaxel
**Label:** Arm B: AZD4635 + durvalumab + cabazitaxel
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Arm A: AZD4635 + durvalumab
- Arm B: AZD4635 + durvalumab + cabazitaxel
**Description:** Subjects will receive AZD4635 orally daily
**Name:** AZD4635
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Arm A: AZD4635 + durvalumab
- Arm B: AZD4635 + durvalumab + cabazitaxel
**Description:** Subjects will receive intravenous durvalumab every 4 weeks for Arm A and every 3 weeks for Arm B.
**Name:** Durvalumab
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- Arm B: AZD4635 + durvalumab + cabazitaxel
**Description:** Subjects will receive intravenous cabazitaxel every 3 weeks
**Name:** Cabazitaxel
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** rPFS was defined as the time from first dose to radiographic progression, assessed by the Investigator per RECIST 1.1 (soft tissue) and PCWG3 (Prostate Cancer Working Group 3) criteria \[bone\] or death from any cause, whichever occurred first.
**Measure:** Radiographic Progression Free Survival (rPFS) in Each Arm Separately to Determine the Efficacy of AZD4635 Plus Durvalumab and of AZD4635 Plus Durvalumab Plus Cabazitaxel in Patients With Metastatic Castrate-resistant Prostate Cancer (mCRPC)
**Time Frame:** From first dose to first documented progression or death from any cause (whichever comes first) (approximately 1 year)
#### Secondary Outcomes
**Description:** rPFS was defined as the time from first dose to radiographic progression, assessed by the Investigator per RECIST 1.1 (soft tissue) and PCWG3 criteria (bone) or death from any cause, whichever occurred first.
**Measure:** rPFS by Adenosine (ADO) Signalling Gene Expression in High and Low Subgroups to Determine the Efficacy of AZD4635 Plus Durvalumab Plus Cabazitaxel in Participants With mCRPC
**Time Frame:** From first dose to first documented progression or death from any cause (whichever comes first), up to two years
**Description:** OS was defined as the time from first dose until death due to any cause regardless of whether the participant withdrew from study treatment or received another anti-cancer therapy.
**Measure:** Overall Survival (OS) in Each Arm Separately to Determine the Efficacy of AZD4635 Plus Durvalumab and of AZD4635 Plus Durvalumab Plus Cabazitaxel in Participants With mCRPC
**Time Frame:** Arm A and B: Every 90 days from the last dose of study drug up to 2 years
**Description:** Confirmed ORR was defined as the proportion of participants with a confirmed complete response (CR) or partial response (PR) using overall radiographic response assessed by RECIST v1.1 and PCWG-3 criteria (bone), and was based on a subset of all treated participants with measurable disease at baseline per the site Investigator.
**Measure:** Number of Participants With Objective Response in Subjects With MCRPC Who Received AZD4635 Plus Durvalumab Plus Cabazitaxel
**Time Frame:** From first dose to first documented progression or death from any cause (whichever comes first), up to two years
**Description:** Confirmed PSA50 response is defined as the proportion of participants who achieved a ≥50% decrease in PSA from baseline to the lowest post-baseline PSA, confirmed by a consecutive PSA at least 3 weeks later and was based on PSA evaluable participants (dosed participants with an abnormal baseline PSA \[≥1 ng/mL\]).
**Measure:** Number of Participants With Prostate-specifin Antigen (PSA50) Response in Subjects With MCRPC Who Received AZD4635 Plus Durvalumab Plus Cabazitaxel
**Time Frame:** Arm A: Screening, Day 1 of each cycle up to 11 months (Each cycle was 28 days in length); Arm B: Screening, Day 1 of each cycle up to 11 months (Cycle 1 to Cycle 10 = 21 days, Cycle 11 onwards = 28 days)
**Description:** "Worst pain" and "Average pain" are 'single question' scores from the BPI short form and may take any value from 0 to 10 (worst outcome). "Interference Pain" is the total score of 7 sub-scores, where each value may take any value from 0 to 10 (worst outcome). The range of the "Interference Score" can be from 0 to 70.
**Measure:** Change From Baseline in Worst Pain in the Daily Activities Scales of the Brief Pain Inventory - Short Form (BPI-SF)
**Time Frame:** Arm A: Screening, Day 1 of each cycle up to 9 months (Each cycle was 28 days in length); Arm B: Screening, Day 1 of each cycle up to 9 months (Each cycle was 21 days in length)
**Description:** "Worst pain" and "Average pain" are 'single question' scores from the BPI short form and may take any value from 0 to 10 (worst outcome). "Interference Pain" is the total score of 7 sub-scores, where each value may take any value from 0 to 10 (worst outcome). The range of the "Interference Score" can be from 0 to 70.
**Measure:** Change From Baseline in Average Pain in the Daily Activities Scales of the Brief Pain Inventory - Short Form (BPI-SF)
**Time Frame:** Arm A: Screening, Day 1 of each cycle up to 9 months (Each cycle was 28 days in length); Arm B: Screening, Day 1 of each cycle up to 9 months (Each cycle was 21 days in length)
**Description:** "Worst pain" and "Average pain" are 'single question' scores from the BPI short form and may take any value from 0 to 10 (worst outcome). "Interference Pain" is the total score of 7 sub-scores, where each value may take any value from 0 to 10 (worst outcome). The range of the "Interference Score" can be from 0 to 70.
**Measure:** Change From Baseline in Pain Interference in the Daily Activities Scales of the Brief Pain Inventory - Short Form (BPI-SF)
**Time Frame:** Arm A: Screening, Day 1 of each cycle up to 9 months (Each cycle was 28 days in length); Arm B: Screening, Day 1 of each cycle up to 9 months (Each cycle was 21 days in length)
**Description:** Pain progression was assessed using BPI-SF.
**Measure:** Number of Participants Who Progressed Based on BPI-SF Item 3
**Time Frame:** Arm A: Screening, Day 1 of each cycle up to 12 months (Each cycle was 28 days in length); Arm B: Screening, Day 1 of each cycle up to 12 months (Cycle 1 to Cycle 10 = 21 days, Cycle 11 onwards = 28 days)
**Description:** The Functional Assessment of Cancer Therapy-Prostate (FACT-P) will be used to measure health related quality of life (HRQL) in men with prostate cancer. It consists of 4 subscales (physical, emotional, functional and social/family well-being) plus a 12-item prostate-specific module, the PCS subscale, which highlights concerns specific to participants with prostate cancer. FAPSI-6 is defined as a symptom score made up of 6 items from within the FACT-P (pain \[n = 3\], fatigue \[n = 1\], weight loss \[n = 1\], and concerns about the condition getting worse \[n = 1\]). Each question in the FACT-P questionnaires has a choice of 5 responses, "Not at all", "A little bit", "Somewhat", "Quite a bit" and "Very much". The scores range from 0 ("Not at all") to 4 ("Very much") for positively phrased questions. Negatively phrased questions have a reverse scoring, from 0 ("Very much") to 4 ("Not at all"). This results in a consistent approach, where higher scores indicate a better quality of life.
**Measure:** Change From Baseline in the FACT Advanced Prostate Symptom Indext-6 (FAPSI-6), as Derived From 6 Items, the FAPSI-8 From 8 Items Within the FACT-P and the Prostate Cancer Symptoms (PCS), From the 12 Items in the Prostrate-specific Module of the FACT-P
**Time Frame:** Arm A: Screening, Day 1 of each cycle up to 9 months (Each cycle was 28 days in length); Arm B: Screening, Day 1 of each cycle up to 9 months (Each cycle was 21 days in length)
**Description:** Investigate the PK of AZD4635 when given in combination with durvalumab, and when given in combination with durvalumab plus cabazitaxel.
**Measure:** Maximum Observed Plasma Concentration (Cmax)
**Time Frame:** Arm A:Cycle 1 to 3, and Cycle 4 onwards, and 90-day follow-up (FU) visit up to 14 months [Each cycle was 28 days in length];Arm B: Cycle 1 to 7 and Cycle 11 onwards, and 90-day FU up to 14 months (Cycle 1 to Cycle 10 = 21 days, Cycle 11 onwards = 28 days)
**Description:** Investigated the PK of AZD4635 when given in combination with durvalumab, and when given in combination with durvalumab plus cabazitaxel.
**Measure:** Terminal Half-life (t1/2λz)
**Time Frame:** Arm A:Cycle 1 to 3, and Cycle 4 onwards, and 90-day follow-up (FU) visit up to 14 months [Each cycle was 28 days in length];Arm B: Cycle 1 to 7 and Cycle 11 onwards, and 90-day FU up to 14 months (Cycle 1 to Cycle 10 = 21 days, Cycle 11 onwards = 28 days)
**Description:** Investigated the PK of AZD4635 when given in combination with durvalumab, and when given in combination with durvalumab plus cabazitaxel.
**Measure:** Area Under the Plasma Concentration Time Curve From Zero to the Time of the Last Measurable Concentration (AUClast)
**Time Frame:** Arm A:Cycle 1 to 3, and Cycle 4 onwards, and 90-day follow-up (FU) visit up to 14 months [Each cycle was 28 days in length];Arm B: Cycle 1 to 7 and Cycle 11 onwards, and 90-day FU up to 14 months (Cycle 1 to Cycle 10 = 21 days, Cycle 11 onwards = 28 days)
**Description:** Investigated the PK of AZD4635 when given in combination with durvalumab, and when given in combination with durvalumab plus cabazitaxel.
**Measure:** Area Under the Plasma Concentration Time Curve From Zero to 24 Hours [AUC(0-24)]
**Time Frame:** Arm A:Cycle 1 to 3, and Cycle 4 onwards, and 90-day follow-up (FU) visit up to 14 months [Each cycle was 28 days in length];Arm B: Cycle 1 to 7 and Cycle 11 onwards, and 90-day FU up to 14 months (Cycle 1 to Cycle 10 = 21 days, Cycle 11 onwards = 28 days)
**Description:** Investigated the PK of AZD4635 when given in combination with durvalumab, and when given in combination with durvalumab plus cabazitaxel.
**Measure:** Area Under the Plasma Concentration Time Curve From Zero Extrapolated to Infinity (AUCinf)
**Time Frame:** Arm A:Cycle 1 to 3, and Cycle 4 onwards, and 90-day follow-up (FU) visit up to 14 months [Each cycle was 28 days in length];Arm B: Cycle 1 to 7 and Cycle 11 onwards, and 90-day FU up to 14 months (Cycle 1 to Cycle 10 = 21 days, Cycle 11 onwards = 28 days)
**Description:** Investigated the PK of AZD4635 when given in combination with durvalumab, and when given in combination with durvalumab plus cabazitaxel.
**Measure:** Apparent Volume of Distribution During the Terminal Phase (Vz/F)
**Time Frame:** Arm A:Cycle 1 to 3, and Cycle 4 onwards, and 90-day follow-up (FU) visit up to 14 months [Each cycle was 28 days in length];Arm B: Cycle 1 to 7 and Cycle 11 onwards, and 90-day FU up to 14 months (Cycle 1 to Cycle 10 = 21 days, Cycle 11 onwards = 28 days)
**Description:** Safety and tolerability of each treatment regimen were assessed in participants with mCRPC.
**Measure:** Number of Subjects With Serious and Non-serious Adverse Events
**Time Frame:** Arm A: From Screening up to 14 months (Each cycle was 28 days in length); Arm B: From Screening up to 14 months (Cycle 1 to Cycle 10 was 21 days in length, and Cycle 11 onwards was 28 days in length)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Histologically confirmed adenocarcinoma of the prostate.
2. Known castrate-resistant disease.
3. Evidence of disease progression ≤6 months.
4. Body weight \>30 kg at screening.
5. Willingness to adhere to the study treatment-specific contraception requirements.
6. Adequate bone marrow reserve and organ function.
7. Adequate organ function for Arm A as demonstrated by all of the following laboratory values:
* Alanine aminotransferase (ALT) ≤2.5 × upper limit of normal (ULN) if no demonstrable liver metastases or ≤5 × ULN in the presence of liver metastases.
* Aspartate aminotransferase (AST) ≤2.5 × ULN if no demonstrable liver metastases or ≤5 × ULN in the presence of liver metastases
* Total bilirubin (TBL) ≤1.5 × ULN
* TBL ≤2.0 × ULN in the case of known Gilbert syndrome with normal direct bilirubin
8. Participants in Arm A must have received the following prior therapy:
* Maximum of 3 lines of therapy in the mCRPC setting
* Prior therapy with one or more NHAs (eg, abiraterone acetate, enzalutamide, apalutamide, darolutamide) in either hormone-sensitive or hormone-refractory settings
* Prior therapy with one or more lines of taxanes (eg, docetaxel and/or cabazitaxel)
* Alternatively, must be taxane-ineligible
* Prior therapy can be in either the hormone-sensitive or the hormone-refractory setting
9. Adequate organ function for Arm B as demonstrated by all of the following laboratory values:
* AST and/or ALT ≤1.5 × ULN
* TBL ≤ ULN
* TBL ≤2.0 × ULN in the case of known Gilbert syndrome with normal direct bilirubin
10. Participants in Arm B must have received the following prior therapy:
* Prior docetaxel (taxane) in either hormone-sensitive or hormone-refractory settings
* Received no prior cytotoxic chemotherapy other than docetaxel for prostate cancer except for estramustine and except adjuvant/neo-adjuvant treatment completed \>3 years ago.
* Prior therapy with only one NHAs (eg, abiraterone acetate or enzalutamide; prior apalutamide is not permitted) for treatment of mCRPC in either hormone-sensitive or hormone-refractory settings.
* Be suitable to receive concomitant Granulocyte-colony stimulating factor during all cycles of cabazitaxel.
* Participants who meet inclusion criteria for Arm B will be allocated preferentially to that arm until recruitment to that arm is completed.
Exclusion Criteria:
1. Active brain metastases or leptomeningeal metastases.
2. There must be no requirement for immunosuppressive doses of systemic corticosteroids for at least 2 weeks prior to study enrollment.
3. History of pneumonitis requiring corticosteroids, second malignancy that is progressing and/or received active treatment ≤3 years before the first dose of study intervention, and hypersensitivity to polysorbate-80 if allocated to cabazitaxel.
4. As judged by the Investigator, any evidence of severe or uncontrolled systemic diseases.
5. Creatinine clearance \<40 mL/min (calculated by Cockcroft-Gault equation).
6. Prior exposure to immune-mediated therapy including.
7. Ongoing treatment with warfarin (Coumadin).
8. Major surgery (excluding placement of vascular access) within 4 weeks of the first dose of study intervention.
**Gender Based:** True
**Maximum Age:** 150 Years
**Minimum Age:** 18 Years
**Sex:** MALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Sacramento
**Country:** United States
**Facility:** Research Site
**State:** California
**Zip:** 95817
**Location 2:**
**City:** Tampa
**Country:** United States
**Facility:** Research Site
**State:** Florida
**Zip:** 33612
**Location 3:**
**City:** Atlanta
**Country:** United States
**Facility:** Research Site
**State:** Georgia
**Zip:** 30318
**Location 4:**
**City:** Saint Louis
**Country:** United States
**Facility:** Research Site
**State:** Missouri
**Zip:** 63110
**Location 5:**
**City:** Winston-Salem
**Country:** United States
**Facility:** Research Site
**State:** North Carolina
**Zip:** 27157
**Location 6:**
**City:** Brasschaat
**Country:** Belgium
**Facility:** Research Site
**Zip:** 2930
**Location 7:**
**City:** Gent
**Country:** Belgium
**Facility:** Research Site
**Zip:** 9000
**Location 8:**
**City:** Bordeaux
**Country:** France
**Facility:** Research Site
**Zip:** 33076
**Location 9:**
**City:** Villejuif
**Country:** France
**Facility:** Research Site
**Zip:** 94805
**Location 10:**
**City:** Goyang-si
**Country:** Korea, Republic of
**Facility:** Research Site
**Zip:** 10408
**Location 11:**
**City:** Seoul
**Country:** Korea, Republic of
**Facility:** Research Site
**Zip:** 06351
**Location 12:**
**City:** Seoul
**Country:** Korea, Republic of
**Facility:** Research Site
**Zip:** 06591
**Location 13:**
**City:** Barcelona
**Country:** Spain
**Facility:** Research Site
**Zip:** 08041
**Location 14:**
**City:** Barcelona
**Country:** Spain
**Facility:** Research Site
**Zip:** 8035
**Location 15:**
**City:** Hospitalet deLlobregat
**Country:** Spain
**Facility:** Research Site
**Zip:** 08907
**Location 16:**
**City:** Madrid
**Country:** Spain
**Facility:** Research Site
**Zip:** 28034
#### Overall Officials
**Official 1:**
**Affiliation:** Dana-Farber Cancer Institute
**Name:** Christopher J Sweeney, MBBS
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Access Criteria:** When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
**Description:** Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
**Info Types:**
- STUDY_PROTOCOL
- SAP
**IPD Sharing:** YES
**Time Frame:** AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
**URL:** https://astrazenecagroup-dt.pharmacm.com/DT/Home
### References Module
#### See Also Links
**Label:** Related Info
**URL:** https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D8731C00002&attachmentIdentifier=094a199c-bf37-4374-90e2-5f80530bdae1&fileName=D8731C00002_Protocol.pdf&versionIdentifier=
**Label:** Related Info
**URL:** https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D8731C00002&attachmentIdentifier=d3ddec19-8569-41e1-9a0d-d7950c823cc6&fileName=D8731C00002_SAP.pdf&versionIdentifier=
**Label:** Related Info
**URL:** https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D8731C00002&attachmentIdentifier=8497cc3d-bcf9-447f-9d24-a712c91a5027&fileName=D8731C00002_CSR_Synopsis.pdf&versionIdentifier=
## Document Section
### Large Document Module
#### Large Docs
- Date: 2020-11-24
- Filename: Prot_000.pdf
- Has ICF: False
- Has Protocol: True
- Has SAP: False
- Label: Study Protocol
- Size: 6777319
- Type Abbrev: Prot
- Upload Date: 2022-10-28T07:57
- Date: 2022-04-20
- Filename: SAP_001.pdf
- Has ICF: False
- Has Protocol: False
- Has SAP: True
- Label: Statistical Analysis Plan
- Size: 14003768
- Type Abbrev: SAP
- Upload Date: 2022-10-28T07:57
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000005834
- Term: Genital Neoplasms, Male
- ID: D000014565
- Term: Urogenital Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000005832
- Term: Genital Diseases, Male
- ID: D000091662
- Term: Genital Diseases
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000011469
- Term: Prostatic Diseases
- ID: D000052801
- Term: Male Urogenital Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M14335
- Name: Prostatic Neoplasms
- Relevance: HIGH
- As Found: Prostate Cancer
- ID: M8946
- Name: Genital Neoplasms, Male
- Relevance: LOW
- As Found: Unknown
- ID: M17315
- Name: Urogenital Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M2876
- Name: Genital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8944
- Name: Genital Diseases, Male
- Relevance: LOW
- As Found: Unknown
- ID: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14333
- Name: Prostatic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27095
- Name: Male Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000011471
- Term: Prostatic Neoplasms
### Intervention Browse Module - Ancestors
- ID: D000074322
- Term: Antineoplastic Agents, Immunological
- ID: D000000970
- Term: Antineoplastic Agents
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M1668
- Name: Docetaxel
- Relevance: LOW
- As Found: Unknown
- ID: M272500
- Name: Durvalumab
- Relevance: HIGH
- As Found: Non-Small Cell
- ID: M451
- Name: Abiraterone Acetate
- Relevance: LOW
- As Found: Unknown
- ID: M147959
- Name: Taxane
- Relevance: LOW
- As Found: Unknown
- ID: M1346
- Name: Antineoplastic Agents, Immunological
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: C000613593
- Term: Durvalumab
### Misc Info Module
#### Removed Countries
- Country: Denmark
- Country: Germany
- Country: Italy
- Country: Netherlands
- Country: United Kingdom
#### Submission Tracking
##### First MCP Info
###### Post Date
- Date: 2022-11-23
- Type: ACTUAL
- Version Holder: 2024-05-24
## Results Section
### Adverse Events Module
#### Event Groups
**Group ID:** EG000
**Title:** Arm A: AZD4635 + Durvalumab
**Deaths Num Affected:** 2
**Deaths Num At Risk:** 2
**Description:** Participants received AZD4635 Dose A orally daily, and durvalumab Dose B intravenously every 4 weeks.
**ID:** EG000
**Other Num Affected:** 2
**Other Num at Risk:** 2
**Serious Number Affected:** 2
**Serious Number At Risk:** 2
**Title:** Arm A: AZD4635 + Durvalumab
**Group ID:** EG001
**Title:** Arm B: AZD4635 + Durvalumab + Cabazitaxel
**Deaths Num Affected:** 7
**Deaths Num At Risk:** 28
**Description:** Participants received AZD4635 Dose A orally daily, durvalumab Dose B intravenously (IV) every 3 weeks (Q3W), and cabazitaxel Dose C IV Q3W
**ID:** EG001
**Other Num Affected:** 28
**Other Num at Risk:** 28
**Serious Number Affected:** 19
**Serious Number At Risk:** 28
**Title:** Arm B: AZD4635 + Durvalumab + Cabazitaxel
**Frequency Threshold:** 5
#### Other Events
**Term:** Urinary tract infection
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA v24.1
**Term:** Anaemia
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Blood and lymphatic system disorders
**Source Vocabulary:** MedDRA v24.1
**Term:** Neutropenia
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Blood and lymphatic system disorders
**Source Vocabulary:** MedDRA v24.1
**Term:** Thrombocytopenia
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Blood and lymphatic system disorders
**Source Vocabulary:** MedDRA v24.1
**Term:** Decreased appetite
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
**Source Vocabulary:** MedDRA v24.1
**Term:** Hyperglycaemia
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
**Source Vocabulary:** MedDRA v24.1
**Term:** Hyperkalaemia
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
**Source Vocabulary:** MedDRA v24.1
**Term:** Hyperuricaemia
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
**Source Vocabulary:** MedDRA v24.1
**Term:** Hypocalcaemia
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
**Source Vocabulary:** MedDRA v24.1
**Term:** Hypokalaemia
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
**Source Vocabulary:** MedDRA v24.1
**Term:** Hypophosphataemia
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
**Source Vocabulary:** MedDRA v24.1
**Term:** Depression
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Psychiatric disorders
**Source Vocabulary:** MedDRA v24.1
**Term:** Insomnia
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Psychiatric disorders
**Source Vocabulary:** MedDRA v24.1
**Term:** Dizziness
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
**Source Vocabulary:** MedDRA v24.1
**Term:** Dysgeusia
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
**Source Vocabulary:** MedDRA v24.1
**Term:** Headache
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
**Source Vocabulary:** MedDRA v24.1
**Term:** Neuropathy peripheral
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
**Source Vocabulary:** MedDRA v24.1
**Term:** Peripheral sensory neuropathy
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
**Source Vocabulary:** MedDRA v24.1
**Term:** Hypertension
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Vascular disorders
**Source Vocabulary:** MedDRA v24.1
**Term:** Hypotension
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Vascular disorders
**Source Vocabulary:** MedDRA v24.1
**Term:** Dyspnoea
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
**Source Vocabulary:** MedDRA v24.1
**Term:** Abdominal pain
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA v24.1
**Term:** Constipation
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA v24.1
**Term:** Diarrhoea
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA v24.1
**Term:** Dry mouth
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA v24.1
**Term:** Dyspepsia
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA v24.1
**Term:** Gastrooesophageal reflux disease
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA v24.1
**Term:** Nausea
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA v24.1
**Term:** Oral pain
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA v24.1
**Term:** Vomiting
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA v24.1
**Term:** Dry skin
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
**Source Vocabulary:** MedDRA v24.1
**Term:** Pruritus
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
**Source Vocabulary:** MedDRA v24.1
**Term:** Arthralgia
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Musculoskeletal and connective tissue disorders
**Source Vocabulary:** MedDRA v24.1
**Term:** Back pain
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Musculoskeletal and connective tissue disorders
**Source Vocabulary:** MedDRA v24.1
**Term:** Flank pain
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Musculoskeletal and connective tissue disorders
**Source Vocabulary:** MedDRA v24.1
**Term:** Muscle spasms
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Musculoskeletal and connective tissue disorders
**Source Vocabulary:** MedDRA v24.1
**Term:** Muscular weakness
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Musculoskeletal and connective tissue disorders
**Source Vocabulary:** MedDRA v24.1
**Term:** Myalgia
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Musculoskeletal and connective tissue disorders
**Source Vocabulary:** MedDRA v24.1
**Term:** Pain in extremity
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Musculoskeletal and connective tissue disorders
**Source Vocabulary:** MedDRA v24.1
**Term:** Haematuria
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Renal and urinary disorders
**Source Vocabulary:** MedDRA v24.1
**Term:** Urinary retention
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Renal and urinary disorders
**Source Vocabulary:** MedDRA v24.1
**Term:** Reproductive system and breast disorders
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Reproductive system and breast disorders
**Source Vocabulary:** MedDRA v24.1
**Term:** Asthenia
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA v24.1
**Term:** Chills
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA v24.1
**Term:** Fatigue
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA v24.1
**Term:** Non-cardiac chest pain
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA v24.1
**Term:** Oedema peripheral
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA v24.1
**Term:** Pain
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA v24.1
**Term:** Pyrexia
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA v24.1
**Term:** Alanine aminotransferase increased
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:** MedDRA v24.1
**Term:** Amylase increased
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:** MedDRA v24.1
**Term:** Aspartate aminotransferase increased
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:** MedDRA v24.1
**Term:** Blood alkaline phosphatase increased
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:** MedDRA v24.1
**Term:** Blood lactate dehydrogenase increased
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:** MedDRA v24.1
**Term:** Lipase increased
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:** MedDRA v24.1
**Term:** Neutrophil count decreased
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:** MedDRA v24.1
**Term:** Weight decreased
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:** MedDRA v24.1
**Term:** White blood cell count decreased
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:** MedDRA v24.1
**Term:** Fall
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Injury, poisoning and procedural complications
**Source Vocabulary:** MedDRA v24.1
#### Serious Events
**Term:** Abscess neck
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA v24.1
##### Stats
**Group ID:** EG000
**Num At Risk:** 2
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 28
**Term:** Diverticulitis
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA v24.1
##### Stats
**Group ID:** EG000
**Num At Risk:** 2
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 28
**Term:** Ureteritis
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA v24.1
##### Stats
**Group ID:** EG000
**Num At Risk:** 2
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 28
**Term:** Urinary tract infection
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA v24.1
##### Stats
**Group ID:** EG000
**Num At Risk:** 2
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 28
**Term:** Anaemia
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Blood and lymphatic system disorders
**Source Vocabulary:** MedDRA v24.1
##### Stats
**Group ID:** EG000
**Num At Risk:** 2
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 28
**Term:** Febrile Neutropenia
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Blood and lymphatic system disorders
**Source Vocabulary:** MedDRA v24.1
##### Stats
**Group ID:** EG000
**Num At Risk:** 2
**Group ID:** EG001
**Num Affected:** 2
**Num At Risk:** 28
**Term:** Decreased Appetite
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
**Source Vocabulary:** MedDRA v24.1
##### Stats
**Group ID:** EG000
**Num At Risk:** 2
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 28
**Term:** Hypotension
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Vascular disorders
**Source Vocabulary:** MedDRA v24.1
##### Stats
**Group ID:** EG000
**Num At Risk:** 2
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 28
**Term:** Dyspnoea
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
**Source Vocabulary:** MedDRA v24.1
##### Stats
**Group ID:** EG000
**Num At Risk:** 2
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 28
**Term:** Haemoptysis
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
**Source Vocabulary:** MedDRA v24.1
##### Stats
**Group ID:** EG000
**Num At Risk:** 2
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 28
**Term:** Colitis
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA v24.1
##### Stats
**Group ID:** EG000
**Num At Risk:** 2
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 28
**Term:** Diarrhoea
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA v24.1
##### Stats
**Group ID:** EG000
**Num At Risk:** 2
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 28
**Term:** Dysphagia
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA v24.1
##### Stats
**Group ID:** EG000
**Num At Risk:** 2
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 28
**Term:** Nausea
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA v24.1
##### Stats
**Group ID:** EG000
**Num At Risk:** 2
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 28
**Term:** Rectal Haemorrhage
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA v24.1
##### Stats
**Group ID:** EG000
**Num At Risk:** 2
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 28
**Term:** Vomiting
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA v24.1
##### Stats
**Group ID:** EG000
**Num At Risk:** 2
**Group ID:** EG001
**Num Affected:** 3
**Num At Risk:** 28
**Term:** Cholecystitis
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Hepatobiliary disorders
**Source Vocabulary:** MedDRA v24.1
##### Stats
**Group ID:** EG000
**Num At Risk:** 2
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 28
**Term:** Cholecystitis Acute
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Hepatobiliary disorders
**Source Vocabulary:** MedDRA v24.1
##### Stats
**Group ID:** EG000
**Num At Risk:** 2
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 28
**Term:** Arthralgia
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Musculoskeletal and connective tissue disorders
**Source Vocabulary:** MedDRA v24.1
##### Stats
**Group ID:** EG000
**Num At Risk:** 2
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 28
**Term:** Myositis
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Musculoskeletal and connective tissue disorders
**Source Vocabulary:** MedDRA v24.1
##### Stats
**Group ID:** EG000
**Num At Risk:** 2
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 28
**Term:** Cystitis Haemorrhagic
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Renal and urinary disorders
**Source Vocabulary:** MedDRA v24.1
##### Stats
**Group ID:** EG000
**Num At Risk:** 2
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 28
**Term:** Haematuria
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Renal and urinary disorders
**Source Vocabulary:** MedDRA v24.1
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 2
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 28
**Term:** Hydronephrosis
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Renal and urinary disorders
**Source Vocabulary:** MedDRA v24.1
##### Stats
**Group ID:** EG000
**Num At Risk:** 2
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 28
**Term:** Urinary Retention
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Renal and urinary disorders
**Source Vocabulary:** MedDRA v24.1
##### Stats
**Group ID:** EG000
**Num At Risk:** 2
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 28
**Term:** Malaise
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA v24.1
##### Stats
**Group ID:** EG000
**Num At Risk:** 2
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 28
**Term:** Pyrexia
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA v24.1
##### Stats
**Group ID:** EG000
**Num At Risk:** 2
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 28
**Term:** Neutrophil Count Decreased
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:** MedDRA v24.1
##### Stats
**Group ID:** EG000
**Num At Risk:** 2
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 28
**Term:** Acute Post Hemorrhagic Anemia
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Blood and lymphatic system disorders
**Source Vocabulary:** MedDRA v24.1
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 2
**Group ID:** EG001
**Num At Risk:** 28
**Time Frame:** All-Cause Mortality: Up to 2 years; Serious and/or other adverse events: From Screening up to 14 months (Each cycle was 28 days in length) for Arm A and from Screening up to 14 months (Cycle 1 to Cycle 10 was 21 days in length, and Cycle 11 onwards was 28 days in length) for Arm B.
## Results Section - Baseline Characteristics Module
### Denomination Counts
**Group ID:** BG000
**Value:** 2
**Group ID:** BG001
**Value:** 28
**Group ID:** BG002
**Value:** 30
**Units:** Participants
### Group
**ID:** BG000
**Title:** Arm A: AZD4635 + Durvalumab
**Description:** Participants received AZD4635 Dose A orally daily, and durvalumab Dose B intravenously every 4 weeks.
### Group
**ID:** BG001
**Title:** Arm B: AZD4635 + Durvalumab + Cabazitaxel
**Description:** Participants received AZD4635 Dose A orally daily, durvalumab Dose B intravenously (IV) every 3 weeks (Q3W), and cabazitaxel Dose C IV Q3W
### Group
**ID:** BG002
**Title:** Total
**Description:** Total of all reporting groups
### Measure
#### Measurement
**Group ID:** BG001
**Spread:** 8.18
**Value:** 68.0
#### Measurement
**Group ID:** BG002
**Spread:** 8.18
**Value:** 68.0
#### Denomination
**Units:** Participants
##### Denomination Counts
**Group ID:** BG000
**Value:** 0
**Group ID:** BG001
**Value:** 28
**Group ID:** BG002
**Value:** 28
**Class Title:**
### Measure
#### Measurement
**Group ID:** BG000
**Value:** 0
#### Measurement
**Group ID:** BG001
**Value:** 28
#### Measurement
**Group ID:** BG002
**Value:** 28
#### Denomination
**Units:** Participants
##### Denomination Counts
**Group ID:** BG000
**Value:** 0
**Group ID:** BG001
**Value:** 28
**Group ID:** BG002
**Value:** 28
**Class Title:** Male
### Measure
#### Measurement
**Group ID:** BG000
**Value:** 0
#### Measurement
**Group ID:** BG001
**Value:** 4
#### Measurement
**Group ID:** BG002
**Value:** 4
**Category Title:** Hispanic or Latino
#### Measurement
**Group ID:** BG000
**Value:** 0
#### Measurement
**Group ID:** BG001
**Value:** 21
#### Measurement
**Group ID:** BG002
**Value:** 21
**Category Title:** Not Hispanic or Latino
#### Measurement
**Group ID:** BG000
**Value:** 0
#### Measurement
**Group ID:** BG001
**Value:** 3
#### Measurement
**Group ID:** BG002
**Value:** 3
**Category Title:** Unknown or Not Reported
#### Denomination
**Units:** Participants
##### Denomination Counts
**Group ID:** BG000
**Value:** 0
**Group ID:** BG001
**Value:** 28
**Group ID:** BG002
**Value:** 28
**Class Title:**
### Measure
#### Measurement
**Group ID:** BG000
**Value:** 0
#### Measurement
**Group ID:** BG001
**Value:** 0
#### Measurement
**Group ID:** BG002
**Value:** 0
**Category Title:** American Indian or Alaska Native
#### Measurement
**Group ID:** BG000
**Value:** 0
#### Measurement
**Group ID:** BG001
**Value:** 5
#### Measurement
**Group ID:** BG002
**Value:** 5
**Category Title:** Asian
#### Measurement
**Group ID:** BG000
**Value:** 0
#### Measurement
**Group ID:** BG001
**Value:** 0
#### Measurement
**Group ID:** BG002
**Value:** 0
**Category Title:** Native Hawaiian or Other Pacific Islander
#### Measurement
**Group ID:** BG000
**Value:** 0
#### Measurement
**Group ID:** BG001
**Value:** 0
#### Measurement
**Group ID:** BG002
**Value:** 0
**Category Title:** Black or African American
#### Measurement
**Group ID:** BG000
**Value:** 0
#### Measurement
**Group ID:** BG001
**Value:** 19
#### Measurement
**Group ID:** BG002
**Value:** 19
**Category Title:** White
#### Measurement
**Group ID:** BG000
**Value:** 0
#### Measurement
**Group ID:** BG001
**Value:** 0
#### Measurement
**Group ID:** BG002
**Value:** 0
**Category Title:** More than one race
#### Measurement
**Group ID:** BG000
**Value:** 0
#### Measurement
**Group ID:** BG001
**Value:** 1
#### Measurement
**Group ID:** BG002
**Value:** 1
**Category Title:** Unknown or Not Reported
#### Denomination
**Units:** Participants
##### Denomination Counts
**Group ID:** BG000
**Value:** 0
**Group ID:** BG001
**Value:** 25
**Group ID:** BG002
**Value:** 25
**Class Title:**
**Denomination Units Selected:**
## Results Section - Baseline Characteristics Module
### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Population Description:** The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk.
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk.
**Title:** Sex/Gender, Customized
**Unit of Measure:** Participants
### Measure 3
**Description:** The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** The number analyzed in the row differs from the overall value as efficacy for low number of participants were not presented.
**Title:** Ethnicity (NIH/OMB)
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk.
**Title:** Race (NIH/OMB)
**Unit of Measure:** Participants
**Population Description:** Safety analysis set consisted of all patients who received at least one dose of study treatment. The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk.
## Results Section - More Information Module
### Certain Agreement
**Other Details:** This document contains trade secrets and confidential commercial information, disclosure of which is prohibited without providing advance notice to AstraZeneca and opportunity to object.
**Restriction Type:** OTHER
**Restrictive Agreement:** True
### Point of Contact
**Email:** [email protected]
**Organization:** AstraZeneca Clinical Study Information Center
**Phone:** 1-877-240-94 79
**Title:** Global Clinical Head
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
### Outcome Measure 6
### Outcome Measure 7
### Outcome Measure 8
### Outcome Measure 9
### Outcome Measure 10
### Outcome Measure 11
### Outcome Measure 12
### Outcome Measure 13
### Outcome Measure 14
### Outcome Measure 15
### Outcome Measure 16
### Outcome Measure 17
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** An upper limit for the 95%CI was not calculated because there were not enough events at later times to get a reliable upper CI.
- **Group ID:** OG001
- **Lower Limit:** 4.2
- **Spread:**
- **Upper Limit:** NA
- **Value:** 5.8
**Title:**
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 14
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 13
**Title:**
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** This value was not calculated since less than 50% patients died during the study.
- **Group ID:** OG001
- **Lower Limit:** 7.9
- **Spread:**
- **Upper Limit:** NA
- **Value:** NA
**Title:**
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:** 0.88
- **Spread:**
- **Upper Limit:** 23.50
- **Value:** 2
**Title:**
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:** 0.06
- **Spread:**
- **Upper Limit:** 0.37
- **Value:** 5
**Title:**
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 2.44
- **Upper Limit:**
- **Value:** 3.4
**Title:**
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 14
**Units:** Participants
**Class:**
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 0
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 2.94
- **Upper Limit:**
- **Value:** -1.6
**Title:**
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 11
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 4.40
- **Upper Limit:**
- **Value:** -0.3
**Title:**
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 13
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 2.88
- **Upper Limit:**
- **Value:** -1.6
**Title:**
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 9
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 3.58
- **Upper Limit:**
- **Value:** -2.1
**Title:**
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 7
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 3.00
- **Upper Limit:**
- **Value:** -1.9
**Title:**
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 8
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 1.85
- **Upper Limit:**
- **Value:** 1.0
**Title:**
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 8
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 2.66
- **Upper Limit:**
- **Value:** -1.7
**Title:**
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 6
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 2.17
- **Upper Limit:**
- **Value:** -0.2
**Title:**
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 5
**Units:** Participants
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 2.09
- **Upper Limit:**
- **Value:** 2.3
**Title:**
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 14
**Units:** Participants
**Class:**
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 0
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 1.19
- **Upper Limit:**
- **Value:** -1.3
**Title:**
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 11
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 3.15
- **Upper Limit:**
- **Value:** 0.6
**Title:**
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 13
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 1.27
- **Upper Limit:**
- **Value:** -0.9
**Title:**
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 9
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 2.15
- **Upper Limit:**
- **Value:** -1.6
**Title:**
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 7
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 1.51
- **Upper Limit:**
- **Value:** -1.4
**Title:**
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 8
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 1.41
- **Upper Limit:**
- **Value:** 0.0
**Title:**
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 8
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 1.47
- **Upper Limit:**
- **Value:** -0.8
**Title:**
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 6
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 0.84
- **Upper Limit:**
- **Value:** -1.2
**Title:**
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 5
**Units:** Participants
#### Outcome Measure 8
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 8.47
- **Upper Limit:**
- **Value:** 8.0
**Title:**
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 14
**Units:** Participants
**Class:**
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 0
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 13.90
- **Upper Limit:**
- **Value:** 2.5
**Title:**
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 11
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 18.96
- **Upper Limit:**
- **Value:** 12.3
**Title:**
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 13
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 12.73
- **Upper Limit:**
- **Value:** 4.9
**Title:**
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 9
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 5.19
- **Upper Limit:**
- **Value:** 1.3
**Title:**
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 7
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 8.40
- **Upper Limit:**
- **Value:** 2.0
**Title:**
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 8
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 9.93
- **Upper Limit:**
- **Value:** 8.1
**Title:**
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 8
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 13.98
- **Upper Limit:**
- **Value:** 7.2
**Title:**
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 6
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 15.16
- **Upper Limit:**
- **Value:** 5.4
**Title:**
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 5
**Units:** Participants
#### Outcome Measure 9
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 1
**Title:**
#### Outcome Measure 10
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 2.88
- **Upper Limit:**
- **Value:** 16.6
**Title:**
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 10
**Units:** Participants
**Class:**
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 0
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 1.68
- **Upper Limit:**
- **Value:** 1.9
**Title:**
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 7
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 5.52
- **Upper Limit:**
- **Value:** -0.7
**Title:**
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 9
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 3.34
- **Upper Limit:**
- **Value:** -0.1
**Title:**
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 7
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 3.36
- **Upper Limit:**
- **Value:** 0.6
**Title:**
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 5
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 1.38
- **Upper Limit:**
- **Value:** 1.5
**Title:**
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 6
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 3.92
- **Upper Limit:**
- **Value:** 0.0
**Title:**
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 7
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 4.15
- **Upper Limit:**
- **Value:** -1.8
**Title:**
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 5
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 4.55
- **Upper Limit:**
- **Value:** -3.0
**Title:**
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 4
**Units:** Participants
#### Outcome Measure 11
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 231.1
- **Upper Limit:**
- **Value:** 483.0
**Title:**
#### Outcome Measure 12
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 4.82
- **Upper Limit:**
- **Value:** 8.87
**Title:**
#### Outcome Measure 13
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 1056
- **Upper Limit:**
- **Value:** 2787
**Title:**
#### Outcome Measure 14
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 1084
- **Upper Limit:**
- **Value:** 2874
**Title:**
#### Outcome Measure 15
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 1272
- **Upper Limit:**
- **Value:** 3311
**Title:**
#### Outcome Measure 16
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 254.4
- **Upper Limit:**
- **Value:** 334.6
**Title:**
#### Outcome Measure 17
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 28
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 28
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 23
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 20
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 28
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 24
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 20
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 9
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 9
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 19
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 17
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 10
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 2
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 1
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 19
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 12
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 4
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 1
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 5
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 4
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 15
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 4
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 5
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 7
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 4
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 8
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 0
**Title:**
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** rPFS was defined as the time from first dose to radiographic progression, assessed by the Investigator per RECIST 1.1 (soft tissue) and PCWG3 (Prostate Cancer Working Group 3) criteria \[bone\] or death from any cause, whichever occurred first.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** Evaluable for efficacy set consisted of dosed patients with a baseline tumour assessment. The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk.
**Reporting Status:** POSTED
**Time Frame:** From first dose to first documented progression or death from any cause (whichever comes first) (approximately 1 year)
**Title:** Radiographic Progression Free Survival (rPFS) in Each Arm Separately to Determine the Efficacy of AZD4635 Plus Durvalumab and of AZD4635 Plus Durvalumab Plus Cabazitaxel in Patients With Metastatic Castrate-resistant Prostate Cancer (mCRPC)
**Type:** PRIMARY
**Unit of Measure:** months
##### Group
**Description:** Participants received AZD4635 Dose A orally daily, and durvalumab Dose B intravenously every 4 weeks.
**ID:** OG000
**Title:** Arm A: AZD4635 + Durvalumab
##### Group
**Description:** Participants received AZD4635 Dose A orally daily, durvalumab Dose B intravenously (IV) every 3 weeks (Q3W), and cabazitaxel Dose C IV Q3W
**ID:** OG001
**Title:** Arm B: AZD4635 + Durvalumab + Cabazitaxel
#### Outcome Measure 2
**Description:** rPFS was defined as the time from first dose to radiographic progression, assessed by the Investigator per RECIST 1.1 (soft tissue) and PCWG3 criteria (bone) or death from any cause, whichever occurred first.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Evaluable for efficacy set consisted of dosed patients with a baseline tumour assessment. The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk. The analysis of rPFS by ADO was not done.
**Reporting Status:** POSTED
**Time Frame:** From first dose to first documented progression or death from any cause (whichever comes first), up to two years
**Title:** rPFS by Adenosine (ADO) Signalling Gene Expression in High and Low Subgroups to Determine the Efficacy of AZD4635 Plus Durvalumab Plus Cabazitaxel in Participants With mCRPC
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants received AZD4635 Dose A orally daily, and durvalumab Dose B intravenously every 4 weeks.
**ID:** OG000
**Title:** Arm A: AZD4635 + Durvalumab
##### Group
**Description:** Participants received AZD4635 Dose A orally daily, durvalumab Dose B intravenously (IV) every 3 weeks (Q3W), and cabazitaxel Dose C IV Q3W
**ID:** OG001
**Title:** Arm B: AZD4635 + Durvalumab + Cabazitaxel
#### Outcome Measure 3
**Description:** OS was defined as the time from first dose until death due to any cause regardless of whether the participant withdrew from study treatment or received another anti-cancer therapy.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** Evaluable for efficacy set consisted of dosed patients with a baseline tumour assessment. The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk.
**Reporting Status:** POSTED
**Time Frame:** Arm A and B: Every 90 days from the last dose of study drug up to 2 years
**Title:** Overall Survival (OS) in Each Arm Separately to Determine the Efficacy of AZD4635 Plus Durvalumab and of AZD4635 Plus Durvalumab Plus Cabazitaxel in Participants With mCRPC
**Type:** SECONDARY
**Unit of Measure:** months
##### Group
**Description:** Participants received AZD4635 Dose A orally daily, and durvalumab Dose B intravenously every 4 weeks.
**ID:** OG000
**Title:** Arm A: AZD4635 + Durvalumab
##### Group
**Description:** Participants received AZD4635 Dose A orally daily, durvalumab Dose B intravenously (IV) every 3 weeks (Q3W), and cabazitaxel Dose C IV Q3W
**ID:** OG001
**Title:** Arm B: AZD4635 + Durvalumab + Cabazitaxel
#### Outcome Measure 4
**Description:** Confirmed ORR was defined as the proportion of participants with a confirmed complete response (CR) or partial response (PR) using overall radiographic response assessed by RECIST v1.1 and PCWG-3 criteria (bone), and was based on a subset of all treated participants with measurable disease at baseline per the site Investigator.
**Parameter Type:** NUMBER
**Population Description:** Evaluable for efficacy set consisted of dosed patients with a baseline tumour assessment. The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk.
**Reporting Status:** POSTED
**Time Frame:** From first dose to first documented progression or death from any cause (whichever comes first), up to two years
**Title:** Number of Participants With Objective Response in Subjects With MCRPC Who Received AZD4635 Plus Durvalumab Plus Cabazitaxel
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants received AZD4635 Dose A orally daily, and durvalumab Dose B intravenously every 4 weeks.
**ID:** OG000
**Title:** Arm A: AZD4635 + Durvalumab
##### Group
**Description:** Participants received AZD4635 Dose A orally daily, durvalumab Dose B intravenously (IV) every 3 weeks (Q3W), and cabazitaxel Dose C IV Q3W
**ID:** OG001
**Title:** Arm B: AZD4635 + Durvalumab + Cabazitaxel
#### Outcome Measure 5
**Description:** Confirmed PSA50 response is defined as the proportion of participants who achieved a ≥50% decrease in PSA from baseline to the lowest post-baseline PSA, confirmed by a consecutive PSA at least 3 weeks later and was based on PSA evaluable participants (dosed participants with an abnormal baseline PSA \[≥1 ng/mL\]).
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** PSA evaluable analysis set consisted of dosed participants with an abnormal baseline PSA (=1ng/mL). The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk.
**Reporting Status:** POSTED
**Time Frame:** Arm A: Screening, Day 1 of each cycle up to 11 months (Each cycle was 28 days in length); Arm B: Screening, Day 1 of each cycle up to 11 months (Cycle 1 to Cycle 10 = 21 days, Cycle 11 onwards = 28 days)
**Title:** Number of Participants With Prostate-specifin Antigen (PSA50) Response in Subjects With MCRPC Who Received AZD4635 Plus Durvalumab Plus Cabazitaxel
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants received AZD4635 Dose A orally daily, and durvalumab Dose B intravenously every 4 weeks.
**ID:** OG000
**Title:** Arm A: AZD4635 + Durvalumab
##### Group
**Description:** Participants received AZD4635 Dose A orally daily, durvalumab Dose B intravenously (IV) every 3 weeks (Q3W), and cabazitaxel Dose C IV Q3W
**ID:** OG001
**Title:** Arm B: AZD4635 + Durvalumab + Cabazitaxel
#### Outcome Measure 6
**Description:** "Worst pain" and "Average pain" are 'single question' scores from the BPI short form and may take any value from 0 to 10 (worst outcome). "Interference Pain" is the total score of 7 sub-scores, where each value may take any value from 0 to 10 (worst outcome). The range of the "Interference Score" can be from 0 to 70.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Full analysis set consisted of all participants who received at least one (non-zero) dose of study treatment. The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk. Only safety data have been provided.
None of the 14 participants at Baseline answered the questionnaire at Cycle 1 Day 1. Therefore, related statistics were not derived for this timepoint.
**Reporting Status:** POSTED
**Time Frame:** Arm A: Screening, Day 1 of each cycle up to 9 months (Each cycle was 28 days in length); Arm B: Screening, Day 1 of each cycle up to 9 months (Each cycle was 21 days in length)
**Title:** Change From Baseline in Worst Pain in the Daily Activities Scales of the Brief Pain Inventory - Short Form (BPI-SF)
**Type:** SECONDARY
**Unit of Measure:** Score on a Scale
##### Group
**Description:** Participants received AZD4635 Dose A orally daily, and durvalumab Dose B intravenously every 4 weeks.
**ID:** OG000
**Title:** Arm A: AZD4635 + Durvalumab
##### Group
**Description:** Participants received AZD4635 Dose A orally daily, durvalumab Dose B intravenously (IV) every 3 weeks (Q3W), and cabazitaxel Dose C IV Q3W
**ID:** OG001
**Title:** Arm B: AZD4635 + Durvalumab + Cabazitaxel
#### Outcome Measure 7
**Description:** "Worst pain" and "Average pain" are 'single question' scores from the BPI short form and may take any value from 0 to 10 (worst outcome). "Interference Pain" is the total score of 7 sub-scores, where each value may take any value from 0 to 10 (worst outcome). The range of the "Interference Score" can be from 0 to 70.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Full analysis set consisted of all participants who received at least one (non-zero) dose of study treatment. The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk. Only safety data have been provided.
None of the 14 participants at Baseline answered the questionnaire at Cycle 1 Day 1 and, therefore, related statistics were not derived for this timepoint.
**Reporting Status:** POSTED
**Time Frame:** Arm A: Screening, Day 1 of each cycle up to 9 months (Each cycle was 28 days in length); Arm B: Screening, Day 1 of each cycle up to 9 months (Each cycle was 21 days in length)
**Title:** Change From Baseline in Average Pain in the Daily Activities Scales of the Brief Pain Inventory - Short Form (BPI-SF)
**Type:** SECONDARY
**Unit of Measure:** Score on a Scale
##### Group
**Description:** Participants received AZD4635 Dose A orally daily, and durvalumab Dose B intravenously every 4 weeks.
**ID:** OG000
**Title:** Arm A: AZD4635 + Durvalumab
##### Group
**Description:** Participants received AZD4635 Dose A orally daily, durvalumab Dose B intravenously (IV) every 3 weeks (Q3W), and cabazitaxel Dose C IV Q3W
**ID:** OG001
**Title:** Arm B: AZD4635 + Durvalumab + Cabazitaxel
#### Outcome Measure 8
**Description:** "Worst pain" and "Average pain" are 'single question' scores from the BPI short form and may take any value from 0 to 10 (worst outcome). "Interference Pain" is the total score of 7 sub-scores, where each value may take any value from 0 to 10 (worst outcome). The range of the "Interference Score" can be from 0 to 70.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Full analysis set consisted of all participants who received at least one (non-zero) dose of study treatment. The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk. Only safety data have been provided.
None of the 14 participants at Baseline answered the questionnaire at Cycle 1 Day 1 and, therefore, related statistics were not derived for this timepoint.
**Reporting Status:** POSTED
**Time Frame:** Arm A: Screening, Day 1 of each cycle up to 9 months (Each cycle was 28 days in length); Arm B: Screening, Day 1 of each cycle up to 9 months (Each cycle was 21 days in length)
**Title:** Change From Baseline in Pain Interference in the Daily Activities Scales of the Brief Pain Inventory - Short Form (BPI-SF)
**Type:** SECONDARY
**Unit of Measure:** Score on a Scale
##### Group
**Description:** Participants received AZD4635 Dose A orally daily, and durvalumab Dose B intravenously every 4 weeks.
**ID:** OG000
**Title:** Arm A: AZD4635 + Durvalumab
##### Group
**Description:** Participants received AZD4635 Dose A orally daily, durvalumab Dose B intravenously (IV) every 3 weeks (Q3W), and cabazitaxel Dose C IV Q3W
**ID:** OG001
**Title:** Arm B: AZD4635 + Durvalumab + Cabazitaxel
#### Outcome Measure 9
**Description:** Pain progression was assessed using BPI-SF.
**Parameter Type:** NUMBER
**Population Description:** Full analysis set consisted of all participants who received at least one (non-zero) dose of study treatment. The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk.
**Reporting Status:** POSTED
**Time Frame:** Arm A: Screening, Day 1 of each cycle up to 12 months (Each cycle was 28 days in length); Arm B: Screening, Day 1 of each cycle up to 12 months (Cycle 1 to Cycle 10 = 21 days, Cycle 11 onwards = 28 days)
**Title:** Number of Participants Who Progressed Based on BPI-SF Item 3
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants received AZD4635 Dose A orally daily, and durvalumab Dose B intravenously every 4 weeks.
**ID:** OG000
**Title:** Arm A: AZD4635 + Durvalumab
##### Group
**Description:** Participants received AZD4635 Dose A orally daily, durvalumab Dose B intravenously (IV) every 3 weeks (Q3W), and cabazitaxel Dose C IV Q3W
**ID:** OG001
**Title:** Arm B: AZD4635 + Durvalumab + Cabazitaxel
#### Outcome Measure 10
**Description:** The Functional Assessment of Cancer Therapy-Prostate (FACT-P) will be used to measure health related quality of life (HRQL) in men with prostate cancer. It consists of 4 subscales (physical, emotional, functional and social/family well-being) plus a 12-item prostate-specific module, the PCS subscale, which highlights concerns specific to participants with prostate cancer. FAPSI-6 is defined as a symptom score made up of 6 items from within the FACT-P (pain \[n = 3\], fatigue \[n = 1\], weight loss \[n = 1\], and concerns about the condition getting worse \[n = 1\]). Each question in the FACT-P questionnaires has a choice of 5 responses, "Not at all", "A little bit", "Somewhat", "Quite a bit" and "Very much". The scores range from 0 ("Not at all") to 4 ("Very much") for positively phrased questions. Negatively phrased questions have a reverse scoring, from 0 ("Very much") to 4 ("Not at all"). This results in a consistent approach, where higher scores indicate a better quality of life.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Full analysis set consisted of all participants who received at least one (non-zero) dose of study treatment. The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk.
None of the 10 participants at Baseline answered the questionnaire at Cycle 1 Day 1. Therefore, related statistics were not derived for this timepoint.
**Reporting Status:** POSTED
**Time Frame:** Arm A: Screening, Day 1 of each cycle up to 9 months (Each cycle was 28 days in length); Arm B: Screening, Day 1 of each cycle up to 9 months (Each cycle was 21 days in length)
**Title:** Change From Baseline in the FACT Advanced Prostate Symptom Indext-6 (FAPSI-6), as Derived From 6 Items, the FAPSI-8 From 8 Items Within the FACT-P and the Prostate Cancer Symptoms (PCS), From the 12 Items in the Prostrate-specific Module of the FACT-P
**Type:** SECONDARY
**Unit of Measure:** Score on a Scale
##### Group
**Description:** Participants received AZD4635 Dose A orally daily, and durvalumab Dose B intravenously every 4 weeks.
**ID:** OG000
**Title:** Arm A: AZD4635 + Durvalumab
##### Group
**Description:** Participants received AZD4635 Dose A orally daily, durvalumab Dose B intravenously (IV) every 3 weeks (Q3W), and cabazitaxel Dose C IV Q3W
**ID:** OG001
**Title:** Arm B: AZD4635 + Durvalumab + Cabazitaxel
#### Outcome Measure 11
**Description:** Investigate the PK of AZD4635 when given in combination with durvalumab, and when given in combination with durvalumab plus cabazitaxel.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** The pharmacokinetics (PK) analysis set consisted of dosed participants for whom an adequate PK profile was obtained. The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk.
**Reporting Status:** POSTED
**Time Frame:** Arm A:Cycle 1 to 3, and Cycle 4 onwards, and 90-day follow-up (FU) visit up to 14 months [Each cycle was 28 days in length];Arm B: Cycle 1 to 7 and Cycle 11 onwards, and 90-day FU up to 14 months (Cycle 1 to Cycle 10 = 21 days, Cycle 11 onwards = 28 days)
**Title:** Maximum Observed Plasma Concentration (Cmax)
**Type:** SECONDARY
**Unit of Measure:** nanogram/millilitre (ng/mL)
##### Group
**Description:** Participants received AZD4635 Dose A orally daily, and durvalumab Dose B intravenously every 4 weeks.
**ID:** OG000
**Title:** Arm A: AZD4635 + Durvalumab
##### Group
**Description:** Participants received AZD4635 Dose A orally daily, durvalumab Dose B intravenously (IV) every 3 weeks (Q3W), and cabazitaxel Dose C IV Q3W
**ID:** OG001
**Title:** Arm B: AZD4635 + Durvalumab + Cabazitaxel
#### Outcome Measure 12
**Description:** Investigated the PK of AZD4635 when given in combination with durvalumab, and when given in combination with durvalumab plus cabazitaxel.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** The PK analysis set consisted of dosed participants for whom an adequate PK profile was obtained. The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk.
**Reporting Status:** POSTED
**Time Frame:** Arm A:Cycle 1 to 3, and Cycle 4 onwards, and 90-day follow-up (FU) visit up to 14 months [Each cycle was 28 days in length];Arm B: Cycle 1 to 7 and Cycle 11 onwards, and 90-day FU up to 14 months (Cycle 1 to Cycle 10 = 21 days, Cycle 11 onwards = 28 days)
**Title:** Terminal Half-life (t1/2λz)
**Type:** SECONDARY
**Unit of Measure:** hour (h)
##### Group
**Description:** Participants received AZD4635 Dose A orally daily, and durvalumab Dose B intravenously every 4 weeks.
**ID:** OG000
**Title:** Arm A: AZD4635 + Durvalumab
##### Group
**Description:** Participants received AZD4635 Dose A orally daily, durvalumab Dose B intravenously (IV) every 3 weeks (Q3W), and cabazitaxel Dose C IV Q3W
**ID:** OG001
**Title:** Arm B: AZD4635 + Durvalumab + Cabazitaxel
#### Outcome Measure 13
**Description:** Investigated the PK of AZD4635 when given in combination with durvalumab, and when given in combination with durvalumab plus cabazitaxel.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** The PK analysis set consisted of dosed participants for whom an adequate PK profile was obtained. The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk.
**Reporting Status:** POSTED
**Time Frame:** Arm A:Cycle 1 to 3, and Cycle 4 onwards, and 90-day follow-up (FU) visit up to 14 months [Each cycle was 28 days in length];Arm B: Cycle 1 to 7 and Cycle 11 onwards, and 90-day FU up to 14 months (Cycle 1 to Cycle 10 = 21 days, Cycle 11 onwards = 28 days)
**Title:** Area Under the Plasma Concentration Time Curve From Zero to the Time of the Last Measurable Concentration (AUClast)
**Type:** SECONDARY
**Unit of Measure:** hour (h)*nanogram/millilitre (ng/mL)
##### Group
**Description:** Participants received AZD4635 Dose A orally daily, and durvalumab Dose B intravenously every 4 weeks.
**ID:** OG000
**Title:** Arm A: AZD4635 + Durvalumab
##### Group
**Description:** Participants received AZD4635 Dose A orally daily, durvalumab Dose B intravenously (IV) every 3 weeks (Q3W), and cabazitaxel Dose C IV Q3W
**ID:** OG001
**Title:** Arm B: AZD4635 + Durvalumab + Cabazitaxel
#### Outcome Measure 14
**Description:** Investigated the PK of AZD4635 when given in combination with durvalumab, and when given in combination with durvalumab plus cabazitaxel.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** The PK analysis set consisted of dosed participants for whom an adequate PK profile was obtained. The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk.
**Reporting Status:** POSTED
**Time Frame:** Arm A:Cycle 1 to 3, and Cycle 4 onwards, and 90-day follow-up (FU) visit up to 14 months [Each cycle was 28 days in length];Arm B: Cycle 1 to 7 and Cycle 11 onwards, and 90-day FU up to 14 months (Cycle 1 to Cycle 10 = 21 days, Cycle 11 onwards = 28 days)
**Title:** Area Under the Plasma Concentration Time Curve From Zero to 24 Hours [AUC(0-24)]
**Type:** SECONDARY
**Unit of Measure:** hour (h)*nanogram/millilitre (ng/mL)
##### Group
**Description:** Participants received AZD4635 Dose A orally daily, and durvalumab Dose B intravenously every 4 weeks.
**ID:** OG000
**Title:** Arm A: AZD4635 + Durvalumab
##### Group
**Description:** Participants received AZD4635 Dose A orally daily, durvalumab Dose B intravenously (IV) every 3 weeks (Q3W), and cabazitaxel Dose C IV Q3W
**ID:** OG001
**Title:** Arm B: AZD4635 + Durvalumab + Cabazitaxel
#### Outcome Measure 15
**Description:** Investigated the PK of AZD4635 when given in combination with durvalumab, and when given in combination with durvalumab plus cabazitaxel.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** The PK analysis set consisted of dosed participants for whom an adequate PK profile was obtained. The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk.
**Reporting Status:** POSTED
**Time Frame:** Arm A:Cycle 1 to 3, and Cycle 4 onwards, and 90-day follow-up (FU) visit up to 14 months [Each cycle was 28 days in length];Arm B: Cycle 1 to 7 and Cycle 11 onwards, and 90-day FU up to 14 months (Cycle 1 to Cycle 10 = 21 days, Cycle 11 onwards = 28 days)
**Title:** Area Under the Plasma Concentration Time Curve From Zero Extrapolated to Infinity (AUCinf)
**Type:** SECONDARY
**Unit of Measure:** hour (h)*nanogram/millilitre (ng/mL)
##### Group
**Description:** Participants received AZD4635 Dose A orally daily, and durvalumab Dose B intravenously every 4 weeks.
**ID:** OG000
**Title:** Arm A: AZD4635 + Durvalumab
##### Group
**Description:** Participants received AZD4635 Dose A orally daily, durvalumab Dose B intravenously (IV) every 3 weeks (Q3W), and cabazitaxel Dose C IV Q3W
**ID:** OG001
**Title:** Arm B: AZD4635 + Durvalumab + Cabazitaxel
#### Outcome Measure 16
**Description:** Investigated the PK of AZD4635 when given in combination with durvalumab, and when given in combination with durvalumab plus cabazitaxel.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** The PK analysis set consisted of dosed participants for whom an adequate PK profile was obtained. The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk.
**Reporting Status:** POSTED
**Time Frame:** Arm A:Cycle 1 to 3, and Cycle 4 onwards, and 90-day follow-up (FU) visit up to 14 months [Each cycle was 28 days in length];Arm B: Cycle 1 to 7 and Cycle 11 onwards, and 90-day FU up to 14 months (Cycle 1 to Cycle 10 = 21 days, Cycle 11 onwards = 28 days)
**Title:** Apparent Volume of Distribution During the Terminal Phase (Vz/F)
**Type:** SECONDARY
**Unit of Measure:** Litre
##### Group
**Description:** Participants received AZD4635 Dose A orally daily, and durvalumab Dose B intravenously every 4 weeks.
**ID:** OG000
**Title:** Arm A: AZD4635 + Durvalumab
##### Group
**Description:** Participants received AZD4635 Dose A orally daily, durvalumab Dose B intravenously (IV) every 3 weeks (Q3W), and cabazitaxel Dose C IV Q3W
**ID:** OG001
**Title:** Arm B: AZD4635 + Durvalumab + Cabazitaxel
#### Outcome Measure 17
**Description:** Safety and tolerability of each treatment regimen were assessed in participants with mCRPC.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** The safety analysis set consisted of all participants who received at least 1 dose of study drug. The data for Arm A was not calculated because of only two participants in this arm due to which there will be a patient identification risk.
**Reporting Status:** POSTED
**Time Frame:** Arm A: From Screening up to 14 months (Each cycle was 28 days in length); Arm B: From Screening up to 14 months (Cycle 1 to Cycle 10 was 21 days in length, and Cycle 11 onwards was 28 days in length)
**Title:** Number of Subjects With Serious and Non-serious Adverse Events
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants received AZD4635 Dose A orally daily, and durvalumab Dose B intravenously every 4 weeks.
**ID:** OG000
**Title:** Arm A: AZD4635 + Durvalumab
##### Group
**Description:** Participants received AZD4635 Dose A orally daily, durvalumab Dose B intravenously (IV) every 3 weeks (Q3W), and cabazitaxel Dose C IV Q3W
**ID:** OG001
**Title:** Arm B: AZD4635 + Durvalumab + Cabazitaxel
### Participant Flow Module
#### Group
**Description:** Participants received AZD4635 Dose A orally daily, and durvalumab Dose B intravenously every 4 weeks.
**ID:** FG000
**Title:** Arm A: AZD4635 + Durvalumab
#### Group
**Description:** Participants received AZD4635 Dose A orally daily, durvalumab Dose B intravenously (IV) every 3 weeks (Q3W), and cabazitaxel Dose C IV Q3W
**ID:** FG001
**Title:** Arm B: AZD4635 + Durvalumab + Cabazitaxel
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
###### Reason
**Group ID:** FG001
**Number of Subjects:** 4
##### Withdraw
**Type:** Study terminated by sponsor
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 18
##### Withdraw
**Type:** Death
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 4
##### Withdraw
**Type:** Adverse Event
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 2
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 28
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 2
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 28
**Pre-Assignment Details:** Participants who met the inclusion and none of the exclusion criteria were enrolled to the study. All study assessments were performed as per the schedule of assessment.
**Recruitment Details:** Participants were enrolled in this study from 04-August-2020 to 08-August-2022.
**Has Results:** True |
## Protocol Section
### Identification Module
**NCT ID:** NCT04040179
**Brief Title:** A Volunteer Study to Collect Imaging Data for the Development of the ntelligentUltrasound Anatomy Guide
**Official Title:** A Volunteer Study to Collect Imaging Data for the Development of the ntelligentUltrasound Anatomy Guide
#### Organization Study ID Info
**ID:** IU2019_AG_03
#### Organization
**Class:** INDUSTRY
**Full Name:** Medaphor Limited
### Status Module
#### Completion Date
**Date:** 2019-09-30
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-10-10
**Type:** ACTUAL
**Last Update Submit Date:** 2019-10-09
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2019-09-30
**Type:** ACTUAL
#### Start Date
**Date:** 2019-08-05
**Type:** ACTUAL
**Status Verified Date:** 2019-07
#### Study First Post Date
**Date:** 2019-07-31
**Type:** ACTUAL
**Study First Submit Date:** 2019-07-30
**Study First Submit QC Date:** 2019-07-30
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** IntelligentUltrasound Limited
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Medaphor Limited
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The aim of this study is to determine if machine learning can be used to automatically highlight key anatomy on the ultrasound image to help anaesthetists perform ultrasound-guided regional anaesthesia.
**Detailed Description:** The study will involve adult volunteers who are willing to be scanned by a trained sonographer to collect ultrasound video data for the following categories:
* Adductor canal
* Popliteal fossa
* Fascia Iliaca
* Rectus sheath
* Axillary
* ESP
* PECS
* Interscalene
Each volunteer will be scanned to collect data for every category in the list. Where applicable, both sides of the body will be scanned.
The videos will be segmented by hand to identify the relevant anatomical regions for each category.
The primary objective for this study is to provide the range of data required to develop robust models in conjunction with additional data from patients undergoing a Peripheral Nerve Block procedure that are able to produce the desired segmentation on the unseen validation images. The models will be scored using the standard "Mean intersection over Union" pixel-level metric for semantic segmentation.
### Conditions Module
**Conditions:**
- Ultrasound Imaging of Anatomical Structures
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 30
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Outcomes Module
#### Primary Outcomes
**Description:** Models with a Mean intersection over Union score of 0.95 or better for each region in each category.
**Measure:** Model development
**Time Frame:** 6 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Male or female, at least 18 years of age;
2. Willing to undergo ultrasound scanning and provide ultrasound video data for the following categories:
* Adductor canal
* Popliteal fossa
* Fascia Iliaca
* Rectus sheath
* Axillary
* ESP
* PECS
* Interscalene
3. Able to comprehend and sign the Informed Consent prior to enrolment in the study.
Exclusion Criteria:
1. Aged \<18 years of age;
2. Unwilling or unable to provide informed consent.
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Healthy volunteers
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Cardiff
**Country:** United Kingdom
**Facility:** Medicentre
**Zip:** CF14 4UJ
## Derived Section
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT04538079
**Acronym:** NOAH
**Brief Title:** Non-invasive Objective Assessment of Hemodynamics in Preterm Neonates
**Official Title:** Non-invasive Objective Assessment of Hemodynamics in Preterm Neonates - the NOAH Study
#### Organization Study ID Info
**ID:** ED001/19UCC
#### Organization
**Class:** OTHER
**Full Name:** University College Cork
### Status Module
#### Completion Date
**Date:** 2021-05-31
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-01-27
**Type:** ACTUAL
**Last Update Submit Date:** 2023-01-25
**Overall Status:** TERMINATED
#### Primary Completion Date
**Date:** 2021-05-31
**Type:** ACTUAL
#### Start Date
**Date:** 2019-11-09
**Type:** ACTUAL
**Status Verified Date:** 2023-01
#### Study First Post Date
**Date:** 2020-09-03
**Type:** ACTUAL
**Study First Submit Date:** 2020-03-05
**Study First Submit QC Date:** 2020-09-02
**Why Stopped:** End of funding period
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University College Cork
#### Responsible Party
**Investigator Affiliation:** University College Cork
**Investigator Full Name:** Dr. Gene Dempsey
**Investigator Title:** Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Study type: Prospective Observational trial Study design: Longitudinal Population: Preterm newborns \<32 weeks gestational age Hypothesis: The inclusion of non-invasive physiological measures of cardiac output, peripheral perfusion and brain oxygenation (NIRS) for preterm neonates is feasible and reveals additional information on the hemodynamic status compared to blood pressure alone. These measurements can improve the ability to rapidly identify those infants who might benefit from intervention and are correlated with short term clinical outcomes.
**Detailed Description:** Understanding neonatal hemodynamics is key to neonatal care. Despite decades of research, uncertainty continues as to how best assess impaired hemodynamics.
Hypotension defined by a low Mean Arterial Blood Pressure (MABP) remains a common issue in preterm infants, affecting up to 30% of extremely preterm infants.
It is common to focus only on MABP thus neglecting the complex and dynamic (patho)physiology that may be present in newborn infants. Providing sufficient cellular oxygenation is the primary task of the circulatory system and different factors may compromise it. In this prospective observational study the investigators will examine various forms of objective non-invasive continuous hemodynamic monitoring methods in very preterm infants
1. For feasibility of non-invasive CO measurement (first 20 patients)
2. For reproducibility and correlation of this measurement and ECHOcardiography (first 40 echocardiographic examinations)
3. For prediction of therapy response.
4. For correlation with clinical definitions of hypotension/hypoperfusion
5. For prediction of later clinical problems/complications of prematurity and impaired hemodynamic status.
### Conditions Module
**Conditions:**
- Hypotension and Shock
- Hypoperfusion
- Hemodynamic Instability
- Intraventricular Hemorrhage
- Cardiac Function
- Circulatory Transition
**Keywords:**
- objective hemodynamic multimodal Monitoring
- premature preterm infant
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 56
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The first 20 participants will be analysed for feasibility and the first 40 ECHOs for accuracy/reproducibility of non-invasive Cardiac Output Monitoring with ECHO as reference Method.
**Intervention Names:**
- Device: Multimodal objective non-invasive Monitoring
**Label:** Feasibility/Accuracy/Reproducibility
#### Arm Group 2
**Description:** Together with the Feasibility/Accuracy/Reproducibility Cohort this group's results will be analysed for prediction of circulatory failure defined as an ultrasound abnormality (IVH grade 3 - 4) or death within the first two weeks of life.
**Intervention Names:**
- Device: Multimodal objective non-invasive Monitoring
**Label:** Prediction of Circulatory Failure
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Feasibility/Accuracy/Reproducibility
- Prediction of Circulatory Failure
**Description:** Multimodal objective non-invasive monitoring including cerebral oxygenation (NIRS), pulse oximetry with Pulsatility Index (PI) and non-invasive Cardiac Output Monitoring will be recorded but not used for clinical decision making. 2 ECHOs will be performed (one within the first 24h, one in the 2nd 24 hours after birth)
**Name:** Multimodal objective non-invasive Monitoring
**Type:** DEVICE
### Outcomes Module
#### Other Outcomes
**Description:** Onset and duration of clinical suspicion of Circulatory Insufficiency in clinical examination (i.e. skin colour, increased capillary refill time\>3seconds) as documented in the clinical charts.
**Measure:** Burden of clinical suspicion indicating Circulatory Insufficiency
**Time Frame:** 48 hours
**Description:** Onset and duration of circulatory insufficiency indicated by laboratory parameters (metabolic acidosis with pH\<7,2 Lactate\>3mmol/L not explainable by intrapartum complications)
**Measure:** Burden of Laboratory parameters indicating Circulatory Insufficiency
**Time Frame:** 48 hours
**Description:** Time spend with Mean Arterial Blood Pressure (MABP) below 30mmHG and/or MABP below gestational age in weeks
**Measure:** Burden and Onset of Hypotension indicating Circulatory Insufficiency
**Time Frame:** 48 hours
**Description:** Time spend wit cerebral regional tissue Saturation (rcStO2) below a value of 60% and/or rcStO2/fraction of tissue oxygen extraction (rcFtO2E) below the infants median value-5%
**Measure:** Burden of Cerebral Oxygenation indicating Circulatory Insufficiency
**Time Frame:** 48 hours
**Description:** Time spend with Cardiac Output in the lower quartile of the Cohort.
**Measure:** Burden of Low Cardiac Output indicating Circulatory Insufficiency
**Time Frame:** 48 hours
**Description:** Time spend with pressure passivity of cerebral regional tissue oxygenation (MABP and or Pulse Pressure to rcStO2/rcFtO2E). Adjusted mutual information and transfer entropy will be used to quantify coupling between MABP or pulse pressure and rcStO2 or rcFtO2E.
**Measure:** Burden of impaired cerebral Autoregulation
**Time Frame:** 48 hours
#### Primary Outcomes
**Description:** Correlation of clinical, laboratory, conventional and multimodal non-invasive monitoring and/or a combination of variables with ultrasound abnormality (IVH grade 3 - 4/any IVH) or death within the first two weeks of life.
**Measure:** Adverse Outcome of Circulatory Failure
**Time Frame:** 14 days
#### Secondary Outcomes
**Description:** The proportion of infants in whom a continuous recording of non-invasive cardiac output (CO) and perfusion index (PI) analysis was obtained for at least 24 hours during the first 48 hours after birth with a good signal quality index
**Measure:** Feasibility of non-invasive Cardiac Output Monitoring and Pulsatility Index
**Time Frame:** 48 hours
**Description:** Reproducibility of cardiac output estimates by non-invasive Cardiac Output compared to echocardiographic examinations will be performed using absolute left ventricular output \[mL/min\]. The Investigators will use Bland-Altman analysis (Bland-Altman plots, Repeatability coefficient. Repeatability Index will be used for between parameter comparison.
**Measure:** Reproducibility of absolute left ventricular cardiac output estimated by echocardiography compared to cardiac output estimated by non-invasive Cardiac Output Monitoring
**Time Frame:** 48 hours
**Description:** Reproducibility of cardiac output estimates by non-invasive Cardiac Output compared to echocardiographic examinations will be performed using left ventricular output indexed to bodyweight \[mL/kg bodyweight/min\]. The Investigators will use Bland-Altman analysis (Bland-Altman plots, Repeatability coefficient. Repeatability Index will be used for between parameter comparison.
**Measure:** Reproducibility of left ventricular cardiac output indexed to bodyweight estimated by echocardiography compared to cardiac output estimated by non-invasive Cardiac Output Monitoring
**Time Frame:** 48 hours
**Description:** Reproducibility of left ventricular stroke volume estimates by non-invasive Cardiac Output compared to echocardiographic examinations will be performed using stroke volume \[mL\]. The Investigators will use Bland-Altman analysis (Bland-Altman plots, Repeatability coefficient. Repeatability Index will be used for between parameter comparison.
**Measure:** Reproducibility of left ventricular stroke volume estimated by echocardiography compared to cardiac output estimated by non-invasive Cardiac Output Monitoring
**Time Frame:** 48 hours
**Description:** Reproducibility of absolute cardiac output estimated by non-invasive Cardiac Output Monitoring compared to echocardiographic examinations will be performed using right ventricular output \[mL/min\]. The Investigators will use Bland-Altman analysis (Bland-Altman plots, Repeatability coefficient. Repeatability Index will be used for between parameter comparison.
**Measure:** Reproducibility of absolute right ventricular cardiac output indexed to bodyweight estimated by echocardiography compared to cardiac output estimated by non-invasive Cardiac Output Monitoring
**Time Frame:** 48 hours
**Description:** Reproducibility of relative right ventricular cardiac output estimates by non-invasive Cardiac Output Monitoring compared to echocardiographic examinations will be performed using right ventricular output indexed to bodyweight \[mL/kg bodyweight/min\]. The Investigators will use Bland-Altman analysis (Bland-Altman plots, Repeatability coefficient. Repeatability Index will be used for between parameter comparison.
**Measure:** Reproducibility of right ventricular cardiac output indexed to bodyweight estimated by echocardiography compared to estimation by non-invasive Cardiac Output Monitoring
**Time Frame:** 48 hours
**Description:** Reproducibility of left ventricular systolic time interval ratio estimates by non-invasive Cardiac Output-Monitoring and echocardiographic examinations will be compared using left ventricular pre-ejection period to left ventricular output time ratio \[no unit\]. The Investigators will use Bland-Altman analysis (Bland-Altman plots, Repeatability coefficient. Repeatability Index will be used for between parameter comparison.
**Measure:** Reproducibility of left ventricular systolic time interval ratio estimated by non-invasive Cardiac Output Monitoring compared to echocardiography
**Time Frame:** 48 hours
**Description:** Cardiac output estimates of non-invasive Cardiac Output-Monitoring and echocardiographic examinations will be compared using absolute superior vena cava flow \[mL/min\]. The Investigators will use Bland-Altman analysis (Bland-Altman plots, Repeatability coefficient. Repeatability Index will be used for between parameter comparison.
**Measure:** Reproducibility of absolute superior vena cava flow estimated by non-invasive Cardiac Output Monitoring compared to estimation by echocardiography
**Time Frame:** 48 hours
**Description:** Cardiac output estimates of non-invasive Cardiac Output-Monitoring and echocardiographic examinations will be compared using superior vena cava flow indexed to bodyweight \[mL/kg bodyweight/min\]. The Investigators will use Bland-Altman analysis (Bland-Altman plots, Repeatability coefficient. Repeatability Index will be used for between parameter comparison.
**Measure:** Reproducibility of superior vena cava flow indexed to bodyweight estimated by non-invasive Cardiac Output Monitoring compared to estimation by echocardiography
**Time Frame:** 48 hours
**Description:** CO-Monitoring and echocardiography will be analysed for correlation using correlation coefficient analysis pairwise for left and right ventricular output indexed to bodyweight \[mL/kg bodyweight/min\], left ventricular pre-ejection period to left ventricular output time ratio and Superior Vena Cava-flow indexed to bodyweight \[mL/kg bodyweight/min\].
**Measure:** Correlation of non-invasive Cardiac Output Monitoring with echocardiography
**Time Frame:** 48 hours
**Description:** Treatment Responsiveness (Volume and/or red blood cells responsiveness) using trend analysis within Corrected Flow Time (FTC \[ms\]) for volume responsiveness including a receiver operating characteristic analysis for infants who received volume and/or red blood cells during the study period. (Comparison of 20min mean as baseline before, during and 20min after treatment. Response is defined as normalization of the above mentioned physiological parameters within 20 minutes after receiving treatment.
**Measure:** Prediction of response to volume/red-blood cell transfusion by Corrected Flow Time estimated with non-invasive Cardiac Output Monitoring
**Time Frame:** 48 hours
**Description:** Treatment Responsiveness (Volume and/or red blood cells responsiveness) using trend analysis within Stroke Volume Variation (SVV) for volume responsiveness including a receiver operating characteristic analysis for infants who received volume and/or red blood cells during the study period. (Comparison of 20min mean as baseline before, during and 20min after treatment. Response is defined as normalization of the above mentioned physiological parameters within 20 minutes after receiving treatment.
**Measure:** Prediction of response to volume/red-blood cell transfusion by St roke Volume Variation estimated with non-invasive Cardiac Output Monitoring
**Time Frame:** 48 hours
**Description:** Treatment Responsiveness (Inotrope) using trend analysis within left ventricular cardiac output indexed to bodyweight \[ml/kg bodyweight/min\] for inotrope responsiveness including a receiver operating characteristic analysis for infants who received inotropes during the study period. (Comparison of 20min mean as baseline before, during and 20min after initiation of inotrope treatment. Response is defined as normalization of the above mentioned physiological parameters within 20 minutes after receiving treatment.
**Measure:** Prediction of Prediction of response to inotropes by non-invasive Cardiac Output Monitoring response to therapy by non-invasive Cardiac Output Monitoring
**Time Frame:** 48 hours
**Description:** Correlation of multimodal non-invasive monitoring with commonly used definitions of hypotension (Mean Arterial Blood Pressure MABP below 30mmHG and/or MABP below gestational age in weeks)
**Measure:** Correlation with definitions of hypotension
**Time Frame:** 48 hours
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Neonates of 23 weeks 0 days to 31 weeks 6 days
* NIRS/non-invasive Cardiac Output - device available
* Parental Informed Consent
Exclusion Criteria:
* Congenital anomalies
* Major cardiac defects
* Hydrops
* Parents decline to consent to the study
**Maximum Age:** 20 Hours
**Minimum Age:** 1 Minute
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
**Study Population:** Preterm Neonates born at a gestational age of 23 weeks 0 days to 31 weeks 6 days.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Cork
**Country:** Ireland
**Facility:** Neonatal Unit Cork University Maternity Hospital
#### Overall Officials
**Official 1:**
**Affiliation:** UCC
**Name:** Eugene M Dempsey, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010335
- Term: Pathologic Processes
- ID: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
### Condition Browse Module - Browse Leaves
- ID: M9556
- Name: Hemorrhage
- Relevance: HIGH
- As Found: Hemorrhage
- ID: M10072
- Name: Hypotension
- Relevance: HIGH
- As Found: Hypotension
- ID: M15577
- Name: Shock
- Relevance: LOW
- As Found: Unknown
- ID: M25869
- Name: Premature Birth
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000007022
- Term: Hypotension
- ID: D000006470
- Term: Hemorrhage
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT05373979
**Acronym:** PN-PROS
**Brief Title:** Development and Validation of Pediatric Narcolepsy Patient Reported Outcomes Scale
**Official Title:** Development and Validation of Pediatric Narcolepsy Patient Reported Outcomes Scale (PN-PROS)
#### Organization Study ID Info
**ID:** IRB-A00029346
#### Organization
**Class:** OTHER
**Full Name:** Boston Children's Hospital
### Status Module
#### Completion Date
**Date:** 2023-04-30
**Type:** ESTIMATED
#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2022-06-01
**Type:** ACTUAL
**Last Update Submit Date:** 2022-05-26
**Overall Status:** UNKNOWN
#### Primary Completion Date
**Date:** 2023-04-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2019-04-02
**Type:** ACTUAL
**Status Verified Date:** 2022-05
#### Study First Post Date
**Date:** 2022-05-13
**Type:** ACTUAL
**Study First Submit Date:** 2022-05-10
**Study First Submit QC Date:** 2022-05-10
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** National Jewish Health
**Class:** OTHER
**Name:** Geisinger Clinic
**Class:** OTHER
**Name:** The Hospital for Sick Children
**Class:** OTHER
**Name:** Stanford University
#### Lead Sponsor
**Class:** OTHER
**Name:** Boston Children's Hospital
#### Responsible Party
**Investigator Affiliation:** Boston Children's Hospital
**Investigator Full Name:** Kiran Maski
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The purpose of this study is to test a pediatric narcolepsy patient reported outcomes tool to assess pediatric narcolepsy symptoms and their effect on daily functioning and quality of life. The goal is to develop a clinical survey that can improve the care of pediatric narcolepsy.
**Detailed Description:** WHO IS ELIGIBLE?
* Children and adolescents with narcolepsy between the ages of 9-17 years
* Diagnosis must be verified by a signed letter from physician in order to participate
* Participants must be able to understand the purpose of the study
PARTICIPATION DETAILS
* Upon enrollment participants will receive an email containing a link to complete HIPAA compliant online surveys about narcolepsy symptoms, quality of life, and daily function. Surveys should take no more than 30 minutes.
* One week later, some participants will receive another email with a link to complete a 10-minute follow up survey
### Conditions Module
**Conditions:**
- Narcolepsy
- Obstructive Sleep Apnea
### Design Module
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 340
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Narcolepsy type 1 (NT1 or narcolepsy with cataplexy) and Narcolepsy type 2 (NT2 or narcolepsy without cataplexy)
**Label:** Narcolepsy
#### Arm Group 2
**Description:** mild to moderate obstructive sleep apnea (OSA; obstructive AHI of 1-15/hour)
**Label:** Obstructive Sleep Apnea
### Outcomes Module
#### Primary Outcomes
**Description:** To evaluate the content validity and reliability of the PN-PROs item pools through a field test of the item pools in a diverse, national sample of pediatric narcolepsy patients with a comparator group of pediatric mild obstructive sleep apnea patients (9-17 years).
**Measure:** Survey Validation
**Time Frame:** 2 Years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Children and adolescents ages 9-17
* Have a diagnosis of narcolepsy type 1, narcolepsy type 2, or mild to moderate obstructive sleep apnea (OSA)
Exclusion Criteria:
* A history of visual or hearing impairment
* A co-morbid neurodevelopmental disorder such as autism or schizophrenia
* No access to computer/tablet/smart phone to complete questionnaires
**Maximum Age:** 17 Years
**Minimum Age:** 9 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
**Study Population:** Patients (and a parent/guardian) with an established narcolepsy type 1, narcolepsy type 2, or OSA diagnoses ages 9-17 years.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Gillian Heckler
**Phone:** 617-919-6212
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Boston
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Gillian Heckler
- **Phone:** 617-919-6212
- **Role:** CONTACT
***Contact 2:***
- **Name:** Kiran Maski, MD, MPH
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Boston Children's Hospital
**State:** Massachusetts
**Status:** RECRUITING
**Zip:** 02115
#### Overall Officials
**Official 1:**
**Affiliation:** Boston Children's Hospital
**Name:** Kiran Maski, MD, MPH
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** No individual participant data will be shared with other researchers outside of Boston Children's Hospital.
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012891
- Term: Sleep Apnea Syndromes
- ID: D000001049
- Term: Apnea
- ID: D000012120
- Term: Respiration Disorders
- ID: D000012140
- Term: Respiratory Tract Diseases
- ID: D000020919
- Term: Sleep Disorders, Intrinsic
- ID: D000020920
- Term: Dyssomnias
- ID: D000012893
- Term: Sleep Wake Disorders
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000006970
- Term: Disorders of Excessive Somnolence
- ID: D000001523
- Term: Mental Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M4361
- Name: Apnea
- Relevance: LOW
- As Found: Unknown
- ID: M15694
- Name: Sleep Apnea Syndromes
- Relevance: LOW
- As Found: Unknown
- ID: M22010
- Name: Sleep Apnea, Obstructive
- Relevance: HIGH
- As Found: Obstructive Sleep Apnea
- ID: M12241
- Name: Narcolepsy
- Relevance: HIGH
- As Found: Narcolepsy
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M14957
- Name: Respiration Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M22242
- Name: Parasomnias
- Relevance: LOW
- As Found: Unknown
- ID: M22654
- Name: Sleep Disorders, Intrinsic
- Relevance: LOW
- As Found: Unknown
- ID: M22655
- Name: Dyssomnias
- Relevance: LOW
- As Found: Unknown
- ID: M15696
- Name: Sleep Wake Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M1717
- Name: Sleepiness
- Relevance: LOW
- As Found: Unknown
- ID: M10021
- Name: Disorders of Excessive Somnolence
- Relevance: LOW
- As Found: Unknown
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
- ID: T4044
- Name: Narcolepsy
- Relevance: HIGH
- As Found: Narcolepsy
### Condition Browse Module - Meshes
- ID: D000020181
- Term: Sleep Apnea, Obstructive
- ID: D000009290
- Term: Narcolepsy
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT03776279
**Brief Title:** A Study of Liposome-entrapped Mitoxantrone Hydrochloride Injection in Relapsed/Refractory Peripheral T-cell Lymphoma and NK/T-cell Lymphoma
**Official Title:** Single-arm, Open and Multi-center Phase II Study of Liposome-entrapped Mitoxantrone Hydrochloride Injection in Relapsed/Refractory Peripheral T-cell Lymphoma and NK/T-cell Lymphoma
#### Organization Study ID Info
**ID:** PLM60-PTCL
#### Organization
**Class:** INDUSTRY
**Full Name:** CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2020-12-30
**Type:** ESTIMATED
#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2018-12-14
**Type:** ACTUAL
**Last Update Submit Date:** 2018-12-13
**Overall Status:** UNKNOWN
#### Primary Completion Date
**Date:** 2020-12-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2018-04-02
**Type:** ACTUAL
**Status Verified Date:** 2018-12
#### Study First Post Date
**Date:** 2018-12-14
**Type:** ACTUAL
**Study First Submit Date:** 2018-12-13
**Study First Submit QC Date:** 2018-12-13
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This is a single-arm, open, multi-center, phase II study to evaluate the efficacy and safety of Mitoxantrone Hydrochloride Liposome Injection in Relapsed or refractory peripheral t-cell and NK/T-cell lymphoma.
**Detailed Description:** The dosage regimen of Liposome-entrapped Mitoxantrone is multi-cycle 20mg/m2 intravenous infusion. Every 4 weeks is a treatment cycle, with administration on the first day of each cycle. End-of-treatment visit will be made to the subjects within 4 weeks after the end of the last administration. Progression-free survival (PFS) follow-up will be conducted to the subjects in stable or improved condition after treatment and the subjects with early termination of treatment due to intolerance in Week 8 after the last administration of study drug, and thereafter once every 8 weeks until PD, death, withdrawal of informed consent form (ICF), starting another new treatment or end of the entire study (whichever occurs first). Meanwhile, overall survival (OS) follow-up will also be conducted to the subjects with PD and starting another new treatment once every 8 weeks until death, withdrawal of ICF or end of the entire study (whichever occurs first).
### Conditions Module
**Conditions:**
- Relapsed or Refractory Peripheral T-cell and NK/T-cell Lymphoma
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 106
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** 4 weeks is a treatment cycle, and the first day of each cycle is administered.
**Intervention Names:**
- Drug: Mitoxantrone Hydrochloride Liposome Injection
**Label:** Mitoxantrone Hydrochloride Liposome Injection
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Mitoxantrone Hydrochloride Liposome Injection
**Description:** Mitoxantrone Hydrochloride Liposome Injection 20 mg/m2 will be infused intravenously once over 60min in 250 ml 5％ glucose injection on the first day during a treatment phase of 4 weeks.
**Name:** Mitoxantrone Hydrochloride Liposome Injection
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** The percentage of complete response (CR) and partial response (PR) in all the enrolled subjects from the date of the first administration (calculated by the optimum response during the entire study period)
**Measure:** Objective response rate (ORR)
**Time Frame:** >4weeks
#### Secondary Outcomes
**Description:** The duration from achieving effective treatment (CR or PR recorded for the first time) until definite relapse or progression for the first time.
**Measure:** Duration of Response(DoR)
**Time Frame:** >3 months
**Description:** The duration from the first administration date until lymphoma progression (PD evaluated by imaging diagnosis) date or all-cause death date (whichever occurs first).
**Measure:** Progression-free survival(PFS)
**Time Frame:** 3 years
**Description:** The duration from the first administration date until all-cause death date.
**Measure:** Overall survival(OS)
**Time Frame:** 3 years
**Description:** The percentage of CR and PR in all the enrolled subjects from the date of the first administration, including the subjects with CR, PRC or SD
**Measure:** Disease control rate(DCR)
**Time Frame:** 3 years
### Eligibility Module
**Eligibility Criteria:** Inclusion criteria
Subjects must satisfy all the following conditions before enrollment:
1. Those who have fully understood the study and have signed the ICF.
2. Male or female, aged 18 or above (including 18).
3. Those with PTCL and NK/T-cell lymphoma confirmed by histopathological and/or cytological examination, with the subtypes as follows:
1. Peripheral T-cell lymphoma, unspecified (PTCL, NOS)
2. Angioimmunoblastic T-cell lymphoma (AITL)
3. ALK+systematic anaplastic large T-cell lymphoma (ALCL, ALK+)
4. ALK-systematic anaplastic large T-cell lymphoma (ALCL，ALK-)
5. Extranobal NK/T cell lymphoma (nasal type) (NKTCL)
6. Enteropathy-associated T-cell lymphoma (EATCL, Type I (traditional type), Type II)
7. Hepatosplenic γδ T-cell lymphoma (HSTCL, γδT) hOther non-Hodgkin's lymphomas from invasive T-cells (other than highly invasive cells) approved by the sponsor, who may be enrolled in the opinion of the investigator.
4. Those receivd at least first-line standard treatment (including chemotherapy and autologous hematopoietic stem cell transplantation) If anthracycline or anthracycline-containing chemotherapy has been used in the past, the efficacy is assessed as response; if they were NK/T-cell lymphoma patients, they need to be treated with asparaginase (or pepsinase, L-asparaginase) treatment.
5. Subjects who must provide the written pathological/histological diagnosis report during the screening period, and agree to provide the tumor tissue sections or fresh tumor tissues to the Center Laboratory for testing.
6. Those with ECOG performance status score of 0 or 1.
7. The estimated survival time was at least 12 weeks.
8. Those at least with one measurable lesion in accordance with the revised standard for evaluation of efficacy in malignant lymphoma (Version 2007): the long axis of the lesion shall be\>1.5 cm or 1.0\~1.5 cm and the short axis of the lesion shall be\>1.0 cm.
9. Subjects who shall meet the following requirements for laboratory examination when screening and who have not received cell growth factor (long-acting granulocyte-colony stimulating factor \[G-CSF\] and \[PEG-CSF\] shall have the interval of 14 days) and platelet or granulocyte infusion within 7 days before hematological evaluation for screening:
1. Absolute value of neutrophils ≥ 1.5 × 109/ L in subjects without involvement of bone marrow; absolute value of neutrophil ≥ 1.0 × 109/ L in subjects with involvement of bone marrow;
2. Hemoglobin ≥ 90 g/L (without red cell infusion within 14 days), hemoglobin ≥ 75 g/ L in subjects with involvement of bone marrow;
3. Platelet ≥ 75 × 109/ L in subjects without involvement of bone marrow; platelet ≥ 50 × 109/ L in subjects with involvement of bone marrow;
4. Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN) (total bilirubin ≤ 3 × ULN if bilirubin level increase is caused by lymphoma invading the liver);
5. Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 × ULN; if AST or ALT increase is caused by lymphoma invading the liver, both AST and ALT shall be ≤ 5 × ULN);
6. Creatinine \< 1.5 × ULN.
10. Female subjects:
1. Without fertility (i.e., unable to get pregnant under physiological condition), including postmenopausal (complete cessation of menstruation for ≥ 1 year) or documented irreversible sterilization including hysterectomy, bilateral ovariectomy or bilateral salpingectomy (rather than tubal ligation);
2. With fertility potential, who shall be negative when serum pregnancy test screening (within 7 days of the first administration of study drug) and agree to take effective contraception measures during the study period and within 90 days after the last administration. Subjects shall always practice contraception strictly in accordance with the labels of contraceptive drugs/devices and the instructions of the investigator. Effective contraception measures shall be defined as follows:
i)Sex partner vasectomized is the sole sex partner of the female subject; ii)Use of IUDs with a failure rate of less than 1% per year iii)Double contraception, e.g. spermatocide plus male condom, female condom, diaphragm, cervical cap or intrauterine device.
Male subjects: who shall have received the vasectomy, or agree to take effective contraception measures during the study period and within 30 days after the last administration.
11. Subjects who are able to comply with the study procedures, restrictions and requirements as judged by the investigator.
Exclusion criteria
Subjects consistent with any one of the following conditions:
1. Subjects in lymphoma leukemia (malignant cell proportion of \> 20% in bone marrow examination);
2. Subjects are consistent with one of the following conditions in the previous anti-tumor treatment history:
1. Those receiving Mitoxantrone or Liposome-entrapped Mitoxantrone previously;
2. Those receiving treatment of Adriamycin or other anthracyclines previously, with the total cumulative dose of \> 360 mg/m2 (when converted to 1 mg Adriamycin, other anthracyclines shall be equivalent to 2 mg Epirubicin or 2 mg Pirarubicin or 2 mg Daunorubicin or 0.5 mg Idarubicin);
3. Those receiving anti-tumor treatment (including chemotherapy, radiotherapy, hormone therapy or administration of TCM with anti-tumor activity) within 4 weeks prior to the first use of the study drug);
4. Those receiving autologous hematopoietic stem cell transplantation within 6 months;
5. Those receiving allogeneic hematopoietic stem cell transplantation previously.
3. Those receiving major surgery (the definition of major surgery shall refer to the Level 3 or 4 surgery stipulated in the Management Practices of Clinical Application of Medical Technology) within 4 weeks prior to enrollment or those who have not completely recovered from any previous invasive operation.
4. Those who have not recovered from toxic response in the previous anti-tumor treatment (\>Grade 1 in NCI-CTCAE \[Version 4.03\], with the exception of hair loss and pigmentation.
5. Those with other malignant tumors previously or currently (except the non-melanoma skin basal cell carcinoma under effective control, breast/cervical carcinoma in situ, and other malignant tumors not treated but under effective control in the past five years).
6. Subjects with known or existing primary or metastatic central nervous system lymphoma, or with existing other cerebral/meningeal diseases.
7. Subjects with uncontrolled hypertension (refers to systolic pressure of 180 mmHg and/or diastolic pressure of 100 mmHg after treatment).
8. Subjects with active hemorrhagic disease.
9. Subjects with active infection, including hepatitis B (positive hepatitis B virus surface antigen and hepatitis B virus DNA of more than 1,000 copies/mL) and hepatitis C (positive hepatitis C virus RNA).
10. Human immunodeficiency virus (HIV) infection (HIV positive).
11. Subjects with history of hepatic fibrosis or cirrhosis or with clinical signs and symptoms suggestive of liver fibrosis or cirrhosis.
12. Subjects with the cardiac function and disease:
1. Male: QTc\>450 ms, female: QTc\>470 ms when ECG examination in the Research Center during the screening period;
2. Clinically significant arrhythmias, including but not limited to complete left bundle branch block, Degree II atrioventricular block and PR interval \> 250 ms;
3. Any risk factor that might increase the QTc interval, e.g. hypokalaemia, inherited long-QT syndrome, with current administration of the drug for prolonging the QT interval or discontinuance for less than 15 days;
4. Congestive heart failure of ≥Grade 2 in the New York Heart Association;
5. Cardiac ejection fraction less than 50% or less than the lower limit of laboratory examination vale range of Research Center;
6. Within six months prior to recruitment occurred myocardial infarction, unstable angina, severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, clinical history of severe pericardial disease, or electrocardiographic evidence of acute ischemia or abnormal active conduction system.
13. Subjects with known history of immediate or delayed hypersensitivity to the similar drug and excipient of the study drug.
14. Pregnant or lactating women.
15. According to the judgement of the investigators ,Those with any severe or uncontrolled systematic disease, systematic complication, other severe complicated diseases (e.g. hemophagocytic syndrome) or special tumor condition that might make the subjects unsuitable for entry into the study or might affect the compliance to the protocol or might cause significant interference with the correct evaluation of safety, toxicity and efficacy of the study drug.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Huiqiang Huang, Doctor
**Phone:** 020-87343350
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Guangzhou
**Contacts:**
***Contact 1:***
- **Name:** Huiqiang Huang, Doctor
- **Phone:** 020-87343350
- **Role:** CONTACT
**Country:** China
**Facility:** Sun Yat-sen University Cancer Center
**State:** Guangdong
**Status:** RECRUITING
**Zip:** 510060
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000009369
- Term: Neoplasms
- ID: D000008232
- Term: Lymphoproliferative Disorders
- ID: D000008206
- Term: Lymphatic Diseases
- ID: D000007160
- Term: Immunoproliferative Disorders
- ID: D000007154
- Term: Immune System Diseases
- ID: D000008228
- Term: Lymphoma, Non-Hodgkin
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC15
- Name: Blood and Lymph Conditions
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M11220
- Name: Lymphoma
- Relevance: HIGH
- As Found: Lymphoma
- ID: M18829
- Name: Lymphoma, T-Cell
- Relevance: HIGH
- As Found: T-cell Lymphoma
- ID: M18833
- Name: Lymphoma, T-Cell, Peripheral
- Relevance: HIGH
- As Found: T-cell Lymphoma
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
- ID: M11225
- Name: Lymphoproliferative Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M11203
- Name: Lymphatic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10206
- Name: Immunoproliferative Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M11222
- Name: Lymphoma, Non-Hodgkin
- Relevance: LOW
- As Found: Unknown
- ID: T3543
- Name: Lymphosarcoma
- Relevance: HIGH
- As Found: Lymphoma
- ID: T4496
- Name: Peripheral T-cell Lymphoma
- Relevance: HIGH
- As Found: T-cell Lymphoma
- ID: T2165
- Name: Extranodal Nasal NK/T Cell Lymphoma
- Relevance: HIGH
- As Found: NK/T-cell Lymphoma
### Condition Browse Module - Meshes
- ID: D000008223
- Term: Lymphoma
- ID: D000016399
- Term: Lymphoma, T-Cell
- ID: D000016411
- Term: Lymphoma, T-Cell, Peripheral
### Intervention Browse Module - Ancestors
- ID: D000000700
- Term: Analgesics
- ID: D000018689
- Term: Sensory System Agents
- ID: D000018373
- Term: Peripheral Nervous System Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000000970
- Term: Antineoplastic Agents
- ID: D000059005
- Term: Topoisomerase II Inhibitors
- ID: D000059003
- Term: Topoisomerase Inhibitors
- ID: D000004791
- Term: Enzyme Inhibitors
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: Analg
- Name: Analgesics
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M11908
- Name: Mitoxantrone
- Relevance: HIGH
- As Found: Retention
- ID: M4032
- Name: Analgesics
- Relevance: LOW
- As Found: Unknown
- ID: M7951
- Name: Enzyme Inhibitors
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000008942
- Term: Mitoxantrone
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT05171179
**Brief Title:** The Use of Pecs Blocks in Combination With Exparel in Breast Reconstruction Surgery
**Official Title:** A Prospective, Randomized Controlled Trial Investigating Pecs Blocks Types I and II as a Method for Administering the Non-Opioid Anesthetic Exparel in Order to Mitigate Postoperative Narcotic Usage, Pain, Nausea, and Hospital Stay in Patients Undergoing Implant-Based Tissue Expander Breast Reconstruction Surgery
#### Organization Study ID Info
**ID:** STU00214187
#### Organization
**Class:** OTHER
**Full Name:** Northwestern University
### Status Module
#### Completion Date
**Date:** 2024-04
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-11-09
**Type:** ACTUAL
**Last Update Submit Date:** 2023-11-08
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-04
**Type:** ESTIMATED
#### Start Date
**Date:** 2021-10-22
**Type:** ACTUAL
**Status Verified Date:** 2023-11
#### Study First Post Date
**Date:** 2021-12-28
**Type:** ACTUAL
**Study First Submit Date:** 2021-11-04
**Study First Submit QC Date:** 2021-12-14
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** Pacira Pharmaceuticals, Inc
#### Lead Sponsor
**Class:** OTHER
**Name:** Northwestern University
#### Responsible Party
**Investigator Affiliation:** Northwestern University
**Investigator Full Name:** Robert Galiano
**Investigator Title:** Associate Professor of Surgery
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Is US Export:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This project intends to more thoroughly investigate the direct influence of Pecs blocks in the administration of Exparel, a non-opioid analgesic, in breast reconstruction surgery. The hypothesis is that this analgesic delivery method will significantly reduce negative outcomes such as post-operative pain, opioid use, and nausea while increasing positive outcomes such as post-operative physical activity.
**Detailed Description:** The research team will be investigating the use of a novel type of local drug administration as well as assessing whether a non-opioid based drug will result in more positive pain outcomes while reducing reliance on narcotics (opioid-based drugs) following surgery.
The drug administration tool, called the Pecs blocks types I and II, utilizes ultrasound to help guide anesthetic injection for local anesthesia. This has been an effective way to deliver local anesthetic during breast surgeries. Meanwhile, a non-opioid analgesic drug (similar to an anesthetic, meaning it is used during surgery to reduce pain) called Exparel has been shown to reduce post-operative use of narcotics, length of stay in hospitals, and pain compared to the current standards in breast reconstruction surgery. Exparel is approved by the FDA for use in surgical sites during breast reconstruction surgery. Exparel has shown to reduce pain and post-surgical nausea and vomiting in breast reconstruction patients. However, the combination of Exparel with Pecs blocks has not been examined in breast reconstruction surgery, and the research team suspects that breast reconstruction patients who are administered Exparel with Pecs blocks will experience less pain, increased mobility, and less nausea following surgery. Furthermore, the researchers hope to show that this non-opioid based drug successfully reduces the necessity to use narcotics following surgery. Narcotics are highly addictive and can lead to dependency following surgery.
The reason the project has three different groups in this study is to show if each group has different outcomes. First, the project hopes to see a difference between the Pecs blocks and normal anesthesia delivery. Then, researchers hope to see a difference between the two Pecs blocks group where the use of Exparel will result in less narcotic use, pain, nausea, and increase mobility.
### Conditions Module
**Conditions:**
- Mammaplasty
**Keywords:**
- breast reconstruction
- mammaplasty
- analgesic
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** 1. Group 1 (Control): Intravenous (IV) lidocaine infusion without Pecs block (standard of care per ERAS protocol)
2. Group 2: Use of Pecs block types I and II with bupivacaine as local anesthetic
3. Group 3: Use of Pecs block types I and II with mixture of bupivacaine and Exparel\* (\*Must include bupivacaine at lower dose to decrease intra-operative variability in pain control due to delayed onset of Exparel and in ability to use lidocaine infusion with injection of Exparel)
##### Masking Info
**Masking:** SINGLE
**Masking Description:** Patient will be randomized into one of the three trial arms. Randomization process will involve 90 envelopes, 30 of which will contain assignment to the study arm with Exparel blocks, 30 which will contain assignment to bupivacaine blocks, and 30 which will contain assignment to lidocaine infusion (the control arm). The PI's attending nurse will randomly distribute an envelope to the study team between V1 and V2. V2, the day of surgery, will be the only visit where the patient would potentially have contact with the treatments. The patient will not be aware of what treatment they receive until after their 2-week follow-up.
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 90
**Type:** ESTIMATED
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Intravenous (IV) lidocaine infusion without Pecs block (standard of care per ERAS protocol)
**Intervention Names:**
- Procedure: Breast Reconstruction (Mammaplasty)
- Drug: Lidocaine
**Label:** Intravenous lidocaine
**Type:** OTHER
#### Arm Group 2
**Description:** Use of Pecs block types I and II with bupivacaine as local anesthetic
**Intervention Names:**
- Procedure: Breast Reconstruction (Mammaplasty)
- Device: Pecs blocks
- Drug: Bupivacaine
**Label:** Blocks+Bupivacaine
**Type:** ACTIVE_COMPARATOR
#### Arm Group 3
**Description:** Use of Pecs block types I and II with mixture of bupivacaine and Exparel\* (\*Must include bupivacaine at lower dose to decrease intra-operative variability in pain control due to delayed onset of Exparel and in ability to use lidocaine infusion with injection of Exparel)
**Intervention Names:**
- Procedure: Breast Reconstruction (Mammaplasty)
- Device: Pecs blocks
- Drug: Exparel
- Drug: Bupivacaine
**Label:** Blocks+Bupivacaine+Exparel
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Blocks+Bupivacaine
- Blocks+Bupivacaine+Exparel
- Intravenous lidocaine
**Description:** Breast Reconstruction (mammaplasty) surgery with implant-based tissue expander
**Name:** Breast Reconstruction (Mammaplasty)
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- Blocks+Bupivacaine
- Blocks+Bupivacaine+Exparel
**Description:** Pectoral nerve (Pecs) blocks I and II function by blocking the pectoral, intercostal, intercostobrachial nerves, and/or long thoracic nerve. These are used primarily for breast surgeries and are gaining momentum as simple administers of local analgesics. Pecs blocks utilize ultrasound to guide injection of local analgesic. It is less invasive and more accurate than most current modes of analgesia administration.
**Name:** Pecs blocks
**Other Names:**
- Pecs blocks I and II
**Type:** DEVICE
#### Intervention 3
**Arm Group Labels:**
- Blocks+Bupivacaine+Exparel
**Description:** Exparel is a sterile, non-pyrogenic white to off-white preservative-free aqueous suspension of multivesicular liposomes (DepoFoam® drug delivery system) containing bupivacaine. Bupivacaine is present at a concentration of 13.3 mg/mL. After injection of Exparel, bupivacaine is released from the multivesicular liposomes over a period of time.
**Name:** Exparel
**Type:** DRUG
#### Intervention 4
**Arm Group Labels:**
- Blocks+Bupivacaine
- Blocks+Bupivacaine+Exparel
**Description:** This is an anesthetic delivered during breast reconstruction surgery that will be given to participants in arms 2 and 3.
**Name:** Bupivacaine
**Type:** DRUG
#### Intervention 5
**Arm Group Labels:**
- Intravenous lidocaine
**Description:** This is an anesthetic delivered during breast reconstruction surgery that will be given to participants in arm 1.
**Name:** Lidocaine
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** • Investigate amount of post-operative opioid consumption post operatively
**Measure:** Opioid consumption
**Time Frame:** 2 weeks post op
#### Secondary Outcomes
**Description:** • Assess Post-Operative Nausea scores among the three arms using the participant-recorded Edmonton Symptom Assessment tool which scores on a scale of one to ten, where ten is the most nausea experienced
**Measure:** Nausea
**Time Frame:** 2 weeks post op
**Description:** • Assess post-operative mobility using the participant-recorded Edmonton Symptom Assessment tool which scores on a scale of one to ten where ten is the most immobile
**Measure:** Mobility
**Time Frame:** 2 weeks post op
**Description:** • Assess the pain patients experience throughout their recovery period using the participant-recorded Edmonton Symptom Assessment tool which scores on a scale of one to ten where ten is the highest pain
**Measure:** Pain Outcomes
**Time Frame:** 2 weeks post op
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Subjects greater than 18 years of age.
2. Subject who are undergoing implant-based, tissue expander breast reconstruction surgery.
Exclusion Criteria:
1. Subjects undergoing flap breast reconstruction.
2. Subjects who are undergoing direct-to-implant surgery.
3. Subjects who have previously undergone radiation therapy.
4. Medical or psychiatric condition that may increase the risk associated with study participation, may complicate patient compliance, or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study.
5. Subjects who are pregnant at the date of surgery.
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Robert Galiano, MD
**Phone:** 3126956022
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Peter Ullrich
**Phone:** 3129267037
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Chicago
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Robert Galiano, MD
- **Phone:** 312-695-6022
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Peter Ullrich
- **Phone:** 3129267037
- **Role:** CONTACT
***Contact 3:***
- **Name:** Mahesh Vaidyanathan, MD
- **Role:** SUB_INVESTIGATOR
***Contact 4:***
- **Name:** Robert Galiano, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Northwestern Memorial Hospital
**State:** Illinois
**Status:** RECRUITING
**Zip:** 60611
#### Overall Officials
**Official 1:**
**Affiliation:** 3126956022
**Name:** Robert Galiano, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M12273
- Name: Nausea
- Relevance: LOW
- As Found: Unknown
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Ancestors
- ID: D000000779
- Term: Anesthetics, Local
- ID: D000000777
- Term: Anesthetics
- ID: D000002492
- Term: Central Nervous System Depressants
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000018689
- Term: Sensory System Agents
- ID: D000018373
- Term: Peripheral Nervous System Agents
- ID: D000000889
- Term: Anti-Arrhythmia Agents
- ID: D000061567
- Term: Voltage-Gated Sodium Channel Blockers
- ID: D000026941
- Term: Sodium Channel Blockers
- ID: D000049990
- Term: Membrane Transport Modulators
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
### Intervention Browse Module - Browse Branches
- Abbrev: AnArAg
- Name: Anti-Arrhythmia Agents
- Abbrev: ChanBlk
- Name: Channel Blockers
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Analg
- Name: Analgesics
### Intervention Browse Module - Browse Leaves
- ID: M11014
- Name: Lidocaine
- Relevance: HIGH
- As Found: Solution
- ID: M4107
- Name: Anesthetics
- Relevance: LOW
- As Found: Unknown
- ID: M5315
- Name: Bupivacaine
- Relevance: HIGH
- As Found: Following
- ID: M4032
- Name: Analgesics
- Relevance: LOW
- As Found: Unknown
- ID: M4109
- Name: Anesthetics, Local
- Relevance: LOW
- As Found: Unknown
- ID: M12245
- Name: Narcotics
- Relevance: LOW
- As Found: Unknown
- ID: M20786
- Name: Analgesics, Non-Narcotic
- Relevance: LOW
- As Found: Unknown
- ID: M4213
- Name: Anti-Arrhythmia Agents
- Relevance: LOW
- As Found: Unknown
- ID: M23177
- Name: Sodium Channel Blockers
- Relevance: LOW
- As Found: Unknown
- ID: M30025
- Name: Diuretics, Potassium Sparing
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000008012
- Term: Lidocaine
- ID: D000002045
- Term: Bupivacaine
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT00224679
**Brief Title:** APACC Study:Prospective Study on Aspirin Efficacy in Reducing Colorectal Adenoma Recurrence
**Official Title:** Prospective Study on Aspirin Efficacy in Reducing Colorectal Adenoma Recurrence
#### Organization Study ID Info
**ID:** AOM 95176
#### Organization
**Class:** OTHER
**Full Name:** Assistance Publique - Hôpitaux de Paris
#### Secondary ID Infos
**ID:** P951202
**ID:** RAF 95176
### Status Module
#### Completion Date
**Date:** 1999-03
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2012-06-05
**Type:** ESTIMATED
**Last Update Submit Date:** 2012-06-04
**Overall Status:** TERMINATED
#### Start Date
**Date:** 1997-03
**Status Verified Date:** 2006-09
#### Study First Post Date
**Date:** 2005-09-23
**Type:** ESTIMATED
**Study First Submit Date:** 2005-09-19
**Study First Submit QC Date:** 2005-09-19
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Société Nationale Française de Gastroentérologie
**Class:** OTHER_GOV
**Name:** Ministry of Health, France
**Class:** INDUSTRY
**Name:** Sanofi-Synthelabo
#### Lead Sponsor
**Class:** OTHER
**Name:** Assistance Publique - Hôpitaux de Paris
### Description Module
**Brief Summary:** Experimental and epidemiologic studies have suggested that aspirin intake reduces the risk for colorectal cancer. In the APACC study we randomly assigned 291 patients to daily Aspirin or Placebo for 4 years. However, the available data are not sufficient to serve as the basis for firm recommendations
**Detailed Description:** The APACC Study is a prospected, randomized, double-blind, placebo-controlled multicentre clinical trial design to test the efficacy of regular low-dose aspirin administration in reducing the recurrence rate of colorectal adenomatous polyps. The study involved 49 gastroenterology centers from various parts of France. Patients were eligible if they had either at least 3 adenomas irrespective of size, or at least one measuring 6mm in diameter or more histologically confirmed colorectal adenomatous polyp by the local pathologist, and 2 independent pathologists, underwent a complete colonoscopy with polypectomy and were then confirmed free of polyps, were aged between 18 and 75 years at recruitment, and were be able to conform to the protocol during the study period. During a 4-week run-in period before enrolment, all subjects took 300 mg aspirin per day to test tolerance and compliance with the treatment. They were then randomized to either of the following three groups: placebo, aspirin as acetylsalicylate of lysine 160 mg/day or aspirin as acetylsalicylate of lysine 300 mg/day. Information on compliance, tolerance of the treatment and concomitant disease is obtained at regular clinical visits every 4 months. Informations on factors such as smocking habits, previous medical history was recorded at enrollment. The primary outcomes were defined as the proportion of subjects in whom at least one new adenoma was detected, and the adenomatous polyp burden calculated as the sum of the diameters of these adenomas at the follow-up colonoscopy 1 and 4 years after enrollment.
### Conditions Module
**Conditions:**
- Colon Adenomas
**Keywords:**
- Colon cancer
- Aspirin
- Adenomas
- Prevention
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 300
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
### Interventions
#### Intervention 1
**Name:** Aspirin
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Measure:** Is daily soluble aspirin associated with a reduction in the risk for recurrent adenomas at 1 and 4 years after starting treatment.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients are aged between 18 and 75 years At least 3 adenomas irrespective size or at least one measuring 6mm or more All subjects had a clean colon at the study entry
Exclusion Criteria:
* No personal history of colon cancer, no inflammatory bowel disease, no familial adenomatous polyposis, no regular use of aspirin
**Maximum Age:** 75 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Paris
**Country:** France
**Facility:** Hôpital COCHIN Service d'Hépato-Gastro-Entérologie
**State:** Ile de France
**Zip:** 75014
#### Overall Officials
**Official 1:**
**Affiliation:** Assistance Publique - Hôpitaux de Paris
**Name:** Stanislas CHAUSSADE, MD
**Role:** PRINCIPAL_INVESTIGATOR
### References Module
#### References
**Citation:** Benamouzig R, Deyra J, Martin A, Girard B, Jullian E, Piednoir B, Couturier D, Coste T, Little J, Chaussade S. Daily soluble aspirin and prevention of colorectal adenoma recurrence: one-year results of the APACC trial. Gastroenterology. 2003 Aug;125(2):328-36. doi: 10.1016/s0016-5085(03)00887-4.
**PMID:** 12891533
**Citation:** Benamouzig R, Uzzan B, Deyra J, Martin A, Girard B, Little J, Chaussade S; Association pour la Prevention par l'Aspirine du Cancer Colorectal Study Group (APACC). Prevention by daily soluble aspirin of colorectal adenoma recurrence: 4-year results of the APACC randomised trial. Gut. 2012 Feb;61(2):255-61. doi: 10.1136/gutjnl-2011-300113. Epub 2011 Sep 2. Erratum In: Gut. 2012 Mar;61(3):472.
**PMID:** 21890814
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000020969
- Term: Disease Attributes
- ID: D000010335
- Term: Pathologic Processes
- ID: D000009375
- Term: Neoplasms, Glandular and Epithelial
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000009369
- Term: Neoplasms
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M3591
- Name: Adenoma
- Relevance: HIGH
- As Found: Adenoma
- ID: M14850
- Name: Recurrence
- Relevance: HIGH
- As Found: Recurrence
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
- ID: M12320
- Name: Neoplasms, Glandular and Epithelial
- Relevance: LOW
- As Found: Unknown
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000000236
- Term: Adenoma
- ID: D000012008
- Term: Recurrence
### Intervention Browse Module - Ancestors
- ID: D000000894
- Term: Anti-Inflammatory Agents, Non-Steroidal
- ID: D000018712
- Term: Analgesics, Non-Narcotic
- ID: D000000700
- Term: Analgesics
- ID: D000018689
- Term: Sensory System Agents
- ID: D000018373
- Term: Peripheral Nervous System Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000000893
- Term: Anti-Inflammatory Agents
- ID: D000018501
- Term: Antirheumatic Agents
- ID: D000005343
- Term: Fibrinolytic Agents
- ID: D000050299
- Term: Fibrin Modulating Agents
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000010975
- Term: Platelet Aggregation Inhibitors
- ID: D000016861
- Term: Cyclooxygenase Inhibitors
- ID: D000004791
- Term: Enzyme Inhibitors
- ID: D000058633
- Term: Antipyretics
### Intervention Browse Module - Browse Branches
- Abbrev: Antipy
- Name: Antipyretics
- Abbrev: Infl
- Name: Anti-Inflammatory Agents
- Abbrev: ARhu
- Name: Antirheumatic Agents
- Abbrev: FiAg
- Name: Fibrinolytic Agents
- Abbrev: Analg
- Name: Analgesics
- Abbrev: PlAggInh
- Name: Platelet Aggregation Inhibitors
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: HB
- Name: Herbal and Botanical
### Intervention Browse Module - Browse Leaves
- ID: M4548
- Name: Aspirin
- Relevance: HIGH
- As Found: Progression
- ID: M4217
- Name: Anti-Inflammatory Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4218
- Name: Anti-Inflammatory Agents, Non-Steroidal
- Relevance: LOW
- As Found: Unknown
- ID: M4032
- Name: Analgesics
- Relevance: LOW
- As Found: Unknown
- ID: M20786
- Name: Analgesics, Non-Narcotic
- Relevance: LOW
- As Found: Unknown
- ID: M20604
- Name: Antirheumatic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M8473
- Name: Fibrinolytic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M13865
- Name: Platelet Aggregation Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M19209
- Name: Cyclooxygenase Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M7951
- Name: Enzyme Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M29176
- Name: Antipyretics
- Relevance: LOW
- As Found: Unknown
- ID: T120
- Name: Cola
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000001241
- Term: Aspirin
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT03310879
**Brief Title:** Study of the CDK4/6 Inhibitor Abemaciclib in Solid Tumors Harboring Genetic Alterations in Genes Encoding D-type Cyclins or Amplification of CDK4 or CDK6
**Official Title:** A Phase II Study of the CDK4/6 Inhibitor Abemaciclib in Patients With Solid Tumors Harboring Genetic Alterations in Genes Encoding D-type Cyclins or Amplification of CDK4 or CDK6
#### Organization Study ID Info
**ID:** 17-343
#### Organization
**Class:** OTHER
**Full Name:** Dana-Farber Cancer Institute
### Status Module
#### Completion Date
**Date:** 2025-04-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-02-06
**Type:** ACTUAL
**Last Update Submit Date:** 2024-02-02
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2017-11-21
**Type:** ACTUAL
**Status Verified Date:** 2024-02
#### Study First Post Date
**Date:** 2017-10-16
**Type:** ACTUAL
**Study First Submit Date:** 2017-10-11
**Study First Submit QC Date:** 2017-10-11
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** Eli Lilly and Company
#### Lead Sponsor
**Class:** OTHER
**Name:** Dana-Farber Cancer Institute
#### Responsible Party
**Investigator Affiliation:** Dana-Farber Cancer Institute
**Investigator Full Name:** Geoffrey Shapiro, MD, PhD
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** This research study is studying a targeted therapy as a possible treatment for cancer abnormality in one of the following genes: CCND1, CCND2, CCND3, CDK4, or CDK6.
The drug involved in this study is:
-Abemaciclib
**Detailed Description:** This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied.
The FDA (the U.S. Food and Drug Administration) has not approved Abemaciclib as a treatment for any disease.
To participate in this study, the participant must have an abnormality in one of the following genes: CCND1, CCND2, CCND3, CDK4, or CDK6. Abnormalities in these genes may cause the cancer to grow more rapidly. CDK4 and CDK6 are proteins that are involved with the cell growth process. D-type cyclins (CCND1, CCND2, and CCND3) are proteins that help control the activity of CDK4 and CDK6.
Abemaciclib is being studied as a treatment for people with advanced cancer. Abemaciclib is a cyclin-dependent kinase (CDK) inhibitor. CDK inhibitors work to stop cell growth. In this research study, the investigators are hoping to learn whether Abemaciclib can be used to slow or stop the growth of cancers with specific genetic abnormalities.
### Conditions Module
**Conditions:**
- Cancer
**Keywords:**
- Cancer
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 38
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** * Abemaciclib will be administered orally on a daily basis
* Dosage will be determine by the PI
**Intervention Names:**
- Drug: Abemaciclib
**Label:** Participants with CCND1, CCND2, or CCND3
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** * Abemaciclib will be administered orally on a daily basis
* Dosage will be determine by the PI
**Intervention Names:**
- Drug: Abemaciclib
**Label:** Participants with CDK4 or CDK6
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Participants with CCND1, CCND2, or CCND3
- Participants with CDK4 or CDK6
**Description:** Abemaciclib is a cyclin-dependent kinase (CDK) inhibitor. CDK inhibitors work to stop cell growth.
**Name:** Abemaciclib
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** proportion of patients who are alive and progression-free at 4 months on both arms.
**Measure:** Progression-Free Rate
**Time Frame:** 4 months
#### Secondary Outcomes
**Description:** objective response rate by RECIST 1.1 for patients enrolled to both arms.
**Measure:** Overall Response Rate
**Time Frame:** 2 years
**Description:** Adverse event data in all participants by CTCAE 4.03
**Measure:** Toxicity
**Time Frame:** 2 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Participants must have a histologically or cytologically confirmed advanced solid tumor of a non-breast origin, for which standard therapy proven to provide clinical benefit does not exist or is no longer effective.
* For enrollment to Arm 1: Participants must have a confirmed CCND1, 2, or 3 high-level amplification, CCND1 mutation, or a CCND1 splice variant expected to lead to nuclear retention of cyclin D1 protein, via DFCI/BWH OncoPanel or any CLIA-certified method.
* For enrollment to Arm 2: Participants must have a confirmed CDK4 or CDK6 high-level amplification, identified via DFCI/BWH OncoPanel or any CLIA-certified method.
* Participants must have evaluable or measurable disease.
* Age ≥ 18 years.
* ECOG performance status of 0-1 (see APPENDIX A).
* Participants must have normal organ and marrow function as defined below:
* Absolute neutrophil count ≥1,500/mcL
* Platelets ≥100,000/mcL
* Total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN)
* AST(SGOT)/ALT(SGPT) ≤ 2.5 × institutional (ULN) -OR-
* AST(SGOT)/ALT(SGPT) ≤ 5 × institutional (ULN) if liver metastases are present
* Serum Creatinine ≤ 1.5 × institutional ULN -OR-
* Creatinine clearance ≥ 60 mL/min (Cockroft-Gault Equation)
* The effects of abemaciclib on the developing human fetus are unknown. For this reason women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 3 months after completion of abemaciclib administration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. A negative serum pregnancy test is required for women of childbearing potential prior to study entry.
* Ability to understand and the willingness to sign a written informed consent document.
* Ability to swallow and retain oral medication.
Exclusion Criteria:
* Participants who have had chemotherapy, biologic therapy, investigational agents, radiotherapy, or major surgery within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study.
* Participants who have had oral targeted therapy or oral tyrosine kinase inhibitors (TKIs) within 5 half-lives prior to entering the study.
* Participants who have received prior treatment with a CDK4/6 inhibitor.
* Participants must have recovered to eligibility levels from prior toxicity or adverse events as a result of previous treatment prior to entering the study.
* Participants who are receiving any other investigational agents.
* Participants with hematologic lymphoma.
* Participants with symptomatic CNS metastases who are neurologically unstable and/or require radiation therapy are excluded.
* Participants with brain metastases that do not meet the above criteria in the opinion of the treating investigator are allowed.
* Symptomatic disease is allowed as long as symptoms are controlled and stable.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to abemaciclib.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Pregnant women are excluded from this study because abemaciclib is an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with abemaciclib, breastfeeding should be discontinued if the mother is treated with abemaciclib. A negative serum pregnancy test is required for women of childbearing potential prior to study entry.
* Participants with known HIV-positive status are ineligible because these participants are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in participants receiving combination antiretroviral therapy when indicated.
* Participants with known active Hepatitis B or Hepatitis C.
* Participants receiving an enzyme-inducing antiepileptic drug (EIAED) who cannot be transferred to a non-EIAED (e.g., levetiracetam, lacosamide, lamotrigine, etc.) prior to the initiation of protocol therapy.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Geoffrey Shapiro, MD, PhD
**Phone:** 617-632-4942
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Boston
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Geoffrey Shapiro
- **Phone:** 617-632-4942
- **Role:** CONTACT
***Contact 2:***
- **Name:** Geoffrey Shapiro, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Dana Farber Cancer Institute
**State:** Massachusetts
**Status:** RECRUITING
**Zip:** 02115
#### Overall Officials
**Official 1:**
**Affiliation:** Dana-Farber Cancer Institute
**Name:** Geoffrey Shapiro, MD, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT00000279
**Brief Title:** Novel Medications for Opiate Detoxification - 4
**Official Title:** Novel Medications for Opiate Detoxification
#### Organization Study ID Info
**ID:** NIDA-09250-4
#### Organization
**Class:** OTHER
**Full Name:** Yale University
#### Secondary ID Infos
**ID:** P50DA009250
**Link:** https://reporter.nih.gov/quickSearch/P50DA009250
**Type:** NIH
**ID:** P50-09250-4
### Status Module
#### Completion Date
**Date:** 1999-08
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2020-06-18
**Type:** ACTUAL
**Last Update Submit Date:** 2020-06-17
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 1999-08
**Type:** ACTUAL
#### Start Date
**Date:** 1994-09
**Status Verified Date:** 2020-06
#### Study First Post Date
**Date:** 1999-09-21
**Type:** ESTIMATED
**Study First Submit Date:** 1999-09-20
**Study First Submit QC Date:** 1999-09-20
### Sponsor Collaborators Module
#### Collaborators
**Class:** NIH
**Name:** National Institute on Drug Abuse (NIDA)
**Class:** FED
**Name:** VA Connecticut Healthcare System
#### Lead Sponsor
**Class:** OTHER
**Name:** Yale University
#### Responsible Party
**Type:** SPONSOR
### Description Module
**Brief Summary:** The purpose of this study is to evaluate novel medications for opiate detoxification.
### Conditions Module
**Conditions:**
- Opioid-Related Disorders
- Substance-Related Disorders
**Keywords:**
- Opioid-Related Disorders
### Design Module
#### Design Info
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
### Interventions
#### Intervention 1
**Name:** Clonidine
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Measure:** Withdrawal severity
### Eligibility Module
**Eligibility Criteria:** Please contact site for information.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** New Haven
**Country:** United States
**Facility:** VA Connecticut Healthcare System
**State:** Connecticut
**Zip:** 06519
#### Overall Officials
**Official 1:**
**Affiliation:** VA Connecticut Healthcare System
**Name:** Thomas R Kosten, M.D.
**Role:** PRINCIPAL_INVESTIGATOR
### References Module
#### References
**Citation:** AM J Drug & Alc. Abuse 21(4): 453-467, 1995; Neuropsychopharm 13(4): 323-333, 1995; Neuropsychopharm 14(3): 187-193, 1996; J Pharma & Experimental Therapeutics 276(3): 1128-1135, 1996.
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000064419
- Term: Chemically-Induced Disorders
- ID: D000001523
- Term: Mental Disorders
- ID: D000079524
- Term: Narcotic-Related Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BC25
- Name: Substance Related Disorders
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M21837
- Name: Substance-Related Disorders
- Relevance: HIGH
- As Found: Substance-Related Disorders
- ID: M12244
- Name: Opioid-Related Disorders
- Relevance: HIGH
- As Found: Opioid-Related Disorders
- ID: M30302
- Name: Chemically-Induced Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M2057
- Name: Narcotic-Related Disorders
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000019966
- Term: Substance-Related Disorders
- ID: D000009293
- Term: Opioid-Related Disorders
### Intervention Browse Module - Ancestors
- ID: D000000700
- Term: Analgesics
- ID: D000018689
- Term: Sensory System Agents
- ID: D000018373
- Term: Peripheral Nervous System Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000000959
- Term: Antihypertensive Agents
- ID: D000013565
- Term: Sympatholytics
- ID: D000001337
- Term: Autonomic Agents
- ID: D000058647
- Term: Adrenergic alpha-2 Receptor Agonists
- ID: D000000316
- Term: Adrenergic alpha-Agonists
- ID: D000000322
- Term: Adrenergic Agonists
- ID: D000018663
- Term: Adrenergic Agents
- ID: D000018377
- Term: Neurotransmitter Agents
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
### Intervention Browse Module - Browse Branches
- Abbrev: Analg
- Name: Analgesics
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: AnAg
- Name: Antihypertensive Agents
### Intervention Browse Module - Browse Leaves
- ID: M4033
- Name: Analgesics, Opioid
- Relevance: LOW
- As Found: Unknown
- ID: M6232
- Name: Clonidine
- Relevance: HIGH
- As Found: ABT-
- ID: M27371
- Name: Opiate Alkaloids
- Relevance: LOW
- As Found: Unknown
- ID: M4032
- Name: Analgesics
- Relevance: LOW
- As Found: Unknown
- ID: M4277
- Name: Antihypertensive Agents
- Relevance: LOW
- As Found: Unknown
- ID: M16344
- Name: Sympatholytics
- Relevance: LOW
- As Found: Unknown
- ID: M20746
- Name: Adrenergic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M3668
- Name: Adrenergic alpha-Agonists
- Relevance: LOW
- As Found: Unknown
- ID: M3673
- Name: Adrenergic Agonists
- Relevance: LOW
- As Found: Unknown
- ID: M20504
- Name: Neurotransmitter Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000003000
- Term: Clonidine
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT02692079
**Acronym:** T-PRF
**Brief Title:** The Effectiveness of Titanium-Prepared Platelet-Rich Fibrin on Angiogenic Biomarkers in Gingival Crevicular Fluid
**Official Title:** The Effect of Titanium-Prepared Platelet-Rich Fibrin (T-PRF) Treatment on the Angiogenic Biomarkers in Gingival Crevicular Fluid (GCF) in Infrabony Defects of Patients With Chronic Periodontitis: A Randomized Controlled Clinical Trial
#### Organization Study ID Info
**ID:** 2014/18
#### Organization
**Class:** OTHER
**Full Name:** Kırıkkale University
### Status Module
#### Completion Date
**Date:** 2014-11
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2016-02-25
**Type:** ESTIMATED
**Last Update Submit Date:** 2016-02-22
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2014-09
**Type:** ACTUAL
#### Start Date
**Date:** 2014-02
**Status Verified Date:** 2016-02
#### Study First Post Date
**Date:** 2016-02-25
**Type:** ESTIMATED
**Study First Submit Date:** 2016-02-18
**Study First Submit QC Date:** 2016-02-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Kırıkkale University
#### Responsible Party
**Investigator Affiliation:** Kırıkkale University
**Investigator Full Name:** Meltem Karsiyaka Hendek
**Investigator Title:** Corresponding author, Clinical Research
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This study investigates the effect of titanium-prepared platelet-rich fibrin (T-PRF) treatment on the angiogenic biomarkers in gingival crevicular fluid (GCF) in infrabony defects of patients with chronic periodontitis. In each patient, the infrabony defect of one side of arch was designated as control group (allograft), while the infrabony defect on the contralateral side of same arch was designated as test group (allograft+T-PRF).
**Detailed Description:** Platelets are the cells initiating the wound healing and also supporting it by secreting various growth factors actively. These growth factors released by platelets act the increase of connective tissue healing, bone regeneration and repair, fibroblast mitogenesis, wound angiogenesis and the activation of macrophages by stimulating cell proliferation signals.
Titanium-prepared, platelet-rich fibrin (T-PRF), is a new platelet concentrate, is formed in titanium tubes may be more efficient to activate platelets in comparison with glass tubes.The titanium tubes is utilized to refrain any inverse effects of glass tubes and also silica.
### Conditions Module
**Conditions:**
- Chronic Periodontitis
- Intrabony Periodontal Defect
**Keywords:**
- Angiogenesis
- Bilateral infrabony defect
- Flap surgery
- Titanium-prepared, platelet-rich fibrin
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 25
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The defects were debrided and root planed with ultrasonic instrumentation and area-specific curets. All sites were washed with sterile salin solution and bleeding control was performed. Test group sites were treated with T-PRF+allograft
**Intervention Names:**
- Procedure: T-PRF
- Procedure: Allograft
**Label:** T-PRF+Allograft
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The defects were debrided and root planed with ultrasonic instrumentation and area-specific curets. All sites were washed with sterile salin solution and bleeding control was performed. Control group sites were treated with only allograft
**Intervention Names:**
- Procedure: Allograft
**Label:** Allograft
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- T-PRF+Allograft
**Description:** Flap Surgery
**Name:** T-PRF
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- Allograft
- T-PRF+Allograft
**Description:** Flap Surgery
**Name:** Allograft
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Measure:** Platelet-derived growth factor-BB (ng/µl) , vascular endothelial growth factor-A (ng/µl), fibroblast growth factor-2 (ng/µl), anjiogenin (ng/µl), angiostatin (ng/µl)
**Time Frame:** Within the first 30 days after surgery
#### Secondary Outcomes
**Measure:** The Volume of Gingival Crevicular Fluid (microliter)
**Time Frame:** Within the first 30 days after surgery
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Clinical Diagnosis of Chronic Periodontitis
* The presence of two or three-wall intrabony defects≥3 mm deep along with an interproximal probing depth ≥5 mm after non-surgical periodontal therapy
Exclusion Criteria:
* Systemic illnesses
* Any medications known to affect the outcomes of periodontal surgery
* Pregnancy and lactation
**Maximum Age:** 59 Years
**Minimum Age:** 26 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010510
- Term: Periodontal Diseases
- ID: D000009059
- Term: Mouth Diseases
- ID: D000009057
- Term: Stomatognathic Diseases
- ID: D000002908
- Term: Chronic Disease
- ID: D000020969
- Term: Disease Attributes
- ID: D000010335
- Term: Pathologic Processes
### Condition Browse Module - Browse Branches
- Abbrev: BC07
- Name: Mouth and Tooth Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M13427
- Name: Periodontitis
- Relevance: HIGH
- As Found: Periodontitis
- ID: M28044
- Name: Chronic Periodontitis
- Relevance: HIGH
- As Found: Chronic Periodontitis
- ID: M13419
- Name: Periodontal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12019
- Name: Mouth Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12017
- Name: Stomatognathic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6147
- Name: Chronic Disease
- Relevance: LOW
- As Found: Unknown
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000010518
- Term: Periodontitis
- ID: D000055113
- Term: Chronic Periodontitis
### Intervention Browse Module - Browse Branches
- Abbrev: PhSol
- Name: Pharmaceutical Solutions
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M21860
- Name: Pharmaceutical Solutions
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT05754879
**Brief Title:** Diagnosis of Congenital Cytomegalovirus Infection in Newborn With Particular Risk
**Official Title:** Congenital Cytomegalovirus Infection by Detection of the Virus in the Saliva of Newborns at Particular Risk: A Retrospective Population-based Study Between February 2019 and December 2021 at the Regional Maternity Hospital of Nancy
#### Organization Study ID Info
**ID:** 2022PI027
#### Organization
**Class:** OTHER
**Full Name:** Central Hospital, Nancy, France
### Status Module
#### Completion Date
**Date:** 2022-12-31
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-03-06
**Type:** ACTUAL
**Last Update Submit Date:** 2023-02-22
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2021-12-31
**Type:** ACTUAL
#### Start Date
**Date:** 2019-02-01
**Type:** ACTUAL
**Status Verified Date:** 2023-02
#### Study First Post Date
**Date:** 2023-03-06
**Type:** ACTUAL
**Study First Submit Date:** 2023-02-13
**Study First Submit QC Date:** 2023-02-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Central Hospital, Nancy, France
#### Responsible Party
**Investigator Affiliation:** Central Hospital, Nancy, France
**Investigator Full Name:** Jean-Michel HASCOET
**Investigator Title:** Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Congenital CMV infection is the leading cause of non-genetic deafness and neurodevelopmental disorders. Its prevalence in France is estimated between 0.3% and 1% of births depending on the study.
Congenital infection is symptomatic in 10% of cases with a large clinical spectrum with different degree of severity. These sequelae develop progressively and fluctuate, which justifies prolonged follow-up of children for several years, even if they are asymptomatic at birth.
There is yet no treatment with AMM in neonates or pregnant women. In France, screening for congenital CMV infection is widely debated. It remains oriented to certain newborns considered at risk or depending on their symptoms and varies with the practices of each Neonatology or Maternity Hospital.
In the Regional Maternity of Nancy, a new screening protocol for congenital CMV infection was implemented from early 2019.
It is based on screening by non-invasive salivary test (CMV PCR) in newborns at particular risk who are included in a registry open for this screening.
The aim of this research was to assess the relevance of the proposed criteria in the Protocol for defining a population at risk of congenital CMV infection thus qualifying for CMV screening. The secondary endpoints are the modalities of the screening test, the evaluation of each risk factor for infection, and the study of affected patients (symptoms, therapeutic intervention, neurological and auditory outcome).
### Conditions Module
**Conditions:**
- Congenital Cytomegalovirus Infection
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** OTHER
#### Enrollment Info
**Count:** 479
**Type:** ACTUAL
**Patient Registry:** True
**Study Type:** OBSERVATIONAL
**Target Duration:** 3 Years
### Outcomes Module
#### Primary Outcomes
**Description:** Comparison between Prevalence in the targeted population and Prevalence in the general Population
**Measure:** Relevance of the Protocol for defining a population at risk
**Time Frame:** baseline
#### Secondary Outcomes
**Description:** Test by PCR in saliva and appropriate indications
**Measure:** Modalities of realisation of screening test
**Time Frame:** baseline
**Description:** Association between Maternal infection and Neonatal CMV infection
**Measure:** Maternal CMV infection as a Risk Factor for Congenital CMV Infection
**Time Frame:** baseline
**Description:** Association of a Neonatal weight below the 10th centile and Neonatal CMV infection
**Measure:** Hypotrophy as a Risk Factor for Congenital CMV Infection
**Time Frame:** baseline
**Description:** Association of a Neonatal head circumference below the 10th centile and Neonatal CMV infection
**Measure:** Microcephaly as a Risk Factor for Congenital CMV Infection
**Time Frame:** baseline
**Description:** Association of any abnormality at fetal ultrasound examination and Neonatal CMV infection
**Measure:** Any foetal ultrasound abnormality as a Risk Factor for Congenital CMV Infection
**Time Frame:** baseline
**Description:** Association of hepatomegaly or splenomegaly and Neonatal CMV infection
**Measure:** Presence of Hepatomegaly or splenomegaly as a Risk Factor for Congenital CMV Infection
**Time Frame:** baseline
**Description:** Any neurological abnormality at clinical examination as a Risk Factor for Congenital CMV Infection
**Measure:** Any neurological abnormality as a Risk Factor for Congenital CMV Infection
**Time Frame:** baseline
**Description:** Any blood count cell abnormality at biological check up as a Risk Factor for Congenital CMV Infection
**Measure:** Any blood count cell abnormality as a Risk Factor for Congenital CMV Infection
**Time Frame:** baseline
**Description:** Any biological hepatic abnormality at biological check up as a Risk Factor for Congenital
**Measure:** Biological hepatic abnormality as a Risk Factor for Congenital CMV Infection
**Time Frame:** baseline
**Description:** Failure at hearing screening as a Risk Factor for Congenital CMV Infection
**Measure:** Hearing abnormality as a Risk Factor for Congenital CMV Infection
**Time Frame:** baseline
**Description:** Association of a birth weight below the 10th centile with a diagnosed Neonatal CMV infection
**Measure:** Hypotrophy as a consequence of diagnosed Congenital CMV Infection
**Time Frame:** baseline
**Description:** Association of a Neonatal head circumference below the 10th centile with a diagnosed Neonatal CMV infection
**Measure:** Microcephaly as a consequence of diagnosed Congenital CMV Infection
**Time Frame:** baseline
**Description:** Association of an hepatomegaly or spenomegly with a diagnosed Neonatal CMV infection
**Measure:** Presence of Hepatomegaly or splenomegaly as a Risk Factor for Congenital CMV Infection
**Time Frame:** Baseline
**Description:** Association of a neurological abnormality at clinical examniation with a diagnosed Neonatal CMV infection
**Measure:** Any neurological abnormality as a consequence of Congenital CMV Infection
**Time Frame:** baseline
**Description:** Association of any blood count cell abnormality with a diagnosed Neonatal CMV infection
**Measure:** Any blood count cell abnormality as a consequence of Congenital CMV Infection
**Time Frame:** baseline
**Description:** Association of any biological hepatic abnormality with a diagnosed Neonatal CMV infection
**Measure:** Biological hepatic abnormality as a consequence of Congenital CMV Infection
**Time Frame:** baseline
**Description:** Association of failure at hearing screening with a diagnosed Neonatal CMV infection
**Measure:** Hearing abnormality as a consequence of Congenital CMV Infection
**Time Frame:** baseline
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Newborn born between Bebruary 2019 and December 2021 in the Regional Maternity Hospital of Nancy
* Patients who were screened for congenital CMV infection by salivary PCR
Exclusion Criteria:
* No one
**Maximum Age:** 3 Weeks
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
**Study Population:** All NewBorn born between January 2019 and December 2021 who have had Screening Congenital Cytomegalovirus Infection by PCR in saliva
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Nancy
**Country:** France
**Facility:** Maternity Hospital CHRU
**Zip:** 54000
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000020969
- Term: Disease Attributes
- ID: D000010335
- Term: Pathologic Processes
- ID: D000006566
- Term: Herpesviridae Infections
- ID: D000004266
- Term: DNA Virus Infections
- ID: D000014777
- Term: Virus Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC01
- Name: Infections
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M10283
- Name: Infections
- Relevance: HIGH
- As Found: Infection
- ID: M6368
- Name: Communicable Diseases
- Relevance: HIGH
- As Found: Infection
- ID: M17522
- Name: Virus Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6791
- Name: Cytomegalovirus Infections
- Relevance: HIGH
- As Found: Cytomegalovirus Infections
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
- ID: M9643
- Name: Herpesviridae Infections
- Relevance: LOW
- As Found: Unknown
- ID: M7442
- Name: DNA Virus Infections
- Relevance: LOW
- As Found: Unknown
- ID: T1720
- Name: Cytomegalic Inclusion Disease
- Relevance: HIGH
- As Found: Cytomegalovirus Infections
- ID: T1480
- Name: Congenital Cytomegalovirus
- Relevance: HIGH
- As Found: Congenital Cytomegalovirus
### Condition Browse Module - Meshes
- ID: D000007239
- Term: Infections
- ID: D000003141
- Term: Communicable Diseases
- ID: D000003586
- Term: Cytomegalovirus Infections
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT05397379
**Brief Title:** A Safety, Tolerability, Efficacy, and Pharmacokinetics Study of HEC96719 in Subjects With Non-Cirrhotic Non-Alcoholic Steatohepatitis
**Official Title:** A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of Orally Administered HEC96719 Tablets in Adult Patients With Presumed Non-Cirrhotic Non-Alcoholic Steatohepatitis
#### Organization Study ID Info
**ID:** HEC96719-NASH-201
#### Organization
**Class:** INDUSTRY
**Full Name:** Sunshine Lake Pharma Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2023-09-05
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-02-21
**Type:** ACTUAL
**Last Update Submit Date:** 2024-02-20
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-09-05
**Type:** ACTUAL
#### Start Date
**Date:** 2021-11-15
**Type:** ACTUAL
**Status Verified Date:** 2022-05
#### Study First Post Date
**Date:** 2022-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2022-05-25
**Study First Submit QC Date:** 2022-05-25
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Sunshine Lake Pharma Co., Ltd.
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** This is a Phase 2, randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, efficacy, and pharmacokinetics of HEC96719 in non-cirrhotic NASH patients.
### Conditions Module
**Conditions:**
- Non-Alcoholic Steatohepatitis
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** QUADRUPLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 68
**Type:** ACTUAL
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Oral dose once daily for 12 weeks
**Intervention Names:**
- Drug: HEC96719
**Label:** HEC96719 0.25 mg
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Oral dose once daily for 12 weeks
**Intervention Names:**
- Drug: HEC96719
**Label:** HEC96719 0.35 mg
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Oral dose once daily for 12 weeks
**Intervention Names:**
- Drug: HEC96719
**Label:** HEC96719 0.5 mg
**Type:** EXPERIMENTAL
#### Arm Group 4
**Description:** Oral dose twice daily for 12 weeks
**Intervention Names:**
- Drug: HEC96719
**Label:** HEC96719 0.25 mg bid
**Type:** EXPERIMENTAL
#### Arm Group 5
**Description:** Oral dose once or twice daily for 12 weeks
**Intervention Names:**
- Drug: Placebo
**Label:** Placebo
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- HEC96719 0.25 mg
- HEC96719 0.25 mg bid
- HEC96719 0.35 mg
- HEC96719 0.5 mg
**Description:** Oral tablets
**Name:** HEC96719
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Placebo
**Description:** Comparator
**Name:** Placebo
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Measure:** Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
**Time Frame:** 12 weeks
#### Secondary Outcomes
**Measure:** Mean Change From Baseline in Percentage of Fat in the Liver as Assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF) at Week 12
**Time Frame:** Baseline and Week 12
**Description:** Area under the curve
**Measure:** Plasma concentration of HEC96719 - AUC
**Time Frame:** 4 weeks
**Description:** Maximum observed concentration
**Measure:** Plasma concentration of HEC96719 - Cmax
**Time Frame:** 4 weeks
**Description:** Time to reach maximum measured plasma concentration
**Measure:** Plasma concentration of HEC96719 - Tmax
**Time Frame:** 4 weeks
**Description:** Determination of half-life
**Measure:** Plasma concentration of HEC96719 - t1/2
**Time Frame:** 4 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* An informed consent document must be signed and dated by the subject
* Male or female, 18 to 65 years of age
* Body mass index (BMI)≥18.0 and≤35.0 kg/m2, and Weight≥40 kg;
* Presumed NASH based on clinical characteristics or prior liver biopsy
* MRI PDFF liver fat content ≥ 10 %
Exclusion Criteria:
* previous diagnosis of other forms of chronic liver disease
* Laboratory Screening Results:
* AST \> 5 x ULN
* ALP \> 3 x ULN
* Total bilirubin \> 1.5 x ULN
* Albumin \< 3.2 g/dL
* INR \> 1.3
* Platelet count \< 100,000 /mm3
* creatinine clearance \<60 ml/min (based on Cockroft Gault method)
* previous exposure to OCA
* uncontrolled diabetes mellitus
* presence of cirrhosis
* patients with contraindications to MRI imaging
**Maximum Age:** 65 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Beijing
**Country:** China
**Facility:** Peking University People's Hospital
**State:** Beijing
**Location 2:**
**City:** Guangzhou
**Country:** China
**Facility:** NanFang Hospital of Southern Medical University
**State:** Guangdong
**Zip:** 510515
**Location 3:**
**City:** Guangzhou
**Country:** China
**Facility:** Affiliated Hospitol of Guangdong Medical University
**State:** Guangdong
**Location 4:**
**City:** Wuhan
**Country:** China
**Facility:** Union Hospital, TongJi Medical College, HuaZhong University of Science and Technology
**State:** Hubei
**Location 5:**
**City:** Changsha
**Country:** China
**Facility:** Hunan Provincial People's Hospital
**State:** Hunan
**Location 6:**
**City:** Changchun
**Country:** China
**Facility:** The First Hospital of Jilin University
**State:** Jilin
**Location 7:**
**City:** Xi'an
**Country:** China
**Facility:** The First Affiliated Hospitol of Xi'an Jiaotong University
**State:** Shanxi
**Location 8:**
**City:** Hangzhou
**Country:** China
**Facility:** The First Affiliated Hospital, Zhejiang University School of Medicine
**State:** Zhejiang
**Location 9:**
**City:** Wenzhou
**Country:** China
**Facility:** The First Affiliated Hospitol of Wenzhou Medical University
**State:** Zhejiang
#### Overall Officials
**Official 1:**
**Affiliation:** Nanfang Hospital, Southern Medical University
**Name:** Jinlin Hou, Doctor
**Role:** STUDY_CHAIR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000008107
- Term: Liver Diseases
- ID: D000004066
- Term: Digestive System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M8375
- Name: Fatty Liver
- Relevance: HIGH
- As Found: Steatohepatitis
- ID: M11107
- Name: Liver Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M30540
- Name: Non-alcoholic Fatty Liver Disease
- Relevance: HIGH
- As Found: Non-alcoholic Steatohepatitis
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T5868
- Name: Visceral Steatosis
- Relevance: HIGH
- As Found: Steatohepatitis
### Condition Browse Module - Meshes
- ID: D000005234
- Term: Fatty Liver
- ID: D000065626
- Term: Non-alcoholic Fatty Liver Disease
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT01746979
**Acronym:** MAESTRO
**Brief Title:** Clinical Trial Testing TH-302 in Combination With Gemcitabine in Previously Untreated Subjects With Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma
**Official Title:** A Randomized, Double-Blind, Phase III Study of the Efficacy and Safety of Gemcitabine in Combination With TH-302 Compared With Gemcitabine in Combination With Placebo in Previously Untreated Subjects With Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma
#### Organization Study ID Info
**ID:** EMR 200592-001
#### Organization
**Class:** INDUSTRY
**Full Name:** Threshold Pharmaceuticals
#### Secondary ID Infos
**ID:** 2012-002957-42
**Type:** EUDRACT_NUMBER
### Status Module
#### Completion Date
**Date:** 2016-05
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-12-02
**Type:** ACTUAL
**Last Update Submit Date:** 2017-10-26
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2016-02
**Type:** ACTUAL
#### Results First Post Date
**Date:** 2017-12-02
**Type:** ACTUAL
**Results First Submit Date:** 2017-07-18
**Results First Submit QC Date:** 2017-10-26
#### Start Date
**Date:** 2012-12
**Status Verified Date:** 2017-10
#### Study First Post Date
**Date:** 2012-12-11
**Type:** ESTIMATED
**Study First Submit Date:** 2012-12-07
**Study First Submit QC Date:** 2012-12-07
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Threshold Pharmaceuticals
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** This Phase 3 trial is a randomized, double-blind, placebo-controlled trial of gemcitabine in combination with TH-302 compared to gemcitabine in combination with placebo in subjects with locally advanced unresectable or metastatic pancreatic adenocarcinoma. Randomized subjects will receive TH-302 plus gemcitabine or gemcitabine plus placebo in 4-week cycles until there is evidence of progressive disease, intolerable toxicity, or the subject discontinues from the trial for other reasons (for example, withdrawal of consent). The primary efficacy endpoint is overall survival (OS) time. The data cut-off for statistical analyses of the primary and secondary endpoints will be reached when 508 events (deaths) will be reported. No planned interim analyses will be conducted. An Independent Safety Monitoring Board (ISMB) will provide periodic evaluations of the unblinded safety data to ensure subject safety and the validity and scientific merit of the study. A total of 660 subjects will be enrolled.
### Conditions Module
**Conditions:**
- Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma
**Keywords:**
- TH-302
- Evofosfamide
- Pancreatic Cancer
- EMR200592-001
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 693
**Type:** ACTUAL
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Drug: TH-302
- Drug: Gemcitabine
**Label:** Gemcitabine plus TH-302
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Intervention Names:**
- Drug: Gemcitabine
- Drug: Placebo (5 percent dextrose - D5W)
**Label:** Gemcitabine plus placebo
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Gemcitabine plus TH-302
**Description:** TH-302 will be administered at a dose of 340 milligrams per square meter (mg/m\^2) as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.
**Name:** TH-302
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Gemcitabine plus TH-302
- Gemcitabine plus placebo
**Description:** Gemcitabine will be administered at a dose of 1000 (mg/m\^2) as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.
**Name:** Gemcitabine
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- Gemcitabine plus placebo
**Description:** TH-302 placebo (5 percent dextrose - D5W) will be administered as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.
**Name:** Placebo (5 percent dextrose - D5W)
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Overall survival is defined as time from randomization to death or last day known to be alive.
**Measure:** Overall Survival
**Time Frame:** From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
#### Secondary Outcomes
**Description:** Progression Free Survival is defined as the time from randomization to either first observation of progressive disease or occurrence of death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
**Measure:** Progression Free Survival
**Time Frame:** From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* At least 18 years of age
* Locally advanced unresectable or metastatic pancreatic ductal adenocarcinoma proven by histology or cytology and previously untreated with chemotherapy or systemic therapy other than:
* Radiosensitizing doses of 5-fluorouracil;
* Radiosensitizing doses of gemcitabine if relapse occurred at least 6 months after completion of gemcitabine;
* Neoadjuvant chemotherapy if relapse occurred at least 6 months after surgical resection;
* Adjuvant chemotherapy if relapse occurred at least 6 months after completion of adjuvant chemotherapy
* Measurable disease (at least one target lesion outside of previous radiation fields) or non-measurable disease by RECIST v.1.1 criteria
* Documentation of disease progression since any prior therapy
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Life expectancy of at least 3 month
* Acceptable liver, renal function and acceptable hematological status
* Other protocol defined inclusion criteria may apply
Exclusion Criteria:
* New York Heart Association (NYHA) Class III or IV congestive heart failure, myocardial infarction within 6 months prior to the date of randomization, unstable arrhythmia or symptomatic peripheral arterial vascular disease
* Symptomatic ischemic heart disease
* Known brain, leptomeningeal or epidural metastases (unless treated and well controlled for at least 3 months)
* Previous malignancy other than pancreatic cancer in the last 5 years, except for adequately treated non-melanoma skin cancer or pre-invasive cancer of the cervix
* Severe chronic obstructive or other pulmonary disease with hypoxemia
* Major surgery, other than diagnostic surgery, less than or equal to 28 days prior to the date of randomization. Subject must have completely recovered from surgery
* Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
* Treatment of pancreatic cancer with radiation therapy or surgery less than or equal to 28 days prior to the date of randomization
* Prior therapy with a hypoxic cytotoxin
* Subjects who participated in an investigational drug or device trial less than or equal to 28 days prior to Day 1 of the first cycle
* Known infection with Human Immunodeficiency Virus (HIV), or an active infection with Hepatitis B or Hepatitis C
* Subjects who have exhibited allergic reactions to a structural compound similar to TH-302 or the drug product excipients or to gemcitabine or its excipients
* Other protocol defined exclusion criteria may apply
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Rockland
**Country:** United States
**Facility:** Please Contact U.S. Medical Information
**State:** Massachusetts
**Location 2:**
**City:** Darmstadt
**Country:** Germany
**Facility:** Please Contact Merck Communication Center
#### Overall Officials
**Official 1:**
**Affiliation:** EMD Serono Inc., a subsidiary of Merck KGaA, Darmstadt, Germany
**Name:** Antonio Gualberto, MD, PhD
**Role:** STUDY_DIRECTOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000002277
- Term: Carcinoma
- ID: D000009375
- Term: Neoplasms, Glandular and Epithelial
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000009369
- Term: Neoplasms
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M13110
- Name: Pancreatic Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M3585
- Name: Adenocarcinoma
- Relevance: HIGH
- As Found: Adenocarcinoma
- ID: M5534
- Name: Carcinoma
- Relevance: LOW
- As Found: Unknown
- ID: M12320
- Name: Neoplasms, Glandular and Epithelial
- Relevance: LOW
- As Found: Unknown
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
- ID: T4387
- Name: Pancreatic Cancer
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000000230
- Term: Adenocarcinoma
### Intervention Browse Module - Ancestors
- ID: D000000964
- Term: Antimetabolites, Antineoplastic
- ID: D000000963
- Term: Antimetabolites
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000000970
- Term: Antineoplastic Agents
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M2985
- Name: Gemcitabine
- Relevance: HIGH
- As Found: Activity
- ID: M4281
- Name: Antimetabolites
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000093542
- Term: Gemcitabine
### Misc Info Module
- Version Holder: 2024-05-24
## Results Section
### Adverse Events Module
#### Event Groups
**Group ID:** EG000
**Title:** TH-302
**Description:** TH-302: TH-302 will be administered at a dose of 340 milligrams per square meter (mg/m\^2) as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.
Gemcitabine: Gemcitabine will be administered at a dose of 1000 (mg/m\^2) as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.
**ID:** EG000
**Other Num Affected:** 341
**Other Num at Risk:** 341
**Serious Number Affected:** 341
**Serious Number At Risk:** 341
**Title:** TH-302
**Group ID:** EG001
**Title:** Placebo
**Description:** Gemcitabine: Gemcitabine will be administered at a dose of 1000 (mg/m\^2) as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.
Placebo (5 percent dextrose - D5W): TH-302 placebo (5 percent dextrose - D5W) will be administered as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.
**ID:** EG001
**Other Num Affected:** 338
**Other Num at Risk:** 338
**Serious Number Affected:** 338
**Serious Number At Risk:** 338
**Title:** Placebo
**Frequency Threshold:** 5
#### Other Events
**Term:** Anaemia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Blood and lymphatic system disorders
**Source Vocabulary:**
**Term:** Leukopenia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Blood and lymphatic system disorders
**Source Vocabulary:**
**Term:** Neutropenia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Blood and lymphatic system disorders
**Source Vocabulary:**
**Term:** Thrombocytopenia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Blood and lymphatic system disorders
**Source Vocabulary:**
**Term:** Decreased appetite
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
**Source Vocabulary:**
**Term:** Dysgeusia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
**Source Vocabulary:**
**Term:** Dyspnoea
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
**Source Vocabulary:**
**Term:** Abdominal pain
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:**
**Term:** Abdominal pain upper
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:**
**Term:** Constipation
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:**
**Term:** Diarrhoea
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:**
**Term:** Nausea
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:**
**Term:** Stomatitis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:**
**Term:** Vomiting
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:**
**Term:** Alopecia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
**Source Vocabulary:**
**Term:** Rash
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
**Source Vocabulary:**
**Term:** Back pain
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Musculoskeletal and connective tissue disorders
**Source Vocabulary:**
**Term:** Asthenia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:**
**Term:** Fatigue
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:**
**Term:** Oedema peripheral
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:**
**Term:** Pyrexia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:**
**Term:** Neutrophil count decreased
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:**
**Term:** Platelet count decreased
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:**
**Term:** White blood cell count decreased
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:**
#### Serious Events
**Term:** Appendicitis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Bacteraemia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 2
**Num At Risk:** 338
**Num Events:** 3
**Term:** Bacterial infection
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Bacterial prostatitis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Biliary sepsis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
##### Stats
**Group ID:** EG000
**Num Affected:** 3
**Num At Risk:** 341
**Num Events:** 3
**Group ID:** EG001
**Num Affected:** 2
**Num At Risk:** 338
**Num Events:** 2
**Term:** Biliary tract infection
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
##### Stats
**Group ID:** EG000
**Num Affected:** 2
**Num At Risk:** 341
**Num Events:** 3
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Bronchopneumonia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
##### Stats
**Group ID:** EG000
**Num Affected:** 2
**Num At Risk:** 341
**Num Events:** 2
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Cellulitis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
##### Stats
**Group ID:** EG000
**Num Affected:** 3
**Num At Risk:** 341
**Num Events:** 3
**Group ID:** EG001
**Num Affected:** 2
**Num At Risk:** 338
**Num Events:** 2
**Term:** Clostridium difficile colitis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Cystitis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Device related infection
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
##### Stats
**Group ID:** EG000
**Num Affected:** 4
**Num At Risk:** 341
**Num Events:** 5
**Group ID:** EG001
**Num Affected:** 2
**Num At Risk:** 338
**Num Events:** 2
**Term:** Device related sepsis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
##### Stats
**Group ID:** EG000
**Num Affected:** 2
**Num At Risk:** 341
**Num Events:** 2
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Diabetic gangrene
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Diverticulitis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Enterococcal infection
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Enterocolitis infectious
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Erysipelas
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Escherichia infection
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Escherichia sepsis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Febrile infection
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Fungal oesophagitis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Herpes zoster
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Infection
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
##### Stats
**Group ID:** EG000
**Num Affected:** 2
**Num At Risk:** 341
**Num Events:** 2
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Infusion site infection
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Klebsiella bacteraemia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 2
**Term:** Klebsiella sepsis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Lower respiratory tract infection
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 2
**Term:** Meningoencephalitis herpetic
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Oesophageal candidiasis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Oropharyngeal candidiasis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Pancreatic abscess
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Penile infection
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Peritonitis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Pharyngitis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Pneumonia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
##### Stats
**Group ID:** EG000
**Num Affected:** 9
**Num At Risk:** 341
**Num Events:** 11
**Group ID:** EG001
**Num Affected:** 8
**Num At Risk:** 338
**Num Events:** 8
**Term:** Respiratory tract infection
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Sepsis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
##### Stats
**Group ID:** EG000
**Num Affected:** 5
**Num At Risk:** 341
**Num Events:** 5
**Group ID:** EG001
**Num Affected:** 5
**Num At Risk:** 338
**Num Events:** 5
**Term:** Septic shock
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num Affected:** 2
**Num At Risk:** 338
**Num Events:** 2
**Term:** Splenic abscess
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Subcutaneous abscess
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Urinary tract infection
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
##### Stats
**Group ID:** EG000
**Num Affected:** 4
**Num At Risk:** 341
**Num Events:** 4
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Urosepsis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Vaginal infection
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Cancer pain
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)
##### Stats
**Group ID:** EG000
**Num Affected:** 2
**Num At Risk:** 341
**Num Events:** 3
**Group ID:** EG001
**Num Affected:** 2
**Num At Risk:** 338
**Num Events:** 2
**Term:** Malignant ascites
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Paraneoplastic syndrome
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Anaemia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Blood and lymphatic system disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 15
**Num At Risk:** 341
**Num Events:** 18
**Group ID:** EG001
**Num Affected:** 16
**Num At Risk:** 338
**Num Events:** 18
**Term:** Bone marrow failure
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Blood and lymphatic system disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Febrile neutropenia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Blood and lymphatic system disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num Affected:** 6
**Num At Risk:** 338
**Num Events:** 7
**Term:** Leukocytosis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Blood and lymphatic system disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Leukopenia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Blood and lymphatic system disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Neutropenia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Blood and lymphatic system disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num Affected:** 9
**Num At Risk:** 338
**Num Events:** 13
**Term:** Pancytopenia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Blood and lymphatic system disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 2
**Num At Risk:** 338
**Num Events:** 2
**Term:** Splenic infarction
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Blood and lymphatic system disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Splenic vein thrombosis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Blood and lymphatic system disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Thrombocytopenia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Blood and lymphatic system disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 19
**Num At Risk:** 338
**Num Events:** 25
**Term:** Anaphylactic reaction
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Immune system disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Drug hypersensitivity
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Immune system disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Hypersensitivity
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Immune system disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Cachexia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Decreased appetite
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 2
**Num At Risk:** 341
**Num Events:** 2
**Group ID:** EG001
**Num Affected:** 2
**Num At Risk:** 338
**Num Events:** 2
**Term:** Dehydration
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 2
**Num At Risk:** 341
**Num Events:** 2
**Group ID:** EG001
**Num Affected:** 2
**Num At Risk:** 338
**Num Events:** 2
**Term:** Diabetes mellitus
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Hyperglycaemia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 2
**Num At Risk:** 341
**Num Events:** 2
**Group ID:** EG001
**Num Affected:** 2
**Num At Risk:** 338
**Num Events:** 2
**Term:** Hypoalbuminaemia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 2
**Num At Risk:** 341
**Num Events:** 2
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Hypoglycaemia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Hypokalaemia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 2
**Num At Risk:** 341
**Num Events:** 2
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Hypovolaemia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Metabolic disorder
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Type 2 diabetes mellitus
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Anxiety
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Psychiatric disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Confusional state
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Psychiatric disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Depression
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Psychiatric disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 2
**Num At Risk:** 341
**Num Events:** 3
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Mental status changes
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Psychiatric disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 2
**Num At Risk:** 338
**Num Events:** 2
**Term:** Suicide attempt
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Psychiatric disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Amnesia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Balance disorder
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Cerebral artery stenosis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Cerebral infarction
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Cerebrovascular accident
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 3
**Num At Risk:** 338
**Num Events:** 3
**Term:** Coma
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Convulsion
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Dizziness
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 2
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Headache
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Hemianopia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Ischaemic stroke
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Spinal cord compression
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Syncope
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Transient ischaemic attack
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Macular hole
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Eye disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Acute coronary syndrome
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Cardiac disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 2
**Num At Risk:** 338
**Num Events:** 2
**Term:** Acute myocardial infarction
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Cardiac disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Aortic valve disease
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Cardiac disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Atrial fibrillation
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Cardiac disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 3
**Num At Risk:** 341
**Num Events:** 3
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Atrial tachycardia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Cardiac disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 2
**Term:** Cardiac arrest
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Cardiac disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Cardiac failure
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Cardiac disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 3
**Num At Risk:** 341
**Num Events:** 3
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Cardiac failure congestive
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Cardiac disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Cardio-respiratory arrest
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Cardiac disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Myocardial infarction
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Cardiac disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 2
**Num At Risk:** 338
**Num Events:** 2
**Term:** Aortic dissection
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Vascular disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Arterial occlusive disease
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Vascular disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Arterial thrombosis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Vascular disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Axillary vein thrombosis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Vascular disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Circulatory collapse
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Vascular disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Deep vein thrombosis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Vascular disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 4
**Num At Risk:** 341
**Num Events:** 4
**Group ID:** EG001
**Num Affected:** 7
**Num At Risk:** 338
**Num Events:** 7
**Term:** Embolism
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Vascular disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 3
**Num At Risk:** 341
**Num Events:** 3
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Hypertension
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Vascular disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 2
**Term:** Hypotension
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Vascular disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Peripheral ischaemia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Vascular disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 2
**Term:** Phlebitis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Vascular disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Shock haemorrhagic
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Vascular disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Thrombophlebitis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Vascular disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Venous thrombosis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Vascular disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Venous thrombosis limb
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Vascular disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 2
**Num At Risk:** 338
**Num Events:** 2
**Term:** Acute interstitial pneumonitis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Acute pulmonary oedema
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Chronic obstructive pulmonary disease
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Dyspnoea
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 2
**Num At Risk:** 341
**Num Events:** 2
**Group ID:** EG001
**Num Affected:** 2
**Num At Risk:** 338
**Num Events:** 2
**Term:** Dyspnoea exertional
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Epistaxis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Hiccups
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Interstitial lung disease
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num Affected:** 2
**Num At Risk:** 338
**Num Events:** 2
**Term:** Pleural effusion
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Pneumonia aspiration
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Pneumonitis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Pulmonary embolism
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 10
**Num At Risk:** 341
**Num Events:** 10
**Group ID:** EG001
**Num Affected:** 11
**Num At Risk:** 338
**Num Events:** 11
**Term:** Respiratory failure
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Abdominal distension
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Abdominal pain
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 7
**Num At Risk:** 341
**Num Events:** 8
**Group ID:** EG001
**Num Affected:** 10
**Num At Risk:** 338
**Num Events:** 10
**Term:** Abdominal pain upper
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 3
**Num At Risk:** 341
**Num Events:** 3
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Ascites
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 5
**Num At Risk:** 341
**Num Events:** 5
**Group ID:** EG001
**Num Affected:** 2
**Num At Risk:** 338
**Num Events:** 2
**Term:** Colitis ischaemic
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Constipation
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 3
**Num At Risk:** 341
**Num Events:** 3
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Diarrhoea
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 2
**Num At Risk:** 341
**Num Events:** 2
**Group ID:** EG001
**Num Affected:** 8
**Num At Risk:** 338
**Num Events:** 11
**Term:** Duodenal obstruction
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 4
**Num At Risk:** 341
**Num Events:** 4
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Duodenal perforation
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Duodenal stenosis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 4
**Num At Risk:** 341
**Num Events:** 4
**Group ID:** EG001
**Num Affected:** 3
**Num At Risk:** 338
**Num Events:** 3
**Term:** Duodenal ulcer
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Duodenal ulcer haemorrhage
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Gastric haemorrhage
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Gastric perforation
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 2
**Num At Risk:** 341
**Num Events:** 2
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Gastric ulcer haemorrhage
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Gastric ulcer perforation
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Gastrointestinal haemorrhage
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 2
**Num At Risk:** 341
**Num Events:** 2
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Gastrointestinal inflammation
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Gastrointestinal obstruction
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 2
**Num At Risk:** 341
**Num Events:** 2
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Gastrointestinal perforation
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Gastrooesophageal reflux disease
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Haematemesis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 2
**Num At Risk:** 341
**Num Events:** 2
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Ileus
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 3
**Num At Risk:** 341
**Num Events:** 3
**Group ID:** EG001
**Num Affected:** 2
**Num At Risk:** 338
**Num Events:** 2
**Term:** Impaired gastric emptying
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Intestinal ischaemia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Intestinal obstruction
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 3
**Num At Risk:** 341
**Num Events:** 4
**Group ID:** EG001
**Num Affected:** 2
**Num At Risk:** 338
**Num Events:** 2
**Term:** Intestinal perforation
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Intra-abdominal haemorrhage
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Large intestinal obstruction
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Large intestine perforation
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Nausea
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 4
**Num At Risk:** 341
**Num Events:** 4
**Group ID:** EG001
**Num Affected:** 3
**Num At Risk:** 338
**Num Events:** 4
**Term:** Obstruction gastric
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 3
**Num At Risk:** 341
**Num Events:** 3
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Oedematous pancreatitis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Oesophageal ulcer
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Oesophageal varices haemorrhage
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Pancreatitis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 2
**Term:** Pancreatitis acute
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Proctalgia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Small intestinal obstruction
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 2
**Num At Risk:** 341
**Num Events:** 2
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Stomatitis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Subileus
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 3
**Num At Risk:** 341
**Num Events:** 3
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Upper gastrointestinal haemorrhage
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 2
**Num At Risk:** 341
**Num Events:** 2
**Group ID:** EG001
**Num Affected:** 2
**Num At Risk:** 338
**Num Events:** 2
**Term:** Vomiting
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 13
**Num At Risk:** 341
**Num Events:** 13
**Group ID:** EG001
**Num Affected:** 7
**Num At Risk:** 338
**Num Events:** 8
**Term:** Bile duct obstruction
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Hepatobiliary disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 6
**Num At Risk:** 341
**Num Events:** 6
**Group ID:** EG001
**Num Affected:** 3
**Num At Risk:** 338
**Num Events:** 3
**Term:** Bile duct stenosis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Hepatobiliary disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 5
**Num At Risk:** 341
**Num Events:** 5
**Group ID:** EG001
**Num Affected:** 5
**Num At Risk:** 338
**Num Events:** 5
**Term:** Bile duct stone
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Hepatobiliary disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 2
**Term:** Biliary dilatation
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Hepatobiliary disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 2
**Num At Risk:** 338
**Num Events:** 2
**Term:** Cholangiectasis acquired
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Hepatobiliary disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Cholangiolitis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Hepatobiliary disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Cholangitis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Hepatobiliary disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 15
**Num At Risk:** 341
**Num Events:** 21
**Group ID:** EG001
**Num Affected:** 12
**Num At Risk:** 338
**Num Events:** 12
**Term:** Cholangitis acute
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Hepatobiliary disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 6
**Num At Risk:** 341
**Num Events:** 10
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Cholecystitis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Hepatobiliary disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 3
**Num At Risk:** 341
**Num Events:** 3
**Group ID:** EG001
**Num Affected:** 2
**Num At Risk:** 338
**Num Events:** 2
**Term:** Cholecystitis acute
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Hepatobiliary disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Cholestasis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Hepatobiliary disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 2
**Num At Risk:** 341
**Num Events:** 2
**Group ID:** EG001
**Num Affected:** 3
**Num At Risk:** 338
**Num Events:** 3
**Term:** Gallbladder obstruction
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Hepatobiliary disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Hepatic failure
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Hepatobiliary disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 2
**Group ID:** EG001
**Num Affected:** 3
**Num At Risk:** 338
**Num Events:** 3
**Term:** Hepatic function abnormal
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Hepatobiliary disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num Affected:** 4
**Num At Risk:** 338
**Num Events:** 4
**Term:** Hepatorenal failure
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Hepatobiliary disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Hyperbilirubinaemia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Hepatobiliary disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 2
**Num At Risk:** 341
**Num Events:** 2
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Jaundice
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Hepatobiliary disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 4
**Num At Risk:** 341
**Num Events:** 5
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Jaundice cholestatic
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Hepatobiliary disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 6
**Num At Risk:** 341
**Num Events:** 6
**Group ID:** EG001
**Num Affected:** 3
**Num At Risk:** 338
**Num Events:** 3
**Term:** Portal hypertension
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Hepatobiliary disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Dermatitis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 2
**Term:** Diabetic foot
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Rash
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Skin maceration
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Yellow skin
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Back pain
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Musculoskeletal and connective tissue disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 3
**Num At Risk:** 341
**Num Events:** 3
**Group ID:** EG001
**Num Affected:** 3
**Num At Risk:** 338
**Num Events:** 3
**Term:** Flank pain
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Musculoskeletal and connective tissue disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 2
**Num At Risk:** 338
**Num Events:** 2
**Term:** Gouty arthritis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Musculoskeletal and connective tissue disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Dysuria
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Renal and urinary disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Haematuria
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Renal and urinary disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Hydronephrosis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Renal and urinary disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Proteinuria
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Renal and urinary disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Renal failure
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Renal and urinary disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 2
**Num At Risk:** 341
**Num Events:** 2
**Group ID:** EG001
**Num Affected:** 2
**Num At Risk:** 338
**Num Events:** 2
**Term:** Renal failure acute
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Renal and urinary disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Renal impairment
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Renal and urinary disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Urinary retention
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Renal and urinary disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Urinary tract obstruction
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Renal and urinary disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Pyloric stenosis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Congenital, familial and genetic disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Asthenia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num Affected:** 4
**Num At Risk:** 338
**Num Events:** 4
**Term:** Chills
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 2
**Num At Risk:** 341
**Num Events:** 2
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Device malfunction
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Device occlusion
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 3
**Num At Risk:** 338
**Num Events:** 3
**Term:** Disease progression
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 2
**Num At Risk:** 341
**Num Events:** 2
**Group ID:** EG001
**Num Affected:** 4
**Num At Risk:** 338
**Num Events:** 4
**Term:** Fatigue
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 3
**Num At Risk:** 341
**Num Events:** 3
**Group ID:** EG001
**Num Affected:** 2
**Num At Risk:** 338
**Num Events:** 2
**Term:** General physical health deterioration
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 14
**Num At Risk:** 341
**Num Events:** 15
**Group ID:** EG001
**Num Affected:** 11
**Num At Risk:** 338
**Num Events:** 12
**Term:** Generalised oedema
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Infusion site extravasation
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Injection site extravasation
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Local swelling
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Malaise
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num Affected:** 2
**Num At Risk:** 338
**Num Events:** 2
**Term:** Multi-organ failure
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 2
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Non-cardiac chest pain
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Oedema peripheral
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num Affected:** 2
**Num At Risk:** 338
**Num Events:** 2
**Term:** Pain
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 2
**Num At Risk:** 341
**Num Events:** 2
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Pyrexia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 11
**Num At Risk:** 341
**Num Events:** 12
**Group ID:** EG001
**Num Affected:** 14
**Num At Risk:** 338
**Num Events:** 15
**Term:** Stent malfunction
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Sudden death
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Alanine aminotransferase increased
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 2
**Num At Risk:** 338
**Num Events:** 2
**Term:** Aspartate aminotransferase increased
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 2
**Num At Risk:** 338
**Num Events:** 2
**Term:** Blood alkaline phosphatase increased
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Blood bilirubin increased
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
##### Stats
**Group ID:** EG000
**Num Affected:** 3
**Num At Risk:** 341
**Num Events:** 3
**Group ID:** EG001
**Num Affected:** 3
**Num At Risk:** 338
**Num Events:** 3
**Term:** Blood creatinine increased
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Blood glucose fluctuation
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** C-reactive protein increased
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Gamma-glutamyltransferase increased
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
##### Stats
**Group ID:** EG000
**Num Affected:** 2
**Num At Risk:** 341
**Num Events:** 2
**Group ID:** EG001
**Num Affected:** 4
**Num At Risk:** 338
**Num Events:** 4
**Term:** General physical condition abnormal
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Hepatic enzyme increased
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Liver function test abnormal
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Neutrophil count decreased
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 2
**Num At Risk:** 338
**Num Events:** 2
**Term:** Platelet count decreased
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
##### Stats
**Group ID:** EG000
**Num Affected:** 2
**Num At Risk:** 341
**Num Events:** 2
**Group ID:** EG001
**Num Affected:** 8
**Num At Risk:** 338
**Num Events:** 8
**Term:** Accidental overdose
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Injury, poisoning and procedural complications
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num Affected:** 2
**Num At Risk:** 338
**Num Events:** 5
**Term:** Cervical vertebral fracture
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Injury, poisoning and procedural complications
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Chemical peritonitis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Injury, poisoning and procedural complications
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Fall
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Injury, poisoning and procedural complications
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Hip fracture
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Injury, poisoning and procedural complications
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Infusion related reaction
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Injury, poisoning and procedural complications
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 1
**Term:** Post procedural bile leak
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Injury, poisoning and procedural complications
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Prescribed overdose
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Injury, poisoning and procedural complications
##### Stats
**Group ID:** EG000
**Num At Risk:** 341
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 338
**Num Events:** 2
**Term:** Rib fracture
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Injury, poisoning and procedural complications
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
**Term:** Traumatic haemothorax
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Injury, poisoning and procedural complications
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 341
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 338
## Results Section - Baseline Characteristics Module
### Denomination Counts
**Group ID:** BG000
**Value:** 346
**Group ID:** BG001
**Value:** 347
**Group ID:** BG002
**Value:** 693
**Units:** Participants
### Group
**ID:** BG000
**Title:** Gemcitabine Plus TH-302
**Description:** TH-302: TH-302 will be administered at a dose of 340 milligrams per square meter (mg/m\^2) as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.
Gemcitabine: Gemcitabine will be administered at a dose of 1000 (mg/m\^2) as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.
### Group
**ID:** BG001
**Title:** Gemcitabine Plus Placebo
**Description:** Gemcitabine: Gemcitabine will be administered at a dose of 1000 (mg/m\^2) as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.
Placebo (5 percent dextrose - D5W): TH-302 placebo (5 percent dextrose - D5W) will be administered as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.
### Group
**ID:** BG002
**Title:** Total
**Description:** Total of all reporting groups
### Measure
#### Measurement
**Group ID:** BG000
**Spread:** 9.70
**Value:** 65
#### Measurement
**Group ID:** BG001
**Spread:** 9.82
**Value:** 63.8
#### Measurement
**Group ID:** BG002
**Spread:** 9.77
**Value:** 64.4
**Class Title:**
### Measure
#### Measurement
**Group ID:** BG000
**Value:** 155
#### Measurement
**Group ID:** BG001
**Value:** 168
#### Measurement
**Group ID:** BG002
**Value:** 323
**Category Title:** Female
#### Measurement
**Group ID:** BG000
**Value:** 191
#### Measurement
**Group ID:** BG001
**Value:** 179
#### Measurement
**Group ID:** BG002
**Value:** 370
**Category Title:** Male
**Class Title:**
**Denomination Units Selected:**
## Results Section - Baseline Characteristics Module
### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
### Point of Contact
**Email:** [email protected]
**Organization:** Threshold Pharmaceuticals
**Phone:** 302-359-0565
**Title:** Thomas Wilson
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:** 7.6
- **Spread:**
- **Upper Limit:** 9.9
- **Value:** 8.9
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:** 6.7
- **Spread:**
- **Upper Limit:** 8.3
- **Value:** 7.6
**Title:**
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:** 4.8
- **Spread:**
- **Upper Limit:** 5.6
- **Value:** 5.5
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:** 3.6
- **Spread:**
- **Upper Limit:** 3.8
- **Value:** 3.7
**Title:**
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Overall survival is defined as time from randomization to death or last day known to be alive.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Reporting Status:** POSTED
**Time Frame:** From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
**Title:** Overall Survival
**Type:** PRIMARY
**Unit of Measure:** months
##### Group
**Description:** TH-302: TH-302 will be administered at a dose of 340 milligrams per square meter (mg/m\^2) as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.
Gemcitabine: Gemcitabine will be administered at a dose of 1000 (mg/m\^2) as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.
**ID:** OG000
**Title:** Gemcitabine Plus TH-302
##### Group
**Description:** Gemcitabine: Gemcitabine will be administered at a dose of 1000 (mg/m\^2) as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.
Placebo (5 percent dextrose - D5W): TH-302 placebo (5 percent dextrose - D5W) will be administered as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.
**ID:** OG001
**Title:** Gemcitabine Plus Placebo
#### Outcome Measure 2
**Description:** Progression Free Survival is defined as the time from randomization to either first observation of progressive disease or occurrence of death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Reporting Status:** POSTED
**Time Frame:** From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
**Title:** Progression Free Survival
**Type:** SECONDARY
**Unit of Measure:** months
##### Group
**Description:** TH-302: TH-302 will be administered at a dose of 340 milligrams per square meter (mg/m\^2) as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.
Gemcitabine: Gemcitabine will be administered at a dose of 1000 (mg/m\^2) as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.
**ID:** OG000
**Title:** Gemcitabine Plus TH-302
##### Group
**Description:** Gemcitabine: Gemcitabine will be administered at a dose of 1000 (mg/m\^2) as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.
Placebo (5 percent dextrose - D5W): TH-302 placebo (5 percent dextrose - D5W) will be administered as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.
**ID:** OG001
**Title:** Gemcitabine Plus Placebo
### Participant Flow Module
#### Group
**Description:** TH-302: TH-302 will be administered at a dose of 340 milligrams per square meter (mg/m\^2) as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.
Gemcitabine: Gemcitabine will be administered at a dose of 1000 (mg/m\^2) as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.
**ID:** FG000
**Title:** Gemcitabine Plus TH-302
#### Group
**Description:** Gemcitabine: Gemcitabine will be administered at a dose of 1000 (mg/m\^2) as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.
Placebo (5 percent dextrose - D5W): TH-302 placebo (5 percent dextrose - D5W) will be administered as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.
**ID:** FG001
**Title:** Gemcitabine Plus Placebo
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 346
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 347
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 346
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 347
**Has Results:** True |
## Protocol Section
### Identification Module
**NCT ID:** NCT00188279
**Brief Title:** Minimum Dose Computed Tomography of the Thorax for Follow-up in Patients With Resected Lung Carcinoma
**Official Title:** Minimum Dose Computed Tomography of the Thorax for Follow-up in Patients With Resected Lung Carcinoma
#### Organization Study ID Info
**ID:** 05-0051-C
#### Organization
**Class:** OTHER
**Full Name:** University Health Network, Toronto
### Status Module
#### Completion Date
**Date:** 2016-10
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2018-10-11
**Type:** ACTUAL
**Last Update Submit Date:** 2018-10-09
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2016-10
**Type:** ACTUAL
#### Start Date
**Date:** 2005-06-21
**Status Verified Date:** 2018-10
#### Study First Post Date
**Date:** 2005-09-16
**Type:** ESTIMATED
**Study First Submit Date:** 2005-09-09
**Study First Submit QC Date:** 2005-09-09
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University Health Network, Toronto
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This study is designed to help decide whether a CAT scan performed at a very low dose of radiation (Minimum dose CT scan) is better than a Chest X-Ray in detecting recurrence of lung cancer in the chest (after surgery).
**Detailed Description:** Lung Carcinoma is expected to kill 18,900 men and women in Canada in 2004. This is more than the combined total for the next three common cancers. The most important factor that determines patient survival is the stage of disease at presentation. Surgical resection is the best chance of cure. However, patients who undergo lung resection with curative intent have a significant incidence of a second lung cancer at 2% per year and a recurrence rate of 38% at 5 years. The current follow-up of these patients relies on periodic physical examination and chest radiography(CXR). However, CXR is insensitive in the detection of lung nodules when compared to standard Computed Tomography of the thorax (SDCT). Computed Tomography detects smaller lung nodules than CXR however, the radiation dose from a SDCT is roughly equivalent to 20 CXR examinations. Screening studies using Low Dose CT of the Thorax (LDCT) in subjects at high risk for lung cancer have demonstrated that LDCT detects three times as many nodules as CXR and four times as many primary lung cancers at one-third the dose of SDCT. Phantom and clinical work with LDCT performed at UHN/MSH suggests that a further reduction in radiation dose (Minimum Dose CT -MnDCT) is possible for nodule detection. Minimum dose CT is performed at a dose one sixth of a SDCT.In addition, if MnDCT is confirmed to be a more sensitive nodule detection technique, it could be used to
1. Increase the interval between repeat out-patient assessment and thereby 2. Reduce the overall cost of surveillance and inconvenience to the patient and 3. Free up clinic time for the surgeon to review more patients and reduce waiting lists
### Conditions Module
**Conditions:**
- Non-small Cell Lung Cancer
**Keywords:**
- ct
- scan
- lung
- follow-up
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** DIAGNOSTIC
#### Enrollment Info
**Count:** 311
**Type:** ACTUAL
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Procedure: Minimum Dose Computed Tomography (MnDCT) scan
**Label:** MnDCT
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- MnDCT
**Description:** Minimum Dose Computed Tomography (MnDCT) scan at regular follow up intervals for up to 5 years post-operatively.
**Name:** Minimum Dose Computed Tomography (MnDCT) scan
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Measure:** Detection of local recurrent disease
**Time Frame:** 5 years
**Measure:** Evaluate the incidence and significance of sub-5mm lung nodules in this patient population
**Time Frame:** 5 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* lung cancer patients undergoing resection with intent to cure
Exclusion Criteria:
* age \< 18 years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Toronto
**Country:** Canada
**Facility:** University Health Network
**State:** Ontario
**Zip:** M5G 2C4
#### Overall Officials
**Official 1:**
**Affiliation:** University Health Network, Toronto
**Name:** Narinder Paul, MD
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009369
- Term: Neoplasms
- ID: D000012142
- Term: Respiratory Tract Neoplasms
- ID: D000013899
- Term: Thoracic Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000008171
- Term: Lung Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: All
- Name: All Conditions
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
### Condition Browse Module - Browse Leaves
- ID: M5534
- Name: Carcinoma
- Relevance: LOW
- As Found: Unknown
- ID: M11172
- Name: Lung Neoplasms
- Relevance: HIGH
- As Found: Lung Carcinoma
- ID: M5546
- Name: Carcinoma, Non-Small-Cell Lung
- Relevance: LOW
- As Found: Unknown
- ID: M14979
- Name: Respiratory Tract Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M16658
- Name: Thoracic Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M11168
- Name: Lung Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000008175
- Term: Lung Neoplasms
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06013579
**Acronym:** HEALTH-COG
**Brief Title:** Effect of High-Intensity Exercise to Attenuate Cognitive Function Limitations and Train Exercise Habits in Older People Living With HIV
**Official Title:** Examining the Effect of High-Intensity Exercise to Attenuate Cognitive Function Limitations and Train Exercise Habits in Older People Living With HIV (HEALTH-Cog)
#### Organization Study ID Info
**ID:** 1R01AG077997-01A1
**Link:** https://reporter.nih.gov/quickSearch/1R01AG077997-01A1
**Type:** NIH
#### Organization
**Class:** OTHER
**Full Name:** University of Alabama at Birmingham
#### Secondary ID Infos
**ID:** 1R01AG077997-01A1
**Link:** https://reporter.nih.gov/quickSearch/1R01AG077997-01A1
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2028-03
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-11-09
**Type:** ACTUAL
**Last Update Submit Date:** 2023-11-07
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2027-09
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-08-01
**Type:** ACTUAL
**Status Verified Date:** 2023-11
#### Study First Post Date
**Date:** 2023-08-28
**Type:** ACTUAL
**Study First Submit Date:** 2023-08-22
**Study First Submit QC Date:** 2023-08-22
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** University of Colorado, Denver
**Class:** OTHER
**Name:** University of Washington
**Class:** NIH
**Name:** National Institute on Aging (NIA)
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Alabama at Birmingham
#### Responsible Party
**Investigator Affiliation:** University of Alabama at Birmingham
**Investigator Full Name:** Pariya L. Fazeli, PhD
**Investigator Title:** Associate Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** People aging with HIV are at higher risk for Alzheimer's disease and related dementias, and although physical activity is a promising target to mitigate such risk, this population engages in low levels of physical activity. Few studies have tested cognitive effects of exercise interventions or examined mechanisms of adherence to long-term exercise among diverse samples of midlife and older people with HIV. The current study will leverage an existing R01 to address these gaps and provide implications for development of personalized approaches for the treatment and prevention of cognitive impairment and dementia in older people with HIV.
**Detailed Description:** The population of people with HIV (PWH) is aging, and are at higher risk for Alzheimer's disease and related dementias (ADRD) than seronegative counterparts. Although physical activity (PA) is a promising protective factor to mitigate ADRD risk, few well-powered PA intervention studies have rigorously tested cognitive outcomes among older PWH, a population with rates of moderate to vigorous PA well below recommended guidelines. Further, given that adherence to habitual PA diminishes after supervised interventions, identifying mechanisms of adherence (MoA) to habitual PA among older PWH is germane to develop effective and durable interventions to protect cognitive health. The proposed R01 will leverage the High-Intensity Exercise Study to Attenuate Limitations and Train Habits in Older Adults With HIV (HEALTH), a two-site RCT (University of Washington \[UW\], University of Colorado Denver \[UCD\]) of 100 older PWH examining: 1) if 4 months of supervised high-intensity interval training (HIIT) mitigates physical function impairments and fatigue to a greater extent than continuous moderate exercise (CME); 2) the effects of a 3 month text-messaging intervention on PA adherence. In contrast to CME, where aerobic exercise is performed continuously for a specified duration, HIIT, which uses repeated alternating bouts of highintensity and lower intensity aerobic exercise, has shown superior efficacy in improving physiological and cognitive outcomes, and is associated with superior enjoyment which may increase adherence to PA regimens. The proposed R01 (HEALTH-COG) will leverage the two HEALTH sites, add a new racially diverse UAB site, and add new measures (psychological MoA measures, cognitive function assessments, biomarkers) and a few 12 month follow-up to the parent study. We estimate that of our planned sample of N=100, n=50 will be enrolled at UAB and n=50 total at UW and UCD. Our primary aim is to compare the effects of a 4 month supervised HIIT or CME intervention on (1°) cognitive functioning and (2°) subjective cognitive symptoms. Our exploratory aim is to evaluate putative biomarkers underlying the effect of PA on cognition (blood markers: e.g., BDNF, VEGF, IL-6 and neuroimaging markers: cerebral blood flow, resting state functional connectivity, and brain volume). Our secondary aim is to determine MoA to long-term PA maintenance at 12 months. This aim will examine distal predictors of long-term PA, including sociodemographic, clinical, and intervention factors (i.e., changes in parent R01 physical outcomes \[cardiorespiratory fitness\], condition \[HIIT vs CME\], \[coaching vs control\]), as well as proximal psychological MoA assessed in real-time, using EMA (e.g., self-efficacy, perceived benefits, motivation, social support). Testing efficacy and mechanisms of exercise interventions on cognitive outcomes and understanding psychological MoA of habitual PA following supervised interventions will aid in the development and implementation of personalized medicine approaches for the treatment and prevention of cognitive impairment and ADRD in older PWH.
### Conditions Module
**Conditions:**
- HIV Infections
- Cognitive Impairment
**Keywords:**
- HIV
- Cognitive Function
- Exercise
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 110
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Following a 4 minute warm-up at 50% VO2peak, the participant walks for up to 42 continuous minutes at 60% VO2peak172, followed by a 4 minute cool-down. The total exercise time is 50 minutes.
**Intervention Names:**
- Behavioral: Phase 1 Gym Exercise CME
- Behavioral: Phase 2 Home Exercise Coaching Text Messages
- Behavioral: Phase 2 Home Exercise Control Text Messages
**Label:** Continuous Moderate Exercise (CME)
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** Following a 5-minute warm-up at 50% VO2peak, high and moderate-intensity exercise bouts alternate, progressing to five bouts of 4-minute high-intensity exercise (90% VO2peak), alternating with four 3-minute bouts of moderate-intensity exercise (50% VO2peak) by week 8, followed by a 5 minute cool-down. The total exercise time is 42 minutes.
**Intervention Names:**
- Behavioral: Phase 1 Gym Exercise HIIT
- Behavioral: Phase 2 Home Exercise Coaching Text Messages
- Behavioral: Phase 2 Home Exercise Control Text Messages
**Label:** High-Intensity Interval Training (HIIT)
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- High-Intensity Interval Training (HIIT)
**Description:** Following a 5-minute warm-up at 50% VO2peak, high and moderate-intensity exercise bouts alternate, progressing to five bouts of 4-minute high-intensity exercise (90% VO2peak), alternating with four 3-minute bouts of moderate-intensity exercise (50% VO2peak) by week 8, followed by a 5 minute cool-down. The total exercise time is 42 minutes.
**Name:** Phase 1 Gym Exercise HIIT
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- Continuous Moderate Exercise (CME)
**Description:** Following a 4 minute warm-up at 50% VO2peak, the participant walks for up to 42 continuous minutes at 60% VO2peak172, followed by a 4 minute cool-down. The total exercise time is 50 minutes.
**Name:** Phase 1 Gym Exercise CME
**Type:** BEHAVIORAL
#### Intervention 3
**Arm Group Labels:**
- Continuous Moderate Exercise (CME)
- High-Intensity Interval Training (HIIT)
**Description:** The coaching intervention will consist of daily text messages tailored to the individual participant's self-reported symptom experiences and barriers to exercise on that specific day. One daily message with a survey will be sent, and responses to survey items will determine the subsequent once daily motivational message.Tailored messages address a range of possible barriers to adherence based on past research, and will provide advice and guidance. Text messages will be varied each week so that even if participants continue to report the same barriers they receive different text messages.
**Name:** Phase 2 Home Exercise Coaching Text Messages
**Type:** BEHAVIORAL
#### Intervention 4
**Arm Group Labels:**
- Continuous Moderate Exercise (CME)
- High-Intensity Interval Training (HIIT)
**Description:** The control group will receive general daily texts from the study team (i.e., "Hope you are doing well!"), and reminding them of their next study appointments. These text messages are primarily social/generic in content and serve to maintain involvement and enhance retention of the control group.
**Name:** Phase 2 Home Exercise Control Text Messages
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** Cognitive assessment battery test speed of processing, learning, memory, executive functioning, verbal fluency, working memory, motor, subjective cognitive complaints, and everyday functioning.
**Measure:** Cognition
**Time Frame:** Baseline visit
**Description:** Cognitive assessment battery test speed of processing, learning, memory, executive functioning, verbal fluency, working memory, motor, subjective cognitive complaints, and everyday functioning.
**Measure:** Cognition
**Time Frame:** 4 month follow-up visit
**Description:** Cognitive assessment battery test speed of processing, learning, memory, executive functioning, verbal fluency, working memory, motor, subjective cognitive complaints, and everyday functioning.
**Measure:** Cognition
**Time Frame:** 7 month follow-up visit
**Description:** Cognitive assessment battery tests speed of processing, learning, memory, executive functioning, verbal fluency, working memory, motor, subjective cognitive complaints, and everyday functioning.
**Measure:** Cognition
**Time Frame:** 12 month follow-up visit
#### Secondary Outcomes
**Description:** Measures of mechanisms of adherence include self-efficacy, motivation, self-regulation strategies, outcome expectations, affective states, and social cohesion and support via in-person surveys and interviews.
**Measure:** Psychological Mechanisms of Adherence
**Time Frame:** 12 month follow-up visit
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Confirmed HIV
* Sedentary lifestyle, defined as self-reported PA that breaks a sweat \<3 days/week, with no regular resistance exercise for 3 months preceding study;
* Fatigued (≥2.0 on either of the first two screening items on the HIV-Related Fatigue Scale)
* On a current, contemporary ART regimen for \>=12 months;
* HIV-1 RNA \<200 copies/mL in the past 12 months (assessed via medical records)
* Willing to engage in a supervised exercise program 3 times/week for 4 months
* Cell phone or email to accept messages
* Weight \<450 lbs
* Medical clearance by study healthcare professional
Exclusion Criteria:
* Weight over 450 pounds
* Use of sex hormone therapy, if on for ≤3 months (stable doses for \>3 months will be permitted)
* Use of other hormone replacement, if on for ≤ 3 months (stable doses \>3 months will be permitted)
* Anemia (Hemoglobin ≤9 g/dL for women or ≤10 g/dL for men) due to contribution to fatigue,
* Diagnosis of mitochondrial disease,
* Active substance abuse or other factors that could prevent compliance or safety with study visits, at the discretion of the site investigator,
* Reasons for medical exclusion, as determined by Nurse Practioner:
1. Uncontrolled hypertension defined as resting systolic blood pressure \>150 mmHg or diastolic blood pressure \>90 mmHg; participants who do not meet these criteria at first screening will be reevaluated, including follow-up evaluation by their primary care provider with initiation or adjustment of anti-hypertensive medications,
2. Unstable ischemic heart disease (e.g., angina, ST segment depression) or serious arrhythmias at rest or during the graded exercise test without negative follow-up evaluation will be cause for exclusion; follow-up evaluation must include diagnostic testing (e.g., thallium stress test) with interpretation by a cardiologist,
3. New York Heart Association Class III or IV congestive heart failure, clinically significant aortic stenosis, uncontrolled angina, or uncontrolled arrhythmia,
4. Pulmonary disease requiring the use of supplemental oxygen at rest or with physical exertion,
5. Malignancy requiring chemotherapy or radiation therapy within 24 weeks prior to enrollment,
6. Poorly controlled diabetes, as evidenced by hemoglobin A1c \> 8.5, documented within 6 months of study visit or current use of insulin,
7. Surgery/trauma/injury/fracture within 24 weeks prior to enrollment that, in the opinion of the study clinician, may impact a subject's baseline functional testing and ability to exercise,
8. Balance impairments that may impact functional testing and ability to safely exercise as reported by the participant or in their medical record,
9. Orthopedic problems (e.g., severe osteoarthritis, rheumatoid arthritis) that greatly limit the ability to perform moderate intensity resistance exercise (e.g., unable to be properly positioned in exercise equipment or to have severely restricted range of motion even after modifications have been made),
10. Persons who, in the judgment of the study clinician, appear to have unstable health or are incapable of safely participating in the exercise intervention.
**Healthy Volunteers:** True
**Maximum Age:** 80 Years
**Minimum Age:** 50 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Pariya Wheeler, PhD
**Phone:** 205-996-0330
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Birmingham
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Pariya Wheeler, PhD
- **Phone:** 205-996-1210
- **Role:** CONTACT
**Country:** United States
**Facility:** University of Alabama at Birmingham
**State:** Alabama
**Status:** NOT_YET_RECRUITING
**Zip:** 35294
**Location 2:**
**City:** Aurora
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Kristine Erlandson, MD
- **Phone:** 303-724-4941
- **Role:** CONTACT
**Country:** United States
**Facility:** University of Colorado Denver
**State:** Colorado
**Status:** RECRUITING
**Zip:** 80045
**Location 3:**
**City:** Seattle
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Allison Webel, PhD
- **Phone:** 216-650-9227
- **Role:** CONTACT
**Country:** United States
**Facility:** University of Washington
**State:** Washington
**Status:** RECRUITING
**Zip:** 98195
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000086982
- Term: Blood-Borne Infections
- ID: D000003141
- Term: Communicable Diseases
- ID: D000007239
- Term: Infections
- ID: D000015229
- Term: Sexually Transmitted Diseases, Viral
- ID: D000012749
- Term: Sexually Transmitted Diseases
- ID: D000016180
- Term: Lentivirus Infections
- ID: D000012192
- Term: Retroviridae Infections
- ID: D000012327
- Term: RNA Virus Infections
- ID: D000014777
- Term: Virus Diseases
- ID: D000091662
- Term: Genital Diseases
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000007153
- Term: Immunologic Deficiency Syndromes
- ID: D000007154
- Term: Immune System Diseases
- ID: D000003072
- Term: Cognition Disorders
- ID: D000019965
- Term: Neurocognitive Disorders
- ID: D000001523
- Term: Mental Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
- Abbrev: BC01
- Name: Infections
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: BC20
- Name: Immune System Diseases
### Condition Browse Module - Browse Leaves
- ID: M29705
- Name: Cognitive Dysfunction
- Relevance: HIGH
- As Found: Cognitive Impairment
- ID: M10283
- Name: Infections
- Relevance: LOW
- As Found: Unknown
- ID: M6368
- Name: Communicable Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M3522
- Name: Acquired Immunodeficiency Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M18250
- Name: HIV Infections
- Relevance: HIGH
- As Found: HIV Infections
- ID: M2593
- Name: Blood-Borne Infections
- Relevance: LOW
- As Found: Unknown
- ID: M15558
- Name: Sexually Transmitted Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17933
- Name: Sexually Transmitted Diseases, Viral
- Relevance: LOW
- As Found: Unknown
- ID: M18640
- Name: Lentivirus Infections
- Relevance: LOW
- As Found: Unknown
- ID: M15026
- Name: Retroviridae Infections
- Relevance: LOW
- As Found: Unknown
- ID: M17522
- Name: Virus Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15149
- Name: RNA Virus Infections
- Relevance: LOW
- As Found: Unknown
- ID: M2876
- Name: Genital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M10199
- Name: Immunologic Deficiency Syndromes
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6301
- Name: Cognition Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M21836
- Name: Neurocognitive Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000015658
- Term: HIV Infections
- ID: D000060825
- Term: Cognitive Dysfunction
### Intervention Browse Module - Browse Branches
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Ot
- Name: Other Dietary Supplements
### Intervention Browse Module - Browse Leaves
- ID: M4854
- Name: Benzocaine
- Relevance: LOW
- As Found: Unknown
- ID: T433
- Name: Tannic Acid
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT04317079
**Brief Title:** Effects of Hydroxytyrosol Administration in Anthropometric Parameters in Overweight and Obese Women
**Official Title:** Evaluation of the Effects of the Administration of 5 Milligrams and 15 Milligrams of Hydroxytyrosol, an Extra Virgin Olive Oil Phenolic Compound, Versus Placebo, Combined With Diet, in Anthropometric Parameters in Overweight and Obese Women
#### Organization Study ID Info
**ID:** HydroxytyrosolStudy
#### Organization
**Class:** OTHER
**Full Name:** National and Kapodistrian University of Athens
### Status Module
#### Completion Date
**Date:** 2019-05-15
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2020-03-20
**Type:** ACTUAL
**Last Update Submit Date:** 2020-03-19
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2019-05-15
**Type:** ACTUAL
#### Start Date
**Date:** 2017-10-30
**Type:** ACTUAL
**Status Verified Date:** 2020-03
#### Study First Post Date
**Date:** 2020-03-20
**Type:** ACTUAL
**Study First Submit Date:** 2020-03-19
**Study First Submit QC Date:** 2020-03-19
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** National and Kapodistrian University of Athens
#### Responsible Party
**Investigator Affiliation:** National and Kapodistrian University of Athens
**Investigator Full Name:** Alexandros Kokkinos
**Investigator Title:** Associate Professor in Internal Medicine
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This study aims to investigate the potential effects of the administration of hydroxytyrosol, which is an extra virgin olive oil phenolic compound, in doses 15 milligrams and 5 milligrams daily versus placebo for 6 months in anthropometric parameters such as body weight, body fat and visceral fat, in combination with diet, in overweight and obese women.
**Detailed Description:** Hydroxytyrosol is an extra virgin olive oil phenolic compound which has known protective effects in LDL oxidation and reduces oxidative stress. Olive oil has been associated with enhanced weight loss, and hydroxytyrosol could have a potential role in this.
Participants entered the study after signing the informed consent document. Detailed medical and family history was taken at baseline visit, and measurement of height, body weight, body fat and visceral fat were also made. Each participant visited a dietitian the same day and written consultation concerning the diet to be followed was given, based on Mediterranean diet and 500 kilocalories below their estimated Basal Metabolic Rate. The above measurements and dietitian consultation were repeated in each visit during the intervention (4,12 and 24 weeks).
Baseline laboratory testing was made including urea, creatinine, aminotransferases and fasting lipids and glucose, while serum and plasma were stored in -80 Celsius degrees for future analyses. Blood samples were also taken at 4, 12 and 24 weeks of the intervention.
All participants had an identical meal test at baseline, at 12 and 24 months and blood samples were collected at times 0, 30, 60, 90, 120, 150 and 180 minutes after meal consumption. Samples were also stored in -80 Celsius degrees for future analyses.
Each participant received in each visit prepackaged the quantity of capsules until the next scheduled visit, and the used empty blisters were returned in the following visit in order to assess compliance in capsules consumption. 24-hour diet recalls were used to assess compliance to diet.
In each visit an investigation concerning potential adverse events was made and data were recorded.
A communication was obtained with each participant who discontinued the study before 24 weeks, the reasons for discontinuation were recorded and data obtained until their last visit before study discontinuation were used in analyses.
Paired analyses were made using the system Statistical Package for the Social Sciences comparing all study groups before and after the intervention.
### Conditions Module
**Conditions:**
- Body Weight
- Visceral Obesity
**Keywords:**
- Hydroxytyrosol
- Body weight
- Visceral fat
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Administration of hydroxytyrosol (15mg versus 5 mg daily) versus placebo for 6 months in combination with diet in order to assess effects in body weight, body fat mass and visceral fat mass loss
##### Masking Info
**Masking:** QUADRUPLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 37
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** 15 milligrams of hydroxytyrosol given as 2 capsules containing 2.5mg of hydroxytyrosol each given three times daily before main meals (totally 6 capsules daily) in combination with diet
**Intervention Names:**
- Dietary Supplement: Hydroxytyrosol
- Other: Diet
**Label:** 15mg of hydroxytyrosol
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** 5 milligrams of hydroxytyrosol given as 2 capsules containing 2.5mg of hydroxytyrosol each given in the morning and at night before meals and 2 capsules of placebo before lunch (totally 6 capsules daily) in combination with diet
**Intervention Names:**
- Dietary Supplement: Hydroxytyrosol
- Other: Diet
**Label:** 5mg of hydroxytyrosol
**Type:** ACTIVE_COMPARATOR
#### Arm Group 3
**Description:** 2 capsules of placebo given 3 times daily before meals (totally 6 capsules daily) in combination with diet
**Intervention Names:**
- Other: Diet
**Label:** placebo
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- 15mg of hydroxytyrosol
- 5mg of hydroxytyrosol
**Description:** Administration of hydroxytyrosol in doses 15mg and 5 mg compared to placebo for 6 months
**Name:** Hydroxytyrosol
**Type:** DIETARY_SUPPLEMENT
#### Intervention 2
**Arm Group Labels:**
- 15mg of hydroxytyrosol
- 5mg of hydroxytyrosol
- placebo
**Description:** Consultation by a dietitian was offered to all participants
**Name:** Diet
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Measurement of body weight via TANITA Bioelectrical Impedance Analysis technology
**Measure:** Change in body weight
**Time Frame:** Baseline, 4,12 and 24 weeks
**Description:** Measurement of body fat mass via bioelectrical impedance (TANITA Bioelectrical Impedance Analysis technology)
**Measure:** Change in body fat mass
**Time Frame:** Baseline, 4,12 and 24 weeks
**Description:** Measurement via TANITA technology
**Measure:** Change in visceral fat
**Time Frame:** Baseline, 4, 12 and 24 weeks
#### Secondary Outcomes
**Description:** Measurement of serum total cholesterol, high-density lipoprotein and triglycerides
**Measure:** Changes in blood lipids
**Time Frame:** Baseline, 12 and 24 weeks
**Description:** Measurement of serum glucose
**Measure:** Changes in blood glucose
**Time Frame:** Baseline, 12 and 24 weeks
**Description:** Measurement of serum insulin
**Measure:** Changes in blood insulin
**Time Frame:** Baseline, 12 and 24 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
Overweight and obese women. Stable body weight (\<5% variation) during the past 3 months before enrollment. Stable hypolipidemic treatment for at least 3 months before enrollment.
Exclusion Criteria:
* Diabetes mellitus
* Neoplasms
* Autoimmune conditions
* Psychiatric disorders (excluding stable depressive disorder)
* Hyper/hypo-thyroidism with recent changes in medical treatment during the past 6 months before enrollment
* Renal impairment, defined as estimated Glomerular Filtration Rate (MDRD) \<60millilitres/min
* Heart failure, defined as left ventricle Ejection Fraction \<40%, use of diuretics or other treatment due to heart failure (antihypertensive medications allowed)
* Impaired liver function, defined as liver transaminases values twice above the upper normal range
* Malabsorption status (inflammatory bowel disease, previous bariatric surgery, chronic pancreatitis)
* Medical treatment known to influence body weight (steroids, oestrogens/ progesterone, topiramate, mirtazapine or anti-obesity treatment)
* Unwillingness to participate to the study
* Baseline waist circumference \>130cm due to technical difficulties in visceral fat measurement
* Pregnancy, lactation
**Healthy Volunteers:** True
**Maximum Age:** 66 Years
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Athens
**Country:** Greece
**Facility:** Diabetes Clinical Research Laboratory, 1st Department of Propaedeutic Internal Medicine
**Zip:** 11527
#### Overall Officials
**Official 1:**
**Affiliation:** National Kapodistrian University of Athens
**Name:** Nikolaos Tentolouris, MD,PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Cotrim BA, Joglar J, Rojas MJ, del Olmo JM, Macias-Gonzalez M, Cuevas MR, Fito M, Munoz-Aguayo D, Planells MI, Farre M, de Fonseca FR, de la Torre R. Unsaturated fatty alcohol derivatives of olive oil phenolic compounds with potential low-density lipoprotein (LDL) antioxidant and antiobesity properties. J Agric Food Chem. 2012 Feb 1;60(4):1067-74. doi: 10.1021/jf203814r. Epub 2012 Jan 20.
**PMID:** 22220510
**Citation:** Peyrol J, Riva C, Amiot MJ. Hydroxytyrosol in the Prevention of the Metabolic Syndrome and Related Disorders. Nutrients. 2017 Mar 20;9(3):306. doi: 10.3390/nu9030306.
**PMID:** 28335507
**Citation:** Colica C, Di Renzo L, Trombetta D, Smeriglio A, Bernardini S, Cioccoloni G, Costa de Miranda R, Gualtieri P, Sinibaldi Salimei P, De Lorenzo A. Antioxidant Effects of a Hydroxytyrosol-Based Pharmaceutical Formulation on Body Composition, Metabolic State, and Gene Expression: A Randomized Double-Blinded, Placebo-Controlled Crossover Trial. Oxid Med Cell Longev. 2017;2017:2473495. doi: 10.1155/2017/2473495. Epub 2017 Aug 9.
**PMID:** 28855976
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000044343
- Term: Overnutrition
- ID: D000009748
- Term: Nutrition Disorders
- ID: D000009765
- Term: Obesity
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
### Condition Browse Module - Browse Leaves
- ID: M5114
- Name: Body Weight
- Relevance: HIGH
- As Found: Body Weight
- ID: M12701
- Name: Obesity
- Relevance: LOW
- As Found: Unknown
- ID: M26186
- Name: Overweight
- Relevance: HIGH
- As Found: Overweight
- ID: M28427
- Name: Obesity, Abdominal
- Relevance: HIGH
- As Found: Visceral Obesity
- ID: M25307
- Name: Overnutrition
- Relevance: LOW
- As Found: Unknown
- ID: M12684
- Name: Nutrition Disorders
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000050177
- Term: Overweight
- ID: D000056128
- Term: Obesity, Abdominal
- ID: D000001835
- Term: Body Weight
### Intervention Browse Module - Ancestors
- ID: D000000890
- Term: Anti-Infective Agents
- ID: D000000975
- Term: Antioxidants
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000020011
- Term: Protective Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000010975
- Term: Platelet Aggregation Inhibitors
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: PlAggInh
- Name: Platelet Aggregation Inhibitors
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: HB
- Name: Herbal and Botanical
### Intervention Browse Module - Browse Leaves
- ID: M108425
- Name: 3,4-dihydroxyphenylethanol
- Relevance: HIGH
- As Found: SLS
- ID: M4214
- Name: Anti-Infective Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4292
- Name: Antioxidants
- Relevance: LOW
- As Found: Unknown
- ID: M21869
- Name: Protective Agents
- Relevance: LOW
- As Found: Unknown
- ID: M13865
- Name: Platelet Aggregation Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: T242
- Name: Olive
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: C000005975
- Term: 3,4-dihydroxyphenylethanol
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT01024179
**Brief Title:** Relationship Between Initial Plaque Characteristics and Stent Surface Coverage Patterns
**Official Title:** Relationship Between Initial Plaque Characteristics and Stent Surface Coverage Patterns After Sirolimus-eluting Stent Implantation Assessment by Optical Coherence Tomography
#### Organization Study ID Info
**ID:** HMUOCT-PLAQUE
#### Organization
**Class:** OTHER
**Full Name:** Harbin Medical University
### Status Module
#### Completion Date
**Date:** 2011-06
**Type:** ESTIMATED
#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2009-12-07
**Type:** ESTIMATED
**Last Update Submit Date:** 2009-12-04
**Overall Status:** UNKNOWN
#### Primary Completion Date
**Date:** 2010-12
**Type:** ESTIMATED
#### Start Date
**Date:** 2009-12
**Status Verified Date:** 2009-12
#### Study First Post Date
**Date:** 2009-12-02
**Type:** ESTIMATED
**Study First Submit Date:** 2009-12-01
**Study First Submit QC Date:** 2009-12-01
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Harbin Medical University
#### Responsible Party
**Old Name Title:** Bo Yu
**Old Organization:** Department of Cardiology of The Second Affiliated Hospital of Harbin Medical University
### Oversight Module
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Vulnerable plaque characterized by thin fibrous cap and large lipid core is an independent risk factor for most of acute cardiac event. Current clinical data showed that thin-cap fibroatheroma was more frequently observed in patients with ACS than SAP. Further OCT study indicated that patients with ACS had significantly higher incidence of incomplete neointimal coverage and malapposition after DES implantation than those with SAP. These findings imply that initial native lesion characteristics may be related to different vessel response (neointimal coverage and malapposition) after stenting. However, there is little data on the relationship between plaque characteristics and vascular response to DES after stent implantation evaluated by OCT.
Therefore, this study was designed to investigate the relationship between initial plaque characteristics and stent surface coverage or late malapposition after SES implantation. The investigators will use high resolution OCT to assess the initial culprit plaque morphology and subsequent vascular response after SES stenting at the time points of post-stenting, 6 months and 12 months. IVUS will also be performed to evaluate the tissue protrusion, malapposition, vessel remodeling at the same time points.
### Conditions Module
**Conditions:**
- Coronary Artery Disease
**Keywords:**
- Optical Coherence Tomography
- Coronary artery disease
- Chronic total occlusion
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 90
**Type:** ESTIMATED
**Phases:**
- PHASE4
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Chronic total occlusion
**Intervention Names:**
- Device: Polymer-based sirolimus-eluting stent (Partner stent )
**Label:** Group B: CTO
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** Non-chronic total occlusion :
1. Fibrous plaque+fibro-calcific plaque + Lipid plaque(\<2 quadrants )
2. Lipid-rich plaque ( ≥2 quadrants )
**Intervention Names:**
- Device: Polymer-based sirolimus-eluting stent (Partner stent )
**Label:** Group A : Non-CTO
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Group A : Non-CTO
- Group B: CTO
**Description:** Partner stent (polymer-based sirolimus-eluting stent) implanted in culprit coronary artery
**Name:** Polymer-based sirolimus-eluting stent (Partner stent )
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Measure:** To investigate the relationship between initial plaque characteristics and stent surface coverage after sirolimus-eluting stent implantation.
**Time Frame:** 6 months
#### Secondary Outcomes
**Measure:** Relationship between tissue prolapse and initial plaque characteristics
**Time Frame:** Post-intervention
**Measure:** Comparison of the differences in vascular response (surface coverage and malapposition) between CTO and non- CTO lesions.
**Time Frame:** 6-month
**Measure:** Late stent malapposition( by OCT and IVUS ).
**Time Frame:** 6 months
**Measure:** Relationship between initial lesion characteristics and stent surface coverage pattern after SES implantation.
**Time Frame:** 12 -month
**Measure:** Comparison of the differences in stent surface coverage between CTO and non- CTO lesions.
**Time Frame:** 12 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria
General Inclusion Criteria：
1. Age:18-75Y
2. Patients with stable angina or acute coronary syndrome considered suitable for coronary revascularization.
3. Patient or legal guardian understands and agrees to comply with all specified study requirements and provides written informed consent.
Angiographic Inclusion Criteria：
1. Significant coronary de novo lesion (\> 70% by visual estimation).
2. Target lesion is de novo native coronary artery lesion that can be treated with 1-2 stents.
3. Reference vessel diameter of 2.5 to 4.0 mm.
Exclusion Criteria：
General Exclusion Criteria：
1. ST-segment elevation myocardial infarction within 7 days prior to the index procedure.
2. Previous CABG.
3. Life expectancy \<12 months due to another medical condition.
4. Contraindication to antiplatelet therapy
5. Creatinine level more than 2.0mg/dL or ESRD.
6. Severe hepatic dysfunction (more than 3 times normal reference values).
7. Planned surgery procedure ≤ 6 months post-index procedure.
8. Known allergy to stainless steel or a history of hypersensitivity to sirolimus or structurally related compounds.
9. Female of childbearing potential with a positive pregnancy test within 7 days before the index procedure, or lactating, or intends to become pregnant during the 12 months post index procedure.
10. Patient is not clinically appropriate for OCT evaluation in the opinion of the investigator.
Angiographic Exclusion Criteria：
1. Study lesion is ostial in location (within 3.0 mm of vessel origin).
2. Study lesion involving arterial segments with highly tortuous anatomy.
3. Complex lesion morphologies (aorto-ostial, bifurcation needs two stents technique, left main, severe thrombi, heavy calcification).
**Maximum Age:** 75 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Bo Yu, MD,PhD
**Phone:** 86-0451-86605180
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Harbin
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Bo Yu, MD.PhD
- **Phone:** 86-0451-86605180
- **Role:** CONTACT
***Contact 2:***
- **Name:** Bo Yu, MD,PhD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** China
**Facility:** The second Affiliated Hospital of Harbin Medical University
**State:** Heilong jiang
**Status:** RECRUITING
**Zip:** 150081
#### Overall Officials
**Official 1:**
**Affiliation:** The Second Affiliated Hospital of Harbin Medical University
**Name:** Bo Yu, MD.PhD
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000006331
- Term: Heart Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000001161
- Term: Arteriosclerosis
- ID: D000001157
- Term: Arterial Occlusive Diseases
- ID: D000014652
- Term: Vascular Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M6549
- Name: Coronary Disease
- Relevance: HIGH
- As Found: Coronary Artery Disease
- ID: M6546
- Name: Coronary Artery Disease
- Relevance: HIGH
- As Found: Coronary Artery Disease
- ID: M19506
- Name: Myocardial Ischemia
- Relevance: HIGH
- As Found: Coronary Artery Disease
- ID: M10543
- Name: Ischemia
- Relevance: LOW
- As Found: Unknown
- ID: M9419
- Name: Heart Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M4469
- Name: Arteriosclerosis
- Relevance: LOW
- As Found: Unknown
- ID: M4465
- Name: Arterial Occlusive Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003324
- Term: Coronary Artery Disease
- ID: D000017202
- Term: Myocardial Ischemia
- ID: D000003327
- Term: Coronary Disease
### Intervention Browse Module - Ancestors
- ID: D000000900
- Term: Anti-Bacterial Agents
- ID: D000000890
- Term: Anti-Infective Agents
- ID: D000000903
- Term: Antibiotics, Antineoplastic
- ID: D000000970
- Term: Antineoplastic Agents
- ID: D000000935
- Term: Antifungal Agents
- ID: D000007166
- Term: Immunosuppressive Agents
- ID: D000007155
- Term: Immunologic Factors
- ID: D000045505
- Term: Physiological Effects of Drugs
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M21960
- Name: Sirolimus
- Relevance: HIGH
- As Found: Included
- ID: M4222
- Name: Anti-Bacterial Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4214
- Name: Anti-Infective Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4224
- Name: Antibiotics, Antitubercular
- Relevance: LOW
- As Found: Unknown
- ID: M6252
- Name: Clotrimazole
- Relevance: LOW
- As Found: Unknown
- ID: M11796
- Name: Miconazole
- Relevance: LOW
- As Found: Unknown
- ID: M4254
- Name: Antifungal Agents
- Relevance: LOW
- As Found: Unknown
- ID: M10212
- Name: Immunosuppressive Agents
- Relevance: LOW
- As Found: Unknown
- ID: M10201
- Name: Immunologic Factors
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000020123
- Term: Sirolimus
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT00093379
**Brief Title:** Capecitabine, Oxaliplatin, and Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer
**Official Title:** A Phase II Study of Capecitabine (Xeloda)/Oxaliplatin (Eloxatin) With Concomitant Radiotherapy (XRT), XELOX/RT in Squamous Cell Carcinoma of the Anal Canal
#### Organization Study ID Info
**ID:** 2003-0874
#### Organization
**Class:** OTHER
**Full Name:** M.D. Anderson Cancer Center
#### Secondary ID Infos
**ID:** P30CA016672
**Link:** https://reporter.nih.gov/quickSearch/P30CA016672
**Type:** NIH
**Domain:** UT MD Anderson Cancer Center
**ID:** MDA-2003-0874
**Type:** OTHER
**ID:** SANOFI-MDA-2003-0874
**Domain:** NCI PDQ
**ID:** CDR0000380771
**Type:** REGISTRY
### Status Module
#### Completion Date
**Date:** 2012-07
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-04-18
**Type:** ACTUAL
**Last Update Submit Date:** 2023-03-22
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2012-07
**Type:** ACTUAL
#### Results First Post Date
**Date:** 2014-04-17
**Type:** ESTIMATED
**Results First Submit Date:** 2013-10-15
**Results First Submit QC Date:** 2014-03-12
#### Start Date
**Date:** 2004-04
**Status Verified Date:** 2023-03
#### Study First Post Date
**Date:** 2004-10-08
**Type:** ESTIMATED
**Study First Submit Date:** 2004-10-06
**Study First Submit QC Date:** 2004-10-07
### Sponsor Collaborators Module
#### Collaborators
**Class:** NIH
**Name:** National Cancer Institute (NCI)
#### Lead Sponsor
**Class:** OTHER
**Name:** M.D. Anderson Cancer Center
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Capecitabine may stop the growth of tumor cells by stopping blood flow to the tumor. Radiation therapy uses high-energy x-rays to damage tumor cells. Capecitabine and oxaliplatin may make tumor cells more sensitive to radiation therapy. Combining capecitabine and oxaliplatin with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving capecitabine and oxaliplatin together with radiation therapy works in treating patients with stage II or stage III anal cancer.
**Detailed Description:** OBJECTIVES:
Primary
* Determine time to treatment failure in patients with stage II-IIIB squamous cell carcinoma of the anal canal treated with capecitabine, oxaliplatin, and radiotherapy (i.e. Capecitabine (Xeloda)/Oxaliplatin (Eloxatin) With Concomitant Radiotherapy (XRT) shortened to XELOX/XRT).
* Determine the toxic effects of this regimen in these patients.
Secondary
* Determine the complete response rate in patients treated with this regimen.
* Determine 2-year local regional control in patients treated with this regimen.
* Determine 2-year colostomy-free survival in patients treated with this regimen.
* Determine 2-year median overall survival in patients treated with this regimen.
* Determine 2-year progression-free survival in patients treated with this regimen.
OUTLINE: Patients receive oral capecitabine\* twice daily on days 1-2, 6-10, 20-24, 27-31, and 41-42, and undergo radiotherapy\* once daily on days 1-3, 6-10, 13-17, 20-24, 27-31, 34-38, and 41-42. Patients also receive oxaliplatin intravenous (IV) over 2 hours on days 1, 8, 22, and 29. Treatment continues in the absence of disease progression or unacceptable toxicity.
NOTE: \*Patients with T3-4 lesions also receive oral capecitabine twice daily and undergo radiotherapy once daily on days 43 and 44.
Patients are followed at 4-6 and 12 weeks and then periodically thereafter.
PROJECTED ACCRUAL: A total of 71 patients will be accrued for this study.
### Conditions Module
**Conditions:**
- Anal Cancer
**Keywords:**
- stage II anal cancer
- stage IIIA anal cancer
- stage IIIB anal cancer
- squamous cell carcinoma of the anus
- Capecitabine
- Xeloda
- Oxaliplatin
- Eloxatin
- Radiotherapy
- XRT
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 20
**Type:** ACTUAL
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Capecitabine (825 mg/m\^2 twice a day, Monday-Friday during weeks 1, 2, 4, and 5) and Oxaliplatin (50 mg/m\^2, Days 1, 8, 22, 29) during the duration of radiation therapy only. Radiotherapy once daily on days 1-3, 6-10, 13-17, 20-24, 27-31, 34-38, and 41-42. Participants with T3-4 lesions undergo radiotherapy once daily on days 43 and 44. The final dose of radiation therapy determined by the T stage of the primary tumor. Radiotherapy = XRT.
**Intervention Names:**
- Drug: Capecitabine
- Drug: Oxaliplatin
- Radiation: Radiation Therapy (XRT)
**Label:** Capecitabine + Oxaliplatin + XRT
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Capecitabine + Oxaliplatin + XRT
**Description:** 825 mg/m\^2 orally twice a day (BID), Mon-Fri during weeks 1, 2, 4, and 5.
**Name:** Capecitabine
**Other Names:**
- Xeloda
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Capecitabine + Oxaliplatin + XRT
**Description:** 50 mg/m\^2 by vein (IV) over 2 hours on days 1, 8, 22, and 29.
**Name:** Oxaliplatin
**Other Names:**
- Eloxatin
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- Capecitabine + Oxaliplatin + XRT
**Description:** Undergo radiotherapy\* once daily on days 1-3, 6-10, 13-17, 20-24, 27-31, 34-38, and 41-42. \*Patients with T3-4 lesions undergo radiotherapy once daily on days 43 and 44.
**Name:** Radiation Therapy (XRT)
**Other Names:**
- XRT
- RT
- Radiotherapy
**Type:** RADIATION
### Outcomes Module
#### Primary Outcomes
**Description:** Treatment failure defined as: Biopsy proven residual disease identified 12 -14 weeks after the conclusion of chemoradiation therapy, Treatment-related mortality or Disease recurrence.
**Measure:** 2 Year Failure Free Survival
**Time Frame:** 2 years
#### Secondary Outcomes
**Description:** Response determined by computed tomography (CT)/magnetic resonance imaging (MRI), digital rectal examination, and proctoscopy, and a biopsy performed for clinical suspicion of residual or progressive disease. Response Evaluation Criteria in Solid Tumors (RECIST) where evaluation of target lesions Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
**Measure:** Number of Participants With Complete Response at 2 Years
**Time Frame:** 2 Years
**Description:** Colostomy-free survival reported as number of participants who did not develop local recurrence or require salvage resection with colostomy.
**Measure:** Number of Participants With 2-year Colostomy-Free Survival
**Time Frame:** 2 Years with median study follow up of 19 months
**Measure:** 2-year Local Regional Control
**Time Frame:** 2 Years
**Measure:** 2-Year Median Overall Survival
**Time Frame:** 2 Years
**Measure:** Number of Participants With Progression-Free Survival at 2-Year
**Time Frame:** 2 Years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Previously untreated patients with histologically proven squamous cell carcinoma of the anal canal.
2. American Joint Committee on Cancer (AJCC) stage II-IIIB (TX 1-4, NX, MO).
3. Age \>/= 16 yrs old.
4. Eastern Cooperative Oncology Group (ECOG) Performance Scale (PS) 0-1.
5. Adequate organ function including: Absolute neutrophil Count (ANC) \>/= 1,500/uL, Platelets \>/= 100,000/uL, Total bilirubin \</= 1.5 \* upper limit of normal (ULN), aspartate aminotransferase (AST or SGOT)/alanine aminotransferase (ALT or SGPT) \</= 3 \* ULN, Creatinine \</= 1.5mg/dL or Creatinine Clearance (CrCL) \>/= 50 cc/min.
6. Patients may have measurable or non-measurable disease. Patients with measurable disease, as defined by the modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria, have at least one lesion that can be accurately measured in at least one dimension with longest diameter to be recorded \>/= 20 mm using conventional techniques or \>/= 10 mm with spiral CT scan (with minimum lesion size no less than double the slice thickness). Lesions seen on colonoscopy or barium studies are not considered measurable lesions.
7. A negative pregnancy test in all women of child-bearing potential, within two weeks of initiating treatment.
8. The effects of oxaliplatin and capecitabine on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because cytotoxic agents are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
9. Ability to understand and the willingness to sign the written informed consent/authorization document.
Exclusion Criteria:
1. Prior chemotherapy with oxaliplatin, capecitabine, or 5-fluorouracil.
2. Prior radiation to the pelvis.
3. Prior surgery for anal cancer excluding prior biopsy.
4. Known history of dihydropyrimidine (DPD) deficiency.
5. Known history of hypersensitivity to platinum-containing compounds.
6. Peripheral neuropathy of \>/= grade 2 by Common Terminology Criteria for Adverse Events (CTCAE) 3.0.
7. Calculated creatinine clearance (CrCl) \< 50 cc/min.
8. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit adherence with study requirements.
9. Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous (IV) alimentation.
10. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with oxaliplatin or capecitabine, breast feeding should be discontinued.
11. Because of the known interaction of capecitabine and coumadin, patients taking coumadin will be ineligible. Patients will be requested to discontinue coumadin and utilize Lovenox if agreeable. Patients must have discontinued coumadin for 7 days before initiating therapy.
12. No prior malignancies (excluding non-melanomatous skin neoplasms) over the past 5 years.
13. HIV-positive patients receiving combination anti-retroviral therapy are excluded from this study because of possible pharmacokinetic interactions with capecitabine or oxaliplatin. This exclusion is for patient safety since patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, and because very few HIV-positive anal canal cancer patients are seen at this institution. This hinders us from accruing enough patients to adequately test the safety of this regimen in this population.
14. Patients with symptomatic pulmonary fibrosis.
**Minimum Age:** 16 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Houston
**Country:** United States
**Facility:** M. D. Anderson Cancer Center at University of Texas
**State:** Texas
**Zip:** 77030-4009
#### Overall Officials
**Official 1:**
**Affiliation:** M.D. Anderson Cancer Center
**Name:** Cathy Eng, MD
**Role:** STUDY_CHAIR
**Official 2:**
**Affiliation:** M.D. Anderson Cancer Center
**Name:** Christopher H. Crane, MD
**Role:** STUDY_CHAIR
### References Module
#### References
**Citation:** Eng C, Jacome AA, Das P, Chang GJ, Rodriguez-Bigas M, Skibber JM, Wolff RA, Qiao W, Xing Y, Sethi S, Ohinata A, Crane CH. A Phase II Study of Capecitabine/Oxaliplatin With Concurrent Radiotherapy in Locally Advanced Squamous Cell Carcinoma of the Anal Canal. Clin Colorectal Cancer. 2019 Dec;18(4):301-306. doi: 10.1016/j.clcc.2019.06.003. Epub 2019 Jul 2.
**PMID:** 31350201
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012004
- Term: Rectal Neoplasms
- ID: D000015179
- Term: Colorectal Neoplasms
- ID: D000007414
- Term: Intestinal Neoplasms
- ID: D000005770
- Term: Gastrointestinal Neoplasms
- ID: D000004067
- Term: Digestive System Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000005767
- Term: Gastrointestinal Diseases
- ID: D000007410
- Term: Intestinal Diseases
- ID: D000001004
- Term: Anus Diseases
- ID: D000012002
- Term: Rectal Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: All
- Name: All Conditions
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M5534
- Name: Carcinoma
- Relevance: LOW
- As Found: Unknown
- ID: M5550
- Name: Carcinoma, Squamous Cell
- Relevance: LOW
- As Found: Unknown
- ID: M4321
- Name: Anus Neoplasms
- Relevance: HIGH
- As Found: Anal Cancer
- ID: M14846
- Name: Rectal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M17890
- Name: Colorectal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M10448
- Name: Intestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8886
- Name: Gastrointestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M7256
- Name: Digestive System Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10444
- Name: Intestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M4320
- Name: Anus Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14844
- Name: Rectal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T362
- Name: Anal Cancer
- Relevance: HIGH
- As Found: Anal Cancer
### Condition Browse Module - Meshes
- ID: D000001005
- Term: Anus Neoplasms
### Intervention Browse Module - Ancestors
- ID: D000000964
- Term: Antimetabolites, Antineoplastic
- ID: D000000963
- Term: Antimetabolites
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000000970
- Term: Antineoplastic Agents
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M377
- Name: Capecitabine
- Relevance: HIGH
- As Found: Function
- ID: M1674
- Name: Oxaliplatin
- Relevance: HIGH
- As Found: Outcomes
- ID: M4281
- Name: Antimetabolites
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000069287
- Term: Capecitabine
- ID: D000077150
- Term: Oxaliplatin
### Misc Info Module
- Version Holder: 2024-05-24
## Results Section
### Adverse Events Module
#### Event Groups
**Group ID:** EG000
**Title:** Capecitabine + Oxaliplatin + XRT
**Description:** Capecitabine (825 mg/m\^2 twice a day, Monday-Friday during weeks 1, 2, 4, and 5) and Oxaliplatin (50 mg/m\^2, Days 1, 8, 22, 29) during the duration of radiation therapy only. Radiotherapy once daily on days 1-3, 6-10, 13-17, 20-24, 27-31, 34-38, and 41-42. Participants with T3-4 lesions undergo radiotherapy once daily on days 43 and 44. The final dose of radiation therapy determined by the T stage of the primary tumor. Radiotherapy = XRT.
**ID:** EG000
**Other Num Affected:** 20
**Other Num at Risk:** 20
**Serious Number Affected:** 20
**Serious Number At Risk:** 20
**Title:** Capecitabine + Oxaliplatin + XRT
**Frequency Threshold:** 5
#### Other Events
**Term:** Allergic Reaction Including Drug Fever
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** Alopecia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** Increased Alanine aminotransferase (ALT, SGPT)
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Blood and lymphatic system disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** Anorexia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** Increased Aspartate aminotransferase (AST, SGOT)
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Blood and lymphatic system disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** Elevated Bilirubin
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Blood and lymphatic system disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** Bloody Stool
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** Blurred Vision
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Eye disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** Bowel Movement, Changes
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** Blood urea nitrogen (BUN) Increase
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Renal and urinary disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** Burn
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Injury, poisoning and procedural complications
**Source Vocabulary:** CTCAE (3.0)
**Term:** Cold Intolerance
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** Constipation
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** Cough
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** Cystitis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Reproductive system and breast disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** Dehydration
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** Dermatitis (Chemoradiation)
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** Dermatitis (Radiation)
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** Dermatology/Skin (Other)
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** Diarrhea
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** Dizziness
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** Dry Mouth
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** Dysuria
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Renal and urinary disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** Fatigue
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** Fever Without Neutropenia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** CTCAE (3.0)
**Term:** Flatulence
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** Gastritis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** Gastrointestinal (Other)
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** Hand-Foot Syndrome
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** Elevated Hemoglobin
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Blood and lymphatic system disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** GI Hemorrhage
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Notes:** Hemorrhage, GI (Anus): 1 participant Hemorrhage, GI (Rectum): 3 participants
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** Hot Flashes
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Reproductive system and breast disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** Hyperpigmentation
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** Hypoalbuminemia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** Hypocalcemia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** Hypokalemia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** Hypomagnesemia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** Hyponatremia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** Hypophosphatemia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** Hypotension
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Blood and lymphatic system disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** Ileus
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** Infection (Other)
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** CTCAE (3.0)
**Term:** Infection Clinical with Grade 3-4 ANC
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Notes:** Infection with Grade 3-4 Absolute Neutrophil Count (ANC); Urinary Tract, Vagina
**Organ System:** Infections and infestations
**Source Vocabulary:** CTCAE (3.0)
**Term:** Infection with Normal ANC
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Notes:** Urinary Tract, Vagina, Vulva
**Organ System:** Infections and infestations
**Source Vocabulary:** CTCAE (3.0)
**Term:** Insomnia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Psychiatric disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** Lymphopenia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Blood and lymphatic system disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** Metabolic Problem
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** Mucositis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** Muscle Cramps
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Musculoskeletal and connective tissue disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** Musculoskeletal Issue (Other)
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Musculoskeletal and connective tissue disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** Nausea
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** Neurological Issues (Other)
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** Neuropathy: Cranial
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Notes:** Cn X Motor-Palate, Pharynx, Larynx
**Organ System:** Nervous system disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** Increased Neutrophils (Absolute neutrophil count (ANC)/Absolute Granulocyte Count (AGC)
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Blood and lymphatic system disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** Pain
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Notes:** Abdomen, Anus, Chest Wall, Eye, Head/Headache, Muscle, Neck, Perineum, Rectum, Tumor, Urethra, Rectal and other areas.
**Organ System:** General disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** Proctitis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** Pruritus
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** Rash Dermatitis (Radiation)
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** Rash/Desquamation
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** Rectal Bleeding
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** Renal/Genitourinary (Other)
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Renal and urinary disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** Rhinorrhea
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** Rigors/Chills
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** Sinus Tachycardia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** Sore Throat
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** Stricture/Stenosis, GI (Rectum)
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** Sweating
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** Taste Alteration
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** Telangiectasia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Blood and lymphatic system disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** Thrombocytopenia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Blood and lymphatic system disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** Ulcer, GI (Rectum)
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** Vaginal Bleeding
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Reproductive system and breast disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** Vaginal Discharge
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Reproductive system and breast disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** Vaginal Dryness
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Reproductive system and breast disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** Vaginal Stenosis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Reproductive system and breast disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** Vaginitis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Reproductive system and breast disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** Vomiting
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** Watery Eye
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Eye disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** Weight Loss
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** CTCAE (3.0)
**Term:** Yeast Infection
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Reproductive system and breast disorders
**Source Vocabulary:** CTCAE (3.0)
#### Serious Events
**Term:** •Increased Aspartate aminotransferase (AST, SGOT)
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Blood and lymphatic system disorders
**Source Vocabulary:** CTCAE (3.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 20
**Term:** Dehydration
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** CTCAE (3.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 20
**Term:** Allergic Reaction Including Drug Fever
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** CTCAE (3.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 20
**Term:** Dermatitis (Chemoradiation)
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
**Source Vocabulary:** CTCAE (3.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 20
**Term:** Dermatitis (Radiation)
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
**Source Vocabulary:** CTCAE (3.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 4
**Num At Risk:** 20
**Term:** Diarrhea
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** CTCAE (3.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 6
**Num At Risk:** 20
**Term:** Fatigue
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** CTCAE (3.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 20
**Term:** Hemoglobin
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Blood and lymphatic system disorders
**Source Vocabulary:** CTCAE (3.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 20
**Term:** Lymphopenia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Blood and lymphatic system disorders
**Source Vocabulary:** CTCAE (3.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 20
**Term:** Nausea
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** CTCAE (3.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 20
**Term:** Pain
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** CTCAE (3.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 4
**Num At Risk:** 20
**Time Frame:** 5 years and 9 months
## Results Section - Baseline Characteristics Module
### Denomination Counts
**Group ID:** BG000
**Value:** 20
**Units:** Participants
### Group
**ID:** BG000
**Title:** Capecitabine + Oxaliplatin + XRT
**Description:** Capecitabine (825 mg/m\^2 twice a day, Monday-Friday during weeks 1, 2, 4, and 5) and Oxaliplatin (50 mg/m\^2, Days 1, 8, 22, 29) during the duration of radiation therapy only. Radiotherapy once daily on days 1-3, 6-10, 13-17, 20-24, 27-31, 34-38, and 41-42. Participants with T3-4 lesions undergo radiotherapy once daily on days 43 and 44. The final dose of radiation therapy determined by the T stage of the primary tumor. Radiotherapy = XRT.
### Measure
#### Measurement
**Group ID:** BG000
**Lower Limit:** 39
**Upper Limit:** 66
**Value:** 55
**Class Title:**
### Measure
#### Measurement
**Group ID:** BG000
**Value:** 16
**Category Title:** Female
#### Measurement
**Group ID:** BG000
**Value:** 4
**Category Title:** Male
**Class Title:**
### Measure
#### Measurement
**Group ID:** BG000
**Value:** 20
**Class Title:** United States
**Denomination Units Selected:**
## Results Section - Baseline Characteristics Module
### Measure 1
**Dispersion Type:** FULL_RANGE
**Parameter Type:** MEDIAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
## Results Section - More Information Module
### Certain Agreement
**PI Sponsor Employee:** True
### Point of Contact
**Email:** [email protected]
**Organization:** The University of Texas (UT) MD Anderson Cancer Center
**Title:** Cathy Eng, MD/ Professor
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
### Outcome Measure 6
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 20
**Title:**
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 16
**Title:**
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 20
**Title:**
#### Outcome Measure 4
#### Outcome Measure 5
#### Outcome Measure 6
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Treatment failure defined as: Biopsy proven residual disease identified 12 -14 weeks after the conclusion of chemoradiation therapy, Treatment-related mortality or Disease recurrence.
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** 2 years
**Title:** 2 Year Failure Free Survival
**Type:** PRIMARY
**Unit of Measure:** participants
##### Group
**Description:** Capecitabine (825 mg/m\^2 twice a day, Monday-Friday during weeks 1, 2, 4, and 5) and Oxaliplatin (50 mg/m\^2, Days 1, 8, 22, 29) during the duration of radiation therapy only. Radiotherapy once daily on days 1-3, 6-10, 13-17, 20-24, 27-31, 34-38, and 41-42. Participants with T3-4 lesions undergo radiotherapy once daily on days 43 and 44. The final dose of radiation therapy determined by the T stage of the primary tumor. Radiotherapy = XRT.
**ID:** OG000
**Title:** Capecitabine + Oxaliplatin + XRT
#### Outcome Measure 2
**Description:** Response determined by computed tomography (CT)/magnetic resonance imaging (MRI), digital rectal examination, and proctoscopy, and a biopsy performed for clinical suspicion of residual or progressive disease. Response Evaluation Criteria in Solid Tumors (RECIST) where evaluation of target lesions Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
**Parameter Type:** NUMBER
**Population Description:** Three (3) participants were not evaluable for response.
**Reporting Status:** POSTED
**Time Frame:** 2 Years
**Title:** Number of Participants With Complete Response at 2 Years
**Type:** SECONDARY
**Unit of Measure:** participants
##### Group
**Description:** Capecitabine (825 mg/m\^2 twice a day, Monday-Friday during weeks 1, 2, 4, and 5) and Oxaliplatin (50 mg/m\^2, Days 1, 8, 22, 29) during the duration of radiation therapy only. Radiotherapy once daily on days 1-3, 6-10, 13-17, 20-24, 27-31, 34-38, and 41-42. Participants with T3-4 lesions undergo radiotherapy once daily on days 43 and 44. The final dose of radiation therapy determined by the T stage of the primary tumor. Radiotherapy = XRT.
**ID:** OG000
**Title:** Capecitabine + Oxaliplatin + XRT
#### Outcome Measure 3
**Description:** Colostomy-free survival reported as number of participants who did not develop local recurrence or require salvage resection with colostomy.
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** 2 Years with median study follow up of 19 months
**Title:** Number of Participants With 2-year Colostomy-Free Survival
**Type:** SECONDARY
**Unit of Measure:** participants
##### Group
**Description:** Capecitabine (825 mg/m\^2 twice a day, Monday-Friday during weeks 1, 2, 4, and 5) and Oxaliplatin (50 mg/m\^2, Days 1, 8, 22, 29) during the duration of radiation therapy only. Radiotherapy once daily on days 1-3, 6-10, 13-17, 20-24, 27-31, 34-38, and 41-42. Participants with T3-4 lesions undergo radiotherapy once daily on days 43 and 44. The final dose of radiation therapy determined by the T stage of the primary tumor. Radiotherapy = XRT.
**ID:** OG000
**Title:** Capecitabine + Oxaliplatin + XRT
#### Outcome Measure 4
**Reporting Status:** NOT_POSTED
**Time Frame:** 2 Years
**Title:** 2-year Local Regional Control
**Type:** SECONDARY
#### Outcome Measure 5
**Reporting Status:** NOT_POSTED
**Time Frame:** 2 Years
**Title:** 2-Year Median Overall Survival
**Type:** SECONDARY
#### Outcome Measure 6
**Reporting Status:** NOT_POSTED
**Time Frame:** 2 Years
**Title:** Number of Participants With Progression-Free Survival at 2-Year
**Type:** SECONDARY
### Participant Flow Module
#### Group
**Description:** Capecitabine (825 mg/m\^2 twice a day, Monday-Friday during weeks 1, 2, 4, and 5) and Oxaliplatin (50 mg/m\^2, Days 1, 8, 22, 29) during the duration of radiation therapy only. Radiotherapy (XRT) once daily on days 1-3, 6-10, 13-17, 20-24, 27-31, 34-38, and 41-42. Participants with T3-4 lesions undergo radiotherapy once daily on days 43 and 44. The final dose of radiation therapy determined by the T stage of the primary tumor.
**ID:** FG000
**Title:** Capecitabine + Oxaliplatin + XRT
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 20
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 20
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
**Recruitment Details:** The recruitment period: April 16, 2004 to May 12, 2009. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.
**Has Results:** True |
## Protocol Section
### Identification Module
**NCT ID:** NCT01268579
**Brief Title:** Pharmacodynamic Effects of Ribavirin in Patients With Tonsil and/or Base of Tongue Squamous Cell Carcinoma
**Official Title:** A Pilot Study to Assess the Pharmacodynamic Effects of Ribavirin in Patients With Tonsil and/or Base of Tongue Squamous Cell Carcinoma
#### Organization Study ID Info
**ID:** 10-218
#### Organization
**Class:** OTHER
**Full Name:** Memorial Sloan Kettering Cancer Center
### Status Module
#### Completion Date
**Date:** 2022-10-31
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-10-02
**Type:** ACTUAL
**Last Update Submit Date:** 2023-09-01
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2022-10-31
**Type:** ACTUAL
#### Results First Post Date
**Date:** 2023-10-02
**Type:** ACTUAL
**Results First Submit Date:** 2023-09-01
**Results First Submit QC Date:** 2023-09-01
#### Start Date
**Date:** 2010-12-28
**Type:** ACTUAL
**Status Verified Date:** 2023-04
#### Study First Post Date
**Date:** 2010-12-31
**Type:** ESTIMATED
**Study First Submit Date:** 2010-12-29
**Study First Submit QC Date:** 2010-12-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Memorial Sloan Kettering Cancer Center
#### Responsible Party
**Type:** SPONSOR
### Description Module
**Brief Summary:** Human papillomavirus (HPV-16) is an important factor in the development of many tonsil and/or base of tongue squamous cell cancers. Although HPV-16 is not thought to cause cancer by itself, it appears to contribute to the development of tonsil and/or base of tongue cancer in many patients. It is likely that treatment for many patients with tonsil and/or base of tongue cancer could be improved if effective therapy to control HPV-16 is developed. The investigators in this study want to learn if ribavirin shows evidence of activity against HPV-16.
Ribavirin is a pill therapy that is approved by the Food and Drug Administration (FDA) as part of the standard treatment for Hepatitis C. Laboratory experiments suggest that ribavirin might also be useful in the treatment of head and neck cancers. However, ribavirin has not yet been tested against head and neck cancer in patients. The purpose of this study is to find out the effects of ribavirin on tonsil and base tongue squamous cell cancer in patients.
The main purpose of this study is to see if ribavirin changes the expression of certain proteins related to HPV infection in the tumor. The study will also find out if ribavirin changes how the tumor appears in a PET/CT scan (positron emission tomography/computed tomography scan).
### Conditions Module
**Conditions:**
- HEAD & NECK Cancer
**Keywords:**
- ribavirin
- VIRAZOLE
- tonsil
- base of tongue
- squamous cell carcinoma
- 10-218
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 9
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** This will be a single institution non-randomized study for patients with tonsil and/or base of tongue squamous cell cancer. This is a pilot study to obtain pharmacodynamic data regarding the effects of ribavirin on tonsil squamous cell cancer.
**Intervention Names:**
- Drug: ribavirin
**Label:** ribavirin
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- ribavirin
**Description:** The clinical intervention in this study is ribavirin therapy for approximately 14 days. Ribavirin 800 mg/day is administered in divided doses, 400 mg PO qAM and 400 mg PO qPM.
**Name:** ribavirin
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** of phosphorylated eIF4E among patients with tonsillar squamous cell carcinoma.
**Measure:** To Explore if Ribavirin Therapy for 2 Weeks Decreases Tumor Expression
**Time Frame:** 2 weeks
#### Secondary Outcomes
**Description:** on molecules that may be regulated directly or indirectly by eIF4E (eg, p16, p21, EGFR, p53).). Immunohistochemistry will be performed on Pathology samples (e.g. diagnostic biopsy), as well as on the post-treatment surgical pathology samples (e.g. definitive surgery),to describe the effects of ribavirin treatment on the expression of phosphorylated eIF4E.
**Measure:** to Explore the Pharmacodynamic Effects of Ribavirin
**Time Frame:** pre-treatment and post treatment
**Description:** Pathology samples (e.g. diagnostic biopsy), as well as on the post-treatment surgical pathology samples (e.g. definitive surgery)
**Measure:** To Explore if Ribavirin Reduces the Expression of HPV-16 Oncoproteins E6 and E7
**Time Frame:** In pre- and post-treatment tumor samples
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Prior diagnostic surgical or core needle biopsy, with confirmation of tonsil and/or base of tongue squamous cell carcinoma that is positive for expression of p16 and phosphorylated eIF4E, as determined by the Department of Pathology at MSKCC. The biopsy may be either of the tonsil base of tongue and/or an involved neck node. 2 unstained slides and/or tissue block must be available from the initial diagnostic biopsy
* Positive expression p16 and phosphorylated eIF4E is defined as \>=30% of tumor cells with cytological and/or nuclear staining
* Age ≥ 18 and ≤ 65 years of age
* Karnofsky Performance Status ≥ 80
* Adequate organ function, as follows:
Adequate bone marrow reserve: absolute neutrophil count (ANC) ≥ 1.5 X 109/L, platelets ≥ 160 X 109/L, hemoglobin ≥ 12 g/dL Hepatic: total bilirubin within 1.5 X upper limit of normal (ULN) ; alkaline phosphatase (AP), aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 X ULN (Patients with Gilbert's syndrome as the cause of hyperbilirubinemia may be eligible if total bilirubin ≤ 2.5 X UNL) Renal: Serum creatinine ≤ 1.3 mg/dL. Patients with serum creatinine \> 1.3 mg/dL may be eligible if creatinine clearance (CrCl) ≥ 55 mL/min based on the standard Cockroft and Gault formula.
* Patients of childbearing potential must have a negative serum pregnancy test within 14 days of treatment. Patients must agree to use a reliable method of birth control during and for 6 months following the last dose of study drug.
* Ability to swallow oral medication.
* Non-surgical patients: If primary radiation +/- chemotherapy (concurrent or sequential) is planned, patients must agree to undergo research biopsy after completion of ribavirin treatment.
Exclusion Criteria:
* Prior chemotherapy or radiation for tonsillar or base of tongue squamous cell cancer
* More than 10 pack-years of tobacco use
* History of hemolytic anemia or thalassemia
* Active infection or serious underlying medical condition that would impair the patient's ability to receive protocol treatment.
* Current therapeutic anticoagulation with Coumadin (warfarin)
* Current or prior treatment with ribavirin
* Known active Hepatitis B or C
* Any prior documented history of transient ischemic attack (TIA) or cerebrovascular accident (CVA)
* New York Heart Association (NYHA) Grade II or greater congestive heart failure
* Clinically significant peripheral vascular disease
* History of unstable angina or myocardial infarction (MI) within the last 3 years
**Maximum Age:** 65 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** New York
**Country:** United States
**Facility:** Memorial Sloan Kettering Cancer Center
**State:** New York
**Zip:** 10065
#### Overall Officials
**Official 1:**
**Affiliation:** Memorial Sloan Kettering Cancer Center
**Name:** David Pfisher, MD
**Role:** PRINCIPAL_INVESTIGATOR
### References Module
#### References
**Citation:** Burman B, Drutman SB, Fury MG, Wong RJ, Katabi N, Ho AL, Pfister DG. Pharmacodynamic and therapeutic pilot studies of single-agent ribavirin in patients with human papillomavirus-related malignancies. Oral Oncol. 2022 May;128:105806. doi: 10.1016/j.oraloncology.2022.105806. Epub 2022 Mar 23.
**PMID:** 35339025
#### See Also Links
**Label:** Memorial Sloan Kettering Cancer Center
**URL:** http://www.mskcc.org/mskcc/html/44.cfm
## Document Section
### Large Document Module
#### Large Docs
- Date: 2015-04-28
- Filename: Prot_SAP_000.pdf
- Has ICF: False
- Has Protocol: True
- Has SAP: True
- Label: Study Protocol and Statistical Analysis Plan
- Size: 864868
- Type Abbrev: Prot_SAP
- Upload Date: 2023-08-31T15:17
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009375
- Term: Neoplasms, Glandular and Epithelial
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000009369
- Term: Neoplasms
- ID: D000018307
- Term: Neoplasms, Squamous Cell
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M5534
- Name: Carcinoma
- Relevance: HIGH
- As Found: Carcinoma
- ID: M5550
- Name: Carcinoma, Squamous Cell
- Relevance: HIGH
- As Found: Squamous Cell Carcinoma
- ID: M12320
- Name: Neoplasms, Glandular and Epithelial
- Relevance: LOW
- As Found: Unknown
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
- ID: M20451
- Name: Neoplasms, Squamous Cell
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000002277
- Term: Carcinoma
- ID: D000002294
- Term: Carcinoma, Squamous Cell
### Intervention Browse Module - Ancestors
- ID: D000000963
- Term: Antimetabolites
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000000998
- Term: Antiviral Agents
- ID: D000000890
- Term: Anti-Infective Agents
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M15083
- Name: Ribavirin
- Relevance: HIGH
- As Found: Bevacizumab
- ID: M4281
- Name: Antimetabolites
- Relevance: LOW
- As Found: Unknown
- ID: M4314
- Name: Antiviral Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4214
- Name: Anti-Infective Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000012254
- Term: Ribavirin
### Misc Info Module
- Version Holder: 2024-05-24
## Results Section
### Adverse Events Module
#### Event Groups
**Group ID:** EG000
**Title:** Ribavirin
**Deaths Num Affected:** 8
**Deaths Num At Risk:** 9
**Description:** This will be a single institution non-randomized study for patients with tonsil and/or base of tongue squamous cell cancer. This is a pilot study to obtain pharmacodynamic data regarding the effects of ribavirin on tonsil squamous cell cancer.
ribavirin: The clinical intervention in this study is ribavirin therapy for approximately 14 days. Ribavirin 800 mg/day is administered in divided doses, 400 mg PO qAM and 400 mg PO qPM.
**ID:** EG000
**Other Num Affected:** 9
**Other Num at Risk:** 9
**Serious Number At Risk:** 9
**Title:** Ribavirin
**Frequency Threshold:** 5
#### Other Events
**Term:** Anemia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Blood and lymphatic system disorders
**Source Vocabulary:**
**Term:** Dyspnea
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
**Source Vocabulary:**
**Term:** Blood bilirubin increase
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:**
**Term:** Fatigue
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:**
**Term:** Anorexia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
**Source Vocabulary:**
**Term:** Aspartate aminotransferase increase
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:**
**Term:** Fever
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:**
**Term:** Gastroesophageal Reflux
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:**
**Term:** Weight loss
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:**
**Term:** Alanine aminotransferase increase
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:**
**Term:** Alkaline phosphatase increase
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:**
**Time Frame:** Up to 1 year
## Results Section - Baseline Characteristics Module
### Denomination Counts
**Group ID:** BG000
**Value:** 9
**Units:** Participants
### Group
**ID:** BG000
**Title:** Ribavirin
**Description:** This will be a single institution non-randomized study for patients with tonsil and/or base of tongue squamous cell cancer. This is a pilot study to obtain pharmacodynamic data regarding the effects of ribavirin on tonsil squamous cell cancer.
ribavirin: The clinical intervention in this study is ribavirin therapy for approximately 14 days. Ribavirin 800 mg/day is administered in divided doses, 400 mg PO qAM and 400 mg PO qPM.
### Measure
#### Measurement
**Group ID:** BG000
**Lower Limit:** 47
**Upper Limit:** 69
**Value:** 59
**Class Title:**
### Measure
#### Measurement
**Group ID:** BG000
**Value:** 2
**Category Title:** Female
#### Measurement
**Group ID:** BG000
**Value:** 7
**Category Title:** Male
**Class Title:**
### Measure
#### Measurement
**Group ID:** BG000
**Value:** 1
**Category Title:** Hispanic or Latino
#### Measurement
**Group ID:** BG000
**Value:** 5
**Category Title:** Not Hispanic or Latino
#### Measurement
**Group ID:** BG000
**Value:** 3
**Category Title:** Unknown or Not Reported
**Class Title:**
### Measure
#### Measurement
**Group ID:** BG000
**Value:** 0
**Category Title:** American Indian or Alaska Native
#### Measurement
**Group ID:** BG000
**Value:** 0
**Category Title:** Asian
#### Measurement
**Group ID:** BG000
**Value:** 0
**Category Title:** Native Hawaiian or Other Pacific Islander
#### Measurement
**Group ID:** BG000
**Value:** 0
**Category Title:** Black or African American
#### Measurement
**Group ID:** BG000
**Value:** 7
**Category Title:** White
#### Measurement
**Group ID:** BG000
**Value:** 0
**Category Title:** More than one race
#### Measurement
**Group ID:** BG000
**Value:** 2
**Category Title:** Unknown or Not Reported
**Class Title:**
### Measure
#### Measurement
**Group ID:** BG000
**Value:** 9
**Class Title:** United States
**Denomination Units Selected:**
## Results Section - Baseline Characteristics Module
### Measure 1
**Dispersion Type:** FULL_RANGE
**Parameter Type:** MEDIAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Ethnicity (NIH/OMB)
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race (NIH/OMB)
**Unit of Measure:** Participants
### Measure 5
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Region of Enrollment
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
**PI Sponsor Employee:** True
### Point of Contact
**Email:** [email protected]
**Organization:** Memorial Sloan Kettering Cancer Center
**Phone:** 646-888-4237
**Title:** Dr. David Pfister MD
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 4
**Title:** Decreased p-eIF4E after 14 days of ribavirin
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 2
**Title:** No decreased p-eIF4E after 14 days of ribavirin
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 3
**Title:** Not evaluable
#### Outcome Measure 2
#### Outcome Measure 3
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** of phosphorylated eIF4E among patients with tonsillar squamous cell carcinoma.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Reporting Status:** POSTED
**Time Frame:** 2 weeks
**Title:** To Explore if Ribavirin Therapy for 2 Weeks Decreases Tumor Expression
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** This will be a single institution non-randomized study for patients with tonsil and/or base of tongue squamous cell cancer. This is a pilot study to obtain pharmacodynamic data regarding the effects of ribavirin on tonsil squamous cell cancer.
ribavirin: The clinical intervention in this study is ribavirin therapy for approximately 14 days. Ribavirin 800 mg/day is administered in divided doses, 400 mg PO qAM and 400 mg PO qPM.
**ID:** OG000
**Title:** Ribavirin
#### Outcome Measure 2
**Description:** on molecules that may be regulated directly or indirectly by eIF4E (eg, p16, p21, EGFR, p53).). Immunohistochemistry will be performed on Pathology samples (e.g. diagnostic biopsy), as well as on the post-treatment surgical pathology samples (e.g. definitive surgery),to describe the effects of ribavirin treatment on the expression of phosphorylated eIF4E.
**Population Description:** N/A - data were not collected
**Reporting Status:** POSTED
**Time Frame:** pre-treatment and post treatment
**Title:** to Explore the Pharmacodynamic Effects of Ribavirin
**Type:** SECONDARY
##### Group
**Description:** This will be a single institution non-randomized study for patients with tonsil and/or base of tongue squamous cell cancer. This is a pilot study to obtain pharmacodynamic data regarding the effects of ribavirin on tonsil squamous cell cancer.
ribavirin: The clinical intervention in this study is ribavirin therapy for approximately 14 days. Ribavirin 800 mg/day is administered in divided doses, 400 mg PO qAM and 400 mg PO qPM.
**ID:** OG000
**Title:** Ribavirin
#### Outcome Measure 3
**Description:** Pathology samples (e.g. diagnostic biopsy), as well as on the post-treatment surgical pathology samples (e.g. definitive surgery)
**Population Description:** N/A - data were not collected
**Reporting Status:** POSTED
**Time Frame:** In pre- and post-treatment tumor samples
**Title:** To Explore if Ribavirin Reduces the Expression of HPV-16 Oncoproteins E6 and E7
**Type:** SECONDARY
##### Group
**Description:** This will be a single institution non-randomized study for patients with tonsil and/or base of tongue squamous cell cancer. This is a pilot study to obtain pharmacodynamic data regarding the effects of ribavirin on tonsil squamous cell cancer.
ribavirin: The clinical intervention in this study is ribavirin therapy for approximately 14 days. Ribavirin 800 mg/day is administered in divided doses, 400 mg PO qAM and 400 mg PO qPM.
**ID:** OG000
**Title:** Ribavirin
### Participant Flow Module
#### Group
**Description:** This will be a single institution non-randomized study for patients with tonsil and/or base of tongue squamous cell cancer. This is a pilot study to obtain pharmacodynamic data regarding the effects of ribavirin on tonsil squamous cell cancer.
ribavirin: The clinical intervention in this study is ribavirin therapy for approximately 14 days. Ribavirin 800 mg/day is administered in divided doses, 400 mg PO qAM and 400 mg PO qPM.
**ID:** FG000
**Title:** Ribavirin
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Adverse Event
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 9
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 6
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 3
**Has Results:** True |
## Protocol Section
### Identification Module
**NCT ID:** NCT01107379
**Acronym:** ORIOS 2
**Brief Title:** Optimization and Refinement of Technique in In-Office Sinus Dilation 2
**Official Title:** Optimization and Refinement of Technique in In-Office Sinus Dilation 2 (ORIOS 2)
#### Organization Study ID Info
**ID:** CPR005010
#### Organization
**Class:** INDUSTRY
**Full Name:** Acclarent
### Status Module
#### Completion Date
**Date:** 2012-07
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2014-09-18
**Type:** ESTIMATED
**Last Update Submit Date:** 2014-09-13
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2012-01
**Type:** ACTUAL
#### Results First Post Date
**Date:** 2014-09-18
**Type:** ESTIMATED
**Results First Submit Date:** 2014-05-28
**Results First Submit QC Date:** 2014-09-13
#### Start Date
**Date:** 2010-04
**Status Verified Date:** 2014-09
#### Study First Post Date
**Date:** 2010-04-21
**Type:** ESTIMATED
**Study First Submit Date:** 2010-04-12
**Study First Submit QC Date:** 2010-04-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Acclarent
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** A prospective, multi-arm, multi-center, observational post-market study of balloon sinus dilatation in the physician office setting under local anesthesia to treat patients with chronic rhinosinusitis (CRS). All products intended for use in this study have been FDA cleared for sale in the U.S.A.
### Conditions Module
**Conditions:**
- Sinusitis
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 203
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Dilation of sinuses using Relieva Balloon Sinuplasty System
**Intervention Names:**
- Device: Relieva Balloon Sinuplasty System
**Label:** Balloon catheter device
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Balloon catheter device
**Description:** Sinuplasty balloon tools for dilation of sinuses in patients with chronic rhinosinusitis
**Name:** Relieva Balloon Sinuplasty System
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Change in patient-reported quality of life survey, Sino-Nasal Outcome Test -20 (SNOT-20), using paired baseline and 24 week data.
The 20 question Sino-Nasal Outcome Test (SNOT-20) will be used to evaluate sinus symptoms and sinus-symptom related quality of life (QOL) at baseline and 24 weeks post-procedure. The change in SNOT-20 score at 24 months will be compared to the baseline SNOT-20 score. Each of the 20 questions in the SNOT-20 survey is scored on a scale of 0 to 5, where '0' represents 'no problem' and '5' represents 'problem as bad as it can be'. The 20 questions are expressed as a mean of the scores. Therefore, the minimum mean score is zero and the maximum mean score is 5.
**Measure:** Mean Intra-patient Change in SNOT-20 Score
**Time Frame:** Baseline and 24 weeks
**Description:** Change in Lund-Mackay CT score for paired baseline and 24 week data.
The Lund-MacKay (LMK) CT (computed tomography) score is a scoring system to evaluate radiographic opacification of the paranasal sinuses. The LMK score will be evaluated at 24 weeks post-procedure compared to baseline. The LMK scoring system rates each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses on a scale of 0 to 2, where '0' is 'no opacification' and '2' is 'complete opacification'. The scores for a given subject are totaled and expressed as the LMK score, where zero is the minimum score, and 24 is the maximum score. A higher score represents greater sinus disease burden.
**Measure:** Mean Intra-patient Change in Lund-Mackay CT Scan Score
**Time Frame:** Baseline and 24 weeks
#### Secondary Outcomes
**Description:** Procedure Tolerability: Proportion of Subjects rating procedure as tolerable or highly tolerable.
**Measure:** Procedure Tolerability
**Time Frame:** Day 0 (Day of Procedure)
**Description:** Technical success of the procedure is defined as successful treatment of sinuses intended for treatment in the office, using balloon catheter tools and traditional endoscopic tools, as necessary
**Measure:** Proportion of Sinuses Successfully Treated in the Office Using Balloon Catheter Tools and Traditional Endoscopic Tools as Necessary
**Time Frame:** Day 0 (Day of Procedure)
**Description:** Procedure success is defined as achievement of the goal of the treatment. The physician will determine procedure success by visual endoscopic exam and absence of serious, procedural adverse events.
**Measure:** Proportion of Sinuses Successfully Treated in the Absence of Serious, Procedural Adverse Events.
**Time Frame:** Day 0 (Day of Procedure)
**Description:** Quality Of Life (QoL) evaluated by analysis of time to return to usual activities of daily living
**Measure:** Mean Number of Days to Return to Normal Activities
**Time Frame:** 2 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Male/Female, 18 year or older
* Diagnosis of Chronic Rhinosinusitis
* Planned Endoscopic Sinus surgery
Exclusion Criteria:
* Cystic Fibrosis
* Severe Polyposis
* Sinonasal tumors
* History of facial trauma precluding access to sinus ostium
* Ciliary Disfunction
* Planned non-sinus surgery (such as rhinoplasty, septoplasty, etc.)
* Pregnant or lactating female
* Inability to tolerate an awake procedure
* Participation in another investigational clinical study involving treatment for chronic rhinosinusitis
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Adult subjects with diagnosis of CRS and planned endoscopic sinus surgery.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Birmingham
**Country:** United States
**State:** Alabama
**Location 2:**
**City:** Las Vegas
**Country:** United States
**State:** Nevada
**Location 3:**
**City:** Dublin
**Country:** United States
**State:** Ohio
#### Overall Officials
**Official 1:**
**Affiliation:** Alabama Alabama Nasal and Sinus Center
**Name:** Michael Sillers, MD
**Role:** PRINCIPAL_INVESTIGATOR
### References Module
#### References
**Citation:** Karanfilov B, Silvers S, Pasha R, Sikand A, Shikani A, Sillers M; ORIOS2 Study Investigators. Office-based balloon sinus dilation: a prospective, multicenter study of 203 patients. Int Forum Allergy Rhinol. 2013 May;3(5):404-11. doi: 10.1002/alr.21112. Epub 2012 Nov 7.
**PMID:** 23136057
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012141
- Term: Respiratory Tract Infections
- ID: D000007239
- Term: Infections
- ID: D000010254
- Term: Paranasal Sinus Diseases
- ID: D000009668
- Term: Nose Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
- ID: D000010038
- Term: Otorhinolaryngologic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC01
- Name: Infections
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: BC09
- Name: Ear, Nose, and Throat Diseases
### Condition Browse Module - Browse Leaves
- ID: M7292
- Name: Dilatation, Pathologic
- Relevance: LOW
- As Found: Unknown
- ID: M15657
- Name: Sinusitis
- Relevance: HIGH
- As Found: Sinusitis
- ID: M10283
- Name: Infections
- Relevance: LOW
- As Found: Unknown
- ID: M6368
- Name: Communicable Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14978
- Name: Respiratory Tract Infections
- Relevance: LOW
- As Found: Unknown
- ID: M13167
- Name: Paranasal Sinus Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12604
- Name: Nose Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12961
- Name: Otorhinolaryngologic Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000012852
- Term: Sinusitis
### Misc Info Module
- Version Holder: 2024-05-24
## Results Section
### Adverse Events Module
#### Event Groups
**Group ID:** EG000
**Title:** Balloon Device
**Description:** Dilation of sinuses using balloon catheter tools
Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for dilation of sinuses
**ID:** EG000
**Other Num Affected:** 44
**Other Num at Risk:** 203
**Serious Number Affected:** 1
**Serious Number At Risk:** 203
**Title:** Balloon Device
**Frequency Threshold:** 0
#### Other Events
**Term:** Peri-orbital edema
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Notes:** Procedure-related. Not device related
**Organ System:** Eye disorders
**Source Vocabulary:**
**Term:** Sinus Infection
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Notes:** Not device or procedure-related
**Organ System:** Respiratory, thoracic and mediastinal disorders
**Source Vocabulary:**
**Term:** Dysphagia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Notes:** Not device or procedure related
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:**
**Term:** Sensorineural Hearing Loss
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Notes:** Not device or procedure related
**Organ System:** Ear and labyrinth disorders
**Source Vocabulary:**
**Term:** Tinnitus
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Notes:** Not device or procedure-rleated
**Organ System:** Ear and labyrinth disorders
**Source Vocabulary:**
**Term:** Allergic reaction to medication (antibiotic)
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Notes:** Not device or procedure-related
**Organ System:** Immune system disorders
**Source Vocabulary:**
**Term:** Facial Pain
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Notes:** Not device or procedure-related
**Organ System:** General disorders
**Source Vocabulary:**
**Term:** Headache
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Notes:** Not device or procedure-related
**Organ System:** General disorders
**Source Vocabulary:**
#### Serious Events
**Term:** Pneumonia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Notes:** Pneumonia occurred approximately 2 months after the procedure. Related to a pre-existing condition. Not device or procedure-related
**Organ System:** Respiratory, thoracic and mediastinal disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 203
**Num Events:** 1
**Time Frame:** 1 year
## Results Section - Baseline Characteristics Module
### Denomination Counts
**Group ID:** BG000
**Value:** 203
**Units:** Participants
### Group
**ID:** BG000
**Title:** Balloon Catheter Device
**Description:** Dilation of sinuses using balloon catheter tools
Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for sinus dilation
### Measure
#### Measurement
**Group ID:** BG000
**Spread:** 15.4
**Value:** 48.6
**Class Title:**
### Measure
#### Measurement
**Group ID:** BG000
**Value:** 108
**Category Title:** Female
#### Measurement
**Group ID:** BG000
**Value:** 95
**Category Title:** Male
**Class Title:**
### Measure
#### Measurement
**Group ID:** BG000
**Value:** 22
**Class Title:** Hispanic/Latino
#### Measurement
**Group ID:** BG000
**Value:** 145
**Class Title:** White/Caucasian
#### Measurement
**Group ID:** BG000
**Value:** 5
**Class Title:** Asian
#### Measurement
**Group ID:** BG000
**Value:** 22
**Class Title:** Black or African
#### Measurement
**Group ID:** BG000
**Value:** 1
**Class Title:** Native Hawaiian / Other Pacific Islander
#### Measurement
**Group ID:** BG000
**Value:** 2
**Class Title:** North American Indian or Inuit
#### Measurement
**Group ID:** BG000
**Value:** 6
**Class Title:** Other (not specified)
### Measure
#### Measurement
**Group ID:** BG000
**Value:** 203
**Class Title:** United States
**Denomination Units Selected:**
## Results Section - Baseline Characteristics Module
### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** NUMBER
**Title:** Race/Ethnicity, Customized
**Unit of Measure:** participants
### Measure 4
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
## Results Section - More Information Module
### Certain Agreement
**Restriction Type:** GT60
**Restrictive Agreement:** True
### Point of Contact
**Email:** [email protected]
**Organization:** Acclarent, Inc.
**Phone:** 650-687-5888
**Title:** Clinical Director
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
### Outcome Measure 6
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 1.03
- **Upper Limit:**
- **Value:** -1.16
**Title:**
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:** 76.3
- **Spread:**
- **Upper Limit:** 87.4
- **Value:** 163
**Title:**
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:** 90.91
- **Spread:**
- **Upper Limit:** 95.13
- **Value:** 552
**Title:**
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 552
**Title:**
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 1.8
- **Upper Limit:**
- **Value:** 2.3
**Title:**
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 3.56
- **Upper Limit:**
- **Value:** -4.32
**Title:**
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Change in patient-reported quality of life survey, Sino-Nasal Outcome Test -20 (SNOT-20), using paired baseline and 24 week data.
The 20 question Sino-Nasal Outcome Test (SNOT-20) will be used to evaluate sinus symptoms and sinus-symptom related quality of life (QOL) at baseline and 24 weeks post-procedure. The change in SNOT-20 score at 24 months will be compared to the baseline SNOT-20 score. Each of the 20 questions in the SNOT-20 survey is scored on a scale of 0 to 5, where '0' represents 'no problem' and '5' represents 'problem as bad as it can be'. The 20 questions are expressed as a mean of the scores. Therefore, the minimum mean score is zero and the maximum mean score is 5.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** The 24 week follow-up was optional for 83 of the 203 enrolled subjects. Additionally, for those who were expected per protocol to return for the 24 week follow-up, not all did return so that data could be collected. Data are available for 113 subjects.
**Reporting Status:** POSTED
**Time Frame:** Baseline and 24 weeks
**Title:** Mean Intra-patient Change in SNOT-20 Score
**Type:** PRIMARY
**Unit of Measure:** Scores on a scale
##### Group
**Description:** Dilation of sinuses using balloon catheter tools
Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for dilation of sinuses
**ID:** OG000
**Title:** Balloon Device
#### Outcome Measure 2
**Description:** Procedure Tolerability: Proportion of Subjects rating procedure as tolerable or highly tolerable.
**Parameter Type:** NUMBER
**Population Description:** Not all subjects were compliant will filling out tolerability questionnaires. Data are available for 198 subjects.
**Reporting Status:** POSTED
**Time Frame:** Day 0 (Day of Procedure)
**Title:** Procedure Tolerability
**Type:** SECONDARY
**Unit of Measure:** number of participants
##### Group
**Description:** Dilation of sinuses using balloon catheter tools
Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for dilation of sinuses
**ID:** OG000
**Title:** Balloon Device
#### Outcome Measure 3
**Description:** Technical success of the procedure is defined as successful treatment of sinuses intended for treatment in the office, using balloon catheter tools and traditional endoscopic tools, as necessary
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** Day 0 (Day of Procedure)
**Title:** Proportion of Sinuses Successfully Treated in the Office Using Balloon Catheter Tools and Traditional Endoscopic Tools as Necessary
**Type:** SECONDARY
**Type Units Analyzed:** sinuses
**Unit of Measure:** number of sinuses
##### Group
**Description:** Dilation of sinuses using balloon catheter tools
Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for dilation of sinuses
**ID:** OG000
**Title:** Balloon Device
#### Outcome Measure 4
**Description:** Procedure success is defined as achievement of the goal of the treatment. The physician will determine procedure success by visual endoscopic exam and absence of serious, procedural adverse events.
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** Day 0 (Day of Procedure)
**Title:** Proportion of Sinuses Successfully Treated in the Absence of Serious, Procedural Adverse Events.
**Type:** SECONDARY
**Type Units Analyzed:** sinuses
**Unit of Measure:** number of sinuses
##### Group
**Description:** Dilation of sinuses using balloon catheter tools
Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for dilation of sinuses
**ID:** OG000
**Title:** Balloon Device
#### Outcome Measure 5
**Description:** Quality Of Life (QoL) evaluated by analysis of time to return to usual activities of daily living
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Not all subjects were compliant with reporting the Number of Days to Return to Normal Activities post procedure. Data are available for 181 subjects.
**Reporting Status:** POSTED
**Time Frame:** 2 weeks
**Title:** Mean Number of Days to Return to Normal Activities
**Type:** SECONDARY
**Unit of Measure:** days
##### Group
**Description:** Dilation of sinuses using balloon catheter tools
Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for dilation of sinuses
**ID:** OG000
**Title:** Balloon Device
#### Outcome Measure 6
**Description:** Change in Lund-Mackay CT score for paired baseline and 24 week data.
The Lund-MacKay (LMK) CT (computed tomography) score is a scoring system to evaluate radiographic opacification of the paranasal sinuses. The LMK score will be evaluated at 24 weeks post-procedure compared to baseline. The LMK scoring system rates each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses on a scale of 0 to 2, where '0' is 'no opacification' and '2' is 'complete opacification'. The scores for a given subject are totaled and expressed as the LMK score, where zero is the minimum score, and 24 is the maximum score. A higher score represents greater sinus disease burden.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** The 24 week follow-up was optional for 83 of the 203 enrolled subjects. Additionally, for those who were expected per protocol to return for the 24 week follow-up, not all did return so that data could be collected. Data are available for 111 subjects.
**Reporting Status:** POSTED
**Time Frame:** Baseline and 24 weeks
**Title:** Mean Intra-patient Change in Lund-Mackay CT Scan Score
**Type:** PRIMARY
**Unit of Measure:** Scores on a scale
##### Group
**Description:** Dilation of sinuses using balloon catheter tools
Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for dilation of sinuses
**ID:** OG000
**Title:** Balloon Device
### Participant Flow Module
#### Group
**Description:** Dilation of sinuses using balloon catheter tools
Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for dilation of sinuses
**ID:** FG000
**Title:** Balloon Device
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 18
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 3
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 203
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 182
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 21
**Pre-Assignment Details:** The lead-in cohort (N=36) consisted of each investigator's first cases where all targeted sinuses were successfully dilated (minimum of 3 cases) with the exception of 4 investigators who participated in the prior ORIOS study.
**Has Results:** True |
## Protocol Section
### Identification Module
**NCT ID:** NCT04887779
**Brief Title:** Pathologist Lung Transplant Study
**Official Title:** Pathologist Led Intervention To Improve Psychological Outcomes and Adherence in Lung Transplant Patients
#### Organization Study ID Info
**ID:** STUDY19060024
#### Organization
**Class:** OTHER
**Full Name:** University of Pittsburgh
### Status Module
#### Completion Date
**Date:** 2022-08-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-02-21
**Type:** ACTUAL
**Last Update Submit Date:** 2022-02-03
**Overall Status:** WITHDRAWN
#### Primary Completion Date
**Date:** 2022-06-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2021-12
**Type:** ESTIMATED
**Status Verified Date:** 2022-02
#### Study First Post Date
**Date:** 2021-05-14
**Type:** ACTUAL
**Study First Submit Date:** 2021-05-11
**Study First Submit QC Date:** 2021-05-13
**Why Stopped:** personale shortage
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Pittsburgh
#### Responsible Party
**Investigator Affiliation:** University of Pittsburgh
**Investigator Full Name:** Blake Gibson
**Investigator Title:** Psychiatry Resident at UPMC Western Psychiatric Hospital
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Using a prospective qualitative approach, explore whether pathologist intervention is feasible as part of multimodal multidisciplinary care model for transplant patients in effecting psychological dimensions such as experience, satisfaction, or patient's understanding of their disease. Additionally, to examine if this intervention improves medication adherence.
**Detailed Description:** Specific Aims 1. Create post-transplant pathologist-led intervention Objective 1a: Recruit 10 patients who have undergone lung transplantation primarily for chronic obstructive pulmonary disease (COPD). Use pathologist to show gross/microscopic explanted organs.
Specific Aim 2. Assess the efficacy of intervention pilot Objective 2a: Immediate (within 1 day after pathologist intervention) phone interview to access patient's reaction, feelings, and experience with intervention and understanding of disease.
Objective 2b: 1 month later, phone interview asking questions related to medication adherence, patient experience with intervention and lung transplant overall, and patient understanding of disease. Results will be compared to first interview.
Objective 2c: Analyze Client Satisfaction Questionnaire (CSQ-8) for quality of life, Basel assessment of adherence to immunosuppressive medications scale (BAASIS) as a self report adherence measure, and conduct a mixed methods/grounded theory analysis of qualitative data (patient experience, disease understanding). This analysis will systematically identify themes, and assign these descriptive words.
Specific Aim 3: Finalize intervention protocol based on pilot testing. Objective 3a. Adjust and refine the content and process of intervention protocol based on findings of pilot study Objective 3b. Final changes will assure readiness for large scale study.
### Conditions Module
**Conditions:**
- Adherence, Patient
- Psychological
- Coping Skills
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** Prospective, no blinding or randomization
##### Masking Info
**Masking:** NONE
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patient viewing ex-planted organ and microscopy with pathologist
**Intervention Names:**
- Behavioral: Pathologist intervention
**Label:** Intervention
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Intervention
**Description:** viewing explanted organ and microscopy
**Name:** Pathologist intervention
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** The Basel Assessment of Adherence to Immunosuppressive Medication Scale (BAASIS©) was developed to assess adherence to immunosuppressive drugs in adult and adolescent transplant recipients. Initiation starts when a patient takes his/her first dose of medication. This is a binary event (yes/no). Implementation of the dosing regimen refers to "the extent to which a patient's actual dosing corresponds to the prescribed dosing regimen, from initiation until the last dose is taken" and implies a dosing history.
Discontinuation refers to "the moment that the patient discontinues his/her medication regimen" and is assessed as a time to event. Persistence is thus the duration between time of initiation and the moment the last dose is taken. Any yes response demonstrates issues with medication adherence.
**Measure:** Basel Assessment of Adherence to Immunosuppressive Medication Scale (BAASIS©)
**Time Frame:** one day after intervention and assessment for change one month later
**Description:** The Client Satisfaction Questionnaire is an 8 item measure of client satisfaction. An "overall score" is calculated by summing the respondent's rating (item rating) score for each scale item. Scores therefore range from 8 to 32, with higher values indicating higher satisfaction. with services with both a parent intervention versus averages of lung transplant patients.
**Measure:** Client Satisfaction Questionnaire (CSQ-8)
**Time Frame:** one day after intervention and assessment for change one month later
#### Secondary Outcomes
**Description:** Assess if patient has gained more understanding of their condition. No specific scale used, assessed by interview.
**Measure:** Patient understanding
**Time Frame:** one day after intervention and assessment for change one month later
**Description:** Discussing patient's overall experience. No specific scale used, assessed by interview.
**Measure:** Patient experience
**Time Frame:** one day after intervention and assessment for change one month later
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Lung transplant patient, transplanted after IRB approval of study -Transplanted primarily for COPD
* English speaking
* within three months of initial transplant (prior to initial discharge)
* \> 18 years old
Exclusion Criteria:
* Transplant indication other than COPD
* \<18 year old
* Non English speaking
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Pittsburgh
**Country:** United States
**Facility:** UPMC Presbyterian Hospital
**State:** Pennsylvania
**Zip:** 15213
#### Overall Officials
**Official 1:**
**Affiliation:** University of Pittsburgh Medical Center Western Psychiatric Hospital
**Name:** Blake Gibson, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT05541679
**Brief Title:** Comparison of Left Bundle Branch Area Versus Right Ventricular Septal Pacing in Patients With High-degree Conduction Disease After Transcatheter Aortic Valve Replacement (Left Bundle BRAVE)
**Official Title:** Comparison of Left Bundle Branch Area Versus Right Ventricular Septal Pacing in Patients With High-degree Conduction Disease After Transcatheter Aortic Valve Replacement
#### Organization Study ID Info
**ID:** E-22-5212
#### Organization
**Class:** OTHER
**Full Name:** Main Line Health
### Status Module
#### Completion Date
**Date:** 2025-12-31
**Type:** ESTIMATED
#### Last Update Post Date
**Date:** 2024-01-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-01-29
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2022-12-28
**Type:** ACTUAL
**Status Verified Date:** 2024-01
#### Study First Post Date
**Date:** 2022-09-15
**Type:** ACTUAL
**Study First Submit Date:** 2022-09-13
**Study First Submit QC Date:** 2022-09-13
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** Medtronic
**Class:** OTHER
**Name:** Sharpe-Strumia Research Foundation
#### Lead Sponsor
**Class:** OTHER
**Name:** Main Line Health
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** True
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The purpose of the study is to investigate the superiority of chronic left bundle branch area pacing compared to traditional right ventricular (RV) septal pacing in patients with high-grade conduction disease after transcatheter aortic valve replacement (TAVR). In this investigator initiated, multicenter, prospective, double-blinded, crossover study, chronic left bundle branch area pacing will be compared to chronic right ventricular septal pacing using echocardiographic measures of left ventricular systolic function in patients with a high cumulative ventricular pacing burden after TAVR.
### Conditions Module
**Conditions:**
- Complete Heart Block
- High Degree Second Degree Atrioventricular Block
- Pacemaker-Induced Cardiomyopathy
- Aortic Valve Stenosis
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
##### Masking Info
**Masking:** QUADRUPLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 46
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Device: Right ventricular septal pacing followed by left bundle branch area pacing
**Label:** Group A
**Type:** EXPERIMENTAL
#### Arm Group 2
**Intervention Names:**
- Device: Left bundle branch area pacing followed by right ventricular septal pacing
**Label:** Group B
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Group A
**Description:** All patients will undergo implantation of right ventricular septal lead, left bundle branch area lead, and atrial lead in the absence of permanent atrial fibrillation with a CRT-pacing generator. Patients will be randomized to pacing protocols based on group assignment and crossover during the study.
**Name:** Right ventricular septal pacing followed by left bundle branch area pacing
**Type:** DEVICE
#### Intervention 2
**Arm Group Labels:**
- Group B
**Description:** All patients will undergo implantation of right ventricular septal lead, left bundle branch area lead, and atrial lead in the absence of permanent atrial fibrillation with a CRT-pacing generator. Patients will be randomized to pacing protocols based on group assignment and crossover during the study.
**Name:** Left bundle branch area pacing followed by right ventricular septal pacing
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Primary efficacy outcome
**Measure:** Change in global longitudinal strain (GLS%)
**Time Frame:** 9 months
**Description:** Primary efficacy outcome
**Measure:** Change in left ventricular ejection fraction (LVEF%)
**Time Frame:** 9 months
**Description:** Primary safety endpoint
**Measure:** Composite of left bundle branch area pacing lead septal myocardial or coronary artery perforation, lead dislodgment, and repeat procedures related to left bundle branch area lead implantation
**Time Frame:** 18 months
#### Secondary Outcomes
**Measure:** Adverse events related to device function
**Time Frame:** 18 months
**Measure:** Quality of life measured using the Minnesota Living with Heart Failure questionnaire (MLHQ)
**Time Frame:** 9 months
**Measure:** Functional capacity measured using the New York Heart Association functional classification (NYHA)
**Time Frame:** 9 months
**Measure:** Six minute walk test score
**Time Frame:** 9 months
**Measure:** Hospitalizations for heart failure
**Time Frame:** 18 months
**Measure:** Mortality
**Time Frame:** 18 months
**Measure:** Right ventricular global longitudinal strain (RVGLS%)
**Time Frame:** 9 months
**Measure:** Left ventricular mechanical systolic dyssynchrony indexed to heart rate (SDI)
**Time Frame:** 9 months
**Measure:** Interventricular mechanical delay (IVMD)
**Time Frame:** 9 months
**Measure:** Left ventricular end-systolic volume
**Time Frame:** 9 months
**Measure:** Left ventricular stroke volume
**Time Frame:** 9 months
**Measure:** Severity of tricuspid regurgitation
**Time Frame:** 18 months
**Measure:** Severity of mitral regurgitation
**Time Frame:** 18 months
**Measure:** Left bundle branch area pacing lead pacing threshold
**Time Frame:** 18 months
**Measure:** Left bundle branch area pacing lead sensed R wave amplitude
**Time Frame:** 18 months
**Measure:** Left bundle branch area pacing lead impedence
**Time Frame:** 18 months
**Measure:** Brain natriuretic peptide or N-terminal pro-brain natriuretic peptide concentration
**Time Frame:** 9 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Subject has at least one of these conduction disturbances:
1. Symptomatic (or hemodynamically significant) bradycardia or symptomatic persistent atrioventricular block including first-degree and Mobitz I (Wenckebach) or Mobitz type II atrioventricular bock
2. High-grade atrioventricular block
3. Third-degree atrioventricular block
* Subject has undergone TAVR (any valve system) in the last four weeks
* Subject is receiving a first-time pacemaker implant
* Subject's most recent documented ejection fraction (by any method) within the past 90 days prior to study enrollment is \> 50% (≥45% if visually estimated at the time of enrollment)
* Subject is a male or female at least 18 years old at the time of consent
* Subject is able to receive a left sided pectoral implant
Exclusion Criteria:
* Subject has ever had a previous or has an existing implantable pulse generator (IPG), implantable cardiac defibrillator (ICD) or biventricular (BiV) implant
* Subject has more than mild para-valvular regurgitation following TAVR implantation.
* Subject has LVEF \< 45% if visually estimated at the time of enrollment
* Subject is indicated for a biventricular pacing device (CRT-P or CRT-D).
* Subject is enrolled in a concurrent study that may confound the results of this study
* Subject has a mechanical heart valve
* Subject is pregnant, or of childbearing potential and not on a reliable form of birth control
* Subject status post heart transplant
* Subject life expectancy less than 2 years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Ali Keramati, MD
**Phone:** 484-476-1000
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Overland Park
**Contacts:**
***Contact 1:***
- **Name:** Krishna Pothineni, MD
- **Role:** CONTACT
**Country:** United States
**Facility:** Kansas City Heart Rhythm Institute
**State:** Kansas
**Status:** RECRUITING
**Zip:** 66211
**Location 2:**
**City:** Ridgewood
**Contacts:**
***Contact 1:***
- **Name:** Mohammadali Habibi, MD
- **Role:** CONTACT
**Country:** United States
**Facility:** Valley Health System
**State:** New Jersey
**Status:** RECRUITING
**Zip:** 07450
**Location 3:**
**City:** Philadelphia
**Contacts:**
***Contact 1:***
- **Name:** Robert Schaller, DO
- **Role:** CONTACT
**Country:** United States
**Facility:** Hospital of the University of Pennsylvania
**State:** Pennsylvania
**Status:** RECRUITING
**Zip:** 19104
**Location 4:**
**City:** Wynnewood
**Contacts:**
***Contact 1:***
- **Name:** Ali Keramati, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Steven Liskov, MD
- **Role:** SUB_INVESTIGATOR
**Country:** United States
**Facility:** Lankenau Medical Center
**State:** Pennsylvania
**Status:** RECRUITING
**Zip:** 19096
#### Overall Officials
**Official 1:**
**Affiliation:** Lankenau Heart Institute
**Name:** Ali Keramati, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000006331
- Term: Heart Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000082862
- Term: Aortic Valve Disease
- ID: D000006349
- Term: Heart Valve Diseases
- ID: D000014694
- Term: Ventricular Outflow Obstruction
- ID: D000001145
- Term: Arrhythmias, Cardiac
- ID: D000075224
- Term: Cardiac Conduction System Disease
- ID: D000010335
- Term: Pathologic Processes
### Condition Browse Module - Browse Branches
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M12154
- Name: Cardiomyopathies
- Relevance: HIGH
- As Found: Cardiomyopathy
- ID: M6475
- Name: Constriction, Pathologic
- Relevance: LOW
- As Found: Unknown
- ID: M4340
- Name: Aortic Valve Stenosis
- Relevance: HIGH
- As Found: Aortic Valve Stenosis
- ID: M9415
- Name: Heart Block
- Relevance: HIGH
- As Found: Heart Block
- ID: M27765
- Name: Atrioventricular Block
- Relevance: HIGH
- As Found: Atrioventricular Block
- ID: M9419
- Name: Heart Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M2379
- Name: Aortic Valve Disease
- Relevance: LOW
- As Found: Unknown
- ID: M9437
- Name: Heart Valve Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17440
- Name: Ventricular Outflow Obstruction
- Relevance: LOW
- As Found: Unknown
- ID: M4453
- Name: Arrhythmias, Cardiac
- Relevance: LOW
- As Found: Unknown
- ID: M1472
- Name: Cardiac Conduction System Disease
- Relevance: LOW
- As Found: Unknown
- ID: T449
- Name: Aortic Valve Stenosis
- Relevance: HIGH
- As Found: Aortic Valve Stenosis
### Condition Browse Module - Meshes
- ID: D000009202
- Term: Cardiomyopathies
- ID: D000001024
- Term: Aortic Valve Stenosis
- ID: D000054537
- Term: Atrioventricular Block
- ID: D000006327
- Term: Heart Block
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT05866679
**Brief Title:** Early Assessment of Ovarian Cancer Aggressiveness by Metabolic Imaging
**Official Title:** Early Assessment of Ovarian Cancer Aggressiveness by Metabolic Imaging
#### Organization Study ID Info
**ID:** 2022-0395
#### Organization
**Class:** OTHER
**Full Name:** M.D. Anderson Cancer Center
#### Secondary ID Infos
**Domain:** NCI-Clinical Trials Registry
**ID:** NCI-2023-03931
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2028-08-31
**Type:** ESTIMATED
#### Last Update Post Date
**Date:** 2024-05-02
**Type:** ACTUAL
**Last Update Submit Date:** 2024-04-30
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2026-08-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-04-12
**Type:** ACTUAL
**Status Verified Date:** 2024-04
#### Study First Post Date
**Date:** 2023-05-19
**Type:** ACTUAL
**Study First Submit Date:** 2023-05-10
**Study First Submit QC Date:** 2023-05-10
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** M.D. Anderson Cancer Center
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** To learn if an MRSI can be performed on a 3T scanner using an investigational contrast drug called hyperpolarized 13-C pyruvate. 3T refers to the "strength" of the MRI machine.
**Detailed Description:** Primary Objective:
1. To assess if increased lactate production measured by HP 13C MRI occurs in suspected ovarian cancer patients who will undergo surgery
2. To evaluate the proportion of increased lactate production in the ovaries measured by HP 13C MRI in low/high ovarian cancer risk patients.
Secondary Objectives:
1. Correlate HP-MR findings to metabolomics, immune profiles, and blood biomarkers of patients undergoing surgical resection.
2. Demonstrate the feasibility and utility of metabolic imaging with HP 13C pyruvate MR in patients with suspected ovarian cancer
3. Correlating imaging findings such as enhancement pattern, ADC values, and advanced image analytics such as texture with pathology and genetic analysis for patients who will undergo surgical resection.
### Conditions Module
**Conditions:**
- Ovarian Cancer
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** DIAGNOSTIC
#### Enrollment Info
**Count:** 30
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Drug: Hyperpolarized 13-C-pyruvate
**Label:** Hyperpolarized 13-C-pyruvate
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Hyperpolarized 13-C-pyruvate
**Description:** Given by PO
**Name:** Hyperpolarized 13-C-pyruvate
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Measure:** Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.03
**Time Frame:** through study completion: an average of 5 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
For the first cohort, the following selection criteria will be applied who are undergoing a screening exam at MD Anderson:
1. Patients with a first degree relative (mother, sister, or daughter) with ovarian cancer or
2. A personal history of breast cancer before age 40 or
3. A personal history of breast cancer diagnosed before age 50, and one or more close relatives diagnosed with breast or ovarian cancer at any age. Two or more close relatives diagnosed with breast cancer before age 50 or with ovarian cancer diagnosed at any age or
4. Ashkenazi Jewish heritage and a personal history of breast cancer before age 50 or
5. Ashkenazi Jewish heritage and a first- or second-degree relative diagnosed with breast cancer before age 50 or with ovarian cancer at any age or
6. Presence of a BRCA1 or BRCA2 mutation or
7. Presence of a mismatch repair gene mutation associated with a hereditary cancer syndrome known as Hereditary Non-Polyposis Colon Cancer (HNPCC)/Lynch syndrome. For the second cohort- 10 Patients will be enrolled who present to MD Anderson for a pelvic ultrasound or have an outside ultrasound or imaging study without a mass or have an adnexal mass (benign) on outside imaging and do not have a high risk for ovarian cancer.
For the third cohort of patients:
10 patients who have suspicion of ovarian malignancy on conventional imaging and will be undergoing surgical resection will be included.
Exclusion Criteria:
(all cohorts)
1. Children, pregnant women, cognitively impaired adults, or prisoners will be excluded from participation.
**Minimum Age:** 18 Months
**Sex:** FEMALE
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Priya Bhosale, MD
**Phone:** (713) 792-0221
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Houston
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Priya Bhosale, MD
- **Phone:** 713-792-0221
- **Role:** CONTACT
***Contact 2:***
- **Name:** Priya Bhosale, Bhosale
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** M D Anderson Cancer Center
**State:** Texas
**Status:** RECRUITING
**Zip:** 77030
#### Overall Officials
**Official 1:**
**Affiliation:** M.D. Anderson Cancer Center
**Name:** Priya Bhosale, MD
**Role:** PRINCIPAL_INVESTIGATOR
### References Module
#### See Also Links
**Label:** M D Anderson Cancer Center
**URL:** http://www.mdanderson.org
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000004701
- Term: Endocrine Gland Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000010049
- Term: Ovarian Diseases
- ID: D000000291
- Term: Adnexal Diseases
- ID: D000005831
- Term: Genital Diseases, Female
- ID: D000052776
- Term: Female Urogenital Diseases
- ID: D000005261
- Term: Female Urogenital Diseases and Pregnancy Complications
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000005833
- Term: Genital Neoplasms, Female
- ID: D000014565
- Term: Urogenital Neoplasms
- ID: D000091662
- Term: Genital Diseases
- ID: D000004700
- Term: Endocrine System Diseases
- ID: D000006058
- Term: Gonadal Disorders
- ID: D000002277
- Term: Carcinoma
- ID: D000009375
- Term: Neoplasms, Glandular and Epithelial
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000096762
- Term: Aberrant Motor Behavior in Dementia
- ID: D000001526
- Term: Behavioral Symptoms
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M12974
- Name: Ovarian Neoplasms
- Relevance: HIGH
- As Found: Ovarian Cancer
- ID: M1704
- Name: Carcinoma, Ovarian Epithelial
- Relevance: HIGH
- As Found: Ovarian Cancer
- ID: M3724
- Name: Aggression
- Relevance: HIGH
- As Found: Aggressiveness
- ID: M5534
- Name: Carcinoma
- Relevance: LOW
- As Found: Unknown
- ID: M7863
- Name: Endocrine Gland Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M12972
- Name: Ovarian Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M3643
- Name: Adnexal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8943
- Name: Genital Diseases, Female
- Relevance: LOW
- As Found: Unknown
- ID: M2876
- Name: Genital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27093
- Name: Female Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14127
- Name: Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M8399
- Name: Female Urogenital Diseases and Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M8945
- Name: Genital Neoplasms, Female
- Relevance: LOW
- As Found: Unknown
- ID: M17315
- Name: Urogenital Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M7862
- Name: Endocrine System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M9163
- Name: Gonadal Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M12320
- Name: Neoplasms, Glandular and Epithelial
- Relevance: LOW
- As Found: Unknown
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
- ID: M6904
- Name: Dementia
- Relevance: LOW
- As Found: Unknown
- ID: M3259
- Name: Aberrant Motor Behavior in Dementia
- Relevance: LOW
- As Found: Unknown
- ID: M4818
- Name: Behavioral Symptoms
- Relevance: LOW
- As Found: Unknown
- ID: T4352
- Name: Ovarian Cancer
- Relevance: HIGH
- As Found: Ovarian Cancer
- ID: T4354
- Name: Ovarian Epithelial Cancer
- Relevance: HIGH
- As Found: Ovarian Cancer
### Condition Browse Module - Meshes
- ID: D000010051
- Term: Ovarian Neoplasms
- ID: D000077216
- Term: Carcinoma, Ovarian Epithelial
- ID: D000000374
- Term: Aggression
### Intervention Browse Module - Browse Branches
- Abbrev: Ot
- Name: Other Dietary Supplements
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: T424
- Name: Pyruvate
- Relevance: HIGH
- As Found: Rapamycin
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT03693079
**Brief Title:** Investigation of Wet Cupping Therapy on Heavy Metal Levels of Steel Industry Workers
**Official Title:** Investigation of Wet Cupping Therapy on Heavy Metal Levels of Steel Industry Workers: A Self Controlled Interventional Study
#### Organization Study ID Info
**ID:** KBU-BAP-17/1-KA-071
#### Organization
**Class:** OTHER
**Full Name:** Karabuk University
### Status Module
#### Completion Date
**Date:** 2018-10-01
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2018-10-02
**Type:** ACTUAL
**Last Update Submit Date:** 2018-09-30
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2018-08-01
**Type:** ACTUAL
#### Start Date
**Date:** 2017-09-03
**Type:** ACTUAL
**Status Verified Date:** 2018-07
#### Study First Post Date
**Date:** 2018-10-02
**Type:** ACTUAL
**Study First Submit Date:** 2018-09-30
**Study First Submit QC Date:** 2018-09-30
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Karabuk University
#### Responsible Party
**Investigator Affiliation:** Karabuk University
**Investigator Full Name:** SULEYMAN ERSOY
**Investigator Title:** Assist.Prof. Department of Family Medicine
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This interventional study investigates the efficacy of Wet cupping therapy on heavy metal levels.The levels of the selected heavy metals will be measured in the blood samples obtained from the participants before and after the interventions
**Detailed Description:** Wet cupping therapy (WCT) is a traditional therapy which was used for centuries especially for detoxifiying purposes.Current literature also points out its blood clarifiying capacity in order to illuminate the underlying mechanism of this ancient treatment.
Steel industry workers, different from the general population are exposed to heavy metals more often.Conducting a study in this special group where we will evaluate the levels of selected heavy metals in blood before and after the three sessions of WCT might let us know its detoxifiying capacity based on measurable parameters.
### Conditions Module
**Conditions:**
- Heavy Metal Toxicity
**Keywords:**
- heavy metal
- wet cupping therapy
- steel industry worker
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 44
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** wet cupping therapy will be applied to all participants
**Intervention Names:**
- Procedure: Wet cupping therapy
**Label:** Wet Cupping
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Wet Cupping
**Description:** CT was applied using plastic disposable vacuum cups on the back in the 5 areas of C7 cervical spine (DU14 acupoint), T2-4 lateral spine bilaterally (BL41-42 acupoint) and T6-8 lateral spine bilaterally (BL44-46). The cupping technique procedure was conducted in five phases:
1. Primary suction; cups are left attached to the skin for 5 minutes.
2. Area disinfection; areas are wiped with sterile gauze after disinfection with povidone iodine.
3. Scarification; Superficial incisions (20-30 gauge), 5 mm length and 1-2 mm depth, are made on the skin with a sterile, number 11 surgical blade.
4. Bloodletting and secondary suction; the cups which had been previously removed are placed again on the scarified areas Blood leaks from the capillary vessels of the skin and subcutaneous tissue and fills the cups, which are left in place for 15 minutes.
5. Removing and dressing; the cups full of blood are removed. The areas of application are wiped with sterile gauze and then a dressing is applied
**Name:** Wet cupping therapy
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** the levels of the calculated heavy metals will be in ppm
**Measure:** Levels of the selected heavy metals in venous blood samples before and after the interventions
**Time Frame:** 3 months
#### Secondary Outcomes
**Description:** the levels of the calculated heavy metals will be in ppm
**Measure:** Levels of the selected heavy metals in cupping blood samples obtained during the first intervention
**Time Frame:** 1 month
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Healthy individuals
* Iron and Steel industry workers
Exclusion Criteria:
* having any chronic disorder
* being on daily medication
* wet cupping application in the last 6 months
**Healthy Volunteers:** True
**Maximum Age:** 55 Years
**Minimum Age:** 18 Years
**Sex:** MALE
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Safranbolu
**Country:** Turkey
**Facility:** Suleyman Ersoy
**State:** Karabuk
**Zip:** 78070
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000011041
- Term: Poisoning
- ID: D000064419
- Term: Chemically-Induced Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BC25
- Name: Substance Related Disorders
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M1480
- Name: Heavy Metal Poisoning
- Relevance: HIGH
- As Found: Heavy Metal Toxicity
- ID: M13931
- Name: Poisoning
- Relevance: LOW
- As Found: Unknown
- ID: M30302
- Name: Chemically-Induced Disorders
- Relevance: LOW
- As Found: Unknown
- ID: T2680
- Name: Heavy Metal Poisoning
- Relevance: HIGH
- As Found: Heavy Metal Toxicity
### Condition Browse Module - Meshes
- ID: D000075322
- Term: Heavy Metal Poisoning
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: BlSubst
- Name: Blood Substitutes
- Abbrev: Micro
- Name: Micronutrients
### Intervention Browse Module - Browse Leaves
- ID: M14088
- Name: Povidone-Iodine
- Relevance: LOW
- As Found: Unknown
- ID: M14087
- Name: Povidone
- Relevance: LOW
- As Found: Unknown
- ID: M10488
- Name: Iodine
- Relevance: LOW
- As Found: Unknown
- ID: M229695
- Name: Cadexomer iodine
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT02013479
**Acronym:** CATALYST
**Brief Title:** Selenium Supplementation in Autoimmune Thyroiditis
**Official Title:** The Chronic Autoimmune Thyroiditis Quality Of Life Selenium Trial
#### Organization Study ID Info
**ID:** DK-CATALYST
#### Organization
**Class:** OTHER
**Full Name:** Odense University Hospital
### Status Module
#### Completion Date
**Date:** 2023-03-23
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-10-31
**Type:** ACTUAL
**Last Update Submit Date:** 2023-10-30
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-03-23
**Type:** ACTUAL
#### Start Date
**Date:** 2014-06
**Status Verified Date:** 2023-10
#### Study First Post Date
**Date:** 2013-12-17
**Type:** ESTIMATED
**Study First Submit Date:** 2013-12-03
**Study First Submit QC Date:** 2013-12-11
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Rigshospitalet, Denmark
**Class:** OTHER
**Name:** Bispebjerg Hospital
**Class:** OTHER
**Name:** Hospital of South West Jutland
**Class:** INDUSTRY
**Name:** Pharma Nord
**Class:** OTHER
**Name:** The Danish Medical Research Council
**Class:** OTHER
**Name:** Region of Southern Denmark
**Class:** OTHER
**Name:** University of Southern Denmark
#### Lead Sponsor
**Class:** OTHER
**Name:** Steen Bonnema
#### Responsible Party
**Investigator Affiliation:** Odense University Hospital
**Investigator Full Name:** Steen Bonnema
**Investigator Title:** Chief Physician
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Our aim is to investigate if selenium supplementation versus placebo adjuvant to the standard treatment with levothyroxine (LT4) in patients with autoimmune thyroiditis will lead to improved thyroid specific quality of life, and reduced autoimmune activity. The trial will include 472 participants (2 X 236) from four clinical trial sites.
**Detailed Description:** Background: Chronic autoimmune thyroiditis (AIT) is a common autoimmune disease that often leads to impaired function of the thyroid gland, increases in incidence with age, and has an 8-9 time female preponderance. Quality of life is often impaired and complaints persist in a considerable number of patients, even after restoration of euthyroidism. The autoimmune component of the disease has been suggested as an explanation for this. Selenium is a micro nutritive essential for human health and the thyroid gland has the highest selenium concentration of all human tissues. Selenoproteins catalyse thyroid hormone metabolism and anti-oxidative processes in thyrocytes. In addition they are important to immune function. In Denmark, patients with AIT have lower blood selenium concentration than the background population. The majority of 13 randomised trials have shown that selenium supplementation decreases serum thyroid peroxidase antibody levels (TPO-Ab) in patients with AIT, when compared with placebo. We hypothesise that adjuvant selenium may be beneficial in the treatment of AIT.
Objectives: To investigate if selenium supplementation versus placebo adjuvant to the standard treatment with levothyroxine (LT4) in patients with AIT will lead to improved thyroid specific quality of life, and reduced autoimmune activity.
Design and trial size: The CATALYST trial is an investigator-initiated randomised, blinded, multicentre clinical trial of selenium supplementation versus placebo in patients with AIT. The trial will include 472 participants (2 X 236) from four clinical trial sites.
Intervention and duration: The experimental intervention group will receive 200 μg selenium-enriched yeast as two oral tablets once daily for 12 months. The control group will receive two placebo tablets, identical in appearance, taste and smell, once daily for 12 months. Six months additional follow-up leads to a trial duration of 18 months. The experimental supplement will be SelenoPrecise® by Pharma Nord ApS.
Time schedule: July 2012 - February 2014: preparation, approval and trial registration . March 2014: first participant first visit. March 2016: last participant first visit. September 2017: last participant last visit. Autumn 2017: analysis of biological samples and data, preparation of manuscripts.
### Conditions Module
**Conditions:**
- Autoimmune Thyroiditis
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** QUADRUPLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 415
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** SelenoPRECISE
**Intervention Names:**
- Dietary Supplement: SelenoPRECISE
**Label:** SelenoPRECISE
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Placebo
**Intervention Names:**
- Dietary Supplement: Placebo
**Label:** Placebo
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- SelenoPRECISE
**Description:** Produced by Pharma Nord ApS, Vejle, Denmark
**Name:** SelenoPRECISE
**Type:** DIETARY_SUPPLEMENT
#### Intervention 2
**Arm Group Labels:**
- Placebo
**Description:** Produced by Pharma Nord ApS, Vejle, Denmark
**Name:** Placebo
**Type:** DIETARY_SUPPLEMENT
### Outcomes Module
#### Primary Outcomes
**Description:** Measured in composite score based on the ThyPRO questionnaire
**Measure:** Thyroid related quality of life
**Time Frame:** 12 months after initation of intervention
#### Secondary Outcomes
**Measure:** Thyroid peroxidase antibody concentration (TPO-Ab)
**Time Frame:** 12 months after initation of intervention
**Measure:** Levothyroxine (LT4) dosage
**Time Frame:** 12 months after initation of intervention
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Age ≥18 years.
2. Serum-TPO-Ab ≥ 100 IU/mL measured within the last 12 months.
3. Receiving LT4 treatment.
- Serum-TSH ≥ 4.0 mU/L measured prior to treatment initiation
4. Written informed consent.
Exclusion Criteria:
1. Previous diagnosis of toxic nodular goitre, Graves' hyperthyroidism, post-partum thyroiditis or thyroid associated orbitopathy (TAO).
2. Previous radioiodine therapy, anti-thyroid treatment or thyroid surgery.
3. Previous diagnosis of non-melanoma skin cancer.
4. Morbidity, rendering the participant unable to process patient reported outcomes or receive intervention during the trial.
5. Systemic immunomodulatory medication.
6. Other medication known to affect thyroid function.
7. Pregnancy, breastfeeding, or planned pregnancy within 18 months.
8. Allergy towards the components in the selenium or placebo pills.
9. Intake of selenium supplementation ≥ 55 μg/d.
10. Unable to read or understand Danish.
11. Lack of informed consent
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Copenhagen
**Country:** Denmark
**Facility:** Clinic of Medical Endocrinology, Copenhagen University Hospital, Rigshospitalet
**Location 2:**
**City:** Copenhagen
**Country:** Denmark
**Facility:** Department of Endocrinology and Gastroenterology, Bispebjerg Hospital
**Location 3:**
**City:** Esbjerg
**Country:** Denmark
**Facility:** Department of Internal Medicine, Hospital of South West Denmark
**Location 4:**
**City:** Odense
**Country:** Denmark
**Facility:** Department of Endorcrinology and Metabolism, Odense University Hospital
#### Overall Officials
**Official 1:**
**Affiliation:** Odense University Hospital
**Name:** Steen J Bonnema, MD, DMSc
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** Odense University Hospital
**Name:** Laszlo Hegedüs, MD, DMSc
**Role:** PRINCIPAL_INVESTIGATOR
**Official 3:**
**Affiliation:** Odense University Hospital
**Name:** Kristian H Winther, MD
**Role:** PRINCIPAL_INVESTIGATOR
**Official 4:**
**Affiliation:** Rigshospitalet, Denmark
**Name:** Torquil Watt, MD, PhD
**Role:** PRINCIPAL_INVESTIGATOR
**Official 5:**
**Affiliation:** Rigshospitalet, Denmark
**Name:** Per Cramon, MD
**Role:** PRINCIPAL_INVESTIGATOR
**Official 6:**
**Affiliation:** Rigshospitalet, Denmark
**Name:** Ulla Feldt-Rasmussen, MD, DMSc
**Role:** PRINCIPAL_INVESTIGATOR
**Official 7:**
**Affiliation:** Rigshospitalet, Denmark
**Name:** Åse K Rasmussen, MD, DMSc
**Role:** PRINCIPAL_INVESTIGATOR
**Official 8:**
**Affiliation:** Hospital of South West Jutland
**Name:** Jeppe Gram, MD, PhD
**Role:** PRINCIPAL_INVESTIGATOR
**Official 9:**
**Affiliation:** Bispebjerg Hospital, Denmark
**Name:** Nils J Knudsen, MD, DMSc
**Role:** PRINCIPAL_INVESTIGATOR
### References Module
#### References
**Citation:** Winther KH, Watt T, Bjorner JB, Cramon P, Feldt-Rasmussen U, Gluud C, Gram J, Groenvold M, Hegedus L, Knudsen N, Rasmussen AK, Bonnema SJ. The chronic autoimmune thyroiditis quality of life selenium trial (CATALYST): study protocol for a randomized controlled trial. Trials. 2014 Apr 9;15:115. doi: 10.1186/1745-6215-15-115.
**PMID:** 24716668
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000013959
- Term: Thyroid Diseases
- ID: D000004700
- Term: Endocrine System Diseases
- ID: D000001327
- Term: Autoimmune Diseases
- ID: D000007154
- Term: Immune System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M16725
- Name: Thyroiditis
- Relevance: HIGH
- As Found: Thyroiditis
- ID: M26156
- Name: Hashimoto Disease
- Relevance: HIGH
- As Found: Autoimmune Thyroiditis
- ID: M16726
- Name: Thyroiditis, Autoimmune
- Relevance: HIGH
- As Found: Autoimmune Thyroiditis
- ID: M16718
- Name: Thyroid Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7862
- Name: Endocrine System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M4629
- Name: Autoimmune Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T6034
- Name: Quality of Life
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
- ID: T3542
- Name: Lymphomatous Thyroiditis
- Relevance: HIGH
- As Found: Autoimmune Thyroiditis
### Condition Browse Module - Meshes
- ID: D000013966
- Term: Thyroiditis
- ID: D000013967
- Term: Thyroiditis, Autoimmune
- ID: D000050031
- Term: Hashimoto Disease
### Intervention Browse Module - Browse Branches
- Abbrev: Micro
- Name: Micronutrients
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M15455
- Name: Selenium
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT03473379
**Acronym:** PROFTC-I
**Brief Title:** Development and Validation of a Tool for Patient-reported Assessment of Cancer-related Financial Toxicity in Italy
**Official Title:** Development and Validation of a Tool for Patient-reported Assessment of Cancer-related Financial Toxicity - Italy
#### Organization Study ID Info
**ID:** PROFTC-I
#### Organization
**Class:** OTHER
**Full Name:** National Cancer Institute, Naples
### Status Module
#### Completion Date
**Date:** 2024-07-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-03-24
**Type:** ACTUAL
**Last Update Submit Date:** 2023-03-23
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-02-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2018-03-01
**Type:** ACTUAL
**Status Verified Date:** 2023-03
#### Study First Post Date
**Date:** 2018-03-22
**Type:** ACTUAL
**Study First Submit Date:** 2018-03-15
**Study First Submit QC Date:** 2018-03-15
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** National Cancer Institute, Naples
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The aim of this study is to develop and validate a patient-reported-outcome instrument (PROFTC-I: Patient Reported Outcome Financial Toxicity in Cancer - Italy) able to describe and measure financial problems of Italian patients receiving cancer treatment.
**Detailed Description:** The project will be conducted according to the methodology delineated by the International Society for Pharmacoeconomics and Outcome Research (ISPOR) Patient Reported Outcomes Content Validity Good Research Practices Task Force in the following phases: concept elicitation and coding, item generation and analysis, instrument refinement and internal validation, and external validation.
### Conditions Module
**Conditions:**
- Cancer
**Keywords:**
- economic difficulty, financial toxicity
### Design Module
#### Design Info
**Observational Model:** OTHER
**Time Perspective:** CROSS_SECTIONAL
#### Enrollment Info
**Count:** 440
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The aim of this phase is to elicit concepts from patients, caregivers, and oncology clinicians through focus groups of patients and caregivers, qualitative interviews and surveys. Approximately 55 patients or caregivers will participate in this phase.
**Label:** Phase 1: concept elicitation and coding
#### Arm Group 2
**Description:** The aim of this phase is produce a draft version of the questionnaire. Approximately 90 patients or caregivers will be recruited in this phase for item ranking and analysis through questionnaire evaluation and cognitive interviews.
**Label:** Phase 2: Item generation and analysis
#### Arm Group 3
**Description:** The aim of this phase is generate the final version of the instrument. Approximately 101 patients or caregivers will participate in this phase by completing the questionnaire
**Label:** Phase 3: Instrument refinement and internal validation
#### Arm Group 4
**Description:** In this phase the questionnaire will undergo further psychometric testing for validation and approximately 220 patients or caregivers will be asked to complete the PROFTC-I questionnaire along with quality of life instruments
**Label:** Phase 4: External validation
### Outcomes Module
#### Primary Outcomes
**Description:** During the development of the questionnaire, individual items (questions), response options, and type of scoring will be determined according to Phases 1-3. Subsequently a principal components analysis (explorative factor analysis) will be done with eigen value set at 1; internal reliability will be assessed by inter-item correlations and Cronbach's alpha ( minimum acceptable 0.70); intraclass correlation coefficient (minimum acceptable 0.80). Correlation of final instrument with the EORTC quality of life questionnaire (criterion validity) will be assessed with using Pearson correlation coefficient.
**Measure:** Validation of Patient reported outcome financial toxicity of cancer Italian(PROFTC-I) questionnaire
**Time Frame:** 48 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Adult patients (\>18 years)
* Histologically or cytologically confirmed diagnosis of any type of solid cancer or haematological malignancy
* Written Informed Consent provided
* Medical treatment (chemotherapy, target agents, immunotherapy, hormonal treatment, radiotherapy or combinations of such therapies) ongoing or terminated within the previous 3 months.
* Caregivers of patients who meet the above criteria
Exclusion Criteria:
* Patients with major cognitive dysfunction or psychiatric disorders
* Patients who have never received anticancer medical or radiation treatment
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Patients with any type of solid cancer or haematological malignancy who has undergone medical treatment, including chemotherapy, target agents, immunotherapy, hormonal treatment, radiotherapy and combinations of such therapies, or their caregivers, will be recruited in northern, central and southern Italian hospitals..
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Francesco Perrone
**Phone:** 0815903571
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Jane Bryce
**Phone:** 0815903571
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Napoli
**Country:** Italy
**Facility:** Azienda dei Colli
**Status:** RECRUITING
**Location 2:**
**City:** Napoli
**Country:** Italy
**Facility:** Istituto Nazionale Tumori, IRCCS Fondazione Pascale
**Status:** RECRUITING
**Location 3:**
**City:** Roma
**Country:** Italy
**Facility:** Istituto Nazionale Tumori Regina Elena - IRCCS - IFO
**Status:** RECRUITING
**Location 4:**
**City:** Roma
**Country:** Italy
**Facility:** Policlinico Universitario Campus Biomedico
**Status:** NOT_YET_RECRUITING
**Location 5:**
**City:** Torino
**Country:** Italy
**Facility:** AO Ordine Mauriziano
**Status:** RECRUITING
#### Overall Officials
**Official 1:**
**Affiliation:** Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale
**Name:** Francesco Perrone
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale
**Name:** Jane Bryce
**Role:** PRINCIPAL_INVESTIGATOR
**Official 3:**
**Affiliation:** Università degli Studi della Campania Luigi Vanvitelli
**Name:** Ciro Gallo
**Role:** PRINCIPAL_INVESTIGATOR
**Official 4:**
**Affiliation:** St. Mary University, Twickenham, London, GB
**Name:** Silvia Riva
**Role:** PRINCIPAL_INVESTIGATOR
**Official 5:**
**Affiliation:** Northwestern University, Feinberg School of Medicine, GIMEMA,EORTC Quality of Life Group - Rappresentante GIMEMA
**Name:** Fabio Efficace
**Role:** PRINCIPAL_INVESTIGATOR
**Official 6:**
**Affiliation:** AIMAC and European Cancer Patient Coalition
**Name:** Francesco De Lorenzo
**Role:** PRINCIPAL_INVESTIGATOR
**Official 7:**
**Affiliation:** Segretario Generale FAVO
**Name:** Elisabetta Iannelli
**Role:** PRINCIPAL_INVESTIGATOR
**Official 8:**
**Affiliation:** FAVO
**Name:** Laura Del Campo
**Role:** PRINCIPAL_INVESTIGATOR
**Official 9:**
**Affiliation:** AIMAC
**Name:** Francesca Traclò
**Role:** PRINCIPAL_INVESTIGATOR
**Official 10:**
**Affiliation:** AO Ordine Mauriziano
**Name:** Massimo Di Maio
**Role:** PRINCIPAL_INVESTIGATOR
**Official 11:**
**Affiliation:** Federation of Italian Cooperative Oncology Groups
**Name:** Luciano Frontini
**Role:** PRINCIPAL_INVESTIGATOR
**Official 12:**
**Affiliation:** Oncologia, Azienda dei Colli, Napoli - CIPOMO
**Name:** Vincenzo Montesarchio
**Role:** PRINCIPAL_INVESTIGATOR
**Official 13:**
**Affiliation:** Centro per gli Studi Economici e Internazionali - Economic Evaluation & Health Technology Assessment (CEIS EEHTA), Università di Roma "Tor Vergata"
**Name:** Lara Gitto
**Role:** PRINCIPAL_INVESTIGATOR
**Official 14:**
**Affiliation:** Dipartimento di Scienze del Farmaco, Università del Piemonte Orientale; Osservatorio Farmaci, Cergas, SDA Bocconi
**Name:** Claudio Jommi
**Role:** PRINCIPAL_INVESTIGATOR
**Official 15:**
**Affiliation:** Welfare e Salute CENSIS (Centro Studi Investimenti Sociali), Roma
**Name:** Concetta Maria Vaccaro
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
### References Module
#### References
**Citation:** Riva S, Arenare L, Di Maio M, Efficace F, Montesarchio V, Frontini L, Giannarelli D, Bryce J, Del Campo L, De Lorenzo F, Iannelli E, Traclo F, Gitto L, Jommi C, Vaccaro CM, Barberio D, Cinieri S, Porta C, Del Mastro L, Zagonel V, Cogoni AA, Bordonaro R, Gimigliano A, Piccirillo MC, Guizzaro L, Gallo C, Perrone F. Cross-sectional study to develop and describe psychometric characteristics of a patient-reported instrument (PROFFIT) for measuring financial toxicity of cancer within a public healthcare system. BMJ Open. 2021 Oct 20;11(10):e049128. doi: 10.1136/bmjopen-2021-049128.
**PMID:** 34670762
**Citation:** Riva S, Efficace F, Di Maio M, Bryce J, Del Campo L, De Lorenzo F, Frontini L, Giannarelli D, Gitto L, Iannelli E, Jommi C, Montesarchio V, Traclo F, Vaccaro CM, Arenare L, Canzanella G, Gimigliano A, Romano F, Savio A, Sparavigna L, Piccirillo MC, Guizzaro L, Gallo C, Perrone F. A qualitative analysis and development of a conceptual model assessing financial toxicity in cancer patients accessing the universal healthcare system. Support Care Cancer. 2021 Jun;29(6):3219-3233. doi: 10.1007/s00520-020-05840-z. Epub 2020 Oct 22.
**PMID:** 33094357
**Citation:** Riva S, Bryce J, De Lorenzo F, Del Campo L, Di Maio M, Efficace F, Frontini L, Giannarelli D, Gitto L, Iannelli E, Jommi C, Montesarchio V, Traclo F, Vaccaro CM, Gallo C, Perrone F. Development and validation of a patient-reported outcome tool to assess cancer-related financial toxicity in Italy: a protocol. BMJ Open. 2019 Sep 9;9(9):e031485. doi: 10.1136/bmjopen-2019-031485.
**PMID:** 31501130
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000013315
- Term: Stress, Psychological
- ID: D000001526
- Term: Behavioral Symptoms
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M2567
- Name: Financial Stress
- Relevance: HIGH
- As Found: Financial Toxicity
- ID: M16105
- Name: Stress, Psychological
- Relevance: LOW
- As Found: Unknown
- ID: M4818
- Name: Behavioral Symptoms
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000086522
- Term: Financial Stress
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT00384579
**Brief Title:** Pilot Study to Assess the Efficacy of Botulinum Toxin B on Pain and Disability in Subjects With Acute Low Back Pain
**Official Title:** Pilot Study to Assess the Efficacy of Botulinum Toxin B (Myobloc®) Treatment of Paravertebral Muscles on Pain and Disability in Subjects Suffering From Acute Low Back Pain
#### Organization Study ID Info
**ID:** DCI P05-71031
#### Organization
**Class:** FED
**Full Name:** Walter Reed Army Medical Center
### Status Module
#### Completion Date
**Date:** 2010-08
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2010-03-02
**Type:** ESTIMATED
**Last Update Submit Date:** 2010-03-01
**Overall Status:** TERMINATED
#### Primary Completion Date
**Date:** 2010-08
**Type:** ESTIMATED
#### Start Date
**Date:** 2008-02
**Status Verified Date:** 2010-02
#### Study First Post Date
**Date:** 2006-10-06
**Type:** ESTIMATED
**Study First Submit Date:** 2006-10-04
**Study First Submit QC Date:** 2006-10-05
**Why Stopped:** No eligible candidates in 2 years of recruiting
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** FED
**Name:** United States Department of Defense
#### Responsible Party
**Old Name Title:** CDR Jack W. Tsao, MD, DPhil
**Old Organization:** Walter Reed Army Medical Center
### Oversight Module
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** This study will test the hypothesis that Botulinum toxin B (Myobloc®) treatment reduces pain and disability in subjects suffering from acute low back pain due to an identifiable muscle strain or back trauma occurring 3 to 6 weeks prior to enrollment. The study will also delineate the duration of medication effect and control for any placebo or mechanical trigger-point injection effect by employing a prospective, double-blind, placebo-controlled design.
**Detailed Description:** This study will assess the efficacy of Botulinum Toxin B (Myobloc®) injected into the lumbar paravertebral muscles for reducing pain and disability in subjects suffering from acute low back pain (duration 3 to 6 weeks) arising from an identifiable muscle strain injury or back trauma. The treatment modality and techniques used are based upon three successful prior open-labeled pilot studies done by this research group investigating the effect of Botulinum Toxin A (BOTOX®) on relief of chronic low back pain. This study, however, will employ a prospective, double-blind, randomized, placebo controlled trial to control for any placebo or mechanical trigger-point injection effects. Subjects will also be assessed for 3 months to define the duration of efficacy of Myobloc®. Sixty subjects will be randomly assigned to one of two groups and will then receive either Myobloc® or placebo injection into the lumbar paravertebral muscles. The subjects will be assessed using validated scales for pain and disability prior to injection and weekly to monthly thereafter for three months. All subjects will continue to receive any medication or physiotherapy per standard of care but those treatments will be recorded and controlled for in the data analysis.
### Conditions Module
**Conditions:**
- Low Back Pain
**Keywords:**
- back
- pain
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** TRIPLE
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Type:** ACTUAL
**Phases:**
- PHASE4
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Botulinum Toxin B
**Intervention Names:**
- Drug: Botulinum toxin B
**Label:** 1
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Placebo
**Intervention Names:**
- Drug: Placebo
**Label:** 2
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- 1
**Description:** Botulinum Toxin B
**Name:** Botulinum toxin B
**Other Names:**
- Myobloc
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- 2
**Description:** Placebo
**Name:** Placebo
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Measure:** Significant improvement in lower back pain
**Time Frame:** 8 weeks
#### Secondary Outcomes
**Measure:** Significant reduction of long term disability
**Time Frame:** 12 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Male or female subjects, 18 to 60 years of age, active duty military, retired military or other DOD beneficiaries eligible for care at military treatment facilities.
* Written informed consent and written authorization for use or release of health and research study information.
* Clear history of an identifiable muscle strain or trauma preceding the onset of low back pain.
* No prior history of vertebral disk disease/condition, sciatica or radiculopathy.
* Normal neurological examination without evidence of radiculopathy.
* Evidence of trigger point tenderness or muscle spasm upon palpation or EMG findings of muscle spasm.
* History of low back pain lasting 3 to 6 weeks from the time of injury or strain.
* VAS score minimum of 5 cm at time of entry into study.
* Ability to follow study instructions and likely to complete all required visits.
* Negative urine pregnancy test prior to the administration of study medication (for females of childbearing potential) (if applicable).
Exclusion Criteria:
* Age less than 18 or greater than 60.
* Not active duty.
* Concomitant use of aminoglycoside antibiotics, curare-like agents, or other agents that might interfere with neuromuscular function.
* Any medical condition that may put the subject at increased risk with exposure to Myobloc®, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis/motor neuron disease, neuropathy, renal stones, or any other disorder that might interfere with neuromuscular function or produce a similar type of low back pain.
* Females who are pregnant, breast-feeding, or planning a pregnancy during the study, or who think that they may be pregnant at the start of the study, or females of childbearing potential who are unable or unwilling to use a reliable form of contraception during the study.
* Known allergy or sensitivity to any of the components in the study medication.
* Evidence of alcohol or substance abuse in 6 months prior to enrollment.
* Systemic medical conditions (such as thyroid disease, hypertension, bleeding disorders, diabetes, cancers, etc.) that are not currently medically managed or controlled.
* Concurrent participation in another investigational drug or device study or participation in the 30 days immediately prior to study enrollment.
* Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study.
* Significant Axis I or II diagnosis determined by a neurologist or psychiatrist in the 6 months prior to entry into the study.
* Duration of low back pain \< 3 weeks or \> 6 weeks.
* Thoracic or cervical spine pain in the absence of acute low back pain.
* Anesthetic or corticosteroid injection to the lumbosacral spine within 8 weeks of enrollment.
* Spine MRI (any region) positive for acute pathology or evidence of radiculopathy on neurological examination.
* History of back surgery within one year or incomplete resolution of back pain due to a previous injury or surgery.
* Subjects involved in litigation, seeking significant disability for low back pain, or with evident secondary gain as determined by the neurologist through chart review and subject interview.
* Any previous use of Myobloc®, Dysport®, or BOTOX®.
**Healthy Volunteers:** True
**Maximum Age:** 60 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Washington
**Country:** United States
**Facility:** Walter Reed Army Medical Center
**State:** District of Columbia
**Zip:** 20307
#### Overall Officials
**Official 1:**
**Affiliation:** Walter Reed Army Medical Center
**Name:** Jack W Tsao, MD
**Role:** PRINCIPAL_INVESTIGATOR
### References Module
#### References
**Citation:** Wipf JE, Deyo RA. Low back pain. Med Clin North Am. 1995 Mar;79(2):231-46. doi: 10.1016/s0025-7125(16)30065-7.
**PMID:** 7877388
**Citation:** Frymoyer JW. Predicting disability from low back pain. Clin Orthop Relat Res. 1992 Jun;(279):101-9.
**PMID:** 1534720
**Citation:** Lew MF, Brashear A, Factor S. The safety and efficacy of botulinum toxin type B in the treatment of patients with cervical dystonia: summary of three controlled clinical trials. Neurology. 2000;55(12 Suppl 5):S29-35.
**PMID:** 11188982
**Citation:** Rand MJ, Whaler BC. Impairment of sympathetic transmission by botulinum toxin. Nature. 1965 May 8;206(984):588-91. doi: 10.1038/206588a0. No abstract available.
**PMID:** 5319286
**Citation:** Aoki KR. Review of a proposed mechanism for the antinociceptive action of botulinum toxin type A. Neurotoxicology. 2005 Oct;26(5):785-93. doi: 10.1016/j.neuro.2005.01.017. Epub 2005 Jul 5.
**PMID:** 16002144
**Citation:** Foster L, Clapp L, Erickson M, Jabbari B. Botulinum toxin A and chronic low back pain: a randomized, double-blind study. Neurology. 2001 May 22;56(10):1290-3. doi: 10.1212/wnl.56.10.1290.
**PMID:** 11376175
**Citation:** Aoki KR. Pharmacology and immunology of botulinum toxin serotypes. J Neurol. 2001 Apr;248 Suppl 1:3-10. doi: 10.1007/pl00007816.
**PMID:** 11357237
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010146
- Term: Pain
- ID: D000009461
- Term: Neurologic Manifestations
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M4714
- Name: Back Pain
- Relevance: HIGH
- As Found: Back Pain
- ID: M19433
- Name: Low Back Pain
- Relevance: HIGH
- As Found: Low Back Pain
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001416
- Term: Back Pain
- ID: D000017116
- Term: Low Back Pain
### Intervention Browse Module - Ancestors
- ID: D000065087
- Term: Acetylcholine Release Inhibitors
- ID: D000049990
- Term: Membrane Transport Modulators
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000018678
- Term: Cholinergic Agents
- ID: D000018377
- Term: Neurotransmitter Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: AnDyAg
- Name: Anti-Dyskinesia Agents
- Abbrev: VaDiAg
- Name: Vasodilator Agents
### Intervention Browse Module - Browse Leaves
- ID: M5183
- Name: Botulinum Toxins
- Relevance: HIGH
- As Found: Face
- ID: M254666
- Name: rimabotulinumtoxinB
- Relevance: LOW
- As Found: Unknown
- ID: M3473
- Name: Acetylcholine
- Relevance: LOW
- As Found: Unknown
- ID: M20758
- Name: Cholinergic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M20504
- Name: Neurotransmitter Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000001905
- Term: Botulinum Toxins
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT05632679
**Brief Title:** Effect of a Personalized Sound Intervention During Autogenous Gingival Grafts in Adults
**Official Title:** Effects of a Personalized Sound Intervention on Anxiety, Pain, and Satisfaction During Autogenous Gingival Graft in Adults: A Randomized Controlled Trial
#### Organization Study ID Info
**ID:** 2021-1146
#### Organization
**Class:** OTHER
**Full Name:** Université de Montréal
### Status Module
#### Completion Date
**Date:** 2024-05-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-07-05
**Type:** ACTUAL
**Last Update Submit Date:** 2023-07-01
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-05-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2022-05-01
**Type:** ACTUAL
**Status Verified Date:** 2023-07
#### Study First Post Date
**Date:** 2022-11-30
**Type:** ACTUAL
**Study First Submit Date:** 2022-09-05
**Study First Submit QC Date:** 2022-11-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Université de Montréal
#### Responsible Party
**Investigator Affiliation:** Université de Montréal
**Investigator Full Name:** Robert Durand
**Investigator Title:** Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Anxiety feeds the avoidance of dental treatments, leading to the neglect of general oral health. This avoidance is often amplified by the fear of potential pain and dissatisfaction after a dental appointment. A music listening intervention could be beneficial to reduce anxiety, pain and dissatisfaction. This intervention has the advantage to be non-invasive, cheap, and easy to implement in clinical settings. The objective of this study is to explore the effects of a personalised musical intervention on anxiety, pain and dissatisfaction associated with an autogenous gingival graft in comparison to the use of an audiobook (control). In this regard, three groups of patients will receive the gingival graft along with the personalized music intervention (n=20), an audiobook (n=20) or standard care (n=20). Participants will be distributed randomly between conditions in a single blind design (surgeons will be unaware of the condition). However, since the third standard care control group was added as of 07-01-2023, all recruited participants will be enrolled in the standard care control group (non-randomized). Self-reported measures of anxiety, pain, and dissatisfaction will be taken at different times (baseline, preoperative, postoperative, and follow-up).
### Conditions Module
**Conditions:**
- Music Intervention
- Gingival Graft
- Anxiety
- Pain
- Dissatisfaction
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Single-blind randomized clinical trial
##### Masking Info
**Masking:** TRIPLE
**Who Masked:**
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 50
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Other: personalized music intervention
**Label:** personalized music intervention
**Type:** EXPERIMENTAL
#### Arm Group 2
**Intervention Names:**
- Other: selected audio book
**Label:** selected audio book
**Type:** ACTIVE_COMPARATOR
#### Arm Group 3
**Label:** standard care
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- personalized music intervention
**Description:** participants who are randomly selected to this group will choose three set of music they prefer among the available selection of instrumental music in the application
**Name:** personalized music intervention
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- selected audio book
**Description:** participants who are randomly selected to this group will choose one audio book they prefer among the available selection of audio books on the tablet
**Name:** selected audio book
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** anxiety, pain and satisfaction measured using VAS scales (0 - 10mm; 0= no anxiety, no pain, no satisfaction, and 10= maximum anxiety, worst pain imaginable, maximum satisfaction)
**Measure:** burden of care
**Time Frame:** immediately before surgery
**Description:** anxiety, pain and satisfaction measured using VAS scales (0 - 10mm; 0= no anxiety, no pain, no satisfaction, and 10= maximum anxiety, worst pain imaginable, maximum satisfaction)
**Measure:** burden of care
**Time Frame:** immediately after surgery
**Description:** anxiety, pain and satisfaction measured using VAS scales (0 - 10mm; 0= no anxiety, no pain, no satisfaction, and 10= maximum anxiety, worst pain imaginable, maximum satisfaction)
**Measure:** burden of care
**Time Frame:** 2 weeks postop
#### Secondary Outcomes
**Description:** age, sex, gender, level of education, yearly income
**Measure:** sociodemographic data
**Time Frame:** 1 week before surgery
**Description:** expected pain and complications, expected and felt efficiency of the sound condition (VAS scales) (0 - 10mm; 0= no pain, no complications, no efficiency, and 10= worst pain imaginable, maximum complication, maximum efficiency)
**Measure:** participants' expectations
**Time Frame:** immediately before surgery
**Description:** expected pain and complications, expected and felt efficiency of the sound condition (VAS scales) (0 - 10mm; 0= no pain, no complications, no efficiency, and 10= worst pain imaginable, maximum complication, maximum efficiency)
**Measure:** participants' expectations
**Time Frame:** immediately after surgery
**Description:** expected pain and complications, expected and felt efficiency of the sound condition (VAS scales) (0 - 10mm; 0= no pain, no complications, no efficiency, and 10= worst pain imaginable, maximum complication, maximum efficiency)
**Measure:** participants' expectations
**Time Frame:** 2 weeks postop
**Description:** A.1. To what extent are you anxious about the following things when you go to the dentist? Not at all A little Somewhat Moderately Very much
1. Painful or uncomfortable procedures
2. Feeling embarrassed or ashamed
3. Not being in control of what is happening
4. Feeling sick, queasy, or disgusted
5. Numbness caused by the anesthetic
6. Not knowing what the dentist is going to do
7. The cost of dental treatment
8. Needles or injections
9. Gagging or choking
10. Having an unsympathetic or unkind dentist
A.2 On the following scale, how would you rate your level of anxiety at the present time?
No anxiety
Maximum anxiety
A.3.1 On the following scale, what level of pain do you experience right now? Worst pain
No pain
imaginable
A.3.2 On the following scale, what level of pain do you expect to experience during surgery? Worst pain
No pain
imaginable
**Measure:** Index of dental anxiety and fear
**Time Frame:** 1 week before surgery
**Description:** A.1. To what extent are you anxious about the following things when you go to the dentist? Not at all A little Somewhat Moderately Very much
1. Painful or uncomfortable procedures
2. Feeling embarrassed or ashamed
3. Not being in control of what is happening
4. Feeling sick, queasy, or disgusted
5. Numbness caused by the anesthetic
6. Not knowing what the dentist is going to do
7. The cost of dental treatment
8. Needles or injections
9. Gagging or choking
10. Having an unsympathetic or unkind dentist
A.2 On the following VAS 10-mm scale, how would you rate your level of anxiety at the present time?
No anxiety
Maximum anxiety
A.3.1 On the following VAS 10-mm scale, what level of pain do you experience right now? Worst pain
No pain
imaginable
A.3.2 On the following VAS 10-mm scale, what level of pain do you expect to experience during surgery? Worst pain
No pain
imaginable
**Measure:** Index of dental anxiety and fear
**Time Frame:** immediately before surgery
**Description:** A.1. To what extent are you anxious about the following things when you go to the dentist? Not at all A little Somewhat Moderately Very much
1. Painful or uncomfortable procedures
2. Feeling embarrassed or ashamed
3. Not being in control of what is happening
4. Feeling sick, queasy, or disgusted
5. Numbness caused by the anesthetic
6. Not knowing what the dentist is going to do
7. The cost of dental treatment
8. Needles or injections
9. Gagging or choking
10. Having an unsympathetic or unkind dentist
A.2 On the following VAS 10-mm scale, how would you rate your level of anxiety at the present time?
No anxiety
Maximum anxiety
A.3.1 On the following VAS 10-mm scale, what level of pain do you experience right now? Worst pain
No pain
imaginable
A.3.2 On the following VAS 10-mm scale, what level of pain do you expect to experience during surgery? Worst pain
No pain
imaginable
**Measure:** Index of dental anxiety and fear
**Time Frame:** immediately after surgery
**Description:** A.1. To what extent are you anxious about the following things when you go to the dentist? Not at all A little Somewhat Moderately Very much
1. Painful or uncomfortable procedures
2. Feeling embarrassed or ashamed
3. Not being in control of what is happening
4. Feeling sick, queasy, or disgusted
5. Numbness caused by the anesthetic
6. Not knowing what the dentist is going to do
7. The cost of dental treatment
8. Needles or injections
9. Gagging or choking
10. Having an unsympathetic or unkind dentist
A.2 On the following VAS 10-mm scale, how would you rate your level of anxiety at the present time?
No anxiety
Maximum anxiety
A.3.1 On the following VAS 10-mm scale, what level of pain do you experience right now? Worst pain
No pain
imaginable
A.3.2 On the following VAS 10-mm scale, what level of pain do you expect to experience during surgery? Worst pain
No pain
imaginable
**Measure:** Index of dental anxiety and fear
**Time Frame:** 2 weeks postop
**Description:** Do not spend too much time on any one statement but give the answer which seems to describe your present feelings best.
Choice of selection: not at all (1), somewhat (2), moderately so (3), very much (4)
Right now:
1. I feel calm
2. I feel secure
3. I am tense
4. I feel strained
5. I feel at ease
6. I feel upset
7. I am presently worrying over possible misfortunes
8. I feel satisfied
9. I feel frightened
10. I feel comfortable
11. I feel self-confident
12. I feel nervous
13. I am jittery
14. I feel indecisive,
15. I am relaxed
16. I feel content,
17. I am worried,
18. I feel confused,
19. I feel steady
20. I feel pleasant
**Measure:** State-trait anxiety inventory (Spielberg DC et al, 1977)
**Time Frame:** 1 week before surgery
**Description:** Do not spend too much time on any one statement but give the answer which seems to describe your present feelings best.
Choice of selection: not at all (1), somewhat (2), moderately so (3), very much (4)
Right now:
1. I feel calm
2. I feel secure
3. I am tense
4. I feel strained
5. I feel at ease
6. I feel upset
7. I am presently worrying over possible misfortunes
8. I feel satisfied
9. I feel frightened
10. I feel comfortable
11. I feel self-confident
12. I feel nervous
13. I am jittery
14. I feel indecisive,
15. I am relaxed
16. I feel content,
17. I am worried,
18. I feel confused,
19. I feel steady
20. I feel pleasant
**Measure:** State-trait anxiety inventory (Spielberg DC et al, 1977)
**Time Frame:** immediately before surgery
**Description:** validated general anxiety questionnaire
**Measure:** State-trait anxiety inventory
**Time Frame:** immediately after surgery
**Description:** Do not spend too much time on any one statement but give the answer which seems to describe your present feelings best.
Choice of selection: not at all (1), somewhat (2), moderately so (3), very much (4)
Right now:
1. I feel calm
2. I feel secure
3. I am tense
4. I feel strained
5. I feel at ease
6. I feel upset
7. I am presently worrying over possible misfortunes
8. I feel satisfied
9. I feel frightened
10. I feel comfortable
11. I feel self-confident
12. I feel nervous
13. I am jittery
14. I feel indecisive,
15. I am relaxed
16. I feel content,
17. I am worried,
18. I feel confused,
19. I feel steady
20. I feel pleasant
**Measure:** State-trait anxiety inventory (Spielberg DC et al, 1977)
**Time Frame:** 2 weeks postop
**Description:** Q.1: Have you ever used strategies to manage your anxiety at the dentist? __Yes ___No 1. If yes, can you indicate them? ___Do breathing exercises ___Meditate ___Playing sports
* Talking, writing, or texting to a friend ___Reading ___Listening to music___Watching a movie
* Playing a game ___Other: ..........................................................................................................................
Q.2: Did you already have a gingival graft in the past? ___Yes ___No
1 If yes, in your opinion, how did the intervention go?
Really bad___ Really good ___
C2.1.1 Why did you choose this answer? .....................................................................................................................................................................................................................................................................................................................................................................................................................
**Measure:** Anxiety coping strategies
**Time Frame:** 1 week before surgery
**Description:** mean consumption per week, # taken today (coffee, tea, sodas, energy drinks, medications = analgesics, stimulants, nutrition supplements, other medications)
**Measure:** Cafeine and medications consumption
**Time Frame:** 1 week before surgery
**Description:** mean consumption per week, # taken today (coffee, tea, sodas, energy drinks, medications = analgesics, stimulants, nutrition supplements, other medications)
**Measure:** Cafeine and medications consumption
**Time Frame:** immediately before surgery
**Description:** mean consumption per week, # taken today (coffee, tea, sodas, energy drinks, medications = analgesics, stimulants, nutrition supplements, other medications)
**Measure:** Cafeine and medications consumption
**Time Frame:** 2 weeks postop
**Description:** valence, arousal, dominance using numerical and illustrated scales (A to I; A = happy/elated, excited/involved, being controlled/taken care of; I = unhappy/sad, calm/bored, being in control/on top of things)
**Measure:** Feelings at the present moment
**Time Frame:** immediately before surgery
**Description:** valence, arousal, dominance using numerical and illustrated scales (A to I; A = happy/elated, excited/involved, being controlled/taken care of; I = unhappy/sad, calm/bored, being in control/on top of things)
**Measure:** Feelings at the present moment
**Time Frame:** immediately after surgery
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Need a gingival graft that will not exceed 1.5 hour of surgery
* Understand spoken and written French or English
* Has the capacity to understand procedures and follow instructions
* Consent to follow instructions
* Consent to receive either the active or control sound condition
* Being 18 years or older
Exclusion Criteria:
* Do not need a gingival graft
* Need a gingival graft that will last more than 1.5 hour of surgery
* Mental health or neurological disorders
* Auditory disorder
* Allergy or intolerance to NSAIDS
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Robert Durand
**Phone:** 514-343-7464
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Montreal
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** René Voyer
- **Phone:** 514-343-7464
- **Role:** CONTACT
**Country:** Canada
**Facility:** Clinique dentaire Antoine Sabeh
**State:** Quebec
**Status:** RECRUITING
**Zip:** H2J 1K1
**Location 2:**
**City:** Montreal
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Robert Durand
- **Phone:** 514-343-7464
- **Role:** CONTACT
**Country:** Canada
**Facility:** Le Groupe des parodontistes
**State:** Quebec
**Status:** RECRUITING
**Zip:** H3H 1R6
**Location 3:**
**City:** Montreal
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Robert Durand, DMD, MS
- **Phone:** 514-343-7464
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Rene Voyer, BS, DMD, MS
- **Phone:** 514-343-5926
- **Role:** CONTACT
***Contact 3:***
- **Name:** Robert Durand, DMD, MS
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 4:***
- **Name:** Rene Voyer, BS, DMD, MS
- **Role:** SUB_INVESTIGATOR
***Contact 5:***
- **Name:** Ryma Kabir, DMD, MS
- **Role:** SUB_INVESTIGATOR
**Country:** Canada
**Facility:** Université de Montréal - Faculty of Dentistry - Dental clinics
**State:** Quebec
**Status:** RECRUITING
**Zip:** H3T 1J4
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001523
- Term: Mental Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M4324
- Name: Anxiety Disorders
- Relevance: HIGH
- As Found: Anxiety
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001008
- Term: Anxiety Disorders
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06125379
**Brief Title:** Brief Mindfulness-based Intervention for Indonesian Teacher in Rural Area
**Official Title:** Investigating the Effectiveness of Mindfulness-based Intervention on Teachers' Stress and Psychological Well-being in Rural Indonesia
#### Organization Study ID Info
**ID:** 012211183
#### Organization
**Class:** OTHER
**Full Name:** International Islamic University Malaysia
### Status Module
#### Completion Date
**Date:** 2024-06-25
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-11-28
**Type:** ACTUAL
**Last Update Submit Date:** 2023-11-22
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-04-25
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-10-15
**Type:** ACTUAL
**Status Verified Date:** 2023-11
#### Study First Post Date
**Date:** 2023-11-09
**Type:** ACTUAL
**Study First Submit Date:** 2023-09-26
**Study First Submit QC Date:** 2023-11-04
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Universitas Ahmad Dahlan
#### Lead Sponsor
**Class:** OTHER
**Name:** International Islamic University Malaysia
#### Responsible Party
**Investigator Affiliation:** International Islamic University Malaysia
**Investigator Full Name:** Jamilah Hanum Abdul Khaiyom, PhD
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** A randomized controlled trial to assess the effectiveness of the brief mindfulness on teachers' perceived stress and their psychological well-being.
**Detailed Description:** Teacher in early childhood education (ECE) in Indonesia is experiencing high intense stress due to work environment, class management, child behaviour problem, and lack administrative support. Stress has also shown negatively impact their psychological well-being, quality of teaching, and to children's' executive function. Research about stress and the effects on teacher well-being is especially lacking for rural schools. They represent a forgotten minority and thus, teacher from rural area need a prompt and direct support in terms of stress management strategies.
This study employs a randomized wait-list controlled trial design (RCT) with an assessment before and after treatment. 4-weeks brief mindfulness-based protocol will be given to 40 teachers as experimental group. 40 other teachers receive wait-list treatment will assign as control group. Measurement of perceived stress level will be using Indonesian version of Perceived Stress Scale (PSS), psychological wellbeing will be measure using Indonesian Well-being Scale (IWS), and mindfulness traits will be measure using Indonesian version of Five Factor Mindfulness Questionnaire (FFMQ). Data analysis using MANOVA and ANOVA to measure the differences between groups and within groups for all tests and constructs measured.
### Conditions Module
**Conditions:**
- Stress, Psychological
**Keywords:**
- mindfulness
- teacher
- Indonesia
- perceived stress
- well-being
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 80
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Group A is an experimental group that will receive mindfulness intervention for 4 consecutive weeks. Group A consists of 2-3 cohorts with 10-15 subjects per cohort.
**Intervention Names:**
- Behavioral: brief mindfulness
**Label:** MindCARE
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Group B is the wait-list control group which did not receive any intervention for 4 weeks.
**Label:** Wait-list control group
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- MindCARE
**Description:** The mindfulness intervention protocol in this study is an adaptation of the Mindfulness Based Stress Reduction (MBSR) protocol with the cultural adaptation suits Indonesia population with addition of Islamic elements (i.e., a series of spiritual approaches) to improve emotional regulation, make sense of their life, be grateful and feel closer to God.
**Name:** brief mindfulness
**Other Names:**
- MindCARE (Mindfulness for Compassion and Relieve Stress)
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** The Perceived Stress Scale (PSS-10) is a 10-item questionnaire widely used to assess stress levels in young people and adults aged 12 and above. It evaluates the degree to which an individual has perceived life as unpredictable, uncontrollable and overloading over the previous month. The PSS score is obtained by summing across all items. A total PSS-10 score from 0 to 40 is presented, with higher scores representing higher levels of stress.
**Measure:** Perceived Stress Scale (PSS
**Time Frame:** 4 weeks
#### Secondary Outcomes
**Description:** The IWS is a well-being self-report instrument developed for the Indonesian general population. The scale consisted of 20 favourable items asking the respondent's sense of well-being in five different domains; Basic Needs (BN), Social Relation (SN), Acceptance (SA), Gratitude (GR), and Spirituality (SP). Score is ranging from 20 (minimum) to 100 (maximum), with higher score indicate higer psychological well-being.
**Measure:** Indonesian Well-being Scale (IWS)
**Time Frame:** 4 weeks
**Description:** The FFMQ consists of 39 items asking the individual to rate the extent to which a statement pertaining to mindfulness is applicable, on a scale from 1(never or rarely true) to 5 (very often or always true). Obtained score ranging from 39 (minimum) to 195 (maximum). Nineteen of the 39 items are reverse scored. These 19 items were reverse-scored prior to analysis, such that higher scores indicate higher mindfulness. Seven of the items comprise the non-reactivity facet, and eight items comprise each of the observing, describing, acting with awareness, and non-judging facets. Total scores for each facet are computed by summing the items after reverse scoring.
**Measure:** Five Facet Mindfulness Scale (FFMQ)
**Time Frame:** 4 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* minimum two years of work experience as early childhood education teacher.
* minimum 25 years of age.
* scoring Moderate (total score 14-26) to High (total score 27-40) perceived stress on PSS-10
Exclusion Criteria:
* have received any formal / manualized mindfulness training prior.
* have ever been diagnosed with chronic stress or other related mental disorders such as anxiety, depression, PTSD.
* people with a history or tendency to commit suicide.
* people with addictive substance dependence who are recovering less than one year.
**Healthy Volunteers:** True
**Maximum Age:** 55 Years
**Minimum Age:** 25 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Ega As Maharani, Master
**Phone:** +6281802720004
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Yogyakarta
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Ega A Maharani, Master
- **Phone:** +6281802720004
- **Role:** CONTACT
**Country:** Indonesia
**Facility:** Ahmad Dahlan University
**Status:** RECRUITING
**Zip:** 55166
#### Overall Officials
**Official 1:**
**Affiliation:** International Islamic University
**Name:** Jamilah HA Khaiyom, Doctoral
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Document Section
### Large Document Module
#### Large Docs
- Date: 2023-09-10
- Filename: Prot_SAP_000.pdf
- Has ICF: False
- Has Protocol: True
- Has SAP: True
- Label: Study Protocol and Statistical Analysis Plan
- Size: 1190186
- Type Abbrev: Prot_SAP
- Upload Date: 2023-10-24T10:55
- Date: 2023-09-10
- Filename: ICF_001.pdf
- Has ICF: True
- Has Protocol: False
- Has SAP: False
- Label: Informed Consent Form
- Size: 212920
- Type Abbrev: ICF
- Upload Date: 2023-10-24T10:48
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001526
- Term: Behavioral Symptoms
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M16105
- Name: Stress, Psychological
- Relevance: HIGH
- As Found: Stress, Psychological
- ID: M4818
- Name: Behavioral Symptoms
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000013315
- Term: Stress, Psychological
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT00808379
**Brief Title:** Concurrent Chemo-Radiotherapy Versus Radiotherapy With Boost in Locally Advanced Unresectable Rectal Cancers
**Official Title:** Concurrent Chemo-Radiotherapy vs Radiotherapy With Boost in Locally Advanced Unresectable Rectal Cancers. A Randomized Phase II Study
#### Organization Study ID Info
**ID:** 260
#### Organization
**Class:** OTHER_GOV
**Full Name:** Tata Memorial Hospital
### Status Module
#### Completion Date
**Date:** 2009-07
**Type:** ESTIMATED
#### Expanded Access Info
**Last Known Status:** ACTIVE_NOT_RECRUITING
#### Last Update Post Date
**Date:** 2008-12-15
**Type:** ESTIMATED
**Last Update Submit Date:** 2008-12-12
**Overall Status:** UNKNOWN
#### Primary Completion Date
**Date:** 2009-02
**Type:** ESTIMATED
#### Start Date
**Date:** 2006-05
**Status Verified Date:** 2008-12
#### Study First Post Date
**Date:** 2008-12-15
**Type:** ESTIMATED
**Study First Submit Date:** 2008-12-12
**Study First Submit QC Date:** 2008-12-12
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER_GOV
**Name:** Tata Memorial Hospital
#### Responsible Party
**Old Name Title:** Dr Reena Engineer (Principal Investigator)
**Old Organization:** Tata Memorial Centre
### Oversight Module
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** At Tata Memorial Hospital 50% of the patients present in the locally advanced stage which is technically unresectable, or that is beyond the realm of a potentially curative surgical resection. The evaluation of treatment approaches for these tumors is hampered by the absence of any substantial randomized studies and the heterogeneous nature of the tumors at presentation.
The management of these tumors has changed over the years, there is emphasis on neoadjuvant chemoradiation therapy, trying to convert a tumor that is initially unresectable to one that is potentially curable by surgery. But only 70-80% of the patients are able to complete this treatment without any significant treatment breaks.
Dose escalated treatment with radiotherapy in locally advanced and unresectable rectal cancers have been tried in many small series with good results and lesser toxicity.
Comparison outcome between the two arms will indicate the relative efficacy and toxicity of neoadjuvant concurrent chemoradiation vs boosted radiotherapy alone in downstaging of advanced cancers.
**Detailed Description:** Aims/ Objectives
1. To compare the resectability rate when patients are treated when conventional chemoradiation to patients treated with radiation alone with an additional boost to the primary tumor in case of unresectable rectal cancers.
2. To study the treatment toxicity and local control rate.
Study methodology This is a phase II Randomised controlled study. Ninety cases of advanced rectal cancer (Stage II - Stage III) will be divided in two equal groups (Arm I \& II) Arm-1(standard arm) - Patients will receive standard external radiation therapy to pelvis + concurrent chemotherapy with Tab Capecitabine. This will be followed by surgery at 6-8 weeks if deemed resectable.
Arm-2 (research arm) Patients in this group will not receive any neo-adjuvant chemotherapy, instead they will receive radiotherapy alone additional dose of localized radiotherapy boost. This will be followed by surgery at 6-8 weeks if deemed resectable.
### Conditions Module
**Conditions:**
- Rectal Cancer
**Keywords:**
- Unresectable rectal cancers
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 90
**Type:** ACTUAL
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Radiation dose to pelvis will be delivered at 1.8 Gy per day, five days per week, to give a total of 25 fractions over a period of five weeks for a total of 45 Gy.
Boost Field - Will be given to all the patients in the radiotherapy alone followed by surgery arm.
The boost will be given with by 3dimensional conformal radiotherapy to a dose of 15-20 Gy. After 45Gy the boost will be planned on the original tumor volume.
**Intervention Names:**
- Radiation: Additional Radiation boost to the primary tumor volume
**Label:** Arm 2 (Radiation + boost )
**Type:** OTHER
#### Arm Group 2
**Description:** The Radiation dose will be delivered at 1.8 Gy per day, five days per week, to give a total of 25 fractions over a period of five weeks for a total of 45 Gy.
Chemotherapy will begin on the first day of radiotherapy and continue until the completion of radiotherapy. Capecitabine will be administered orally daily 2000 mg/m2 in two divided doses (approximately 12 hours apart) for 2 weeks followed by a 1-week rest period given as 3 week cycles.
**Intervention Names:**
- Drug: Chemoradiation
**Label:** Arm 1 (standard) Chemoradiation
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Arm 1 (standard) Chemoradiation
**Description:** Chemotherapy will begin on the first day of radiotherapy and continue until the completion of radiotherapy. Capecitabine will be administered orally daily 2000 mg/m2 in two divided doses (approximately 12 hours apart) for 2 weeks followed by a 1-week rest period given as 3 week cycles.
**Name:** Chemoradiation
**Other Names:**
- Capebine
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Arm 2 (Radiation + boost )
**Description:** 15-20Gy
**Name:** Additional Radiation boost to the primary tumor volume
**Other Names:**
- Radiation Boost
**Type:** RADIATION
### Outcomes Module
#### Primary Outcomes
**Measure:** Comparison of resectability rate of in the two groups at 6-8 weeks following radiotherapy.
**Time Frame:** 3 years
**Measure:** Side effects and other adverse effects in the two groups during radiotherapy and up to 2 years post radiotherapy.
**Time Frame:** 3 years
#### Secondary Outcomes
**Measure:** Comparison of pathological downstaging between the two groups who undergo surgery.
**Time Frame:** 3 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Patients with measurable disease, medically able to undergo pelvic surgery.
2. Patients with unresectable adenocarcinoma of the rectum located up to 12 cm from the anal verge without evidence of distant metastases.
3. Patients must be 18 years old or greater.
4. Patients with clinical stage T3 orT4 based on endorectal ultrasound or physical exam.
5. Patients with lab values within standard protocol parameters
6. Karnofsky performance status \> 60.
7. No history of other malignancies within 5 years, except non-melanoma skin cancer, in situ carcinoma of the cervix or ductal carcinoma of the breast. Previous invasive cancer permitted if disease-free at least 5 years
8. Patient must sign study-specific consent prior to randomization.
Exclusion Criteria:
1. Any evidence of distant metastasis
2. Synchronous primary colon carcinomas, except T1 lesions
3. Prior radiation therapy to the pelvis
4. Prior chemotherapy for malignancies
5. Pregnancy or lactation.
6. Serious, uncontrolled, concurrent infection(s).
7. Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months.
8. Evidence of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent, or interfering with compliance of oral drug intake.
9. Other serious uncontrolled medical conditions that the investigator feels might compromise study participation.
10. Major surgery within 4 weeks of the study treatment.
11. Lack of physical integrity of the upper gastrointestinal tract or mal-absorption syndrome.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Mumbai
**Country:** India
**Facility:** Tata Memorial Centre
**State:** Maharashtra
**Zip:** 400012
#### Overall Officials
**Official 1:**
**Affiliation:** Tata Memorial Hospital
**Name:** Reena Engineer, MD
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000015179
- Term: Colorectal Neoplasms
- ID: D000007414
- Term: Intestinal Neoplasms
- ID: D000005770
- Term: Gastrointestinal Neoplasms
- ID: D000004067
- Term: Digestive System Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000005767
- Term: Gastrointestinal Diseases
- ID: D000007410
- Term: Intestinal Diseases
- ID: D000012002
- Term: Rectal Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M14846
- Name: Rectal Neoplasms
- Relevance: HIGH
- As Found: Rectal Cancer
- ID: M17890
- Name: Colorectal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M10448
- Name: Intestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8886
- Name: Gastrointestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M7256
- Name: Digestive System Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10444
- Name: Intestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14844
- Name: Rectal Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000012004
- Term: Rectal Neoplasms
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M377
- Name: Capecitabine
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT02989779
**Acronym:** AHIMSA-1
**Brief Title:** Neurokinin (NK) 1 Antagonist for Pathological Aggression for Harmful, Impulsive, and Self-/Aggressive Behaviour
**Official Title:** NK1 Antagonists for Pathological Aggression: A Protocol for Harmful, Impulsive, and Self-/Aggressive Behavior (AHIMSA-1) Trial
#### Organization Study ID Info
**ID:** 2016-1986-GRA
#### Organization
**Class:** OTHER
**Full Name:** St. Joseph's Healthcare Hamilton
### Status Module
#### Completion Date
**Date:** 2020-06
**Type:** ESTIMATED
#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2019-04-22
**Type:** ACTUAL
**Last Update Submit Date:** 2019-04-18
**Overall Status:** UNKNOWN
#### Primary Completion Date
**Date:** 2020-03
**Type:** ESTIMATED
#### Start Date
**Date:** 2017-01
**Status Verified Date:** 2019-04
#### Study First Post Date
**Date:** 2016-12-12
**Type:** ESTIMATED
**Study First Submit Date:** 2016-11-23
**Study First Submit QC Date:** 2016-12-08
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** University Health Network, Toronto
#### Lead Sponsor
**Class:** OTHER
**Name:** St. Joseph's Healthcare Hamilton
#### Responsible Party
**Investigator Affiliation:** St. Joseph's Healthcare Hamilton
**Investigator Full Name:** Gary Chaimowitz
**Investigator Title:** Local Primary Investigator, Head of Forensics
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Neurokinin (NK) -1 antagonist will be administered to study patients in a double-blind placebo trial. Patients receive assessments including Anger Disorder Scale (ADS) and Modified Overt Aggression Scale (MOAS) and perform computerized study tasks during MRI before the trial begins. Patients receive either one week of the drug or one week of placebo and perform the same tasks and assessments. Then patients receive another week of the alternate pill, followed by another round of tasks during MRI and assessments.
### Conditions Module
**Conditions:**
- Aggression
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
##### Masking Info
**Masking:** QUADRUPLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 50
**Type:** ESTIMATED
**Phases:**
- PHASE1
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** NK1 Antagonist 7 days followed by placebo 7 days.
**Intervention Names:**
- Drug: NK1 Antagonist
- Drug: Placebo Oral Capsule
**Label:** Active/Placebo crossover
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Placebo for 7 days followed by NK1 Antagonist 7 days.
**Intervention Names:**
- Drug: NK1 Antagonist
- Drug: Placebo Oral Capsule
**Label:** Placebo/Active Crossover
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Active/Placebo crossover
- Placebo/Active Crossover
**Name:** NK1 Antagonist
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Active/Placebo crossover
- Placebo/Active Crossover
**Name:** Placebo Oral Capsule
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Measure:** Change in Modified Overt Aggression Scale
**Time Frame:** 1 week
#### Secondary Outcomes
**Description:** computer task
**Measure:** Change in Ball passing task
**Time Frame:** 1 week
**Description:** Computer task
**Measure:** Change in Point Subtraction Aggression Task (PSAT)
**Time Frame:** 1 week
**Measure:** Change in Anger Disorders Scale (ADS)
**Time Frame:** 1 week
**Measure:** Change in Buss-Perry Aggression Questionniare (BPAQ)
**Time Frame:** 1 week
**Measure:** Change in State-Trait Anger Expression Inventory
**Time Frame:** 1 week
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* are outpatients between 18 and 65 years old inclusive
* meet diagnostic criteria for either Intermittent Explosive Disorder or the adult-modified criteria for Disruptive Mood Dysregulation Disorder (Appendix A)
* have maintained a stable regimen of psychotropic medications (antidepressants, antipsychotics, anticonvulsants, and anxiolytics) for at least 4 weeks prior to study enrolment and throughout the duration of the treatment phase of the study
* If participating in psychotherapy, must have been in stable treatment for at least 3 months prior to entry into the study, with no anticipation of change in the frequency of therapeutic sessions, or the therapeutic focus over the duration of the study
* Have capacity with respect to medical decision-making and consent to participate
* pass the TMS Assessment Safety Survey (TASS) MRI safety questionnaire
Exclusion Criteria:
* have a diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or other primary psychotic disorder
* meet criteria for a current manic episode or hypomanic episode
* have a diagnosis of dementia or other neurodegenerative illness affecting the central nervous system
* have a history of substance dependence or abuse within the last 3 months
* are pregnant or currently nursing\*
* \*Patients will be tested before and after the study with a urine pregnancy test.
* are taking contraindicated or interacting medications from product monograph of aprepitant
* have an implanted intracranial device or pacemaker
* have a diagnosis of severe hepatic insufficiency
**Maximum Age:** 65 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Sheila Verhage-Brown, MD
**Phone:** 905-522-1155
**Phone Ext:** 36356
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Hamilton
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Sheila Verhage-Brown, MD
- **Phone:** 905-522-1155
- **Phone Ext:** 36356
- **Role:** CONTACT
**Country:** Canada
**Facility:** St. Joseph's Healthcare Hamilton
**State:** Ontario
**Status:** RECRUITING
**Zip:** L8N3K7
### IPD Sharing Statement Module
**Description:** De-identified information will be shared with University Health Network, Toronto Western Hospital (UHN-TWH) for analysis, as a collaboration site.
**IPD Sharing:** YES
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000096762
- Term: Aberrant Motor Behavior in Dementia
- ID: D000001526
- Term: Behavioral Symptoms
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
### Condition Browse Module - Browse Leaves
- ID: M10220
- Name: Impulsive Behavior
- Relevance: LOW
- As Found: Unknown
- ID: M3724
- Name: Aggression
- Relevance: HIGH
- As Found: Aggression
- ID: M6904
- Name: Dementia
- Relevance: LOW
- As Found: Unknown
- ID: M3259
- Name: Aberrant Motor Behavior in Dementia
- Relevance: LOW
- As Found: Unknown
- ID: M4818
- Name: Behavioral Symptoms
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000000374
- Term: Aggression
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M17988
- Name: Neurokinin A
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT05162079
**Acronym:** ES-REFLUJO
**Brief Title:** Protocol for the ESREFLUJO Study: Epidemiological Study of Heartburn and Gastroesophageal Reflux in Community Pharmacy
**Official Title:** Protocol for the ESREFLUJO Study: Epidemiological Study of Heartburn and Gastroesophageal Reflux in Community Pharmacy
#### Organization Study ID Info
**ID:** SEFAC1.20I.
#### Organization
**Class:** OTHER
**Full Name:** Universidad Miguel Hernandez de Elche
### Status Module
#### Completion Date
**Date:** 2022-09-01
**Type:** ESTIMATED
#### Expanded Access Info
**Last Known Status:** NOT_YET_RECRUITING
#### Last Update Post Date
**Date:** 2021-12-17
**Type:** ACTUAL
**Last Update Submit Date:** 2021-12-16
**Overall Status:** UNKNOWN
#### Primary Completion Date
**Date:** 2022-07-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2022-03-01
**Type:** ESTIMATED
**Status Verified Date:** 2021-12
#### Study First Post Date
**Date:** 2021-12-17
**Type:** ACTUAL
**Study First Submit Date:** 2021-11-16
**Study First Submit QC Date:** 2021-12-16
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Universidad Miguel Hernandez de Elche
#### Responsible Party
**Investigator Affiliation:** Universidad Miguel Hernandez de Elche
**Investigator Full Name:** Elsa López Pintor
**Investigator Title:** Lecturer
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Introduction: Symptoms as heartburn and/or reflux is frequent consultations in community pharmacies, the characterization of them is crucial to provide appropriate patient counseling. To facilitate the assistance work of the community pharmacist and its coordination between different levels of care, a group of experts in Community Pharmacy, Primary Care, and Gastroenterology has recently worked on an algorithm to manage these symptoms.
Objective: Analyse the epidemiological characteristics of patients who consult for symptoms of heartburn and/or reflux in Spanish community pharmacies, and evaluate the clinical and humanistic results of the protocolization of a Professional Pharmaceutical Service in said patients.
Methods and analysis: The study design consists of a cross-sectional descriptive part, in which the clinical and sociodemographic characteristics of the patients who come to the community pharmacy will be evaluated for consultation derived from heartburn and/or reflux symptoms and a before-after descriptive study in which will evaluate the clinical and humanistic results in patients who come to the pharmacy after receiving pharmaceutical care.
### Conditions Module
**Conditions:**
- Reflux
**Keywords:**
- HEARTBURN, DYSPEPSIA, REFLUX, PHARMACY
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 1200
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Outcomes Module
#### Primary Outcomes
**Description:** At the initial visit, sociodemographic variables will be collected through a Data Collection Notebook (CDR): sex, age, level of education, employment status, civil status.
**Measure:** Collection of sociodemographic data of participants
**Time Frame:** 8 minutes each questionnaire
**Description:** At the initial visit, clinical data will be collected through a Data Collection Notebook (CDR):
* Risk factors: Body mass index (BMI), smoking, food consumption
• Weight and height will be combined to report BMI in kg/m\^2.
* Symptoms throught the questionnaire: The Gastro-oesophageal Reflux Disease Impact Scale (GIS)
* Treatments or medications used
**Measure:** Collection of clinical data of participants
**Time Frame:** 8 minutes each questionnaire
**Description:** An independent external monitor will make a telephone call to each patient to collect the evolution of the patient´s symptoms through a questionnaire: The Gastro-oesophageal Reflux Disease Impact Scale (GIS). It is a scale of frequency, the lower scores mean better health in the patient less frequency of disturbances)
**Measure:** Detail the evolution of the patient's symptoms 14 days after intervention
**Time Frame:** 5 minutes
**Description:** An independent external monitor will make a telephone call to each patient to collect the evolution of the patient´s symptoms through a questionnaire: Degree of satisfaction with the pharmaceutical care received (The score is the level of agreement, high punctuation means more satisfaction) and If the patient gets medication: Treatment Satisfaction Questionnaire for Medication (TSMQ, v1.4). (The score is the level of satisfaction, high punctuation means more satisfaction)
**Measure:** Evaluate patient satisfaction
**Time Frame:** 5 minutes
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Population´s age ≥ 18 years
* Patients who consult for mild symptoms of heartburn and/or gastroesophageal reflux or request treatment for it.
Exclusion Criteria:
* Subjects who request treatment for symptoms of heartburn and/or gastroesophageal reflux for another person
* Women with high-risk pregnancies
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Spanish patients who visit the pharmacies asking for advice of acid-reflux symptoms or requesting non-prescription medication for it
### References Module
#### References
**Citation:** Lopez-Pintor E, Puig-Molto M, Lumbreras B. EsReflux Protocol: Epidemiological Study of Heartburn and Reflux-like Symptoms in Spanish Community Pharmacies. Int J Environ Res Public Health. 2022 Aug 9;19(16):9807. doi: 10.3390/ijerph19169807.
**PMID:** 36011453
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000015154
- Term: Esophageal Motility Disorders
- ID: D000003680
- Term: Deglutition Disorders
- ID: D000004935
- Term: Esophageal Diseases
- ID: D000005767
- Term: Gastrointestinal Diseases
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000012817
- Term: Signs and Symptoms, Digestive
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: BC09
- Name: Ear, Nose, and Throat Diseases
### Condition Browse Module - Browse Leaves
- ID: M7589
- Name: Dyspepsia
- Relevance: LOW
- As Found: Unknown
- ID: M8880
- Name: Gastroesophageal Reflux
- Relevance: HIGH
- As Found: Gastroesophageal Reflux
- ID: M9444
- Name: Heartburn
- Relevance: HIGH
- As Found: Heartburn
- ID: M17874
- Name: Esophageal Motility Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M17875
- Name: Esophageal Spasm, Diffuse
- Relevance: LOW
- As Found: Unknown
- ID: M6882
- Name: Deglutition Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M8085
- Name: Esophageal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15622
- Name: Signs and Symptoms, Digestive
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000005764
- Term: Gastroesophageal Reflux
- ID: D000006356
- Term: Heartburn
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT01168479
**Acronym:** FLAME
**Brief Title:** FLAME: Investigate the Benefit of a Focal Lesion Ablative Microboost in Prostate Cancer
**Official Title:** FLAME: Single Blind Randomized Phase III Trial to Investigate the Benefit of a Focal Lesion Ablative Microboost in Prostate Cancer
#### Organization Study ID Info
**ID:** UMCU-FLAME
#### Organization
**Class:** OTHER
**Full Name:** UMC Utrecht
### Status Module
#### Completion Date
**Date:** 2016-01
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2020-06-02
**Type:** ACTUAL
**Last Update Submit Date:** 2020-06-01
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2016-01
**Type:** ACTUAL
#### Start Date
**Date:** 2009-09
**Status Verified Date:** 2020-06
#### Study First Post Date
**Date:** 2010-07-23
**Type:** ESTIMATED
**Study First Submit Date:** 2010-07-21
**Study First Submit QC Date:** 2010-07-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** UMC Utrecht
#### Responsible Party
**Investigator Affiliation:** UMC Utrecht
**Investigator Full Name:** L.G.W. Kerkmeijer
**Investigator Title:** L.G.W. Kerkmeijer, MD, PhD
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Rationale: Dose escalation in external-beam irradiation has proven to benefit outcome in local prostate cancer. Randomized trials were performed up to doses of 78 Gy in 2 Gy fractions. Nevertheless, the five-year biochemical relapse rate still was approximately 35% in the high-dose arm. Therefore further dose escalation seems to be required. A feasibility study up to appr. 85 Gy on the entire prostate has already been performed and showed acceptable toxicity when combined with adequate position verification. Higher doses to the entire prostate are expected to increase severe toxicity. As local recurrences only occur at the site of the primary macroscopic tumour area the next step in increasing the dose should be an ablative boost to the macroscopic tumour alone, while electively irradiating the rest of the prostate to the current gold standard dose. Feasibility of this approach has been shown for an ablative dose of 95 Gy to the macroscopic tumour within the prostate.
**Detailed Description:** Objective:
* Primary study objective: To demonstrate the superiority of the ablative microboost dose schedule regarding 5-year biochemical no evidence of disease rate compared to the current standard of care.
* Secondary study objectives: Establish and compare the rates of treatment-related toxicity, quality of life and disease-free survival.
Study design: Single blind prospective randomized controlled phase III trial.
Study population: Patients with intermediate or high risk adenocarcinoma of the prostate. Intermediate or high risk is defined according to the Ash et al. 2000 criteria as:
* One (intermediate-risk) or more (high-risk) factors: T2, or Gleasonscore=7, or iPSA 10-20 ng/mL
* One or more (high-risk) factors: T3, or Gleasonscore \>7, or iPSA \>20 ng/mL
Intervention: The standard arm receives the current gold standard, namely 77Gy to the prostate in 35 fractions of 2.2 Gy, 5 times per week. In the experimental arm patients receive in addition to the current gold standard of 77 Gy to the prostate an integrated boost to the macroscopically visible tumour to reach a total dose of 95 Gy in 35 fractions of 2.7 Gy, 5 times per week.
Main study endpoint: To decrease the five-year biochemical relapse rate with at least 10%.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Patients will have to fill in a quality of life questionnaire before and after the radiotherapy treatments. The risk associated with the increased dose to the macroscopic tumour is an increase of toxicity and a reduction of quality of life.
### Conditions Module
**Conditions:**
- Prostate Cancer
- Radiotherapy
- MRI
**Keywords:**
- prostate cancer
- external beam radiotherapy
- dose escalation
- dose painting
- 95Gy in 35 fractions
- MRI
- FLAME
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 571
**Type:** ACTUAL
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The standard arm receives the current gold standard, namely 77Gy to the prostate in 35 fractions of 2.2 Gy, 5 times per week.
**Intervention Names:**
- Radiation: standard arm
**Label:** standard arm
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** In the experimental arm patients receive in addition to the current gold standard of 77 Gy to the prostate an integrated boost to the macroscopically visible tumour to reach a total dose of 95 Gy in 35 fractions of 2.7 Gy, 5 times per week.
**Intervention Names:**
- Radiation: FLAME boost
**Label:** FLAME boost
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- FLAME boost
**Description:** In the experimental arm patients receive in addition to the current gold standard of 77 Gy to the prostate an integrated boost to the macroscopically visible tumour to reach a total dose of 95 Gy in 35 fractions of 2.7 Gy, 5 times per week.
**Name:** FLAME boost
**Other Names:**
- FLAME
**Type:** RADIATION
#### Intervention 2
**Arm Group Labels:**
- standard arm
**Description:** The standard arm receives the current gold standard, namely 77Gy to the prostate in 35 fractions of 2.2 Gy, 5 times per week.
**Name:** standard arm
**Other Names:**
- normal dose
**Type:** RADIATION
### Outcomes Module
#### Primary Outcomes
**Description:** PSA relapse is defined by the Phoenix definition (2005) as nadir +2ng/ml.
**Measure:** To demonstrate the superiority of the ablative microboost dose schedule regarding 5-year biochemical no evidence of disease rate compared to the current standard of care.
**Time Frame:** Every six months for 10 years
#### Secondary Outcomes
**Description:** Toxicity is scored by Common Toxicity Criteria (CTC). Every grade\>2 is considered severe toxicity.
**Measure:** Establish and compare the rates of treatment-related toxicity.
**Time Frame:** Every six months until 10 years
**Description:** Quality of life is measured by: SF-36, EORTC-C30 and EORTC-PR25.
**Measure:** quality of life
**Time Frame:** every six months until 10 year
**Description:** Death with metastases is considered a death caused by the disease.
**Measure:** Disease specific survival
**Time Frame:** every 6 montths until 10 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Prostate cancer patients scheduled for external beam radiotherapy using IMRT and fiducial marker-based position verification
* Intermediate and high risk prostate cancer, defined by Ash et al. 2000, namely:
* One or more factors: T2, or Gleasonscore \>7, or iPSA \> 10 ng/mL
* WHO score 0-2
Exclusion Criteria:
* Low risk prostate cancer, defined by Ash et al. 2000
* World Heath Organisation (WHO) score \>2
* International Prostate Symptom Score (IPSS) \>20
* If for any patient related reason an MRI cannot be performed
* If anticoagulation cannot be stopped temporarily regarding the implant of fiducial markers
* Previous prostatectomy (except from Trans Urethral Prostatectomy (TURP))
* TURP within 3 months from start treatment
* Previous pelvic irradiation
**Minimum Age:** 18 Years
**Sex:** MALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Leuven
**Country:** Belgium
**Facility:** University Hospitals Leuven
**State:** Vlaans-Brabant
**Zip:** 3000
**Location 2:**
**City:** Nijmegen
**Country:** Netherlands
**Facility:** Radboud UMC
**State:** Gelderland
**Zip:** 6500HB
**Location 3:**
**City:** Amsterdam
**Country:** Netherlands
**Facility:** NKI-AvL
**State:** Noord-Holland
**Zip:** 1066CX
**Location 4:**
**City:** Utrecht
**Country:** Netherlands
**Facility:** University Medical Center Utrecht
**Zip:** 3584CX
#### Overall Officials
**Official 1:**
**Affiliation:** UMC Utrecht
**Name:** Linda Kerkmeijer, MD, PhD
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** NKI
**Name:** Uulke van der Heide, PhD
**Role:** STUDY_DIRECTOR
### References Module
#### References
**Citation:** Kowalchuk RO, Kim H, Harmsen WS, Jeans EB, Morris LK, Mullikin TC, Miller RC, Wong WW, Vargas CE, Trifiletti DM, Phillips RM, Choo CR, Davis BJ, Beriwal S, Tendulkar RD, Stish BJ, Breen WG, Waddle MR. Cost effectiveness of treatment strategies for high risk prostate cancer. Cancer. 2022 Nov 1;128(21):3815-3823. doi: 10.1002/cncr.34450. Epub 2022 Sep 7.
**PMID:** 36070558
**Citation:** Groen VH, Haustermans K, Pos FJ, Draulans C, Isebaert S, Monninkhof EM, Smeenk RJ, Kunze-Busch M, de Boer JCJ, van der Voort van Zijp J, Kerkmeijer LGW, van der Heide UA. Patterns of Failure Following External Beam Radiotherapy With or Without an Additional Focal Boost in the Randomized Controlled FLAME Trial for Localized Prostate Cancer. Eur Urol. 2022 Sep;82(3):252-257. doi: 10.1016/j.eururo.2021.12.012. Epub 2021 Dec 23.
**PMID:** 34953603
**Citation:** Kerkmeijer LGW, Groen VH, Pos FJ, Haustermans K, Monninkhof EM, Smeenk RJ, Kunze-Busch M, de Boer JCJ, van der Voort van Zijp J, van Vulpen M, Draulans C, van den Bergh L, Isebaert S, van der Heide UA. Focal Boost to the Intraprostatic Tumor in External Beam Radiotherapy for Patients With Localized Prostate Cancer: Results From the FLAME Randomized Phase III Trial. J Clin Oncol. 2021 Mar 1;39(7):787-796. doi: 10.1200/JCO.20.02873. Epub 2021 Jan 20.
**PMID:** 33471548
**Citation:** van Schie MA, Janssen TM, Eekhout D, Walraven I, Pos FJ, de Ruiter P, Kotte ANTJ, Monninkhof EM, Kerkmeijer LGW, Draulans C, de Roover R, Haustermans K, Kunze-Busch M, Smeenk RJ, van der Heide UA. Knowledge-Based Assessment of Focal Dose Escalation Treatment Plans in Prostate Cancer. Int J Radiat Oncol Biol Phys. 2020 Nov 15;108(4):1055-1062. doi: 10.1016/j.ijrobp.2020.06.072. Epub 2020 Jul 3.
**PMID:** 32629078
**Citation:** Monninkhof EM, van Loon JWL, van Vulpen M, Kerkmeijer LGW, Pos FJ, Haustermans K, van den Bergh L, Isebaert S, McColl GM, Smeenk RJ, Noteboom J, Walraven I, Peeters PHM, van der Heide UA. Standard whole prostate gland radiotherapy with and without lesion boost in prostate cancer: Toxicity in the FLAME randomized controlled trial. Radiother Oncol. 2018 Apr;127(1):74-80. doi: 10.1016/j.radonc.2017.12.022. Epub 2018 Jan 11.
**PMID:** 29336835
**Citation:** Lips IM, van der Heide UA, Haustermans K, van Lin EN, Pos F, Franken SP, Kotte AN, van Gils CH, van Vulpen M. Single blind randomized phase III trial to investigate the benefit of a focal lesion ablative microboost in prostate cancer (FLAME-trial): study protocol for a randomized controlled trial. Trials. 2011 Dec 5;12:255. doi: 10.1186/1745-6215-12-255.
**PMID:** 22141598
#### See Also Links
**Label:** Click here for more information about this study: FLAME 'Multicenter Randomized Phase III Trial to Investigate the Benefit of a Focal Lesion Ablative Microboost in patients treated with External Beam Radiotherapy for Localized Prostate Cancer'
**URL:** https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3286435/pdf/1745-6215-12-255.pdf
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000005834
- Term: Genital Neoplasms, Male
- ID: D000014565
- Term: Urogenital Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000005832
- Term: Genital Diseases, Male
- ID: D000091662
- Term: Genital Diseases
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000011469
- Term: Prostatic Diseases
- ID: D000052801
- Term: Male Urogenital Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M14335
- Name: Prostatic Neoplasms
- Relevance: HIGH
- As Found: Prostate Cancer
- ID: M8946
- Name: Genital Neoplasms, Male
- Relevance: LOW
- As Found: Unknown
- ID: M17315
- Name: Urogenital Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M2876
- Name: Genital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8944
- Name: Genital Diseases, Male
- Relevance: LOW
- As Found: Unknown
- ID: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14333
- Name: Prostatic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27095
- Name: Male Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000011471
- Term: Prostatic Neoplasms
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT04900779
**Brief Title:** Evaluation of Glycocalyx in Major Abdominal and Thoracic Surgery
**Official Title:** Prospective Observational Study to Evaluate Glycocalyx Alteration in Major Abdominal and Thoracic Surgery
#### Organization Study ID Info
**ID:** PR(AG)569/2020
#### Organization
**Class:** OTHER
**Full Name:** Hospital Universitari Vall d'Hebron Research Institute
### Status Module
#### Completion Date
**Date:** 2022-05-31
**Type:** ESTIMATED
#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2021-05-25
**Type:** ACTUAL
**Last Update Submit Date:** 2021-05-24
**Overall Status:** UNKNOWN
#### Primary Completion Date
**Date:** 2021-12-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2021-02-02
**Type:** ACTUAL
**Status Verified Date:** 2021-05
#### Study First Post Date
**Date:** 2021-05-25
**Type:** ACTUAL
**Study First Submit Date:** 2021-05-20
**Study First Submit QC Date:** 2021-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Hospital Universitari Vall d'Hebron Research Institute
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Background:
The glycocalyx is a fundamental component of the endothelial barrier and alterations at this level have been shown to exacerbate the inflammatory response in the microcirculation. Its degradation in the surgical patient, has been tested in interventions that involve regional or general ischemia, for example in cardiac surgery, major vascular surgery or transplantation. On interventions that do not involve ischemic events the literature is limited, such is the case of those patients undergoing major abdominal and thoracic surgery.
Objective:
Assess whether there is a glycocalyx degradation in major elective abdominal and thoracic surgery, measured as an increase in plasma syndecane-1 levels during the first 24 hours of postoperative care.
Methodology:
Prospective observational study in patients undergoing major elective thoracic and abdominal surgery at the University Hospital Vall d´Hebrón. Measurement of the syndecane-1 plasma levels are going to be done during the first 24 hours after the intervention. It is intended to evaluate whether its elevation is related to anesthetic perioperative factors, and if it has an impact con morbildity and mortality in the following 6 months after the procedure.
### Conditions Module
**Conditions:**
- Major Elective Abdominal and Thoracic Surgery
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 117
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Outcomes Module
#### Primary Outcomes
**Description:** Degradation of glucocalix measured by plasmatic syndecan -1 levels
**Measure:** plasmatic syndecan -1 levels
**Time Frame:** In the first 24 hours after the procedure
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients older than 18 years old
* Patients that are scheduled to major abdominal and thoracic elective surgery in Universtity Hospital Vall d´ Hebrón.
* Patients ASA I, II and III.
* Patients that after the intervention have their recovering in the Surgical ICU
Exclusion Criteria:
* Patients ASA IV and V.
* Patients that are hospitilized previous to the surgery.
* Patients that undergo emergent surgery.
* Patients with Chronic or Acute Renal Failure previous to the surgery.
* Patients with past medical history of autoinmune disseases.
* Patients with an active infection previous to the surgery.
* Patients in treatment with steroids previous to the surgery
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Patients older than 18 years old that undergo major abdominal and thoracic elective surgery in University Hospital Vall d´Hebron.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Lysha M Laurens
**Phone:** +34698209872
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Barcelona
**Contacts:**
***Contact 1:***
- **Name:** Lysha M Laurens
- **Phone:** +34698209872
- **Role:** CONTACT
**Country:** Spain
**Facility:** Hospital Universitari Vall d´Hebron
**Status:** RECRUITING
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000094665
- Term: Dissection, Blood Vessel
- ID: D000000783
- Term: Aneurysm
- ID: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000094683
- Term: Acute Aortic Syndrome
- ID: D000001018
- Term: Aortic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M4114
- Name: Aortic Dissection
- Relevance: HIGH
- As Found: Thoracic
- ID: M3081
- Name: Dissection, Blood Vessel
- Relevance: LOW
- As Found: Unknown
- ID: M4113
- Name: Aneurysm
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M3085
- Name: Acute Aortic Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M4334
- Name: Aortic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000000784
- Term: Aortic Dissection
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06343779
**Acronym:** RAPIDe-3
**Brief Title:** Study of Oral Deucrictibant Soft Capsule for On-Demand Treatment of Angioedema Attacks in Adolescents and Adults With Hereditary Angioedema
**Official Title:** A Phase 3, Randomized, Double-blind, Placebo-controlled, Cross-over Study of Oral Deucrictibant Soft Capsule for On-Demand Treatment of Attacks in Adolescents and Adults With Hereditary Angioedema
#### Organization Study ID Info
**ID:** PHA022121-C306
#### Organization
**Class:** INDUSTRY
**Full Name:** Pharvaris Netherlands B.V.
### Status Module
#### Completion Date
**Date:** 2026-03
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-02
**Type:** ACTUAL
**Last Update Submit Date:** 2024-04-30
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2026-03
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-02-26
**Type:** ACTUAL
**Status Verified Date:** 2024-04
#### Study First Post Date
**Date:** 2024-04-03
**Type:** ACTUAL
**Study First Submit Date:** 2024-03-18
**Study First Submit QC Date:** 2024-03-26
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Pharvaris Netherlands B.V.
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, 2-period, 2-treatment cross-over study to evaluate the efficacy and safety of orally administered deucrictibant compared to placebo for the on-demand treatment of HAE attacks, including non-severe laryngeal attacks, in participants ≥12 to ≤75 years of age with HAE type 1 or type 2 (HAE-1/2), a proportion of whom are using long-term prophylactic medication for HAE.
**Detailed Description:** The study consists of a Screening Phase during which eligibility is confirmed, a Treatment Phase in which participants will be randomized and receive double blinded study drug to treat 2 qualifying HAE attacks (i.e., 2 Treatment Periods within the Treatment Phase), and an End-of-Study Follow-up Phase after the second attack treated with study drug. In addition, for adolescent participants (age ≥12 to \<18 years), PK samples are collected after administration of deucrictibant at Day 1 in a non-attack state.
### Conditions Module
**Conditions:**
- Hereditary Angioedema
- Hereditary Angioedema Type I
- Hereditary Angioedema Type II
- Hereditary Angioedema Types I and II
- Hereditary Angioedema Attack
- Hereditary Angioedema With C1 Esterase Inhibitor Deficiency
- Hereditary Angioedema - Type 1
- Hereditary Angioedema - Type 2
- C1 Esterase Inhibitor [C1-INH] Deficiency
- C1 Esterase Inhibitor Deficiency
- C1 Esterase Inhibitor, Deficiency of
- C1 Inhibitor Deficiency
**Keywords:**
- HAE
- HAE Type I
- HAE Type II
- Oral Treatment
- Bradykinin B2 Receptor Antagonists
- PHVS416
- PHA121
- On-Demand
- Deucrictibant
- Pharvaris
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
##### Masking Info
**Masking:** QUADRUPLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 120
**Type:** ESTIMATED
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Deucrictibant administered for first HAE attack, placebo administered for second HAE attack.
**Intervention Names:**
- Drug: Deucrictibant, Placebo
**Label:** Arm 1
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Placebo administered for first HAE attack, deucrictibant administered for second HAE attack.
**Intervention Names:**
- Drug: Deucrictibant, Placebo
**Label:** Arm 2
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Arm 1
- Arm 2
**Description:** Deucrictibant Soft Capsules for Oral Use
**Name:** Deucrictibant, Placebo
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** The PGI-C (7-point scale) is used to evaluate the change in the HAE attack symptoms as compared to pre-treatment.
**Measure:** Time to onset of symptom relief, defined as Patient Global Impression of Change (PGI-C) rating of at least "a little better" for 2 consecutive timepoints within 12 hours post-treatment.
**Time Frame:** Pre-treatment to 12 hours post-treatment.
#### Secondary Outcomes
**Description:** The PGI-C (7-point scale) is used to evaluate the change in the HAE attack symptoms as compared to pre-treatment.
**Measure:** Proportion of study drug-treated attacks achieving PGI-C rating of at least "a little better" at 4 hours post-treatment.
**Time Frame:** Pre-treatment to 4 hours post-treatment.
**Description:** The PGI-C (7-point scale) is used to evaluate the change in the HAE attack symptoms as compared to pre-treatment.
**Measure:** Time to substantial symptom relief, defined as achieving PGI-C rating of at least "better" for 2 consecutive timepoints within 12 hours post-treatment.
**Time Frame:** Pre-treatment to 12 hours post-treatment.
**Description:** Defined as achieving ≥1 point reduction in PGI-S (5-point scale) from pre-treatment for 2 consecutive timepoints within 12 hours post-treatment.
**Measure:** Time to substantial symptom relief by Patient Global Impression of Severity (PGI-S).
**Time Frame:** Pre-treatment to 12 hours post-treatment.
**Description:** The PGI-S (5-point scale) is used to evaluate the severity of HAE attack symptoms.
**Measure:** Time to complete symptom resolution, defined as achieving PGI-S rating of "none" within 48 hours post-treatment.
**Time Frame:** Pre-treatment to 48 hours post-treatment.
**Description:** EoP time defined as the earliest post-treatment timepoint after which all subsequent PGI-C ratings are stable or improved.
**Measure:** Time to End of Progression (EoP) in attack symptoms within 12 hours.
**Time Frame:** Pre-treatment to 12 hours post-treatment.
**Description:** Rescue medication is defined as the participant's usual acute on-demand HAE treatment taken if symptoms persist or progress after study drug administration.
**Measure:** Proportion of study drug-treated attacks requiring rescue medication within 24 hours post-treatment.
**Time Frame:** Pre-treatment to 24 hours post-treatment.
**Description:** Defined as achieving PGI-S rating of "none" with one dose of study drug at 24 hours post-treatment.
**Measure:** Proportion of attacks achieving symptom resolution.
**Time Frame:** Pre-treatment to 24 hours post-treatment.
**Description:** Defined as a ≥50% reduction in AMRA composite score from pre-treatment for 2 consecutive timepoints within 12 hours post-treatment.
**Measure:** Time to substantial symptom relief by Angioedema Symptom Rating Scale (AMRA).
**Time Frame:** Pre-treatment to 12 hours post-treatment.
**Description:** Defined as all item scores in AMRA having a value ≤10 for 2 consecutive timepoints within 24 hours post-treatment.
**Measure:** Time to almost complete or complete symptom relief by AMRA.
**Time Frame:** Pre-treatment to 24 hours post-treatment.
**Description:** Defined as all item scores in AMRA having a value ≤10 at 24 hours post-treatment.
**Measure:** Proportion of study drug-treated attacks reaching almost complete or complete symptom relief by AMRA.
**Time Frame:** Pre-treatment to 24 hours post-treatment.
**Description:** Defined as the earliest post-treatment timepoint after which every individual AMRA item is stable or improved at all subsequent timepoints.
**Measure:** Time to EoP in attack symptoms within 12 hours.
**Time Frame:** Pre-treatment to 12 hours post-treatment.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Provision of written informed consent/assent.
2. Male or female, aged ≥12 to ≤75 years at the time of providing written informed consent/assent.
3. Diagnosis of HAE-1/2.
4. History of at least 2 HAE attacks in the last 3 months before screening.
5. Experience with using standard-of-care treatment to effectively manage on-demand treatment for HAE attacks.
6. Participants on long-term prophylactic therapy with plasma-derived C1-INH (danazol, anti-fibrinolytics, berotralstat, or lanadelumab) must be on a stable dose and regimen and intend to remain on the same dose for 6 months before screening and the duration of the study.
7. Capable of recording, without assistance, electronic HAE diary and ePRO data using an electronic device.
8. For adolescent participants aged ≥12 and \<18 years of age: body weight \>40 kg.
9. Female participants of childbearing potential must agree to the protocol specified pregnancy testing and contraception methods.
Exclusion Criteria:
1. Any female who is pregnant, plans to become pregnant, or is breastfeeding.
2. Any diagnosis of angioedema other than HAE-1/2.
3. Any clinically significant comorbidity or systemic dysfunction that would interfere with the participant's safety or ability to participate in the study.
4. Use of attenuated androgens for short-term prophylaxis within the last 30 days before the time of randomization.
5. Abnormal hepatic function.
6. Abnormal renal function (eGFR \<60 ml/min/1.73 m2).
7. History of alcohol or drug abuse within the previous year, or current evidence of substance dependence or abuse.
8. Has received prior on-demand HAE treatment with deucrictibant.
9. Currently participating in any other investigational drug study or receiving other investigational treatment within the last 30 days, or within 5 half-lives (whichever is longer) of the time of randomization.
10. Prior gene therapy for any indication at any time.
11. Use of concomitant medications that are strong inhibitors/inducers of CYP3A4 within the last 30 days, or within 5 half-lives (whichever is longer) of the time of randomization.
12. Known hypersensitivity to study drug or any of the excipients of study drug.
**Maximum Age:** 75 Years
**Minimum Age:** 12 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Pharvaris Clinical Team
**Phone:** +31 (71) 203-6410
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Birmingham
**Country:** United States
**Facility:** Study Site
**State:** Alabama
**Status:** RECRUITING
**Zip:** 35209
**Location 2:**
**City:** Paradise Valley
**Country:** United States
**Facility:** Study Site
**State:** Arizona
**Status:** RECRUITING
**Zip:** 85258
**Location 3:**
**City:** Little Rock
**Country:** United States
**Facility:** Study Site
**State:** Arkansas
**Status:** RECRUITING
**Zip:** 72205
**Location 4:**
**City:** Santa Monica
**Country:** United States
**Facility:** Study Site
**State:** California
**Status:** RECRUITING
**Zip:** 90404
**Location 5:**
**City:** Walnut Creek
**Country:** United States
**Facility:** Study Site
**State:** California
**Status:** RECRUITING
**Zip:** 94598
**Location 6:**
**City:** Colorado Springs
**Country:** United States
**Facility:** Study Site
**State:** Colorado
**Status:** RECRUITING
**Zip:** 80907-6231
**Location 7:**
**City:** Chevy Chase
**Country:** United States
**Facility:** Study Site
**State:** Maryland
**Status:** RECRUITING
**Zip:** 20815
**Location 8:**
**City:** Dallas
**Country:** United States
**Facility:** Study Site
**State:** Texas
**Status:** RECRUITING
**Zip:** 75231
**Location 9:**
**City:** San Juan
**Country:** Puerto Rico
**Facility:** Study Site
**Status:** RECRUITING
**Zip:** 00918
#### Overall Officials
**Official 1:**
**Affiliation:** Pharvaris Netherlands B.V.
**Name:** Study Director, Pharvaris
**Role:** STUDY_DIRECTOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000014581
- Term: Urticaria
- ID: D000017445
- Term: Skin Diseases, Vascular
- ID: D000012871
- Term: Skin Diseases
- ID: D000006969
- Term: Hypersensitivity, Immediate
- ID: D000006967
- Term: Hypersensitivity
- ID: D000007154
- Term: Immune System Diseases
- ID: D000081208
- Term: Hereditary Complement Deficiency Diseases
- ID: D000081207
- Term: Primary Immunodeficiency Diseases
- ID: D000030342
- Term: Genetic Diseases, Inborn
- ID: D000007153
- Term: Immunologic Deficiency Syndromes
### Condition Browse Module - Browse Branches
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC16
- Name: Diseases and Abnormalities at or Before Birth
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M4127
- Name: Angioedema
- Relevance: HIGH
- As Found: Angioedema
- ID: M27584
- Name: Angioedemas, Hereditary
- Relevance: HIGH
- As Found: C1 Esterase Inhibitor Deficiency
- ID: M28606
- Name: Hereditary Angioedema Types I and II
- Relevance: HIGH
- As Found: Hereditary Angioedema Type I
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17330
- Name: Urticaria
- Relevance: LOW
- As Found: Unknown
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M19714
- Name: Skin Diseases, Vascular
- Relevance: LOW
- As Found: Unknown
- ID: M10018
- Name: Hypersensitivity
- Relevance: LOW
- As Found: Unknown
- ID: M10020
- Name: Hypersensitivity, Immediate
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6879
- Name: Deficiency Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M2286
- Name: Hereditary Complement Deficiency Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10199
- Name: Immunologic Deficiency Syndromes
- Relevance: LOW
- As Found: Unknown
- ID: M2285
- Name: Primary Immunodeficiency Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M23686
- Name: Genetic Diseases, Inborn
- Relevance: LOW
- As Found: Unknown
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: T2734
- Name: Hereditary Angioedema
- Relevance: HIGH
- As Found: Hereditary Angioedema
- ID: T4202
- Name: Oculocerebral Syndrome With Hypopigmentation
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000000799
- Term: Angioedema
- ID: D000054179
- Term: Angioedemas, Hereditary
- ID: D000056829
- Term: Hereditary Angioedema Types I and II
### Intervention Browse Module - Browse Branches
- Abbrev: VaDiAg
- Name: Vasodilator Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M5197
- Name: Bradykinin
- Relevance: LOW
- As Found: Unknown
- ID: M10725
- Name: Kininogens
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT05048979
**Acronym:** MOVE-IT
**Brief Title:** Telehealth to Improve Functional Status and Quality of Life in Veterans With PAD
**Official Title:** Telehealth to Improve Functional Status and Quality of Life in Veterans With PAD (CDA 20-073)
#### Organization Study ID Info
**ID:** CDX 21-006
#### Organization
**Class:** FED
**Full Name:** VA Office of Research and Development
### Status Module
#### Completion Date
**Date:** 2026-04-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-10-10
**Type:** ACTUAL
**Last Update Submit Date:** 2023-10-04
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-04-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2021-12-01
**Type:** ACTUAL
**Status Verified Date:** 2023-10
#### Study First Post Date
**Date:** 2021-09-17
**Type:** ACTUAL
**Study First Submit Date:** 2021-09-01
**Study First Submit QC Date:** 2021-09-08
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** FED
**Name:** VA Office of Research and Development
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Is US Export:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The present study aims to increase Veteran access to supervised exercise therapy and expand its role in improving functional status, quality of life, and cardiovascular risk profile of Veterans with PAD.
**Detailed Description:** The investigators will use the VA Telehealth service to deploy a remotely accessible supervised exercise training program and evaluate whether a telehealth-based intervention can improve walking performance, quality of life, and ultimately cardiac risk in Veterans with PAD. The impetus for the current proposal stems from the following: 1) over 50% of VA-enrolled Veterans live in rural communities; 2) Veterans with PAD are older (mean age, 70 years), further increasing their risk for functional decline; and 3) there is a significant lack of access to facility-based supervised exercise training for Veterans with PAD. The objectives include the following:
1. To develop a telehealth-facilitated exercise intervention for Veterans with PAD that serves as a Veteran centric new model of care.
2. To integrate Veteran preferences into the development of a telehealth-facilitated supervised exercise program.
3. To assess the long-term patterns of functional impairment and quality of life among Veterans with PAD not undergoing supervised exercise training.
### Conditions Module
**Conditions:**
- Peripheral Artery Disease
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Enrollment in a 12-week, 3 day a week, aerobic training program in a self-selected location. The exercise training will be via telehealth. Arm 1 will receive aforementioned intervention. Arm 2 will received no intervention.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 154
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Prospective pre-post pilot study design. (N=54)
**Intervention Names:**
- Other: Exercise
**Label:** Exercise
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Prospective cohort study design. (N=100)
**Label:** No exercise
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Exercise
**Description:** Telehealth-facilitated supervised exercise program. Veterans with PAD will be enrolled in a 12-week, 3 day a week, aerobic training program in a self-selected location.
**Name:** Exercise
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Participants will be asked to walk in an unobstructed 100-ft hall for 6 continuous minutes with the goal of walking the greatest distance possible. Participants are allowed to stop and rest (standing or sitting), but the stopwatch will continue to run. The key outcome is distance walked. This outcome will be evaluated at the 3-month mark.
**Measure:** 6-minute walk test
**Time Frame:** At 3-months
**Description:** Will evaluate the following: 1) symptoms while walking (typical and atypical); 2) perceived difficulty walking defined distances (ranging from walking indoors to 1,500 feet or 5 blocks); 3) and perceived difficulty walking defined speeds; and 4) ability to climb stairs. Assessments are made on a graded scale from 0 to 4. A difficulty score a 0 represents very difficult and 4 represents no difficulty. The graded scores are multiplied by prespecified weights for each distance, speed, or number of flights of stairs. The products are then summed and divided by the maximum possible score ranging from 0 (inability to perform the task) to 100 (no difficulty performing the task). This outcome will be evaluated at the 3-month mark.
**Measure:** Walking impairment Questionnaire (WIQ)
**Time Frame:** At 3-months
**Description:** The Vascular Quality of Life Questionnaire (VascuQol) is a PAD specific and commonly used health related quality of life questionnaire with positive responsiveness correlated to both clinical improvement and deterioration on short and long term follow-up subsequent to treatment interventions. The VascuQol consists of items that span five domains (pain, symptoms, activities, emotional, and social). Each item is scored on a seven-point rating scale, where 1 represents the worst and 7 the best possible score. A sum score is calculated by dividing the sum all items by 25. This outcome will be evaluated at the 3-month mark.
**Measure:** Vascular quality of life questionnaire (VascuQol)
**Time Frame:** At 3-months
**Description:** The Flourish Measure is a composite evaluation of human well-being with excellent viability, and applicability in both community and workplace. The Flourish Measure consists of 12 questions that span 6 domains (happiness and life satisfaction, mental and physical health, meaning and purpose, character and virtue, close social relationships, financial and material stability). Each item is scored on an eleven-point rating scale of 0-10 with higher scores indicating favorable responses. Scores are calculated by summing the scores of all six domains. This outcome will be evaluated at the 3-month mark.
**Measure:** Flourish measure
**Time Frame:** At 3-months
**Description:** The walking time at which the subjects first experienced lower extremity pain. This outcome will be evaluated at the 3-month mark.
**Measure:** Claudication onset time
**Time Frame:** At 3-months
**Description:** Walking time at which ambulation cannot continue due to maximal lower extremity pain. This outcome will be evaluated at the 3-month mark.
**Measure:** Peak walking time
**Time Frame:** At 3-months
**Description:** Time it takes subject to walk 10 meters. Measured in seconds. This outcome will be evaluated at the 3-month mark.
**Measure:** 10 meter walk
**Time Frame:** At 3-months
**Description:** Subject balance evaluated by having them stand with feet side-by-side, semi-tandem, and then tandem. For each stance outcome is measures as yes or no. This outcome will be evaluated at the 3-month mark.
**Measure:** Balance test
**Time Frame:** At 3-months
**Description:** Measured in number of repetitions (8 pound weight for men and 5 pound weight for women). This outcome will be evaluated at the 3-month mark.
**Measure:** 30-sec arm curls
**Time Frame:** At 3-months
**Description:** Measured in number of repetitions. This outcome will be evaluated at the 3-month mark.
**Measure:** 30-sec-chair stands
**Time Frame:** At 3-months
**Description:** Time it takes to go from sitting to standing and walking 8 feet. Measured in seconds. This outcome will be evaluated at the 3-month mark.
**Measure:** 8 feet get up and go walk
**Time Frame:** At 3-months.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Diagnosis of PAD, defined as a history of an ankle-brachial index (ABI) of 0.90, prior revascularization of a lower limb for symptomatic disease more than 30 days prior to presentation, or ABI \>0.90 with evidence of PAD based on noninvasive vascular laboratory testing or angiography
* \[and presence of claudication, defined as fatigue, discomfort, cramping or pain of vascular origin in the muscles of the lower extremities that is consistently induced by exercise and consistently relieved by rest within 10 minutes.\]
* In addition, participants will require access to cellular signal at place of residence and/or exercise location
Exclusion Criteria:
* Justification for exclusion criteria centers on inability to safely participate in the remote intervention. Specific exclusion criteria includes the following:
* major lower extremity amputation
* critical limb ischemia
* inability to ambulate without a walker or wheelchair
* significant visual or hearing impairment
* individuals whose function is limited by severe conditions such as severe ischemic heart disease or \> Class II NYHA heart failure
* individuals capable of ambulating at a level comparable to the amount of exercise to be prescribed at baseline
* individuals currently enrolled in another exercise trial or cardiac rehab program
* individuals with uncontrolled psychiatric illness or dementia
* categorically vulnerable
* pregnant women, prisoners, children, or persons who lack decision-making capacity
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Jorge A Gutierrez, MD
**Phone:** (919) 286-0411
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Durham
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Laurel B Koss, MS OTR
- **Phone:** (919) 286-0411
- **Phone Ext:** 775648
- **Role:** CONTACT
***Contact 2:***
- **Name:** Jorge Antonio Gutierrez, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Durham VA Medical Center, Durham, NC
**State:** North Carolina
**Status:** RECRUITING
**Zip:** 27705-3875
#### Overall Officials
**Official 1:**
**Affiliation:** Durham VA Medical Center, Durham, NC
**Name:** Jorge Antonio Gutierrez, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000050197
- Term: Atherosclerosis
- ID: D000001161
- Term: Arteriosclerosis
- ID: D000001157
- Term: Arterial Occlusive Diseases
- ID: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000016491
- Term: Peripheral Vascular Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
### Condition Browse Module - Browse Leaves
- ID: M29213
- Name: Peripheral Arterial Disease
- Relevance: HIGH
- As Found: Peripheral Artery Disease
- ID: M18894
- Name: Peripheral Vascular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M26188
- Name: Atherosclerosis
- Relevance: LOW
- As Found: Unknown
- ID: M4469
- Name: Arteriosclerosis
- Relevance: LOW
- As Found: Unknown
- ID: M4465
- Name: Arterial Occlusive Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T6034
- Name: Quality of Life
- Relevance: HIGH
- As Found: Quality of Life
### Condition Browse Module - Meshes
- ID: D000058729
- Term: Peripheral Arterial Disease
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT00306579
**Brief Title:** Myocardial Damage In Patients With Cerebral Infarction
**Official Title:** Myocardial Damage In Patients With Cerebral Infarction. Prevalence and Characteristics as Measured by Troponins, Electrocardiographic Changes and Myocardial Perfusion Imaging.
#### Organization Study ID Info
**ID:** 054B26A43722225
#### Organization
**Class:** OTHER
**Full Name:** Danish Heart Foundation
### Status Module
#### Completion Date
**Date:** 2005-05
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-08-08
**Type:** ACTUAL
**Last Update Submit Date:** 2017-08-07
**Overall Status:** COMPLETED
#### Start Date
**Date:** 2003-08
**Status Verified Date:** 2017-08
#### Study First Post Date
**Date:** 2006-03-24
**Type:** ESTIMATED
**Study First Submit Date:** 2006-03-23
**Study First Submit QC Date:** 2006-03-23
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** Fonden for Lægevidenskabelig Forskning for Fyns Amt.
**Class:** INDUSTRY
**Name:** Novo Nordisk A/S
**Class:** OTHER
**Name:** AJ Andersen og Hustrus Fond
**Class:** UNKNOWN
**Name:** Overlægerådet Legatudvalg
**Class:** OTHER
**Name:** Raimond and Dagmar Ringgård-Bohn's Foundation
**Class:** UNKNOWN
**Name:** Bankdirektør Hans Stener og hustru Agnes Steners legat
**Class:** OTHER
**Name:** Odense University Hospital
#### Lead Sponsor
**Class:** OTHER
**Name:** Danish Heart Foundation
### Description Module
**Brief Summary:** Introduction
For several years "ischemic" electrocardiographic (ECG) changes in the acute phase of ischemic stroke have been reported. Whether these ECG changes reflect true myocardial ischemia remains controversial. So far no study has assessed different markers of myocardial ischemia or necrosis in consecutive patients admitted to hospital with an acute ischemic stroke.
Purpose
The main purpose of this study is to determine the potential burden of reversible and irreversible myocardial ischemia in patients with an acute ischemic stroke.
Patients and methods
Serial blood samples for measuring troponin T, CK-MB and NT-proBNP are collected in 250 patients with evidence of an acute ischemic stroke admitted to the Department of Neurology at Odense University Hospital. In addition resting 12-lead ECG recordings will be obtained on a daily basis, and a 24-hour ST-segment ambulatory monitoring will be performed once within the first week of hospitalisation. Finally, myocardial perfusion patterns during rest will be evaluated by means of a myocardial perfusion scintigraphy in patients with an elevated troponin T level.
Six months later control measurements of troponin T, CK-MB and NT-proBNP and a 12-lead ECG will be obtained.
Expectations
The study will contribute with original observations in patients with acute ischemic stroke considering the following issues:
1. The prevalence and characteristics of ECG changes suggestive of myocardial ischemia.
2. The prevalence of transient ST-segment changes on ambulatory monitoring.
3. The prevalence and degree of myocardial necrosis as judged from biochemical markers.
4. The prevalence of reversible and irreversible perfusion defects on myocardial scintigraphy.
5. The prevalence, size and patterns of NT-proBNP.
6. Whether there is a change in ECG and biochemical markers over a 6-month follow-up period.
The results may have clinical implications regarding early and late treatment as well as clinical follow-up of patients recovering from an episode of acute ischemic stroke.
### Conditions Module
**Conditions:**
- Ischemic Stroke
**Keywords:**
- Ischemic Stroke
- Myocardial ischemia
- Myocardial necrosis
### Design Module
#### Design Info
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 250
**Study Type:** OBSERVATIONAL
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Acute ischemic stroke.
2. Age ≥ 18 years old.
3. Written, informed consent.
Exclusion Criteria:
1. Onset of stroke symptoms 8 to 21 days before admission.
2. Transient ischemic attack.
3. Intracerebral or subarachnoid haemorrhage.
4. Previous myocardial infarction.
5. Any pathological Q waves on the baseline ECG.
6. Current atrial fibrillation.
7. Unstable angina pectoris ≤ 3 weeks before admission.
8. Systolic blood pressure ≤ 90 mmHg and symptoms.
9. Resuscitation after cardiac arrest.
10. Unwillingness to participate.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Overall Officials
**Official 1:**
**Affiliation:** Department of Cardiology, Odense University Hospital
**Name:** Jesper K. Jensen, MD
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** Department of Cardiology, Odense University Hospital
**Name:** Hans Mickley, DMSci
**Role:** STUDY_DIRECTOR
**Official 3:**
**Affiliation:** Department of Neurology, Odense University Hospital
**Name:** Søren Bak, MD, PhD
**Role:** STUDY_CHAIR
**Official 4:**
**Affiliation:** Department of Nuclear Medicine, Odense University Hospital
**Name:** Poul Flemming H. Carlsen, DMSci
**Role:** STUDY_CHAIR
**Official 5:**
**Affiliation:** Department of Clinical Chemistry, Aalborg Hospital
**Name:** Søren R. Kristensen, DMSci
**Role:** STUDY_CHAIR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000020521
- Term: Stroke
- ID: D000002561
- Term: Cerebrovascular Disorders
- ID: D000001927
- Term: Brain Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000007511
- Term: Ischemia
- ID: D000010335
- Term: Pathologic Processes
- ID: D000009336
- Term: Necrosis
- ID: D000020520
- Term: Brain Infarction
- ID: D000002545
- Term: Brain Ischemia
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC14
- Name: Heart and Blood Diseases
### Condition Browse Module - Browse Leaves
- ID: M10543
- Name: Ischemia
- Relevance: LOW
- As Found: Unknown
- ID: M22306
- Name: Stroke
- Relevance: LOW
- As Found: Unknown
- ID: M2400
- Name: Ischemic Stroke
- Relevance: HIGH
- As Found: Ischemic Stroke
- ID: M5793
- Name: Cerebral Infarction
- Relevance: HIGH
- As Found: Cerebral Infarction
- ID: M12155
- Name: Myocardial Infarction
- Relevance: LOW
- As Found: Unknown
- ID: M10282
- Name: Infarction
- Relevance: HIGH
- As Found: Infarction
- ID: M6546
- Name: Coronary Artery Disease
- Relevance: LOW
- As Found: Unknown
- ID: M19506
- Name: Myocardial Ischemia
- Relevance: LOW
- As Found: Unknown
- ID: M12284
- Name: Necrosis
- Relevance: LOW
- As Found: Unknown
- ID: M5810
- Name: Cerebrovascular Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M5204
- Name: Brain Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M22305
- Name: Brain Infarction
- Relevance: LOW
- As Found: Unknown
- ID: M5794
- Name: Brain Ischemia
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000083242
- Term: Ischemic Stroke
- ID: D000002544
- Term: Cerebral Infarction
- ID: D000007238
- Term: Infarction
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT02897479
**Brief Title:** A Phase II Study of HMPL-504 in Lung Sarcomatoid Carcinoma and Other Non-small Cell Lung Cancer
**Official Title:** A Phase II, Open-label Study to Evaluate the Efficacy and Safety of HMPL-504 in Locally Advanced/Metastatic MET-Mutation-Positive Pulmonary Sarcomatoid Carcinomas and Other Non-small Cell Lung Cancer
#### Organization Study ID Info
**ID:** 2016-504-00CH1
#### Organization
**Class:** INDUSTRY
**Full Name:** Hutchmed
### Status Module
#### Completion Date
**Date:** 2021-12-30
**Type:** ESTIMATED
#### Expanded Access Info
**Last Known Status:** ACTIVE_NOT_RECRUITING
#### Last Update Post Date
**Date:** 2021-11-30
**Type:** ACTUAL
**Last Update Submit Date:** 2021-11-29
**Overall Status:** UNKNOWN
#### Primary Completion Date
**Date:** 2021-12-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2016-12
**Type:** ACTUAL
**Status Verified Date:** 2021-08
#### Study First Post Date
**Date:** 2016-09-13
**Type:** ESTIMATED
**Study First Submit Date:** 2016-08-29
**Study First Submit QC Date:** 2016-09-07
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Hutchison Medipharma Limited
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This is a Phase II, open-label, multicenter study of Savolitinib administered orally once per day(QD) to locally advanced/metastatic PSC patients and other NSCLC patients with MET Exon 14 mutation. The targeted population is the patients with MET Exon 14 mutation who have failed prior systemic therapy (ies), or are unwilling or can not tolerate to receive chemotherapy. Pathological diagnosis will be confirmed retrospectively by the central pathological laboratory.
**Detailed Description:** Savolitinib will be administrated 600mg or 400mg once per day (QD). The treatment will be discontinued for the patients who experience disease progression, death or experience unacceptable toxicity, whichever occurs first. A cycle of study treatment will be defined as 21 days of continuous dosing.
### Conditions Module
**Conditions:**
- Lung Sarcomatoid Carcinoma
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 76
**Type:** ACTUAL
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Pulmonary Sarcomatoid Carcinomas
**Intervention Names:**
- Drug: Savolitinib
**Label:** Savolitinib
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Savolitinib
**Description:** Enrolled patients will be treated with Savolitinib 600mg or 400mg once per day(QD), till disease progression, death or unacceptable toxicity, whichever comes first. A cycle of study treatment will be defined as 21 days of continuous dosing.
**Name:** Savolitinib
**Other Names:**
- hmpl-504
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** ORR is defined as the proportion of patients with complete response or partial response. The confirmation of response for patients who has PR or CR at first time should be performed by at least 4 weeks and in this study, it could be performed by the scheduled tumor assessment 6 weeks later
**Measure:** To assess objective response rate (ORR)
**Time Frame:** 1year
#### Secondary Outcomes
**Description:** PFS is defined as the Progression free surviva of patients with complete response or partial response or stable disease. In the case of SD, measurements must have met the SD criteria at least once after study entry at a minimum interval of 6 weeks.
**Measure:** Progression free survival(PFS)
**Time Frame:** 1year
**Description:** The safety will be assessed using the following safety outcome measures: incidence of adverse events, physical examinations,vital signs and laboratory tests (including hematology, clinical chemistry, urine tests and other indicators)12-ECG parameters and echocardiogram.
**Measure:** Safety Assessment Parameter
**Time Frame:** 1year
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* 1.Fully understood the study and voluntarily signed Informed Consent Form
* 2.Age \> 18 years
* 3.Histologically or cytologically documented locally advanced or Metastatic pulmonary sarcomatoid carcinoma (PSC) patients and other Non-small cell lung cancer（NSCLC） with MET Exon 14 mutation who have failed piror systemic therapy(ies), or are unwilling or unable to receive chemotherapy
* 4.Patient should have measurable disease per RECIST1.1
* 5.ECOG performance status of 0, or 1
* 6.Expected survival \> 12 weeks
Exclusion Criteria:
* 1.Co-existing malignancy or malignancies diagnosed within the last 3 years other than lung cancer with the exception of adequately treated skin basal cell carcinoma or cervical cancer in situ.
* 2.Any anti-cancer therapy, including chemotherapy, hormonal therapy, biologic therapy or radiotherapy within 3weeks prior to initiation of study treatment, or received TKI (for ex. EGFR-TKI) treatment within 2 week prior to initiation of study treatment
* 3.Palliative radiation to bone metastases within 2 weeks prior to the initiation of study treatment
* 4.Herbal therapy within 1 week prior to the initiation of study treatment
* 5. has EGFR, ALK or ROS 1 positive mutation
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Beijing
**Country:** China
**Facility:** Beijing Cancer Hopspital
**State:** Beijing
**Location 2:**
**City:** Shanghai
**Country:** China
**Facility:** Shanghai Chest Hospital
**State:** Shanghai
**Zip:** 210000
#### Overall Officials
**Official 1:**
**Affiliation:** Shanghai Chest Hospital
**Name:** Shun LU, doctor
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Yu Y, Ren Y, Fang J, Cao L, Liang Z, Guo Q, Han S, Ji Z, Wang Y, Sun Y, Chen Y, Li X, Xu H, Zhou J, Jiang L, Cheng Y, Han Z, Shi J, Chen G, Ma R, Fan Y, Sun S, Jiao L, Jia X, Wang L, Lu P, Xu Q, Luo X, Su W, Lu S. Circulating tumour DNA biomarkers in savolitinib-treated patients with non-small cell lung cancer harbouring MET exon 14 skipping alterations: a post hoc analysis of a pivotal phase 2 study. Ther Adv Med Oncol. 2022 Oct 31;14:17588359221133546. doi: 10.1177/17588359221133546. eCollection 2022.
**PMID:** 36339926
**Citation:** Paik PK, Pfeiffer BM, Vioix H, Garcia A, Postma MJ. Matching-Adjusted Indirect Comparison (MAIC) of Tepotinib with Other MET Inhibitors for the Treatment of Advanced NSCLC with MET Exon 14 Skipping Mutations. Adv Ther. 2022 Jul;39(7):3159-3179. doi: 10.1007/s12325-022-02163-9. Epub 2022 May 11.
**PMID:** 35543963
**Citation:** Lu S, Fang J, Li X, Cao L, Zhou J, Guo Q, Liang Z, Cheng Y, Jiang L, Yang N, Han Z, Shi J, Chen Y, Xu H, Zhang H, Chen G, Ma R, Sun S, Fan Y, Li J, Luo X, Wang L, Ren Y, Su W. Once-daily savolitinib in Chinese patients with pulmonary sarcomatoid carcinomas and other non-small-cell lung cancers harbouring MET exon 14 skipping alterations: a multicentre, single-arm, open-label, phase 2 study. Lancet Respir Med. 2021 Oct;9(10):1154-1164. doi: 10.1016/S2213-2600(21)00084-9. Epub 2021 Jun 21.
**PMID:** 34166627
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009375
- Term: Neoplasms, Glandular and Epithelial
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000009369
- Term: Neoplasms
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: All
- Name: All Conditions
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
### Condition Browse Module - Browse Leaves
- ID: M5534
- Name: Carcinoma
- Relevance: HIGH
- As Found: Carcinoma
- ID: M11172
- Name: Lung Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M5546
- Name: Carcinoma, Non-Small-Cell Lung
- Relevance: LOW
- As Found: Unknown
- ID: M12320
- Name: Neoplasms, Glandular and Epithelial
- Relevance: LOW
- As Found: Unknown
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000002277
- Term: Carcinoma
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT03148379
**Brief Title:** Single-use Efficiency Instruments With Patient Specific Technique (MyKnee®) Versus Traditional Metal Instruments With Conventional Surgical Technique
**Official Title:** A Multi-center, Prospective, Randomized Study Comparing Surgical and Economic Parameters of Total Knee Replacement Performed With Single-use Efficiency Instruments With Patient Specific Technique (MyKnee®) Versus Traditional Metal Instruments With Conventional Surgical Technique.
#### Organization Study ID Info
**ID:** 20161119
#### Organization
**Class:** INDUSTRY
**Full Name:** Medacta USA
### Status Module
#### Completion Date
**Date:** 2022-03-30
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-08-08
**Type:** ACTUAL
**Last Update Submit Date:** 2023-08-04
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2022-03-30
**Type:** ACTUAL
#### Results First Post Date
**Date:** 2023-08-08
**Type:** ACTUAL
**Results First Submit Date:** 2023-06-30
**Results First Submit QC Date:** 2023-08-04
#### Start Date
**Date:** 2017-10-11
**Type:** ACTUAL
**Status Verified Date:** 2023-06
#### Study First Post Date
**Date:** 2017-05-11
**Type:** ACTUAL
**Study First Submit Date:** 2017-04-20
**Study First Submit QC Date:** 2017-05-08
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Medacta USA
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** True
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** To compare economic factors and the rate of adverse events between two types of instrumentation used for total knee replacement: Single-use Efficiency Instruments with Patient Specific Technique (MyKnee®) Traditional Metal Instruments with Conventional Surgical Technique
### Conditions Module
**Conditions:**
- Osteoarthritis
**Keywords:**
- Total Knee Replacement
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 32
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Experimental group: Patients randomized into this group will undergo surgery utilizing single-use Efficiency Instruments with patient-specific technique (MyKnee® patient-matched cutting blocks)
**Intervention Names:**
- Device: Customized patient instruments
**Label:** Customized patient instruments
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Control Group: Patients will undergo conventional surgical technique
**Intervention Names:**
- Device: Traditional Metal Instruments
**Label:** Traditional metal instruments
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Customized patient instruments
**Description:** Single use efficiency instruments and cutting blocks specifically made for each patient using pre-op MRI or CT scans to make bone cuts and select implant size.
**Name:** Customized patient instruments
**Other Names:**
- Single-use Efficiency Instruments with Patient Specific Technique (MyKnee®)
**Type:** DEVICE
#### Intervention 2
**Arm Group Labels:**
- Traditional metal instruments
**Description:** Traditional metal instrument will be used to make bone cuts and size the components in this control group.
**Name:** Traditional Metal Instruments
**Other Names:**
- Traditional Metal Instruments with Conventional Surgical Technique
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Total time patient is in operating room
**Measure:** OR Total Time
**Time Frame:** Day of Surgery
**Description:** Time to open surgical instruments
**Measure:** Opening Instruments
**Time Frame:** Day of Surgery
**Description:** Time to set up back surgical table
**Measure:** Back Table Setup Time
**Time Frame:** Day of Surgery
**Description:** Time tourniquet is on patient during surgery
**Measure:** Tourniquet Time
**Time Frame:** Day of Surgery
**Description:** Time from incision to skin closure during surgery
**Measure:** Incision to Skin Closure
**Time Frame:** Day of Surgery
**Description:** Time to prepare bone for implant during surgery
**Measure:** Bone Prep Time
**Time Frame:** Day of Surgery
**Description:** Time to resection patella during surgery
**Measure:** Patella Resection Time
**Time Frame:** Day of Surgery
**Description:** Time to clean up following surgery
**Measure:** Clean-up Time
**Time Frame:** Day of Surgery
#### Secondary Outcomes
**Description:** Post op 1 day hemoglobin range
**Measure:** Hemoglobin Range
**Time Frame:** 24 hours or at discharge if patient does not stay overnight
**Description:** Weigh surgical waste at the end of each surgery
**Measure:** Surgical Waste Weight
**Time Frame:** Day of Surgery
**Description:** Radiographic analysis of mechanical axis alignment
**Measure:** Mechanical Axis
**Time Frame:** Pre-Operative
**Description:** Radiographic analysis of mechanical axis alignment
**Measure:** Mechanical Axis
**Time Frame:** Post-Operative
**Description:** Radiographic analysis of Tibial Posterior Slope
**Measure:** Tibial Slope
**Time Frame:** Pre-Operative
**Description:** Radiographic analysis of Tibial Posterior Slope
**Measure:** Tibial Slope
**Time Frame:** Post-Operative
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age 18 to 75 years
* BMI ≤35
* Undergoing unilateral total knee arthroplasty due to osteoarthritis (primary or post-traumatic OA)
* Able and willing to give consent and to comply with study requirements, including follow up visit at 6 weeks
Exclusion Criteria:
* Pregnant women or those seeking to become pregnant. Pregnancy test is administered prior to surgery as part of routine care by the hospital / surgery center for all female patients of childbearing potential
* Is participating in another clinical study
* Has inflammatory arthritis
* Has knee avascular necrosis
* Has severe deformity, defined as greater than 10 degrees varus or valgus relative to the mechanical axis
* Has retained hardware in the knee that requires removal or interferes with Total Knee Arthroplasty (TKA) procedure
**Healthy Volunteers:** True
**Maximum Age:** 75 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Marrero
**Country:** United States
**Facility:** Tandem Clinical Research, LLC
**State:** Louisiana
**Zip:** 70072
**Location 2:**
**City:** Billings
**Country:** United States
**Facility:** Ortho Montana
**State:** Montana
**Zip:** 59101
**Location 3:**
**City:** Meadville
**Country:** United States
**Facility:** Orthopedic Associates Meadville
**State:** Pennsylvania
**Zip:** 16335
**Location 4:**
**City:** Austin
**Country:** United States
**Facility:** Texas Orthopedics
**State:** Texas
**Zip:** 78759
**Location 5:**
**City:** West Jordan
**Country:** United States
**Facility:** Jordan Valley Medical Center of Orthopedics Rehabilitation and Excellence
**State:** Utah
**Zip:** 84088
#### Overall Officials
**Official 1:**
**Affiliation:** Medacta USA
**Name:** Mukesh Ahuja, MBBS, MS
**Role:** STUDY_DIRECTOR
## Document Section
### Large Document Module
#### Large Docs
- Date: 2019-05-17
- Filename: Prot_SAP_000.pdf
- Has ICF: False
- Has Protocol: True
- Has SAP: True
- Label: Study Protocol and Statistical Analysis Plan
- Size: 493437
- Type Abbrev: Prot_SAP
- Upload Date: 2023-06-30T15:42
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001168
- Term: Arthritis
- ID: D000007592
- Term: Joint Diseases
- ID: D000009140
- Term: Musculoskeletal Diseases
- ID: D000012216
- Term: Rheumatic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC05
- Name: Musculoskeletal Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
### Condition Browse Module - Browse Leaves
- ID: M12926
- Name: Osteoarthritis
- Relevance: HIGH
- As Found: Osteoarthritis
- ID: M4476
- Name: Arthritis
- Relevance: LOW
- As Found: Unknown
- ID: M10621
- Name: Joint Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12097
- Name: Musculoskeletal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15045
- Name: Rheumatic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6323
- Name: Collagen Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000010003
- Term: Osteoarthritis
### Misc Info Module
#### Submission Tracking
##### First MCP Info
###### Post Date
- Date: 2023-07-25
- Type: ACTUAL
- Version Holder: 2024-05-24
## Results Section
### Adverse Events Module
#### Event Groups
**Group ID:** EG000
**Title:** Customized Patient Instruments
**Deaths Num At Risk:** 21
**Description:** Experimental group: Patients randomized into this group will undergo surgery utilizing single-use Efficiency Instruments with patient-specific technique (MyKnee® patient-matched cutting blocks)
Customized patient instruments: Single use efficiency instruments and cutting blocks specifically made for each patient using pre-op MRI or CT scans to make bone cuts and select implant size.
**ID:** EG000
**Other Num at Risk:** 21
**Serious Number At Risk:** 21
**Title:** Customized Patient Instruments
**Group ID:** EG001
**Title:** Traditional Metal Instruments
**Deaths Num At Risk:** 11
**Description:** Control Group: Patients will undergo conventional surgical technique
Traditional Metal Instruments: Traditional metal instrument will be used to make bone cuts and size the components in this control group.
**ID:** EG001
**Other Num at Risk:** 11
**Serious Number At Risk:** 11
**Title:** Traditional Metal Instruments
**Frequency Threshold:** 0
**Time Frame:** Surgery to 6 weeks post-op
## Results Section - Baseline Characteristics Module
### Denomination Counts
**Group ID:** BG000
**Value:** 21
**Group ID:** BG001
**Value:** 11
**Group ID:** BG002
**Value:** 32
**Units:** Participants
### Group
**ID:** BG000
**Title:** Customized Patient Instruments
**Description:** Experimental group: Patients randomized into this group will undergo surgery utilizing single-use Efficiency Instruments with patient-specific technique (MyKnee® patient-matched cutting blocks)
Customized patient instruments: Single use efficiency instruments and cutting blocks specifically made for each patient using pre-op MRI or CT scans to make bone cuts and select implant size.
### Group
**ID:** BG001
**Title:** Traditional Metal Instruments
**Description:** Control Group: Patients will undergo conventional surgical technique
Traditional Metal Instruments: Traditional metal instrument will be used to make bone cuts and size the components in this control group.
### Group
**ID:** BG002
**Title:** Total
**Description:** Total of all reporting groups
### Measure
#### Measurement
**Group ID:** BG000
**Lower Limit:** 56
**Upper Limit:** 75
**Value:** 67.24
#### Measurement
**Group ID:** BG001
**Lower Limit:** 53
**Upper Limit:** 70
**Value:** 65
#### Measurement
**Group ID:** BG002
**Lower Limit:** 53
**Upper Limit:** 75
**Value:** 66.47
#### Denomination
**Units:** Participants
##### Denomination Counts
**Group ID:** BG000
**Value:** 21
**Group ID:** BG001
**Value:** 11
**Group ID:** BG002
**Value:** 32
**Class Title:**
### Measure
#### Measurement
**Group ID:** BG000
**Value:** 6
#### Measurement
**Group ID:** BG001
**Value:** 8
#### Measurement
**Group ID:** BG002
**Value:** 14
**Category Title:** Female
#### Measurement
**Group ID:** BG000
**Value:** 15
#### Measurement
**Group ID:** BG001
**Value:** 3
#### Measurement
**Group ID:** BG002
**Value:** 18
**Category Title:** Male
#### Denomination
**Units:** Participants
##### Denomination Counts
**Group ID:** BG000
**Value:** 21
**Group ID:** BG001
**Value:** 11
**Group ID:** BG002
**Value:** 32
**Class Title:**
### Measure
#### Measurement
**Group ID:** BG002
**Value:** 0
#### Denomination
**Units:** Participants
##### Denomination Counts
**Group ID:** BG000
**Value:** 0
**Group ID:** BG001
**Value:** 0
**Group ID:** BG002
**Value:** 0
**Class Title:**
### Measure
#### Measurement
**Group ID:** BG000
**Value:** 21
#### Measurement
**Group ID:** BG001
**Value:** 11
#### Measurement
**Group ID:** BG002
**Value:** 32
#### Denomination
**Units:** Participants
##### Denomination Counts
**Group ID:** BG000
**Value:** 21
**Group ID:** BG001
**Value:** 11
**Group ID:** BG002
**Value:** 32
**Class Title:** United States
**Denomination Units Selected:**
## Results Section - Baseline Characteristics Module
### Measure 1
**Dispersion Type:** FULL_RANGE
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Race and Ethnicity were not collected from any participant.
**Title:** Race and Ethnicity Not Collected
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
## Results Section - More Information Module
### Certain Agreement
**Restriction Type:** GT60
**Restrictive Agreement:** True
### Point of Contact
**Email:** [email protected]
**Organization:** Medacta USA
**Phone:** 352-359-3581
**Title:** Rena Mandino, Director of Clinical Research
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
### Outcome Measure 6
### Outcome Measure 7
### Outcome Measure 8
### Outcome Measure 9
### Outcome Measure 10
### Outcome Measure 11
### Outcome Measure 12
### Outcome Measure 13
### Outcome Measure 14
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:** 81.90
- **Spread:**
- **Upper Limit:** 113.27
- **Value:** 93.00
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:** 82.73
- **Spread:**
- **Upper Limit:** 101.00
- **Value:** 92.72
**Title:**
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:** 4.20
- **Spread:**
- **Upper Limit:** 33.50
- **Value:** 8.23
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:** 3.70
- **Spread:**
- **Upper Limit:** 14.00
- **Value:** 7.42
**Title:**
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:** 5.68
- **Spread:**
- **Upper Limit:** 31.32
- **Value:** 21.33
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:** 1.42
- **Spread:**
- **Upper Limit:** 37.73
- **Value:** 21.62
**Title:**
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:** 47.43
- **Spread:**
- **Upper Limit:** 76.48
- **Value:** 58.75
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:** 46.07
- **Spread:**
- **Upper Limit:** 72.13
- **Value:** 58.25
**Title:**
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:** 41.77
- **Spread:**
- **Upper Limit:** 112.92
- **Value:** 55.37
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:** 43.57
- **Spread:**
- **Upper Limit:** 63.87
- **Value:** 55.03
**Title:**
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:** 12.47
- **Spread:**
- **Upper Limit:** 32.78
- **Value:** 17.83
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:** 9.95
- **Spread:**
- **Upper Limit:** 17.87
- **Value:** 17.67
**Title:**
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:** 0.83
- **Spread:**
- **Upper Limit:** 5.93
- **Value:** 2.27
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:** 1.18
- **Spread:**
- **Upper Limit:** 3.32
- **Value:** 2.22
**Title:**
#### Outcome Measure 8
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:** 1.48
- **Spread:**
- **Upper Limit:** 20.98
- **Value:** 7.67
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:** 1.37
- **Spread:**
- **Upper Limit:** 24.13
- **Value:** 8.40
**Title:**
#### Outcome Measure 9
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:** 8.9
- **Spread:**
- **Upper Limit:** 18.1
- **Value:** 13.3
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:** 11.5
- **Spread:**
- **Upper Limit:** 15.8
- **Value:** 13.3
**Title:**
#### Outcome Measure 10
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:** 21.0
- **Spread:**
- **Upper Limit:** 35.3
- **Value:** 29.8
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:** 17.6
- **Spread:**
- **Upper Limit:** 23.9
- **Value:** 21.1
**Title:**
#### Outcome Measure 11
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:** 165.9
- **Spread:**
- **Upper Limit:** 186.6
- **Value:** 175.5
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:** 168.1
- **Spread:**
- **Upper Limit:** 184.4
- **Value:** 175.85
**Title:**
#### Outcome Measure 12
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:** 0.0
- **Spread:**
- **Upper Limit:** 179.5
- **Value:** 78.4
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:** 0.8
- **Spread:**
- **Upper Limit:** 186.0
- **Value:** 72.6
**Title:**
#### Outcome Measure 13
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:** 2.0
- **Spread:**
- **Upper Limit:** 12.0
- **Value:** 7.6
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:** 3.0
- **Spread:**
- **Upper Limit:** 12.0
- **Value:** 7.6
**Title:**
#### Outcome Measure 14
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:** 0.0
- **Spread:**
- **Upper Limit:** 6.5
- **Value:** 4.3
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:** 2.7
- **Spread:**
- **Upper Limit:** 8.4
- **Value:** 4.2
**Title:**
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Total time patient is in operating room
**Dispersion Type:** Full Range
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Day of Surgery
**Title:** OR Total Time
**Type:** PRIMARY
**Unit of Measure:** minutes
##### Group
**Description:** Experimental group: Patients randomized into this group will undergo surgery utilizing single-use Efficiency Instruments with patient-specific technique (MyKnee® patient-matched cutting blocks)
Customized patient instruments: Single use efficiency instruments and cutting blocks specifically made for each patient using pre-op MRI or CT scans to make bone cuts and select implant size.
**ID:** OG000
**Title:** Customized Patient Instruments
##### Group
**Description:** Control Group: Patients will undergo conventional surgical technique
Traditional Metal Instruments: Traditional metal instrument will be used to make bone cuts and size the components in this control group.
**ID:** OG001
**Title:** Traditional Metal Instruments
#### Outcome Measure 2
**Description:** Time to open surgical instruments
**Dispersion Type:** Full Range
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Day of Surgery
**Title:** Opening Instruments
**Type:** PRIMARY
**Unit of Measure:** minutes
##### Group
**Description:** Experimental group: Patients randomized into this group will undergo surgery utilizing single-use Efficiency Instruments with patient-specific technique (MyKnee® patient-matched cutting blocks)
Customized patient instruments: Single use efficiency instruments and cutting blocks specifically made for each patient using pre-op MRI or CT scans to make bone cuts and select implant size.
**ID:** OG000
**Title:** Customized Patient Instruments
##### Group
**Description:** Control Group: Patients will undergo conventional surgical technique
Traditional Metal Instruments: Traditional metal instrument will be used to make bone cuts and size the components in this control group.
**ID:** OG001
**Title:** Traditional Metal Instruments
#### Outcome Measure 3
**Description:** Time to set up back surgical table
**Dispersion Type:** Full Range
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Day of Surgery
**Title:** Back Table Setup Time
**Type:** PRIMARY
**Unit of Measure:** minutes
##### Group
**Description:** Experimental group: Patients randomized into this group will undergo surgery utilizing single-use Efficiency Instruments with patient-specific technique (MyKnee® patient-matched cutting blocks)
Customized patient instruments: Single use efficiency instruments and cutting blocks specifically made for each patient using pre-op MRI or CT scans to make bone cuts and select implant size.
**ID:** OG000
**Title:** Customized Patient Instruments
##### Group
**Description:** Control Group: Patients will undergo conventional surgical technique
Traditional Metal Instruments: Traditional metal instrument will be used to make bone cuts and size the components in this control group.
**ID:** OG001
**Title:** Traditional Metal Instruments
#### Outcome Measure 4
**Description:** Time tourniquet is on patient during surgery
**Dispersion Type:** Full Range
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Day of Surgery
**Title:** Tourniquet Time
**Type:** PRIMARY
**Unit of Measure:** minutes
##### Group
**Description:** Experimental group: Patients randomized into this group will undergo surgery utilizing single-use Efficiency Instruments with patient-specific technique (MyKnee® patient-matched cutting blocks)
Customized patient instruments: Single use efficiency instruments and cutting blocks specifically made for each patient using pre-op MRI or CT scans to make bone cuts and select implant size.
**ID:** OG000
**Title:** Customized Patient Instruments
##### Group
**Description:** Control Group: Patients will undergo conventional surgical technique
Traditional Metal Instruments: Traditional metal instrument will be used to make bone cuts and size the components in this control group.
**ID:** OG001
**Title:** Traditional Metal Instruments
#### Outcome Measure 5
**Description:** Time from incision to skin closure during surgery
**Dispersion Type:** Full Range
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Day of Surgery
**Title:** Incision to Skin Closure
**Type:** PRIMARY
**Unit of Measure:** minutes
##### Group
**Description:** Experimental group: Patients randomized into this group will undergo surgery utilizing single-use Efficiency Instruments with patient-specific technique (MyKnee® patient-matched cutting blocks)
Customized patient instruments: Single use efficiency instruments and cutting blocks specifically made for each patient using pre-op MRI or CT scans to make bone cuts and select implant size.
**ID:** OG000
**Title:** Customized Patient Instruments
##### Group
**Description:** Control Group: Patients will undergo conventional surgical technique
Traditional Metal Instruments: Traditional metal instrument will be used to make bone cuts and size the components in this control group.
**ID:** OG001
**Title:** Traditional Metal Instruments
#### Outcome Measure 6
**Description:** Time to prepare bone for implant during surgery
**Dispersion Type:** Full Range
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Day of Surgery
**Title:** Bone Prep Time
**Type:** PRIMARY
**Unit of Measure:** minutes
##### Group
**Description:** Experimental group: Patients randomized into this group will undergo surgery utilizing single-use Efficiency Instruments with patient-specific technique (MyKnee® patient-matched cutting blocks)
Customized patient instruments: Single use efficiency instruments and cutting blocks specifically made for each patient using pre-op MRI or CT scans to make bone cuts and select implant size.
**ID:** OG000
**Title:** Customized Patient Instruments
##### Group
**Description:** Control Group: Patients will undergo conventional surgical technique
Traditional Metal Instruments: Traditional metal instrument will be used to make bone cuts and size the components in this control group.
**ID:** OG001
**Title:** Traditional Metal Instruments
#### Outcome Measure 7
**Description:** Time to resection patella during surgery
**Dispersion Type:** Full Range
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Day of Surgery
**Title:** Patella Resection Time
**Type:** PRIMARY
**Unit of Measure:** minutes
##### Group
**Description:** Experimental group: Patients randomized into this group will undergo surgery utilizing single-use Efficiency Instruments with patient-specific technique (MyKnee® patient-matched cutting blocks)
Customized patient instruments: Single use efficiency instruments and cutting blocks specifically made for each patient using pre-op MRI or CT scans to make bone cuts and select implant size.
**ID:** OG000
**Title:** Customized Patient Instruments
##### Group
**Description:** Control Group: Patients will undergo conventional surgical technique
Traditional Metal Instruments: Traditional metal instrument will be used to make bone cuts and size the components in this control group.
**ID:** OG001
**Title:** Traditional Metal Instruments
#### Outcome Measure 8
**Description:** Time to clean up following surgery
**Dispersion Type:** Full Range
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Day of Surgery
**Title:** Clean-up Time
**Type:** PRIMARY
**Unit of Measure:** minutes
##### Group
**Description:** Experimental group: Patients randomized into this group will undergo surgery utilizing single-use Efficiency Instruments with patient-specific technique (MyKnee® patient-matched cutting blocks)
Customized patient instruments: Single use efficiency instruments and cutting blocks specifically made for each patient using pre-op MRI or CT scans to make bone cuts and select implant size.
**ID:** OG000
**Title:** Customized Patient Instruments
##### Group
**Description:** Control Group: Patients will undergo conventional surgical technique
Traditional Metal Instruments: Traditional metal instrument will be used to make bone cuts and size the components in this control group.
**ID:** OG001
**Title:** Traditional Metal Instruments
#### Outcome Measure 9
**Description:** Post op 1 day hemoglobin range
**Dispersion Type:** Full Range
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** 24 hours or at discharge if patient does not stay overnight
**Title:** Hemoglobin Range
**Type:** SECONDARY
**Unit of Measure:** grams per deciliter (g/dl)
##### Group
**Description:** Experimental group: Patients randomized into this group will undergo surgery utilizing single-use Efficiency Instruments with patient-specific technique (MyKnee® patient-matched cutting blocks)
Customized patient instruments: Single use efficiency instruments and cutting blocks specifically made for each patient using pre-op MRI or CT scans to make bone cuts and select implant size.
**ID:** OG000
**Title:** Customized Patient Instruments
##### Group
**Description:** Control Group: Patients will undergo conventional surgical technique
Traditional Metal Instruments: Traditional metal instrument will be used to make bone cuts and size the components in this control group.
**ID:** OG001
**Title:** Traditional Metal Instruments
#### Outcome Measure 10
**Description:** Weigh surgical waste at the end of each surgery
**Dispersion Type:** Full Range
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Day of Surgery
**Title:** Surgical Waste Weight
**Type:** SECONDARY
**Unit of Measure:** pounds
##### Group
**Description:** Experimental group: Patients randomized into this group will undergo surgery utilizing single-use Efficiency Instruments with patient-specific technique (MyKnee® patient-matched cutting blocks)
Customized patient instruments: Single use efficiency instruments and cutting blocks specifically made for each patient using pre-op MRI or CT scans to make bone cuts and select implant size.
**ID:** OG000
**Title:** Customized Patient Instruments
##### Group
**Description:** Control Group: Patients will undergo conventional surgical technique
Traditional Metal Instruments: Traditional metal instrument will be used to make bone cuts and size the components in this control group.
**ID:** OG001
**Title:** Traditional Metal Instruments
#### Outcome Measure 11
**Description:** Radiographic analysis of mechanical axis alignment
**Dispersion Type:** Full Range
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Pre-Operative
**Title:** Mechanical Axis
**Type:** SECONDARY
**Unit of Measure:** degrees
##### Group
**Description:** Experimental group: Patients randomized into this group will undergo surgery utilizing single-use Efficiency Instruments with patient-specific technique (MyKnee® patient-matched cutting blocks)
Customized patient instruments: Single use efficiency instruments and cutting blocks specifically made for each patient using pre-op MRI or CT scans to make bone cuts and select implant size.
**ID:** OG000
**Title:** Customized Patient Instruments
##### Group
**Description:** Control Group: Patients will undergo conventional surgical technique
Traditional Metal Instruments: Traditional metal instrument will be used to make bone cuts and size the components in this control group.
**ID:** OG001
**Title:** Traditional Metal Instruments
#### Outcome Measure 12
**Description:** Radiographic analysis of mechanical axis alignment
**Dispersion Type:** Full Range
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Post-Operative
**Title:** Mechanical Axis
**Type:** SECONDARY
**Unit of Measure:** degrees
##### Group
**Description:** Experimental group: Patients randomized into this group will undergo surgery utilizing single-use Efficiency Instruments with patient-specific technique (MyKnee® patient-matched cutting blocks)
Customized patient instruments: Single use efficiency instruments and cutting blocks specifically made for each patient using pre-op MRI or CT scans to make bone cuts and select implant size.
**ID:** OG000
**Title:** Customized Patient Instruments
##### Group
**Description:** Control Group: Patients will undergo conventional surgical technique
Traditional Metal Instruments: Traditional metal instrument will be used to make bone cuts and size the components in this control group.
**ID:** OG001
**Title:** Traditional Metal Instruments
#### Outcome Measure 13
**Description:** Radiographic analysis of Tibial Posterior Slope
**Dispersion Type:** Full Range
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Pre-Operative
**Title:** Tibial Slope
**Type:** SECONDARY
**Unit of Measure:** degrees
##### Group
**Description:** Experimental group: Patients randomized into this group will undergo surgery utilizing single-use Efficiency Instruments with patient-specific technique (MyKnee® patient-matched cutting blocks)
Customized patient instruments: Single use efficiency instruments and cutting blocks specifically made for each patient using pre-op MRI or CT scans to make bone cuts and select implant size.
**ID:** OG000
**Title:** Customized Patient Instruments
##### Group
**Description:** Control Group: Patients will undergo conventional surgical technique
Traditional Metal Instruments: Traditional metal instrument will be used to make bone cuts and size the components in this control group.
**ID:** OG001
**Title:** Traditional Metal Instruments
#### Outcome Measure 14
**Description:** Radiographic analysis of Tibial Posterior Slope
**Dispersion Type:** Full Range
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Post-Operative
**Title:** Tibial Slope
**Type:** SECONDARY
**Unit of Measure:** degrees
##### Group
**Description:** Experimental group: Patients randomized into this group will undergo surgery utilizing single-use Efficiency Instruments with patient-specific technique (MyKnee® patient-matched cutting blocks)
Customized patient instruments: Single use efficiency instruments and cutting blocks specifically made for each patient using pre-op MRI or CT scans to make bone cuts and select implant size.
**ID:** OG000
**Title:** Customized Patient Instruments
##### Group
**Description:** Control Group: Patients will undergo conventional surgical technique
Traditional Metal Instruments: Traditional metal instrument will be used to make bone cuts and size the components in this control group.
**ID:** OG001
**Title:** Traditional Metal Instruments
### Participant Flow Module
#### Group
**Description:** Experimental group: Patients randomized into this group will undergo surgery utilizing single-use Efficiency Instruments with patient-specific technique (MyKnee® patient-matched cutting blocks)
Customized patient instruments: Single use efficiency instruments and cutting blocks specifically made for each patient using pre-op MRI or CT scans to make bone cuts and select implant size.
**ID:** FG000
**Title:** Customized Patient Instruments
#### Group
**Description:** Control Group: Patients will undergo conventional surgical technique
Traditional Metal Instruments: Traditional metal instrument will be used to make bone cuts and size the components in this control group.
**ID:** FG001
**Title:** Traditional Metal Instruments
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 21
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 11
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 20
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 11
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 1
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
**Has Results:** True |
## Protocol Section
### Identification Module
**NCT ID:** NCT05089279
**Brief Title:** Study to Evaluate the Safety and Pharmacokinetics of CKD-349 in Healthy Adult Volunteers
**Official Title:** An Open Label, Randomized, Single-dose, 2-sequence, 2-period, Cross-over Phase 1 Study to Evaluate the Safety and Pharmacokinetics of CKD-349 in Healthy Adult Volunteers
#### Organization Study ID Info
**ID:** A111_01BE2019
#### Organization
**Class:** INDUSTRY
**Full Name:** Chong Kun Dang Pharmaceutical
### Status Module
#### Completion Date
**Date:** 2022-04-06
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-10-07
**Type:** ACTUAL
**Last Update Submit Date:** 2022-10-05
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2022-01-18
**Type:** ACTUAL
#### Start Date
**Date:** 2021-11-03
**Type:** ACTUAL
**Status Verified Date:** 2021-12
#### Study First Post Date
**Date:** 2021-10-22
**Type:** ACTUAL
**Study First Submit Date:** 2021-10-14
**Study First Submit QC Date:** 2021-10-14
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Chong Kun Dang Pharmaceutical
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Study to Evaluate the Safety and Pharmacokinetics of CKD-349
**Detailed Description:** An Open Label, Randomized, Single-dose, 2-sequence, 2-period, Cross-over Phase 1 Study to Evaluate the Safety and Pharmacokinetics of CKD-349 in Healthy Adult Volunteers
### Conditions Module
**Conditions:**
- Chronic Heart Failure
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 71
**Type:** ACTUAL
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Period 1: D113/ Period 2: CKD-349
**Intervention Names:**
- Drug: D113
- Drug: CKD-349
**Label:** Sequence 1
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Period 1: CKD-349/ Period 2: D113
**Intervention Names:**
- Drug: D113
- Drug: CKD-349
**Label:** Sequence2
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Sequence 1
- Sequence2
**Description:** QD, PO
**Name:** D113
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Sequence 1
- Sequence2
**Description:** QD, PO
**Name:** CKD-349
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** AUCt: Area under the concentration-time curve from time zero to time
**Measure:** AUCt of CKD-349
**Time Frame:** 0, 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours
**Description:** Cmax: Maximum plasma concentration of the drug
**Measure:** Cmax of CKD-349
**Time Frame:** 0, 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours
#### Secondary Outcomes
**Description:** Area under the concentration-time curve from zero up to ∞
**Measure:** AUCinf of CKD-349
**Time Frame:** 0, 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours
**Description:** Time to maximum plasma concentration
**Measure:** Tmax of CKD-349
**Time Frame:** 0, 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours
**Description:** AUCt/AUCinf
**Measure:** AUCt/AUCinf of CKD-349
**Time Frame:** 0, 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours
**Description:** Terminal elimination half-life
**Measure:** T1/2 of CKD-349
**Time Frame:** 0, 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Healthy adult volunteers aged ≥ 19 years
2. Weight ≥50kg (man) or 45kg (woman), with calculated body mass index (BMI) of 18 to 30 kg/m2
3. Those who have no congenital diseases or chronic diseases and have no abnormal symptoms or findings.
4. Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serology, urology) and 12-lead ECG results at screening.
5. Those who agree to contraception until 7 days after clinical trial.
6. Individuals who voluntarily decide to participate and agree to comply with the cautions after fully understand the detailed description of this clinical trial.
Exclusion Criteria:
1. Those who have clinically significant diseases or history in digestive systems, cardiovascular system, endocrine system, respiratory system, blood·tumor, infectious disease, kidney and urogenital system, mental·nervous system, musculoskeletal system, immune system, otolaryngology, skin system, ophthalmology system, etc.
2. Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery.
3. Those who take barbiturate and any related drugs which may cause induction or inhibition of drug metabolism within 1 month before the first administration of investigational products or take drugs that may interfere with this clinical trials within 10 day before the first administration
4. Those who received investigational products or participated in bioequivalence tests within 6 months before the first administration of clinical trial drugs.
5. Those who donated whole blood within 8 weeks or donated ingredients within 2 weeks, or received a blood transfusion within 4 weeks.
6. Those who exceed an alcohol and cigarette consumption than below criteria A. Alcohol: Man- 21 glasses/week, Woman - 14 glasses/week (1 glass: Soju 50mL, Wine 30mL, or beer 250mL) B. Smoking: 20 cigarettes/day
7. Those who overreacts to the ingredient of this drug and is administering an angiotensin conversion enzyme (ACE) inhibitor or has not passed 36 hours since discontinuation of administration and has a history of vascular edema when administering an angiotensin conversion enzyme (ACE) inhibitor or an angiotensin receptor antagonist (ARB).
8. Those who are deemed insufficient to participate in this clinical study by investigators.
9. Woman who are pregnant or breastfeeding.
**Healthy Volunteers:** True
**Minimum Age:** 19 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Seoul
**Country:** Korea, Republic of
**Facility:** H Plus Yangji Hospital
**State:** Gwanak-gu
**Zip:** 08779
#### Overall Officials
**Official 1:**
**Affiliation:** Study Principal Investigator
**Name:** JaeWoo Kim
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000006331
- Term: Heart Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M9421
- Name: Heart Failure
- Relevance: HIGH
- As Found: Heart Failure
- ID: M9419
- Name: Heart Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
- ID: T4202
- Name: Oculocerebral Syndrome With Hypopigmentation
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000006333
- Term: Heart Failure
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT05367479
**Brief Title:** Antibiotics, Gastric Bypass, and the Microbiome
**Official Title:** The Effect of Peri-operative Antibiotic Class on Microbiome Changes After Roux-en-Y Gastric Bypass
#### Organization Study ID Info
**ID:** PRO00030985
#### Organization
**Class:** OTHER
**Full Name:** Medical College of Wisconsin
### Status Module
#### Completion Date
**Date:** 2020-01-09
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-05-10
**Type:** ACTUAL
**Last Update Submit Date:** 2022-05-05
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2020-01-09
**Type:** ACTUAL
#### Start Date
**Date:** 2018-07-18
**Type:** ACTUAL
**Status Verified Date:** 2022-05
#### Study First Post Date
**Date:** 2022-05-10
**Type:** ACTUAL
**Study First Submit Date:** 2022-05-05
**Study First Submit QC Date:** 2022-05-05
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Medical College of Wisconsin
#### Responsible Party
**Investigator Affiliation:** Medical College of Wisconsin
**Investigator Full Name:** Tammy Kindel, MD, PhD
**Investigator Title:** Associate Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This study randomizes patients to two commonly used peri-procedural antibiotics after gastric bypass with the pre and post-operative collection of stool samples, to identify significant differences in relative abundances of gut microbiota phyla, genera and species between the two antibiotic groups used. Gastric bypass may beneficially affect hypertension by altering the post-operative microbiome and specific antibiotics can further enhance the resolution rate by improving microbial diversity and richness.
**Detailed Description:** Eligible patients will be reviewed to meet inclusion criteria. Patients will be approached for enrollment at their pre-operative clinic appointment. If patients agree, consent will be signed.
Demographics will be collected on all patients including past medical, surgical and obesity history. Blood pressure will be recorded in the office, hypertensive medication record reviewed, post-operative follow-up and stool samples will be collected at 5 visits (V1-V5): 2 weeks pre-op, day of surgery, 2 weeks post-op, and 3 months post-op. Patients will be randomized at the time of surgery to receive intravenous cefazolin or clindamycin (weight-based dosing) as a pre-operative antibiotic within 60 minutes of incision time. Both antibiotics are routinely used as a single intravenous pre-operative dose for surgical site infection prophylaxis during Roux-en-Y gastric bypass and does not alter the standard of care. In routine care, clindamycin is given when there is a cefazolin allergy. Vancomycin is given if there is an allergy to both. We have a protocol that all bariatric surgeons follow rather than preference. There should be equipoise regarding the risk of a skin, superficial or deep surgical site infection between the two choices.
Hypertension will be considered resolved when the blood pressure is \<140/90 without medication. Data points for collection were chosen to identify both short and long-term changes in the microbiome as well as assess for changes in the microbiome related to dietary modifications required with surgery.
Stool samples will be collected from participants in this study. Stool samples will be collected at the convenience of the participant at time points designated in the study design. The participant will be given a stool sample kit(s) to take home during the time of consent. The stool sample will be received by the research laboratory at a follow-up visit, or returned via FedEx with materials supplied in the stool collection kit. Following receipt in the laboratory, the stool samples will be stored in Dr. Kindel's lab (4th floor CRI) at -80 degrees where they will later undergo bacterial genomic DNA and RNA isolation using standardized techniques and later analysis for 16S and metagenomic sequencing analysis.
### Conditions Module
**Conditions:**
- Obesity, Morbid
- Hypertension
- Bariatric Surgery Candidate
**Keywords:**
- gut microbiome
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** BASIC_SCIENCE
#### Enrollment Info
**Count:** 23
**Type:** ACTUAL
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** standard of care as a pre-operative antibiotic given with 60 minutes of incision before gastric bypass surgery. given intravenous as a single dose, weight based.
**Intervention Names:**
- Drug: Antibiotic
**Label:** Cefazolin
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** also standard of care alternative as a pre-operative antibiotic given with 60 minutes of incision before gastric bypass surgery. given intravenous as a single dose, weight based.
**Intervention Names:**
- Drug: Antibiotic
**Label:** Clindamycin
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Cefazolin
- Clindamycin
**Description:** Peri-operative, intravenous antibiotic for surgical site infection
**Name:** Antibiotic
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** a distinct bacterial community
**Measure:** operational taxonomic units
**Time Frame:** 3 months postoperatively
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria: Patients who are approved for a primary RYGB at MCW's bariatric surgery program as treatment for morbid obesity and obesity-associated co-morbidities. Patients will be eligible who are: 1.) female or male 2.) 18-70 years of age, 3.) hypertensive
Exclusion Criteria: Patients are ineligible if they: 1.) have a diagnosis of cirrhosis, 2.) are taking antibiotics, probiotics, or immune modulating medications for one month prior to or after surgery, 3.) have a history of bowel resections, inflammatory bowel disease and/or celiac disease, 4.) have a life-threatening reaction to penicillin/cephalosporins or clindamycin.
**Maximum Age:** 70 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Milwaukee
**Country:** United States
**Facility:** Froedtert Hospital
**State:** Wisconsin
**Zip:** 53226
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009765
- Term: Obesity
- ID: D000050177
- Term: Overweight
- ID: D000044343
- Term: Overnutrition
- ID: D000009748
- Term: Nutrition Disorders
- ID: D000001835
- Term: Body Weight
### Condition Browse Module - Browse Branches
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M10024
- Name: Hypertension
- Relevance: LOW
- As Found: Unknown
- ID: M12701
- Name: Obesity
- Relevance: LOW
- As Found: Unknown
- ID: M12702
- Name: Obesity, Morbid
- Relevance: HIGH
- As Found: Obesity, Morbid
- ID: M26186
- Name: Overweight
- Relevance: LOW
- As Found: Unknown
- ID: M25307
- Name: Overnutrition
- Relevance: LOW
- As Found: Unknown
- ID: M12684
- Name: Nutrition Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M5114
- Name: Body Weight
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000009767
- Term: Obesity, Morbid
### Intervention Browse Module - Ancestors
- ID: D000000890
- Term: Anti-Infective Agents
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M5687
- Name: Cefazolin
- Relevance: LOW
- As Found: Unknown
- ID: M4222
- Name: Anti-Bacterial Agents
- Relevance: HIGH
- As Found: Initial
- ID: M6214
- Name: Clindamycin
- Relevance: LOW
- As Found: Unknown
- ID: M220697
- Name: Clindamycin palmitate
- Relevance: LOW
- As Found: Unknown
- ID: M231711
- Name: Clindamycin phosphate
- Relevance: LOW
- As Found: Unknown
- ID: M4224
- Name: Antibiotics, Antitubercular
- Relevance: LOW
- As Found: Unknown
- ID: M4214
- Name: Anti-Infective Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000000900
- Term: Anti-Bacterial Agents
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT00323479
**Brief Title:** Arthralgia During Anastrozole Therapy for Breast Cancer
**Official Title:** A Multicentre, Open Study Assessing Joint Disorders Under ARIMIDEX® (1mg/Day) as Adjuvant Treatment in Post Menopausal Women With Early Breast Cancer
#### Organization Study ID Info
**ID:** D5392L00013
#### Organization
**Class:** INDUSTRY
**Full Name:** AstraZeneca
#### Secondary ID Infos
**ID:** 2005-00-5441-19 EUDRACT number
### Status Module
#### Completion Date
**Date:** 2009-01
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2012-04-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2012-03-13
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2009-01
**Type:** ACTUAL
#### Results First Post Date
**Date:** 2012-04-06
**Type:** ESTIMATED
**Results First Submit Date:** 2010-01-26
**Results First Submit QC Date:** 2012-03-13
#### Start Date
**Date:** 2006-06
**Status Verified Date:** 2012-03
#### Study First Post Date
**Date:** 2006-05-09
**Type:** ESTIMATED
**Study First Submit Date:** 2006-05-08
**Study First Submit QC Date:** 2006-05-08
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** AstraZeneca
#### Responsible Party
**Type:** SPONSOR
### Description Module
**Brief Summary:** The purpose of this study is to describe the joint symptoms and structural joint changes under anastrozole as adjuvant treatment in postmenopausal women with early breast cancer.
### Conditions Module
**Conditions:**
- Early Breast Cancer
**Keywords:**
- breast cancer treatment
- joint disorders
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 114
**Type:** ACTUAL
**Phases:**
- PHASE4
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
### Interventions
#### Intervention 1
**Description:** 1mg/Day oral
**Name:** Anastrozole
**Other Names:**
- ARIMIDEX
- ZD1033
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Measure:** Number of Participants With New Events of Arthralgia
**Time Frame:** 12 months
#### Secondary Outcomes
**Description:** Functional index of cochin score (from 0 to 90) : sum up of 18 questions on activities involving hands (each question scored from 0 = yes without difficulties (best) to 5 = impossible (worst)) based on 99 patients due to missing values.
**Measure:** Functional Index of Cochin at 12 Months in Patients Under Anastrozole.
**Time Frame:** 12 months
**Description:** Results are based on 97 patients due to missing values
**Measure:** Serum Collagen Degradation Type I - CTX-I at 12 Months in Patients Under Anastrozole
**Time Frame:** 12 months
**Description:** X ray evaluation of arthritis in 30 articulations ; each articulation scored from (0 = no arthritis to 4 = severe arthritis) based on 92 patients due to missing values
**Measure:** Kellgren and Lawrence Score at 12 Months in Patients Under Anastrozole
**Time Frame:** 12 months
**Description:** X ray assessment on hands and wrists based on 99 patients due to missing values
**Measure:** Synovial Membrane Thickness at 12 Months in Patients Under Anastrozole
**Time Frame:** 12 months
**Description:** Treatment compliance. results based on 109 patients due to missing values
**Measure:** Percentage of Participant With Therapeutic Maintenance Under Anastrozole
**Time Frame:** 12 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Post menopausal woman with a breast cancer and scheduled for an adjuvant treatment with anastrozole
* WHO performance status 0, 1 or 2
* Provision of written informed consent
Exclusion Criteria:
* Recurrence of breast cancer, inflammatory rheumatism
* treatment by chondromodulator, oral glucocorticoid, aromatase inhibitor, anti estrogen, Herceptin
* Diabetes treated by insulin
* Severe renal or hepatic disease
* Known hypersensitivity to anastrozole
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Bordeaux
**Country:** France
**Facility:** Research Site
**Location 2:**
**City:** Caen
**Country:** France
**Facility:** Research Site
**Location 3:**
**City:** Lyon
**Country:** France
**Facility:** Research Site
**Location 4:**
**City:** Paris
**Country:** France
**Facility:** Research Site
**Location 5:**
**City:** Poitiers
**Country:** France
**Facility:** Research Site
#### Overall Officials
**Official 1:**
**Affiliation:** AstraZeneca
**Name:** AstraZeneca France Medical Director, MD
**Role:** STUDY_DIRECTOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000001941
- Term: Breast Diseases
- ID: D000012871
- Term: Skin Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC05
- Name: Musculoskeletal Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M5220
- Name: Breast Neoplasms
- Relevance: HIGH
- As Found: Breast Cancer
- ID: M10621
- Name: Joint Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M20833
- Name: Arthralgia
- Relevance: LOW
- As Found: Unknown
- ID: M5218
- Name: Breast Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T6036
- Name: Menopause
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001943
- Term: Breast Neoplasms
### Intervention Browse Module - Ancestors
- ID: D000018931
- Term: Antineoplastic Agents, Hormonal
- ID: D000000970
- Term: Antineoplastic Agents
- ID: D000047072
- Term: Aromatase Inhibitors
- ID: D000065088
- Term: Steroid Synthesis Inhibitors
- ID: D000004791
- Term: Enzyme Inhibitors
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000004965
- Term: Estrogen Antagonists
- ID: D000006727
- Term: Hormone Antagonists
- ID: D000006730
- Term: Hormones, Hormone Substitutes, and Hormone Antagonists
- ID: D000045505
- Term: Physiological Effects of Drugs
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M1781
- Name: Anastrozole
- Relevance: HIGH
- As Found: Targeting
- ID: M20966
- Name: Antineoplastic Agents, Hormonal
- Relevance: LOW
- As Found: Unknown
- ID: M25769
- Name: Aromatase Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M7951
- Name: Enzyme Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M8116
- Name: Estrogens
- Relevance: LOW
- As Found: Unknown
- ID: M8114
- Name: Estrogen Antagonists
- Relevance: LOW
- As Found: Unknown
- ID: M30483
- Name: Estrogen Receptor Antagonists
- Relevance: LOW
- As Found: Unknown
- ID: M9789
- Name: Hormones
- Relevance: LOW
- As Found: Unknown
- ID: M9788
- Name: Hormone Antagonists
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000077384
- Term: Anastrozole
### Misc Info Module
- Version Holder: 2024-05-24
## Results Section
### Adverse Events Module
**Description:** 110 participants were included in the safety population, those who had taken at least one dose of treatment
#### Event Groups
**Group ID:** EG000
**Title:** Anastrozole 1 mg
**Description:** Anastrozole 1 mg once daily
**ID:** EG000
**Other Num Affected:** 106
**Other Num at Risk:** 110
**Serious Number Affected:** 6
**Serious Number At Risk:** 110
**Title:** Anastrozole 1 mg
**Frequency Threshold:** 5
#### Other Events
**Term:** arthralgia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Musculoskeletal and connective tissue disorders
**Source Vocabulary:** MedDRA 10.0
**Term:** hot flush
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Vascular disorders
**Source Vocabulary:** MedDRA 11.0
**Term:** pain in extremity
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Musculoskeletal and connective tissue disorders
**Source Vocabulary:** MedDRA 11.0
**Term:** asthenia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA 11.0
**Term:** back pain
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Musculoskeletal and connective tissue disorders
**Source Vocabulary:** MedDRA 11.0
**Term:** insomnia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Psychiatric disorders
**Source Vocabulary:** MedDRA 11.0
**Term:** headache
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
**Source Vocabulary:** MedDRA 11.0
**Term:** vertigo
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Ear and labyrinth disorders
**Source Vocabulary:** MedDRA 11.0
**Term:** abdominal pain upper
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA 11.0
**Term:** nausea
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA 11.0
**Term:** fatigue
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA 11.0
**Term:** musculoskeletal chest pain
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Musculoskeletal and connective tissue disorders
**Source Vocabulary:** MedDRA 11.0
**Term:** musculosketal pain
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Musculoskeletal and connective tissue disorders
**Source Vocabulary:** MedDRA 11.0
**Term:** neck pain
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Musculoskeletal and connective tissue disorders
**Source Vocabulary:** MedDRA 11.0
**Term:** breast fibrosis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Reproductive system and breast disorders
**Source Vocabulary:** MedDRA 11.0
**Term:** breast oedema
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Reproductive system and breast disorders
**Source Vocabulary:** MedDRA 11.0
**Term:** breast pain
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Reproductive system and breast disorders
**Source Vocabulary:** MedDRA 11.0
**Term:** erythema
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
**Source Vocabulary:** MedDRA 11.0
**Term:** lymphoedema
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Vascular disorders
**Source Vocabulary:** MedDRA 11.0
#### Serious Events
**Term:** Sudden death unexplained
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA 11.0
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 110
**Term:** Lymphangitis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA 11.0
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 110
**Term:** Pneumopathy
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
**Source Vocabulary:** MedDRA 11.0
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 110
**Term:** Calculus urinary bladder
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Renal and urinary disorders
**Source Vocabulary:** MedDRA 11.0
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 110
**Term:** Depression worsened
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Psychiatric disorders
**Source Vocabulary:** MedDRA 11.0
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 110
**Term:** General body pain
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA 11.0
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 110
**Term:** Parathyroid adenoma
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)
**Source Vocabulary:** MedDRA 11.0
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 110
**Term:** Femur fracture
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Injury, poisoning and procedural complications
**Source Vocabulary:** MedDRA 11.0
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 110
## Results Section - Baseline Characteristics Module
### Denomination Counts
**Group ID:** BG000
**Value:** 106
**Units:** Participants
### Group
**ID:** BG000
**Title:** Anastrozole 1 mg
**Description:** Anastrozole 1 mg once daily
### Measure
#### Measurement
**Group ID:** BG000
**Spread:** 6.87
**Value:** 62.87
**Class Title:**
### Measure
#### Measurement
**Group ID:** BG000
**Value:** 106
**Category Title:** Female
#### Measurement
**Group ID:** BG000
**Value:** 0
**Category Title:** Male
**Class Title:**
**Denomination Units Selected:**
## Results Section - Baseline Characteristics Module
### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age Continuous
**Unit of Measure:** year
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
**Restriction Type:** LTE60
**Restrictive Agreement:** True
### Point of Contact
**Email:** [email protected]
**Organization:** AstraZeneca
**Title:** Gerard Lynch
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
### Outcome Measure 6
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 37
**Title:**
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 9.46
- **Upper Limit:**
- **Value:** 4.32
**Title:**
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 0.28
- **Upper Limit:**
- **Value:** 0.5
**Title:**
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 13.64
- **Upper Limit:**
- **Value:** 12.66
**Title:**
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 0.62
- **Upper Limit:**
- **Value:** 1.77
**Title:**
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 80.7
**Title:**
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** 12 months
**Title:** Number of Participants With New Events of Arthralgia
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** Anastrozole 1 mg once daily
**ID:** OG000
**Title:** Anastrozole 1 mg
#### Outcome Measure 2
**Description:** Functional index of cochin score (from 0 to 90) : sum up of 18 questions on activities involving hands (each question scored from 0 = yes without difficulties (best) to 5 = impossible (worst)) based on 99 patients due to missing values.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** 12 months
**Title:** Functional Index of Cochin at 12 Months in Patients Under Anastrozole.
**Type:** SECONDARY
**Unit of Measure:** Units on scale
##### Group
**Description:** Anastrozole 1 mg once daily
**ID:** OG000
**Title:** Anastrozole 1 mg
#### Outcome Measure 3
**Description:** Results are based on 97 patients due to missing values
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** 12 months
**Title:** Serum Collagen Degradation Type I - CTX-I at 12 Months in Patients Under Anastrozole
**Type:** SECONDARY
**Unit of Measure:** Ng/mL
##### Group
**Description:** Anastrozole 1 mg once daily
**ID:** OG000
**Title:** Anastrozole 1 mg
#### Outcome Measure 4
**Description:** X ray evaluation of arthritis in 30 articulations ; each articulation scored from (0 = no arthritis to 4 = severe arthritis) based on 92 patients due to missing values
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** 12 months
**Title:** Kellgren and Lawrence Score at 12 Months in Patients Under Anastrozole
**Type:** SECONDARY
**Unit of Measure:** Units on scale
##### Group
**Description:** Anastrozole 1 mg once daily
**ID:** OG000
**Title:** Anastrozole 1 mg
#### Outcome Measure 5
**Description:** X ray assessment on hands and wrists based on 99 patients due to missing values
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEDIAN
**Reporting Status:** POSTED
**Time Frame:** 12 months
**Title:** Synovial Membrane Thickness at 12 Months in Patients Under Anastrozole
**Type:** SECONDARY
**Unit of Measure:** millimeter
##### Group
**Description:** Anastrozole 1 mg once daily
**ID:** OG000
**Title:** Anastrozole 1 mg
#### Outcome Measure 6
**Description:** Treatment compliance. results based on 109 patients due to missing values
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** 12 months
**Title:** Percentage of Participant With Therapeutic Maintenance Under Anastrozole
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Anastrozole 1 mg once daily
**ID:** OG000
**Title:** Anastrozole 1 mg
### Participant Flow Module
#### Group
**Description:** Anastrozole 1 mg once daily
**ID:** FG000
**Title:** Anastrozole 1 mg
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Adverse Event
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
##### Withdraw
**Type:** Protocol Violation
###### Reason
**Group ID:** FG000
**Number of Subjects:** 3
##### Withdraw
**Type:** house moving
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 114
##### Milestone
**Type:** Safety Population
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 110
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 106
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 8
**Pre-Assignment Details:** Patients were included by an investigator-oncologist who followed them up every 3 months over a period of one year (i.e., 5 visits). An investigator rheumatologist carried out the rheumatological evaluations at inclusion and then every 6 months over a period of one year (i.e., 3 visits)
**Recruitment Details:** Patients were included by an investigator-oncologist between 15 June 2006 and 31 December 2007
**Has Results:** True |
## Protocol Section
### Identification Module
**NCT ID:** NCT02117479
**Brief Title:** Study of Ruxolitinib in Pancreatic Cancer Patients (Janus 1)
**Official Title:** A Randomized, Double-Blind, Phase 3 Study of the JAK1/2 Inhibitor, Ruxolitinib or Placebo in Combination With Capecitabine in Subjects With Advanced or Metastatic Adenocarcinoma of the Pancreas Who Have Failed or Are Intolerant to First-Line Chemotherapy (The JANUS 1 Study)
#### Organization Study ID Info
**ID:** INCB 18424-362
#### Organization
**Class:** INDUSTRY
**Full Name:** Incyte Corporation
### Status Module
#### Completion Date
**Date:** 2016-12
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-03-26
**Type:** ACTUAL
**Last Update Submit Date:** 2019-03-14
**Overall Status:** TERMINATED
#### Primary Completion Date
**Date:** 2016-02
**Type:** ACTUAL
#### Results First Post Date
**Date:** 2017-07-11
**Type:** ACTUAL
**Results First Submit Date:** 2017-02-09
**Results First Submit QC Date:** 2017-06-09
#### Start Date
**Date:** 2014-03
**Type:** ACTUAL
**Status Verified Date:** 2019-03
#### Study First Post Date
**Date:** 2014-04-21
**Type:** ESTIMATED
**Study First Submit Date:** 2014-04-16
**Study First Submit QC Date:** 2014-04-17
**Why Stopped:** The study was terminated early based on the results of the planned interim analysis.
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Incyte Corporation
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Determining the efficacy, based upon overall survival, of ruxolitinib added to capecitabine for the treatment of advanced or metastatic pancreatic cancer.
**Detailed Description:** This was a randomized, double-blinded, placebo-controlled, Phase 3 study, in which approximately 310 participants with advanced or metastatic adenocarcinoma of the pancreas who have failed, or were intolerant to first-line chemotherapy, were to be randomized (1:1) to one of the following treatment groups:
* Treatment A (N = 155): Capecitabine + ruxolitinib
* Treatment B (N = 155): Capecitabine + placebo
Treatment consisted of repeating 21-day cycles. Capecitabine was self-administered for the first 14 days of each cycle, and ruxolitinib/placebo was self-administered daily for each cycle. Treatment for all participants continued as long as the regimen was tolerated, and the participant did not meet discontinuation criteria. Participants who discontinued study treatment before study termination were monitored for safety up to 30-35 days from the end of treatment. All participants were followed for survival until study termination or the safety follow-up visit.
### Conditions Module
**Conditions:**
- Pancreatic Cancer
**Keywords:**
- Metastatic pancreatic cancer
- Metastatic pancreatic adenocarcinoma that is recurrent
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 321
**Type:** ACTUAL
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Drug: Ruxolitinib
- Drug: Capecitabine
**Label:** Ruxolitinib plus capecitabine
**Type:** EXPERIMENTAL
#### Arm Group 2
**Intervention Names:**
- Drug: Placebo
- Drug: Capecitabine
**Label:** Placebo plus capecitabine
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Ruxolitinib plus capecitabine
**Description:** 5 mg tablets to be administered by mouth twice daily (BID)
**Name:** Ruxolitinib
**Other Names:**
- Jakafi ®
- Jakavi ®
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Placebo plus capecitabine
**Description:** 5 mg tablets to be administered by mouth twice daily (BID)
**Name:** Placebo
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- Placebo plus capecitabine
- Ruxolitinib plus capecitabine
**Description:** 150 and 500 mg tablets to be administered by mouth twice daily (BID)
**Name:** Capecitabine
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Overall survival is reported here based on the number of deaths from randomization up to 6-months or to the data cutoff 11FEB2016.
**Measure:** Overall Survival (OS)
**Time Frame:** Randomization until death due to any cause; up to the data cutoff 11FEB2016.
#### Secondary Outcomes
**Description:** Progressive Disease (PD) is defined using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, unequivocal progression of non-target lesions, or the appearance of new lesions.
**Measure:** Progression-free Survival (PFS)
**Time Frame:** Randomization to disease progression, or death due to any cause if sooner; up to 6-months or to the data cutoff 11FEB2016.
**Description:** PFS is defined as the time from randomization until the earliest date of disease progression determined by investigator assessment of objective radiographic disease assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause if sooner. Progressive Disease (PD) is defined using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, unequivocal progression of non-target lesions, or the appearance of new lesions.
**Measure:** Percentage of Participants Achieving Progression Free Survival (PFS)
**Time Frame:** Randomization to disease progression, or death due to any cause if sooner; up to 6-months or to the data cutoff 11FEB2016.
**Description:** Objective response rate determined by radiographic disease assessments per RECIST (v1.1), by investigator assessment and was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) by Response Evaluation Criteria in Solid Tumours (RECIST) at any post baseline visit. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI) : Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions with no worsening of non-target lesions and no new lesions; Overall Response (OR) = CR + PR.
**Measure:** Objective Response Rate (ORR)
**Time Frame:** Baseline through end of study; up to 6-months or to the data cutoff 11FEB2016.
**Description:** Duration of overall response was defined as the time in months from Complete Response (CR) or Partial Response (PR) by Response Evaluation Criteria in Solid Tumours (RECIST v1.1) until the first date Progressive Disease (PD) was objectively documented or until the date of death.
**Measure:** Duration of Response
**Time Frame:** Baseline through end of study; up to 6-months or to the data cutoff 11FEB2016.
**Description:** A treatment-emergent AE was defined as an event occurring after exposure to at least 1 dose of study drug (ruxolitinib or placebo). A treatment-related AE was defined as an event with a definite, probable, or possible causality to study medication. A serious AE is an event resulting in death, hospitalization, persistent or significant disability/incapacity, or is life threatening, a congenital anomaly/birth defect or requires medical or surgical intervention to prevent 1 of the outcomes above. The intensity of an AE was graded according to the National Cancer Institute common terminology criteria for adverse events (NCI-CTCAE) version 4.03: Grade 1 (Mild); Grade 2 (Moderate); Grade 3 (Severe); Grade 4 (life-threatening).
**Measure:** Participants With Treatment-Emergent Adverse Events (TEAEs)
**Time Frame:** Baseline through approximately 30 days post treatment discontinuation; up to 6-months or to the data cutoff 11FEB2016.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Histologically or cytologically confirmed adenocarcinoma of the pancreas.
* Advanced adenocarcinoma of the pancreas that is inoperable or metastatic.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
* Received 1 prior chemotherapy regimen for advanced or metastatic disease (not including neoadjuvant and/or adjuvant therapy).
* ≥ 2 weeks elapsed from the completion of previous treatment regimen and participants must have recovered or be at a new stable baseline from any related toxicities.
* Radiographically measurable or evaluable disease
* Modified Glasgow Prognostic Score (mGPS) of 1 or 2 as defined below:
1. mGPS of 1: C-reactive protein \>10 mg/L and albumin ≥35 g/L
2. mGPS of 2: C-reactive protein \>10 mg/L and albumin \<35 g/L
Exclusion Criteria:
* Received more than 1 prior regimen for advanced or metastatic disease.
* Ongoing radiation therapy, radiation therapy administered within 30 days of enrollment.
* Concurrent anticancer therapy (eg, chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, hormonal therapy, investigational therapy, or tumor embolization).
* Prior severe reaction to fluoropyrimidines, known dihydropyrimidine dehydrogenase deficiency (DPD), or other known hypersensitivity to active substances, including fluorouracil (5-FU), or ruxolitinib, or any of their excipients.
* Prior treatment with a JAK inhibitor for any indication.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Avondale
**Country:** United States
**State:** Arizona
**Location 2:**
**City:** Chandler
**Country:** United States
**State:** Arizona
**Location 3:**
**City:** Gilbert
**Country:** United States
**State:** Arizona
**Location 4:**
**City:** Glendale
**Country:** United States
**State:** Arizona
**Location 5:**
**City:** Mesa
**Country:** United States
**State:** Arizona
**Location 6:**
**City:** Phoenix
**Country:** United States
**State:** Arizona
**Location 7:**
**City:** Scottsdale
**Country:** United States
**State:** Arizona
**Location 8:**
**City:** Surprise
**Country:** United States
**State:** Arizona
**Location 9:**
**City:** Tucson
**Country:** United States
**State:** Arizona
**Location 10:**
**City:** Hot Springs
**Country:** United States
**State:** Arkansas
**Location 11:**
**City:** Jonesboro
**Country:** United States
**State:** Arkansas
**Location 12:**
**City:** Anaheim
**Country:** United States
**State:** California
**Location 13:**
**City:** Bakersfield
**Country:** United States
**State:** California
**Location 14:**
**City:** Berkeley
**Country:** United States
**State:** California
**Location 15:**
**City:** Beverly Hills
**Country:** United States
**State:** California
**Location 16:**
**City:** Chula Vista
**Country:** United States
**State:** California
**Location 17:**
**City:** Covina
**Country:** United States
**State:** California
**Location 18:**
**City:** Downey
**Country:** United States
**State:** California
**Location 19:**
**City:** El Cajon
**Country:** United States
**State:** California
**Location 20:**
**City:** Fullerton
**Country:** United States
**State:** California
**Location 21:**
**City:** Gilroy
**Country:** United States
**State:** California
**Location 22:**
**City:** Glendale
**Country:** United States
**State:** California
**Location 23:**
**City:** La Mesa
**Country:** United States
**State:** California
**Location 24:**
**City:** Long Beach
**Country:** United States
**State:** California
**Location 25:**
**City:** Los Angeles
**Country:** United States
**State:** California
**Location 26:**
**City:** Lynwood
**Country:** United States
**State:** California
**Location 27:**
**City:** Modesto
**Country:** United States
**State:** California
**Location 28:**
**City:** Montebello
**Country:** United States
**State:** California
**Location 29:**
**City:** Northridge
**Country:** United States
**State:** California
**Location 30:**
**City:** Oceanside
**Country:** United States
**State:** California
**Location 31:**
**City:** Orange
**Country:** United States
**State:** California
**Location 32:**
**City:** Redondo Beach
**Country:** United States
**State:** California
**Location 33:**
**City:** San Diego
**Country:** United States
**State:** California
**Location 34:**
**City:** San Francisco
**Country:** United States
**State:** California
**Location 35:**
**City:** San Luis Obispo
**Country:** United States
**State:** California
**Location 36:**
**City:** Santa Ana
**Country:** United States
**State:** California
**Location 37:**
**City:** Santa Maria
**Country:** United States
**State:** California
**Location 38:**
**City:** Santa Monica
**Country:** United States
**State:** California
**Location 39:**
**City:** Torrance
**Country:** United States
**State:** California
**Location 40:**
**City:** Whittier
**Country:** United States
**State:** California
**Location 41:**
**City:** Aurora
**Country:** United States
**State:** Colorado
**Location 42:**
**City:** Boulder
**Country:** United States
**State:** Colorado
**Location 43:**
**City:** Colorado Springs
**Country:** United States
**State:** Colorado
**Location 44:**
**City:** Denver
**Country:** United States
**State:** Colorado
**Location 45:**
**City:** Grand Junction
**Country:** United States
**State:** Colorado
**Location 46:**
**City:** Longmont
**Country:** United States
**State:** Colorado
**Location 47:**
**City:** Thornton
**Country:** United States
**State:** Colorado
**Location 48:**
**City:** New Britain
**Country:** United States
**State:** Connecticut
**Location 49:**
**City:** New Haven
**Country:** United States
**State:** Connecticut
**Location 50:**
**City:** Southington
**Country:** United States
**State:** Connecticut
**Location 51:**
**City:** Trumbull
**Country:** United States
**State:** Connecticut
**Location 52:**
**City:** Newark
**Country:** United States
**State:** Delaware
**Location 53:**
**City:** Boca Raton
**Country:** United States
**State:** Florida
**Location 54:**
**City:** Hollywood
**Country:** United States
**State:** Florida
**Location 55:**
**City:** Miami
**Country:** United States
**State:** Florida
**Location 56:**
**City:** Pembroke Pines
**Country:** United States
**State:** Florida
**Location 57:**
**City:** Atlanta
**Country:** United States
**State:** Georgia
**Location 58:**
**City:** Austell
**Country:** United States
**State:** Georgia
**Location 59:**
**City:** Carrollton
**Country:** United States
**State:** Georgia
**Location 60:**
**City:** Cartersville
**Country:** United States
**State:** Georgia
**Location 61:**
**City:** Douglasville
**Country:** United States
**State:** Georgia
**Location 62:**
**City:** Marietta
**Country:** United States
**State:** Georgia
**Location 63:**
**City:** Newnan
**Country:** United States
**State:** Georgia
**Location 64:**
**City:** Rome
**Country:** United States
**State:** Georgia
**Location 65:**
**City:** Thomasville
**Country:** United States
**State:** Georgia
**Location 66:**
**City:** Arlington Heights
**Country:** United States
**State:** Illinois
**Location 67:**
**City:** Chicago
**Country:** United States
**State:** Illinois
**Location 68:**
**City:** Hinsdale
**Country:** United States
**State:** Illinois
**Location 69:**
**City:** Niles
**Country:** United States
**State:** Illinois
**Location 70:**
**City:** Urbana
**Country:** United States
**State:** Illinois
**Location 71:**
**City:** Goshen
**Country:** United States
**State:** Indiana
**Location 72:**
**City:** Indianapolis
**Country:** United States
**State:** Indiana
**Location 73:**
**City:** Topeka
**Country:** United States
**State:** Kansas
**Location 74:**
**City:** Ashland
**Country:** United States
**State:** Kentucky
**Location 75:**
**City:** Louisville
**Country:** United States
**State:** Kentucky
**Location 76:**
**City:** Metairie
**Country:** United States
**State:** Louisiana
**Location 77:**
**City:** New Orleans
**Country:** United States
**State:** Louisiana
**Location 78:**
**City:** Scarborough
**Country:** United States
**State:** Maine
**Location 79:**
**City:** Annapolis
**Country:** United States
**State:** Maryland
**Location 80:**
**City:** Baltimore
**Country:** United States
**State:** Maryland
**Location 81:**
**City:** Bethesda
**Country:** United States
**State:** Maryland
**Location 82:**
**City:** Rockville
**Country:** United States
**State:** Maryland
**Location 83:**
**City:** Worcester
**Country:** United States
**State:** Massachusetts
**Location 84:**
**City:** Ann Arbor
**Country:** United States
**State:** Michigan
**Location 85:**
**City:** Detroit
**Country:** United States
**State:** Michigan
**Location 86:**
**City:** Kalamazoo
**Country:** United States
**State:** Michigan
**Location 87:**
**City:** Lansing
**Country:** United States
**State:** Michigan
**Location 88:**
**City:** Woodbury
**Country:** United States
**State:** Minnesota
**Location 89:**
**City:** Bolivar
**Country:** United States
**State:** Missouri
**Location 90:**
**City:** Kansas City
**Country:** United States
**State:** Missouri
**Location 91:**
**City:** Saint Louis
**Country:** United States
**State:** Missouri
**Location 92:**
**City:** Kalispell
**Country:** United States
**State:** Montana
**Location 93:**
**City:** Hastings
**Country:** United States
**State:** Nebraska
**Location 94:**
**City:** Omaha
**Country:** United States
**State:** Nebraska
**Location 95:**
**City:** Papillion
**Country:** United States
**State:** Nebraska
**Location 96:**
**City:** Las Vegas
**Country:** United States
**State:** Nevada
**Location 97:**
**City:** Lebanon
**Country:** United States
**State:** New Hampshire
**Location 98:**
**City:** East Orange
**Country:** United States
**State:** New Jersey
**Location 99:**
**City:** Farmington
**Country:** United States
**State:** New Mexico
**Location 100:**
**City:** Binghamton
**Country:** United States
**State:** New York
**Location 101:**
**City:** Bronx
**Country:** United States
**State:** New York
**Location 102:**
**City:** Fresh Meadows
**Country:** United States
**State:** New York
**Location 103:**
**City:** Hudson
**Country:** United States
**State:** New York
**Location 104:**
**City:** Johnson City
**Country:** United States
**State:** New York
**Location 105:**
**City:** New York
**Country:** United States
**State:** New York
**Location 106:**
**City:** Nyack
**Country:** United States
**State:** New York
**Location 107:**
**City:** Rochester
**Country:** United States
**State:** New York
**Location 108:**
**City:** Durham
**Country:** United States
**State:** North Carolina
**Location 109:**
**City:** Wake Forest
**Country:** United States
**State:** North Carolina
**Location 110:**
**City:** Winston-Salem
**Country:** United States
**State:** North Carolina
**Location 111:**
**City:** Canton
**Country:** United States
**State:** Ohio
**Location 112:**
**City:** Columbus
**Country:** United States
**State:** Ohio
**Location 113:**
**City:** Middletown
**Country:** United States
**State:** Ohio
**Location 114:**
**City:** Oregon
**Country:** United States
**State:** Ohio
**Location 115:**
**City:** Toledo
**Country:** United States
**State:** Ohio
**Location 116:**
**City:** Eugene
**Country:** United States
**State:** Oregon
**Location 117:**
**City:** Portland
**Country:** United States
**State:** Oregon
**Location 118:**
**City:** Springfield
**Country:** United States
**State:** Oregon
**Location 119:**
**City:** Tualatin
**Country:** United States
**State:** Oregon
**Location 120:**
**City:** Philadelphia
**Country:** United States
**State:** Pennsylvania
**Location 121:**
**City:** Charleston
**Country:** United States
**State:** South Carolina
**Location 122:**
**City:** Seneca
**Country:** United States
**State:** South Carolina
**Location 123:**
**City:** Spartanburg
**Country:** United States
**State:** South Carolina
**Location 124:**
**City:** Chattanooga
**Country:** United States
**State:** Tennessee
**Location 125:**
**City:** Knoxville
**Country:** United States
**State:** Tennessee
**Location 126:**
**City:** Memphis
**Country:** United States
**State:** Tennessee
**Location 127:**
**City:** Nashville
**Country:** United States
**State:** Tennessee
**Location 128:**
**City:** Arlington
**Country:** United States
**State:** Texas
**Location 129:**
**City:** Austin
**Country:** United States
**State:** Texas
**Location 130:**
**City:** Beaumont
**Country:** United States
**State:** Texas
**Location 131:**
**City:** Bedford
**Country:** United States
**State:** Texas
**Location 132:**
**City:** Cedar Park
**Country:** United States
**State:** Texas
**Location 133:**
**City:** Dallas
**Country:** United States
**State:** Texas
**Location 134:**
**City:** Denton
**Country:** United States
**State:** Texas
**Location 135:**
**City:** El Paso
**Country:** United States
**State:** Texas
**Location 136:**
**City:** Fort Worth
**Country:** United States
**State:** Texas
**Location 137:**
**City:** Houston
**Country:** United States
**State:** Texas
**Location 138:**
**City:** Plano
**Country:** United States
**State:** Texas
**Location 139:**
**City:** Round Rock
**Country:** United States
**State:** Texas
**Location 140:**
**City:** San Antonio
**Country:** United States
**State:** Texas
**Location 141:**
**City:** Temple
**Country:** United States
**State:** Texas
**Location 142:**
**City:** Tyler
**Country:** United States
**State:** Texas
**Location 143:**
**City:** Waco
**Country:** United States
**State:** Texas
**Location 144:**
**City:** Ogden
**Country:** United States
**State:** Utah
**Location 145:**
**City:** Salt Lake City
**Country:** United States
**State:** Utah
**Location 146:**
**City:** Blacksburg
**Country:** United States
**State:** Virginia
**Location 147:**
**City:** Richmond
**Country:** United States
**State:** Virginia
**Location 148:**
**City:** Roanoke
**Country:** United States
**State:** Virginia
**Location 149:**
**City:** Salem
**Country:** United States
**State:** Virginia
**Location 150:**
**City:** Wytheville
**Country:** United States
**State:** Virginia
**Location 151:**
**City:** Seattle
**Country:** United States
**State:** Washington
**Location 152:**
**City:** Vancouver
**Country:** United States
**State:** Washington
**Location 153:**
**City:** Madison
**Country:** United States
**State:** Wisconsin
**Location 154:**
**City:** Australian Capital Territory
**Country:** Australia
**Location 155:**
**City:** New South Wales
**Country:** Australia
**Location 156:**
**City:** South Australia
**Country:** Australia
**Location 157:**
**City:** Victoria
**Country:** Australia
**Location 158:**
**City:** Aalst
**Country:** Belgium
**Location 159:**
**City:** Brugge
**Country:** Belgium
**Location 160:**
**City:** Bruxelles
**Country:** Belgium
**Location 161:**
**City:** Edegem
**Country:** Belgium
**Location 162:**
**City:** Gent
**Country:** Belgium
**Location 163:**
**City:** Gilly
**Country:** Belgium
**Location 164:**
**City:** Kortrijk
**Country:** Belgium
**Location 165:**
**City:** Leuven
**Country:** Belgium
**Location 166:**
**City:** Calgary
**Country:** Canada
**State:** Alberta
**Location 167:**
**City:** Oshawa
**Country:** Canada
**State:** Ontario
**Location 168:**
**City:** Sault Ste. Marie
**Country:** Canada
**State:** Ontario
**Location 169:**
**City:** Toronto
**Country:** Canada
**State:** Ontario
**Location 170:**
**City:** Greenfield Park
**Country:** Canada
**State:** Quebec
**Location 171:**
**City:** Laval
**Country:** Canada
**State:** Quebec
**Location 172:**
**City:** Montreal
**Country:** Canada
**State:** Quebec
**Location 173:**
**City:** Aschaffenburg
**Country:** Germany
**Location 174:**
**City:** Berlin
**Country:** Germany
**Location 175:**
**City:** Bochum
**Country:** Germany
**Location 176:**
**City:** Essen
**Country:** Germany
**Location 177:**
**City:** Frankford
**Country:** Germany
**Location 178:**
**City:** Koeln
**Country:** Germany
**Location 179:**
**City:** Velbert
**Country:** Germany
**Location 180:**
**City:** Aviano
**Country:** Italy
**Location 181:**
**City:** Bari
**Country:** Italy
**Location 182:**
**City:** Bergamo
**Country:** Italy
**Location 183:**
**City:** Brescia
**Country:** Italy
**Location 184:**
**City:** Cremona
**Country:** Italy
**Location 185:**
**City:** Firenze
**Country:** Italy
**Location 186:**
**City:** Genova
**Country:** Italy
**Location 187:**
**City:** Lido di Camaiore
**Country:** Italy
**Location 188:**
**City:** Milano
**Country:** Italy
**Location 189:**
**City:** Napoli
**Country:** Italy
**Location 190:**
**City:** Pisa
**Country:** Italy
**Location 191:**
**City:** Rimini
**Country:** Italy
**Location 192:**
**City:** Roma
**Country:** Italy
**Location 193:**
**City:** Hwasun-gun
**Country:** Korea, Republic of
**Location 194:**
**City:** Seongnam-si
**Country:** Korea, Republic of
**Location 195:**
**City:** Seoul
**Country:** Korea, Republic of
**Location 196:**
**City:** Auckland
**Country:** New Zealand
**Location 197:**
**City:** Christchurch
**Country:** New Zealand
**Location 198:**
**City:** Hamilton
**Country:** New Zealand
**Location 199:**
**City:** Badajoz
**Country:** Spain
**Location 200:**
**City:** Barcelona
**Country:** Spain
**Location 201:**
**City:** Madrid
**Country:** Spain
**Location 202:**
**City:** Malaga
**Country:** Spain
**Location 203:**
**City:** Seville
**Country:** Spain
**Location 204:**
**City:** Taichung
**Country:** Taiwan
**Location 205:**
**City:** Tainan
**Country:** Taiwan
**Location 206:**
**City:** Taipei
**Country:** Taiwan
**Location 207:**
**City:** Patumwan
**Country:** Thailand
**Location 208:**
**City:** Ratchathewi
**Country:** Thailand
**Location 209:**
**City:** Seetatarom
**Country:** Thailand
**Location 210:**
**City:** Aberdeen
**Country:** United Kingdom
**Location 211:**
**City:** Bangor
**Country:** United Kingdom
**Location 212:**
**City:** Birmingham
**Country:** United Kingdom
**Location 213:**
**City:** Boston
**Country:** United Kingdom
**Location 214:**
**City:** Bristol
**Country:** United Kingdom
**Location 215:**
**City:** Cardiff
**Country:** United Kingdom
**Location 216:**
**City:** Glasgow
**Country:** United Kingdom
**Location 217:**
**City:** Guildford
**Country:** United Kingdom
**Location 218:**
**City:** Harlow
**Country:** United Kingdom
**Location 219:**
**City:** Huddersfield
**Country:** United Kingdom
**Location 220:**
**City:** Lancaster
**Country:** United Kingdom
**Location 221:**
**City:** Leeds
**Country:** United Kingdom
**Location 222:**
**City:** London
**Country:** United Kingdom
**Location 223:**
**City:** Manchester
**Country:** United Kingdom
**Location 224:**
**City:** Newcastle upon Tyne
**Country:** United Kingdom
**Location 225:**
**City:** Nottingham
**Country:** United Kingdom
**Location 226:**
**City:** Plymouth
**Country:** United Kingdom
**Location 227:**
**City:** Southampton
**Country:** United Kingdom
**Location 228:**
**City:** Sutton
**Country:** United Kingdom
**Location 229:**
**City:** Welwyn Garden City
**Country:** United Kingdom
**Location 230:**
**City:** Wirral
**Country:** United Kingdom
#### Overall Officials
**Official 1:**
**Affiliation:** Incyte Corporation
**Name:** Fitzroy Dawkins, M.D.
**Role:** STUDY_DIRECTOR
### References Module
#### References
**Citation:** Hurwitz H, Van Cutsem E, Bendell J, Hidalgo M, Li CP, Salvo MG, Macarulla T, Sahai V, Sama A, Greeno E, Yu KH, Verslype C, Dawkins F, Walker C, Clark J, O'Reilly EM. Ruxolitinib + capecitabine in advanced/metastatic pancreatic cancer after disease progression/intolerance to first-line therapy: JANUS 1 and 2 randomized phase III studies. Invest New Drugs. 2018 Aug;36(4):683-695. doi: 10.1007/s10637-018-0580-2. Epub 2018 Mar 6.
**PMID:** 29508247
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000004067
- Term: Digestive System Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000004701
- Term: Endocrine Gland Neoplasms
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000010182
- Term: Pancreatic Diseases
- ID: D000004700
- Term: Endocrine System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M13110
- Name: Pancreatic Neoplasms
- Relevance: HIGH
- As Found: Pancreatic Cancer
- ID: M3585
- Name: Adenocarcinoma
- Relevance: LOW
- As Found: Unknown
- ID: M14850
- Name: Recurrence
- Relevance: LOW
- As Found: Unknown
- ID: M8886
- Name: Gastrointestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M7256
- Name: Digestive System Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M7863
- Name: Endocrine Gland Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M13102
- Name: Pancreatic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7862
- Name: Endocrine System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T4387
- Name: Pancreatic Cancer
- Relevance: HIGH
- As Found: Pancreatic Cancer
### Condition Browse Module - Meshes
- ID: D000010190
- Term: Pancreatic Neoplasms
### Intervention Browse Module - Ancestors
- ID: D000000964
- Term: Antimetabolites, Antineoplastic
- ID: D000000963
- Term: Antimetabolites
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000000970
- Term: Antineoplastic Agents
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Gast
- Name: Gastrointestinal Agents
### Intervention Browse Module - Browse Leaves
- ID: M377
- Name: Capecitabine
- Relevance: HIGH
- As Found: Function
- ID: M22554
- Name: Pancrelipase
- Relevance: LOW
- As Found: Unknown
- ID: M13114
- Name: Pancreatin
- Relevance: LOW
- As Found: Unknown
- ID: M4281
- Name: Antimetabolites
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000069287
- Term: Capecitabine
### Misc Info Module
- Version Holder: 2024-05-24
## Results Section
### Adverse Events Module
**Description:** The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
#### Event Groups
**Group ID:** EG000
**Title:** Ruxolitinib Plus Capecitabine
**Description:** Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
**ID:** EG000
**Other Num Affected:** 147
**Other Num at Risk:** 153
**Serious Number Affected:** 94
**Serious Number At Risk:** 153
**Title:** Ruxolitinib Plus Capecitabine
**Group ID:** EG001
**Title:** Placebo Plus Capecitabine
**Description:** Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
**ID:** EG001
**Other Num Affected:** 145
**Other Num at Risk:** 154
**Serious Number Affected:** 83
**Serious Number At Risk:** 154
**Title:** Placebo Plus Capecitabine
**Frequency Threshold:** 5
#### Other Events
**Term:** Nausea
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (17.0)
**Term:** Anemia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Blood and lymphatic system disorders
**Source Vocabulary:** MedDRA (17.0)
**Term:** Fatigue
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA (17.0)
**Term:** Diarrhea
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (17.0)
**Term:** Abdominal pain
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (17.0)
**Term:** Palmar-plantar erythrodysaesthesia syndrome
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
**Source Vocabulary:** MedDRA (17.0)
**Term:** Vomiting
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (17.0)
**Term:** Constipation
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (17.0)
**Term:** Stomatitis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (17.0)
**Term:** Decreased appetite
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
**Source Vocabulary:** MedDRA (17.0)
**Term:** Pyrexia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA (17.0)
**Term:** Ascites
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (17.0)
**Term:** Back pain
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Musculoskeletal and connective tissue disorders
**Source Vocabulary:** MedDRA (17.0)
**Term:** Dizziness
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
**Source Vocabulary:** MedDRA (17.0)
**Term:** Oedema peripheral
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA (17.0)
**Term:** Asthenia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA (17.0)
**Term:** Abdominal distension
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (17.0)
**Term:** Dehydration
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
**Source Vocabulary:** MedDRA (17.0)
**Term:** Hypotension
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Vascular disorders
**Source Vocabulary:** MedDRA (17.0)
**Term:** Abdominal pain upper
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (17.0)
**Term:** Hyponatraemia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
**Source Vocabulary:** MedDRA (17.0)
**Term:** Insomnia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Psychiatric disorders
**Source Vocabulary:** MedDRA (17.0)
**Term:** Dyspnoea
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
**Source Vocabulary:** MedDRA (17.0)
**Term:** Oedema
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA (17.0)
**Term:** Urinary tract infection
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA (17.0)
**Term:** Aspartate aminotransferase increased
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:** MedDRA (17.0)
**Term:** Cough
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
**Source Vocabulary:** MedDRA (17.0)
**Term:** Fall
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Injury, poisoning and procedural complications
**Source Vocabulary:** MedDRA (17.0)
**Term:** Weight decreased
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:** MedDRA (17.0)
**Term:** Alanine aminotransferase increased
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:** MedDRA (17.0)
**Term:** Flatulence
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (17.0)
**Term:** Hiccups
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
**Source Vocabulary:** MedDRA (17.0)
**Term:** Pleural effusion
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
**Source Vocabulary:** MedDRA (17.0)
**Term:** Arthralgia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Musculoskeletal and connective tissue disorders
**Source Vocabulary:** MedDRA (17.0)
**Term:** Chills
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA (17.0)
**Term:** Hypertension
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Vascular disorders
**Source Vocabulary:** MedDRA (17.0)
**Term:** Muscular weakness
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Musculoskeletal and connective tissue disorders
**Source Vocabulary:** MedDRA (17.0)
**Term:** Pain in extremity
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Musculoskeletal and connective tissue disorders
**Source Vocabulary:** MedDRA (17.0)
**Term:** Hyperglycaemia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
**Source Vocabulary:** MedDRA (17.0)
**Term:** Dysgeusia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
**Source Vocabulary:** MedDRA (17.0)
**Term:** Dry mouth
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (17.0)
**Term:** Hypokalaemia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
**Source Vocabulary:** MedDRA (17.0)
#### Serious Events
**Term:** Anaemia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Blood and lymphatic system disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 4
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 3
**Num At Risk:** 154
**Term:** Disseminated intravascular coagulation
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Blood and lymphatic system disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 154
**Term:** Febrile neutropenia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Blood and lymphatic system disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 2
**Num At Risk:** 154
**Term:** Leukocytosis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Blood and lymphatic system disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 154
**Term:** Neutropenia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Blood and lymphatic system disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 2
**Num At Risk:** 154
**Term:** Pancytopenia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Blood and lymphatic system disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 154
**Term:** Acute myocardial infarction
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Cardiac disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 154
**Term:** Cardiac arrest
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Cardiac disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 2
**Num At Risk:** 153
**Group ID:** EG001
**Num At Risk:** 154
**Term:** Cardiac failure
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Cardiac disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 153
**Group ID:** EG001
**Num At Risk:** 154
**Term:** Coronary artery disease
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Cardiac disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 153
**Group ID:** EG001
**Num At Risk:** 154
**Term:** Myocardial infarction
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Cardiac disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 2
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 154
**Term:** Sinus tachycardia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Cardiac disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 154
**Term:** Tachycardia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Cardiac disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 154
**Term:** Conjunctival haemorrhage
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Eye disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 153
**Group ID:** EG001
**Num At Risk:** 154
**Term:** Abdominal distension
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 154
**Term:** Abdominal pain
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 6
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 19
**Num At Risk:** 154
**Term:** Abdominal pain upper
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 154
**Term:** Ascites
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 5
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 154
**Term:** Colitis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 153
**Group ID:** EG001
**Num At Risk:** 154
**Term:** Constipation
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 4
**Num At Risk:** 154
**Term:** Diarrhoea
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 5
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 4
**Num At Risk:** 154
**Term:** Duodenal obstruction
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 2
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 3
**Num At Risk:** 154
**Term:** Duodenal stenosis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 154
**Term:** Dysphagia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 154
**Term:** Enteritis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 153
**Group ID:** EG001
**Num At Risk:** 154
**Term:** Enterocolitis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 153
**Group ID:** EG001
**Num At Risk:** 154
**Term:** Gastrointestinal haemorrhage
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 2
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 154
**Term:** Haematemesis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 153
**Group ID:** EG001
**Num At Risk:** 154
**Term:** Ileus
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 153
**Group ID:** EG001
**Num At Risk:** 154
**Term:** Impaired gastric emptying
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 154
**Term:** Intestinal infarction
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 154
**Term:** Intestinal obstruction
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 2
**Num At Risk:** 154
**Term:** Intestinal perforation
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 153
**Group ID:** EG001
**Num At Risk:** 154
**Term:** Melaena
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 154
**Term:** Nausea
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 4
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 5
**Num At Risk:** 154
**Term:** Obstruction gastric
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 153
**Group ID:** EG001
**Num At Risk:** 154
**Term:** Oesophageal varices haemorrhage
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 153
**Group ID:** EG001
**Num At Risk:** 154
**Term:** Pancreatic pseudocyst
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 154
**Term:** Peritoneal haemorrhage
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 154
**Term:** Small intestinal obstruction
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 2
**Num At Risk:** 154
**Term:** Stomatitis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 2
**Num At Risk:** 153
**Group ID:** EG001
**Num At Risk:** 154
**Term:** Upper gastrointestinal haemorrhage
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 3
**Num At Risk:** 154
**Term:** Vomiting
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 7
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 4
**Num At Risk:** 154
**Term:** Asthenia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 3
**Num At Risk:** 154
**Term:** Device leakage
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 154
**Term:** Device malfunction
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 153
**Group ID:** EG001
**Num At Risk:** 154
**Term:** Fatigue
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 154
**Term:** General physical health deterioration
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 3
**Num At Risk:** 154
**Term:** Hypothermia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 153
**Group ID:** EG001
**Num At Risk:** 154
**Term:** Malaise
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 154
**Term:** Multi-organ failure
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 153
**Group ID:** EG001
**Num At Risk:** 154
**Term:** Oedema
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 154
**Term:** Pain
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 3
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 2
**Num At Risk:** 154
**Term:** Pyrexia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 8
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 154
**Term:** Systemic inflammatory response syndrome
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 154
**Term:** Bile duct obstruction
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Hepatobiliary disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 3
**Num At Risk:** 154
**Term:** Bile duct stenosis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Hepatobiliary disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 153
**Group ID:** EG001
**Num At Risk:** 154
**Term:** Biliary dilatation
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Hepatobiliary disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 154
**Term:** Biloma
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Hepatobiliary disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 154
**Term:** Cholangitis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Hepatobiliary disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 3
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 2
**Num At Risk:** 154
**Term:** Cholecystitis acute
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Hepatobiliary disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 153
**Group ID:** EG001
**Num At Risk:** 154
**Term:** Cholelithiasis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Hepatobiliary disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 154
**Term:** Hepatic failure
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Hepatobiliary disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 153
**Group ID:** EG001
**Num At Risk:** 154
**Term:** Hepatic function abnormal
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Hepatobiliary disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 153
**Group ID:** EG001
**Num At Risk:** 154
**Term:** Hyperbilirubinaemia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Hepatobiliary disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 2
**Num At Risk:** 154
**Term:** Jaundice
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Hepatobiliary disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 3
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 3
**Num At Risk:** 154
**Term:** Jaundice cholestatic
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Hepatobiliary disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 154
**Term:** Portal vein thrombosis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Hepatobiliary disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 154
**Term:** Bacteraemia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 2
**Num At Risk:** 154
**Term:** Biliary sepsis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 2
**Num At Risk:** 154
**Term:** Biliary tract infection
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 2
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 154
**Term:** Bronchitis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 153
**Group ID:** EG001
**Num At Risk:** 154
**Term:** Candida infection
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 153
**Group ID:** EG001
**Num At Risk:** 154
**Term:** Cholangitis suppurative
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 153
**Group ID:** EG001
**Num At Risk:** 154
**Term:** Device related infection
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 153
**Group ID:** EG001
**Num At Risk:** 154
**Term:** Escherichia infection
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 153
**Group ID:** EG001
**Num At Risk:** 154
**Term:** Infection
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 2
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 154
**Term:** Klebsiella infection
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 2
**Num At Risk:** 153
**Group ID:** EG001
**Num At Risk:** 154
**Term:** Klebsiella sepsis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 153
**Group ID:** EG001
**Num At Risk:** 154
**Term:** Liver abscess
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 154
**Term:** Lower respiratory tract infection
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 153
**Group ID:** EG001
**Num At Risk:** 154
**Term:** Peritonitis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 153
**Group ID:** EG001
**Num At Risk:** 154
**Term:** Peritonitis bacterial
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 153
**Group ID:** EG001
**Num At Risk:** 154
**Term:** Pneumonia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 4
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 7
**Num At Risk:** 154
**Term:** Pneumonia klebsiella
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 154
**Term:** Postoperative abscess
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 154
**Term:** Sepsis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 5
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 5
**Num At Risk:** 154
**Term:** Septic shock
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 2
**Num At Risk:** 154
**Term:** Skin candida
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 153
**Group ID:** EG001
**Num At Risk:** 154
**Term:** Urinary tract infection
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 2
**Num At Risk:** 153
**Group ID:** EG001
**Num At Risk:** 154
**Term:** Accidental overdose
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Injury, poisoning and procedural complications
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 153
**Group ID:** EG001
**Num At Risk:** 154
**Term:** Fall
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Injury, poisoning and procedural complications
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 153
**Group ID:** EG001
**Num At Risk:** 154
**Term:** Spinal compression fracture
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Injury, poisoning and procedural complications
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 153
**Group ID:** EG001
**Num At Risk:** 154
**Term:** Blood bilirubin increased
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 4
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 154
**Term:** Hepatic enzyme increased
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 154
**Term:** Liver function test abnormal
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 153
**Group ID:** EG001
**Num At Risk:** 154
**Term:** Platelet count decreased
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 153
**Group ID:** EG001
**Num At Risk:** 154
**Term:** Transaminases increased
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 153
**Group ID:** EG001
**Num At Risk:** 154
**Term:** White blood cell count decreased
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 153
**Group ID:** EG001
**Num At Risk:** 154
**Term:** Decreased appetite
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 154
**Term:** Dehydration
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 7
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 4
**Num At Risk:** 154
**Term:** Failure to thrive
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 2
**Num At Risk:** 154
**Term:** Hyperglycaemia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 3
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 2
**Num At Risk:** 154
**Term:** Hyperkalaemia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 2
**Num At Risk:** 153
**Group ID:** EG001
**Num At Risk:** 154
**Term:** Hypoglycaemia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 3
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 154
**Term:** Hypokalaemia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 2
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 2
**Num At Risk:** 154
**Term:** Hyponatraemia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 5
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 154
**Term:** Hypovolaemia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 154
**Term:** Malnutrition
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 154
**Term:** Back pain
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Musculoskeletal and connective tissue disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 3
**Num At Risk:** 154
**Term:** Flank pain
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Musculoskeletal and connective tissue disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 2
**Num At Risk:** 154
**Term:** Mobility decreased
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Musculoskeletal and connective tissue disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 154
**Term:** Muscular weakness
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Musculoskeletal and connective tissue disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 3
**Num At Risk:** 154
**Term:** Musculoskeletal pain
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Musculoskeletal and connective tissue disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 154
**Term:** Cancer pain
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 2
**Num At Risk:** 153
**Group ID:** EG001
**Num At Risk:** 154
**Term:** Metastases to peritoneum
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 153
**Group ID:** EG001
**Num At Risk:** 154
**Term:** Small intestine carcinoma metastatic
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 153
**Group ID:** EG001
**Num At Risk:** 154
**Term:** Tumour associated fever
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 2
**Num At Risk:** 153
**Group ID:** EG001
**Num At Risk:** 154
**Term:** Tumour pain
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 153
**Group ID:** EG001
**Num At Risk:** 154
**Term:** Complex regional pain syndrome
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 153
**Group ID:** EG001
**Num At Risk:** 154
**Term:** Dizziness
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 154
**Term:** Encephalopathy
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 154
**Term:** Headache
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 153
**Group ID:** EG001
**Num At Risk:** 154
**Term:** Ischaemic stroke
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 153
**Group ID:** EG001
**Num At Risk:** 154
**Term:** Lethargy
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 154
**Term:** Parkinson's disease
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 153
**Group ID:** EG001
**Num At Risk:** 154
**Term:** Syncope
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 154
**Term:** Unresponsive to stimuli
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 154
**Term:** Confusional state
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Psychiatric disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 154
**Term:** Delirium
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Psychiatric disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 2
**Num At Risk:** 153
**Group ID:** EG001
**Num At Risk:** 154
**Term:** Mental status changes
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Psychiatric disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 153
**Group ID:** EG001
**Num At Risk:** 154
**Term:** Renal failure
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Renal and urinary disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 3
**Num At Risk:** 153
**Group ID:** EG001
**Num At Risk:** 154
**Term:** Renal failure acute
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Renal and urinary disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 5
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 154
**Term:** Ureteric obstruction
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Renal and urinary disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 153
**Group ID:** EG001
**Num At Risk:** 154
**Term:** Atelectasis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 154
**Term:** Chronic obstructive pulmonary disease
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 153
**Group ID:** EG001
**Num At Risk:** 154
**Term:** Cough
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 154
**Term:** Dyspnoea
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 5
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 4
**Num At Risk:** 154
**Term:** Epistaxis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 153
**Group ID:** EG001
**Num At Risk:** 154
**Term:** Hypoxia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 154
**Term:** Pleural effusion
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 5
**Num At Risk:** 154
**Term:** Pulmonary embolism
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 5
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 2
**Num At Risk:** 154
**Term:** Pulmonary oedema
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 154
**Term:** Respiratory arrest
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 153
**Group ID:** EG001
**Num At Risk:** 154
**Term:** Respiratory failure
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 153
**Group ID:** EG001
**Num At Risk:** 154
**Term:** Skin ulcer
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 154
**Term:** Embolism
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Vascular disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 2
**Num At Risk:** 154
**Term:** Haematoma
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Vascular disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 153
**Group ID:** EG001
**Num At Risk:** 154
**Term:** Hypertension
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Vascular disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 154
**Term:** Hypotension
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Vascular disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num Affected:** 3
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 2
**Num At Risk:** 154
**Term:** Phlebitis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Vascular disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 154
**Term:** Anxiety
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Psychiatric disorders
**Source Vocabulary:** MedDRA (17.0)
##### Stats
**Group ID:** EG000
**Num At Risk:** 153
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 154
**Time Frame:** From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
## Results Section - Baseline Characteristics Module
### Denomination Counts
**Group ID:** BG000
**Value:** 161
**Group ID:** BG001
**Value:** 160
**Group ID:** BG002
**Value:** 321
**Units:** Participants
### Group
**ID:** BG000
**Title:** Ruxolitinib Plus Capecitabine
**Description:** Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
### Group
**ID:** BG001
**Title:** Placebo Plus Capecitabine
**Description:** Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
### Group
**ID:** BG002
**Title:** Total
**Description:** Total of all reporting groups
### Measure
#### Measurement
**Group ID:** BG000
**Spread:** 9.35
**Value:** 67.3
#### Measurement
**Group ID:** BG001
**Spread:** 9.55
**Value:** 65.6
#### Measurement
**Group ID:** BG002
**Spread:** 9.48
**Value:** 66.4
**Class Title:**
### Measure
#### Measurement
**Group ID:** BG000
**Value:** 65
#### Measurement
**Group ID:** BG001
**Value:** 68
#### Measurement
**Group ID:** BG002
**Value:** 133
**Class Title:** ≤ 65 years
#### Measurement
**Group ID:** BG000
**Value:** 96
#### Measurement
**Group ID:** BG001
**Value:** 92
#### Measurement
**Group ID:** BG002
**Value:** 188
**Class Title:** > 65 years
### Measure
#### Measurement
**Group ID:** BG000
**Value:** 66
#### Measurement
**Group ID:** BG001
**Value:** 64
#### Measurement
**Group ID:** BG002
**Value:** 130
**Category Title:** Female
#### Measurement
**Group ID:** BG000
**Value:** 95
#### Measurement
**Group ID:** BG001
**Value:** 96
#### Measurement
**Group ID:** BG002
**Value:** 191
**Category Title:** Male
**Class Title:**
**Denomination Units Selected:**
## Results Section - Baseline Characteristics Module
### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** NUMBER
**Title:** Age, Customized
**Unit of Measure:** participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
**Population Description:** The intent-to-treat (ITT) population consisted of all participants randomized to the study.
## Results Section - More Information Module
### Certain Agreement
**Other Details:** Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
**Restriction Type:** OTHER
**Restrictive Agreement:** True
### Limitations and Caveats
**Description:** The study was terminated as other related studies of ruxolitinib did not provide sufficient efficacy to warrant continuation at the recommendation of the Data Monitoring Committee.
### Point of Contact
**Organization:** Incyte Corporation
**Phone:** 855 463-3463
**Title:** Study Director
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** 0.747
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.256
**CI Upper Limit Comment:**
**Dispersion Type:**
**Dispersion Value:**
**Estimate Comment:**
**Group Description:**
**Non-Inferiority Comment:**
**Non-Inferiority Type:** OTHER
**Other Analysis Description:**
**P-Value:**
**P-Value Comment:**
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.969
**Statistical Comment:**
**Statistical Method:**
**Tested Non-Inferiority:**
### Outcome Measure 2
#### Analysis
**CI Lower Limit:** 0.827
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.348
**CI Upper Limit Comment:**
**Dispersion Type:**
**Dispersion Value:**
**Estimate Comment:**
**Group Description:**
**Non-Inferiority Comment:**
**Non-Inferiority Type:** OTHER
**Other Analysis Description:**
**P-Value:**
**P-Value Comment:**
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 1.056
**Statistical Comment:**
**Statistical Method:**
**Tested Non-Inferiority:**
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
### Outcome Measure 6
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 113
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 124
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 48
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 36
**Title:**
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:** 41.0
- **Spread:**
- **Upper Limit:** 46.0
- **Value:** 43.0
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:** 42.0
- **Spread:**
- **Upper Limit:** 48.0
- **Value:** 44.0
**Title:**
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:** 12.7
- **Spread:**
- **Upper Limit:** 25.9
- **Value:** 18.9
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:** 13.6
- **Spread:**
- **Upper Limit:** 26.8
- **Value:** 19.8
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:** 2.5
- **Spread:**
- **Upper Limit:** 12.2
- **Value:** 6.1
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:** 2.3
- **Spread:**
- **Upper Limit:** 11.3
- **Value:** 5.7
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:** 0.5
- **Spread:**
- **Upper Limit:** 7.5
- **Value:** 2.5
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:** 1.0
- **Spread:**
- **Upper Limit:** 8.5
- **Value:** 3.4
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:** 0.5
- **Spread:**
- **Upper Limit:** 7.5
- **Value:** 2.5
- **Comment:** PFS was not evaluable in the placebo group due to the insufficient number of participants with events.
- **Group ID:** OG001
- **Lower Limit:** NA
- **Spread:**
- **Upper Limit:** NA
- **Value:** NA
**Title:**
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 3.7
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 1.9
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 0
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 0
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 3.7
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 1.9
**Title:**
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** The median duration of response was not evaluable in the treatment group due to the insufficient number of participants with events.
- **Group ID:** OG000
- **Lower Limit:** NA
- **Spread:**
- **Upper Limit:** NA
- **Value:** NA
- **Comment:** The median duration of response was not evaluable in the treatment group due to the insufficient number of participants with events.
- **Group ID:** OG001
- **Lower Limit:** NA
- **Spread:**
- **Upper Limit:** NA
- **Value:** NA
**Title:**
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 152
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 152
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 73
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 59
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 94
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 83
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 112
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 113
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 89
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 75
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 12
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 22
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 68
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 48
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 131
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 122
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 60
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 46
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 20
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 15
**Title:**
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Overall survival is reported here based on the number of deaths from randomization up to 6-months or to the data cutoff 11FEB2016.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** The intent-to-treat (ITT) population consisted of all participants randomized to the study.
**Reporting Status:** POSTED
**Time Frame:** Randomization until death due to any cause; up to the data cutoff 11FEB2016.
**Title:** Overall Survival (OS)
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
**ID:** OG000
**Title:** Ruxolitinib Plus Capecitabine
##### Group
**Description:** Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
**ID:** OG001
**Title:** Placebo Plus Capecitabine
#### Outcome Measure 2
**Description:** Progressive Disease (PD) is defined using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, unequivocal progression of non-target lesions, or the appearance of new lesions.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** The intent-to-treat (ITT) population consisted of all participants randomized to the study.
**Reporting Status:** POSTED
**Time Frame:** Randomization to disease progression, or death due to any cause if sooner; up to 6-months or to the data cutoff 11FEB2016.
**Title:** Progression-free Survival (PFS)
**Type:** SECONDARY
**Unit of Measure:** days
##### Group
**Description:** Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
**ID:** OG000
**Title:** Ruxolitinib Plus Capecitabine
##### Group
**Description:** Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
**ID:** OG001
**Title:** Placebo Plus Capecitabine
#### Outcome Measure 3
**Description:** PFS is defined as the time from randomization until the earliest date of disease progression determined by investigator assessment of objective radiographic disease assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause if sooner. Progressive Disease (PD) is defined using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, unequivocal progression of non-target lesions, or the appearance of new lesions.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** The intent-to-treat (ITT) population consisted of all participants randomized to the study.
**Reporting Status:** POSTED
**Time Frame:** Randomization to disease progression, or death due to any cause if sooner; up to 6-months or to the data cutoff 11FEB2016.
**Title:** Percentage of Participants Achieving Progression Free Survival (PFS)
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
**ID:** OG000
**Title:** Ruxolitinib Plus Capecitabine
##### Group
**Description:** Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
**ID:** OG001
**Title:** Placebo Plus Capecitabine
#### Outcome Measure 4
**Description:** Objective response rate determined by radiographic disease assessments per RECIST (v1.1), by investigator assessment and was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) by Response Evaluation Criteria in Solid Tumours (RECIST) at any post baseline visit. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI) : Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions with no worsening of non-target lesions and no new lesions; Overall Response (OR) = CR + PR.
**Parameter Type:** NUMBER
**Population Description:** The intent-to-treat (ITT) population consisted of all participants randomized to the study.
**Reporting Status:** POSTED
**Time Frame:** Baseline through end of study; up to 6-months or to the data cutoff 11FEB2016.
**Title:** Objective Response Rate (ORR)
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
**ID:** OG000
**Title:** Ruxolitinib Plus Capecitabine
##### Group
**Description:** Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
**ID:** OG001
**Title:** Placebo Plus Capecitabine
#### Outcome Measure 5
**Description:** Duration of overall response was defined as the time in months from Complete Response (CR) or Partial Response (PR) by Response Evaluation Criteria in Solid Tumours (RECIST v1.1) until the first date Progressive Disease (PD) was objectively documented or until the date of death.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** The intent-to-treat (ITT) population consisted of all participants randomized to the study.
**Reporting Status:** POSTED
**Time Frame:** Baseline through end of study; up to 6-months or to the data cutoff 11FEB2016.
**Title:** Duration of Response
**Type:** SECONDARY
**Unit of Measure:** days
##### Group
**Description:** Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
**ID:** OG000
**Title:** Ruxolitinib Plus Capecitabine
##### Group
**Description:** Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
**ID:** OG001
**Title:** Placebo Plus Capecitabine
#### Outcome Measure 6
**Description:** A treatment-emergent AE was defined as an event occurring after exposure to at least 1 dose of study drug (ruxolitinib or placebo). A treatment-related AE was defined as an event with a definite, probable, or possible causality to study medication. A serious AE is an event resulting in death, hospitalization, persistent or significant disability/incapacity, or is life threatening, a congenital anomaly/birth defect or requires medical or surgical intervention to prevent 1 of the outcomes above. The intensity of an AE was graded according to the National Cancer Institute common terminology criteria for adverse events (NCI-CTCAE) version 4.03: Grade 1 (Mild); Grade 2 (Moderate); Grade 3 (Severe); Grade 4 (life-threatening).
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
**Reporting Status:** POSTED
**Time Frame:** Baseline through approximately 30 days post treatment discontinuation; up to 6-months or to the data cutoff 11FEB2016.
**Title:** Participants With Treatment-Emergent Adverse Events (TEAEs)
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
**ID:** OG000
**Title:** Ruxolitinib Plus Capecitabine
##### Group
**Description:** Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
**ID:** OG001
**Title:** Placebo Plus Capecitabine
### Participant Flow Module
#### Group
**Description:** Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
**ID:** FG000
**Title:** Ruxolitinib Plus Capecitabine
#### Group
**Description:** Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
**ID:** FG001
**Title:** Placebo Plus Capecitabine
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Death
###### Reason
**Group ID:** FG000
**Number of Subjects:** 13
###### Reason
**Group ID:** FG001
**Number of Subjects:** 8
##### Withdraw
**Type:** Adverse Event
###### Reason
**Group ID:** FG000
**Number of Subjects:** 8
###### Reason
**Group ID:** FG001
**Number of Subjects:** 16
##### Withdraw
**Type:** Subject decision
###### Reason
**Group ID:** FG000
**Number of Subjects:** 8
###### Reason
**Group ID:** FG001
**Number of Subjects:** 9
##### Withdraw
**Type:** Disease progression
###### Reason
**Group ID:** FG000
**Number of Subjects:** 104
###### Reason
**Group ID:** FG001
**Number of Subjects:** 108
##### Withdraw
**Type:** Noncompliance with study treatment
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
##### Withdraw
**Type:** Study terminated by the sponsor
###### Reason
**Group ID:** FG000
**Number of Subjects:** 4
###### Reason
**Group ID:** FG001
**Number of Subjects:** 6
##### Withdraw
**Type:** Physician Decision
###### Reason
**Group ID:** FG000
**Number of Subjects:** 7
###### Reason
**Group ID:** FG001
**Number of Subjects:** 2
##### Withdraw
**Type:** Other unspecified
###### Reason
**Group ID:** FG000
**Number of Subjects:** 11
###### Reason
**Group ID:** FG001
**Number of Subjects:** 7
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 161
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 160
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 5
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 4
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 156
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 156
**Pre-Assignment Details:** Treatment was started as soon as possible after randomization (within 3 days) and consisted of continuous 21-day cycles. Capecitabine was self-administered for the first 14 days of each cycle, and ruxolitinib/placebo was self-administered for the entire cycle.
**Recruitment Details:** Participants with advanced or metastatic adenocarcinoma of the pancreas who had failed or were intolerant to first-line chemotherapy were randomized in the study.
**Has Results:** True |
## Protocol Section
### Identification Module
**NCT ID:** NCT06354179
**Acronym:** EASY
**Brief Title:** Evaluation of the Benefits of Administering Immunosuppressive Drugs as Single Daily Doses Over the First Year After Liver Transplantation (EASY)
**Official Title:** Evaluation of the Benefits of Administering Immunosuppressive Drugs as Single Daily Doses Over the First Year After Liver Transplantation
#### Organization Study ID Info
**ID:** 87RI23_0031 (EASY)
#### Organization
**Class:** OTHER
**Full Name:** University Hospital, Limoges
### Status Module
#### Completion Date
**Date:** 2027-07-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-04-11
**Type:** ACTUAL
**Last Update Submit Date:** 2024-04-09
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2027-07-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-04
#### Study First Post Date
**Date:** 2024-04-09
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-03
**Study First Submit QC Date:** 2024-04-03
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University Hospital, Limoges
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** World Health Organization considers non-adherence has a strong negative impact on the health of patients with chronic diseases. In transplantation, adherence to immunosuppressive drug regimens associates with late rejection and graft loss making it a critical determinant of patient outcome. The prevalence of non-adherence in transplant patients, including liver transplant patients, can be as high as 40%. Among others, life-long intake and complexity of immunosuppressive regimen make patients prone to non-adherence. For instance, non-adherence is more prevalent among patients with higher numbers of immunosuppressive drugs. One of the most commonly cited causes of non-adherence is forgetfulness and disruptions in routine, with the evening dose of twice daily regimens being the most likely to be affected6. Besides non-adherence, the constraints generated in everyday life by immunosuppression (including timely and regular drug intake) and the complexity of the immunosuppressive regimens represent a burden for the patients and are probably associated with a health-related quality of life deterioration. Therefore, long-term adherence and quality of life after liver transplantation might be improved by using a well-tolerated and easy-to-handle immunosuppressive regimen.
The immunosuppressive regimen after liver transplantation is in most cases based on different combinations of tacrolimus, mycophenolate mofetil and corticosteroids. While corticosteroids are administered once daily, tacrolimus can be administered either twice-daily (BID) as an immediate-release, or once-daily (QD) as an extended-release formulation. Among once-daily tacrolimus formulations, LCP-tacrolimus (ENVARSUS XR®) is approved for the prevention of transplant rejection in adult liver allograft recipients. It has demonstrated similar outcomes compared to immediate-release tacrolimus BID, in both kidney and liver transplantation. Mycophenolate has only been approved for BID administration, preventing from taking all immunosuppressive drugs once daily. Yet, single daily dosing would probably contribute to better adherence and quality of life in patients receiving a life-long treatment.
Although the half-life of mycophenolic acid (MPA), the active moiety of mycophenolate mofetil (MMF) is compatible with once-daily administration, no published randomized clinical study has ever evaluated the efficacy and safety of MMF administered QD.
The narrow therapeutic index and wide pharmacokinetic variability of tacrolimus and mycophenolate justify individual dose adjustment by means of therapeutic drug monitoring (TDM), in order to minimize the risk of acute rejection and the occurrence of adverse events. For tacrolimus, TDM is generally based on the trough concentration (C0) and sometimes on the area under the concentration-time curve (AUC), while for mycophenolate it should be based on the AUC of MPA. However, the dose adjustment of MMF in liver transplant patients is most of the time performed a posteriori, based on clinical signs of inefficacy of toxicity.
Limited sampling strategies with maximum a posteriori Bayesian estimation have been developed by our team for both molecules in adult liver transplant patients to estimate their AUC, which is considered the best marker of exposure for both. Therefore, tacrolimus AUC0-24h can be estimated by Bayesian estimation using samples collected before administration (C0), 8 (C8h) and 12 (C12h) hours after the administration of ENVARSUS XR®, or 1 and 3 hours after the administration of PROGRAF® and ADVAGRAF®. For mycophenolate, the MPA AUC can be estimated using samples collected 20 min, 1 and 3 hours after MMF administration, by Bayesian estimation.
Even if limited to 2 or 3 blood samples, tacrolimus TDM for ENVARSUS® requires late sampling (12h post-dose). To overcome the necessity of a longer hospital stay, microsampling devices (MSD) such as the Volumetric absorptive microsampling (VAMS®) device (Mitra®) can be used by the patients to take samples themselves, at home. Moreover, they are less invasive than venipuncture and collect low but accurate volumes of blood for analysis.
In this context, we propose a randomized controlled non-inferiority study to demonstrate that in liver transplant recipients, an immunosuppressive strategy based on single daily doses of LCP-tacrolimus (ENVARSUS XR®) and mycophenolate mofetil (CELLCEPT®) started at M6 post-transplantation is not inferior to XR-tacrolimus (ADVAGRAF®) and MMF administered BID, in terms of incidence of treatment failure (see below) at the end of the first year after transplantation, and to obtain adherence, quality of life and safety data. In order to compare solely MMF QD to MMF BID, patients on ENVARSUS XR® and MMF QD will be compared to a third group of patients receiving ENVARSUS XR® and MMF BID. A direct comparison of efficacy and safety, quality of life, adherence and exposure indices will be performed between ENVARSUS XR® and ADVAGRAF®.
### Conditions Module
**Conditions:**
- Liver Transplantation
- Immunosuppression
**Keywords:**
- liver transplantation
- immunosuppression
- tacrolimus
- mycophenolate
- adherence
- once-daily intake
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 162
**Type:** ESTIMATED
**Phases:**
- PHASE4
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Drug: XR-tacrolimus QD + MMF BID
**Label:** Standard of care
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Intervention Names:**
- Drug: LCP-tacrolimus QD + MMF BID
**Label:** Test 1
**Type:** EXPERIMENTAL
#### Arm Group 3
**Intervention Names:**
- Drug: LCP-tacrolimus QD + MMF QD
**Label:** Test 2
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Standard of care
**Description:** Patients receive tacrolimus once daily (QD) and MMF twice daily (BID) as per the usual care.
**Name:** XR-tacrolimus QD + MMF BID
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Test 1
**Description:** Patients start on LCP-Tacrolimus once daily (QD) and MMF twice daily (BID) as per the usual care. The MMF dose may be decreased at any time during the study according to the investigator's decision.
**Name:** LCP-tacrolimus QD + MMF BID
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- Test 2
**Description:** Patients start on LCP-Tacrolimus once daily (QD) and MMF twice daily (BID) as per usual care. At 6 months post-transplantation (±1 month), MMF administration frequency will be switched from BID to QD, in the morning, at the same daily dose
**Name:** LCP-tacrolimus QD + MMF QD
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Treatment failure, defined by the occurrence of any of the following events: Patient death, Graft loss, Biopsy-proven acute rejection, rejection activity index score ≥4 according to the Banff criteria
**Measure:** Treatment failure
**Time Frame:** month 12
#### Secondary Outcomes
**Description:** Adherence evaluated using the BAASIS questionnaire and patient diaries. Arm LCP-tacrolimus vs. Arm XR-tacrolimus
**Measure:** Adherence to treatment
**Time Frame:** Month 18
**Description:** Health-related quality of life composite scores evaluated using the SF-36 questionnaire. Arm LCP-tacrolimus vs. Arm XR-tacrolimus
**Measure:** measuring of quality of life
**Time Frame:** Month 18
**Description:** Adherence evaluated using the BAASIS questionnaire and patient diaries. Benefits of switching from Arm MMF BID to Arm MMF QD
**Measure:** Adherence to treatment
**Time Frame:** Month 18
**Description:** Health-related quality of life composite scores evaluated using the SF-36 questionnaire. Benefits of switching from Arm MMF BID to Arm MMF QD
**Measure:** measuring of quality of life
**Time Frame:** Month 18
**Description:** Adverse events and their severity whenever applicable during the first year after transplantation ( Gastro-intestinal, Cytomegalovirus (CMV) infection or reactivation, Neutropenia, Sepsis, Renal function impairment, post-transplant diabetes mellitus, Hypertension, Hyperlipidemia, Tremor). Arm LCP-tacrolimus vs. Arm XR-tacrolimus
**Measure:** Appearance Adverse events
**Time Frame:** month 18
**Description:** Adverse events and their severity whenever applicable during the first year after transplantation ( Gastro-intestinal, CMV infection or reactivation, Neutropenia, Sepsis, Renal function impairment, post-transplant diabetes mellitus, Hypertension, Hyperlipidemia, Tremor). Arm MMF BID to Arm MMF QD
**Measure:** Appearance Adverse events
**Time Frame:** month 18
**Description:** average daily exposure of tacrolimus by AUC 0-24h determined by Bayesian estimation compare between the 3 arms
**Measure:** Comparison tacrolimus daily exposure
**Time Frame:** month 18
**Description:** average daily exposure of MPA AUC 0-24h determined by Bayesian estimation compare between the 3 arms
**Measure:** Comparison of MPA daily exposure
**Time Frame:** month 18
**Description:** measurement of Tacrolimus dose at C0 to comparison between the 3 arms
**Measure:** Comparison of Tacrolimus dose
**Time Frame:** month 18
**Description:** measurement of Tacrolimus AUC 0-24h to comparison between the 3 arms
**Measure:** Comparison of Tacrolimus AUC 0-24h
**Time Frame:** month 18
**Description:** measurement of MPA AUC 0-24h to comparison between the 3 arms
**Measure:** Comparison of MPA AUC 0-24h
**Time Frame:** month 18
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Recipients of a first liver allograft from a deceased donor
* Transplanted for less than four weeks at enrolment.
* Without inter-current progressive life-threatening or graft-threatening disease.
* Having signed a written informed consent for their participation in the study.
* Affiliated to, or beneficiary of, a social security regimen
Exclusion Criteria:
* Recipients of a split-liver transplantation.
* Recipients of any transplanted organ other than the liver
* Patient who has undergone colon resection
* Patients under legal protection (guardianship, curatorship).
* Patient presenting any contra-indication to tacrolimus or to MMF according to the summary of product characteristics (SmPC) of ENVARSUS®, ADVAGRAF® and CELLCEPT®.
* Patients in whom everolimus-based calcineurin inhibitors (CNI) minimization is anticipated
* Patients treated with HIV or HCV protease inhibitors.
* Pregnant or lactating women.
* Women of childbearing potential without any effective contraceptive method (according to the guidelines of CTFG, Clinical Trial Facilitation Group, related to contraception and pregnancy test in clinical trials) or not practicing sexual abstinence.
* Sexually active men having a female partner, without any effective contraception.
* Patients incapable of understanding the purposes and risks of the study, who cannot give written informed consent, or who are unwilling to comply with the study protocol.
* Patients already enrolled in another clinical study evaluating drugs or therapeutic strategies.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Caroline MONCHAUD, Pharm D
**Phone:** 555056140
**Phone Ext:** +33
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Hélène ROUSSEL
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Clichy
**Country:** France
**Facility:** Beaujon hospital - APHP
**Zip:** 92110
**Location 2:**
**City:** Lille
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Sébastien DHARANCY, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Sébastien DHARANCY, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** France
**Facility:** Lille university hospital
**Zip:** 59000
**Location 3:**
**City:** Limoges
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Marilyne DEBETTE-GRATIEN, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Marilyne DEBETTE-GRATIEN, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** France
**Facility:** Limoges university hospital
**Zip:** 87042
**Location 4:**
**City:** Lyon
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Teresa ANTONINI, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Teresa ANTONINI, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** France
**Facility:** Lyon university hospital
**Zip:** 69000
**Location 5:**
**City:** Montpellier
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Georges-Philippe PAGEAUX, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Georges-Philippe PAGEAUX, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** France
**Facility:** Montpellier university hospital
**Zip:** 34000
**Location 6:**
**City:** Nice
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Rodolphe ANTY, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Rodolphe ANTY, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** France
**Facility:** Nice university hospital
**Zip:** 06202
**Location 7:**
**City:** Paris
**Country:** France
**Facility:** Pitie Salpetriere hospital - APHP
**Zip:** 75013
**Location 8:**
**City:** Pessac
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Jean-Baptiste HIRIART, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Jean-Baptiste HIRIART, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** France
**Facility:** Bordeaux university hospital
**Zip:** 33604
**Location 9:**
**City:** Poitiers
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Christine SILVAIN, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Christine SILVAIN, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** France
**Facility:** Poitiers university hospital
**Zip:** 86000
**Location 10:**
**City:** Rennes
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Pauline HOUSSEL-DEBRY, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Pauline HOUSSEL-DEBRY, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** France
**Facility:** Rennes university hospital
**Zip:** 35033
**Location 11:**
**City:** Strasbourg
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Camille BESCH, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Camille BESCH, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** France
**Facility:** Strasbourg university hospital
**Zip:** 67000
**Location 12:**
**City:** Tours
**Country:** France
**Facility:** Tours university Hospital
**Zip:** 37000
**Location 13:**
**City:** Villejuif
**Country:** France
**Facility:** Paul Brousse Hospital - APHP
**Zip:** 94800
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Intervention Browse Module - Ancestors
- ID: D000007166
- Term: Immunosuppressive Agents
- ID: D000007155
- Term: Immunologic Factors
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000065095
- Term: Calcineurin Inhibitors
- ID: D000004791
- Term: Enzyme Inhibitors
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Hemat
- Name: Hematinics
### Intervention Browse Module - Browse Leaves
- ID: M12128
- Name: Mycophenolic Acid
- Relevance: LOW
- As Found: Unknown
- ID: M18950
- Name: Tacrolimus
- Relevance: HIGH
- As Found: 3 weeks
- ID: M11110
- Name: Liver Extracts
- Relevance: LOW
- As Found: Unknown
- ID: M10212
- Name: Immunosuppressive Agents
- Relevance: LOW
- As Found: Unknown
- ID: M10201
- Name: Immunologic Factors
- Relevance: LOW
- As Found: Unknown
- ID: M30452
- Name: Calcineurin Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M7951
- Name: Enzyme Inhibitors
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000016559
- Term: Tacrolimus
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT05457179
**Acronym:** PARCS
**Brief Title:** Physical Activity to Reduce Cardiometabolic Risk in Adults With Serious Mental Illness (PARCS) Study
**Official Title:** Physical Activity to Reduce Cardiometabolic Risk in Adults With Serious Mental Illness (PARCS) Study
#### Organization Study ID Info
**ID:** 11008
#### Organization
**Class:** OTHER
**Full Name:** Kansas State University
### Status Module
#### Completion Date
**Date:** 2025-03-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-03-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-03-04
**Overall Status:** ENROLLING_BY_INVITATION
#### Primary Completion Date
**Date:** 2025-03-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2022-08-01
**Type:** ACTUAL
**Status Verified Date:** 2024-03
#### Study First Post Date
**Date:** 2022-07-13
**Type:** ACTUAL
**Study First Submit Date:** 2022-03-19
**Study First Submit QC Date:** 2022-07-10
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Augusta University
**Class:** OTHER
**Name:** Dartmouth College
**Class:** OTHER
**Name:** University of Cincinnati
#### Lead Sponsor
**Class:** OTHER
**Name:** Kansas State University
#### Responsible Party
**Investigator Affiliation:** Kansas State University
**Investigator Full Name:** Gina Besenyi
**Investigator Title:** Assistant Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The aim of this project is to trial the protocol of a park-based physical activity (PA) intervention in adults with serious mental illness (SMI) in a community mental health center's peer support program.
**Detailed Description:** Adults with serious mental illness or serious mental illness (SMI) suffer from drastically higher rates of premature mortality (as much as a 10-25 years reduction in life expectancy) compared to the general population. Co-morbid medical conditions (i.e., heart disease, diabetes) are a fundamental cause. The iatrogenic cardiometabolic effects associated with antipsychotic drugs complicate matters. Underlying modifiable cardiometabolic risk factors (e.g., obesity, hypertension, poor physical fitness) are more prevalent and manifest earlier in the lifecourse in persons with SMI compared with the rest of society. Physical activity (PA) is an extensively recognized modifiable behavior that can reduce numerous cardiometabolic risk factors as well as improve quality of life (QOL) in people with SMI. Evidence-based methods for developing PA interventions among adults with SMI often incorporate individual attention, peer counselors, structured group PA, novel technology, self-monitoring, and behavior change strategies. However, challenges exist for both delivery and sustainability of effective PA treatment strategies for people with SMI in community settings. Indeed, development and testing of innovative, evidence-based PA interventions with SMI populations has been identified as a top research priority.
Parks are acknowledged as key community PA intervention settings given their low cost, ubiquity, and provision of structured and unstructured PA opportunities. Parks offer numerous physical, psychological, and social benefits associated with improved health behaviors and outcomes. Growing evidence, including our own, has documented relationships between access and use of parks and green space with greater PA, mood, and QOL, and less obesity, stress, morbidity and mortality. Further, outdoor PA is associated with increased enjoyment, satisfaction, and long-term adherence to PA, supporting it as an ideal approach to PA behavior change, especially among those with SMI. Despite potential benefits of park-based PA, few interventions have been tested rigorously, and none have focused specifically on adults with SMI. Certified peer specialists (CPSs), trained persons with lived recovery experience working in mental health settings, offer a potential delivery mechanism for park-based PA. Pulling from the Recovery Model incorporating elements of peer support and collaborative treatment approaches our long-term goal is to maximize the reach and clinical impact of evidence-based PA interventions to reduce cardiometabolic risk among adults with SMI through the use of existing CPS services and park-based PA.
The PARCS Study uses a novel approach for physical activity (PA) intervention delivery and sustainability among adults (18+yrs) with SMI through incorporation of freely available park resources into established peer counseling programs. The purpose of the PARCS study is two-fold: 1) Test the feasibility and acceptability of a CPS-led PA intervention among adults with SMI in park settings, and 2) evaluate the effectiveness of the PARCS intervention on a) SCT mechanisms of action (i.e., PA self-efficacy, goal setting, and social support) and b) PA, fitness, and health outcomes.
The PARCS Study aims to establish a sustainable, scalable, and reimbursable intervention model by leveraging existing resources (CPS services, parks) to reduce cardiometabolic risk in adults with SMI. Combining information from previous feasibility and effectiveness PA trials with adults with SMI, park-based PA literature, qualitative and quantitative feedback from pilot studies, the PARCS Study will optimize a 12-week PA intervention originally developed for people with chronic schizophrenia in an indoor setting, to an outdoor group exercise setting in parks. This study will utilize a two-arm randomized active control group design with pre- and posttest measures (n=100). Arm one, will consist of a 12-week park-based PA intervention, including sessions three days per week at times and days convenient for each participating facility. Under the guidance of trained research staff, four CPSs, who have experience working with peer groups, will be selected to help deliver the intervention. Park-based activity sessions will last approximately 60 minutes and consist of 10 minutes of warm up, 15 minutes of simple strength training activities, 25 minutes of moderate to vigorous aerobic activities (e.g., walking), and 10 minutes of cool down. The eight full-body strength training exercises will use body weight and/or elastic bands and will include a circuit of chest press, seated row, squat, shoulder press, biceps curl, triceps extension, calf raise, and reverse crunch. These activities have been selected to improve functional capacity of common daily living activities (e.g., ability to stand from seated position, lift groceries, use stairs, etc). During pilot studies, an ACSM-certified group fitness instructor developed scaled group-based activity sessions that progress in activity level over time with participants' capabilities. Sessions will strive to incorporate fun, social, adaptable activities that enable a wide variety of subjects to participate. Arm two, the active control group, will receive information about the importance of park-based PA, and a map of park locations but will not participate in park-based PA sessions. Participants in the control group will be invited to participate in park PA sessions after they have completed posttest. Participants in both groups will receive a Fitbit and usual care outpatient peer group treatment services, including routine counseling and health and wellness information/activities given by CPSs.
### Conditions Module
**Conditions:**
- Mental Disorders, Severe
- Mental Illness Persistent
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Two-arm multi-site randomized clinical trial. The intervention arm will consist of peer counselor-led park-based physical activity sessions 3 days per week for 12 weeks incorporated into weekly peer counseling sessions. The active control arm will consist of physical activity and park information. Both arms will include standard of care peer-group counseling services.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 100
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** PARCS is a park-based physical activity intervention including aerobic and resistance training adapted for adults with serious mental illness and led by certified peer counselors as part of peer group mental health recovery services.
**Intervention Names:**
- Behavioral: Park-based physical activity
**Label:** Intervention
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The active control group will receive information about the importance of park-based PA and a map of local park locations but will not participate in structured park-based PA sessions. Participants in the control group will be invited to participate in park PA sessions after they have completed posttest.
Participants in both groups will receive usual care outpatient peer group treatment services, including routine counseling and health and wellness information/activities given by CPSs.
**Intervention Names:**
- Behavioral: Active Control
**Label:** Active Control
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Intervention
**Description:** The experimental arm will optimize a 12-week intervention 3 days/wk, last approximately 60 minutes, and consist of 10 minutes of warm up, 15 minutes of simple strength training activities, 25 minutes of moderate to vigorous aerobic activities (e.g., walking), and 10 minutes of cool down. The eight full-body strength training exercises will use body weight and/or elastic bands and will include a circuit of chest press, seated row, squat, shoulder press, biceps curl, triceps extension, calf raise, and reverse crunch. Sessions will include education and skill building activities focused on Social Cognitive Theory mechanisms of change including self-efficacy, goal setting, and social support. Under the guidance of trained research staff, certified peer specialists who have experience working with peer groups, will be selected to help deliver the intervention.
**Name:** Park-based physical activity
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- Active Control
**Description:** The active control group will receive information about the importance of park-based PA and a map of local park locations but will not participate in structured park-based PA sessions. Participants in the control group will be invited to participate in park PA sessions after they have completed posttest.
**Name:** Active Control
**Type:** BEHAVIORAL
### Outcomes Module
#### Other Outcomes
**Description:** Feasibility will be assessed via the Structured Assessment of FEeasibility (SAFE) which measures intervention feasibility within a mental health services framework. Completed by mental health facility administrators or staff, this measure includes 16 items that capture information in three categories: intervention, resource consequences, and evaluation. The SAFE measure has demonstrated excellent inter-rater and test-retest reliability (0.84, 95% confidence interval (CI) 0.79-0.89; 0.89, 95% CI 0.85-0.93 respectively). Rather than using a summary score, the individual items should be considered (e.g., yes, partial, no, unable to rate).
**Measure:** Feasibility - Facility
**Time Frame:** After completion of all waves of the study (approximately 2 years)
**Description:** estimates include percent body fat via Tanita DC-430U or similar bioelectrical impedance scale, BMI via height and weight (via stadiometer and Tanita scale),waist circumference with spring-loaded Gulick tape measure
**Measure:** Change in Body Composition
**Time Frame:** pre and post 12-week intervention
**Description:** Health-related HRQOL will be assessed using the World Health Organization Quality of Life brief assessment (WHOQOL-BREF), a 26-item self-report questionnaire that measures four domains:
physical health, psychological health, social relationships, and environment
**Measure:** Change in Health-Related Quality of Life
**Time Frame:** pre and post 12-week intervention
**Description:** Depressive symptoms will be assessed using an eight-item Personal Health Questionnaire depression scale (PHQ-9) a 9-item self-report scale which captures the severity of depressive symptoms experienced over the previous two weeks. We will also measure cross-cutting symptoms via DSM-5 (self-report, 23-items, 4pt Likert scale)
**Measure:** Change in Depressive Symptoms
**Time Frame:** pre and post 12-week intervention
**Description:** Measured via Generalized Anxiety Disorder (GAD-7; self-report, 7-items, 3pt Likert scale)
**Measure:** Change in Anxiety
**Time Frame:** pre and post 12-week intervention
**Description:** World Health Organization Disability Assessment Schedule (WHODAS 2.0; self-report, 12-items, 5pt Likert Scale
**Measure:** Change in General Health and Disability
**Time Frame:** pre and post 12-week intervention
#### Primary Outcomes
**Description:** Feasibility will be assessed by attendance at park PA sessions. Higher attendance indicates greater engagement with the intervention
**Measure:** Feasibility - Attendance
**Time Frame:** Ongoing during the 12-week intervention period
**Description:** Acceptability will be assessed via PA enjoyment captured using the Physical Activity Enjoyment Scale (PACES), an 18-item scale where participants rate feelings about PA on a 7-point Likert scale, from 1 (I enjoy it) to 7 (I hate it).
**Measure:** Acceptability - Change in PA Enjoyment
**Time Frame:** post 12-week intervention
**Description:** Acceptability will also be assessed via PA session satisfaction measured using the abbreviated Physical Activity Class Satisfaction Questionnaire (PACSQ) which rates satisfaction of park-based class sessions on an 8-point Likert scale. PACSQ is a valid measure for capturing client satisfaction within exercise classes in the following nine dimensions: mastery experiences, cognitive development, teaching, normative success, interaction with others, fun and enjoyment, improvement of health and fitness, diversionary experiences, and relaxation. Each of the dimensions of satisfaction is measured using an 8-point Likert scale, with responses ranging from 1="No satisfaction" to 8="Very satisfying". PACSQ has shown acceptable reliability in each of its subscales (all α's ≥ .85), and survey items are highly correlated with participants' intentions to attend a similar course in the future.
**Measure:** Acceptability - PA session satisfaction
**Time Frame:** post 12-week intervention
#### Secondary Outcomes
**Description:** The SCT mechanism of self-efficacy will be measured using the Self Efficacy for Exercise (SEE) Scale, a 9-item self-report Likert scale asking how confident participants are they could exercise three times a week for 20 minutes under various conditions (felt stressed, felt tired). Answers range from 1 (not confident) to 10 (very confident). The SEE scale has an internal consistency of 0.92 and has been used in a variety of populations.
**Measure:** Change in Self-efficacy for Exercise
**Time Frame:** pre and post 12-week intervention
**Description:** Self-efficacy and intentions for spending time in nature will be assessed using the Spending Time in Nature Measures, which has high internal consistency (α = .93 self-efficacy; .91 intentions). Self-efficacy will be assessed with 14 items asking participants how confident they are spending at least 2 hours/week in green and natural spaces on a scale from 1 (not confident at all) to 5 (extremely confident). Intensions to spend time in nature will be measured with 8 items asking participants their intentions to spend time in nature in the next three months. Answers are assessed on a 5pt Likert scale where 1 = 'Strongly disagree' to 5 = ' Strongly agree'. The scales are moderately correlated with each other (r = .56, p \< .001) and are strongly related to time spent in nature with large effect sizes (eta2 \> .20).
**Measure:** Change in Self-efficacy and Intensions for Spending Time in Nature
**Time Frame:** pre and post 12-week intervention
**Description:** The SCT mechanism of goal setting will be measured using the Exercise Goal Setting Scale, a 10-item self-report 5pt Likert scale assessing goal-setting strategies such as self-monitoring and problem solving. Participants respond on a 5-point scale ranging from 1 (does not describe me) to 5 (completely describes me) and scores are averaged across the 10 items. This scale has good internal consistency (0.89).
**Measure:** Change in Exercise Goal Setting
**Time Frame:** pre and post 12-week intervention
**Description:** Social support for exercise will be measured using a modified scale consisting of the Social Support and Exercise Survey, a 13-item survey that assess respondents' perceptions of positive and negative social support for exercise habits. Participants will rate the frequency with which CPSs and peers have done or said what was described in the items during the previous 3 months on a 5-point scale, ranging from 1 (none) to 5 (very often). Two subscales will be calculated (participation, rewards and punishments) for CPSs and peers with SMI. Cronbach's alphas range from .73-.80 in people with SMI. Research has shown that social support relates to goal setting practices in people with mental illness (r2=.11).
**Measure:** Change in Support and Exercise
**Time Frame:** pre and post 12-week intervention
**Description:** Moderate to vigorous (MVPA) minutes per week will be objectively measured using Fitbit wearable devices (San Francisco, CA). Fitbit devices track a variety of health and fitness-related outcomes including steps, distance, heart rate, active minutes, calories, and sleep. Fitbit devices have high validity and reliability (ICCs range from 0.71-1.00 across studies)207-209 and have established feasibility and acceptability among adults with SMI. PA will be calculated as mean minutes of MVPA per session and per week. We will also assess physical activity using the Rapid Assessment of Physical Activity (RAPA). The RAPA is a 9-item dichotomous (Yes/No) measure of PA intensity (light, moderate, vigorous) and type (aerobic, flexibility, strength).
**Measure:** Physical Activity Participation
**Time Frame:** Ongoing during the 12-week intervention period
**Description:** Aerobic fitness will be measured as distance traveled during a 6-minute walk test. Greater distance indicates better fitness.
**Measure:** Change in Aerobic Fitness
**Time Frame:** pre and post 12-week intervention
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Authorized for peer group treatment through the behavioral health facility
* Medically cleared to participate in physical activity (if indicated by ACSM 11th Edition pre-exercise participation screener)
Exclusion Criteria:
* Under 18 years of age
* Unable to obtain physician clearance (if indicated by ACSM 11th Edition pre-exercise participation screener)
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Augusta
**Country:** United States
**Facility:** Serenity Behavioral Health Systems
**State:** Georgia
**Zip:** 30906
**Location 2:**
**City:** Junction City
**Country:** United States
**Facility:** Pawnee Mental Health
**State:** Kansas
**Zip:** 66441
#### Overall Officials
**Official 1:**
**Affiliation:** Kansas State University
**Name:** Gina M Besenyi, MPH, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Access Criteria:** To be determined
**Description:** Deidentified data will be shared with colleagues who have a reasonable request and analysis plan with appropriate credit. Data will be shared according to NIMH's Data Sharing Policy (NOT-MH-19-033).
**Info Types:**
- STUDY_PROTOCOL
- ICF
**IPD Sharing:** YES
**Time Frame:** Data will be made available to other interested researchers once major findings have been published or within two years of the project completion date, whichever is sooner.
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M4815
- Name: Mental Disorders
- Relevance: HIGH
- As Found: Mental Illness
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001523
- Term: Mental Disorders
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT04733079
**Acronym:** GOUTEmail
**Brief Title:** Treat-to-target by Email During Urate-lowering Therapy in Gout
**Official Title:** Treat-to-target by Email During Urate-lowering Therapy in Gout
#### Organization Study ID Info
**ID:** APHP18067
#### Organization
**Class:** OTHER
**Full Name:** Assistance Publique - Hôpitaux de Paris
### Status Module
#### Completion Date
**Date:** 2024-10-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-08-30
**Type:** ACTUAL
**Last Update Submit Date:** 2022-08-29
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2023-04-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2021-12-15
**Type:** ACTUAL
**Status Verified Date:** 2022-08
#### Study First Post Date
**Date:** 2021-02-01
**Type:** ACTUAL
**Study First Submit Date:** 2021-01-24
**Study First Submit QC Date:** 2021-01-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Assistance Publique - Hôpitaux de Paris
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Gout is secondary to urate crystal deposition after chronic elevation of serum urate level (SUL). Long-term lowering SUL below 360 µmol/L allows dissolution of deposited crystals and disease cure. There is currently a paradoxical observation: while urate-lowering therapy (ULT) is available and efficient there is an increase of gout prevalence and severity. The apparent failure of ULT in gout management is due to several causes including unadjusted dosage, no SUL verification, irregular follow-up and low treatment compliance.
In contrast, a nurse-led treat-to-target (T2T) strategy with regular adaptations of ULT until reaching SUL target allows gout cure in more than 90% of patients. We hypothesize that an electronic messaging-led T2T strategy will allow obtaining similar results.
The aim of this study is to demonstrate that email-led T2T strategy during ULT is superior to usual care.
**Detailed Description:** The study will include 204 gouty patients without ULT or with ineffective ULT. This is a multicenter and randomized study (e-mail follow-up vs usual follow-up groups).
This study will include the following visits:
* Selection/inclusion visit (V0):
* If available biological data (leucocyte count, hemoglobin level, creatininemia and estimated glomerular filtration rate (eGFR), SUL) were assessed during the last month, , included patient will be randomized at the end of the consultation to follow either an email-led T2T strategy or usual ULT care.
* In the absence of biological results, the patient will be reviewed within the month with blood analysis and then randomized.
* Follow-up visits: consultations will be carried out according to the usual care of the referring physician.
* Visit M12 end of research: clinical evaluation of gout, demographic characteristics, medication, type and dose of ULT, blood analysis (serum creatinine level, eGFR, SUL).
The study ends after the M12 consultation. The total duration of participation in the study is 12 months.
### Conditions Module
**Conditions:**
- Gout
- Inflammatory Rheumatism
- Hyperuricemia
- Posology Adjustment
**Keywords:**
- Treat-to-target
- Gout
- Tophus
- Urate crystals
- Urate-lowering therapy
- Febuxostat
- Allopurinol
- Therapeutic strategy
- Electronic messaging
- Therapeutic compliance
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 204
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Email-led treat-to-target strategy with regular adaptation of ULT via electronic messaging
**Intervention Names:**
- Other: Cleanweb electronic messaging ePro
**Label:** E-mail follow-up group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Adaptation and follow-up of ULT according to referring physician's habits
**Intervention Names:**
- Other: Usual follow-up
**Label:** Usual follow-up group
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- E-mail follow-up group
**Description:** Patient and their medecin will communicate regulary via Cleanweb electronic messaging ePro to adapt the posology of THU untill the target urecemia is reached
**Name:** Cleanweb electronic messaging ePro
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Usual follow-up group
**Description:** Adaptation and follow-up of ULT according to referring physician's habits
**Name:** Usual follow-up
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Measure:** Proportion of patients with target SUL (<360 μmol /L or <300 μmol /L in tophaceous gout)
**Time Frame:** Month 12
#### Secondary Outcomes
**Measure:** Average dose of ULT (allopurinol and febuxostat)
**Time Frame:** Month 12
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Adults aged over 18 years old
* Gout confirmed by identification of urate crystals by joint fluid or tophus analysis or by ultrasound of the affected joint or
* Gout according to Nijmegen criteria (presence of a score ≥ 8/13) depending on the following items:
Man (2 pts) Previous crisis (2 pts) Involvement of first metatarsophalangeal joint (MTP1) (2.5 pts) Maximum pain within 24 hours (0.5pt) Redness (1 pt) HTA or cardiovascular disease (1.5 pts) SUL \> 360 μmol/l during the crisis (3.5 pts)
* Patients without ULT or with an ineffective ULT defined by an SUL \> 360 μmol/l in intercritical pahse
* Patients who routinely use e-mail
Exclusion Criteria:
* Participating in another trial including the administration of a drug
* Patients treated with azathioprine
* Patients intolerant to hypouricemic treatments
* Unable to use the internet
* Difficulty understanding French
* Illiteracy
* Pregnant womenor breastfeeding mothers (see PHC article L.1121-5)
* Persons deprived of liberty by judicial or administrative decision, persons receiving psychiatric care under Sections L. 3212-1 and L. 3213-1 and persons admitted to a health or social institution for purposes other than research (see CSP Article L.1121-6)
* Major persons subject to a measure of legal protection or unseeding to express consent (see PHC Article L.1121-8)
* Persons not affiliated to a social security plan or beneficiaries of such a plan (see PHC Article L.1121-8-1)
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Korng EA, PH-PU
**Phone:** 1 49 95 88 25
**Phone Ext:** +33
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Paris
**Contacts:**
***Contact 1:***
- **Name:** Hang-Korng Pr EA, PHPU
- **Role:** CONTACT
**Country:** France
**Facility:** Rhumathology department
**State:** Ile-De-France
**Status:** RECRUITING
**Zip:** 75010
**Location 2:**
**City:** Paris
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Johann BEAUDREUIL, PUPH
- **Phone:** 01 49 95 88 28
- **Role:** CONTACT
**Country:** France
**Facility:** Hopital LARIBOISIERE - Rhumatologie
**Status:** RECRUITING
**Zip:** 75010
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001168
- Term: Arthritis
- ID: D000007592
- Term: Joint Diseases
- ID: D000009140
- Term: Musculoskeletal Diseases
- ID: D000070657
- Term: Crystal Arthropathies
- ID: D000011686
- Term: Purine-Pyrimidine Metabolism, Inborn Errors
- ID: D000008661
- Term: Metabolism, Inborn Errors
- ID: D000030342
- Term: Genetic Diseases, Inborn
- ID: D000008659
- Term: Metabolic Diseases
- ID: D000010335
- Term: Pathologic Processes
- ID: D000003240
- Term: Connective Tissue Diseases
- ID: D000013290
- Term: Streptococcal Infections
- ID: D000016908
- Term: Gram-Positive Bacterial Infections
- ID: D000001424
- Term: Bacterial Infections
- ID: D000001423
- Term: Bacterial Infections and Mycoses
- ID: D000007239
- Term: Infections
### Condition Browse Module - Browse Branches
- Abbrev: BC05
- Name: Musculoskeletal Diseases
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BC16
- Name: Diseases and Abnormalities at or Before Birth
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC01
- Name: Infections
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M15045
- Name: Rheumatic Diseases
- Relevance: HIGH
- As Found: Rheumatism
- ID: M24343
- Name: Hyperuricemia
- Relevance: HIGH
- As Found: Hyperuricemia
- ID: M9177
- Name: Gout
- Relevance: HIGH
- As Found: Gout
- ID: M6323
- Name: Collagen Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15042
- Name: Rheumatic Fever
- Relevance: HIGH
- As Found: Inflammatory Rheumatism
- ID: M2454
- Name: Hyperthermia
- Relevance: LOW
- As Found: Unknown
- ID: M8464
- Name: Fever
- Relevance: LOW
- As Found: Unknown
- ID: M4476
- Name: Arthritis
- Relevance: LOW
- As Found: Unknown
- ID: M10621
- Name: Joint Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12097
- Name: Musculoskeletal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M630
- Name: Crystal Arthropathies
- Relevance: LOW
- As Found: Unknown
- ID: M11641
- Name: Metabolism, Inborn Errors
- Relevance: LOW
- As Found: Unknown
- ID: M14540
- Name: Purine-Pyrimidine Metabolism, Inborn Errors
- Relevance: LOW
- As Found: Unknown
- ID: M23686
- Name: Genetic Diseases, Inborn
- Relevance: LOW
- As Found: Unknown
- ID: M11639
- Name: Metabolic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6464
- Name: Connective Tissue Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10283
- Name: Infections
- Relevance: LOW
- As Found: Unknown
- ID: M6368
- Name: Communicable Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M16080
- Name: Streptococcal Infections
- Relevance: LOW
- As Found: Unknown
- ID: M4722
- Name: Bacterial Infections
- Relevance: LOW
- As Found: Unknown
- ID: M19252
- Name: Gram-Positive Bacterial Infections
- Relevance: LOW
- As Found: Unknown
- ID: M12136
- Name: Mycoses
- Relevance: LOW
- As Found: Unknown
- ID: M4721
- Name: Bacterial Infections and Mycoses
- Relevance: LOW
- As Found: Unknown
- ID: T4999
- Name: Rheumatic Fever
- Relevance: HIGH
- As Found: Inflammatory Rheumatism
- ID: T163
- Name: Acute Articular Rheumatism
- Relevance: HIGH
- As Found: Inflammatory Rheumatism
### Condition Browse Module - Meshes
- ID: D000012213
- Term: Rheumatic Fever
- ID: D000006073
- Term: Gout
- ID: D000012216
- Term: Rheumatic Diseases
- ID: D000033461
- Term: Hyperuricemia
### Intervention Browse Module - Browse Branches
- Abbrev: ARhu
- Name: Antirheumatic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M434
- Name: Febuxostat
- Relevance: LOW
- As Found: Unknown
- ID: M17277
- Name: Uric Acid
- Relevance: LOW
- As Found: Unknown
- ID: M3834
- Name: Allopurinol
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT01870479
**Brief Title:** Music & Cancer - Live Music During Chemotherapy
**Official Title:** Music & Cancer - Live Music During Chemotherapy. Randomized Study of the Effect of Live Music During Chemotherapy Treatment
#### Organization Study ID Info
**ID:** S-20120118
#### Organization
**Class:** OTHER
**Full Name:** University of Southern Denmark
### Status Module
#### Completion Date
**Date:** 2017-03
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2018-06-19
**Type:** ACTUAL
**Last Update Submit Date:** 2018-06-17
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2017-01
**Type:** ACTUAL
#### Start Date
**Date:** 2013-05
**Type:** ACTUAL
**Status Verified Date:** 2018-06
#### Study First Post Date
**Date:** 2013-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2013-04-09
**Study First Submit QC Date:** 2013-06-03
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Danish Cancer Society
**Class:** OTHER
**Name:** University of Aarhus
#### Lead Sponsor
**Class:** OTHER
**Name:** Margrethe Langer Bro
#### Responsible Party
**Investigator Affiliation:** University of Southern Denmark
**Investigator Full Name:** Margrethe Langer Bro
**Investigator Title:** Assistant professor
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Main purpose: To determine if live music moderates the level of chemotherapy related anxiety, in patients with haematological cancer
The investigators hypothesize that live music:
1. Have an ameliorating effect on physical and psychological symptoms during chemotherapy treatment
2. May counteract the patients feeling of loss of identity and alienation in this particular group of cancer patients.
3. Is more effective in patients with good musical abilities.
4. Is more effective than taped music.
Method: Intervention groups:
1. Listening to patient-preferred live music during chemotherapy
2. Listening to patient-preferred taped music during chemotherapy
3. Standard care
Endpoints:
Primary: Level of anxiety measured by STAI. Secondary: Serum catecholamines.
Background: In order to establish the intervention procedures, the investigators have carried out a pilot study at the hematology department at Hospital of Southwest Denmark, including students from the Academy of Music and Dramatic Arts, Southern Denmark. The pilot results indicates that live music has an uplifting, pain relieving, and then releasing effect and that music has a positive impact on hospitalisation. According to the evaluation forms filled out by 243 cancer patients, the music experience has provided human anchorage/cohesion as a counterweight to disease fixation and alienation Chemotherapy involves major physical and psychological problems. Not much has been provided in the clinical setting which relieves the symptoms of anxiety associated with chemotherapy. A review of the literature illustrate the need for developing new potential areas of intervention that takes into account, that not only do cancer patients face challenges in everyday life ranging from physiological changes over social to psychological problems, but also during treatment procedures, which may cause a higher level of anxiety associated with these procedures, e.g., chemotherapy infusion.This project investigates to what degree live music may relieve some of these symptoms during treatment for haematological cancer. The project is created in order to both measure psychosocial effects as well as direct stress measures, i.e. serum catecholamine. These physiological changes are measured in order to shed light on the mechanism behind the potential effects of live music on discomfort in connection with chemotherapy treatment.
Perspectives: The vision of the project focus on strengthening the cancer patients' ability to cope with physiological and psychological issues during chemotherapy sessions and to make the patients conscious of music as an option in these coping efforts. Hopefully, the results will provide a scientific basis for an evaluation of the perspectives and the potentials of live music treatment during chemotherapy infusion among cancer patients.
### Conditions Module
**Conditions:**
- Non Hodgkin´s Lymphomas
- Hodgkin´s Lymphomas
**Keywords:**
- Malignant Lymphoma
- Chemotherapy
- Music therapy
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 143
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patient preferred live music during chemotherapy session.
**Intervention Names:**
- Other: Live music
**Label:** Live music
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Patient preferred taped music during chemotherapy
**Intervention Names:**
- Other: Taped music
**Label:** Taped music
**Type:** ACTIVE_COMPARATOR
#### Arm Group 3
**Description:** Usual care during chemotherapy
**Label:** Control
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Live music
**Name:** Live music
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Taped music
**Name:** Taped music
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** STAI-S Spielberger State-Trait Anxiety Scale-State
**Measure:** Anxiety (STAI)
**Time Frame:** Measurement of STAI after the 5. chemotherapy (on average 8 weeks after inclusion)
#### Secondary Outcomes
**Description:** Blood samples
**Measure:** Serum catecholamines
**Time Frame:** Measured before and after each chemotherapy (at baseline and on average after 2, 4, 6, and 8 weeks after inclusion)
**Description:** Patient diary
**Measure:** Nausea
**Time Frame:** Between each visit (at baseline and on average after 1, 3, 5, and 7 weeks after inclusion)
**Description:** Quality of Life Questionnaire: QLQ-C30
**Measure:** Quality of life
**Time Frame:** Visit 1, 2, 4, 6, 7. (at basline and on average after 2, 4, 6, and 8 weeks after inclusion)
**Description:** Hospital Anxiety and Depression Scale (HADS)
**Measure:** Anxiety (HADS)
**Time Frame:** Visit 1, 2, 3 and 4 (at baseline and on average 2, 4, 6 weeks after inclusion)
**Description:** questionaire: The Distress Thermometer
**Measure:** Distress
**Time Frame:** Visit 1, 2, 4 and 6 (at basline and on average after 2, 4, 6, and 8 weeks after inclusion)
**Description:** STAI-S Spielberger State-Trait Anxiety Scale-State
**Measure:** Anxiety (STAI)
**Time Frame:** Measurement of STAI at baseline and after each chemotherapy 1 to 5 (on average 2, 4, 6 and 8 weeks after inclusion) as well as differences from baseline.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age 18+
* Newly diagnosed with malignant lymphoma and planned first line chemotherapy treatment
* Able to give informed consent
Exclusion Criteria:
* Patients who do not speak or understand Danish
* Patients who are deaf or blind.
* Any comorbidity that postpone planed chemotherapy for more than 4 weeks
* Patients with alcohol or drugs misuse problems as stated in the medical record.
* Patients with untreated mental illness as identified in the medical record
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Aarhus
**Country:** Denmark
**Facility:** Aarhus University Hospital
**State:** Central Denmark Region
**Zip:** 8000
**Location 2:**
**City:** Esbjerg
**Country:** Denmark
**Facility:** Hospital of Southwest Jutland
**State:** Region Of Southwest Denmark
**Zip:** 6700
**Location 3:**
**City:** Odense
**Country:** Denmark
**Facility:** Odense University Hospital
**State:** Region Of Southwest Denmark
**Zip:** 5000
**Location 4:**
**City:** Odense
**Country:** Denmark
**Facility:** The Academy of Music and Dramatic Arts, Southern Denmark
**State:** Region Of Southwest Denmark
**Zip:** 5000
**Location 5:**
**City:** Roskilde
**Country:** Denmark
**Facility:** Roskilde Sygehus
**State:** Region Zealand
**Zip:** 4000
**Location 6:**
**City:** Copenhagen
**Country:** Denmark
**Facility:** Rigshospitalet
**State:** The Capital Region Of Denmark
**Zip:** 2100
**Location 7:**
**City:** Copenhagen
**Country:** Denmark
**Facility:** Herlev Hospital
**State:** The Capital Region Of Denmark
**Zip:** 2730
#### Overall Officials
**Official 1:**
**Affiliation:** IRS, Southern Denmark. Assistant professor at The Academy of Music in Southern Denmark
**Name:** Margrethe L Bro, PhD student
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000009369
- Term: Neoplasms
- ID: D000008232
- Term: Lymphoproliferative Disorders
- ID: D000008206
- Term: Lymphatic Diseases
- ID: D000007160
- Term: Immunoproliferative Disorders
- ID: D000007154
- Term: Immune System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC15
- Name: Blood and Lymph Conditions
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M11220
- Name: Lymphoma
- Relevance: HIGH
- As Found: Lymphoma
- ID: M9751
- Name: Hodgkin Disease
- Relevance: LOW
- As Found: Unknown
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
- ID: M11225
- Name: Lymphoproliferative Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M11203
- Name: Lymphatic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10206
- Name: Immunoproliferative Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T3543
- Name: Lymphosarcoma
- Relevance: HIGH
- As Found: Lymphoma
- ID: T2817
- Name: Hodgkin Lymphoma
- Relevance: HIGH
- As Found: Hodgkin Lymphoma
### Condition Browse Module - Meshes
- ID: D000008223
- Term: Lymphoma
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT05536479
**Brief Title:** Evaluation of Autogenous Stored Versus Autogenous Fresh Mineralized Dentin Graft for Alveolar Ridge Preservation
**Official Title:** Clinical, Radiographic and Histomorphometric Evaluation of Autogenous Stored Versus Autogenous Fresh Mineralized Dentin Graft for Alveolar Ridge Preservation: A Randomized Controlled Clinical Trial
#### Organization Study ID Info
**ID:** ARPerio22
#### Organization
**Class:** OTHER
**Full Name:** Cairo University
### Status Module
#### Completion Date
**Date:** 2023-09
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-09-10
**Type:** ACTUAL
**Last Update Submit Date:** 2022-09-08
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2023-05
**Type:** ESTIMATED
#### Start Date
**Date:** 2022-10
**Type:** ESTIMATED
**Status Verified Date:** 2022-09
#### Study First Post Date
**Date:** 2022-09-10
**Type:** ACTUAL
**Study First Submit Date:** 2022-09-08
**Study First Submit QC Date:** 2022-09-08
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Cairo University
#### Responsible Party
**Investigator Affiliation:** Cairo University
**Investigator Full Name:** Nada Mohamed Wahsh
**Investigator Title:** Principal investigator. Nada Wahsh
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Tooth extraction triggers a cascade of biological events mediated by both the local inflammatory response that follows the surgical intervention and the deprivation of masticatory stimulation of the periodontium, which elicit an alteration of the homoeostasis and structural integrity of the periodontal tissues. Bone remodeling kicks off after tooth loss and continues for several months with most changes taking place in the first three months.
Interestingly, Schmidt-Schultz and Schultz, found that intact growth factors are conserved even in the collagenous extracellular matrix of ancient human bone and teeth. Thus, the application of stored dentin may have similar benefits as fresh dentin, preserving intact growth factors for a prolonged period avoiding the need to perform multiple surgical interventions simultaneously. The volume of the particulate dentin is more than twice of the original root volume. Thus, the idea of using autogenous stored mineralized dentin grafts (ASMDG) in ARP evolved.
**Detailed Description:** Immediately following tooth extraction, the alveolar ridge comes across its normal physiologic healing process that results in respective alveolar bone loss, structural and compositional changes of the covering soft tissues, as well as morphological alterations.
In an attempt to cutback horizontal and vertical ridge losses, various techniques have been successfully proven to preserve the alveolar ridge including autografts, allografts, xenografts, alloplasts and autogenous dentin grafts. However, fresh autogenous bone graft is still considered gold standard since it exhibits bioactive cell instructive matrix properties and is non-immunogenic and non - pathogenic in spite of the need for harvesting bone and possible morbidity resulting from it. Nevertheless, no gold-standard technique is applicable for every clinical situation.
The similarities between dentin and alveolar bone may help the human body to show an acceptable biological behavior to dentin graft. It is therefore not surprising that dentin that comprises more than 85% of tooth structure can serve as a native bone grafting material, which is reflected by the interaction between mineralized dentin and osteogenic cells that attach and produce mineralized bone matrix directly on the dentin graft.
Mineralized dentin particles have the advantage to maintain its mechanical stability, allowing early loading after grafting in fresh sockets and bone defects where the mineralized dentin is firmly integrated with newly formed bone, creating a solid site for anchorage of dental implants.
Fresh ground dentin has been used successfully as a grafting material alternative in alveolar ridge preservation which has been manifested in that the clinically grafted sites demonstrated limited ridge resorption which allowed for subsequent implant placement without the need to use additional graft biomaterials.
### Conditions Module
**Conditions:**
- Alveolar Bone Loss
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 30
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Autogenous stored mineralized dentin graft (ASMDG) particles will be prepared by immersing tooth particles in basic ethanol for 10 min for disinfection, then washed twice in saline and dried using sterile gauze The disinfected particles will then be stored at room temperature for 21 days in a sterile container. After 21 days, a second extraction will be performed followed by mixing the stored graft with a few drops of sterile saline to be packed in a socket after extraction
**Intervention Names:**
- Procedure: Autogenous stored mineralized dentin graft (ASMDG)
**Label:** Autogenous stored mineralized dentin graft (ASMDG)
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Autogenous fresh mineralized dentin graft (AFMDG) particles will be prepared by immersing tooth particles in basic ethanol for 10 min for disinfection, then washed twice in saline and dried using sterile gauze
**Intervention Names:**
- Procedure: Autogenous fresh mineralized dentin graft (AFMDG)
**Label:** Autogenous fresh mineralized dentin graft (AFMDG)
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Autogenous stored mineralized dentin graft (ASMDG)
**Description:** Autogenous stored mineralized dentin graft (ASMDG) particles will be prepared by immersing tooth particles in basic ethanol for 10 min for disinfection, then washed twice in saline and dried using sterile gauze.
The disinfected particles will then be stored at room temperature for 21 days in a sterile container. After 21 days, a second extraction will be performed followed by mixing the stored graft with a few drops of sterile saline to be packed in a socket after extraction
**Name:** Autogenous stored mineralized dentin graft (ASMDG)
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- Autogenous fresh mineralized dentin graft (AFMDG)
**Description:** Autogenous fresh mineralized dentin graft (AFMDG) particles will be prepared by immersing tooth particles in basic ethanol for 10 min for disinfection, then washed twice in saline and dried using sterile gauze.
**Name:** Autogenous fresh mineralized dentin graft (AFMDG)
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** The horizontal buccolingual alveolar ridge width will be measured radiographically on a CBCT at three levels: at -1 mm, -3 mm, -5 mm below the most coronal aspect of the crest (HW-1, HW-3, HW-5), and clinically by a caliper at -3 mm and -5 mm (HW-3 and HW-5). Measurements will be taken at baseline and after 4 months postoperatively to calculate the change.
**Measure:** Change in buccolingual horizontal alveolar ridge width
**Time Frame:** 4 months
#### Secondary Outcomes
**Description:** The alveolar buccal ridge height will be measured radiographically on a CBCT at baseline and after 4 months postoperatively.
**Measure:** Alveolar buccal ridge height
**Time Frame:** 4 months
**Description:** Visual Analogue Scale (VAS) with numbers from 0 to 10 ('no pain' to 'worst pain imaginable')
**Measure:** Postoperative pain
**Time Frame:** 24 hours
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Potential candidates requiring extraction of maxillary non-molar teeth.
* Periodontally healthy adjacent teeth.
* Extraction sockets having no more than 50% of buccal alveolar bone loss
Exclusion Criteria:
* Smokers.
* Patients reporting systemic conditions that may compromise healing or bone metabolism (e.g., uncontrolled diabetes, hyperthyroidism).
* Patients having a history of radiotherapy, chemotherapy, or bisphosphonate therapy.
* Females who were pregnant or planning to get pregnant during the study course.
* Root canal treated teeth and teeth with acute infection at the site of extraction
**Healthy Volunteers:** True
**Maximum Age:** 60 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Nada Wahsh, Bachelor
**Phone:** 01026191091
**Role:** CONTACT
**Contact 2:**
**Name:** Cairo University
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Cairo
**Contacts:**
***Contact 1:***
- **Name:** Faculty of dentistry
- **Role:** CONTACT
**Country:** Egypt
**Facility:** Cairo university
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
### References Module
#### References
**Citation:** Avila-Ortiz G, Chambrone L, Vignoletti F. Effect of alveolar ridge preservation interventions following tooth extraction: A systematic review and meta-analysis. J Clin Periodontol. 2019 Jun;46 Suppl 21:195-223. doi: 10.1111/jcpe.13057. Erratum In: J Clin Periodontol. 2020 Jan;47(1):129.
**PMID:** 30623987
**Citation:** Schmidt-Schultz TH, Schultz M. Intact growth factors are conserved in the extracellular matrix of ancient human bone and teeth: a storehouse for the study of human evolution in health and disease. Biol Chem. 2005 Aug;386(8):767-76. doi: 10.1515/BC.2005.090.
**PMID:** 16201872
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001862
- Term: Bone Resorption
- ID: D000001847
- Term: Bone Diseases
- ID: D000009140
- Term: Musculoskeletal Diseases
- ID: D000055093
- Term: Periodontal Atrophy
- ID: D000010510
- Term: Periodontal Diseases
- ID: D000009059
- Term: Mouth Diseases
- ID: D000009057
- Term: Stomatognathic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC05
- Name: Musculoskeletal Diseases
- Abbrev: BC07
- Name: Mouth and Tooth Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M18747
- Name: Alveolar Bone Loss
- Relevance: HIGH
- As Found: Alveolar Bone Loss
- ID: M5141
- Name: Bone Resorption
- Relevance: LOW
- As Found: Unknown
- ID: M5126
- Name: Bone Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12097
- Name: Musculoskeletal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M4589
- Name: Atrophy
- Relevance: LOW
- As Found: Unknown
- ID: M28025
- Name: Periodontal Atrophy
- Relevance: LOW
- As Found: Unknown
- ID: M13419
- Name: Periodontal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12019
- Name: Mouth Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12017
- Name: Stomatognathic Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000016301
- Term: Alveolar Bone Loss
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M3777
- Name: Ethanol
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT01060579
**Brief Title:** Study of AR-12286 Versus Latanoprost in Patients With Elevated Intraocular Pressure
**Official Title:** A Phase 2, Double-masked, Randomized, Active-controlled, Dose-response Study Assessing the Safety and Ocular Hypotensive Efficacy of AR-12286 in Patients With Elevated Intraocular Pressure
#### Organization Study ID Info
**ID:** AR-12286-CS202
#### Organization
**Class:** INDUSTRY
**Full Name:** Aerie Pharmaceuticals
### Status Module
#### Completion Date
**Date:** 2010-08
**Type:** ACTUAL
#### Disp First Post Date
**Date:** 2014-04-21
**Type:** ESTIMATED
**Disp First Submit Date:** 2014-02-17
**Disp First Submit QC Date:** 2014-03-25
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2014-05-08
**Type:** ESTIMATED
**Last Update Submit Date:** 2014-04-18
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2010-08
**Type:** ACTUAL
#### Start Date
**Date:** 2010-02
**Status Verified Date:** 2014-04
#### Study First Post Date
**Date:** 2010-02-02
**Type:** ESTIMATED
**Study First Submit Date:** 2010-01-30
**Study First Submit QC Date:** 2010-02-01
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Aerie Pharmaceuticals
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** A 28 day study of the safety and efficacy of two concentrations of topical AR-12286 in treating ocular hypertension and open-angle glaucoma compared to latanoprost. Hypothesis: The ocular hypotensive efficacy of each dose of AR-12286 ophthalmic solution will not be different from that of an active control.
### Conditions Module
**Conditions:**
- Glaucoma
**Keywords:**
- Glaucoma
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 217
**Type:** ACTUAL
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Drug: AR-12286 0.5% ophthalmic solution
**Label:** AR-12286 0.5% ophthalmic solution
**Type:** EXPERIMENTAL
#### Arm Group 2
**Intervention Names:**
- Drug: AR-12286 0.25% Ophthalmic solution
**Label:** AR-12286 0.25% Ophthalmic Solution
**Type:** EXPERIMENTAL
#### Arm Group 3
**Intervention Names:**
- Drug: Latanoprost ophthalmic solution
**Label:** Latanoprost 0.005% ophthalmic solution
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- AR-12286 0.5% ophthalmic solution
**Description:** q.d. PM
**Name:** AR-12286 0.5% ophthalmic solution
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- AR-12286 0.25% Ophthalmic Solution
**Description:** q.d. PM
**Name:** AR-12286 0.25% Ophthalmic solution
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- Latanoprost 0.005% ophthalmic solution
**Description:** q.d. PM
**Name:** Latanoprost ophthalmic solution
**Other Names:**
- Xalatan(R)
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Measure:** The primary efficacy endpoint will be the mean intraocular pressure (IOP) across subjects within treatment group on each day at each post-treatment timepoint
**Time Frame:** 28 days of dosing
#### Secondary Outcomes
**Measure:** Mean change from diurnally adjusted baseline IOP at each timepoint
**Time Frame:** 28 days of dosing
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. 18 years of age or greater.
2. Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT) and currently being treated with ocular hypotensive medication.
3. Unmedicated (post-washout) IOP ≥ 22 mm Hg at 2 eligibility visits (07:00-09:00 hr), 2-7 days apart.
4. Corrected visual acuity in each eye +1.0 logMAR or better by ETDRS in each eye (equivalent to 20/200).
5. Has used a commercially available IOP-lowering medication in one or both eyes for at least 30 days over the 90 days prior to the screening visit.
6. Able and willing to give signed informed consent and follow study instructions.
Exclusion Criteria:
Ophthalmic (in either eye):
1. Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure. Note: Previous laser peripheral iridotomy is acceptable.
2. Intraocular pressure \> 36 mm Hg
3. Known hypersensitivity to any component of the formulation (benzalkonium chloride, etc.), or to topical anesthetics.
4. Previous glaucoma intraocular surgery or glaucoma laser procedures in study eye(s).
5. Refractive surgery in study eye(s) (e.g., radial keratotomy, PRK, LASIK, etc.).
6. Ocular trauma within the past six months, or ocular surgery or laser treatment within the past three months.
7. History or evidence of ocular infection, inflammation, clinically significant blepharitis or conjunctivitis at baseline (Visit 1), or of herpes simplex keratitis
8. Contact lens wear within 30 minutes of instillation of study medication.
9. Ocular medication of any kind within 30 days of Visit 1, with the exception of a) ocular hypotensive medications (which must be washed out according to the provided schedule), b) lid scrubs (which may be used prior to, but not after Visit 1) or c) lubricating drops for dry eye (which may be used throughout the study).
10. Clinically significant ocular disease (e.g. corneal edema, uveitis, severe keratoconjunctivitis sicca) which might interfere with the study, including glaucomatous damage so severe that washout of ocular hypotensive medications for one month is not judged safe (i.e., cup-disc ratio \> 0.8).
11. Central corneal thickness greater than 600 μ.
12. Any abnormality preventing reliable applanation tonometry of either eye.
Systemic:
1. Clinically significant abnormalities in laboratory tests at screening.
2. Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia gravis, hepatic, renal, endocrine or cardiovascular disorders) which might interfere with the study.
3. Participation in any investigational study within the past 30 days.
4. Changes of systemic medication that could have a substantial effect on IOP within 30 days prior to screening, or anticipated during the study.
5. Due to status of preclinical safety program, women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control. An adult woman is considered to be of childbearing potential unless she is one year post-menopausal or three months post-surgical sterilization. All females of childbearing potential must have a negative urine pregnancy test result at the screening examination and must not intend to become pregnant during the study.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Inglewood
**Country:** United States
**Facility:** United Medical Research Institute
**State:** California
**Zip:** 90301
**Location 2:**
**City:** Petaluma
**Country:** United States
**Facility:** North Bay Eye Associates
**State:** California
**Zip:** 94954
**Location 3:**
**City:** Poway
**Country:** United States
**Facility:** Centre For Health Care
**State:** California
**Zip:** 92064
**Location 4:**
**City:** Stuart
**Country:** United States
**Facility:** East Florida Eye Institute
**State:** Florida
**Zip:** 34994
**Location 5:**
**City:** Tamarac
**Country:** United States
**Facility:** Marvin Greenberg, MD
**State:** Florida
**Zip:** 33321
**Location 6:**
**City:** Roswell
**Country:** United States
**Facility:** Coastal Research Associates, LLC
**State:** Georgia
**Zip:** 30076
**Location 7:**
**City:** Shawnee Mission
**Country:** United States
**Facility:** Bradley Kwapiszeski, MD
**State:** Kansas
**Zip:** 66204
**Location 8:**
**City:** Louisville
**Country:** United States
**Facility:** Taustine Eye Center
**State:** Kentucky
**Zip:** 40217
**Location 9:**
**City:** St Louis
**Country:** United States
**Facility:** Comprehensive Eye Care
**State:** Missouri
**Zip:** 63090
**Location 10:**
**City:** New York
**Country:** United States
**Facility:** Mount Sinai School Of Medicine
**State:** New York
**Zip:** 10029
**Location 11:**
**City:** Rochester
**Country:** United States
**Facility:** Rochester Ophthalmology Group
**State:** New York
**Zip:** 14618
**Location 12:**
**City:** Slingerlands
**Country:** United States
**Facility:** Glaucoma Consultants of the Capital Region
**State:** New York
**Zip:** 12159
**Location 13:**
**City:** Charlotte
**Country:** United States
**Facility:** Charlotte Eye Ear Nose and Throat
**State:** North Carolina
**Zip:** 28210
**Location 14:**
**City:** Tulsa
**Country:** United States
**Facility:** The Eye Institute
**State:** Oklahoma
**Zip:** 74104
**Location 15:**
**City:** Rapid City
**Country:** United States
**Facility:** Black Hills Regional Eye Institute
**State:** South Dakota
**Zip:** 57701
**Location 16:**
**City:** Maryville
**Country:** United States
**Facility:** Univ Eye Surgeons, Maryville Ctr.
**State:** Tennessee
**Zip:** 37803
**Location 17:**
**City:** Austin
**Country:** United States
**Facility:** Texan Eye
**State:** Texas
**Zip:** 78731
**Location 18:**
**City:** San Antonio
**Country:** United States
**Facility:** Medical Center Ophth. Associates
**State:** Texas
**Zip:** 78731
#### Overall Officials
**Official 1:**
**Affiliation:** Aerie Pharmaceuticals, Inc.
**Name:** Thomas van Haarlem, MD
**Role:** STUDY_DIRECTOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000005128
- Term: Eye Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC11
- Name: Eye Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC14
- Name: Heart and Blood Diseases
### Condition Browse Module - Browse Leaves
- ID: M9013
- Name: Glaucoma
- Relevance: HIGH
- As Found: Glaucoma
- ID: M12731
- Name: Ocular Hypertension
- Relevance: HIGH
- As Found: Elevated Intraocular Pressure
- ID: M10024
- Name: Hypertension
- Relevance: LOW
- As Found: Unknown
- ID: M8271
- Name: Eye Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000005901
- Term: Glaucoma
- ID: D000009798
- Term: Ocular Hypertension
### Intervention Browse Module - Browse Branches
- Abbrev: PhSol
- Name: Pharmaceutical Solutions
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: AnAg
- Name: Antihypertensive Agents
### Intervention Browse Module - Browse Leaves
- ID: M21860
- Name: Pharmaceutical Solutions
- Relevance: HIGH
- As Found: Procedure
- ID: M12814
- Name: Ophthalmic Solutions
- Relevance: HIGH
- As Found: Start
- ID: M1775
- Name: Latanoprost
- Relevance: HIGH
- As Found: Brain Stimulation
- ID: M4277
- Name: Antihypertensive Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000019999
- Term: Pharmaceutical Solutions
- ID: D000077338
- Term: Latanoprost
- ID: D000009883
- Term: Ophthalmic Solutions
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT05494879
**Brief Title:** Effectiveness of Microkinesitherapy in Seniors
**Official Title:** Evaluation of the Effect of Microkinesitherapy Treatment on Psychosomatic Functions in Community-dwelling Older Adults: A Pilot Study
#### Organization Study ID Info
**ID:** Micro_Poznan
#### Organization
**Class:** OTHER
**Full Name:** The Opole University of Technology
### Status Module
#### Completion Date
**Date:** 2023-07-18
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-08-10
**Type:** ACTUAL
**Last Update Submit Date:** 2022-08-09
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2022-08-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2022-08-17
**Type:** ESTIMATED
**Status Verified Date:** 2022-08
#### Study First Post Date
**Date:** 2022-08-10
**Type:** ACTUAL
**Study First Submit Date:** 2022-07-29
**Study First Submit QC Date:** 2022-08-09
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** The Opole University of Technology
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Many specialists stress that the aging process is individual, its course, severity and occurrence of disease are not the same for all seniors. The studies indicate that SA should be conceptualized as a process, using developmental trajectories of functioning as component parts, and can take several forms. The nature of "successful" trajectories varied from a limited decline over time (e.g., cognitive and physical functioning), stability over time (e.g., self-perceived health) to recovery (from social loneliness) and growth (in life satisfaction and emotional support provided). Therefore, the aim of this study was to investigate the effectiveness of microkinesitherapy treatment in community-dwelling older adults.
**Detailed Description:** new therapeutic methods are being proposed that can be used in the community to steer the aging process toward "healthy aging." An example of a holistic approach to the patient can be found in microkinesitherapy. The focus of microkinesitherapy is to find and restore areas of the body that have lost their vitality and mobility, using gentle touches on various body tissues using specific body maps. The aim of this study was to investigate the effectiveness of microkinesitherapy treatment in community-dwelling older adults. It was decided to evaluate the impact of a single therapy session on a range of psycho-somatic indicators. The hypotheses were as follows: (H1) The microkinesitherapy intervention will improve the physical function assessed using the Senior Fitness Test, (H2) A single microkinesitherapy treatment will not affect gait performance, (H3) A single microkinesitherapy treatment will improve the quality of life of the participants.
### Conditions Module
**Conditions:**
- Microkinesitherapy
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 24
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The study group received a single therapy session of microkinesitherapy. The entire procedure lasted about 10 minutes. Microkinesitherapy is based on locating information in the patient's body about previous traumas/traumas that have been experienced physically and emotionally, which the body could not eliminate. This information is interpreted on the body by sensitive tensions and called "body scars" and does not necessarily remain in the brain.
**Intervention Names:**
- Behavioral: microkinesitherapy treatment
**Label:** microkinesitherapy treatment
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- microkinesitherapy treatment
**Description:** The therapeutic session of microkinesitherapy included a seeking of "body scares" both taking into account somatic dysfunctions as well as psychosomatic disorders. According to the creators of the method, Grosjean and Benini "Everything that happens with us in a toxic level, either physically or emotionally, are stored by the brain which keeps memories and generates links that may harm the function of the cells generating a vast array of symptoms and dysfunctions".
**Name:** microkinesitherapy treatment
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** The Senior Fitness Test (also known as the Fullerton test) was used to assess physical fitness. Five motor tasks were evaluated, including strength, endurance, flexibility, agility, balance, and motor coordination. The sixth component of the test: the 6-minute walk test could not be performed due to the patients' low functional status.
**Measure:** Change of the Senior Fitness Test
**Time Frame:** baseline, 1-month follow-up
**Description:** Gait cycle analysis was performed with the subject barefoot over a distance of 5 m long and 2 m wide, making 2 passes (10 m) at normal gait speed. For gait analysis, a wireless inertial sensor system BTS G-WALK (BTS Bioengineering S.p.A., Milan, Italy) was used, placed by means of a semi-elastic belt at the level of the fifth lumbar vertebra (L5) and the first two sacral vertebrae (S1-S2).
**Measure:** Change of the gait parameters
**Time Frame:** baseline, 1-month follow-up
**Description:** The WHO's questions stem from multiple statements about quality of life, health and well-being from people with and without disease, and health professionals. The questionnaire was validated and identifies four major domains: Physical health, Psychological, Social relationships, Environment. Each individual item of the WHOQOL-BREF is scored from 1 to 5 on a response scale, which is stipulated as a five-point ordinal scale. The scores are then transformed to a 0-100 or 4-20 scales. Lower score indicates poorer quality of life
**Measure:** Change of the quality of life
**Time Frame:** baseline, 1-month follow-up
**Description:** The GHQ-12 General Health Questionnaire enables the identification of people whose mental state has broken down temporarily or over the long term as a result of difficulties experienced, problems or as a result of mental illness, and those who are at significant risk of mental health disorders. A version of the GHQ-28 provides an overall score that is an indicator of the patient's mental health, divided into 4 scales: somatic symptoms; anxiety, insomnia; dysfunction and symptoms of depression. The scoring type used in this study was Likert scoring methods (0-1-2-3). Higher score indicates greater disorder
**Measure:** Change of the mental health
**Time Frame:** baseline, 1-month follow-up
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* informed consent to participate in the study
Exclusion Criteria:
* pneumonia, tuberculosis and other respiratory inflammatory disease in all stages and forms
* less than 6 months after a heart attack, state after thoracic and cardiac surgery
* uncontrolled hypertension
* insulin-dependent diabetes
* lung cancer
* cognitive impairment or Mini-Mental State Examination \< 24.
**Healthy Volunteers:** True
**Maximum Age:** 100 Years
**Minimum Age:** 50 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Opole
**Country:** Poland
**Facility:** Faculty of Physical Education and Physiotherapy, Opole University of Technology
**Zip:** 45-758
### IPD Sharing Statement Module
**Description:** The data presented in this study are available upon request from the corresponding author.
**Info Types:**
- STUDY_PROTOCOL
**IPD Sharing:** YES
**Time Frame:** 6-months
## Derived Section
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT03105479
**Brief Title:** Comparison of Cadazolid Versus Vancomycin in Children With Clostridium Difficile-associated Diarrhea (CDAD)
**Official Title:** A Prospective, Multicenter Study to Investigate the Pharmacokinetics, Safety, and Efficacy of Cadazolid Versus Vancomycin in Pediatric Subjects With Clostridium Difficile-associated Diarrhea
#### Organization Study ID Info
**ID:** AC-061A303
#### Organization
**Class:** INDUSTRY
**Full Name:** Actelion
#### Secondary ID Infos
**ID:** 2015-004805-17
**Type:** EUDRACT_NUMBER
### Status Module
#### Completion Date
**Date:** 2018-04-17
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-04-03
**Type:** ACTUAL
**Last Update Submit Date:** 2019-03-14
**Overall Status:** TERMINATED
#### Primary Completion Date
**Date:** 2018-04-17
**Type:** ACTUAL
#### Results First Post Date
**Date:** 2019-04-03
**Type:** ACTUAL
**Results First Submit Date:** 2019-01-08
**Results First Submit QC Date:** 2019-03-14
#### Start Date
**Date:** 2017-04-14
**Type:** ACTUAL
**Status Verified Date:** 2019-03
#### Study First Post Date
**Date:** 2017-04-10
**Type:** ACTUAL
**Study First Submit Date:** 2017-03-23
**Study First Submit QC Date:** 2017-04-03
**Why Stopped:** Study suspended in October 2017 and terminated April 17, 2018 after decision to discontinue the study drug development
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Actelion
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Cadazolid has demonstrated activity against a bacteria named Clostridium difficile in animal studies. The results of a first study conducted in adult patients have suggested efficacy of the new antibiotic, cadazolid, in the treatment of diarrhea caused by this bacteria. This is the first study of cadazolid in children. The overall purpose of this study is to provide reassurance on the safety and efficacy of cadazolid in children suffering from infection due to Clostridium difficile.
**Detailed Description:** This multicenter, study will be run into two parts. Both parts will be run in consecutive age cohorts, starting from the oldest age categories(12 to \< 18 years old) to the youngest (birth to \< 3 months).
* Part A is an open-label, dose finding part to be conducted in at least 24 subjects.
* Part B follows a randomized, assessor-blinded, parallel-group design with vancomycin used as an active comparator. Part B will be conducted in about 176 children.
In both parts, the treatment period will be 10 days and will be followed by a Follow-up period of 28-32 days.
### Conditions Module
**Conditions:**
- Clostridium Difficile Infection
**Keywords:**
- vancomycin
- children
- cadazolid
- clostridium difficile associated diarrhea
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Masking Description:** Assessor masking in Part B only (no masking in Part A)
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 1
**Type:** ACTUAL
**Phases:**
- PHASE2
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Subjects from 12 years to 18 years old (exclusive) will receive cadazolid 500 mg per day for 10 days. The dose may be adjusted based on the pharmacokinetic (PK) and safety data reviewed for the first 3 subjects.
**Intervention Names:**
- Drug: Cadazolid
**Label:** Part A / Cohort A
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Subjects from 6 years to 12 years old (exclusive) will receive cadazolid for 10 days. The dose will depend on the PK and safety data from cohort A reviewed by the Independent Data Monitoring Committee (IDMC).
**Intervention Names:**
- Drug: Cadazolid
**Label:** Part A / Cohort B
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Subjects from 2 years to 6 years old (exclusive) will receive cadazolid for 10 days. The dose will depend on the PK and safety data from cohort B reviewed by the IDMC.
**Intervention Names:**
- Drug: Cadazolid
**Label:** Part A / Cohort C
**Type:** EXPERIMENTAL
#### Arm Group 4
**Description:** Subjects from 3 months to 2 years old (exclusive) will receive cadazolid for 10 days. The dose will depend on the PK and safety data from cohort C reviewed by the IDMC.
**Intervention Names:**
- Drug: Cadazolid
**Label:** Part A/ Cohort D
**Type:** EXPERIMENTAL
#### Arm Group 5
**Description:** Subjects from birth to 3 months old (exclusive) will receive cadazolid for 10 days. The dose will depend on the PK and safety data from cohort D reviewed by the IDMC.
**Intervention Names:**
- Drug: Cadazolid
**Label:** Part A/ Cohort E
**Type:** EXPERIMENTAL
#### Arm Group 6
**Description:** Subjects from birth to 18 years old (exclusive) will receive cadazolid for 10 days, at the dose defined in the corresponding age cohort in Part A.
**Intervention Names:**
- Drug: Cadazolid
**Label:** Part B / Cadazolid
**Type:** EXPERIMENTAL
#### Arm Group 7
**Description:** Subjects from birth to 18 years old (exclusive) will receive vancomycin capsule (for subjects able to swallow) or vancomycin solution (for the others) during 10 days .
**Intervention Names:**
- Drug: Vancomycin capsule
- Drug: Vancomycin solution
**Label:** Part B / Vancomycin
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Part A / Cohort A
- Part A / Cohort B
- Part A / Cohort C
- Part A/ Cohort D
- Part A/ Cohort E
- Part B / Cadazolid
**Description:** Granules for oral suspension to be administered twice daily
**Name:** Cadazolid
**Other Names:**
- ACT-179811
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Part B / Vancomycin
**Description:** Capsule containing 125 mg of vancomycin to be administered orally 4 times a day
**Name:** Vancomycin capsule
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- Part B / Vancomycin
**Description:** Vancomycin powder to be administered as oral solution at a dose of 40 mg/kg/day, 3 to 4 times a day
**Name:** Vancomycin solution
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** This is the percentage of participants in part B reported as with a clinical cure. Clinical Cure is defined as: • \<3 unformed bowel movement (UBM) per day (or no water diarrhea if subjects \< 2 years of age), for at least 2 consecutive days between first dose of study treatment up to end of treatment (EOT) (inclusive) AND • Subject remains well up to EOT + 2 days (inclusive) based on investigator judgment AND • No need for additional antimicrobial treatment active against Clostridium difficile-associated diarrhea (CDAD) between first dose of study treatment up to EOT + 2 days (inclusive). percentage of subjects with a clinical cure
**Measure:** Clinical Cure Rate During Part B
**Time Frame:** Day 10 (End of Treatment) + 2 days
**Description:** Blood samples are collected at different timepoints on Day 10 for the determination of cadazolid Cmax after 10 days of treatment.
**Measure:** Maximal Plasma Concentration (Cmax) of Cadazolid During Part A
**Time Frame:** Day 10 (End of Treatment)
**Description:** Blood samples are collected at different timepoints to determine the time when the maximal plasma concentration of cadazolid is reached.
**Measure:** Time to Reach Cmax (Tmax) of Cadazolid During Part A
**Time Frame:** Day 10 (End of Treatment)
**Description:** Blood samples are collected at different timepoints for the determination of the cadazolid AUC over one dosing interval (0-12h) on Day 10.
**Measure:** Area Under the Plasma Concentration Time Curve (AUC) of Cadazolid During Part A
**Time Frame:** Day 10 (End of Treatment)
**Description:** A fecal sample is collected as the end-of-treatment visit in all participants in Part A.
**Measure:** Fecal Concentrations of Cadazolid During Part A
**Time Frame:** Day 10 (End of Treatment)
#### Secondary Outcomes
**Description:** This is the percentage of participants in Part A reported as with a clinical cure. Clinical Cure is defined as: • \<3 unformed bowel movement (UBM) per day (or no water diarrhea if subjects \< 2 years of age), for at least 2 consecutive days between first dose of study treatment up to end of treatment (EOT) (inclusive) AND • Subject remains well up to EOT + 2 days (inclusive) based on investigator judgment AND • No need for additional antimicrobial treatment active against Clostridium difficile-associated diarrhea (CDAD) between first dose of study treatment up to EOT + 2 days (inclusive).
**Measure:** Clinical Cure Rate During Part A
**Time Frame:** Day 10 (End of Treatment) + 2 days
**Description:** This is the percentage of participants in Parts A and B reported as with sustained clinical cure. Sustained clinical cure is defined as • Clinical Cure and no Recurrence until 30 days after the last study drug intake (end of study).
**Measure:** Sustained Clinical Cure Rate During Part A and Part B
**Time Frame:** Day 40 (on average)
**Description:** This is the percentage of participants in Parts A and B assessed as having a recurrence out of subjects meeting the criteria for Clinical Cure. Recurrence is defined as: • Clinical Cure AND New episode of diarrhea with ≥ 3 UBMs (or watery diarrhea if subject \< 2 years) on any day between EOT + 3 days and end of study AND • Stool test showing positive C. difficile (as defined in Inclusion Criterion 4), AND •Antimicrobial treatment active against CDAD started between EOT + 3 days and end of study.
**Measure:** Recurrence Rate During Part A and Part B
**Time Frame:** Day 40 (on average)
**Description:** This it the time (in days) elapsed between the last dose of study drug and the onset day of new episode of diarrhea reported as Kaplan-Meier estimates (KM estimates)
**Measure:** Time to Recurrence in Part B
**Time Frame:** Day 40 (on average)
**Description:** This is the time (in days) elapsed between the first dose of study treatment and the resolution of diarrhea and reported as Kaplan-Meier estimates (KM estimates). The date of resolution of Diarrhea (ROD) is defined as the date of the first day of the 2 consecutive days on treatment with \< 3 UBM (or no watery diarrhea for subjects \< 2 years of age). Time to ROD is the time (in days) elapsed between the first dose of study treatment and the ROD
**Measure:** Time to Resolution of Diarrhea in Part B
**Time Frame:** Day 10
**Description:** Number of participants who prematurely discontinued the study treatment due to an adverse event
**Measure:** Adverse Events Leading to Premature Discontinuation of Study Treatment
**Time Frame:** Up to Day 10
**Description:** Number of participants with any marked abnormalities in laboratory parameters up to 7 days after end of treatment
**Measure:** Marked Abnormalities in Clinical Laboratory Parameters
**Time Frame:** Day 17 (on average)
**Description:** Number of subjects with any treatment-emergent abnormalities in vital signs (up to 7 days after end of treatment)
**Measure:** Marked Abnormalities in Vital Signs
**Time Frame:** Day 17 (on average)
**Description:** Number of subjects with any TEAEs. A TEAE is any adverse event temporally associated with the use of study treatment (from study treatment initiation until 7 days after study treatment discontinuation) whether or not considered by the investigator as related to study treatment.
**Measure:** Treatment-emergent Adverse Events (TEAES)
**Time Frame:** Day 17 (on average)
### Eligibility Module
**Eligibility Criteria:** Key Inclusion Criteria:
* Signed informed consent by parents or legally authorized representatives (LAR) and assent by the child according to local requirements prior to initiation of any study-mandated procedure.
* Male or female from birth to \< 18 years of age, diagnosed with Clostridium Difficile-associated diarrhea (CDAD).
* Females of childbearing potential must have a negative pregnancy test at screening and must agree to use an adequate and reliable method of contraception.
Key Exclusion Criteria:
* Positive Rotavirus test for subjects \< 5 years.
* Fulminant or life-threatening CDAD.
* More than one previous episode of CDAD in the 3 month period prior to enrollment / randomization.
* Antimicrobial treatment active against CDAD administered within 24 h prior to screening except for metronidazole treatment failures (MTF).
* Subjects with body weight \< 3 kg.
* Inflammatory bowel disease, chronic abdominal pain, or chronic diarrhea of any etiology.
* Fecal microbiota transplant (FMT), immunoglobulin therapy, or any investigational drug to prevent or treat CDAD within 1 month period (or 5 half-lives in case of investigational drug, whichever is longer) prior to enrollment / randomization.
* Monoclonal antibodies against C. difficile within 6 months prior to enrollment / randomization.
* Previous vaccination against C. difficile.
* Known mental disorders.
* Any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study, or compliance with the protocol.
**Maximum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Idaho Falls
**Country:** United States
**Facility:** Snake River Research, PLLC
**State:** Idaho
**Zip:** 83404
**Location 2:**
**City:** Chicago
**Country:** United States
**Facility:** University of Chicago, Dept. Of Medicine
**State:** Illinois
**Zip:** 60637
**Location 3:**
**City:** Shreveport
**Country:** United States
**Facility:** Louisiana State University Health Sciences Center - Shreveport
**State:** Louisiana
**Zip:** 71103
**Location 4:**
**City:** Syracuse
**Country:** United States
**Facility:** SUNY Upstate Medical University - Upstate Golisano Children's Hospital (GCH) - Pediatric Designated AIDS Center
**State:** Ohio
**Zip:** 13210
**Location 5:**
**City:** Houston
**Country:** United States
**Facility:** Texas Children's Hospital Feigin Cente
**State:** Texas
**Zip:** 77030
**Location 6:**
**City:** Jette
**Country:** Belgium
**Facility:** Universitair Ziekenhuis Brussel - Kinderziekenhuis
**Zip:** 1090
**Location 7:**
**City:** Calgary
**Country:** Canada
**Facility:** Infection Prevention & Control, AGW5 Foothills Medical Center 1403 29th Street N.W.
**Zip:** T2N 2T9
**Location 8:**
**City:** Brno
**Country:** Czechia
**Facility:** FN Brno
**Zip:** 62500
**Location 9:**
**City:** Budapest
**Country:** Hungary
**Facility:** Egyesített Szent István és Szent László Kórház - Rendelőintézet / Gyermekinfektológiai Osztály
**Zip:** 1097
**Location 10:**
**City:** Gyula
**Country:** Hungary
**Facility:** Pándy Kálmán Megyei Kórház
**Zip:** 5700
**Location 11:**
**City:** Milano
**Country:** Italy
**Facility:** Ospedale Buzzi
**Zip:** 20154
**Location 12:**
**City:** Roma
**Country:** Italy
**Facility:** Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale Pediatrico Bambino Gesu
**Zip:** 00165
**Location 13:**
**City:** Bydgoszcz
**Country:** Poland
**Facility:** Wojewodzki Szpital Obserwacyjno-Zakazny im. Tadeusza Browicza
**Zip:** 85-030
**Location 14:**
**City:** Poznan
**Country:** Poland
**Facility:** Specjalistyczny Zespół Opieki Zdrowotnej nad Matką i Dzieckiem
**Zip:** 61-734
**Location 15:**
**City:** Rzeszow
**Country:** Poland
**Facility:** Gabinet Lekarski Bartosz Korczowski
**Zip:** 35-302
**Location 16:**
**City:** Warsaw
**Country:** Poland
**Facility:** Klinika Gastroenterologii, Hepatologii, Zaburzeń Odżywiania i Pediatrii, Instytut "Pomnik - Centrum Zdrowia Dziecka"
**Zip:** 04-730
**Location 17:**
**City:** Bucharest
**Country:** Romania
**Facility:** Institutul National De Boli Infectioase "Prof. Dr. Matei Bals", sectia IX pediatrie
**Zip:** 21105
**Location 18:**
**City:** Iasi
**Country:** Romania
**Facility:** Spitalul Clinic de Boli Infectioase "Sfanta Parascheva" Iasi, Clinica de Boli Infectioase I,
**Zip:** 700116
**Location 19:**
**City:** Barcelona
**Country:** Spain
**Facility:** Hospital Sant Joan de Déu, Esplugues
**Zip:** 8950
**Location 20:**
**City:** Madrid
**Country:** Spain
**Facility:** Hospital Universitario Infantil LA PAZ
**Zip:** 28046
## Document Section
### Large Document Module
#### Large Docs
- Date: 2017-03-01
- Filename: Prot_000.pdf
- Has ICF: False
- Has Protocol: True
- Has SAP: False
- Label: Study Protocol
- Size: 2397107
- Type Abbrev: Prot
- Upload Date: 2019-03-14T09:15
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012817
- Term: Signs and Symptoms, Digestive
- ID: D000016908
- Term: Gram-Positive Bacterial Infections
- ID: D000001424
- Term: Bacterial Infections
- ID: D000001423
- Term: Bacterial Infections and Mycoses
- ID: D000007239
- Term: Infections
### Condition Browse Module - Browse Branches
- Abbrev: BC01
- Name: Infections
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M10283
- Name: Infections
- Relevance: LOW
- As Found: Unknown
- ID: M6368
- Name: Communicable Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7159
- Name: Diarrhea
- Relevance: HIGH
- As Found: Diarrhea
- ID: M6247
- Name: Clostridium Infections
- Relevance: HIGH
- As Found: Clostridium Difficile Infection
- ID: M15622
- Name: Signs and Symptoms, Digestive
- Relevance: LOW
- As Found: Unknown
- ID: M4722
- Name: Bacterial Infections
- Relevance: LOW
- As Found: Unknown
- ID: M19252
- Name: Gram-Positive Bacterial Infections
- Relevance: LOW
- As Found: Unknown
- ID: M12136
- Name: Mycoses
- Relevance: LOW
- As Found: Unknown
- ID: M4721
- Name: Bacterial Infections and Mycoses
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003015
- Term: Clostridium Infections
- ID: D000003967
- Term: Diarrhea
### Intervention Browse Module - Ancestors
- ID: D000000900
- Term: Anti-Bacterial Agents
- ID: D000000890
- Term: Anti-Infective Agents
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: PhSol
- Name: Pharmaceutical Solutions
### Intervention Browse Module - Browse Leaves
- ID: M17388
- Name: Vancomycin
- Relevance: HIGH
- As Found: Interaction
- ID: M21860
- Name: Pharmaceutical Solutions
- Relevance: LOW
- As Found: Unknown
- ID: M4222
- Name: Anti-Bacterial Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4214
- Name: Anti-Infective Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000014640
- Term: Vancomycin
### Misc Info Module
#### Removed Countries
- Country: Czech Republic
- Version Holder: 2024-05-24
## Results Section
### Adverse Events Module
**Description:** All adverse events (AE) which occurred at any time during the treatment period (10 days with cadazolid) and during the follow-up period (about 30 days) are reported. All AEs reported below occurred during the follow-up period.
#### Event Groups
**Group ID:** EG000
**Title:** Overall Study (Part A and Part B)
**Deaths Num At Risk:** 1
**Description:** Only one subject was included in cohort A; no subject was enrolled in the other cohorts of Part A or Part B due to early study termination.
**ID:** EG000
**Other Num Affected:** 1
**Other Num at Risk:** 1
**Serious Number At Risk:** 1
**Title:** Overall Study (Part A and Part B)
**Frequency Threshold:** 0
#### Other Events
**Term:** Sore throat
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
**Source Vocabulary:** MedDRA 20.0
**Term:** Headache
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
**Source Vocabulary:** MedDRA 20.0
**Term:** Vomiting
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA 20.0
**Time Frame:** From study treatment initiation up to Day 37 (i.e., 27 days after the end of treatment)
## Results Section - Baseline Characteristics Module
### Denomination Counts
**Group ID:** BG000
**Value:** 1
**Units:** Participants
### Group
**ID:** BG000
**Title:** Part A / Cohort A
**Description:** Subjects from 12 years to 18 years old (exclusive) will receive cadazolid 500 mg per day for 10 days. The dose may be adjusted based on the pharmacokinetic (PK) and safety data reviewed for the first 3 subjects.
### Measure
#### Measurement
**Group ID:** BG000
**Value:** 1
#### Denomination
**Units:** Participants
##### Denomination Counts
**Group ID:** BG000
**Value:** 1
**Class Title:** Adolescents (12 years to < 18 years)
#### Measurement
**Group ID:** BG000
**Value:** 0
#### Denomination
**Units:** Participants
##### Denomination Counts
**Group ID:** BG000
**Value:** 1
**Class Title:** Children (2 years to < 12 years
#### Measurement
**Group ID:** BG000
**Value:** 0
#### Denomination
**Units:** Participants
##### Denomination Counts
**Group ID:** BG000
**Value:** 1
**Class Title:** infants and toddlers (3 months to < 2 years
### Measure
#### Measurement
**Group ID:** BG000
**Value:** 1
**Category Title:** Female
#### Measurement
**Group ID:** BG000
**Value:** 0
**Category Title:** Male
#### Denomination
**Units:** Participants
##### Denomination Counts
**Group ID:** BG000
**Value:** 1
**Class Title:**
### Measure
#### Denomination
**Units:** Participants
##### Denomination Counts
**Group ID:** BG000
**Value:** 0
**Class Title:**
**Denomination Units Selected:**
## Results Section - Baseline Characteristics Module
### Measure 1
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Age, Customized
**Unit of Measure:** Participants
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Race and Ethnicity were not collected from any participant.
**Title:** Race and Ethnicity Not Collected
**Unit of Measure:** Participants
**Population Description:** Only one subject was enrolled in Part A. Part B was not conducted due to early study termination. Consequently the baseline characteristics are from one subject only.
## Results Section - More Information Module
### Certain Agreement
**Other Details:** Any study-related publication written independently by investigators must be submitted to Actelion for review at least 30 days prior to submission for publication or presentation. Upon review, Actelion may provide comments, and may also request alterations and/or deletions for the sole purpose of protecting its confidential information and/or patent rights.
**Restriction Type:** OTHER
**Restrictive Agreement:** True
### Limitations and Caveats
**Description:** Only one subject was enrolled due to early study termination. Consequently results are not meaningful and no statistical analyses could be performed.
### Point of Contact
**Email:** [email protected]
**Organization:** Actelion Pharmaceuticals Ltd
**Phone:** 0041615656565
**Title:** clinical trial disclosure desk
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
### Outcome Measure 6
### Outcome Measure 7
### Outcome Measure 8
### Outcome Measure 9
### Outcome Measure 10
### Outcome Measure 11
### Outcome Measure 12
### Outcome Measure 13
### Outcome Measure 14
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
#### Outcome Measure 2
#### Outcome Measure 3
#### Outcome Measure 4
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 4520
**Title:**
#### Outcome Measure 6
#### Outcome Measure 7
#### Outcome Measure 8
#### Outcome Measure 9
#### Outcome Measure 10
#### Outcome Measure 11
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 0
**Title:**
#### Outcome Measure 12
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 0
**Title:**
#### Outcome Measure 13
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 0
**Title:**
#### Outcome Measure 14
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 0
**Title:**
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** This is the percentage of participants in part B reported as with a clinical cure. Clinical Cure is defined as: • \<3 unformed bowel movement (UBM) per day (or no water diarrhea if subjects \< 2 years of age), for at least 2 consecutive days between first dose of study treatment up to end of treatment (EOT) (inclusive) AND • Subject remains well up to EOT + 2 days (inclusive) based on investigator judgment AND • No need for additional antimicrobial treatment active against Clostridium difficile-associated diarrhea (CDAD) between first dose of study treatment up to EOT + 2 days (inclusive). percentage of subjects with a clinical cure
**Population Description:** Due to the premature study termination, no subject was enrolled into Part B and consequently the percentage of subjects with a clinical cure could not be reported.
**Reporting Status:** POSTED
**Time Frame:** Day 10 (End of Treatment) + 2 days
**Title:** Clinical Cure Rate During Part B
**Type:** PRIMARY
##### Group
**Description:** Due to early termination of the study, no subject was enrolled into Part B.
**ID:** OG000
**Title:** Part B
#### Outcome Measure 2
**Description:** Blood samples are collected at different timepoints on Day 10 for the determination of cadazolid Cmax after 10 days of treatment.
**Population Description:** Due to the premature study termination, cadazolid concentrations were obtained from only one subject and pharmacokineitc plasma profile was not analyzed because of lack of meaningful data.
**Reporting Status:** POSTED
**Time Frame:** Day 10 (End of Treatment)
**Title:** Maximal Plasma Concentration (Cmax) of Cadazolid During Part A
**Type:** PRIMARY
##### Group
**Description:** One Subject aged between 12 and 18 years old received cadazolid 500 mg per day for 10 days.
**ID:** OG000
**Title:** Part A / Cohort A
#### Outcome Measure 3
**Description:** Blood samples are collected at different timepoints to determine the time when the maximal plasma concentration of cadazolid is reached.
**Population Description:** Due to the premature study termination, cadazolid concentrations were obtained from only one subject and pharmacokineitc plasma profile was not analyzed because of lack of meaningful data.
**Reporting Status:** POSTED
**Time Frame:** Day 10 (End of Treatment)
**Title:** Time to Reach Cmax (Tmax) of Cadazolid During Part A
**Type:** PRIMARY
##### Group
**Description:** One Subject aged between 12 and 18 years old received cadazolid 500 mg per day for 10 days.
**ID:** OG000
**Title:** Part A / Cohort A
#### Outcome Measure 4
**Description:** Blood samples are collected at different timepoints for the determination of the cadazolid AUC over one dosing interval (0-12h) on Day 10.
**Population Description:** Due to the premature study termination, cadazolid concentrations were obtained from only one subject and pharmacokineitc plasma profile was not analyzed because of lack of meaningful data.
**Reporting Status:** POSTED
**Time Frame:** Day 10 (End of Treatment)
**Title:** Area Under the Plasma Concentration Time Curve (AUC) of Cadazolid During Part A
**Type:** PRIMARY
##### Group
**Description:** One Subject aged between 12 and 18 years old received cadazolid 500 mg per day for 10 days.
**ID:** OG000
**Title:** Part A / Cohort A
#### Outcome Measure 5
**Description:** A fecal sample is collected as the end-of-treatment visit in all participants in Part A.
**Parameter Type:** NUMBER
**Population Description:** Due to premature termination, fecal sample was collected from only one subject, consequently mean values cannot be provided and no statistical analyses can be performed.
**Reporting Status:** POSTED
**Time Frame:** Day 10 (End of Treatment)
**Title:** Fecal Concentrations of Cadazolid During Part A
**Type:** PRIMARY
**Unit of Measure:** mcg/g
##### Group
**Description:** One Subject aged between 12 and 18 years old received cadazolid 500 mg per day for 10 days.
**ID:** OG000
**Title:** Part A / Cohort A
#### Outcome Measure 6
**Description:** This is the percentage of participants in Part A reported as with a clinical cure. Clinical Cure is defined as: • \<3 unformed bowel movement (UBM) per day (or no water diarrhea if subjects \< 2 years of age), for at least 2 consecutive days between first dose of study treatment up to end of treatment (EOT) (inclusive) AND • Subject remains well up to EOT + 2 days (inclusive) based on investigator judgment AND • No need for additional antimicrobial treatment active against Clostridium difficile-associated diarrhea (CDAD) between first dose of study treatment up to EOT + 2 days (inclusive).
**Population Description:** Due to premature termination, data were collected from only one subject, consequently percentage of participants with clinical cure cannot be calculated and no statistical analyses can be performed
**Reporting Status:** POSTED
**Time Frame:** Day 10 (End of Treatment) + 2 days
**Title:** Clinical Cure Rate During Part A
**Type:** SECONDARY
##### Group
**Description:** One Subject aged between 12 and 18 years old received cadazolid 500 mg per day for 10 days.
**ID:** OG000
**Title:** Part A / Cohort A
#### Outcome Measure 7
**Description:** This is the percentage of participants in Parts A and B reported as with sustained clinical cure. Sustained clinical cure is defined as • Clinical Cure and no Recurrence until 30 days after the last study drug intake (end of study).
**Population Description:** Due to the premature termination of the study and consequent lack of meaningful data, no analyses were performed.
**Reporting Status:** POSTED
**Time Frame:** Day 40 (on average)
**Title:** Sustained Clinical Cure Rate During Part A and Part B
**Type:** SECONDARY
##### Group
**Description:** Only one subject was included in cohort A; no subject was enrolled in the other cohorts due to early study termination.
**ID:** OG000
**Title:** Part A / Cohorts A to E
##### Group
**Description:** No subject was enrolled in cohort B due to early study termination.
**ID:** OG001
**Title:** Part B / Cadazolid
#### Outcome Measure 8
**Description:** This is the percentage of participants in Parts A and B assessed as having a recurrence out of subjects meeting the criteria for Clinical Cure. Recurrence is defined as: • Clinical Cure AND New episode of diarrhea with ≥ 3 UBMs (or watery diarrhea if subject \< 2 years) on any day between EOT + 3 days and end of study AND • Stool test showing positive C. difficile (as defined in Inclusion Criterion 4), AND •Antimicrobial treatment active against CDAD started between EOT + 3 days and end of study.
**Population Description:** Due to the premature termination of the study and consequent lack of meaningful data, no analyses were performed.
**Reporting Status:** POSTED
**Time Frame:** Day 40 (on average)
**Title:** Recurrence Rate During Part A and Part B
**Type:** SECONDARY
##### Group
**Description:** Only one subject was included in cohort A; no subject was enrolled in the other cohorts due to early study termination.
**ID:** OG000
**Title:** Part A / Cohorts A to E
##### Group
**Description:** No subject was enrolled in cohort B due to early study termination.
**ID:** OG001
**Title:** Part B / Cadazolid
#### Outcome Measure 9
**Description:** This it the time (in days) elapsed between the last dose of study drug and the onset day of new episode of diarrhea reported as Kaplan-Meier estimates (KM estimates)
**Population Description:** Due to premature termination, no subject was enrolled in Part B. Consequently, no data can be reported during Part B
**Reporting Status:** POSTED
**Time Frame:** Day 40 (on average)
**Title:** Time to Recurrence in Part B
**Type:** SECONDARY
##### Group
**Description:** Due to early termination of the study, no subject was enrolled into Part B.
**ID:** OG000
**Title:** Part B
#### Outcome Measure 10
**Description:** This is the time (in days) elapsed between the first dose of study treatment and the resolution of diarrhea and reported as Kaplan-Meier estimates (KM estimates). The date of resolution of Diarrhea (ROD) is defined as the date of the first day of the 2 consecutive days on treatment with \< 3 UBM (or no watery diarrhea for subjects \< 2 years of age). Time to ROD is the time (in days) elapsed between the first dose of study treatment and the ROD
**Population Description:** Due to premature termination, data were collected from only one subject, consequently KM estimates cannot be calculated and no statistical analyses can be performed
**Reporting Status:** POSTED
**Time Frame:** Day 10
**Title:** Time to Resolution of Diarrhea in Part B
**Type:** SECONDARY
##### Group
**Description:** Due to early termination of the study, no subject was enrolled into Part B.
**ID:** OG000
**Title:** Part B
#### Outcome Measure 11
**Description:** Number of participants who prematurely discontinued the study treatment due to an adverse event
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Due to premature termination, no subject was enrolled in Part B. Consequently, no data can be reported during Part B
**Reporting Status:** POSTED
**Time Frame:** Up to Day 10
**Title:** Adverse Events Leading to Premature Discontinuation of Study Treatment
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Only one subject was included in cohort A; no subject was enrolled in the other cohorts due to early study termination.
**ID:** OG000
**Title:** Part A / Cohorts A to E
##### Group
**Description:** No subject was enrolled in cohort B due to early study termination.
**ID:** OG001
**Title:** Part B / Cadazolid
#### Outcome Measure 12
**Description:** Number of participants with any marked abnormalities in laboratory parameters up to 7 days after end of treatment
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Due to premature termination, no subject was enrolled in Part B. Consequently, no data can be reported during Part B
**Reporting Status:** POSTED
**Time Frame:** Day 17 (on average)
**Title:** Marked Abnormalities in Clinical Laboratory Parameters
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Only one subject was included in cohort A; no subject was enrolled in the other cohorts due to early study termination.
**ID:** OG000
**Title:** Part A / Cohorts A to E
##### Group
**Description:** No subject was enrolled in cohort B due to early study termination.
**ID:** OG001
**Title:** Part B / Cadazolid
#### Outcome Measure 13
**Description:** Number of subjects with any treatment-emergent abnormalities in vital signs (up to 7 days after end of treatment)
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Due to premature termination, no subject was enrolled in Part B. Consequently, no data can be reported during Part B
**Reporting Status:** POSTED
**Time Frame:** Day 17 (on average)
**Title:** Marked Abnormalities in Vital Signs
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Only one subject was included in cohort A; no subject was enrolled in the other cohorts due to early study termination.
**ID:** OG000
**Title:** Part A / Cohorts A to E
##### Group
**Description:** No subject was enrolled in cohort B due to early study termination.
**ID:** OG001
**Title:** Part B / Cadazolid
#### Outcome Measure 14
**Description:** Number of subjects with any TEAEs. A TEAE is any adverse event temporally associated with the use of study treatment (from study treatment initiation until 7 days after study treatment discontinuation) whether or not considered by the investigator as related to study treatment.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Due to premature termination, no subject was enrolled in Part B. Consequently, no data can be reported during Part B
**Reporting Status:** POSTED
**Time Frame:** Day 17 (on average)
**Title:** Treatment-emergent Adverse Events (TEAES)
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Only one subject was included in cohort A; no subject was enrolled in the other cohorts due to early study termination.
**ID:** OG000
**Title:** Part A / Cohorts A to E
##### Group
**Description:** No subject was enrolled in cohort B due to early study termination.
**ID:** OG001
**Title:** Part B / Cadazolid
### Participant Flow Module
#### Group
**Description:** Subjects from 12 years to 18 years old (exclusive) are to be treated with cadazolid 250 mg twice daily for 10 days. The dose may be adjusted based on the pharmacokinetic (PK) and safety data reviewed for the first 3 subjects.
**ID:** FG000
**Title:** Part A / Cohort A
#### Group
**Description:** Subjects from 6 years to 12 years old (exclusive) are to be treated with cadazolid for 10 days (dose determined based on the PK and safety data from cohort A reviewed by the Independent Data Monitoring Committee (IDMC)).
**ID:** FG001
**Title:** Part A / Cohort B
#### Group
**Description:** Subjects from 2 years to 6 years old (exclusive) are to be treated with cadazolid for 10 days. (dose determined based on the PK and safety data from cohort B reviewed by the IDMC).
**ID:** FG002
**Title:** Part A / Cohort C
#### Group
**Description:** Subjects from 3 months to 2 years old (exclusive) are to be treated with cadazolid for 10 days (dose determined based on the PK and safety data from cohort B reviewed by the IDMC).
**ID:** FG003
**Title:** Part A/ Cohort D
#### Group
**Description:** Subjects from birth to 3 months old (exclusive) are to be treated with cadazolid for 10 days (dose determined based on the PK and safety data from cohort B reviewed by the IDMC). .
**ID:** FG004
**Title:** Part A/ Cohort E
#### Group
**Description:** Subjects from birth to 18 years old (exclusive) are to be treated with cadazolid for 10 days, at the dose defined in the corresponding age cohort in Part A.
**ID:** FG005
**Title:** Part B / Cadazolid
#### Group
**Description:** Subjects from birth to 18 years old (exclusive)are to be treated with vancomycin for 10 days either as capsules (for subjects able to swallow) or oral solution (for the others) .
**ID:** FG006
**Title:** Part B / Vancomycin
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 1
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG006
**Number of Subjects:** 0
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 1
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG006
**Number of Subjects:** 0
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG006
**Number of Subjects:** 0
**Recruitment Details:** Due to early termination of the study after sponsor's decision to discontinue the development of cadazolid, only one patient was enrolled at one site in the US.
**Has Results:** True |
## Protocol Section
### Identification Module
**NCT ID:** NCT03570879
**Acronym:** MYMOTE-1
**Brief Title:** Laparoscopic Myomectomy With Morcellation or Transvaginal Extraction of Surgical Specimens.
**Official Title:** Analysis of Surgical Outcomes in Women Undergoing Laparoscopic Myomectomy With Morcellation or Transvaginal Extraction of Surgical Specimens
#### Organization Study ID Info
**ID:** MYMOTE-1
#### Organization
**Class:** OTHER
**Full Name:** Università degli Studi dell'Insubria
### Status Module
#### Completion Date
**Date:** 2024-05-01
**Type:** ESTIMATED
#### Expanded Access Info
**Last Known Status:** NOT_YET_RECRUITING
#### Last Update Post Date
**Date:** 2021-09-30
**Type:** ACTUAL
**Last Update Submit Date:** 2021-09-28
**Overall Status:** UNKNOWN
#### Primary Completion Date
**Date:** 2023-05-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2022-05-01
**Type:** ESTIMATED
**Status Verified Date:** 2021-09
#### Study First Post Date
**Date:** 2018-06-27
**Type:** ACTUAL
**Study First Submit Date:** 2018-05-30
**Study First Submit QC Date:** 2018-06-26
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Università degli Studi dell'Insubria
#### Responsible Party
**Investigator Affiliation:** Università degli Studi dell'Insubria
**Investigator Full Name:** Antonio Simone Laganà
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** True
**Is FDA Regulated Drug:** False
**Is US Export:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Laparoscopic myomectomy represents the fertility-sparing gold standard approach for the management of subserosal and intramural uterine myomas: this technique allows faster recovery, less complications and improved surgical outcomes than laparotomy.
Despite these validated cornerstones of minimally invasive gynecology, the best approach for specimen retrieval is still debated. Among these approaches, surgical specimen retrieval after laparoscopic myomectomy could be performed by mini-laparotomy, by power morcellation using morcellator inserted through one of the ancillary trocars, or by transvaginal extraction through an endobag inserted at level of the posterior vaginal fornix (between the utero-sacral ligaments).
Unfortunately, mini-laparotomy has poor esthetic outcome and does not conform the current standards of minimally invasive surgery.
In addition, on 24 November 24 2014 the Food and Drug Administration updated a Safety Communication about Power Morcellation, warning against the use of laparoscopic power morcellators in the majority of women undergoing myomectomy or hysterectomy for treatment of fibroids, due to the risk of spreading an unsuspected uterine sarcoma within the abdomen and pelvis.
Considering this scenario, transvaginal extraction may represents a feasible approach for specimen retrieval. In this view, the current study aims to retrospectively compare surgical outcomes in women that underwent laparoscopic myomectomy with subsequent power morcellation (before the issuing of the abovementioned Safety Communication by the Food and Drug Administration) or transvaginal extraction (after the issuing of the abovementioned Safety Communication by the Food and Drug Administration) of the surgical specimens.
### Conditions Module
**Conditions:**
- Myoma;Uterus
**Keywords:**
- Laparoscopy
- Power morcellation
- Transvaginal extraction
### Design Module
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 250
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Women that underwent laparoscopic myomectomy with subsequent power morcellation of the surgical specimens.
**Intervention Names:**
- Device: Power morcellation
**Label:** Power morcellation
#### Arm Group 2
**Description:** Women that underwent laparoscopic myomectomy with subsequent transvaginal extraction of the surgical specimens.
**Intervention Names:**
- Procedure: Transvaginal extraction
**Label:** Transvaginal extraction
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Power morcellation
**Description:** Power morcellation of surgical specimens after laparoscopic myomectomy.
**Name:** Power morcellation
**Type:** DEVICE
#### Intervention 2
**Arm Group Labels:**
- Transvaginal extraction
**Description:** Transvaginal extraction of surgical specimens after laparoscopic myomectomy.
**Name:** Transvaginal extraction
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** Number of surgical complications (Clavien-Dindo Classification)
**Measure:** Complication rate
**Time Frame:** Within 12 months after surgery.
#### Secondary Outcomes
**Description:** Duration of the surgery, expressed in minutes.
**Measure:** Operative time
**Time Frame:** Through study completion, an average of 10 years (retrospective analysis)
**Description:** Blood loss during the surgery, expressed in milliliters (ml).
**Measure:** Blood loss
**Time Frame:** Through study completion, an average of 10 years (retrospective analysis)
**Description:** Duration of the hospitalization, expressed in days
**Measure:** Hospital stay
**Time Frame:** Through study completion, an average of 10 years (retrospective analysis)
**Description:** Sexual function evaluated by Female Sexual Function Index questionnaire, investigating quantity and quality of sex \[scale total score minimum: 2 (worse outcome), maximum: 36 (best outcome)\]
**Measure:** Sexual function
**Time Frame:** 6 and 12 months after surgery.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Women affected by single or multiple uterine myomas.
* Signed informed consent.
Exclusion Criteria:
* Human papilloma virus-related pathologies at pap-smear within the 12 months preceding surgery.
* Women with obliteration of the cul-de-sac.
* Women with the suspected cancer of gynecological origin.
* Women who had never experienced complete sexual intercourse before the operation.
**Maximum Age:** 45 Years
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** FEMALE
**Standard Ages:**
- ADULT
**Study Population:** Women that underwent laparoscopic myomectomy with subsequent power morcellation (before the issuing of the abovementioned Safety Communication by the Food and Drug Administration) or transvaginal extraction (after the issuing of the abovementioned Safety Communication by the Food and Drug Administration) of the surgical specimens.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Antonio Simone Laganà, M.D.
**Phone:** +393296279579
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Università degli Studi dell'Insubria
**Name:** Antonio Simone Laganà, M.D.
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** Università degli Studi dell'Insubria
**Name:** Jvan Casarin, M.D.
**Role:** PRINCIPAL_INVESTIGATOR
**Official 3:**
**Affiliation:** Università degli Studi dell'Insubria
**Name:** Antonella Cromi, M.D., Ph.D.
**Role:** STUDY_CHAIR
**Official 4:**
**Affiliation:** Università degli Studi dell'Insubria
**Name:** Fabio Ghezzi, M.D.
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009379
- Term: Neoplasms, Muscle Tissue
- ID: D000018204
- Term: Neoplasms, Connective and Soft Tissue
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000009369
- Term: Neoplasms
- ID: D000009372
- Term: Neoplasms, Connective Tissue
- ID: D000003240
- Term: Connective Tissue Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: All
- Name: All Conditions
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
### Condition Browse Module - Browse Leaves
- ID: M12166
- Name: Myoma
- Relevance: LOW
- As Found: Unknown
- ID: M10901
- Name: Leiomyoma
- Relevance: HIGH
- As Found: Myoma;Uterus
- ID: M25846
- Name: Myofibroma
- Relevance: HIGH
- As Found: Myoma;Uterus
- ID: M20350
- Name: Neoplasms, Connective and Soft Tissue
- Relevance: LOW
- As Found: Unknown
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
- ID: M12317
- Name: Neoplasms, Connective Tissue
- Relevance: LOW
- As Found: Unknown
- ID: M6464
- Name: Connective Tissue Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000007889
- Term: Leiomyoma
- ID: D000047708
- Term: Myofibroma
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT00000779
**Brief Title:** A Phase I Comparative Blinded Trial of Several HIV-1 Derived Immunogens in Infected Individuals With >= 500 CD4 Cells/mm3
**Official Title:** A Phase I Comparative Blinded Trial of Several HIV-1 Derived Immunogens in Infected Individuals With >= 500 CD4 Cells/mm3
#### Organization Study ID Info
**ID:** ACTG 214
#### Organization
**Class:** NIH
**Full Name:** National Institute of Allergy and Infectious Diseases (NIAID)
#### Secondary ID Infos
**Domain:** DAIDS ES Registry Number
**ID:** 11191
**Type:** REGISTRY
### Status Module
#### Completion Date
**Date:** 1996-09
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-11-04
**Type:** ACTUAL
**Last Update Submit Date:** 2021-10-27
**Overall Status:** COMPLETED
**Status Verified Date:** 2021-10
#### Study First Post Date
**Date:** 2001-08-31
**Type:** ESTIMATED
**Study First Submit Date:** 1999-11-02
**Study First Submit QC Date:** 2001-08-30
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** NIH
**Name:** National Institute of Allergy and Infectious Diseases (NIAID)
#### Responsible Party
**Type:** SPONSOR
### Description Module
**Brief Summary:** PRIMARY: To compare the immunogenicity and safety of each of several HIV-1 derived immunogens versus control in HIV-infected individuals with CD4 counts greater than or equal to 500 cells/mm3.
SECONDARY: To determine whether significant advantages to any one vaccine exist.
Before large clinical trials of anti-HIV vaccines are undertaken, it is important to determine whether there are significant advantages to any one of the vaccines currently offered for such studies.
**Detailed Description:** Before large clinical trials of anti-HIV vaccines are undertaken, it is important to determine whether there are significant advantages to any one of the vaccines currently offered for such studies.
Patients are randomized to receive one of four vaccines or one of two placebo controls. The vaccines are: rgp 120/HIV-1IIIB, rgp 120/HIV-1MN, rgp 120/HIV-1SF, and env 2-3. The two control immunogens are aluminum hydroxide (alum) and BIOCINE Placebo Vaccine 2 (MF-59 adjuvant emulsion in citrate buffer). Patients are vaccinated at weeks 0, 4, 8, 12, 16, 20, 28, and 36. If significant benefit is seen among vaccine patients, then placebo patients may receive vaccination with one of the immunogens producing an immune response.
### Conditions Module
**Conditions:**
- HIV Infections
**Keywords:**
- Vaccines, Synthetic
- HIV-1
- Adjuvants, Immunologic
- AIDS-Related Complex
- HIV Envelope Protein gp120
- AIDS Vaccines
- HIV Therapeutic Vaccine
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 130
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
### Interventions
#### Intervention 1
**Name:** Aluminum hydroxide
**Type:** BIOLOGICAL
#### Intervention 2
**Name:** MF59
**Type:** BIOLOGICAL
#### Intervention 3
**Name:** rgp120/HIV-1IIIB
**Type:** BIOLOGICAL
#### Intervention 4
**Name:** rgp120/HIV-1MN
**Type:** BIOLOGICAL
#### Intervention 5
**Name:** rgp120/HIV-1 SF-2
**Type:** BIOLOGICAL
#### Intervention 6
**Name:** Env 2-3
**Type:** BIOLOGICAL
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria
Concurrent Medication:
Allowed:
* Short-term nonsteroidal anti-inflammatory therapy.
Patients must have:
* HIV seropositivity.
* CD4 count \>= 500 cells/mm3.
* Successful establishment of EBV-transformed B-cell lines at study entry.
* Consent of parent or guardian if \< 18 years of age.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
* Suspected or known allergies to any vaccine components.
* Medical contraindication.
* Problem with compliance.
Concurrent Medication:
Excluded:
* Antiretroviral therapy (e.g., AZT, ddI, or ddC).
* Agents with putative immunomodulating activity (e.g., interferon, steroids, hematopoietin).
* Parenteral therapies (including SC allergy sensitization).
* Other investigational HIV drugs or therapies.
Prior Medication:
Excluded:
* Any prior vaccinations against HIV.
* Antiretroviral therapy (e.g., AZT, ddI, or ddC) within the past 6 months.
* Agents with putative immunomodulating activity (e.g., interferon, steroids, hematopoietin) within the past 3 months.
* Parenteral therapies (including SC allergy sensitization) within the past 3 months.
* Other investigational HIV drugs or therapies within the past 3 months.
**Minimum Age:** 13 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Los Angeles
**Country:** United States
**Facility:** UCLA CARE Center CRS
**State:** California
**Location 2:**
**City:** Palo Alto
**Country:** United States
**Facility:** Stanford CRS
**State:** California
**Zip:** 94115
**Location 3:**
**City:** San Jose
**Country:** United States
**Facility:** Santa Clara Valley Med. Ctr.
**State:** California
**Zip:** 951282699
**Location 4:**
**City:** San Mateo
**Country:** United States
**Facility:** San Mateo County AIDS Program
**State:** California
**Zip:** 943055107
**Location 5:**
**City:** Aurora
**Country:** United States
**Facility:** University of Colorado Hospital CRS
**State:** Colorado
**Zip:** 80262
**Location 6:**
**City:** Boston
**Country:** United States
**Facility:** Massachusetts General Hospital ACTG CRS
**State:** Massachusetts
**Zip:** 02114
**Location 7:**
**City:** Boston
**Country:** United States
**Facility:** Bmc Actg Crs
**State:** Massachusetts
**Zip:** 02118
**Location 8:**
**City:** Boston
**Country:** United States
**Facility:** Beth Israel Deaconess Med. Ctr., ACTG CRS
**State:** Massachusetts
**Zip:** 02215
**Location 9:**
**City:** New York
**Country:** United States
**Facility:** NY Univ. HIV/AIDS CRS
**State:** New York
**Zip:** 10016
**Location 10:**
**City:** Seattle
**Country:** United States
**Facility:** University of Washington AIDS CRS
**State:** Washington
**Zip:** 981224304
#### Overall Officials
**Official 1:**
**Name:** Schooley RT
**Role:** STUDY_CHAIR
**Official 2:**
**Name:** Walker B
**Role:** STUDY_CHAIR
### References Module
#### References
**Citation:** Schooley RT, Spino C, Chiu S, DeGruttola V, Kuritzkes DR. Poor immunogenicity of HIV-1 envelope vaccines with alum or MF59 aduvant in HIV-infected individuals: results of two randomized trials. Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:204 (abstract no 756)
**Citation:** Schooley RT, Spino C, Kuritzkes D, Walker BD, Valentine FA, Hirsch MS, Cooney E, Friedland G, Kundu S, Merigan TC Jr, McElrath MJ, Collier A, Plaeger S, Mitsuyasu R, Kahn J, Haslett P, Uherova P, deGruttola V, Chiu S, Zhang B, Jones G, Bell D, Ketter N, Twadell T, Chernoff D, Rosandich M. Two double-blinded, randomized, comparative trials of 4 human immunodeficiency virus type 1 (HIV-1) envelope vaccines in HIV-1-infected individuals across a spectrum of disease severity: AIDS Clinical Trials Groups 209 and 214. J Infect Dis. 2000 Nov;182(5):1357-64. doi: 10.1086/315860. Epub 2000 Oct 9.
**PMID:** 11023459
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000086982
- Term: Blood-Borne Infections
- ID: D000003141
- Term: Communicable Diseases
- ID: D000007239
- Term: Infections
- ID: D000015229
- Term: Sexually Transmitted Diseases, Viral
- ID: D000012749
- Term: Sexually Transmitted Diseases
- ID: D000016180
- Term: Lentivirus Infections
- ID: D000012192
- Term: Retroviridae Infections
- ID: D000012327
- Term: RNA Virus Infections
- ID: D000014777
- Term: Virus Diseases
- ID: D000091662
- Term: Genital Diseases
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000007153
- Term: Immunologic Deficiency Syndromes
- ID: D000007154
- Term: Immune System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC01
- Name: Infections
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: BC20
- Name: Immune System Diseases
### Condition Browse Module - Browse Leaves
- ID: M10283
- Name: Infections
- Relevance: LOW
- As Found: Unknown
- ID: M6368
- Name: Communicable Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M3522
- Name: Acquired Immunodeficiency Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M18250
- Name: HIV Infections
- Relevance: HIGH
- As Found: HIV Infections
- ID: M3735
- Name: AIDS-Related Complex
- Relevance: LOW
- As Found: Unknown
- ID: M2593
- Name: Blood-Borne Infections
- Relevance: LOW
- As Found: Unknown
- ID: M15558
- Name: Sexually Transmitted Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17933
- Name: Sexually Transmitted Diseases, Viral
- Relevance: LOW
- As Found: Unknown
- ID: M18640
- Name: Lentivirus Infections
- Relevance: LOW
- As Found: Unknown
- ID: M15026
- Name: Retroviridae Infections
- Relevance: LOW
- As Found: Unknown
- ID: M17522
- Name: Virus Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15149
- Name: RNA Virus Infections
- Relevance: LOW
- As Found: Unknown
- ID: M2876
- Name: Genital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M10199
- Name: Immunologic Deficiency Syndromes
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000015658
- Term: HIV Infections
### Intervention Browse Module - Ancestors
- ID: D000000276
- Term: Adjuvants, Immunologic
- ID: D000007155
- Term: Immunologic Factors
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000000863
- Term: Antacids
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000005765
- Term: Gastrointestinal Agents
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Gast
- Name: Gastrointestinal Agents
### Intervention Browse Module - Browse Leaves
- ID: M17360
- Name: Vaccines
- Relevance: LOW
- As Found: Unknown
- ID: M3877
- Name: Aluminum Hydroxide
- Relevance: HIGH
- As Found: Mg/kg body weight
- ID: M3628
- Name: Adjuvants, Immunologic
- Relevance: LOW
- As Found: Unknown
- ID: M35911
- Name: MF59 oil emulsion
- Relevance: LOW
- As Found: Unknown
- ID: M10201
- Name: Immunologic Factors
- Relevance: LOW
- As Found: Unknown
- ID: M4188
- Name: Antacids
- Relevance: LOW
- As Found: Unknown
- ID: M4219
- Name: Anti-Ulcer Agents
- Relevance: LOW
- As Found: Unknown
- ID: M8881
- Name: Gastrointestinal Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000000536
- Term: Aluminum Hydroxide
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT00264979
**Acronym:** METASYNC
**Brief Title:** Evaluation of 2 Resection Strategies of Synchronous Colorectal Cancer Metastases
**Official Title:** Prospective Randomized Study Comparing the Morbidity and Mortality After Liver Resection for Synchronous Colorectal Cancer Metastases When Performed Either During or 12 to 14 Weeks After the Primary Resection
#### Organization Study ID Info
**ID:** DGS 2005/0193
#### Organization
**Class:** OTHER
**Full Name:** Rennes University Hospital
#### Secondary ID Infos
**ID:** PHRC/04-01
**ID:** CIC0203/030
### Status Module
#### Completion Date
**Date:** 2017-12-11
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-03-11
**Type:** ACTUAL
**Last Update Submit Date:** 2019-03-08
**Overall Status:** TERMINATED
#### Primary Completion Date
**Date:** 2017-12-11
**Type:** ACTUAL
#### Start Date
**Date:** 2006-03-02
**Type:** ACTUAL
**Status Verified Date:** 2019-03
#### Study First Post Date
**Date:** 2005-12-13
**Type:** ESTIMATED
**Study First Submit Date:** 2005-12-12
**Study First Submit QC Date:** 2005-12-12
**Why Stopped:** Stop recommended following the last sequential analysis
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER_GOV
**Name:** Ministry of Health, France
#### Lead Sponsor
**Class:** OTHER
**Name:** Rennes University Hospital
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The surgical strategy for the treatment of synchronous colorectal cancer liver metastases has not still been defined. The purpose of this study is to compare two treatment strategies in which liver resection is performed either during, or 12 to 14 weeks after the primary resection. Endpoints include the rate of severe complications and survival.
**Detailed Description:** In France, 35 000 colorectal cancers are diagnosed each year, 15 to 25% of which with hepatic metastases. It is nowadays admitted that the complete resection of these hepatic metastases represents the only treatment that has been shown to increase survival. The aim of this study is to evaluate the efficacy/safety ratio of the liver surgery when performed simultaneously or at distance of the primitive tumour ablation. Patients are randomized to undergo liver surgery either during, or 12 to 14 weeks after the primary resection. The primary endpoint is the rate of patients with at least one severe complication within 60 days after surgery. Secondary endpoints evaluate long-term clinical outcomes, in particular recurrence-free survival.
### Conditions Module
**Conditions:**
- Colorectal Cancer
- Hepatic Metastases
**Keywords:**
- Colorectal cancer
- Sequential or simultaneous surgery
- Synchronous hepatic metastases
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 105
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Simultaneous surgery of colorectal cancer and synchronous liver metastases
**Intervention Names:**
- Procedure: Simultaneous surgery
**Label:** 1
**Type:** OTHER
#### Arm Group 2
**Description:** Sequential surgeries of colorectal cancer and synchronous liver metastases
**Intervention Names:**
- Procedure: Sequential surgery
**Label:** 2
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- 1
**Description:** Simultaneous surgery of colorectal cancer and synchronous liver metastases
**Name:** Simultaneous surgery
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- 2
**Description:** Sequential surgeries of colorectal cancer and synchronous liver metastases: the metastases surgery will be programmed 12 to 14 weeks after the primary tumour exeresis.
**Name:** Sequential surgery
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Measure:** Rate of patients with at least one postoperative severe complication within 60 days after each surgery
**Time Frame:** 60 days after each surgery
#### Secondary Outcomes
**Measure:** Death rate during hospitalization or within 60 days after each surgery
**Time Frame:** 60 days after each surgery
**Measure:** Rate and number of severe general, digestive or hepatic complications
**Time Frame:** 2 years after the first surgery
**Measure:** Rate of unachieved hepatic resection
**Time Frame:** Day of the hepatic surgery
**Measure:** Global survival distribution and 2 years global survival rate
**Time Frame:** 2 years after the first surgery
**Measure:** Recurrence-free survival distribution and 2 years recurrence-free survival rate
**Time Frame:** 2 years
**Measure:** Two years recurrence rate
**Time Frame:** 2 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Male and female adults over 18 years old
* At least one adenocarcinoma of colon and/or rectum, histologically proven.
* No local complication at the time of surgery (no occlusion, no sub-occlusion, no massive hemorrhage, no abscesses or local invasion)
* At least one hepatic metastasis which R0 resection is possible through a conventional simple resection
* Informed written consent.
Non inclusion criteria:
* Heart, Respiratory or Renal failure
* Physical or psychological dependence
* Chronic liver disease
* Extra-hepatic metastases
Exclusion Criteria (at time of surgery)
* Localized or diffuse peritoneal carcinomatosis
* Non resectable lymph node metastases
* Colorectal or hepatic tumour extension towards abdominal wall and/or adjacent organ making liver R0 resection impossible immediately
* Other hepatic lesions diagnosed with ultrasound making liver R0 resection impossible immediately
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Amiens
**Country:** France
**Facility:** Chirurgie générale viscérale et digestive - Hôpital Nord
**Zip:** 80080
**Location 2:**
**City:** Besancon
**Country:** France
**Facility:** Service de Chirurgie viscérale, digestive et cancérologie - Hôpital Jean Mingoz
**Zip:** 25000
**Location 3:**
**City:** Dijon
**Country:** France
**Facility:** Chirurgie digestive, thoracique et cancérologie
**Zip:** 21000
**Location 4:**
**City:** Lyon
**Country:** France
**Facility:** Département de Chirurgie - CRLCC Léon Bérard
**Zip:** 69008
**Location 5:**
**City:** Nantes
**Country:** France
**Facility:** Clinique Chirurgicale A - Hôtel Dieu
**Zip:** 44093
**Location 6:**
**City:** Nantes
**Country:** France
**Facility:** Clinique Chirurgicale I - Hôpital Nord
**Zip:** 44093
**Location 7:**
**City:** Paris
**Country:** France
**Facility:** Centre de Chirurgie et Réanimation Digestives - Hôpital Saint Antoine
**Zip:** 75570
**Location 8:**
**City:** Paris
**Country:** France
**Facility:** Service de Chirurgie hépato-biliaire et Transplantation Hépatique- Paris Saint Antoine
**Location 9:**
**City:** Poitiers
**Country:** France
**Facility:** Service de Chirurgie - Hôpital Jean Bernard
**Zip:** 86021
**Location 10:**
**City:** Rennes
**Country:** France
**Facility:** Service d'Oncologie Digestive- CRLCC Eugène Marquis
**Zip:** 35000
**Location 11:**
**City:** Rennes
**Country:** France
**Facility:** Département de Chirurgie Viscérale - Hôpital Pontchaillou
**Zip:** 35033
**Location 12:**
**City:** Strasbourg
**Country:** France
**Facility:** Centre de Chirurgie Viscérale et de Transplantation - CHU de Hautepierre
**Zip:** 67098
**Location 13:**
**City:** Vannes
**Country:** France
**Facility:** Chirurgie Viscérale Digestive - CH Chubert
**Zip:** 70555
**Location 14:**
**City:** Villejuif
**Country:** France
**Facility:** Centre Hépato-biliaire - Hôpital Paul Brousse
#### Overall Officials
**Official 1:**
**Affiliation:** CHU Rennes
**Name:** Karim Boudjema, MD, PhD
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** Centre Eugène Marquis - CRLCC Rennes
**Name:** Jean-Luc Raoul, MD
**Role:** PRINCIPAL_INVESTIGATOR
**Official 3:**
**Affiliation:** CHU Rennes
**Name:** Eric Bellissant, MD, PhD
**Role:** STUDY_CHAIR
### References Module
#### References
**Citation:** Martin R, Paty P, Fong Y, Grace A, Cohen A, DeMatteo R, Jarnagin W, Blumgart L. Simultaneous liver and colorectal resections are safe for synchronous colorectal liver metastasis. J Am Coll Surg. 2003 Aug;197(2):233-41; discussion 241-2. doi: 10.1016/S1072-7515(03)00390-9.
**PMID:** 12892803
**Citation:** Weber JC, Bachellier P, Oussoultzoglou E, Jaeck D. Simultaneous resection of colorectal primary tumour and synchronous liver metastases. Br J Surg. 2003 Aug;90(8):956-62. doi: 10.1002/bjs.4132.
**PMID:** 12905548
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007414
- Term: Intestinal Neoplasms
- ID: D000005770
- Term: Gastrointestinal Neoplasms
- ID: D000004067
- Term: Digestive System Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000005767
- Term: Gastrointestinal Diseases
- ID: D000003108
- Term: Colonic Diseases
- ID: D000007410
- Term: Intestinal Diseases
- ID: D000012002
- Term: Rectal Diseases
- ID: D000009385
- Term: Neoplastic Processes
- ID: D000010335
- Term: Pathologic Processes
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC06
- Name: Digestive System Diseases
### Condition Browse Module - Browse Leaves
- ID: M12307
- Name: Neoplasm Metastasis
- Relevance: HIGH
- As Found: Metastases
- ID: M17890
- Name: Colorectal Neoplasms
- Relevance: HIGH
- As Found: Colorectal Cancer
- ID: M10448
- Name: Intestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8886
- Name: Gastrointestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M7256
- Name: Digestive System Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6336
- Name: Colonic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10444
- Name: Intestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14844
- Name: Rectal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12330
- Name: Neoplastic Processes
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000015179
- Term: Colorectal Neoplasms
- ID: D000009362
- Term: Neoplasm Metastasis
### Intervention Browse Module - Browse Branches
- Abbrev: Hemat
- Name: Hematinics
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M11110
- Name: Liver Extracts
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT00791479
**Brief Title:** Effects of LY2189265 on Glycemic Control in Participants With Type 2 Diabetes
**Official Title:** Assessment of Dose-Dependent Effects of LY2189265 on Glycemic Control in Patients With Type 2 Diabetes Treated Only With Lifestyle Interventions
#### Organization Study ID Info
**ID:** 12565
#### Organization
**Class:** INDUSTRY
**Full Name:** Eli Lilly and Company
#### Secondary ID Infos
**Domain:** Eli Lilly and Company
**ID:** H9X-MC-GBCK
**Type:** OTHER
**Domain:** India
**ID:** CTRI/2009/091/000105
**Type:** REGISTRY
### Status Module
#### Completion Date
**Date:** 2010-01
**Type:** ACTUAL
#### Disp First Post Date
**Date:** 2010-10-27
**Type:** ESTIMATED
**Disp First Submit Date:** 2010-10-25
**Disp First Submit QC Date:** 2010-10-25
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2014-12-10
**Type:** ESTIMATED
**Last Update Submit Date:** 2014-12-08
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2010-01
**Type:** ACTUAL
#### Results First Post Date
**Date:** 2014-12-10
**Type:** ESTIMATED
**Results First Submit Date:** 2014-10-03
**Results First Submit QC Date:** 2014-12-08
#### Start Date
**Date:** 2008-12
**Status Verified Date:** 2014-12
#### Study First Post Date
**Date:** 2008-11-14
**Type:** ESTIMATED
**Study First Submit Date:** 2008-11-12
**Study First Submit QC Date:** 2008-11-12
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Eli Lilly and Company
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This is a study to demonstrate that different doses of once-weekly LY2189265 injected subcutaneously will have dose proportional effect on hemoglobin A1c (HbA1c) at 12 weeks in participants with type 2 diabetes mellitus.
**Detailed Description:** Participants in the trial will be randomized to one of the LY2189265 doses (4 doses are planned, range 0.1-1.5 milligram \[mg\]) or placebo. The main purpose is to assess dose-dependent effect of this new compound on blood glucose over a period of 12 weeks. Therefore, glycosylated hemoglobin (HbA1c) is chosen as the primary efficacy measure. Several other attributes of glycemic control and endocrine function of pancreas will be assessed as secondary objectives. These secondary objectives will be used to compare the effect of the experimental compound and placebo. Since LY2189265 is in early phase of development, comprehensive safety assessment is planned to learn more about possible side-effects and to establish benefit/risk profile of individual doses of the drug. The trial is organized in four phases: screening, lead-in period to establish baseline status of participants in each group, treatment period during which participants will be randomized into 1 of 5 groups (4 will receive one of the LY2189265 doses, 1 group will receive placebo), and safety follow up. Maximum of 9 study visits are planned. Study drug (LY2189265 or placebo) will be administered once weekly via subcutaneous (SC) injections. Rescue intervention was allowed after randomization for those participants whose hyperglycemia reached pre-defined unacceptable high values. Participants on rescue therapy remained in the study and continued to receive study drug. Participants who received rescue therapy were included in the analysis population, but only measurements obtained prior to the beginning of rescue therapy were included in specified efficacy analyses.
A 3-mg LY2189265 dose was discontinued and replaced with the 1.5 mg dose based on dose finding Study H9X-MC-GBCF; NCT00734474. Except where noted, data summaries from the 3 discontinued 3-mg LY2189265 participants (n=3) are not included due to the small number of participants and the short treatment duration.
### Conditions Module
**Conditions:**
- Diabetes Mellitus, Type 2
**Keywords:**
- Diabetes, type 2 diabetes
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** TRIPLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 167
**Type:** ACTUAL
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** LY2189265: 0.1 milligram (mg), subcutaneous (SC), once weekly (QW)
**Intervention Names:**
- Drug: LY2189265 and Lifestyle Measures
**Label:** 0.1 milligram (mg) LY2189265
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** LY2189265: 0.5 milligram (mg), subcutaneous (SC), once weekly (QW)
**Intervention Names:**
- Drug: LY2189265 and Lifestyle Measures
**Label:** 0.5 milligram (mg) LY2189265
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** LY2189265: 1.0 milligram (mg), subcutaneous (SC), once weekly (QW)
**Intervention Names:**
- Drug: LY2189265 and Lifestyle Measures
**Label:** 1.0 milligram (mg) LY2189265
**Type:** EXPERIMENTAL
#### Arm Group 4
**Description:** LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW)
**Intervention Names:**
- Drug: LY2189265 and Lifestyle Measures
**Label:** 1.5 milligram (mg) LY2189265
**Type:** EXPERIMENTAL
#### Arm Group 5
**Description:** Placebo: subcutaneous (SC) once weekly (QW)
**Intervention Names:**
- Drug: Placebo solution and Lifestyle Measures
**Label:** Placebo
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- 0.1 milligram (mg) LY2189265
- 0.5 milligram (mg) LY2189265
- 1.0 milligram (mg) LY2189265
- 1.5 milligram (mg) LY2189265
**Description:** Subcutaneous injection once-weekly for up to 12 weeks
**Name:** LY2189265 and Lifestyle Measures
**Other Names:**
- Dulaglutide
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Placebo
**Description:** Subcutaneous injection once-weekly for up to 12 weeks
**Name:** Placebo solution and Lifestyle Measures
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Least Squares (LS) means of change from baseline for glycosylated hemoglobin (HbA1c) were calculated using mixed model repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline HbA1c as covariate.
**Measure:** Change From Baseline in Glycosylated Hemoglobin (HbA1c)
**Time Frame:** Baseline, 12 weeks
#### Secondary Outcomes
**Description:** Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline glycosylated hemoglobin (HbA1c) as covariate.
**Measure:** Change From Baseline in Glycosylated Hemoglobin (HbA1c)
**Time Frame:** Baseline, 4 weeks, 8 weeks
**Description:** Fasting blood glucose is a test to determine how much glucose (sugar) is in a blood sample after an overnight fast. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline fasting glucose as covariate.
**Measure:** Change From Baseline in Fasting Blood Glucose
**Time Frame:** Baseline, 12 weeks
**Description:** Percentages of participants who achieved glycosylated hemoglobin (HbA1c) levels of \<7.0% or ≤6.5% were compared across treatment arms using the Cochran-Armitage trend test.
**Measure:** Percentage of Participants Who Achieve Glycosylated Hemoglobin (HbA1c) <7% or ≤6.5%
**Time Frame:** 12 weeks
**Description:** Change from baseline in mean daily blood glucose values were measured with a 7-point self-monitored blood glucose (SMBG) profile over a 24-hour period in the 7-day period prior to each visit. The 7-point SMBG profile consisted of preprandial blood glucose measures before the morning, midday, and evening meals; blood glucose measures 2 hours after the start of the morning, midday, and evening meals; and the fasting blood glucose obtained the following morning. Mean at 12 weeks was assessed in all treatment groups. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and as covariate.
**Measure:** Change From Baseline in Daily Mean Blood Glucose Values From the 7-point Self Monitored Blood Glucose (SMBG) Profiles
**Time Frame:** Baseline, 12 weeks
**Description:** Change from baseline in beta (β)-cell function (HOMA2-%B) was assessed by using the homeostatic model assessment (HOMA) to quantify β-cell function. HOMA2-%B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state beta cell function (%B), as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. Least Squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline HOMA2-%B as covariate.
**Measure:** Change From Baseline in Beta-cell Function (HOMA2-%B)
**Time Frame:** Baseline, 12 weeks
**Description:** Change from baseline in insulin sensitivity (HOMA2-%S) was assessed by using the homeostatic model assessment (HOMA) to quantify insulin sensitivity. HOMA2-%S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state insulin sensitivity (%S), as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. Least Squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline HOMA2-%S as covariate.
**Measure:** Change From Baseline in Insulin Sensitivity (HOMA2-%S)
**Time Frame:** Baseline, 12 weeks
**Description:** The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR\^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. The PR segment begins at the endpoint of the P wave and ends at the onset of the QRS complex. Least Squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline measurement as covariate.
**Measure:** Change From Baseline in Electrocardiograms (ECGs) - Fridericia-corrected QT (QTcF) and PR Interval
**Time Frame:** Baseline, 12 weeks
**Description:** Least Squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline measurement as covariate.
**Measure:** Change From Baseline in Electrocardiograms (ECGs) - Heart Rate
**Time Frame:** Baseline, 12 weeks
**Description:** Sitting pulse rate was measured. Least Squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline measurement as covariate.
**Measure:** Change From Baseline in Pulse Rate
**Time Frame:** Baseline, 12 weeks
**Description:** Sitting systolic blood pressure (SBP) and sitting diastolic blood pressure (DBP) were measured. Least Squares (LS) means of change were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline measurement as covariate.
**Measure:** Change From Baseline in Blood Pressure (BP)
**Time Frame:** Baseline, 12 weeks
**Description:** Hypoglycemic events were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined an event during which typical symptoms of hypoglycemia were accompanied by a blood glucose level of ≤3.9 millimoles per liter \[mmol/L\]), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured blood glucose of ≤3.9 mmol/L), or nocturnal (defined as any hypoglycemic event that occurred between bedtime and breakfast with a measured blood glucose of ≤3.9 mmol/L). Participant reports of hypoglycemic events were collected at the beginning of each visit starting at Baseline. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
**Measure:** Number of Participants With Self-reported Hypoglycemic Events
**Time Frame:** Baseline through 12 weeks
**Description:** Hypoglycemic events (HE) were classified as severe (defined as events requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined an event during which typical symptoms of hypoglycemia were accompanied by a blood glucose level of ≤3.9 millimoles per liter \[mmol/L\]), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured blood glucose of ≤3.9 mmol/L), or nocturnal (defined as any HE that occurred between bedtime and breakfast with a measured blood glucose of ≤3.9 mmol/L). Participant reports of HE were collected at the beginning of each visit starting at Baseline and the annualized rate was reported. Least Squares (LS) means rates were adjusted for pre-study therapy, country, and baseline body mass index. A summary of AEs regardless of causality is located in the Reported AEs module. Some model-adjusted LS means are less than 0 and may be interpreted as very low rates.
**Measure:** Rate of Self-reported Hypoglycemic Events
**Time Frame:** Baseline through 12 weeks
**Description:** A treatment emergent adverse event is any untoward medical occurrence that either occurs or worsens at any time after the first injection of study drug following randomization and which does not necessarily have to have a causal relationship. The number of participants with one or more treatment emergent adverse event was reported. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
**Measure:** Treatment Emergent Adverse Events
**Time Frame:** Baseline through 12 weeks
**Description:** Least Squares (LS) means was calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline measurement as covariate.
**Measure:** Change From Baseline in Body Weight
**Time Frame:** Baseline, 12 weeks
**Description:** LY2189265 anti-drug antibodies (ADA) were assessed at baseline, 4 and 12 weeks, and at the safety follow-up visit 4 weeks after study drug discontinuation (16 weeks). The number of participants with initial postbaseline detection of treatment emergent (defined as a 4-fold increase in the ADA titer from baseline) LY2189265 ADA at each time point were summarized.
**Measure:** Antibody Production and Effects to LY2189265
**Time Frame:** Baseline, 4 weeks, 12 weeks, 16 weeks
**Description:** The population mean estimates and standard deviations were calculated for pharmacokinetic parameters (area under the concentration time curve (AUC) from zero to 168 hours). Evaluable PK concentrations from the 4 week, 8 week, and 12 week timepoints were combined and utilized in a population approach to determine the population mean estimate and standard deviation at steady-state.
**Measure:** Collection and Evaluation of Plasma Levels (Pharmacokinetics [PK]) of LY2189265
**Time Frame:** 4 weeks, 8 weeks, 12 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Diabetes mellitus, type 2
* Treatment regimens: diet and exercise only or are taking metformin as monotherapy and are willing to discontinue this medication
* Have completed at least 8 weeks of wash-out prior to randomization (if on metformin therapy at screening)
* Have a qualifying glycosylated hemoglobin (HbA1c) value, as determined by the central laboratory: at screening (for diet and exercise only ≥7.0% to ≤9.5%; for metformin monotherapy \>6.5% to ≤9.0%) and at time of randomization for all participants ≥6.5% to ≤9.5%
* Females of childbearing potential must test negative for pregnancy and agree to use a reliable birth control method
* Have a body mass index (BMI) between 23 and 40 kilograms/meter squared (kg/m\^2), inclusive, for participants who are native to, and reside in, South and/or East Asia; all other participants must have a BMI between 25 and 40 kg/m\^2, inclusive.
* Stable weight for 3 months prior to screening
Exclusion Criteria:
* Diabetes mellitus, type 1
* Taking any glucose-lowering oral agents other than metformin within 3 months prior to screening
* Use of glucagon-like peptide-1 (GLP-1) analog (for example, exenatide) within 6 months prior to screening or being treated within insulin (with the exception of short-term management of acute conditions that occurred more than 3 months immediately prior to screening)
* Use of medications (prescription or over-the counter) to promote weight loss
* Chronic (\>2 weeks) use of systemic glucocorticoid therapy
* Gastric emptying abnormality, history of bariatric surgery or chronic use of drugs that affect gastrointestinal motility
* Use of central nervous system (CNS) stimulant (for example, Ritalin-sustained release \[SR\])
* Cardiovascular event within 6 months prior to screening
* Poorly controlled hypertension (determined by a mean seated systolic blood pressure (BP) ≥160 millimeters of mercury (mmHg) or mean seated diastolic BP ≥95 mmHg at screening or randomization)
* Electrocardiogram (ECG) reading considered outside the normal limits by the investigator and relevant for interpretation or indicating cardiac disease
* Liver disease, hepatitis, chronic hepatitis, or alanine transaminase levels \>3.0 times upper limit of normal
* Clinical signs or symptoms of pancreatitis or history of chronic or acute pancreatitis at time of screening
* Amylase ≥3 times the upper limit of normal and/or lipase ≥2 times upper limit of normal which are determined by central labs at the time of screening
* Serum creatinine ≥1.5 milligrams per deciliter (mg/dL) for men or ≥1.4 mg/dL for women or a creatinine clearance \<60 milliliter (mL)/minute which are determined by central labs at the time of screening
* Uncontrolled diabetes (defined as 2 or more episode of hyperosmolar state requiring hospitalization in the 6 months prior to screening)
* Significant active, uncontrolled endocrine or autoimmune abnormality
* History of a transplanted organ (corneal transplants are allowed)
* Active or untreated malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years
* Have any other condition, in the opinion of the investigator, that may preclude the participant from following or completing the protocol
* Investigator site personnel directly affiliated with this study and/or their immediate families (spouse, parent, child, or sibling, whether biological or legally adopted)
* Sponsor employees
* Received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
* Participated in an interventional medical, surgical, or pharmaceutical study within 30 days prior to entry into the study
* Have previously completed or withdrawn from this study after providing informed consent
**Maximum Age:** 75 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Concord
**Country:** United States
**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
**State:** California
**Zip:** 94520
**Location 2:**
**City:** Lancaster
**Country:** United States
**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
**State:** California
**Zip:** 93534
**Location 3:**
**City:** Mission Hills
**Country:** United States
**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
**State:** California
**Zip:** 91345
**Location 4:**
**City:** Palm Springs
**Country:** United States
**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
**State:** California
**Zip:** 92262
**Location 5:**
**City:** Vincennes
**Country:** United States
**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
**State:** Indiana
**Zip:** 47591
**Location 6:**
**City:** Wichita
**Country:** United States
**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
**State:** Kansas
**Zip:** 67208
**Location 7:**
**City:** Bloomfield Hills
**Country:** United States
**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
**State:** Michigan
**Zip:** 48302
**Location 8:**
**City:** Calabash
**Country:** United States
**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
**State:** North Carolina
**Zip:** 28467
**Location 9:**
**City:** Tabor City
**Country:** United States
**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
**State:** North Carolina
**Zip:** 28463
**Location 10:**
**City:** Beaver
**Country:** United States
**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
**State:** Pennsylvania
**Zip:** 15009
**Location 11:**
**City:** North Myrtle Beach
**Country:** United States
**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
**State:** South Carolina
**Zip:** 29582
**Location 12:**
**City:** Menomonee Falls
**Country:** United States
**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
**State:** Wisconsin
**Zip:** 53051
**Location 13:**
**City:** Dubrovnik
**Country:** Croatia
**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
**Zip:** 20000
**Location 14:**
**City:** Osijek
**Country:** Croatia
**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
**Zip:** HR-31000
**Location 15:**
**City:** Varazdin
**Country:** Croatia
**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
**Zip:** HR-42000
**Location 16:**
**City:** Zagreb
**Country:** Croatia
**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
**Zip:** HR-10000
**Location 17:**
**City:** Aalborg
**Country:** Denmark
**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
**Zip:** DK-9000
**Location 18:**
**City:** Aarhus
**Country:** Denmark
**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
**Zip:** 8000
**Location 19:**
**City:** Copenhagen
**Country:** Denmark
**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
**Zip:** 2300
**Location 20:**
**City:** Frederiksberg
**Country:** Denmark
**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
**Zip:** 2000
**Location 21:**
**City:** Hillerod
**Country:** Denmark
**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
**Zip:** Dk-3400
**Location 22:**
**City:** Kobenhavn
**Country:** Denmark
**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
**Zip:** 2400
**Location 23:**
**City:** Bangalore
**Country:** India
**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
**Zip:** 560052
**Location 24:**
**City:** Bilaspur
**Country:** India
**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
**Zip:** 495006
**Location 25:**
**City:** Hyderabaad
**Country:** India
**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
**Zip:** 500001
**Location 26:**
**City:** Indore
**Country:** India
**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
**Zip:** 452001
**Location 27:**
**City:** Kochin
**Country:** India
**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
**Zip:** 682026
**Location 28:**
**City:** Mumbai
**Country:** India
**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
**Zip:** 400 067
**Location 29:**
**City:** New Delhi
**Country:** India
**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
**Zip:** 110 029
**Location 30:**
**City:** Mexico City
**Country:** Mexico
**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
**Zip:** 06700
**Location 31:**
**City:** Monterrey
**Country:** Mexico
**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
**Zip:** 64570
**Location 32:**
**City:** Bialystok
**Country:** Poland
**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
**Zip:** 15-950
**Location 33:**
**City:** Szczecin
**Country:** Poland
**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
**Zip:** 71-252
**Location 34:**
**City:** Wroclaw
**Country:** Poland
**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
**Zip:** 503-349
**Location 35:**
**City:** Carolina
**Country:** Puerto Rico
**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
**Zip:** 00983
**Location 36:**
**City:** San German
**Country:** Puerto Rico
**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
**Zip:** 00685
**Location 37:**
**City:** Arkhangelsk
**Country:** Russian Federation
**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
**Zip:** 163045
**Location 38:**
**City:** Moscow
**Country:** Russian Federation
**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
**Zip:** 119881
**Location 39:**
**City:** Rostov-On-Don
**Country:** Russian Federation
**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
**Zip:** 344022
**Location 40:**
**City:** Saint Petersburg
**Country:** Russian Federation
**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
**Zip:** 193257
**Location 41:**
**City:** Alcira
**Country:** Spain
**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
**Zip:** 46600
**Location 42:**
**City:** Dos Hermanas
**Country:** Spain
**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
**Zip:** 41014
**Location 43:**
**City:** Lleida
**Country:** Spain
**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
**Zip:** 25198
**Location 44:**
**City:** Malaga
**Country:** Spain
**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
**Zip:** 29010
**Location 45:**
**City:** Santa Cruz De Tenerife
**Country:** Spain
**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
**Zip:** 38320
**Location 46:**
**City:** Torrevieja
**Country:** Spain
**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
**Zip:** 03186
#### Overall Officials
**Official 1:**
**Affiliation:** Eli Lilly and Company
**Name:** Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST)
**Role:** STUDY_CHAIR
### References Module
#### References
**Citation:** Grunberger G, Chang A, Garcia Soria G, Botros FT, Bsharat R, Milicevic Z. Monotherapy with the once-weekly GLP-1 analogue dulaglutide for 12 weeks in patients with Type 2 diabetes: dose-dependent effects on glycaemic control in a randomized, double-blind, placebo-controlled study. Diabet Med. 2012 Oct;29(10):1260-7. doi: 10.1111/j.1464-5491.2012.03745.x.
**PMID:** 22804250
#### See Also Links
**Label:** Related Info
**URL:** http://www.ncbi.nlm.nih.gov/pubmed/22804250
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000044882
- Term: Glucose Metabolism Disorders
- ID: D000008659
- Term: Metabolic Diseases
- ID: D000004700
- Term: Endocrine System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M7115
- Name: Diabetes Mellitus
- Relevance: HIGH
- As Found: Diabetes
- ID: M7119
- Name: Diabetes Mellitus, Type 2
- Relevance: HIGH
- As Found: Diabetes Mellitus, Type 2
- ID: M11639
- Name: Metabolic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M25403
- Name: Glucose Metabolism Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M7862
- Name: Endocrine System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003920
- Term: Diabetes Mellitus
- ID: D000003924
- Term: Diabetes Mellitus, Type 2
### Intervention Browse Module - Ancestors
- ID: D000097789
- Term: Glucagon-Like Peptide-1 Receptor Agonists
- ID: D000007004
- Term: Hypoglycemic Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
### Intervention Browse Module - Browse Branches
- Abbrev: PhSol
- Name: Pharmaceutical Solutions
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Hypo
- Name: Hypoglycemic Agents
- Abbrev: Gast
- Name: Gastrointestinal Agents
### Intervention Browse Module - Browse Leaves
- ID: M21860
- Name: Pharmaceutical Solutions
- Relevance: LOW
- As Found: Unknown
- ID: M258626
- Name: Dulaglutide
- Relevance: HIGH
- As Found: Fluconazole
- ID: M9043
- Name: Glucagon
- Relevance: LOW
- As Found: Unknown
- ID: M3401
- Name: Glucagon-Like Peptide-1 Receptor Agonists
- Relevance: LOW
- As Found: Unknown
- ID: M26997
- Name: Glucagon-Like Peptide 1
- Relevance: LOW
- As Found: Unknown
- ID: M10054
- Name: Hypoglycemic Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: C000555680
- Term: Dulaglutide
### Misc Info Module
- Version Holder: 2024-05-24
## Results Section
### Adverse Events Module
#### Event Groups
**Group ID:** EG000
**Title:** 0.1 Milligrams (mg) LY2189265
**Description:** LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** EG000
**Other Num Affected:** 20
**Other Num at Risk:** 35
**Serious Number At Risk:** 35
**Title:** 0.1 Milligrams (mg) LY2189265
**Group ID:** EG001
**Title:** 0.5 Milligrams (mg) LY2189265
**Description:** LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** EG001
**Other Num Affected:** 16
**Other Num at Risk:** 34
**Serious Number Affected:** 1
**Serious Number At Risk:** 34
**Title:** 0.5 Milligrams (mg) LY2189265
**Group ID:** EG002
**Title:** 1.0 Milligrams (mg) LY2189265
**Description:** LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** EG002
**Other Num Affected:** 17
**Other Num at Risk:** 34
**Serious Number Affected:** 1
**Serious Number At Risk:** 34
**Title:** 1.0 Milligrams (mg) LY2189265
**Group ID:** EG003
**Title:** 1.5 Milligrams (mg) LY2189265
**Description:** LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** EG003
**Other Num Affected:** 15
**Other Num at Risk:** 29
**Serious Number Affected:** 1
**Serious Number At Risk:** 29
**Title:** 1.5 Milligrams (mg) LY2189265
**Group ID:** EG004
**Title:** 3.0 Milligrams (mg) LY2189265
**Description:** LY2189265: 3.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** EG004
**Other Num Affected:** 1
**Other Num at Risk:** 3
**Serious Number At Risk:** 3
**Title:** 3.0 Milligrams (mg) LY2189265
**Group ID:** EG005
**Title:** Placebo
**Description:** Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** EG005
**Other Num Affected:** 15
**Other Num at Risk:** 32
**Serious Number Affected:** 1
**Serious Number At Risk:** 32
**Title:** Placebo
**Frequency Threshold:** 3
#### Other Events
**Term:** Vertigo
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Ear and labyrinth disorders
**Source Vocabulary:** MedDRA 12.0
**Term:** Abdominal discomfort
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA 12.0
**Term:** Abdominal distension
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA 12.0
**Term:** Abdominal pain
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA 12.0
**Term:** Abdominal pain upper
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA 12.0
**Term:** Constipation
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA 12.0
**Term:** Diarrhoea
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA 12.0
**Term:** Dyspepsia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA 12.0
**Term:** Faeces hard
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA 12.0
**Term:** Flatulence
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA 12.0
**Term:** Gastrooesophageal reflux disease
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA 12.0
**Term:** Nausea
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA 12.0
**Term:** Vomiting
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA 12.0
**Term:** Fatigue
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA 12.0
**Term:** Hunger
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA 12.0
**Term:** Injection site haematoma
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA 12.0
**Term:** Non-cardiac chest pain
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA 12.0
**Term:** Pain
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA 12.0
**Term:** Pyrexia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA 12.0
**Term:** Nasopharyngitis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA 12.0
**Term:** Otitis media
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA 12.0
**Term:** Pharyngitis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA 12.0
**Term:** Upper respiratory tract infection
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA 12.0
**Term:** Urinary tract infection
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA 12.0
**Term:** Vulvovaginal mycotic infection
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA 12.0
**Term:** Arthropod bite
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Injury, poisoning and procedural complications
**Source Vocabulary:** MedDRA 12.0
**Term:** Back injury
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Injury, poisoning and procedural complications
**Source Vocabulary:** MedDRA 12.0
**Term:** Fall
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Injury, poisoning and procedural complications
**Source Vocabulary:** MedDRA 12.0
**Term:** Neck injury
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Injury, poisoning and procedural complications
**Source Vocabulary:** MedDRA 12.0
**Term:** Rib fracture
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Injury, poisoning and procedural complications
**Source Vocabulary:** MedDRA 12.0
**Term:** Skull fracture
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Injury, poisoning and procedural complications
**Source Vocabulary:** MedDRA 12.0
**Term:** Upper limb fracture
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Injury, poisoning and procedural complications
**Source Vocabulary:** MedDRA 12.0
**Term:** Laboratory test abnormal
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:** MedDRA 12.0
**Term:** Lipase increased
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:** MedDRA 12.0
**Term:** Pancreatic enzymes increased
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:** MedDRA 12.0
**Term:** Decreased appetite
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
**Source Vocabulary:** MedDRA 12.0
**Term:** Dyslipidaemia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
**Source Vocabulary:** MedDRA 12.0
**Term:** Hyperlipidaemia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
**Source Vocabulary:** MedDRA 12.0
**Term:** Hypertriglyceridaemia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
**Source Vocabulary:** MedDRA 12.0
**Term:** Arthralgia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Musculoskeletal and connective tissue disorders
**Source Vocabulary:** MedDRA 12.0
**Term:** Back pain
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Musculoskeletal and connective tissue disorders
**Source Vocabulary:** MedDRA 12.0
**Term:** Muscle spasms
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Musculoskeletal and connective tissue disorders
**Source Vocabulary:** MedDRA 12.0
**Term:** Myalgia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Musculoskeletal and connective tissue disorders
**Source Vocabulary:** MedDRA 12.0
**Term:** Neck pain
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Musculoskeletal and connective tissue disorders
**Source Vocabulary:** MedDRA 12.0
**Term:** Pain in extremity
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Musculoskeletal and connective tissue disorders
**Source Vocabulary:** MedDRA 12.0
**Term:** Dizziness
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
**Source Vocabulary:** MedDRA 12.0
**Term:** Headache
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
**Source Vocabulary:** MedDRA 12.0
**Term:** Hypoaesthesia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
**Source Vocabulary:** MedDRA 12.0
**Term:** Neuropathy peripheral
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
**Source Vocabulary:** MedDRA 12.0
**Term:** Somnolence
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
**Source Vocabulary:** MedDRA 12.0
**Term:** Anxiety
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Psychiatric disorders
**Source Vocabulary:** MedDRA 12.0
**Term:** Insomnia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Psychiatric disorders
**Source Vocabulary:** MedDRA 12.0
**Term:** Cough
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
**Source Vocabulary:** MedDRA 12.0
**Term:** Oropharyngeal pain
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
**Source Vocabulary:** MedDRA 12.0
**Term:** Rhinorrhoea
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
**Source Vocabulary:** MedDRA 12.0
**Term:** Sinus congestion
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
**Source Vocabulary:** MedDRA 12.0
**Term:** Cold sweat
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
**Source Vocabulary:** MedDRA 12.0
**Term:** Hyperhidrosis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
**Source Vocabulary:** MedDRA 12.0
#### Serious Events
**Term:** Atrial flutter
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Cardiac disorders
**Source Vocabulary:** MedDRA 12.0
##### Stats
**Group ID:** EG000
**Num At Risk:** 35
**Group ID:** EG001
**Num At Risk:** 34
**Group ID:** EG002
**Num Affected:** 1
**Num At Risk:** 34
**Num Events:** 1
**Group ID:** EG003
**Num At Risk:** 29
**Group ID:** EG004
**Num At Risk:** 3
**Group ID:** EG005
**Num At Risk:** 32
**Term:** Abdominal distension
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA 12.0
##### Stats
**Group ID:** EG000
**Num At Risk:** 35
**Group ID:** EG001
**Num At Risk:** 34
**Group ID:** EG002
**Num At Risk:** 34
**Group ID:** EG003
**Num Affected:** 1
**Num At Risk:** 29
**Num Events:** 1
**Group ID:** EG004
**Num At Risk:** 3
**Group ID:** EG005
**Num At Risk:** 32
**Term:** Abdominal pain
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA 12.0
##### Stats
**Group ID:** EG000
**Num At Risk:** 35
**Group ID:** EG001
**Num At Risk:** 34
**Group ID:** EG002
**Num At Risk:** 34
**Group ID:** EG003
**Num Affected:** 1
**Num At Risk:** 29
**Num Events:** 1
**Group ID:** EG004
**Num At Risk:** 3
**Group ID:** EG005
**Num At Risk:** 32
**Term:** Pancreatitis haemorrhagic
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA 12.0
##### Stats
**Group ID:** EG000
**Num At Risk:** 35
**Group ID:** EG001
**Num At Risk:** 34
**Group ID:** EG002
**Num At Risk:** 34
**Group ID:** EG003
**Num At Risk:** 29
**Group ID:** EG004
**Num At Risk:** 3
**Group ID:** EG005
**Num Affected:** 1
**Num At Risk:** 32
**Num Events:** 1
**Term:** Cholelithiasis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Hepatobiliary disorders
**Source Vocabulary:** MedDRA 12.0
##### Stats
**Group ID:** EG000
**Num At Risk:** 35
**Group ID:** EG001
**Num At Risk:** 34
**Group ID:** EG002
**Num At Risk:** 34
**Group ID:** EG003
**Num At Risk:** 29
**Group ID:** EG004
**Num At Risk:** 3
**Group ID:** EG005
**Num Affected:** 1
**Num At Risk:** 32
**Num Events:** 1
**Term:** Breast cancer
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)
**Source Vocabulary:** MedDRA 12.0
##### Stats
**Group ID:** EG000
**Num At Risk:** 35
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 34
**Num Events:** 1
**Group ID:** EG002
**Num At Risk:** 34
**Group ID:** EG003
**Num At Risk:** 29
**Group ID:** EG004
**Num At Risk:** 3
**Group ID:** EG005
**Num At Risk:** 32
## Results Section - Baseline Characteristics Module
### Denomination Counts
**Group ID:** BG000
**Value:** 35
**Group ID:** BG001
**Value:** 34
**Group ID:** BG002
**Value:** 34
**Group ID:** BG003
**Value:** 29
**Group ID:** BG004
**Value:** 3
**Group ID:** BG005
**Value:** 32
**Group ID:** BG006
**Value:** 167
**Units:** Participants
### Group
**ID:** BG000
**Title:** 0.1 Milligrams (mg) LY2189265
**Description:** LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
### Group
**ID:** BG001
**Title:** 0.5 Milligrams (mg) LY2189265
**Description:** LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
### Group
**ID:** BG002
**Title:** 1.0 Milligrams (mg) LY2189265
**Description:** LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
### Group
**ID:** BG003
**Title:** 1.5 Milligrams (mg) LY2189265
**Description:** LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
### Group
**ID:** BG004
**Title:** 3.0 Milligrams (mg) LY2189265
**Description:** LY2189265: 3.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
### Group
**ID:** BG005
**Title:** Placebo
**Description:** Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
### Group
**ID:** BG006
**Title:** Total
**Description:** Total of all reporting groups
### Measure
#### Measurement
**Group ID:** BG000
**Spread:** 9.15
**Value:** 56.33
#### Measurement
**Group ID:** BG001
**Spread:** 9.06
**Value:** 56.91
#### Measurement
**Group ID:** BG002
**Spread:** 8.76
**Value:** 57.16
#### Measurement
**Group ID:** BG003
**Spread:** 7.88
**Value:** 57.45
#### Measurement
**Group ID:** BG004
**Spread:** 7.15
**Value:** 60.82
#### Measurement
**Group ID:** BG005
**Spread:** 9.33
**Value:** 55.03
#### Measurement
**Group ID:** BG006
**Spread:** 8.78
**Value:** 56.64
**Class Title:**
### Measure
#### Measurement
**Group ID:** BG000
**Value:** 24
#### Measurement
**Group ID:** BG001
**Value:** 18
#### Measurement
**Group ID:** BG002
**Value:** 18
#### Measurement
**Group ID:** BG003
**Value:** 16
#### Measurement
**Group ID:** BG004
**Value:** 2
#### Measurement
**Group ID:** BG005
**Value:** 14
#### Measurement
**Group ID:** BG006
**Value:** 92
**Category Title:** Female
#### Measurement
**Group ID:** BG000
**Value:** 11
#### Measurement
**Group ID:** BG001
**Value:** 16
#### Measurement
**Group ID:** BG002
**Value:** 16
#### Measurement
**Group ID:** BG003
**Value:** 13
#### Measurement
**Group ID:** BG004
**Value:** 1
#### Measurement
**Group ID:** BG005
**Value:** 18
#### Measurement
**Group ID:** BG006
**Value:** 75
**Category Title:** Male
**Class Title:**
### Measure
#### Measurement
**Group ID:** BG000
**Value:** 1
#### Measurement
**Group ID:** BG001
**Value:** 0
#### Measurement
**Group ID:** BG002
**Value:** 2
#### Measurement
**Group ID:** BG003
**Value:** 0
#### Measurement
**Group ID:** BG004
**Value:** 0
#### Measurement
**Group ID:** BG005
**Value:** 0
#### Measurement
**Group ID:** BG006
**Value:** 3
**Class Title:** American Indian or Alaska Native
#### Measurement
**Group ID:** BG000
**Value:** 4
#### Measurement
**Group ID:** BG001
**Value:** 5
#### Measurement
**Group ID:** BG002
**Value:** 5
#### Measurement
**Group ID:** BG003
**Value:** 4
#### Measurement
**Group ID:** BG004
**Value:** 0
#### Measurement
**Group ID:** BG005
**Value:** 5
#### Measurement
**Group ID:** BG006
**Value:** 23
**Class Title:** Asian
#### Measurement
**Group ID:** BG000
**Value:** 1
#### Measurement
**Group ID:** BG001
**Value:** 1
#### Measurement
**Group ID:** BG002
**Value:** 0
#### Measurement
**Group ID:** BG003
**Value:** 1
#### Measurement
**Group ID:** BG004
**Value:** 1
#### Measurement
**Group ID:** BG005
**Value:** 1
#### Measurement
**Group ID:** BG006
**Value:** 5
**Class Title:** Black or African American
#### Measurement
**Group ID:** BG000
**Value:** 0
#### Measurement
**Group ID:** BG001
**Value:** 0
#### Measurement
**Group ID:** BG002
**Value:** 1
#### Measurement
**Group ID:** BG003
**Value:** 0
#### Measurement
**Group ID:** BG004
**Value:** 0
#### Measurement
**Group ID:** BG005
**Value:** 0
#### Measurement
**Group ID:** BG006
**Value:** 1
**Class Title:** Native Hawaiian or Other Pacific Islander
#### Measurement
**Group ID:** BG000
**Value:** 29
#### Measurement
**Group ID:** BG001
**Value:** 28
#### Measurement
**Group ID:** BG002
**Value:** 26
#### Measurement
**Group ID:** BG003
**Value:** 24
#### Measurement
**Group ID:** BG004
**Value:** 2
#### Measurement
**Group ID:** BG005
**Value:** 25
#### Measurement
**Group ID:** BG006
**Value:** 134
**Class Title:** White
#### Measurement
**Group ID:** BG000
**Value:** 0
#### Measurement
**Group ID:** BG001
**Value:** 0
#### Measurement
**Group ID:** BG002
**Value:** 0
#### Measurement
**Group ID:** BG003
**Value:** 0
#### Measurement
**Group ID:** BG004
**Value:** 0
#### Measurement
**Group ID:** BG005
**Value:** 1
#### Measurement
**Group ID:** BG006
**Value:** 1
**Class Title:** Multiple
### Measure
#### Measurement
**Group ID:** BG000
**Value:** 16
#### Measurement
**Group ID:** BG001
**Value:** 15
#### Measurement
**Group ID:** BG002
**Value:** 13
#### Measurement
**Group ID:** BG003
**Value:** 11
#### Measurement
**Group ID:** BG004
**Value:** 3
#### Measurement
**Group ID:** BG005
**Value:** 17
#### Measurement
**Group ID:** BG006
**Value:** 75
**Class Title:** United States
#### Measurement
**Group ID:** BG000
**Value:** 5
#### Measurement
**Group ID:** BG001
**Value:** 5
#### Measurement
**Group ID:** BG002
**Value:** 4
#### Measurement
**Group ID:** BG003
**Value:** 4
#### Measurement
**Group ID:** BG004
**Value:** 0
#### Measurement
**Group ID:** BG005
**Value:** 5
#### Measurement
**Group ID:** BG006
**Value:** 23
**Class Title:** Mexico
#### Measurement
**Group ID:** BG000
**Value:** 0
#### Measurement
**Group ID:** BG001
**Value:** 1
#### Measurement
**Group ID:** BG002
**Value:** 2
#### Measurement
**Group ID:** BG003
**Value:** 2
#### Measurement
**Group ID:** BG004
**Value:** 0
#### Measurement
**Group ID:** BG005
**Value:** 0
#### Measurement
**Group ID:** BG006
**Value:** 5
**Class Title:** Puerto Rico
#### Measurement
**Group ID:** BG000
**Value:** 2
#### Measurement
**Group ID:** BG001
**Value:** 3
#### Measurement
**Group ID:** BG002
**Value:** 1
#### Measurement
**Group ID:** BG003
**Value:** 1
#### Measurement
**Group ID:** BG004
**Value:** 0
#### Measurement
**Group ID:** BG005
**Value:** 1
#### Measurement
**Group ID:** BG006
**Value:** 8
**Class Title:** Spain
#### Measurement
**Group ID:** BG000
**Value:** 2
#### Measurement
**Group ID:** BG001
**Value:** 2
#### Measurement
**Group ID:** BG002
**Value:** 5
#### Measurement
**Group ID:** BG003
**Value:** 5
#### Measurement
**Group ID:** BG004
**Value:** 0
#### Measurement
**Group ID:** BG005
**Value:** 2
#### Measurement
**Group ID:** BG006
**Value:** 16
**Class Title:** Poland
#### Measurement
**Group ID:** BG000
**Value:** 4
#### Measurement
**Group ID:** BG001
**Value:** 2
#### Measurement
**Group ID:** BG002
**Value:** 2
#### Measurement
**Group ID:** BG003
**Value:** 3
#### Measurement
**Group ID:** BG004
**Value:** 0
#### Measurement
**Group ID:** BG005
**Value:** 3
#### Measurement
**Group ID:** BG006
**Value:** 14
**Class Title:** Croatia
#### Measurement
**Group ID:** BG000
**Value:** 2
#### Measurement
**Group ID:** BG001
**Value:** 1
#### Measurement
**Group ID:** BG002
**Value:** 2
#### Measurement
**Group ID:** BG003
**Value:** 0
#### Measurement
**Group ID:** BG004
**Value:** 0
#### Measurement
**Group ID:** BG005
**Value:** 0
#### Measurement
**Group ID:** BG006
**Value:** 5
**Class Title:** Russian Federation
#### Measurement
**Group ID:** BG000
**Value:** 4
#### Measurement
**Group ID:** BG001
**Value:** 5
#### Measurement
**Group ID:** BG002
**Value:** 5
#### Measurement
**Group ID:** BG003
**Value:** 3
#### Measurement
**Group ID:** BG004
**Value:** 0
#### Measurement
**Group ID:** BG005
**Value:** 4
#### Measurement
**Group ID:** BG006
**Value:** 21
**Class Title:** India
### Measure
#### Measurement
**Group ID:** BG000
**Spread:** 4.75
**Value:** 32.92
#### Measurement
**Group ID:** BG001
**Spread:** 5.39
**Value:** 32.26
#### Measurement
**Group ID:** BG002
**Spread:** 4.50
**Value:** 32.22
#### Measurement
**Group ID:** BG003
**Spread:** 4.29
**Value:** 31.04
#### Measurement
**Group ID:** BG004
**Spread:** 3.96
**Value:** 35.38
#### Measurement
**Group ID:** BG005
**Spread:** 5.23
**Value:** 32.07
#### Measurement
**Group ID:** BG006
**Spread:** 4.83
**Value:** 32.20
**Class Title:**
### Measure
#### Measurement
**Group ID:** BG000
**Spread:** 3.19
**Value:** 3.90
#### Measurement
**Group ID:** BG001
**Spread:** 3.80
**Value:** 3.72
#### Measurement
**Group ID:** BG002
**Spread:** 2.54
**Value:** 3.28
#### Measurement
**Group ID:** BG003
**Spread:** 4.08
**Value:** 4.62
#### Measurement
**Group ID:** BG004
**Spread:** 3.04
**Value:** 5.00
#### Measurement
**Group ID:** BG005
**Spread:** 4.74
**Value:** 3.91
#### Measurement
**Group ID:** BG006
**Spread:** 3.68
**Value:** 3.88
**Class Title:**
### Measure
#### Measurement
**Group ID:** BG000
**Spread:** 17.28
**Value:** 87.08
#### Measurement
**Group ID:** BG001
**Spread:** 21.34
**Value:** 90.20
#### Measurement
**Group ID:** BG002
**Spread:** 16.95
**Value:** 86.89
#### Measurement
**Group ID:** BG003
**Spread:** 18.63
**Value:** 85.81
#### Measurement
**Group ID:** BG004
**Spread:** 25.51
**Value:** 100.90
#### Measurement
**Group ID:** BG005
**Spread:** 18.94
**Value:** 90.87
#### Measurement
**Group ID:** BG006
**Spread:** 18.68
**Value:** 88.43
**Class Title:**
### Measure
#### Measurement
**Group ID:** BG000
**Spread:** 0.55
**Value:** 7.13
#### Measurement
**Group ID:** BG001
**Spread:** 0.60
**Value:** 7.18
#### Measurement
**Group ID:** BG002
**Spread:** 0.66
**Value:** 7.28
#### Measurement
**Group ID:** BG003
**Spread:** 0.43
**Value:** 7.25
#### Measurement
**Group ID:** BG004
**Spread:** 0.15
**Value:** 7.63
#### Measurement
**Group ID:** BG005
**Spread:** 0.63
**Value:** 7.36
#### Measurement
**Group ID:** BG006
**Spread:** 0.58
**Value:** 7.24
**Class Title:**
**Denomination Units Selected:**
## Results Section - Baseline Characteristics Module
### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** NUMBER
**Title:** Race/Ethnicity, Customized
**Unit of Measure:** participants
### Measure 4
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
### Measure 5
**Description:** Body mass index is an estimate of body fat based on body weight divided by height squared.
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Body Mass Index (BMI)
**Unit of Measure:** kilograms/square meters (kg/m^2)
### Measure 6
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Duration of Diabetes
**Unit of Measure:** years
### Measure 7
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Body Weight
**Unit of Measure:** kilogram (kg)
### Measure 8
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Glycosylated Hemoglobin (HbA1c)
**Unit of Measure:** percentage of glycosylated hemoglobin
**Population Description:** Participants who received at least one dose of study drug.
## Results Section - More Information Module
### Certain Agreement
**Restriction Type:** GT60
**Restrictive Agreement:** True
### Point of Contact
**Organization:** Eli Lilly and Company
**Phone:** 800-545-5979
**Title:** Chief Medical Officer
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:**
**CI Number of Sides:**
**CI Percentage Value:**
**CI Upper Limit:**
**CI Upper Limit Comment:**
**Dispersion Type:**
**Dispersion Value:**
**Estimate Comment:**
**Group Description:** Test of log linear dose response with placebo.
**Non-Inferiority Comment:**
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:**
**P-Value:** <0.001
**P-Value Comment:** A priori threshold for statistical significance was p\<0.05.
**Parameter Type:**
**Parameter Value:**
**Statistical Comment:**
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:**
**CI Number of Sides:**
**CI Percentage Value:**
**CI Upper Limit:**
**CI Upper Limit Comment:**
**Dispersion Type:**
**Dispersion Value:**
**Estimate Comment:**
**Group Description:** Test of log linear dose response without placebo.
**Non-Inferiority Comment:**
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:**
**P-Value:** <0.001
**P-Value Comment:** A priori threshold for statistical significance was p\<0.05.
**Parameter Type:**
**Parameter Value:**
**Statistical Comment:**
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:**
**CI Number of Sides:**
**CI Percentage Value:**
**CI Upper Limit:**
**CI Upper Limit Comment:**
**Dispersion Type:**
**Dispersion Value:**
**Estimate Comment:**
**Group Description:**
**Non-Inferiority Comment:**
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:**
**P-Value:** 0.069
**P-Value Comment:** An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -0.37
**Statistical Comment:**
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:**
**CI Number of Sides:**
**CI Percentage Value:**
**CI Upper Limit:**
**CI Upper Limit Comment:**
**Dispersion Type:**
**Dispersion Value:**
**Estimate Comment:**
**Group Description:**
**Non-Inferiority Comment:**
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:**
**P-Value:** <0.001
**P-Value Comment:** An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -0.89
**Statistical Comment:**
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:**
**CI Number of Sides:**
**CI Percentage Value:**
**CI Upper Limit:**
**CI Upper Limit Comment:**
**Dispersion Type:**
**Dispersion Value:**
**Estimate Comment:**
**Group Description:**
**Non-Inferiority Comment:**
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:**
**P-Value:** <0.001
**P-Value Comment:** An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -1.04
**Statistical Comment:**
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:**
**CI Number of Sides:**
**CI Percentage Value:**
**CI Upper Limit:**
**CI Upper Limit Comment:**
**Dispersion Type:**
**Dispersion Value:**
**Estimate Comment:**
**Group Description:**
**Non-Inferiority Comment:**
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:**
**P-Value:** <0.001
**P-Value Comment:** An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -1.04
**Statistical Comment:**
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
### Outcome Measure 2
#### Analysis
**CI Lower Limit:**
**CI Number of Sides:**
**CI Percentage Value:**
**CI Upper Limit:**
**CI Upper Limit Comment:**
**Dispersion Type:**
**Dispersion Value:**
**Estimate Comment:**
**Group Description:** Test of log linear dose response with placebo.
**Non-Inferiority Comment:**
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:**
**P-Value:** <0.001
**P-Value Comment:** Treatment comparison at Week 4. A priori threshold for statistical significance was p\<0.05.
**Parameter Type:**
**Parameter Value:**
**Statistical Comment:**
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:**
**CI Number of Sides:**
**CI Percentage Value:**
**CI Upper Limit:**
**CI Upper Limit Comment:**
**Dispersion Type:**
**Dispersion Value:**
**Estimate Comment:**
**Group Description:** Test of log linear dose response without placebo.
**Non-Inferiority Comment:**
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:**
**P-Value:** 0.023
**P-Value Comment:** Treatment comparison at Week 4. A priori threshold for statistical significance was p\<0.05.
**Parameter Type:**
**Parameter Value:**
**Statistical Comment:**
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:**
**CI Number of Sides:**
**CI Percentage Value:**
**CI Upper Limit:**
**CI Upper Limit Comment:**
**Dispersion Type:**
**Dispersion Value:**
**Estimate Comment:**
**Group Description:** Test of log linear dose response with placebo.
**Non-Inferiority Comment:**
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:**
**P-Value:** <0.001
**P-Value Comment:** Treatment comparison at Week 8. A priori threshold for statistical significance was p\<0.05.
**Parameter Type:**
**Parameter Value:**
**Statistical Comment:**
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:**
**CI Number of Sides:**
**CI Percentage Value:**
**CI Upper Limit:**
**CI Upper Limit Comment:**
**Dispersion Type:**
**Dispersion Value:**
**Estimate Comment:**
**Group Description:** Test of log linear dose response without placebo.
**Non-Inferiority Comment:**
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:**
**P-Value:** <0.001
**P-Value Comment:** Treatment comparison at Week 8. A priori threshold for statistical significance was P\<0.05.
**Parameter Type:**
**Parameter Value:**
**Statistical Comment:**
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
### Outcome Measure 3
#### Analysis
**CI Lower Limit:**
**CI Number of Sides:**
**CI Percentage Value:**
**CI Upper Limit:**
**CI Upper Limit Comment:**
**Dispersion Type:**
**Dispersion Value:**
**Estimate Comment:**
**Group Description:** Test of log linear dose response with placebo.
**Non-Inferiority Comment:**
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:**
**P-Value:** <0.001
**P-Value Comment:** A priori threshold for statistical significance was p\<0.05.
**Parameter Type:**
**Parameter Value:**
**Statistical Comment:**
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:**
**CI Number of Sides:**
**CI Percentage Value:**
**CI Upper Limit:**
**CI Upper Limit Comment:**
**Dispersion Type:**
**Dispersion Value:**
**Estimate Comment:**
**Group Description:** Test of log linear dose response without placebo.
**Non-Inferiority Comment:**
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:**
**P-Value:** <0.001
**P-Value Comment:** A priori threshold for statistical significance was p\<0.05.
**Parameter Type:**
**Parameter Value:**
**Statistical Comment:**
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:**
**CI Number of Sides:**
**CI Percentage Value:**
**CI Upper Limit:**
**CI Upper Limit Comment:**
**Dispersion Type:**
**Dispersion Value:**
**Estimate Comment:**
**Group Description:**
**Non-Inferiority Comment:**
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:**
**P-Value:** 0.456
**P-Value Comment:** An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -7.81
**Statistical Comment:**
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:**
**CI Number of Sides:**
**CI Percentage Value:**
**CI Upper Limit:**
**CI Upper Limit Comment:**
**Dispersion Type:**
**Dispersion Value:**
**Estimate Comment:**
**Group Description:**
**Non-Inferiority Comment:**
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:**
**P-Value:** <0.001
**P-Value Comment:** An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -26.53
**Statistical Comment:**
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:**
**CI Number of Sides:**
**CI Percentage Value:**
**CI Upper Limit:**
**CI Upper Limit Comment:**
**Dispersion Type:**
**Dispersion Value:**
**Estimate Comment:**
**Group Description:**
**Non-Inferiority Comment:**
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:**
**P-Value:** <0.001
**P-Value Comment:** An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -29.96
**Statistical Comment:**
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:**
**CI Number of Sides:**
**CI Percentage Value:**
**CI Upper Limit:**
**CI Upper Limit Comment:**
**Dispersion Type:**
**Dispersion Value:**
**Estimate Comment:**
**Group Description:**
**Non-Inferiority Comment:**
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:**
**P-Value:** <0.001
**P-Value Comment:** An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -33.71
**Statistical Comment:**
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
### Outcome Measure 4
#### Analysis
**CI Lower Limit:**
**CI Number of Sides:**
**CI Percentage Value:**
**CI Upper Limit:**
**CI Upper Limit Comment:**
**Dispersion Type:**
**Dispersion Value:**
**Estimate Comment:**
**Group Description:**
**Non-Inferiority Comment:**
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:**
**P-Value:** <0.001
**P-Value Comment:** Treatment comparison of glycosylated hemoglobin (HbA1c) levels \<7.0%.
**Parameter Type:**
**Parameter Value:**
**Statistical Comment:** The Cochran-Armitage trend test included the placebo arm.
**Statistical Method:** Cochran-Armitage trend test
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:**
**CI Number of Sides:**
**CI Percentage Value:**
**CI Upper Limit:**
**CI Upper Limit Comment:**
**Dispersion Type:**
**Dispersion Value:**
**Estimate Comment:**
**Group Description:**
**Non-Inferiority Comment:**
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:**
**P-Value:** <0.001
**P-Value Comment:** Treatment comparison of glycosylated hemoglobin (HbA1c) levels ≤6.5%.
**Parameter Type:**
**Parameter Value:**
**Statistical Comment:** The Cochran-Armitage trend test included the placebo arm.
**Statistical Method:** Cochran-Armitage trend test
**Tested Non-Inferiority:** False
### Outcome Measure 5
#### Analysis
**CI Lower Limit:**
**CI Number of Sides:**
**CI Percentage Value:**
**CI Upper Limit:**
**CI Upper Limit Comment:**
**Dispersion Type:**
**Dispersion Value:**
**Estimate Comment:**
**Group Description:** Test of log linear dose response with placebo.
**Non-Inferiority Comment:**
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:**
**P-Value:** <0.001
**P-Value Comment:** A priori threshold for statistical significance was p\<0.05.
**Parameter Type:**
**Parameter Value:**
**Statistical Comment:**
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:**
**CI Number of Sides:**
**CI Percentage Value:**
**CI Upper Limit:**
**CI Upper Limit Comment:**
**Dispersion Type:**
**Dispersion Value:**
**Estimate Comment:**
**Group Description:** Test of log linear dose response without placebo.
**Non-Inferiority Comment:**
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:**
**P-Value:** <0.001
**P-Value Comment:** A priori threshold for statistical significance was p\<0.05.
**Parameter Type:**
**Parameter Value:**
**Statistical Comment:**
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:**
**CI Number of Sides:**
**CI Percentage Value:**
**CI Upper Limit:**
**CI Upper Limit Comment:**
**Dispersion Type:**
**Dispersion Value:**
**Estimate Comment:**
**Group Description:**
**Non-Inferiority Comment:**
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:**
**P-Value:** 0.378
**P-Value Comment:** An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -9.65
**Statistical Comment:**
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:**
**CI Number of Sides:**
**CI Percentage Value:**
**CI Upper Limit:**
**CI Upper Limit Comment:**
**Dispersion Type:**
**Dispersion Value:**
**Estimate Comment:**
**Group Description:**
**Non-Inferiority Comment:**
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:**
**P-Value:** <0.001
**P-Value Comment:** An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -26.09
**Statistical Comment:**
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:**
**CI Number of Sides:**
**CI Percentage Value:**
**CI Upper Limit:**
**CI Upper Limit Comment:**
**Dispersion Type:**
**Dispersion Value:**
**Estimate Comment:**
**Group Description:**
**Non-Inferiority Comment:**
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:**
**P-Value:** <0.001
**P-Value Comment:** An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -36.34
**Statistical Comment:**
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:**
**CI Number of Sides:**
**CI Percentage Value:**
**CI Upper Limit:**
**CI Upper Limit Comment:**
**Dispersion Type:**
**Dispersion Value:**
**Estimate Comment:**
**Group Description:**
**Non-Inferiority Comment:**
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:**
**P-Value:** <0.001
**P-Value Comment:** An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -38.67
**Statistical Comment:**
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
### Outcome Measure 6
#### Analysis
**CI Lower Limit:**
**CI Number of Sides:**
**CI Percentage Value:**
**CI Upper Limit:**
**CI Upper Limit Comment:**
**Dispersion Type:**
**Dispersion Value:**
**Estimate Comment:**
**Group Description:** Test of log linear dose response with placebo.
**Non-Inferiority Comment:**
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:**
**P-Value:** <0.001
**P-Value Comment:** A priori threshold for statistical significance was p\<0.05.
**Parameter Type:**
**Parameter Value:**
**Statistical Comment:**
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:**
**CI Number of Sides:**
**CI Percentage Value:**
**CI Upper Limit:**
**CI Upper Limit Comment:**
**Dispersion Type:**
**Dispersion Value:**
**Estimate Comment:**
**Group Description:** Test of log linear dose response without placebo.
**Non-Inferiority Comment:**
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:**
**P-Value:** 0.036
**P-Value Comment:** A priori threshold for statistical significance was p\<0.05.
**Parameter Type:**
**Parameter Value:**
**Statistical Comment:**
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
### Outcome Measure 7
#### Analysis
**CI Lower Limit:**
**CI Number of Sides:**
**CI Percentage Value:**
**CI Upper Limit:**
**CI Upper Limit Comment:**
**Dispersion Type:**
**Dispersion Value:**
**Estimate Comment:**
**Group Description:** Test of log linear dose response with placebo.
**Non-Inferiority Comment:**
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:**
**P-Value:** 0.450
**P-Value Comment:** A priori threshold for statistical significance was p\<0.05.
**Parameter Type:**
**Parameter Value:**
**Statistical Comment:**
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:**
**CI Number of Sides:**
**CI Percentage Value:**
**CI Upper Limit:**
**CI Upper Limit Comment:**
**Dispersion Type:**
**Dispersion Value:**
**Estimate Comment:**
**Group Description:** Test of log linear dose response without placebo.
**Non-Inferiority Comment:**
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:**
**P-Value:** 0.329
**P-Value Comment:** A priori threshold for statistical significance was p\<0.05.
**Parameter Type:**
**Parameter Value:**
**Statistical Comment:**
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
### Outcome Measure 8
### Outcome Measure 9
### Outcome Measure 10
### Outcome Measure 11
### Outcome Measure 12
### Outcome Measure 13
### Outcome Measure 14
### Outcome Measure 15
#### Analysis
**CI Lower Limit:**
**CI Number of Sides:**
**CI Percentage Value:**
**CI Upper Limit:**
**CI Upper Limit Comment:**
**Dispersion Type:**
**Dispersion Value:**
**Estimate Comment:**
**Group Description:** Test of log linear dose response with placebo.
**Non-Inferiority Comment:**
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:**
**P-Value:** 0.969
**P-Value Comment:** A priori threshold for statistical significance was p\<0.05.
**Parameter Type:**
**Parameter Value:**
**Statistical Comment:**
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:**
**CI Number of Sides:**
**CI Percentage Value:**
**CI Upper Limit:**
**CI Upper Limit Comment:**
**Dispersion Type:**
**Dispersion Value:**
**Estimate Comment:**
**Group Description:** Test of log linear dose response without placebo.
**Non-Inferiority Comment:**
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:**
**P-Value:** 0.009
**P-Value Comment:** A priori threshold for statistical significance was p\<0.05.
**Parameter Type:**
**Parameter Value:**
**Statistical Comment:**
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:**
**CI Number of Sides:**
**CI Percentage Value:**
**CI Upper Limit:**
**CI Upper Limit Comment:**
**Dispersion Type:**
**Dispersion Value:**
**Estimate Comment:**
**Group Description:**
**Non-Inferiority Comment:**
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:**
**P-Value:** 0.140
**P-Value Comment:** An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 1.19
**Statistical Comment:**
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:**
**CI Number of Sides:**
**CI Percentage Value:**
**CI Upper Limit:**
**CI Upper Limit Comment:**
**Dispersion Type:**
**Dispersion Value:**
**Estimate Comment:**
**Group Description:**
**Non-Inferiority Comment:**
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:**
**P-Value:** 0.247
**P-Value Comment:** An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 1.04
**Statistical Comment:**
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:**
**CI Number of Sides:**
**CI Percentage Value:**
**CI Upper Limit:**
**CI Upper Limit Comment:**
**Dispersion Type:**
**Dispersion Value:**
**Estimate Comment:**
**Group Description:**
**Non-Inferiority Comment:**
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:**
**P-Value:** 0.975
**P-Value Comment:** An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 0.27
**Statistical Comment:**
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:**
**CI Number of Sides:**
**CI Percentage Value:**
**CI Upper Limit:**
**CI Upper Limit Comment:**
**Dispersion Type:**
**Dispersion Value:**
**Estimate Comment:**
**Group Description:**
**Non-Inferiority Comment:**
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:**
**P-Value:** 1.00
**P-Value Comment:** An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -0.11
**Statistical Comment:**
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
### Outcome Measure 16
### Outcome Measure 17
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 0.11
- **Upper Limit:**
- **Value:** -0.37
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 0.12
- **Upper Limit:**
- **Value:** -0.89
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:** 0.11
- **Upper Limit:**
- **Value:** -1.03
- **Comment:**
- **Group ID:** OG003
- **Lower Limit:**
- **Spread:** 0.13
- **Upper Limit:**
- **Value:** -1.04
- **Comment:**
- **Group ID:** OG004
- **Lower Limit:**
- **Spread:** 0.13
- **Upper Limit:**
- **Value:** 0.01
**Title:**
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 0.09
- **Upper Limit:**
- **Value:** -0.28
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 0.09
- **Upper Limit:**
- **Value:** -0.51
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:** 0.08
- **Upper Limit:**
- **Value:** -0.46
- **Comment:**
- **Group ID:** OG003
- **Lower Limit:**
- **Spread:** 0.10
- **Upper Limit:**
- **Value:** -0.53
- **Comment:**
- **Group ID:** OG004
- **Lower Limit:**
- **Spread:** 0.10
- **Upper Limit:**
- **Value:** -0.01
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 0.10
- **Upper Limit:**
- **Value:** -0.33
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 0.10
- **Upper Limit:**
- **Value:** -0.74
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:** 0.10
- **Upper Limit:**
- **Value:** -0.78
- **Comment:**
- **Group ID:** OG003
- **Lower Limit:**
- **Spread:** 0.12
- **Upper Limit:**
- **Value:** -0.90
- **Comment:**
- **Group ID:** OG004
- **Lower Limit:**
- **Spread:** 0.11
- **Upper Limit:**
- **Value:** -0.00
**Title:**
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 4.09
- **Upper Limit:**
- **Value:** -11.59
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 4.26
- **Upper Limit:**
- **Value:** -30.31
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:** 4.18
- **Upper Limit:**
- **Value:** -33.73
- **Comment:**
- **Group ID:** OG003
- **Lower Limit:**
- **Spread:** 4.78
- **Upper Limit:**
- **Value:** -37.49
- **Comment:**
- **Group ID:** OG004
- **Lower Limit:**
- **Spread:** 4.44
- **Upper Limit:**
- **Value:** -3.78
**Title:**
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 47.1
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 73.3
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 75.0
- **Comment:**
- **Group ID:** OG003
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 71.4
- **Comment:**
- **Group ID:** OG004
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 21.4
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 14.7
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 53.3
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 50.0
- **Comment:**
- **Group ID:** OG003
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 52.4
- **Comment:**
- **Group ID:** OG004
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 7.1
**Title:**
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 4.74
- **Upper Limit:**
- **Value:** -15.77
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 4.88
- **Upper Limit:**
- **Value:** -32.21
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:** 4.68
- **Upper Limit:**
- **Value:** -42.46
- **Comment:**
- **Group ID:** OG003
- **Lower Limit:**
- **Spread:** 5.46
- **Upper Limit:**
- **Value:** -44.79
- **Comment:**
- **Group ID:** OG004
- **Lower Limit:**
- **Spread:** 5.05
- **Upper Limit:**
- **Value:** -6.12
**Title:**
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 6.76
- **Upper Limit:**
- **Value:** 13.18
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 7.04
- **Upper Limit:**
- **Value:** 31.66
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:** 7.64
- **Upper Limit:**
- **Value:** 39.04
- **Comment:**
- **Group ID:** OG003
- **Lower Limit:**
- **Spread:** 8.11
- **Upper Limit:**
- **Value:** 29.29
- **Comment:**
- **Group ID:** OG004
- **Lower Limit:**
- **Spread:** 7.44
- **Upper Limit:**
- **Value:** -2.06
**Title:**
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 6.62
- **Upper Limit:**
- **Value:** -2.41
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 6.92
- **Upper Limit:**
- **Value:** 6.10
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:** 7.44
- **Upper Limit:**
- **Value:** -4.80
- **Comment:**
- **Group ID:** OG003
- **Lower Limit:**
- **Spread:** 7.95
- **Upper Limit:**
- **Value:** 12.98
- **Comment:**
- **Group ID:** OG004
- **Lower Limit:**
- **Spread:** 7.34
- **Upper Limit:**
- **Value:** 0.58
**Title:**
#### Outcome Measure 8
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 2.09
- **Upper Limit:**
- **Value:** 1.34
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 2.11
- **Upper Limit:**
- **Value:** -1.18
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:** 2.01
- **Upper Limit:**
- **Value:** 4.56
- **Comment:**
- **Group ID:** OG003
- **Lower Limit:**
- **Spread:** 2.33
- **Upper Limit:**
- **Value:** -0.63
- **Comment:**
- **Group ID:** OG004
- **Lower Limit:**
- **Spread:** 2.19
- **Upper Limit:**
- **Value:** 0.70
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 2.20
- **Upper Limit:**
- **Value:** 3.22
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 2.23
- **Upper Limit:**
- **Value:** 4.57
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:** 2.15
- **Upper Limit:**
- **Value:** -0.55
- **Comment:**
- **Group ID:** OG003
- **Lower Limit:**
- **Spread:** 2.46
- **Upper Limit:**
- **Value:** 2.83
- **Comment:**
- **Group ID:** OG004
- **Lower Limit:**
- **Spread:** 2.33
- **Upper Limit:**
- **Value:** -0.89
**Title:**
#### Outcome Measure 9
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 1.48
- **Upper Limit:**
- **Value:** 1.38
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 1.51
- **Upper Limit:**
- **Value:** 1.16
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:** 1.44
- **Upper Limit:**
- **Value:** 1.88
- **Comment:**
- **Group ID:** OG003
- **Lower Limit:**
- **Spread:** 1.67
- **Upper Limit:**
- **Value:** 4.18
- **Comment:**
- **Group ID:** OG004
- **Lower Limit:**
- **Spread:** 1.58
- **Upper Limit:**
- **Value:** 0.67
**Title:**
#### Outcome Measure 10
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 1.44
- **Upper Limit:**
- **Value:** 0.19
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 1.49
- **Upper Limit:**
- **Value:** 0.25
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:** 1.43
- **Upper Limit:**
- **Value:** 1.02
- **Comment:**
- **Group ID:** OG003
- **Lower Limit:**
- **Spread:** 1.65
- **Upper Limit:**
- **Value:** 1.34
- **Comment:**
- **Group ID:** OG004
- **Lower Limit:**
- **Spread:** 1.54
- **Upper Limit:**
- **Value:** 1.29
**Title:**
#### Outcome Measure 11
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 2.04
- **Upper Limit:**
- **Value:** -2.21
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 2.12
- **Upper Limit:**
- **Value:** 0.51
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:** 2.02
- **Upper Limit:**
- **Value:** -2.57
- **Comment:**
- **Group ID:** OG003
- **Lower Limit:**
- **Spread:** 2.33
- **Upper Limit:**
- **Value:** 1.88
- **Comment:**
- **Group ID:** OG004
- **Lower Limit:**
- **Spread:** 2.18
- **Upper Limit:**
- **Value:** -0.68
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 1.21
- **Upper Limit:**
- **Value:** -0.24
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 1.26
- **Upper Limit:**
- **Value:** 0.59
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:** 1.20
- **Upper Limit:**
- **Value:** 0.42
- **Comment:**
- **Group ID:** OG003
- **Lower Limit:**
- **Spread:** 1.39
- **Upper Limit:**
- **Value:** 1.56
- **Comment:**
- **Group ID:** OG004
- **Lower Limit:**
- **Spread:** 1.30
- **Upper Limit:**
- **Value:** 1.07
**Title:**
#### Outcome Measure 12
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 0
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 2
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 2
- **Comment:**
- **Group ID:** OG003
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 3
- **Comment:**
- **Group ID:** OG004
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 0
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 1
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 0
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 0
- **Comment:**
- **Group ID:** OG003
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 0
- **Comment:**
- **Group ID:** OG004
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 0
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 0
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 0
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 0
- **Comment:**
- **Group ID:** OG003
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 0
- **Comment:**
- **Group ID:** OG004
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 0
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 1
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 2
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 1
- **Comment:**
- **Group ID:** OG003
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 2
- **Comment:**
- **Group ID:** OG004
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 0
**Title:**
#### Outcome Measure 13
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 0.72
- **Upper Limit:**
- **Value:** -0.08
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 0.73
- **Upper Limit:**
- **Value:** 0.25
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:** 0.73
- **Upper Limit:**
- **Value:** 1.68
- **Comment:**
- **Group ID:** OG003
- **Lower Limit:**
- **Spread:** 0.79
- **Upper Limit:**
- **Value:** 0.61
- **Comment:**
- **Group ID:** OG004
- **Lower Limit:**
- **Spread:** 0.75
- **Upper Limit:**
- **Value:** -0.09
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 0.10
- **Upper Limit:**
- **Value:** 0.19
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 0.10
- **Upper Limit:**
- **Value:** -0.01
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:** 0.10
- **Upper Limit:**
- **Value:** -0.01
- **Comment:**
- **Group ID:** OG003
- **Lower Limit:**
- **Spread:** 0.11
- **Upper Limit:**
- **Value:** 0.02
- **Comment:**
- **Group ID:** OG004
- **Lower Limit:**
- **Spread:** 0.11
- **Upper Limit:**
- **Value:** 0.01
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 0
- **Upper Limit:**
- **Value:** 0
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 0
- **Upper Limit:**
- **Value:** 0
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:** 0
- **Upper Limit:**
- **Value:** 0
- **Comment:**
- **Group ID:** OG003
- **Lower Limit:**
- **Spread:** 0
- **Upper Limit:**
- **Value:** 0
- **Comment:**
- **Group ID:** OG004
- **Lower Limit:**
- **Spread:** 0
- **Upper Limit:**
- **Value:** 0
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 0.62
- **Upper Limit:**
- **Value:** 0.20
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 0.64
- **Upper Limit:**
- **Value:** 0.16
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:** 0.62
- **Upper Limit:**
- **Value:** 1.21
- **Comment:**
- **Group ID:** OG003
- **Lower Limit:**
- **Spread:** 0.71
- **Upper Limit:**
- **Value:** 0.21
- **Comment:**
- **Group ID:** OG004
- **Lower Limit:**
- **Spread:** 0.67
- **Upper Limit:**
- **Value:** -0.08
**Title:**
#### Outcome Measure 14
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 21
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 17
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 20
- **Comment:**
- **Group ID:** OG003
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 18
- **Comment:**
- **Group ID:** OG004
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 1
- **Comment:**
- **Group ID:** OG005
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 18
**Title:**
#### Outcome Measure 15
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 0.42
- **Upper Limit:**
- **Value:** -0.19
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 0.43
- **Upper Limit:**
- **Value:** -0.34
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:** 0.42
- **Upper Limit:**
- **Value:** -1.11
- **Comment:**
- **Group ID:** OG003
- **Lower Limit:**
- **Spread:** 0.48
- **Upper Limit:**
- **Value:** -1.49
- **Comment:**
- **Group ID:** OG004
- **Lower Limit:**
- **Spread:** 0.45
- **Upper Limit:**
- **Value:** -1.38
**Title:**
#### Outcome Measure 16
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 0
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 0
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 1
- **Comment:**
- **Group ID:** OG003
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 0
- **Comment:**
- **Group ID:** OG004
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 0
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 0
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 0
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 0
- **Comment:**
- **Group ID:** OG003
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 0
- **Comment:**
- **Group ID:** OG004
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 0
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 0
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 0
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 0
- **Comment:**
- **Group ID:** OG003
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 0
- **Comment:**
- **Group ID:** OG004
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 0
**Title:**
#### Outcome Measure 17
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 1503
- **Upper Limit:**
- **Value:** 2294
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 4356
- **Upper Limit:**
- **Value:** 6650
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:** 7645
- **Upper Limit:**
- **Value:** 11671
- **Comment:**
- **Group ID:** OG003
- **Lower Limit:**
- **Spread:** 10905
- **Upper Limit:**
- **Value:** 16649
- **Comment:**
- **Group ID:** OG004
- **Lower Limit:**
- **Spread:** 20657
- **Upper Limit:**
- **Value:** 31538
**Title:**
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Least Squares (LS) means of change from baseline for glycosylated hemoglobin (HbA1c) were calculated using mixed model repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline HbA1c as covariate.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Participants who received at least one dose of study drug and have glycosylated hemoglobin (HbA1c) change from baseline data available. Only pre-rescue measurements were used.
**Reporting Status:** POSTED
**Time Frame:** Baseline, 12 weeks
**Title:** Change From Baseline in Glycosylated Hemoglobin (HbA1c)
**Type:** PRIMARY
**Unit of Measure:** percentage of glycosylated hemoglobin
##### Group
**Description:** LY2189265: 0.1 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
**ID:** OG000
**Title:** 0.1 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265 0.5 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
**ID:** OG001
**Title:** 0.5 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265 1.0 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
**ID:** OG002
**Title:** 1.0 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265 1.5 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
**ID:** OG003
**Title:** 1.5 Milligrams (mg) LY2189265
##### Group
**Description:** Placebo: subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
**ID:** OG004
**Title:** Placebo
#### Outcome Measure 2
**Description:** Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline glycosylated hemoglobin (HbA1c) as covariate.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Participants who received at least one dose of study drug and have glycosylated hemoglobin (HbA1c) change from baseline data available. Only pre-rescue measurements were used.
**Reporting Status:** POSTED
**Time Frame:** Baseline, 4 weeks, 8 weeks
**Title:** Change From Baseline in Glycosylated Hemoglobin (HbA1c)
**Type:** SECONDARY
**Unit of Measure:** percentage of glycosylated hemoglobin
##### Group
**Description:** LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG000
**Title:** 0.1 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG001
**Title:** 0.5 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG002
**Title:** 1.0 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG003
**Title:** 1.5 Milligrams (mg) LY2189265
##### Group
**Description:** Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG004
**Title:** Placebo
#### Outcome Measure 3
**Description:** Fasting blood glucose is a test to determine how much glucose (sugar) is in a blood sample after an overnight fast. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline fasting glucose as covariate.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Participants who received at least one dose of study drug and have fasting blood glucose change from baseline data available. Only pre-rescue measurements were used.
**Reporting Status:** POSTED
**Time Frame:** Baseline, 12 weeks
**Title:** Change From Baseline in Fasting Blood Glucose
**Type:** SECONDARY
**Unit of Measure:** milligrams per deciliter (mg/dL)
##### Group
**Description:** LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
**ID:** OG000
**Title:** 0.1 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG001
**Title:** 0.5 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG002
**Title:** 1.0 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG003
**Title:** 1.5 Milligrams (mg) LY2189265
##### Group
**Description:** Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG004
**Title:** Placebo
#### Outcome Measure 4
**Description:** Percentages of participants who achieved glycosylated hemoglobin (HbA1c) levels of \<7.0% or ≤6.5% were compared across treatment arms using the Cochran-Armitage trend test.
**Parameter Type:** NUMBER
**Population Description:** Participants who received at least one dose of study drug and have HbA1c data available. Only pre-rescue measurements were used.
**Reporting Status:** POSTED
**Time Frame:** 12 weeks
**Title:** Percentage of Participants Who Achieve Glycosylated Hemoglobin (HbA1c) <7% or ≤6.5%
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG000
**Title:** 0.1 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG001
**Title:** 0.5 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG002
**Title:** 1.0 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG003
**Title:** 1.5 Milligrams (mg) LY2189265
##### Group
**Description:** Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG004
**Title:** Placebo
#### Outcome Measure 5
**Description:** Change from baseline in mean daily blood glucose values were measured with a 7-point self-monitored blood glucose (SMBG) profile over a 24-hour period in the 7-day period prior to each visit. The 7-point SMBG profile consisted of preprandial blood glucose measures before the morning, midday, and evening meals; blood glucose measures 2 hours after the start of the morning, midday, and evening meals; and the fasting blood glucose obtained the following morning. Mean at 12 weeks was assessed in all treatment groups. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and as covariate.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Participants who received at least one dose of study drug and have blood glucose change from baseline data available. Only pre-rescue measurements were used.
**Reporting Status:** POSTED
**Time Frame:** Baseline, 12 weeks
**Title:** Change From Baseline in Daily Mean Blood Glucose Values From the 7-point Self Monitored Blood Glucose (SMBG) Profiles
**Type:** SECONDARY
**Unit of Measure:** milligrams per deciliter (mg/dL)
##### Group
**Description:** LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG000
**Title:** 0.1 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG001
**Title:** 0.5 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG002
**Title:** 1.0 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG003
**Title:** 1.5 Milligrams (mg) LY2189265
##### Group
**Description:** Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG004
**Title:** Placebo
#### Outcome Measure 6
**Description:** Change from baseline in beta (β)-cell function (HOMA2-%B) was assessed by using the homeostatic model assessment (HOMA) to quantify β-cell function. HOMA2-%B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state beta cell function (%B), as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. Least Squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline HOMA2-%B as covariate.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Participants who received at least one dose of study drug and have beta-cell function (HOMA2-%B) change from baseline data available. Only pre-rescue measurements were used.
**Reporting Status:** POSTED
**Time Frame:** Baseline, 12 weeks
**Title:** Change From Baseline in Beta-cell Function (HOMA2-%B)
**Type:** SECONDARY
**Unit of Measure:** percentage of HOMA2-%B
##### Group
**Description:** LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG000
**Title:** 0.1 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG001
**Title:** 0.5 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG002
**Title:** 1.0 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG003
**Title:** 1.5 Milligrams (mg) LY2189265
##### Group
**Description:** Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG004
**Title:** Placebo
#### Outcome Measure 7
**Description:** Change from baseline in insulin sensitivity (HOMA2-%S) was assessed by using the homeostatic model assessment (HOMA) to quantify insulin sensitivity. HOMA2-%S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state insulin sensitivity (%S), as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. Least Squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline HOMA2-%S as covariate.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Participants who received at least one dose of study drug and have insulin sensitivity change from baseline data available. Only pre-rescue measurements were used.
**Reporting Status:** POSTED
**Time Frame:** Baseline, 12 weeks
**Title:** Change From Baseline in Insulin Sensitivity (HOMA2-%S)
**Type:** SECONDARY
**Unit of Measure:** percentage of HOMA2-%S
##### Group
**Description:** LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG000
**Title:** 0.1 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG001
**Title:** 0.5 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG002
**Title:** 1.0 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG003
**Title:** 1.5 Milligrams (mg) LY2189265
##### Group
**Description:** Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG004
**Title:** Placebo
#### Outcome Measure 8
**Description:** The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR\^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. The PR segment begins at the endpoint of the P wave and ends at the onset of the QRS complex. Least Squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline measurement as covariate.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Participants who received at least one dose of study drug and have Fridericia-corrected QT (QTcF) or PR interval change from baseline data available.
**Reporting Status:** POSTED
**Time Frame:** Baseline, 12 weeks
**Title:** Change From Baseline in Electrocardiograms (ECGs) - Fridericia-corrected QT (QTcF) and PR Interval
**Type:** SECONDARY
**Unit of Measure:** millisecond (msec)
##### Group
**Description:** LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG000
**Title:** 0.1 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG001
**Title:** 0.5 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG002
**Title:** 1.0 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG003
**Title:** 1.5 Milligrams (mg) LY2189265
##### Group
**Description:** Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG004
**Title:** Placebo
#### Outcome Measure 9
**Description:** Least Squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline measurement as covariate.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Participants who received at least one dose of study drug and have heart rate change from baseline data available.
**Reporting Status:** POSTED
**Time Frame:** Baseline, 12 weeks
**Title:** Change From Baseline in Electrocardiograms (ECGs) - Heart Rate
**Type:** SECONDARY
**Unit of Measure:** beats per minute (bpm)
##### Group
**Description:** LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG000
**Title:** 0.1 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG001
**Title:** 0.5 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG002
**Title:** 1.0 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG003
**Title:** 1.5 Milligrams (mg) LY2189265
##### Group
**Description:** Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG004
**Title:** Placebo
#### Outcome Measure 10
**Description:** Sitting pulse rate was measured. Least Squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline measurement as covariate.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Participants who received at least one dose of study drug and have pulse rate change from baseline data available.
**Reporting Status:** POSTED
**Time Frame:** Baseline, 12 weeks
**Title:** Change From Baseline in Pulse Rate
**Type:** SECONDARY
**Unit of Measure:** beats per minute (bpm)
##### Group
**Description:** LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG000
**Title:** 0.1 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG001
**Title:** 0.5 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG002
**Title:** 1.0 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG003
**Title:** 1.5 Milligrams (mg) LY2189265
##### Group
**Description:** Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG004
**Title:** Placebo
#### Outcome Measure 11
**Description:** Sitting systolic blood pressure (SBP) and sitting diastolic blood pressure (DBP) were measured. Least Squares (LS) means of change were calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline measurement as covariate.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Participants who received at least one dose of study drug and have blood pressure change from baseline data available.
**Reporting Status:** POSTED
**Time Frame:** Baseline, 12 weeks
**Title:** Change From Baseline in Blood Pressure (BP)
**Type:** SECONDARY
**Unit of Measure:** millimeters of mercury (mmHg)
##### Group
**Description:** LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG000
**Title:** 0.1 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG001
**Title:** 0.5 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG002
**Title:** 1.0 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG003
**Title:** 1.5 Milligrams (mg) LY2189265
##### Group
**Description:** Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG004
**Title:** Placebo
#### Outcome Measure 12
**Description:** Hypoglycemic events were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined an event during which typical symptoms of hypoglycemia were accompanied by a blood glucose level of ≤3.9 millimoles per liter \[mmol/L\]), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured blood glucose of ≤3.9 mmol/L), or nocturnal (defined as any hypoglycemic event that occurred between bedtime and breakfast with a measured blood glucose of ≤3.9 mmol/L). Participant reports of hypoglycemic events were collected at the beginning of each visit starting at Baseline. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
**Parameter Type:** NUMBER
**Population Description:** Participants who received at least one dose of study drug and have self-reported hypoglycemic event data available. Only pre-rescue measurements were used.
**Reporting Status:** POSTED
**Time Frame:** Baseline through 12 weeks
**Title:** Number of Participants With Self-reported Hypoglycemic Events
**Type:** SECONDARY
**Unit of Measure:** participants
##### Group
**Description:** LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG000
**Title:** 0.1 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG001
**Title:** 0.5 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG002
**Title:** 1.0 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG003
**Title:** 1.5 Milligrams (mg) LY2189265
##### Group
**Description:** Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG004
**Title:** Placebo
#### Outcome Measure 13
**Description:** Hypoglycemic events (HE) were classified as severe (defined as events requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined an event during which typical symptoms of hypoglycemia were accompanied by a blood glucose level of ≤3.9 millimoles per liter \[mmol/L\]), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured blood glucose of ≤3.9 mmol/L), or nocturnal (defined as any HE that occurred between bedtime and breakfast with a measured blood glucose of ≤3.9 mmol/L). Participant reports of HE were collected at the beginning of each visit starting at Baseline and the annualized rate was reported. Least Squares (LS) means rates were adjusted for pre-study therapy, country, and baseline body mass index. A summary of AEs regardless of causality is located in the Reported AEs module. Some model-adjusted LS means are less than 0 and may be interpreted as very low rates.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Participants who received at least one dose of study drug and have self-reported hypoglycemic event data available. Only pre-rescue measurements were used.
**Reporting Status:** POSTED
**Time Frame:** Baseline through 12 weeks
**Title:** Rate of Self-reported Hypoglycemic Events
**Type:** SECONDARY
**Unit of Measure:** Events per participant per year
##### Group
**Description:** LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG000
**Title:** 0.1 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG001
**Title:** 0.5 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG002
**Title:** 1.0 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG003
**Title:** 1.5 Milligrams (mg) LY2189265
##### Group
**Description:** Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG004
**Title:** Placebo
#### Outcome Measure 14
**Description:** A treatment emergent adverse event is any untoward medical occurrence that either occurs or worsens at any time after the first injection of study drug following randomization and which does not necessarily have to have a causal relationship. The number of participants with one or more treatment emergent adverse event was reported. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
**Parameter Type:** NUMBER
**Population Description:** Participants who received at least one dose of study drug.
**Reporting Status:** POSTED
**Time Frame:** Baseline through 12 weeks
**Title:** Treatment Emergent Adverse Events
**Type:** SECONDARY
**Unit of Measure:** participants
##### Group
**Description:** LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG000
**Title:** 0.1 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG001
**Title:** 0.5 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG002
**Title:** 1.0 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG003
**Title:** 1.5 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 3.0 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG004
**Title:** 3.0 Milligrams (mg) LY2189265
##### Group
**Description:** Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG005
**Title:** Placebo
#### Outcome Measure 15
**Description:** Least Squares (LS) means was calculated using a mixed-effects model for repeated measures (MMRM) with pre-study therapy, country, dose, visit, and dose-by-visit interaction as fixed effects and baseline measurement as covariate.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Participants who received at least one dose of study drug and have body weight change from baseline data available.
**Reporting Status:** POSTED
**Time Frame:** Baseline, 12 weeks
**Title:** Change From Baseline in Body Weight
**Type:** SECONDARY
**Unit of Measure:** kilogram (kg)
##### Group
**Description:** LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG000
**Title:** 0.1 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG001
**Title:** 0.5 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG002
**Title:** 1.0 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG003
**Title:** 1.5 Milligrams (mg) LY2189265
##### Group
**Description:** Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG004
**Title:** Placebo
#### Outcome Measure 16
**Description:** LY2189265 anti-drug antibodies (ADA) were assessed at baseline, 4 and 12 weeks, and at the safety follow-up visit 4 weeks after study drug discontinuation (16 weeks). The number of participants with initial postbaseline detection of treatment emergent (defined as a 4-fold increase in the ADA titer from baseline) LY2189265 ADA at each time point were summarized.
**Parameter Type:** NUMBER
**Population Description:** Participants who received at least one dose of study drug with evaluable LY2189265 anti-drug antibodies (ADA) data.
**Reporting Status:** POSTED
**Time Frame:** Baseline, 4 weeks, 12 weeks, 16 weeks
**Title:** Antibody Production and Effects to LY2189265
**Type:** SECONDARY
**Unit of Measure:** participants
##### Group
**Description:** LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG000
**Title:** 0.1 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG001
**Title:** 0.5 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG002
**Title:** 1.0 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG003
**Title:** 1.5 Milligrams (mg) LY2189265
##### Group
**Description:** Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG004
**Title:** Placebo
#### Outcome Measure 17
**Description:** The population mean estimates and standard deviations were calculated for pharmacokinetic parameters (area under the concentration time curve (AUC) from zero to 168 hours). Evaluable PK concentrations from the 4 week, 8 week, and 12 week timepoints were combined and utilized in a population approach to determine the population mean estimate and standard deviation at steady-state.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Participants who received at least one dose of LY2189265 (0.1-3.0 milligrams \[mg\]) with evaluable pharmacokinetic data.
**Reporting Status:** POSTED
**Time Frame:** 4 weeks, 8 weeks, 12 weeks
**Title:** Collection and Evaluation of Plasma Levels (Pharmacokinetics [PK]) of LY2189265
**Type:** SECONDARY
**Unit of Measure:** nanograms*hour/milliliter (ng*h/mL)
##### Group
**Description:** LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG000
**Title:** 0.1 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG001
**Title:** 0.5 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG002
**Title:** 1.0 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG003
**Title:** 1.5 Milligrams (mg) LY2189265
##### Group
**Description:** LY2189265: 3.0 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** OG004
**Title:** 3.0 Milligrams (mg) LY2189265
### Participant Flow Module
#### Group
**Description:** LY2189265: 0.1 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** FG000
**Title:** 0.1 Milligrams (mg) LY2189265
#### Group
**Description:** LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** FG001
**Title:** 0.5 Milligrams (mg) LY2189265
#### Group
**Description:** LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** FG002
**Title:** 1.0 Milligrams (mg) LY2189265
#### Group
**Description:** LY2189265: 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** FG003
**Title:** 1.5 Milligrams (mg) LY2189265
#### Group
**Description:** LY2189265: 3.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** FG004
**Title:** 3.0 Milligrams (mg) LY2189265
#### Group
**Description:** Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
**ID:** FG005
**Title:** Placebo
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Dose Discontinued per Sponsor Decision
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
###### Reason
**Group ID:** FG003
**Number of Subjects:** 0
###### Reason
**Group ID:** FG004
**Number of Subjects:** 3
###### Reason
**Group ID:** FG005
**Number of Subjects:** 0
##### Withdraw
**Type:** Adverse Event
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
###### Reason
**Group ID:** FG003
**Number of Subjects:** 2
###### Reason
**Group ID:** FG004
**Number of Subjects:** 0
###### Reason
**Group ID:** FG005
**Number of Subjects:** 1
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
###### Reason
**Group ID:** FG003
**Number of Subjects:** 0
###### Reason
**Group ID:** FG004
**Number of Subjects:** 0
###### Reason
**Group ID:** FG005
**Number of Subjects:** 1
##### Withdraw
**Type:** Protocol Violation
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
###### Reason
**Group ID:** FG003
**Number of Subjects:** 1
###### Reason
**Group ID:** FG004
**Number of Subjects:** 0
###### Reason
**Group ID:** FG005
**Number of Subjects:** 0
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
###### Reason
**Group ID:** FG003
**Number of Subjects:** 1
###### Reason
**Group ID:** FG004
**Number of Subjects:** 0
###### Reason
**Group ID:** FG005
**Number of Subjects:** 1
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 35
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 34
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 34
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 29
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 3
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 32
##### Milestone
**Type:** Received at Least One Dose of Study Drug
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 35
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 34
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 34
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 29
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 3
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 32
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 33
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 31
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 34
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 25
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 29
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 2
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 3
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 4
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 3
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 3
**Has Results:** True |
## Protocol Section
### Identification Module
**NCT ID:** NCT00255879
**Brief Title:** Movement Disorders Caused by Antipsychotic Drugs in Older Patients
**Official Title:** Neuroleptic Induced Movement Disorders in Older Patients
#### Organization Study ID Info
**ID:** R01MH059101
**Link:** https://reporter.nih.gov/quickSearch/R01MH059101
**Type:** NIH
#### Organization
**Class:** OTHER
**Full Name:** University of California, San Diego
#### Secondary ID Infos
**ID:** R01MH059101
**Link:** https://reporter.nih.gov/quickSearch/R01MH059101
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2004-08
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2013-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2013-06-05
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2004-08
**Type:** ACTUAL
#### Start Date
**Date:** 1999-01
**Status Verified Date:** 2005-11
#### Study First Post Date
**Date:** 2005-11-21
**Type:** ESTIMATED
**Study First Submit Date:** 2005-11-16
**Study First Submit QC Date:** 2005-11-16
### Sponsor Collaborators Module
#### Collaborators
**Class:** NIH
**Name:** National Institute of Mental Health (NIMH)
#### Lead Sponsor
**Class:** OTHER
**Name:** University of California, San Diego
#### Responsible Party
**Investigator Affiliation:** University of California, San Diego
**Investigator Full Name:** Dilip V. Jeste
**Investigator Title:** Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Description Module
**Brief Summary:** This study will assess the risk of experiencing tardive dyskinesia and other movement disturbances associated with three atypical antipsychotic drugs among middle-aged and elderly psychiatric patients.
**Detailed Description:** Use of antipsychotic drugs can result in tardive dyskinesia and extrapyramidal symptoms. Tardive dyskinesia (TD) is a syndrome that causes repetitive, involuntary, purposeless movements in the tongue, lips, or jaw. It can also cause facial grimacing, random movements of arms, legs, fingers, and toes, as well as swaying movements of the trunk or hips. Extrapyramidal symptoms (EPS) include a variety of symptoms, such as involuntary movements, tremors, rigidity, body restlessness, and changes in breathing and heart rate. TD and EPS are side effects of older antipsychotic drugs. Newer antipsychotic drugs, such as quetiapine, olanzapine, and risperidone, do not present as large a risk of developing these side effects. This study will assess the incidence of and risk factors for tardive dyskinesia and extrapyramidal symptoms associated with quetiapine, olanzapine, and risperidone among middle-aged and elderly individuals with psychotic disorders. Additionally, the study will examine the effect of these drugs on symptoms of pre-existing, drug-induced TD. It will also explore the impact of movement disorder symptoms on everyday functioning and quality of life.
Some participants in this open-label study will be randomly assigned to receive quetiapine, olanzapine, or risperidone. Participants who are not randomly assigned to a medication will still receive one of the three medications, based on the decision of their physician. Initial evaluations will be conducted to collect demographic information, as well as medical, psychiatric, and pharmacologic histories. Dosing will be determined by each participant's psychiatrist. All participants will be followed for approximately 5 years. They will report to the study site for outcome assessments at baseline, Months 1 and 3, and every 3 months for the remainder of the study.
### Conditions Module
**Conditions:**
- Dyskinesia, Drug-Induced
**Keywords:**
- Schizophrenia
- Neuroleptic
- Tardive dyskinesia
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 250
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
### Interventions
#### Intervention 1
**Name:** Quetiapine
**Type:** DRUG
#### Intervention 2
**Name:** Risperidone
**Type:** DRUG
#### Intervention 3
**Name:** Olanzapine
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Measure:** Extrapyramidal symptoms; measured at Months 1 and 3 and every 3 months for the remainder of the study
**Measure:** Tardive dyskinesia; measured at Months 1 and 3 and every 3 months for the remainder of the study
#### Secondary Outcomes
**Measure:** Everyday functioning; measured at Months 1 and 3 and every 3 months for the remainder of the study
**Measure:** Quality of life; measured at Months 1 and 3 and every 3 months for the remainder of the study
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* DSM-IV diagnosis of any psychiatric disorder for which an antipsychotic medication is needed
Exclusion Criteria:
* N/A
**Minimum Age:** 40 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** San Diego
**Country:** United States
**Facility:** University of California, San Diego Division of Geriatric Psychiatry
**State:** California
**Zip:** 92161
#### Overall Officials
**Official 1:**
**Affiliation:** University of California, San Diego
**Name:** Dilip V. Jeste, MD
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000009461
- Term: Neurologic Manifestations
- ID: D000020258
- Term: Neurotoxicity Syndromes
- ID: D000064420
- Term: Drug-Related Side Effects and Adverse Reactions
- ID: D000064419
- Term: Chemically-Induced Disorders
- ID: D000011041
- Term: Poisoning
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BC25
- Name: Substance Related Disorders
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M15376
- Name: Schizophrenia
- Relevance: LOW
- As Found: Unknown
- ID: M22574
- Name: Dyskinesias
- Relevance: HIGH
- As Found: Dyskinesia
- ID: M12029
- Name: Movement Disorders
- Relevance: HIGH
- As Found: Movement Disorders
- ID: M680
- Name: Tardive Dyskinesia
- Relevance: LOW
- As Found: Unknown
- ID: M7583
- Name: Dyskinesia, Drug-Induced
- Relevance: HIGH
- As Found: Dyskinesia, Drug-Induced
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M22080
- Name: Neurotoxicity Syndromes
- Relevance: LOW
- As Found: Unknown
- ID: M30303
- Name: Drug-Related Side Effects and Adverse Reactions
- Relevance: LOW
- As Found: Unknown
- ID: M30302
- Name: Chemically-Induced Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M13931
- Name: Poisoning
- Relevance: LOW
- As Found: Unknown
- ID: T4120
- Name: Neurotoxicity Syndromes
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000020820
- Term: Dyskinesias
- ID: D000009069
- Term: Movement Disorders
- ID: D000004409
- Term: Dyskinesia, Drug-Induced
### Intervention Browse Module - Ancestors
- ID: D000012702
- Term: Serotonin Antagonists
- ID: D000018490
- Term: Serotonin Agents
- ID: D000018377
- Term: Neurotransmitter Agents
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000014150
- Term: Antipsychotic Agents
- ID: D000014149
- Term: Tranquilizing Agents
- ID: D000002492
- Term: Central Nervous System Depressants
- ID: D000011619
- Term: Psychotropic Drugs
- ID: D000018492
- Term: Dopamine Antagonists
- ID: D000015259
- Term: Dopamine Agents
- ID: D000000932
- Term: Antiemetics
- ID: D000001337
- Term: Autonomic Agents
- ID: D000018373
- Term: Peripheral Nervous System Agents
- ID: D000005765
- Term: Gastrointestinal Agents
- ID: D000017367
- Term: Selective Serotonin Reuptake Inhibitors
- ID: D000014179
- Term: Neurotransmitter Uptake Inhibitors
- ID: D000049990
- Term: Membrane Transport Modulators
- ID: D000000928
- Term: Antidepressive Agents
### Intervention Browse Module - Browse Branches
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: PsychDr
- Name: Psychotropic Drugs
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: AnEm
- Name: Antiemetics
- Abbrev: Gast
- Name: Gastrointestinal Agents
- Abbrev: CaAg
- Name: Cardiotonic Agents
### Intervention Browse Module - Browse Leaves
- ID: M20999
- Name: Risperidone
- Relevance: HIGH
- As Found: Evening
- ID: M1675
- Name: Olanzapine
- Relevance: HIGH
- As Found: Tailored
- ID: M16904
- Name: Antipsychotic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M399
- Name: Quetiapine Fumarate
- Relevance: HIGH
- As Found: Tip
- ID: M15512
- Name: Serotonin
- Relevance: LOW
- As Found: Unknown
- ID: M20504
- Name: Neurotransmitter Agents
- Relevance: LOW
- As Found: Unknown
- ID: M14474
- Name: Psychotropic Drugs
- Relevance: LOW
- As Found: Unknown
- ID: M7473
- Name: Dopamine
- Relevance: LOW
- As Found: Unknown
- ID: M20596
- Name: Dopamine Antagonists
- Relevance: LOW
- As Found: Unknown
- ID: M17962
- Name: Dopamine Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4251
- Name: Antiemetics
- Relevance: LOW
- As Found: Unknown
- ID: M8881
- Name: Gastrointestinal Agents
- Relevance: LOW
- As Found: Unknown
- ID: M19649
- Name: Selective Serotonin Reuptake Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M4247
- Name: Antidepressive Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000077152
- Term: Olanzapine
- ID: D000018967
- Term: Risperidone
- ID: D000069348
- Term: Quetiapine Fumarate
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT01736579
**Brief Title:** Long-Term Study of IGIV, 10% in Alzheimer´s Disease
**Official Title:** A Study of the Long-Term Safety and Efficacy of Immune Globulin Intravenous (Human), 10% Solution (IGIV, 10%) in Mild to Moderate Alzheimer´s Disease
#### Organization Study ID Info
**ID:** 161202
#### Organization
**Class:** INDUSTRY
**Full Name:** Takeda
### Status Module
#### Completion Date
**Date:** 2013-06-04
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-05-19
**Type:** ACTUAL
**Last Update Submit Date:** 2021-04-30
**Overall Status:** TERMINATED
#### Primary Completion Date
**Date:** 2013-06-04
**Type:** ACTUAL
#### Results First Post Date
**Date:** 2016-08-23
**Type:** ESTIMATED
**Results First Submit Date:** 2016-07-13
**Results First Submit QC Date:** 2016-07-13
#### Start Date
**Date:** 2012-11-29
**Type:** ACTUAL
**Status Verified Date:** 2021-04
#### Study First Post Date
**Date:** 2012-11-29
**Type:** ESTIMATED
**Study First Submit Date:** 2012-11-27
**Study First Submit QC Date:** 2012-11-27
**Why Stopped:** The study was terminated because the first Phase 3 did not demonstrate efficacy on the co-primary endpoints. The known safety profile remained unchanged.
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Baxalta now part of Shire
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The purpose of this long-term study is to provide additional evidence of safety and efficacy of IGIV, 10% treatment in participants with Alzheimer´s Disease who have completed the Phase 3 Baxter precursor study 160701. All participants will receive IGIV, 10% at either 0.2 g/kg or 0.4 g/kg body weight depending on their treatment assignment in Baxter study 160701. Participants and investigators will be blinded to dose unless otherwise notified by the sponsor.
### Conditions Module
**Conditions:**
- Alzheimer´s Disease
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 6
**Type:** ACTUAL
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** IGIV, 10% at 0.2 g/kg body weight every 2 weeks for up to 3 years, 6 months.
**Intervention Names:**
- Drug: Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
**Label:** IGIV, 10% at 0.2 g/kg body weight
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** IGIV, 10% at 0.4 g/kg body weight every 2 weeks for up to 3 years, 6 months
**Intervention Names:**
- Drug: Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
**Label:** IGIV, 10% at 0.4 g/kg body weight
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- IGIV, 10% at 0.2 g/kg body weight
- IGIV, 10% at 0.4 g/kg body weight
**Name:** Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
**Other Names:**
- Gammagard Liquid
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Measure:** Number and Severity of Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
**Time Frame:** 6 months
**Measure:** Number of Infusions Temporally Associated With Adverse Events (AEs) and Serious Adverse Events (SAEs)
**Time Frame:** 6 months
**Measure:** Number of Infusions Causally Associated With Adverse Events (AEs) and Serious Adverse Events (SAEs)
**Time Frame:** 6 months
**Measure:** Number of Infusions Discontinued, Slowed or Interrupted Due to an Adverse Event (AE) or Serious Adverse Event (SAE)
**Time Frame:** 6 months
#### Secondary Outcomes
**Description:** The ADAS-Cog is a validated psychometric instrument that evaluates memory (word recall, word recognition), attention, reasoning (following commands), language (naming, comprehension), orientation, ideational praxis (placing letter in envelope) and constructional praxis (copying geometric designs). This test was administered by experienced raters certified by Alzheimer's Disease Cooperative Study (ADCS) at the site. Scores on the ADAS-Cog range from 0-70 with higher scores indicating greater impairment.
**Measure:** Total Score of the Cognitive Subscale of the Alzheimer's Disease Assessment Scale (ADAS-Cog)
**Time Frame:** 6 months
**Description:** The SIB is a 40-item psychometric assessment that is composed of simple one-step commands combined with gestures. The scoring range is from 0 to 100 with a lower score indicating greater cognitive impairment.
**Measure:** Total Score of the Cognitive Subscale of the Severe Impairment Battery (SIB)
**Time Frame:** 6 months
**Description:** The ADCS-ADL scale is a validated tool to assess instrumental and basic activities of daily living based on a 23 item structured interview of the caregiver or qualified study partner. Scores on the ADCS-ADL range from 0-78 with lower scores indicating greater impairment; hence decreases from baseline reflect potential functional deterioration.
**Measure:** Alzheimer's Disease Cooperative Study (ADCS) - Activities of Daily Living (ADL) Inventory (ADCS-ADL/ ADCS-ADL-severe)
**Time Frame:** 6 months
**Description:** The MMSE is a test for cognitive dysfunction. The test provides a 30-point composite rating for spatial and temporal orientation, verbal recall, simple attention, working memory, naming, repetition, comprehension, writing and constructional abilities. The total score can range from 0 to 30 with a higher score indicating better function.
**Measure:** Mini Mental State Examination (MMSE)
**Time Frame:** 6 months
**Description:** The NPI is a validated instrument used to assess behavioral psychopathology in Alzheimer's Disease; it evaluates the frequency and severity of 12 neuropsychiatric features including delusions, hallucinations, dysphoria, anxiety, agitation/aggression, euphoria, disinhibition, irritability/lability, apathy, aberrant motor activity, sleep and night-time behavior change, and appetite and eating change. The NPI total score ranged 0-144, with higher scores indicating greater impairment.
**Measure:** Neuropsychiatric Inventory (NPI) Score
**Time Frame:** 6 months
**Description:** The QOL-AD is a validated, 13-item instrument developed specifically for individuals with dementia. The assessment rates the participant's quality of life for physical, emotional, interpersonal, and environmental domains. The QOL-AD total score ranged 13-52. Lower scores on the QOL-AD are associated with a lower quality of life.
**Measure:** Logsdon Quality of Life in Alzheimer's Disease (QOL-AD)
**Time Frame:** 6 months
**Description:** EQ-5D is a participant answered questionnaire scoring 5 dimensions - mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ-5D total score ranges from 0 (worst health state) to 1 (perfect health state) and 1 reflects the best outcome. The EQ-5D also includes a standard vertical 20 cm visual analogue scale (VAS) ranging from best imaginable health state \[100\] to worst imaginable health state \[0\]. Caregivers are asked to describe how they believe a participant would rate his/her health state that day.
**Measure:** EQ-5D Questionnaire (Proxy Version)
**Time Frame:** 6 months
**Description:** The HRUQ determines if there is a difference in healthcare utilization and health-related expenditures, most notably nursing home (ie, skilled nursing facility) admissions, when subjects are treated with study product. This assessment is performed with the primary caregiver. This assessment is descriptive and does not contain specific scores.
**Measure:** Healthcare Resource Utilization Questionnaire (HRUQ)
**Time Frame:** 6 months
**Description:** The Caregiver burden questionnaires is a self-administered questionnaire that has been developed to measure the emotional, physical, and social impact of caregiving on Alzheimer's Disease caregivers. A Total score is calculated from this measure by summing the responses across the items. The Total score may range from 9-45, with higher scores indicating greater burden.
**Measure:** Caregiver Burden Questionnaire
**Time Frame:** 6 months
**Description:** Time to skilled nursing facility placement is defined as permanent admission to a skilled nursing facility. Time will be defined as the number of months between enrollment into this clinical study and placement in a skilled nursing facility placement.
**Measure:** Time to Skilled Nursing Facility Placement
**Time Frame:** 6 months
**Description:** Volumetric MRI measurements were obtained to assess rate of whole brain atrophy and ventricular enlargement. Additional volumetric measurements may be analyzed when specific hypotheses and methods are defined. Additional volumetric MRI analysis may include (but may not be limited to) one or more of the following: rate of hippocampal atrophy, entorhinal cortical thickness, and/or regional cortical thinning.
**Measure:** Volumetric MRI
**Time Frame:** 6 months
### Eligibility Module
**Eligibility Criteria:** Main Inclusion Criteria:
* Completed 18 months of study treatment and assessments in Baxter precursor study 160701
* Diagnosis of probable Alzheimer´s Disease (AD)
* Able to comply with testing and infusion regimen (including adequate corrected visual acuity and hearing ability)
* Has a caregiver (study partner) who is willing and able to participate
Main Exclusion Criteria:
* Significant neurological disease other than AD
* Clinically significant cardiac/cardiovascular problems (e.g. uncontrolled blood pressure, atrial fibrillation, heart disease, clotting disorders, strokes, or recent heart attack)
* Contraindication to undergoing MRI (e.g. pacemaker \[with the exception of an MRI-compatible pacemaker\], severe claustrophobia, ferromagnetic implants such as a metal plate)
* Specific findings on brain MRI (microhemorrhages, superficial siderosis, vasogenic edema, a macrohemorrhage, major stroke, or multiple lacunae)
* Active malignancy or history of malignancy within 5 years prior to screening with the exception of the following: adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, and stable prostate cancer not requiring treatment
* Uncontrolled major depression, psychosis, or other major psychiatric disorder(s)
* Poorly controlled diabetes
* Serious problems with liver or kidneys
* Known history of hypersensitivity following infusions of human blood or blood components (e.g. human immunoglobulins or human albumin)
* Current or recent treatment with immunomodulatory therapies (with the exception of immunoglobulin and non-systemic and low-dose systemic corticosteroids)
* Recent use of investigational drugs or biologics, including those aimed at altering AD progression (with the exception of immunoglobulin)
* Active immunization for the treatment of AD at any time
There are reasons why it might not be appropriate to participate in this trial. Please contact Medical Information at [email protected] for details.
**Minimum Age:** 51 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Rochester
**Country:** United States
**State:** New York
#### Overall Officials
**Official 1:**
**Affiliation:** Takeda
**Name:** Study Director
**Role:** STUDY_DIRECTOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000003704
- Term: Dementia
- ID: D000001927
- Term: Brain Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000024801
- Term: Tauopathies
- ID: D000019636
- Term: Neurodegenerative Diseases
- ID: D000019965
- Term: Neurocognitive Disorders
- ID: D000001523
- Term: Mental Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M3885
- Name: Alzheimer Disease
- Relevance: HIGH
- As Found: Alzheimer's Disease
- ID: M6904
- Name: Dementia
- Relevance: LOW
- As Found: Unknown
- ID: M5204
- Name: Brain Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M23002
- Name: Tauopathies
- Relevance: LOW
- As Found: Unknown
- ID: M21558
- Name: Neurodegenerative Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M21836
- Name: Neurocognitive Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
- ID: T2192
- Name: Familial Alzheimer Disease
- Relevance: HIGH
- As Found: Alzheimer's Disease
### Condition Browse Module - Meshes
- ID: D000000544
- Term: Alzheimer Disease
### Intervention Browse Module - Ancestors
- ID: D000007155
- Term: Immunologic Factors
- ID: D000045505
- Term: Physiological Effects of Drugs
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: PhSol
- Name: Pharmaceutical Solutions
### Intervention Browse Module - Browse Leaves
- ID: M4225
- Name: Antibodies
- Relevance: HIGH
- As Found: Cap
- ID: M21860
- Name: Pharmaceutical Solutions
- Relevance: LOW
- As Found: Unknown
- ID: M10184
- Name: Immunoglobulins
- Relevance: HIGH
- As Found: Cap
- ID: M19117
- Name: Immunoglobulins, Intravenous
- Relevance: HIGH
- As Found: Active exercises
- ID: M8836
- Name: gamma-Globulins
- Relevance: HIGH
- As Found: Dronabinol
- ID: M20191
- Name: Rho(D) Immune Globulin
- Relevance: HIGH
- As Found: Dronabinol
- ID: M10201
- Name: Immunologic Factors
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000007136
- Term: Immunoglobulins
- ID: D000000906
- Term: Antibodies
- ID: D000005719
- Term: gamma-Globulins
- ID: D000016756
- Term: Immunoglobulins, Intravenous
- ID: D000018029
- Term: Rho(D) Immune Globulin
### Misc Info Module
- Version Holder: 2024-05-24
## Results Section
### Adverse Events Module
#### Event Groups
**Group ID:** EG000
**Title:** IGIV, 10% at 0.2 g/kg Body Weight
**Description:** IGIV, 10% at 0.2 g/kg body weight every 2 weeks.
**ID:** EG000
**Other Num Affected:** 1
**Other Num at Risk:** 2
**Serious Number At Risk:** 2
**Title:** IGIV, 10% at 0.2 g/kg Body Weight
**Group ID:** EG001
**Title:** IGIV, 10% at 0.4 g/kg Body Weight
**Description:** IGIV, 10% at 0.4 g/kg body weight every 2 weeks.
**ID:** EG001
**Other Num Affected:** 1
**Other Num at Risk:** 2
**Serious Number At Risk:** 2
**Title:** IGIV, 10% at 0.4 g/kg Body Weight
**Frequency Threshold:** 5
#### Other Events
**Term:** Infusion Site Pain
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA
**Term:** Tooth Infection
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA
**Term:** Blood Pressure Increased
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:** MedDRA
**Term:** Urticaria
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
**Source Vocabulary:** MedDRA
**Time Frame:** Throughout the study period (6 months)
## Results Section - Baseline Characteristics Module
### Denomination Counts
**Group ID:** BG000
**Value:** 2
**Group ID:** BG001
**Value:** 2
**Group ID:** BG002
**Value:** 4
**Units:** Participants
### Group
**ID:** BG000
**Title:** IGIV, 10% at 0.2 g/kg Body Weight
**Description:** IGIV, 10% at 0.2 g/kg body weight every 2 weeks
### Group
**ID:** BG001
**Title:** IGIV, 10% at 0.4 g/kg Body Weight
**Description:** IGIV, 10% at 0.4 g/kg body weight every 2 weeks
### Group
**ID:** BG002
**Title:** Total
**Description:** Total of all reporting groups
### Measure
#### Measurement
**Group ID:** BG000
**Value:** 0
#### Measurement
**Group ID:** BG001
**Value:** 0
#### Measurement
**Group ID:** BG002
**Value:** 0
**Category Title:** <=18 years
#### Measurement
**Group ID:** BG000
**Value:** 0
#### Measurement
**Group ID:** BG001
**Value:** 0
#### Measurement
**Group ID:** BG002
**Value:** 0
**Category Title:** Between 18 and 65 years
#### Measurement
**Group ID:** BG000
**Value:** 2
#### Measurement
**Group ID:** BG001
**Value:** 2
#### Measurement
**Group ID:** BG002
**Value:** 4
**Category Title:** >=65 years
**Class Title:**
### Measure
#### Measurement
**Group ID:** BG000
**Value:** 1
#### Measurement
**Group ID:** BG001
**Value:** 1
#### Measurement
**Group ID:** BG002
**Value:** 2
**Category Title:** Female
#### Measurement
**Group ID:** BG000
**Value:** 1
#### Measurement
**Group ID:** BG001
**Value:** 1
#### Measurement
**Group ID:** BG002
**Value:** 2
**Category Title:** Male
**Class Title:**
**Denomination Units Selected:**
## Results Section - Baseline Characteristics Module
### Measure 1
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Age, Categorical
**Unit of Measure:** Participants
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
**Other Details:** Baxalta's agreements with PIs may vary per requirements of individual PI, but contain common elements. For this study, PIs are restricted from independently publishing results until the earlier of the primary multicenter publication or 12 months after study completion. Baxalta requires a review of results communications (eg, for confidential information) ≥30 days prior to submission or communication. Baxalta may request an additional delay of ≤60 days eg, for intellectual property protection.
**Restriction Type:** OTHER
**Restrictive Agreement:** True
### Limitations and Caveats
**Description:** This study was an extension of study 160701 and was stopped early due to lack of evidence of clinical benefit of IGIV treatment in Alzheimer's Disease patients in Baxalta study 160701. Summary tables available for safety data only.
### Point of Contact
**Email:** [email protected]
**Organization:** Shire
**Phone:** +1 866 842 5335
**Title:** Study Director
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
### Outcome Measure 6
### Outcome Measure 7
### Outcome Measure 8
### Outcome Measure 9
### Outcome Measure 10
### Outcome Measure 11
### Outcome Measure 12
### Outcome Measure 13
### Outcome Measure 14
### Outcome Measure 15
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 2
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 0
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 1
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 1
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 0
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 0
**Title:**
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 1
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 0
**Title:**
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 1
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 1
**Title:**
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 0
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 0
**Title:**
#### Outcome Measure 5
#### Outcome Measure 6
#### Outcome Measure 7
#### Outcome Measure 8
#### Outcome Measure 9
#### Outcome Measure 10
#### Outcome Measure 11
#### Outcome Measure 12
#### Outcome Measure 13
#### Outcome Measure 14
#### Outcome Measure 15
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** 6 months
**Title:** Number and Severity of Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
**Type:** PRIMARY
**Unit of Measure:** adverse events
##### Group
**Description:** IGIV, 10% at 0.2 g/kg body weight every 2 weeks
**ID:** OG000
**Title:** IGIV, 10% at 0.2 g/kg Body Weight
##### Group
**Description:** IGIV, 10% at 0.4 g/kg body weight every 2 weeks
**ID:** OG001
**Title:** IGIV, 10% at 0.4 g/kg Body Weight
#### Outcome Measure 2
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** 6 months
**Title:** Number of Infusions Temporally Associated With Adverse Events (AEs) and Serious Adverse Events (SAEs)
**Type:** PRIMARY
**Type Units Analyzed:** Infusions
**Unit of Measure:** infusions
##### Group
**Description:** IGIV, 10% at 0.2 g/kg body weight every 2 weeks
**ID:** OG000
**Title:** IGIV, 10% at 0.2 g/kg Body Weight
##### Group
**Description:** IGIV, 10% at 0.4 g/kg body weight every 2 weeks
**ID:** OG001
**Title:** IGIV, 10% at 0.4 g/kg Body Weight
#### Outcome Measure 3
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** 6 months
**Title:** Number of Infusions Causally Associated With Adverse Events (AEs) and Serious Adverse Events (SAEs)
**Type:** PRIMARY
**Type Units Analyzed:** Infusions
**Unit of Measure:** infusions
##### Group
**Description:** IGIV, 10% at 0.2 g/kg body weight every 2 weeks
**ID:** OG000
**Title:** IGIV, 10% at 0.2 g/kg Body Weight
##### Group
**Description:** IGIV, 10% at 0.4 g/kg body weight every 2 weeks
**ID:** OG001
**Title:** IGIV, 10% at 0.4 g/kg Body Weight
#### Outcome Measure 4
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** 6 months
**Title:** Number of Infusions Discontinued, Slowed or Interrupted Due to an Adverse Event (AE) or Serious Adverse Event (SAE)
**Type:** PRIMARY
**Type Units Analyzed:** Infusions
**Unit of Measure:** infusions
##### Group
**Description:** IGIV, 10% at 0.2 g/kg body weight every 2 weeks
**ID:** OG000
**Title:** IGIV, 10% at 0.2 g/kg Body Weight
##### Group
**Description:** IGIV, 10% at 0.4 g/kg body weight every 2 weeks
**ID:** OG001
**Title:** IGIV, 10% at 0.4 g/kg Body Weight
#### Outcome Measure 5
**Description:** The ADAS-Cog is a validated psychometric instrument that evaluates memory (word recall, word recognition), attention, reasoning (following commands), language (naming, comprehension), orientation, ideational praxis (placing letter in envelope) and constructional praxis (copying geometric designs). This test was administered by experienced raters certified by Alzheimer's Disease Cooperative Study (ADCS) at the site. Scores on the ADAS-Cog range from 0-70 with higher scores indicating greater impairment.
**Population Description:** This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality.
**Reporting Status:** POSTED
**Time Frame:** 6 months
**Title:** Total Score of the Cognitive Subscale of the Alzheimer's Disease Assessment Scale (ADAS-Cog)
**Type:** SECONDARY
##### Group
**Description:** IGIV, 10% at 0.2 g/kg body weight every 2 weeks
**ID:** OG000
**Title:** IGIV, 10% at 0.2 g/kg Body Weight
##### Group
**Description:** IGIV, 10% at 0.4 g/kg body weight every 2 weeks
**ID:** OG001
**Title:** IGIV, 10% at 0.4 g/kg Body Weight
#### Outcome Measure 6
**Description:** The SIB is a 40-item psychometric assessment that is composed of simple one-step commands combined with gestures. The scoring range is from 0 to 100 with a lower score indicating greater cognitive impairment.
**Population Description:** This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality.
**Reporting Status:** POSTED
**Time Frame:** 6 months
**Title:** Total Score of the Cognitive Subscale of the Severe Impairment Battery (SIB)
**Type:** SECONDARY
##### Group
**Description:** IGIV, 10% at 0.2 g/kg body weight every 2 weeks
**ID:** OG000
**Title:** IGIV, 10% at 0.2 g/kg Body Weight
##### Group
**Description:** IGIV, 10% at 0.4 g/kg body weight every 2 weeks
**ID:** OG001
**Title:** IGIV, 10% at 0.4 g/kg Body Weight
#### Outcome Measure 7
**Description:** The ADCS-ADL scale is a validated tool to assess instrumental and basic activities of daily living based on a 23 item structured interview of the caregiver or qualified study partner. Scores on the ADCS-ADL range from 0-78 with lower scores indicating greater impairment; hence decreases from baseline reflect potential functional deterioration.
**Population Description:** This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality.
**Reporting Status:** POSTED
**Time Frame:** 6 months
**Title:** Alzheimer's Disease Cooperative Study (ADCS) - Activities of Daily Living (ADL) Inventory (ADCS-ADL/ ADCS-ADL-severe)
**Type:** SECONDARY
##### Group
**Description:** IGIV, 10% at 0.2 g/kg body weight every 2 weeks
**ID:** OG000
**Title:** IGIV, 10% at 0.2 g/kg Body Weight
##### Group
**Description:** IGIV, 10% at 0.4 g/kg body weight every 2 weeks
**ID:** OG001
**Title:** IGIV, 10% at 0.4 g/kg Body Weight
#### Outcome Measure 8
**Description:** The MMSE is a test for cognitive dysfunction. The test provides a 30-point composite rating for spatial and temporal orientation, verbal recall, simple attention, working memory, naming, repetition, comprehension, writing and constructional abilities. The total score can range from 0 to 30 with a higher score indicating better function.
**Population Description:** This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality.
**Reporting Status:** POSTED
**Time Frame:** 6 months
**Title:** Mini Mental State Examination (MMSE)
**Type:** SECONDARY
##### Group
**Description:** IGIV, 10% at 0.2 g/kg body weight every 2 weeks
**ID:** OG000
**Title:** IGIV, 10% at 0.2 g/kg Body Weight
##### Group
**Description:** IGIV, 10% at 0.4 g/kg body weight every 2 weeks
**ID:** OG001
**Title:** IGIV, 10% at 0.4 g/kg Body Weight
#### Outcome Measure 9
**Description:** The NPI is a validated instrument used to assess behavioral psychopathology in Alzheimer's Disease; it evaluates the frequency and severity of 12 neuropsychiatric features including delusions, hallucinations, dysphoria, anxiety, agitation/aggression, euphoria, disinhibition, irritability/lability, apathy, aberrant motor activity, sleep and night-time behavior change, and appetite and eating change. The NPI total score ranged 0-144, with higher scores indicating greater impairment.
**Population Description:** This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality.
**Reporting Status:** POSTED
**Time Frame:** 6 months
**Title:** Neuropsychiatric Inventory (NPI) Score
**Type:** SECONDARY
##### Group
**Description:** IGIV, 10% at 0.2 g/kg body weight every 2 weeks
**ID:** OG000
**Title:** IGIV, 10% at 0.2 g/kg Body Weight
##### Group
**Description:** IGIV, 10% at 0.4 g/kg body weight every 2 weeks
**ID:** OG001
**Title:** IGIV, 10% at 0.4 g/kg Body Weight
#### Outcome Measure 10
**Description:** The QOL-AD is a validated, 13-item instrument developed specifically for individuals with dementia. The assessment rates the participant's quality of life for physical, emotional, interpersonal, and environmental domains. The QOL-AD total score ranged 13-52. Lower scores on the QOL-AD are associated with a lower quality of life.
**Population Description:** This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality.
**Reporting Status:** POSTED
**Time Frame:** 6 months
**Title:** Logsdon Quality of Life in Alzheimer's Disease (QOL-AD)
**Type:** SECONDARY
##### Group
**Description:** IGIV, 10% at 0.2 g/kg body weight every 2 weeks
**ID:** OG000
**Title:** IGIV, 10% at 0.2 g/kg Body Weight
##### Group
**Description:** IGIV, 10% at 0.4 g/kg body weight every 2 weeks
**ID:** OG001
**Title:** IGIV, 10% at 0.4 g/kg Body Weight
#### Outcome Measure 11
**Description:** EQ-5D is a participant answered questionnaire scoring 5 dimensions - mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ-5D total score ranges from 0 (worst health state) to 1 (perfect health state) and 1 reflects the best outcome. The EQ-5D also includes a standard vertical 20 cm visual analogue scale (VAS) ranging from best imaginable health state \[100\] to worst imaginable health state \[0\]. Caregivers are asked to describe how they believe a participant would rate his/her health state that day.
**Population Description:** This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality.
**Reporting Status:** POSTED
**Time Frame:** 6 months
**Title:** EQ-5D Questionnaire (Proxy Version)
**Type:** SECONDARY
##### Group
**Description:** IGIV, 10% at 0.2 g/kg body weight every 2 weeks
**ID:** OG000
**Title:** IGIV, 10% at 0.2 g/kg Body Weight
##### Group
**Description:** IGIV, 10% at 0.4 g/kg body weight every 2 weeks
**ID:** OG001
**Title:** IGIV, 10% at 0.4 g/kg Body Weight
#### Outcome Measure 12
**Description:** The HRUQ determines if there is a difference in healthcare utilization and health-related expenditures, most notably nursing home (ie, skilled nursing facility) admissions, when subjects are treated with study product. This assessment is performed with the primary caregiver. This assessment is descriptive and does not contain specific scores.
**Population Description:** This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality.
**Reporting Status:** POSTED
**Time Frame:** 6 months
**Title:** Healthcare Resource Utilization Questionnaire (HRUQ)
**Type:** SECONDARY
##### Group
**Description:** IGIV, 10% at 0.2 g/kg body weight every 2 weeks
**ID:** OG000
**Title:** IGIV, 10% at 0.2 g/kg Body Weight
##### Group
**Description:** IGIV, 10% at 0.4 g/kg body weight every 2 weeks
**ID:** OG001
**Title:** IGIV, 10% at 0.4 g/kg Body Weight
#### Outcome Measure 13
**Description:** The Caregiver burden questionnaires is a self-administered questionnaire that has been developed to measure the emotional, physical, and social impact of caregiving on Alzheimer's Disease caregivers. A Total score is calculated from this measure by summing the responses across the items. The Total score may range from 9-45, with higher scores indicating greater burden.
**Population Description:** This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality.
**Reporting Status:** POSTED
**Time Frame:** 6 months
**Title:** Caregiver Burden Questionnaire
**Type:** SECONDARY
##### Group
**Description:** IGIV, 10% at 0.2 g/kg body weight every 2 weeks
**ID:** OG000
**Title:** IGIV, 10% at 0.2 g/kg Body Weight
##### Group
**Description:** IGIV, 10% at 0.4 g/kg body weight every 2 weeks
**ID:** OG001
**Title:** IGIV, 10% at 0.4 g/kg Body Weight
#### Outcome Measure 14
**Description:** Time to skilled nursing facility placement is defined as permanent admission to a skilled nursing facility. Time will be defined as the number of months between enrollment into this clinical study and placement in a skilled nursing facility placement.
**Population Description:** This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality.
**Reporting Status:** POSTED
**Time Frame:** 6 months
**Title:** Time to Skilled Nursing Facility Placement
**Type:** SECONDARY
##### Group
**Description:** IGIV, 10% at 0.2 g/kg body weight every 2 weeks
**ID:** OG000
**Title:** IGIV, 10% at 0.2 g/kg Body Weight
##### Group
**Description:** IGIV, 10% at 0.4 g/kg body weight every 2 weeks
**ID:** OG001
**Title:** IGIV, 10% at 0.4 g/kg Body Weight
#### Outcome Measure 15
**Description:** Volumetric MRI measurements were obtained to assess rate of whole brain atrophy and ventricular enlargement. Additional volumetric measurements may be analyzed when specific hypotheses and methods are defined. Additional volumetric MRI analysis may include (but may not be limited to) one or more of the following: rate of hippocampal atrophy, entorhinal cortical thickness, and/or regional cortical thinning.
**Population Description:** This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality.
**Reporting Status:** POSTED
**Time Frame:** 6 months
**Title:** Volumetric MRI
**Type:** SECONDARY
##### Group
**Description:** IGIV, 10% at 0.2 g/kg body weight every 2 weeks
**ID:** OG000
**Title:** IGIV, 10% at 0.2 g/kg Body Weight
##### Group
**Description:** IGIV, 10% at 0.4 g/kg body weight every 2 weeks
**ID:** OG001
**Title:** IGIV, 10% at 0.4 g/kg Body Weight
### Participant Flow Module
#### Group
**Description:** IGIV, 10% at 0.2 g/kg body weight every 2 weeks
**ID:** FG000
**Title:** IGIV, 10% at 0.2 g/kg Body Weight
#### Group
**Description:** IGIV, 10% at 0.4 g/kg body weight every 2 weeks
**ID:** FG001
**Title:** IGIV, 10% at 0.4 g/kg Body Weight
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Termination of Study by Sponsor
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
###### Reason
**Group ID:** FG001
**Number of Subjects:** 2
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 2
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 2
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 2
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 2
**Pre-Assignment Details:** Six participants were enrolled (i.e. signed informed consent form), of which 2 failed screening and 4 were treated with study product.
**Recruitment Details:** Enrollment was conducted at one clinical site in the US.
**Has Results:** True |
## Protocol Section
### Identification Module
**NCT ID:** NCT02549079
**Brief Title:** Soluble Factors in the Serum of Severely Burned Patients
**Official Title:** Soluble Factors in the Serum of Severely Burned Patients
#### Organization Study ID Info
**ID:** EK104/08
#### Organization
**Class:** OTHER
**Full Name:** RWTH Aachen University
### Status Module
#### Completion Date
**Date:** 2008-12
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2015-09-15
**Type:** ESTIMATED
**Last Update Submit Date:** 2015-09-14
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2008-12
**Type:** ACTUAL
#### Start Date
**Date:** 2004-01
**Status Verified Date:** 2015-09
#### Study First Post Date
**Date:** 2015-09-14
**Type:** ESTIMATED
**Study First Submit Date:** 2015-09-11
**Study First Submit QC Date:** 2015-09-11
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** RWTH Aachen University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The present study investigates the levels of certain soluble factors in the blood of patients with severe burn injury. Serum levels of different soluble factors will be correlated with the clinical outcome, presence of sepsis, the area of burn, and other clinical parameters in order to make a statement regarding their use as biomarkers in the prediction and monitoring of burn patients.
**Detailed Description:** Burn patients still represent a critical patient collective with a high mortality rate although treatment technologies have improved over the years. One problem healthcare professionals face is the fact that reliable biomarker which predict the clinical outcome, the onset of sepsis, and monitor the severity of disease in burn patients are still missing. These biomarkers would allow an early adoption of treatment modalities to improve the outcome and prevent life-threatening complications.
Blood samples from severely burned patients will be collected over a period of five days and different cytokines (for example the macrophage migration inhibitory factor protein family) will be measured in the serum. Clinical data of the patients (sepsis, total body surface area of burns, abbreviated burn severity index, sepsis-related organ failure assessment, etc.) will be documented and correlated to the levels of soluble factors.
### Conditions Module
**Conditions:**
- Burn Patients
### Design Module
#### Bio Spec
**Description:** blood samples
**Retention:** SAMPLES_WITH_DNA
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 23
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
### Interventions
#### Intervention 1
**Description:** Blood will be taken from all patients meeting the inclusion criteria.
**Name:** Blood sample
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Patients will be monitored over five days and death (with underlying condition, time) will be determined and documented by medical doctors.
**Measure:** Survival of a total of 23 burn patients during their treatment in the ICU
**Time Frame:** five days
#### Secondary Outcomes
**Description:** Onset of systemic inflammatory response syndrome, sepsis, septic shock will be monitored by medical doctors by standardized assessment of clinical parameters according to the consensus of the American College of Chest Physicians (ACCP) and the Society of Critical Care Medicine (SCCM) (released in Critical Care Med, 20(6):864-74, 1992, Pubmed ID: 1597042)
**Measure:** Onset of sepsis of a total of 23 burn patients during their treatment in the ICU
**Time Frame:** five days
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* 18 years of age
* minimum of 10% total body surface area burn
* needing ICU treatment
Exclusion Criteria:
* younger than 18 years of age
* immunosuppression (e.g. HIV)
* undergone surgery 2 weeks prior to burn injury
* malignancies
* severe diseases (myocardial infarction, lung embolism)
* declining to participate in the study
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Patients with burn injuries treated in the burn intensive care unit
### Contacts Locations Module
#### Overall Officials
**Official 1:**
**Affiliation:** RWTH Aachen University
**Name:** Norbert Pallua, M.D., Ph.D.
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M5326
- Name: Burns
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT04185779
**Brief Title:** COLO-COHORT (Colorectal Cancer Cohort) Study
**Official Title:** COLO-COHORT (Colorectal Cancer Cohort) Study
#### Organization Study ID Info
**ID:** 1
#### Organization
**Class:** OTHER
**Full Name:** South Tyneside and Sunderland NHS Foundation Trust
### Status Module
#### Completion Date
**Date:** 2026-08-15
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2020-10-22
**Type:** ACTUAL
**Last Update Submit Date:** 2020-10-19
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-08-15
**Type:** ESTIMATED
#### Start Date
**Date:** 2019-12-13
**Type:** ACTUAL
**Status Verified Date:** 2020-06
#### Study First Post Date
**Date:** 2019-12-04
**Type:** ACTUAL
**Study First Submit Date:** 2019-05-29
**Study First Submit QC Date:** 2019-12-02
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Newcastle University
#### Lead Sponsor
**Class:** OTHER
**Name:** South Tyneside and Sunderland NHS Foundation Trust
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This is a cross-sectional study aimed at identifying factors which best predicts patients at high risk of colorectal cancer or colorectal adenomas and to develop a risk prediction model.
**Detailed Description:** Bowel cancer is the second commonest cause of cancer death in the UK with 16000 people dying per year. Although the NHS Bowel Cancer Screening Programme (BCSP) detects cancers at an earlier stage only 10% of all cancers are detected through screening.
Currently, the only criteria for screening is age and no account is taken of other known risk factors such as smoking, alcohol, family history or obesity. Stool FIT (a new stool test which detects blood that can't be seen with the naked eye) will be introduced into the English BCSP, but there is poor evidence for its use in patients presenting with symptoms. There is also emerging data that there may be differences in the gut bacteria of people with and without cancer or pre cancerous bowel polyps (adenomas).
This will be a national multi-centre study over 5-years. 10000 Patients undergoing colonoscopy as part of BCSP or due to symptoms will be recruited. Patients will be asked to fill in a health questionnaire, have their height, weight, waist circumference measured. Patients will also receive blood tests, stool tests or saliva tests depending on the indication for their colonoscopy. The results of the colonoscopy and any samples taken will be collated. Patients will receive a patient experience questionnaire or food frequency questionnaire. A further 10,000 patients from the North of England will be consented to be contacted for future studies with some of the information above collected.
The aim of this study is to develop a risk prediction model to help determine which patients are at highest risk of having adenomas or bowel cancer. The investigators will also explore the significance of the gut bacteria composition in patients with adenomas or cancer to help inform this risk model. Additionally the investigators will develop a large platform of patients who consent to be contacted for future research.
### Conditions Module
**Conditions:**
- Colorectal Cancer
- Colorectal Adenoma
- Colorectal Neoplasm
- Predictive Cancer Model
- Model
### Design Module
#### Bio Spec
**Description:** DNA extraction from blood, saliva and stool
**Retention:** SAMPLES_WITH_DNA
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** CROSS_SECTIONAL
#### Enrollment Info
**Count:** 15000
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** This group will comprise of 10,000 patients who have been referred for a colonoscopy. We will be collecting information on their past medical history, smoking history, alcohol history, medication history and family history in addition to their colonoscopy findings. In 6000 of these patients, they will have blood tests, Faecal Immunochemical Test (FIT) level, blood or saliva for DNA extraction and stool microbiome taken. In 4000 of these patients, we will record recent blood tests of interest and they will have no new samples taken. All 10000 patients will also either complete a food frequency questionnaire or endoscopy patient experience questionnaire.
**Intervention Names:**
- Diagnostic Test: Colonoscopy
**Label:** Group A (Cross-sectional arm)
#### Arm Group 2
**Description:** This will be 10,000 patients who will consent for future contact for future research studies.
**Intervention Names:**
- Diagnostic Test: Colonoscopy
**Label:** COLO-SPEED (Group B, consent for contact arm)
### Interventions
#### Intervention 1
**Arm Group Labels:**
- COLO-SPEED (Group B, consent for contact arm)
- Group A (Cross-sectional arm)
**Description:** Diagnostic colonoscopy
**Name:** Colonoscopy
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** Incidence of colorectal neoplasia (colorectal cancer and advanced adenomas)
**Measure:** Occurrence of colorectal neoplasia
**Time Frame:** 5 years
#### Secondary Outcomes
**Description:** Assessing trends in variation of stool microbiome in patients with normal colon, adenomas, bowel cancer)
**Measure:** Stool microbiome pattern
**Time Frame:** 5 years
**Description:** A registry of patients who consent to be contacted in the future for future research studies
**Measure:** Number of participants who consent for future contact
**Time Frame:** 5 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
Group A
* Aged ≥30 years\* and able to give informed consent
* Patients attending colonoscopy
* Through Bowel Cancer Screening Programme (FIT positive, Bowelscope conversion, surveillance)
* Through standard NHS care (most commonly due to iron deficiency anaemia, altered bowel habit, weight loss, rectal bleeding, planned polypectomy\*\*, those referred on basis of family history, abnormal cross-sectional imaging, polyp surveillance or post CRC surveillance)
* The age of 30 was chosen to ensure that this is a population likely to be enriched for colorectal neoplasia with neoplasia below this age uncommon \*\*In those attending for planned polypectomy, the results from the initial colonoscopy and the endoscopy where the polypectomy is undertaken will be summated for purposes of calculating the neoplasia profile
(COLO-SPEED) Group B
* Any patient attending for colonoscopy and able to give informed consent
* ≥ 18 years old
* Patient from the North of England
Exclusion Criteria:
Group A
* Unable to give informed consent
* Known polyposis syndrome
* Previous total colectomy
* Known colonic stricture which would limit complete colonoscopy
* Attending for planned therapeutic procedure other than polypectomy, such as insertion of colonic stent
* Attending for assessment of known inflammatory bowel disease (IBD) activity or for IBD surveillance
* Patients currently recruited into an interventional CTIMP for CRC prevention\*
COLO-SPEED (Group B) \*\*
* Unable to give informed consent
* Not in a centre supported by COLO-SPEED infrastructure (North of England)
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Patients who have been referred for a colonoscopy (minimum age limits as above in inclusion criteria) either through the bowel cancer screening programme, as part of a surveillance programme or due to symptoms
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Sara Koo
**Phone:** 0191 404 1000
**Role:** CONTACT
**Contact 2:**
**Name:** Amy Burns
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** South Shields
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Colin Rees
- **Role:** CONTACT
**Country:** United Kingdom
**Facility:** South Tyneside and Sunderland NHS Foundation Trust
**State:** Tyne And Wear
**Status:** RECRUITING
**Zip:** NE34 0PL
**Location 2:**
**City:** Kettering
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Ajay Verma
- **Role:** CONTACT
**Country:** United Kingdom
**Facility:** Kettering General Hospitals NHS Foundation Trust
**Status:** NOT_YET_RECRUITING
**Zip:** NN16 8UZ
**Location 3:**
**City:** Stockton-on-Tees
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Roisin Bevan
- **Role:** CONTACT
**Country:** United Kingdom
**Facility:** North Tees and Hartlepool NHS Foundation Trust
**Status:** RECRUITING
**Zip:** TS19 8PE
#### Overall Officials
**Official 1:**
**Affiliation:** Newcastle University
**Name:** Colin Rees
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007414
- Term: Intestinal Neoplasms
- ID: D000005770
- Term: Gastrointestinal Neoplasms
- ID: D000004067
- Term: Digestive System Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000005767
- Term: Gastrointestinal Diseases
- ID: D000003108
- Term: Colonic Diseases
- ID: D000007410
- Term: Intestinal Diseases
- ID: D000012002
- Term: Rectal Diseases
- ID: D000009375
- Term: Neoplasms, Glandular and Epithelial
- ID: D000009370
- Term: Neoplasms by Histologic Type
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M17890
- Name: Colorectal Neoplasms
- Relevance: HIGH
- As Found: Colorectal Cancer
- ID: M3591
- Name: Adenoma
- Relevance: HIGH
- As Found: Adenoma
- ID: M10448
- Name: Intestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8886
- Name: Gastrointestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M7256
- Name: Digestive System Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6336
- Name: Colonic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10444
- Name: Intestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14844
- Name: Rectal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12320
- Name: Neoplasms, Glandular and Epithelial
- Relevance: LOW
- As Found: Unknown
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000015179
- Term: Colorectal Neoplasms
- ID: D000000236
- Term: Adenoma
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M3777
- Name: Ethanol
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06265779
**Acronym:** IOE+JLCJ-S
**Brief Title:** Transcranial Direct Current Stimulation Combined With Intermittent Oral to Esophageal Tube on Dysphagia
**Official Title:** Therapeutic Effect of Transcranial Direct Current Stimulation Combined With Intermittent Oral to Esophageal Feeding on Swallowing Disorders in Patients With Cerebral Infarction: Double Blind Randomized Controlled Study
#### Organization Study ID Info
**ID:** 2024-KY-0122
#### Organization
**Class:** OTHER
**Full Name:** People's Hospital of Zhengzhou University
### Status Module
#### Completion Date
**Date:** 2024-12-15
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-03-06
**Type:** ACTUAL
**Last Update Submit Date:** 2024-03-02
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-11-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-02-29
**Type:** ACTUAL
**Status Verified Date:** 2024-03
#### Study First Post Date
**Date:** 2024-02-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-01-22
**Study First Submit QC Date:** 2024-02-10
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Zeng Changhao
#### Responsible Party
**Investigator Affiliation:** People's Hospital of Zhengzhou University
**Investigator Full Name:** Zeng Changhao
**Investigator Title:** Research Director
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The study is a double-blind randomized controlled trial, lasting for 15 days for each participant. Patients with post-stroke dysphagia who receive treatment at the Rehabilitation Department are selected as the study subjects. The patients are randomly assigned to either the experimental group or the placebo group. All patients receive routine rehabilitation therapy and swallowing rehabilitation training, along with enteral nutrition support using Intermittent Oro-esophageal Tube. In addition to these interventions, patients in the experimental group receive transcranial direct current stimulation, while the instruments used for patients in the placebo group only illuminate an indicator light without any actual effect.
**Detailed Description:** Transcranial direct current stimulation is currently very popular. The study is a double-blind randomized controlled trial, lasting for 15 days for each participant. Patients with post-stroke dysphagia who receive treatment at the Rehabilitation Department are selected as the study subjects. The patients are randomly assigned to either the experimental group or the placebo group. All patients receive routine rehabilitation therapy and swallowing rehabilitation training, along with enteral nutrition support using Intermittent Oro-esophageal Tube. In addition to these interventions, patients in the experimental group receive transcranial direct current stimulation, while the instruments used for patients in the placebo group only illuminate an indicator light without any actual effect.
### Conditions Module
**Conditions:**
- Cerebral Infarction
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** QUADRUPLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 84
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The patients are randomly assigned to either the experimental group or the placebo group. All patients receive routine rehabilitation therapy and swallowing rehabilitation training, along with enteral nutrition support using Intermittent Oro-esophageal Tube. In addition to these interventions, patients in the experimental group receive transcranial direct current stimulation, while the instruments used for patients in the placebo group only illuminate an indicator light without any actual effect.
**Intervention Names:**
- Behavioral: Comprehensive rehabilitation therapy
- Device: Intermittent Oro-esophageal Tube Feeding
- Device: Transcranial direct current stimulation
**Label:** The experimental group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The patients are randomly assigned to either the experimental group or the placebo group. All patients receive routine rehabilitation therapy and swallowing rehabilitation training, along with enteral nutrition support using Intermittent Oro-esophageal Tube. In addition to these interventions, patients in the experimental group receive transcranial direct current stimulation, while the instruments used for patients in the placebo group only illuminate an indicator light without any actual effect.
**Intervention Names:**
- Behavioral: Comprehensive rehabilitation therapy
- Device: Intermittent Oro-esophageal Tube Feeding
**Label:** The placebo group
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- The experimental group
- The placebo group
**Description:** Including： Basic treatment, including corresponding control of risk factors and education on healthy lifestyles.
Swallowing training, including lemon ice stimulation, mendelson maneuver, empty swallowing training, and pronunciation training.
Pulmonary function training, including standing training, cough training, and diaphragm muscle training.
**Name:** Comprehensive rehabilitation therapy
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- The experimental group
- The placebo group
**Description:** All patients are given enteral nutritional support with Intermittent Oro-esophageal Tube according to the following procedure: Before each feeding, inside and outside of the tube was cleaned with water. During feeding, the patient should maintain a semi-reclining or sitting position with mouth opened, and the tube was inserted slowly and smoothly into the upper part of the esophagus by medical staffs while the appropriate depth of intubation was checked with the calibration markings on the tube wall. The distance from the incisors to the head part of the tube should be between 22-25 cm. However, the specific depth should be evaluated based on patients' feedback and adjusted accordingly. After insertion, the tail part of the tube should be put into a container full of water and the absence of continuous bubbles indicated a successful intubation. Then, the feeding was to be conducted three times per day with 50 ml per minute and 400-600ml for each feeding.
**Name:** Intermittent Oro-esophageal Tube Feeding
**Type:** DEVICE
#### Intervention 3
**Arm Group Labels:**
- The experimental group
**Description:** In this study, transcranial direct current stimulation is performed using a battery-powered constant current stimulator. This device delivers the current through two electrodes immersed in saline solution. Specifically, a 50mm\*50mm anodal electrode pad is placed at the center of the healthy side swallowing sensory-motor cortex of the patient. According to the positioning method of the international 10-20 electrode system, the swallowing sensory-motor cortex of the left brain is located at the midpoint between C3 and T3, while that of the right brain is located at the midpoint between C4 and T4. The cathode is placed on the opposite shoulder, using a current of 1mA, once a day, for 20 minutes each time, and 5 days a week. The instruments used for placebo patients will not have any actual effect.
**Name:** Transcranial direct current stimulation
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Penetration-Aspiration Scale is used to measure swallowing safety, which is also the primary outcome of this study. Before and after treatment, patients are required to undergo a swallow study to complete the assessment. This scale evaluates the patient's swallowing function level and aspiration risk by assessing leakage and aspiration during the patient's swallowing process. The results are divided into eight levels, with higher levels indicating poorer swallowing function and lower swallowing safety.
**Measure:** Penetration Aspiration Scale
**Time Frame:** day 1 and day 15
#### Secondary Outcomes
**Description:** During Dysphagia-Functional Oral Intake Scale assessment, evaluators engage in communication with the patient, conduct observations, and make records to assess the patient's oral intake ability. The Functional Oral Intake Scale assessment form includes seven levels of scoring, ranging from level 1 to level 7, indicating a progressive improvement in the patient's oral intake ability. In general, the result below level 6 indicates unsafe for oral intake while level 6 and above indicates that eating via mouth can be safely conducted.
**Measure:** Functional Oral Intake Scale
**Time Frame:** day 1 and day 15
**Description:** The Swallowing Quality of Life Questionnaire (SWAL-QOL) is used to evaluate the impact of swallowing function on patients' quality of life. The questionnaire consists of 44 questions related to swallowing function and quality of life. Each question is answered using a 5-point rating scale. In this study, the final score is converted into a percentage. The higher scores indicate the better quality of life.
**Measure:** Swallowing Quality of Life Questionnaire
**Time Frame:** day 1 and day 15
**Description:** To assess the patients' depression levels, a questionnaire is used. The questionnaire consists of 9 questions related to depressive symptoms, and each question is answered using a 4-point rating scale. The total score ranges from 0 to 27, with higher scores indicating a greater tendency towards depression.
**Measure:** Patient Health Questionnaire-9
**Time Frame:** day 1 and day 15
**Description:** Body weight measurement of the infants was conducted by the same nurse according to the relevant standards.
**Measure:** Body weight
**Time Frame:** day 1 and day 15
**Description:** The relevant indicators include total protein (TP, g/L) from the blood test within 24h after admission and the last day of treatment, generally, with empty-stomach infants and in the morning.
**Measure:** Nutritional status-total protein
**Time Frame:** day 1 and day 15
**Description:** The relevant indicators include albumin (ALB, g/L)from the blood test within 24h after admission and the last day of treatment, generally, with empty-stomach infants and in the morning
**Measure:** Nutritional status-albumin
**Time Frame:** day 1 and day 15
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Meet the diagnostic criteria for ischemic stroke confirmed by MRI or CT;
* Age \> 18 years;
* First-time stroke;
* Swallowing disorder confirmed by swallowing contrast study or flexible endoscopic evaluation of swallowing;
* Requires enteral nutrition support;
* Stable vital signs, no severe cognitive impairment or aphasia, able to cooperate with treatment;
* Transferred to the rehabilitation department within fifteen days of onset;
* Stable vital signs.
Exclusion Criteria:
* Presence of contraindications for invasive oral endoscopy;
* Concurrent presence of other neurodegenerative diseases that may cause swallowing disorders, such as neurodegenerative diseases;
* Concurrent presence of other neurological disorders;
* Tracheostomized patients;
* Concurrent liver, kidney failure, tumor, or hematological disorders;
* Pregnancy;
* Presence of contraindications for transcranial direct current stimulation, such as epilepsy, cerebral edema;
* Recent use of centrally acting drugs that interfere with the effects of transcranial direct current stimulation, such as carbamazepine, phenytoin, valproic acid, etc.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Zhefeng Wang, Master
**Phone:** 19501376864
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Weijia Zhao, Master
**Phone:** 17839973473
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Seoul
**Contacts:**
***Contact 1:***
- **Name:** Wei Liu, Master
- **Role:** CONTACT
**Country:** Korea, Republic of
**Facility:** Center Rehabilitation Hospital
**Status:** RECRUITING
#### Overall Officials
**Official 1:**
**Affiliation:** Site Coordinator of United Medical Group located in Miami
**Name:** Nieto Luis, Master
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007511
- Term: Ischemia
- ID: D000010335
- Term: Pathologic Processes
- ID: D000009336
- Term: Necrosis
- ID: D000020520
- Term: Brain Infarction
- ID: D000002545
- Term: Brain Ischemia
- ID: D000002561
- Term: Cerebrovascular Disorders
- ID: D000001927
- Term: Brain Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000020521
- Term: Stroke
- ID: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: BC09
- Name: Ear, Nose, and Throat Diseases
### Condition Browse Module - Browse Leaves
- ID: M5793
- Name: Cerebral Infarction
- Relevance: HIGH
- As Found: Cerebral Infarction
- ID: M10282
- Name: Infarction
- Relevance: HIGH
- As Found: Infarction
- ID: M6882
- Name: Deglutition Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M10543
- Name: Ischemia
- Relevance: LOW
- As Found: Unknown
- ID: M12284
- Name: Necrosis
- Relevance: LOW
- As Found: Unknown
- ID: M22305
- Name: Brain Infarction
- Relevance: LOW
- As Found: Unknown
- ID: M5794
- Name: Brain Ischemia
- Relevance: LOW
- As Found: Unknown
- ID: M5810
- Name: Cerebrovascular Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M5204
- Name: Brain Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M22306
- Name: Stroke
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000002544
- Term: Cerebral Infarction
- ID: D000007238
- Term: Infarction
### Intervention Browse Module - Browse Branches
- Abbrev: PhSol
- Name: Pharmaceutical Solutions
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: Ot
- Name: Other Dietary Supplements
### Intervention Browse Module - Browse Leaves
- ID: M21860
- Name: Pharmaceutical Solutions
- Relevance: LOW
- As Found: Unknown
- ID: M4854
- Name: Benzocaine
- Relevance: LOW
- As Found: Unknown
- ID: T433
- Name: Tannic Acid
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
#### Removed Countries
- Country: China
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT04487379
**Brief Title:** Ultrasound Crestal Bone Topography of Edentulous Ridges
**Official Title:** Evaluation of Crestal Bone Topography of Edentulous Ridges: A Retrospective Study Comparing Ultrasonography to Cone-Beam Computed Tomography (CBCT)
#### Organization Study ID Info
**ID:** HUM00183733
#### Organization
**Class:** OTHER
**Full Name:** University of Michigan
### Status Module
#### Completion Date
**Date:** 2020-12-01
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-01-15
**Type:** ACTUAL
**Last Update Submit Date:** 2021-01-13
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2020-12-01
**Type:** ACTUAL
#### Start Date
**Date:** 2020-06-16
**Type:** ACTUAL
**Status Verified Date:** 2021-01
#### Study First Post Date
**Date:** 2020-07-27
**Type:** ACTUAL
**Study First Submit Date:** 2020-07-17
**Study First Submit QC Date:** 2020-07-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Michigan
#### Responsible Party
**Investigator Affiliation:** University of Michigan
**Investigator Full Name:** Hsun-Liang Chan
**Investigator Title:** Clinical Associate Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** A successful implant surgery primarily relies on a prudent evaluation of oral anatomy and meticulous treatment planning. Additionally, of paramount importance that dictates the types of procedures, material selection and ultimately success of implant surgery is the quality and quantity of the edentulous ridge. Ultrasound imaging (US), another cross-sectional imaging modality, has been extensively used in the medical diagnostics field. The ability of ultrasound to image soft tissue-bone interface makes it particularly promising for studying bone ridge width and crestal bone topography. Therefore, this retrospective human study aimed to compare bone width measurements between US and CBCT. This study also investigated the possible correlation between the crestal bone surface quality imaged by US and CBCT.
### Conditions Module
**Conditions:**
- Ultrasonography
### Design Module
#### Design Info
**Observational Model:** CASE_ONLY
**Time Perspective:** CROSS_SECTIONAL
#### Enrollment Info
**Count:** 28
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** This group had edentulous ridge planning to receive a dental implant and had ultrasound and cone-beam computed tomography images of the ridge.
**Label:** Group with edentulous ridge
### Outcomes Module
#### Primary Outcomes
**Description:** measure the edentulous ridge width at 1, 2 and 3 mm apical to the crest on ultrasound images
**Measure:** Accuracy of ultrasound for estimating ridge width
**Time Frame:** up to 3 months after image was taken
#### Secondary Outcomes
**Description:** Evaluate the crestal bone surface quality with ultrasound
**Measure:** Accuracy of ultrasound for assessing ridge surface quality
**Time Frame:** up to 3 months after image was taken
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patient records at the Graduate Periodontal Clinic
* With both US and CBCT scans taking within 3 months between each other from Jan 2016 to Mar 2020
* These images had to include at least one edentulous ridge at the anterior, premolar or molar site.
* Multiple sites in a given patient may be included.
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
**Study Population:** Records of patients who had at least 1 edentulous ridge with a plan for implant placement, had cone-beam computed tomography as standard procedure and ultrasound imaging for off-label use of evaluating the ridge were included.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Ann Arbor
**Country:** United States
**Facility:** University of Michigan School of Dentistry
**State:** Michigan
**Zip:** 48109
### IPD Sharing Statement Module
**Description:** Not plan to share IPD.
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009059
- Term: Mouth Diseases
- ID: D000009057
- Term: Stomatognathic Diseases
- ID: D000014076
- Term: Tooth Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC07
- Name: Mouth and Tooth Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M12026
- Name: Mouth, Edentulous
- Relevance: HIGH
- As Found: Edentulous
- ID: M12019
- Name: Mouth Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12017
- Name: Stomatognathic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M16831
- Name: Tooth Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000009066
- Term: Mouth, Edentulous
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06140979
**Brief Title:** Visual Focused Play Intervention for Children With ADHD
**Official Title:** Efficacy of Visual Focusing Game on Children With Attention Deficit Hyperactivity Disorder and Mechanisms of Functional Near-Infrared Spectroscopic Imaging
#### Organization Study ID Info
**ID:** KY20232300-F-1
#### Organization
**Class:** OTHER
**Full Name:** Xijing Hospital
### Status Module
#### Completion Date
**Date:** 2024-06-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-11-21
**Type:** ACTUAL
**Last Update Submit Date:** 2023-11-18
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-06-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-11-10
**Type:** ESTIMATED
**Status Verified Date:** 2023-11
#### Study First Post Date
**Date:** 2023-11-21
**Type:** ACTUAL
**Study First Submit Date:** 2023-11-12
**Study First Submit QC Date:** 2023-11-18
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Xijing Hospital
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** This is a single-center, randomized, double-blind, sham-controlled study that will recruit children with attention deficit hyperactivity disorder and randomly assign them to a test group and a control group. The patients in the test group will be given a visual focus game to play and the patients in the control group will be given an animated video of the game that had no therapeutic effect. Treatment will be required at least 5 times per week for 2 weeks, with each game or video session lasting 30 minutes. Clinical scales and functional near-infrared spectroscopic imaging will be performed before and at the end of the 2 weeks of treatment, respectively.
### Conditions Module
**Conditions:**
- Attention Deficit Hyperactivity Disorder
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** The patients in the test group will be given a visual focus game to play and the patients in the control group will be given an animated video of the game that had no therapeutic effect.
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 40
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The patients in the test group will be given a visual focus game to play, and the treatment will be required at least 5 times per week for 2 weeks, with each session lasting 30 minutes.
**Intervention Names:**
- Behavioral: Playing the game
**Label:** Test Group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The patients in the control group were given an animated video of the game that had no therapeutic effect, and the video will be required at least 5 times per week for 2 weeks, with each session lasting 30 minutes.
**Intervention Names:**
- Behavioral: Watching the gameplay video
**Label:** Control Group
**Type:** SHAM_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Test Group
**Description:** The intervention is based on a parkour game in which the player runs forward as a cartoon character, avoiding obstacles in front of him/her while collecting gold coins and various props. In this process, players need to stay focused and operate in time to avoid obstacles or collect rewards, and as time goes on, the difficulty of the game increases until eventually they cannot avoid obstacles. As time goes on, the difficulty of the game will increase until the end of the game when you can't avoid the obstacles.
**Name:** Playing the game
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- Control Group
**Description:** The intervention consists of a 30-minute non-therapeutic video of a parkour game, which is paused every 10 minutes and requires the patient to click "continue" until the end of the video. No other action is required.
**Name:** Watching the gameplay video
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** The Attention Deficit Hyperactivity Disorder Rating Scale is commonly used to determine whether children have symptoms of ADHD, how severe they are, and how impaired they are. As such, it is a combination of symptom and functional impairment ratings (e.g., unless it is at least moderately impaired to rate a 2 or 3 on a symptom). This is usually done by the clinician based on information provided by the parent/guardian or teacher.
**Measure:** Change in Attention Deficit Hyperactivity Disorder Rating Scale scores between baseline and post-treatment
**Time Frame:** Baseline and 2 weeks
#### Secondary Outcomes
**Description:** The Parent Symptom Questionnaire is a child behavior rating scale for parents developed by Conners that is easy to understand and takes parents only 5 to 10 minutes to complete. The scale is primarily used to assess attention deficit hyperactivity disorder in children and can reflect the effectiveness of treatment.
**Measure:** Change in the Parent Symptom Questionnaire scores between baseline and post-treatment
**Time Frame:** Baseline and 2 weeks
**Description:** Functional near-infrared spectroscopic imaging is a safe and fast screening method. It reflects brain activity by measuring blood oxygen levels in the cerebral cortex with promptness, accuracy, and short duration.
**Measure:** Changes in Functional Near-Infrared Spectral Imaging between Baseline and Post-Treatment
**Time Frame:** Baseline and 2 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Meeting the diagnostic criteria for ADHD in the U.S. Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5);
* Aged 6-14 years old;
* Right-handedness (habitual or good use of the right hand in daily life, work, study and labor activities);
* Voluntarily agree to sign an informed consent form;
Exclusion Criteria:
* Wechsler Intelligence Scale for Children (WISC) \<80 points;
* The cranial CT or MRI found that there are clear infarction foci, soft foci, occupations and other organic lesions;
* Suffering from serious physical diseases or other severe mental diseases, such as schizophrenia, bipolar disorder, etc;
* Inability to cooperate with fNIRS data collection
**Maximum Age:** 14 Years
**Minimum Age:** 6 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Min Cai
**Phone:** 86-15353508787
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** The First Affiliated Hospital of the Air Force Medical University
**Name:** Min Cai
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Anguera JA, Boccanfuso J, Rintoul JL, Al-Hashimi O, Faraji F, Janowich J, Kong E, Larraburo Y, Rolle C, Johnston E, Gazzaley A. Video game training enhances cognitive control in older adults. Nature. 2013 Sep 5;501(7465):97-101. doi: 10.1038/nature12486.
**PMID:** 24005416
**Citation:** Barkley RA. Attention-deficit/hyperactivity disorder, self-regulation, and time: toward a more comprehensive theory. J Dev Behav Pediatr. 1997 Aug;18(4):271-9.
**PMID:** 9276836
**Citation:** Pandian GSB, Jain A, Raza Q, Sahu KK. Digital health interventions (DHI) for the treatment of attention deficit hyperactivity disorder (ADHD) in children - a comparative review of literature among various treatment and DHI. Psychiatry Res. 2021 Mar;297:113742. doi: 10.1016/j.psychres.2021.113742. Epub 2021 Jan 19.
**PMID:** 33515870
**Citation:** Kollins SH, Childress A, Heusser AC, Lutz J. Effectiveness of a digital therapeutic as adjunct to treatment with medication in pediatric ADHD. NPJ Digit Med. 2021 Mar 26;4(1):58. doi: 10.1038/s41746-021-00429-0.
**PMID:** 33772095
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000019958
- Term: Attention Deficit and Disruptive Behavior Disorders
- ID: D000065886
- Term: Neurodevelopmental Disorders
- ID: D000001523
- Term: Mental Disorders
- ID: D000020820
- Term: Dyskinesias
- ID: D000009461
- Term: Neurologic Manifestations
- ID: D000009422
- Term: Nervous System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M4594
- Name: Attention Deficit Disorder with Hyperactivity
- Relevance: HIGH
- As Found: Attention Deficit Hyperactivity Disorder
- ID: M9999
- Name: Hyperkinesis
- Relevance: HIGH
- As Found: Hyperactivity
- ID: M21830
- Name: Attention Deficit and Disruptive Behavior Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M30644
- Name: Neurodevelopmental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M22574
- Name: Dyskinesias
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000006948
- Term: Hyperkinesis
- ID: D000001289
- Term: Attention Deficit Disorder with Hyperactivity
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT04411979
**Brief Title:** Effects of 12 Weeks Walking on Cognitive Function in Schizophrenia
**Official Title:** Cognitive Function and Energy Metabolites in Schizophrenia: the Effect of Wearable Device-assisted Walking
#### Organization Study ID Info
**ID:** MOST 107-2635-B-182A-002
#### Organization
**Class:** OTHER
**Full Name:** Chang Gung Memorial Hospital
#### Secondary ID Infos
**Domain:** Chang Gung Memorial Hospital
**ID:** 201702283A3C601
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2019-10-15
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2020-06-02
**Type:** ACTUAL
**Last Update Submit Date:** 2020-05-28
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2019-07-17
**Type:** ACTUAL
#### Start Date
**Date:** 2018-09-27
**Type:** ACTUAL
**Status Verified Date:** 2018-02
#### Study First Post Date
**Date:** 2020-06-02
**Type:** ACTUAL
**Study First Submit Date:** 2020-05-22
**Study First Submit QC Date:** 2020-05-28
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER_GOV
**Name:** Ministry of Science and Technology, Taiwan
#### Lead Sponsor
**Class:** OTHER
**Name:** Chang Gung Memorial Hospital
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This study is a 12-week randomized-controlled clinical trial. It will be planned to conduct in a total of 120 male and female subjects from the Department of Psychiatry at Kaohsiung Chang Gung Memorial Hospital. Eligible subjects will be psychiatric patients, aged between 20-65 years old, who have psychiatric diagnosis of schizophrenia and fulfill the inclusion and exclusion criteria. The intervention with aerobic walking programs will be initiated after randomization for patients who continue their usual treatment. Subjects will be enrolled for 12 weeks aerobic walking treatment and randomly assigned to (1) treatment-as-usual, (2) treatment-as-usual plus aerobic walking. We will measure the treatment response to clarify the effect of aerobic walking in patients with schizophrenia. This study is being performed to investigate the possibly beneficial effects of aerobic walking on cognitive function and energy metabolites in schizophrenia.
**Detailed Description:** This 12-week randomized-controlled clinical trial will be planned to conduct in a total of 120 male and female subjects from the Department of Psychiatry at Kaohsiung Chang Gung Memorial Hospital. Eligible subjects will be psychiatric patients, aged between 20-65 years old, who have psychiatric diagnosis of schizophrenia and fulfill the inclusion and exclusion criteria. The intervention with aerobic walking programs will be initiated after randomization for patients who continue their usual treatment. Subjects will be enrolled for 12 weeks aerobic walking treatment and randomly assigned to (1) treatment-as-usual, (2) treatment-as-usual plus aerobic walking. The wearable watch will be used during the participants join the walking programs. We will measure the treatment response to investigate the effect of aerobic walking in patients with schizophrenia. This study is being performed to investigate the possibly beneficial effects of aerobic walking on cognitive function in schizophrenia.
### Conditions Module
**Conditions:**
- Schizophrenia
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 85
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Label:** treatment-as-usual
**Type:** NO_INTERVENTION
#### Arm Group 2
**Intervention Names:**
- Other: treatment-as-usual plus aerobic walking
**Label:** treatment-as-usual plus aerobic walking
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- treatment-as-usual plus aerobic walking
**Description:** aerobic walking
**Name:** treatment-as-usual plus aerobic walking
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** cognitive function change assessed by Brief Assessment of Cognition in Schizophrenia
**Measure:** cognitive function change
**Time Frame:** week 12
**Description:** change assessment
**Measure:** treatment change assessed by serum levels of energy metabolites (e.g., β-hydroxybutyrate)
**Time Frame:** week 12
#### Secondary Outcomes
**Description:** minimum value 30, maximum value 210; higher scores mean a worse outcome
**Measure:** treatment change assessed by the Positive and Negative Syndrome Scale
**Time Frame:** week 12
**Description:** change assessment
**Measure:** treatment change assessed by peripheral blood metabolic profiles (e.g., plasma cholesterol level)
**Time Frame:** week 12
**Description:** change assessment
**Measure:** treatment change assessed by metabolic profiles (e.g., body weight in kilograms)
**Time Frame:** week 6, week 12
**Description:** change assessment
**Measure:** treatment change assessed by serum levels of inflammatory cytokines (e.g., IL-8)
**Time Frame:** week 12
**Description:** change assessment
**Measure:** treatment change assessed by 6-minute walk test
**Time Frame:** week 12
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. The patient has been diagnosed of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, fifth edition criteria (DSM-5) criteria
2. The patient has the ability to complete the written informed consent
Exclusion Criteria:
1. The patient has been diagnosed with organic mental disorders, intelligence disability, dementia, major depressive disorder, bipolar affective disorder, and alcohol or substance use disorder
2. The patient has major systemic physical diseases, including cardiovascular diseases, uncontrollable arrhythmia, renal diseases, liver diseases or thyroid diseases
3. The patient has certified as physical disability
4. The patient is pregnant or has genetic diseases or infectious conditions
**Maximum Age:** 65 Years
**Minimum Age:** 20 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Kaohsiung
**Country:** Taiwan
**Facility:** Department of Psychiatry, Kaohsiung Chang Gung Memorial Hospital
#### Overall Officials
**Official 1:**
**Affiliation:** Department of Psychiatry, Kaohsiung Chang Gung Memorial Hospital
**Name:** Yu-Chi Huang, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000019967
- Term: Schizophrenia Spectrum and Other Psychotic Disorders
- ID: D000001523
- Term: Mental Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M15376
- Name: Schizophrenia
- Relevance: HIGH
- As Found: Schizophrenia
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M21838
- Name: Schizophrenia Spectrum and Other Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000012559
- Term: Schizophrenia
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT05293379
**Acronym:** VACCIPREV
**Brief Title:** Prospective, Multicenter Study Assessing a Screening Campaign for Cardiovascular Diseases Risk Factors During SARS-CoV-2 Epidemic
**Official Title:** Prospective, Multicenter Study Assessing a Screening Campaign for Cardiovascular Diseases Risk Factors During SARS-CoV-2 Epidemic
#### Organization Study ID Info
**ID:** VACCIPREV
#### Organization
**Class:** OTHER
**Full Name:** Elsan
### Status Module
#### Completion Date
**Date:** 2022-07-01
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-12-07
**Type:** ACTUAL
**Last Update Submit Date:** 2022-12-05
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2021-09-01
**Type:** ACTUAL
#### Start Date
**Date:** 2021-07-01
**Type:** ACTUAL
**Status Verified Date:** 2022-12
#### Study First Post Date
**Date:** 2022-03-24
**Type:** ACTUAL
**Study First Submit Date:** 2022-03-11
**Study First Submit QC Date:** 2022-03-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Elsan
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The goal of this prospective study is to evaluate the impact of an innovative screening campagn (using the medical device "CONSULT STATION®" on french population healthcare . The main aims of this study are:
* To determine whether a screening campaign for cardiovascular disease risk factor has a greater impact on the population who is not monitored by a primary care physician
* To determine whether people who are not monitored by a primary care physician have greater cardiovascular risk
* To determine whether the screening campaign offered to the general population has strengthened the relationship between community medecine and healthcare circuit coordination
Data of patients from vaccination center who agreed to participate to the screening campaign by using the medical device "CONSULT STATION®" will be analyzed.
Patients will also be called at least 3 months after their visit in the vaccination center in order to assess the impact of the screening campaign on their medical monitoring
**Detailed Description:** Cardiovascular diseases and its complications are the leading cause of death in the world. In France, they are the second leading cause of death after cancer, with over 140,000 deaths each year.
The number of people with cardiovascular disease increases with the aging of the population, and strong social and territorial inequalities persist. Innovative cardiovascular risk factors screening campaign can have significant public interest, especially to raise awareness and diagnose a particular population which is not monitored by a physician on a regular basis.
The VACCIPREV project emerged during the Covid-19 pandemic. The founding idea was to use the time people spent in vaccination centers to raise awareness and to diagnose people, for some, never go to a health facility. Indeed, a portion of the population free of all medical conditions, of all ages, including young people without known comorbidities, then crossed the threshold of our institutions to get vaccinated.
VACCIPREV is part of a global territorial prevention will to propose to this population flow an innovative medical technology optimizing all stages of vaccination.
In association with a French company named "H4D", developing a connected teleconsultation booth (CONSULT STATION®), an independent health check was thus structured, in addition with two questionnaires given during the waiting phase before vaccination: one concerning tobacco dependance and the other assessing the sleep quality. This health check focuses on the early detection of cardiovascular risk factors. It is indeed a key issue for medical management and VACCIPREV allows to respond to this issue in an innovative and playful way.
The CONSULT STATION® (Class IIa medical device certified according to European Directive 93/42/EEC) offers 15-minutes assessment of blood pressure, heart rate, oxygen saturation, BMI, but also the performance of visual tests. Accompanied by a caregiver in the process, the person gets in real time these different medical constants and thanks to a simple and graduated evaluation scale, a review of his results and a recommendation to visit his doctor if necessary. In case of potentially pathological results, and with the person's consent, contact informations (telephone/email) were collected to remotely assess the impact of this screening campaign.
VACCIPREV programme included an idependant medical check-up with the connected booth H4D, questionnaires of tabacco dependance and assessment of sleep quality and a remote assessment of their impact on the medical management of people with pathological constants. A telephone interview was carried out after a period of at least 3 months following the passage in the cabin to complete the medical questionnaire in order to evaluate changes in patients medical management. This included assessing the impact of the approach.
It was an observational study on data from an historic and prospective cohorte, multicentered national and not randomized. The study period was between 1st july 2021 and 1st july 2022.
The main objective of the study was to determine whether the innovative screening campaign has impacted the health management of the population.
Secondary objectives were:
* To determine whether the screening campaign's impact was greater in the population who is not monitored by a primary care physician
* To determine whether people who are not monitored by a physician have greater cardiovascular risk
* To determine whether the screening campaign offered to the general population has strengthened the relationship between community medecine and healthcare circuit coordination The objectives will be analysed both for all centers but aslo for each center in order to highlight a possible regional differences in the medical management of the population. Evaluation criteria concerning the objectives covered by this protocol will be based on a description of the data collected from the telephone interview (consultation with a general physician, consultation with a specialist, statement from a primary care physician)
### Conditions Module
**Conditions:**
- Health Behavior
- Cardiovascular Diseases
- Cardiovascular Morbidity
**Keywords:**
- cardiovascular risk factors
- public health
- screening campaign
- cardiovascular disease
- prevention
- medical management
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 2400
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients from 3 vaccination centers who agreed to participate to the VACCIPREV program by using the teleconsultation booth and completing the questionnaires of tobacco dependance and assessment of sleep quality.
**Intervention Names:**
- Other: Connected teleconsultation booth
**Label:** Patients sensitized in the VACCIPREV program
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Patients sensitized in the VACCIPREV program
**Description:** 15-minutes assessment in a connected teleconsultation booth.
**Name:** Connected teleconsultation booth
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Number of patients with pathological vitals and have initiated a medical management by a primary care physician or a specialist and whose constants'pathological criteria is confirmed by a physician
**Measure:** Rate of patients with pathological constants and have initiated a medical management
**Time Frame:** An average of 3 months
#### Secondary Outcomes
**Description:** Number of patients without a primary care physician with pathological findings and have initiated medical management by a general physician or a specialist and whose constant's pathological criteria is confirmed by the physician
**Measure:** Impact of the screening campaign in the population without a primary care physician
**Time Frame:** An average of 3 months
**Description:** Comparison of cardiovascular disease risk factors in patients monitored by a primary care physician with patients who are not monitored by a primary care physician
**Measure:** Cardiovascular risk factors in the population without a primary care physician
**Time Frame:** An average of 3 months
**Description:** The reinforcement of patients' reffering to community medecine will be evaluated with NECTAR software (establishment of the connection with community medicine)
**Measure:** Impact of the VACCIPREV program in strengthening the relationship between the community medecine and the coordination of healthcare circuits.
**Time Frame:** An average of 3 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients informed of the study (information sheet given to patients) and who had not given their opposition to the collection of data for research purposes
* Woman or man aged 18 or over
* Patients registered with a social security scheme
Exclusion Criteria:
* Patients unable to understand the directives requested for the use of the cabin
* Patients under legal protection
* Patients who have expressed their opposition to the use of their data
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** The targeting of patients covered the period from July 2021 to September 2021 corresponding to the period where the booth were available in vaccination centers. Data's extraction will extend from July 2021 to July 2022 in order to have a follow-up of at least 3 months after the passage in the cabin and to observe the potential modifications or initiation of patient care management.
More than 6,000 people were sensitized within the framework of the VACCIPREV program, among them, about 2,400 patients have agreed to benefit from the independent assessment via the CONSULT STATION® within this same program in 3 months on the 3 sites. About 750 patients had a result with pathological constants and were invited to consult their attending physician.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Blendecques
**Country:** France
**Facility:** Clinique de Saint Omer
**Zip:** 62575
**Location 2:**
**City:** Saint Quentin
**Country:** France
**Facility:** Hôpital Privé Saint Claude
**Zip:** 02100
**Location 3:**
**City:** Valenciennes
**Country:** France
**Facility:** Clinique Vauban
**Zip:** 59300
**Location 4:**
**City:** Valenciennes
**Country:** France
**Facility:** Hôpital privé du Hainaut
**Zip:** 59300
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Meshes
- ID: D000002318
- Term: Cardiovascular Diseases
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT05529979
**Acronym:** SAFE
**Brief Title:** Epione® Post-Market Clinical Follow-up Study
**Official Title:** Post-Market Clinical Follow-Up Study of a Robotic Device for Image Guided Percutaneous Needle Placement in the Abdomen
#### Organization Study ID Info
**ID:** QS-NIS-G-H-2101
#### Organization
**Class:** INDUSTRY
**Full Name:** Quantum Surgical
### Status Module
#### Completion Date
**Date:** 2023-11
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-08-09
**Type:** ACTUAL
**Last Update Submit Date:** 2023-08-08
**Overall Status:** ACTIVE_NOT_RECRUITING
#### Primary Completion Date
**Date:** 2023-02-22
**Type:** ACTUAL
#### Start Date
**Date:** 2022-04-21
**Type:** ACTUAL
**Status Verified Date:** 2023-08
#### Study First Post Date
**Date:** 2022-09-07
**Type:** ACTUAL
**Study First Submit Date:** 2022-06-07
**Study First Submit QC Date:** 2022-09-06
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Quantum Surgical
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** True
**Is FDA Regulated Drug:** False
**Is US Export:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Post-Market Clinical Follow-up study in order to consolidate performance and safety data of the EPIONE® device when used for percutaneous procedures in the abdomen
**Detailed Description:** The objective of this PMCF study is to compile data on the routine use of the EPIONE® device in subjects undergoing CT-guided percutaneous procedures in the abdomen.
The objectives are:
1. to evaluate the technical success of the device
2. to evaluate performance parameters (accuracy measures, adjustements, post-intervention ablation success, local tumor recurrence, operator satisfaction) and the safety of the device
55 patients are planned in this post-market study.
### Conditions Module
**Conditions:**
- Cancer Abdomen
**Keywords:**
- Percutaneous
- CT-guided
- Ablation
- Biopsy
- Abscess Drainage
- Fiducial Placement
- Abdomen
- Liver
- Kidney
- Robotics
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 55
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients treated by percutaneous CT-guided procedures in the abdomen with the EPIONE® device
**Intervention Names:**
- Device: EPIONE® CT-Guided Percutaneous procedures
**Label:** Intervention with the EPIONE® device
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Intervention with the EPIONE® device
**Description:** The EPIONE device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one or more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutaneous procedures.
**Name:** EPIONE® CT-Guided Percutaneous procedures
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Number of targets reached ; the target is considered to have been reached when the needle is positioned accurately enough to allow the planned procedure to be performed.
**Measure:** Technical Success
**Time Frame:** through study completion up to 36 months
#### Secondary Outcomes
**Description:** accuracy of the needle placement: deviation between the planned and actual needle position once inserted
**Measure:** Needle placement accuracy
**Time Frame:** through study completion up to 36 months
**Description:** Detail of the number/nature of adjustments performed after the initial insertion of the needle
**Measure:** Number and nature of needle adjustments to reach the target
**Time Frame:** through study completion up to 36 months
**Description:** Minimal Ablation Margin(s) measure(s) if applicable (mm)
**Measure:** Post-intervention ablation success
**Time Frame:** through study completion up to 36 months
**Description:** Evaluation of the local tumor progression following the ablation (if applicable)
**Measure:** Local tumor recurrence
**Time Frame:** through study completion up to 36 months
**Description:** 5-point Likert scale: very Dissatisfied/dissatisfied/neutral/satisfied/highly satisfied
**Measure:** Operator satisfaction
**Time Frame:** through study completion up to 36 months
**Description:** Safety of the device
**Measure:** Adverse Events related to device or procedure
**Time Frame:** through study completion up to 36 months
**Description:** Evaluation of the device dysfunction
**Measure:** Device dysfunction
**Time Frame:** through study completion up to 36 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patient \>18 years old,
* Patient for whom a CT-guided procedure in abdomen has been prescribed and agreed by a multidisciplinary team of radiologists, surgeons and clinicians,
* Patient with a confirmed non-opposition.
Exclusion Criteria:
* Patient unable to undergo general anesthesia,
* Pregnant or breast-feeding females
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Patients treated/operated in routine practice, in accordance with the device's intended use, without any additional nor burdensome procedure.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Villejuif
**Country:** France
**Facility:** Gustave Roussy Institut
**Zip:** 94000
#### Overall Officials
**Official 1:**
**Affiliation:** Gustave Roussy, Cancer Campus, Grand Paris
**Name:** THIERRY DE BAERE, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC01
- Name: Infections
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M37
- Name: Abscess
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Browse Branches
- Abbrev: Hemat
- Name: Hematinics
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M11110
- Name: Liver Extracts
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT03709979
**Brief Title:** Effect Of Position On Laryngeal Visualisation With The C-Mac Videolaryngoscope
**Official Title:** Inönü University Department of Anesthesia
#### Organization Study ID Info
**ID:** C-Mac
#### Organization
**Class:** OTHER
**Full Name:** Inonu University
### Status Module
#### Completion Date
**Date:** 2019-02-18
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-02-19
**Type:** ACTUAL
**Last Update Submit Date:** 2019-02-18
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2019-02-18
**Type:** ACTUAL
#### Start Date
**Date:** 2019-01-21
**Type:** ACTUAL
**Status Verified Date:** 2019-02
#### Study First Post Date
**Date:** 2018-10-17
**Type:** ACTUAL
**Study First Submit Date:** 2018-10-11
**Study First Submit QC Date:** 2018-10-16
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Inonu University
#### Responsible Party
**Investigator Affiliation:** Inonu University
**Investigator Full Name:** Zekine Begec
**Investigator Title:** Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The aim of this study is to demonstrate the effect of C-Mac videolaryngoscopy with Miller Blade size 0 and 1 on the intubation conditions in children less than 2 years age with a roll inserted under the shoulders.
**Detailed Description:** The laryngoscopic view of the glottis is improved when the angle of the line of vision between the pharyngeal - laryngeal axis and the oral cavity axis is narrow. A roll inserted under the shoulders of the infant will help line up the oral, laryngeal, and pharyngeal axes making direct laryngoscopy easier.
The investigators hypothesized that laryngoscopic view and intubation conditions using C-Mac videolaryngoscope with Miller Blade size 0 and 1 would be better with a roll under shoulder in children under 2 years.
### Conditions Module
**Conditions:**
- Anesthesia
- Intubation
- Laryngoscopy
**Keywords:**
- video laryngoscopy
- Pediatric patient
- Position
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- OUTCOMES_ASSESSOR
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 96
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Children will be intubated by C-MAC videolaryngoscope with placing a folded towel under the shoulder.
**Intervention Names:**
- Device: C-MAC videolaryngoscope
**Label:** C-MAC with folded towel position
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** Children will be intubated by C-MAC videolaryngoscope with flat position (non-inserted a folded towel)
**Intervention Names:**
- Device: C-MAC videolaryngoscope
**Label:** C-MAC with flat position
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- C-MAC with flat position
- C-MAC with folded towel position
**Description:** An intubating device that is used for endotracheal intubation. Endotracheal intubation will be performed by anesthesiologist with C-MAC videolaryngoscope
**Name:** C-MAC videolaryngoscope
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Percentage of glottic opening score of 100% denotes visualization of the entire glottis, from the anterior commissure of the vocal cords to the inter-arytenoid notch. If no part of the glottic opening was visualized, the POGO score was recorded as 0%
**Measure:** Percentage of glottic opening score
**Time Frame:** immediately before endotracheal intubation
#### Secondary Outcomes
**Description:** Time to intubation will be measured from the time the videolaryngoscope entered the patient's mouth until the first capnograph trace is seen on the monitor
**Measure:** Time to intubation
**Time Frame:** From beginning of holding videolaryngoscope to seeing two meaningful end-tidal carbon dioxide levels up to 3 minutes
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* less than 2 years age undergoing general anaesthesia with tracheal intubation for elective surgery
* American Society of Anesthesiologists' physical status either 1 or 2 are included
Exclusion Criteria:
* upper respiratory tract infection within the previous 4 weeks
* airway difficulties in the preoperative evaluation
* unstable reactions during intubation
**Healthy Volunteers:** True
**Maximum Age:** 24 Months
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Malatya
**Country:** Turkey
**Facility:** Turgut Ozal Medical Center
**Zip:** 44315
#### Overall Officials
**Official 1:**
**Affiliation:** Inonu University Medical Faculty
**Name:** Zekine Begec, Professor
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Kim EH, Lee JH, Song IK, Kim JT, Kim BR, Kim HS. Effect of head position on laryngeal visualisation with the McGrath MAC videolaryngoscope in paediatric patients: A randomised controlled trial. Eur J Anaesthesiol. 2016 Jul;33(7):528-34. doi: 10.1097/EJA.0000000000000448.
**PMID:** 26986776
## Document Section
### Large Document Module
#### Large Docs
- Date: 2016-12-21
- Filename: Prot_SAP_000.pdf
- Has ICF: False
- Has Protocol: True
- Has SAP: True
- Label: Study Protocol and Statistical Analysis Plan
- Size: 337801
- Type Abbrev: Prot_SAP
- Upload Date: 2019-01-17T05:54
## Derived Section
### Intervention Browse Module - Browse Branches
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M4107
- Name: Anesthetics
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT04792879
**Acronym:** CODOVEIN
**Brief Title:** Assessment of Peripheral Veins Doppler Ultrasound for Diagnosis of Acute Right Heart Failure in Suspicion or Follow-up of Pulmonary Hypertension
**Official Title:** Assessment of Peripheral Veins Doppler Ultrasound for Diagnosis of Acute Right Heart Failure in Suspicion or Follow-up of Pulmonary Hypertension
#### Organization Study ID Info
**ID:** 2021-A00100-41
#### Organization
**Class:** OTHER
**Full Name:** Poitiers University Hospital
### Status Module
#### Completion Date
**Date:** 2022-11-21
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-12-01
**Type:** ACTUAL
**Last Update Submit Date:** 2022-11-30
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2022-11-21
**Type:** ACTUAL
#### Start Date
**Date:** 2021-06-14
**Type:** ACTUAL
**Status Verified Date:** 2022-11
#### Study First Post Date
**Date:** 2021-03-11
**Type:** ACTUAL
**Study First Submit Date:** 2021-03-08
**Study First Submit QC Date:** 2021-03-10
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Poitiers University Hospital
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Occurrence of acute right heart failure (ARHF) remains common during pulmonary hypertension (PH). Right atrial pressure (RAP) invasive measurement is the gold standard to diagnose ARHF in order to improve diuretic treatment management. Existence of indirect signs of ARHF on venous Doppler ultrasound waveform has long been described, but correlation with RAP has not been properly established yet. It is the aim of our study in order to obtain an additional tool to manage ARHF.
### Conditions Module
**Conditions:**
- Acute Right Heart Failure
- Pulmonary Hypertension
- Peripheral Veins Doppler Ultrasound
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** DIAGNOSTIC
#### Enrollment Info
**Count:** 103
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Diagnostic Test: Peripheral veins Doppler ultrasound
**Label:** Peripheral veins Doppler ultrasound
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Peripheral veins Doppler ultrasound
**Description:** Patients undergoing a right heart catheterization for PH diagnosis or annual follow-up in the cardiological unit of the university hospital of Poitiers will be included. A venous Doppler ultrasound will be performed by a vascular physician, with experience in vascular ultrasound imaging, within 4 hours before the right heart catheterization. Morphological parameters of vena cava, and velocimetric parameters of femoral, jugular and supra-hepatic veins will be assessed in order to study their correlation with right auricular pressure value.
**Name:** Peripheral veins Doppler ultrasound
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** Sensitivity, specificity, positive and negative likelihood ratios of venous stasis index\*, measured by Pulsed Doppler on common femoral veins, as a diagnostic criterion for ARHF (defined by RAP ≥10 mm Hg).
\* Defined as duration of non-anterograde venous flow during 3 seconds/ 3 seconds
**Measure:** Sensitivity, specificity, positive and negative likelihood ratios of venous stasis index
**Time Frame:** Inclusion day within 4 hours before the right heart catheterization
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Adult patient (age ≥ 18 years old)
* Patient referred to the cardiology department for a right heart catheterization with measurement of RAP, regardless of the indication.
* Free subject, without guardianship or curatorship or subordination
* People affiliated to or beneficiary of a social security schemes
* Informed consent signed by the patient after clear and fair information about the study.
Exclusion Criteria:
* Minor patient (age \< 18 years)
* Refusal to participate in the study
* Patient with hemodynamic instability, unable to tolerate a delay in treatment caused by the ultrasound examination.
* Patient requiring diuretic treatment within the next 4 hours
* Patient with a life expectancy of less than 24 hours.
* History of proximal deep venous thrombosis involving the inferior vena cava and/or common iliac veins and/or femoral veins.
* History of extrinsic venous compression on the inferior vena cava and/or common iliac veins and/or femoral veins.
* Persons who do not benefit from a Social Security scheme or who do not benefit from it through a third party.
* Persons benefiting from reinforced protection, namely minors, pregnant and nursing women, persons deprived of liberty by a judicial or administrative decision, persons staying in health or social institutions, adults under legal protection and finally patients in emergency situations.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Poitiers
**Country:** France
**Facility:** CHU de Poitiers
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000006331
- Term: Heart Diseases
- ID: D000008171
- Term: Lung Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M10024
- Name: Hypertension
- Relevance: HIGH
- As Found: Hypertension
- ID: M9421
- Name: Heart Failure
- Relevance: HIGH
- As Found: Heart Failure
- ID: M10027
- Name: Hypertension, Pulmonary
- Relevance: HIGH
- As Found: Pulmonary Hypertension
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M9419
- Name: Heart Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M11168
- Name: Lung Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000006976
- Term: Hypertension, Pulmonary
- ID: D000006973
- Term: Hypertension
- ID: D000006333
- Term: Heart Failure
### Intervention Browse Module - Browse Branches
- Abbrev: HB
- Name: Herbal and Botanical
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: T204
- Name: Kava
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT05575479
**Acronym:** PDQ
**Brief Title:** PA Behavior and HRQoL in Parkinson's Disease Patients Patients: Role of Social Cognitive Variables
**Official Title:** Physical Activity Behavior and Health-Related Quality of Life in Parkinson's Disease Patients: Role of Social Cognitive Variables
#### Organization Study ID Info
**ID:** 2015B0259
#### Organization
**Class:** OTHER
**Full Name:** Ohio State University
### Status Module
#### Completion Date
**Date:** 2015-10
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-10-12
**Type:** ACTUAL
**Last Update Submit Date:** 2022-10-10
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2015-10
**Type:** ACTUAL
#### Start Date
**Date:** 2015-08
**Status Verified Date:** 2022-10
#### Study First Post Date
**Date:** 2022-10-12
**Type:** ACTUAL
**Study First Submit Date:** 2015-09-14
**Study First Submit QC Date:** 2022-10-10
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Ohio State University
#### Responsible Party
**Investigator Affiliation:** Ohio State University
**Investigator Full Name:** Brian Focht
**Investigator Title:** Associate Professor of Kinesiology Department of Human Sciences
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The primary aim of the study will be to examine Social Cognitive Theory (SCT) correlates, of physical activity (PA) participation and health-related quality of life (HRQoL) in Parkinson's disease participants.
**Detailed Description:** The body of evidence in the physical therapy and rehabilitation literature supports that physical activity is associated with improvements in quality of life for Parkinson's Disease (PD) patients. However, few studies have examined the underlying variables that may account for this relationship in PD patients. Researchers have examined stages of readiness to exercise in PD patients and barriers to exercise and found a strong association between self-efficacy and exercise in PD patients, rather than disability .
Researchers suggest that social cognitive theory (SCT) constructs are important correlates of physical activity for PD patients and should be targeted in interventions. A more comprehensive study of SCT correlates - Self-Efficacy (SE), Outcome Expectations (OE), and Self-Regulation (SR) should provide a better understanding of the factors that contribute to physical activity participation and the physical activity / health-related quality of life relationship in PD patients.
### Conditions Module
**Conditions:**
- Parkinson Disease
- Idiopathic Parkinson Disease
- Idiopathic Parkinson's Disease
- Parkinson Disease, Idiopathic
- Parkinson's Disease
- Parkinson's Disease, Idiopathic
**Keywords:**
- Social Cognitive Theory
- Physical Activity
- Quality of Life
- Parkinsons
### Design Module
#### Design Info
**Observational Model:** OTHER
**Time Perspective:** CROSS_SECTIONAL
#### Enrollment Info
**Count:** 500
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients with idiopathic parkinson's disease
**Label:** Idiopathic Parkinson's Patients
### Outcomes Module
#### Other Outcomes
**Description:** hierarchical linear regression model will be used to examine the SCT constructs as potential mediators between self-reported PA and HRQoL in PD patients. Also, any variables determined to have significant impact in the multiple regression models will be controlled for in the HLM, allowing us to investigate the effects of certain variables while controlling for the effects of others.
**Measure:** Social Cognitive Theory (SCT) constructs as mediators between self-reported PA and HRQoL
**Time Frame:** Outcomes as measured at a single baseline assessment
**Description:** multiple linear regression analysis will then be used to examine the relationship between the social cognitive theory constructs and self-reported physical activity in PD patients.
**Measure:** SCT constructs correlation to self-reported PA
**Time Frame:** Outcomes as measured at a single baseline assessment
#### Primary Outcomes
**Description:** multiple linear regression analysis will be used to determine if higher HRQoL is significantly related to self-reported physical activity in PD patients.
**Measure:** Health-Related Quality of Life (HRQoL) correlation to self-reported physical activity (PA)
**Time Frame:** participant's respond to survey questions only 1 time
#### Secondary Outcomes
**Description:** multiple linear regression analysis will be used to determine if higher levels of SE, OE, and SR are significantly related to self-reported HRQoL.
**Measure:** Self-efficacy (SE), Outcomes Expectations (OE), and Self-Regulation (SR) correlation to self-reported HRQoL
**Time Frame:** Outcomes as measured at a single baseline assessment
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. English speaking
2. Parkinson's disease diagnosed by a neurologist
Exclusion Criteria:
1. Atypical Parkinson's
2. Supranuclear Palsy
3. Deep Brain Stimulation (DBS) or other brain surgery
4. Not living independently (living in assisted-living or skilled-nursing facility)
5. Spouse or caregiver responding instead of PD participant
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** The investigators are using a cross-sectional experimental design of 404 geographically diverse Parkinson's participants. Physiologic (Hoehn \& Yahr) and psychological (surveys and single-item measures) measures will be collected via web-based surveys in Qualtrics accessed through a link.
Sample Using (Fritz \& MacKinnon, 2007) article on the required sample size necessary to detect mediated effects, using the empirical estimates in Table 3 for the Baron and Kenny test with ť = .59, α = .59 and β = .14, the desired sample size needed for a power of .8 would be 404. In this population, the investigators expect that some PD participants may start the survey and be unable to finish. For this reason, the investigators would like to oversample by 25% with a target of 505 participants.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Columbus
**Country:** United States
**Facility:** The Ohio State University
**State:** Ohio
**Zip:** 43210
#### Overall Officials
**Official 1:**
**Affiliation:** Associate Professor Kinesiology
**Name:** Brian C Focht, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### References Module
#### See Also Links
**Label:** Qualtrics Survey Study Link
**URL:** http://tinyurl.com/p5h58to
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000020734
- Term: Parkinsonian Disorders
- ID: D000001480
- Term: Basal Ganglia Diseases
- ID: D000001927
- Term: Brain Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000009069
- Term: Movement Disorders
- ID: D000080874
- Term: Synucleinopathies
- ID: D000019636
- Term: Neurodegenerative Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
### Condition Browse Module - Browse Leaves
- ID: M13213
- Name: Parkinson Disease
- Relevance: HIGH
- As Found: Parkinson's Disease
- ID: M22494
- Name: Parkinsonian Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M25603
- Name: Ganglion Cysts
- Relevance: LOW
- As Found: Unknown
- ID: M16358
- Name: Synovial Cyst
- Relevance: LOW
- As Found: Unknown
- ID: M4774
- Name: Basal Ganglia Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5204
- Name: Brain Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12029
- Name: Movement Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M2217
- Name: Synucleinopathies
- Relevance: LOW
- As Found: Unknown
- ID: M21558
- Name: Neurodegenerative Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T6034
- Name: Quality of Life
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000010300
- Term: Parkinson Disease
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT01633879
**Brief Title:** Addressing Proven Factors in HIV Prevention for Latino Youth
**Official Title:** Health and Success: Addressing Proven Factors in HIV Prevention for Latino Youth
#### Organization Study ID Info
**ID:** 5R01HD062084
**Link:** https://reporter.nih.gov/quickSearch/5R01HD062084
**Type:** NIH
#### Organization
**Class:** INDUSTRY
**Full Name:** Education Development Center, Inc.
### Status Module
#### Completion Date
**Date:** 2014-07
**Type:** ESTIMATED
#### Expanded Access Info
**Last Known Status:** ENROLLING_BY_INVITATION
#### Last Update Post Date
**Date:** 2012-07-04
**Type:** ESTIMATED
**Last Update Submit Date:** 2012-07-03
**Overall Status:** UNKNOWN
#### Primary Completion Date
**Date:** 2013-12
**Type:** ESTIMATED
#### Start Date
**Date:** 2009-07
**Status Verified Date:** 2012-07
#### Study First Post Date
**Date:** 2012-07-04
**Type:** ESTIMATED
**Study First Submit Date:** 2012-06-29
**Study First Submit QC Date:** 2012-07-03
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Education Development Center, Inc.
#### Responsible Party
**Investigator Affiliation:** Education Development Center, Inc.
**Investigator Full Name:** Lydia O'Donnell
**Investigator Title:** Senior Scientist
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This study tests the effectiveness of the bilingual Health and Success program, which aims to support Latino parents and schools in their efforts to promote the academic success and healthy choices of youth, with the goal of reducing barriers that lead to elevated levels of HIV/AIDS in urban Latino communities.
### Conditions Module
**Conditions:**
- HIV
- Sexually Transmitted Infections
**Keywords:**
- parenting, prevention, HIV/AIDS, adolescents, Latino
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 3400
**Type:** ESTIMATED
**Phases:**
- PHASE2
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** audio-CD parent EDC supporting positive parenting practices
**Intervention Names:**
- Behavioral: audio-CD parent education
**Label:** parent education
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** health and success parent and school intervention
**Intervention Names:**
- Behavioral: health and success parent and school
**Label:** parent and school intervention
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** brochures to parents
**Label:** print materials
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- parent education
**Description:** audio CD stories in English and Spanish that support positive parenting practices
**Name:** audio-CD parent education
**Other Names:**
- health and success
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- parent and school intervention
**Description:** Parenting education and school intervention
**Name:** health and success parent and school
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** The study will examine whether there is a reduction in risky sexual behavior among youth exposed to the two treatment conditions compared to the control condition.
**Measure:** reduction in risk behavior
**Time Frame:** 18 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* youth attend school selected as study site
* youth in 6-7th grade
Exclusion Criteria:
* parent/youth non-English or Spanish speakers
**Healthy Volunteers:** True
**Maximum Age:** 14 Years
**Minimum Age:** 10 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000003141
- Term: Communicable Diseases
- ID: D000007239
- Term: Infections
- ID: D000091662
- Term: Genital Diseases
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000020969
- Term: Disease Attributes
- ID: D000010335
- Term: Pathologic Processes
### Condition Browse Module - Browse Branches
- Abbrev: BC01
- Name: Infections
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: BC20
- Name: Immune System Diseases
### Condition Browse Module - Browse Leaves
- ID: M10283
- Name: Infections
- Relevance: LOW
- As Found: Unknown
- ID: M6368
- Name: Communicable Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M3522
- Name: Acquired Immunodeficiency Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M18250
- Name: HIV Infections
- Relevance: LOW
- As Found: Unknown
- ID: M15558
- Name: Sexually Transmitted Diseases
- Relevance: HIGH
- As Found: Sexually Transmitted Infections
- ID: M2876
- Name: Genital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000012749
- Term: Sexually Transmitted Diseases
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT01501279
**Brief Title:** Ultrasound Guided Pudendal Block in Transurethral Prostatectomies
**Official Title:** Ultrasound Guided Pudendal Block in Transurethral Prostatectomies
#### Organization Study ID Info
**ID:** Diskapi2011
#### Organization
**Class:** OTHER
**Full Name:** Diskapi Teaching and Research Hospital
### Status Module
#### Completion Date
**Date:** 2013-04
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2016-06-13
**Type:** ESTIMATED
**Last Update Submit Date:** 2016-06-10
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2013-04
**Type:** ACTUAL
#### Start Date
**Date:** 2011-12
**Status Verified Date:** 2011-12
#### Study First Post Date
**Date:** 2011-12-29
**Type:** ESTIMATED
**Study First Submit Date:** 2011-12-20
**Study First Submit QC Date:** 2011-12-26
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Diskapi Teaching and Research Hospital
#### Responsible Party
**Investigator Affiliation:** Diskapi Teaching and Research Hospital
**Investigator Full Name:** derya özkan
**Investigator Title:** consultant MD
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The pudendal nerve conveys sensory, motor, sympathetic fibres to the perineum, bladder neck and proximal urethra. Pain management during transurethral procedures is a major concern.Patients who have been catheterized under anesthesia complained of urgency in the postoperative period because of catheter-related bladder irritation. We want to investigate that the effect of pudendal block to postoperative pain, bladder spasm and patient comfort in transurethral prostatectomies
**Detailed Description:** Outcome measures USG guided transperineal pudendal block success Postoperative pain score (VAS score) Postoperative bladder spasm (Severity of bladder discomfort will record as severe(behavioral responses such as strong vocal response, flailing limbs),moderate (not accompanied by any behavioral responses) and no bladder discomfort.
Postoperative patient's comfort (poor, sufficient, good)
### Conditions Module
**Conditions:**
- Pain, Postoperative
**Keywords:**
- pudendal nerve block
- postoperative pain
- bladder spasm
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- OUTCOMES_ASSESSOR
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 40
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** USG guided pudendal nerve block performed under general anesthesia
**Intervention Names:**
- Procedure: Pudendal nerve block
**Label:** pudendal nerve block
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Control group without nerve block
**Label:** no nerve block
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- pudendal nerve block
**Description:** the pudendal nerve block is going to be performed to the medial of ischial tuberosity with USG guidance in lithotomy position
**Name:** Pudendal nerve block
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** Postoperative bladder spasm (Severity of bladder discomfort will record as severe(behavioral responses such as strong vocal response, flailing limbs),moderate (not accompanied by any behavioral responses) and no bladder discomfort.
**Measure:** postoperative bladder spasm
**Time Frame:** postoperative 12 h
#### Secondary Outcomes
**Description:** VAS score (0-10)
**Measure:** postoperative pain
**Time Frame:** postoperative 12 h
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* ASA I,II,III status
* Who were scheduled to have elective transurethral resection of the prostate
Exclusion Criteria:
* Chronic renal failure
* coagulopathy
* active anorectal disease
* active urinary tract infection
* uncontrolled diabetes
**Maximum Age:** 80 Years
**Minimum Age:** 50 Years
**Sex:** MALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Ankara
**Country:** Turkey
**Facility:** Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital 1. Anesthesiology Clinic
**Zip:** 06110
#### Overall Officials
**Official 1:**
**Affiliation:** Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital 1. Anesthesiology Clinic
**Name:** Derya Özkan, MD
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital 1. Anesthesiology Clinic
**Name:** Taylan Akkaya, MD
**Role:** STUDY_DIRECTOR
**Official 3:**
**Affiliation:** Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital Urology Clinic
**Name:** Nihat Karakoyunlu, MD
**Role:** STUDY_CHAIR
**Official 4:**
**Affiliation:** Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital 1. AnesthesiologyClinic
**Name:** Julide Ergil, MD
**Role:** STUDY_CHAIR
**Official 5:**
**Affiliation:** Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital 3. Urology Clinic
**Name:** Hamit Ersoy, MD
**Role:** STUDY_CHAIR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000011183
- Term: Postoperative Complications
- ID: D000010335
- Term: Pathologic Processes
- ID: D000010146
- Term: Pain
- ID: D000009461
- Term: Neurologic Manifestations
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC05
- Name: Musculoskeletal Diseases
### Condition Browse Module - Browse Leaves
- ID: M13069
- Name: Pain, Postoperative
- Relevance: HIGH
- As Found: Pain, Postoperative
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M15837
- Name: Spasm
- Relevance: LOW
- As Found: Unknown
- ID: M12077
- Name: Muscle Cramp
- Relevance: LOW
- As Found: Unknown
- ID: M14065
- Name: Postoperative Complications
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000010149
- Term: Pain, Postoperative
### Intervention Browse Module - Browse Branches
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M4107
- Name: Anesthetics
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT00820079
**Brief Title:** ADX10059 as a Monotherapy in Patients With Gastroesophageal Reflux (GERD)
**Official Title:** A Phase 2B, Randomised, Double-blind, Placebo-controlled, Parallel Group, Multi-centre Study to Investigate the Efficacy, Mechanism of Action, Pharmacokinetics, Safety and Tolerability of the mGluR5 Negative Allosteric Modulator ADX10059 as Monotherapy in Patients With Gastroesophageal Reflux Disease (GERD)
#### Organization Study ID Info
**ID:** ADX10059-204
#### Organization
**Class:** INDUSTRY
**Full Name:** Addex Pharma S.A.
#### Secondary ID Infos
**ID:** 2008-005104-10
### Status Module
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2009-12-24
**Type:** ESTIMATED
**Last Update Submit Date:** 2009-12-23
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2009-10
**Type:** ACTUAL
#### Start Date
**Date:** 2008-12
**Status Verified Date:** 2009-12
#### Study First Post Date
**Date:** 2009-01-09
**Type:** ESTIMATED
**Study First Submit Date:** 2009-01-08
**Study First Submit QC Date:** 2009-01-08
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Addex Pharma S.A.
#### Responsible Party
**Old Name Title:** Study Director
**Old Organization:** Addex Pharma SA
### Oversight Module
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Evaluation of the effect of ADX10059 on symptom control in patients with gastroesophageal reflux.
### Conditions Module
**Conditions:**
- Gastroesophageal Reflux
**Keywords:**
- Gastroesophageal reflux
- Heartburn
- Regurgitation
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 120
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Twice-daily
**Intervention Names:**
- Drug: ADX10059
**Label:** ADX10059 120 mg
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** twice-daily
**Intervention Names:**
- Drug: ADX10059 Matching Placebo
**Label:** ADX10059 Matching Placebo
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- ADX10059 120 mg
**Description:** oral administration
**Name:** ADX10059
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- ADX10059 Matching Placebo
**Description:** oral administration
**Name:** ADX10059 Matching Placebo
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Measure:** Number of GERD symptom free days in week 2 of study medication treatment
**Time Frame:** 2 weeks
#### Secondary Outcomes
**Measure:** GERD symptoms
**Time Frame:** 2 weeks
**Measure:** Sleep disturbance
**Time Frame:** 2 weeks
**Measure:** Use of antacid rescue medication
**Time Frame:** 2 weeks
**Measure:** Global assessment of GERD
**Time Frame:** 2 weeks
**Measure:** Effect on lower oesophageal sphincter and reflux episodes
**Time Frame:** 2 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* diagnosis of typical GERD
* well controlled on a standard clinical symptoms controlled dose of PPI treatment
* body mass index ≤32 kg/m2
Exclusion Criteria:
* exclusively atypical symptoms of GERD
* symptoms that have been shown not to be associated with GERD
* erosive oesophagitis
* hiatus hernia \> 3 cm
* current diagnosis of co-existing psychiatric disease
* known clinically significant allergy or known hypersensitivity to drugs
* pregnant or breast-feeding
* has received sodium valproate or topiramate within 30 days of Screening
* has a history of a significant medical condition that may affect the safety of the patient or preclude adequate participation in the study
**Maximum Age:** 70 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Wien
**Country:** Austria
**Facility:** Wien
**Location 2:**
**City:** Leuven
**Country:** Belgium
**Facility:** Leuven
**Location 3:**
**City:** Bordeaux
**Country:** France
**Facility:** Bordeaux
**Location 4:**
**City:** Lyon
**Country:** France
**Facility:** Lyon
**Location 5:**
**City:** Nantes
**Country:** France
**Facility:** Nantes
**Location 6:**
**City:** Berlin
**Country:** Germany
**Facility:** Berlin
**Location 7:**
**City:** Dresden
**Country:** Germany
**Facility:** Dresden
**Location 8:**
**City:** Gorlitz
**Country:** Germany
**Facility:** Gorlitz
**Location 9:**
**City:** Leipzig
**Country:** Germany
**Facility:** Leipzig
**Location 10:**
**City:** Magdeburg
**Country:** Germany
**Facility:** Madgeburg 12
**Location 11:**
**City:** Magdeburg
**Country:** Germany
**Facility:** Magdeburg 13
### References Module
#### References
**Citation:** Zerbib F, Bruley des Varannes S, Roman S, Tutuian R, Galmiche JP, Mion F, Tack J, Malfertheiner P, Keywood C. Randomised clinical trial: effects of monotherapy with ADX10059, a mGluR5 inhibitor, on symptoms and reflux events in patients with gastro-oesophageal reflux disease. Aliment Pharmacol Ther. 2011 Apr;33(8):911-21. doi: 10.1111/j.1365-2036.2011.04596.x. Epub 2011 Feb 14.
**PMID:** 21320138
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000015154
- Term: Esophageal Motility Disorders
- ID: D000003680
- Term: Deglutition Disorders
- ID: D000004935
- Term: Esophageal Diseases
- ID: D000005767
- Term: Gastrointestinal Diseases
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000004941
- Term: Esophagitis
- ID: D000005759
- Term: Gastroenteritis
- ID: D000010437
- Term: Peptic Ulcer
- ID: D000004378
- Term: Duodenal Diseases
- ID: D000007410
- Term: Intestinal Diseases
- ID: D000013272
- Term: Stomach Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BC09
- Name: Ear, Nose, and Throat Diseases
### Condition Browse Module - Browse Leaves
- ID: M8880
- Name: Gastroesophageal Reflux
- Relevance: HIGH
- As Found: Gastroesophageal Reflux
- ID: M9444
- Name: Heartburn
- Relevance: LOW
- As Found: Unknown
- ID: M8091
- Name: Esophagitis
- Relevance: LOW
- As Found: Unknown
- ID: M8092
- Name: Esophagitis, Peptic
- Relevance: HIGH
- As Found: Gastroesophageal Reflux
- ID: M17874
- Name: Esophageal Motility Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M17875
- Name: Esophageal Spasm, Diffuse
- Relevance: LOW
- As Found: Unknown
- ID: M6882
- Name: Deglutition Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M8085
- Name: Esophageal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8875
- Name: Gastroenteritis
- Relevance: LOW
- As Found: Unknown
- ID: M17206
- Name: Ulcer
- Relevance: LOW
- As Found: Unknown
- ID: M13348
- Name: Peptic Ulcer
- Relevance: LOW
- As Found: Unknown
- ID: M7552
- Name: Duodenal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10444
- Name: Intestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M16062
- Name: Stomach Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000005764
- Term: Gastroesophageal Reflux
- ID: D000004942
- Term: Esophagitis, Peptic
### Misc Info Module
#### Removed Countries
- Country: Netherlands
- Country: Switzerland
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT02668679
**Brief Title:** The Effect of Dream Doctors in Children Undergoing Digestive Endoscopic Procedures
**Official Title:** The Effect of Dream Doctors in Children Undergoing Digestive Endoscopic Procedures: Physiological and Biological Assessment of Emotional and Cognitive Consequences
#### Organization Study ID Info
**ID:** 0068-15-EMC
#### Organization
**Class:** OTHER
**Full Name:** HaEmek Medical Center, Israel
### Status Module
#### Completion Date
**Date:** 2018-07-18
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2018-10-03
**Type:** ACTUAL
**Last Update Submit Date:** 2018-10-02
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2018-07-18
**Type:** ACTUAL
#### Start Date
**Date:** 2016-03-30
**Type:** ACTUAL
**Status Verified Date:** 2018-10
#### Study First Post Date
**Date:** 2016-01-29
**Type:** ESTIMATED
**Study First Submit Date:** 2016-01-10
**Study First Submit QC Date:** 2016-01-28
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** HaEmek Medical Center, Israel
#### Responsible Party
**Investigator Affiliation:** HaEmek Medical Center, Israel
**Investigator Full Name:** Sarit Peleg
**Investigator Title:** Head of Pediatric Gastroenterology Unit
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Background: Performance of endoscopy in children requires more patience, experience, and expertise than in adults. The anxiety of the children is related to parent's separation, loss of self-control, unknown surroundings and strange people that are taking care of them, and frequently unpleasant or even painful procedures. Painful and frightening procedures in children have been shown to result in short-term physiologic changes and long-term behavioral changes. The response to unpleasant stimuli with stress and fear may be exaggerated in children and experienced as pain. Most infants and children and many teenagers need deep sedation or light general anesthesia to complete a successful and safe procedure. Induction of general anesthesia is a stressful procedure itself. Strategies to reduce preanesthesia anxiety include pharmacologic and non-pharmacologic interventions.
However, this evidence is based mainly on self reports rather than objective measurements. Therefore, objective and non-invasive measurements to be utilized in the current study, should provide an assessment tools regardless the children's age.
Multiple studies, beginning in the 1970's, have shown that humor has many positive effects on physical and mental health and well-being. Previous investigations have reported that humor has beneficial effects on the immune system, stress related to potentially fatal illnesses, pain tolerance, and mental functions.
Dream doctors (DDs) are professional medical clowns or stage artists, who received training specifically to understand medical patient's need and to give the patient adjuvant therapy during hospital admissions or ambulatory treatment.The Israel dream doctors project, integrates professional medical clowning into the medical services provided at Israeli hospitals.Studies already proved that presence of medical clowns significantly reduces the level of anxiety during induction of anesthesia in children. Hypothesis of the study: 1) DDs lessen the level of anxiety and attention impairment in children undergoing gastroscopies. 2) DDs improve the satisfaction of children and their parents during gastroscopies.
The aim of this study is: 1) To explore the influence of DDs on the satisfaction of children and their parents undergoing gastroscopy, utilizing questioners. 2) To explore the effects of DDs on anxiety and attention of children and their parents, undergoing gastroscopies by means of GSR, startle response and pre-pulse inhibition (PPI) tests, as well as , and measuring anxiety-related biologic indices.
**Detailed Description:** The effect of Dream Doctors in children undergoing digestive endoscopic procedures: Physiological and biological assessment of emotional and cognitive consequences.
Background: Since the advent of pediatric gastrointestinal endoscopy in the early 1970's, there has been a remarkable increase in the number of diagnostic and therapeutic procedures performed in infants and children. Performance of endoscopy in children requires more patience, experience, and expertise than in adults. The anxiety of the children is related to parent's separation, loss of self-control, unknown surroundings and strange people that are taking care of them, and frequently unpleasant or even painful procedures. Painful and frightening procedures in children have been shown to result in short-term physiologic changes and long-term behavioral changes. The response to unpleasant stimuli with stress and fear may be exaggerated in children and experienced as pain. Most infants and children and many teenagers need deep sedation or light general anesthesia to complete a successful and safe procedure. Induction of general anesthesia is a stressful procedure itself. Strategies to reduce preanesthesia anxiety include pharmacologic and non-pharmacologic interventions.
However, this evidence is based mainly on self reports rather than objective measurements. Therefore, objective and non-invasive measurements to be utilized in the current study, should provide an assessment tools regardless the children's age.
Multiple studies, beginning in the 1970's, have shown that humor has many positive effects on physical and mental health and well-being. Previous investigations have reported that humor has beneficial effects on the immune system, stress related to potentially fatal illnesses, pain tolerance, and mental functions.
Dream doctors are professional medical clowns or stage artists, who received training specifically to understand medical patient's need and to give the patient adjuvant therapy during hospital admissions or ambulatory treatment. Laughter has physiological effects on different body mechanisms and it affects the cardiovascular system (decreasing heart rate and blood pressure), strengthens the immune system, and lowers level of stress hormones like Norepinephrine. Humor can also help in strengthening the bond between therapist and patient and reduce stress and anxiety and enhance recovery. The Israel dream doctors project, integrates professional medical clowning into the medical services provided at Israeli hospitals. The DDs are part of the multidisciplinary staff, principally but not only, in pediatric wards. Studies already proved that presence of medical clowns significantly reduces the level of anxiety during induction of anesthesia in children. In the pediatric ward in Afula Medical Center, the investigators have experience with DDs for preparing children to kidney scans.
Pre-Puls Inhibition PPI A computerized human startle response monitoring system (SR-HLAB STARTLE REFLEX, San Diego Instruments, San Diego, CA) was used to deliver acoustic startle stimuli via headphones and record and score the corresponding electro myographic activity from the orbicularis oculi muscle. Two disposable electrodes (sensor area 12 mm2) were placed approximately 0.75-1cm below the pupil on the orbicularis oculi muscle and 3rd reference electrode on the mastoid bone. The skin area at the electrode site was cleaned with a cotton swab saturated with rubbing alcohol, then prepared by gently rubbing a small amount of EEG \& ECG Skin Prepping Gel (Signa Gel- Parker Laboratories Inc., Fairfield, New jersey, USA), and cleaned again with a cotton swab.
The session (a total of 56 trials) is started with 3 min acclimatization period with a 60 dB background noise level that is delivered continuously throughout the test session. The session is comprised from two blocks. block1: comprised from randomly delivered six trials of single 40 msec 120 dB "pulse alone" startle stimuli in order to evaluate the startle response, ten "pre" stimuli (at 74, 78, 82, 86 or 92 dB), and thirty "pre pulse" trials that consisted of a single 120 dB pulse preceded (120 msec inter-stimulus-interval) by a 20 msec pre pulse of 14, 18, 22, 26 or 32 dB above background (i.e., 74, 78, 82, 86 or 92 dB). Block1 trials were delivered on average 20 sec inter-trial-interval ITI (15-25 sec, total 46 trials). Block2: comprised of the last ten trials of "pulse alone" startle, at fixed 2 sec ITI in order to evaluate a measure of habituation in response to repeated delivery of the startling stimuli. Finally, prepulse inhibition (PPI) was calculated as the percent of the habituated response as follows \[100-(max response to "pre pulse" trial / max response to "pulse alone" trial X 100)\]
GSR - Galvanic Skin Response Electrodermal activity will be measured by the differences of the skin conductivity. Two 5 mm electrodes will be placed on fingers 2 and 4 of the non-dominant hand. The electrodes will be connected to sensor and amplifying receiver with a 10Hz sampling rate.
Different portions of the skin can show differences in conductivity, due to sweat related to stress. Thus, measuring the skin conductivity of the non-dominant hand was shown to reduce this variability.
Hypothesis of the study: 1) DDs lessen the level of anxiety and attention impairment in children undergoing gastroscopies. 2) DDs improve the satisfaction of children and their parents during gastroscopies.
The aim of this study is: 1) To explore the influence of DDs on the satisfaction of children and their parents undergoing gastroscopy, utilizing questioners. 2) To explore the effects of DDs on anxiety and attention of children and their parents, undergoing gastroscopies by means of GSR, startle response and pre-pulse inhibition (PPI) tests and measuring anxiety-related biologic indices.
Patients and Methods: This randomized, controlled study will be conducted with children undergoing deep sedation during pediatric upper gastrointestinal endoscopies in the Gastroenterology institute of the Emek Medical Center,Afula, Israel. One hundred children (age 1-18 years) scheduled to undergo deep sedation and elective gastroscopy will be enrolled. During enrollment, the potential clown involvement will be explained to parents. Patients will be assigned to one of two groups: Group 1:children and their parents with the presence of DD upon arrival to the Gastroenterology institute and throughout the induction of sedation, gastroscopy and recovery. Group 2: children and their parents undergoing gastroscopy with deep sedation without the presence of a DD.
The randomization process: In Afula Medical Center, the investigators perform gastroscopies weekly. During the study period the investigators will perform the gastroscopies one week with the DD and one week without the DD.The patients will not be aware to that fact that in some weeks the DD is participating during the sedation induction in some of the patients (every other week). The DD will use various methods for entertaining the child and alleviate stress according to the child's age. The parents and the children will be given anxiety questioners to fill before the induction of sedation. At the end of the gastroscopy the parents and the children will be given satisfaction questioners. The children will perform Pre-Pulse inhibition (PPI) test and GSR before and after the gastroscopy to assess physiological and biological emotional and cognitive consequences. The parents will perform PPI test and GSR before, during and after the gastroscopy (no caffeine or nicotine consumption will be allowed 30min before examination). The anesthesiologist and the nurse at the recovery room will fill a questioner evaluating the behavior of the child during the induction of sedation and awakening. While inserting an IV line blood spots will be taken for stress hormones: cortisol, epinephrine, and norepinephrine. The following physical indices will be measured: blood pressure, pulse, saturation and body temperature. The amount of drugs given for deep sedation will be evaluated.
The current study hold two major innovativeness: (a) The effects of DD as part of the medical team in gastroscopy in children. (b) The physiological and biological evaluation of the emotional and cognitive consequences in children and their parents during gastroscopy.
Statistical analysis:
The study design is Mixed design (2X3), with DD as between subject factor (with or without DD) and stage of treatment as within subject factor (prior, during and after gastroscopy examination).Thus, we will conduct a Two-Way ANOVA (2X3) with post hoc Tukey's test. Significant interactions will be further analyzed with One-Way ANOVA. Moreover to relate physiological and biological measurement to questioner items, Pearson's correlations will be calculated.
The study schedule:
1. Recruitment: 1.5 year
2. Study period: for each patient the study will be held during the day of gastroscopy.
3. Examination of blood serum by ELISA: 3 months.
3. Analysis of results: three months 4. Targeted date as to completion of project: two years from the study beginning.
Project staff:
1. Dr Peleg Sarit - Board certified in Pediatrics and Pediatric Gastroenterology and Nutrition.
2. Dr Rinawi Firas - Board certified in Pediatrics and Pediatric Gastroenterology and Nutrition.
3. Dr Efrat Rachel - Board certified in Anesthesiology and Pediatrics.
4. Professor Avital Avi - Behavioral Neuroscience Lab, Head.
5. Mrs Lazimi Ilanit - Pediatric and Pediatric Gastroenterology nurse.
6. Mr Yaron (Sancho) Goshen - Experienced DD.
7. Mrs Yaara Tirosh Kamienchick - Research coordinator. Institutional overview: Dr Peleg Sarit, Pediatric Gastroenterology Unit, Emek Medical Center, Shderot Itzhak Rabin 21 Afula, 18101, Israel Phone: +972-4-6494104 Fax: +972-4-6495532 Email: [email protected]
Ethics:
The study will be conducted according to the ethical principles of the Declaration of Helsinki. Informed consent will be obtained following explicit description of the study outline and alternatives for participation. It will be made clear that declining to participate in the study will not jeopardize, in any way, the quality of care received. The signed consent will be filed in the patient's medical record. The principal investigators will have full access to the data prior to publication. CRFs will be identified and coded by study number and initials only.
### Conditions Module
**Conditions:**
- Gastrointestinal Diseases
**Keywords:**
- Dream Doctors
- Medical Clown
- Pediatrics
- Sedation
- Endoscopy
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 99
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The DD will use various methods for entertaining the child and alleviate stress . The parents and the children will be given anxiety and satisfaction questionnaires. The children and parents will perform Pre-Pulse inhibition (PPI) test and GSR. In addition, stress hormones will be assessed (cortisol, epinephrine, and norepinephrine) and the following physical indices will be measured: blood pressure, pulse, saturation and body temperature. The amount of drugs given for deep sedation will be evaluated.
**Intervention Names:**
- Procedure: Sedation of children during gastroscopy with and without the presence of dream doctor
- Device: evaluation of stress with PPI and GSR
- Biological: blood specimens for stress hormones
- Other: Physiological indices for evaluation of stress
**Label:** Children and their parents with the presence of Dream Doctors
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** No DD during the gastroscopy. The parents and the children will be given anxiety and satisfaction questionnaires. The children and parents will perform Pre-Pulse inhibition (PPI) test and GSR. In addition, stress hormones will be assessed (cortisol, epinephrine, and norepinephrine) and the following physical indices will be measured: blood pressure, pulse, saturation and body temperature. The amount of drugs given for deep sedation will be evaluated.
**Intervention Names:**
- Procedure: Sedation of children during gastroscopy with and without the presence of dream doctor
- Device: evaluation of stress with PPI and GSR
- Biological: blood specimens for stress hormones
- Other: Physiological indices for evaluation of stress
**Label:** Children and their parents without the presence of DD
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Children and their parents with the presence of Dream Doctors
- Children and their parents without the presence of DD
**Description:** children and their parents with and without the presence of DD upon arrival to the Gastroenterology institute and throughout the induction of sedation, gastroscopy and recovery.
**Name:** Sedation of children during gastroscopy with and without the presence of dream doctor
**Other Names:**
- dream doctor
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- Children and their parents with the presence of Dream Doctors
- Children and their parents without the presence of DD
**Description:** evaluation of stress in children undergoing gastroscopy with sedation with and without the presence of a dream doctor by measurement of PPI and GSR
**Name:** evaluation of stress with PPI and GSR
**Other Names:**
- PPI GSR
**Type:** DEVICE
#### Intervention 3
**Arm Group Labels:**
- Children and their parents with the presence of Dream Doctors
- Children and their parents without the presence of DD
**Description:** evaluation of stress in children undergoing gastroscopy with sedation with and without the presence of a dream doctor by measurement of stress hormones.
**Name:** blood specimens for stress hormones
**Other Names:**
- stress hormones
**Type:** BIOLOGICAL
#### Intervention 4
**Arm Group Labels:**
- Children and their parents with the presence of Dream Doctors
- Children and their parents without the presence of DD
**Description:** evaluation of stress in children undergoing gastroscopy with sedation with and without the presence of a dream doctor by measurement of blood pressure, pulse, saturation and body temperature.
**Name:** Physiological indices for evaluation of stress
**Other Names:**
- physiological indices
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The following physical indices will be measured: blood pressure (mmHG)
**Measure:** Level of anxiety in children undergoing gastroscopies measured by biological indices (blood pressure)
**Time Frame:** Up to 12 hours during the day of gastroscopy for each patient.
**Description:** The following physical indices will be measured: pulse per minute
**Measure:** Level of anxiety in children undergoing gastroscopies measured by biological indices (pulse)
**Time Frame:** Up to 12 hours during the day of gastroscopy for each patient.
**Description:** The following physical indices will be measured: saturation meaning level of oxygen in blood with pulse oximeter in units
**Measure:** Level of anxiety in children undergoing gastroscopies measured by biological indices (saturation)
**Time Frame:** Up to 12 hours during the day of gastroscopy for each patient.
**Description:** The following physical indices will be measured: body temperature in celsius degrees
**Measure:** Level of anxiety in children undergoing gastroscopies measured by biological indices (body temperature)
**Time Frame:** Up to 12 hours during the day of gastroscopy for each patient.
**Description:** The following physical indices will be measured:The amount of drugs given for deep sedation will be evaluated, in milligrams per kilogram body weight.
**Measure:** Level of anxiety in children undergoing gastroscopies measured by biological indices (sedation drug level)
**Time Frame:** Up to 12 hours during the day of gastroscopy for each patient.
**Description:** The investigators would use a monitoring device that would assess startle reflex reaction measured by blinking of the eye. Monitoring would be done with electrodes of EMG device that would be located on orbicularis oculi muscle and will monitor response. Startle reflex response (anxiety)- Assessed by millivolts registered by electromyography (EMG) electrodes.
**Measure:** level of anxiety in children undergoing gastroscopies and their parents measured by PPI
**Time Frame:** Up to 12 hours during the day of gastroscopy for each patient.
**Description:** The investigators would use a monitoring device that would assess physiological reactivity by measurement of skin conductance (galvanic skin response).
**Measure:** level of anxiety in children undergoing gastroscopies and their parents measured by GSR
**Time Frame:** Up to 12 hours during the day of gastroscopy for each patient.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Children aged 1-18 years undergoing gastroscopy.
* Informed consent of the parents
Exclusion Criteria:
* Developmental delay or neurologic disease
* Children who underwent endoscopy in the past
* Parents that don't agree to participate in the study
* ASA≥3
* Children or parents hearing problem.
**Maximum Age:** 18 Years
**Minimum Age:** 1 Year
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Afula
**Country:** Israel
**Facility:** Emek Medical Center
**Zip:** 1834111
#### Overall Officials
**Official 1:**
**Affiliation:** Emek Medical Center
**Name:** Sarit Peleg, MD
**Role:** PRINCIPAL_INVESTIGATOR
### References Module
#### References
**Citation:** Tolia V, Peters JM, Gilger MA. Sedation for pediatric endoscopic procedures. J Pediatr Gastroenterol Nutr. 2000 May;30(5):477-85. doi: 10.1097/00005176-200005000-00003. No abstract available.
**PMID:** 10817274
**Citation:** Soker Z. Play and Learning: What really children wan't to learn through play? 'Megamot' (Trends) for research. Behav. Sci.1993; 34:497-520.
**Citation:** Puder C. The healthful effects of laughter. CYC-Net 2003; 55:32-42.
**Citation:** Golan G, Tighe P, Dobija N, Perel A, Keidan I. Clowns for the prevention of preoperative anxiety in children: a randomized controlled trial. Paediatr Anaesth. 2009 Mar;19(3):262-6. doi: 10.1111/j.1460-9592.2008.02903.x. Epub 2008 Dec 23.
**PMID:** 19143948
**Citation:** Vagnoli L, Caprilli S, Messeri A. Parental presence, clowns or sedative premedication to treat preoperative anxiety in children: what could be the most promising option? Paediatr Anaesth. 2010 Oct;20(10):937-43. doi: 10.1111/j.1460-9592.2010.03403.x.
**PMID:** 20849499
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M7255
- Name: Digestive System Diseases
- Relevance: HIGH
- As Found: Gastrointestinal Diseases
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: HIGH
- As Found: Gastrointestinal Diseases
### Condition Browse Module - Meshes
- ID: D000005767
- Term: Gastrointestinal Diseases
- ID: D000004066
- Term: Digestive System Diseases
### Intervention Browse Module - Ancestors
- ID: D000006730
- Term: Hormones, Hormone Substitutes, and Hormone Antagonists
- ID: D000045505
- Term: Physiological Effects of Drugs
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: VaCoAg
- Name: Vasoconstrictor Agents
- Abbrev: Resp
- Name: Respiratory System Agents
- Abbrev: Infl
- Name: Anti-Inflammatory Agents
### Intervention Browse Module - Browse Leaves
- ID: M9789
- Name: Hormones
- Relevance: HIGH
- As Found: Loss
- ID: M12575
- Name: Norepinephrine
- Relevance: LOW
- As Found: Unknown
- ID: M7992
- Name: Epinephrine
- Relevance: LOW
- As Found: Unknown
- ID: M9912
- Name: Hydrocortisone
- Relevance: LOW
- As Found: Unknown
- ID: M155245
- Name: Hydrocortisone 17-butyrate 21-propionate
- Relevance: LOW
- As Found: Unknown
- ID: M228609
- Name: Hydrocortisone acetate
- Relevance: LOW
- As Found: Unknown
- ID: M263259
- Name: Hydrocortisone hemisuccinate
- Relevance: LOW
- As Found: Unknown
- ID: M30371
- Name: Racepinephrine
- Relevance: LOW
- As Found: Unknown
- ID: M211043
- Name: Epinephryl borate
- Relevance: LOW
- As Found: Unknown
- ID: M9788
- Name: Hormone Antagonists
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000006728
- Term: Hormones
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT05698979
**Acronym:** BETOX
**Brief Title:** Evaluation of Botulinum TOXin Type A in the Treatment of Buerger's Disease
**Official Title:** Evaluation of Botulinum TOXin Type A in the Treatment of Buerger's Disease
#### Organization Study ID Info
**ID:** RC31/20/0445
#### Organization
**Class:** OTHER
**Full Name:** University Hospital, Toulouse
### Status Module
#### Completion Date
**Date:** 2024-06-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-07-12
**Type:** ACTUAL
**Last Update Submit Date:** 2023-07-10
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-06-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-08-30
**Type:** ESTIMATED
**Status Verified Date:** 2023-07
#### Study First Post Date
**Date:** 2023-01-26
**Type:** ACTUAL
**Study First Submit Date:** 2023-01-05
**Study First Submit QC Date:** 2023-01-16
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University Hospital, Toulouse
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The main objective is to assess the feasibility of treatment by injecting botulinum toxin A into the hand or foot of patients with signs of critical ischemia secondary to Buerger's disease. The injection of botulinum toxin A is carried out at the end of a single session during an hospitalization. Furthermore, tolerance and effects on the disease are evaluated at 1, 3 and 6 months post injections.
**Detailed Description:** Buerger's disease or obliterate thromboangiitis(TAO) is a rare disease. It is an inflammatory, segmental and occlusive disease affecting small and medium caliber arteries and veins in the extremities of the limbs. It mainly affects young men, who traditionally smoke, before the age of 45. There is currently no specific treatment for Buerger's disease. Surgical treatment is rarely feasible, due to distal and diffuse damage. Several studies have evaluated the perivascular injection of botulinum toxin type A (BTX) in patients with severe Raynaud syndromes linked to scleroderma, with promising results.
Studies with BTX have shown reduced pain, improved tissue perfusion with laser doppler, and healing of digital ulcers.
The patients are treated with a single session with botulinum toxin A injections during an hospital visit, and the judgmental criteria are assessed at 1, 3 and 6 months post injections.
The injections are made at 4 injection points at the palmar or distal plantar fold, at the level of the neurovascular beams, 2h after topical anesthesia by lidocaine cream under occlusion, associated or not with nitrous oxide inhaled at the time of the injections (BOTOX® 100 U, botulinum toxin A injections in each hand or foot, for a final dose of 50 U (1 ml) per extremity).
### Conditions Module
**Conditions:**
- Buerger Disease
- Raynaud Syndrome
**Keywords:**
- botulinum toxin A
- botox
- feasibility
- raynaud
- buerger
- tolerance
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 8
**Type:** ESTIMATED
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Botox Injection
**Intervention Names:**
- Drug: BOTOX INJECTION
**Label:** drug administration
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- drug administration
**Description:** The patient will be treated with a single session with botulinum toxin A injections at the hospital, and the judgmental criteria will be assessed at 1, 3 and 6 months post injections.
The injections will be made in 4 injection points at the palmar or distal plantar fold, at the level of the neurovascular beams, 2h after topical anesthesia by lidocaine cream under occlusion, associated or not with nitrous oxide inhaled at the time of the injections (BOTOX® 100 U).
In the event of multiple lesions, a single limb is injected based on clinical severity (ulcer, gangrene) and ischemia parameters (lowest TCPO2).
**Name:** BOTOX INJECTION
**Other Names:**
- botulinum toxin
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** The feasibility criterion corresponds to the number of patients who actually received the planned injections within the defined time limits, among the patients who should have received the injection according to the criteria of the protocol.
**Measure:** Feasibility in Number of patients
**Time Frame:** through study completion, an average of 18 months
#### Secondary Outcomes
**Description:** collection of temporary low grade adverse events (hematoma, erythema, ecchymosis at the injection site, pain, before/after and during injection)
**Measure:** tolerance of participants
**Time Frame:** during injection
**Description:** collection of temporary low grade adverse events (hematoma, erythema, ecchymosis at the injection site, pain, before/after and during injection)
**Measure:** tolerance of participants
**Time Frame:** 2 hours after injection
**Description:** collection of temporary high grade adverse events (muscle weakness, temporary or prolonged headache, general muscle weakness or muscle group at distance from injection site, difficulty swallowing, dyspnea, immediate allergic reaction to injections)
**Measure:** tolerance during injection
**Time Frame:** during injection
**Description:** collection of temporary high grade adverse events (muscle weakness, temporary or prolonged headache, general muscle weakness or muscle group at distance from injection site, difficulty swallowing, dyspnea, immediate allergic reaction to injections)
**Measure:** tolerance after injection
**Time Frame:** 2 hours after injection
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Age ≥ 18 years
2. patient with Buerger's disease according to Olin criteria (ref)
3. with digital ischemia with critical upper or lower limb ischemia criteria defined as Upper limb: pain and/or trophic disorders for at least 15 days AND digital pressure less than 50 mmHg Or TCPO2 30 mmHg) Or/and Lower limb: pain and/or trophic disorders for at least 15 days AND ankle pressure less than 50 mmHg (70 mmHg if diabetes), or 30 mmHg at the toe (50 mmHg if diabetes) or TCPO2 30 mmHg).
4. Ability to attend study visits
5. Ability to complete daily study agenda
6. Ability to give free and informed consent
7. Membership of a Social Security scheme
Exclusion Criteria:
1. History of myasthenia gravis or Eaton-Lambert syndrome
2. History of inflammatory myositis for less than 2 years or pre-existing motor neuron disease or superior limb neuropathy.
3. Known allergy to botulinum toxin or cream lidocaine, albumin or inhaled nitrous oxide/oxygen.
4. Progressive infection of one hand or foot
5. Aminoglycoside treatment
6. Pregnant or nursing women
7. History of vascular surgery of surgical sympathectomy of upper or lower limb
8. Revascularization procedure considered within 3 months of inclusion
9. Risk of major amputation within 3 months of inclusion
10. Iloprost expected within one month of study treatment
11. Hyperbaric chamber sessions scheduled within one month of study treatment
12. Life expectancy less than 6 months
13. Contraindication to one or more of the following products: BOTOX 100 UNITS ALLERGAN, LIDOCAINE/PRILOCAINE 5%, cream or NITROUS OXIDE MEDICINAL
14. Patients treated by class III anti arhythmic drugs for example amiodarone 15 ) Patient with guardians, curators, or protection of justice
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Julie Malloizel-Delaunay, MD
**Phone:** 05 61 32 30 33
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** University Hospital, Toulouse
**Name:** Julie Malloizel-Delaunay, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### See Also Links
**Label:** Related Info
**URL:** https://www.has-sante.fr/upload/docs/application/pdf/AOMI_recos.pdf
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001157
- Term: Arterial Occlusive Diseases
- ID: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000014657
- Term: Vasculitis
- ID: D000090122
- Term: Livedoid Vasculopathy
- ID: D000013927
- Term: Thrombosis
- ID: D000016769
- Term: Embolism and Thrombosis
- ID: D000016491
- Term: Peripheral Vascular Diseases
- ID: D000017445
- Term: Skin Diseases, Vascular
- ID: D000012871
- Term: Skin Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M14772
- Name: Raynaud Disease
- Relevance: HIGH
- As Found: Raynaud's Syndrome
- ID: M16678
- Name: Thromboangiitis Obliterans
- Relevance: HIGH
- As Found: Buerger's Disease
- ID: M4465
- Name: Arterial Occlusive Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17405
- Name: Vasculitis
- Relevance: LOW
- As Found: Unknown
- ID: M2750
- Name: Livedoid Vasculopathy
- Relevance: LOW
- As Found: Unknown
- ID: M16686
- Name: Thrombosis
- Relevance: LOW
- As Found: Unknown
- ID: M7784
- Name: Embolism
- Relevance: LOW
- As Found: Unknown
- ID: M19128
- Name: Embolism and Thrombosis
- Relevance: LOW
- As Found: Unknown
- ID: M29213
- Name: Peripheral Arterial Disease
- Relevance: LOW
- As Found: Unknown
- ID: M18894
- Name: Peripheral Vascular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M19714
- Name: Skin Diseases, Vascular
- Relevance: LOW
- As Found: Unknown
- ID: T889
- Name: Buerger Disease
- Relevance: HIGH
- As Found: Buerger's Disease
- ID: T3486
- Name: Livedoid Vasculopathy
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000013919
- Term: Thromboangiitis Obliterans
- ID: D000011928
- Term: Raynaud Disease
### Intervention Browse Module - Ancestors
- ID: D000065087
- Term: Acetylcholine Release Inhibitors
- ID: D000049990
- Term: Membrane Transport Modulators
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000018678
- Term: Cholinergic Agents
- ID: D000018377
- Term: Neurotransmitter Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
### Intervention Browse Module - Browse Branches
- Abbrev: AnArAg
- Name: Anti-Arrhythmia Agents
- Abbrev: ChanBlk
- Name: Channel Blockers
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Analg
- Name: Analgesics
- Abbrev: VaDiAg
- Name: Vasodilator Agents
### Intervention Browse Module - Browse Leaves
- ID: M11014
- Name: Lidocaine
- Relevance: LOW
- As Found: Unknown
- ID: M4107
- Name: Anesthetics
- Relevance: LOW
- As Found: Unknown
- ID: M5183
- Name: Botulinum Toxins
- Relevance: HIGH
- As Found: Face
- ID: M21257
- Name: Botulinum Toxins, Type A
- Relevance: LOW
- As Found: Unknown
- ID: M250193
- Name: abobotulinumtoxinA
- Relevance: LOW
- As Found: Unknown
- ID: M12546
- Name: Nitrous Oxide
- Relevance: LOW
- As Found: Unknown
- ID: M3473
- Name: Acetylcholine
- Relevance: LOW
- As Found: Unknown
- ID: M20758
- Name: Cholinergic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M20504
- Name: Neurotransmitter Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000001905
- Term: Botulinum Toxins
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT01259479
**Brief Title:** Satraplatin in Children and Young Adults With Refractory Solid Tumors Including Brain Tumors
**Official Title:** A Phase I Trial and Pharmacokinetic Study of the Oral Platinum Analog Satraplatin in Children and Young Adults With Refractory Solid Tumors Including Brain Tumors
#### Organization Study ID Info
**ID:** 110047
#### Organization
**Class:** NIH
**Full Name:** National Institutes of Health Clinical Center (CC)
#### Secondary ID Infos
**ID:** 11-C-0047
### Status Module
#### Completion Date
**Date:** 2015-05-29
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2018-07-05
**Type:** ACTUAL
**Last Update Submit Date:** 2018-07-03
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2013-08-01
**Type:** ACTUAL
#### Start Date
**Date:** 2010-12-03
**Status Verified Date:** 2015-05-29
#### Study First Post Date
**Date:** 2010-12-14
**Type:** ESTIMATED
**Study First Submit Date:** 2010-12-11
**Study First Submit QC Date:** 2010-12-11
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** NIH
**Name:** National Cancer Institute (NCI)
### Description Module
**Brief Summary:** Background:
* Cisplatin and carboplatin are standard cancer treatment drugs used for various childhood cancers, including brain tumors. Both drugs frequently have severe side effects that may reduce their effectiveness, particularly in children, and new treatments are needed that may be similarly effective but less toxic for cancer patients.
* Satraplatin is an experimental drug, similar to cisplatin and carboplatin, that has not yet been approved by the Food and Drug Administration. Satraplatin has been shown to treat cancer by interfering with genetic material (DNA) in cancer cells. Some adults with cancer who have received satraplatin had slowing of the growth or shrinkage of their tumor. Researchers are interested in determining whether satraplatin can be effective for cancers that occur in children.
Objectives:
* To evaluate the safety and effectiveness of satraplatin as a treatment for children and young adults who have solid tumors that have not responded to standard treatment.
* To study the effects of satraplatin on the body in terms of side effects and blood chemistry.
* To examine the effect that genetic variations may have on the effectiveness of satraplatin.
Eligibility:
- Children, adolescents, and young adults between 3 and 21 years of age who have solid tumors (including brain tumors) that have not responded to standard treatment.
Design:
* Participants will be screened with a full physical examination and medical history, blood tests, and tumor imaging studies.
* Participants will receive satraplatin pills to be taken every day in the morning for 5 consecutive days, with no food for 2 hours before or 1 hour after the dose. Participants will then have 23 days without the drug to complete a 28-day cycle of treatment. Participants will also receive medication to prevent nausea and vomiting 30 minutes before the first dose of satraplatin. Following the first dose of satraplatin, medication for nausea will be given if needed.
* Satraplatin doses will be adjusted based on response to treatment, including potential side effects. Participants will have frequent blood tests and imaging studies to evaluate the effectiveness of the treatment and monitor any side effects, as well as hearing tests and other examinations as required by the study researchers.
* Participants will receive satraplatin every 4 weeks for up to 2 years until serious side effects occur or the tumor stops responding to treatment.
**Detailed Description:** BACKGROUND
The platinum compounds cisplatin and carboplatin are standard agents in the treatment of a variety of childhood cancers. However, cumulative and long-term renal and ototoxicity are a concern related to cisplatin administration, particularly in young children.
Several mechanisms of resistance to platinum compounds have been described including decreased drug accumulation due to altered drug uptake or the presence of a membrane efflux pump, increased intracellular levels of thiol-containing groups that detoxify and modulate platinum, and removal of the platinum-DNA adducts by DNA repair pathways called nucleotide excision repair (NER) and base excision repair (BER) pathways.
Polymorphisms in DNA repair genes have been shown in some cancers to predict better treatment response to platinum treatment.
Satraplatin is an oral platinum analog with similar preclinical in vitro and in vivo activity to that of cisplatin and carboplatin, and with activity in platinum resistant models.
Dose-limiting satraplatin toxicities in adults include nausea, vomiting, and myelosuppression. Neither renal nor neurologic toxicities have been described.
Satraplatin has demonstrated clinical activity in adult refractory tumors at the recommended phase II and III dose of 80 mg/m2/dose daily for 5 days every 28 or 35 days.
OBJECTIVES
To determine the maximum tolerated dose (MTD) of oral satraplatin administered on a once daily for 5 days every 28 days schedule in pediatric patients with relapsed or refractory solid tumors including brain tumors.
To define the toxicities of oral satraplatin and characterize the pharmacokinetics of oral satraplatin in children with refractory cancer.
To determine the preliminary antitumor activity of satraplatin.
To evaluate the pharmacogenomic expression of DNA repair genes in peripheral blood mononuclear blood cells.
ELIGIBILITY
Patients greater than or equal to 3 years and less than or equal to 25 years at enrollment with relapsed or refractory solid tumors including brain tumors.
Adequate organ function
DESIGN
This is a phase I trial of satraplatin administered once daily orally for 5 days every 28 days. A cycle of therapy is considered to be 28 days. The starting dose level is 60 mg/m(2)/dose with escalations to 80, 110, 140 mg/m(2)/dose. The MTD will be defined based on satraplatin tolerability during cycle one.
Disease status will be evaluated prior to every odd treatment cycle and therapy may continue for up to 2 years in the absence of progressive disease or unacceptable toxicity.
Plasma pharmacokinetics and pharmacogenomics will be evaluated during the first treatment cycle.
### Conditions Module
**Conditions:**
- Solid Tumors
- Brain Tumors
- Brain Metastases
**Keywords:**
- Solid Tumors
- Maximum Tolerated Dose
- Parmacokinetics
- Pharmacogenomics
- Satraplatin
- Cancer
- Solid Tumor
- Brain Tumor
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 9
**Type:** ACTUAL
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Dose escalation, continuous treatment without DLTs
**Intervention Names:**
- Drug: Satraplatin
**Label:** 1
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- 1
**Description:** Orally, once daily for 5 days repeated every 28 days, dose-escalation
**Name:** Satraplatin
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Measure:** MTD
**Time Frame:** 1 Year
#### Secondary Outcomes
**Measure:** PKs
**Time Frame:** 1 Year
**Measure:** Definte anti-tumore activity
**Time Frame:** 1 Year
**Measure:** PGs
**Time Frame:** 1 Year
### Eligibility Module
**Eligibility Criteria:** * INCLUSION CRITERIA:
1. Age: greater than or equal to 3 years and less than or equal to 25 years of age at the time of study enrollment.
2. Diagnosis: Patients with refractory solid tumors including brain tumors (including brain metastases). All patients must have had histological verification of the solid tumor at initial diagnosis or relapse with the exception of patients with diffuse intrinsic brainstem tumors, optic pathway tumors, or CNS germ cell tumors with elevations of reliable serum or CSF tumor markers (alpha-fetoprotein or beta-HCG).
3. Disease status: Patients must have measurable or evaluable disease.
4. Prior Therapy: Refractory to standard therapy and no other standard curative treatment options are available. Patients must have fully recovered to less than or equal to grade 1 from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.
i. Stem Cell Transplantation: Patients must be greater than or equal to 3 months since autologous stem cell transplant and greater than or equal to 6 months since allogeneic stem cell transplant prior to study entry.
ii. Radiation Therapy: Extensive radiation therapy (craniospinal, more than half of the pelvis, TBI) must be completed at least 3 months prior to study entry. The last dose of all other local palliative radiation must be at least 2 weeks prior to study entry.
iii. Myelosuppressive chemotherapy: The last dose of myelosuppressive chemotherapy must be at least 21 days prior to study entry. Therapy with nitrosoureas must be at least 6 weeks prior to study entry; and therapy with temozolomide must be 4 weeks prior to study entry.
iv. Investigational anti-cancer agents: The last dose of all investigational agents must be at least 30 days prior to study entry.
v. Growth factors: The last dose of growth factors such as filgrastim and epoetin must be at least one week prior to study entry. The last dose of long-acting colony stimulating factors, such as pegfilgrastim, must be 2 weeks prior to study entry.
vi. Biologic anti-cancer agents: The last dose of nonmyelosuppressive biologic agents for the treatment of the patient s cancer must be at least 7 days prior to study entry.
vii. Immunotherapy: At least 6 weeks since the completion of any type of immunotherapy, e.g. tumor vaccines.
viii. Monoclonal antibody: At least 3 half-lives of the antibody after the last dose of a monoclonal antibody. (See table on Children s Oncology Group Phase I Consortium DVL homepage https://members.childrensoncologygroup.org/Disc/devtherapeu tics/default.asp for listing of monoclonal antibody half-lives.)
ix. Corticosteroids: Patients with brain tumors must be on a stable or tapering dose of corticosteroids for 7 days prior to the date of the baseline scan performed for the purpose of assessing response to therapy on this study.
5. Performance status: Patients greater than 10 years of age must have a Karnofsky performance level of greater than or equal to 50%, and children less than or equal to 10 years old must have a Lansky performance of greater than or equal to 50% (Appendix I). Patients who are wheelchair bound because of paralysis should be considered ambulatory when they are up in their wheel chair.
6. Hematologic Function: Patients must have an absolute neutrophil count greater than or equal to 1000/microL, hemoglobin greater than or equal to 9g/dl (transfusion permitted), and platelet greater than or equal to 75,000/?l (transfusion independent).
7. Hepatic Function: Patients must have bilirubin less than or equal to 1.5 times the upper limit of normal (ULN) for age, with the exception of Gilbert syndrome, and ALT within less than or equal to 3.0 times the ULN.
8. Renal Function: Patients must have a creatinine clearance or radioisotope GFR greater than or equal to 60ml/min/1.73 m(2) or a normal serum creatinine based on age described below.
* Less than or equal to 5 years of age: a maximum serum creatinine of 0.8 mg/dL
* Older than 5 years of age but less than or equal to the age of 10: a maximum serum creatinine of 1.0 mg/dL
* Older than 10 years of age and less than or equal to the age of 15: a maximum serum creatinine of 1.2 mg/dL
* Older than 15 years of age: a maximum serum creatinine of 1.5 mg/dL
9. Informed Consent: Diagnostic or laboratory studies performed exclusively to determine eligibility for this trial must only be done after obtaining written informed consent from all patients or their legal guardians (if the patient is \<18 years old). When appropriate, pediatric patients will be included in all discussions. This can be accomplished through one of the following mechanisms:
1. the NCI, POB screening protocol,
2. an IRB-approved institutional screening protocol or
3. the study-specific protocol.
Documentation of the informed consent for screening will be maintained in the patient s research chart. Studies or procedures that were performed for clinical indications (not exclusively to determine eligibility) may be used for baseline values even if the studies were done before informed consent was obtained.
10. Durable Power of Attorney (DPA): All patients \>18 years of age will be offered the opportunity to assign DPA so that another person can make decisions about their medical care if they become incapacitated or cognitively impaired.
EXCLUSION CRITERIA:
1. Pregnant or breast-feeding females are excluded due to potential risks of fetal and teratogenic adverse events of an investigational agent. Pregnancy tests (urine BhCG) must be obtained prior to enrollment on this study in girls, age 9 years or older. Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method. Abstinence is an acceptable method of birth control.
2. Last dose of any investigational agent given within the past 30 days. 3. Ongoing radiation therapy, chemotherapy, hormonal therapy directed at the tumor, immunotherapy, or biologic therapy.
4. Active graft versus host disease.
5. Graft vs Host Disease (GVHD) therapy or agents to prevent organ rejection post-transplant: Patients who are receiving cyclosporine, tacrolimus or other agents to prevent either GVHD post bone marrow transplant or organ rejection post transplant are not eligible for this trial.
6. Clinically significant uncontrolled unrelated systemic illness such as serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction.
7. Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study.
8. Inability to swallow capsules as capsules cannot be crushed or broken
9. Prior treatment with satraplatin.
**Maximum Age:** 25 Years
**Minimum Age:** 3 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Bethesda
**Country:** United States
**Facility:** National Institutes of Health Clinical Center, 9000 Rockville Pike
**State:** Maryland
**Zip:** 20892
#### Overall Officials
**Official 1:**
**Affiliation:** National Cancer Institute (NCI)
**Name:** Brigitte C Widemann, M.D.
**Role:** PRINCIPAL_INVESTIGATOR
### References Module
#### References
**Citation:** Daw NC, Billups CA, Rodriguez-Galindo C, McCarville MB, Rao BN, Cain AM, Jenkins JJ, Neel MD, Meyer WH. Metastatic osteosarcoma. Cancer. 2006 Jan 15;106(2):403-12. doi: 10.1002/cncr.21626.
**PMID:** 16353204
**Citation:** Ferguson WS, Harris MB, Goorin AM, Gebhardt MC, Link MP, Shochat SJ, Siegal GP, Devidas M, Grier HE. Presurgical window of carboplatin and surgery and multidrug chemotherapy for the treatment of newly diagnosed metastatic or unresectable osteosarcoma: Pediatric Oncology Group Trial. J Pediatr Hematol Oncol. 2001 Aug-Sep;23(6):340-8. doi: 10.1097/00043426-200108000-00004.
**PMID:** 11563767
**Citation:** MacDonald TJ, Arenson EB, Ater J, Sposto R, Bevan HE, Bruner J, Deutsch M, Kurczynski E, Luerssen T, McGuire-Cullen P, O'Brien R, Shah N, Steinbok P, Strain J, Thomson J, Holmes E, Vezina G, Yates A, Phillips P, Packer R. Phase II study of high-dose chemotherapy before radiation in children with newly diagnosed high-grade astrocytoma: final analysis of Children's Cancer Group Study 9933. Cancer. 2005 Dec 15;104(12):2862-71. doi: 10.1002/cncr.21593.
**PMID:** 16315242
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000016543
- Term: Central Nervous System Neoplasms
- ID: D000009423
- Term: Nervous System Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000001927
- Term: Brain Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
### Condition Browse Module - Browse Leaves
- ID: M12307
- Name: Neoplasm Metastasis
- Relevance: LOW
- As Found: Unknown
- ID: M5209
- Name: Brain Neoplasms
- Relevance: HIGH
- As Found: Brain Tumor
- ID: M18937
- Name: Central Nervous System Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M12367
- Name: Nervous System Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M5204
- Name: Brain Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000009369
- Term: Neoplasms
- ID: D000001932
- Term: Brain Neoplasms
### Intervention Browse Module - Ancestors
- ID: D000000970
- Term: Antineoplastic Agents
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M231225
- Name: Satraplatin
- Relevance: HIGH
- As Found: Last 3 months
### Intervention Browse Module - Meshes
- ID: C000081294
- Term: Satraplatin
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT02794779
**Acronym:** MODCL
**Brief Title:** Minimum Oxytocin Dose for Cesarean During Labor: Adaptative Clinical Trial
**Official Title:** Minimum Oxytocin Dose for Cesarean During Labor: Adaptative Clinical Trial
#### Organization Study ID Info
**ID:** anestesiatccthiago1416
#### Organization
**Class:** OTHER
**Full Name:** Brasilia University Hospital
### Status Module
#### Completion Date
**Date:** 2017-12
**Type:** ESTIMATED
#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2017-01-31
**Type:** ESTIMATED
**Last Update Submit Date:** 2017-01-30
**Overall Status:** UNKNOWN
#### Primary Completion Date
**Date:** 2017-12
**Type:** ESTIMATED
#### Start Date
**Date:** 2016-07
**Status Verified Date:** 2017-01
#### Study First Post Date
**Date:** 2016-06-09
**Type:** ESTIMATED
**Study First Submit Date:** 2016-06-04
**Study First Submit QC Date:** 2016-06-08
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Brasilia University Hospital
#### Responsible Party
**Investigator Affiliation:** Brasilia University Hospital
**Investigator Full Name:** Gabriel Magalhaes Nunes Guimaraes
**Investigator Title:** MD, MSc
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Introduction: postpartum hemorrage is a leading cause of death after cesarean sections in Brazil. Oxytocin is the main drug for both prophylaxis and threatment of postpartum hemorrage because uterine atony is the most prevalent cause. Both excessive and too low oxytocin doses threaten the life of women.
Objective: to determine the minimum effective dose of oxytocin for cesareans during labor.
Method: adaptative clinical trial using a modified up and down method of two sequential groups: rule of three and continuous infusion. Allocation in rule of three or continuous infusion will be random and masked for patients and anesthesiologists. The minimum effective dose will be the effective dose for 90% of success (ED90 for preventing uterine atony).
### Conditions Module
**Conditions:**
- Cesarean Section During Labor
**Keywords:**
- cesarean section
- labor
- oxytocin
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 64
**Type:** ESTIMATED
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Intravenous bolus infusion of oxytocin 3UI followed by re-asessment of uterine tone by obstetrician after 3 minutes. Infusion stops when uterine tone is adequate and is repeated if inadequate to the maximum of 9UI (3 bolus infusions). If uretine tone is inadequate after 9UI then other methods for preventing bleeding will be used.
**Intervention Names:**
- Drug: Oxytocin
**Label:** Rule of three
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Continuous infusion of variable rate if 0,4 UI of oxytocin until obstetrician determines that uterine tone is adequate.
**Intervention Names:**
- Drug: Oxytocin
**Label:** Continuous infusion
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Continuous infusion
- Rule of three
**Description:** Intravenous bolus infusion of oxytocin 3UI followed by re-asessment of uterine tone by obstetrician after 3 minutes. Infusion stops when uterine tone is adequate and is repeated if inadequate to the maximum of 9UI (3 bolus infusions). If uretine tone is inadequate after 9UI then other methods for preventing bleeding will be used.
**Name:** Oxytocin
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Minumum oxytocin dose for preventing uterine atony in 90% of cesareans.
**Measure:** Oxytocin dose
**Time Frame:** 10 minutes
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Cesarean delivery during labor.
* Spinal anesthesia
Exclusion Criteria:
* Change of anesthesia
**Maximum Age:** 130 Years
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Gabriel MN Guimaraes, MD, MSc
**Phone:** +5561996455997
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Helga BG Silva, MD, PhD
**Phone:** 5561991755997
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Brasilia
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Gabriel MN Guimaraes, MD MsC
- **Phone:** 6196455997
- **Role:** CONTACT
**Country:** Brazil
**Facility:** Hospital Universitário de Brasília
**State:** Distrito Federal
**Status:** RECRUITING
**Zip:** 70000000
## Derived Section
### Intervention Browse Module - Ancestors
- ID: D000010120
- Term: Oxytocics
- ID: D000012102
- Term: Reproductive Control Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
### Intervention Browse Module - Browse Branches
- Abbrev: Repr
- Name: Reproductive Control Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M13041
- Name: Oxytocin
- Relevance: HIGH
- As Found: Joint
### Intervention Browse Module - Meshes
- ID: D000010121
- Term: Oxytocin
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT04876079
**Acronym:** REVERSIBLE
**Brief Title:** Prevention of Mild-to-moderate Hypoglycemia in Type 1 Diabetes
**Official Title:** Towards Prevention of Mild-to-moderate Hypoglycemia in Type 1 Diabetes With Oral Glucose at a Higher Blood Glucose Threshold
#### Organization Study ID Info
**ID:** 2022-1119
#### Organization
**Class:** OTHER
**Full Name:** Institut de Recherches Cliniques de Montreal
### Status Module
#### Completion Date
**Date:** 2023-06-30
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-08-31
**Type:** ACTUAL
**Last Update Submit Date:** 2023-08-29
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-06-01
**Type:** ACTUAL
#### Start Date
**Date:** 2021-06-01
**Type:** ACTUAL
**Status Verified Date:** 2023-08
#### Study First Post Date
**Date:** 2021-05-06
**Type:** ACTUAL
**Study First Submit Date:** 2021-05-03
**Study First Submit QC Date:** 2021-05-03
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Institut de Recherches Cliniques de Montreal
#### Responsible Party
**Investigator Affiliation:** Institut de Recherches Cliniques de Montreal
**Investigator Full Name:** Rémi Rabasa-Lhoret
**Investigator Title:** Full professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** According to guidelines, when a mild-to-moderate hypoglycemia occurs (capillary blood glucose \< 4.0 mmol/L), 15-20g of rapidly absorbed carbohydrates should be ingested. Patients should re-test and re-ingest 15-20g carbohydrates every 15 minutes until they recover from hypoglycemia. These recommendations were principally based on two studies conducted in the 80s before the introduction of intensive insulin therapy. In practice, only 32-50% of patients follow the current guidelines. In addition, recent studies suggest that under current intensive insulin therapies, an initial correction with 15g of oral glucose may be insufficient to rapidly correct mild-to-moderate hypoglycemia. With the development and increasing usage of newer glucose monitoring technologies, the community is witnessing a shift in hypoglycemia management, from a reactive to a proactive approach (e.g., prevent imminent episodes rather than treating established episodes).
### Conditions Module
**Conditions:**
- Type 1 Diabetes
**Keywords:**
- Hypoglycemia
- Type 1 diabetes
- Carbohydrates
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 30
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** 16g of carbohydrates will be given when glucose levels are below 4.0 mmol/L (management per guidelines)
**Intervention Names:**
- Other: Test to induce a decline in plasma glucose
- Device: Dexcom G6
- Other: Dex4
- Drug: Insulin
**Label:** 16g of carbohydrates - Plasma glucose < 4.0 mmol/L
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** 16g of carbohydrates will be given when glucose levels are equal or below 4.5 mmol/L.
**Intervention Names:**
- Other: Test to induce a decline in plasma glucose
- Device: Dexcom G6
- Other: Dex4
- Drug: Insulin
**Label:** 16g of carbohydrates - Plasma glucose ≤ 4.5 mmol/L
**Type:** ACTIVE_COMPARATOR
#### Arm Group 3
**Description:** 16g of carbohydrates will be given when glucose levels are equal or below 5.0 mmol/L.
**Intervention Names:**
- Other: Test to induce a decline in plasma glucose
- Device: Dexcom G6
- Other: Dex4
- Drug: Insulin
**Label:** 16g of carbohydrates - Plasma glucose ≤ 5.0 mmol/L
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- 16g of carbohydrates - Plasma glucose < 4.0 mmol/L
- 16g of carbohydrates - Plasma glucose ≤ 4.5 mmol/L
- 16g of carbohydrates - Plasma glucose ≤ 5.0 mmol/L
**Description:** Participants will be admitted at the research center at 7:00 after an overnight fast. A venous catheter will be inserted into an arm vein for blood sampling purposes. A subcutaneous insulin bolus will be administered to bring plasma glucose to the glycemic threshold. Oral carbohydrates (16g) will be given when plasma glucose levels are at the target threshold. Sixty minutes after carbohydrates consumption, a standardized meal will be provided and participants will be discharged 90 minutes after the meal.
**Name:** Test to induce a decline in plasma glucose
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- 16g of carbohydrates - Plasma glucose < 4.0 mmol/L
- 16g of carbohydrates - Plasma glucose ≤ 4.5 mmol/L
- 16g of carbohydrates - Plasma glucose ≤ 5.0 mmol/L
**Description:** Participants will have to wear a Dexcom G6 during study interventions
**Name:** Dexcom G6
**Type:** DEVICE
#### Intervention 3
**Arm Group Labels:**
- 16g of carbohydrates - Plasma glucose < 4.0 mmol/L
- 16g of carbohydrates - Plasma glucose ≤ 4.5 mmol/L
- 16g of carbohydrates - Plasma glucose ≤ 5.0 mmol/L
**Description:** When the glycemic threshold is reach, participants will be given 16g of Dex4
**Name:** Dex4
**Type:** OTHER
#### Intervention 4
**Arm Group Labels:**
- 16g of carbohydrates - Plasma glucose < 4.0 mmol/L
- 16g of carbohydrates - Plasma glucose ≤ 4.5 mmol/L
- 16g of carbohydrates - Plasma glucose ≤ 5.0 mmol/L
**Description:** A subcutaneous insulin bolus will be given to induce a decline in plasma glucose and reach the glycemic threshold.
**Name:** Insulin
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Measure:** Time spent of glucose levels < 4.0 mmol/L
**Time Frame:** 60 minutes after carbohydrates consumption
#### Secondary Outcomes
**Measure:** Plasma glucose levels at 5 minutes after carbohydrates consumption
**Time Frame:** 5 minutes after carbohydrates consumption
**Measure:** Plasma glucose levels at 10 minutes after carbohydrates consumption
**Time Frame:** 10 minutes after carbohydrates consumption
**Measure:** Plasma glucose levels at 15 minutes after carbohydrates consumption
**Time Frame:** 15 minutes after carbohydrates consumption
**Measure:** Plasma glucose levels at 20 minutes after carbohydrates consumption
**Time Frame:** 20 minutes after carbohydrates consumption
**Measure:** Plasma glucose levels at 30 minutes after carbohydrates consumption
**Time Frame:** 30 minutes after carbohydrates consumption
**Measure:** Plasma glucose levels at 45 minutes after carbohydrates consumption
**Time Frame:** 45 minutes after carbohydrates consumption
**Measure:** Plasma glucose levels at 60 minutes after carbohydrates consumption
**Time Frame:** 60 minutes after carbohydrates consumption
**Measure:** Lowest plasma glucose level eached after CHO consumption
**Time Frame:** 60 minutes after carbohydrates consumption
**Measure:** Time from CHO consumption to the lowest plasma glucose level reached
**Time Frame:** 60 minutes after carbohydrates consumption
**Measure:** Time from CHO consumption to plasma glucose < 3.5 mmol/L
**Time Frame:** 60 minutes after carbohydrates consumption
**Measure:** Percentage of participants reaching hypoglycemia (< 4.0 mmol/L) after CHO consumption
**Time Frame:** 60 minutes after carbohydrates consumption
**Description:** Only calculated for participants who will have glucose levels \< 4.0 mmol/L
**Measure:** Percentage of participants for whom hypoglycemia was corrected at 10 minutes after CHO consumption
**Time Frame:** 10 minutes after carbohydrates consumption
**Description:** Only calculated for participants who will have glucose levels \< 4.0 mmol/L
**Measure:** Percentage of participants for whom hypoglycemia was corrected at 15 minutes after CHO consumption
**Time Frame:** 15 minutes after carbohydrates consumption
**Description:** Only calculated for participants who will have glucose levels \< 4.0 mmol/L
**Measure:** Percentage of participants for whom hypoglycemia was corrected at 20 minutes after CHO consumption
**Time Frame:** 20 minutes after carbohydrates consumption
**Description:** Only calculated for participants who will have glucose levels \< 4.0 mmol/L
**Measure:** Percentage of participants for whom hypoglycemia was corrected at 25 minutes after CHO consumption
**Time Frame:** 25 minutes after carbohydrates consumption
**Description:** Only calculated for participants who will have glucose levels \< 4.0 mmol/L
**Measure:** Percentage of participants for whom hypoglycemia was corrected at 30 minutes after CHO consumption
**Time Frame:** 30 minutes after carbohydrates consumption
**Description:** Only calculated for participants who will have glucose levels \< 4.0 mmol/L
**Measure:** Percentage of participants for whom hypoglycemia was corrected at 35 minutes after CHO consumption
**Time Frame:** 35 minutes after carbohydrates consumption
**Description:** Only calculated for events with glucose level \< 4.0 mmol/L
**Measure:** Percentage of hypoglycemic events that were corrected at 10 minutes after CHO consumption
**Time Frame:** 10 minutes after carbohydrates consumption
**Description:** Only calculated for events with glucose level \< 4.0 mmol/L
**Measure:** Percentage of hypoglycemic events that were corrected at 15 minutes after CHO consumption
**Time Frame:** 15 minutes after carbohydrates consumption
**Description:** Only calculated for events with glucose level \< 4.0 mmol/L
**Measure:** Percentage of hypoglycemic events that were corrected at 20 minutes after CHO consumption
**Time Frame:** 20 minutes after carbohydrates consumption
**Description:** Only calculated for events with glucose level \< 4.0 mmol/L
**Measure:** Percentage of hypoglycemic events that were corrected at 25 minutes after CHO consumption
**Time Frame:** 25 minutes after carbohydrates consumption
**Description:** Only calculated for events with glucose level \< 4.0 mmol/L
**Measure:** Percentage of hypoglycemic events that were corrected at 30 minutes after CHO consumption
**Time Frame:** 30 minutes after carbohydrates consumption
**Description:** Only calculated for events with glucose level \< 4.0 mmol/L
**Measure:** Percentage of hypoglycemic events that were corrected at 35 minutes after CHO consumption
**Time Frame:** 35 minutes after carbohydrates consumption
**Description:** Only calculated for participants who will have glucose levels \< 4.0 mmol/L
**Measure:** Percentage of participants requiring a second treatment with carbohydrates at 20 minutes after the first CHO consumption
**Time Frame:** 20 minutes after carbohydrates consumption
**Description:** Only calculated for participants who will have glucose levels \< 4.0 mmol/L
**Measure:** Percentage of participants requiring a second treatment with carbohydrates at 40 minutes after the first CHO consumption
**Time Frame:** 40 minutes after carbohydrates consumption
**Description:** Only calculated for participants who will have glucose levels \< 4.0 mmol/L
**Measure:** Percentage of participants requiring a second treatment with carbohydrates at 60 minutes after the first CHO consumption
**Time Frame:** 60 minutes after carbohydrates consumption
**Measure:** Percentage of participants experiencing a rebound hyperglycemia (≥ 10.0 mmol/L) within the first hour following the first carbobydrates consumption
**Time Frame:** 60 minutes after carbohydrates consumption
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Males and females ≥ 18 years old
2. Clinical diagnosis of type 1 diabetes for at least one year
3. Treatment with multiple daily insulin injections or insulin pump therapy with insulin analogs (rapid, ultra-rapid and basal insulin)
4. A glycated hemoglobin A1c ≤ 10%
Exclusion Criteria:
1. Clinically significant microvascular complications: nephropathy (eGFR \< 40 ml/min), severe proliferative retinopathy as judged by the investigator, neuropathy (particularly diagnosed gastroparesis)
2. Recent (\< 3 months) acute macrovascular event (e.g., acute coronary syndrome or cardiac surgery)
3. Known significant cardiac rhythm abnormality based on investigator's judgement
4. Known significant neurological abnormality (e.g., seizure disorder) based on investigator's judgement
5. Ongoing pregnancy or breastfeeding
6. Severe hypoglycemia episode within 1 month of screening
7. Known uncorrected hypokalemia within the past 3 months (potassium \< 3.5 mmol/L)
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Montreal
**Country:** Canada
**Facility:** Montreal Clinical Research Institute
**State:** Quebec
**Zip:** H2W 1R7
#### Overall Officials
**Official 1:**
**Affiliation:** Institut de recherches cliniques de Montréal
**Name:** Rémi Rabasa-Lhoret
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000044882
- Term: Glucose Metabolism Disorders
- ID: D000008659
- Term: Metabolic Diseases
- ID: D000004700
- Term: Endocrine System Diseases
- ID: D000001327
- Term: Autoimmune Diseases
- ID: D000007154
- Term: Immune System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC20
- Name: Immune System Diseases
### Condition Browse Module - Browse Leaves
- ID: M7115
- Name: Diabetes Mellitus
- Relevance: HIGH
- As Found: Diabetes
- ID: M7117
- Name: Diabetes Mellitus, Type 1
- Relevance: HIGH
- As Found: Type 1 Diabetes
- ID: M10053
- Name: Hypoglycemia
- Relevance: HIGH
- As Found: Hypoglycemia
- ID: M11639
- Name: Metabolic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M25403
- Name: Glucose Metabolism Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M7862
- Name: Endocrine System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M4629
- Name: Autoimmune Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003920
- Term: Diabetes Mellitus
- ID: D000003922
- Term: Diabetes Mellitus, Type 1
- ID: D000007003
- Term: Hypoglycemia
### Intervention Browse Module - Ancestors
- ID: D000007004
- Term: Hypoglycemic Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
### Intervention Browse Module - Browse Branches
- Abbrev: Hypo
- Name: Hypoglycemic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M10365
- Name: Insulin
- Relevance: HIGH
- As Found: Day 1
- ID: M173166
- Name: Insulin, Globin Zinc
- Relevance: LOW
- As Found: Unknown
- ID: M10054
- Name: Hypoglycemic Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000007328
- Term: Insulin
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT03758079
**Brief Title:** Comparison of Gabapentin With Doxepin in the Management of Uremic Pruritus
**Official Title:** Comparison of Gabapentin With Doxepin in the Management of Uremic Pruritus: Pilot Study
#### Organization Study ID Info
**ID:** 064-17/717
#### Organization
**Class:** OTHER
**Full Name:** University of Balamand
### Status Module
#### Completion Date
**Date:** 2018-10-08
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2018-11-29
**Type:** ACTUAL
**Last Update Submit Date:** 2018-11-28
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2018-10-08
**Type:** ACTUAL
#### Start Date
**Date:** 2018-06-01
**Type:** ACTUAL
**Status Verified Date:** 2018-11
#### Study First Post Date
**Date:** 2018-11-29
**Type:** ACTUAL
**Study First Submit Date:** 2018-11-19
**Study First Submit QC Date:** 2018-11-28
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Balamand
#### Responsible Party
**Investigator Affiliation:** University of Balamand
**Investigator Full Name:** Julien Bachour, MD
**Investigator Title:** Principle Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Is US Export:** True
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** This is a single blind randomized trial to compare efficacy and side effects of Gabapentin with Doxepin. Hemodialysis patients with uremic pruritus at one dialysis center of Saint George Hospital University Medical Centre were included in this study. Patients were divided into 2 groups to receive either 10 mg Doxepin daily or Gabapentin at a dose of 100mg after each hemodialysis session (increased as tolerated) for 4 weeks, after which patients were treated reversley. Pruritus severity and its effect on quality of life will be assessed by using visual analog scale (VAS), 5-D pruritus scale and dermatology life quality index (DLQI). Include patients will have to fill these forms at baseline and at end of week1, week2 and week4
**Detailed Description:** Pruritus is one of the frustrating skin manifestations of advanced renal failure. Many options have been used for the management of uremic pruritus (UP) such as Pregabalin, Gabapentin, Doxepine and Desloratidine. Gabapentin, a GABAergic drug, has been found to be effective in the treatment of uremic pruritus. Doxepin, a potent antihistamine drug, is used orally or topically in many pruritic conditions such as UP, idiopathic pruritus, atopic dermatitis, neurogenic, or psychogenic pruritus and, in the management of the UP in hemodialysis patients.
No comparative head to head study between Gabapentin and Doxepine has been conducted to date. The aim of this study was to compare Gabapentin and Doxepin in treatment of uremic pruritus in hemodialysis patients.
### Conditions Module
**Conditions:**
- Uremic Pruritus
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 14
**Type:** ACTUAL
**Phases:**
- PHASE4
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** 10 mg Doxepin daily for 4 weeks
**Intervention Names:**
- Drug: Doxepin
**Label:** Doxepin
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** Gabapentin 100mg after each dialysis session
**Intervention Names:**
- Drug: Gabapentin
**Label:** Gabapentin
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Doxepin
**Description:** 10 mg Doxepin for 4 weeks
**Name:** Doxepin
**Other Names:**
- Silenor
- Sinequan
- Adapin
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Gabapentin
**Description:** dose of 100mg after each hemodialysis session (increased as tolerated) for 4 weeks
**Name:** Gabapentin
**Other Names:**
- Neurontin
- Gralise
- Gabarone
- Fanatrex
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** a 10cm horizontal line marked from zero (no pruritus) to 10 (worst possible pruritus). The pruritus will be assessed subjectively and scored as follows: no pruritus (VAS score 0), mild (VAS score 1-3) with episodic and localized pruritus without disturbance in usual work and sleep, moderate (VAS score 4-7) with generalized and continuous pruritus without sleep disturbance and severe (VAS score 8-10) with generalized, continuous pruritus and sleep disturbance.
**Measure:** Change from baseline in Worst-itching Visual Analog Scale (VAS) at week 4
**Time Frame:** 1, 2, 4 weeks
**Description:** multidimensional questionnaire. The five dimensions are degree, duration, direction, disability and distribution. The scores of each of the five domains will be achieved separately and then summed together to obtain a total 5-D score ranging between five (no pruritus) and 25 (most severe pruritus). For the distribution domain, the number of affected body parts is tallied (potential sum 0-16) and the sum is sorted into five scoring bins: sum of 0-21⁄4score of 1, sum of 3-51⁄4score of 2, sum of 6-101⁄4score of 3, sum of 11-131⁄4score of 4 and sum of 14-161⁄4score of 5
**Measure:** Change from baseline in 5-D Itch Scale score at week 4
**Time Frame:** 1, 2, 4 weeks
**Description:** 10-Item questionnaire evaluating: impact of skin condition on HRQoL during the past week, symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment. A Score range from 0 to 30.
**Measure:** Change from baseline in Dermatology life quality index (DLQI) at week 4
**Time Frame:** 1, 2, 4 weeks
#### Secondary Outcomes
**Description:** Number of patients who report side effects while on each treatment
**Measure:** side effects of each treatment
**Time Frame:** 4 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* prevalent patients undergoing HD with UP for at least three months
* any medications with antipruritic effects to be discontinued one week before the study
* Hemodialysis performed for 3-4 h thrice weekly via a low flux polysulphonedialyser \[1.3-1.6 m2 surface areas\] using bicarbonate and/or acetate dialysis fluid
* well controlled Calcium, Phosphorus and iPTH levels
Exclusion Criteria:
* patients labeled high risk of fall (Having a score more than 16/20 using part 1 from Falls Risk Assessment Tool (FRAT)
* patients taking drugs that interact with doxepin or gabapentin
* patients with hepatic failure
* patients with hyperthyroidism
* patients with narrow angle glaucoma
* patients with heart block or decompensated heart failure or hypotension (defined as systolic blood pressure less than 90 mmHg) or myocardial infarction in the past three months
* history of allergy to gabapentin or doxepin
* uncontrolled psychiatric diseases
* pregnant patients
* patients with psoriasis, atopic dermatitis or any other condition that can justify the pruritus
**Maximum Age:** 80 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Beirut
**Country:** Lebanon
**Facility:** Saint George Hospital University Medical Center
#### Overall Officials
**Official 1:**
**Affiliation:** University of Balamand/Saint George Hospital University Medical Center
**Name:** Roger N Haber, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012871
- Term: Skin Diseases
- ID: D000012877
- Term: Skin Manifestations
### Condition Browse Module - Browse Branches
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M14396
- Name: Pruritus
- Relevance: HIGH
- As Found: Pruritus
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15680
- Name: Skin Manifestations
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000011537
- Term: Pruritus
### Intervention Browse Module - Ancestors
- ID: D000000700
- Term: Analgesics
- ID: D000018689
- Term: Sensory System Agents
- ID: D000018373
- Term: Peripheral Nervous System Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000000927
- Term: Anticonvulsants
- ID: D000014151
- Term: Anti-Anxiety Agents
- ID: D000014149
- Term: Tranquilizing Agents
- ID: D000002492
- Term: Central Nervous System Depressants
- ID: D000011619
- Term: Psychotropic Drugs
- ID: D000018691
- Term: Excitatory Amino Acid Antagonists
- ID: D000018683
- Term: Excitatory Amino Acid Agents
- ID: D000018377
- Term: Neurotransmitter Agents
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000018692
- Term: Antimanic Agents
- ID: D000068776
- Term: Sleep Aids, Pharmaceutical
- ID: D000006993
- Term: Hypnotics and Sedatives
- ID: D000000929
- Term: Antidepressive Agents, Tricyclic
- ID: D000000928
- Term: Antidepressive Agents
- ID: D000006633
- Term: Histamine Antagonists
- ID: D000018494
- Term: Histamine Agents
### Intervention Browse Module - Browse Branches
- Abbrev: Analg
- Name: Analgesics
- Abbrev: AntiConv
- Name: Anticonvulsants
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: PsychDr
- Name: Psychotropic Drugs
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: AAll
- Name: Anti-Allergic Agents
- Abbrev: AnEm
- Name: Antiemetics
- Abbrev: Gast
- Name: Gastrointestinal Agents
- Abbrev: Derm
- Name: Dermatologic Agents
### Intervention Browse Module - Browse Leaves
- ID: M1694
- Name: Gabapentin
- Relevance: HIGH
- As Found: Mutation
- ID: M7491
- Name: Doxepin
- Relevance: HIGH
- As Found: Aquatic Exercise
- ID: M4032
- Name: Analgesics
- Relevance: LOW
- As Found: Unknown
- ID: M4246
- Name: Anticonvulsants
- Relevance: LOW
- As Found: Unknown
- ID: M16905
- Name: Anti-Anxiety Agents
- Relevance: LOW
- As Found: Unknown
- ID: M14474
- Name: Psychotropic Drugs
- Relevance: LOW
- As Found: Unknown
- ID: M20771
- Name: Excitatory Amino Acid Antagonists
- Relevance: LOW
- As Found: Unknown
- ID: M20504
- Name: Neurotransmitter Agents
- Relevance: LOW
- As Found: Unknown
- ID: M7338
- Name: Diphenhydramine
- Relevance: LOW
- As Found: Unknown
- ID: M14268
- Name: Promethazine
- Relevance: LOW
- As Found: Unknown
- ID: M10043
- Name: Hypnotics and Sedatives
- Relevance: LOW
- As Found: Unknown
- ID: M4247
- Name: Antidepressive Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4248
- Name: Antidepressive Agents, Tricyclic
- Relevance: LOW
- As Found: Unknown
- ID: M9709
- Name: Histamine Antagonists
- Relevance: LOW
- As Found: Unknown
- ID: M9708
- Name: Histamine
- Relevance: LOW
- As Found: Unknown
- ID: M212144
- Name: Histamine phosphate
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000077206
- Term: Gabapentin
- ID: D000004316
- Term: Doxepin
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT01182779
**Acronym:** HIT-1
**Brief Title:** Trial of Proton Versus Carbon Ion Radiation Therapy in Patients With Chordoma of the Skull Base
**Official Title:** Randomised Trial of Proton vs. Carbon Ion Radiation Therapy in Patients With Chordoma of the Skull Base -Clinical Phase III Study-
#### Organization Study ID Info
**ID:** HIT-1
#### Organization
**Class:** OTHER
**Full Name:** Heidelberg University
### Status Module
#### Completion Date
**Date:** 2023-08
**Type:** ESTIMATED
#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2010-08-17
**Type:** ESTIMATED
**Last Update Submit Date:** 2010-08-16
**Overall Status:** UNKNOWN
#### Primary Completion Date
**Date:** 2015-08
**Type:** ESTIMATED
#### Start Date
**Date:** 2010-07
**Status Verified Date:** 2010-07
#### Study First Post Date
**Date:** 2010-08-17
**Type:** ESTIMATED
**Study First Submit Date:** 2010-07-26
**Study First Submit QC Date:** 2010-08-16
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Heidelberg University
#### Responsible Party
**Old Name Title:** Juergen Debus, MD PhD, Dept. of Radiation Oncology, INF 400, 69120 Heidelberg
**Old Organization:** University of Heidelberg
### Oversight Module
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** This study is a prospective randomised clinical phase III trial. The primary objective of this study is to evaluate, if the innovative therapy (carbon ion irradiation) in chordomas is superior to the standard proton treatment with respect to the local-progression free survival (LPFS).
**Detailed Description:** The study is a prospective randomised clinical phase III trial. The trial will be carried out at Heidelberger Ionenstrahl-Therapie (HIT) centre as monocentric trial.
Proton therapy is the gold standard in the treatment of skull base chordomas. However, high-LET beams such as carbon ions theoretically offer biologic advantages by enhanced biologic effectiveness in slow-growing tumors. Up until now it was impossible to compare two different particle therapies, i.e. proton and carbon ion therapy directly with each other. The aim of this study is to find out, whether the biological advantages of carbon ion therapy mentioned above can also be clinically confirmed.
Patients with skull base chordoma will be randomised to either proton or carbon ion radiation therapy. As a standard, patients will undergo non-invasive, rigid immobilization and target volume delineation will be carried out based on CT and MRI data. The biologically isoeffective target dose to the PTV in carbon ion treatment (accelerated dose) will be 63 Gy E ± 5% and 72 Gy E ± 5% (standard dose) in proton therapy respectively. Local-progression free survival (LPFS) will be analysed as primary end point. Toxicity and survival are the secondary end points. Also matters of interest are patterns of recurrence, prognostic factors and plan quality.
### Conditions Module
**Conditions:**
- Chordoma
- Tumor
- Treatment
**Keywords:**
- base of skull chordoma
- radiation
- carbon ions
- protons
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 319
**Type:** ESTIMATED
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Arm A (carbon ion therapy):
Total dose to the PTV2 - 45 Gy E in 3 Gy E /d, 4-6 days a week, 15 fractions Total dose to the PTV1 - 63 Gy E ± 5%, further 5-7 fractions a 3 Gy E.
**Intervention Names:**
- Radiation: Carbon ion
**Label:** A
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Arm B (proton therapy):
Total dose to the PTV2 - 50 to 56 Gy E in 2 Gy E /d, 4-6 days a week, 28 fractions Total dose to the PTV1 - 72 Gy E ± 5%, further 6-9 fractions a 2 Gy E.
**Intervention Names:**
- Radiation: Protons
**Label:** B
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- A
**Description:** Arm A (carbon ion therapy):
Total dose to the PTV2 - 45 Gy E in 3 Gy E /d, 4-6 days a week, 15 fractions Total dose to the PTV1 - 63 Gy E ± 5%, further 5-7 fractions a 3 Gy E.
**Name:** Carbon ion
**Type:** RADIATION
#### Intervention 2
**Arm Group Labels:**
- B
**Description:** Arm B (proton therapy):
Total dose to the PTV2 - 50 to 56 Gy E in 2 Gy E /d, 4-6 days a week, 28 fractions Total dose to the PTV1 - 72 Gy E ± 5%, further 6-9 fractions a 2 Gy E.
**Name:** Protons
**Type:** RADIATION
### Outcomes Module
#### Primary Outcomes
**Description:** The primary objective of this study is to evaluate, if the innovative therapy (carbon ion irradiation) in chordomas is superior to the standard proton treatment with respect to the LPFS defined as time from the randomisation to observed local reccurrence or death from any cause in the absence of documented local disease progression. Lo-cal recurrence defined as MRT or CT - morphological tumor progress in the former irradiated region. A 10% increase in the LPFS is considered clinically relevant as-suming that the LPFS rate for the proton therapy is 70%.
**Measure:** local-progression free survival (LPFS)
**Time Frame:** 8-years
#### Secondary Outcomes
**Description:** Assessment of overall survival, progression free and metastasis free survival.
**Measure:** Survival
**Time Frame:** 8-years
**Description:** Local recurrences will be confirmed radiologically and histologically whenever possible. At least two medical doctors (radiation oncologist and/or radiologist) will be required to judge of the recurrence.
**Measure:** Local control and patterns of recurrence
**Time Frame:** 8 years
**Description:** Acute and late toxicity will be analysed due to Common Terminology Criteria for Adverse Events: CTCAE V4.0 for acute reaction and RTOG/EORTC for late effects.
**Measure:** Toxicity
**Time Frame:** 8 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Karnofsky Performance Score ≥60%
* Age \>18 years and \<80 years
* Informed consent signed by the patient
* Histological confirmation of chordoma with infiltration of the skull base.
Exclusion Criteria:
* Inability to understand the aims of the study, no informed consent
* Prior RT of skull base region
* Other malignancies with disease-free interval \< 5 years (excepting pre- cancerous lesions)
* Participation in another trial
* Pregnancy
* Simultaneous CHT or Immunotherapy.
**Maximum Age:** 80 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Anna V. Nikoghosyan, MD
**Phone:** +496221568202
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Juergen Debus, MD, PhD
**Phone:** +496221568202
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Heidelberg
**Contacts:**
***Contact 1:***
- **Name:** Juergen Debus, MD, PhD
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 2:***
- **Name:** Anna V. Nikoghosyan, MD
- **Role:** SUB_INVESTIGATOR
**Country:** Germany
**Facility:** University of Heidelberg
**Status:** RECRUITING
**Zip:** 69120
#### Overall Officials
**Official 1:**
**Affiliation:** Heidelberg University
**Name:** Juergen Debus, MD PhD
**Role:** PRINCIPAL_INVESTIGATOR
### References Module
#### References
**Citation:** Munzenrider JE, Liebsch NJ. Proton therapy for tumors of the skull base. Strahlenther Onkol. 1999 Jun;175 Suppl 2:57-63. doi: 10.1007/BF03038890.
**PMID:** 10394399
**Citation:** Ares C, Hug EB, Lomax AJ, Bolsi A, Timmermann B, Rutz HP, Schuller JC, Pedroni E, Goitein G. Effectiveness and safety of spot scanning proton radiation therapy for chordomas and chondrosarcomas of the skull base: first long-term report. Int J Radiat Oncol Biol Phys. 2009 Nov 15;75(4):1111-8. doi: 10.1016/j.ijrobp.2008.12.055. Epub 2009 Apr 20.
**PMID:** 19386442
**Citation:** Hug EB. Review of skull base chordomas: prognostic factors and long-term results of proton-beam radiotherapy. Neurosurg Focus. 2001 Mar 15;10(3):E11. doi: 10.3171/foc.2001.10.3.12.
**PMID:** 16734403
**Citation:** Hug EB, Slater JD. Proton radiation therapy for chordomas and chondrosarcomas of the skull base. Neurosurg Clin N Am. 2000 Oct;11(4):627-38.
**PMID:** 11082173
**Citation:** Weber DC, Rutz HP, Pedroni ES, Bolsi A, Timmermann B, Verwey J, Lomax AJ, Goitein G. Results of spot-scanning proton radiation therapy for chordoma and chondrosarcoma of the skull base: the Paul Scherrer Institut experience. Int J Radiat Oncol Biol Phys. 2005 Oct 1;63(2):401-9. doi: 10.1016/j.ijrobp.2005.02.023.
**PMID:** 16168833
**Citation:** Schulz-Ertner D, Karger CP, Feuerhake A, Nikoghosyan A, Combs SE, Jakel O, Edler L, Scholz M, Debus J. Effectiveness of carbon ion radiotherapy in the treatment of skull-base chordomas. Int J Radiat Oncol Biol Phys. 2007 Jun 1;68(2):449-57. doi: 10.1016/j.ijrobp.2006.12.059. Epub 2007 Mar 23.
**PMID:** 17363188
**Citation:** Mizoe JE, Hasegawa A, Takagi R, Bessho H, Onda T, Tsujii H. Carbon ion radiotherapy for skull base chordoma. Skull Base. 2009 May;19(3):219-24. doi: 10.1055/s-0028-1114295.
**PMID:** 19881902
**Citation:** Nikoghosyan AV, Karapanagiotou-Schenkel I, Munter MW, Jensen AD, Combs SE, Debus J. Randomised trial of proton vs. carbon ion radiation therapy in patients with chordoma of the skull base, clinical phase III study HIT-1-Study. BMC Cancer. 2010 Nov 5;10:607. doi: 10.1186/1471-2407-10-607.
**PMID:** 21054824
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009373
- Term: Neoplasms, Germ Cell and Embryonal
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000009369
- Term: Neoplasms
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M6057
- Name: Chordoma
- Relevance: HIGH
- As Found: Chordoma
- ID: M12318
- Name: Neoplasms, Germ Cell and Embryonal
- Relevance: LOW
- As Found: Unknown
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
- ID: T1175
- Name: Chordoma
- Relevance: HIGH
- As Found: Chordoma
### Condition Browse Module - Meshes
- ID: D000002817
- Term: Chordoma
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT05037279
**Acronym:** EVER
**Brief Title:** Evaluating Safety and Efficacy of Verity-BCG in BCG-naïve Patients With Intermediate and High-risk Non-muscle Invasive Bladder (NMIBC)
**Official Title:** A Multicenter, Randomized, Double-blind, Controlled Phase III Non-inferiority Study Assessing Efficacy and Safety of VERITY-BCG in Management of Intermediate and High-risk Non-muscle Invasive Bladder Cancer (NMIBC) in BCG-naïve Patients.
#### Organization Study ID Info
**ID:** VRT-BCG-01
#### Organization
**Class:** INDUSTRY
**Full Name:** Verity Pharmaceuticals Inc.
### Status Module
#### Completion Date
**Date:** 2026-01-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-10-14
**Type:** ACTUAL
**Last Update Submit Date:** 2022-10-11
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-12-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-01-01
**Type:** ESTIMATED
**Status Verified Date:** 2022-04
#### Study First Post Date
**Date:** 2021-09-08
**Type:** ACTUAL
**Study First Submit Date:** 2021-07-28
**Study First Submit QC Date:** 2021-08-31
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Verity Pharmaceuticals Inc.
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** The aim of this study is to evaluate the effect of Verity-BCG in patients with intermediate and high-risk non-muscle-invasive bladder cancer (NMIBC) and to compare our findings to the standard of care BCG formulation, OncoTICE (BCG) in order to examine our hypothesis that Verity-BCG is at least non-inferior to OncoTICE in achieving 24-month Recurrence Free Survival in NMIBC patients who are at high risk of recurrence and have never been treated with intradermal or intravesical BCG before, with the exception of tuberculosis vaccination in childhood.
**Detailed Description:** This study is a randomized, active control, double-blind clinical trial aimed at demonstrating non - inferiority of VERITY-BCG to OncoTICE, the current standard of care, with respect to two-year Recurrence Free Survival (RFS) rates in NMIBC BCG - naïve patients that are at high risk for recurrence (defined as \>50%).
• Recurrence will be defined as the reappearance of any of the NMIBC tumors as confirmed by cystoscopic biopsy or TURBT.
### Conditions Module
**Conditions:**
- Bladder Cancer
- Bladder Cancer Recurrent
- Neoplasm Recurrence
- Urothelial Carcinoma Bladder
- Urothelial Carcinoma Recurrent
- Non-Invasive Bladder Urothelial Carcinoma
**Keywords:**
- Interventional
- Non-inferiority study
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** QUADRUPLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 540
**Type:** ESTIMATED
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** * Bacillus Calmette-Guérin (BCG): Strain Russian BCG-I
* Freeze-dried powder for bladder instillation
**Intervention Names:**
- Drug: Bacillus Calmette-Guerin: Strain Russian BCG-I
**Label:** Verity-BCG
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** * Standard of Care
* Bacillus Calmette-Guérin (BCG): Strain TICE
* Freeze-dried powder for bladder instillation
**Intervention Names:**
- Drug: Bacillus Calmette-Guerin: Strain TICE
**Label:** OncoTICE
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Verity-BCG
**Description:** * Induction: 80 mg weekly for 6 weeks.
* Maintenance for intermediate AUA risk patients will be for 3 weeks at 3, 6, and 12 months.
* Maintenance for high AUA risk patients will be for 3 weeks at 3, 6, 12, 18, 24, 30 and 36 months.
**Name:** Bacillus Calmette-Guerin: Strain Russian BCG-I
**Other Names:**
- Verity-BCG
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- OncoTICE
**Description:** * Induction: 50 mg weekly for 6 weeks.
* Maintenance for intermediate AUA risk patients will be for 3 weeks at 3, 6, and 12 months.
* Maintenance for high AUA risk patients will be for 3 weeks at 3, 6, 12, 18, 24, 30 and 36 months.
**Name:** Bacillus Calmette-Guerin: Strain TICE
**Other Names:**
- OncoTICE
**Type:** DRUG
### Outcomes Module
#### Other Outcomes
**Description:** Incidence of treatment-emergent AEs and SAEs defined according to the CTCAE v5.0;
**Measure:** Safety: Incidence of treatment-emergent AEs and SAEs
**Time Frame:** 36 months
**Description:** Number of subjects discontinuing study drug due to AEs
**Measure:** Safety: Number of discontinued subjects
**Time Frame:** 36
**Description:** Usage of concomitant medications over time.
**Measure:** Safety: concomitant medications
**Time Frame:** 36 months
#### Primary Outcomes
**Description:** Cumulative Recurrence Free Survival (RFS) at 24 months following 1st intravesical instillation as estimated using the Kaplan - Meier estimator of the survival function.
Recurrence will be defined as the reappearance of any of the NMIBC tumors as confirmed by cystoscopic biopsy or TURBT.
**Measure:** Recurrence Free Survival (RFS) at 24 months
**Time Frame:** 24 months
#### Secondary Outcomes
**Description:** Cumulative Recurrence Free Survival (RFS) at 36 months following 1st intravesical instillation as estimated using the Kaplan - Meier estimator of the survival function.
**Measure:** Recurrence Free Survival (RFS)
**Time Frame:** 36 months
**Description:** Progression Free Survival (PFS) at 24 months as estimated using the Kaplan - Meier estimator of the survival function.
**Measure:** Progression Free Survival (PFS)
**Time Frame:** 24 months
**Description:** Progression Free Survival (PFS) at 36 months as estimated using the Kaplan - Meier estimator of the survival function.
**Measure:** Progression Free Survival (PFS)
**Time Frame:** 36 months
**Description:** Overall Survival (OS) at 36 months as estimated using the Kaplan - Meier estimator of the survival function.
**Measure:** Overall Survival (OS)
**Time Frame:** 36 months
**Description:** Change in Quality of Life as measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire for NMIBC (EORTC-QLQ-NMIBC24) over 36 months.
The EORTC QLQ-NMIBC24 is a 24-item self-administered questionnaire that measures health-related quality of life in patients with intermediate to high-risk NMIBC. Items are ranked by the patient from 1 to 4 indicating the extent to which they have experienced those symptoms or problems. 1 = Not at All, 2 = A little, 3=Quite a bit, 4 = Very Much.
- High Score is equivalent to more problems, except for items on sexual function and sexual enjoyment for which a high score is interpreted as better function.
**Measure:** Change in Quality of Life
**Time Frame:** 36 months
**Description:** Change in functioning and symptom status as measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire for Cancer Patients (EORTC-QLQ-C30) over 36 months.
The EORTC QLQ-C30 consists of 30 items and measures Health Related Quality of Life as well as presence of symptoms across all cancer types. The QLQ-C30 includes nine multi-item scales:
* 5 functional scales (physical, role, cognitive, emotional, and social)
* 3 symptom scales (fatigue, pain, and nausea and vomiting);
* A global health and quality-of-life scale\*
* Several single-item symptom measures
28 Items are ranked 1 to 4. 1 = Not at All, 2 = A little, 3=Quite a bit, 4 = Very Much.
\*2 items are ranked 1 to 7. 1=Very Poor, 7 = Excellent.
High score = More symptoms or worse problems
\*High Score = Better overall health or Quality of life.
**Measure:** Change in functioning and symptom status
**Time Frame:** 36 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Male or Female
* 18 years and older
* Low or high-grade NMIBC as defined by 2004 World Health Organization (WHO)/International Society of Urological Pathology (ISUP) classification and Grade 2 or 3 in the 1973 classification, diagnosed within 60 days of registration.
* Pathologically confirmed and completely resected stage Ta or T1 urothelial cell carcinoma, with or without associated carcinoma in situ (CIS), diagnosed within 60 days of registration.
1. Patients with T1 disease must have imaging demonstrating no evidence of metastatic disease (based on MRI or CT scan) within 90 days of registration, to confirm stage T1N0M0 disease.
2. For patients with stage T1 disease, repeat TURBT must be performed as per standard of care/CUA guidelines.
* Patients may have intermediate or high recurrence risk disease, as indicated by the probability of 2-year recurrence of ≥ 50% based on the EORTC Bladder Cancer risk calculator.
* ECOG performance status of 0-2
* Adequate organ and marrow function as defined below:
* leukocytes ≥3,000/mcL
* absolute neutrophil count ≥1,500/mcL
* platelets ≥100,000/mcL
* total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN)
* AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN
* creatinine ≤ institutional ULN OR glomerular filtration rate (GFR) ≥50 mL/min/1.73 m2 unless data exists supporting safe use of BCG at lower kidney function values, no lower than 30 mL/min/1.73 m2
* For women of childbearing potential involved in any sexual intercourse that could lead to pregnancy: Negative pregnancy test and willingness to use contraceptive (consistent with local regulations) during 120 days after the last dose of the study treatment. Note: The use of contraceptive methods does not apply to subjects who are abstinent for at least 4 weeks before Day 1 and will continue to be abstinent from penile-vaginal intercourse 120 days after last dose of study drug treatment. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant.
* Note: A woman of non-childbearing potential is defined as follows:
* Has had surgical sterilization (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy);
* Has had a cessation of menses for at least 12 months without an alternative medical cause, and a follicle-stimulating hormone (FSH) test confirming nonchildbearing potential (refer to laboratory reference ranges for confirmatory levels).
* Male patients with female partner of childbearing potential must agree to be abstinent or practice an effective method of contraception.
Male patients must agree to refrain from donating sperm during the treatment period and for at least 120 days after the last dose of study treatment.
Exclusion Criteria:
* Presence of urothelial carcinoma involving the upper urinary tract or prostatic urethra documented by radiological imaging or biopsy, performed within 12 months of the start of treatment. Should the imaging or biopsy be performed outside the window it will be up to the physicians' discretion to re-scan/biopsy. This is considered T4 disease.
* CIS only disease.
* Pure squamous cell carcinoma or adenocarcinoma.
* Presence of micropapillary components.
* Other prior non-bladder malignancy, except for the following:
* adequately treated basal cell or squamous cell skin cancer.
* in situ cervical cancer.
* adequately treated stage I or II cancer currently in complete remission, or any other cancer from which the patient has been disease free for five years.
* patients with localized prostate cancer who are being followed by an active surveillance program are also eligible.
* Prior intravesical BCG or intradermal BCG, with the exception of tuberculosis vaccination in childhood.
* Chronic administration of steroids (\>10 mg prednisone) at the time of randomization.
* Current or planned concomitant biologic therapy, radiation therapy, hormonal therapy, chemotherapy, surgery, or other cancer therapy while on study.
* Prior chemoradiation treatment (trimodal therapy or "TMT") for bladder cancer.
* Currently being treated or scheduled to have treatment with any systemic or intravesical chemotherapeutic agent during the study.
* Receiving any other investigational agents.
* The presence of an impaired immune response irrespective of whether this impairment is congenital or caused by disease, drugs or other therapy.
* Known positive HIV serology.
* Presence of a urinary tract infection; treatment should be withheld until urine culture is negative and antibiotic therapy is stopped.
* Trauma to the urinary bladder. In case of gross hematuria, therapy should be stopped or postponed until the hematuria has been successfully treated or has resolved.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to BCG vaccine.
* Uncontrolled intercurrent illness.
* Psychiatric illness/social situations that would limit compliance with study requirements.
* Pregnancy: pregnant women are excluded from this study because VERITY-BCG is an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with VERITY-BCG, breastfeeding should be discontinued if the mother is treated with VERITY-BCG.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Jalees Farhan
**Phone:** 1-800-977-9778
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Taniya Mann
**Phone:** 1-800-977-9778
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Princess Margaret Cancer Centre, 610 University Ave Toronto, ON, M5G 2M9, Canada
**Name:** Alexandre R Zlotta, MD
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** Princess Margaret Cancer Centre, 700 University Ave, 6-824 Toronto, ON, M5G 1X6, Canada
**Name:** Girish S Kulkarni, MD
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009375
- Term: Neoplasms, Glandular and Epithelial
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000009369
- Term: Neoplasms
- ID: D000020969
- Term: Disease Attributes
- ID: D000010335
- Term: Pathologic Processes
- ID: D000014571
- Term: Urologic Neoplasms
- ID: D000014565
- Term: Urogenital Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000052776
- Term: Female Urogenital Diseases
- ID: D000005261
- Term: Female Urogenital Diseases and Pregnancy Complications
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000001745
- Term: Urinary Bladder Diseases
- ID: D000014570
- Term: Urologic Diseases
- ID: D000052801
- Term: Male Urogenital Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: All
- Name: All Conditions
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M5534
- Name: Carcinoma
- Relevance: HIGH
- As Found: Carcinoma
- ID: M5551
- Name: Carcinoma, Transitional Cell
- Relevance: HIGH
- As Found: Urothelial Carcinoma
- ID: M5030
- Name: Urinary Bladder Neoplasms
- Relevance: HIGH
- As Found: Bladder Cancer
- ID: M14850
- Name: Recurrence
- Relevance: HIGH
- As Found: Recurrent
- ID: M12320
- Name: Neoplasms, Glandular and Epithelial
- Relevance: LOW
- As Found: Unknown
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
- ID: M17320
- Name: Urologic Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M17315
- Name: Urogenital Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27093
- Name: Female Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14127
- Name: Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M8399
- Name: Female Urogenital Diseases and Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M5026
- Name: Urinary Bladder Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17319
- Name: Urologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27095
- Name: Male Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T5693
- Name: Transitional Cell Carcinoma
- Relevance: HIGH
- As Found: Urothelial Carcinoma
### Condition Browse Module - Meshes
- ID: D000002277
- Term: Carcinoma
- ID: D000001749
- Term: Urinary Bladder Neoplasms
- ID: D000002295
- Term: Carcinoma, Transitional Cell
- ID: D000012008
- Term: Recurrence
### Intervention Browse Module - Ancestors
- ID: D000000276
- Term: Adjuvants, Immunologic
- ID: D000007155
- Term: Immunologic Factors
- ID: D000045505
- Term: Physiological Effects of Drugs
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M4793
- Name: BCG Vaccine
- Relevance: HIGH
- As Found: Acute Myelogenous Leukemia
- ID: M17360
- Name: Vaccines
- Relevance: LOW
- As Found: Unknown
- ID: M3628
- Name: Adjuvants, Immunologic
- Relevance: LOW
- As Found: Unknown
- ID: M10201
- Name: Immunologic Factors
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000001500
- Term: BCG Vaccine
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT02343679
**Brief Title:** Novartis PhII Ceritinib (LDK378) in R/R ALK+ Hem Malignancies
**Official Title:** A Phase II Study of the ALK Inhibitor, Ceritinib (LDK378), in Relapsed/Refractory ALK+ Hematologic Malignancies
#### Organization Study ID Info
**ID:** Pro00056623
#### Organization
**Class:** OTHER
**Full Name:** Duke University
### Status Module
#### Completion Date
**Date:** 2022-10
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-02-01
**Type:** ESTIMATED
**Last Update Submit Date:** 2017-01-30
**Overall Status:** WITHDRAWN
#### Primary Completion Date
**Date:** 2020-10
**Type:** ESTIMATED
#### Start Date
**Date:** 2015-05
**Status Verified Date:** 2017-01
#### Study First Post Date
**Date:** 2015-01-22
**Type:** ESTIMATED
**Study First Submit Date:** 2014-12-03
**Study First Submit QC Date:** 2015-01-16
**Why Stopped:** No accrual due to rarity of disease.
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** Novartis
#### Lead Sponsor
**Class:** OTHER
**Name:** Anne Beaven, MD
#### Responsible Party
**Investigator Affiliation:** Duke University
**Investigator Full Name:** Anne Beaven, MD
**Investigator Title:** Assistant Professor of Medicine
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This is a phase II, single arm, unblinded study of ceritinib in patients with rel/ref hematologic malignancies. Up to 24 evaluable subjects will be enrolled with an interim analysis for efficacy after the first 9 subjects are enrolled. Any subject who takes at least one dose of study drug will be evaluable for safety. Only subjects who complete at least 1 cycle of study drug and have clear progression on physical exam or have had at least one restaging study will be considered evaluable for response. Each subject will receive the same dose of 750mg po daily at the study entry. Subjects with stable disease or better will be allowed to continue study drug until disease progression or until intolerable adverse events or patient or physician decision. Intrapatient dose reductions will be allowed for adverse events. This is a multicenter study with Duke as the lead site. Blood and tissue samples, will be collected and used for exploratory analysis.
**Detailed Description:** This is a phase II, single arm, unblinded study of ceritinib in patients with rel/ref hematologic malignancies. Up to 24 evaluable subjects will be enrolled with an interim analysis for efficacy after the first 9 subjects are enrolled. Any subject who takes at least on dose of study drug will be evaluable for safety. Only subjects who complete at least 1 cycle of study drug and have clear progression on physical exam or have had at least one restaging study will be considered evaluable for response. Each subject will receive the same dose of 750mg po daily at the study entry. Subjects with stable disease or better will be allowed to continue study drug until disease progression or until intolerable adverse events or patient or physician decision. Intrapatient dose reductions will be allowed for adverse events. Blood and tissue samples, will be collected and used for exploratory analysis.
Dose Level 0 (starting dose) 750mg/day Dose level -1 600mg/day Dose level -2 450mg/day
Baseline evaluations are to be conducted within 30 days prior to start of protocol therapy unless otherwise noted in the time to events table. Scans and x-rays must be performed within six weeks prior to the start of therapy. Bone marrow biopsy must be performed within twelve weeks prior to starting therapy. In the event that the patient's condition is deteriorating, laboratory evaluations should be repeated within 48 hours prior to initiation of the next cycle of therapy. All the labs have to be within the study eligibility range prior to the start of study treatment.
All visits should occur within 3 days before or after the scheduled day of the visit. An early or late visit will not shorten or extend the duration of that cycle - all cycles will be 28 days.
If study drug is held for any reason then the missed days should still be counted as a day in the cycle. However, if the study drug is on hold when a 28 day cycle ends, then day 1 of the next cycle and the necessary evaluations should not be started until drug is restarted. Therefore, the cycle during which a drug is held could potentially have more than 28 days.
Patients will be followed for up to 2 years after completion of therapy or until progression of disease or death, whichever comes first. In follow up, patients will be seen every 3 months for physical exam, lab draws for the first two years after completing all study drugs or until alternative therapy is begun or until progression of disease or death-whichever comes first. Radiographic imaging will be performed every 6 months for the first two years after study drug is completed.
Patients removed from study for unacceptable adverse events will be followed until resolution or stabilization of the adverse event and will continue to be followed until progression of disease or death. Unacceptable adverse events are those that lead to stopping of a study drug and for which there is no resolution of drug related toxicity after a 6 week washout period so that the subject is removed from study as defined in section 6.
Patients removed from the study due to progressive disease will be followed until resolution or stabilization of any adverse events due to the agents, after which their follow up will be completed.
At a minimum, all patients who discontinue ceritinib treatment, including those who refuse to return for a final visit, will be contacted for safety evaluations during the 30 days following the last dose of treatment
### Conditions Module
**Conditions:**
- Hematologic Malignancies
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Type:** ACTUAL
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** all ALK + hematologic malignancies patients will receive ceritinib
**Intervention Names:**
- Drug: ceritinib
**Label:** Ceritinib for ALK + patients
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Ceritinib for ALK + patients
**Description:** Ceritinib will be administered to ALK + hematologic malignancies orally at the 750mg/day dose that has been calculated as the maximum tolerated dose in prior phase I trials in lung cancer patients. Intra patient dose reductions will be allowed for toxicities. Subjects with stable disease or better will be allowed to continue study drug until disease progression or until intolerable adverse events or patient or physician choice.
**Name:** ceritinib
**Other Names:**
- LDK378
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** ORR defined as CR + PR. Stable disease of at least 3 months will also be reported.
**Measure:** Overall Response Rate (ORR)
**Time Frame:** 5 years
#### Secondary Outcomes
**Description:** Calculate the median time until disease progression or death in patients treated with ceritinib
**Measure:** Progression Free Survival (PFS)
**Time Frame:** 5 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Alk+R/R hematologic malignancy including but not limited to ALK+ALCL or ALK+LBCL \> 1 prior standard cytotoxic regimen
* Age \>18
* ECOG performance status \<2
* Evidence of measurable or evaluable disease
* Toxicities ≤ grade 2 due to prior therapies Exception: any grade alopecia
* Platelets \>75 x 109/L
* ANC\>1.5 x 109/L
* AST/ALT\<3.0 x ULN, except liver involvement by their lymphoma, include if AST/ALT\<5 x ULN.
* Total Bilirubin\<1.5 x ULN, (includes gilbert's syndrome if total bilirubin \<3.0 x ULN and direct bilirubin \<1.5 x ULN)
* Potassium, magnesium, total calcium and phosphorous \> lower limits of normal
* Calculated or measured CrCl\> 30ml/min
* Ability to provide written informed consent
* Willing/able to comply with scheduled visits, treatment plans, laboratory tests and other procedures
* Women/men of reproductive potential must agree to use effective birth control during study and for 3 months after receiving study drug.
* Must have existing tissue available for correlative studies
Exclusion Criteria:
* No chemotherapy, radiation or surgical resection of malignancy \< 3 weeks before start of study drug
* Prior therapy with other ALK inhibitor investigational agents except crizotinib
* Active, uncontrolled, serious infection or medical or psychiatric illness likely to interfere with trial
* Known HIV infection
* Extensive disseminated bilateral interstitial fibrosis or interstitial lung disease, (history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, obliterative bronchiolitis or clinically significant radiation pneumonitis) i.e. affecting daily living or requiring ongoing therapeutic intervention.
* Symptomatic CNS metastases and neurologically unstable or increasing doses of steroids \< 2 weeks prior to study entry
* Major surgery 4 weeks before initiating protocol therapy.
* Hypersensitivity to microcrystalline cellulose, mannitol, crospovidone, colloidal silicon dioxide, magnesium stearate
* Diagnosis or treatment for malignancy other than NHL \< 3 years before Day 1 of protocol therapy. Exceptions:
* Basal or squamous cell carcinoma of the skin
* In situ malignancy - completely resected.
* Prostate cancer treated with prostatectomy or radiotherapy \> 2 years before Day 1 of protocol therapy and PSA is undetectable
* In situ malignancy - completely resected
* Current treatment with another investigational agent \< 14 days before enrollment. Other non-treatment studies allowed if it won't interfere with study participation.
* Myocardial infarction or unstable angina 6 months before enrollment or New York Hospital Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
o QTcF\>450msec
* Oral steroids \> 4mg dexamethasone or equivalent/day excluding steroids used for adrenal insufficiency
* Impaired GI function from significant small bowel resection or gastric bypass surgery or inability to swallow up to five ceritinib capsules daily
* Ongoing GI adverse events \> grade 2 (e.g. nausea, vomiting, or diarrhea) at start of study.
* Receiving medications that meet one of the following criteria and that cannot be discontinued at least 1 week prior to start of treatment and for the duration of participation:
* Medication with a significant known risk of prolonging the QT interval or inducing Torsades de Pointes http://www.azcert.org/medical-pros/drug-lists/drug-lists.cfm
* Strong inhibitors or strong inducers of CYP3A4/5 http://medicine.iupui.edu/flockhart/table.htm or http://www.druginteractioninfo.org
* Therapeutic doses of warfarin sodium (Coumadin) or coumadin-derived anti-coagulant.
* Enzyme-inducing anticonvulsive agents
* Herbal supplements
* Pregnant or nursing (lactating) women
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Durham
**Country:** United States
**Facility:** Duke University Medical Center
**State:** North Carolina
**Zip:** 27710
#### Overall Officials
**Official 1:**
**Affiliation:** Duke University
**Name:** Anne Beaven, MD
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000006402
- Term: Hematologic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC15
- Name: Blood and Lymph Conditions
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M21314
- Name: Hematologic Neoplasms
- Relevance: HIGH
- As Found: Hematologic Malignancies
- ID: M9490
- Name: Hematologic Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000009369
- Term: Neoplasms
- ID: D000019337
- Term: Hematologic Neoplasms
### Intervention Browse Module - Ancestors
- ID: D000092004
- Term: Tyrosine Kinase Inhibitors
- ID: D000047428
- Term: Protein Kinase Inhibitors
- ID: D000004791
- Term: Enzyme Inhibitors
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000000970
- Term: Antineoplastic Agents
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Gast
- Name: Gastrointestinal Agents
- Abbrev: AA
- Name: Amino Acids
### Intervention Browse Module - Browse Leaves
- ID: M81041
- Name: Ceritinib
- Relevance: HIGH
- As Found: Packing
- ID: M239062
- Name: Lactitol
- Relevance: LOW
- As Found: Unknown
- ID: M2889
- Name: Tyrosine Kinase Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M25820
- Name: Protein Kinase Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M7951
- Name: Enzyme Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: T22
- Name: Tyrosine
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: C000586847
- Term: Ceritinib
### Misc Info Module
- Version Holder: 2024-05-24
|