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## Protocol Section
### Identification Module
**NCT ID:** NCT06332079
**Acronym:** HAITI
**Brief Title:** Holmium-166 TARE in Liver Limited Unresectable Colorectal Cancer Patients
**Official Title:** Phase II Study Evaluating Holmium-166 TARE Followed by Maintenance Therapy in Liver Limited Unresectable Colorectal Cancer Patients After First-line Chemotherapy and Target Agents
#### Organization Study ID Info
**ID:** HAITI 2023-505356-22-00
#### Organization
**Class:** OTHER
**Full Name:** Gruppo Oncologico del Nord-Ovest
### Status Module
#### Completion Date
**Date:** 2027-02
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-03-27
**Type:** ACTUAL
**Last Update Submit Date:** 2024-03-25
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2026-11
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-03-13
**Type:** ACTUAL
**Status Verified Date:** 2024-03
#### Study First Post Date
**Date:** 2024-03-27
**Type:** ACTUAL
**Study First Submit Date:** 2024-03-08
**Study First Submit QC Date:** 2024-03-25
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Gruppo Oncologico del Nord-Ovest
#### 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 assess the efficacy of 166Ho-TARE followed by maintenance therapy with fluoropyrimidine and anti-EGFR or bevacizumab in liver-limited unresectable colorectal cancer patients, in terms of progression free rate 9- and 8-months for cohort A and B, respectively.
**Detailed Description:** HAITI is a phase II, single-arm trial of 166Ho-TARE followed by maintenance therapy in liver-limited unresectable colorectal cancer patients, achieving partial response or stable disease according to RECIST 1.1 criteria after 6-12 cycles of induction first-line chemotherapy.
Two cohorts of patients are included:
* left sided RAS/BRAF wild-type (cohort A)
* right-sided and/or RAS mutated (cohort B)
Enrolled patients will be treated with different maintenance therapy according to study cohort (fluoropyrimidine + anti-EGFR or bevacizumab).
### Conditions Module
**Conditions:**
- Colorectal Cancer Metastatic
**Keywords:**
- HOLMIUM
- TARE
- Maintenance therapy
- Liver-limited colorectal cancer
- Unresectable colorectal cancer
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** Two cohorts of patients will be included according to the two main prognostic populations in mCRC (left sided, RAS/BRAF wild-type and, right-sided and/or RAS mutated tumors) treated with different maintenance therapy (fluoropyrimidine plus anti-EGFR or bevacizumab).
A total of 23 patients will be enrolled in each cohort.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 46
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Eligible patients will receive Scout dose procedure. After 1-2 weeks, patients eligible for radioembolization will receive 166Ho-TARE and at least after 3 weeks, maintenance treatment with fluoropyrimidine plus target agents (anti-EGFR or bevacizumab) according to the respective study cohort.
Maintenance treatment:
Cohort A:
* CETUXIMAB iv day1, over 1 hours, 500 mg/sqm or PANITUMUMAB iv over 1 hours, 6 mg/kg, every 14 days
* LED 200 mg/sqm iv over 1 hour, day 1
* 5-FLUOROURACIL ic 48 h, starting on day 1 every 14 days; 2400 mg/sqm and 400 mg/sqm bolus if FOLFOX/FOLFIRI in the induction treatment
Cohort B:
* BEVACIZUMAB 5 mg/kg iv biweekly day1, over 30 minutes
* LED 200 mg/sqm iv over 1 hour, day 1
* 5-FLUOROURACIL ic 48 h, starting on day 1 every 14 days; 2400 mg/sqm and 400 mg/sqm bolus if FOLFOX/FOLFIRI in the induction treatment
CAPECITABINE, 1000 mg/sqm orally twice daily, day 1-14, plus bevacizumab 7,5 mg/kg iv every 21 days is allowed.
**Intervention Names:**
- Procedure: 166Holmium TARE
- Drug: Cetuximab
- Drug: Panitumumab
- Drug: 5-Fluorouracil
- Drug: Bevacizumab
- Drug: Capecitabine
**Label:** COHORT A/B
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- COHORT A/B
**Description:** 166Ho-TARE treatment comprises of two hospital visits: one for a work-up procedure and another for the therapy procedure, with usually a 1-2 weeks interval.
**Name:** 166Holmium TARE
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- COHORT A/B
**Description:** Target agent
**Name:** Cetuximab
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- COHORT A/B
**Description:** Target agent
**Name:** Panitumumab
**Type:** DRUG
#### Intervention 4
**Arm Group Labels:**
- COHORT A/B
**Description:** Chemotherapy
**Name:** 5-Fluorouracil
**Type:** DRUG
#### Intervention 5
**Arm Group Labels:**
- COHORT A/B
**Description:** Target agent
**Name:** Bevacizumab
**Type:** DRUG
#### Intervention 6
**Arm Group Labels:**
- COHORT A/B
**Description:** Chemotherapy
**Name:** Capecitabine
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** PFS is defined as the time from study enrolment to the first documentation of objective disease progression or death due to any cause, whichever occurs first. PFS will be censored on the date of the last evaluable on study tumor assessment documenting absence of progressive disease for patients who are alive, on study and progression free at the time of the analysis.
**Measure:** Progression-free survival (PFS) Rate
**Time Frame:** 36 months
#### Secondary Outcomes
**Description:** Overall Toxicity rate is defined as the percentage of patients, relative to the total of enrolled subjects, who receive 166Ho-TARE and at least one cycle of chemotherapy, experiencing any adverse event, according to National Cancer Institute Common Toxicity Criteria (version 5.0) during the study treatment.
**Measure:** Overall Toxicity rate
**Time Frame:** 36 months
**Description:** Grade 3/ Grade 4 Toxicity rate is defined as the percentage of patients, relative to the total of enrolled subjects, who receive 166Ho-TARE and at least one cycle of chemotherapy, experiencing a specific adverse event of severity grade 3/ grade 4, according to National Cancer Institute Common Toxicity Criteria (version 5.0) during the study treatment.
**Measure:** Grade 3/ Grade 4 Toxicity rate
**Time Frame:** 36 months
**Description:** Post-treatment DCR, is defined as the percentage of patients, relative to the total of enrolled subjects, achieving a complete (CR), partial (PR) response or stable disease (SD), according to RECIST 1.1 criteria, during the study treatment. The determination of clinical response will be based on investigator reported measurements. Tumor re-assessment with CT scan will be repeated every 8- weeks.
**Measure:** Post-treatment Disease Control Rate (DCR)
**Time Frame:** 36 months
**Description:** Progression free survival (PFS), is defined as the time from study enrolment to the first documentation of objective disease progression or death due to any cause, whichever occurs first. PFS will be censored on the date of the last evaluable on study tumor assessment documenting absence of progressive disease for patients who are alive, on study and progression free at the time of the analysis.
**Measure:** Progression free survival
**Time Frame:** 36 months
**Description:** Overall Survival (OS), is defined as the time from enrolment to death from any cause. For patients still alive at the time of analysis, the OS time will be censored on the last date the patients were known to be alive.
**Measure:** Overall Survival
**Time Frame:** 36 months
**Description:** Dose-response relationships are defined as the relationships between the tumor-absorbed doses calculated on post-treatment SPECT-CT (dependent variables) and the following independent variables: tumor response (SD, PR, CR according to RECIST CRITERIA v 1.1), progression free survival rate, and Overall Survival.
**Measure:** Dose-response relationships
**Time Frame:** 36 months
**Description:** The EORTC QLQ-CR29 is a patient-reported outcome measure to evaluate health-related quality of life among colorectal cancer patients in research and clinical practice.
QoL assessed using the EORTC QLQ-CR29 questionnaire will be evaluate at specific time-points (baseline, tumor reassessment and disease progression) and will be assessed through descriptive summary statistics.
**Measure:** Quality of Life (QoL) assessed using the EORTC QLQ-CR29 questionnaire
**Time Frame:** 36 months
**Description:** The EORTC QLQ-CR30 is 30-item instrument designed to measure quality of life in all cancer patients.
QoL assessed using the EORTC QLQ-CR30 questionnaire will be evaluate at specific time-points (baseline, tumor reassessment and disease progression) and will be assessed through descriptive summary statistics.
**Measure:** Quality of Life (QoL) assessed using the EORTC QLQ-CR30 questionnaire
**Time Frame:** 36 months
**Description:** The EuroQol EQ-5D comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
QoL assessed using the EuroQol EQ-5D questionnaire will be evaluate at specific time-points (baseline, tumor reassessment and disease progression) and will be assessed through descriptive summary statistics.
**Measure:** Quality of Life (QoL) assessed using the EuroQol EQ-5D questionnaire
**Time Frame:** 36 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Written informed consent to study procedures;
* Age ≥18 years;
* Histologically proven diagnosis of colorectal adenocarcinoma, with or without primary tumour in situ;
* Liver-only disease at radiological exams involving less than 50% of liver volume;
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤2;
* Patients with partial response or stable disease according to RECIST 1.1 criteria deemed unresectable after 6-12 cycles of induction first-line chemotherapy;
* Life expectancy of at least 12 weeks;
* Hematopoietic function: absolute neutrophil count ≥ 1,500/mm3; platelet count
≥100,000/mm3; haemoglobin level ≥ 9 g/dL;
* Liver function: total bilirubin ≤ 1.5 times upper limit of normal (ULN); alkaline phosphatase
≤ 5 times ULN; AST ≤ 5 times ULN;
* Renal function: creatinine clearance \> 50 mL/min or serum creatinine 1.5 x UNL; no renal disease that would preclude study treatment or follow-up;
* Women of childbearing potential must have a negative blood pregnancy test at the screening visit. For this trial, women of childbearing potential are defined as all women after puberty, unless they are postmenopausal for at least 12 months, are surgically sterile, or are sexually inactive. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient;
* Subjects and their partners must be willing to avoid pregnancy during the trial. Male subjects with female partners of childbearing potential and female subjects of childbearing potential must, therefore, be willing to use adequate contraception as outlined in Section 7.5 - Contraception, starting during study screening visit throughout the study period up to 180 days after the last dose of chemotherapy Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject;
* Will and ability to comply with the protocol
Inclusion criteria for Cohort A:
* RAS/BRAF wild-type and left sided primary tumor
* First-line induction chemotherapy regimen permitted up to 6-12 cycles with:
FOLFOX or FOLFIRI + anti-EGFR (cetuximab or panitumumab). Patients who interrupted anti-EGFR target therapy during induction phase due to toxicity or other reasons, candidate to maintenance with fluoropyridine alone therapy can be enrolled.
Inclusion criteria for Cohort B:
* RAS mutated and/or right-sided primary tumor
* First-line induction chemotherapy regimen admitted up to 6-12 cycles with:
FOLFOX/FOLFIRI/XELOX + bevacizumab or FOLFOXIRI + bevacizumab. Patients who interrupted bevacizumab during induction phase due to toxicity or other reasons, candidate to maintenance with fluoropyridine alone therapy can be enrolled.
Exclusion Criteria:
* Patients with radiological evidence of extra liver distant metastases.
* Evidence of ascites, cirrhosis, portal hypertension, main portal venous tumour involvement or thrombosis, or any other contraindications to radioembolization treatment;
* Previous radiotherapy delivered to the liver;
* Patients with BRAF mutated and/or MSI-high tumours;
* Previous history of malignancy within the last 5 years will be excluded with the exception of localized basal and squamous cell carcinoma or cervical cancer in situ;
* Treatment with any investigational drug within 30 days prior to enrolment or 2 investigational agent half-lives (whichever is longer);
* Active uncontrolled infections or other clinically relevant concomitant illness contraindicating study procedures and treatment administration Clinically significant (e.g. active) cardiovascular disease for example cerebrovascular accidents (≤6 months), myocardial infarction (≤6 months), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure (CHF), serious cardiac arrhythmia requiring medication
* Pregnant or lactating women. Women of childbearing potential with either a positive or no pregnancy test at baseline. Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study and until 180 days after the last trial treatment;
* History of a previous allergic reaction to contrast media that would preclude safe angiography of the hepatic arteries, in the opinion of the treating Interventional Radiologist;
* Known hypersensitivity to fluoropyrimidine, anti-VEGF or anti-EGFR MoAb.
* Psychiatric or addictive disorders, or other conditions that, in the opinion of the investigator, would preclude study participation;
* Withdrawal of the consent to take part to the study
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Gianluca Masi, MD
**Phone:** +39050992466
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Laura Delliponti
**Phone:** +39.050.992192
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Pisa
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Beatrice Borelli, MD, PhD
- **Phone:** +39050992192
- **Role:** CONTACT
***Contact 2:***
- **Name:** Gianluca Masi, MD
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 3:***
- **Name:** Beatrice Borelli, MD, PhD
- **Role:** SUB_INVESTIGATOR
**Country:** Italy
**Facility:** Azienda Ospedaliero Universitaria Pisana
**Status:** RECRUITING
**Zip:** 56126
#### Overall Officials
**Official 1:**
**Affiliation:** Azienda Ospedaliero, Universitaria Pisana
**Name:** Gianluca Masi, MD
**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
### 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: 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
### Condition Browse Module - Meshes
- ID: D000015179
- Term: Colorectal Neoplasms
### Intervention Browse Module - Ancestors
- ID: D000074322
- Term: Antineoplastic Agents, Immunological
- ID: D000000970
- Term: Antineoplastic Agents
- ID: D000020533
- Term: Angiogenesis Inhibitors
- ID: D000043924
- Term: Angiogenesis Modulating Agents
- ID: D000006133
- Term: Growth Substances
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000006131
- Term: Growth Inhibitors
- ID: D000000964
- Term: Antimetabolites, Antineoplastic
- ID: D000000963
- Term: Antimetabolites
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000007166
- Term: Immunosuppressive Agents
- ID: D000007155
- Term: Immunologic Factors
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Hemat
- Name: Hematinics
### Intervention Browse Module - Browse Leaves
- ID: M315
- Name: Cetuximab
- Relevance: HIGH
- As Found: Solid
- ID: M8600
- Name: Fluorouracil
- Relevance: HIGH
- As Found: According
- ID: M377
- Name: Capecitabine
- Relevance: HIGH
- As Found: Function
- ID: M246
- Name: Bevacizumab
- Relevance: HIGH
- As Found: Non-
- ID: M11110
- Name: Liver Extracts
- Relevance: LOW
- As Found: Unknown
- ID: M1822
- Name: Panitumumab
- Relevance: HIGH
- As Found: 2/day
- ID: M1346
- Name: Antineoplastic Agents, Immunological
- 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: M4281
- Name: Antimetabolites
- 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: D000068258
- Term: Bevacizumab
- ID: D000068818
- Term: Cetuximab
- ID: D000077544
- Term: Panitumumab
- ID: D000069287
- Term: Capecitabine
- ID: D000005472
- Term: Fluorouracil
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT01954979
**Brief Title:** Abatacept to Treat Steroid Refractory Chronic Graft Versus Host Disease (cGVHD)
**Official Title:** A Phase I Study of Abatacept in the Treatment of Patients With Steroid Refractory Chronic Graft Versus Host Disease (cGVHD)
#### Organization Study ID Info
**ID:** 13-358
#### Organization
**Class:** OTHER
**Full Name:** Beth Israel Deaconess Medical Center
### Status Module
#### Completion Date
**Date:** 2024-01-16
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-01-18
**Type:** ACTUAL
**Last Update Submit Date:** 2024-01-16
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-06-01
**Type:** ACTUAL
#### Start Date
**Date:** 2014-03-27
**Type:** ACTUAL
**Status Verified Date:** 2024-01
#### Study First Post Date
**Date:** 2013-10-07
**Type:** ESTIMATED
**Study First Submit Date:** 2013-09-27
**Study First Submit QC Date:** 2013-09-27
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** Bristol-Myers Squibb
**Class:** OTHER
**Name:** Dana-Farber Cancer Institute
#### Lead Sponsor
**Class:** OTHER
**Name:** Beth Israel Deaconess Medical Center
#### Responsible Party
**Investigator Affiliation:** Beth Israel Deaconess Medical Center
**Investigator Full Name:** Jacalyn Rosenblatt
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The participant is invited to take part in this study because they have chronic Graft versus Host Disease (cGVHD) that is not responding to standard treatment with steroids. This research study is a way of gaining new knowledge about the treatment of patients with cGVHD. This research study is evaluating a drug called abatacept.
Abatacept is a drug that alters and suppresses the immune system. Abatacept is approved by the Food and Drug Administration (FDA) for the treatment of moderate to severe active rheumatoid arthritis in adults and of severe juvenile idiopathic arthritis (JIA) in patients who have failed prior therapy with disease-modifying anti-rheumatic drugs (DMARDs). These are autoimmune conditions, ie caused by an overactive immune system that attacks normal tissues and organs. It is currently being tested in a variety of other autoimmune conditions. In this case it is considered experimental.
cGVHD is caused by the donor cells attacking various organs of the recipient. The investigators try to minimize this immune attack by using corticosteroids such as prednisone. In severe cases prednisone is not sufficient and other immunosuppressive medications are used in addition in order to more efficiently control cGVHD and to limit the dose and consequently the multiple side-effects of corticosteroids. This study is being done to determine if the use of abatacept is safe in patients with cGVHD and if it can facilitate a better control of cGVHD.
During this study the participants will be evaluated for side effects from the treatment with abatacept, and for response of the cGVHD to the treatment. There will be two groups of participants in the study. The first group will be treated at a relatively low dose of abatacept. If this is found to be safe then the second group will be treated at a higher dose. Three to four tablespoons of blood will be drawn at every 2 week visit in order to determine your blood counts, kidney and liver function. Some of the blood will be used in a research lab in order to study measures of your immune system and how they might be affected by the treatment.
**Detailed Description:** Before the research starts (screening): After signing the consent form, the participant will be asked to undergo some screening tests or procedures to find out if they can be in the research study. Many of these tests and procedures are likely to be part of regular cGVHD care and may be done even if it turns out that the participant does not take part in the research study. If the participant has had some of these tests or procedures recently, they may or may not have to be repeated.
* Complete Medical History and Physical Examination
* Blood Collection: 3-4 tablespoons of blood will be drawn to measure the participants complete blood counts, kidney, liver and thyroid function
* Disease Assessment: Depending on what organs are affected by their cGVHD the participant may undergo blood tests or a skin exam or an eye exam or a dental exam.
* Electrocardiogram (EKG): a noninvasive test that measures the electrical activity of the participant's heart
* A tuberculin skin test and a quantiferon blood test to rule out tuberculosis
* Pregnancy testing if applicable
* HIV and Hepatitis blood test: 2-3 teaspoons of blood will be collected to perform an HIV test. The participant will be asked to sign a separate consent form for this test. The participant's doctor will discuss the results of this test with the participant and the results will become a part of their permanent medical record. The participant may seek private HIV testing prior to consenting, and based on the results may choose whether or not to participate in this study or have the HIV test become part of their medical records.
If these tests show that the participant is eligible to participate in the research study, the participant will begin the study treatment. If the participant does not meet the eligibility criteria, the participant will not be able to participate in this research study.
Additional research procedures to be performed at the time of screening:
- Research blood testing: to study measures of the participant's immune system
After the screening procedures confirm that the participant is eligible to participate in the research study:
* Since the investigators are looking for the highest dose of the study drug that can be administered safely without severe or unmanageable side effects in participants that have abatacept, not everyone who participates in this research study will receive the same dose of the study drug. The dose the participant gets will depend on the number of participants who have been enrolled in the study before the participant and how well they have tolerated their doses.
* The total duration of treatment on this study is approximately 113 days or 6 treatments. Doses 1-3 will be administered every two weeks. One month following Dose 3, abatacept will be administered every four weeks for the remaining three doses (Doses 4-6.) The treatment will be given intravenously on these days. One month following your last dose of treatment, the participant will be seen in clinic. The participant will be seen in the clinic weekly through dose 4, then every 2 weeks for follow up even if the participant doesn't have treatment.
* The first group of participants will be treated with a lower dose of abatacept. If this dose is determined to be safe then the second group will be treated at a higher dose.
During treatment the participant will be seen in the clinic every two weeks. At every visit the following will be performed:
* Complete Medical History and Physical Examination
* Blood Collection: 3-4 tablespoons of blood will be drawn to measure their complete blood counts, kidney, liver and thyroid function
* Research blood testing: to study measures of the participant's immune system
* On the days of treatment the participant will undergo an assessment of cGVHD depending on what organs are affected
After the final dose of the study drug:
After the participant has completed taking the drug on the study, the following procedures and tests will take place:
* Safety assessment 28 days after the last dose of the study drug.
* Complete Medical History and Physical Examination
* Blood Collection: 3-4 tablespoons of blood will be drawn to measure the participant's complete blood counts, kidney, liver and thyroid function
* Disease Assessment: by physical exam and blood tests if the participant has leukemia or multiple myeloma, or physical exam and PET/CT or CT scan if the participant has lymphoma. These will be done at the safety assessment visit and at the 3 and 6 month follow up visits.
* Electrocardiogram
* Research blood testing: to study measures of your immune system
* Once the participant has completed treatment on study they will be followed monthly for 6 months
### Conditions Module
**Conditions:**
- Chronic Graft Versus Host Disease
**Keywords:**
- Graft versus Host Disease
- ABATACEPT
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 56
**Type:** ACTUAL
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Abatacept will be administered for a total of 6 doses. Doses 1-3 will be administered at two week intervals (+/-2 days). One month following Dose 3, abatacept will be administered, and given at four-week intervals (+/-2 days) for three doses (Doses 4-6.) Patients will be followed for toxicity for 28 days following last dose of Abatacept. Patients will then be seen monthly for six months.
**Intervention Names:**
- Drug: Abatacept
**Label:** Abatacept
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Abatacept
**Description:** The study will follow a standard 3+3 design with two escalating doses of abatacept to determine the maximum tolerated dose (MTD): 3 mg/kg (dose level 1) and 10 mg/kg (dose level 2). Dose-limiting toxicities (DLTs) are defined as any Grade 3 or 4 toxicities judged to be probably or definitely related to abatacept.
**Name:** Abatacept
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Determination of the Maximum Tolerated Dose (among two dose levels) and toxicity profile of a 141 day/6 dose course of abatacept in patients with steroid refractory cGVHD.
**Measure:** Determination of the Maximum Tolerated Dose (among two dose levels) and toxicity profile of a 141 day/6 dose course of abatacept in patients with steroid refractory cGVHD.
**Time Frame:** 2 Years
#### Secondary Outcomes
**Description:** Determination of the efficacy (in terms of cGVHD symptoms, score and steroid dose) of a 141 day/6 dose course of abatacept in patients with steroid refractory cGVHD
**Measure:** Determination of the efficacy (in terms of cGVHD symptoms, score and steroid dose) of a 141 day/6 dose course of abatacept in patients with steroid refractory cGVHD
**Time Frame:** 2 Years
**Description:** Examination of the immunologic effects associated with the administration of abatacept in patients with steroid refractory cGVHD.
**Measure:** Examination of the immunologic effects associated with the administration of abatacept in patients with steroid refractory cGVHD.
**Time Frame:** 2 Years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
Participants must meet the following criteria on screening examination to be eligible to participate in the study:
* Participants must be recipients of an allogeneic bone marrow or stem cell transplantation with myeloablative or reduced intensity conditioning regimens.
* Participants must be at least 100 days after the transplantation or a donor lymphocyte infusion.
* Participants must have cGVHD (as defined by the National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease)
* Participants may have either extensive or limited cGVHD requiring systemic treatment
* Participants must have steroid refractory cGVHD, defined as having persistent signs and symptoms of chronic GVHD despite the use of prednisone at ≥ 0. 5 mg/kg/day (or equivalent) for at least 4 weeks in the preceding 12 months. Patients may remain on steroids while enrolled in the study.
* No addition or subtraction of other immunosuppressive medications for at least 4 weeks prior to starting treatment.
* On stable immunosuppressive regimen for 2 weeks prior to enrollment. Adjustment of immunosuppressive medications to maintain a therapeutic level is permitted.
* Age ≥ 18 years at the time of signing the informed consent form.
Reproductive Status: Definition of Women of Child-Bearing Potential (WOCBP). WOCBP comprises women who have experienced menarche and who have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or who are not post-menopausal (see definition below).
Post-menopause is defined as:
* Women who have had amenorrhea for ≥ 12 consecutive months (without another cause) and who have a documented serum follicle-stimulating hormone (FSH) level \> 35 mIU/mL.
* Women who have irregular menstrual periods and a documented serum FSH level \> 35 mIU/mL.
* Women who are taking hormone replacement therapy (HRT).
The following women are WOCBP:
* Women using the following methods to prevent pregnancy: Oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as intrauterine devices or barrier methods (diaphragm, condoms, spermicides).
* Women who are practicing abstinence.
* Women who have a partner who is sterile (eg, due to vasectomy). WOCBP must be using an acceptable method of contraception to avoid pregnancy throughout the study and for up to 10 weeks after the last dose of study drug in such a manner that the risk of pregnancy is minimized.
* WOCBP must have a negative serum or urine pregnancy test result (minimum sensitivity 25 IU/L or equivalent units of HCG) within 0 to 48 hours before the first dose of study drug.
* Women must not be breast-feeding.
* Sexually active fertile men must use effective birth control if their partners are WOCBP.
* Life expectancy of greater than \> 3 months.
* ECOG performance status ≤ 2 (see Appendix A).
* Laboratory test results within these ranges:
* Absolute neutrophil count ≥ 1500/mm³
* Serum creatinine ≤ 2.0 mg/dL
* Renal function assessed by calculated creatinine clearance ≥ 60ml/min by Cockcroft-Gault formula (see Appendix B: Cockcroft-Gault estimation of CrCl).
* Total bilirubin ≤ 1.5 x ULN (unless hepatic dysfunction is caused by cGVHD)AST (SGOT) and ALT (SGPT) ≤ 3 x ULN (unless hepatic dysfunction is caused by cGVHD).
* Patients much have a negative PPD skin test and a negative Quantiferon assay.
* Must possess the ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
* Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study.
* Any serious medical condition (including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia), laboratory abnormality, or psychiatric illness/ social situation that would prevent the subject from signing the informed consent form or limit compliance with study requirements.
* Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
* Use of any other experimental drug or therapy within 28 days of starting treatment with abatacept.
* Use of biologic antibody therapy for cGVHD with rituximab, alemtuzumab, or ATG within 6 months of starting treatment with abatacept.
* Use of TNF alpha inhibitors within four weeks prior to study entry.
* Ongoing prednisone requirement \>1 mg/kg/day (or equivalent)
* New immunosuppressive medication or ECP within 28 days of starting treatment with abatacept.
* Donor lymphocyte infusion within 100 days prior to enrollment.
* Active malignant disease relapse or other active malignancy with the exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast.
* Participants who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
* Known seropositive for or positive viral load for HIV or positive viral loads for infectious hepatitis, type B (HBV) or C (HCV).
* Uncontrolled intercurrent active infection. Controlled infection on long term suppressive or maintenance therapy is permissible.
* Use of live vaccines within four weeks of starting abatacept.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Boston
**Country:** United States
**Facility:** Dana-Farber Cancer Institute
**State:** Massachusetts
**Zip:** 02115
**Location 2:**
**City:** Boston
**Country:** United States
**Facility:** Beth Israel Deaconess Medical Center
**State:** Massachusetts
**Zip:** 02215
#### Overall Officials
**Official 1:**
**Affiliation:** Beth Israel Deaconess Medical Center
**Name:** Jacalyn Rosenblatt, MD
**Role:** PRINCIPAL_INVESTIGATOR
### References Module
#### References
**Citation:** Nahas MR, Soiffer RJ, Kim HT, Alyea EP 3rd, Arnason J, Joyce R, Antin JH, Ho VT, Stroopinsky D, Li S, Levine JD, McMasters M, Jain S, Hamdan A, Tzachanis D, Bryant MP, Logan EK, Bazemore J, Stewart J, Joyce A, Stephenson S, Washington A, Cole L, Pyzer A, Leaf RK, Avigan DE, Rosenblatt J. Phase 1 clinical trial evaluating abatacept in patients with steroid-refractory chronic graft-versus-host disease. Blood. 2018 Jun 21;131(25):2836-2845. doi: 10.1182/blood-2017-05-780239. Epub 2018 Mar 16.
**PMID:** 29549175
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007154
- Term: Immune System Diseases
- ID: D000092124
- Term: Organizing Pneumonia
- ID: D000001989
- Term: Bronchiolitis Obliterans
- ID: D000001988
- Term: Bronchiolitis
- ID: D000001991
- Term: Bronchitis
- ID: D000001982
- Term: Bronchial Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
- ID: D000008173
- Term: Lung Diseases, Obstructive
- ID: D000008171
- Term: Lung Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BC01
- Name: Infections
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M9189
- Name: Graft vs Host Disease
- Relevance: HIGH
- As Found: Graft Versus Host Disease
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M5264
- Name: Bronchiolitis
- Relevance: LOW
- As Found: Unknown
- ID: M2893
- Name: Bronchiolitis Obliterans Syndrome
- Relevance: HIGH
- As Found: Chronic Graft Versus Host Disease
- ID: M5265
- Name: Bronchiolitis Obliterans
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M13904
- Name: Pneumonia
- Relevance: LOW
- As Found: Unknown
- ID: M2894
- Name: Organizing Pneumonia
- Relevance: LOW
- As Found: Unknown
- ID: M5267
- Name: Bronchitis
- Relevance: LOW
- As Found: Unknown
- 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: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: HIGH
- As Found: Chronic Graft Versus Host Disease
- ID: T2832
- Name: Homologous Wasting Disease
- Relevance: HIGH
- As Found: Graft Versus Host Disease
- ID: T871
- Name: Bronchiolitis Obliterans
- Relevance: LOW
- As Found: Unknown
- ID: T872
- Name: Bronchiolitis Obliterans Organizing Pneumonia
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000092122
- Term: Bronchiolitis Obliterans Syndrome
- ID: D000006086
- Term: Graft vs Host Disease
### Intervention Browse Module - Ancestors
- ID: D000082082
- Term: Immune Checkpoint Inhibitors
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000074322
- Term: Antineoplastic Agents, Immunological
- ID: D000000970
- Term: Antineoplastic Agents
- ID: D000007166
- Term: Immunosuppressive Agents
- ID: D000007155
- Term: Immunologic Factors
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000018501
- Term: Antirheumatic Agents
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: ARhu
- Name: Antirheumatic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M483
- Name: Abatacept
- Relevance: HIGH
- As Found: Panel
- ID: M2342
- Name: Immune Checkpoint Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M1346
- Name: Antineoplastic Agents, Immunological
- 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: M20604
- Name: Antirheumatic Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000069594
- Term: Abatacept
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT00005179
**Brief Title:** Diet, Exercise and Cardiovascular Health Among Ethnic Children
#### Organization Study ID Info
**ID:** 1057
#### Organization
**Class:** OTHER
**Full Name:** Augusta University
#### Secondary ID Infos
**ID:** R03HL047534
**Link:** https://reporter.nih.gov/quickSearch/R03HL047534
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 1990-06
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2015-12-23
**Type:** ESTIMATED
**Last Update Submit Date:** 2015-12-21
**Overall Status:** COMPLETED
#### Start Date
**Date:** 1985-09
**Status Verified Date:** 2000-04
#### Study First Post Date
**Date:** 2000-05-26
**Type:** ESTIMATED
**Study First Submit Date:** 2000-05-25
**Study First Submit QC Date:** 2000-05-25
### Sponsor Collaborators Module
#### Collaborators
**Class:** NIH
**Name:** National Heart, Lung, and Blood Institute (NHLBI)
#### Lead Sponsor
**Class:** OTHER
**Name:** Augusta University
### Description Module
**Brief Summary:** To document the patterns of influence or socialization from parents to children in regard to the transmission of cardiovascular disease risk related behaviors such as diet and physical activity.
**Detailed Description:** BACKGROUND:
While much of the research in heart disease prevention has focused on relationships among cardiovascular disease risk factors, cardiovascular disease morbidity and mortality, there is a growing recognition of the importance of various health behaviors, such as what people eat, how much they exercise, if they smoke, their habitual approach to life including Type A behavior. Many of these risk related behaviors are correlated with the various cardiovascular disease risks. This study determined differences in social influence patterns in regard to diet and exercise between obese and non-obese families, and the impact on the obesity, dietary and exercise habits, and risk factors of children beginning at three to four years of age until seven to eight years.
DESIGN NARRATIVE:
This prospective, longitudinal study collected data on the twelve cohorts of families. Blood pressures, resting pulse, height, weight, skinfolds, plasma cholesterol fractions and Type A behavior data were collected on the children at five times over the course of five years. During the four years between each of the clinic measurements, observational data were collected on the diet and exercise habits of the children. At the time of clinic assessment, clinic data were also collected on the parents of the children and self report data on the parents' diet, exercise habits, and other psychosocial variables. Two substudies were also conducted. The first assessed energy expenditure levels of children in the three age groups of 3-4 years, 5-6 years, and 7-8 years and the three body types of lean, average, and obese in 12 different activities. The second substudy assessed the accuracy of mothers' 24-hour recall of the diet and exercise behaviors of their 3-4 year old children as compared to observational data on the same behaviors.
### Conditions Module
**Conditions:**
- Cardiovascular Diseases
- Heart Diseases
- Obesity
### Design Module
**Study Type:** OBSERVATIONAL
### Eligibility Module
**Eligibility Criteria:** No eligibility criteria
**Maximum Age:** 100 Years
**Sex:** MALE
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
### References Module
#### References
**Citation:** Baranowski T, Hooks P, Tsong Y, Cieslik C, Nader PR. Aerobic physical activity among third- to sixth-grade children. J Dev Behav Pediatr. 1987 Aug;8(4):203-6.
**PMID:** 3611360
**Citation:** Eck LH, Klesges RC, Hanson CL, Baranowski T, Henske J. A comparison of four commonly used nutrient database programs. J Am Diet Assoc. 1988 May;88(5):602-4.
**PMID:** 3367021
**Citation:** Hooks PC, Tsong Y, Baranowski T, Henske JC, Nader PR, Levin JS. Recruitment strategies for multiethnic family and community health research. Fam Community Health. 1988 May;11(1):48-59. doi: 10.1097/00003727-198805000-00009. No abstract available.
**PMID:** 10286764
**Citation:** Baranowski T, Tsong Y, Henske J, Dunn JK, Hooks P. Ethnic variation in blood pressure among preadolescent children. Pediatr Res. 1988 Mar;23(3):270-4. doi: 10.1203/00006450-198803000-00008.
**PMID:** 3353173
**Citation:** Brodwick M, Baranowski T, Rassin DK. Patterns of infant feeding in a tri-ethnic population. J Am Diet Assoc. 1989 Aug;89(8):1129-32. No abstract available.
**PMID:** 2760374
**Citation:** Baranowski T, Bryan GT, Rassin DK, Harrison JA, Henske JC. Ethnicity, infant-feeding practices, and childhood adiposity. J Dev Behav Pediatr. 1990 Oct;11(5):234-9.
**PMID:** 2258441
**Citation:** Baranowski T, Tsong Y, Brodwick M. Scaling of response scale adverbs among black-American adults. Percept Mot Skills. 1990 Oct;71(2):547-59. doi: 10.2466/pms.1990.71.2.547.
**PMID:** 2251088
**Citation:** Baranowski T: Validity of Self Report of Physical Activity: An Information Processing Approach. Research Quarterly for Exercise and Sport, (in press), 0000
**Citation:** Perry C, Baranowski T, Parcel G: Social and Environmental Triggers and Reinforcements for Health Behavior: Social Learning Theory. In: Glanz K, Lewis FM, Rimer B, (Eds) Health Behaviors and Health Education Theory, Research and Practice. San Francisco: Jossey-Bass, (in press), 0000
**Citation:** Baranowski T, Bryan GT, Harrison JA, Rassin DK, Greaves KA, Baranowski JH. Height, infant-feeding practices and cardiovascular functioning among 3 or 4 year old children in three ethnic groups. J Clin Epidemiol. 1992 May;45(5):513-8. doi: 10.1016/0895-4356(92)90100-2.
**PMID:** 1588357
**Citation:** Higginbotham JC, Baranowski T, Puhl J, Greaves KA. Ethnicity, gender, and Type A differences in resting heart rate and blood pressure among young children. Ethn Dis. 1991 Spring;1(2):123-34.
**PMID:** 1842529
**Citation:** Treiber FA, Baranowski T, Braden DS, Strong WB, Levy M, Knox W. Social support for exercise: relationship to physical activity in young adults. Prev Med. 1991 Nov;20(6):737-50. doi: 10.1016/0091-7435(91)90068-f. Erratum In: Prev Med 1992 May;21(3):392.
**PMID:** 1766945
**Citation:** Baranowski T, Sprague D, Baranowski JH, Harrison JA. Accuracy of maternal dietary recall for preschool children. J Am Diet Assoc. 1991 Jun;91(6):669-74.
**PMID:** 2040780
**Citation:** Durant RH, Baranowski T, Davis H, Thompson WO, Puhl J, Greaves KA, Rhodes T. Reliability and variability of heart rate monitoring in 3-, 4-, or 5-yr-old children. Med Sci Sports Exerc. 1992 Feb;24(2):265-71.
**PMID:** 1549018
**Citation:** Puhl J, Greaves K, Hoyt M, Baranowski T. Children's Activity Rating Scale (CARS): description and calibration. Res Q Exerc Sport. 1990 Mar;61(1):26-36. doi: 10.1080/02701367.1990.10607475.
**PMID:** 2091164
**Citation:** DuRant RH, Baranowski T, Puhl J, Rhodes T, Davis H, Greaves KA, Thompson WO. Evaluation of the Children's Activity Rating Scale (CARS) in young children. Med Sci Sports Exerc. 1993 Dec;25(12):1415-21.
**PMID:** 8107551
**Citation:** Baranowski T, Domel SB. A cognitive model of children's reporting of food intake. Am J Clin Nutr. 1994 Jan;59(1 Suppl):212S-217S. doi: 10.1093/ajcn/59.1.212S.
**PMID:** 8279427
**Citation:** Baranowski T, Thompson WO, DuRant RH, Baranowski J, Puhl J. Observations on physical activity in physical locations: age, gender, ethnicity, and month effects. Res Q Exerc Sport. 1993 Jun;64(2):127-33. doi: 10.1080/02701367.1993.10608789.
**PMID:** 8341835
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC14
- Name: Heart and Blood Diseases
### Condition Browse Module - Browse Leaves
- ID: M12701
- Name: Obesity
- Relevance: LOW
- As Found: Unknown
- ID: M9419
- Name: Heart Diseases
- Relevance: HIGH
- As Found: Heart Disease
### Condition Browse Module - Meshes
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000006331
- Term: Heart Diseases
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT05562479
**Brief Title:** Effect of Sars-cov-2 on Donor Oocyte Quality and Quantity, a Multicenter Retrospective Study.
**Official Title:** Effect of Sars-cov-2 on Donor Oocyte Quality and Quantity, a Multicenter Retrospective Study.
#### Organization Study ID Info
**ID:** Novafem
#### Organization
**Class:** OTHER
**Full Name:** Novafem
### Status Module
#### Completion Date
**Date:** 2022-09-18
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-10-05
**Type:** ACTUAL
**Last Update Submit Date:** 2022-10-03
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2022-07-15
**Type:** ACTUAL
#### Start Date
**Date:** 2021-12-12
**Type:** ACTUAL
**Status Verified Date:** 2022-10
#### Study First Post Date
**Date:** 2022-09-30
**Type:** ACTUAL
**Study First Submit Date:** 2022-09-28
**Study First Submit QC Date:** 2022-09-28
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Novafem
#### Responsible Party
**Investigator Affiliation:** Novafem
**Investigator Full Name:** Jose Pablo Saffon
**Investigator Title:** Director
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Purpose: To determine the impact of SARS-CoV-2 infection and immunization on ovarian response to controlled ovarian stimulation (COS) and embryo development after in vitro fertilization (IVF) Methods: A retrospective multicentric cohort study of 427 oocyte donors was conducted between January 1st, 2018 and September 18th, 2022. Patients who recovered from SARS-CoV-2 infection, vaccinated or non-exposed were included. Demographic, cycle characteristics, and laboratory outcomes were compared.
**Detailed Description:** This was a multicenter retrospective cohort study performed at the Centro de Fertilidad y Genetica Novafem, Bogota, Colombia, and Clinica de la Mujer - Medicina Reproductiva, Viña del Mar, Chile. The Ethics Committee approved the study protocol of both centers. Informed contents were obtained from patients for data collection with scientific use.
All donors who underwent COS for oocyte donation between January 1st, 2018 and July 31th, 2022 were screened for eligibility and followed up to September 18th, 2022.
Oocyte donation cycles were utilized because this model is an excellent choice for controlling known female characteristics. Previous research concluded that a major predictor of ART outcomes is maternal age.
Eligibility criteria were donors aged older than 18 years or younger than 35 years. After providing informed consent, the patients were questioned about their confirmed past SARS-Cov-2 infection/vaccination status. Patients were categorized into the vaccinated group if they had received two dosages of any SARS-CoV-2 vaccines (BNT162b2 mRNA Pfizer-Biontech, mRNA-1273 Moderna or inactivated SARS-CoV-2 vaccine Sinovac) with a break of at least three weeks between each dose. First and second vaccine dates were requested of vaccinated patients. Vaccine administration details, such as vaccine type, dose, date, manufacturer, and lot number, were collected from immunization records.
For recovering patients, the date of a negative nasopharyngeal COVID polymerase chain reaction (PCR) test was registered. None of the recovering patients were vaccinated with any SARS-CoV-2 vaccine. Both clinics strictly required a negative PCR test for SARS-CoV-2 RNA detection 5 days before oocyte retrieval, except for those patients who were less than 3 months following recovery from SARS-Cov-2 infection. Patients in the control group were selected from medical records prior to March 2020 to ensure they did not have the infection and were not vaccinated.
Data including the patient age, body mass index (BMI), antral follicle count (AFC), anti mullerian hormone (AMH), days of stimulation, average dose of gonadotropins, the number of retrieved oocytes, mature oocytes, fertilized oocytes and top quality embryos obtained were recorded. Other parameters were calculated such as the ratio between the number of retrieved oocytes and the number of mature follicles in order to assess the adequacy of response of the follicle to the LH/hCG trigger; the fertilization rate (FR), which was defined as the proportion of inseminated oocytes with 2PN at the time of the fertilization check on Day 1 and finally the blastocyst development rate, defined as the proportion of 2PN zygotes which are at the blastocyst stage at Day 5.
All analyses were performed using SPSS 23.0 (SPSS Inc., Chicago, IL, USA). Normally, distributed data were compared across study groups by univariate ANOVA. All P-values were tested as two-tailed and considered significant at \<0.05.
### Conditions Module
**Conditions:**
- Ovarian Reserve
- SARS-CoV-2 Infection
- Blastocyst
**Keywords:**
- COVID-19; SARS-CoV-2
- embryos;
- endometrium;
- female reproductive system
- in vitro fertilization;
- menstrual cycle;
- oocytes;
- ovarian reserve
- blastocyst
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 428
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Evaluate the results within oocyte retrieval, oocyte fertilisation and blastocyst formation.
**Intervention Names:**
- Biological: Sars Cov 2 infection
- Biological: Sars Cov 2 vaccination
**Label:** Non exposed to Sars Cov 2 egg donors
#### Arm Group 2
**Description:** Evaluate the results within oocyte retrieval, oocyte fertilisation and blastocyst formation, after being exposed to the infection.
**Label:** Exposed to Sars Cov 2 Infection
#### Arm Group 3
**Description:** Evaluate the results within oocyte retrieval, oocyte fertilisation and blastocyst formation, after being exposed to vaccination.
**Label:** Exposed to Sars Cov 2 Vaccines
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Non exposed to Sars Cov 2 egg donors
**Description:** Donors recovered from Sars Cov 2 Infection
**Name:** Sars Cov 2 infection
**Type:** BIOLOGICAL
#### Intervention 2
**Arm Group Labels:**
- Non exposed to Sars Cov 2 egg donors
**Description:** Egg Donors vaccinated
**Name:** Sars Cov 2 vaccination
**Type:** BIOLOGICAL
### Outcomes Module
#### Primary Outcomes
**Measure:** MII mature oocytes after retrieval
**Time Frame:** 2018 to 2022
**Measure:** Fertilization rate
**Time Frame:** 2018 to 2022
**Measure:** Blastocyst rate formation
**Time Frame:** 2018 to 2022
#### Secondary Outcomes
**Measure:** antral follicular count before retrieval
**Time Frame:** 2018 to 2022
### Eligibility Module
**Eligibility Criteria:** Inclusion
* Age: 18 - 32 Years
* Body Mass Index between 18 and 26
* AFC: Antral follicular count over 15 in total.
* AMH: Anti-Mullerian hormone over 2.5
* Signed consents.
* Covid vaccines and infection information (for case group).
Exclusion:
* Egg donors with incomplete information of days of stimulation, average dose of gonadotropins, the number of retrieved oocytes, mature oocytes, fertilised oocytes and top-quality embryos obtained.
* Familial genetic disorders.
* Menstrual cycle disorders.
* Polycystic ovary syndrome.
**Healthy Volunteers:** True
**Maximum Age:** 32 Years
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** FEMALE
**Standard Ages:**
- ADULT
**Study Population:** Patients were categorized into the vaccinated group if they had received two dosages of any SARS-CoV-2 vaccines with a break of at least three weeks between each dose. First and second vaccine dates were requested from vaccinated patients. Vaccine administration details, such as vaccine type, dose, date, manufacturer, and lot number, were collected from immunization records.
For recovering patients, the date of an adverse nasopharyngeal COVID polymerase chain reaction (PCR) test was registered. None of the recovering patients were vaccinated with any SARS-CoV-2 vaccine. Both clinics strictly required a negative PCR test for SARS-CoV-2 RNA detection 5 days before oocyte retrieval, except for those patients who were less than 3 months following recovery from SARS-Cov-2 infection. Patients in the control group were selected from medical records before March 2020 to ensure they did not have an infection and were not vaccinated.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Bogotá
**Country:** Colombia
**Facility:** Novafem
#### Overall Officials
**Official 1:**
**Affiliation:** Universitat Autonoma de Barcelona
**Name:** Jose A Moreno, PhD
**Role:** STUDY_CHAIR
## 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: SARS-CoV-2 Infection
- ID: M10283
- Name: Infections
- Relevance: LOW
- As Found: Unknown
- ID: M6368
- Name: Communicable Diseases
- 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: 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
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M17360
- Name: Vaccines
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT03976479
**Acronym:** SuppWFPBD
**Brief Title:** Body Composition, Nutritional and Cardiovascular Status and Lifestyle Factors of Adults Who Are on Plant-Based Diet
**Official Title:** Body Composition, Nutritional and Cardiovascular Status and Lifestyle Factors of Adults Who Are on Short-, Medium- and Long-term Plant-Based Diet
#### Organization Study ID Info
**ID:** KR3
#### Organization
**Class:** OTHER
**Full Name:** Barbara Jakše s.p.
### Status Module
#### Completion Date
**Date:** 2019-08-30
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-12-02
**Type:** ACTUAL
**Last Update Submit Date:** 2019-11-27
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2019-07-30
**Type:** ACTUAL
#### Start Date
**Date:** 2019-05-28
**Type:** ACTUAL
**Status Verified Date:** 2019-11
#### Study First Post Date
**Date:** 2019-06-06
**Type:** ACTUAL
**Study First Submit Date:** 2019-06-01
**Study First Submit QC Date:** 2019-06-04
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** University Medical Centre Ljubljana
#### Lead Sponsor
**Class:** OTHER
**Name:** Boštjan Jakše
#### Responsible Party
**Investigator Affiliation:** Barbara Jakše s.p.
**Investigator Full Name:** Boštjan Jakše
**Investigator Title:** Physical education teacher (Phd student of Nutrition)
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** There is an objective lack of data on the body composition, nutritional status, cardiovascular status and lifestyle of adults on a plant-based diet (PBD). The aim in this cross-sectional study investigators will document the differences in the body composition, nutritional intake and general health status of healthy adults aged 18 to 80 years who are on plant-based diet of 0.5-10 years and to determine if their body composition status is associated to the duration of eating with PBD between the 3 groups: those that are 0.5-2 years (short-term), 2-5 years (medium-term) and 5-10 years (long-term) on PBD.
This study will also include the monitoring of other factors of healthy and active lifestyle of PBD participants, namely the status of habitual and organized physical activity, the status of daily long-term seating, the status of stress and hygiene of sleep, socio-economic status and the motive(s)/reasons for starting PBD. Investigators will also record their maximum (lifetime) body weight, body weight upon entering the PBD lifestyle, and using data from participants, blood analysis to collect their basic biochemistry results, and data on current blood pressure status.
The investigators hypothesis is that:
(H1): There are no differences in nutritional status between people who are short- (0.5-2 years), the medium- (2-5 years) or the long-term (5-10 years) on PBD.
(H2): At least 80% of the tested subjects have plasma lipid values and blood pressure within the reference values.
(H3): There is difference in lipid profile and body composition between people who are short- and the medium but not between medium and long-term PBD.
**Detailed Description:** In the study investigators will voluntarily enroll all participants within inclusion/exclusion criteria that are willing to participate in the study. Investigators will anticipate that for approx. 150-200 healthy adult PBD participants investigators will require approx. 2555 invited and interviewed candidates, of both sexes, aged 18-80 years, without restrictions on current body mass index (BMI) status, that are on PBD for 0.5-10 years and live a healthy and active lifestyle.
The methods to be used are a medically approved bioimpedance body composition monitor (Tanita, 780 S MA, Tokyo, Japan), medically approved body weight scale and body height gauge (MPE 250K100HM), a 3-day dietary record (3-DR), one adopted by NIH: socio-demographic, economic status and motive for PBD questionnaire, and three standardized questionnaires: (1) habitual and organized physical activity, and the frequency of sitting (IPAQ-long), (2) stress (PSQ-30), and (3) quality of sleep (PSQI).
Concerning 3-DR, the study participants will weight and record all foods, beverages consumed, as well as leftovers, and dietary supplements over three consecutive days (two weekdays and one weekend) using electronic kitchen scales. The study participants will choose the day of the beginning of dietary recording within a given period (i. e.: Sunday, Monday, Tuesday or Thursday, Friday, Saturday). When exact weighing will not be possible (e.g., in case of eating out), household measures (spoon, cup, glass, etc.) and a picture book with household measures in adults' portion sizes (photos of reference foods with their actual gram weight) (NIJZ, 2016), allowed semi-quantitative recording. For the evaluation of dietary intake, investigators will use dietary software, Open Platform for Clinical Nutrition (OPEN), which is a web-based application (http://opkp.si/) and has been developed by the Jozef Stefan Institute and supported by the EuroFIR AISBL (http://eurofir.org) and the European Federation of the Association of Dietitians (EFAD). Dietary software has been upgraded to 3-DR methodology.
Food intake data (from 3-DR) will be used for assessment of energy, macro- and micronutrients intakes using OPEN. The energy and nutrient contents of commercial food or home prepared foods, will estimated by recipe simulation using labelled ingredients and nutrient contents. OPEN will be continuously updated by adding those products or recopies recorded by study participants on PBD.
In order to assess the nutritional intake from dietary supplements, we will use Res-Pons d.o.o. services, which professionally manages the database with all dietary supplements products on the Slovenian market (Pretehtajte.si, 2018).
Investigators will also record their maximum (lifetime) body weight, body weight upon entering the PBD lifestyle, and using data taken blood analysis to collect their basic biochemistry results, measured in a standard and comparable method (plasma lipids, uric acid and a hemogram), and data on current blood pressure status.
### Conditions Module
**Conditions:**
- Conditions Influencing Health Status
- Body Weight
- Lipid Metabolism Disorders
- Uricemia
- Blood Pressure Disorders
- Physical Stress
- Sleep Disorder
- Stress, Psychological
**Keywords:**
- Body composition
- Nutritional status
- Lipids
- Blood pressure
- Lifestyle factors
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** CROSS_SECTIONAL
#### Enrollment Info
**Count:** 166
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
### Interventions
#### Intervention 1
**Description:** Body composition status, nutritional status, cardiovasculat status, health status, lifestyle factors
**Name:** Body composition, questionnaires, biochemistry and blood pressure results
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Body weight measured with medically approved weighing scale
**Measure:** Body weight status
**Time Frame:** Cross-sectional (June-July 2019)
**Description:** Height status measured with medically approved weighing scale with height rod
**Measure:** Height status
**Time Frame:** Cross-sectional (June-July 2019)
**Description:** Measured weight and height will be combined to report BMI in kg/m\^2
**Measure:** Body mass index (BMI) status
**Time Frame:** Cross-sectional (June-July 2019)
**Description:** Lean tissue mass measured with medically approved bioimpedance analysis
**Measure:** Lean tissue mass status
**Time Frame:** Cross-sectional (June-July 2019)
**Description:** Fat tissue mass measured with medically approved bioimpedance analysis
**Measure:** Fat tissue mass status
**Time Frame:** Cross-sectional (June-July 2019)
**Description:** Nutrititional status measured with 3-day dietary record (3-DR)
**Measure:** Nutritional status
**Time Frame:** Cross-sectional (June-July 2019)
**Description:** Serum total cholesterol concentration
**Measure:** Serum cholesterol status
**Time Frame:** Cross-sectional (June-July 2019)
**Description:** Serum concentration of oxidized LDL-cholesterol
**Measure:** Oxidized Low Density Lipoprotein (LDL)-cholesterol status
**Time Frame:** Cross-sectional (June-July 2019)
**Description:** Serum HDL cholesterol contentration
**Measure:** Serum HDL cholesterol status
**Time Frame:** Cross-sectional (June-July 2019)
**Description:** Serum triglyceride concentrations
**Measure:** Serum triglyceride status
**Time Frame:** Cross-sectional (June-July 2019)
**Description:** Blood pressure status
**Measure:** Blood pressure status
**Time Frame:** Cross-sectional (June-July 2019)
#### Secondary Outcomes
**Description:** Socio-economic and demographic status measured using Nutritional behaviours of adults Slovenians from the point of of health prevention questionnaire (Slovenian NIH)
**Measure:** Socio-economic and demographic status
**Time Frame:** Cross-sectional (June-July 2019)
**Description:** Physical activity status measured by The International Physical Activity Questionnaires (IPAQ)
**Measure:** Physical activity status
**Time Frame:** Cross-sectional (June-July 2019)
**Description:** Stress status measured with Perceived Stress Questionnaire (PSQ)
**Measure:** Stress status
**Time Frame:** Cross-sectional (June-July 2019)
**Description:** Sleep status measured with The Pittsburgh Sleep Quality Index (PSQI)
**Measure:** Sleep status
**Time Frame:** Cross-sectional (June-July 2019)
**Description:** Serum uric acid concentration (safety outcome)
**Measure:** Serum uric acid status
**Time Frame:** Cross-sectional (June-July 2019)
**Description:** Hemoglobin concentration (safety outcome)
**Measure:** Hemoglobin status
**Time Frame:** Cross-sectional (June-July 2019)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Adults, age from 18-80 years, on PBD longer than 0.5 years.
* PB dieters who may have some kind of food intolerance or food restriction (e.g. gluten, tomato, peanuts, citrus, etc.).
* No restriction on participants current BMI
* Knowing (BIA measured) PB dieters baseline BM and fat %
* Currently smoking tobacco products is not an exclusion criterion, but we will record it and report in demographic data
Exclusion Criteria:
* Adults on PBD but with active diseases (e.g. cardiovascular diseases, type 2 diabetes, cancer, autoimmune and neurodegenerative disease ect.).
* Adults on PBD with the current use of drugs for measured blood markers (lipids and blood pressure).
* Without major musculoskeletal restrictions
* Pregnant and lactating woman
* Currently competitive or top level athletes
**Healthy Volunteers:** True
**Maximum Age:** 80 Years
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Heatlhy and active long-term PB dieters
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Ljubljana
**Country:** Slovenia
**Facility:** PDP Spodnje Črnuče
**Zip:** 1000
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
### References Module
#### References
**Citation:** Karlsen MC, Rogers G, Miki A, Lichtenstein AH, Folta SC, Economos CD, Jacques PF, Livingston KA, McKeown NM. Theoretical Food and Nutrient Composition of Whole-Food Plant-Based and Vegan Diets Compared to Current Dietary Recommendations. Nutrients. 2019 Mar 14;11(3):625. doi: 10.3390/nu11030625.
**PMID:** 30875784
**Citation:** Melina V, Craig W, Levin S. Position of the Academy of Nutrition and Dietetics: Vegetarian Diets. J Acad Nutr Diet. 2016 Dec;116(12):1970-1980. doi: 10.1016/j.jand.2016.09.025.
**PMID:** 27886704
**Citation:** Satija A, Bhupathiraju SN, Spiegelman D, Chiuve SE, Manson JE, Willett W, Rexrode KM, Rimm EB, Hu FB. Healthful and Unhealthful Plant-Based Diets and the Risk of Coronary Heart Disease in U.S. Adults. J Am Coll Cardiol. 2017 Jul 25;70(4):411-422. doi: 10.1016/j.jacc.2017.05.047.
**PMID:** 28728684
**Citation:** Willett W, Rockstrom J, Loken B, Springmann M, Lang T, Vermeulen S, Garnett T, Tilman D, DeClerck F, Wood A, Jonell M, Clark M, Gordon LJ, Fanzo J, Hawkes C, Zurayk R, Rivera JA, De Vries W, Majele Sibanda L, Afshin A, Chaudhary A, Herrero M, Agustina R, Branca F, Lartey A, Fan S, Crona B, Fox E, Bignet V, Troell M, Lindahl T, Singh S, Cornell SE, Srinath Reddy K, Narain S, Nishtar S, Murray CJL. Food in the Anthropocene: the EAT-Lancet Commission on healthy diets from sustainable food systems. Lancet. 2019 Feb 2;393(10170):447-492. doi: 10.1016/S0140-6736(18)31788-4. Epub 2019 Jan 16. No abstract available. Erratum In: Lancet. 2019 Feb 9;393(10171):530. Lancet. 2019 Jun 29;393(10191):2590. Lancet. 2020 Feb 1;395(10221):338. Lancet. 2020 Oct 3;396(10256):e56.
**PMID:** 30660336
#### See Also Links
**Label:** NIJZ, Slikovno-gradivo-za-dolocanje-vnosa-zivil, 2016. Available at: http://www.nijz.si/sl/publikacije/slikovno-gradivo-za-dolocanje-vnosa-zivil , assesed 30.05.2019
**URL:** http://www.nijz.si/sl/publikacije/slikovno-gradivo-za-dolocanje-vnosa-zivil
**Label:** OPEN Platform for Clinical Nutrition
**URL:** http://opkp.si/
**Label:** EuroFIR AISBL
**URL:** http://eurofir.org
**Label:** Res Pons d.o.o.
**URL:** https://pretehtajte.si/
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000009461
- Term: Neurologic Manifestations
- ID: D000001523
- Term: Mental Disorders
- ID: D000001526
- Term: Behavioral Symptoms
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
### Condition Browse Module - Browse Leaves
- ID: M5114
- Name: Body Weight
- Relevance: HIGH
- As Found: Body Weight
- ID: M11639
- Name: Metabolic Diseases
- Relevance: HIGH
- As Found: Metabolism Disorders
- ID: M22242
- Name: Parasomnias
- Relevance: LOW
- As Found: Unknown
- ID: M24343
- Name: Hyperuricemia
- Relevance: LOW
- As Found: Unknown
- ID: M16105
- Name: Stress, Psychological
- Relevance: HIGH
- As Found: Stress, Psychological
- ID: M27029
- Name: Lipid Metabolism Disorders
- Relevance: HIGH
- As Found: Lipid Metabolism Disorders
- ID: M15696
- Name: Sleep Wake Disorders
- Relevance: HIGH
- As Found: Sleep Disorders
- ID: M12404
- Name: Neurologic Manifestations
- 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: M4818
- Name: Behavioral Symptoms
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000012893
- Term: Sleep Wake Disorders
- ID: D000008659
- Term: Metabolic Diseases
- ID: D000052439
- Term: Lipid Metabolism Disorders
- ID: D000001835
- Term: Body Weight
- ID: D000013315
- Term: Stress, Psychological
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT01267279
**Brief Title:** Effect of Zoledronic Acid on Femoral Bone Loss Following Total Hip Arthroplasty
**Official Title:** Effect of Zoledronic Acid on Femoral Bone Loss Following Total Hip Arthroplasty
#### Organization Study ID Info
**ID:** SJRC-Reclast
#### Organization
**Class:** OTHER
**Full Name:** Spokane Joint Replacement Center
### Status Module
#### Completion Date
**Date:** 2014-12
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2018-12-19
**Type:** ACTUAL
**Last Update Submit Date:** 2018-11-27
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2014-12
**Type:** ACTUAL
#### Results First Post Date
**Date:** 2018-12-19
**Type:** ACTUAL
**Results First Submit Date:** 2018-10-17
**Results First Submit QC Date:** 2018-11-27
#### Start Date
**Date:** 2005-01
**Status Verified Date:** 2018-11
#### Study First Post Date
**Date:** 2010-12-28
**Type:** ESTIMATED
**Study First Submit Date:** 2010-12-24
**Study First Submit QC Date:** 2010-12-27
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Spokane Joint Replacement Center
#### Responsible Party
**Investigator Affiliation:** Spokane Joint Replacement Center
**Investigator Full Name:** David F. Scott, MD
**Investigator Title:** PI
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** In a randomized, double-blind trial, BMD of the operated proximal femur after total hip replacement measured by dual-energy x-ray absorptiometry (DXA) were compared for up to two years in patients receiving IV ZOL 5 mg infusion (n = 27) or placebo (IV saline infusion; n = 24) at two weeks and one year after surgery.
### Conditions Module
**Conditions:**
- Osteoporosis
### 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:** 51
**Type:** ACTUAL
**Phases:**
- PHASE4
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Other: Placebo
**Label:** Placebo
**Type:** PLACEBO_COMPARATOR
#### Arm Group 2
**Intervention Names:**
- Drug: Zoledronic acid
**Label:** Zoledronic Acid
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Zoledronic Acid
**Description:** Zoledronic acid per protocol
**Name:** Zoledronic acid
**Other Names:**
- Reclast
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Placebo
**Description:** Placebo
**Name:** Placebo
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Change in bone mineral density (BMD) (per dual energy x-ray absorptiometry (DXA) imaging) from 1 week post-operative data in the Standard and Custom Gruen Zones around the femoral stem.
**Measure:** Bone Mineral Density (BMD)
**Time Frame:** 2 years post-operative
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients undergoing primary elective total hip replacement
Exclusion Criteria:
* Osteoporosis (BMD ≤-2.5)
* Trauma to the operated femur, hip revisions, femoral dysplasia, trochanteric osteotomy, inflammatory arthritis
* Severe renal impairment
* Use of any medications affecting BMD
* Known sensitivity to bisphosphonates
* Severe dental problems, and pregnancy or being able to conceive and not using reliable birth control methods
**Healthy Volunteers:** True
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001851
- Term: Bone Diseases, Metabolic
- ID: D000001847
- Term: Bone Diseases
- ID: D000009140
- Term: Musculoskeletal Diseases
- ID: D000008659
- Term: Metabolic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC05
- Name: Musculoskeletal Diseases
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M12947
- Name: Osteoporosis
- Relevance: HIGH
- As Found: Osteoporosis
- ID: M5126
- Name: Bone Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5130
- Name: Bone Diseases, Metabolic
- Relevance: LOW
- As Found: Unknown
- ID: M12097
- Name: Musculoskeletal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M11639
- Name: Metabolic Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000010024
- Term: Osteoporosis
### Intervention Browse Module - Ancestors
- ID: D000050071
- Term: Bone Density Conservation Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
### Intervention Browse Module - Browse Branches
- Abbrev: BDCA
- Name: Bone Density Conservation Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M1699
- Name: Zoledronic Acid
- Relevance: HIGH
- As Found: Lymphoblastic
### Intervention Browse Module - Meshes
- ID: D000077211
- Term: Zoledronic Acid
### Misc Info Module
- Version Holder: 2024-05-24
## Results Section
### Adverse Events Module
#### Event Groups
**Group ID:** EG000
**Title:** Placebo
**Deaths Num At Risk:** 24
**Description:** Placebo
**ID:** EG000
**Other Num at Risk:** 24
**Serious Number Affected:** 2
**Serious Number At Risk:** 24
**Title:** Placebo
**Group ID:** EG001
**Title:** Zoledronic Acid
**Deaths Num At Risk:** 27
**Description:** Zoledronic acid: Zoledronic acid per protocol
**ID:** EG001
**Other Num Affected:** 2
**Other Num at Risk:** 27
**Serious Number Affected:** 3
**Serious Number At Risk:** 27
**Title:** Zoledronic Acid
**Frequency Threshold:** 0
#### Other Events
**Term:** Flu-like symptoms
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:**
#### Serious Events
**Term:** hepatic liver mass
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Hepatobiliary disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 24
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 27
**Term:** THA revision
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Musculoskeletal and connective tissue disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 24
**Num Events:** 1
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 27
**Num Events:** 1
**Term:** Liver cancer
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Hepatobiliary disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 24
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 27
**Num Events:** 1
**Term:** Muscular atrophy
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Musculoskeletal and connective tissue disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 24
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 27
**Num Events:** 1
## Results Section - Baseline Characteristics Module
### Denomination Counts
**Group ID:** BG000
**Value:** 24
**Group ID:** BG001
**Value:** 27
**Group ID:** BG002
**Value:** 51
**Units:** Participants
### Group
**ID:** BG000
**Title:** Placebo
**Description:** Placebo
### Group
**ID:** BG001
**Title:** Zoledronic Acid
**Description:** Zoledronic acid: Zoledronic acid per protocol
### Group
**ID:** BG002
**Title:** Total
**Description:** Total of all reporting groups
### Measure
#### Measurement
**Group ID:** BG000
**Lower Limit:** 51
**Upper Limit:** 77
**Value:** 61.8
#### Measurement
**Group ID:** BG001
**Lower Limit:** 33
**Upper Limit:** 84
**Value:** 60.25
#### Measurement
**Group ID:** BG002
**Lower Limit:** 33
**Upper Limit:** 84
**Value:** 61.03
#### Denomination
**Units:** Participants
##### Denomination Counts
**Group ID:** BG000
**Value:** 24
**Group ID:** BG001
**Value:** 27
**Group ID:** BG002
**Value:** 51
**Class Title:**
### Measure
#### Measurement
**Group ID:** BG000
**Value:** 13
#### Measurement
**Group ID:** BG001
**Value:** 15
#### Measurement
**Group ID:** BG002
**Value:** 28
**Category Title:** Female
#### Measurement
**Group ID:** BG000
**Value:** 11
#### Measurement
**Group ID:** BG001
**Value:** 12
#### Measurement
**Group ID:** BG002
**Value:** 23
**Category Title:** Male
#### Denomination
**Units:** Participants
##### Denomination Counts
**Group ID:** BG000
**Value:** 24
**Group ID:** BG001
**Value:** 27
**Group ID:** BG002
**Value:** 51
**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:** 24
#### Measurement
**Group ID:** BG001
**Value:** 27
#### Measurement
**Group ID:** BG002
**Value:** 51
#### Denomination
**Units:** Participants
##### Denomination Counts
**Group ID:** BG000
**Value:** 24
**Group ID:** BG001
**Value:** 27
**Group ID:** BG002
**Value:** 51
**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
### Point of Contact
**Email:** [email protected]
**Organization:** Spokane Joint Replacement Center
**Phone:** 509-466-6393
**Title:** Principal Investigator
## Results Section - Outcome Measures Module
### Outcome Measure 1
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 15.2
- **Upper Limit:**
- **Value:** -3.97
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 9.8
- **Upper Limit:**
- **Value:** 14.30
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 11.4
- **Upper Limit:**
- **Value:** -27.3
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 12.4
- **Upper Limit:**
- **Value:** -9.58
**Title:**
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Change in bone mineral density (BMD) (per dual energy x-ray absorptiometry (DXA) imaging) from 1 week post-operative data in the Standard and Custom Gruen Zones around the femoral stem.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** 2 years post-operative
**Title:** Bone Mineral Density (BMD)
**Type:** PRIMARY
**Unit of Measure:** Percent change
##### Group
**Description:** Placebo
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Zoledronic acid: Zoledronic acid per protocol
**ID:** OG001
**Title:** Zoledronic Acid
### Participant Flow Module
#### Group
**Description:** Placebo
**ID:** FG000
**Title:** Placebo
#### Group
**Description:** Zoledronic acid: Zoledronic acid per protocol
**ID:** FG001
**Title:** Zoledronic Acid
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 24
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 27
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 22
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 21
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 2
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 6
**Has Results:** True |
## Protocol Section
### Identification Module
**NCT ID:** NCT02980679
**Brief Title:** A Study to Compare the Safety and Imaging Pattern of Cyclotron-produced Technetium (CTC) vs. Generator-produced Technetium (G-PERT) in People With Thyroid Disorders Who Need Surgery
**Official Title:** A Pivotal Phase III Study of Cyclotron-produced Tc-99m Pertechnetate (CTC) Compared to Generator-produced Tc-99m Pertechnetate (G-PERT) in Subjects With Thyroid Disorders
#### Organization Study ID Info
**ID:** DX-CTC-003
#### Organization
**Class:** OTHER
**Full Name:** University of Alberta
#### Secondary ID Infos
**Domain:** Health Research Ethics Board of Alberta Cancer Committee
**ID:** HREBA.CC-16-0695
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2019-02-25
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-04-11
**Type:** ACTUAL
**Last Update Submit Date:** 2022-04-01
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2019-02-25
**Type:** ACTUAL
#### Start Date
**Date:** 2017-03-03
**Type:** ACTUAL
**Status Verified Date:** 2018-11
#### Study First Post Date
**Date:** 2016-12-02
**Type:** ESTIMATED
**Study First Submit Date:** 2016-11-22
**Study First Submit QC Date:** 2016-11-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Alberta
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** A 99mTc Pertechnetate (G-PERT) scan is a nuclear medicine test that can create an image of the thyroid gland and other organs. G-PERT is approved by Health Canada for the direct imaging and measurement of thyroid uptake.
Doctors and researchers at the University of Alberta have developed a new method of producing 99mTc Pertechnetate (called CTC). It is made in a cyclotron at the Medical Isotope and Cyclotron Facility (MICF) at the University of Alberta, Edmonton, Alberta. This new production method will provide another source of 99mTc Pertechnetate. The aim of this study is to confirm that CTC is safe and can be used interchangeably with G-PERT.
**Detailed Description:** The clinical trial will be a Phase III, prospective, crossover, image interpretation blinded, single site study. All subjects will receive Tc-99m pertechnetate (one CTC and one G-PERT administration separated by at least 48 hours) and subsequently be imaged for thyroid uptake and whole body biodistribution. The order of the scans will be randomized. The thyroid image will be interpreted for uptake / no uptake in the thyroid, and the whole body biodistribution image will be interpreted for uptake / no uptake in selected anatomical sites. Interpretation of thyroid imaging results will be compared with other clinical findings (such as pre-surgical ultrasound, fine needle aspirate, and post-surgical pathology results, when available). All imaging assessments will be conducted by 1 blinded Nuclear Medicine physician. A safety evaluation will be conducted on all subjects receiving CTC, consisting of vital signs, haematology and SMA-12 serum biochemistry profile (pre-injection and post-imaging), and, for both CTC and G-PERT, an adverse event assessment (until the subject leaves the Nuclear Medicine department) after each administration.
### Conditions Module
**Conditions:**
- Thyroid Gland Diseases
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** DIAGNOSTIC
#### Enrollment Info
**Count:** 25
**Type:** ACTUAL
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** One experimental (CTC) and one standard (G-PERT) scan, at least 48 hours apart, before thyroid surgery. The order of the scans will be randomized.
**Intervention Names:**
- Drug: CTC
- Drug: G-PERT
**Label:** CTC and G-PERT Imaging
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- CTC and G-PERT Imaging
**Description:** After injection of CTC, a whole body and thyroid scan will be performed.
**Name:** CTC
**Other Names:**
- Cyclotron-produced technetium
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- CTC and G-PERT Imaging
**Description:** After injection of G-PERT, a whole body and thyroid scan will be performed.
**Name:** G-PERT
**Other Names:**
- Generator-produced technetium
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** The primary efficacy endpoint is the clinical comparability of CTC with G-PERT consisting of a combination of the following results:
1. A thyroid image, assessed for uptake or no uptake in the thyroid.
2. A whole body biodistribution study, assessed for uptake or no uptake in selected anatomical areas.
**Measure:** Clinical Comparability of CTC with G-PERT
**Time Frame:** up to 1 year
#### Secondary Outcomes
**Description:** Vital signs are measured before injection of CTC and after CTC scan and changes will be summarized.
**Measure:** Change in vital signs after CTC injection
**Time Frame:** Before CTC injection and after CTC scan (within ~30 min)
**Description:** A blood sample is drawn before injection of CTC and after CTC scan. The haematology and SMA-12 serum biochemistry parameters will be recorded and all changes will be summarized.
**Measure:** Changes in haematology / SMA-12 serum biochemistry after CTC injection
**Time Frame:** Before CTC injection and after CTC scan (within ~30 min)
**Description:** Subjects will be monitored for adverse events after CTC and G-PERT scans while in the Nuclear Medicine Department. All adverse events observed or reported will be recorded and assessed.
**Measure:** Number of participants with adverse events
**Time Frame:** up to 1 year
**Description:** Correlation of thyroid images with other clinical findings (such as pre-surgical ultrasound, FNA, and post-surgical pathology results, when available).
**Measure:** Correlation of CTC with other clinical findings
**Time Frame:** up to 1 year
**Description:** Calculation of diagnostic outcomes (TP, TN, FP, FN) and the corresponding diagnostic parameters (sensitivity, specificity, accuracy).
**Measure:** CTC diagnostic outcomes and parameters
**Time Frame:** up to 1 year
**Description:** The overall clinical comparability of CTC with G-PERT using diagnostic outcomes (True Positive, True Negative, False Positive, False Negative) to determine the corresponding diagnostic parameters (sensitivity, specificity, accuracy).
**Measure:** Overall clinical comparability of CTC with G-PERT
**Time Frame:** up to 1 year
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Male or female ≥ 18 years of age and \< 80 years of age.
2. Have a proven or suspected thyroid pathology that requires surgery by standard clinical criteria.
3. Able and willing to follow instructions and comply with the protocol.
4. Provide written informed consent prior to participation in the study.
Exclusion Criteria:
1. Nursing or pregnant females.
**Maximum Age:** 79 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Edmonton
**Country:** Canada
**Facility:** Cross Cancer Institute
**State:** Alberta
**Zip:** T6G 1Z2
#### Overall Officials
**Official 1:**
**Affiliation:** Associate Professor of Surgery and Oncology; Director, Division of Surgical Oncology, Department of Oncology
**Name:** Todd P McMullen, MD, PhD, FRCSC, FACS
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000004700
- Term: Endocrine System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M16718
- Name: Thyroid Diseases
- Relevance: HIGH
- As Found: Thyroid
- ID: M7862
- Name: Endocrine System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000013959
- Term: Thyroid Diseases
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M16442
- Name: Sodium Pertechnetate Tc 99m
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT04482179
**Brief Title:** Transcranial Magnetic Stimulation and Constraint Induced Language Therapy for Alzheimer Disease
**Official Title:** A Phase II, Randomized, Blinded Study of Transcranial Magnetic Stimulation and Constraint Induced Language Therapy for the Treatment of Chronic Aphasia - Alzheimer Disease Sub-study
#### Organization Study ID Info
**ID:** 831532
#### Organization
**Class:** OTHER
**Full Name:** University of Pennsylvania
#### Secondary ID Infos
**ID:** R01DC016800-01A1
**Link:** https://reporter.nih.gov/quickSearch/R01DC016800-01A1
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2024-08-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-02-01
**Type:** ACTUAL
**Last Update Submit Date:** 2024-01-31
**Overall Status:** ACTIVE_NOT_RECRUITING
#### Primary Completion Date
**Date:** 2024-08-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2020-02-19
**Type:** ACTUAL
**Status Verified Date:** 2024-01
#### Study First Post Date
**Date:** 2020-07-22
**Type:** ACTUAL
**Study First Submit Date:** 2020-07-17
**Study First Submit QC Date:** 2020-07-17
### Sponsor Collaborators Module
#### Collaborators
**Class:** NIH
**Name:** National Institutes of Health (NIH)
**Class:** NIH
**Name:** National Institute on Deafness and Other Communication Disorders (NIDCD)
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Pennsylvania
#### Responsible Party
**Investigator Affiliation:** University of Pennsylvania
**Investigator Full Name:** H. Branch Coslett
**Investigator Title:** Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Impaired verbal communication is a cardinal symptom of Alzheimer Disease (AD) and the source of enormous distress and disability. Effective therapies for this deficit are lacking. In light of the emerging literature demonstrating that Transcranial Magnetic Stimulation (TMS) improves general cognition in subjects with Alzheimer Disease (AD), the investigators propose to study the effectiveness of TMS as a therapy for impaired verbal communication. The hypothesis to be tested is that TMS combined with Constraint Induced Language Therapy (CILT) improves verbal communication more than sham TMS and CILT. A second aim is to use state-of-the-art neuroimaging to understand the mechanisms underlying any beneficial effect of the treatment.
**Detailed Description:** TMS is a technique by which a brief electrical current is induced in brain tissue causing a brief suppression of the excitability of the underlying tissue; the technique, which was introduced in the 1980s and has been extensively used around the world, has been shown to transiently improve or disrupt specific cognitive operations. To achieve this end, a coil is positioned against the subject's head. The delivery of a single pulse begins with the discharge of current from a capacitor into a circular or figure-of-eight coil; this electrical current generates a brief magnetic field of up to 2.2 Tesla. As the pulse of electricity has a rise time of 0.2 ms. and a duration of 1 ms., the magnetic field changes in intensity quite rapidly. Because the magnetic field passes freely through the scalp, skull, and meninges, the flux in the magnetic field induces a small electric field in the brain that transiently alters neural activity.
TMS may be delivered in a variety of ways. The investigators propose to use 10 Hz TMS; that is, TMS pulses will be delivered at a frequency of 10/second, for a total of 1200 pulses. Using the figure-of-eight coil to be employed here, TMS is thought to affect activity in approximately 1 cubic cm. of cortex. Many investigators have employed TMS for AD with a frequency of 10 Hz and most have delivered 1200 pulses per session.
The baseline phase will consist of 3 sessions, each lasting 1-2 hours depending on the stamina of the subject. The point of the baseline testing is to characterize the subject's language function. To that end, a number of standard language and neuropsychological tasks will be administered. These include the Western Aphasia Battery, Pyramids and Palm Trees test, Figural Fluency Test, word and non-word repetition tasks, spontaneous narrative production, CILT stimulus naming, and the Repeatable Battery for the Assessment of Neuropsychological Status. Additionally, during the baseline, subjects will undergo MRI of the brain or, if they have a contraindication to MRI, a CAT scan of the head. No contrast will be used.
In the treatment phase, there will be 10 TMS sessions over 2 consecutive weeks in which 30 two-second stimulation trains of 10 Hz TMS will be delivered every 30 seconds to the left inferior pars triangularis and to the left posterior superior left temporal gyrus at 100% motor threshold. There will be a total of 600 pulses to each site in each session for a total of 1200 pulses per session. Each TMS treatment session will be immediately followed by a 60-90 minute session of CILT.
There will be two 3-month post-treatment visits and two 6-month post-treatment visits in which the full battery of language and cognitive assessments will be repeated. Subjects who are able to undergo MRI scanning will have anatomic and fMRI scans at the first 6-month post-treatment visit.
The investigators will pair TMS with CILT which has been shown to have positive outcomes in post-stroke aphasia. CILT invokes use-dependent learning in communicative interactions by requiring spoken output and restricting use of alternative forms of communication, such as gestures. The investigators will use a dual card-matching task modeled after Maher et al. As in the original CILT design, the participant interacts verbally with a conversational partner (here, the speech language pathologist), in turn requesting a card of given description and complying with the partner's request. In this way, the treatment targets both production and comprehension. Moreover, as verbal targets increase in linguistic complexity across the protocol ("a ball", "throw a ball"; "Do you have a ball"?), a variety of lexical and phrasal structures are targeted. Studies of CILT have reported gains on multiple language behaviors, supporting its broad engagement of the language network.
### Conditions Module
**Conditions:**
- Alzheimer Disease
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Participants will be randomized to either TMS or sham TMS in a 2:1 allocation ratio.
##### Masking Info
**Masking:** QUADRUPLE
**Masking Description:** The individual administering TMS will keep the master file of subject assignments, but all other individuals in contact with the subject or their data will be unaware of group assignment. Participants will not be informed of their assignment to active or sham status.
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 30
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** There will be 10 TMS sessions over 2 consecutive weeks in which 30 two-second stimulation trains of 10 Hz TMS will be delivered every 30 seconds to the left inferior pars triangularis and to the left posterior superior left temporal gyrus. Each TMS treatment session will be immediately followed by a 60-90 minute session of Constrained Induced Language Therapy (CILT).
**Intervention Names:**
- Device: Active TMS
- Behavioral: CILT
**Label:** Active TMS
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** There will be 10 TMS sessions over 2 consecutive weeks in which 30 two-second stimulation trains of 10 Hz sham TMS will be delivered every 30 seconds to the left inferior pars triangularis and to the left posterior superior left temporal gyrus. Sham TMS will be administered with a sham TMS coil that looks and sounds like the active coil but does not generate a magnetic field. Each TMS treatment session will be immediately followed by a 60-90 minute session of Constrained Induced Language Therapy (CILT).
**Intervention Names:**
- Behavioral: CILT
- Device: Sham TMS
**Label:** Sham TMS
**Type:** SHAM_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Active TMS
**Description:** Active TMS will be delivered at 100% motor threshold
**Name:** Active TMS
**Type:** DEVICE
#### Intervention 2
**Arm Group Labels:**
- Active TMS
- Sham TMS
**Description:** 60-90 minutes of CILT will be administered during each treatment session
**Name:** CILT
**Other Names:**
- Constraint Induced Language Therapy
**Type:** BEHAVIORAL
#### Intervention 3
**Arm Group Labels:**
- Sham TMS
**Description:** Sham TMS will be administered
**Name:** Sham TMS
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Overall change in Western Aphasia Battery - Aphasia Quotient (WAB-AQ) between the first baseline visit and the 6-month follow-up visit. WAB-AQ is measured on a scale from 0 to 100, with higher scores meaning greater language ability
**Measure:** Change in WAB-AQ
**Time Frame:** 6-months post-treatment
#### Secondary Outcomes
**Description:** Change in naming accuracy on the Philadelphia Naming Test (PNT) between the first baseline visit and the 6-month follow-up visit. PNT naming accuracy is measured as a percentage from 0% to 100% with higher percentages meaning better naming ability.
**Measure:** Change in PNT
**Time Frame:** 6-months post-treatment
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* A diagnosis of mild-moderate AD as defined by the National Institute of Aging - Alzheimer's Disease and Related Disorders Association criteria
* Mild-moderate cognitive impairment, indicated by Mini-Mental Status Exam (MMSE) scores between 23 and 15 inclusive
* Must be right handed as defined by the Edinburgh Handedness Inventory
* Must be a native English speaker
* Must be able to understand the nature of the study, and give informed consent
Exclusion Criteria:
* History of stroke
* History of seizure
* History of any other significant neurologic disease (e.g., ALS)
* Significant depression as defined by the Geriatric Depression Scale.
* Any significant medical disorder that, in the view of the investigators, could threaten the subject's ability to complete the study (e.g., cancer, significant cardiac disease)
* Any contraindications to TMS, including uncontrolled seizures, previous brain surgery, and history of tinnitus
**Maximum Age:** 85 Years
**Minimum Age:** 60 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Philadelphia
**Country:** United States
**Facility:** University of Pennsylvania
**State:** Pennsylvania
**Zip:** 19104
#### Overall Officials
**Official 1:**
**Affiliation:** University of Pennsylvania
**Name:** H. Branch Coslett, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Hamilton RH, Chrysikou EG, Coslett B. Mechanisms of aphasia recovery after stroke and the role of noninvasive brain stimulation. Brain Lang. 2011 Jul;118(1-2):40-50. doi: 10.1016/j.bandl.2011.02.005. Epub 2011 Apr 2.
**PMID:** 21459427
**Citation:** Medina J, Norise C, Faseyitan O, Coslett HB, Turkeltaub PE, Hamilton RH. Finding the Right Words: Transcranial Magnetic Stimulation Improves Discourse Productivity in Non-fluent Aphasia After Stroke. Aphasiology. 2012 Sep 1;26(9):1153-1168. doi: 10.1080/02687038.2012.710316. Epub 2012 Aug 29.
**PMID:** 23280015
**Citation:** Seniow J, Waldowski K, Lesniak M, Iwanski S, Czepiel W, Czlonkowska A. Transcranial magnetic stimulation combined with speech and language training in early aphasia rehabilitation: a randomized double-blind controlled pilot study. Top Stroke Rehabil. 2013 May-Jun;20(3):250-61. doi: 10.1310/tsr2003-250.
**PMID:** 23841973
**Citation:** Silvanto J, Muggleton N, Walsh V. State-dependency in brain stimulation studies of perception and cognition. Trends Cogn Sci. 2008 Dec;12(12):447-54. doi: 10.1016/j.tics.2008.09.004. Epub 2008 Oct 24.
**PMID:** 18951833
**Citation:** Ayache SS, Farhat WH, Zouari HG, Hosseini H, Mylius V, Lefaucheur JP. Stroke rehabilitation using noninvasive cortical stimulation: motor deficit. Expert Rev Neurother. 2012 Aug;12(8):949-72. doi: 10.1586/ern.12.83.
**PMID:** 23002939
**Citation:** Kakuda W, Abo M, Shimizu M, Sasanuma J, Okamoto T, Yokoi A, Taguchi K, Mitani S, Harashima H, Urushidani N, Urashima M; NEURO Investigators. A multi-center study on low-frequency rTMS combined with intensive occupational therapy for upper limb hemiparesis in post-stroke patients. J Neuroeng Rehabil. 2012 Jan 20;9(1):4. doi: 10.1186/1743-0003-9-4.
**PMID:** 22264239
**Citation:** Koganemaru S, Mima T, Thabit MN, Ikkaku T, Shimada K, Kanematsu M, Takahashi K, Fawi G, Takahashi R, Fukuyama H, Domen K. Recovery of upper-limb function due to enhanced use-dependent plasticity in chronic stroke patients. Brain. 2010 Nov;133(11):3373-84. doi: 10.1093/brain/awq193. Epub 2010 Aug 5.
**PMID:** 20688810
**Citation:** Shewan CM, Kertesz A. Reliability and validity characteristics of the Western Aphasia Battery (WAB). J Speech Hear Disord. 1980 Aug;45(3):308-24. doi: 10.1044/jshd.4503.308.
**PMID:** 7412225
**Citation:** Mirman D, Chen Q, Zhang Y, Wang Z, Faseyitan OK, Coslett HB, Schwartz MF. Neural organization of spoken language revealed by lesion-symptom mapping. Nat Commun. 2015 Apr 16;6:6762. doi: 10.1038/ncomms7762.
**PMID:** 25879574
**Citation:** Howard, D., & Patterson, K. E. (1992). The Pyramids and Palm Trees Test: A Test of Semantic Access from Words and Pictures. Thames Valley Test Company
**Citation:** Nicholas LE, Brookshire RH. A system for quantifying the informativeness and efficiency of the connected speech of adults with aphasia. J Speech Hear Res. 1993 Apr;36(2):338-50. doi: 10.1044/jshr.3602.338.
**PMID:** 8487525
**Citation:** Foygel, D., & Dell, G. S. (2000). Models of impaired lexical access in speech production. Journal of Memory and Language, 43(2), 182-216.
**Citation:** Pulvermuller F, Neininger B, Elbert T, Mohr B, Rockstroh B, Koebbel P, Taub E. Constraint-induced therapy of chronic aphasia after stroke. Stroke. 2001 Jul;32(7):1621-6. doi: 10.1161/01.str.32.7.1621.
**PMID:** 11441210
**Citation:** Medaglia JD, Huang W, Segarra S, Olm C, Gee J, Grossman M, Ribeiro A, McMillan CT, Bassett DS. Brain network efficiency is influenced by the pathologic source of corticobasal syndrome. Neurology. 2017 Sep 26;89(13):1373-1381. doi: 10.1212/WNL.0000000000004324. Epub 2017 Aug 4.
**PMID:** 28779011
**Citation:** Ahmed MA, Darwish ES, Khedr EM, El Serogy YM, Ali AM. Effects of low versus high frequencies of repetitive transcranial magnetic stimulation on cognitive function and cortical excitability in Alzheimer's dementia. J Neurol. 2012 Jan;259(1):83-92. doi: 10.1007/s00415-011-6128-4. Epub 2011 Jun 14.
**PMID:** 21671144
**Citation:** Bentwich J, Dobronevsky E, Aichenbaum S, Shorer R, Peretz R, Khaigrekht M, Marton RG, Rabey JM. Beneficial effect of repetitive transcranial magnetic stimulation combined with cognitive training for the treatment of Alzheimer's disease: a proof of concept study. J Neural Transm (Vienna). 2011 Mar;118(3):463-71. doi: 10.1007/s00702-010-0578-1. Epub 2011 Jan 19.
**PMID:** 21246222
**Citation:** Brem, A. K., Schilberg, L., Freitas, C., Atkinson, N., Seligson, E., & Pascual-Leone, A. (2013). Effects of cognitive training and rTMS in Alzheimer's disease. Alzheimer's & Dementia: The Journal of the Alzheimer's Association, 9(4), P664.
**Citation:** Buckner RL, Sepulcre J, Talukdar T, Krienen FM, Liu H, Hedden T, Andrews-Hanna JR, Sperling RA, Johnson KA. Cortical hubs revealed by intrinsic functional connectivity: mapping, assessment of stability, and relation to Alzheimer's disease. J Neurosci. 2009 Feb 11;29(6):1860-73. doi: 10.1523/JNEUROSCI.5062-08.2009.
**PMID:** 19211893
**Citation:** Cheng CPW, Wong CSM, Lee KK, Chan APK, Yeung JWF, Chan WC. Effects of repetitive transcranial magnetic stimulation on improvement of cognition in elderly patients with cognitive impairment: a systematic review and meta-analysis. Int J Geriatr Psychiatry. 2018 Jan;33(1):e1-e13. doi: 10.1002/gps.4726. Epub 2017 May 11.
**PMID:** 28493371
**Citation:** Cotelli M, Calabria M, Manenti R, Rosini S, Zanetti O, Cappa SF, Miniussi C. Improved language performance in Alzheimer disease following brain stimulation. J Neurol Neurosurg Psychiatry. 2011 Jul;82(7):794-7. doi: 10.1136/jnnp.2009.197848. Epub 2010 Jun 23.
**PMID:** 20574108
**Citation:** Cotelli M, Manenti R, Cappa SF, Geroldi C, Zanetti O, Rossini PM, Miniussi C. Effect of transcranial magnetic stimulation on action naming in patients with Alzheimer disease. Arch Neurol. 2006 Nov;63(11):1602-4. doi: 10.1001/archneur.63.11.1602.
**PMID:** 17101829
**Citation:** Deters KD, Nho K, Risacher SL, Kim S, Ramanan VK, Crane PK, Apostolova LG, Saykin AJ; Alzheimer's Disease Neuroimaging Initiative. Genome-wide association study of language performance in Alzheimer's disease. Brain Lang. 2017 Sep;172:22-29. doi: 10.1016/j.bandl.2017.04.008. Epub 2017 May 31.
**PMID:** 28577822
**Citation:** Drumond Marra HL, Myczkowski ML, Maia Memoria C, Arnaut D, Leite Ribeiro P, Sardinha Mansur CG, Lancelote Alberto R, Boura Bellini B, Alves Fernandes da Silva A, Tortella G, Ciampi de Andrade D, Teixeira MJ, Forlenza OV, Marcolin MA. Transcranial Magnetic Stimulation to Address Mild Cognitive Impairment in the Elderly: A Randomized Controlled Study. Behav Neurol. 2015;2015:287843. doi: 10.1155/2015/287843. Epub 2015 Jun 16.
**PMID:** 26160997
**Citation:** Engels MM, Stam CJ, van der Flier WM, Scheltens P, de Waal H, van Straaten EC. Declining functional connectivity and changing hub locations in Alzheimer's disease: an EEG study. BMC Neurol. 2015 Aug 20;15:145. doi: 10.1186/s12883-015-0400-7.
**PMID:** 26289045
**Citation:** Faroqi-Shah, Y., & Virion, C. R. (2009). Constraint-induced language therapy for agrammatism: Role of grammaticality constraints. Aphasiology, 23(7-8), 977-988.
**Citation:** Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.
**PMID:** 1202204
**Citation:** Fornito A, Zalesky A, Breakspear M. The connectomics of brain disorders. Nat Rev Neurosci. 2015 Mar;16(3):159-72. doi: 10.1038/nrn3901.
**PMID:** 25697159
**Citation:** Haffen E, Chopard G, Pretalli JB, Magnin E, Nicolier M, Monnin J, Galmiche J, Rumbach L, Pazart L, Sechter D, Vandel P. A case report of daily left prefrontal repetitive transcranial magnetic stimulation (rTMS) as an adjunctive treatment for Alzheimer disease. Brain Stimul. 2012 Jul;5(3):264-266. doi: 10.1016/j.brs.2011.03.003. Epub 2011 Mar 30. No abstract available.
**PMID:** 22037125
**Citation:** Hameister, I., Nickels, L., Abel, S., & Croot, K. (2017). "Do you have mowing the lawn?"-improvements in word retrieval and grammar following constraint-induced language therapy in primary progressive aphasia. Aphasiology, 31(3), 308-331.
**Citation:** Hodges JR, Salmon DP, Butters N. Semantic memory impairment in Alzheimer's disease: failure of access or degraded knowledge? Neuropsychologia. 1992 Apr;30(4):301-14. doi: 10.1016/0028-3932(92)90104-t.
**PMID:** 1603295
**Citation:** Koch G, Bonni S, Pellicciari MC, Casula EP, Mancini M, Esposito R, Ponzo V, Picazio S, Di Lorenzo F, Serra L, Motta C, Maiella M, Marra C, Cercignani M, Martorana A, Caltagirone C, Bozzali M. Transcranial magnetic stimulation of the precuneus enhances memory and neural activity in prodromal Alzheimer's disease. Neuroimage. 2018 Apr 1;169:302-311. doi: 10.1016/j.neuroimage.2017.12.048. Epub 2017 Dec 19.
**PMID:** 29277405
**Citation:** Lee J, Choi BH, Oh E, Sohn EH, Lee AY. Treatment of Alzheimer's Disease with Repetitive Transcranial Magnetic Stimulation Combined with Cognitive Training: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study. J Clin Neurol. 2016 Jan;12(1):57-64. doi: 10.3988/jcn.2016.12.1.57. Epub 2015 Sep 11.
**PMID:** 26365021
**Citation:** Martin A, Fedio P. Word production and comprehension in Alzheimer's disease: the breakdown of semantic knowledge. Brain Lang. 1983 May;19(1):124-41. doi: 10.1016/0093-934x(83)90059-7.
**PMID:** 6860932
**Citation:** Medaglia JD, Lynall ME, Bassett DS. Cognitive network neuroscience. J Cogn Neurosci. 2015 Aug;27(8):1471-91. doi: 10.1162/jocn_a_00810. Epub 2015 Mar 24.
**PMID:** 25803596
**Citation:** Mohs RC, Rosen WG, Davis KL. The Alzheimer's disease assessment scale: an instrument for assessing treatment efficacy. Psychopharmacol Bull. 1983;19(3):448-50. No abstract available.
**PMID:** 6635122
**Citation:** Norise C, Hamilton RH. Non-invasive Brain Stimulation in the Treatment of Post-stroke and Neurodegenerative Aphasia: Parallels, Differences, and Lessons Learned. Front Hum Neurosci. 2017 Jan 23;10:675. doi: 10.3389/fnhum.2016.00675. eCollection 2016.
**PMID:** 28167904
**Citation:** Rabey JM, Dobronevsky E. Repetitive transcranial magnetic stimulation (rTMS) combined with cognitive training is a safe and effective modality for the treatment of Alzheimer's disease: clinical experience. J Neural Transm (Vienna). 2016 Dec;123(12):1449-1455. doi: 10.1007/s00702-016-1606-6. Epub 2016 Sep 8.
**PMID:** 27631152
**Citation:** Rabey JM, Dobronevsky E, Aichenbaum S, Gonen O, Marton RG, Khaigrekht M. Repetitive transcranial magnetic stimulation combined with cognitive training is a safe and effective modality for the treatment of Alzheimer's disease: a randomized, double-blind study. J Neural Transm (Vienna). 2013 May;120(5):813-9. doi: 10.1007/s00702-012-0902-z. Epub 2012 Oct 18.
**PMID:** 23076723
**Citation:** Rossi S, Hallett M, Rossini PM, Pascual-Leone A; Safety of TMS Consensus Group. Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research. Clin Neurophysiol. 2009 Dec;120(12):2008-2039. doi: 10.1016/j.clinph.2009.08.016. Epub 2009 Oct 14.
**PMID:** 19833552
**Citation:** Rubinov M, Sporns O. Complex network measures of brain connectivity: uses and interpretations. Neuroimage. 2010 Sep;52(3):1059-69. doi: 10.1016/j.neuroimage.2009.10.003. Epub 2009 Oct 9.
**PMID:** 19819337
**Citation:** Saur D, Lange R, Baumgaertner A, Schraknepper V, Willmes K, Rijntjes M, Weiller C. Dynamics of language reorganization after stroke. Brain. 2006 Jun;129(Pt 6):1371-84. doi: 10.1093/brain/awl090. Epub 2006 Apr 25.
**PMID:** 16638796
**Citation:** Stam CJ. Modern network science of neurological disorders. Nat Rev Neurosci. 2014 Oct;15(10):683-95. doi: 10.1038/nrn3801. Epub 2014 Sep 4.
**PMID:** 25186238
**Citation:** Szatloczki G, Hoffmann I, Vincze V, Kalman J, Pakaski M. Speaking in Alzheimer's Disease, is That an Early Sign? Importance of Changes in Language Abilities in Alzheimer's Disease. Front Aging Neurosci. 2015 Oct 20;7:195. doi: 10.3389/fnagi.2015.00195. eCollection 2015.
**PMID:** 26539107
**Citation:** Vacas SM, Stella F, Loureiro JC, Simoes do Couto F, Oliveira-Maia AJ, Forlenza OV. Noninvasive brain stimulation for behavioural and psychological symptoms of dementia: A systematic review and meta-analysis. Int J Geriatr Psychiatry. 2019 Sep;34(9):1336-1345. doi: 10.1002/gps.5003. Epub 2018 Oct 17.
**PMID:** 30246461
**Citation:** van den Heuvel MP, Hulshoff Pol HE. Exploring the brain network: a review on resting-state fMRI functional connectivity. Eur Neuropsychopharmacol. 2010 Aug;20(8):519-34. doi: 10.1016/j.euroneuro.2010.03.008. Epub 2010 May 14.
**PMID:** 20471808
**Citation:** van den Heuvel MP, Sporns O. Network hubs in the human brain. Trends Cogn Sci. 2013 Dec;17(12):683-96. doi: 10.1016/j.tics.2013.09.012.
**PMID:** 24231140
**Citation:** Wu Y, Xu W, Liu X, Xu Q, Tang L, Wu S. Adjunctive treatment with high frequency repetitive transcranial magnetic stimulation for the behavioral and psychological symptoms of patients with Alzheimer's disease: a randomized, double-blind, sham-controlled study. Shanghai Arch Psychiatry. 2015 Oct;27(5):280-8. doi: 10.11919/j.issn.1002-0829.215107.
**PMID:** 26977125
## 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: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M3885
- Name: Alzheimer Disease
- Relevance: HIGH
- As Found: Alzheimer's Disease
- ID: M4352
- Name: Aphasia
- Relevance: LOW
- As Found: Unknown
- 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
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000000544
- Term: Alzheimer Disease
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT00634179
**Brief Title:** A Phase I/II Trial of VR-CHOP in Lymphoma Patients
**Official Title:** A Phase I/II Trial of VR-CHOP for Patients With Untreated Follicular Lymphoma and Other Low Grade B-Cell Lymphomas
#### Organization Study ID Info
**ID:** IRB00002996
#### Organization
**Class:** OTHER
**Full Name:** Emory University
#### Secondary ID Infos
**Domain:** Winship Cancer Institute
**ID:** X05215
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2015-11
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2016-10-27
**Type:** ESTIMATED
**Last Update Submit Date:** 2016-09-21
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2015-11
**Type:** ACTUAL
#### Results First Post Date
**Date:** 2016-03-15
**Type:** ESTIMATED
**Results First Submit Date:** 2016-02-17
**Results First Submit QC Date:** 2016-02-17
#### Start Date
**Date:** 2008-02
**Status Verified Date:** 2016-09
#### Study First Post Date
**Date:** 2008-03-12
**Type:** ESTIMATED
**Study First Submit Date:** 2008-02-11
**Study First Submit QC Date:** 2008-03-11
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** Millennium Pharmaceuticals, Inc.
#### Lead Sponsor
**Class:** OTHER
**Name:** Emory University
#### Responsible Party
**Investigator Affiliation:** Emory University
**Investigator Full Name:** Christopher R. Flowers
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** This is an open-label (doctors and patients know which drug will be given), single center, phase 1/2 clinical trial. The primary objective is to determine whether VR-CHOP provides benefit to patients with previously untreated indolent non-Hodgkin's lymphomas (NHL).
**Detailed Description:** This study will assess whether adding bortezomib (Velcade) to R-CHOP (in a new combination called VR-CHOP) can further improve outcomes in patients with indolent NHL who have not previously received treatment.
Patients who are eligible to take part in the study will receive VR-CHOP at the doses of Velcade and vincristine established in phase 1. Patients will receive VR-CHOP for up to 8 cycles of treatment (each of 21 days duration). During treatment, patients will be assessed for their response to therapy and for possible side effects. All patients will go on to receive maintenance therapy after completion of their initial treatment as designed by the protocol.
### Conditions Module
**Conditions:**
- Lymphoma, B-Cell
- Follicular Lymphoma
**Keywords:**
- Lymphoma
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 37
**Type:** ACTUAL
**Phases:**
- PHASE1
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** INDUCTION: Patients receive bortezomib IV on days 1 and 8; rituximab IV, doxorubicin hydrochloride IV over 3-5 minutes, cyclophosphamide IV over 60 minutes, and vincristine sulfate IV over 10 minutes on day 1; and prednisone PO on days 1-5. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression.
MAINTENANCE: Patients achieving complete response (CR) receive rituximab IV once every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or partial response (PR) receive rituximab IV and bortezomib once weekly for 4 weeks every 6 months for up to 2 years in the absence of disease progression or unacceptable toxicity.
**Intervention Names:**
- Drug: Bortezomib
- Biological: Rituximab
- Drug: Doxorubicin
- Drug: Cyclophosphamide
- Drug: Vincristine
- Drug: Prednisone
**Label:** Treatment (VR-CHOP regimen)
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Treatment (VR-CHOP regimen)
**Description:** Bortezomib 1.6 mg/m² given on days 1 and 8
**Name:** Bortezomib
**Other Names:**
- Velcade
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Treatment (VR-CHOP regimen)
**Description:** Rituximab 375 mg/m²
**Name:** Rituximab
**Other Names:**
- Rituxin
- MabThera
**Type:** BIOLOGICAL
#### Intervention 3
**Arm Group Labels:**
- Treatment (VR-CHOP regimen)
**Description:** Doxorubicin 50 mg/m²
**Name:** Doxorubicin
**Other Names:**
- Adriamycin
**Type:** DRUG
#### Intervention 4
**Arm Group Labels:**
- Treatment (VR-CHOP regimen)
**Description:** Cyclophosphamide 750 mg/m²
**Name:** Cyclophosphamide
**Other Names:**
- Neosar
**Type:** DRUG
#### Intervention 5
**Arm Group Labels:**
- Treatment (VR-CHOP regimen)
**Description:** Vincristine 1.4 mg/m² (capped at 1.5 mg maximum) given on day 1
**Name:** Vincristine
**Other Names:**
- Oncovin
**Type:** DRUG
#### Intervention 6
**Arm Group Labels:**
- Treatment (VR-CHOP regimen)
**Description:** Prednisone 100 mg/day given orally on days 1-5
**Name:** Prednisone
**Other Names:**
- Deltasone
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** INDUCTION: Patients receive bortezomib IV on days 1 and 8; rituximab IV, doxorubicin hydrochloride IV over 3-5 minutes, cyclophosphamide IV over 60 minutes, and vincristine sulfate IV over 10 minutes on day 1; and prednisone PO on days 1-5. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression.
**Measure:** Maximal Tolerated Doses of Bortezomib and Vincristine When Used in Combination of Bortezomib, Rituximab and the CHOP Chemotherapy Regimen (Phase I)
**Time Frame:** Cycle 1 for MTD, following completion of therapy for CR, up to 24 weeks
#### Secondary Outcomes
**Description:** Response was assessed by computerized tomography (CT) after every 2 cycles of induction therapy, one time at least 4 weeks after completing induction (i.e., prior to maintenance), and then every 3 months while on maintenance therapy. At the conclusion of maintenance therapy, patients underwent one post-treatment scan, with further scans completed at the discretion of the treating physician. Positron emission tomography was permitted but only CT measurements were used to determine response.
**Measure:** An Estimate of the Overall Response Rate (ORR)(Complete Response [CR] + CR Unconfirmed [CRu] + Partial Response [PR]) to Bortezomib and Rituximab (VR)-CHOP According to International Workshop to Standardize Response Criteria (IWRC) Criteria
**Time Frame:** Following completion of therapy, up to 2 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Tissue diagnosis of a previously untreated, cluster of differentiation antigen 20+ (CD20+), B-cell non-Hodgkin lymphoma.
* For the Phase 1 trial: patients with any of the following diagnoses are eligible:
* Follicular Lymphomas (Grade 1, 2, 3a, 3b)
* Small Lymphocytic Lymphoma
* Marginal Zone Lymphomas
* For the Phase 2 trial: patients with any of the following diagnoses are eligible:
* Follicular Lymphomas (Grade 1, 2, 3a)
* Small Lymphocytic Lymphoma
* Marginal Zone Lymphomas
* Patients with follicular or other low-grade lymphoma must have an indication for treatment based on modified Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria or a Follicular Lymphoma International Prognostic Index (FLIPI) score ≥ 3.
* Indications for treatment based on modified GELF criteria include any one of the following:
* B symptoms or other lymphoma-related symptoms
* Involvement of 3 nodal sites, each with a diameter of 3 cm
* Any nodal or extranodal tumor mass with a diameter of 7 cm
* Splenomegaly greater than 16 cm by CT scan.
* Pleural effusions or peritoneal ascites
* Cytopenias (leukocytes \< 1.0 x 10 /L and/or platelets \< 100 x 10/L)
* Leukemia (\> 5.0 x 10 /L circulating malignant cells)
* Indications for treatment based on FLIPI criteria include any three of the following:
* Age ≥ 60 years
* Ann Arbor stage III or IV
* Hemoglobin level \< 120 g/L
* Number of nodal areas involved \> 4
* Serum lactate dehydrogenase (LDH) level \> normal
* Only chemotherapy-naïve subjects are eligible. Subjects may have received prednisone (\< 2 months of therapy) or radiation ≤ 2 sites of therapy.
* Voluntary written informed consent and Health Insurance Portability and Accountability Act (HIPAA) Authorization before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
* Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
* Female patients of child bearing potential must have a negative β-human chorionic gonadotropin (β-hCG) test.
* Male subject agrees to use an acceptable method for contraception for the duration of the study.
* ≥ 18 years of age at the time of registration.
* Patients must have adequate renal function as demonstrated by a serum creatinine \< 1.5 mg/dl unless felt to be secondary to lymphoma.
* Must have an alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤ 3.5 the upper limit of normal and a total bilirubin ≤ 2.0 mg/dL unless secondary to lymphoma.
* Must have a cardiac left ventricular ejection fraction ≥ 50%.
* At least 1 measurable tumor mass (greater than 1.5 cm in the longest dimension and greater than 1.0 cm in the short axis).
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
Exclusion Criteria:
* Subject with primary or secondary central nervous system (CNS) lymphoma (current or previously treated) will not be eligible.
* A history of unrelated (non-lymphomatous) neoplasm within the past 10 years other than non-melanoma skin cancer or in-situ cervix cancer. Subjects with a prior diagnosis of malignancy more than 10 years may be entered into the study at the discretion of the Principal Investigator.
* Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
* Patient has received other investigational drugs with 14 days before enrollment.
* Patient has hypersensitivity to boron or mannitol.
* Female subject is pregnant or breast-feeding. Chemotherapeutic agents are known to have teratogenic effects on developing embryos and to cause chromosomal damage to gametes. These agents also cause bone marrow suppression and can be excreted in milk. Confirmation that the subject is not pregnant must be established by a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
* Patient has ≥ Grade 2 peripheral neuropathy within 14 days before enrollment.
* Myocardial infarction within 6 months prior to enrollment or has New York Heart 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. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.
* Patient has a platelet count of \< 10 x 10¹⁰/L (unless due to bone marrow involvement with lymphoma documented within 14 days before enrollment).
* Patient has an absolute neutrophil count of \< 1.0 x 10⁹/L (unless due to bone marrow involvement with lymphoma documented within 14 days before enrollment).
* Patient has a calculated or measured creatinine clearance of \< 20 mL/minute within 14 days before enrollment.
* Presence of antibodies to HIV.
* Subject unwilling to give informed consent.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Atlanta
**Country:** United States
**Facility:** Emory University Winship Cancer Institute
**State:** Georgia
**Zip:** 30322
#### Overall Officials
**Official 1:**
**Affiliation:** Emory University
**Name:** Christopher Flowers, MD
**Role:** PRINCIPAL_INVESTIGATOR
### References Module
#### References
**Citation:** Sinha R, Kaufman JL, Khoury HJ Jr, King N, Shenoy PJ, Lewis C, Bumpers K, Hutchison-Rzepka A, Tighiouart M, Heffner LT, Lechowicz MJ, Lonial S, Flowers CR. A phase 1 dose escalation study of bortezomib combined with rituximab, cyclophosphamide, doxorubicin, modified vincristine, and prednisone for untreated follicular lymphoma and other low-grade B-cell lymphomas. Cancer. 2012 Jul 15;118(14):3538-48. doi: 10.1002/cncr.26660. Epub 2012 Jan 3.
**PMID:** 22535574
**Citation:** Cohen JB, Switchenko JM, Koff JL, Sinha R, Kaufman JL, Khoury HJ, Bumpers N, Colbert A, Hutchison-Rzepka A, Nastoupil LJ, Heffner LT, Langston AA, Lechowicz MJ, Lonial S, Flowers CR. A phase II study of bortezomib added to rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone in patients with previously untreated indolent non-Hodgkin's lymphoma. Br J Haematol. 2015 Nov;171(4):539-46. doi: 10.1111/bjh.13637. Epub 2015 Aug 7.
**PMID:** 26248505
## 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: M11221
- Name: Lymphoma, Follicular
- Relevance: HIGH
- As Found: Follicular lymphoma
- ID: M18828
- Name: Lymphoma, B-Cell
- Relevance: HIGH
- As Found: Lymphoma, B-Cell
- 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: T2361
- Name: Follicular Lymphoma
- Relevance: HIGH
- As Found: Follicular lymphoma
- ID: T640
- Name: B-cell Lymphoma
- Relevance: HIGH
- As Found: Lymphoma, B-Cell
### Condition Browse Module - Meshes
- ID: D000008223
- Term: Lymphoma
- ID: D000008224
- Term: Lymphoma, Follicular
- ID: D000016393
- Term: Lymphoma, B-Cell
### Intervention Browse Module - Ancestors
- ID: D000007166
- Term: Immunosuppressive Agents
- ID: D000007155
- Term: Immunologic Factors
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000018501
- Term: Antirheumatic Agents
- ID: D000018906
- Term: Antineoplastic Agents, Alkylating
- ID: D000000477
- Term: Alkylating Agents
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000000970
- Term: Antineoplastic Agents
- ID: D000019653
- Term: Myeloablative Agonists
- ID: D000074322
- Term: Antineoplastic Agents, Immunological
- ID: D000000903
- Term: Antibiotics, Antineoplastic
- ID: D000059005
- Term: Topoisomerase II Inhibitors
- ID: D000059003
- Term: Topoisomerase Inhibitors
- ID: D000004791
- Term: Enzyme Inhibitors
- ID: D000000893
- Term: Anti-Inflammatory 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: D000000972
- Term: Antineoplastic Agents, Phytogenic
- ID: D000050257
- Term: Tubulin Modulators
- ID: D000050256
- Term: Antimitotic Agents
- ID: D000050258
- Term: Mitosis Modulators
### Intervention Browse Module - Browse Branches
- Abbrev: Infl
- Name: Anti-Inflammatory Agents
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: ARhu
- Name: Antirheumatic Agents
- Abbrev: Infe
- Name: Anti-Infective Agents
### Intervention Browse Module - Browse Leaves
- ID: M14121
- Name: Prednisone
- Relevance: HIGH
- As Found: Min
- ID: M6727
- Name: Cyclophosphamide
- Relevance: HIGH
- As Found: Cycle
- ID: M373
- Name: Rituximab
- Relevance: HIGH
- As Found: Healthy
- ID: M7492
- Name: Doxorubicin
- Relevance: HIGH
- As Found: Women
- ID: M227339
- Name: Liposomal doxorubicin
- Relevance: LOW
- As Found: Unknown
- ID: M17495
- Name: Vincristine
- Relevance: HIGH
- As Found: Volume
- ID: M376
- Name: Bortezomib
- Relevance: HIGH
- As Found: 14 days
- ID: M10212
- Name: Immunosuppressive Agents
- 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: M20942
- Name: Antineoplastic Agents, Alkylating
- Relevance: LOW
- As Found: Unknown
- ID: M3820
- Name: Alkylating Agents
- Relevance: LOW
- As Found: Unknown
- ID: M1346
- Name: Antineoplastic Agents, Immunological
- 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: M7951
- Name: Enzyme Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M4217
- Name: Anti-Inflammatory 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
- ID: M26197
- Name: Tubulin Modulators
- Relevance: LOW
- As Found: Unknown
- ID: M26196
- Name: Antimitotic Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000011241
- Term: Prednisone
- ID: D000003520
- Term: Cyclophosphamide
- ID: D000069283
- Term: Rituximab
- ID: D000004317
- Term: Doxorubicin
- ID: D000014750
- Term: Vincristine
- ID: D000069286
- Term: Bortezomib
### Misc Info Module
- Version Holder: 2024-05-24
## Results Section
### Adverse Events Module
#### Event Groups
**Group ID:** EG000
**Title:** Phase I: Induction
**Description:** Phase I will identify the maximal tolerated doses of bortezomib and vincristine when used in a combination of bortezomib, rituximab and the CHOP chemotherapy regimen.
**ID:** EG000
**Other Num Affected:** 16
**Other Num at Risk:** 19
**Serious Number Affected:** 3
**Serious Number At Risk:** 19
**Title:** Phase I: Induction
**Group ID:** EG001
**Title:** Phase II: Maintenance
**Description:** In Phase II, the trial will evaluate the efficacy and safety of the MTD combination of VELCADE and rituximab-CHOP in additional subjects who have untreated follicular B-NHL. (Grade 1, 2, 3a), small lymphocytic lymphoma, or marginal zone lymphoma.
**ID:** EG001
**Other Num Affected:** 22
**Other Num at Risk:** 29
**Serious Number Affected:** 1
**Serious Number At Risk:** 29
**Title:** Phase II: Maintenance
**Frequency Threshold:** 0
#### Other Events
**Term:** Neutropenia
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Blood and lymphatic system disorders
**Source Vocabulary:**
**Term:** Thrombocytopenia
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Blood and lymphatic system disorders
**Source Vocabulary:**
**Term:** Nausea
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:**
**Term:** Neuropathy
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
**Source Vocabulary:**
**Term:** Fatigue
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:**
**Term:** Vomiting
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:**
**Term:** Diarrhea
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:**
**Term:** Rash
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
**Source Vocabulary:**
**Term:** Dyspepsia
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:**
**Term:** Low Potassium
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
**Source Vocabulary:**
**Term:** Pain
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
**Source Vocabulary:**
**Term:** Anemia
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Blood and lymphatic system disorders
**Source Vocabulary:**
**Term:** Febrile Neutropenia
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Blood and lymphatic system disorders
**Source Vocabulary:**
**Term:** Hyperglycemia
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
**Source Vocabulary:**
**Term:** Extravasation
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Blood and lymphatic system disorders
**Source Vocabulary:**
**Term:** Fever
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Immune system disorders
**Source Vocabulary:**
**Term:** Hypoxia
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
**Source Vocabulary:**
**Term:** Parotitis
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Immune system disorders
**Source Vocabulary:**
**Term:** Weakness
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:**
**Term:** Tachycardia
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Cardiac disorders
**Source Vocabulary:**
#### Serious Events
**Term:** Thrombosis
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Blood and lymphatic system disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 19
**Group ID:** EG001
**Num At Risk:** 29
**Term:** Fatigue
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 19
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 29
**Term:** Vomiting
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 19
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 29
**Term:** Diarrhea
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 19
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 29
**Term:** Pain
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 19
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 29
**Term:** Febrile Neutropenia
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Blood and lymphatic system disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 19
**Group ID:** EG001
**Num At Risk:** 29
**Term:** Anxiety/Depression
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Psychiatric disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 19
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 29
**Term:** Cellulitis
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 19
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 29
**Term:** Dehydration
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 19
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 29
**Term:** Dyspnea
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 19
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 29
**Term:** Extravasation
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Blood and lymphatic system disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 19
**Group ID:** EG001
**Num At Risk:** 29
**Term:** Prolonged QT Interval
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Cardiac disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 19
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 29
**Term:** Urinary Tract Infection
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
##### Stats
**Group ID:** EG000
**Num At Risk:** 19
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 29
## Results Section - Baseline Characteristics Module
### Denomination Counts
**Group ID:** BG000
**Value:** 37
**Units:** Participants
### Group
**ID:** BG000
**Title:** Treatment (VR-CHOP Regimen)
**Description:** INDUCTION: Patients receive bortezomib IV on days 1 and 8; rituximab IV, doxorubicin hydrochloride IV over 3-5 minutes, cyclophosphamide IV over 60 minutes, and vincristine sulfate IV over 10 minutes on day 1; and prednisone PO on days 1-5. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression.
MAINTENANCE: Patients achieving complete response (CR) receive rituximab IV once every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or partial response (PR) receive rituximab IV and bortezomib once weekly for 4 weeks every 6 months for up to 2 years in the absence of disease progression or unacceptable toxicity.
### Measure
#### Measurement
**Group ID:** BG000
**Lower Limit:** 28
**Upper Limit:** 71
**Value:** 58
**Class Title:**
### Measure
#### Measurement
**Group ID:** BG000
**Value:** 17
**Category Title:** Female
#### Measurement
**Group ID:** BG000
**Value:** 20
**Category Title:** Male
**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:** 11
**Category Title:** Black or African American
#### Measurement
**Group ID:** BG000
**Value:** 26
**Category Title:** White
#### Measurement
**Group ID:** BG000
**Value:** 0
**Category Title:** More than one race
#### Measurement
**Group ID:** BG000
**Value:** 0
**Category Title:** Unknown or Not Reported
**Class Title:**
### Measure
#### Measurement
**Group ID:** BG000
**Value:** 37
**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:** Race (NIH/OMB)
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
**Population Description:** A total of 37 patients were enrolled on this study. However, not all patients participated in both phases of this study. For phase I, 19 patients were enrolled, and for phase II, 30 patients were enrolled.
## Results Section - More Information Module
### Certain Agreement
**PI Sponsor Employee:** True
### Point of Contact
**Email:** [email protected]
**Organization:** Emory University
**Phone:** 404-778-3935
**Title:** Christopher R. Flowers, MD, MS
## 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:** 0.63
- **Spread:**
- **Upper Limit:** 1.88
- **Value:** 1.62
**Title:**
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 13
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 19
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 6
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 10
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 19
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 29
**Title:**
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** INDUCTION: Patients receive bortezomib IV on days 1 and 8; rituximab IV, doxorubicin hydrochloride IV over 3-5 minutes, cyclophosphamide IV over 60 minutes, and vincristine sulfate IV over 10 minutes on day 1; and prednisone PO on days 1-5. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** Cycle 1 for MTD, following completion of therapy for CR, up to 24 weeks
**Title:** Maximal Tolerated Doses of Bortezomib and Vincristine When Used in Combination of Bortezomib, Rituximab and the CHOP Chemotherapy Regimen (Phase I)
**Type:** PRIMARY
**Unit of Measure:** mg/m^2
##### Group
**Description:** Maximal tolerated dose (MTD) of bortezomib when vincristine is capped at 1.5 mg
**ID:** OG000
**Title:** MTD of Bortezomib With Vincristine Capped at 1.5 mg
#### Outcome Measure 2
**Description:** Response was assessed by computerized tomography (CT) after every 2 cycles of induction therapy, one time at least 4 weeks after completing induction (i.e., prior to maintenance), and then every 3 months while on maintenance therapy. At the conclusion of maintenance therapy, patients underwent one post-treatment scan, with further scans completed at the discretion of the treating physician. Positron emission tomography was permitted but only CT measurements were used to determine response.
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** Following completion of therapy, up to 2 years
**Title:** An Estimate of the Overall Response Rate (ORR)(Complete Response [CR] + CR Unconfirmed [CRu] + Partial Response [PR]) to Bortezomib and Rituximab (VR)-CHOP According to International Workshop to Standardize Response Criteria (IWRC) Criteria
**Type:** SECONDARY
**Unit of Measure:** participants
##### Group
**Description:** INDUCTION: Patients receive bortezomib IV on days 1 and 8; rituximab IV, doxorubicin hydrochloride IV over 3-5 minutes, cyclophosphamide IV over 60 minutes, and vincristine sulfate IV over 10 minutes on day 1; and prednisone PO on days 1-5. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression.
**ID:** OG000
**Title:** Phase I: Induction
##### Group
**Description:** INDUCTION: Patients receive bortezomib IV on days 1 and 8; rituximab IV, doxorubicin hydrochloride IV over 3-5 minutes, cyclophosphamide IV over 60 minutes, and vincristine sulfate IV over 10 minutes on day 1; and prednisone PO on days 1-5. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression.
MAINTENANCE: Patients achieving CR receive rituximab IV once every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or PR receive rituximab IV and bortezomib once weekly for 4 weeks every 6 months for up to 2 years in the absence of disease progression or unacceptable toxicity.
Bortezomib: Bortezomib 1.6 mg/m² given on days 1 and 8
Rituximab: Rituximab 375 mg/m²
Doxorubicin: Doxorubicin 50 mg/m²
Cyclophosphamide: Cyclophosphamide 750 mg/m²
Vincristine: Vincristine 1.4 mg/m² (capped at 1.5 mg maximum) given on day 1
Prednisone: Prednisone 100 mg/day given orally on
**ID:** OG001
**Title:** Phase II: Maintenance
### Participant Flow Module
#### Group
**Description:** Phase I will identify the maximal tolerated doses of bortezomib and vincristine when used in a combination of bortezomib, rituximab and the cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) chemotherapy regimen.
In Phase II, the trial will evaluate the efficacy and safety of the MTD combination of VELCADE and rituximab-CHOP in additional subjects who have untreated follicular B-cell non-Hodgkin's lymphoma (B-NHL)(Grade 1, 2, 3a), small lymphocytic lymphoma, or marginal zone lymphoma.
**ID:** FG000
**Title:** Treatment (VR-CHOP Regimen)
#### Period
**Title:** Phase I: Induction
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 19
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 19
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
#### Period
**Title:** Phase II: Maintenance
##### Withdraw
**Type:** Diagnosis changed after re-review
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 30
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 29
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 1
**Pre-Assignment Details:** A total of 37 patients were enrolled. However, not all patients participated in both phases of this study. For phase I, 19 patients were enrolled, and for phase II, 30 patients were enrolled.
**Recruitment Details:** All patients were recruited from Winship Cancer Institute of Emory University.
**Has Results:** True |
## Protocol Section
### Identification Module
**NCT ID:** NCT02690779
**Brief Title:** Bowel Preparation Quality for Screening Colonoscopy
**Official Title:** Impact of a Patient Educational Video on Bowel Preparation Quality for Screening Colonoscopy: a Quality Assurance Project
#### Organization Study ID Info
**ID:** 131668
#### Organization
**Class:** OTHER
**Full Name:** Vanderbilt University Medical Center
### Status Module
#### Completion Date
**Date:** 2015-11
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-03-27
**Type:** ACTUAL
**Last Update Submit Date:** 2017-03-23
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2015-11
**Type:** ACTUAL
#### Start Date
**Date:** 2015-08
**Type:** ACTUAL
**Status Verified Date:** 2017-03
#### Study First Post Date
**Date:** 2016-02-24
**Type:** ESTIMATED
**Study First Submit Date:** 2016-01-19
**Study First Submit QC Date:** 2016-02-19
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Vanderbilt University Medical Center
#### Responsible Party
**Investigator Affiliation:** Vanderbilt University Medical Center
**Investigator Full Name:** Keith Obstein
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The study will consist of a prospective observational period performed in the GI Endoscopy Lab. The objective is to document the quality of bowel preps in patients undergoing a screening colonoscopy with and without an educational intervention.
**Detailed Description:** The educational intervention will consist of a 2-3 minute video demonstrating video images of adequate and inadequate bowel preps, and reviewing instructions for split dose prep administration. This video will be posted on YouTube. Group 1 will consist of 30 subjects who will be instructed to view this video prior to beginning their colonoscopy preparation. Information to access the YouTube video will be provided to the patients by endoscopy nurse assessment staff when contacting the patients as per standard practice to review appointment scheduling and procedure-day logistics. Group 2 will consist of 30 subjects who will not receive instructions to view the video.
Nursing staff will be asked to grade bowel preps according to the Boston Bowel Preparation Scale (BBPS), a validated and reliable instrument for assessing quality of bowel preparation \[6\]. Using the BBPS, a four point scoring system is applied to each of the three broad regions of the colon: the right side of the colon (including the cecum and ascending colon), the transverse section of the colon (including the hepatic and splenic flexures), and the left side of the colon (including the descending colon, sigmoid colon, and rectum). The points are assigned as follows: (0), unprepared colon segment, (1), portion of the mucosa of the colon segment seen, (2), minor amount of residual staining, (3), entire mucosa of colon segment seen well. The three segment scores are then summed for a total BBPS score, which ranges from 0 to 9. The maximum BBPS score for a perfectly clean colon without any residual liquid is 9, and the minimum BBPS score for an unprepared colon is 0. The endoscopy nurse who is in the procedure room will be scoring the bowel preparation. This protocol has been employed previously in the VUMC Endoscopy Lab and the endoscopy nurses at Vanderbilt have completed a detailed in-service training session on using the BBPS scoring system. Prior to initiation of this current study protocol, the endoscopy nurses will have a BBPS scoring system review session to ensure continued reliable and valid BBPS scores. The endoscopy nurses will be blinded to whether the patient viewed the video or not.
### Conditions Module
**Conditions:**
- Screening Colonoscopies
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** TRIPLE
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** SCREENING
#### Enrollment Info
**Count:** 155
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The educational intervention will consist of a 2-3 minute video demonstrating video images of adequate and inadequate bowel preps, and reviewing instructions for split dose prep administration. This video will be posted on YouTube. Group 1 will consist of 30 subjects who will be instructed to view this video prior to beginning their colonoscopy preparation. Information to access the YouTube video will be provided to the patients by endoscopy nurse assessment staff when contacting the patients as per standard practice to review appointment scheduling and procedure-day logistics.
**Intervention Names:**
- Other: Educational intervention
**Label:** Patients watching educational video
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Group 2 will consist of 30 subjects who will not receive instructions to view the video. They will be given routine care instructions for bowel prep.
**Intervention Names:**
- Other: Routine Care Instructions
**Label:** Patients not watching educational video
**Type:** SHAM_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Patients watching educational video
**Description:** 2-3 minute video demonstrating video images of adequate and inadequate bowel preps, and reviewing instructions for split dose prep administration.
**Name:** Educational intervention
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Patients not watching educational video
**Description:** patients will follow routine care and instructions
**Name:** Routine Care Instructions
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Measure:** Adequate bowel preparation as defined by the Boston Bowel Preparation Scale (total score ≥6 with no score less than 2)
**Time Frame:** At time of colonoscopy
#### Secondary Outcomes
**Measure:** Bowel preparation quality as defined by the Boston Bowel Preparation Scale (total and segment scores)
**Time Frame:** At time of colonoscopy
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Elective outpatient procedures performed for diagnostic purposes:
* screening colonoscopy
* surveillance colonoscopy
Exclusion Criteria:
* Colonoscopy for diagnosis/therapy of acute gastrointestinal hemorrhage or for planned therapeutic intervention
* Colonoscopy performed on hospital inpatients
**Healthy Volunteers:** True
**Minimum Age:** 45 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Nashville
**Country:** United States
**Facility:** Vanderbilt University Medical Center
**State:** Tennessee
**Zip:** 37232
#### Overall Officials
**Official 1:**
**Affiliation:** Vanderbilt University Medical Center
**Name:** Keith Obstein, MD, MPH
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT05332379
**Brief Title:** Regional Hemodynamic Parameter Changes After Spinal Anesthesia
**Official Title:** Measurement of Regional Hemodynamic Parameters Before and After Spinal Anesthesia With Doppler USG
#### Organization Study ID Info
**ID:** 09.2021.1406
#### Organization
**Class:** OTHER
**Full Name:** Marmara University
### Status Module
#### Completion Date
**Date:** 2023-07-20
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-10-18
**Type:** ACTUAL
**Last Update Submit Date:** 2023-10-17
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-07-20
**Type:** ACTUAL
#### Start Date
**Date:** 2022-04-01
**Type:** ACTUAL
**Status Verified Date:** 2023-10
#### Study First Post Date
**Date:** 2022-04-18
**Type:** ACTUAL
**Study First Submit Date:** 2022-04-11
**Study First Submit QC Date:** 2022-04-11
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Marmara University
#### Responsible Party
**Investigator Affiliation:** Marmara University
**Investigator Full Name:** Ruslan Abdullayev
**Investigator Title:** Assist. Prof.
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Spinal anesthesia is a regional anesthesia method used for surgical procedures generally involving the lower abdominal area, perineum, and lower extremities. Various tests are performed to evaluate the block level after spinal anesthesia, incluyding pinprick test, cold application, and motor examination. These tests are performed to check whether the pain, sympathetic and motor nerve fibers are affected, respectively, after the block; and good communication with the patient is important here. However, it is extremely difficult to evaluate these tests in pediatric, geriatric, mentally retarded or uncooperative patients.
Sympathectomy can be used as a criterion to evaluate the success of the block that occurs after the spinal anesthesia procedure. Sympathetic nerve fibers are the first to be affected by the block, and the success of the block can be evaluated with the revealed sympathectomy. Sympathectomy in the lower extremities after spinal block increases arterial blood flow. This increase in blood flow can be detected by the Pulsed Wave Doppler feature of USG.
### Conditions Module
**Conditions:**
- Spinal Anesthesia Evaluation
**Keywords:**
- Spinal anesthesia
- Test
- Pulsed Wave Doppler
- Sympathectomy
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 35
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
### Interventions
#### Intervention 1
**Description:** Pulsed Wave Doppler USG examination of the posterior tibial artery on the left or right lower extremity will be performed before spinal anesthesia, at the 5th and 10th minutes after the spinal anesthesia. Blood flow velocities and vessel diameters will be measured.
**Name:** Pulsed Wave Doppler USG examination
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** Posterior tibial artery velocities (peak systolic, end-diastolic) and vessel diameters will be measured after the spinal anesthesia procedure.
**Measure:** Arterial velocity changes
**Time Frame:** At the 5th and 10th minutes after the spinal anesthesia procedure
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Elective surgery under spinal anesthesia
* American Society of Anesthesiologists (ASA) I-II physical status
Exclusion Criteria:
* Contraindication for spinal anesthesia
* ASA physical status \>II
* Vasoactive drug usage
**Maximum Age:** 65 Years
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Patients scheduled for elective operation with spinal anesthesia will be recruited for the study. Posterior tibial artery velocities (peak systolic, end-diastolic) and the vessel diameters will be measured via USG Pulsed Wave Doppler mode. Three measurements will be performed: before spinal anesthesia, at the 5th and at the 10th minutes after the subarachnoid injection. The patients' sensory and motor examinations will be performed as well.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Istanbul
**Country:** Turkey
**Facility:** Marmara University School of Medicine
**State:** Pendik
**Zip:** 34899
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## 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:** NCT00133679
**Brief Title:** Chronic Sildenafil for Severe Diaphragmatic Hernia
**Official Title:** Chronic Sildenafil for Severe Diaphragmatic Hernia
#### Organization Study ID Info
**ID:** K23HL079922-01
**Link:** https://reporter.nih.gov/quickSearch/K23HL079922-01
**Type:** NIH
#### Organization
**Class:** OTHER
**Full Name:** University of California, San Francisco
### Status Module
#### Completion Date
**Date:** 2013-10
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-01-13
**Type:** ACTUAL
**Last Update Submit Date:** 2021-01-12
**Overall Status:** TERMINATED
#### Primary Completion Date
**Date:** 2013-07
**Type:** ACTUAL
#### Results First Post Date
**Date:** 2021-01-13
**Type:** ACTUAL
**Results First Submit Date:** 2020-12-07
**Results First Submit QC Date:** 2021-01-12
#### Start Date
**Date:** 2006-02
**Status Verified Date:** 2021-01
#### Study First Post Date
**Date:** 2005-08-23
**Type:** ESTIMATED
**Study First Submit Date:** 2005-08-22
**Study First Submit QC Date:** 2005-08-22
**Why Stopped:** Change in clinical practice allowing chronic therapy at 6 weeks of age, incompatible with possibility of placebo beyond 6 weeks of age on study protocol
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Children's Hospital Los Angeles
**Class:** OTHER
**Name:** Ann & Robert H Lurie Children's Hospital of Chicago
#### Lead Sponsor
**Class:** OTHER
**Name:** University of California, San Francisco
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The purpose of this study is to test if sildenafil is effective in the treatment of infants with severe congenital diaphragmatic hernia (determined by the presence of prolonged pulmonary hypertension or prolonged oxygen supplementation on mechanical ventilation), as measured by the estimated pulmonary artery systolic pressure following treatment.
**Detailed Description:** Congenital diaphragmatic hernia (CDH) is a condition characterized by pulmonary parenchymal and vascular hypoplasia. Severe CDH carries a high rate of mortality, and significant morbidity among survivors. This proposal is a randomized, blinded, placebo-controlled study designed to evaluate the efficacy and potential mechanisms of activity of sildenafil, a phosphodiesterase-5 inhibitor, for treatment of severe CDH. Infants who meet criteria at ≥10d of age predicting a poor outcome \[death or chronic lung disease (CLD) severe enough to require hospital discharge on supplemental oxygen (O2)\] will be eligible for the study. Infants whose parents consent for the study will undergo an initial echocardiogram to assess the degree of pulmonary hypertension. They will then begin either sildenafil or placebo therapy for a 45d course. A final echocardiogram will be performed after the experimental drug course is completed. The pulmonary arterial systolic pressure estimate during hyperoxic conditions will be compared between the sildenafil and placebo groups. Infants from either group who have severely elevated pulmonary arterial pressure (despite supplemental O2) will be considered for open-label sildenafil, which will continue after hospital discharge, depending on the results of a cardiac catheterization performed for clinical care.
### Conditions Module
**Conditions:**
- Hernia, Diaphragmatic
- Hypertension, Pulmonary
- Hypoplasia, Pulmonary
**Keywords:**
- Chronic lung disease
- Nitric oxide
- cyclic guanosine monophosphate
- phosphodiesterase inhibitor
### 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:** 9
**Type:** ACTUAL
**Phases:**
- PHASE4
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Sildenafil x 45 days
**Intervention Names:**
- Drug: sildenafil
**Label:** 1
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Placebo x 45 d
**Intervention Names:**
- Drug: Placebo
**Label:** 2
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- 1
**Description:** Sildenafil 0.5 mg/kg every 6 hours orally x 45 d
**Name:** sildenafil
**Other Names:**
- Viagra, Revatio
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- 2
**Description:** Placebo suspension (equal volume to experimental drug) x 45 days
**Name:** Placebo
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Measure:** Estimated Systolic Pulmonary Arterial Pressure at Final Echocardiogram
**Time Frame:** 7 weeks
#### Secondary Outcomes
**Measure:** Systemic Levels of Vasoactive Substances at the Time of Final Echocardiogram
**Time Frame:** 7 weeks
**Measure:** Adverse Effects of Sildenafil Therapy
**Time Frame:** 2 years
**Measure:** Somatic Growth at 1 and 2 Years of Age
**Time Frame:** 2 years
**Measure:** Neurodevelopmental Outcome at 1 and 2 Years of Age
**Time Frame:** 2 years
**Measure:** Respiratory Status at 1 and 2 Years of Age
**Time Frame:** 2 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Congenital diaphragmatic hernia
* 10-42 days (d) of age
* Significant illness severity as demonstrated by:
* Receiving assisted ventilation and
* FiO2 \>= 0.40 at 10-14d of age, or
* FiO2 \>= 0.40 for \>=48hours at 15-27d of age, or
* FiO2 \>= 0.35 at 28-42d of age
* Or, need for extracorporeal support at \>=10d of age
* Or, estimated pulmonary arterial or right ventricular systolic pressure of \>= 2/3 systemic pressure at 14-42d of age
Exclusion Criteria:
* Structural congenital heart disease (other than patent ductus arteriosus or patent foramen ovale/atrial septal defect \[ASD\] or non-hemodynamically significant ventricular septal defect \[VSD\])
* Sildenafil contraindicated (until condition resolves):
* Unable to absorb oral medication, or
* Unstable systemic blood pressure, or
* Receiving a drug that may interfere with sildenafil metabolism, or
* Renal insufficiency
* Hepatic insufficiency Previous use of sildenafil
**Maximum Age:** 42 Days
**Minimum Age:** 10 Days
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Los Angeles
**Country:** United States
**Facility:** Children's Hospital of Los Angeles
**State:** California
**Zip:** 90027
**Location 2:**
**City:** San Francisco
**Country:** United States
**Facility:** University of California San Francisco Children's Hospital
**State:** California
**Zip:** 94143
**Location 3:**
**City:** Chicago
**Country:** United States
**Facility:** Children's Memorial Hospital
**State:** Illinois
**Zip:** 60614
#### Overall Officials
**Official 1:**
**Affiliation:** University of California, San Francisco
**Name:** Roberta L Keller, MD
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000006973
- Term: Hypertension
- ID: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000020763
- Term: Pathological Conditions, Anatomical
- ID: D000082122
- Term: Internal Hernia
- ID: D000000013
- Term: Congenital Abnormalities
- 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: BC23
- Name: Symptoms and General Pathology
- Abbrev: BC16
- Name: Diseases and Abnormalities at or Before Birth
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M10024
- Name: Hypertension
- Relevance: LOW
- As Found: Unknown
- ID: M11168
- Name: Lung Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M9625
- Name: Hernia
- Relevance: HIGH
- As Found: Hernia
- ID: M10027
- Name: Hypertension, Pulmonary
- Relevance: HIGH
- As Found: Hypertension, Pulmonary
- ID: M30544
- Name: Hernias, Diaphragmatic, Congenital
- Relevance: HIGH
- As Found: Diaphragmatic Hernia
- ID: M9626
- Name: Hernia, Diaphragmatic
- Relevance: HIGH
- As Found: Hernia, Diaphragmatic
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M22519
- Name: Pathological Conditions, Anatomical
- Relevance: LOW
- As Found: Unknown
- ID: M2344
- Name: Internal Hernia
- Relevance: LOW
- As Found: Unknown
- ID: M25675
- Name: Hernia, Abdominal
- Relevance: LOW
- As Found: Unknown
- ID: M12
- Name: Congenital Abnormalities
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
- ID: T1482
- Name: Congenital Diaphragmatic Hernia
- Relevance: HIGH
- As Found: Diaphragmatic Hernia
### Condition Browse Module - Meshes
- ID: D000006976
- Term: Hypertension, Pulmonary
- ID: D000065630
- Term: Hernias, Diaphragmatic, Congenital
- ID: D000006547
- Term: Hernia
- ID: D000006548
- Term: Hernia, Diaphragmatic
### Intervention Browse Module - Ancestors
- ID: D000014665
- Term: Vasodilator Agents
- ID: D000058986
- Term: Phosphodiesterase 5 Inhibitors
- ID: D000010726
- Term: Phosphodiesterase Inhibitors
- ID: D000004791
- Term: Enzyme Inhibitors
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000064804
- Term: Urological Agents
### Intervention Browse Module - Browse Branches
- Abbrev: VaDiAg
- Name: Vasodilator Agents
- Abbrev: Urol
- Name: Urological Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Resp
- Name: Respiratory System Agents
- Abbrev: AnCoag
- Name: Anticoagulants
- Abbrev: Ot
- Name: Other Dietary Supplements
### Intervention Browse Module - Browse Leaves
- ID: M292
- Name: Sildenafil Citrate
- Relevance: HIGH
- As Found: Atrial Fibrillation
- ID: M12507
- Name: Nitric Oxide
- Relevance: LOW
- As Found: Unknown
- ID: M13629
- Name: Phosphodiesterase Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M21320
- Name: Citric Acid
- Relevance: LOW
- As Found: Unknown
- ID: M1837
- Name: Sodium Citrate
- Relevance: LOW
- As Found: Unknown
- ID: M17412
- Name: Vasodilator Agents
- Relevance: LOW
- As Found: Unknown
- ID: M29332
- Name: Phosphodiesterase 5 Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M7951
- Name: Enzyme Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: T382
- Name: Citrate
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000068677
- Term: Sildenafil Citrate
### Misc Info Module
- Version Holder: 2024-05-24
## Results Section
### Adverse Events Module
**Description:** Study was terminated. All efforts to locate the data have been exhausted and data has been lost and/or destroyed.
#### Event Groups
**Group ID:** EG000
**Title:** Sildenafil
**Description:** Sildenafil x 45 days
sildenafil: Sildenafil 0.5 mg/kg every 6 hours orally x 45 d
**ID:** EG000
**Title:** Sildenafil
**Group ID:** EG001
**Title:** Placebo
**Description:** Placebo x 45 d
Placebo: Placebo suspension (equal volume to experimental drug) x 45 days
**ID:** EG001
**Title:** Placebo
**Frequency Threshold:** 0
**Time Frame:** Study was terminated. All efforts to locate the data have been exhausted and data has been lost and/or destroyed.
## Results Section - Baseline Characteristics Module
### Denomination Counts
**Group ID:** BG000
**Value:** 0
**Group ID:** BG001
**Value:** 0
**Group ID:** BG002
**Value:** 0
**Units:** Participants
### Group
**ID:** BG000
**Title:** Sildenafil
**Description:** Sildenafil x 45 days
sildenafil: Sildenafil 0.5 mg/kg every 6 hours orally x 45 d
### Group
**ID:** BG001
**Title:** Placebo
**Description:** Placebo x 45 d
Placebo: Placebo suspension (equal volume to experimental drug) x 45 days
### Group
**ID:** BG002
**Title:** Total
**Description:** Total of all reporting groups
### Measure
**Category Title:** <=18 years
**Category Title:** Between 18 and 65 years
**Category Title:** >=65 years
**Class Title:**
### Measure
**Category Title:** Female
**Category Title:** Male
**Class Title:**
### Measure
**Class Title:** United States
**Denomination Units Selected:**
## Results Section - Baseline Characteristics Module
### Measure 1
**Title:** Age, Categorical
### Measure 2
**Title:** Sex: Female, Male
### Measure 3
**Title:** Region of Enrollment
**Unit of Measure:** participants
**Population Description:** Study was terminated. All efforts to locate the data have been exhausted and data has been lost and/or destroyed.
## Results Section - More Information Module
### Certain Agreement
**PI Sponsor Employee:** True
### Point of Contact
**Email:** [email protected]
**Organization:** University of California, San Francisco
**Phone:** (415) 476-1888
**Title:** Roberta Keller, MD
## 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
#### Outcome Measure 2
#### Outcome Measure 3
#### Outcome Measure 4
#### Outcome Measure 5
#### Outcome Measure 6
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Population Description:** Study was terminated. All efforts to locate the data have been exhausted and data has been lost and/or destroyed.
**Reporting Status:** POSTED
**Time Frame:** 7 weeks
**Title:** Estimated Systolic Pulmonary Arterial Pressure at Final Echocardiogram
**Type:** PRIMARY
##### Group
**Description:** Sildenafil x 45 days
sildenafil: Sildenafil 0.5 mg/kg every 6 hours orally x 45 d
**ID:** OG000
**Title:** Sildenafil
##### Group
**Description:** Placebo x 45 d
Placebo: Placebo suspension (equal volume to experimental drug) x 45 days
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 2
**Population Description:** Study was terminated. All efforts to locate the data have been exhausted and data has been lost and/or destroyed.
**Reporting Status:** POSTED
**Time Frame:** 7 weeks
**Title:** Systemic Levels of Vasoactive Substances at the Time of Final Echocardiogram
**Type:** SECONDARY
##### Group
**Description:** Sildenafil x 45 days
sildenafil: Sildenafil 0.5 mg/kg every 6 hours orally x 45 d
**ID:** OG000
**Title:** Sildenafil
##### Group
**Description:** Placebo x 45 d
Placebo: Placebo suspension (equal volume to experimental drug) x 45 days
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 3
**Population Description:** Study was terminated. All efforts to locate the data have been exhausted and data has been lost and/or destroyed.
**Reporting Status:** POSTED
**Time Frame:** 2 years
**Title:** Adverse Effects of Sildenafil Therapy
**Type:** SECONDARY
##### Group
**Description:** Sildenafil x 45 days
sildenafil: Sildenafil 0.5 mg/kg every 6 hours orally x 45 d
**ID:** OG000
**Title:** Sildenafil
##### Group
**Description:** Placebo x 45 d
Placebo: Placebo suspension (equal volume to experimental drug) x 45 days
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 4
**Population Description:** Study was terminated. All efforts to locate the data have been exhausted and data has been lost and/or destroyed.
**Reporting Status:** POSTED
**Time Frame:** 2 years
**Title:** Somatic Growth at 1 and 2 Years of Age
**Type:** SECONDARY
##### Group
**Description:** Sildenafil x 45 days
sildenafil: Sildenafil 0.5 mg/kg every 6 hours orally x 45 d
**ID:** OG000
**Title:** Sildenafil
##### Group
**Description:** Placebo x 45 d
Placebo: Placebo suspension (equal volume to experimental drug) x 45 days
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 5
**Population Description:** Study was terminated. All efforts to locate the data have been exhausted and data has been lost and/or destroyed.
**Reporting Status:** POSTED
**Time Frame:** 2 years
**Title:** Neurodevelopmental Outcome at 1 and 2 Years of Age
**Type:** SECONDARY
##### Group
**Description:** Sildenafil x 45 days
sildenafil: Sildenafil 0.5 mg/kg every 6 hours orally x 45 d
**ID:** OG000
**Title:** Sildenafil
##### Group
**Description:** Placebo x 45 d
Placebo: Placebo suspension (equal volume to experimental drug) x 45 days
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 6
**Population Description:** Study was terminated. All efforts to locate the data have been exhausted and data has been lost and/or destroyed.
**Reporting Status:** POSTED
**Time Frame:** 2 years
**Title:** Respiratory Status at 1 and 2 Years of Age
**Type:** SECONDARY
##### Group
**Description:** Sildenafil x 45 days
sildenafil: Sildenafil 0.5 mg/kg every 6 hours orally x 45 d
**ID:** OG000
**Title:** Sildenafil
##### Group
**Description:** Placebo x 45 d
Placebo: Placebo suspension (equal volume to experimental drug) x 45 days
**ID:** OG001
**Title:** Placebo
### Participant Flow Module
#### Group
**Description:** Sildenafil x 45 days
sildenafil: Sildenafil 0.5 mg/kg every 6 hours orally x 45 d
**ID:** FG000
**Title:** Sildenafil
#### Group
**Description:** Placebo x 45 d
Placebo: Placebo suspension (equal volume to experimental drug) x 45 days
**ID:** FG001
**Title:** Placebo
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
##### 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:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
**Recruitment Details:** Study was terminated. All efforts to locate the data have been exhausted and data has been lost and/or destroyed.
**Has Results:** True |
## Protocol Section
### Identification Module
**NCT ID:** NCT05263479
**Brief Title:** A Study of HS-20089 in Patients With Advanced Solid Tumors
**Official Title:** A Phase I, Open-label, Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of HS-20089 in Patients With Advanced Solid Tumors
#### Organization Study ID Info
**ID:** HS-20089-101
#### Organization
**Class:** INDUSTRY
**Full Name:** Hansoh BioMedical R&D Company
### Status Module
#### Completion Date
**Date:** 2026-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-04-03
**Type:** ACTUAL
**Last Update Submit Date:** 2024-04-01
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2022-01-05
**Type:** ACTUAL
**Status Verified Date:** 2024-04
#### Study First Post Date
**Date:** 2022-03-02
**Type:** ACTUAL
**Study First Submit Date:** 2021-10-29
**Study First Submit QC Date:** 2022-02-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Shanghai Hansoh Biomedical 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:** HS-20089 is a novel DAR-6 antibody-drug conjugate （ADC） targeting B7-H4. In preclinical studies, it inhibited tumor cell growth expressing B7-H4 in vitro and in vivo. The first-in-human trial is conducted to assess the maximum tolerated dose (MTD) and dose limiting toxicity (DLT), to evaluate the pharmacokinetics, safety and preliminary anti-tumor activity of HS-20089 in Patients With Advanced Solid Tumors.
**Detailed Description:** This is a Phase 1a/1b open-label, multicenter study with dose escalation and dose expansion cohorts to evaluate the safety, tolerability, PK and preliminary efficacy of HS-20089 in patients with advanced solid tumors.
The Dose Escalation will include an initial accelerated titration design followed by a Bayesian optimal interval (BOIN) design. Enrollment into Dose Expansion will begin after identification of the MTD and/or MAD in Phase 1a. In Phase 1b, preliminary efficacy will be evaluated in planned expansion cohorts that include patients with specific tumor types that are B7-H4+ advanced solid tumors.
### Conditions Module
**Conditions:**
- Advanced Solid Tumor
**Keywords:**
- HS-20089
- ADC
- B7-H4
- Advanced Solid Tumor
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** SEQUENTIAL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 177
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** HS-20089 for IV infusion of various dose strengths administered in 21 day dosing cycles.
**Intervention Names:**
- Drug: HS-20089 (Phase Ia：Dose escalation )
**Label:** HS-20089 (Phase Ia：Dose escalation )
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The recommended dose from the dose-escalation stage and other potential doses will be further explored.
**Intervention Names:**
- Drug: HS-20089 (Phase Ib: Dose expansion)
**Label:** HS-20089 (Phase Ib: Dose expansion)
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- HS-20089 (Phase Ia：Dose escalation )
**Description:** Participants will receive HS-20089 in 21 day dosing cycles. Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and unequivocal disease progression.
**Name:** HS-20089 (Phase Ia：Dose escalation )
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- HS-20089 (Phase Ib: Dose expansion)
**Description:** IV administration of HS-20089 Q3W; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.
**Name:** HS-20089 (Phase Ib: Dose expansion)
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** To determine the MTD for further evaluation of IV administration of HS-20089 in subjects with advanced solid tumors.
**Measure:** Maximum Tolerated Dose of HS-20089
**Time Frame:** 3 weeks after initiation of treatment
#### Secondary Outcomes
**Description:** The CTCAE criteria will be used to assess adverse events on this trial.
**Measure:** Incidence and severity of treatment-emergent adverse events
**Time Frame:** Baseline through study completion(90 days after last dose)
**Description:** Cmax will be obtained after single dose of HS-20089 on Day 1.
**Measure:** Observed maximum plasma concentration (Cmax) after single dose of HS-20089
**Time Frame:** From pre-dose to 120 hours after single dose on Day 1
**Description:** Cmax ss will be obtained on Day 1 of dosing in the 21-Day cycle of therapy.
**Measure:** Observed maximum plasma concentration (Cmax ss) after multiple dose of HS-20089
**Time Frame:** From pre-dose to 24 hours after the dose on Day 1 of the 21-Day cycle of therapy
**Description:** Apparent terminal half-life is the time measured for the concentration to decrease by one half.
**Measure:** Apparent terminal half-life (t1/2) after single dose of HS-20089
**Time Frame:** From pre-dose to 120 hours after single dose on Day 1
**Description:** Area under the plasma concentration versus time curve from time zero to the 24-hour sampling time at which the concentration was at or above the lower limit of quantification (LLQ).
**Measure:** Area under plasma concentration versus time curve from zero to the 24-hour sampling time (AUC0-24) after single dose of HS-20089
**Time Frame:** From pre-dose to 24 hours after single dose on Day 1
**Description:** Area under the plasma concentration versus time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLQ).
**Measure:** Area under plasma concentration versus time curve from zero to last sampling time (AUC0-t) after single dose of HS-20089
**Time Frame:** From pre-dose to 120 hours after single dose on Day 1
**Description:** AUC0-∞ was calculated by combining AUC0-t and AUCextra. AUCextra represents an extrapolated value obtained by Clast/ λz, where Clast is the calculated plasma concentration at the last sampling time point at which the measured plasma concentration is at or above the LLQ and λz is the apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase.
**Measure:** Area under the plasma concentration versus time curve from time zero to infinity (AUC0-∞) after single dose of HS-20089
**Time Frame:** From pre-dose to 120 hours after single dose on Day 1
**Description:** Anti-tumor efficacy will be assessed by best radiographic response based on Response Evaluation Criteria in Solid Tumors at baseline (Day -28 to -1). For patients that continue on repeating 21-Day cycles after the primary evaluation period, progression will be assessed after each 6 weeks of therapy. ORR is defined as the percentage of patients with a complete response (CR) or partial response (PR) that was confirmed at a subsequent scan at least 4 weeks later, as assessed according to RECIST version 1.1.
**Measure:** To further evaluation of the anti-tumor activity of HS-20089 by assessment of objective response rate (ORR)
**Time Frame:** From the date of first occurrence of complete response (CR) or partial response (PR) on 2 consecutive occasions (≥4 weeks), until the date of disease progression or withdrawal from study，up to 2 years
**Description:** Number of participants who test positive for ADA to HS-20089 will be reported.
**Measure:** Anti-drug Antibodies (ADA) of HS-20089
**Time Frame:** Baseline through study completion(90 days after last dose)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Men or women aged more than or equal to (≥) 18 years
2. Advanced solid tumor patients confirmed by histology or cytology for who that standard treatment is invalid, unavailable or intolerable
3. Patients have at least one target lesion according to RECEST 1.1. The requirements for target lesions are: measurable lesions without local treatment such as irradiation, or with definite progress after local treatment, with the longest diameter ≥ 10 mm in the baseline period (in case of lymph nodes, the shortest axis ≥ 15 mm is required)
4. ECOG performance status was 0-1 and did not deteriorate in the previous 2 weeks
5. Estimated life expectancy greater than (\>) 12 weeks
6. Females should be using adequate contraceptive measures throughout the study; should not be breastfeeding at the time of screening, during the study and until 3 months after completion of the study; and must have evidence of non-childbearing potential
7. Sign Informed Consent Form
Exclusion Criteria:
1. Treatment with any of the following:
1. Previous or current treatment with drugs targeting B7-H4
2. Any cytotoxic chemotherapy, investigational agents or anticancer drugs within 28 days of the first dose of study drug
3. Radiotherapy with a limited field of radiation for palliation within 2 weeks of the first dose of study drug, or patients received more than 30% of the bone marrow irradiation, or large-scale radiotherapy within 4 weeks of the first dose.
4. Major surgery (including craniotomy, thoracotomy, or laparotomy, etc.) within 4 weeks of the first dose of study drug.
5. Known and untreated, or active central nervous system metastases.
2. Existing abnormal CTCAE≥grade 2 resulted from previous treatment
3. History of other malignancy
4. Inadequate bone marrow reserve or organ function
5. Evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV), unless the hepatitis is considered to be cured, Known history of HIV
6. History of hypersensitivity to any active or inactive ingredient of HS-20089.
7. Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements.
8. Any disease or condition that, in the opinion of the investigator, would compromise the safety of the patient or interfere with study assessments.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Jiong Wu, PhD
**Phone:** 13601637369
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Jian Zhang, PhD
**Phone:** 18017312991
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Shanghai
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Jiong Wu, PhD
- **Phone:** 13601637369
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Jian Zhang, PhD
- **Phone:** 18017312991
- **Role:** CONTACT
**Country:** China
**Facility:** Fudan University Cancer Hospital
**State:** Shanghai
**Status:** RECRUITING
**Zip:** 200032
#### Overall Officials
**Official 1:**
**Affiliation:** Fudan University
**Name:** Jiong Wu, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Meshes
- ID: D000009369
- Term: Neoplasms
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT04181879
**Acronym:** PolyPrime
**Brief Title:** Appropriate Polypharmacy in Older People in Primary Care
**Official Title:** A Pilot Cluster Randomised Controlled Trial of a Theory-based Intervention to Improve Appropriate Polypharmacy in Older People in Primary Care
#### Organization Study ID Info
**ID:** B19/20
#### Organization
**Class:** OTHER
**Full Name:** Queen's University, Belfast
### Status Module
#### Completion Date
**Date:** 2021-12
**Type:** ESTIMATED
#### Expanded Access Info
**Last Known Status:** ACTIVE_NOT_RECRUITING
#### Last Update Post Date
**Date:** 2021-12-02
**Type:** ACTUAL
**Last Update Submit Date:** 2021-11-19
**Overall Status:** UNKNOWN
#### Primary Completion Date
**Date:** 2021-10-21
**Type:** ACTUAL
#### Start Date
**Date:** 2019-09-01
**Type:** ACTUAL
**Status Verified Date:** 2021-11
#### Study First Post Date
**Date:** 2019-12-02
**Type:** ACTUAL
**Study First Submit Date:** 2019-11-25
**Study First Submit QC Date:** 2019-11-26
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** University of Dublin, Trinity College
**Class:** OTHER
**Name:** Royal College of Surgeons, Ireland
**Class:** OTHER
**Name:** National University of Ireland, Galway, Ireland
**Class:** OTHER
**Name:** Belfast Health and Social Care Trust
#### Lead Sponsor
**Class:** OTHER
**Name:** Queen's University, Belfast
#### Responsible Party
**Investigator Affiliation:** Queen's University, Belfast
**Investigator Full Name:** Carmel Hughes
**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:** In the past, prescribing many medicines (polypharmacy) was seen in a negative light. However, because people are living longer and have several medical conditions at the same time, views on polypharmacy have changed. The challenge is to have the correct balance between enough medicines and too many medicines. Members of the research team have developed a new approach to achieving this balance. This approach has been tested in two general practices in Northern Ireland (NI). The approach (intervention package) currently consists of two parts: (1) a video showing how general practitioners (GPs) can prescribe appropriate polypharmacy for older patients, and (2) an appointment system for patients to visit a GP to have their medicines reviewed. As the intervention package was developed and tested in NI, further testing needs to be carried out in NI and the six border counties of the Republic of Ireland (ROI; Cavan, Donegal, Leitrim, Louth, Monaghan, and Sligo). This will be done in three stages or phases. In phase 1, which is now complete, 13 GPs were interviewed across 12 practices in the six border counties in the ROI; shown the video, asked about this new approach and asked if any changes are needed before doing more testing. In the next two phases (Phase 2 \& 3) a small study will be carried out involving 12 practices: six practices in NI and six practices in the six border counties in the ROI and approximately 10 patients per practice. GP practices will either receive the intervention package and conduct medication reviews with recruited patients (intervention group) or continue to treat recruited patients as usual (control group). Interviews with up to 10 GPs and six members of practice staff (i.e. those involved in implementing the intervention within each practice) respectively in the six intervention group practices will also be conducted at the end of the intervention. Patients from the six intervention group practices will be asked to complete a feedback questionnaire after the delivery of the intervention (i.e. after completion of their final follow-up questionnaires).
**Detailed Description:** Design: We will perform a pilot cluster randomised controlled trial where 12 GP practices will be randomly assigned (6 GP practices per arm) to the intervention group versus usual care. Randomisation will be stratified according to location (Northern Ireland /Republic of Ireland - Cavan, Donegal, Leitrim, Louth, Monaghan and Sligo). GP practices will be randomly allocated to the intervention or usual care arm after patient screening and recruitment. A total of 120 patients (60 per study arm, approximately 10 patients, randomly selected, per GP practice) will be enrolled into the study.
Design: Pilot cluster randomized controlled trial
Unit of randomization: GP practice.
Unit of analysis: Patient and GP practice.
Setting: Practices located in Northern Ireland will be recruited via Research Nurse(s) from the Northern Ireland Clinical Research Network (NICRN - Primary Care). In the Republic of Ireland a Research Nurse(s) from Trinity College Dublin will recruit GP practices located in the border counties of Cavan, Donegal, Leitrim, Louth, Monaghan and Sligo.
Study aim: The overall aim of the study is to undertake a pilot cluster randomised controlled trial (cRCT) of a theory-based intervention targeting prescribing of appropriate polypharmacy in primary care (PolyPrime) to assess the feasibility of a definitive cRCT of the PolyPrime intervention.
The main study objectives are:
* To test approaches to sampling, recruitment and retention of GP practices
* To test approaches to screening, recruitment and retention of patients
* To test the feasibility of using medication appropriateness (assessed using the STOPP/START criteria) as the primary outcome in a future cRCT
* To identify the intervention's likely mechanism of action
* To assess if the intervention was delivered and received as intended (intervention fidelity)
* To identify the resources used in the set-up and delivery of the intervention and their associated costs
* To assess the feasibility of a future cost-effectiveness analysis
* To further validate the Medication-Related Burden quality of life (MRQ-QoL) tool
* To obtain estimates of effect size between groups, cluster size and intraclass correlation coefficients (ICCs) to inform the sample size calculation for a full RCT
Recruitment strategy for patients: Each recruited general practice will be asked to recruit 10 older patients meeting the inclusion criteria (i.e. over 70 years old, receiving four or more regular medicines, not cognitively impaired, not have a terminal illness, resident in the community, be in receipt of a valid general medical services (GMS) card in the Republic of Ireland, or for Northern Ireland patients, registered for NHS primary care services and registered with and/or regularly attending the practice for a minimum of 12 months). Each recruited GP practice will also display a patient recruitment poster in their practice waiting areas. Posters will direct patients to ask at reception if they are interested in taking part in the study.
The GP Practice Manager (or equivalent) will screen patient records facilitated and supported by the research nurses. Each practice will identify and filter potentially eligible participants via patient records. This will be done in batches depending upon the size of the practice list. Patients will be screened on the basis of the inclusion/exclusion criteria as specified in the protocol. A screening log will be provided to practices to record screening and recruitment activity, including the reason(s) for not being enrolled on the study. The screening log will be kept securely at the practice and no identifying data will leave the practice.
Intervention delivery: The intervention (video) will be delivered to recruited GPs allocated to the intervention arm using the 'Riverside' software programme. This software programme allows electronic, multimedia material to be delivered to healthcare professionals and students. GPs will be provided with a single generic username and password that will allow them to access the video on a secure online server. Prior to the commencement of the study, all participating GPs will be provided with instructions from the researcher on how to access the video. The researcher will be fully contactable during the study to answer any questions or queries that participating GPs may have about accessing the video.
Once consented, patients recruited by the GP practices allocated to the intervention arm will be asked to attend two appointments (telephone or online consultations where a face-to-face consultation is not possible) at a time convenient to them to have their medicines reviewed by a GP in addition to their usual care. Patients recruited by the GP practices allocated to the control arm will continue to receive usual care.
Data will be collected from recruited GPs, recruited patients and practice records. Recruited patients will be asked to complete a number of questionnaires relating to their general well-being and use of the health service (e.g. hospital admissions) at baseline, six months and nine months post-initial medication review in the intervention arm and the equivalent time points in the control arm. The follow up time points for the control arm will be based on the average length of time from the completion of baseline data collection to six and nine months post initial medication review in the intervention arm. Patient data (including medical history, clinical conditions, biochemical data (i.e. test results) and prescribed medications) will also be collected from GP records at baseline, six months and nine months by a Research Nurse from the Northern Ireland Clinical Research Network (NICRN Primary Care) or Trinity College Dublin (TCD).
At the end of the intervention, interviews will be conducted with up to 10 GPs and six members of practice staff (i.e. those involved in implementing the intervention within each practice) respectively in the six intervention arm practices. GPs will be asked about their views on the support provided by the research team; the intervention package (and supporting materials); study procedures (e.g. screening, recruitment, etc.), while practice staff will be asked about their views on the study procedures (e.g. screening, recruitment, etc.) and acceptability of the intervention. Patients from the six intervention group practices will be asked to complete a feedback questionnaire after the delivery of the intervention (i.e. after completion of their final follow-up questionnaires). Patients will be asked about their views on the study procedures (e.g. completing questionnaires, recruitment etc.) and acceptability of the intervention.
Who is funding the study: HSC R\&D Division Cross-border Healthcare Intervention Trials in Ireland Network (CHITIN), UK and Ireland
### Conditions Module
**Conditions:**
- Polypharmacy
**Keywords:**
- Older people
- Primary care
- General Practitioners
- Behaviour Change Techniques
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** A pilot cluster randomised controlled trial (cRCT). Eligible GP practices will be allocated to intervention or control (usual care) arm by a Northern Ireland Clinical Trials Unit (NICTU) statistician using an automated randomisation system. Practices will be randomised on a 1:1 allocation ratio stratified by country (i.e. Northern Ireland or the Republic of Ireland).
##### Masking Info
**Masking:** SINGLE
**Masking Description:** Members of the research team who are pharmacists will undertake an assessment of medication appropriateness following medication review by GPs and will be blind to the allocation of patients to either arm.
Due to the nature of the intervention package (i.e. access to the video and patient recall), we will be unable to blind the GPs or patients.
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** HEALTH_SERVICES_RESEARCH
#### Enrollment Info
**Count:** 68
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** GPs will receive the intervention package and conduct medication reviews with recruited patients
**Intervention Names:**
- Behavioral: Intervention
**Label:** Intervention
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** GPs will continue to treat recruited patients as usual
**Label:** Usual care
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Intervention
**Description:** * GPs allocated to the intervention will be given access to the intervention package and asked to perform medication reviews with approximately 10 patients on two occasions (initial and 6-months follow-up).
* The intervention package consists of two components: (a) an online video demonstrating how GPs can improve appropriate polypharmacy during typical consultations with older patients; (b) a patient recall process (appointment with the GP for a medication review).
* GPs will be asked to schedule appointments with consenting patients (telephone or online consultations where a face-to-face consultation is not possible). During these appointments, GPs will undertake medication reviews ('a structured, critical examination of a person's medicines with the objective of reaching an agreement with the person about treatment, optimising the impact of medicines, minimising the number of medication-related problems and reducing waste').
**Name:** Intervention
**Other Names:**
- PolyPrime
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Measure:** The number of patients contacted and recruited
**Time Frame:** Through study completion, an average of 1 year
**Measure:** The number of GP practices contacted and recruited
**Time Frame:** Through study completion, an average of 1 year
**Description:** The number of patients retained over the study period
**Measure:** The retention rate of patients
**Time Frame:** Through study completion, an average of 1 year
**Description:** The number of GP practices retained over the study period
**Measure:** The retention rate of GP practices
**Time Frame:** Through study completion, an average of 1 year
**Description:** Assessed using STOPP/START criteria
**Measure:** Medication appropriateness
**Time Frame:** Baseline
**Description:** Assessed using STOPP/START criteria
**Measure:** Medication appropriateness
**Time Frame:** Six months' post-initial medication review in the intervention arm and the equivalent time points in the control arm
**Description:** Assessed using STOPP/START criteria
**Measure:** Medication appropriateness
**Time Frame:** Nine months' post-initial medication review in the intervention arm and the equivalent time points in the control arm
#### Secondary Outcomes
**Description:** The number of times the GPs watched the online video; taken from the hosting website
**Measure:** The number of video view counts per GP participant for the online video
**Time Frame:** Through study completion, an average of 1 year
**Description:** Collected on study-specific data collection forms
**Measure:** The numbers of appointments scheduled
**Time Frame:** Through study completion, an average of 1 year
**Description:** Collected on study-specific data collection forms
**Measure:** The number of medication review appointments attended (first and second reviews)
**Time Frame:** Through study completion, an average of 1 year
**Description:** The length of the medication reviews will be based on audio-recordings of a selection of patient medication reviews
**Measure:** The length of the medication reviews
**Time Frame:** Through study completion, an average of 1 year
**Description:** Recorded on GP practice staff data collection form
**Measure:** The number of scheduled weekly meetings within each practice at which explicit plans were made to recall patients for medication reviews
**Time Frame:** Through study completion, an average of 1 year
**Description:** The number of prompts made by reception staff will be recorded on a GP practice staff data collection form
**Measure:** The number of prompts made by reception staff
**Time Frame:** Through study completion, an average of 1 year
**Measure:** The resource use and associated costs of the intervention
**Time Frame:** Baseline, six months' post-initial medication review in the intervention arm and the equivalent time points in the control arm and nine months' post-initial medication review in the intervention arm and the equivalent time points in the control arm
**Description:** As reported in GP notes and compared with self-reported health service use
**Measure:** Participant health and social care service use
**Time Frame:** Baseline, six months' post-initial medication review in the intervention arm and the equivalent time points in the control arm and 12 months' post--initial medication review in the intervention arm and the equivalent time points in the control arm
**Description:** Measured using the EQ-5D-5L
**Measure:** Health-related quality of life
**Time Frame:** Baseline, six months' post-initial medication review in the intervention arm and the equivalent time points in the control arm and nine months' post-initial medication review in the intervention arm and the equivalent time points in the control arm
**Description:** Measured using the Medication-Related Burden Quality of Life (MRB-QoL) tool
**Measure:** Medication-Related Burden Quality of Life
**Time Frame:** Baseline, six months' post-initial medication review in the intervention arm and the equivalent time points in the control arm and nine months' post-initial medication review in the intervention arm and the equivalent time points in the control arm
**Measure:** Estimates of effect size between groups, cluster size and intraclass correlation coefficients (ICCs)
**Time Frame:** Through study completion, an average of 1 year
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients must be ≥70 years
* Patients must be receiving four or more regular medicines
* Patients must be resident in the community
* Patients must be in receipt of a valid general medical services (GMS) card in the Republic of Ireland, or in the case of Northern Ireland patients, registered for NHS primary care services
* Patients must be registered with and/or regularly attending the practice for a minimum of 12 months
Exclusion Criteria:
* Care home residents
* Patients who are cognitively impaired
* Patients with a terminal illness
* Involved in other Investigational Medicinal Product (IMP) or medicines management studies
**Healthy Volunteers:** True
**Minimum Age:** 70 Years
**Sex:** ALL
**Standard Ages:**
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Dublin
**Country:** Ireland
**Facility:** Trinity College Dublin
**Zip:** D02PN40
**Location 2:**
**City:** Belfast
**Country:** United Kingdom
**Facility:** Queen's University Belfast
**State:** Antrim
**Zip:** BT9 7BL
#### Overall Officials
**Official 1:**
**Affiliation:** Queen's University, Belfast
**Name:** Carmel Hughes, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** The current data sharing plans for this study are unknown and will be available at a later date
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Cadogan CA, Ryan C, Gormley GJ, Francis JJ, Passmore P, Kerse N, Hughes CM. A feasibility study of a theory-based intervention to improve appropriate polypharmacy for older people in primary care. Pilot Feasibility Stud. 2017 Jul 20;4:23. doi: 10.1186/s40814-017-0166-3. eCollection 2018. Erratum In: Pilot Feasibility Stud. 2017 Oct 24;3:48.
**PMID:** 28748106
**Citation:** Cadogan CA, Ryan C, Francis JJ, Gormley GJ, Passmore P, Kerse N, Hughes CM. Development of an intervention to improve appropriate polypharmacy in older people in primary care using a theory-based method. BMC Health Serv Res. 2016 Nov 16;16(1):661. doi: 10.1186/s12913-016-1907-3.
**PMID:** 27852287
**Citation:** Rankin A, Cadogan CA, Barry HE, Gardner E, Agus A, Molloy GJ, Gorman A, Ryan C, Leathem C, Maxwell M, Gormley GJ, Ferrett A, McCarthy P, Fahey T, Hughes CM; PolyPrime team. An external pilot cluster randomised controlled trial of a theory-based intervention to improve appropriate polypharmacy in older people in primary care (PolyPrime): study protocol. Pilot Feasibility Stud. 2021 Mar 19;7(1):77. doi: 10.1186/s40814-021-00822-2.
**PMID:** 33741071
**Citation:** Rankin A, Molloy GJ, Cadogan CA, Barry HE, Gorman A, Ryan C, Ferrett A, McCarthy P, Gormley GJ, Fahey T, Hughes CM; PolyPrime team. Protocol for a process evaluation of an external pilot cluster randomised controlled trial of a theory-based intervention to improve appropriate polypharmacy in older people in primary care: the PolyPrime study. Trials. 2021 Jul 14;22(1):449. doi: 10.1186/s13063-021-05410-6.
**PMID:** 34261527
**Citation:** Rankin A, Gorman A, Cole J, Cadogan CA, Barry HE, Agus A, Logan D, McDowell C, Molloy GJ, Ryan C, Leathem C, Maxwell M, Brennan C, Gormley GJ, Ferrett A, McCarthy P, Fahey T, Hughes CM; PolyPrime team. An external pilot cluster randomised controlled trial of a theory-based intervention to improve appropriate polypharmacy in older people in primary care (PolyPrime). Pilot Feasibility Stud. 2022 Sep 10;8(1):203. doi: 10.1186/s40814-022-01161-6.
**PMID:** 36088445
## Annotation Section
### Unposted Annotation
#### Event: RELEASE
- Date: 2022-09-12
- Date Unknown: Unknown
#### Event: RESET
- Date: 2023-07-27
- Date Unknown: Unknown
## Derived Section
### Misc Info Module
#### Submission Tracking
- Estimated Results First Submit Date: 2022-09-12
##### Submission Infos
- MCP Release N: Unknown
- Release Date: 2022-09-12
- Reset Date: 2023-07-27
- Unrelease Date: Unknown
- Unrelease Date Unknown: Unknown
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT02920879
**Brief Title:** Airway Effects of PEEP During Anesthesia Induction.
**Official Title:** Airway Effects of PEEP During Anesthesia Induction.
#### Organization Study ID Info
**ID:** PC02
#### Organization
**Class:** OTHER
**Full Name:** Region Örebro County
### Status Module
#### Expanded Access Info
**Last Known Status:** NOT_YET_RECRUITING
#### Last Update Post Date
**Date:** 2016-10-03
**Type:** ESTIMATED
**Last Update Submit Date:** 2016-09-30
**Overall Status:** UNKNOWN
#### Primary Completion Date
**Date:** 2017-02
**Type:** ESTIMATED
#### Start Date
**Date:** 2016-10
**Status Verified Date:** 2016-09
#### Study First Post Date
**Date:** 2016-09-30
**Type:** ESTIMATED
**Study First Submit Date:** 2016-09-28
**Study First Submit QC Date:** 2016-09-28
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Region Örebro County
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This study investigates airway effects of PEEP during maskventilation at anesthesia induction. Four patient groups will be ventilated with different PEEP and driving pressures to evaluate time to open airway after start of positive pressure maskventilation during anesthesia induction.
**Detailed Description:** The use of continuous positive pressure (CPAP/PEEP) during pre-oxygenation and mask-ventilation in patients undergoing anesthesia induction is increasing. Continuous positive pressures have several respiratory benefits with well-documented data on both spontaneously breathing patients and intubated patients. However the effects of PEEP on anesthetized patients during mask-ventilation is poorly investigated. In a previous trial the that the investigators conducted, a PEEP-level of 10 cmH2O during mask ventilation after anesthesia induction surprisingly delayed time to alveolar ventilation compared to ZEEP. In order to investigate this phenomenon, four groups of patients will be compared during preoxygenation and mask ventilation after anesthesia induction.
Each group consisting of 30 patients will be pre-oxygenated and mask ventilated with different CPAP/PEEP levels and different driving pressures. Time to open airway is measured as number of respiratory cycles until detection of CO2 on the capnograph.
### Conditions Module
**Conditions:**
- Airway Management
- Positive End Expiratory Pressure
- Mask-ventilation
- Anesthesia Induction
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 120
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients will be preoxygenated with a CPAP-level of 0 cmH2O and after anesthesia induction, mask-ventilated with ZEEP and a driving pressure of 10 cmH2O./PEEP-level, driving pressure
**Intervention Names:**
- Procedure: PEEP-level, driving pressure
**Label:** 0 CPAP/ 0 PEEP, driving pressure 10
**Type:** OTHER
#### Arm Group 2
**Description:** Patients will be pre-oxygenated with a CPAP-level of 0 cmH2O and after anesthesia induction, mask-ventilated with ZEEP and a driving pressure of 20 cmH2O./PEEP-level, driving pressure
**Intervention Names:**
- Procedure: PEEP-level, driving pressure
**Label:** 0 CPAP/ 0 PEEP driving pressure 20
**Type:** OTHER
#### Arm Group 3
**Description:** Patients will be pre-oxygenated with a CPAP-level of 10 cmH2O and after anesthesia induction, mask-ventilated with PEEP 10 cmH2O and a driving pressure of 10 cmH2O./PEEP-level, driving pressure
**Intervention Names:**
- Procedure: PEEP-level, driving pressure
**Label:** 10 CPAP / 10 PEEP, driving pressure 10
**Type:** OTHER
#### Arm Group 4
**Description:** Patients will be pre-oxygenated with a CPAP-level of 10 cmH2O and after anesthesia induction, mask-ventilated with ZEEP and a driving pressure of 10 cmH2O./PEEP-level, driving pressure
**Intervention Names:**
- Procedure: PEEP-level, driving pressure
**Label:** 10 CPAP/ 0 PEEP, driving pressure 10
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- 0 CPAP/ 0 PEEP driving pressure 20
- 0 CPAP/ 0 PEEP, driving pressure 10
- 10 CPAP / 10 PEEP, driving pressure 10
- 10 CPAP/ 0 PEEP, driving pressure 10
**Description:** Different levels of PEEP and different levels of driving pressures during mask-ventilation at anesthesia induction.
**Name:** PEEP-level, driving pressure
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** Time to open airway depending on ventilatory settings
**Measure:** Time to open airway
**Time Frame:** 20 minutes
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. ≥ 18- ≤ 65 years male or female.
2. Elective surgery under general anesthesia
3. ASA-classification 1-3
4. Signed and dated informed consent
Exclusion Criteria:
1. BMI \> 30
2. Predicted difficult mask-ventilation
3. Known hiatus hernia or GERD
**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:** Per Cajander, MD
**Phone:** +46707173663
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Johanna Savilampi, PhD
**Phone:** +46706315154
**Role:** CONTACT
## 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:** NCT06082479
**Brief Title:** The Effect of Intra Oral Cryotherapy in Patients With Symptomatic Apical Periodontitis
**Official Title:** The Effect of Cryotherapy on Pain and Substancs P Level in Patients With Symptomatic Apical Periodontitis (A Randomized Clinical Trial)
#### Organization Study ID Info
**ID:** 304
#### Organization
**Class:** OTHER
**Full Name:** Ain Shams University
### Status Module
#### Completion Date
**Date:** 2023-02-01
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-01-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-01-29
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-02-01
**Type:** ACTUAL
#### Start Date
**Date:** 2022-09-01
**Type:** ACTUAL
**Status Verified Date:** 2024-01
#### Study First Post Date
**Date:** 2023-10-13
**Type:** ACTUAL
**Study First Submit Date:** 2023-09-29
**Study First Submit QC Date:** 2023-10-08
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Ain Shams University
#### Responsible Party
**Investigator Affiliation:** Ain Shams University
**Investigator Full Name:** Maram Obeid
**Investigator Title:** Professor of Endodontics
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The participants were divided into two groups: Group I (cryotherapy) (n =10) after the completion of the mechanical preparation intra oral cryotherapy was applied. Group II (control) (n =10) received standard root canal treatment without the application of any type of cryotherapy.
**Detailed Description:** 1-Patients selection: 20 patients with symptomatic apical peridontitis related to mandibular premolars were selected . After proper anestehsia, Access cavity preparation was performed. The working length measured using apex locator. chemicomechanical preparation was done. for cryotherapy group: cold pack (ice gel enveloped by a sealed plastic cover) measuring 2.5 x 5 centimetres was placed intraorally on the vestibular surface of the treated tooth for a total time of 30 minutes. apical fluid sample was collected by paper point and the root canal was then filled using gutta percha and resin-based sealer.The access cavity was sealed using glass ionomer restoration. for the control group normal treatment was done and apical fluid was collested also before obturation.
### Conditions Module
**Conditions:**
- Post Operative Pain
- Inflammation
**Keywords:**
- Cryotherapy
- substance P
- apical periodontitis
- post operative pain
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** This study was designed to be a randomized, controlled, single-blinded, single-center clinical trial.
##### Masking Info
**Masking:** DOUBLE
**Masking Description:** A) Sequence generation;was done using a random sequence number generated by computer software.
B) Allocation Concealment Mechanism: Folded, numbered papers were placed in tightly sealed envelopes containing the patient's coding
**Who Masked:**
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 20
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** no application of any type of cryotherapy.
**Label:** control group
**Type:** NO_INTERVENTION
#### Arm Group 2
**Description:** after the completion of the mechanical preparation. A 2.5 x5 centimetre gel pack was placed in the mouth on the vestibular surface of the treated tooth.
**Intervention Names:**
- Procedure: intraoral cryotherapy,ice gel
**Label:** cryotherapy group
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- cryotherapy group
**Description:** A cold pack (ice gel enveloped by a sealed plastic cover) measuring 2.5 x 5 centimetres was placed intraorally on the vestibular surface of the treated tooth. Each cold pack was kept for ten minutes.3 packs were used for each patient, for a total time of 30 minutes.Patients were instructed to remove the cold pack for 1-2 minutes if they felt extreme cold or a burning sensation .The temperature of the gel was checked by a digital thermometer (Brannan, UK) after it was removed from the freezer and kept in an ice box (Cosmoplast, UAE) containing a cooling gel (Exam Packaging, Belgium).
**Name:** intraoral cryotherapy,ice gel
**Other Names:**
- cold therapy,ice pack
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** On a10-cm Visual Analogue Scale (VAS) questionnaire, each patient reported their level of pain as follows: There is no pain at 0, 1-3, mild, 4-6, moderate, 7-9, severe, and 10, the worst pain.
**Measure:** Level of post operative pain using 10 cm visual analoge scale (VAS)
**Time Frame:** after 6hours, 24hours, 48hours, 72hours h, and 7days after the visit
#### Secondary Outcomes
**Description:** Apical fluid samples were obtained using paper points size 25 passing 2 mm beyond the apex.where they were soaked by the periapical interstitial fluid for 1 minute .Four mm from the tip of each paper point was cut and dropped into 1.5-mL Eppendorf tubes (Swanscombe, UK) with 1 mL (pH 7.4) phosphate buffered saline, then stored at -80°C. Levels of substance p were measured using the ELISAtest.
**Measure:** Level of inflammatory mediator substance P in apical fluid
**Time Frame:** base line: immediately after procedure.the second is 30 minutes later in both groups.
### Eligibility Module
**Eligibility Criteria:** Inclusion criteria:
* clinical diagnosis of symptomatic apical periodontitis related to ving a mandibular single-rooted premolars
* radigraphically: absence of periapical radiolucency on x ray.
Exclusion criteria:
* The presence of any systemic disease or allergic reactions
* Vulnerable population: prisoners, pregnant women, mentally ill people, etc.
* Use of analgesic or antibiotic medication within three days
* A radiographically untraceable canal
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Cairo
**Country:** Egypt
**Facility:** Ain Shams University
#### Overall Officials
**Official 1:**
**Affiliation:** Faculty of Dentistry,Ain Shams University
**Name:** Maram F Obeid, Professor
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**Access Criteria:** review the purpose of request
**Description:** detailed Statistical Analysis Plan
**Info Types:**
- SAP
**IPD Sharing:** YES
**Time Frame:** 2025 ,available for a year
### References Module
#### References
**Citation:** Gundogdu EC, Arslan H. Effects of Various Cryotherapy Applications on Postoperative Pain in Molar Teeth with Symptomatic Apical Periodontitis: A Preliminary Randomized Prospective Clinical Trial. J Endod. 2018 Mar;44(3):349-354. doi: 10.1016/j.joen.2017.11.002. Epub 2018 Feb 3.
**PMID:** 29398090
**Citation:** Keskin C, Aksoy A, Kalyoncuoglu E, Keles A, Ilik AA, Komec O, Yuzgulec E, Akgun H, Alak SG, Tokur O. Effect of intracanal cryotherapy on the inflammatory cytokine, proteolytic enzyme levels and post-operative pain in teeth with asymptomatic apical periodontitis: A randomized clinical trial. Int Endod J. 2023 Aug;56(8):932-942. doi: 10.1111/iej.13937. Epub 2023 May 30.
**PMID:** 37222468
#### See Also Links
**Label:** worked on inflammatory mediators in similar matter
**URL:** https://dsu.journals.ekb.eg/article_192084.html
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010335
- Term: Pathologic Processes
- ID: D000010510
- Term: Periodontal Diseases
- ID: D000009059
- Term: Mouth Diseases
- ID: D000009057
- Term: Stomatognathic Diseases
- ID: D000011183
- Term: Postoperative Complications
- ID: D000010146
- Term: Pain
- ID: D000009461
- Term: Neurologic Manifestations
- ID: D000010483
- Term: Periapical Diseases
- ID: D000007571
- Term: Jaw Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC07
- Name: Mouth and Tooth Diseases
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC05
- Name: Musculoskeletal Diseases
### Condition Browse Module - Browse Leaves
- ID: M10293
- Name: Inflammation
- Relevance: HIGH
- As Found: Inflammation
- ID: M13069
- Name: Pain, Postoperative
- Relevance: HIGH
- As Found: Post Operative Pain
- ID: M13427
- Name: Periodontitis
- Relevance: HIGH
- As Found: Periodontitis
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M13395
- Name: Periapical Periodontitis
- Relevance: HIGH
- As Found: Apical 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: M14065
- Name: Postoperative Complications
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: M13393
- Name: Periapical Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10601
- Name: Jaw Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000010518
- Term: Periodontitis
- ID: D000010485
- Term: Periapical Periodontitis
- ID: D000007249
- Term: Inflammation
- ID: D000010149
- Term: Pain, Postoperative
### Intervention Browse Module - Browse Branches
- Abbrev: ARhu
- Name: Antirheumatic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M243257
- Name: Methyl salicylate
- Relevance: LOW
- As Found: Unknown
- ID: M16161
- Name: Substance P
- Relevance: LOW
- As Found: Unknown
- ID: M17988
- Name: Neurokinin A
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT02116179
**Brief Title:** DVD-based HIV/HCV Prevention Intervention for Drug-Involved Latino Criminal Justice Clients
**Official Title:** DVD-based HIV/HCV Intervention for Drug-Involved Latino Criminal Justice Clients
#### Organization Study ID Info
**ID:** 5R34DA031063
**Link:** https://reporter.nih.gov/quickSearch/5R34DA031063
**Type:** NIH
#### Organization
**Class:** OTHER
**Full Name:** University of Delaware
#### Secondary ID Infos
**ID:** 5R34DA031063
**Link:** https://reporter.nih.gov/quickSearch/5R34DA031063
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2016-05
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2016-10-21
**Type:** ESTIMATED
**Last Update Submit Date:** 2016-10-19
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2016-05
**Type:** ACTUAL
#### Start Date
**Date:** 2014-07
**Status Verified Date:** 2016-10
#### Study First Post Date
**Date:** 2014-04-16
**Type:** ESTIMATED
**Study First Submit Date:** 2014-04-14
**Study First Submit QC Date:** 2014-04-15
### Sponsor Collaborators Module
#### Collaborators
**Class:** NIH
**Name:** National Institute on Drug Abuse (NIDA)
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Delaware
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The purpose of the study are the following: 1) Pilot test and conduct baseline and 3 month follow up assessments to evaluate the preliminary efficacy of the DVD-based HIV/HCV intervention by randomly assigning 210 Latino corrections-involved, outpatient abuse treatment clients to either the experimental intervention or to a wait list control group; and 2) to evaluate both participant and interventionist acceptability of this novel DVD-based intervention.
They study hypothesis are the following:
1. participants in the intervention condition will report greater reductions in sexual risk behaviors (e.g., unprotected sexual contact) from baseline to 3 month follow-up compared to the control group;
2. participants will report greater reductions in drug risk behaviors (e.g., sharing injection equipment, drug use during sex) from baseline to 3 month follow-up compared to the control group;
3. participants who report more HIV prevention information, motivation, and behavioral skills will report fewer sexual risk behaviors.
**Detailed Description:** The specific aims for Stage1b are: (1) to pilot test and evaluate the effectiveness of the DVD-based HIV intervention by recruiting 210 Latino offenders mandated to substance abuse treatment; and (2) to evaluate both participant and interventionist acceptability of this novel DVD intervention. Participants will be recruited from a local community agency that provides outpatient substance abuse treatment services for court-mandated individuals. Eligible participants will be self-identified Latino/Hispanic, between the ages of 18 and 49, heterosexual, and all participants will be involved with the criminal justice system. Participants will be randomized into either an intervention or a wait-list control condition. The intervention consists of one DVD-based group session facilitated by an interventionist. Sexual risk, drug use, mental health, and background information will be assessed at baseline, and again at 3 months after the intervention session. At the end of the intervention session, each participant will complete an acceptability questionnaire, and the interventionist will complete a checklist to assess treatment fidelity. It is hypothesized that both sexual risk and drug use behaviors will decrease between baseline and follow-up for the intervention group compared to the control group. The project is innovative because it will develop a DVD-based, culturally-appropriate and language specific, HIV/Hepatitis C virus prevention intervention for Latino offenders. The proposed research is significant, because it is expected to produce a brief HIV/Hepatitis C virus intervention that can be implemented within the criminal justice system and targets a high risk group.
It is hypothesized that participants in the intervention condition will report significant reductions in sexual risk behaviors (e.g., unprotected sexual contact) and drug risk behaviors (e.g. sharing injection equipment, drug use while having sex) from baseline to 3 - month follow-up when compared to control group. The main analysis here is to compare the proportion (or mean) of primary outcomes for those measured at 3-month (post-intervention) to those measured at baseline (pre-intervention) between the intervention and control group. The null is that there will be no differences, and alternative hypotheses would be that the intervention group will report more of a reduction in risk behaviors than control group. These hypotheses can be tested by either repeated-measures ANCOVA or regression with the robust cluster estimator obtained after controlling for intervention condition.
### Conditions Module
**Conditions:**
- Human Immunodeficiency Virus
- Acquired Immunodeficiency Syndrome
- Hepatitis C
**Keywords:**
- Human Immunodeficiency Virus
- Acquired Immunodeficiency Syndrome
- Hepatitis C
- Hispanic
- Criminal Justice
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 201
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** DVD Intervention presented at one 90 minute group session
**Intervention Names:**
- Behavioral: DVD Intervention
**Label:** DVD Intervention
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Group will get no intervention until after 90 day follow up
**Label:** Wait list Control Group
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- DVD Intervention
**Description:** Participants will be randomly assigned, with a baseline and 3 month follow up assessments
**Name:** DVD Intervention
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Measure:** Sexual risk behaviors
**Time Frame:** 90 days
#### Secondary Outcomes
**Measure:** Drug Use Behaviors
**Time Frame:** 90 days
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* must be between 18 - 49 years of age
* self-identify as Hispanic or Latino
* be involved in the criminal justice system
* report a history of drug use
* be in an outpatient substance abuse program
* self-identify as heterosexual
Exclusion Criteria:
* be HIV positive
* be cognitively impaired
**Healthy Volunteers:** True
**Maximum Age:** 49 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Coral Gables
**Country:** United States
**Facility:** University of Delaware Center for Drug and Alcohol Studies
**State:** Florida
**Zip:** 33143
#### Overall Officials
**Official 1:**
**Affiliation:** Florida International University
**Name:** Gladys E Ibanez, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000008107
- Term: Liver Diseases
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000006525
- Term: Hepatitis, Viral, Human
- ID: D000014777
- Term: Virus Diseases
- ID: D000007239
- Term: Infections
- ID: D000012327
- Term: RNA Virus Infections
- ID: D000086982
- Term: Blood-Borne Infections
- ID: D000003141
- Term: Communicable Diseases
- ID: D000018178
- Term: Flaviviridae Infections
- ID: D000007154
- Term: Immune System Diseases
- ID: D000015229
- Term: Sexually Transmitted Diseases, Viral
- ID: D000012749
- Term: Sexually Transmitted Diseases
- ID: D000016180
- Term: Lentivirus Infections
- ID: D000012192
- Term: Retroviridae Infections
- ID: D000012897
- Term: Slow Virus Diseases
- ID: D000091662
- Term: Genital Diseases
- ID: D000091642
- Term: Urogenital Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC01
- Name: Infections
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: BC20
- Name: Immune System Diseases
### Condition Browse Module - Browse Leaves
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M9592
- Name: Hepatitis A
- Relevance: LOW
- As Found: Unknown
- ID: M9591
- Name: Hepatitis
- Relevance: HIGH
- As Found: Hepatitis
- 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: M17522
- Name: Virus Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M9611
- Name: Hepatitis C
- Relevance: HIGH
- As Found: Hepatitis C
- 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: M11107
- Name: Liver 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: M9610
- Name: Hepatitis, Viral, Human
- Relevance: LOW
- As Found: Unknown
- ID: M15149
- Name: RNA Virus Infections
- Relevance: LOW
- As Found: Unknown
- ID: M2593
- Name: Blood-Borne Infections
- Relevance: LOW
- As Found: Unknown
- ID: M20324
- Name: Flaviviridae Infections
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- 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: 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
### Condition Browse Module - Meshes
- ID: D000006526
- Term: Hepatitis C
- ID: D000000163
- Term: Acquired Immunodeficiency Syndrome
- ID: D000015658
- Term: HIV Infections
- ID: D000006505
- Term: Hepatitis
- ID: D000007153
- Term: Immunologic Deficiency Syndromes
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT02759679
**Brief Title:** Canine-Assisted Profiling of Lung Cancer From Human Breath
**Official Title:** Canine-Assisted Profiling of Lung Cancer From Human Breath
#### Organization Study ID Info
**ID:** REK_2013/2053
#### Organization
**Class:** OTHER
**Full Name:** Haukeland University Hospital
### Status Module
#### Completion Date
**Date:** 2019-12
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-03-01
**Type:** ACTUAL
**Last Update Submit Date:** 2024-02-29
**Overall Status:** TERMINATED
#### Primary Completion Date
**Date:** 2019-12
**Type:** ACTUAL
#### Start Date
**Date:** 2016-05
**Type:** ACTUAL
**Status Verified Date:** 2024-02
#### Study First Post Date
**Date:** 2016-05-03
**Type:** ESTIMATED
**Study First Submit Date:** 2016-03-17
**Study First Submit QC Date:** 2016-04-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Haukeland University Hospital
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The study aims to optimize and define a reproducible and non-invasive method for canine assisted lung cancer detection, using human breath samples from patients and controls for training and testing purposes.
### Conditions Module
**Conditions:**
- Lung Cancer
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** TRIPLE
**Who Masked:**
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** DIAGNOSTIC
#### Enrollment Info
**Count:** 650
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients with lung cancer
**Intervention Names:**
- Other: Human breath samples
**Label:** Lung cancer
**Type:** OTHER
#### Arm Group 2
**Description:** Controls being either healthy or having other lung disease
**Intervention Names:**
- Other: Human breath samples
**Label:** Controls
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Controls
- Lung cancer
**Name:** Human breath samples
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Patients and Controls deliver breath samples to be presented for dogs in a Remote facility. Outcomes will be reported for individual dogs and combinations of dogs.
**Measure:** Sensitivity and specificity for lung cancer, of canines sniffing breath samples
**Time Frame:** 2 years
### Eligibility Module
**Eligibility Criteria:** Inclusion criteria:
Healthy volunteers, lung cancer or other lung disease.
Exclusion criteria:
Other known malignancy.
**Healthy Volunteers:** True
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Bergen
**Country:** Norway
**Facility:** Haukeland University Hospital
#### Overall Officials
**Official 1:**
**Affiliation:** Haukeland University Hospital, Bergen, Norway
**Name:** Øystein Fløtten, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012142
- Term: Respiratory Tract Neoplasms
- ID: D000013899
- Term: Thoracic Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000008171
- Term: Lung Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M11172
- Name: Lung Neoplasms
- Relevance: HIGH
- As Found: Lung Cancer
- 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:** NCT01991379
**Brief Title:** MEK162 in Combination With Imatinib Mesylate in Patients With Untreated Advanced Gastrointestinal Stromal Tumor (GIST)
**Official Title:** A Phase Ib/II Study of MEK162 in Combination With Imatinib Mesylate in Patients With Untreated Advanced Gastrointestinal Stromal Tumor (GIST)
#### Organization Study ID Info
**ID:** 13-162
#### Organization
**Class:** OTHER
**Full Name:** Memorial Sloan Kettering Cancer Center
### Status Module
#### Completion Date
**Date:** 2024-11
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-12-04
**Type:** ACTUAL
**Last Update Submit Date:** 2023-12-01
**Overall Status:** ACTIVE_NOT_RECRUITING
#### Primary Completion Date
**Date:** 2024-11
**Type:** ESTIMATED
#### Start Date
**Date:** 2013-11
**Status Verified Date:** 2023-12
#### Study First Post Date
**Date:** 2013-11-25
**Type:** ESTIMATED
**Study First Submit Date:** 2013-11-18
**Study First Submit QC Date:** 2013-11-18
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Memorial Sloan Kettering Cancer Center
#### Responsible Party
**Type:** SPONSOR
### Description Module
**Brief Summary:** The purpose of this study is to evaluate the effects, good and/or bad, of MEK162 and imatinib on the patient and on Gastrointestinal Stromal Tumor (GIST).
Funding Source - FDA OOPD, Array/Pfizer
### Conditions Module
**Conditions:**
- Gastrointestinal Stromal Tumor (GIST)
**Keywords:**
- MEK162
- Imatinib
- 13-162
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 75
**Type:** ACTUAL
**Phases:**
- PHASE1
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Pts will be treated with the combination therapy of MEK162 \& imatinib. The phase Ib portion of the study, pts will receive imatinib at 400 mg once daily \& MEK162 at the standard 3+3 escalation doses. Phase Ib expansion cohort, pts will receive the RP2D: imatinib 400 mg once daily (standard of care first line imatinib dose) \& MEK162 at the RP2D twice daily. The phase II portion of the study, pts will receive imatinib at 400 mg once daily \& MEK162 at the RP2D. The MEK162 RP2D was originally determined based on the phase Ib escalation data \& it was established as 45 mg BID. After the completion of the phase Ib dose expansion \& initiation of phase II, the MEK162 RP2D was reduced to 30 mg BID30 for better long term tolerability. Patient's will now begin MEK162 at the revised RP2D of 30 mg BID. 1 cycle is 28 days. If no progression of the tumor is seen, pts will continue on therapy. Pts who have progression of disease will proceed directly to second line therapy as per standard of care.
**Intervention Names:**
- Drug: MEK162
- Drug: Imatinib Mesylate (Gleevec®; STI571; NSC #716051)
- Other: Blood draws
- Procedure: biopsy
**Label:** MEK162 in Combination With Imatinib Mesylate
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- MEK162 in Combination With Imatinib Mesylate
**Description:** Patients should take the study drug with a glass of water. MEK162 can be taken with or without food.
**Name:** MEK162
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- MEK162 in Combination With Imatinib Mesylate
**Name:** Imatinib Mesylate (Gleevec®; STI571; NSC #716051)
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- MEK162 in Combination With Imatinib Mesylate
**Name:** Blood draws
**Type:** OTHER
#### Intervention 4
**Arm Group Labels:**
- MEK162 in Combination With Imatinib Mesylate
**Description:** Following informed consent, the first 20 mandatory patients, except for patients who have already been treated with imatinib prior to consent, and subsequent voluntary patients enrolled on the phase II portion of the trial will undergo research biopsies. Patients should hold both imatinib and MEK162 doses on the day they undergo a biopsy.
**Name:** biopsy
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** The first three patients will be enrolled at Dose Level 1. If dose level 1 is not found to be tolerable, then the next cohort will be enrolled at dose level -1. If dose level -1 is not found to be tolerable, then the study may be terminated based on discussions with the sponsor and the combination may be deemed intolerable. If 0/3 patients or 1/6 patients experience a DLT on dose level 2, this will be the RP2D.
**Measure:** maximum tolerated dose (MTD) (phase 1b portion)
**Time Frame:** 1 year
**Description:** Response Rate (CR+PR, RECIST 1.1). Response rate (RECIST 1.1) will be determined as the proportion of evaluable patients who have complete response or partial response defined by the RECIST 1.1.
**Measure:** Best Response Rate (phase II portion)
**Time Frame:** 2 years
#### Secondary Outcomes
**Description:** defined by RECIST 1.1 criteria and by CHOI criteria RR will be estimated as the proportion of patients who have complete response or partial response for each criterion.
**Measure:** Response Rate (RR) (phase 1b portion)
**Time Frame:** 1 year
**Description:** PFS will be calculated using Kaplan-Meier estimate among all patients enrolled. Patients who have not experienced the event of interest by the end of the study will be censored at the time of the last follow-up.
**Measure:** Progression Free Survival (PFS)
**Time Frame:** 1 year
**Description:** It will be determined as the proportion of patients who have complete response or partial response defined by the CHOI criteria with a two-sided 95% CI provided.
**Measure:** RR by CHOI criteria (phase II portion)
**Time Frame:** 1 year
**Description:** It will be determined as the proportion of patients who have complete response or partial response defined by the EORTC criteria with a two-sided 95% CI provided.
**Measure:** RR by EORTC criteria
**Time Frame:** 1 year
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients must have pathologically confirmed GIST.
* In the Phase Ib portion, must have locally advanced or metastatic GIST and have progressed on imatinib.
* In the Phase II portion, patients must be newly diagnosed or treatment naïve, or have been off adjuvant imatinib therapy for at least 3 months. Patients with newly diagnosed GIST and who had been on imatinib for up to 4 weeks prior to signing the consent are allowed to enroll in order to expedite accrual.
* Patients must be at least 18 years of age.
* Disease must be measurable by RECIST 1.1.
* ECOG Performance Status 0 or 1.
* Adequate renal, hepatic, and hematologic function as the following: Serum Creatinine ≤ 1.5 mg/dL, Total Serum Bilirubin ≤ 1.5 x upper limit of normal (ULN), Serum AST (SGOT) and/or ALT (SGPT) ≤ 2.5 x ULN (or ≤ 5.0 x ULN if considered due to tumor)ANC ≥ 1500/mm3, Platelets ≥ 100,000/mm3, and hemoglobin ≥ 10g/dL.
* Patients of childbearing potential must have a negative serum pregnancy test within 14 days of treatment. Patients must agree to use a reliable barrier method of birth control during and for 3 months following the last dose of study drug.
* Patient must have adequate cardiac function (left ventricular ejection fraction (LVEF) ≥50% as determined by a multigated acquisition (MUGA) scan or echocardiogram; and QTc interval≤480 ms.
* Patient must be able to take oral medications.
* Patients must sign an informed consent document.
Exclusion Criteria:
* In the phase II portion of the study, patients that have been previously treated with any systemic therapy for GIST are not permitted to enroll, with the exception of adjuvant imatinib systemic therapy or exposure to imatinib within 4 weeks of signing consent.
* Patients have a severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection).
* Patients have known brain metastasis.
* Patients have known chronic liver disease (i.e., cirrhosis)
* Known positive serology for HIV, active Hepatitis B, and/or active Hepatitis C infection.
* Other active malignancy (other than malignancies, which the investigator determines are unlikely to interfere with treatment and safety analysis).
* Patients have a history or current evidence of Central Serous Retinopathy (CSR) or retinal vein occlusion (RVO) or predisposing factors to CSR or RVO (i.e. uncontrolled glaucoma or ocular hypertension, uncontrolled diabetes mellitus, hyperviscosity or hypercoagulability syndromes).
* History of retinal degenerative disease.
* History of Gilbert's syndrome.
* Patients have clinically significant cardiovascular disease, including any of the following:
1) History of acute coronary syndrome including myocardial infarction, unstable angina, CABG, coronary angioplasty or stenting \< 6 months prior to screening; 2) symptomatic chronic heart failure (New York Heart Association Criteria, Class II-IV); 3) evidence of clinically significant cardiac arrhythmias and/or conduction abnormalities \< 6 months prior to screening except atrial fibrillation (AF) and paroxysmal supraventricular tachycardia (PSVT).
* Uncontrolled arterial hypertension despite appropriate medical therapy.
* Patients who have neuromuscular disorders that are associated with elevated creatinine phosphokinase (i.e. inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy).
* Uncontrolled impairment of gastrointestinal function or gastrointestinal disease (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome). Patients who have ulcerative colitis or other gastrointestinal diseases that are well controlled are allowed to proceed with this study.
* Prior therapy with a MEK inhibitor.
* Patients had a major surgery within 3 weeks prior to study entry or who have not recovered from side effects of such procedure.
* Women who are pregnant or lactating.
* Sexually active males unless they use a condom during intercourse while taking the drug and for 15 days after stopping treatment and should not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid.
* Patients with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.
**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:** Ping Chi, MD, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### References Module
#### References
**Citation:** Chi P, Qin LX, Nguyen B, Kelly CM, D'Angelo SP, Dickson MA, Gounder MM, Keohan ML, Movva S, Nacev BA, Rosenbaum E, Thornton KA, Crago AM, Yoon S, Ulaner G, Yeh R, Martindale M, Phelan HT, Biniakewitz MD, Warda S, Lee CJ, Berger MF, Schultz ND, Singer S, Hwang S, Chen Y, Antonescu CR, Tap WD. Phase II Trial of Imatinib Plus Binimetinib in Patients With Treatment-Naive Advanced Gastrointestinal Stromal Tumor. J Clin Oncol. 2022 Mar 20;40(9):997-1008. doi: 10.1200/JCO.21.02029. Epub 2022 Jan 18.
**PMID:** 35041493
#### See Also Links
**Label:** Memorial Sloan Kettering Cancer Center
**URL:** http://www.mskcc.org/
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009372
- Term: Neoplasms, Connective Tissue
- ID: D000018204
- Term: Neoplasms, Connective and Soft Tissue
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000009369
- Term: Neoplasms
- ID: D000005770
- Term: Gastrointestinal Neoplasms
- ID: D000004067
- Term: Digestive System Neoplasms
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000005767
- Term: Gastrointestinal Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M25642
- Name: Gastrointestinal Stromal Tumors
- Relevance: HIGH
- As Found: Gastrointestinal Stromal Tumors
- ID: M12317
- Name: Neoplasms, Connective Tissue
- Relevance: LOW
- As Found: Unknown
- 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: 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: T2444
- Name: Gastrointestinal Stromal Tumors
- Relevance: HIGH
- As Found: Gastrointestinal Stromal Tumors
### Condition Browse Module - Meshes
- ID: D000046152
- Term: Gastrointestinal Stromal Tumors
### 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: AA
- Name: Amino Acids
### Intervention Browse Module - Browse Leaves
- ID: M324
- Name: Imatinib Mesylate
- Relevance: HIGH
- As Found: Days per
- 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: D000068877
- Term: Imatinib Mesylate
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06060379
**Acronym:** 626 Giochiamo
**Brief Title:** Giochiamo 626 - Gaming for Health and Safety in Workplaces
**Official Title:** Giochiamo 626 - Gaming for Health and Safety in Workplaces
#### Organization Study ID Info
**ID:** 6-FIN/RIC2023
#### Organization
**Class:** OTHER
**Full Name:** Universitas Mercatorum
### Status Module
#### Completion Date
**Date:** 2024-09
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-02-12
**Type:** ACTUAL
**Last Update Submit Date:** 2024-02-08
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-02
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-10-09
**Type:** ACTUAL
**Status Verified Date:** 2024-02
#### Study First Post Date
**Date:** 2023-09-29
**Type:** ACTUAL
**Study First Submit Date:** 2023-09-18
**Study First Submit QC Date:** 2023-09-23
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** University of Roma La Sapienza
#### Lead Sponsor
**Class:** OTHER
**Name:** Universitas Mercatorum
#### Responsible Party
**Investigator Affiliation:** Universitas Mercatorum
**Investigator Full Name:** Alice Mannocci
**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 the "626 Giochiamo" project is to realise and evaluate the effectiveness of a training course involving the use of games, which helps to convey the basic principles of health and safety in the workplace.
**Detailed Description:** The seminar on health and safety in the workplace and basic principles will be presented to the recruited workers. At the end of the intervention they will be divided into two groups: the control group and the intervention group. The intervention group will be involved in a meeting dedicated to games in three different types, board, card and role-playing games.
A questionnaire on occupational health and safety knowledge will be administered to all study participants before the seminar (T=0), after the seminar (T=1) and after the intervention group has played (T=2).
### Conditions Module
**Conditions:**
- Health
- Safety
- Workplace
**Keywords:**
- Health and Safety workplace
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** The trial consists of three meetings. In the first meeting all enrolled participants will take part in a seminar. Before the seminar starts and at the end, a questionnaire will be administered to them to investigate their prior and acquired knowledge on the subject.
At the end the participants will be divided into two groups, the control group will not participate in the second phase, the intervention group will be invited to a game meeting. The third meeting will take place days later, where the third and final game will be conducted with the intervention group. At the end of the game, the questionnaire will be administered.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Partecipant will participate in playful encounters
**Intervention Names:**
- Other: GiochiAMO a 626
**Label:** Intervention gruop
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Subjects will not partecipate in the games
**Label:** Control group
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Intervention gruop
**Description:** The subjects of the intervention group will play three different games: a role-playing game, a card game and a board game.
**Name:** GiochiAMO a 626
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Effectiveness is understood as acquiring and increasing knowledge of key concepts on safety in the workplace, the roles of key persons who can influence health and safety, and the tools available for evaluation and monitoring.
**Measure:** The percentage of knowledge increased as a result of participation in the games
**Time Frame:** Participants are assessed by means of a questionnaire administered at the beginning of the trial (t=0), one day after the seminar (t=1) and after one month (t=2).
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
-
Exclusion Criteria:
* No worker
**Healthy Volunteers:** True
**Maximum Age:** 69 Years
**Minimum Age:** 17 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Alice Mannocci
**Phone:** +39.06.499790978
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Giuseppe La Torre
**Phone:** +39.06.499790978
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Roma
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Alice MANNOCCI, PhD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Giuseppe LA TORRE, PhD
- **Role:** SUB_INVESTIGATOR
**Country:** Italy
**Facility:** Alice Mannocci
**State:** RM
**Status:** RECRUITING
**Zip:** 00186
#### Overall Officials
**Official 1:**
**Affiliation:** Universitas Mercatorum
**Name:** Alice Mannocci
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** We will share aggregated data, individual data will be submitted upon request by the individual concerned to the Research Contact Person (principal investigator: Alice Mannocci).
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Cocchiara RA, Sestili C, Di Bella O, Backhaus I, Sinopoli A, D'Egidio V, Lia L, Saulle R, Mannocci A, La Torre G. "GiochiAMO," a Gaming Intervention to Prevent Smoking and Alcohol Habits Among Children: A Single-Arm Field Trial. Games Health J. 2020 Apr;9(2):113-120. doi: 10.1089/g4h.2019.0125. Epub 2019 Nov 26.
**PMID:** 31770005
**Citation:** D'Egidio V, Lia L, Sinopoli A, Backhaus I, Mannocci A, Saulle R, Sestili C, Cocchiara R, Di Bella O, Yordanov T, Mazzacane M, La Torre G. Results of the Italian project 'GiochiAMO' to improve nutrition and PA among children. J Public Health (Oxf). 2021 Jun 7;43(2):405-412. doi: 10.1093/pubmed/fdz129.
**PMID:** 31786612
**Citation:** La Torre G, Mannocci A, Saulle R, Sinopoli A, D'Egidio V, Sestili C, Manfuso R, Masala D. [GiochiAMO! The protocol of a school based intervention for the promotion of physical activity and nutrition among children]. Clin Ter. 2016 Sep-Oct;167(5):152-155. doi: 10.7417/CT.2016.1947. Italian.
**PMID:** 27845482
**Citation:** La Torre G, Sinopoli A, Sestili C, D'Egidio V, Di Bella O, Cocchiara RA, Sciarra I, Saulle R, Backhaus I, Mannocci A. "GiochiAMO": a school-based smoking and alcohol prevention program for children - a pilot randomized field trial. Part 2. Ann Ig. 2018 Jul-Aug;30(4):273-284. doi: 10.7416/ai.2018.2219.
**PMID:** 29895045
**Citation:** La Torre G, Mannocci A, Saulle R, Sinopoli A, D'Egidio V, Sestili C, Manfuso R, Masala D. Improving knowledge and behaviors on diet and physical activity in children: results of a pilot randomized field trial. Ann Ig. 2017 Nov-Dec;29(6):584-594. doi: 10.7416/ai.2017.2187.
**PMID:** 29048455
**Citation:** La Torre G, D'Egidio V, Sestili C, Cocchiara RA, Cianfanelli S, Di Bella O, Lia L, Dorelli B, Cammalleri V, Backhaus I, Pagano F, Anguissola C, Vitiello A, Carsetti R, Mannocci A, Giochiamo Collaborative Group. ImmunizziAMO: A School-Based Field Trial to Teach New Generations the Importance of Vaccination through Games and to Fight Vaccine Hesitancy in Italy. Vaccines (Basel). 2020 Jun 5;8(2):280. doi: 10.3390/vaccines8020280.
**PMID:** 32517111
## Derived Section
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT03906279
**Brief Title:** Choroidal Thickness Change in Response to Physiological and Refractive Changes
**Official Title:** Automatic Measurements of Choroidal Thickness Change in Response to Physiological and Refractive Changes
#### Organization Study ID Info
**ID:** ST002.2018
#### Organization
**Class:** OTHER
**Full Name:** Wrocław University of Science and Technology
### Status Module
#### Completion Date
**Date:** 2026-02
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-03-29
**Type:** ACTUAL
**Last Update Submit Date:** 2022-03-27
**Overall Status:** ACTIVE_NOT_RECRUITING
#### Primary Completion Date
**Date:** 2024-02
**Type:** ESTIMATED
#### Start Date
**Date:** 2019-04-10
**Type:** ACTUAL
**Status Verified Date:** 2022-03
#### Study First Post Date
**Date:** 2019-04-08
**Type:** ACTUAL
**Study First Submit Date:** 2019-04-03
**Study First Submit QC Date:** 2019-04-03
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Wroclaw Medical University
#### Lead Sponsor
**Class:** OTHER
**Name:** Wrocław University of Science and 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:** There is a great need for precise and repeatable measurements of the choroidal thickness. Including the diurnal physiological changes, accommodation and refractive error impact on those measurements.
### Conditions Module
**Conditions:**
- Refractive Errors
- Accommodation Disorder
### Design Module
#### Design Info
**Observational Model:** CASE_CROSSOVER
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 250
**Type:** ESTIMATED
**Patient Registry:** True
**Study Type:** OBSERVATIONAL
**Target Duration:** 3 Months
### Arms Interventions Module
#### Arm Group 1
**Label:** Myopic participants
#### Arm Group 2
**Label:** Emmetropic participants
#### Arm Group 3
**Label:** Hyperopic participants
### Outcomes Module
#### Primary Outcomes
**Description:** OCT EDI recorded scans will be proceed with the custom-made software to determine choroidal thickness in the submacular region.
**Measure:** Submacular choroidal thickness
**Time Frame:** 1 day
**Description:** OCT EDI recorded scans will be proceed with the custom-made software to determine choroidal thickness in the peripapillar region.
**Measure:** Peripapillar choroidal thickness
**Time Frame:** 1 day
#### Secondary Outcomes
**Description:** Measured with optical biometer (Lenstar)
**Measure:** Axial length of the globe
**Time Frame:** 1 day
**Description:** Measured with optical biometer (Lenstar)
**Measure:** Anterior chamber depth - optical biometry
**Time Frame:** 1 day
**Description:** Measured with optical biometer (Lenstar)
**Measure:** Phakic lens thickness
**Time Frame:** 1 day
**Description:** Measured with optical biometer (Lenstar)
**Measure:** White to white diameter
**Time Frame:** 1 day
**Description:** Measured with optical coherent tomography for anterior chamber
**Measure:** Angle to angle diameter of anterior chamber
**Time Frame:** 1 day
**Description:** Measured with optical coherent tomography for anterior chamber
**Measure:** Anterior chamber depth - OCT
**Time Frame:** 1 day
**Description:** Keratometry from autorefractokeratometer, topography or tomography recordings, radius measured in mm, magnitude of corneal astigmatism measured in local changes of dioptric power.
**Measure:** Corneal keratometry (steep meridian and its axis and flat meridian with its axis)
**Time Frame:** 1 day
**Description:** Subjective refraction made by trained optometrist. Spherical ametropia measured by dioptric power of spherical equivalent lens and magnitude of astigmatism measured in cylindrical dioptries of correcting lens with its axis. Mode of notation: sphero-cylinder with negative cylinder (e.g. +0.50DS -0.50DC 180ax)
**Measure:** Spherical ametropia with cylindrical power of correcting lenses
**Time Frame:** 1 day
**Description:** examined on ETDRS charts different for right and left eye
**Measure:** Best-corrected visual acuity
**Time Frame:** 1 day
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* participants with refractive error
* willing and able to understand and sign an informed consent form
Exclusion Criteria:
* patient unable to participate in the study
* any disease that causes visual opacity of optic media that unable to perform OCT scanning
* current enrolment in another clinical trial/research project
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Patients with refractive error
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Wrocław
**Country:** Poland
**Facility:** Department of Optics and Photonics
**Zip:** 50-370
#### Overall Officials
**Official 1:**
**Affiliation:** Wrocław University of Science and Technology
**Name:** Joanna Przeździecka-Dołyk, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** We intend to share anonymised data
**IPD Sharing:** UNDECIDED
## 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
### Condition Browse Module - Browse Leaves
- ID: M14872
- Name: Refractive Errors
- Relevance: HIGH
- As Found: Refractive Errors
- ID: M8271
- Name: Eye Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000012030
- Term: Refractive Errors
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06010979
**Brief Title:** Clinical Cohort Study of Knee Arthroplasty Assisted by Digital Technology
**Official Title:** Clinical Cohort Study of Knee Arthroplasty Assisted by Digital Technology
#### Organization Study ID Info
**ID:** TKAcohort
#### Organization
**Class:** OTHER
**Full Name:** Peking University Third Hospital
### Status Module
#### Completion Date
**Date:** 2026-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-08-25
**Type:** ACTUAL
**Last Update Submit Date:** 2023-08-24
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2026-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-01-01
**Type:** ESTIMATED
**Status Verified Date:** 2023-08
#### Study First Post Date
**Date:** 2023-08-25
**Type:** ACTUAL
**Study First Submit Date:** 2023-08-09
**Study First Submit QC Date:** 2023-08-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Tian Hua
#### Responsible Party
**Investigator Affiliation:** Peking University Third Hospital
**Investigator Full Name:** Tian Hua
**Investigator Title:** archiater
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Through this cohort study, previous clinical data can be systematically reviewed and supplemented through clinical follow-up. Prospective enrollment and follow-up observation of subsequent patients can also be carried out to build a retrospective-prospective two-way cohort study. The intraoperative, perioperative, clinical follow-up and health economics of surgical robot, computer navigation, personalized osteotomy guide and other digital technologies and traditional TKA were comprehensively and objectively compared, the results and conclusions of the center were summarized and reported, and the effectiveness and safety of digital assistive technology applied to TKA were explored, providing references for clinical diagnosis and follow-up research.
**Detailed Description:** Through this cohort study, previous clinical data can be systematically reviewed and supplemented by follow-up visits. Prospective enrollment and follow-up of subsequent patients can also be carried out to build a retrospective-prospective two-way cohort study. The preoperative situation (general statistical information, educational level, preoperative clinical function score, etc.), intraoperative situation (operative time, intraoperative blood loss, intraoperative complications, etc.), perioperative situation (total postoperative blood loss, blood transfusion rate, postoperative complications, etc.) and clinical follow-up situation were comprehensively and objectively compared with surgical robot, computer navigation, personalized osteotomy guide and other digital technologies and traditional TKA We summarized and reported the results and conclusions of the center (postoperative force line, implant location, pain, mobility, clinical function score, patient satisfaction and postoperative complications, etc.) and health economics (average length of stay, hospitalization cost, etc.) to provide reference for clinical diagnosis and follow-up research.
### Conditions Module
**Conditions:**
- Knee Osteoarthritis
**Keywords:**
- total knee arthroplasty
- knee osteoarthritis
- computer navigation
- robotic system
- patient-spercific instrumentation
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** OTHER
#### Enrollment Info
**Count:** 12000
**Type:** ESTIMATED
**Patient Registry:** True
**Study Type:** OBSERVATIONAL
**Target Duration:** 3 Years
### Arms Interventions Module
#### Arm Group 1
**Description:** Conventional instrument-assisted knee arthroplasty
**Intervention Names:**
- Procedure: conventional intrumentation assisted knee arthroplasty
**Label:** conventional group
#### Arm Group 2
**Description:** computer navigation assisted knee arthroplasty
**Intervention Names:**
- Procedure: computer navigation assisted knee arthroplasty
**Label:** CAS group
#### Arm Group 3
**Description:** robotic system assisted knee arthroplasty
**Intervention Names:**
- Procedure: robotic system assisted knee arthroplasty
**Label:** RAS group
#### Arm Group 4
**Description:** patient-spercific instrumentation assisted knee arthroplasty
**Intervention Names:**
- Procedure: patient-spercific assisted knee arthroplasty
**Label:** PSI group
### Interventions
#### Intervention 1
**Arm Group Labels:**
- conventional group
**Description:** conventional intrumentation assisted knee arthroplasty
**Name:** conventional intrumentation assisted knee arthroplasty
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- CAS group
**Description:** computer navigation assisted knee arthroplasty
**Name:** computer navigation assisted knee arthroplasty
**Type:** PROCEDURE
#### Intervention 3
**Arm Group Labels:**
- RAS group
**Description:** robotic system assisted knee arthroplasty
**Name:** robotic system assisted knee arthroplasty
**Type:** PROCEDURE
#### Intervention 4
**Arm Group Labels:**
- PSI group
**Description:** patient-spercific assisted knee arthroplasty
**Name:** patient-spercific assisted knee arthroplasty
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** The postoperative HKA Angle was measured, that is, the Angle between the center of the hip joint and the center of the knee joint and the center of the knee joint and the center of the ankle joint on the full-length X-ray film of the lower limb. The target Angle was defined as 0°, the Angle was positive when the knee was varus, the Angle was negative when the knee was varus, and the acceptable range was ±3°, beyond which the line deviation was defined.
**Measure:** mechanical axis
**Time Frame:** Postoperative day 3
#### Secondary Outcomes
**Description:** The surgical time is defined as the time from incision to the completion of the skin suture, accurate to minutes
**Measure:** operation time
**Time Frame:** immediately after the surgery
**Description:** Intraoperative blood loss = total amount of fluid drawn during the operation - intraoperative irrigation volume + intraoperative gauze infiltration blood loss, accurate to ml
**Measure:** Intraoperative blood loss
**Time Frame:** immediately after the surgery
**Description:** Various complications occurred during the operation were recorded
**Measure:** Intraoperative complications
**Time Frame:** immediately after the surgery
**Description:** Gross linear equation was used to calculate total blood loss and latent blood loss 3 days after surgery. Total blood loss = preoperative blood volume (PBV) × (preoperative hematocrit - postoperative hematocrit). PBV was calculated using Nadler method: PBV=K1× height (m) 3+K2× weight (kg) +K3, where male K1=0.3669, K2=0.03219, K3=0.6041; Female K1=0.3561, K2=0.03308, K3=0.1833. Postoperative total blood loss = total blood loss - intraoperative blood loss;
**Measure:** Total postoperative blood loss
**Time Frame:** Postoperative day 3
**Description:** The postoperative blood transfusion situation and the amount of blood transfusion were recorded. The blood was transfused mainly with suspended red blood cells, and the amount of a single transfusion was 400ml. The Hb situation was evaluated again by blood routine review on the morning of the second day after transfusion.
Indications for postoperative blood transfusion: No blood transfusion for Hb up to 8g/L or above; Hb up to 7g/L (including) must be transfused; Hb is between 7-8g/L, and blood transfusion should be given when anemia symptoms such as dizziness, weakness, palpitation, etc.
**Measure:** Blood transfusion rate
**Time Frame:** At discharge
**Description:** The postoperative complications such as wound nonunion, wound infection, hematomas and anemia were recorded.
**Measure:** Postoperative complication
**Time Frame:** 3 years postoperatively
**Description:** On the horizontal plane of CT scan of the affected knee, the Angle between the line of the posterior condyle of the femoral prosthesis and the line of the transcondyle of the femur was shown. The target Angle was defined as 0° external rotation of the femoral prosthesis, positive Angle during external rotation, negative Angle during internal rotation, acceptable range of ±2°, beyond which was defined as angular deviation
**Measure:** Rotation Angle of femur prosthesis
**Time Frame:** Postoperative day 3
**Description:** The pain of the affected limb was assessed by Visual analogue scale. The highest score is ten and the lowest score is zero. A higher score indicates a higher level of pain.
**Measure:** Visual analogue scale
**Time Frame:** Postoperative day 3
**Description:** The pain of the affected limb was assessed by Visual analogue scale. The highest score is ten and the lowest score is zero. A higher score indicates a higher level of pain.
**Measure:** Visual analogue scale
**Time Frame:** 2 weeks postoperatively
**Description:** The pain of the affected limb was assessed by Visual analogue scale. The highest score is ten and the lowest score is zero. A higher score indicates a higher level of pain.
**Measure:** Visual analogue scale
**Time Frame:** 6 weeks postoperatively
**Description:** The pain of the affected limb was assessed by Visual analogue scale. The highest score is ten and the lowest score is zero. A higher score indicates a higher level of pain.
**Measure:** Visual analogue scale
**Time Frame:** 3 months postoperatively
**Description:** The pain of the affected limb was assessed by Visual analogue scale. The highest score is ten and the lowest score is zero. A higher score indicates a higher level of pain.
**Measure:** Visual analogue scale
**Time Frame:** 6 months postoperatively
**Description:** The pain of the affected limb was assessed by Visual analogue scale. The highest score is ten and the lowest score is zero. A higher score indicates a higher level of pain.
**Measure:** Visual analogue scale
**Time Frame:** 12 months postoperatively
**Description:** The pain of the affected limb was assessed by Visual analogue scale. The highest score is ten and the lowest score is zero. A higher score indicates a higher level of pain.
**Measure:** Visual analogue scale
**Time Frame:** 24 months postoperatively
**Description:** The pain of the affected limb was assessed by Visual analogue scale. The highest score is ten and the lowest score is zero. A higher score indicates a higher level of pain.
**Measure:** Visual analogue scale
**Time Frame:** 36 months postoperatively
**Description:** The Range of motion of the knee on the operative side of the patient was measured
**Measure:** Range of motion
**Time Frame:** 3 days postoperatively
**Description:** The Range of motion of the knee on the operative side of the patient was measured
**Measure:** Range of motion
**Time Frame:** 2 weeks postoperatively
**Description:** The Range of motion of the knee on the operative side of the patient was measured
**Measure:** Range of motion
**Time Frame:** 6 weeks postoperatively
**Description:** The Range of motion of the knee on the operative side of the patient was measured
**Measure:** Range of motion
**Time Frame:** 3 months postoperatively
**Description:** The Range of motion of the knee on the operative side of the patient was measured
**Measure:** Range of motion
**Time Frame:** 6 months postoperatively
**Description:** The Range of motion of the knee on the operative side of the patient was measured
**Measure:** Range of motion
**Time Frame:** 12 months postoperatively
**Description:** The Range of motion of the knee on the operative side of the patient was measured
**Measure:** Range of motion
**Time Frame:** 24 months postoperatively
**Description:** The Range of motion of the knee on the operative side of the patient was measured
**Measure:** Range of motion
**Time Frame:** 36 months postoperatively
**Description:** This method is to evaluate the patient's knee joint and its function in two aspects according to the particularity of joint replacement surgery through the evaluator interview and physical examination, that is, to obtain the information of joint anatomy, biomechanics and other aspects, and to understand the patient's functional recovery. Knee joint evaluation is to evaluate the impact of surgery on the joint and the recovery of the joint after surgery, such as: joint pain, joint range of motion, ligament stability, muscle strength, bone alignment, contracture deformity; Functional assessments include activities of daily living, walking ability, going up and down stairs, and the need for AIDS. The evaluation was numerically quantified (see table), and the knee joint score and the functional score were obtained respectively. The higher the value, the better the function.
**Measure:** knee society score
**Time Frame:** 6 weeks postoperatively
**Description:** This method is to evaluate the patient's knee joint and its function in two aspects according to the particularity of joint replacement surgery through the evaluator interview and physical examination, that is, to obtain the information of joint anatomy, biomechanics and other aspects, and to understand the patient's functional recovery. Knee joint evaluation is to evaluate the impact of surgery on the joint and the recovery of the joint after surgery, such as: joint pain, joint range of motion, ligament stability, muscle strength, bone alignment, contracture deformity; Functional assessments include activities of daily living, walking ability, going up and down stairs, and the need for AIDS. The evaluation was numerically quantified (see table), and the knee joint score and the functional score were obtained respectively. The higher the value, the better the function.
**Measure:** knee society score
**Time Frame:** 3 months postoperatively
**Description:** This method is to evaluate the patient's knee joint and its function in two aspects according to the particularity of joint replacement surgery through the evaluator interview and physical examination, that is, to obtain the information of joint anatomy, biomechanics and other aspects, and to understand the patient's functional recovery. Knee joint evaluation is to evaluate the impact of surgery on the joint and the recovery of the joint after surgery, such as: joint pain, joint range of motion, ligament stability, muscle strength, bone alignment, contracture deformity; Functional assessments include activities of daily living, walking ability, going up and down stairs, and the need for AIDS. The evaluation was numerically quantified (see table), and the knee joint score and the functional score were obtained respectively. The higher the value, the better the function.
**Measure:** knee society score
**Time Frame:** 6 months postoperatively
**Description:** This method is to evaluate the patient's knee joint and its function in two aspects according to the particularity of joint replacement surgery through the evaluator interview and physical examination, that is, to obtain the information of joint anatomy, biomechanics and other aspects, and to understand the patient's functional recovery. Knee joint evaluation is to evaluate the impact of surgery on the joint and the recovery of the joint after surgery, such as: joint pain, joint range of motion, ligament stability, muscle strength, bone alignment, contracture deformity; Functional assessments include activities of daily living, walking ability, going up and down stairs, and the need for AIDS. The evaluation was numerically quantified (see table), and the knee joint score and the functional score were obtained respectively. The higher the value, the better the function.
**Measure:** knee society score
**Time Frame:** 12 months postoperatively
**Description:** This method is to evaluate the patient's knee joint and its function in two aspects according to the particularity of joint replacement surgery through the evaluator interview and physical examination, that is, to obtain the information of joint anatomy, biomechanics and other aspects, and to understand the patient's functional recovery. Knee joint evaluation is to evaluate the impact of surgery on the joint and the recovery of the joint after surgery, such as: joint pain, joint range of motion, ligament stability, muscle strength, bone alignment, contracture deformity; Functional assessments include activities of daily living, walking ability, going up and down stairs, and the need for AIDS. The evaluation was numerically quantified (see table), and the knee joint score and the functional score were obtained respectively. The higher the value, the better the function.
**Measure:** knee society score
**Time Frame:** 24 months postoperatively
**Description:** This method is to evaluate the patient's knee joint and its function in two aspects according to the particularity of joint replacement surgery through the evaluator interview and physical examination, that is, to obtain the information of joint anatomy, biomechanics and other aspects, and to understand the patient's functional recovery. Knee joint evaluation is to evaluate the impact of surgery on the joint and the recovery of the joint after surgery, such as: joint pain, joint range of motion, ligament stability, muscle strength, bone alignment, contracture deformity; Functional assessments include activities of daily living, walking ability, going up and down stairs, and the need for AIDS. The evaluation was numerically quantified (see table), and the knee joint score and the functional score were obtained respectively. The higher the value, the better the function.
**Measure:** knee society score
**Time Frame:** 36 months postoperatively
**Description:** This score is used to assess the severity of arthritis and its therapeutic effect based on the patient's relevant signs and symptoms. The structure and function of the knee joint were evaluated by pain, stiffness and joint function. A higher score indicates better functionality.
**Measure:** Western Ontario and McMaster Universities Osteoarthritis Index
**Time Frame:** 6 weeks postoperatively
**Description:** This score is used to assess the severity of arthritis and its therapeutic effect based on the patient's relevant signs and symptoms. The structure and function of the knee joint were evaluated by pain, stiffness and joint function. A higher score indicates better functionality.
**Measure:** Western Ontario and McMaster Universities Osteoarthritis Index
**Time Frame:** 3 months postoperatively
**Description:** This score is used to assess the severity of arthritis and its therapeutic effect based on the patient's relevant signs and symptoms. The structure and function of the knee joint were evaluated by pain, stiffness and joint function. A higher score indicates better functionality.
**Measure:** Western Ontario and McMaster Universities Osteoarthritis Index
**Time Frame:** 6 months postoperatively
**Description:** This score is used to assess the severity of arthritis and its therapeutic effect based on the patient's relevant signs and symptoms. The structure and function of the knee joint were evaluated by pain, stiffness and joint function. A higher score indicates better functionality.
**Measure:** Western Ontario and McMaster Universities Osteoarthritis Index
**Time Frame:** 12 months postoperatively
**Description:** This score is used to assess the severity of arthritis and its therapeutic effect based on the patient's relevant signs and symptoms. The structure and function of the knee joint were evaluated by pain, stiffness and joint function. A higher score indicates better functionality.
**Measure:** Western Ontario and McMaster Universities Osteoarthritis Index
**Time Frame:** 24 months postoperatively
**Description:** This score is used to assess the severity of arthritis and its therapeutic effect based on the patient's relevant signs and symptoms. The structure and function of the knee joint were evaluated by pain, stiffness and joint function. A higher score indicates better functionality.
**Measure:** Western Ontario and McMaster Universities Osteoarthritis Index
**Time Frame:** 36 months postoperatively
**Description:** At follow-up, patients' satisfaction scores were recorded (using 5-Likert scale). The higher the score, the higher the satisfaction
**Measure:** Patient satisfaction
**Time Frame:** 6 months postoperatively
**Description:** At follow-up, patients' satisfaction scores were recorded (using 5-Likert scale). The higher the score, the higher the satisfaction
**Measure:** Patient satisfaction
**Time Frame:** 12 months postoperatively
**Description:** At follow-up, patients' satisfaction scores were recorded (using 5-Likert scale). The higher the score, the higher the satisfaction
**Measure:** Patient satisfaction
**Time Frame:** 24 months postoperatively
**Description:** At follow-up, patients' satisfaction scores were recorded (using 5-Likert scale). The higher the score, the higher the satisfaction
**Measure:** Patient satisfaction
**Time Frame:** 36 months postoperatively
**Description:** The number of days a patient stays in hospital from admission to discharge
**Measure:** Length of stay
**Time Frame:** an average of 3 days postoperatively
**Description:** The total cost of a patient from admission to discharge
**Measure:** Medical expenses
**Time Frame:** an average of 3 days postoperatively
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* a. primary knee osteoarthritis;
* b. Unilateral primary knee replacement;
* c. Surgical methods were traditional surgery, surgical robot, computer navigation or personalized osteotomy guide
Exclusion Criteria:
* a. A history of renal insufficiency (Cr \> 2.5), liver insufficiency, severe heart disease (or coronary stenting within the last 12 months), severe respiratory disease, history of VTE or high risk of thrombosis (hereditary/acquired thrombotic disease), cotting disorder, stroke, and malignancy;
* b. Those who do not accept this test for any reason and refuse to sign the informed consent.
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
**Study Population:** Patients undergoing knee replacement in our hospital
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Tian Hua, MD
**Phone:** 86-13511065187
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Zheng Yuhang, MD
**Phone:** 86-18811185091
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Beijing
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Tian Hua, MD
- **Phone:** 86-18211070116
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Zheng Yuhang, bachelor
- **Phone:** 86-18811185091
- **Role:** CONTACT
**Country:** China
**Facility:** Peking University Third Hospital
**State:** Beijing
**Status:** RECRUITING
**Zip:** 100181
#### Overall Officials
**Official 1:**
**Affiliation:** Director
**Name:** Tian Hua, MD
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**Access Criteria:** All the researchers who need it
**Description:** It will be published as an academic paper
**Info Types:**
- STUDY_PROTOCOL
- CSR
**IPD Sharing:** YES
**Time Frame:** When data collection is complete
## 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: M22168
- Name: Osteoarthritis, Knee
- Relevance: HIGH
- As Found: Knee 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
- ID: D000020370
- Term: Osteoarthritis, Knee
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT05258279
**Brief Title:** Lenvatinib in Combination With Carboplatin Pemetrexed and Pembrolizumab for NSCLC With EGFR Mutations
**Official Title:** A Phase II Study of Lenvatinib (E7080/MK-7902) in Combination With Carboplatin Pemetrexed and Pembrolizumab (MK-3475) for Patients With Pretreated Advanced Non-squamous Non-small Cell Lung Cancer Harboring EGFR Mutations
#### Organization Study ID Info
**ID:** NEJ052
#### Organization
**Class:** OTHER
**Full Name:** Juntendo University
### Status Module
#### Completion Date
**Date:** 2024-10
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-10-04
**Type:** ACTUAL
**Last Update Submit Date:** 2023-10-03
**Overall Status:** ACTIVE_NOT_RECRUITING
#### Primary Completion Date
**Date:** 2023-10
**Type:** ESTIMATED
#### Start Date
**Date:** 2022-07-01
**Type:** ACTUAL
**Status Verified Date:** 2023-10
#### Study First Post Date
**Date:** 2022-02-28
**Type:** ACTUAL
**Study First Submit Date:** 2022-02-17
**Study First Submit QC Date:** 2022-02-17
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** Merck Sharp & Dohme LLC
#### Lead Sponsor
**Class:** OTHER
**Name:** Juntendo University
#### Responsible Party
**Investigator Affiliation:** Juntendo University
**Investigator Full Name:** Ryo Ko
**Investigator Title:** Assistant professor, Department of Respiratory Medicine
**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:** The purpose of this study is to assess the safety and efficacy of pemetrexed + carboplatin + pembrolizumab (MK-3475) with lenvatinib (MK-7902/E7080) in patients with advanced nonsquamous non-small cell lung cancer harboring EGFR mutations.
### Conditions Module
**Conditions:**
- Non-squamous Non-small-cell Lung Cancer
- EGFR Activating Mutation
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 30
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants receive carboplatin Area Under Curve 5 mg/mL/min (AUC5) via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for 4 cycles PLUS pemetrexed 500 mg/m\^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib via oral capsule once daily for up to 2 years.
**Intervention Names:**
- Drug: Pembrolizumab
- Drug: Lenvatinib
- Drug: Carboplatin
- Drug: Pemetrexed
**Label:** Pemetrexed+Carboplatin+Pembrolizumab+Lenvatinib
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Pemetrexed+Carboplatin+Pembrolizumab+Lenvatinib
**Description:** IV infusion Q3W
**Name:** Pembrolizumab
**Other Names:**
- MK-3475
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Pemetrexed+Carboplatin+Pembrolizumab+Lenvatinib
**Description:** Oral capsule once daily
**Name:** Lenvatinib
**Other Names:**
- MK-7902
- E7080
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- Pemetrexed+Carboplatin+Pembrolizumab+Lenvatinib
**Description:** IV infusion Q3W
**Name:** Carboplatin
**Type:** DRUG
#### Intervention 4
**Arm Group Labels:**
- Pemetrexed+Carboplatin+Pembrolizumab+Lenvatinib
**Description:** IV infusion Q3W
**Name:** Pemetrexed
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1.
**Measure:** Objective Response Rate (ORR) as Assessed by BICR according to RECIST 1.1
**Time Frame:** Up to approximately 18 months
#### Secondary Outcomes
**Description:** ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1.
**Measure:** Objective Response Rate (ORR) as Assessed by investigators according to RECIST 1.1.
**Time Frame:** Up to approximately 18 months
**Description:** PFS is defined as the time from date of randomization to the date of the first documentation of progressive disease (PD) or death from any cause, whichever occurs first. Per RECIST 1.1.
**Measure:** Progression-free Survival (PFS) as Assessed by investigators according to RECIST 1.1
**Time Frame:** Up to approximately 30 months
**Description:** OS is defined as the time from randomization to the time of death from any cause. OS will be presented.
**Measure:** Overall Survival (OS)
**Time Frame:** Up to approximately 30 months
**Description:** For participants who demonstrated CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions), DOR is defined as the time from the first documented evidence of CR or PR until PD or death from any cause, whichever occurs first. Per RECIST 1.1.
**Measure:** Duration of Response (DOR) as Assessed by investigators according to RECIST 1.1.
**Time Frame:** Up to approximately 30 months
**Description:** An adverse event is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
**Measure:** Number of Participants with One or More Adverse Events
**Time Frame:** Up to approximately 30 months
**Description:** ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) or Stable Disease (SD) per RECIST 1.1.
**Measure:** Disease Control Rate (DCR) as Assessed by investigators according to RECIST 1.1.
**Time Frame:** Up to approximately 18 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Have a histologically or cytologically confirmed diagnosis of incurable Stage IIIB, IIIC, IVA, IVB (American Joint Committee on Cancer \[AJCC\], version 8) non-squamous NSCLC. Postoperative recurrence is acceptable if the disease is not curable.
2. Have documentation of tumor activating EGFR mutation, specifically either exon 19 deletion or exon 21 L858R.
3. Have investigator determined radiographic disease progression per RECIST 1.1 after treatment with EGFR-TKI therapy:
1. Participants previously treated with 1st or 2nd generation EGFR TKI (eg, erlotinib/afatinib/gefitinib) are required to have confirmed documented absence of EGFR T790M mutation.
2. Participants with confirmed acquired T790M mutation after 1st or 2nd generation EGFR-TKI (eg, erlotinib/afatinib/gefitinib) are required to have osimertinib TKI treatment failure prior to enrollment.
3. Participants previously failed osimertinib TKI treatment as 1st line therapy are eligible regardless of their EGFR T790M mutation status.
4. Participants treated with a combination of EGFR TKIs and antibodies targeting the VEGF pathway will also be eligible.
4. Have measurable disease per RECIST 1.1.
5. Be male or female ≥ 20 years of age inclusive, at the time of signing the informed consent form (ICF).
6. Have a life expectancy of at least 3 months.
7. Have an ECOG performance status of 0 or 1 within 7 days prior to the first dose of study intervention but before registration.
8. A male participant must agree to use a contraception during the treatment period.
9. A female participant is eligible to participate if she is not pregnant, not breastfeeding
10. The participant provides written informed consent for the study.
11. Have adequate organ function.
12. Have adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP ≤ 150/90 mmHg and no change in antihypertensive medications within 1 week prior to registration.
Exclusion Criteria:
1. Has known untreated central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, clinically stable, and have not required steroids for at least 14 days prior to the first dose of study intervention.
2. Has history of (noninfectious) pneumonitis that required systemic steroids or current pneumonitis/interstitial lung disease.
3. Radiographic evidence of intratumoral cavitations, encasement, or invasion of a major blood vessel. Additionally, the degree of proximity to major blood vessels should be considered because for exclusion because of the potential risk of severe hemorrhage associated with tumor shrinkage/necrosis after lenvatinib therapy (in the chest, major blood vessels include the main pulmonary artery, the left and right pulmonary arteries, the 4 major pulmonary veins, the superior or inferior vena cava, and the aorta).
4. Has a known history of an additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of that disease of that disease recurrence for at least 3 year since initiation of that therapy.
5. Has an autoimmune disease that has required systemic treatment in the past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is allowed.
6. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (doses exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study intervention.
7. Has had an allogeneic tissue/solid organ transplant.
8. Has a known history of human immunodeficiency virus (HIV) infection. HIV testing is not required unless mandated by the local health authority.
9. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \[HBsAg\] reactive or HBV-DNA detected) or known active Hepatitis C virus (HCV antibody reactive).
10. Has a history of a gastrointestinal condition or procedure that in the opinion of the investigator may affect oral drug absorption.
11. Has active hemoptysis (at least 0.5 tsp of bright red blood) within 2 weeks prior to the first dose of study intervention.
12. Has significant cardiovascular impairment within 12 months prior to the first dose of study intervention, including history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction, cerebrovascular accident (CVA)/stroke, or cardiac arrhythmia associated with hemodynamic instability.
13. Has a known history of active tuberculosis.
14. Has an active infection requiring systemic therapy.
15. Has had major surgery within 3 weeks prior to first dose of study interventions.
Note: Adequate wound healing after major surgery must be assessed clinically, independent of time elapsed for eligibility.
16. Has known psychiatric or substance abuse disorders that would interfere with the participant's cooperation to meet with the requirements of the study.
17. Previously had a severe hypersensitivity reaction to treatment with a monoclonal antibody or has s known sensitivity to any component of lenvatinib or pembrolizumab, or as applicable, carboplatin, or pemetrexed.
18. A women of childbearing potential (WOCBP) who has a positive urine pregnancy test within 72 hours prior to registration. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
19. Has preexisting ≥ Grade 3 gastrointestinal or non-gastrointestinal fistula. Prior/Concomitant Therapy
20. Has received prior systemic cytotoxic chemotherapy for their metastatic NSCLC. Note: Prior treatment with chemotherapy and/or radiation as part of neoadjuvant/adjuvant therapy is allowed as long as therapy was completed at least 6 months prior to the diagnosis of metastatic NSCLC.
21. Has received prior treatment with pembrolizumab or any other anti-PD-1, anti-PD-L1, anti-PD-L2 agent, with lenvatinib or any other RTKi, or with an agent directed to another stimulatory or co-inhibitory T cell receptor (eg, CTLA-4, OX-40, CD137, GITR).
22. Has received radiotherapy within 14 days prior to the first dose of study intervention or received lung radiation therapy of \> 30 Gy within 6 months prior to the first dose of study intervention.
23. Has received systemic steroid therapy (in doses exceeding 10 mg daily of prednisone equivalent) within 7 days prior to the first dose of study intervention.
24. Has received a live vaccine within 30 days prior to the first dose of study intervention. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, and Bacillus Calmette-Guerin (BCG). Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed.
25. Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks prior to the first dose of study intervention.
Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been \> 4 weeks after the last dose of the previous investigational agent.
26. Participants with proteinuria \> 1+ on urinalysis will undergo 24-hour urine collection for quantitative assessment of proteinuria. Participants with urine protein ≥ 1 g/24 hours will be ineligible.
27. Has a prolongation of QTc interval (calculated using Fridericia's formula) of \> 480 msec.
28. Has left ventricular ejection fraction (LVFE) below 50% as determined by multigated acquisition scan (MUGA) or echocardiogram (ECHO).
29. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's ability to participate for the full duration of the study, or make it not in the best interest of the participant to participate, in the opinion of the treating investigator.
**Minimum Age:** 20 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Urayasu
**Country:** Japan
**Facility:** Juntendo Urayasu Hospital
**State:** Chiba
**Zip:** 279-0021
**Location 2:**
**City:** Kawasaki
**Country:** Japan
**Facility:** St. Marianna University Hospital
**State:** Kanagawa
**Zip:** 216-8511
**Location 3:**
**City:** Yokohama
**Country:** Japan
**Facility:** Kanagawa Cardiovascular and Respiratory Center
**State:** Kanagawa
**Zip:** 236-0051
**Location 4:**
**City:** Yokohama
**Country:** Japan
**Facility:** Kanagawa Cancer Center
**State:** Kanagawa
**Zip:** 241-8515
**Location 5:**
**City:** Hidaka
**Country:** Japan
**Facility:** Saitama Medical University International Medical Center
**State:** Saitama
**Zip:** 350-1298
**Location 6:**
**City:** Ina
**Country:** Japan
**Facility:** Saitama Cancer Center
**State:** Saitama
**Zip:** 362-0806
**Location 7:**
**City:** Nagaizumi-cho
**Country:** Japan
**Facility:** Shizuoka Cancer Center
**State:** Shizuoka
**Zip:** 411-8777
**Location 8:**
**City:** Bunkyo-ku
**Country:** Japan
**Facility:** Juntendo University Hospital
**State:** Tokyo
**Zip:** 113-8431
**Location 9:**
**City:** Bunkyo-ku
**Country:** Japan
**Facility:** Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
**State:** Tokyo
**Zip:** 113-8677
**Location 10:**
**City:** Chiba
**Country:** Japan
**Facility:** Chiba University Hospital
**Zip:** 26-8677
#### Overall Officials
**Official 1:**
**Affiliation:** Department of Respiratory Medicine, Juntendo University
**Name:** Ryo Ko, MD, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012142
- Term: Respiratory Tract Neoplasms
- ID: D000013899
- Term: Thoracic Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000008171
- Term: Lung Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
- ID: D000002283
- Term: Carcinoma, Bronchogenic
- ID: D000001984
- Term: Bronchial Neoplasms
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M11172
- Name: Lung Neoplasms
- Relevance: HIGH
- As Found: Lung Cancer
- ID: M5546
- Name: Carcinoma, Non-Small-Cell Lung
- Relevance: HIGH
- As Found: Non-Small Cell Lung Cancer
- ID: M5534
- Name: Carcinoma
- 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
- ID: M5540
- Name: Carcinoma, Bronchogenic
- Relevance: LOW
- As Found: Unknown
- ID: M5260
- Name: Bronchial Neoplasms
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000008175
- Term: Lung Neoplasms
- ID: D000002289
- Term: Carcinoma, Non-Small-Cell Lung
### Intervention Browse Module - Ancestors
- ID: D000000970
- Term: Antineoplastic Agents
- ID: D000074322
- Term: Antineoplastic Agents, Immunological
- ID: D000082082
- Term: Immune Checkpoint Inhibitors
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000004791
- Term: Enzyme Inhibitors
- ID: D000005493
- Term: Folic Acid Antagonists
- ID: D000019384
- Term: Nucleic Acid Synthesis Inhibitors
- ID: D000047428
- Term: Protein Kinase Inhibitors
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Micro
- Name: Micronutrients
- Abbrev: Hemat
- Name: Hematinics
- Abbrev: Vi
- Name: Vitamins
### Intervention Browse Module - Browse Leaves
- ID: M349416
- Name: Pembrolizumab
- Relevance: HIGH
- As Found: Blind
- ID: M18650
- Name: Carboplatin
- Relevance: HIGH
- As Found: System
- ID: M353738
- Name: Lenvatinib
- Relevance: HIGH
- As Found: Fibrillation
- ID: M264
- Name: Pemetrexed
- Relevance: HIGH
- As Found: General
- ID: M1346
- Name: Antineoplastic Agents, Immunological
- Relevance: LOW
- As Found: Unknown
- ID: M2342
- Name: Immune Checkpoint Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M7951
- Name: Enzyme Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M8618
- Name: Folic Acid
- Relevance: LOW
- As Found: Unknown
- ID: M17546
- Name: Vitamin B Complex
- Relevance: LOW
- As Found: Unknown
- ID: M8619
- Name: Folic Acid Antagonists
- Relevance: LOW
- As Found: Unknown
- ID: M25820
- Name: Protein Kinase Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: T447
- Name: Folinic Acid
- Relevance: LOW
- As Found: Unknown
- ID: T446
- Name: Folic Acid
- Relevance: LOW
- As Found: Unknown
- ID: T448
- Name: Folate
- Relevance: LOW
- As Found: Unknown
- ID: T475
- Name: Vitamin B9
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000016190
- Term: Carboplatin
- ID: C000582435
- Term: Pembrolizumab
- ID: D000068437
- Term: Pemetrexed
- ID: C000531958
- Term: Lenvatinib
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT04947579
**Acronym:** AS SpA axSpA
**Brief Title:** A Study of CC-99677 in Participants With Active Ankylosing Spondylitis
**Official Title:** A Phase 2 Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of CC-99677 in Subjects With Active Ankylosing Spondylitis
#### Organization Study ID Info
**ID:** CC-99677-AS-001
#### Organization
**Class:** INDUSTRY
**Full Name:** Celgene
#### Secondary ID Infos
**Domain:** UTN Number
**ID:** U1111-1265-3951
**Type:** REGISTRY
**ID:** 2019-004108-37
**Type:** EUDRACT_NUMBER
### Status Module
#### Completion Date
**Date:** 2023-02-21
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-01
**Type:** ACTUAL
**Last Update Submit Date:** 2024-04-03
**Overall Status:** TERMINATED
#### Primary Completion Date
**Date:** 2023-02-21
**Type:** ACTUAL
#### Results First Post Date
**Date:** 2024-05-01
**Type:** ACTUAL
**Results First Submit Date:** 2024-02-21
**Results First Submit QC Date:** 2024-04-03
#### Start Date
**Date:** 2021-08-25
**Type:** ACTUAL
**Status Verified Date:** 2024-04
#### Study First Post Date
**Date:** 2021-07-01
**Type:** ACTUAL
**Study First Submit Date:** 2021-06-23
**Study First Submit QC Date:** 2021-06-23
**Why Stopped:** The study has been terminated due to Non-Safety reasons because of lack of efficacy in the short-term acute phase.
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Celgene
#### 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 study is designed to learn about response to CC-99677 treatment by measuring signs and symptoms of Ankylosing Spondylitis (AS), objective measures of disease activity, quality of life assessments, pharmacokinetics, safety, and tolerability over a 12-week double-blind period.
### Conditions Module
**Conditions:**
- Spondylitis, Ankylosing
**Keywords:**
- Ankylosing Spondylitis
- CC-99677
- MK2inhibitor
- Spinal Diseases
- Bone Diseases
- Musculoskeletal Diseases
- Arthritis
- Joint Diseases
### 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:** 167
**Type:** ACTUAL
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** 49 participants will be randomized to CC-99677 150 mg in biologic naive main study
**Intervention Names:**
- Drug: CC-99677
**Label:** Administration of CC-99677 150 mg QD PO
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** 49 participants will be randomized to CC-99677 60 mg in biologic naive main study
**Intervention Names:**
- Drug: CC-99677
**Label:** Administration of CC-99677 60mg QD PO
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** 49 participants will be randomized to placebo in biologic naive main study
**Intervention Names:**
- Other: Placebo
**Label:** Administration of Placebo QD PO
**Type:** PLACEBO_COMPARATOR
#### Arm Group 4
**Description:** 20 participants will be randomized to CC-99677 150 mg in biologic-failure substudy
**Intervention Names:**
- Drug: CC-99677
**Label:** Administration of CC-99677 150 mg QD PO.
**Type:** EXPERIMENTAL
#### Arm Group 5
**Description:** 20 participants will be randomized to CC-99677 60 mg in biologic-failure substudy
**Intervention Names:**
- Drug: CC-99677
**Label:** Administration of CC-99677 60mg QD PO.
**Type:** EXPERIMENTAL
#### Arm Group 6
**Description:** 10 participants will be randomized to placebo in biologic-failure substudy
**Intervention Names:**
- Other: Placebo
**Label:** Placebo additional dose cohort
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Administration of CC-99677 150 mg QD PO
- Administration of CC-99677 150 mg QD PO.
- Administration of CC-99677 60mg QD PO
- Administration of CC-99677 60mg QD PO.
**Description:** Oral
**Name:** CC-99677
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Administration of Placebo QD PO
- Placebo additional dose cohort
**Description:** Oral
**Name:** Placebo
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Percentage of participants who achieve an improvement in disease activity from baseline of ≥ 20% and ≥ 1 unit in at least 3 of the 4 SpondyloArthritis International Society (ASAS) domains on a scale of 0 to 10, and no worsening from baseline of ≥ 20% and ≥ 1 unit in the remaining domain on a scale of 0 to 10. Baseline is the last non-missing value on or before the date of the first dose of investigational product. The four ASAS Domains are:
* Patient Global Assessment of Disease (0 to 10 unit Numerical Rating Scale \[NRS\]);
* Total Back Pain NRS;
* Function (the Bath Ankylosing Spondylitis Functional Index \[BASFI\] score NRS);
* Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\] NRS Questions #5 and #6 for morning stiffness).
**Measure:** Percentage of Participants Who Achieve ASAS 20 at Week 12
**Time Frame:** Week 12
#### Secondary Outcomes
**Description:** Percentage of participants who achieve an improvement in disease activity from baseline of ≥ 40% and ≥ 2 unit in at least 3 of the 4 SpondyloArthritis International Society (ASAS) domains on a scale of 0 to 10, and no worsening at all from baseline in the remaining domain. Baseline is the last non-missing value on or before the date of the first dose of investigational product. The four ASAS Domains are:
* Patient Global Assessment of Disease (0 to 10 unit Numerical Rating Scale \[NRS\]);
* Total Back Pain NRS;
* Function (the Bath Ankylosing Spondylitis Functional Index \[BASFI\] score NRS);
* Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\] NRS Questions #5 and #6 for morning stiffness).
**Measure:** Percentage of Participants Who Achieve ASAS 40 at Week 12
**Time Frame:** Week 12
**Description:** ASDAS-CRP is a score of disease activity that combines patient reported assessments of back pain (Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\] question 2), duration of morning stiffness (BASDAI question 6), peripheral joint pain and/or swelling (BASDAI question 3), general wellbeing, and CRP in a weighted manner. The cut-off values for disease activity states and improvement scores are defined as follows: \<1.3 inactive disease, ≥1.3 and \<2.1 low disease activity, ≥2.1 and ≤3.5 high disease activity and 3.5 very high disease activity. The minimum clinically important difference (MCID) are defined as: change of at least 1.1 unit for 'clinically important improvement' and change of at least 2.0 units for 'major improvement'. Baseline is the last non-missing value on or before the date of the first dose of investigational product. ASDAS-CRP Formula: 0.12xBack Pain+0.06xDuration of Morning Stiffness+0.11xPatient Global+0.07xPeripheral Pain/Swelling+0.58xln(CRP+1)
**Measure:** Change From Baseline in Ankylosing Spondylitis Disease Activity Score With CRP (ASDAS-CRP) at Week 12
**Time Frame:** Baseline and Week 12
**Description:** Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is a composite score based on a self-administered survey of six questions using a 0 to 10 unit numerical rating scale (NRS) that assesses five major symptoms of AS during the last week: 1) fatigue; 2) spinal pain; 3) peripheral joint pain/swelling; 4) areas of localized tenderness; 5a) morning stiffness severity upon wakening; 5b) morning stiffness duration upon wakening. To give each of the five symptoms equal weighting, the mean of the two scores relating to morning stiffness is taken. The resulting 0 to 50 score is divided by 5 to give a final 0 to 10 BASDAI score. A BASDAI score of 4 or greater is considered to be indicative of active AS disease. Baseline is the last non-missing value on or before the date of the first dose of investigational product.
**Measure:** Change From Baseline in BASDAI at Week 12
**Time Frame:** Baseline and Week 12
**Description:** Bath Ankylosing Spondylitis Functional Index (BASFI) is a composite score based on a self administered survey of ten questions using a 0 to 10 unit numerical rating scale (NRS) that assesses degree of mobility and functional ability during the last week. The questionnaire consists of eight questions regarding function in AS and the two last questions reflecting ability to cope with everyday life. The left-hand box of 0 represents "easy," and the right-hand box represents "impossible." The resulting 0 to 100 score is divided by 10 to give a final 0 to 10 BASFI score. A higher BASFI score correlates to reduced functional ability. Baseline is the last non-missing value on or before the date of the first dose of investigational product.
**Measure:** Change From Baseline in BASFI at Week 12
**Time Frame:** Baseline and Week 12
**Description:** Change from Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) scores of the sacroiliac joints. The SPARCC assesses 16 sites for enthesitis using a score of "0" for no activity or "1" for activity. Sites assessed include Medial epicondyle (left/right \[L/R\]), Lateral epicondyle (L/R), Supraspinatus insertion into greater tuberosity of humerus (L/R), Greater trochanter (L/R), Quadriceps insertion into superior border of patella (L/R), Patellar ligament insertion into inferior pole of patella or tibial tubercle (L/R), Achilles tendon insertion into calcaneum (L/R), and Plantar fascia insertion into calcaneum (L/R). The SPARCC is the sum of all site scores (range 0 to 16). Higher scores indicate more severe enthesitis. Baseline is the last non-missing value on or before the date of the first dose of investigational product.
**Measure:** Change From Baseline in the SPARCC SI Joint Score at Week 12
**Time Frame:** Baseline and Week 12
**Description:** Change from Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) scores of the total spine. All 23 disco-vertebral units (DVU) of the spine (from C2 to S1) were scored for bone marrow edema. A single DVU has 18 scoring units, and each has score of 0 or 1, bringing the maximum total score to 414, the sum ranges from 0 to 414 with higher scores reflecting worse disease.
Baseline is the last non-missing value on or before the date of the first dose of investigational product.
**Measure:** Change From Baseline in the SPARCC Spine Score at Week 12
**Time Frame:** Baseline and Week 12
**Description:** Percent change from baseline in high-sensitivity C-reactive protein (hsCRP). Baseline is the last non-missing value on or before the date of the first dose of investigational product.
**Measure:** Percent Change From Baseline in hsCRP at Week 12
**Time Frame:** Baseline and Week 12
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Diagnosis of Ankylosing Spondylitis (AS) fulfilling the modified New York criteria
* Active axial disease at Screening and Baseline defined by a Bath Ankylosing
* Spondylitis Disease Activity Index (BASDAI) score ≥ 4 and Total Back Pain ≥ 4
* Failed prior treatment with at least 2 NSAIDs for at least 4 weeks each
* Participant has never received a biologic therapy eg, tumor necrosis factor (TNF) antagonist or monoclonal antibody \[mAb\] against IL-17A (biologic naive main study), or have taken more than one biologic therapy (biologic-failure substudy) for the treatment of AS
Exclusion Criteria:
* Radiographic evidence of total ankylosis of the spine
* Clinically significant back pain caused by diseases other than AS
* Concurrent treatment or treatment within the 6 months prior to Baseline with cell depleting biologic agents
* Participation in any study of an investigational drug, including those for COVID-19
* History of malignancy
* Oral corticosteroids (prednisone or equivalent) \> 10 mg/day systemically for ≥ 2 weeks prior to Baseline Visit
**Maximum Age:** 65 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Flagstaff
**Country:** United States
**Facility:** Local Institution - 024
**State:** Arizona
**Zip:** 86001
**Location 2:**
**City:** Gilbert
**Country:** United States
**Facility:** Local Institution - 021
**State:** Arizona
**Zip:** 58297
**Location 3:**
**City:** Phoenix
**Country:** United States
**Facility:** Local Institution - 022
**State:** Arizona
**Zip:** 95037
**Location 4:**
**City:** Tucson
**Country:** United States
**Facility:** Local Institution - 025
**State:** Arizona
**Zip:** 85704
**Location 5:**
**City:** Tustin
**Country:** United States
**Facility:** Local Institution - 017
**State:** California
**Zip:** 92780
**Location 6:**
**City:** Saint Clair Shores
**Country:** United States
**Facility:** Local Institution - 026
**State:** Michigan
**Zip:** 48081
**Location 7:**
**City:** Cleveland
**Country:** United States
**Facility:** Local Institution - 028
**State:** Ohio
**Zip:** 44106
**Location 8:**
**City:** Dayton
**Country:** United States
**Facility:** Local Institution - 004
**State:** Ohio
**Zip:** 45417
**Location 9:**
**City:** Portland
**Country:** United States
**Facility:** Local Institution - 009
**State:** Oregon
**Zip:** 97239
**Location 10:**
**City:** Duncansville
**Country:** United States
**Facility:** Local Institution - 003
**State:** Pennsylvania
**Zip:** 16635
**Location 11:**
**City:** Jackson
**Country:** United States
**Facility:** Local Institution - 005
**State:** Tennessee
**Zip:** 38305
**Location 12:**
**City:** Memphis
**Country:** United States
**Facility:** Local Institution - 002
**State:** Tennessee
**Zip:** 38119
**Location 13:**
**City:** Austin
**Country:** United States
**Facility:** Local Institution - 029
**State:** Texas
**Zip:** 78731
**Location 14:**
**City:** Colleyville
**Country:** United States
**Facility:** Local Institution - 006
**State:** Texas
**Zip:** 76034
**Location 15:**
**City:** Fort Worth
**Country:** United States
**Facility:** Local Institution - 019
**State:** Texas
**Zip:** 76107
**Location 16:**
**City:** Houston
**Country:** United States
**Facility:** Local Institution - 008
**State:** Texas
**Zip:** 77099
**Location 17:**
**City:** Shanghai
**Country:** China
**Facility:** Local Institution - 154
**State:** Shanghai
**Zip:** 200040
**Location 18:**
**City:** Guangzhou
**Country:** China
**Facility:** Local Institution - 151
**Zip:** 510630
**Location 19:**
**City:** Hangzhou
**Country:** China
**Facility:** Local Institution - 152
**Zip:** 310014
**Location 20:**
**City:** Huangpu District
**Country:** China
**Facility:** Local Institution - 153
**Zip:** 200000
**Location 21:**
**City:** Wuhan
**Country:** China
**Facility:** Local Institution - 150
**Zip:** 430030
**Location 22:**
**City:** Brno
**Country:** Czechia
**Facility:** Local Institution - 205
**Zip:** 61141
**Location 23:**
**City:** Ostrava
**Country:** Czechia
**Facility:** Local Institution - 206
**Zip:** 702 00
**Location 24:**
**City:** Ostrava
**Country:** Czechia
**Facility:** Local Institution - 207
**Zip:** 702 00
**Location 25:**
**City:** Pardubice
**Country:** Czechia
**Facility:** Local Institution - 201
**Zip:** 530 02
**Location 26:**
**City:** Praha 11
**Country:** Czechia
**Facility:** Local Institution - 211
**Zip:** 148 00
**Location 27:**
**City:** Praha 3
**Country:** Czechia
**Facility:** Local Institution - 202
**Zip:** 13000
**Location 28:**
**City:** Praha 4
**Country:** Czechia
**Facility:** Local Institution - 203
**Zip:** 140 00
**Location 29:**
**City:** Uherské Hradište
**Country:** Czechia
**Facility:** Local Institution - 204
**Zip:** 686 01
**Location 30:**
**City:** Herne
**Country:** Germany
**Facility:** Local Institution - 900
**Zip:** 44649
**Location 31:**
**City:** Bialystok
**Country:** Poland
**Facility:** Local Institution - 311
**Zip:** 15-077
**Location 32:**
**City:** Bialystok
**Country:** Poland
**Facility:** Local Institution - 315
**Zip:** 15-351
**Location 33:**
**City:** Bydgoszcz
**Country:** Poland
**Facility:** Local Institution - 305
**Zip:** 85-065
**Location 34:**
**City:** Bydgoszcz
**Country:** Poland
**Facility:** Local Institution - 302
**Zip:** 85-168
**Location 35:**
**City:** Elblag
**Country:** Poland
**Facility:** Local Institution - 301
**Zip:** 82-300
**Location 36:**
**City:** Katowice
**Country:** Poland
**Facility:** Local Institution - 307
**Zip:** 40-282
**Location 37:**
**City:** Krakow
**Country:** Poland
**Facility:** Local Institution - 300
**Zip:** 30-002
**Location 38:**
**City:** Krakow
**Country:** Poland
**Facility:** Local Institution - 308
**Zip:** 30-363
**Location 39:**
**City:** Nowa Sol
**Country:** Poland
**Facility:** Local Institution - 310
**Zip:** 67-100
**Location 40:**
**City:** Onyksowa 10
**Country:** Poland
**Facility:** Local Institution - 313
**Zip:** 20-582
**Location 41:**
**City:** Sochaczew
**Country:** Poland
**Facility:** Local Institution - 312
**Zip:** 96-500
**Location 42:**
**City:** Torun
**Country:** Poland
**Facility:** Local Institution - 306
**Zip:** 87-100
**Location 43:**
**City:** Warsaw
**Country:** Poland
**Facility:** Local Institution - 303
**Zip:** 02-691
**Location 44:**
**City:** Wroclaw
**Country:** Poland
**Facility:** Local Institution - 309
**Zip:** 52-416
**Location 45:**
**City:** Brasov
**Country:** Romania
**Facility:** Local Institution - 400
**Zip:** 500283
**Location 46:**
**City:** Bucuresti
**Country:** Romania
**Facility:** Local Institution - 404
**Zip:** 011025
**Location 47:**
**City:** Bucuresti
**Country:** Romania
**Facility:** Local Institution - 402
**Zip:** 011172
**Location 48:**
**City:** Bucuresti
**Country:** Romania
**Facility:** Local Institution - 403
**Zip:** 011172
**Location 49:**
**City:** A Coruña
**Country:** Spain
**Facility:** Local Institution - 604
**Zip:** 15006
**Location 50:**
**City:** Barcelona
**Country:** Spain
**Facility:** Local Institution - 607
**Zip:** 08035
**Location 51:**
**City:** Cordoba
**Country:** Spain
**Facility:** Local Institution - 606
**Zip:** 14001
**Location 52:**
**City:** Merida
**Country:** Spain
**Facility:** Local Institution - 605
**Zip:** 06800
**Location 53:**
**City:** Sabadell
**Country:** Spain
**Facility:** Local Institution - 601
**Zip:** 8208
**Location 54:**
**City:** Santiago De Compostela
**Country:** Spain
**Facility:** Local Institution - 602
**Zip:** 15706
**Location 55:**
**City:** Sevilla
**Country:** Spain
**Facility:** Local Institution - 603
**Zip:** 41013
**Location 56:**
**City:** Adapazari
**Country:** Turkey
**Facility:** Local Institution - 702
**Zip:** 54100
**Location 57:**
**City:** Altındağ/Ankara
**Country:** Turkey
**Facility:** Local Institution - 707
**Zip:** 06230
**Location 58:**
**City:** Ankara
**Country:** Turkey
**Facility:** Local Institution - 700
**Zip:** 06100
**Location 59:**
**City:** Edirne
**Country:** Turkey
**Facility:** Local Institution - 701
**Zip:** 22030
**Location 60:**
**City:** Istanbul
**Country:** Turkey
**Facility:** Local Institution - 705
**Zip:** 34098
**Location 61:**
**City:** Izmir
**Country:** Turkey
**Facility:** Local Institution - 706
**Zip:** 35100
**Location 62:**
**City:** Karabaglar
**Country:** Turkey
**Facility:** Local Institution - 704
**Zip:** 35360
**Location 63:**
**City:** Trabzon
**Country:** Turkey
**Facility:** Local Institution - 703
**Zip:** 61080
#### Overall Officials
**Official 1:**
**Affiliation:** Bristol-Myers Squibb
**Name:** Bristol-Myers Squibb, MD
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**Access Criteria:** See Plan Description
**Description:** Information relating to our policy on data sharing and the process for requesting data can be found at the following link:
https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
**Info Types:**
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
- ANALYTIC_CODE
**IPD Sharing:** YES
**Time Frame:** See Plan Description
**URL:** https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
### References Module
#### See Also Links
**Label:** BMS Clinical Trial Information
**URL:** https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
**Label:** FDA Safety Alerts and Recalls
**URL:** http://www.fda.gov/safety/medwatch/safetyinformation/default.htm
**Label:** BMS Clinical Trial Patient Recruiting
**URL:** https://www.BMSStudyConnect.com
## Document Section
### Large Document Module
#### Large Docs
- Date: 2022-09-21
- Filename: Prot_SAP_000.pdf
- Has ICF: False
- Has Protocol: True
- Has SAP: True
- Label: Study Protocol and Statistical Analysis Plan
- Size: 4895769
- Type Abbrev: Prot_SAP
- Upload Date: 2024-02-21T10:02
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001850
- Term: Bone Diseases, Infectious
- ID: D000007239
- Term: Infections
- ID: D000001847
- Term: Bone Diseases
- ID: D000009140
- Term: Musculoskeletal Diseases
- ID: D000013122
- Term: Spinal Diseases
- ID: D000001168
- Term: Arthritis
- ID: D000007592
- Term: Joint Diseases
- ID: D000089183
- Term: Axial Spondyloarthritis
- ID: D000025242
- Term: Spondylarthropathies
- ID: D000000844
- Term: Ankylosis
### Condition Browse Module - Browse Branches
- Abbrev: BC05
- Name: Musculoskeletal Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC01
- Name: Infections
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M15919
- Name: Spinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5126
- Name: Bone Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15961
- Name: Spondylitis
- Relevance: HIGH
- As Found: Spondylitis
- ID: M23035
- Name: Spondylarthritis
- Relevance: HIGH
- As Found: Spondylitis
- ID: M10621
- Name: Joint Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M4476
- Name: Arthritis
- Relevance: LOW
- As Found: Unknown
- ID: M12097
- Name: Musculoskeletal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15962
- Name: Spondylitis, Ankylosing
- Relevance: HIGH
- As Found: Spondylitis, Ankylosing
- ID: M10283
- Name: Infections
- Relevance: LOW
- As Found: Unknown
- ID: M6368
- Name: Communicable Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5129
- Name: Bone Diseases, Infectious
- Relevance: LOW
- As Found: Unknown
- ID: M2697
- Name: Axial Spondyloarthritis
- Relevance: LOW
- As Found: Unknown
- ID: M23036
- Name: Spondylarthropathies
- Relevance: LOW
- As Found: Unknown
- ID: M4170
- Name: Ankylosis
- Relevance: LOW
- As Found: Unknown
- ID: T5412
- Name: Spondylarthropathy
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000013166
- Term: Spondylitis
- ID: D000025241
- Term: Spondylarthritis
- ID: D000013167
- Term: Spondylitis, Ankylosing
### Misc Info Module
#### Removed Countries
- Country: Canada
- Country: Russian Federation
#### Submission Tracking
##### First MCP Info
###### Post Date
- Date: 2024-03-21
- Type: ACTUAL
- Version Holder: 2024-05-24
## Results Section
### Adverse Events Module
**Description:** Placebo patients from week 0 - week 12 are reported separately in Biologic Naive or Biologic Failure arms. Placebo patients who are rerandomized at week 12 to CC99677 60 mg or 150 mg are reported separately in "Placebo to CC-99677" Biologic Naive or Biologic Failure arms.
#### Event Groups
**Group ID:** EG000
**Title:** CC-99677 150 mg Biologic Naive
**Deaths Num At Risk:** 49
**Description:** CC-99677 150 mg Biologic Naive QD PO through Week 64 or until early discontinuation
**ID:** EG000
**Other Num Affected:** 11
**Other Num at Risk:** 49
**Serious Number At Risk:** 49
**Title:** CC-99677 150 mg Biologic Naive
**Group ID:** EG001
**Title:** CC-99677 60 mg Biologic Naive
**Deaths Num At Risk:** 49
**Description:** CC-99677 60 mg Biologic Naive QD PO through Week 64 or until early discontinuation
**ID:** EG001
**Other Num Affected:** 26
**Other Num at Risk:** 49
**Serious Number At Risk:** 49
**Title:** CC-99677 60 mg Biologic Naive
**Group ID:** EG002
**Title:** Placebo Biologic Naive
**Deaths Num At Risk:** 7
**Description:** Placebo Biologic Naive QD PO from week 0 - 12
**ID:** EG002
**Other Num at Risk:** 7
**Serious Number Affected:** 1
**Serious Number At Risk:** 7
**Title:** Placebo Biologic Naive
**Group ID:** EG003
**Title:** Placebo to CC-99677 150 mg Biologic Naive
**Deaths Num Affected:** 1
**Deaths Num At Risk:** 21
**Description:** At week 12, participants rerandomized to CC-99677 150 mg PO QD through Week 64 or until early discontinuation
**ID:** EG003
**Other Num Affected:** 8
**Other Num at Risk:** 21
**Serious Number Affected:** 3
**Serious Number At Risk:** 21
**Title:** Placebo to CC-99677 150 mg Biologic Naive
**Group ID:** EG004
**Title:** Placebo to CC-99677 60 mg Biologic Naive
**Deaths Num At Risk:** 21
**Description:** At week 12, participants rerandomized to CC-99677 60 mg PO QD through Week 64 or until early discontinuation
**ID:** EG004
**Other Num Affected:** 7
**Other Num at Risk:** 21
**Serious Number At Risk:** 21
**Title:** Placebo to CC-99677 60 mg Biologic Naive
**Group ID:** EG005
**Title:** CC-99677 150 mg Biologic Failure
**Deaths Num At Risk:** 8
**Description:** CC-99677 150 mg Biologic Failure QD PO through Week 64 or until early discontinuation
**ID:** EG005
**Other Num Affected:** 6
**Other Num at Risk:** 8
**Serious Number Affected:** 3
**Serious Number At Risk:** 8
**Title:** CC-99677 150 mg Biologic Failure
**Group ID:** EG006
**Title:** CC-99677 60 mg Biologic Failure
**Deaths Num At Risk:** 7
**Description:** CC-99677 60 mg Biologic Failure QD PO through Week 64 or until early discontinuation
**ID:** EG006
**Other Num Affected:** 4
**Other Num at Risk:** 7
**Serious Number At Risk:** 7
**Title:** CC-99677 60 mg Biologic Failure
**Group ID:** EG007
**Title:** Placebo Biologic Failure
**Deaths Num At Risk:** 2
**Description:** Placebo Biologic Failure QD PO from week 0 - 12
**ID:** EG007
**Other Num Affected:** 1
**Other Num at Risk:** 2
**Serious Number Affected:** 1
**Serious Number At Risk:** 2
**Title:** Placebo Biologic Failure
**Group ID:** EG008
**Title:** Placebo to CC-99677 150 mg Biologic Failure
**Deaths Num At Risk:** 1
**Description:** At week 12, participants rerandomized to CC-99677 150 mg PO QD through Week 64 or until early discontinuation
**ID:** EG008
**Other Num Affected:** 1
**Other Num at Risk:** 1
**Serious Number At Risk:** 1
**Title:** Placebo to CC-99677 150 mg Biologic Failure
**Group ID:** EG009
**Title:** Placebo to CC-99677 60 mg Biologic Failure
**Deaths Num At Risk:** 2
**Description:** At week 12, participants rerandomized to CC-99677 60 mg PO QD through Week 64 or until early discontinuation
**ID:** EG009
**Other Num Affected:** 1
**Other Num at Risk:** 2
**Serious Number At Risk:** 2
**Title:** Placebo to CC-99677 60 mg Biologic Failure
**Frequency Threshold:** 5
#### Other Events
**Term:** Lymphadenopathy
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Blood and lymphatic system disorders
**Source Vocabulary:** MedDRA 25.1
**Term:** Iridocyclitis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Eye disorders
**Source Vocabulary:** MedDRA 25.1
**Term:** Swelling of eyelid
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Eye disorders
**Source Vocabulary:** MedDRA 25.1
**Term:** Abdominal distension
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA 25.1
**Term:** Aphthous ulcer
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA 25.1
**Term:** Diarrhoea
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA 25.1
**Term:** Pyrexia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA 25.1
**Term:** COVID-19
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA 25.1
**Term:** Genital candidiasis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA 25.1
**Term:** Gingivitis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA 25.1
**Term:** Laryngitis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA 25.1
**Term:** Nasopharyngitis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA 25.1
**Term:** Oral candidiasis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA 25.1
**Term:** Otitis media
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA 25.1
**Term:** Pharyngitis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA 25.1
**Term:** Pulpitis dental
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA 25.1
**Term:** Respiratory tract infection
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA 25.1
**Term:** Rhinitis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA 25.1
**Term:** Tonsillitis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA 25.1
**Term:** Upper respiratory tract infection
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA 25.1
**Term:** Viral infection
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA 25.1
**Term:** Viral upper respiratory tract infection
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA 25.1
**Term:** Head injury
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Injury, poisoning and procedural complications
**Source Vocabulary:** MedDRA 25.1
**Term:** Rib fracture
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Injury, poisoning and procedural complications
**Source Vocabulary:** MedDRA 25.1
**Term:** Alanine aminotransferase increased
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:** MedDRA 25.1
**Term:** Blood creatine phosphokinase increased
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:** MedDRA 25.1
**Term:** Electrocardiogram QT prolonged
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:** MedDRA 25.1
**Term:** Hepatic enzyme increased
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:** MedDRA 25.1
**Term:** Transaminases increased
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:** MedDRA 25.1
**Term:** Ankylosing spondylitis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Musculoskeletal and connective tissue disorders
**Source Vocabulary:** MedDRA 25.1
**Term:** Dizziness
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
**Source Vocabulary:** MedDRA 25.1
**Term:** Headache
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
**Source Vocabulary:** MedDRA 25.1
**Term:** Radiculopathy
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
**Source Vocabulary:** MedDRA 25.1
**Term:** Depressed mood
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Psychiatric disorders
**Source Vocabulary:** MedDRA 25.1
**Term:** Renal colic
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Renal and urinary disorders
**Source Vocabulary:** MedDRA 25.1
**Term:** Pneumothorax
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
**Source Vocabulary:** MedDRA 25.1
#### Serious Events
**Term:** Myocardial infarction
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Cardiac disorders
**Source Vocabulary:** MedDRA 25.1
##### Stats
**Group ID:** EG000
**Num At Risk:** 49
**Group ID:** EG001
**Num At Risk:** 49
**Group ID:** EG002
**Num At Risk:** 7
**Group ID:** EG003
**Num Affected:** 1
**Num At Risk:** 21
**Group ID:** EG004
**Num At Risk:** 21
**Group ID:** EG005
**Num At Risk:** 8
**Group ID:** EG006
**Num At Risk:** 7
**Group ID:** EG007
**Num At Risk:** 2
**Group ID:** EG008
**Num At Risk:** 1
**Group ID:** EG009
**Num At Risk:** 2
**Term:** Colitis ulcerative
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA 25.1
##### Stats
**Group ID:** EG000
**Num At Risk:** 49
**Group ID:** EG001
**Num At Risk:** 49
**Group ID:** EG002
**Num At Risk:** 7
**Group ID:** EG003
**Num At Risk:** 21
**Group ID:** EG004
**Num At Risk:** 21
**Group ID:** EG005
**Num Affected:** 1
**Num At Risk:** 8
**Group ID:** EG006
**Num At Risk:** 7
**Group ID:** EG007
**Num At Risk:** 2
**Group ID:** EG008
**Num At Risk:** 1
**Group ID:** EG009
**Num At Risk:** 2
**Term:** Asthenia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA 25.1
##### Stats
**Group ID:** EG000
**Num At Risk:** 49
**Group ID:** EG001
**Num At Risk:** 49
**Group ID:** EG002
**Num Affected:** 1
**Num At Risk:** 7
**Group ID:** EG003
**Num At Risk:** 21
**Group ID:** EG004
**Num At Risk:** 21
**Group ID:** EG005
**Num At Risk:** 8
**Group ID:** EG006
**Num At Risk:** 7
**Group ID:** EG007
**Num At Risk:** 2
**Group ID:** EG008
**Num At Risk:** 1
**Group ID:** EG009
**Num At Risk:** 2
**Term:** Oral candidiasis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA 25.1
##### Stats
**Group ID:** EG000
**Num At Risk:** 49
**Group ID:** EG001
**Num At Risk:** 49
**Group ID:** EG002
**Num At Risk:** 7
**Group ID:** EG003
**Num At Risk:** 21
**Group ID:** EG004
**Num At Risk:** 21
**Group ID:** EG005
**Num Affected:** 1
**Num At Risk:** 8
**Group ID:** EG006
**Num At Risk:** 7
**Group ID:** EG007
**Num At Risk:** 2
**Group ID:** EG008
**Num At Risk:** 1
**Group ID:** EG009
**Num At Risk:** 2
**Term:** Clavicle fracture
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Injury, poisoning and procedural complications
**Source Vocabulary:** MedDRA 25.1
##### Stats
**Group ID:** EG000
**Num At Risk:** 49
**Group ID:** EG001
**Num At Risk:** 49
**Group ID:** EG002
**Num At Risk:** 7
**Group ID:** EG003
**Num Affected:** 1
**Num At Risk:** 21
**Group ID:** EG004
**Num At Risk:** 21
**Group ID:** EG005
**Num At Risk:** 8
**Group ID:** EG006
**Num At Risk:** 7
**Group ID:** EG007
**Num At Risk:** 2
**Group ID:** EG008
**Num At Risk:** 1
**Group ID:** EG009
**Num At Risk:** 2
**Term:** Concussion
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Injury, poisoning and procedural complications
**Source Vocabulary:** MedDRA 25.1
##### Stats
**Group ID:** EG000
**Num At Risk:** 49
**Group ID:** EG001
**Num At Risk:** 49
**Group ID:** EG002
**Num At Risk:** 7
**Group ID:** EG003
**Num At Risk:** 21
**Group ID:** EG004
**Num At Risk:** 21
**Group ID:** EG005
**Num Affected:** 1
**Num At Risk:** 8
**Group ID:** EG006
**Num At Risk:** 7
**Group ID:** EG007
**Num At Risk:** 2
**Group ID:** EG008
**Num At Risk:** 1
**Group ID:** EG009
**Num At Risk:** 2
**Term:** Road traffic accident
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Injury, poisoning and procedural complications
**Source Vocabulary:** MedDRA 25.1
##### Stats
**Group ID:** EG000
**Num At Risk:** 49
**Group ID:** EG001
**Num At Risk:** 49
**Group ID:** EG002
**Num At Risk:** 7
**Group ID:** EG003
**Num At Risk:** 21
**Group ID:** EG004
**Num At Risk:** 21
**Group ID:** EG005
**Num Affected:** 1
**Num At Risk:** 8
**Group ID:** EG006
**Num At Risk:** 7
**Group ID:** EG007
**Num At Risk:** 2
**Group ID:** EG008
**Num At Risk:** 1
**Group ID:** EG009
**Num At Risk:** 2
**Term:** Metastases to peritoneum
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)
**Source Vocabulary:** MedDRA 25.1
##### Stats
**Group ID:** EG000
**Num At Risk:** 49
**Group ID:** EG001
**Num At Risk:** 49
**Group ID:** EG002
**Num At Risk:** 7
**Group ID:** EG003
**Num Affected:** 1
**Num At Risk:** 21
**Group ID:** EG004
**Num At Risk:** 21
**Group ID:** EG005
**Num At Risk:** 8
**Group ID:** EG006
**Num At Risk:** 7
**Group ID:** EG007
**Num At Risk:** 2
**Group ID:** EG008
**Num At Risk:** 1
**Group ID:** EG009
**Num At Risk:** 2
**Term:** Psychotic disorder
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Psychiatric disorders
**Source Vocabulary:** MedDRA 25.1
##### Stats
**Group ID:** EG000
**Num At Risk:** 49
**Group ID:** EG001
**Num At Risk:** 49
**Group ID:** EG002
**Num At Risk:** 7
**Group ID:** EG003
**Num At Risk:** 21
**Group ID:** EG004
**Num At Risk:** 21
**Group ID:** EG005
**Num At Risk:** 8
**Group ID:** EG006
**Num At Risk:** 7
**Group ID:** EG007
**Num Affected:** 1
**Num At Risk:** 2
**Group ID:** EG008
**Num At Risk:** 1
**Group ID:** EG009
**Num At Risk:** 2
**Time Frame:** Participants were assessed for all-cause mortality from their first dose to their study completion (Up to approximately 17 months). SAEs and Other AEs were assessed from first dose up to 28 days post last dose (Up to approximately 16 months).
## Results Section - Baseline Characteristics Module
### Denomination Counts
**Group ID:** BG000
**Value:** 49
**Group ID:** BG001
**Value:** 49
**Group ID:** BG002
**Value:** 49
**Group ID:** BG003
**Value:** 5
**Group ID:** BG004
**Value:** 7
**Group ID:** BG005
**Value:** 8
**Group ID:** BG006
**Value:** 167
**Units:** Participants
### Group
**ID:** BG000
**Title:** Placebo Biologic Naive
**Description:** Placebo Biologic Naive QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
### Group
**ID:** BG001
**Title:** CC-99677 60 mg Biologic Naive
**Description:** CC-99677 60 mg Biologic Naive QD PO through Week 64 or until early discontinuation
### Group
**ID:** BG002
**Title:** CC-99677 150 mg Biologic Naive
**Description:** CC-99677 150 mg Biologic Naive QD PO through Week 64 or until early discontinuation
### Group
**ID:** BG003
**Title:** Placebo Biologic Failure
**Description:** Placebo Biologic Failure QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
### Group
**ID:** BG004
**Title:** CC-99677 60 mg Biologic Failure
**Description:** CC-99677 60 mg Biologic Failure QD PO through Week 64 or until early discontinuation
### Group
**ID:** BG005
**Title:** CC-99677 150 mg Biologic Failure
**Description:** CC-99677 150 mg Biologic Failure QD PO through Week 64 or until early discontinuation
### Group
**ID:** BG006
**Title:** Total
**Description:** Total of all reporting groups
### Measure
#### Measurement
**Group ID:** BG000
**Spread:** 10.27
**Value:** 44.1
#### Measurement
**Group ID:** BG001
**Spread:** 11.78
**Value:** 40.5
#### Measurement
**Group ID:** BG002
**Spread:** 9.75
**Value:** 40.4
#### Measurement
**Group ID:** BG003
**Spread:** 7.16
**Value:** 43.8
#### Measurement
**Group ID:** BG004
**Spread:** 10.06
**Value:** 44.4
#### Measurement
**Group ID:** BG005
**Spread:** 9.46
**Value:** 42.5
#### Measurement
**Group ID:** BG006
**Spread:** 10.48
**Value:** 41.9
**Class Title:**
### Measure
#### Measurement
**Group ID:** BG000
**Value:** 8
#### Measurement
**Group ID:** BG001
**Value:** 6
#### Measurement
**Group ID:** BG002
**Value:** 12
#### Measurement
**Group ID:** BG003
**Value:** 1
#### Measurement
**Group ID:** BG004
**Value:** 1
#### Measurement
**Group ID:** BG005
**Value:** 0
#### Measurement
**Group ID:** BG006
**Value:** 28
**Category Title:** Female
#### Measurement
**Group ID:** BG000
**Value:** 41
#### Measurement
**Group ID:** BG001
**Value:** 43
#### Measurement
**Group ID:** BG002
**Value:** 37
#### Measurement
**Group ID:** BG003
**Value:** 4
#### Measurement
**Group ID:** BG004
**Value:** 6
#### Measurement
**Group ID:** BG005
**Value:** 8
#### Measurement
**Group ID:** BG006
**Value:** 139
**Category Title:** Male
**Class Title:**
### Measure
#### Measurement
**Group ID:** BG000
**Value:** 2
#### Measurement
**Group ID:** BG001
**Value:** 2
#### Measurement
**Group ID:** BG002
**Value:** 0
#### Measurement
**Group ID:** BG003
**Value:** 0
#### Measurement
**Group ID:** BG004
**Value:** 0
#### Measurement
**Group ID:** BG005
**Value:** 0
#### Measurement
**Group ID:** BG006
**Value:** 4
**Category Title:** Hispanic or Latino
#### Measurement
**Group ID:** BG000
**Value:** 47
#### Measurement
**Group ID:** BG001
**Value:** 47
#### Measurement
**Group ID:** BG002
**Value:** 49
#### Measurement
**Group ID:** BG003
**Value:** 5
#### Measurement
**Group ID:** BG004
**Value:** 7
#### Measurement
**Group ID:** BG005
**Value:** 8
#### Measurement
**Group ID:** BG006
**Value:** 163
**Category Title:** Not Hispanic or Latino
#### 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:** 0
#### Measurement
**Group ID:** BG006
**Value:** 0
**Category Title:** Unknown or Not Reported
**Class Title:**
### Measure
#### Measurement
**Group ID:** BG000
**Value:** 0
#### Measurement
**Group ID:** BG001
**Value:** 1
#### Measurement
**Group ID:** BG002
**Value:** 0
#### Measurement
**Group ID:** BG003
**Value:** 0
#### Measurement
**Group ID:** BG004
**Value:** 0
#### Measurement
**Group ID:** BG005
**Value:** 0
#### Measurement
**Group ID:** BG006
**Value:** 1
**Category Title:** American Indian or Alaska Native
#### Measurement
**Group ID:** BG000
**Value:** 1
#### 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:** 2
**Category Title:** Asian
#### 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:** 0
#### Measurement
**Group ID:** BG006
**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
#### Measurement
**Group ID:** BG003
**Value:** 0
#### Measurement
**Group ID:** BG004
**Value:** 0
#### Measurement
**Group ID:** BG005
**Value:** 0
#### Measurement
**Group ID:** BG006
**Value:** 0
**Category Title:** Black or African American
#### Measurement
**Group ID:** BG000
**Value:** 48
#### Measurement
**Group ID:** BG001
**Value:** 48
#### Measurement
**Group ID:** BG002
**Value:** 48
#### Measurement
**Group ID:** BG003
**Value:** 5
#### Measurement
**Group ID:** BG004
**Value:** 7
#### Measurement
**Group ID:** BG005
**Value:** 8
#### Measurement
**Group ID:** BG006
**Value:** 164
**Category 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:** 0
#### Measurement
**Group ID:** BG006
**Value:** 0
**Category Title:** More than one race
#### 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:** 0
#### Measurement
**Group ID:** BG006
**Value:** 0
**Category Title:** Unknown or Not Reported
**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:** 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
## Results Section - More Information Module
### Certain Agreement
**Other Details:** Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
**Restriction Type:** OTHER
**Restrictive Agreement:** True
### Point of Contact
**Email:** [email protected]
**Organization:** Bristol-Myers Squibb
**Phone:** Please Email
**Title:** Bristol-Myers Squibb Study Director
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** -18.2
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 22.7
**CI Upper Limit Comment:**
**Dispersion Type:**
**Dispersion Value:**
**Estimate Comment:** CC99677 60 mg - Placebo
**Group Description:**
**Non-Inferiority Comment:**
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:**
**P-Value:** 0.829
**P-Value Comment:**
**Parameter Type:** Stratified difference
**Parameter Value:** 2.4
**Statistical Comment:**
**Statistical Method:** Cochran-Mantel-Haenszel
**Tested Non-Inferiority:**
#### Analysis
**CI Lower Limit:** -13.8
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 27.5
**CI Upper Limit Comment:**
**Dispersion Type:**
**Dispersion Value:**
**Estimate Comment:** CC99677 150 mg - Placebo
**Group Description:**
**Non-Inferiority Comment:**
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:**
**P-Value:** 0.512
**P-Value Comment:**
**Parameter Type:** Stratified difference
**Parameter Value:** 7.3
**Statistical Comment:**
**Statistical Method:** Cochran-Mantel-Haenszel
**Tested Non-Inferiority:**
### Outcome Measure 2
#### Analysis
**CI Lower Limit:** -14.9
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 21.0
**CI Upper Limit Comment:**
**Dispersion Type:**
**Dispersion Value:**
**Estimate Comment:** CC99677 60 mg - Placebo
**Group Description:**
**Non-Inferiority Comment:**
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:**
**P-Value:** 0.725
**P-Value Comment:**
**Parameter Type:** Stratified difference
**Parameter Value:** 3.3
**Statistical Comment:**
**Statistical Method:** Cochran-Mantel-Haenszel
**Tested Non-Inferiority:**
#### Analysis
**CI Lower Limit:** -7.2
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 30.5
**CI Upper Limit Comment:**
**Dispersion Type:**
**Dispersion Value:**
**Estimate Comment:** CC99677 150 mg - Placebo
**Group Description:**
**Non-Inferiority Comment:**
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:**
**P-Value:** 0.219
**P-Value Comment:**
**Parameter Type:** Stratfied difference
**Parameter Value:** 12.2
**Statistical Comment:**
**Statistical Method:** Cochran-Mantel-Haenszel
**Tested Non-Inferiority:**
### Outcome Measure 3
#### Analysis
**CI Lower Limit:** -0.50
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.16
**CI Upper Limit Comment:**
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.167
**Estimate Comment:** CC99677 60 mg - Placebo
**Group Description:**
**Non-Inferiority Comment:**
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:**
**P-Value:** 0.299
**P-Value Comment:**
**Parameter Type:** Difference in Adjusted Means
**Parameter Value:** -0.17
**Statistical Comment:**
**Statistical Method:** Longitudinal data analysis model
**Tested Non-Inferiority:**
#### Analysis
**CI Lower Limit:** -0.45
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.22
**CI Upper Limit Comment:**
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.168
**Estimate Comment:** CC99677 150 mg - Placebo
**Group Description:**
**Non-Inferiority Comment:**
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:**
**P-Value:** 0.488
**P-Value Comment:**
**Parameter Type:** Difference in Adjusted Means
**Parameter Value:** -0.12
**Statistical Comment:**
**Statistical Method:** Longitudinal data analysis model
**Tested Non-Inferiority:**
### Outcome Measure 4
#### Analysis
**CI Lower Limit:** -0.76
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.79
**CI Upper Limit Comment:**
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.391
**Estimate Comment:** CC99677 60 mg - Placebo
**Group Description:**
**Non-Inferiority Comment:**
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:**
**P-Value:** 0.970
**P-Value Comment:**
**Parameter Type:** Difference in Adjusted Means
**Parameter Value:** 0.01
**Statistical Comment:**
**Statistical Method:** Longitudinal data analysis model
**Tested Non-Inferiority:**
#### Analysis
**CI Lower Limit:** -0.95
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.61
**CI Upper Limit Comment:**
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.393
**Estimate Comment:** CC99677 150 mg - Placebo
**Group Description:**
**Non-Inferiority Comment:**
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:**
**P-Value:** 0.668
**P-Value Comment:**
**Parameter Type:** Difference in Adjusted Means
**Parameter Value:** -0.17
**Statistical Comment:**
**Statistical Method:** Longitudinal data analysis model
**Tested Non-Inferiority:**
### Outcome Measure 5
#### Analysis
**CI Lower Limit:** -0.77
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.88
**CI Upper Limit Comment:**
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.416
**Estimate Comment:** CC99677 60 mg - Placebo
**Group Description:**
**Non-Inferiority Comment:**
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:**
**P-Value:** 0.890
**P-Value Comment:**
**Parameter Type:** Difference in Adjusted Means
**Parameter Value:** 0.06
**Statistical Comment:**
**Statistical Method:** Longitudinal data analysis model
**Tested Non-Inferiority:**
#### Analysis
**CI Lower Limit:** -0.57
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.08
**CI Upper Limit Comment:**
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.417
**Estimate Comment:** CC99677 150 mg - Placebo
**Group Description:**
**Non-Inferiority Comment:**
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:**
**P-Value:** 0.545
**P-Value Comment:**
**Parameter Type:** Difference in Adjusted Means
**Parameter Value:** 0.25
**Statistical Comment:**
**Statistical Method:** Longitudinal data analysis model
**Tested Non-Inferiority:**
### Outcome Measure 6
#### Analysis
**CI Lower Limit:** -2.26
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.70
**CI Upper Limit Comment:**
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.999
**Estimate Comment:** CC99677 60 mg - Placebo
**Group Description:**
**Non-Inferiority Comment:**
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:**
**P-Value:** 0.778
**P-Value Comment:**
**Parameter Type:** Difference in Adjusted Means
**Parameter Value:** -0.28
**Statistical Comment:**
**Statistical Method:** Longitudinal data analysis model
**Tested Non-Inferiority:**
#### Analysis
**CI Lower Limit:** -3.02
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.03
**CI Upper Limit Comment:**
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 1.022
**Estimate Comment:** CC99677 150 mg - Placebo
**Group Description:**
**Non-Inferiority Comment:**
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:**
**P-Value:** 0.330
**P-Value Comment:**
**Parameter Type:** Difference in Adjusted Means
**Parameter Value:** -1.00
**Statistical Comment:**
**Statistical Method:** Longitudinal data analysis model
**Tested Non-Inferiority:**
### Outcome Measure 7
#### Analysis
**CI Lower Limit:** -3.93
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 2.28
**CI Upper Limit Comment:**
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 1.567
**Estimate Comment:** CC99677 60 mg - Placebo
**Group Description:**
**Non-Inferiority Comment:**
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:**
**P-Value:** 0.600
**P-Value Comment:**
**Parameter Type:** Difference in Adjusted Means
**Parameter Value:** -0.82
**Statistical Comment:**
**Statistical Method:** Longitudinal data analysis model
**Tested Non-Inferiority:**
#### Analysis
**CI Lower Limit:** -4.49
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.87
**CI Upper Limit Comment:**
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 1.605
**Estimate Comment:** CC99677 150 mg - Placebo
**Group Description:**
**Non-Inferiority Comment:**
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:**
**P-Value:** 0.416
**P-Value Comment:**
**Parameter Type:** Difference in Adjusted Means
**Parameter Value:** -1.31
**Statistical Comment:**
**Statistical Method:** Longitudinal data analysis model
**Tested Non-Inferiority:**
### Outcome Measure 8
#### Analysis
**CI Lower Limit:** -27.31
**CI Number of Sides:**
**CI Percentage Value:** 95
**CI Upper Limit:** 14.79
**CI Upper Limit Comment:**
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 10.741
**Estimate Comment:**
**Group Description:**
**Non-Inferiority Comment:**
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:**
**P-Value:**
**P-Value Comment:**
**Parameter Type:** Adjusted Mean
**Parameter Value:** -6.26
**Statistical Comment:**
**Statistical Method:**
**Tested Non-Inferiority:**
#### Analysis
**CI Lower Limit:** -36.57
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** -0.58
**CI Upper Limit Comment:**
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 9.181
**Estimate Comment:**
**Group Description:**
**Non-Inferiority Comment:**
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:**
**P-Value:**
**P-Value Comment:**
**Parameter Type:** Adjusted Mean
**Parameter Value:** -18.58
**Statistical Comment:**
**Statistical Method:**
**Tested Non-Inferiority:**
#### Analysis
**CI Lower Limit:** -31.96
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 7.65
**CI Upper Limit Comment:**
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 10.105
**Estimate Comment:**
**Group Description:**
**Non-Inferiority Comment:**
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:**
**P-Value:**
**P-Value Comment:**
**Parameter Type:** Adjusted Mean
**Parameter Value:** -12.16
**Statistical Comment:**
**Statistical Method:**
**Tested Non-Inferiority:**
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 48.8
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 51.2
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 56.1
- **Comment:**
- **Group ID:** OG003
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 66.7
- **Comment:**
- **Group ID:** OG004
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 83.3
- **Comment:**
- **Group ID:** OG005
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 57.1
**Title:**
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 22.0
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 25.6
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 34.1
- **Comment:**
- **Group ID:** OG003
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 33.3
- **Comment:**
- **Group ID:** OG004
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 50.0
- **Comment:**
- **Group ID:** OG005
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 28.6
**Title:**
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 0.856
- **Upper Limit:**
- **Value:** -0.69
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 0.681
- **Upper Limit:**
- **Value:** -0.87
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:** 0.869
- **Upper Limit:**
- **Value:** -0.80
- **Comment:**
- **Group ID:** OG003
- **Lower Limit:**
- **Spread:** 0.621
- **Upper Limit:**
- **Value:** -0.84
- **Comment:**
- **Group ID:** OG004
- **Lower Limit:**
- **Spread:** 0.464
- **Upper Limit:**
- **Value:** -1.02
- **Comment:**
- **Group ID:** OG005
- **Lower Limit:**
- **Spread:** 0.323
- **Upper Limit:**
- **Value:** -0.44
**Title:**
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 1.862
- **Upper Limit:**
- **Value:** -1.88
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 1.494
- **Upper Limit:**
- **Value:** -1.96
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:** 2.080
- **Upper Limit:**
- **Value:** -2.03
- **Comment:**
- **Group ID:** OG003
- **Lower Limit:**
- **Spread:** 0.651
- **Upper Limit:**
- **Value:** -1.63
- **Comment:**
- **Group ID:** OG004
- **Lower Limit:**
- **Spread:** 1.394
- **Upper Limit:**
- **Value:** -2.20
- **Comment:**
- **Group ID:** OG005
- **Lower Limit:**
- **Spread:** 1.517
- **Upper Limit:**
- **Value:** -1.43
**Title:**
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 1.727
- **Upper Limit:**
- **Value:** -1.22
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 1.985
- **Upper Limit:**
- **Value:** -1.33
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:** 2.542
- **Upper Limit:**
- **Value:** -1.28
- **Comment:**
- **Group ID:** OG003
- **Lower Limit:**
- **Spread:** 0.850
- **Upper Limit:**
- **Value:** -1.77
- **Comment:**
- **Group ID:** OG004
- **Lower Limit:**
- **Spread:** 1.841
- **Upper Limit:**
- **Value:** -1.47
- **Comment:**
- **Group ID:** OG005
- **Lower Limit:**
- **Spread:** 0.703
- **Upper Limit:**
- **Value:** -1.29
**Title:**
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 3.168
- **Upper Limit:**
- **Value:** 0.25
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 5.453
- **Upper Limit:**
- **Value:** -0.81
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:** 6.084
- **Upper Limit:**
- **Value:** -1.72
- **Comment:**
- **Group ID:** OG003
- **Lower Limit:**
- **Spread:** 1.258
- **Upper Limit:**
- **Value:** -0.17
- **Comment:**
- **Group ID:** OG004
- **Lower Limit:**
- **Spread:** 7.608
- **Upper Limit:**
- **Value:** -3.00
- **Comment:**
- **Group ID:** OG005
- **Lower Limit:**
- **Spread:** 4.093
- **Upper Limit:**
- **Value:** -3.00
**Title:**
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 7.557
- **Upper Limit:**
- **Value:** -0.92
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 8.331
- **Upper Limit:**
- **Value:** -1.53
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:** 7.081
- **Upper Limit:**
- **Value:** -1.86
- **Comment:**
- **Group ID:** OG003
- **Lower Limit:**
- **Spread:** 7.371
- **Upper Limit:**
- **Value:** -8.17
- **Comment:**
- **Group ID:** OG004
- **Lower Limit:**
- **Spread:** 5.128
- **Upper Limit:**
- **Value:** -2.40
- **Comment:**
- **Group ID:** OG005
- **Lower Limit:**
- **Spread:** 8.640
- **Upper Limit:**
- **Value:** -2.71
**Title:**
#### Outcome Measure 8
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 474.199
- **Upper Limit:**
- **Value:** 72.83
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 64.157
- **Upper Limit:**
- **Value:** -1.43
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:** 130.181
- **Upper Limit:**
- **Value:** 20.88
- **Comment:**
- **Group ID:** OG003
- **Lower Limit:**
- **Spread:** 55.618
- **Upper Limit:**
- **Value:** -13.68
- **Comment:**
- **Group ID:** OG004
- **Lower Limit:**
- **Spread:** 66.057
- **Upper Limit:**
- **Value:** 8.52
- **Comment:**
- **Group ID:** OG005
- **Lower Limit:**
- **Spread:** 1226.664
- **Upper Limit:**
- **Value:** 452.34
**Title:**
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Percentage of participants who achieve an improvement in disease activity from baseline of ≥ 20% and ≥ 1 unit in at least 3 of the 4 SpondyloArthritis International Society (ASAS) domains on a scale of 0 to 10, and no worsening from baseline of ≥ 20% and ≥ 1 unit in the remaining domain on a scale of 0 to 10. Baseline is the last non-missing value on or before the date of the first dose of investigational product. The four ASAS Domains are:
* Patient Global Assessment of Disease (0 to 10 unit Numerical Rating Scale \[NRS\]);
* Total Back Pain NRS;
* Function (the Bath Ankylosing Spondylitis Functional Index \[BASFI\] score NRS);
* Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\] NRS Questions #5 and #6 for morning stiffness).
**Parameter Type:** NUMBER
**Population Description:** All treated participants who have non-missing response at week 12
**Reporting Status:** POSTED
**Time Frame:** Week 12
**Title:** Percentage of Participants Who Achieve ASAS 20 at Week 12
**Type:** PRIMARY
**Unit of Measure:** Percentage of Participants
##### Group
**Description:** Placebo Biologic Naive QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
**ID:** OG000
**Title:** Placebo Biologic Naive
##### Group
**Description:** CC-99677 60 mg Biologic Naive QD PO through Week 64 or until early discontinuation
**ID:** OG001
**Title:** CC-99677 60 mg Biologic Naive
##### Group
**Description:** CC-99677 150 mg Biologic Naive QD PO through Week 64 or until early discontinuation
**ID:** OG002
**Title:** CC-99677 150 mg Biologic Naive
##### Group
**Description:** Placebo Biologic Failure QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
**ID:** OG003
**Title:** Placebo Biologic Failure
##### Group
**Description:** CC-99677 60 mg Biologic Failure QD PO through Week 64 or until early discontinuation
**ID:** OG004
**Title:** CC-99677 60 mg Biologic Failure
##### Group
**Description:** CC-99677 150 mg Biologic Failure QD PO through Week 64 or until early discontinuation
**ID:** OG005
**Title:** CC-99677 150 mg Biologic Failure
#### Outcome Measure 2
**Description:** Percentage of participants who achieve an improvement in disease activity from baseline of ≥ 40% and ≥ 2 unit in at least 3 of the 4 SpondyloArthritis International Society (ASAS) domains on a scale of 0 to 10, and no worsening at all from baseline in the remaining domain. Baseline is the last non-missing value on or before the date of the first dose of investigational product. The four ASAS Domains are:
* Patient Global Assessment of Disease (0 to 10 unit Numerical Rating Scale \[NRS\]);
* Total Back Pain NRS;
* Function (the Bath Ankylosing Spondylitis Functional Index \[BASFI\] score NRS);
* Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\] NRS Questions #5 and #6 for morning stiffness).
**Parameter Type:** NUMBER
**Population Description:** All treated participants who have non-missing response at week 12
**Reporting Status:** POSTED
**Time Frame:** Week 12
**Title:** Percentage of Participants Who Achieve ASAS 40 at Week 12
**Type:** SECONDARY
**Unit of Measure:** Percentage of Participants
##### Group
**Description:** Placebo Biologic Naive QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
**ID:** OG000
**Title:** Placebo Biologic Naive
##### Group
**Description:** CC-99677 60 mg Biologic Naive QD PO through Week 64 or until early discontinuation
**ID:** OG001
**Title:** CC-99677 60 mg Biologic Naive
##### Group
**Description:** CC-99677 150 mg Biologic Naive QD PO through Week 64 or until early discontinuation
**ID:** OG002
**Title:** CC-99677 150 mg Biologic Naive
##### Group
**Description:** Placebo Biologic Failure QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
**ID:** OG003
**Title:** Placebo Biologic Failure
##### Group
**Description:** CC-99677 60 mg Biologic Failure QD PO through Week 64 or until early discontinuation
**ID:** OG004
**Title:** CC-99677 60 mg Biologic Failure
##### Group
**Description:** CC-99677 150 mg Biologic Failure QD PO through Week 64 or until early discontinuation
**ID:** OG005
**Title:** CC-99677 150 mg Biologic Failure
#### Outcome Measure 3
**Description:** ASDAS-CRP is a score of disease activity that combines patient reported assessments of back pain (Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\] question 2), duration of morning stiffness (BASDAI question 6), peripheral joint pain and/or swelling (BASDAI question 3), general wellbeing, and CRP in a weighted manner. The cut-off values for disease activity states and improvement scores are defined as follows: \<1.3 inactive disease, ≥1.3 and \<2.1 low disease activity, ≥2.1 and ≤3.5 high disease activity and 3.5 very high disease activity. The minimum clinically important difference (MCID) are defined as: change of at least 1.1 unit for 'clinically important improvement' and change of at least 2.0 units for 'major improvement'. Baseline is the last non-missing value on or before the date of the first dose of investigational product. ASDAS-CRP Formula: 0.12xBack Pain+0.06xDuration of Morning Stiffness+0.11xPatient Global+0.07xPeripheral Pain/Swelling+0.58xln(CRP+1)
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** All treated participants with baseline and week 12 measurements
**Reporting Status:** POSTED
**Time Frame:** Baseline and Week 12
**Title:** Change From Baseline in Ankylosing Spondylitis Disease Activity Score With CRP (ASDAS-CRP) at Week 12
**Type:** SECONDARY
**Unit of Measure:** Units on a scale
##### Group
**Description:** Placebo Biologic Naive QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
**ID:** OG000
**Title:** Placebo Biologic Naive
##### Group
**Description:** CC-99677 60 mg Biologic Naive QD PO through Week 64 or until early discontinuation
**ID:** OG001
**Title:** CC-99677 60 mg Biologic Naive
##### Group
**Description:** CC-99677 150 mg Biologic Naive QD PO through Week 64 or until early discontinuation
**ID:** OG002
**Title:** CC-99677 150 mg Biologic Naive
##### Group
**Description:** Placebo Biologic Failure QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
**ID:** OG003
**Title:** Placebo Biologic Failure
##### Group
**Description:** CC-99677 60 mg Biologic Failure QD PO through Week 64 or until early discontinuation
**ID:** OG004
**Title:** CC-99677 60 mg Biologic Failure
##### Group
**Description:** CC-99677 150 mg Biologic Failure QD PO through Week 64 or until early discontinuation
**ID:** OG005
**Title:** CC-99677 150 mg Biologic Failure
#### Outcome Measure 4
**Description:** Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is a composite score based on a self-administered survey of six questions using a 0 to 10 unit numerical rating scale (NRS) that assesses five major symptoms of AS during the last week: 1) fatigue; 2) spinal pain; 3) peripheral joint pain/swelling; 4) areas of localized tenderness; 5a) morning stiffness severity upon wakening; 5b) morning stiffness duration upon wakening. To give each of the five symptoms equal weighting, the mean of the two scores relating to morning stiffness is taken. The resulting 0 to 50 score is divided by 5 to give a final 0 to 10 BASDAI score. A BASDAI score of 4 or greater is considered to be indicative of active AS disease. Baseline is the last non-missing value on or before the date of the first dose of investigational product.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** All treated participants with baseline and week 12 measurements
**Reporting Status:** POSTED
**Time Frame:** Baseline and Week 12
**Title:** Change From Baseline in BASDAI at Week 12
**Type:** SECONDARY
**Unit of Measure:** Units on a scale
##### Group
**Description:** Placebo Biologic Naive QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
**ID:** OG000
**Title:** Placebo Biologic Naive
##### Group
**Description:** CC-99677 60 mg Biologic Naive QD PO through Week 64 or until early discontinuation
**ID:** OG001
**Title:** CC-99677 60 mg Biologic Naive
##### Group
**Description:** CC-99677 150 mg Biologic Naive QD PO through Week 64 or until early discontinuation
**ID:** OG002
**Title:** CC-99677 150 mg Biologic Naive
##### Group
**Description:** Placebo Biologic Failure QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
**ID:** OG003
**Title:** Placebo Biologic Failure
##### Group
**Description:** CC-99677 60 mg Biologic Failure QD PO through Week 64 or until early discontinuation
**ID:** OG004
**Title:** CC-99677 60 mg Biologic Failure
##### Group
**Description:** CC-99677 150 mg Biologic Failure QD PO through Week 64 or until early discontinuation
**ID:** OG005
**Title:** CC-99677 150 mg Biologic Failure
#### Outcome Measure 5
**Description:** Bath Ankylosing Spondylitis Functional Index (BASFI) is a composite score based on a self administered survey of ten questions using a 0 to 10 unit numerical rating scale (NRS) that assesses degree of mobility and functional ability during the last week. The questionnaire consists of eight questions regarding function in AS and the two last questions reflecting ability to cope with everyday life. The left-hand box of 0 represents "easy," and the right-hand box represents "impossible." The resulting 0 to 100 score is divided by 10 to give a final 0 to 10 BASFI score. A higher BASFI score correlates to reduced functional ability. Baseline is the last non-missing value on or before the date of the first dose of investigational product.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** All treated participants with baseline and week 12 measurements
**Reporting Status:** POSTED
**Time Frame:** Baseline and Week 12
**Title:** Change From Baseline in BASFI at Week 12
**Type:** SECONDARY
**Unit of Measure:** Units on a scale
##### Group
**Description:** Placebo Biologic Naive QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
**ID:** OG000
**Title:** Placebo Biologic Naive
##### Group
**Description:** CC-99677 60 mg Biologic Naive QD PO through Week 64 or until early discontinuation
**ID:** OG001
**Title:** CC-99677 60 mg Biologic Naive
##### Group
**Description:** CC-99677 150 mg Biologic Naive QD PO through Week 64 or until early discontinuation
**ID:** OG002
**Title:** CC-99677 150 mg Biologic Naive
##### Group
**Description:** Placebo Biologic Failure QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
**ID:** OG003
**Title:** Placebo Biologic Failure
##### Group
**Description:** CC-99677 60 mg Biologic Failure QD PO through Week 64 or until early discontinuation
**ID:** OG004
**Title:** CC-99677 60 mg Biologic Failure
##### Group
**Description:** CC-99677 150 mg Biologic Failure QD PO through Week 64 or until early discontinuation
**ID:** OG005
**Title:** CC-99677 150 mg Biologic Failure
#### Outcome Measure 6
**Description:** Change from Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) scores of the sacroiliac joints. The SPARCC assesses 16 sites for enthesitis using a score of "0" for no activity or "1" for activity. Sites assessed include Medial epicondyle (left/right \[L/R\]), Lateral epicondyle (L/R), Supraspinatus insertion into greater tuberosity of humerus (L/R), Greater trochanter (L/R), Quadriceps insertion into superior border of patella (L/R), Patellar ligament insertion into inferior pole of patella or tibial tubercle (L/R), Achilles tendon insertion into calcaneum (L/R), and Plantar fascia insertion into calcaneum (L/R). The SPARCC is the sum of all site scores (range 0 to 16). Higher scores indicate more severe enthesitis. Baseline is the last non-missing value on or before the date of the first dose of investigational product.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** All treated participants with baseline and week 12 measurements
**Reporting Status:** POSTED
**Time Frame:** Baseline and Week 12
**Title:** Change From Baseline in the SPARCC SI Joint Score at Week 12
**Type:** SECONDARY
**Unit of Measure:** Units on a scale
##### Group
**Description:** Placebo Biologic Naive QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
**ID:** OG000
**Title:** Placebo Biologic Naive
##### Group
**Description:** CC-99677 60 mg Biologic Naive QD PO through Week 64 or until early discontinuation
**ID:** OG001
**Title:** CC-99677 60 mg Biologic Naive
##### Group
**Description:** CC-99677 150 mg Biologic Naive QD PO through Week 64 or until early discontinuation
**ID:** OG002
**Title:** CC-99677 150 mg Biologic Naive
##### Group
**Description:** Placebo Biologic Failure QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
**ID:** OG003
**Title:** Placebo Biologic Failure
##### Group
**Description:** CC-99677 60 mg Biologic Failure QD PO through Week 64 or until early discontinuation
**ID:** OG004
**Title:** CC-99677 60 mg Biologic Failure
##### Group
**Description:** CC-99677 150 mg Biologic Failure QD PO through Week 64 or until early discontinuation
**ID:** OG005
**Title:** CC-99677 150 mg Biologic Failure
#### Outcome Measure 7
**Description:** Change from Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) scores of the total spine. All 23 disco-vertebral units (DVU) of the spine (from C2 to S1) were scored for bone marrow edema. A single DVU has 18 scoring units, and each has score of 0 or 1, bringing the maximum total score to 414, the sum ranges from 0 to 414 with higher scores reflecting worse disease.
Baseline is the last non-missing value on or before the date of the first dose of investigational product.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** All treated participants with baseline and week 12 measurements
**Reporting Status:** POSTED
**Time Frame:** Baseline and Week 12
**Title:** Change From Baseline in the SPARCC Spine Score at Week 12
**Type:** SECONDARY
**Unit of Measure:** Units on a scale
##### Group
**Description:** Placebo Biologic Naive QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
**ID:** OG000
**Title:** Placebo Biologic Naive
##### Group
**Description:** CC-99677 60 mg Biologic Naive QD PO through Week 64 or until early discontinuation
**ID:** OG001
**Title:** CC-99677 60 mg Biologic Naive
##### Group
**Description:** CC-99677 150 mg Biologic Naive QD PO through Week 64 or until early discontinuation
**ID:** OG002
**Title:** CC-99677 150 mg Biologic Naive
##### Group
**Description:** Placebo Biologic Failure QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
**ID:** OG003
**Title:** Placebo Biologic Failure
##### Group
**Description:** CC-99677 60 mg Biologic Failure QD PO through Week 64 or until early discontinuation
**ID:** OG004
**Title:** CC-99677 60 mg Biologic Failure
##### Group
**Description:** CC-99677 150 mg Biologic Failure QD PO through Week 64 or until early discontinuation
**ID:** OG005
**Title:** CC-99677 150 mg Biologic Failure
#### Outcome Measure 8
**Description:** Percent change from baseline in high-sensitivity C-reactive protein (hsCRP). Baseline is the last non-missing value on or before the date of the first dose of investigational product.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** All treated participants with baseline and week 12 measurements
**Reporting Status:** POSTED
**Time Frame:** Baseline and Week 12
**Title:** Percent Change From Baseline in hsCRP at Week 12
**Type:** SECONDARY
**Unit of Measure:** Percent change in hsCRP
##### Group
**Description:** Placebo Biologic Naive QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
**ID:** OG000
**Title:** Placebo Biologic Naive
##### Group
**Description:** CC-99677 60 mg Biologic Naive QD PO through Week 64 or until early discontinuation
**ID:** OG001
**Title:** CC-99677 60 mg Biologic Naive
##### Group
**Description:** CC-99677 150 mg Biologic Naive QD PO through Week 64 or until early discontinuation
**ID:** OG002
**Title:** CC-99677 150 mg Biologic Naive
##### Group
**Description:** Placebo Biologic Failure QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
**ID:** OG003
**Title:** Placebo Biologic Failure
##### Group
**Description:** CC-99677 60 mg Biologic Failure QD PO through Week 64 or until early discontinuation
**ID:** OG004
**Title:** CC-99677 60 mg Biologic Failure
##### Group
**Description:** CC-99677 150 mg Biologic Failure QD PO through Week 64 or until early discontinuation
**ID:** OG005
**Title:** CC-99677 150 mg Biologic Failure
### Participant Flow Module
#### Group
**Description:** Placebo Biologic Naive QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
**ID:** FG000
**Title:** Placebo Biologic Naive
#### Group
**Description:** CC-99677 60 mg Biologic Naive QD PO through Week 64 or until early discontinuation
**ID:** FG001
**Title:** CC-99677 60 mg Biologic Naive
#### Group
**Description:** CC-99677 150 mg Biologic Naive QD PO through Week 64 or until early discontinuation
**ID:** FG002
**Title:** CC-99677 150 mg Biologic Naive
#### Group
**Description:** Placebo Biologic Failure QD PO from week 0 - 12. At week 12, participants rerandomized to CC-99677 (150 mg or 60 mg PO QD) through Week 64 or until early discontinuation
**ID:** FG003
**Title:** Placebo Biologic Failure
#### Group
**Description:** CC-99677 60 mg Biologic Failure QD PO through Week 64 or until early discontinuation
**ID:** FG004
**Title:** CC-99677 60 mg Biologic Failure
#### Group
**Description:** CC-99677 150 mg Biologic Failure QD PO through Week 64 or until early discontinuation
**ID:** FG005
**Title:** CC-99677 150 mg Biologic Failure
#### Period
**Title:** Week 0 - Week 12 (Placebo-Controlled)
##### Withdraw
**Type:** Adverse Event
###### 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:** 0
##### Withdraw
**Type:** Other reasons
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 1
###### Reason
**Group ID:** FG003
**Number of Subjects:** 0
###### 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:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
###### Reason
**Group ID:** FG002
**Number of Subjects:** 2
###### Reason
**Group ID:** FG003
**Number of Subjects:** 0
###### Reason
**Group ID:** FG004
**Number of Subjects:** 2
###### Reason
**Group ID:** FG005
**Number of Subjects:** 0
##### Withdraw
**Type:** Study terminated by sponsor
###### Reason
**Group ID:** FG000
**Number of Subjects:** 5
###### Reason
**Group ID:** FG001
**Number of Subjects:** 6
###### Reason
**Group ID:** FG002
**Number of Subjects:** 7
###### Reason
**Group ID:** FG003
**Number of Subjects:** 1
###### Reason
**Group ID:** FG004
**Number of Subjects:** 0
###### Reason
**Group ID:** FG005
**Number of Subjects:** 1
##### Withdraw
**Type:** Protocol Deviation
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### 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:** 0
###### Reason
**Group ID:** FG005
**Number of Subjects:** 0
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 49
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 49
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 49
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 5
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 7
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 8
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 42
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 42
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 39
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 3
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 5
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 7
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 7
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 7
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 10
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 2
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 2
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 1
#### Period
**Title:** Week 12 - Week 64 (Long-Term Extension)
##### Withdraw
**Type:** Death
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 1
###### Reason
**Group ID:** FG003
**Number of Subjects:** 0
###### Reason
**Group ID:** FG004
**Number of Subjects:** 0
###### 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:** 0
###### 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:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 1
###### Reason
**Group ID:** FG003
**Number of Subjects:** 0
###### Reason
**Group ID:** FG004
**Number of Subjects:** 0
###### Reason
**Group ID:** FG005
**Number of Subjects:** 0
##### Withdraw
**Type:** Study terminated by sponsor
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 54
###### Reason
**Group ID:** FG002
**Number of Subjects:** 46
###### Reason
**Group ID:** FG003
**Number of Subjects:** 0
###### Reason
**Group ID:** FG004
**Number of Subjects:** 5
###### Reason
**Group ID:** FG005
**Number of Subjects:** 4
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 2
###### Reason
**Group ID:** FG002
**Number of Subjects:** 4
###### Reason
**Group ID:** FG003
**Number of Subjects:** 0
###### Reason
**Group ID:** FG004
**Number of Subjects:** 1
###### Reason
**Group ID:** FG005
**Number of Subjects:** 3
##### Withdraw
**Type:** Other reasons
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 5
###### Reason
**Group ID:** FG002
**Number of Subjects:** 8
###### Reason
**Group ID:** FG003
**Number of Subjects:** 0
###### Reason
**Group ID:** FG004
**Number of Subjects:** 1
###### Reason
**Group ID:** FG005
**Number of Subjects:** 0
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 63
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 61
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 7
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 8
##### Milestone
**Type:** Placebo Patients Re-randomized to CC-99677 60 mg
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 21
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 2
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 0
##### Milestone
**Type:** Placebo Patients Re-randomized to CC-99677 150 mg
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 21
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 1
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 1
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 1
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 0
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 62
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 60
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 7
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 8
**Pre-Assignment Details:** Participants originally randomized to the CC-99677 60 mg or 150 mg Biologic Naive or Biologic Failure arms in the Placebo-Controlled period continued receiving the same intervention until week 64 in the Long-Term Extension period.
**Has Results:** True |
## Protocol Section
### Identification Module
**NCT ID:** NCT05579379
**Brief Title:** DESENSITIZE-PD: Intestinal Levodopa + Entacapone Therapy (Lecigon®) to Support Dopaminergic Desensitization in PD
**Official Title:** DESENSITIZE-PD: Intestinal Levodopa + Entacapone Therapy (Lecigon®) to Support Dopaminergic Desensitization in Parkinson's Disease
#### Organization Study ID Info
**ID:** 388/2022BO2
#### Organization
**Class:** OTHER
**Full Name:** University Hospital Tuebingen
### Status Module
#### Completion Date
**Date:** 2024-09
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-10-18
**Type:** ACTUAL
**Last Update Submit Date:** 2022-10-14
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-09
**Type:** ESTIMATED
#### Start Date
**Date:** 2022-10
**Type:** ESTIMATED
**Status Verified Date:** 2022-10
#### Study First Post Date
**Date:** 2022-10-13
**Type:** ACTUAL
**Study First Submit Date:** 2022-10-10
**Study First Submit QC Date:** 2022-10-10
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** STADAPHARM GmbH
#### Lead Sponsor
**Class:** OTHER
**Name:** University Hospital Tuebingen
#### Responsible Party
**Investigator Affiliation:** University Hospital Tuebingen
**Investigator Full Name:** Daniel Weiss
**Investigator Title:** Prof. Dr.
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** 20 patients with idiopathic Parkinson's disease, who are planned to undergo intestinal L-Dopa + entacapone (Lecigon®) treatment will be included into this observational single-armed study. These patient will be observed for hyperdopaminergic complications and neuropsychiatric fluctuations postprocedure at 3, 6 and 12 months.
**Detailed Description:** This study is planned as non-interventional observational single-armed study in patients that are planned to undergo intestinal L-Dopa + entacapone (Lecigon®) treatment as regular treatment choice outside the study protocol and under the accepted regulatory approval and indication criteria (according to German "Fachinformation Lecigon®"). Patients will be observed at the pre-interventional baseline (oral treatment, before treatment initiation with Lecigon®), 3-month, 6-month follow-up, and final 12-month follow-up. As primary interest, the investigator will analyze the contrast of the pre-interventional baseline and 12-month follow-up in terms of the Ardouin Behavioural Scale which evaluates the hyperdopaminergic complications and neuropsychiatric fluctuations in a semi-structured interview. As additional exploratory outcomes, the investigator will study the "Neuropsychiatric fluctuation scale", impulse control disorders with the "QUIP rating scale (QUIP-RS)". Moreover, the investigator will study apathy outcomes using the "Apathy Evaluation Scale" that mainly relates to the dopaminergic off-state. Outcomes of post-interventional apathy are particularly important, since i) they may coincide with hypodopaminergic off-states, and ii) since outcomes of postoperative apathy are a limitation of existing DBS therapy. Avoiding worsening of apathy might be a strength of intestinal L-Dopa therapy in this regard. Further, the investigator will study established measures of motor sensitization/de-sensitization in particular motor fluctuations and dyskinesia (MDS-UPDRS IV) and Unified Dyskinesia Rating Scale (UDysRS). For completeness, the investigator will characterize MDS-UPDRS III motor state in addition.
Since dopaminergic desensitization occurs with considerable delay of rather weeks and months after changing oral to continuous treatment, the investigator expect a reduction of dopaminergic motor and neuropsychiatric complications within the first 6 months from introducing Lecigon® together with a stable course until final 12-month follow-up. The outcomes will be decided as contrast of the pre-interventional baseline (V0) in best oral treatment compared to 12 month follow-up of Lecigon® treatment.
### Conditions Module
**Conditions:**
- Parkinson Disease
**Keywords:**
- Parkinson's disease
- dopaminergic sensitization
- hyperdopaminergic complications
- neuropsychiatric complications
- intestinal L-Dopa therapy
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 20
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Outcomes Module
#### Primary Outcomes
**Description:** To evaluate the hyperdopaminergic complications and neuropsychiatric fluctuations from baseline to 12-months follow-up.
Minimum value: 0, maximum value: 84, higher score means worse outcome.
**Measure:** Ardouin Behavioural Scale
**Time Frame:** At baseline, 3 months, 6 months and 12 months, respectively
#### Secondary Outcomes
**Description:** To identify and quantify neuropsychiatric fluctuations during motor fluctuations.
Minimum value for OFF items: 0, maximum value for OFF items: 30, higher score means worse outcome.
Minimum value for ON items: 0, maximum value for ON items: 30, higher score means worse outcome.
**Measure:** Neuropsychiatric Fluctuation Scale
**Time Frame:** At baseline, 3 months, 6 months and 12 months, respectively
**Description:** To assess the severity of impulsive-compulsive disorders. Minimum value: 0, maximum value: 112, higher score means worse outcome.
**Measure:** Questionnaire for impulsive-compulsive disorders in Parkinson's disease (QUIP)
**Time Frame:** At baseline, 3 months, 6 months and 12 months, respectively
**Description:** To quantify and characterize the apathy. Minimum value: 0, maximum value: 54, higher score means worse outcome.
**Measure:** Apathy Evaluation Scale
**Time Frame:** At baseline, 3 months, 6 months and 12 months, respectively
**Description:** To measure the severity of Parkinson symptoms. Minimum value: 0, maximum value: 132, higher score means worse outcome.
**Measure:** Movement Disorders Society -Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III
**Time Frame:** At baseline, 3 months, 6 months and 12 months, respectively
**Description:** To measure the severity of motor complications. Minimum value: 0, maximum value: 24, higher score means worse outcome.
**Measure:** Movement Disorders Society -Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV
**Time Frame:** At baseline, 3 months, 6 months and 12 months, respectively
**Description:** To evaluate involuntary movements. Minimum value: 0, maximum value: 104, higher score means worse outcome.
**Measure:** Unified Dyskinesia Rating Scale (UDyRS)
**Time Frame:** At baseline, 3 months, 6 months and 12 months, respectively
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Written declaration of consent
* Age \> 18 years and \< 80 years
* Idiopathic Parkinson's syndrome (according to British Brain Bank criteria), including genetic forms
* L-dopa responsive Parkinson's syndrome
* Duration of disease \> 5 years
* The treatment decision for Lecigon® was made as a regular treatment decision according to the established indication criteria outside the study
* Motor fluctuations on oral dopaminergic therapy with uncontrolled motor off symptoms
* Presence or history of dyskinesia based on available medical records or self-reported history
* History of dopaminergic neuropsychiatric therapy complications based on available physician's letters or self-reported history:
* impulse control disorders or
* dopamine dysregulation syndrome or
* off-condition apathy or
* affective response fluctuations or
* affective hypomanic or manic complications
* hyperdopaminergic behavioral complications (such as binge eating or hobbyism or punding or increased creativity or risk seeking behavior; analogous to Ardouin Behaviour Scale Chapter IV - hyperdopaminergic behaviors).
Exclusion Criteria:
* Dementia according to ICD-10 criteria; mild cognitive impairment (MCI) according to screening tools such as MoCA or MMSE is not considered an exclusion criterion as long as ICD-10 criteria for dementia are not met regardless of MoCA/MMSE score.
* Acute paranoid psychosis or suicidality (however, impulse control disorder or dopamine dysregulation syndrome is not an exclusion criterion; illusions or (pseudo)-hallucinations are also not an exclusion criterion, as long as there is no risk to the patient or others according to clinical judgment; patients may be allowed to participate in the study after remission of the psychosis/suicidality)
* Pregnancy
* Contraindications to therapy with Lecigon® according the Summary of Product Characteristics (SmPC)
* Hypersensitivity to the active ingredients of Lecigon®.
* Narrow-angle glaucoma
* Severe heart failure
* Severe cardiac arrhythmia
* Acute stroke
* Severe impairment of liver function
* Non-selective MAO inhibitors and selective type A MAO inhibitors must not be used concomitantly with Lecigon®. These inhibitors must have been discontinued at least two weeks prior to starting treatment with Lecigon®. Lecigon® may be used concomitantly with the manufacturer's recommended dose of an MAO inhibitor with selectivity for MAO type B (e.g., selegiline hydrochloride)
* Conditions in which sympathomimetics (adrenergics) are contraindicated, e.g., pheochromocytoma, hyperthyroidism, and Cushing's syndrome.
* Previous malignant neuroleptic syndrome (NMS) and/or nontraumatic rhabdomyolysis.
* Suspected undiagnosed skin lesions or history of melanoma (levodopa could activate malignant melanoma).
**Maximum Age:** 80 Years
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** We will enroll patients with Parkinson's disease, who are eligible for intestinal treatment with Lecigon® as a regular treatment option outside of the study protocol and under the accepted eligibility and indication criteria.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Daniel T Weiss, MD
**Phone:** 0049-7071-29-82340
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Idil Cebi, MD
**Phone:** 0049-7071-29-85650
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** University Hospital Tuebingen
**Name:** Daniel Weiss, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** A study database will be established with our Institute for Clinical Epidemiology and Applied Biometry. Pseudonymized data can be made available after publication upon reasonable request to the Principal Investigator
**IPD Sharing:** UNDECIDED
### References Module
#### References
**Citation:** Weiss D, Volkmann J, Fasano A, Kuhn A, Krack P, Deuschl G. Changing Gears - DBS For Dopaminergic Desensitization in Parkinson's Disease? Ann Neurol. 2021 Nov;90(5):699-710. doi: 10.1002/ana.26164. Epub 2021 Jul 20.
**PMID:** 34235776
**Citation:** Weiss D, Ebersbach G, Moller JC, Schwarz J, Arlt C, Fritz B, Sensken SC, Eggert K. Do we start too late? Insights from the real-world non-interventional BALANCE study on the present use of levodopa/carbidopa intestinal gel in advanced Parkinson's disease in Germany and Switzerland. Parkinsonism Relat Disord. 2022 Oct;103:85-91. doi: 10.1016/j.parkreldis.2022.08.018. Epub 2022 Aug 24.
**PMID:** 36087571
**Citation:** Schmitt E, Krack P, Castrioto A, Klinger H, Bichon A, Lhommee E, Pelissier P, Fraix V, Thobois S, Moro E, Martinez-Martin P. The Neuropsychiatric Fluctuations Scale for Parkinson's Disease: A Pilot Study. Mov Disord Clin Pract. 2018 Mar 23;5(3):265-272. doi: 10.1002/mdc3.12607. eCollection 2018 May-Jun.
**PMID:** 30363450
**Citation:** Papay K, Mamikonyan E, Siderowf AD, Duda JE, Lyons KE, Pahwa R, Driver-Dunckley ED, Adler CH, Weintraub D. Patient versus informant reporting of ICD symptoms in Parkinson's disease using the QUIP: validity and variability. Parkinsonism Relat Disord. 2011 Mar;17(3):153-5. doi: 10.1016/j.parkreldis.2010.11.015. Epub 2010 Dec 24.
**PMID:** 21186135
**Citation:** Probst CC, Winter LM, Moller B, Weber H, Weintraub D, Witt K, Deuschl G, Katzenschlager R, van Eimeren T. Validation of the questionnaire for impulsive-compulsive disorders in Parkinson's disease (QUIP) and the QUIP-rating scale in a German speaking sample. J Neurol. 2014 May;261(5):936-42. doi: 10.1007/s00415-014-7299-6. Epub 2014 Mar 9. Erratum In: J Neurol. 2015 Sep;262(9):2200.
**PMID:** 24609972
**Citation:** Weintraub D, Mamikonyan E, Papay K, Shea JA, Xie SX, Siderowf A. Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale. Mov Disord. 2012 Feb;27(2):242-7. doi: 10.1002/mds.24023. Epub 2011 Dec 1.
**PMID:** 22134954
## 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
### 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
### Condition Browse Module - Meshes
- ID: D000010300
- Term: Parkinson Disease
### Intervention Browse Module - Browse Branches
- Abbrev: CaAg
- Name: Cardiotonic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: AnDyAg
- Name: Anti-Dyskinesia Agents
### Intervention Browse Module - Browse Leaves
- ID: M7473
- Name: Dopamine
- Relevance: LOW
- As Found: Unknown
- ID: M10982
- Name: Levodopa
- Relevance: LOW
- As Found: Unknown
- ID: M252093
- Name: Entacapone
- Relevance: LOW
- As Found: Unknown
- ID: M20595
- Name: Dopamine Agonists
- Relevance: LOW
- As Found: Unknown
- ID: M7471
- Name: Dihydroxyphenylalanine
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06186479
**Brief Title:** Clinical Trial With Aconite Pain Oil in Oncology Patients Under Chemotherapy to Prevent CIPN Grade-II, to Reduce Symptoms and to Improve the Quality of Life of Patients With CIPN
**Official Title:** Clinical Trial With Aconite Pain Oil in Oncology Patients Under Chemotherapy to Prevent Grade-II Chemotherapy-induced Polyneuropathy (CIPN), to Reduce Symptoms Typical of CIPN, and to Improve the Quality of Life of Patients With CIPN
#### Organization Study ID Info
**ID:** kp-acs-2
#### Organization
**Class:** OTHER
**Full Name:** WALA Heilmittel GmbH
### Status Module
#### Completion Date
**Date:** 2027-07-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-04-09
**Type:** ACTUAL
**Last Update Submit Date:** 2024-04-05
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2027-07-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-03-13
**Type:** ACTUAL
**Status Verified Date:** 2024-03
#### Study First Post Date
**Date:** 2024-01-02
**Type:** ACTUAL
**Study First Submit Date:** 2023-11-27
**Study First Submit QC Date:** 2023-12-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** WALA Heilmittel GmbH
#### 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 clinical trial is planned as a prospective, multicentre, blinded, randomised, placebo-controlled, national clinical trial in Germany. The clinical trial is designed for testing the prophylactic and therapeutic effects of Aconite pain oil as compared to placebo in oncological patients receiving neurotoxic chemotherapy with taxanes and/or platinum derivatives.
### Conditions Module
**Conditions:**
- Chemotherapy-induced Polyneuropathy
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** TRIPLE
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 350
**Type:** ESTIMATED
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Drug: Aconite pain oil
**Label:** Verum
**Type:** EXPERIMENTAL
#### Arm Group 2
**Intervention Names:**
- Drug: Placebo
**Label:** Placebo
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Verum
**Description:** Participants apply 6 ml oil topically 2 times per day (morning and evening) for 15 to 27 weeks on chemotherapy-free days as long as they receive chemotherapy.
**Name:** Aconite pain oil
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Placebo
**Description:** Participants apply 6 ml oil topically 2 times per day (morning and evening) for 15 to 27 weeks on chemotherapy-free days as long as they receive chemotherapy.
**Name:** Placebo
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** for neuralgia, paraesthesia, peripheral motor polyneuropathy, peripheral sensory polyneuropathy
**Measure:** Percentage of CIPN grade II and higher measured by "Common Terminology Criteria for Adverse Events" (CTC-AE v4.0 of 2010)
**Time Frame:** on average every 3 weeks for max. 27 weeks
**Measure:** The date of occurrence of CIPN by the principal investigator/investigator using the EORTC-QLQ-CIPN20
**Time Frame:** on average every 3 weeks for max. 27 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. A consent form, fully dated and signed by the patient and the principal investigator/investigator, is available
2. Patients with a minimum age of 18 years
3. Patients with a Karnofsky Index ≥ 70%
4. Patients with an assumed life expectancy of at least 12 months
5. Patients with solid tumours
6. Patients who are scheduled to receive unmodified chemotherapy with taxanes or platinum derivatives or their combination approved in Germany for at least 3 months (start of chemotherapy within the next 10 days)
7. Patients of childbearing age must provide a negative pregnancy test
Exclusion Criteria:
1. Participation in an interventional trial (with an investigational product) that is concurrent or occurred within 4 weeks prior to inclusion in this trial
2. Pregnant and breastfeeding patients or patients who are not using effective contraception (Pearl index \< 1)
3. Patients treated with topical and/or internally administered medicinal products or cosmetics containing aconite (Aconitum napellus), camphor (Camphora), lavender essential oil (Lavandulae aetheroleum), and/or quartz within 4 weeks prior to inclusion in this trial
4. Patients with known hypersensitivity to camphor and/or any of the other ingredients of Aconite Pain Oil, as well as peanut or soy
5. Patients who are not expected to be able to comprehend the significance of the clinical trial, to demonstrate the necessary compliance, and/or to complete the patient questionnaire and patient diary in the German-language for language-related, cognitive, or other reasons
6. Patients with a planned application of chemotherapy at ≥4-week intervals
7. Patients with alcohol/drug/medication dependency
8. Patients with known genetic predispositions to polyneuropathies
9. Patients with previous or current polyneuropathy irrespective of cause
10. Patients with previous or current use of neurotoxic medication (e.g., taxanes, platinum derivatives, metronidazole, isoniazid, amiodarone, vinca alkaloids, checkpoint inhibitors)
11. Patients with the following known comorbidities that predispose them to CIPN:
inadequately substituted hypothyroidism, renal insufficiency grade 4 and above, vasculitis/collagenosis, inadequately treated diabetes mellitus
12. Patients with active and/or clinically relevant infectious diseases: HIV, Lyme disease, hepatitis B/C, herpes infections
13. Known presence of multiple myeloma or non-Hodgkin's lymphoma
14. Present neurological diseases, Alzheimer's disease, multiple sclerosis, Parkinson's disease, and other neurological diseases that make it difficult or impossible to assess the primary endpoint according to the investigator's opinion
15. Patients with metastases in the central nervous system
16. History of amputation of extremities
17. Patients with distal muscle weakness and/or atrophy
18. Skin lesions or other findings in the area of the extremities that make it impossible to use the investigational product (e.g., hand-foot syndrome)
19. Presence of any other serious acute or chronic organic or mental illness with severe impairment of the general condition that impairs or prevents regular participation in the trial
20. Use of co-analgesics such as gabapentin, pregabalin, amitriptyline, nortriptyline, clomipramine, imipramine, duloxetine 1 week before commencement of the trial (baseline) and intake during the trial before reaching CIPN grade III
21. Planned acupuncture for the treatment of CIPN during the trial
22. Topical application of substances such as lidocaine, capsaicin, botulinum toxin, amitriptyline, menthol to hands and/or feet up to 1 week before trial entry (baseline) and application during the trial
23. Electrotherapy on the extremities up to 1 week before the start of the trial (baseline) and during the trial
**Maximum Age:** 100 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Florian Stintzing, Prof. Dr.
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Mannheim
**Contacts:**
***Contact 1:***
- **Name:** R.-D. Hofheinz, Prof. Dr.
- **Role:** CONTACT
**Country:** Germany
**Facility:** Medizinische Fakultät Mannheim der Uniklinik Heidelberg
**Status:** RECRUITING
**Zip:** 68167
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010523
- Term: Peripheral Nervous System Diseases
- ID: D000009468
- Term: Neuromuscular Diseases
- ID: D000009422
- Term: Nervous System Diseases
### Condition Browse Module - Browse Branches
- 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
### Condition Browse Module - Browse Leaves
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M13999
- Name: Polyneuropathies
- Relevance: HIGH
- As Found: Polyneuropathy
- ID: M13432
- Name: Peripheral Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12411
- Name: Neuromuscular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T6034
- Name: Quality of Life
- Relevance: HIGH
- As Found: Quality of Life
### Condition Browse Module - Meshes
- ID: D000011115
- Term: Polyneuropathies
### Intervention Browse Module - Browse Branches
- Abbrev: HB
- Name: Herbal and Botanical
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: T48
- Name: Aconite
- Relevance: HIGH
- As Found: Agrylin®
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT04649879
**Brief Title:** Convalescent Plasma for Treatment of COVID-19
**Official Title:** Convalescent Plasma for Treatment of COVID-19: An Open Randomised Controlled Trial
#### Organization Study ID Info
**ID:** CP3
#### Organization
**Class:** OTHER
**Full Name:** Karolinska University Hospital
### Status Module
#### Completion Date
**Date:** 2022-01-26
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-02-09
**Type:** ACTUAL
**Last Update Submit Date:** 2022-01-26
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2022-01-26
**Type:** ACTUAL
#### Start Date
**Date:** 2020-12-03
**Type:** ACTUAL
**Status Verified Date:** 2022-01
#### Study First Post Date
**Date:** 2020-12-02
**Type:** ACTUAL
**Study First Submit Date:** 2020-12-01
**Study First Submit QC Date:** 2020-12-01
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Karolinska Institutet
**Class:** OTHER
**Name:** Danderyd Hospital
**Class:** OTHER
**Name:** Falu Hospital
#### Lead Sponsor
**Class:** OTHER
**Name:** Joakim Dillner
#### Responsible Party
**Investigator Affiliation:** Karolinska University Hospital
**Investigator Full Name:** Joakim Dillner
**Investigator Title:** Professor of Infectious Disease Epidemiology; Director of R&D
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Convalescent plasma has been shown to be safe and effective for treatment of several diseases. Preliminary data indicate that it is safe for treatment of COVID-19. We found that viremia upon admission identifies patients at 7 fold increased risk of admission to intensive care and 8 fold increased risk of death. CP treatment appeared to result in rapid viral clearance in a small case series. CP appeared to be well tolerated in a phase I study in which patients only received one dose of CP and a phase II study in which CP was given until viremia disappeared (unpublished data).
Randomised controlled studies assessing the efficacy of CP are lacking and thus the efficacy of CP is unknown. Preliminary data indicate that treatment should be given early, prior to development of severe illness. Detection of viremia upon admission identifies a group at high risk of severe disease and death that has the most to benefit from CP. Phase II study data indicates that treatment should be given until SARS-CoV-2 is no longer detected in serum and the donor antibody neutralization titres should be ≥1/640. A randomised controlled trial in which viremic patients are treated with CP with the equivalent of an antibody titre ≥1/640 is thus required to determine if CP can be an effective COVID-19 treatment.
### Conditions Module
**Conditions:**
- Covid19
**Keywords:**
- COVID-19 convalescent plasma treatment
- SARS-CoV-2 infection
- Viremia
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Patients will be randomised 2:1 to treatment with convalescent plasma and standard of care only. Randomisation is by random permutated blocks using Redcap or equivalent.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 59
**Type:** ACTUAL
**Phases:**
- PHASE2
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** * Participants will receive 200 ml convalescent plasma daily until SARS-CoV-2 is no longer detectable in the blood up to a maximum of 10 CP infusions.
* If steroid therapy has not already been initiated, betamethasone 3 mg daily will be given concomitantly with steroid therapy or longer if clinically indicated but for a maximum of 10 days.
**Intervention Names:**
- Biological: SARS-CoV-2 convalescent plasma
**Label:** Convalescent plasma treatment
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Standard of care for COVID-19 patients.
**Intervention Names:**
- Other: Standard of care
**Label:** Control
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Convalescent plasma treatment
**Description:** Participants will receive 200 ml convalescent plasma daily until SARS-CoV-2 is no longer detectable in the blood up to a maximum of 10 CP infusions. CP will be given as a slow infusion over 2 hours. CP neutralization titre of ≥ 1/640 or an ELISA reactivity against the Spike protein of SARS-CoV-2 by the Euroimmun commercial assay \>9 is desired. New antibody tests are under development and can be used instead if equivalence to neutralization or Euroimmun ELISA is demonstrated.
**Name:** SARS-CoV-2 convalescent plasma
**Type:** BIOLOGICAL
#### Intervention 2
**Arm Group Labels:**
- Control
**Description:** Standard of care as determined by hospital practices for COVID-19 patients.
**Name:** Standard of care
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Death of a study participant within 28 days.
**Measure:** COVID-19 related mortality within 28 days
**Time Frame:** Measured 28 days after inclusion into the study.
#### Secondary Outcomes
**Description:** Death of a study participant within 60 days.
**Measure:** COVID-19 related mortality within 60 days
**Time Frame:** Measured 60 days after inclusion into the study.
**Description:** * The need for mechanical ventilation and date when this was initiated
* For patients not eligible for intensive care: each day when PaO2/FiO2 ratio was less than 70 for ≥ 12 hours. PaO2 and FiO2 will be estimated from SO2% and O2 flow in nasal cannula, face mask or face mask with reservoir based on EPIC II data. A ratio of 70 is approximately equal to 90% SO2 with 8-9 L of Oxygen flow using a face mask with a reservoir.
**Measure:** Requirement of invasive ventilation or Pao2/FiO2 ≤ 70 for ≥ 12 hours in the case of patients not eligible for intensive care
**Time Frame:** Until discharged from the hospital, up to 2 months
**Description:** Possible adverse events will be elicited using a modification and Swedish translation (appendix 6) of Common Terminology Criteria for Adverse Events v5.0 and they will be continuously reported to the sponsor. Adverse events related to convalescent plasma therapy shall be followed to assess reversibility.
**Measure:** Adverse events
**Time Frame:** The reporting period for AEs starts at inclusion and ends at the final follow-up visit 2 months after inclusion.
**Description:** Measured as doses of convalescent plasma administered (1-10 infusions, 200ml).
**Measure:** Dose of plasma needed to clear viremia
**Time Frame:** 28 days
**Description:** Blood samples for detection of SARS-CoV-2 in the blood will be taken prior to treatment start, daily during treatment and until two consecutive negative results are obtained.
**Measure:** Time to clearance of viremia
**Time Frame:** Until discharged from the hospital, up to 2 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age greater than or equal to 18
* Admitted to a study hospital
* Active COVID-19 defined as symptoms + SARS CoV-2 identified from upper or lower airway samples and blood
* Negative pregnancy test taken before inclusion and use of an acceptable effective method of contraception until treatment discontinuation if the participant is a woman of childbearing potential
* Written informed consent after meeting with a study physician and ability and willingness to complete follow up
Exclusion Criteria:
* No matching plasma donor (Exact matching in the ABO system is required)
* Unavailability of plasma
* Estimated glomerular filtration rate \<30 (kidney failure stage III or more)
* Pregnancy (urinary-hcg)
* Breast feeding
* Inability to give informed consent
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Falun
**Country:** Sweden
**Facility:** Department of Infectious Disease, Falu Hospital
**State:** Dalarn
**Zip:** 79182
**Location 2:**
**City:** Stockholm
**Country:** Sweden
**Facility:** Department of Geriatrics, Karolinska University Hospital
**Zip:** 171 76
**Location 3:**
**City:** Stockholm
**Country:** Sweden
**Facility:** Danderyd Hospital
**Zip:** 18257
### IPD Sharing Statement Module
**Description:** The investigators will be sharing the data, but the management plan is being designed.
**Info Types:**
- STUDY_PROTOCOL
**IPD Sharing:** YES
### References Module
#### References
**Citation:** Dillner J, Ursing J. Convalescent plasma for treatment of COVID-19: study protocol for an open randomised controlled trial in Sweden. BMJ Open. 2021 Dec 8;11(12):e048337. doi: 10.1136/bmjopen-2020-048337.
**PMID:** 34880010
## 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: M10283
- Name: Infections
- Relevance: LOW
- As Found: Unknown
- ID: M6368
- Name: Communicable Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17511
- Name: Viremia
- 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: 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
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Infl
- Name: Anti-Inflammatory Agents
- Abbrev: Resp
- Name: Respiratory System Agents
### Intervention Browse Module - Browse Leaves
- ID: M4225
- Name: Antibodies
- Relevance: LOW
- As Found: Unknown
- ID: M10184
- Name: Immunoglobulins
- Relevance: LOW
- As Found: Unknown
- ID: M4909
- Name: Betamethasone
- Relevance: LOW
- As Found: Unknown
- 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:** NCT04305379
**Acronym:** BLANKET
**Brief Title:** Augmented BLAdder NecK rEconstruction Trial for Improved Urinary Function After Radical Prostatectomy
**Official Title:** Augmented BLAdder NecK rEconstruction Trial for Improved Urinary Function After Radical Prostatectomy
#### Organization Study ID Info
**ID:** IRB00208651
#### Organization
**Class:** OTHER
**Full Name:** Johns Hopkins University
### Status Module
#### Completion Date
**Date:** 2021-03-01
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-03-17
**Type:** ACTUAL
**Last Update Submit Date:** 2021-03-15
**Overall Status:** TERMINATED
#### Primary Completion Date
**Date:** 2021-03-01
**Type:** ACTUAL
#### Start Date
**Date:** 2020-01-16
**Type:** ACTUAL
**Status Verified Date:** 2021-03
#### Study First Post Date
**Date:** 2020-03-12
**Type:** ACTUAL
**Study First Submit Date:** 2020-03-10
**Study First Submit QC Date:** 2020-03-10
**Why Stopped:** Stopped due to COVID-19 pandemic, low priority among initiatives and officially terminated.
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Johns Hopkins University
#### 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 investigators are conducting a prospective, randomized trial to investigate whether patients randomized to receive an augmented bladder neck reconstruction (aBNR) at the time of robotic-assisted laparoscopic prostatectomy experience improved urinary function post-operatively compared to patients who undergo prostatectomy with a standard BNR. An aBNR here consists of the autologous medial umbilical ligament sling as well as a bladder neck intussusception stitch. The standard BNR group will receive the intussusception stitch only.
**Detailed Description:** A bladder neck reconstruction is a standard step in performing a radical prostatectomy. Over the years, various maneuvers to improve continence have been tried and studied including intussusception stitches and slings. Slings of various origins have been used by surgeons at the time of radical prostatectomy without consistent evidence demonstrating a benefit (vas deferens, biologic). However, use of the medial umbilical ligament to create a sling has not previously been studied in a randomized trial.
The medial umbilical ligaments are normally cut during intraperitoneal robotic-assisted laparoscopic radical prostatectomy to allow the surgeon access to the Retzius space between the bladder and pubic bone. To create a medial umbilical ligament autologous sling, the ligaments are dissected out and wrapped around the vesicourethral anastomosis.
The investigators are conducting a prospective, randomized trial to investigate whether patients randomized to receive an augmented bladder neck reconstruction (aBNR) at the time of robotic-assisted laparoscopic prostatectomy experience improved urinary function post-operatively compared to patients who undergo prostatectomy with a standard BNR. An aBNR here consists of the autologous medial umbilical ligament sling as well as a bladder neck intussusception stitch. The standard BNR group will receive the intussusception stitch only.
### Conditions Module
**Conditions:**
- Prostate Cancer
- Urinary Incontinence
- Surgery
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Masking Description:** The surgeon will be masked until the time of bladder neck reconstruction during the radical prostatectomy.
**Who Masked:**
- PARTICIPANT
- OUTCOMES_ASSESSOR
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 31
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Augmented Bladder Neck Reconstruction (Sling + Intussusception)
**Intervention Names:**
- Procedure: Augmented Bladder Neck Reconstruction
**Label:** Augmented Bladder Neck Reconstruction
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Standard Bladder Neck Reconstruction (Intussusception Only)
**Intervention Names:**
- Procedure: Standard Bladder Neck Reconstruction
**Label:** Standard Bladder Neck Reconstruction
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Augmented Bladder Neck Reconstruction
**Description:** Augmented Bladder Neck Reconstruction including a Medial Umbilical Ligament Sling plus Intussusception
**Name:** Augmented Bladder Neck Reconstruction
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- Standard Bladder Neck Reconstruction
**Description:** Standard Bladder Neck Reconstruction with Intussusception Only
**Name:** Standard Bladder Neck Reconstruction
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** Score of 0-100 on questionnaire with higher scores reflecting better health-related quality of life related to urinary incontinence (closer to 0 is more incontinence, closer to 100 is less incontinence).
**Measure:** EPIC Urinary Incontinence subscale score
**Time Frame:** 1 Month
#### Secondary Outcomes
**Description:** Score of 0-100 on questionnaire with higher scores reflecting better health-related quality of life related to urinary incontinence (closer to 0 is more incontinence, closer to 100 is less incontinence).
**Measure:** EPIC Urinary Incontinence subscale score
**Time Frame:** 2 Weeks
**Description:** Score of 0-100 on questionnaire with higher scores reflecting better health-related quality of life related to urinary incontinence (closer to 0 is more incontinence, closer to 100 is less incontinence).
**Measure:** EPIC Urinary Incontinence subscale score
**Time Frame:** 3 Months
**Description:** Score of 0-100 on questionnaire with higher scores reflecting better health-related quality of life related to urinary incontinence (closer to 0 is more incontinence, closer to 100 is less incontinence).
**Measure:** EPIC Urinary Incontinence subscale score
**Time Frame:** 6 Months
**Description:** Score of 0-100 on questionnaire with higher scores reflecting better health-related quality of life related to urinary incontinence (closer to 0 is more incontinence, closer to 100 is less incontinence).
**Measure:** EPIC Urinary Incontinence subscale score
**Time Frame:** 12 Months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Men aged 40 to 70 years of age with localized prostate cancer (clinical stage T2c or less, Gleason grade 5+5=10 or less without any evidence of distant metastases)
* Scheduled to undergo curative robot-assisted radical prostatectomy
Exclusion Criteria:
* Planned pre-operative or post-operative (within 1 month) androgen therapy
* Planned pre-operative or post-operative (within 1 month) radiation therapy
* History of spinal trauma or surgery to the brain or spinal cord
* Pre-operative history of stress urinary incontinence
**Maximum Age:** 70 Years
**Minimum Age:** 40 Years
**Sex:** MALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Baltimore
**Country:** United States
**Facility:** Johns Hopkins Hospital
**State:** Maryland
**Zip:** 21287
#### Overall Officials
**Official 1:**
**Affiliation:** Johns Hopkins University
**Name:** Mohamad E Allaf, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000052801
- Term: Male Urogenital Diseases
- ID: D000014555
- Term: Urination Disorders
- ID: D000014570
- Term: Urologic Diseases
- ID: D000052776
- Term: Female Urogenital Diseases
- ID: D000005261
- Term: Female Urogenital Diseases and Pregnancy Complications
- ID: D000059411
- Term: Lower Urinary Tract Symptoms
- ID: D000020924
- Term: Urological Manifestations
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
### Condition Browse Module - Browse Leaves
- ID: M14335
- Name: Prostatic Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M17299
- Name: Urinary Incontinence
- Relevance: HIGH
- As Found: Urinary Incontinence
- ID: M7936
- Name: Enuresis
- Relevance: LOW
- As Found: Unknown
- ID: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27095
- Name: Male Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17305
- Name: Urination Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M17319
- Name: Urologic 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: M29464
- Name: Lower Urinary Tract Symptoms
- Relevance: LOW
- As Found: Unknown
- ID: M22659
- Name: Urological Manifestations
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000014549
- Term: Urinary Incontinence
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT04170179
**Brief Title:** Systemic Chemotherapy Plus Lenvatinib and Toripalimab for HCC With Extrahepatic Metastasis
**Official Title:** Systemic Chemotherapy of Oxaliplatin, Leucovorin, 5-fluorouracil Plus Lenvatinib and Toripalimab for Hepatocellular Carcinoma With Extrahepatic Metastasis: a Prospective, Single-arm Trial
#### Organization Study ID Info
**ID:** HCC-S068
#### Organization
**Class:** OTHER
**Full Name:** Sun Yat-sen University
### Status Module
#### Completion Date
**Date:** 2021-04-01
**Type:** ESTIMATED
#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2021-02-23
**Type:** ACTUAL
**Last Update Submit Date:** 2021-02-19
**Overall Status:** UNKNOWN
#### Primary Completion Date
**Date:** 2021-04-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2019-11-19
**Type:** ACTUAL
**Status Verified Date:** 2021-02
#### Study First Post Date
**Date:** 2019-11-20
**Type:** ACTUAL
**Study First Submit Date:** 2019-11-18
**Study First Submit QC Date:** 2019-11-18
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Sun Yat-sen University
#### Responsible Party
**Investigator Affiliation:** Sun Yat-sen University
**Investigator Full Name:** Shi Ming
**Investigator Title:** Proffessor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The purpose of this study is to evaluate the efficacy and safety of Systemic chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin plus lenvatinib and toripalimab in patients with hepatocellular carcinoma with extrahepatic metastasis
**Detailed Description:** Systemic chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin was effective and safe for advanced hepatocellular carcinoma. Lenvatinib was non-inferior to sorafenib in overall survival in untreated advanced hepatocellular carcinoma, and programmed cell death protein-1 (PD-1) antibody was effective and tolerable in patients with advanced hepatocellular carcinoma. No study has evaluated systemic chemotherapyplus lenvatinib and toripalimab. Thus, the investigators carried out this prospective, single-arm study to find out it.
### Conditions Module
**Conditions:**
- Hepatocellular Carcinoma
**Keywords:**
- Hepatocellular Carcinoma
- Lenvatinib
- Toripalimab
- Systemic chemotherapy
- Oxaliplatin, leucovorin, 5-fluorouracil
- Extrahepatic metastasis
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 25
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Systemic chemotherapy of oxaliplatin , fluorouracil, and leucovorin every 3 weeks. Lenvatinib 12 mg (or 8 mg) once daily (QD) oral dosing. Toripalimab 240mg intravenously every 3 weeks.
**Intervention Names:**
- Procedure: Systemic chemotherapy
- Drug: Lenvatinib
- Drug: Toripalimab
**Label:** Systemic chemotherapy plus lenvatinib and toripalimab
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Systemic chemotherapy plus lenvatinib and toripalimab
**Description:** administration of oxaliplatin , fluorouracil, and leucovorin via the peripherally inserted central catheter every 3 weeks
**Name:** Systemic chemotherapy
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- Systemic chemotherapy plus lenvatinib and toripalimab
**Description:** 12 mg (or 8 mg) once daily (QD) oral dosing.
**Name:** Lenvatinib
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- Systemic chemotherapy plus lenvatinib and toripalimab
**Description:** 240mg intravenously every 3 weeks
**Name:** Toripalimab
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Progression was defined as progressive disease by independent radiologic review according to mRECIST or death from any cause
**Measure:** Progression free survival rate at 6 months
**Time Frame:** 6 months
#### Secondary Outcomes
**Description:** OS is the length of time from the date of randomization until death from any cause.
**Measure:** Overall survival (OS)
**Time Frame:** 6 months
**Description:** PFS is defined as the time from the date of randomization to the date of the first objectively documented tumor progression or death due to any cause.
**Measure:** Progression free survival (PFS)
**Time Frame:** 6 months
**Description:** ORR, as determined based on tumor response according to mRECIST, is defined as the proportion of all randomized subjects whose best overall response (BOR) is either a CR or PR.
**Measure:** Objective response rate (ORR)
**Time Frame:** 6 months
**Description:** Safety will be evaluated according to the NCI CTCAE Version 4.03. All observations pertinent to the safety of the study medication will be recorded on the CRF and included in the final report.
**Measure:** Adverse events
**Time Frame:** 6 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL)
* Patients must have at least one tumor lesion that can be accurately measured according to EASL criteria.
* Barcelona clinic liver cancer-stage C
* Eastern Cooperative Oncology Group performance status of 0 to 2
* With no previous treatment
* Presence of extrahepatic metastasis
* No Cirrhosis or cirrhotic status of Child-Pugh class A only
* Not amendable to surgical resection ,local ablative therapy and any other cured treatment.
* The following laboratory parameters:
Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 30 g/L ASL and AST ≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) \>1,500/mm3
Exclusion Criteria:
* Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
* Known history of HIV
* History of organ allograft
* History of immunotherapy
* Known or suspected allergy to the investigational agents or any agent given in association with this trial.
* Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
* Evidence of bleeding diathesis.
* Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
* Known central nervous system tumors including metastatic brain disease
**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:** Ming Shi, MD
**Phone:** +862087343938
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** QiJiong Li, MD
**Phone:** +862087343938
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Guangzhou
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Ming Shi, MD
- **Phone:** 8620-87343115
- **Role:** CONTACT
**Country:** China
**Facility:** Cancer Center Sun Yat-sen University
**State:** Guangdong
**Status:** RECRUITING
**Zip:** 510060
## 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: D000009385
- Term: Neoplastic Processes
- ID: D000010335
- Term: Pathologic Processes
- ID: D000000230
- Term: Adenocarcinoma
- ID: D000008113
- Term: Liver Neoplasms
- ID: D000004067
- Term: Digestive System Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000008107
- Term: Liver Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: All
- Name: All Conditions
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M5534
- Name: Carcinoma
- Relevance: HIGH
- As Found: Carcinoma
- ID: M9613
- Name: Carcinoma, Hepatocellular
- Relevance: HIGH
- As Found: Hepatocellular Carcinoma
- ID: M12307
- Name: Neoplasm Metastasis
- Relevance: HIGH
- As Found: Metastases
- 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: M12330
- Name: Neoplastic Processes
- Relevance: LOW
- As Found: Unknown
- ID: M3585
- Name: Adenocarcinoma
- Relevance: LOW
- As Found: Unknown
- ID: M11113
- Name: Liver 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: M11107
- Name: Liver Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000002277
- Term: Carcinoma
- ID: D000009362
- Term: Neoplasm Metastasis
- ID: D000006528
- Term: Carcinoma, Hepatocellular
### Intervention Browse Module - Ancestors
- ID: D000000970
- Term: Antineoplastic Agents
- ID: D000047428
- Term: Protein Kinase Inhibitors
- ID: D000004791
- Term: Enzyme Inhibitors
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
### Intervention Browse Module - Browse Branches
- Abbrev: Micro
- Name: Micronutrients
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: ANeo
- Name: Antineoplastic Agents
### Intervention Browse Module - Browse Leaves
- ID: M6191
- Name: Leucovorin
- Relevance: LOW
- As Found: Unknown
- ID: M8600
- Name: Fluorouracil
- Relevance: LOW
- As Found: Unknown
- ID: M353738
- Name: Lenvatinib
- Relevance: HIGH
- As Found: Fibrillation
- ID: M1674
- Name: Oxaliplatin
- 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
### Intervention Browse Module - Meshes
- ID: C000531958
- Term: Lenvatinib
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT03665779
**Brief Title:** Nitric Oxide Donor Isosorbide Mono Nitrate for Induction of Labor With Pre-labor Rupture of Membranes
**Official Title:** Nitric Oxide Donor Isosorbide Mono Nitrate for Cervical Ripening in Induction of Labor in Term or Post Term Pregnancies in Females With Pre-labor Rupture of Membranes
#### Organization Study ID Info
**ID:** AN1988
#### Organization
**Class:** OTHER
**Full Name:** Cairo University
### Status Module
#### Completion Date
**Date:** 2019-05-01
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2020-06-23
**Type:** ACTUAL
**Last Update Submit Date:** 2020-06-21
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2019-04-30
**Type:** ACTUAL
#### Start Date
**Date:** 2018-08-01
**Type:** ACTUAL
**Status Verified Date:** 2020-06
#### Study First Post Date
**Date:** 2018-09-11
**Type:** ACTUAL
**Study First Submit Date:** 2018-08-30
**Study First Submit QC Date:** 2018-09-08
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** ahmed nagy shaker ramadan
#### Responsible Party
**Investigator Affiliation:** Cairo University
**Investigator Full Name:** ahmed nagy shaker ramadan
**Investigator Title:** resident of obstetrics and gynecology
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** The study aims to evaluate and assess the effectiveness and safety of vaginal administration of isosorbide mono nitrate (IMN) to induce cervical ripening and shorten the interval time between induction and delivery in women undergoing induction of labor at term or post term with prelabor rupture of membrane.
Research Hypothesis:
In women undergoing induction of labor at term or post term with pre-labor rupture of membrane, vaginal administration of isosorbide mono nitrate (IMN) is effective to induce cervical ripening and shorten the interval time between induction and delivery.
Research Questions:
Does vaginal administration of isosorbide mono nitrate (IMN) induce cervical ripening and shorten the interval time between induction and delivery in women undergoing induction of labor at term or post term with prelabor rupture of membrane?
**Detailed Description:** * Study Design: Prospective double blinded randomized placebo-controlled Clinical trial
* Time plan: Approximately 6 months according to calculated sample size.
* study setting: this study will be conducted obstetrics and gynecology department at Cairo university.
* study population: patient will be recruited in this study those attending labor ward for induction of labor in term or post term pregnancies in females with pre-labor rupture of membranes
* Methodology in details
All women will be subjected to
-History taking:
* Verbal consent.
* Detailed clinical history.
* Personal history: Name, Age, Parity, Occupation, Residency and Special habits.
* Present history: History of onset, course and duration of vaginal bleeding or bloody vaginal discharge, presence of uterine contraction, PROM, IUGR or any indication of induction of labor.
* Obstetric history: History of previous preterm labor, previous abortion, previous full term deliveries, RH incompatibility, mode of delivery and fetal outcome.
* Menstrual history: For estimation of gestational age using Naegele's rule, provided that she had regular cycles for the last three months before she got pregnant and was not taking contraceptive pills during this period and she was sure of her dates.
Term pregnancy defined as delivery between 37 and 42 weeks of gestation. Gestational age was assessed from the menstrual history and confirmed by measurement of fetal crown-rump length at a first-trimester scan. Post-term pregnancy defined as delivery after 42 weeks of gestation.
* Past history: History of medical disorders, drug therapy or allergy or history of intake of other tocolytic drugs.
* Family history : For any similar condition
-Examination
* Full clinical examination (pulse, temperature and the blood pressure).
* General examination including chest, heart and abdominal examination for fundal level.
* Local clinical examination; with special attention to pelvic examination to assess the state of the cervix (dilatation, effacement, PROM, station and presenting part) and to assess vaginal bleeding or amniotic fluid in vagina if present and to exclude cephalic-pelvic disproportion.
* Routine ante-natal investigations (Rh, Hb, fasting and postprandial blood sugar and complete urine analysis).(CBC with differential and CRP to exclude chorioamnionitis)
* Ultrasonography examination : to assess the following data:
* Gestational age
* Fetal viability
* Fetal presentation and EFW.
* Exclusion of any fetal congenital anomalies.
* To ensure that the all inclusion criteria are present.
* Check amniotic fluid index.
* Intervention:
After admission for labor induction, cervical assessment is done to see dilatation (cm), length (cm), position, consistency, and station of presenting part to get the modified Bishop score and to confirm pre-labor rupture of membrane.
In vaginal IMN group (group 1) 40 mg tablet of intra-vaginal IMN (Effox; MINAPHARMA, Cairo, Egypt) will be placed into the posterior fornix of the vagina, through a digital vaginal examination, every 4 h for a maximum of four doses. The medication will be stopped with the onset of labor. Oxytocin will be started 6 h after the last dose of IMN in women not in active phase of labor but have Bishop score is \>6. Intravenous oxytocin is initiated at an infusion flow rate of 4 mIU/min and will be doubled as necessary, with 30-min intervals between increasing the doses, up to a maximum of 16 mIU/min. To obtain this concentration, 5 IU of synthetic oxytocin are added to 500 ml of a 5% dextrose solution. Further management of labor will be done according to the hospitals protocols.
In placebo group (group 2) 40 mg intra-vaginal pyridoxine placebos every 4 h for a maximum of four doses will be given, followed by intravenous oxytocin infusion and management of labor as in group 1.
In both groups, the pregnant females who don't progress to labor (regular contractions with continued cervical changes) with no cervical changes ( bishop score equal to or less than 6) after a maximum of four doses and oxytocin infusion, this will be considered failure of induction and those patients will delivered by cesarean section.
Subjects will be followed-up regularly after taking the medications by obstetricians who are unaware of the group to which the patient belongs. Uterine contraction and fetal heart rate (FHR) will be checked every 30 min. Prophylactic or "latency" antibiotics, typically ampicillin and erythromycin for prevention of chorioamnionitis. Symptoms and vital signs will be monitored at regular intervals. Subjects will be asked to report when they have uterine contraction or abnormal symptoms such as headache, nausea, shivering.
signs of chorioamnionitis (e.g : fever, uterine fundal tenderness, maternal and fetal tachycardia, purulent or foul smelling discharge) will be checked at regular intervals.
Pelvic examination will be done with each dose and with the onset of uterine contractions. Doses will be stopped with the onset of uterine contractions or when the maximum doses reached.
After documentation of all the collected data, the following will be studied:
* Induction to onset of labor time.
* Induction to delivery time.
* Failure of induction due to maternal or fetal cause.
* Need for augmentation of labor by oxytocin.
* Recording any maternal or fetal morbidities.
Possible Risk:
Risks of induction of labor as failure of induction or maternal or fetal morbidities.
Side effects of the used drugs. Complications of PROM either maternal or fetal.
### Conditions Module
**Conditions:**
- Induction of Labor Affected Fetus / Newborn
- Rupture of Membranes Prior to Onset of Labor
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** The patients will be divided into 2 groups:
Group 1:
70 pregnant females, induction of labor will be done by Intra vaginal isosorbide mono nitrate (Effox 40 mg MINAPHARM)
Group 2:
70 pregnant females, induction will be done by placebo (pyridoxine) administered in the posterior vaginal fornix.
##### Masking Info
**Masking:** DOUBLE
**Masking Description:** A double-blind study is one in which neither the participants nor the experimenters know who is receiving a particular treatment. This procedure is utilized to prevent bias in research results. Double-blind studies are particularly useful for preventing bias due to demand characteristics or the placebo effect. In a double-blind study, the investigators who interact with the participants would not know who was receiving the actual drug and who was receiving a placebo.
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 140
**Type:** ACTUAL
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** 70 pregnant females, induction of labor will be done by Intra vaginal isosorbide mono nitrate (Effox 40 mg MINAPHARM)
**Intervention Names:**
- Drug: isosorbide mononitrate
**Label:** isosorbide mono-nitrate group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** 70 pregnant females, induction will be done by placebo (pyridoxine) administered in the posterior vaginal fornix.
**Intervention Names:**
- Drug: Placebo
**Label:** placebo group
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- isosorbide mono-nitrate group
**Description:** 70 pregnant females, induction of labor will be done by Intra vaginal isosorbide mono nitrate (Effox 40 mg MINAPHARM) repeated every 4 hours maximum 4 times
**Name:** isosorbide mononitrate
**Other Names:**
- Effox
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- placebo group
**Description:** 70 pregnant females, induction will be done by placebo (pyridoxine) administered in the posterior vaginal fornix.repeated every 4 hours maximum 4 times
**Name:** Placebo
**Other Names:**
- pyridoxine
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** the effectiveness and safety of vaginal administration of isosorbide mono nitrate (IMN) to induce cervical ripening for induction of labor at term or post term pregnancy with prelabor rupture of membrane regarding (Induction to onset of labor time, Induction to delivery time)
**Measure:** induction of labor
**Time Frame:** up to 24 hours
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Singleton pregnancy.
* Cephalic presentation.
* Bishop score \< or = 6.
* Average size of the fetus.
* Adequate pelvic dimensions.
* Prelabour rupture of membranes.
* Term or post-term pregnancies with an indication for labor induction either maternal or fetal.
Exclusion Criteria:
* Previous uterine scar (e.g. caesarian delivery or unknown uterine incision , previous hysterotomy or myomectomy of the uterine corpus involving entry of the uterine cavity or extensive myometrial dissection, previous uterine rupture)
* Patients with regular uterine contractions.
* Malpresentation.
* Multifetal gesta1tion.
* Established fetal distress ( e.g. thick meconium stained liguor or non reassuring CTG changes)
* Indication for CS, e.g. Major degree of cephalopelvic disproportion and fetal macrosomia.
* Placenta previa or vasa previa.
* Active genital herpes infection.
* Severe maternal illness (e.g. severe preeclampsia).
* Laboratory and clinical sign of chorioamnionitis.
**Gender Based:** True
**Maximum Age:** 40 Years
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Cairo
**Country:** Egypt
**Facility:** faculty of medicine - Cairo university
**State:** Kasr El Ainy
**Zip:** 11562
#### Overall Officials
**Official 1:**
**Affiliation:** university
**Name:** waleed M EL Khyat, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Afifi AN, Taymour MA, El-Khayat WM. Isosorbide mononitrate for cervical ripening in induction of labor for pregnant women with PROM at or post term. Int J Gynaecol Obstet. 2021 Dec;155(3):512-517. doi: 10.1002/ijgo.13604. Epub 2021 Feb 18.
**PMID:** 33458819
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000014947
- Term: Wounds and Injuries
- ID: D000007744
- Term: Obstetric Labor Complications
- 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: BC26
- Name: Wounds and Injuries
- Abbrev: All
- Name: All Conditions
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
### Condition Browse Module - Browse Leaves
- ID: M15241
- Name: Rupture
- Relevance: HIGH
- As Found: Rupture
- ID: M8452
- Name: Fetal Membranes, Premature Rupture
- Relevance: HIGH
- As Found: Rupture of Membranes Prior to Onset of Labor
- ID: M14149
- Name: Pregnancy, Prolonged
- Relevance: LOW
- As Found: Unknown
- ID: M25869
- Name: Premature Birth
- Relevance: LOW
- As Found: Unknown
- ID: M17685
- Name: Wounds and Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M10764
- Name: Obstetric Labor Complications
- 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: D000005322
- Term: Fetal Membranes, Premature Rupture
- ID: D000012421
- Term: Rupture
### Intervention Browse Module - Ancestors
- ID: D000014803
- Term: Vitamin B Complex
- ID: D000014815
- Term: Vitamins
- ID: D000018977
- Term: Micronutrients
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000004234
- Term: Diuretics, Osmotic
- ID: D000004232
- Term: Diuretics
- ID: D000045283
- Term: Natriuretic Agents
- ID: D000014665
- Term: Vasodilator Agents
- ID: D000020030
- Term: Nitric Oxide Donors
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
### Intervention Browse Module - Browse Branches
- Abbrev: Micro
- Name: Micronutrients
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: NaAg
- Name: Natriuretic Agents
- Abbrev: NiOxD
- Name: Nitric Oxide Donors
- Abbrev: VaDiAg
- Name: Vasodilator Agents
- Abbrev: Resp
- Name: Respiratory System Agents
- Abbrev: Hemat
- Name: Hematinics
- Abbrev: Vi
- Name: Vitamins
### Intervention Browse Module - Browse Leaves
- ID: M23026
- Name: Vitamin B 6
- Relevance: LOW
- As Found: Unknown
- ID: M14583
- Name: Pyridoxal
- Relevance: LOW
- As Found: Unknown
- ID: M14589
- Name: Pyridoxine
- Relevance: HIGH
- As Found: Asparaginase
- ID: M10578
- Name: Isosorbide
- Relevance: HIGH
- As Found: 210
- ID: M10579
- Name: Isosorbide Dinitrate
- Relevance: HIGH
- As Found: Recumbent
- ID: M244430
- Name: Isosorbide-5-mononitrate
- Relevance: HIGH
- As Found: Recumbent
- ID: M12507
- Name: Nitric Oxide
- Relevance: LOW
- As Found: Unknown
- ID: M8618
- Name: Folic Acid
- Relevance: LOW
- As Found: Unknown
- ID: M17558
- Name: Vitamins
- Relevance: LOW
- As Found: Unknown
- ID: M17546
- Name: Vitamin B Complex
- Relevance: LOW
- As Found: Unknown
- ID: M21009
- Name: Micronutrients
- Relevance: LOW
- As Found: Unknown
- ID: M16885
- Name: Trace Elements
- Relevance: LOW
- As Found: Unknown
- ID: M7411
- Name: Diuretics
- Relevance: LOW
- As Found: Unknown
- ID: M17412
- Name: Vasodilator Agents
- Relevance: LOW
- As Found: Unknown
- ID: T474
- Name: Vitamin B6
- Relevance: LOW
- As Found: Unknown
- ID: T459
- Name: Pyridoxal
- Relevance: LOW
- As Found: Unknown
- ID: T461
- Name: Pyridoxine
- Relevance: HIGH
- As Found: Asparaginase
- ID: T446
- Name: Folic Acid
- Relevance: LOW
- As Found: Unknown
- ID: T448
- Name: Folate
- Relevance: LOW
- As Found: Unknown
- ID: T475
- Name: Vitamin B9
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000011736
- Term: Pyridoxine
- ID: D000007547
- Term: Isosorbide
- ID: D000007548
- Term: Isosorbide Dinitrate
- ID: C000030397
- Term: Isosorbide-5-mononitrate
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT04408079
**Brief Title:** A Study to Evaluate the Tolerance, Efficacy and Pharmacokinetics of TQB3558 Tablets
**Official Title:** A Phase I, Open-label, Dose Escalation and Expansion Study to Evaluate the Tolerance, Efficacy and Pharmacokinetics of TQB3558 Tablets
#### Organization Study ID Info
**ID:** TQB3558-Ⅰ-01
#### Organization
**Class:** INDUSTRY
**Full Name:** Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2022-10-31
**Type:** ESTIMATED
#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2020-07-08
**Type:** ACTUAL
**Last Update Submit Date:** 2020-07-06
**Overall Status:** UNKNOWN
#### Primary Completion Date
**Date:** 2022-07-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2020-06-25
**Type:** ACTUAL
**Status Verified Date:** 2020-06
#### Study First Post Date
**Date:** 2020-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2020-05-26
**Study First Submit QC Date:** 2020-05-26
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Chia Tai Tianqing Pharmaceutical Group 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 study to evaluate the maximum tolerated dose (MTD) , occurrence of all adverse events (AE) and serious adverse events (SAE) , pharmacokinetic parameters and antitumor effect of TQB3558 tablets in Chinese adult patients with advanced solid tumors .The study is divided into phase Ia and phase Ib. Phase Ia: dose escalation period, to evaluate the safety and tolerability of TQB3558 tablets, determine MTD; Phase Ib: effectiveness exploration period, to expand the safe and effective dose group, recommend appropriate dosage and method for subsequent clinical research.
### 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:** 70
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** TQB3558 tablets administered orally once. Then TQB3558 tablet administered orally, once daily in 28-day cycle after 4 days of first administration.
**Intervention Names:**
- Drug: TQB3558
**Label:** TQB3558 Tablets
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- TQB3558 Tablets
**Description:** TQB3558 is a kinase inhibitor of the TRK protein family.
**Name:** TQB3558
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** MTD was defined as the dose in which more than 2 of up to 6 patients developed a DLT.
**Measure:** Maximum tolerated dose (MTD)
**Time Frame:** Baseline up to 28 days
**Description:** The occurrence of all adverse events (AE) and serious adverse events (SAE).
**Measure:** Adverse events (AE) and serious adverse events (SAE)
**Time Frame:** Baseline up to 28 days
**Description:** Percentage of participants achieving complete response (CR) and partial response (PR).
**Measure:** Overall response rate (ORR)
**Time Frame:** up to 96 weeks
#### Secondary Outcomes
**Description:** To characterize the pharmacokinetics of TQB3558 by assessment of time to reach maximum plasma concentration.
**Measure:** Tmax
**Time Frame:** 15minutes, 30minutes, 1hour, 2hour, 4hour, 6hour, 8hour,10hour, 24hour, 48hour post-dose on day 1 and day 11; 30minutes pre-dose on day 1, day 5, day 7,day 8 ,day 9 and day 11.
**Description:** Cmax is the maximum plasma concentration of TQB3558 or metabolite(s).
**Measure:** Cmax
**Time Frame:** 15minutes, 30minutes, 1hour, 2hour, 4hour, 6hour, 8hour,10hour, 24hour, 48hour post-dose on day 1 and day 11; 30minutes pre-dose on day 1, day 5, day 7,day 8 ,day 9 and day 11.
**Description:** To characterize the pharmacokinetics of TQB3558 by assessment of area under the plasma concentration time curve from zero to infinity.
**Measure:** AUC0-t
**Time Frame:** 15minutes, 30minutes, 1hour, 2hour, 4hour, 6hour, 8hour,10hour, 24hour, 48hour post-dose on day 1 and day 11; 30minutes pre-dose on day 1, day 5, day 7,day 8 ,day 9 and day 11.
**Description:** CL/f is total clearance rate for TQB3558.
**Measure:** CL/f
**Time Frame:** 15minutes, 30minutes, 1hour, 2hour, 4hour, 6hour, 8hour,10hour, 24hour, 48hour post-dose on day 1 and day 11; 30minutes pre-dose on day 1, day 5, day 7,day 8 ,day 9 and day 11.
**Description:** Percentage of participants achieving Complete Response (CR) and Partial Response (PR) and Stable Disease (SD).
**Measure:** Disease control rate（DCR）
**Time Frame:** up to 96 weeks
**Description:** PFS defined as the time from first dose to the first documented progressive disease (PD) or death from any cause.
**Measure:** Progression-free survival (PFS)
**Time Frame:** up to 96 weeks
**Description:** DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.
**Measure:** Duration of Response (DOR)
**Time Frame:** up to 96 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* 1. Histologically or cytologically confirmed advanced malignant solid tumors, without conventional treatment methods or fail or relapse after treatment.
2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1; Life expectancy ≥12 weeks.
3. Has at least one measurable lesion (based on RECIST 1.1) or bone metastases. 4. Adequate organ system function. 5. Patients need to adopt effective methods of contraception. 6. Understood and signed an informed consent form.
Exclusion Criteria:
* 1. Has received TRK inhibitors. 2. Has participated in any other clinical trials, or used other anti-cancer drugs, or received major surgical operations within 4 weeks before first administration.
3. Has received local radiotherapy within 7 days or bone marrow radiotherapy within 4 weeks before the first administration.
4. Has other malignant tumors in 2 years, except for cured or locally curable cancers.
5. Has known spinal cord compression and cancerous meningitis. 6. Has interstitial lung disease, drug-induced interstitial lung disease, history of radiation lung disease requiring steroid therapy.
7. Uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage.
8. Obvious cardiovascular diseases. 9. Has a history of autoimmune disease, immunodeficiency. 10. Lactating women. 11. According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
**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:** Zan Shen, Doctor
**Phone:** 021-24058431
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Shanghai
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Zan Shen, Doctor
- **Phone:** 021-24058431
- **Role:** CONTACT
***Contact 2:***
- **Name:** Zan Shen, Doctor
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** China
**Facility:** Shanghai Sixth People's Hospital
**State:** Shanghai
**Status:** RECRUITING
**Zip:** 200233
## Derived Section
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06081179
**Brief Title:** Does Serotonin System Stimulation Increase Pro-social Behavior? - A Comparative Pharmacological Neuroscientific Study in Healthy Humans
**Official Title:** Does Serotonin System Stimulation Increase Pro-social Behavior? - A Comparative Pharmacological Neuroscientific Study in Healthy Humans
#### Organization Study ID Info
**ID:** 2A-SC-1
#### Organization
**Class:** OTHER
**Full Name:** University of Zurich
### Status Module
#### Completion Date
**Date:** 2025-06
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-12-07
**Type:** ACTUAL
**Last Update Submit Date:** 2023-11-30
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-04
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-10-24
**Type:** ACTUAL
**Status Verified Date:** 2023-11
#### Study First Post Date
**Date:** 2023-10-13
**Type:** ACTUAL
**Study First Submit Date:** 2023-09-25
**Study First Submit QC Date:** 2023-10-03
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Zurich
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Is US Export:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The study looks into whether administering psychedelic substances that stimulate the serotonin system influences pro-social behavior when compared to administering substances that stimulate the dopamine system in healthy individuals.
**Detailed Description:** Psychedelic substances have been shown to be powerful modulators of social perception and behavior during the acute experience. This is of particular interest given that social relationships play a key role in the development and resolution of psychiatric symptoms. However, the neuropharmacological mechanism underlying pro-social effects and time-dependent changes currently remain unclear. This study therefore aims at answering two key questions: 1) Does stimulation of the serotonin system induce lasting effects on pro-social behavior? and 2) Are these effects specific to serotonergic stimulation? The following proposed study will assess these questions by investigating objective, ecologically valid measures of pro-social cognition four weeks after different pharmacological challenges (MDMA, an entactogen and releaser of serotonin, norepinephrine, and dopamine; psilocybin: a classical psychedelic and serotonin 2A receptor agonist, methylphenidate: an amphetamine and norepinephrine-dopamine re-uptake inhibitor) in healthy volunteers.
### Conditions Module
**Conditions:**
- Healthy
**Keywords:**
- MDMA
- Psilocybin
- Methylphenidate
- pro-social behavior
- healthy controls
- psychedelics
- serotonin
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** single-center, double-blind, parallel-group, randomized study design
##### Masking Info
**Masking:** DOUBLE
**Masking Description:** double-blinded
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
**Primary Purpose:** BASIC_SCIENCE
#### Enrollment Info
**Count:** 120
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** 40 participants will receive psilocybin
**Intervention Names:**
- Drug: Psilocybin
**Label:** Psilocybin
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** 40 participants will receive MDMA
**Intervention Names:**
- Drug: 3,4 Methylenedioxymethamphetamine
**Label:** MDMA
**Type:** ACTIVE_COMPARATOR
#### Arm Group 3
**Description:** 40 participants will receive methylphenidate
**Intervention Names:**
- Drug: Methylphenidate
**Label:** Methylphenidate
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Psilocybin
**Description:** Single dose of psilocybin (15mg), orally in form of capsules
**Name:** Psilocybin
**Other Names:**
- magic mushrooms
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- MDMA
**Description:** Single dose of MDMA (100mg), orally in form of capsules
**Name:** 3,4 Methylenedioxymethamphetamine
**Other Names:**
- MDMA
- Ecstasy
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- Methylphenidate
**Description:** Single dose of methylphenidate (60mg), orally in form of capsules
**Name:** Methylphenidate
**Other Names:**
- Ritalin
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** The Multifaceted Empathy Test is a task assessing the cognitive and emotional aspects of empathy. Participants process 40 photos of people in emotionally charged situations. Each aspect of empathy (implicit and explicit emotional empathy, and cognitive empathy) is tested with 20 positive valence stimuli and 20 negative valence stimuli, yielding a total of 120 trials.
**Measure:** Multifaceted Empathy Test
**Time Frame:** t0 - 10 days (+/- 7 days) and t0 + 4 weeks (+/- 3 days); t0 being the day of substance administration
**Description:** The Moral Inference task is an approach to evaluate the computational basis of moral inference and its temporal dynamics. Participants observe and predict the decisions of two "agents" who repeatedly choose on administering painful electric shocks to another person in a different room in return for money, and rate them every third trial for their moral character. At the end of the game there is a short trust game. Participants can win actual money in this game (up to 1 CHF).
**Measure:** Moral Inference Task
**Time Frame:** t0 - 10 days (+/- 7 days) and t0 + 4 weeks (+/- 3 days); t0 being the day of substance administration
**Description:** The Zurich Prosocial Game is a computer-based pro-social game which allows for assessment of prosocial behavior, considering the influence of helping cost, distress cues in helping behavior, and reciprocity on pro-social behavior through different trial types. Participants can win actual money in this game (up to 6.50 CHF).
**Measure:** Zurich Prosocial Game
**Time Frame:** t0 - 10 days (+/- 7 days) and t0 + 4 weeks (+/- 3 days); t0 being the day of substance administration
**Description:** The Social Gaze Task is a paradigm in which participants' gaze is used to control the gaze of a tropomorphic virtual figure. The aim is to capture the reciprocal and interactive nature of joint attention. Participants' gaze behavior is recorded using an eye-tracking device. The outcome measures we will use are pupil size, valence, and arousal ratings.
**Measure:** Social Gaze Task
**Time Frame:** t0 - 10 days (+/- 7 days) and t0 + 4 weeks (+/- 3 days); t0 being the day of substance administration
**Description:** In the Moral Expansion Task, the influence of social distance is elicited by having participants indicate countries with different social distances and decide how much money out of CHF 100 they would like to donate to the Red Cross in each country. One participant's choice is then randomly selected, and the donation is implemented while the chosen participant receives the remaining amount.
**Measure:** Moral Expansion Task
**Time Frame:** t0 - 10 days (+/- 7 days) and t0 + 4 weeks (+/- 3 days); t0 being the day of substance administration
**Description:** The Social Network Questionnaire is used to assess the size of a person's social network and the emotional support and strain experienced from that network. Participants provide the initials of personal contacts from various domains with whom they have had contact with in the past 4 weeks. 28 items are rated on a 6-point scale, asking how much emotional support and emotional burden they have felt from their social contacts. The total score for those items ranges from 28 to 168.
**Measure:** Social Network Questionnaire
**Time Frame:** t0 - 10 days (+/- 7 days) and t0 + 4 weeks (+/- 3 days); t0 being the day of substance administration
**Description:** The Pro-social Voting Behavior is used to evaluate pro-social voting behavior as a real-world measure of social behavior. The scale consists of 11 items. Each item is rated on a 4-point scale. The total score ranges from 11 to 44. Not all items are accounted equally to capture pro-social voting behavior, as some are reversed.
**Measure:** Pro-social Voting Behavior
**Time Frame:** t0 - 10 days (+/- 7 days) and t0 + 4 weeks (+/- 3 days); t0 being the day of substance administration
**Description:** The Oxford Utilitarianism Scale measures two dimensions of utilitarian tendencies. The scale consists of 9 items. Each item is rated on a 7-point scale. The total score ranges from 9 to 63.
**Measure:** Oxford Utilitarianism Scale
**Time Frame:** t0 - 10 days (+/- 7 days) and t0 + 4 weeks (+/- 3 days); t0 being the day of substance administration
**Description:** The Compassion Scale measures an individual's level of compassion towards others. The scale consists of 16 items. Each item is rated on a 5-point scale. The total score ranges from 16 to 80.
**Measure:** Compassion Scale
**Time Frame:** t0 - 10 days (+/- 7 days) and t0 + 4 weeks (+/- 3 days); t0 being the day of substance administration
**Description:** The Inclusion of others in the self is designed to assess the perceived relationship between an individual's self and other people/all living things. It consists of two items. Each item is rated as circles corresponding to a numerical score, ranging from 1 to 8. The total score ranges from 2 to 16.
**Measure:** Inclusion of others in the self
**Time Frame:** t0 - 10 days (+/- 7 days), t0, and t0 + 4 weeks (+/- 3 days); t0 being the day of substance administration
#### Secondary Outcomes
**Description:** The 5-Dimensional Altered States of Consciousness Rating Scale measures subjective experiences of altered states of consciousness. It contains 94 items, which are formulated as a visual analog scale, assessing different dimensions of altered states of consciousness.
**Measure:** 5-Dimensional Altered States of Consciousness Rating Scale
**Time Frame:** t0 (the day of substance administration)
**Description:** The 5-Dimensional Altered States of Consciousness Rating Scale short is a shorter version of the 5-Dimensional Altered States of Consciousness Rating Scale for measuring subjective experiences of altered states of consciousness. The scale consists of 15 items chosen from the full version, which are formulated as a visual analog scale.
**Measure:** 5-Dimensional Altered States of Consciousness Rating Scale short
**Time Frame:** t0 (the day of substance administration)
**Description:** The Mystical Experience Questionnaire is used to assess mystical experiences. The scale consists of 30 items. Each item is rated on a 6-point scale (from 0 to 5). The total score ranges from 0 to 150.
**Measure:** Mystical Experience Questionnaire
**Time Frame:** t0 (the day of substance administration)
**Description:** The Persisting Effects Questionnaire is used to assess changes in attitudes, moods, behavior, and spiritual experience. The scale consists of 144 items. 140 items are rated on a 6-point scale (from 0 to 5). The last four items use different scaling. The total score ranges from 4 to 724.
**Measure:** Persisting Effects Questionnaire
**Time Frame:** t0 + 4 weeks (+/- 3 days) and t0 + 16 weeks (+/- 7 days); t0 being the day of substance administration
**Description:** The Epistemic and personal transformation is used to capture the intensity and qualities of epistemic and personal transformation and participants' expectations and desires thereof. Both pre and post versions include open questions and 4 items that are rated on a visual analog scale from 0 to 100. The total score ranges from 0 to 400 for pre and post versions each. The post version additionally captures the substance intake assumption of the participants.
**Measure:** Epistemic and personal transformation (pre and post versions)
**Time Frame:** t0 (the day of substance administration)
**Description:** The Symptom Checklist 90-R is used to assess a broad range of psychological problems and symptoms of psychopathology within the past seven days. It consists of 90 items. Each item is rated on a 5-point scale (from 0 to 4). The total score ranges from 0 to 360.
**Measure:** Symptom Checklist 90-R
**Time Frame:** t0 - 10 days (+/- 7 days) and t0 + 16 weeks (+/- 7 days); t0 being the day of substance administration
**Description:** The Positive and Negative Affect Schedule is used to assess both positive and negative affect. It consists of two 10-item scales, one measuring positive affect and one measuring negative affect. Each item is rated on a 5-point scale (from 0 to 4). The total scores range from 0 to 80.
**Measure:** The Positive and Negative Affect Schedule
**Time Frame:** t0 - 10 days (+/- 7 days), t0, t0 + 4 weeks (+/- 3 days), and t0 + 16 weeks (+/- 7 days); t0 being the day of substance administration
**Description:** The FEELINGS scales consist of a series of six short questionnaires to assess regulation, self-esteem, satisfaction with life, life orientation, and meaning in life. Emotional Regulation Questionnaire uses a 7-point scale with a total score range from 7 to 70 (10 items). Satisfaction with Life Scale uses a 7-point scale with a total score range from 5 to 35 (5 items). Rosenberg Self-Esteem Scale uses a 4-point scale with a total score range from 10 to 40 (10 items). Life Orientation Test-Revised uses a 5-point scale with a total score range from 10 to 50 (10 items). Lebenssinn-Fragebogen uses a 7-point scale with a total score range from 10 to 70 (10 items). HSF uses a 5-point scale with a total score range from 6 to 30 (6 items).
**Measure:** FEELINGS
**Time Frame:** t0 - 10 days (+/- 7 days) and t0 + 16 weeks (+/- 7 days); t0 being the day of substance administration
**Description:** Ego Consciousness Change of Perspective Questionnaire is used to measure the two dimensions Consciousness and Ego. Questions for the acute effects of substance intake (27 items) and questions for the longer-lasting effects (6 items) are included. Each item is rated on a visual analog scale from 0 to 100. The total score ranges from 0 to 3300.
**Measure:** Ego Consciousness Change of Perspective Questionnaire (1 & 2)
**Time Frame:** t0 and t0 + 4 weeks (+/- 3 days); t0 being the day of substance administration
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Healthy male or female at the age of 18-40
* Willing and capable to give informed consent for study participation as documented by signature (Informed Consent Form) after the nature of the study has been thoroughly explained
* Willing to refrain from drinking alcohol the day before testing session, from drinking alcohol and caffeinated drinks at the testing days and from consuming psychoactive substances two weeks before the first investigation visit and for the duration of the study
* Willing to abstain from using drugs that may interfere with the effects of the study medications including sleeping aids, cough medications, beta-blocker or other substances with potentially relevant psychoactive and cardiovascular effects.
* Able and willing to comply with all study requirements
* Good physical health with no unstable medical conditions, as determined by medical history, physical examination, routine blood labs, electrocardiogram, urine analysis, and urine toxicology
* Women of childbearing potential (as defined by: 'the age of carrying or giving birth to a child', normally between 14-45 years of age, not in menopause, last menstrual period (LMP) less than 12 months, no removal of ovaries or uterus, no ligature of Fallopian tubes') must be using an effective, established method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices. Note: female participants who are surgically sterilized/hysterectomized or post-menopausal for longer than 2 years are not considered as being of childbearing potential
* Willing not to drive a traffic vehicle or to operate machines within 48h following substance administration
* Have a family member or friend who can pick them up after the substance administration sessions (driving is forbidden at drug treatment days)
Exclusion Criteria:
* Poor knowledge of the German language
* Previous significant adverse response to a hallucinogenic drug (incl. psilocybin), MDMA, or methylphenidate
* Allergy or hypersensitivity to previous use of MDMA, psilocybin, or methylphenidate
* Lifetime history of hallucinogen (incl. psilocybin), MDMA, or methylphenidate use on more than 10 occasions
* Personal and family history of major psychiatric disease (e.g., schizophrenia, schizoaffective disorder, psychosis, major depression, bipolar disorder, psychotic disorder, substance addiction/abuse other than caffeine and nicotine) as defined in the DSM-V (1st and 2nd degree relatives)
* History of suicidal behavior
* Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, etc. of the participant
* Attention-Deficit/Hyperactivity-Disorder (ADHD)
* Any current major medical condition (e.g., neurologic, cardiovascular, metabolic, infectious disease) or any unstable illness as determined by medical history or laboratory tests
* Uncorrected hypo-or hyperthyroidism
* Uncorrected hypo-and hypertension
* Epilepsy
* Abnormal electrocardiogram
* BMI \<17 or \>35
* Personal history of head trauma, brain/cardiac surgery, fainting, or electroconvulsive therapy
* Personal and family history of seizure disorder and strokes (1st and 2nd degree relatives)
* Participation in another study where pharmaceutical compounds are given within the 30 days preceding and during the present study
* Current psychopharmacological treatment or medication that affects brain function
* Use of medications that are contraindicated or otherwise interfere with the effects of the study medications (monoamine oxidase inhibitors, antidepressants, sedatives etc.)
* Women who are pregnant or breast feeding, or have the intention to become pregnant during the study (for safety reasons, a urine pregnancy test will be done at the screening visit and before the substance administration)
* Enrollment of the investigator, his/her family members, employees, and other dependent persons
**Healthy Volunteers:** True
**Maximum Age:** 40 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Lydia Belinger
**Phone:** 058 384 34 15
**Phone Ext:** +41
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Zürich
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Lydia Belinger
- **Phone:** 058 384 34 15
- **Phone Ext:** +41
- **Role:** CONTACT
***Contact 2:***
- **Name:** Marcus Herdener, PD Dr. med.
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 3:***
- **Name:** Lydia Belinger, MSc
- **Role:** SUB_INVESTIGATOR
***Contact 4:***
- **Name:** Etna E.J. Engeli, Dr.
- **Role:** SUB_INVESTIGATOR
***Contact 5:***
- **Name:** Nathalie M. Rieser, Dr.
- **Role:** SUB_INVESTIGATOR
***Contact 6:***
- **Name:** Laurent Becciolini, Dr. med.
- **Role:** SUB_INVESTIGATOR
**Country:** Switzerland
**Facility:** Psychiatrische Universitätsklinik Zürich
**Status:** RECRUITING
**Zip:** 8032
### References Module
#### References
**Citation:** Preller KH, Vollenweider FX. Modulation of Social Cognition via Hallucinogens and "Entactogens". Front Psychiatry. 2019 Dec 3;10:881. doi: 10.3389/fpsyt.2019.00881. eCollection 2019.
**PMID:** 31849730
**Citation:** Cruwys T, Haslam SA, Dingle GA, Haslam C, Jetten J. Depression and Social Identity: An Integrative Review. Pers Soc Psychol Rev. 2014 Aug;18(3):215-238. doi: 10.1177/1088868314523839. Epub 2014 Apr 12.
**PMID:** 24727974
## Derived Section
### Intervention Browse Module - Ancestors
- ID: D000000697
- Term: Central Nervous System Stimulants
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000018765
- Term: Dopamine Uptake Inhibitors
- ID: D000014179
- Term: Neurotransmitter Uptake Inhibitors
- ID: D000049990
- Term: Membrane Transport Modulators
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000015259
- Term: Dopamine Agents
- ID: D000018377
- Term: Neurotransmitter Agents
- ID: D000006213
- Term: Hallucinogens
- ID: D000011619
- Term: Psychotropic Drugs
- ID: D000018490
- Term: Serotonin Agents
- ID: D000018759
- Term: Adrenergic Uptake Inhibitors
- ID: D000018663
- Term: Adrenergic Agents
### 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: M20876
- Name: N-Methyl-3,4-methylenedioxyamphetamine
- Relevance: HIGH
- As Found: Theoretical
- ID: M14419
- Name: Psilocybin
- Relevance: HIGH
- As Found: Embolization
- ID: M11748
- Name: Methylphenidate
- Relevance: HIGH
- As Found: Squamous cell carcinoma
- ID: M9305
- Name: Hallucinogens
- Relevance: LOW
- As Found: Unknown
- ID: M15512
- Name: Serotonin
- Relevance: LOW
- As Found: Unknown
- ID: M17835
- Name: 3,4-Methylenedioxyamphetamine
- Relevance: LOW
- As Found: Unknown
- ID: M4029
- Name: Central Nervous System Stimulants
- 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: M20504
- Name: Neurotransmitter Agents
- Relevance: LOW
- As Found: Unknown
- ID: M14474
- Name: Psychotropic Drugs
- Relevance: LOW
- As Found: Unknown
- ID: M20746
- Name: Adrenergic Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000008774
- Term: Methylphenidate
- ID: D000011562
- Term: Psilocybin
- ID: D000018817
- Term: N-Methyl-3,4-methylenedioxyamphetamine
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT02662179
**Brief Title:** Are the Fried Criteria Predictive of a Functional Decline in Older People With Solid Malignant Tumors?
**Official Title:** Are the Fried Criteria Predictive of a Functional Decline in Older People With Solid Malignant Tumors?
#### Organization Study ID Info
**ID:** CHUB-Fried
#### Organization
**Class:** OTHER
**Full Name:** Brugmann University Hospital
### Status Module
#### Completion Date
**Date:** 2019-04-02
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-04-04
**Type:** ACTUAL
**Last Update Submit Date:** 2019-04-02
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2019-04-02
**Type:** ACTUAL
#### Start Date
**Date:** 2015-11-01
**Type:** ACTUAL
**Status Verified Date:** 2019-04
#### Study First Post Date
**Date:** 2016-01-25
**Type:** ESTIMATED
**Study First Submit Date:** 2015-11-27
**Study First Submit QC Date:** 2016-01-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Brugmann University Hospital
#### Responsible Party
**Investigator Affiliation:** Brugmann University Hospital
**Investigator Full Name:** Murielle Surquin
**Investigator Title:** Head of clinic
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Identifying the frail elderly patients or those at risk of becoming frail has become a cornerstone of modern geriatric medicine. Many instruments have been developed to identify fragility at the individual level. The 'Fragile' phenotype defined by Fried is based on 5 criteria: weakness, slowness, low level of activity, exhaustion, and unintentional weight loss. The patient is fragile if it meets at least three out of five criteria. It is 'pre-fragile' if it meets one or two criteria.
In onco-geriatrics, the International onco-geriatrics society recommends the implementation of a 'G8 scale' to detect elderly patients at risk of fragility. People with a positive G8 are then referred to the geriatric team to benefit from a comprehensive geriatric assessment. This evaluation is interpreted by the geriatrician, who proposes an action plan to overcome the various problems of the elderly patient. The evaluation can also help the oncologist in the choice of treatment for the patient: palliative care, standard treatment or adapted treatment (No-go, Go-go or slow-go).
The investigators would like to assess if fragility as defined by the Fried criteria is predictive of a functional, physical or cognitive decline, or a loss of quality of life in patients treated for a solid malignant tumor.
Furthermore, they will assess if the frailness categorization has an impact on the oncologic treatment decision. Does the oncologist switches the patient's oncologic treatment after being informed of the frailness status ?
**Detailed Description:** Identifying the frail elderly patients or those at risk of becoming frail has become a cornerstone of modern geriatric medicine. The term 'frail' has been elusive during quite a long time. Several studies have been conducted over the last 15 years to clarify this concept: fragility is a clinical syndrome defined by an increase of vulnerability following a decline in physiological reserves and organic functions, that compromises the ability to cope with daily life or acute stress.
Many instruments have been developed to identify fragility at the individual level. The 'Fragile' phenotype defined by Fried (Cardiovascular Health Study) is based on 5 criteria: weakness, slowness, low level of activity, exhaustion, and unintentional weight loss. The patient is fragile if it meets at least three out of five criteria. It is 'pre-fragile' if it meets one or two criteria.
In onco-geriatrics, the International onco-geriatrics society recommends the implementation of a 'G8 scale' to detect elderly patients at risk of fragility. People with a positive G8 are then referred to the geriatric team to benefit from a comprehensive geriatric assessment. This evaluation is interpreted by the geriatrician, who draws an action plan to overcome the various problems of the elderly patient. The evaluation also helps the oncologist in the choice of treatment for the patient: palliative care, standard treatment or adapted treatment (No-go, Go-go or slow-go).
However, many studies have shown that fragile patients had a greater morbidity and mortality than non-fragile patients. The rate of postoperative complications and the length of stay are significantly higher in fragile patients suffering from a colorectal cancer treated by elective surgery.
On the other hand and quite surprisingly, another study showed that none of the comprehensive geriatric assessment based fragility indicators was able to predict a post-surgery functional decline in patients having undergone surgery for colorectal cancer.
One of the primary goals of geriatry being to maintain the autonomy and independence of patients.
The investigators would thus like to assess if fragility as defined by the Fried criteria is predictive of a functional, physical or cognitive decline, or a loss of quality of life in patients treated for a solid malignant tumor.
Furthermore, they will assess if the frailness categorization has an impact on the oncologic treatment decision. Does the oncologist switches the patient's oncologic treatment after being informed of the frailness status ?
### Conditions Module
**Conditions:**
- Elderly Patients With a Solid Tumor
**Keywords:**
- Elderly patients
- Onco-geriatrics
- Fried criteria
### Design Module
#### Design Info
**Observational Model:** OTHER
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 62
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The group will include elderly patients with a malignant solid tumor: ovary cancer, breast cancer, digestive cancer (colo-rectal, pancreas), lung cancer or urinary tract cancer (including bladder cancer).
**Intervention Names:**
- Other: Quality of life evaluation
- Other: Functional decline assessment
- Other: Physical decline assessment
- Other: Cognitive decline assessment
**Label:** Elderly patients with solid tumors
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Elderly patients with solid tumors
**Description:** Assess the quality of life ('SF-36' questionnaire) of patients 3 and 6 months after oncologic treatment. Since a diagnosis of frailness will have been established before the oncologic treatment, a correlation between the decline and the 'frail' categorization according to the Fried criteria can be established or denied.
**Name:** Quality of life evaluation
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Elderly patients with solid tumors
**Description:** Assess functional decline ('Katz ADL' Score and 'Lawton IADL' Score) 3 and 6 months after oncologic treatment. Since a diagnosis of frailness will have been established before the oncologic treatment, a correlation between the decline and the 'frail' categorization according to the Fried criteria can be established or denied.
**Name:** Functional decline assessment
**Type:** OTHER
#### Intervention 3
**Arm Group Labels:**
- Elderly patients with solid tumors
**Description:** Assess physical decline (walking speed and prehension force) 3 and 6 months after oncologic treatment. Since a diagnosis of frailness will have been established before the oncologic treatment, a correlation between the decline and the 'frail' categorization according to the Fried criteria can be established or denied.
**Name:** Physical decline assessment
**Type:** OTHER
#### Intervention 4
**Arm Group Labels:**
- Elderly patients with solid tumors
**Description:** Assess cognitive decline 3 and 6 months ('MMSE 30' questionnaire) after oncologic treatment. Since a diagnosis of frailness will have been established before the oncologic treatment, a correlation between the decline and the 'frail' categorization according to the Fried criteria can be established or denied.
**Name:** Cognitive decline assessment
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The functional decline will be assessed by using the Katz Basic Activities of Daily Living (ADL) score
**Measure:** Functional decline - Katz (ADL)
**Time Frame:** 3 months after oncologic treatment
**Description:** The functional decline will be assessed by using the Katz Basic Activities of Daily Living (ADL) score
**Measure:** Functional decline - Katz (ADL)
**Time Frame:** 6 months after oncologic treatment
**Description:** The functional decline will be assessed by using the Lawton Instrumental Activities of Daily Living (IADL) score
**Measure:** Functional decline - Lawton (IADL)
**Time Frame:** 3 months after oncologic treatment
**Description:** The functional decline will be assessed by using the Lawton Instrumental Activities of Daily Living (IADL) score
**Measure:** Functional decline - Lawton (IADL)
**Time Frame:** 6 months after oncologic treatment
**Description:** Will be assessed by the 'Timed Up and Go' test (TUG)
**Measure:** Physical decline - walking speed
**Time Frame:** 3 months after oncologic treatment
**Description:** Will be assessed by the 'Timed Up and Go' test (TUG)
**Measure:** Physical decline - walking speed
**Time Frame:** 6 months after oncologic treatment
**Description:** Prehension force (Grip test) will be measured
**Measure:** Physical decline - prehension force
**Time Frame:** 3 months after oncologic treatment
**Description:** Prehension force (Grip test) will be measured
**Measure:** Physical decline - prehension force
**Time Frame:** 6 months after oncologic treatment
**Description:** Will be assessed by the mini mental state evaluation (MMSE 30) questionnaire
**Measure:** Cognitive decline - MMSE 30
**Time Frame:** 3 months after oncologic treatment
**Description:** Will be assessed by the mini mental state evaluation (MMSE 30) questionnaire
**Measure:** Cognitive decline - MMSE 30
**Time Frame:** 6 months after oncologic treatment
**Description:** Will be assessed by the Short Form-36 (SF-36) questionnaire
**Measure:** Quality of life - SF 36
**Time Frame:** 3 months after oncologic treatment
**Description:** Will be assessed by the Short Form-36 (SF-36) questionnaire
**Measure:** Quality of life - SF36
**Time Frame:** 6 months after oncologic treatment
#### Secondary Outcomes
**Description:** Patients will be classified as frail, vulnerable or robust according to the Fried criteria. Does the oncologist changes his/her therapeutic treatment decision after being aware of the frailness categorization ?
**Measure:** Switch in oncologic treatment decision
**Time Frame:** Between diagnosis and oncologic treatment - maximum 8 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients with a solid malign tumor: ovary cancer, breast cancer, digestive cancer (colo-rectal, pancreas), lung cancer, urinary tract cancer (including bladder cancer).
* Patients having not undergone treatment yet (be it surgery, chemotherapy or radiotherapy)
* Ambulatory or hospitalized patients
Exclusion Criteria:
* Patients unable to participate in the global geriatric evaluation (auditive or visual problems)
* Language barrier
* Clear therapeutic abstention
* Bedridden patients
**Minimum Age:** 70 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- OLDER_ADULT
**Study Population:** Elderly patients with solid tumors
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Brussels
**Country:** Belgium
**Facility:** Erasme Hospital
**Zip:** 1070
**Location 2:**
**City:** Brussels
**Country:** Belgium
**Facility:** CHU Brugmann
#### Overall Officials
**Official 1:**
**Affiliation:** CHU Brugmann
**Name:** Florence Rousseau, MD
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** CHU Brugmann
**Name:** Murielle Surquin, MD,PhD
**Role:** PRINCIPAL_INVESTIGATOR
### References Module
#### References
**Citation:** Chen X, Mao G, Leng SX. Frailty syndrome: an overview. Clin Interv Aging. 2014 Mar 19;9:433-41. doi: 10.2147/CIA.S45300. eCollection 2014.
**PMID:** 24672230
**Citation:** Extermann M, Aapro M, Bernabei R, Cohen HJ, Droz JP, Lichtman S, Mor V, Monfardini S, Repetto L, Sorbye L, Topinkova E; Task Force on CGA of the International Society of Geriatric Oncology. Use of comprehensive geriatric assessment in older cancer patients: recommendations from the task force on CGA of the International Society of Geriatric Oncology (SIOG). Crit Rev Oncol Hematol. 2005 Sep;55(3):241-52. doi: 10.1016/j.critrevonc.2005.06.003.
**PMID:** 16084735
**Citation:** Kristjansson SR, Nesbakken A, Jordhoy MS, Skovlund E, Audisio RA, Johannessen HO, Bakka A, Wyller TB. Comprehensive geriatric assessment can predict complications in elderly patients after elective surgery for colorectal cancer: a prospective observational cohort study. Crit Rev Oncol Hematol. 2010 Dec;76(3):208-17. doi: 10.1016/j.critrevonc.2009.11.002. Epub 2009 Dec 14.
**PMID:** 20005123
**Citation:** Ronning B, Wyller TB, Jordhoy MS, Nesbakken A, Bakka A, Seljeflot I, Kristjansson SR. Frailty indicators and functional status in older patients after colorectal cancer surgery. J Geriatr Oncol. 2014 Jan;5(1):26-32. doi: 10.1016/j.jgo.2013.08.001. Epub 2013 Aug 30.
**PMID:** 24484715
## Derived Section
### Condition Browse Module - Meshes
- ID: D000009369
- Term: Neoplasms
### Intervention Browse Module - Browse Branches
- Abbrev: Gast
- Name: Gastrointestinal Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M22554
- Name: Pancrelipase
- Relevance: LOW
- As Found: Unknown
- ID: M13114
- Name: Pancreatin
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT04712279
**Brief Title:** The (HD)IVACOV Trial (The High-Dose IVermectin Against COVID-19 Trial)
**Official Title:** High-Dose Ivermectin for Mild-to-Moderate COVID-19 - The (HD)IVACOV Trial
#### Organization Study ID Info
**ID:** CORPO-DRUG-SARSCoV2-001
#### Organization
**Class:** OTHER
**Full Name:** Corpometria Institute
### Status Module
#### Completion Date
**Date:** 2021-04-20
**Type:** ESTIMATED
#### Expanded Access Info
**Last Known Status:** NOT_YET_RECRUITING
#### Last Update Post Date
**Date:** 2021-01-15
**Type:** ACTUAL
**Last Update Submit Date:** 2021-01-14
**Overall Status:** UNKNOWN
#### Primary Completion Date
**Date:** 2021-03-21
**Type:** ESTIMATED
#### Start Date
**Date:** 2021-01-25
**Type:** ESTIMATED
**Status Verified Date:** 2021-01
#### Study First Post Date
**Date:** 2021-01-15
**Type:** ACTUAL
**Study First Submit Date:** 2021-01-13
**Study First Submit QC Date:** 2021-01-14
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Corpometria Institute
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Is US Export:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Ivermectin, a classical antiparasitic and anti-scabies agent, has demonstrated antiviral activity for a variety of viruses including chikungunya virus, zyka virus and dengue virus and was tested as a potentially effective for COVID-19.
Although ivermectin demonstrated potent in vitro action by reducing viral load by 5000x after 48 hours of incubation, simultaneous pharmacokinetics simulations suggested that the minimum effective concentrations would be unfeasible to be reached within safety range (EC-50 = 2 Micromol).
However, despite the theoretical unfeasible concentrations to be achieved, preliminary observational yet well-structured studies followed by randomized clinical trials (RCTs) demonstrated ivermectin efficacy when combined with hydroxychloroquine, doxycycline or azithromycin, which was corroborated by a recent systematic review and metanalysis. In common, a dose-response effect for effectiveness was observed, and no adverse effects was reported at any dose between 0.2mg/kg/day and 1.0mg/kg/day.
Based on the scientific rationale combined with the preliminary evidence, ivermectin has sufficient evidence to be tested in higher doses in a RCT for COVID-19. The investigators propose to test ivermectin at high doses as a treatment for patients recently diagnosed with COVID-19, aiming to explore the possible protective role of high-dose ivermectin in SARS-CoV-2 infection in terms of reduction of clinic and virologic disease duration, and prevention of oxygen use, hospitalization, mechanical ventilation, death, and post-COVID persisting symptoms.
**Detailed Description:** Overall
COVID-19 is a multisystemic disease caused by SARS-CoV-2 that has become a pandemic largely due to a combination of favorable transmission and infection characteristics for its spread, including prolonged preclinical or also asymptomatic yet transmitting period, relatively highly resistant to mechanical and physical barriers and prolonged survival in the air, and transmission patterns not yet fully elucidated.
While vaccines are not widely available, the number of new cases should not decrease dramatically, unfortunately, since a large percentage of the population has not been infected by the SARS-CoV-2 yet, reinfection becomes increasingly plausible with mutations in the virus, and virus contention policies failed to be 100% effective.
Considering potential antiviral approaches for COVID-19, their effectiveness only make sense if tested and given early in the disease, during viral dissemination. The learning that oseltamivir is only effective for Influenza A in the first three days of disease finds strong plausibility, and reinforces the expected lack of effectiveness of any drug with in vitro or preliminary antiviral activity reported when tested in hospitalized or non-mild patients, once COVID-19 presents tend to present mild symptoms during the viral dissemination stage.
An actual early detection of COVID-19, i.e., before its progression to further inflammatory stages, is challenging, once the earliest symptoms tend to be unspecific, mild, and hardly attributable to COVID-19. By suspecting of COVID-19 in the presence of any symptom, specific to COVID-19 or not, sensitivity was met to be above 90% while specificity was also relatively high (above 50%). In addition, time-to-treat, rather than which drug to choose, could better determine the effectiveness of a specific approach.
Ivermectin: potential antiviral activity for COVID-19
Among drugs potentially effective for COVID-19, despite the classical antiparasitic and anti-scabies use, ivermectin has demonstrated antiviral activity for a variety of viruses by inhibiting and reducing the viral shedding duration, including chikungunya and other alphaviruses, zyka virus, dengue virus and other simple-strain RNA viruses.
In the search for drugs with anti-SARS-CoV-2 activity, considering its effects on other viruses, ivermectin was tested in a Vero-hSLAM cell model and demonstrated potent in vitro action, by reducing viral load by 5000x after 48 hours of incubation. However, after initial promising results, simultaneous pharmacokinetics simulations suggested that the minimum effective concentrations would be unfeasible to be reached within safety range (EC-50 = 2 Micromol).
Although the theoretical minimum concentration required for antiviral action was apparently at least 17 times higher than the lethal dose and up to 10,000 times the usually prescribed doses for humans ( IC50 of 2.2 - 2.8 µM for monkeys), which would reduce the chances of ivermectin efficacy for COVID-19, preliminary observational yet well-structured studies demonstrated substantial synergistic action of ivermectin when added to "standard of care", usually hydroxychloroquine with or without macrolides. In a specific study, the use of ivermectin, even in low doses, reduced by 40% the absolute risk of death among patients more severely affected by COVID-19.
Some randomized clinical trials (RCTs) demonstrated efficacy of ivermectin when combined with hydroxychloroquine, doxycycline or azithromycin, in both mildly (and presumedly early) and more severely affected subjects with COVID-19. Demonstrated benefits included lower disease progression and reduced COVID-related mortality.
In comparative analyses, combinations between ivermectin and azithromycin, doxycycline or hydroxychloroquine demonstrated superiority compared to combinations between hydroxychloroquine and azithromycin or hydroxychloroquine alone.
The exact mechanisms of action remain nuclear. At least one study employing higher doses (0.6mg/kg/day) demonstrated in vivo antiviral activity, but only when maximum concentration reached serum levels above 160 ng/ml, which only occurred in 45% of subjects, even at higher doses. The antiviral mechanisms include modification in the ACE-2 glycation patterns, inhibition of the viral Helicase (NSP13) and disruption of the alpha-importin heterodimer.
In a recent systematic review and metanalysis, a dose-response correlation has also been observed in terms of endpoints, reinforcing the role of ivermectin as actins as an anti-SARS-CoV-2 action drug. However, even in lower doses ivermectin was able to demonstrate clinical benefits, allowing the hypothesis that ivermectin also exerts anti-inflammatory effects, which could include the blockage of STAT-1 migration to the nucleus, and could justify its use even at later stages of the disease.
Collectively, higher yet safe ivermectin doses find stronger plausibility and preliminary evidence to be tested in RCTs. In addition, approaches to increase ivermectin absorption and bioavailability should be encouraged.
Based on the scientific rationale combined with preliminary evidence, ivermectin has sufficient evidence to be tested at higher doses in a RCT for COVID-19. The investigators propose to test ivermectin at high doses as a treatment for patients recently diagnosed with COVID-19. This study is intended to explore the possible protective role of high-dose ivermectin in SARS-CoV-2 infection in terms of reduction of clinic and virologic disease duration, and prevention of oxygen use, hospitalization, mechanical ventilation, death, and post-COVID persisting symptoms.
### Conditions Module
**Conditions:**
- Covid19
**Keywords:**
- COVID-19
- SARS-CoV-2
- Covid19
- Ivermectin
### 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:** 294
**Type:** ESTIMATED
**Phases:**
- PHASE2
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Drug: Ivermectin 0.6mg/kg/day
- Drug: Hydroxychloroquine
**Label:** Ivermectin 0.6mg/kg/day
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Intervention Names:**
- Drug: Ivermectin 1.0mg/kg/day
- Drug: Hydroxychloroquine
**Label:** Ivermectin 1.0mg/kg/day
**Type:** ACTIVE_COMPARATOR
#### Arm Group 3
**Intervention Names:**
- Drug: Placebo
- Drug: Hydroxychloroquine
**Label:** Placebo
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Ivermectin 0.6mg/kg/day
**Description:** Use of ivermectin 0.6m/kg/day q.d.for 05 days
**Name:** Ivermectin 0.6mg/kg/day
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Ivermectin 1.0mg/kg/day
**Description:** Ivermectin 1.0mg/kg/day q.d. for 05 days
**Name:** Ivermectin 1.0mg/kg/day
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- Placebo
**Description:** Placebo q.d.for 05 days
**Name:** Placebo
**Type:** DRUG
#### Intervention 4
**Arm Group Labels:**
- Ivermectin 0.6mg/kg/day
- Ivermectin 1.0mg/kg/day
- Placebo
**Description:** Hydroxychloroquine 200mg/day q.d. for 05 days
**Name:** Hydroxychloroquine
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Treatment efficacy of high-dose Ivermectin relative to placebo arm as assessed by World Health Organization (WHO) Clinical Progression Scale \[0 to 10; 0 = uninfected; 10 = death\]
**Measure:** World Health Organization (WHO) Clinical Progression Scale [0 to 10; 0 = uninfected; 10 = death]
**Time Frame:** Day 14
#### Secondary Outcomes
**Description:** Treatment efficacy of high-dose Ivermectin relative to placebo arm as assessed by World Health Organization (WHO) COVID=19 Ordinal Scale for Clinical Improvement \[1 to 8; 1 = not hospitalized, no limitation on activities; 8 = death\]
**Measure:** World Health Organization (WHO) COVID=19 Ordinal Scale for Clinical Improvement [1 to 8; 1 = not hospitalized, no limitation on activities; 8 = death] [Time Frame: Day 7]
**Time Frame:** Day 7
**Description:** Recovery is defined as the first day on which the subject satisfies category one from the COVID ordinal scale (defined in Section 5.1): (1) Not hospitalized, no limitations on activities. \[Parameter: Number of days until achieve Category 1 of the World Health Organization (WHO) COVID=19 Ordinal Scale for Clinical Improvement \[1 to 8; 1 = not hospitalized, no limitation on activities; 8 = death\]
**Measure:** Time-to-recovery
**Time Frame:** Day 28
**Description:** Treatment efficacy of high-dose Ivermectin relative to placebo arm as assessed by viral load measured by rtPCR-SARS-CoV-2 (CTs)
**Measure:** Viral load
**Time Frame:** Day 5
**Description:** Treatment efficacy of high-dose Ivermectin relative to placebo arm as assessed by viral load measured by positivity rate (% of positive, detected rtSARS-CoV-2)
**Measure:** Positivity rate of rtPCR-SARS-CoV-2 (qualitative analysis)
**Time Frame:** Day 5
**Description:** Treatment efficacy of high-dose Ivermectin relative to placebo arm as assessed by duration of fatigue (days)
**Measure:** Duration of fatigue
**Time Frame:** Day 14
**Description:** Treatment efficacy of high-dose Ivermectin relative to placebo arm as assessed by duration of anosmia (days)
**Measure:** Duration of anosmia
**Time Frame:** Day 14
**Description:** Treatment efficacy of high-dose Ivermectin relative to placebo arm as assessed by duration of overall symptoms (days)
**Measure:** Overall duration of clinical manifestations
**Time Frame:** Day 14
**Description:** Defined as the number of subjects who have required additional drugs (glucocorticoids, anticoagulants, etc) or interventions allocated to each arm divided by the number of subjects randomized to that specific arm (%). Treatment efficacy of high-dose Ivermectin relative to placebo arm as assessed by the proportion of subjects needing additional drugs or interventions in each arm.
**Measure:** Proportion of subjects needing additional drugs or interventions
**Time Frame:** Day 28
**Description:** Defined as the number of subjects who have required oxygen use allocated to each arm divided by the number of subjects randomized to that specific arm (%). Treatment efficacy of high-dose Ivermectin relative to placebo arm as assessed by the proportion of subjects needing oxygen use in each arm.
**Measure:** Proportion of subjects needing oxygen use
**Time Frame:** Day 28
**Description:** Defined as the number of subjects who have required high-flow oxygen use or non-invasive mechanical ventilation allocated to each arm divided by the number of subjects randomized to that specific arm (%). Treatment efficacy of high-dose Ivermectin relative to placebo arm as assessed by the proportion of subjects needing high-flow oxygen use or non-invasive mechanical ventilation in each arm.
**Measure:** Proportion of subjects needing high-flow oxygen therapy or non-invasive ventilation
**Time Frame:** Day 28
**Description:** Defined as the number of hospitalizations in each arm divided by the number of subjects randomized to that specific arm (%). Treatment efficacy of high-dose Ivermectin relative to placebo arm as assessed by the proportion of hospitalizations in each arm.
**Measure:** Proportion of hospitalizations
**Time Frame:** Day 28
**Description:** Treatment efficacy of high-dose Ivermectin relative to placebo arm as assessed by the number of mechanical ventilation use in each arm divided by the number of subjects randomized to that specific arm (%).
**Measure:** Proportion of mechanical ventilation use
**Time Frame:** Day 28
**Description:** Treatment efficacy of high-dose Ivermectin relative to placebo arm as assessed by the number of subjects needing use of pressors in each arm divided by the number of subjects randomized to that specific arm (%).
**Measure:** Proportion of pressors use
**Time Frame:** Day 28
**Description:** Treatment efficacy of high-dose Ivermectin relative to placebo arm as assessed by the number of subjects who have died in each arm divided by the numbers of subjects randomized to the treatment arm (%).
**Measure:** Proportion of deaths
**Time Frame:** Day 28
**Description:** Treatment efficacy of high-dose Ivermectin relative to placebo arm as assessed by the number of subjects persisting with mental symptoms after COVID-19 resolution in each arm divided by the number of subjects randomized to that specific arm (%).
**Measure:** Proportion of post-COVID mental symptoms
**Time Frame:** Day 30
**Description:** Treatment efficacy of high-dose Ivermectin relative to placebo arm as assessed by the number of subjects persisting with mental symptoms after COVID-19 resolution in each arm divided by the number of subjects randomized to that specific arm (%).
**Measure:** Proportion of post-COVID mental symptoms
**Time Frame:** Day 60
**Description:** Treatment efficacy of high-dose Ivermectin relative to placebo arm as assessed by the number of subjects persisting with mental symptoms after COVID-19 resolution in each arm divided by the number of subjects randomized to that specific arm (%).
**Measure:** Proportion of post-COVID mental symptoms
**Time Frame:** Day 90
**Description:** Treatment efficacy of high-dose Ivermectin relative to placebo arm as assessed by the number of subjects persisting with physical symptoms after COVID-19 resolution in each arm divided by the number of subjects randomized to that specific arm (%).
**Measure:** Proportion of post-COVID physical symptoms
**Time Frame:** Day 30
**Description:** Treatment efficacy of high-dose Ivermectin relative to placebo arm as assessed by the number of subjects persisting with physical symptoms after COVID-19 resolution in each arm divided by the number of subjects randomized to that specific arm (%).
**Measure:** Proportion of post-COVID physical symptoms
**Time Frame:** Day 60
**Description:** Treatment efficacy of high-dose Ivermectin relative to placebo arm as assessed by the number of subjects persisting with physical symptoms after COVID-19 resolution in each arm divided by the number of subjects randomized to that specific arm (%).
**Measure:** Proportion of post-COVID physical symptoms
**Time Frame:** Day 90
**Description:** Treatment efficacy of high-dose Ivermectin relative to placebo arm as assessed by the number of subjects persisting with any symptoms after COVID-19 resolution in each arm divided by the number of subjects randomized to that specific arm (%).
**Measure:** Proportion of post-COVID overall symptoms
**Time Frame:** Day 30
**Description:** Treatment efficacy of high-dose Ivermectin relative to placebo arm as assessed by the number of subjects persisting with any symptoms after COVID-19 resolution in each arm divided by the number of subjects randomized to that specific arm (%).
**Measure:** Proportion of post-COVID overall symptoms
**Time Frame:** Day 60
**Description:** Treatment efficacy of high-dose Ivermectin relative to placebo arm as assessed by the number of subjects persisting with any symptoms after COVID-19 resolution in each arm divided by the number of subjects randomized to that specific arm (%).
**Measure:** Proportion of post-COVID overall symptoms
**Time Frame:** Day 90
**Description:** Treatment efficacy of high-dose Ivermectin relative to placebo arm as assessed by the duration of new oxygen use measured in days among subjects that did not require oxygen upon randomization and required oxygen use after the beginning of treatment, in each arm (days)
**Measure:** Duration of new oxygen use
**Time Frame:** Day 28
**Description:** Treatment efficacy of high-dose Ivermectin relative to placebo arm as assessed by the duration of hospitalization measured in days among subjects that required hospitalization, in each arm (days)
**Measure:** Duration of hospitalization
**Time Frame:** Day 28
**Description:** Treatment efficacy of high-dose Ivermectin relative to placebo arm as assessed by the duration of mechanical ventilation measured in days among subjects that required mechanical ventilation, in each arm (days)
**Measure:** Duration of mechanical ventilation
**Time Frame:** Day 28
**Description:** Treatment efficacy of high-dose Ivermectin relative to placebo arm as assessed by the number of subjects presenting increased ultrasensitive C-reactive protein (usCRP) at Days 1, 2, 3 and 7, divided by the number of subjects randomized to that specific arm (%).
**Measure:** Proportion of increased ultrasensitive C-reactive protein (usCRP) (defined as usRCP > 7 mg/L)
**Time Frame:** Day 1
**Description:** Treatment efficacy of high-dose Ivermectin relative to placebo arm as assessed by the number of subjects presenting increased ultrasensitive C-reactive protein (usCRP) at Days 1, 2, 3 and 7, divided by the number of subjects randomized to that specific arm (%).
**Measure:** Proportion of increased ultrasensitive C-reactive protein (usCRP) (defined as usRCP > 7 mg/L)
**Time Frame:** Day 3
**Description:** Treatment efficacy of high-dose Ivermectin relative to placebo arm as assessed by the number of subjects presenting increased ultrasensitive C-reactive protein (usCRP) at Days 1, 2, 3 and 7, divided by the number of subjects randomized to that specific arm (%).
**Measure:** Proportion of increased ultrasensitive C-reactive protein (usCRP) (defined as usRCP > 7 mg/L)
**Time Frame:** Day 7
**Description:** Treatment efficacy of high-dose Ivermectin relative to placebo arm as assessed by the number of subjects presenting ESR decrease \> 50% at Days 2, 3 and 7, divided by the number of subjects randomized to that specific arm (%).
**Measure:** Proportion of decrease in erythrocyte sedimentation rate (ESR) (defined as ESR decrease > 50% compared to Day 1)
**Time Frame:** Day 1
**Description:** Treatment efficacy of high-dose Ivermectin relative to placebo arm as assessed by the number of subjects presenting ESR decrease \> 50% at Days 2, 3 and 7, divided by the number of subjects randomized to that specific arm (%).
**Measure:** Proportion of decrease in erythrocyte sedimentation rate (ESR) (defined as ESR decrease > 50% compared to Day 1)
**Time Frame:** Day 3
**Description:** Treatment efficacy of high-dose Ivermectin relative to placebo arm as assessed by the number of subjects presenting ESR decrease \> 50% at Days 2, 3 and 7, divided by the number of subjects randomized to that specific arm (%).
**Measure:** Proportion of decrease in erythrocyte sedimentation rate (ESR) (defined as ESR decrease > 50% compared to Day 1)
**Time Frame:** Day 7
**Description:** Treatment efficacy of high-dose Ivermectin relative to placebo arm as assessed by the number of subjects presenting eosinophils increase \> 50% at Days 2, 3 and 7, divided by the number of subjects randomized to that specific arm (%).
**Measure:** Proportion of increase in eosinophils (defined as eosinophils increase > 50% compared to Day 1)
**Time Frame:** Day 1
**Description:** Treatment efficacy of high-dose Ivermectin relative to placebo arm as assessed by the number of subjects presenting eosinophils increase \> 50% at Days 2, 3 and 7, divided by the number of subjects randomized to that specific arm (%).
**Measure:** Proportion of increase in eosinophils (defined as eosinophils increase > 50% compared to Day 1)
**Time Frame:** Day 3
**Description:** Treatment efficacy of high-dose Ivermectin relative to placebo arm as assessed by the number of subjects presenting eosinophils increase \> 50% at Days 2, 3 and 7, divided by the number of subjects randomized to that specific arm (%).
**Measure:** Proportion of increase in eosinophils (defined as eosinophils increase > 50% compared to Day 1)
**Time Frame:** Day 7
**Description:** Treatment efficacy of high-dose Ivermectin relative to placebo arm as assessed by the number of subjects presenting increased d-dimer protein (usCRP) at Day 7, divided by the number of subjects randomized to that specific arm (%).
**Measure:** Proportion of increased d-dimer (defined as d-dimer > 500 mg/dL)
**Time Frame:** Day 7
**Description:** Treatment efficacy of high-dose Ivermectin relative to placebo arm as assessed by duration of symptoms, complications, or any other COVID-related clinical or biochemical sign of disease
**Measure:** Disease duration
**Time Frame:** Day 14
**Description:** Treatment efficacy of high-dose Ivermectin relative to placebo arm as assessed by change in viral load from baseline to Day 5 measured by rtPCR-SARS-CoV-2 (CTs)
**Measure:** Change in viral load from baseline to Day 5
**Time Frame:** Day 30
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Laboratory or clinically confirmed positive SARS-CoV-2 rtPCR test (AndroCoV Clinical Scoring for COVID-19 Diagnosis1) within 7 days prior to randomization
2. ≥18 years old
3. Laboratory confirmed positive SARS-CoV-2 rtPCR test within 7 days prior to randomization
4. Clinical status on the COVID-19 Ordinal Scale (defined in Section 5.1) of 1 to 3
5. Subject (or legally authorized representative) gives written informed consent prior to performing any study procedures
6. Subject (or legally authorized representative) agree that subject will not participate in another COVID-19 trial while participating in this study
Exclusion Criteria:
1. Subject enrolled in a study to investigate a treatment for COVID-19
2. Require oxygen use, hospitalization or mechanical ventilation
3. Tachycardia (HR \> 150 bpm) or hypotension (BP \< 90/60 mmHg)
4. Patients who are allergic to the investigational product or similar drugs (or any excipients);
5. Subjects with QTcF \> 450 ms
6. Subjects with uncontrolled medical conditions that could compromise participation in the study - uncontrolled hypertension (BP \> 220/120 mmHg), uncontrolled hypothyroidism (TSH \> 10 iU/L), uncontrolled diabetes mellitus (HbA1c \> 12%)
7. Alanine Transaminase (ALT) or Aspartate Transaminase (AST) \> 5 times the upper limit of normal.
8. Estimated glomerular filtration rate (eGFR) \< 30 ml/min or requiring dialysis
9. Subject (or legally authorized representative) not willing or unable to provide informed consent
**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:** Flavio A Cadegiani, MD, PhD
**Phone:** +55 61 99650.6111
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Corpometria Institute
**Name:** Ricardo A Zimerman, MD
**Role:** STUDY_DIRECTOR
**Official 2:**
**Affiliation:** Corpometria Institute; Applied Biology
**Name:** Flavio A Cadegiani, MD, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### References Module
#### References
**Citation:** Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.
**PMID:** 32109013
**Citation:** Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11. Erratum In: Lancet. 2020 Mar 28;395(10229):1038. Lancet. 2020 Mar 28;395(10229):1038.
**PMID:** 32171076
**Citation:** Lauer SA, Grantz KH, Bi Q, Jones FK, Zheng Q, Meredith HR, Azman AS, Reich NG, Lessler J. The Incubation Period of Coronavirus Disease 2019 (COVID-19) From Publicly Reported Confirmed Cases: Estimation and Application. Ann Intern Med. 2020 May 5;172(9):577-582. doi: 10.7326/M20-0504. Epub 2020 Mar 10.
**PMID:** 32150748
**Citation:** Li L, Liu J, Qin K. Comparison of double-dose vs standard-dose oseltamivir in the treatment of influenza: A systematic review and meta-analysis. J Clin Pharm Ther. 2020 Oct;45(5):918-926. doi: 10.1111/jcpt.13203. Epub 2020 Jun 4.
**PMID:** 32497319
**Citation:** Varghese FS, Kaukinen P, Glasker S, Bespalov M, Hanski L, Wennerberg K, Kummerer BM, Ahola T. Discovery of berberine, abamectin and ivermectin as antivirals against chikungunya and other alphaviruses. Antiviral Res. 2016 Feb;126:117-24. doi: 10.1016/j.antiviral.2015.12.012. Epub 2016 Jan 2.
**PMID:** 26752081
**Citation:** Padhy BM, Mohanty RR, Das S, Meher BR. Therapeutic potential of ivermectin as add on treatment in COVID 19: A systematic review and meta-analysis. J Pharm Pharm Sci. 2020;23:462-469. doi: 10.18433/jpps31457.
**PMID:** 33227231
**Citation:** Rajter JC, Sherman MS, Fatteh N, Vogel F, Sacks J, Rajter JJ. Use of Ivermectin Is Associated With Lower Mortality in Hospitalized Patients With Coronavirus Disease 2019: The Ivermectin in COVID Nineteen Study. Chest. 2021 Jan;159(1):85-92. doi: 10.1016/j.chest.2020.10.009. Epub 2020 Oct 13.
**PMID:** 33065103
**Citation:** Elgazzar, A et al. Efficacy and Safety of Ivermectin for Treatment and prophylaxis of COVID-19 Pandemic. Research Square doi.org/10.21203, 2020
**Citation:** Chowdhury, ATMM et al. A Randomized Trial of Ivermectin-Doxycycline and Hydroxychloroquine-Azithromycin therapy on COVID19 patients. Research Square: https://doi.org/10.21203/rs.3.rs-38896/v1, 2020.
**Citation:** Niaee, MS et al. Ivermectin as an adjunct treatment for hospitalized adult COVID-19 patients: A randomized multi-center clinical trial. Research Square: https://doi.org/10.21203/rs.3.rs-109670/v1, 2020.
**Citation:** Francés-Monerris, A et al. Has Ivermectin Virus-Directed Effects against SARS-CoV-2? Rationalizing the Action of a Potential Multitarget Antiviral Agent. ChemRxiv, 2020.
## 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: 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
### Intervention Browse Module - Ancestors
- ID: D000000962
- Term: Antimalarials
- ID: D000000981
- Term: Antiprotozoal Agents
- ID: D000000977
- Term: Antiparasitic Agents
- ID: D000000890
- Term: Anti-Infective Agents
- ID: D000004791
- Term: Enzyme Inhibitors
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000018501
- Term: Antirheumatic Agents
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: ARhu
- Name: Antirheumatic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M9940
- Name: Hydroxychloroquine
- Relevance: HIGH
- As Found: Bone marrow
- ID: M10590
- Name: Ivermectin
- Relevance: HIGH
- As Found: Psychoeducation
- ID: M4280
- Name: Antimalarials
- Relevance: LOW
- As Found: Unknown
- ID: M4298
- Name: Antiprotozoal Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4294
- Name: Antiparasitic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4214
- Name: Anti-Infective Agents
- Relevance: LOW
- As Found: Unknown
- ID: M7951
- Name: Enzyme Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M20604
- Name: Antirheumatic Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000006886
- Term: Hydroxychloroquine
- ID: D000007559
- Term: Ivermectin
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06017479
**Brief Title:** Effectiveness of Single Dose Fosfomycin and Single Dose Levofloxacin as Pre-urodynamic Antibiotic for UTI Prevention
**Official Title:** Effectiveness of Single Dose Fosfomycin and Single Dose Levofloxacin as Pre-urodynamic Antibiotic Prophylaxis for Urinary Tract Infection Prevention in Post-Urodynamic Examination
#### Organization Study ID Info
**ID:** 22-11-1343
#### Organization
**Class:** OTHER
**Full Name:** Indonesia University
### Status Module
#### Completion Date
**Date:** 2024-03-25
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-04-18
**Type:** ACTUAL
**Last Update Submit Date:** 2024-04-17
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2024-03-25
**Type:** ACTUAL
#### Start Date
**Date:** 2022-12-30
**Type:** ACTUAL
**Status Verified Date:** 2024-04
#### Study First Post Date
**Date:** 2023-08-30
**Type:** ACTUAL
**Study First Submit Date:** 2023-08-24
**Study First Submit QC Date:** 2023-08-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Indonesia University
#### Responsible Party
**Investigator Affiliation:** Indonesia University
**Investigator Full Name:** dr. Harrina Erlianti Rahadjo, Sp.U(K), PhD
**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 goal of this clinical trial is to compare the use of single dose fosfomycin and single dose levofloxacin as pre-urodynamic antibiotic prophylaxis for urinary tract infection prevention post-urodynamic in patients with lower urinary tract symptoms. The main question\[s\] it aims to answer are:
* What is the difference between the effectiveness of administering a single dose of fosfomycin and levofloxacin prior to the procedure in terms of the incidence rate of urinary tract infection (UTI) post-urodynamic examination?
* What is the incidence rate of UTI in the administration of single-dose fosfomycin and levofloxacin prior to the procedure on the incidence rate of UTI post-urodynamic examination? Participants fulfilling the inclusion criteria will be taken their history and vital signs and consume either fosfomycin or levofloxacin based on the randomisation prior to urodynamic procedure. Afterwards, participants will undergo urine analysis 4 days post urodynamic to evaluate if there's any urinary tract infection. If there is any bacteria present, the sample will be cultured to identify bacteria found in the urine.
**Detailed Description:** This study employs a single-blinded randomized clinical trial design to compare the proportion of UTI post-urodynamic examination between the group receiving single-dose levofloxacin pre-urodynamic examination and the group receiving levofloxacin post-urodynamic examination for three days. The target population is patients undergoing urodynamic examination at Dr. Cipto Mangunkusumo National Referral Hospital, Persahabatan National Hospital, and Siloam Asri Hospital. The total sample size in this study is 126 patients. On the fourth day post-urodynamic examination, urinalysis and urine culture are performed to determine the diagnosis of UTI. To analyze the association between UTI and therapy groups, a chi-square test is used. Results are considered statistically significant if p \< 0.05.
### Conditions Module
**Conditions:**
- Urological System Complication of Procedure
- Urinary Tract Infections
**Keywords:**
- urodynamic
- urinary tract infections
- fosfomycin
- levofloxacin
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** This study is an experimental study with a single-blinded randomized clinical trial design to compare the proportion of UTIs in a group of patients receiving fosfomycin 3 grams and patients receiving levofloxacin 500 miligrams single dose one hour before urodynamic examination. To determine the sample treatment group, blocked randomization technique is used in this study.
##### Masking Info
**Masking:** SINGLE
**Masking Description:** This study uses a single-blinded design because the outcome assessed in this study is urinalysis which is the objective outcome. The urinalysis evaluator is blinded to the drug regimen obtained by the research subjects.
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 126
**Type:** ACTUAL
**Phases:**
- PHASE1
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Fosfomycin 3 g single dosage 1 hour before the urodynamic examination
**Intervention Names:**
- Drug: Fosfomycin 3000 MG
**Label:** Pre-urodynamic Fosfomycin
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Levofloxacin 500 miligrams single dosage 1 hour before the urodynamic examination
**Intervention Names:**
- Drug: Levofloxacin 500mg
**Label:** Pre-urodynamic Levofloxacin
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Pre-urodynamic Fosfomycin
**Description:** Fosfomycin 3 g single dosage 1 hour before the urodynamic examination
**Name:** Fosfomycin 3000 MG
**Other Names:**
- Monuril
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Pre-urodynamic Levofloxacin
**Description:** Levofloxacin 500 mg single dosage 1 hour before the urodynamic examination
**Name:** Levofloxacin 500mg
**Other Names:**
- Levaquin
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Urinary tract infection is defined based on the result of urinalysis in which one of the following condition present : leukocytes \> 5 / high power field, bacteria positive, nitrite positive, and/or positive leukocyte esterase
**Measure:** Number of Participant With Urinary Tract Infection
**Time Frame:** 4 days post-urodynamic procedure
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Male/female patients \> 18 years who have indications for urodynamics
* Willing to participate in research
Exclusion Criteria:
* Allergy to levofloxacin
* Allergy to fosfomycin
* History of taking antibiotics in 1 month
* Pregnant
* Uncontrolled DM
* Use of urinary catheter
* Having a UTI before urodynamics, based on clinical symptoms and urine examination results
* Refuse to participate in research
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Jakarta Pusat
**Country:** Indonesia
**Facility:** Cipto Mangunkusumo Hospital
**State:** DKI Jakarta
**Zip:** 10430
#### Overall Officials
**Official 1:**
**Affiliation:** Indonesia University
**Name:** Harrina E Rahardjo, Professor
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Access Criteria:** Anyone who wishes to access the data
**Description:** These are the study protocol used in this study
**Info Types:**
- STUDY_PROTOCOL
**IPD Sharing:** YES
**Time Frame:** Immediately following publication. No end date
### References Module
#### References
**Citation:** Rahardjo HE, Tirtayasa PM, Afriansyah A, Parikesit D, Akbar MI. The Effectiveness of a Three Day Course Antibiotic Post-urodynamic Study in Preventing Lower Urinary Tract Infection. Acta Med Indones. 2016 Apr;48(2):84-90.
**PMID:** 27550876
**Citation:** Chu CM, Lowder JL. Diagnosis and treatment of urinary tract infections across age groups. Am J Obstet Gynecol. 2018 Jul;219(1):40-51. doi: 10.1016/j.ajog.2017.12.231. Epub 2018 Jan 2.
**PMID:** 29305250
**Citation:** Fajfr M, Balik M, Cermakova E, Bostik P. Effective Treatment for Uncomplicated Urinary Tract Infections with Oral Fosfomycin, Single Center Four Year Retrospective Study. Antibiotics (Basel). 2020 Aug 13;9(8):511. doi: 10.3390/antibiotics9080511.
**PMID:** 32823650
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000014570
- Term: Urologic Diseases
- ID: D000052776
- Term: Female Urogenital Diseases
- ID: D000005261
- Term: Female Urogenital Diseases and Pregnancy Complications
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000052801
- Term: Male Urogenital 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
### Condition Browse Module - Browse Leaves
- ID: M10283
- Name: Infections
- Relevance: HIGH
- As Found: Infection
- ID: M6368
- Name: Communicable Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17302
- Name: Urinary Tract Infections
- Relevance: HIGH
- As Found: Urinary Tract Infections
- ID: M17319
- Name: Urologic 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: M27095
- Name: Male Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000007239
- Term: Infections
- ID: D000014552
- Term: Urinary Tract Infections
### Intervention Browse Module - Ancestors
- ID: D000000892
- Term: Anti-Infective Agents, Urinary
- ID: D000000890
- Term: Anti-Infective Agents
- ID: D000000900
- Term: Anti-Bacterial 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
- ID: D000000970
- Term: Antineoplastic Agents
- ID: D000065609
- Term: Cytochrome P-450 CYP1A2 Inhibitors
- ID: D000065607
- Term: Cytochrome P-450 Enzyme Inhibitors
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: ANeo
- Name: Antineoplastic Agents
### Intervention Browse Module - Browse Leaves
- ID: M4222
- Name: Anti-Bacterial Agents
- Relevance: LOW
- As Found: Unknown
- ID: M30370
- Name: Levofloxacin
- Relevance: HIGH
- As Found: Sodium chloride
- ID: M17946
- Name: Ofloxacin
- Relevance: LOW
- As Found: Unknown
- ID: M4224
- Name: Antibiotics, Antitubercular
- Relevance: LOW
- As Found: Unknown
- ID: M8700
- Name: Fosfomycin
- Relevance: HIGH
- As Found: Course of treatment
- ID: M4214
- Name: Anti-Infective 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
### Intervention Browse Module - Meshes
- ID: D000064704
- Term: Levofloxacin
- ID: D000005578
- Term: Fosfomycin
### Misc Info Module
#### Submission Tracking
- Estimated Results First Submit Date: 2024-04-23
##### Submission Infos
- MCP Release N: Unknown
- Release Date: 2024-04-23
- Reset Date: Unknown
- Unrelease Date: Unknown
- Unrelease Date Unknown: Unknown
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT00363779
**Brief Title:** Effect of Cyclosporine Therapy on Gene Expression in Patients With Large Granular Lymphocyte Leukemia
**Official Title:** Microarray Analysis of the Effect of Cyclosporine Therapy on Gene Expression Patterns in Large Granular Lymphocytic Leukemia
#### Organization Study ID Info
**ID:** 060177
#### Organization
**Class:** NIH
**Full Name:** National Institutes of Health Clinical Center (CC)
#### Secondary ID Infos
**ID:** 06-C-0177
### Status Module
#### Completion Date
**Date:** 2010-11
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2015-07-21
**Type:** ESTIMATED
**Last Update Submit Date:** 2015-06-26
**Overall Status:** TERMINATED
#### Primary Completion Date
**Date:** 2010-11
**Type:** ACTUAL
#### Results First Post Date
**Date:** 2012-07-06
**Type:** ESTIMATED
**Results First Submit Date:** 2012-03-30
**Results First Submit QC Date:** 2012-05-29
#### Start Date
**Date:** 2006-06
**Status Verified Date:** 2015-06
#### Study First Post Date
**Date:** 2006-08-15
**Type:** ESTIMATED
**Study First Submit Date:** 2006-08-10
**Study First Submit QC Date:** 2006-08-10
**Why Stopped:** Study terminated due to low accrual and the investigator left the NIH.
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** NIH
**Name:** National Cancer Institute (NCI)
#### Responsible Party
**Investigator Affiliation:** National Institutes of Health Clinical Center (CC)
**Investigator Full Name:** Thomas Waldmann, M.D.
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Background:
* Large granular lymphocyte (LGL) leukemia is a low-grade non-Hodgkin's lymphoma.
* LGL is associated with low numbers of white blood cells (leading to recurring infections), red blood cells (causing anemia) and platelets (causing abnormal bleeding).
* Cyclosporine (CSA) is an immunosuppressive drug that improves low blood cell counts in about 50 percent of patients with LGL leukemia.
Objectives:
* To identify what factors determine why cyclosporine works in some patients and not in others.
* To identify what causes low blood counts in LGL leukemia.
Eligibility: Patients 18 years of age and older with LGL leukemia.
Design:
* Patients have a medical history, physical examination blood tests, bone marrow biopsy and x-ray studies, including chest x-rays and computed tomography (CT) scans of the chest, abdomen and pelvis. Patients with an easily accessible enlarged lymph node have a node biopsy (removal of a small piece of tissue for microscopic examination).
* Patients take cyclosporine twice a day by mouth. Blood samples are taken at least weekly to adjust the cyclosporine dosing to maintain therapeutic serum levels.
* Patients undergo apheresis (collection of white blood cells) at a number of different time points in the study (maximum 6 times) to look at the differences in the leukemia cells before and during treatment with cyclosporine. For apheresis, blood is withdrawn through a needle in an arm vein and directed through a catheter (plastic tube) into a machine that separates it into its components. The white cells are extracted and the rest of the blood is returned through the same needle or through a second needle in the other arm.
**Detailed Description:** Background:
* LGL leukemia is a low grade non-Hodgkins Lymphoma characterized by tissue invasion of the marrow, spleen and liver
* Recurrent infections due to chronic neutropenia and transfusion-dependent anemia are the principal causes for initiation of therapy
* Approximately 50% of patients treated with cyclosporine (CSA) respond to treatment. CSA appears to correct the associated cytopenia without decreasing LGL numbers, suggesting it may inhibit LGL secretion of yet unidentified mediators of neutropenia and anemia.
* Analysis of differential gene expression profiles in patients with LGL leukemia treated with cyclosporine has the potential to detect as yet unidentified, therapeutic targets and possibly provide predictors of CSA responsiveness.
Objective:
* Identify changes in gene expression patterns induced by cyclosporine therapy in patients with LGL leukemia
* Identify differences between responding and non-responding patients
Eligibility:
-Patients with Large Granular Lymphocyte leukemia
Design:
* Patients will be treated with cyclosporine at a dose of 5-10mg/kg/day in divided doses, with doses adjusted to maintain a therapeutic serum level between 200-400ng/ml. These therapeutic levels shall be maintained for 3 months.
* Tumor response will be evaluated after 3 months therapy, the dose of CsA may then be tapered to that required to sustain a response or discontinued if no evidence of response, or after relapse.
* Blood sampling or Lymphapheresis for collection of circulating malignant cells will be performed at a number of different time points. Gene expression profiling will be carried out on Affymetrix microarrays to compare pretreatment and post-treatment samples.
### Conditions Module
**Conditions:**
- Large Granular Lymphocytic Leukemia
- LGL Leukemia
**Keywords:**
- Large Granular Lymphocyte (LGL)
- LGL
- Leukemia
- Cyclosporine
- Microarray
- Gene Expression
- Cyclosporin
- Large Granular Lymphocyte Leukemia
- LGL Leukemia
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 5
**Type:** ACTUAL
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Large Granular Lymphocyte Leukemia (LGL) is a low grade non-Hodgkins lymphoma characterized by tissue invasion of the marrow, spleen, and liver. Cyclosporine 5-10 mg/kg/day was administered as an oral preparation given every 12 hours. Doses are adjusted to maintain a therapeutic level between 200-400 ng/ml.
**Intervention Names:**
- Drug: Cyclosporine
- Genetic: Gene expression analysis
- Genetic: Microarray analysis
- Other: Laboratory biomarker analysis
**Label:** LGL Patients administered cyclosporine
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- LGL Patients administered cyclosporine
**Description:** An oral preparation given every 12 hours, 5-10 mg/kg/day in divided doses. Doses are adjusted to maintain a therapeutic level between 200-400 ng/ml. Levels will be checked twice weekly and once the patient has achieved steady state levels they shall be monitored once every 2 weeks. These therapeutic levels shall be maintained for 3 months.
**Name:** Cyclosporine
**Other Names:**
- Ciclosporin
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- LGL Patients administered cyclosporine
**Description:** A permutation test will be performed to examine whether the overall expression profile changes due to treatment. This will be done by comparing the number of significant genes to the distribution of this number if in fact there is no difference between pre-treatment and post-treatment gene expression.
**Name:** Gene expression analysis
**Type:** GENETIC
#### Intervention 3
**Arm Group Labels:**
- LGL Patients administered cyclosporine
**Description:** Gene expression profiling will be carried out on Affymetrix microarrays to compare pretreatment and posttreatment samples.
**Name:** Microarray analysis
**Type:** GENETIC
#### Intervention 4
**Arm Group Labels:**
- LGL Patients administered cyclosporine
**Description:** Analysis of differential gene expression profiles in patients with LGL leukemia treated with cyclosporine.
**Name:** Laboratory biomarker analysis
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The goal was to examine which genes had a 2-fold gene expression between pre-treatment (baseline) and post treatment (12 weeks). Genes significant at the 0.001 level will be considered as differentially expressed due to treatment.
**Measure:** Changes in Gene Expression Patterns
**Time Frame:** Baseline and 12 weeks
#### Secondary Outcomes
**Description:** Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.
**Measure:** Number of Participants With Adverse Events
**Time Frame:** 3 months
### Eligibility Module
**Eligibility Criteria:** * INCLUSION CRITERIA:
1. All patients must have a histologic or cytologic diagnosis of T-cell LGL leukemia as determined by the Laboratory of Pathology or Hematology at the Clinical Center, National Institutes of Health
2. All patients must have hemocytopenias such as granulocyte count less than 1,200/ul, platelet count less than 100,000/ul or hemoglobin less than 10 g/dl, or require hematopoietic support (transfusion or colony stimulating factors) to maintain counts at these or higher levels.
3. Patients must have measurable or evaluable disease
4. Patients must have a creatinine of less than 2.0 mg/dl.
5. Omission of cytotoxic chemotherapy for 3 weeks prior to entry into the trial is required. However, patients receiving stable corticosteroids will be eligible.
6. Age greater than 18 years
7. Karnofsky performance greater than 70%
8. Patients must have a life expectancy of greater than 3 months.
9. Patients must be able to understand and sign an Informed Consent form.
10. All female patients must use adequate contraception during participation in this trial and for three months after completing therapy.
EXCLUSION CRITERIA:
1. Patients with uncontrolled hypertension
2. Pregnant and nursing patients are not eligible for the study as CSA crosses the placenta. Based on clinical use, premature births and low birth weight were consistently observed. Breast-feeding is contraindicated because CSA enters the blood milk and may possibly be administered to the child.
3. Underlying immunodeficiency state including human immunodeficiency virus (HIV) seropositivity.
4. Positive for antibodies to hepatitis C or positive for hepatitis B surface antigen,
5. Patients with serious intercurrent illnesses, concurrent hepatic, renal, cardiac, neurologic, pulmonary, infectious or metabolic disease of such severity that it would preclude the patients' ability to tolerate cyclosporine.
6. Patients who received cyclosporine for LGL leukemia previously and failed to respond.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_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, National Institutes of Health
**Name:** Thomas Waldmann, M.D.
**Role:** PRINCIPAL_INVESTIGATOR
### References Module
#### References
**Citation:** Lamy T, Loughran TP Jr. Clinical features of large granular lymphocyte leukemia. Semin Hematol. 2003 Jul;40(3):185-95. doi: 10.1016/s0037-1963(03)00133-1.
**PMID:** 12876667
**Citation:** Vie H, Chevalier S, Garand R, Moisan JP, Praloran V, Devilder MC, Moreau JF, Soulillou JP. Clonal expansion of lymphocytes bearing the gamma delta T-cell receptor in a patient with large granular lymphocyte disorder. Blood. 1989 Jul;74(1):285-90.
**PMID:** 2546620
**Citation:** Lamy T, Dauriac C, Le Prise PY. Long-term survival in chronic granulocytic leukaemia. Br J Haematol. 1989 Oct;73(2):279. doi: 10.1111/j.1365-2141.1989.tb00270.x. No abstract available.
**PMID:** 2818949
#### See Also Links
**Label:** Genetics Home Reference
**URL:** http://ghr.nlm.nih.gov/
**Label:** Medline Plus
**URL:** http://www.nlm.nih.gov/medlineplus/
**Label:** Drug Information
**URL:** http://druginfo.nlm.nih.gov/drugportal/drugportal.jsp
**Label:** US FDA Resources
**URL:** http://www.clinicaltrials.gov/ct2/info/fdalinks
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000009369
- Term: Neoplasms
- ID: D000006402
- Term: Hematologic Diseases
- ID: D000008232
- Term: Lymphoproliferative Disorders
- ID: D000008206
- Term: Lymphatic Diseases
- ID: D000007160
- Term: Immunoproliferative Disorders
- ID: D000007154
- Term: Immune System Diseases
- ID: D000015458
- Term: Leukemia, T-Cell
### 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: 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: Lymphocytic Leukemia
- ID: M27552
- Name: Leukemia, Large Granular Lymphocytic
- Relevance: HIGH
- As Found: Large Granular Lymphocytic Leukemia
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
- ID: M9490
- Name: Hematologic Diseases
- 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: M18119
- Name: Leukemia, T-Cell
- Relevance: LOW
- As Found: Unknown
- ID: T238
- Name: Aggressive NK Cell Leukemia
- Relevance: HIGH
- As Found: Large Granular Lymphocytic Leukemia
- ID: T5568
- Name: T-cell Large Granular Lymphocyte Leukemia
- Relevance: HIGH
- As Found: Large Granular Lymphocytic Leukemia
### Condition Browse Module - Meshes
- ID: D000007938
- Term: Leukemia
- ID: D000007945
- Term: Leukemia, Lymphoid
- ID: D000054066
- Term: Leukemia, Large Granular Lymphocytic
### Intervention Browse Module - Ancestors
- ID: D000004791
- Term: Enzyme Inhibitors
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000007166
- Term: Immunosuppressive Agents
- ID: D000007155
- Term: Immunologic Factors
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000000935
- Term: Antifungal Agents
- ID: D000000890
- Term: Anti-Infective Agents
- ID: D000003879
- Term: Dermatologic Agents
- ID: D000018501
- Term: Antirheumatic Agents
- ID: D000065095
- Term: Calcineurin Inhibitors
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: ARhu
- Name: Antirheumatic Agents
- Abbrev: Derm
- Name: Dermatologic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Hemat
- Name: Hematinics
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: Ot
- Name: Other Dietary Supplements
### Intervention Browse Module - Browse Leaves
- ID: M18961
- Name: Cyclosporine
- Relevance: HIGH
- As Found: New
- ID: M6730
- Name: Cyclosporins
- Relevance: HIGH
- As Found: New
- ID: M11110
- Name: Liver Extracts
- Relevance: LOW
- As Found: Unknown
- ID: M4854
- Name: Benzocaine
- Relevance: LOW
- As Found: Unknown
- ID: M7951
- Name: Enzyme Inhibitors
- 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: 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: M4214
- Name: Anti-Infective Agents
- Relevance: LOW
- As Found: Unknown
- ID: M7074
- Name: Dermatologic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M20604
- Name: Antirheumatic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M30452
- Name: Calcineurin Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: T433
- Name: Tannic Acid
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000016572
- Term: Cyclosporine
- ID: D000003524
- Term: Cyclosporins
### Misc Info Module
- Version Holder: 2024-05-24
## Results Section
### Adverse Events Module
#### Event Groups
**Group ID:** EG000
**Title:** LGL Patients Administered Cyclosporine
**Description:** Large Granular Lymphocyte Leukemia (LGL) is a low grade non-Hodgkins lymphoma characterized by tissue invasion of the marrow, spleen, and liver. Cyclosporine 5-10 mg/kg/day was administered as an oral preparation given every 12 hours. Doses are adjusted to maintain a therapeutic level between 200-400 ng/ml.
**ID:** EG000
**Other Num Affected:** 5
**Other Num at Risk:** 5
**Serious Number Affected:** 2
**Serious Number At Risk:** 5
**Title:** LGL Patients Administered Cyclosporine
**Frequency Threshold:** 0
#### Other Events
**Term:** ALT, SGPT (serum glutamic pyruvic transaminase)
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:** CTC3.0
**Term:** AST, SGOT(serum glutamic oxaloacetic transaminase)
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:** CTC3.0
**Term:** Albumin, serum-low (hypoalbuminemia)
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
**Source Vocabulary:** CTC3.0
**Term:** Alkaline phosphatase
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:** CTC3.0
**Term:** Bicarbonate, serum-low
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:** CTC3.0
**Term:** Bilirubin (hyperbilirubinemia)
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:** CTC3.0
**Term:** Calcium, serum-low (hypocalcemia)
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
**Source Vocabulary:** CTC3.0
**Term:** Cholesterol, serum-high (hypercholesteremia)
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:** CTC3.0
**Term:** Creatinine
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:** CTC3.0
**Term:** Dizziness
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
**Source Vocabulary:** CTC3.0
**Term:** Glucose, serum-high (hyperglycemia)
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
**Source Vocabulary:** CTC3.0
**Term:** Hemoglobin
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Blood and lymphatic system disorders
**Source Vocabulary:** CTC3.0
**Term:** Hypertension
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Vascular disorders
**Source Vocabulary:** CTC3.0
**Term:** Infection with normal ANC or Grade 1 or 2 neutrophils::Upper airway NOS
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** CTC3.0
**Term:** Insomnia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Psychiatric disorders
**Source Vocabulary:** CTC3.0
**Term:** Leukocytes (total WBC)
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:** CTC3.0
**Term:** Lymphopenia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Blood and lymphatic system disorders
**Source Vocabulary:** CTC3.0
**Term:** Magnesium, serum-low (hypomagnesemia)
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
**Source Vocabulary:** CTC3.0
**Term:** Nausea
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** CTC3.0
**Term:** Neutrophils/granulocytes (ANC/AGC)
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:** CTC3.0
**Term:** Pain::Bone
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Musculoskeletal and connective tissue disorders
**Source Vocabulary:** CTC3.0
**Term:** Pain::Head/headache
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
**Source Vocabulary:** CTC3.0
**Term:** Pain::Muscle
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)
**Source Vocabulary:** CTC3.0
**Term:** Phosphate, serum-low (hypophosphatemia)
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
**Source Vocabulary:** CTC3.0
**Term:** Platelets
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:** CTC3.0
**Term:** Potassium, serum-high (hyperkalemia)
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
**Source Vocabulary:** CTC3.0
**Term:** Potassium, serum-low (hypokalemia)
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
**Source Vocabulary:** CTC3.0
**Term:** Rash: acne/acneiform
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
**Source Vocabulary:** CTC3.0
**Term:** Sodium, serum-low (hyponatremia)
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
**Source Vocabulary:** CTC3.0
**Term:** Tremor
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
**Source Vocabulary:** CTC3.0
**Term:** Triglyceride, serum-high (hypertriglyceridemia)
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
**Source Vocabulary:** CTC3.0
**Term:** Uric acid, serum-high (hyperuricemia)
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
**Source Vocabulary:** CTC3.0
#### Serious Events
**Term:** Infection with normal ANC or Grade 1 or 2 neutrophils-Lung (pneumonia)
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** CTC3.0
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 5
**Num Events:** 1
**Term:** Second malignancy-possibly related to cancer treatment (Specify) new abdominal mass
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)
**Source Vocabulary:** CTC3.0
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 5
**Num Events:** 1
**Time Frame:** 3 yrs, 10 months
## Results Section - Baseline Characteristics Module
### Denomination Counts
**Group ID:** BG000
**Value:** 5
**Units:** Participants
### Group
**ID:** BG000
**Title:** LGL Patients Administered Cyclosporine
**Description:** Large Granular Lymphocyte Leukemia (LGL) is a low grade non-Hodgkins lymphoma characterized by tissue invasion of the marrow, spleen, and liver. Cyclosporine 5-10 mg/kg/day was administered as an oral preparation given every 12 hours. Doses are adjusted to maintain a therapeutic level between 200-400 ng/ml.
### Measure
#### Measurement
**Group ID:** BG000
**Value:** 0
**Category Title:** <=18 years
#### Measurement
**Group ID:** BG000
**Value:** 2
**Category Title:** Between 18 and 65 years
#### Measurement
**Group ID:** BG000
**Value:** 3
**Category Title:** >=65 years
**Class Title:**
### Measure
#### Measurement
**Group ID:** BG000
**Spread:** 6.09
**Value:** 67.7
**Class Title:**
### Measure
#### Measurement
**Group ID:** BG000
**Value:** 0
**Category Title:** Female
#### Measurement
**Group ID:** BG000
**Value:** 5
**Category Title:** Male
**Class Title:**
### Measure
#### Measurement
**Group ID:** BG000
**Value:** 0
**Category Title:** Hispanic or Latino
#### Measurement
**Group ID:** BG000
**Value:** 5
**Category Title:** Not Hispanic or Latino
#### Measurement
**Group ID:** BG000
**Value:** 0
**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:** 1
**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:** 4
**Category Title:** White
#### Measurement
**Group ID:** BG000
**Value:** 0
**Category Title:** More than one race
#### Measurement
**Group ID:** BG000
**Value:** 0
**Category Title:** Unknown or Not Reported
**Class Title:**
### Measure
#### Measurement
**Group ID:** BG000
**Value:** 5
**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
### Limitations and Caveats
**Description:** As there were only 5 patients treated, the primary endpoints of this protocol were not met and there is not enough data generated for statistical analysis. This protocol is being terminated due to low accrual and the investigator leaving the NIH.
### Point of Contact
**Email:** [email protected]
**Organization:** National Cancer Institute (NCI), National Institutes of Health (NIH)
**Phone:** 301-496-6653
**Title:** Thomas Waldmann, M.D.
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 5
**Title:**
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** The goal was to examine which genes had a 2-fold gene expression between pre-treatment (baseline) and post treatment (12 weeks). Genes significant at the 0.001 level will be considered as differentially expressed due to treatment.
**Population Description:** This outcome measure was not performed because there were insufficient data points to provide any statistical power.
**Reporting Status:** POSTED
**Time Frame:** Baseline and 12 weeks
**Title:** Changes in Gene Expression Patterns
**Type:** PRIMARY
##### Group
**Description:** Large Granular Lymphocyte Leukemia (LGL) is a low grade non-Hodgkins lymphoma characterized by tissue invasion of the marrow, spleen, and liver. Cyclosporine 5-10 mg/kg/day was administered as an oral preparation given every 12 hours. Doses are adjusted to maintain a therapeutic level between 200-400 ng/ml.
**ID:** OG000
**Title:** LGL Patients Administered Cyclosporine
#### Outcome Measure 2
**Description:** Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** 3 months
**Title:** Number of Participants With Adverse Events
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Large Granular Lymphocyte Leukemia (LGL) is a low grade non-Hodgkins lymphoma characterized by tissue invasion of the marrow, spleen, and liver. Cyclosporine 5-10 mg/kg/day was administered as an oral preparation given every 12 hours. Doses are adjusted to maintain a therapeutic level between 200-400 ng/ml.
**ID:** OG000
**Title:** LGL Patients Administered Cyclosporine
### Participant Flow Module
#### Group
**Description:** Large Granular Lymphocyte Leukemia (LGL) is a low grade non-Hodgkins lymphoma characterized by tissue invasion of the marrow, spleen, and liver. Cyclosporine 5-10 mg/kg/day was administered as an oral preparation given every 12 hours. Doses are adjusted to maintain a therapeutic level between 200-400 ng/ml.
**ID:** FG000
**Title:** LGL Patients Administered Cyclosporine
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 5
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 5
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
**Has Results:** True |
## Protocol Section
### Identification Module
**NCT ID:** NCT05731479
**Brief Title:** Radiofrequency Diathermy and Therapeutic Exercise Protocol in Women With Abdominal Diastasis
**Official Title:** Effectiveness of a Radiofrequency Diathermy and Therapeutic Exercise Protocol in Women With Abdominal Diastasis. Randomized Controlled Trial
#### Organization Study ID Info
**ID:** 2524988
#### Organization
**Class:** OTHER
**Full Name:** University of Valencia
### Status Module
#### Completion Date
**Date:** 2026-06
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-03-17
**Type:** ACTUAL
**Last Update Submit Date:** 2023-03-14
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-06
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-01-16
**Type:** ACTUAL
**Status Verified Date:** 2022-12
#### Study First Post Date
**Date:** 2023-02-16
**Type:** ACTUAL
**Study First Submit Date:** 2023-01-26
**Study First Submit QC Date:** 2023-02-07
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Valencia
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Diastasis recti abdominis (DRA) is defined as the presence of divergence between the rectus abdominis muscles along the linea alba. DRA is associated with decreased abdominal strength and degraded health and physical functioning, which results in poorer body perception and satisfaction and negatively affects the quality of life in its multiple spheres (social, sexual and personal). Regarding the different treatment techniques for DRA, different treatments have been described, such as bandages, electrotherapy or therapeutic exercise, the latter being the most scientifically supported option to approach DRA conservatively. Exercise has shown positive effects on DRA severity, abdominal muscle thickness, abdominal strength and endurance, and quality of life in women with DRA.
Another treatment that has shown promising effects in various pathologies is radiofrequency diathermy using the Capacitive-Resistive Electrical Transfer system. The capacitive mode acts on soft tissues containing electrolytes such as muscles and vascular and lymphatic tissues. On the other hand, the resistive mode acts on tissues of higher density and fat and fiber content, such as bones, ligaments and tendons. It has been documented that this type of therapy acts favoring the vascularization of tissues, decreasing inflammation and favoring the processes of cellular repair and analgesia. Its beneficial effect on low back pain and various pelvic floor disorders has been studied. However, at present, there are no studies evaluating the effectiveness of this type of intervention in people with abdominal diastasis.
In view of the above, the objective of our study is to evaluate the effectiveness of a protocol based on therapeutic exercise preceded by a radiofrequency diathermy program on anthropometric parameters, anatomo-physiological parameters, functional parameters, and parameters related to psychological aspects in women with postpartum abdominal diastasis.
**Detailed Description:** A longitudinal randomized controlled experimental study will be carried out. The sample will be composed of 34 postpartum women, randomly distributed in two groups: i) diathermy + exercise group (GDE) (n=17), and ii) placebo diathermy + exercise group (GPE) (n=17).
The evaluations will be performed at two time points: i) before the intervention (T1), and ii) after the last session (T2).
### Conditions Module
**Conditions:**
- Abdominal Diastasis
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 34
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Application of diathermy and a therapeutic exercise protocol.
**Intervention Names:**
- Other: Diathermy + exercise group
**Label:** Diathermy + exercise group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Application of the diathermy device without energy emission and a therapeutic exercise protocol.
**Intervention Names:**
- Other: Diathermy placebo + exercise group
**Label:** Diathermy placebo + exercise group
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Diathermy + exercise group
**Description:** The Diathermy + Exercise group will receive diathermy for 15 minutes, of which 5 minutes will be applied in the capacitive method and 10 minutes in the resistive method. You will then perform 20 minutes of the following exercises: 1) Bird-Dog, 2) Crunch, 3) Obliques, 4) Drawing, 5) Half plank and 6) Side-plank. You will perform 8-12 repetitions and 3 sets of each exercise. 3 sessions of 35 minutes per week for 8 weeks.
**Name:** Diathermy + exercise group
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Diathermy placebo + exercise group
**Description:** The Placebo + Exercise group will receive 15 minutes of application of the diathermy device without energy emission. It will then perform the same therapeutic exercise protocol described in the GDE. 3 sessions of 35 minutes per week for 8 weeks.
**Name:** Diathermy placebo + exercise group
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The distance between rectus abdominis in millimetres (mm) will be assessed with an ultrasound machine, using a high-resolution linear array transducer.
**Measure:** Rectus abdominis distance
**Time Frame:** Baseline
**Description:** The distance between rectus abdominis in millimetres (mm) will be assessed with an ultrasound machine, using a high-resolution linear array transducer.
**Measure:** Rectus abdominis distance
**Time Frame:** Immediately after the intervention
**Description:** The rectus abdominis thickness in millimetres (mm) will be assessed with an ultrasound machine, using a high-resolution linear array transducer.
**Measure:** Rectus abdominis thickness
**Time Frame:** Baseline
**Description:** The rectus abdominis thickness in millimetres (mm) will be assessed with an ultrasound machine, using a high-resolution linear array transducer.
**Measure:** Rectus abdominis thickness
**Time Frame:** Immediately after the intervention
#### Secondary Outcomes
**Description:** Body composition by means of Bioimpedance (Tanita DC-430MA, Tanita Corporation of America, Inc., Arlington Heights, IL, USA).
**Measure:** Body composition
**Time Frame:** Baseline
**Description:** Body composition by means of Bioimpedance (Tanita DC-430MA, Tanita Corporation of America, Inc., Arlington Heights, IL, USA).
**Measure:** Body composition
**Time Frame:** Immediately after the intervention
**Description:** Strength of the abdominal flexor musculature by means of a dynamometer (Lafayette, Indiana, USA)
**Measure:** Strength of the abdominal flexor musculature
**Time Frame:** Baseline
**Description:** Strength of the abdominal flexor musculature by means of a dynamometer (Lafayette, Indiana, USA)
**Measure:** Strength of the abdominal flexor musculature
**Time Frame:** Immediately after the intervention
**Description:** Kinesiophobia with the Tampa Scale of Kinesiophobia-11 questionnaire: It maintains items 1, 2, 3, 5, 6, 7, 10, 11, 13, 15, and 17 from the original 17-point scale, and its score ranges from 11-44, where the lowest 11 means no or negligible kinesiophobia, and the higher scores indicate an increasing degree of kinesiophobia
**Measure:** Kinesiophobia
**Time Frame:** Baseline
**Description:** Kinesiophobia with the Tampa Scale of Kinesiophobia-11 questionnaire: It maintains items 1, 2, 3, 5, 6, 7, 10, 11, 13, 15, and 17 from the original 17-point scale, and its score ranges from 11-44, where the lowest 11 means no or negligible kinesiophobia, and the higher scores indicate an increasing degree of kinesiophobia
**Measure:** Kinesiophobia
**Time Frame:** Immediately after the intervention
**Description:** Body image using the Multidimensional Body Self Relations Questionnaire: It consists of 69 items each rated on a 5-point scale from 1 to 5 (strongly disagree-strongly agree). The higher the score, the greater the satisfaction with one's own body image, so the total score of the instrument requires reversing the score of the items that indicate dissatisfaction
**Measure:** Body image
**Time Frame:** Baseline
**Description:** Body image using the Multidimensional Body Self Relations Questionnaire: It consists of 69 items each rated on a 5-point scale from 1 to 5 (strongly disagree-strongly agree). The higher the score, the greater the satisfaction with one's own body image, so the total score of the instrument requires reversing the score of the items that indicate dissatisfaction
**Measure:** Body image
**Time Frame:** Immediately after the intervention
**Description:** Perception of change after the intervention with the Patient Perception of Change after Treatment questionnaire. consisting of a verbal scale, with 7 points "very much improved", "much improved", "minimally improved", "no change", "minimally worse", "much worse", "very much worse".
**Measure:** Perception of change after the intervention
**Time Frame:** Baseline
**Description:** Perception of change after the intervention with the Patient Perception of Change after Treatment questionnaire. consisting of a verbal scale, with 7 points "very much improved", "much improved", "minimally improved", "no change", "minimally worse", "much worse", "very much worse".
**Measure:** Perception of change after the intervention
**Time Frame:** Immediately after the intervention
**Description:** Linea alba thickness in millimetres (mm) will be assessed with an ultrasound machine, using a high-resolution linear array transducer.
**Measure:** Linea alba thickness
**Time Frame:** Baseline
**Description:** Linea alba thickness in millimetres (mm) will be assessed with an ultrasound machine, using a high-resolution linear array transducer.
**Measure:** Linea alba thickness
**Time Frame:** Immediately after the intervention
**Description:** Linea alba distortion index in millimetres (mm) will be assessed with an ultrasound machine, using a high-resolution linear array transducer.
**Measure:** Linea alba distortion index
**Time Frame:** Baseline
**Description:** Linea alba distortion index in millimetres (mm) will be assessed with an ultrasound machine, using a high-resolution linear array transducer.
**Measure:** Linea alba distortion index
**Time Frame:** Immediately after the intervention
**Description:** Stabilization capacity and resistance of the abdomino-lumbo-pelvic capsule, with a battery of validated maneuvers: gluteal bridge, gluteal bridge with unipodal support, lateral planks and horizontal plank.
The measurement unit is the second (s) for all maneuvers, and the time for each manoeuvre shall be averaged.
**Measure:** Stabilization capacity and resistance of the abdomino-lumbo-pelvic capsule
**Time Frame:** Baseline
**Description:** Stabilization capacity and resistance of the abdomino-lumbo-pelvic capsule, with a battery of validated maneuvers: gluteal bridge, gluteal bridge with unipodal support, lateral planks and horizontal plank.
The measurement unit is the second (s) for all maneuvers, and the time for each manoeuvre shall be averaged.
**Measure:** Stabilization capacity and resistance of the abdomino-lumbo-pelvic capsule
**Time Frame:** Immediately after the intervention
**Description:** Abdominal circumference will be assessed by means of tape measure in centimetres (cm). Two measurements shall be taken and averaged.
**Measure:** Abdominal circumference
**Time Frame:** Baseline
**Description:** Abdominal circumference will be assessed by means of tape measure in centimetres (cm). Two measurements shall be taken and averaged.
**Measure:** Abdominal circumference
**Time Frame:** Immediately after the intervention
**Description:** Abdominal fold will be assessed by means of a plicometer in milimetres (mm). Two measurements shall be taken and averaged.
**Measure:** Abdominal fold
**Time Frame:** Baseline
**Description:** Abdominal fold will be assessed by means of a plicometer in milimetres (mm). Two measurements shall be taken and averaged.
**Measure:** Abdominal fold
**Time Frame:** Immediately after the intervention
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Women aged 18 to 45 years,
* 3 to 24 months postpartum
* Criteria of abdominal diastasis according to Beer's criteria (Beer et al.2009)
Exclusion Criteria:
* Rejection to sign the informed consent form
* Presence of any metabolic, neurological or connective tissue disease, as well as cognitive alterations.
**Maximum Age:** 45 Years
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Marta Inglés, PhD
**Phone:** 686320380
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Valencia
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Marta Inglés, PhD
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Elena Muñoz Gómez, PhD
- **Role:** CONTACT
**Country:** Spain
**Facility:** Faculty of Physiotherapy. University of Valencia
**Status:** RECRUITING
**Zip:** 46002
#### Overall Officials
**Official 1:**
**Affiliation:** University of Valencia
**Name:** Marta Inglés, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Gluppe SB, Engh ME, Bo K. Immediate Effect of Abdominal and Pelvic Floor Muscle Exercises on Interrecti Distance in Women With Diastasis Recti Abdominis Who Were Parous. Phys Ther. 2020 Aug 12;100(8):1372-1383. doi: 10.1093/ptj/pzaa070.
**PMID:** 32302393
**Citation:** Keshwani N, Mathur S, McLean L. The impact of exercise therapy and abdominal binding in the management of diastasis recti abdominis in the early post-partum period: a pilot randomized controlled trial. Physiother Theory Pract. 2021 Sep;37(9):1018-1033. doi: 10.1080/09593985.2019.1675207. Epub 2019 Oct 23.
**PMID:** 31642725
**Citation:** Thabet AA, Alshehri MA. Efficacy of deep core stability exercise program in postpartum women with diastasis recti abdominis: a randomised controlled trial. J Musculoskelet Neuronal Interact. 2019 Mar 1;19(1):62-68.
**PMID:** 30839304
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000014947
- Term: Wounds and Injuries
- ID: D000004204
- Term: Joint Dislocations
- ID: D000007592
- Term: Joint Diseases
- ID: D000009140
- Term: Musculoskeletal Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: All
- Name: All Conditions
- Abbrev: BC05
- Name: Musculoskeletal Diseases
### Condition Browse Module - Browse Leaves
- ID: M2454
- Name: Hyperthermia
- Relevance: LOW
- As Found: Unknown
- ID: M618
- Name: Diastasis, Muscle
- Relevance: HIGH
- As Found: Abdominal Diastasis
- ID: M17685
- Name: Wounds and Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M7385
- Name: Joint Dislocations
- 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
### Condition Browse Module - Meshes
- ID: D000070630
- Term: Diastasis, Muscle
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT03521479
**Brief Title:** A Phase 2, Muti-Center Study of Repeat Dosing of Squaric Acid Dibutyl Ester in Subjects With Herpes Labialis
**Official Title:** A Phase 2, Muti-Center Study of Repeat Dosing of Squaric Acid Dibutyl Ester in Subjects With Herpes Labialis
#### Organization Study ID Info
**ID:** P2c
#### Organization
**Class:** INDUSTRY
**Full Name:** Squarex, LLC
### Status Module
#### Completion Date
**Date:** 2019-10-05
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-08-06
**Type:** ACTUAL
**Last Update Submit Date:** 2021-08-04
**Overall Status:** TERMINATED
#### Primary Completion Date
**Date:** 2018-10-05
**Type:** ACTUAL
#### Results First Post Date
**Date:** 2021-06-15
**Type:** ACTUAL
**Results First Submit Date:** 2021-05-19
**Results First Submit QC Date:** 2021-05-19
#### Start Date
**Date:** 2018-03-12
**Type:** ACTUAL
**Status Verified Date:** 2021-08
#### Study First Post Date
**Date:** 2018-05-11
**Type:** ACTUAL
**Study First Submit Date:** 2018-04-29
**Study First Submit QC Date:** 2018-04-29
**Why Stopped:** Study drug out of specification
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Squarex, LLC
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Primary Objective: To assess local and generalized adverse events with repeat topical application of 2% and 0.5% squaric acid dibutyl ester (SADBE) in subjects with frequent herpes labialis (4 or more episodes in the previous 12 months).
Secondary Objective: To assess efficacy of repeat topical application of 2% and 0.5% SADBE in the prevention of herpes labialis episodes.
**Detailed Description:** Primary oral infection with the herpes simplex virus (HSV) typically occurs at a young age, is asymptomatic, and is not associated with significant morbidity. After primary oral infection, HSV may persist in a latent state in the trigeminal ganglion and later reactivate as the more common herpes labialis, or "cold sores." Common triggers for reactivation are well known and include ultraviolet light, trauma, fatigue, stress, fever, inflammation, and menstruation. These lesions affect up to 45 percent of the U.S. population. They classically manifest as a well-localized cluster of small vesicles along the vermilion border of the lip or adjacent skin. The vesicles subsequently rupture, ulcerate, and crust within 24 to 48 hours. Spontaneous healing occurs over seven to 10 days.
In immunocompetent patients, herpes labialis usually is mild and self-limited. However, pain, swelling, and cosmetic concerns may prompt physician consultation. Orally administered antiviral agents, such as acyclovir (Zovirax) or valacyclovir (Valtrex), have a modest clinical benefit if initiated during the prodrome. Topical treatment with 1% penciclovir cream (Denavir) may reduce healing time and pain slightly, even if initiated after the prodrome. However, reduction in healing time with systemic or topical agents is modest.
Squaric acid dibutyl ester (SADBE) is a topical immunotherapeutic agent used in the treatment of verruca vulgaris and alopecia areata. During a recent FDA Compounding Advisory Committee Meeting, it was recommended that squaric acid dibutylester be included on the list of bulk drug substances allowed for use in compounding under section 503A of the Federal Food, Drug, and Cosmetic Act. And SADBE has now been so listed under section 503A.
A study completed by Lee et al of 29 patients with recalcitrant warts demonstrated complete clearance in 69% of patients with application every 2-4 weeks. Silverberg et al showed a complete clearance in 58% of patients (n=61) when SADBE was applied 3 times weekly. A placebo-controlled clinical study completed at Massachusetts General Hospital showed that squaric acid prevented recurrence of herpetic lesions. The effect of SADBE of delaying new herpes labialis outbreaks was highly significant (p\<0.01) as compared to placebo.
Primary Objective: To assess local and generalized adverse events with repeat topical application of 2% and 0.5% squaric acid dibutyl ester (SADBE) in subjects with frequent herpes labialis (4 or more episodes in the previous 12 months).
Secondary Objective: To assess efficacy of repeat topical application of 2% and 0.5% SADBE in the prevention of herpes labialis episodes.
### Conditions Module
**Conditions:**
- Herpes Labialis
- HSV
**Keywords:**
- Squaric Acid
- SADBE
- Squaric acid dibutyl ester
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Subjects will receive on a double blind basis one of two treatment regimens:
* Group A: 15 subjects, treated with 2% SADBE on day 0 and with 2% SADBE on the visits at week 3, week 6, week 9, and month 8.
* Group B: 15 subjects, treated with 2% SADBE on day 0 and with 0.5% SADBE on the visits at week 3, week 6, week 9, and month 8.
And subjects will be recruited on an open label basis to two other treatment regimens:
* Group C: 15 subjects, treated with 2% SADBE on day 0, month 3, and month 6.
* Group D: 15 subjects, treated with 2% SADBE on day 0 and month 6.
##### Masking Info
**Masking:** QUADRUPLE
**Masking Description:** The double-blinding only applies between groups A and B. Subjects for groups C and D will be recruited on an open label basis.
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 40
**Type:** ACTUAL
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Treated with 2% Squaric Acid Dibutyl Ester (SADBE) on day 0 and with 2% SADBE on the visits at week 3, week 6, week 9, and month 8.
**Intervention Names:**
- Drug: Squaric Acid Dibutyl Ester
**Label:** Group A
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Treated with 2% Squaric Acid Dibutyl Ester (SADBE) on day 0 and with 0.5% SADBE on the visits at week 3, week 6, week 9, and month 8.
**Intervention Names:**
- Drug: Squaric Acid Dibutyl Ester
**Label:** Group B
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Treated with 2% Squaric Acid Dibutyl Ester (SADBE) on day 0, month 3, and month 6.
**Intervention Names:**
- Drug: Squaric Acid Dibutyl Ester
**Label:** Group C
**Type:** ACTIVE_COMPARATOR
#### Arm Group 4
**Description:** Treated with 2% Squaric Acid Dibutyl Ester (SADBE) on day 0 and month 6.
**Intervention Names:**
- Drug: Squaric Acid Dibutyl Ester
**Label:** Group D
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Group A
- Group B
- Group C
- Group D
**Description:** Repeat topical application of 2% and 0.5% squaric acid dibutyl ester (SADBE) in subjects with frequent herpes labialis (4 or more episodes in the previous 12 months).
**Name:** Squaric Acid Dibutyl Ester
**Other Names:**
- Repeat Dosing
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Local and generalized adverse events with repeat topical application of 2% and 0.5% squaric acid dibutyl ester (SADBE) in subjects with frequent herpes labialis (4 or more episodes in the previous 12 months).
**Measure:** Local and Generalized Adverse Events
**Time Frame:** 9 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Age ≥ 18 and ≤ 65
2. Clinical diagnosis of herpes labialis, which may be made at the screening visit based on the patient's self-reported history of symptoms. An active herpes labialis outbreak at the time of entry into the clinical trial will neither be required nor will be an exclusion criterion.
3. Self report having four (4) or more episodes of herpes labialis in the past 12 months.
Subjects will NOT be told that four-or-more episodes in the previous 12 months is the entry criterion. Subjects will be asked "How many separate episodes of cold sores have you had in the previous 12 months?" They will be included if they give an answer of four or more and excluded if they give an answer of three or fewer.
4. At least half of the subject's episodes of the previous 12 months should be vesicular in nature and at least half preceded by prodromal symptoms. Prodromal symptoms may include tingling, itching, burning or pain before the development of a herpetic lesion.
Exclusion Criteria:
1. Pregnant or lactating females.
2. Current or recurrent non-herpetic infection or any underlying condition that may predispose to infection or anyone who has been admitted to the hospital due to bacteremia, pneumonia or any other serious infection in the last 12 months.
3. Therapy with glucocorticoid or immunosuppressants at time of recruitment or within past 4 weeks prior to the screening visit, or at any time during the study (including inhaled corticosteroids for asthma), except for topical steroids in sites other than face.
4. History of malignancy (except patients with surgically cured basal cell or squamous cell skin cancers).
5. History of organ transplantation.
6. HIV-positive status determined by history at screening or known history of any other immunosuppressive disease.
7. Severe co-morbidities (CHF \[NYHA class II or worse\], MI, CVA or TIA) within 3 months of screening visit, current unstable angina pectoris or oxygen-dependent severe pulmonary disease.
8. Known hypersensitivity to Dimethyl sulfoxide (DMSO).
9. Any condition judged by the investigator to cause this clinical trial to be detrimental to the patient.
10. Subject is currently enrolled in another investigational device or drug trial(s), or subject has received other investigational agent(s) within 28 days of the screening visit.
11. Previous exposure to SADBE (squaric acid or squaric acid dibutyl ester).
12. Subject has an abnormal skin condition (e.g., acne, eczema, rosacea, psoriasis, albinism, or chronic vesiculo-bullous disorder) that occurs in the area ordinarily affected by herpes labialis
13. Subject has an abnormal skin condition (e.g., eczema, rosacea, psoriasis, albinism, or chronic vesiculo-bullous disorder) that occurs in the inner aspect of either upper arm (the area where drug will be applied).
14. Subject has had a vaccine for either HSV-1 or HSV-2.
15. Subject has had treatment with anti-viral therapy (including ABREVA) within 2 weeks before first dose of SADBE or at any time during the study.
**Maximum Age:** 65 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Doral
**Country:** United States
**Facility:** International Research Partners, LLC
**State:** Florida
**Zip:** 33166
**Location 2:**
**City:** Saint Paul
**Country:** United States
**Facility:** Prism Clinical Research, LLC
**State:** Minnesota
**Zip:** 55114
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Document Section
### Large Document Module
#### Large Docs
- Date: 2017-12-19
- Filename: Prot_SAP_000.pdf
- Has ICF: False
- Has Protocol: True
- Has SAP: True
- Label: Study Protocol and Statistical Analysis Plan
- Size: 538826
- Type Abbrev: Prot_SAP
- Upload Date: 2021-05-19T11:33
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000006566
- Term: Herpesviridae Infections
- ID: D000004266
- Term: DNA Virus Infections
- ID: D000014777
- Term: Virus Diseases
- ID: D000007239
- Term: Infections
- ID: D000017193
- Term: Skin Diseases, Viral
- ID: D000012874
- Term: Skin Diseases, Infectious
- ID: D000012871
- Term: Skin Diseases
- ID: D000008047
- Term: Lip Diseases
- ID: D000009059
- Term: Mouth Diseases
- ID: D000009057
- Term: Stomatognathic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC01
- Name: Infections
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC07
- Name: Mouth and Tooth Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M9639
- Name: Herpes Simplex
- Relevance: HIGH
- As Found: Herpes
- ID: M9638
- Name: Herpes Labialis
- Relevance: HIGH
- As Found: Herpes Labialis
- ID: M10283
- Name: Infections
- Relevance: LOW
- As Found: Unknown
- ID: M6368
- Name: Communicable Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M9643
- Name: Herpesviridae Infections
- Relevance: LOW
- As Found: Unknown
- ID: M17522
- Name: Virus Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7442
- Name: DNA Virus Infections
- Relevance: LOW
- As Found: Unknown
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M19501
- Name: Skin Diseases, Viral
- Relevance: LOW
- As Found: Unknown
- ID: M15677
- Name: Skin Diseases, Infectious
- 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: D000006561
- Term: Herpes Simplex
- ID: D000006560
- Term: Herpes Labialis
### 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: M209120
- Name: Squaric acid dibutyl ester
- Relevance: HIGH
- As Found: Ibrexafungerp
- 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: C000020637
- Term: Squaric acid dibutyl ester
### Misc Info Module
- Version Holder: 2024-05-24
## Results Section
### Adverse Events Module
**Description:** At risk participants listed below as 30 because the 10 participants in each group was counted on 3 separate occasions.
#### Event Groups
**Group ID:** EG000
**Title:** Group A
**Deaths Num At Risk:** 10
**Description:** Treated with 2% Squaric Acid Dibutyl Ester (SADBE) on day 0 and with 2% SADBE on the visits at week 3, week 6, week 9, and month 8.
Squaric Acid Dibutyl Ester: Repeat topical application of 2% and 0.5% squaric acid dibutyl ester (SADBE) in subjects with frequent herpes labialis (4 or more episodes in the previous 12 months).
**ID:** EG000
**Other Num Affected:** 13
**Other Num at Risk:** 30
**Serious Number At Risk:** 10
**Title:** Group A
**Group ID:** EG001
**Title:** Group B
**Deaths Num At Risk:** 10
**Description:** Treated with 2% Squaric Acid Dibutyl Ester (SADBE) on day 0 and with 0.5% SADBE on the visits at week 3, week 6, week 9, and month 8.
Squaric Acid Dibutyl Ester: Repeat topical application of 2% and 0.5% squaric acid dibutyl ester (SADBE) in subjects with frequent herpes labialis (4 or more episodes in the previous 12 months).
**ID:** EG001
**Other Num Affected:** 12
**Other Num at Risk:** 30
**Serious Number At Risk:** 10
**Title:** Group B
**Group ID:** EG002
**Title:** Group C
**Deaths Num At Risk:** 10
**Description:** Treated with 2% Squaric Acid Dibutyl Ester (SADBE) on day 0, month 3, and month 6.
Squaric Acid Dibutyl Ester: Repeat topical application of 2% and 0.5% squaric acid dibutyl ester (SADBE) in subjects with frequent herpes labialis (4 or more episodes in the previous 12 months).
**ID:** EG002
**Other Num Affected:** 6
**Other Num at Risk:** 30
**Serious Number At Risk:** 10
**Title:** Group C
**Group ID:** EG003
**Title:** Group D
**Deaths Num At Risk:** 10
**Description:** Treated with 2% Squaric Acid Dibutyl Ester (SADBE) on day 0 and month 6.
Squaric Acid Dibutyl Ester: Repeat topical application of 2% and 0.5% squaric acid dibutyl ester (SADBE) in subjects with frequent herpes labialis (4 or more episodes in the previous 12 months).
**ID:** EG003
**Other Num Affected:** 4
**Other Num at Risk:** 30
**Serious Number At Risk:** 10
**Title:** Group D
**Frequency Threshold:** 0
#### Other Events
**Term:** Rash
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Notes:** Day 0-20
**Organ System:** Skin and subcutaneous tissue disorders
**Source Vocabulary:**
**Term:** Rash
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Notes:** Day 21-41
**Organ System:** Skin and subcutaneous tissue disorders
**Source Vocabulary:**
**Term:** Rash
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Notes:** Day 42+
**Organ System:** Skin and subcutaneous tissue disorders
**Source Vocabulary:**
**Time Frame:** 172 days
## Results Section - Baseline Characteristics Module
### Denomination Counts
**Group ID:** BG000
**Value:** 10
**Group ID:** BG001
**Value:** 10
**Group ID:** BG002
**Value:** 10
**Group ID:** BG003
**Value:** 10
**Group ID:** BG004
**Value:** 40
**Units:** Participants
### Group
**ID:** BG000
**Title:** Group A
**Description:** Treated with 2% Squaric Acid Dibutyl Ester (SADBE) on day 0 and with 2% SADBE on the visits at week 3, week 6, week 9, and month 8.
Squaric Acid Dibutyl Ester: Repeat topical application of 2% and 0.5% squaric acid dibutyl ester (SADBE) in subjects with frequent herpes labialis (4 or more episodes in the previous 12 months).
### Group
**ID:** BG001
**Title:** Group B
**Description:** Treated with 2% Squaric Acid Dibutyl Ester (SADBE) on day 0 and with 0.5% SADBE on the visits at week 3, week 6, week 9, and month 8.
Squaric Acid Dibutyl Ester: Repeat topical application of 2% and 0.5% squaric acid dibutyl ester (SADBE) in subjects with frequent herpes labialis (4 or more episodes in the previous 12 months).
### Group
**ID:** BG002
**Title:** Group C
**Description:** Treated with 2% Squaric Acid Dibutyl Ester (SADBE) on day 0, month 3, and month 6.
Squaric Acid Dibutyl Ester: Repeat topical application of 2% and 0.5% squaric acid dibutyl ester (SADBE) in subjects with frequent herpes labialis (4 or more episodes in the previous 12 months).
### Group
**ID:** BG003
**Title:** Group D
**Description:** Treated with 2% Squaric Acid Dibutyl Ester (SADBE) on day 0 and month 6.
Squaric Acid Dibutyl Ester: Repeat topical application of 2% and 0.5% squaric acid dibutyl ester (SADBE) in subjects with frequent herpes labialis (4 or more episodes in the previous 12 months).
### Group
**ID:** BG004
**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
#### Measurement
**Group ID:** BG003
**Value:** 0
#### Measurement
**Group ID:** BG004
**Value:** 0
**Category Title:** <=18 years
#### Measurement
**Group ID:** BG000
**Value:** 10
#### Measurement
**Group ID:** BG001
**Value:** 10
#### Measurement
**Group ID:** BG002
**Value:** 10
#### Measurement
**Group ID:** BG003
**Value:** 10
#### Measurement
**Group ID:** BG004
**Value:** 40
**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
#### Measurement
**Group ID:** BG003
**Value:** 0
#### Measurement
**Group ID:** BG004
**Value:** 0
**Category Title:** >=65 years
**Class Title:**
### Measure
#### Measurement
**Group ID:** BG000
**Spread:** 11.3
**Value:** 42.3
#### Measurement
**Group ID:** BG001
**Spread:** 10.1
**Value:** 39.2
#### Measurement
**Group ID:** BG002
**Spread:** 12.4
**Value:** 47.1
#### Measurement
**Group ID:** BG003
**Spread:** 13.1
**Value:** 47.2
#### Measurement
**Group ID:** BG004
**Spread:** 11.83
**Value:** 43.94
**Class Title:**
### Measure
#### Measurement
**Group ID:** BG000
**Value:** 7
#### Measurement
**Group ID:** BG001
**Value:** 5
#### Measurement
**Group ID:** BG002
**Value:** 5
#### Measurement
**Group ID:** BG003
**Value:** 6
#### Measurement
**Group ID:** BG004
**Value:** 23
**Category Title:** Female
#### Measurement
**Group ID:** BG000
**Value:** 3
#### Measurement
**Group ID:** BG001
**Value:** 5
#### Measurement
**Group ID:** BG002
**Value:** 5
#### Measurement
**Group ID:** BG003
**Value:** 4
#### Measurement
**Group ID:** BG004
**Value:** 17
**Category Title:** Male
**Class Title:**
### Measure
#### Measurement
**Group ID:** BG000
**Value:** 1
#### Measurement
**Group ID:** BG001
**Value:** 1
#### Measurement
**Group ID:** BG002
**Value:** 0
#### Measurement
**Group ID:** BG003
**Value:** 0
#### Measurement
**Group ID:** BG004
**Value:** 2
**Class Title:** Asian
#### Measurement
**Group ID:** BG000
**Value:** 0
#### Measurement
**Group ID:** BG001
**Value:** 0
#### Measurement
**Group ID:** BG002
**Value:** 1
#### Measurement
**Group ID:** BG003
**Value:** 1
#### Measurement
**Group ID:** BG004
**Value:** 2
**Class Title:** African American or Black
#### Measurement
**Group ID:** BG000
**Value:** 8
#### Measurement
**Group ID:** BG001
**Value:** 9
#### Measurement
**Group ID:** BG002
**Value:** 7
#### Measurement
**Group ID:** BG003
**Value:** 8
#### Measurement
**Group ID:** BG004
**Value:** 32
**Class Title:** White
#### Measurement
**Group ID:** BG000
**Value:** 1
#### Measurement
**Group ID:** BG001
**Value:** 0
#### Measurement
**Group ID:** BG002
**Value:** 2
#### Measurement
**Group ID:** BG003
**Value:** 1
#### Measurement
**Group ID:** BG004
**Value:** 4
**Class Title:** Hispanic or Latino
### Measure
#### Measurement
**Group ID:** BG000
**Value:** 10
#### Measurement
**Group ID:** BG001
**Value:** 10
#### Measurement
**Group ID:** BG002
**Value:** 10
#### Measurement
**Group ID:** BG003
**Value:** 10
#### Measurement
**Group ID:** BG004
**Value:** 40
**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:** Race/Ethnicity, Customized
**Unit of Measure:** Participants
### Measure 5
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
## Results Section - More Information Module
### Certain Agreement
### Point of Contact
**Email:** [email protected]
**Organization:** Squarex LLC
**Phone:** 6512078270
**Title:** Hugh McTavish
## Results Section - Outcome Measures Module
### Outcome Measure 1
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 24
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 14
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 17
- **Comment:**
- **Group ID:** OG003
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 6
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 2
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 3
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 1
- **Comment:**
- **Group ID:** OG003
- **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:** 7
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 6
- **Comment:**
- **Group ID:** OG003
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 4
**Title:**
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Local and generalized adverse events with repeat topical application of 2% and 0.5% squaric acid dibutyl ester (SADBE) in subjects with frequent herpes labialis (4 or more episodes in the previous 12 months).
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** 9 months
**Title:** Local and Generalized Adverse Events
**Type:** PRIMARY
**Unit of Measure:** events
##### Group
**Description:** Treated with 2% Squaric Acid Dibutyl Ester (SADBE) on day 0 and with 2% SADBE on the visits at week 3, week 6, week 9, and month 8.
Squaric Acid Dibutyl Ester: Repeat topical application of 2% and 0.5% squaric acid dibutyl ester (SADBE) in subjects with frequent herpes labialis (4 or more episodes in the previous 12 months).
**ID:** OG000
**Title:** Group A
##### Group
**Description:** Treated with 2% Squaric Acid Dibutyl Ester (SADBE) on day 0 and with 0.5% SADBE on the visits at week 3, week 6, week 9, and month 8.
Squaric Acid Dibutyl Ester: Repeat topical application of 2% and 0.5% squaric acid dibutyl ester (SADBE) in subjects with frequent herpes labialis (4 or more episodes in the previous 12 months).
**ID:** OG001
**Title:** Group B
##### Group
**Description:** Treated with 2% Squaric Acid Dibutyl Ester (SADBE) on day 0, month 3, and month 6.
Squaric Acid Dibutyl Ester: Repeat topical application of 2% and 0.5% squaric acid dibutyl ester (SADBE) in subjects with frequent herpes labialis (4 or more episodes in the previous 12 months).
**ID:** OG002
**Title:** Group C
##### Group
**Description:** Treated with 2% Squaric Acid Dibutyl Ester (SADBE) on day 0 and month 6.
Squaric Acid Dibutyl Ester: Repeat topical application of 2% and 0.5% squaric acid dibutyl ester (SADBE) in subjects with frequent herpes labialis (4 or more episodes in the previous 12 months).
**ID:** OG003
**Title:** Group D
### Participant Flow Module
#### Group
**Description:** Treated with 2% Squaric Acid Dibutyl Ester (SADBE) on day 0 and with 2% SADBE on the visits at week 3, week 6, week 9, and month 8.
Squaric Acid Dibutyl Ester: Repeat topical application of 2% and 0.5% squaric acid dibutyl ester (SADBE) in subjects with frequent herpes labialis (4 or more episodes in the previous 12 months).
**ID:** FG000
**Title:** Group A
#### Group
**Description:** Treated with 2% Squaric Acid Dibutyl Ester (SADBE) on day 0 and with 0.5% SADBE on the visits at week 3, week 6, week 9, and month 8.
Squaric Acid Dibutyl Ester: Repeat topical application of 2% and 0.5% squaric acid dibutyl ester (SADBE) in subjects with frequent herpes labialis (4 or more episodes in the previous 12 months).
**ID:** FG001
**Title:** Group B
#### Group
**Description:** Treated with 2% Squaric Acid Dibutyl Ester (SADBE) on day 0, month 3, and month 6.
Squaric Acid Dibutyl Ester: Repeat topical application of 2% and 0.5% squaric acid dibutyl ester (SADBE) in subjects with frequent herpes labialis (4 or more episodes in the previous 12 months).
**ID:** FG002
**Title:** Group C
#### Group
**Description:** Treated with 2% Squaric Acid Dibutyl Ester (SADBE) on day 0 and month 6.
Squaric Acid Dibutyl Ester: Repeat topical application of 2% and 0.5% squaric acid dibutyl ester (SADBE) in subjects with frequent herpes labialis (4 or more episodes in the previous 12 months).
**ID:** FG003
**Title:** Group D
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 10
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 10
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 10
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 10
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 10
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 10
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 10
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 10
##### 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
**Has Results:** True |
## Protocol Section
### Identification Module
**NCT ID:** NCT02965079
**Acronym:** REXECOR
**Brief Title:** Registry on the EXperience of Extracorporeal CO2 Removal in Intensive Care Units
**Official Title:** Registry on the EXperience of Extracorporeal CO2 Removal in Intensive Care Units
#### Organization Study ID Info
**ID:** APHP
#### Organization
**Class:** OTHER
**Full Name:** Rexecor
### Status Module
#### Completion Date
**Date:** 2022-06
**Type:** ESTIMATED
#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2020-10-14
**Type:** ACTUAL
**Last Update Submit Date:** 2020-10-11
**Overall Status:** UNKNOWN
#### Primary Completion Date
**Date:** 2022-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2016-01
**Status Verified Date:** 2020-09
#### Study First Post Date
**Date:** 2016-11-16
**Type:** ESTIMATED
**Study First Submit Date:** 2016-11-09
**Study First Submit QC Date:** 2016-11-11
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Rexecor
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Investigators will aim to conduct an observational study in order to assess very thoroughly all patients implanted by Extracorporeal carbon dioxide removal (ECCO2R) in 10 critical care units of Paris and its surburb (APHP, Assistance Publique des hôpitaux de Paris).
Secondary objectives will be:
1. to assess efficacy and safety of ECCO2R,
2. to compare the data issue from the registry to others studies assessing the same population and to other centers and
3. to compare the different ECCOR devices in terms of efficacy and adverse events.
**Detailed Description:** The registry will be conducted prospectively during 2 years in 10 ICUs of l'APHP on behalf on the CEDIT. The 10 centers are : (1) ICU of l'hôpital europeén Georges Pompidou, (2) ICU of l'Hôpital Louis Mourier, (3) ICU of l'Hôpital de Bicêtre, (4) ICU of GHPS, (5) Respiratory ICU of GHPS, (6) ICU of l'Hôpital Lariboisière (7) ICU of l'Hôpital Cochin (8) ICU of l'Hôpital Saint-Antoine (9)ICU of l'Hôpital Henri Mondor and (10) ICU of l'Hôpital Tenon.
The primary outcome will be the number of patients implanted by ECCO2R monthly in each center during the 2 years period study.
Secondary outcomes will be ICU-mortality, invasive ventilation duration, non invasive ventilation duration, ICU duration, modalities of ventilation at the ICU discharge, hemorragic complications due to the ECCOR device, thrombotic complications due to ECCO2R device, intravascular hemolysis due to ECCO2R device, duration of ECCO2R, adjunct therapy to ECCO2R and reasons of ECCO2R discontinuation.
### Conditions Module
**Conditions:**
- Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease
- Patients With Acute Respiratory Distress Syndrome
**Keywords:**
- extracorporeal CO2 removal
- registry
- COPD and ARDS
- CEDIT on behalf of APHP
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 200
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
### Interventions
#### Intervention 1
**Description:** The ECCO2R system was developed from the principle of ECMO systems by underscoring the importance of carbon dioxide elimination rather than direct improvement of oxygenation in some patients. The circuit of the ECCO2R system can be set up in venovenous (VV) or arteriovenous (AV). For VV setup, a low flow pump is used to maintain a low extracorporeal flow rate using only 20-30 % of cardiac output. The ECCO2R system does not provide complete pulmonary function as it can achieve only limited oxygenation but provides predominantly carbon dioxide removal. As neither VV nor AV circuit allows full cardiopulmonary bypass, the system provides respiratory function but no cardiac support
**Name:** ECCO2R
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Number of ECCO2R implantation monthly by center
**Measure:** Incidence of ECCO2R use
**Time Frame:** Recorded monthly up to 100 weeks (24 months)
#### Secondary Outcomes
**Measure:** ICU mortality
**Time Frame:** Recorded From date of ICU admission until the date of death or ICU discharge, assessed up to 100 weeks
**Measure:** Duration of mechanical ventilation
**Time Frame:** Recorded from ICU admission until the date of death or ICU discharge,assessed up to 100 weeks
**Measure:** ICU duration
**Time Frame:** Recorded from ICU admission until the date of death or ICU discharge,assessed up to 100 weeks
**Measure:** Ventilation modalities at discharge
**Time Frame:** Recorded from the initiation of ventilation until ventilation removal,assessed up to 100 weeks
**Measure:** hemorragic and thrombotic complications
**Time Frame:** Recorded from the date of ECCO2R implantation until the removal of the device,assessed up to 100 weeks
**Measure:** hemolysis
**Time Frame:** Recorded from the date of ECCO2R implantation until the removal of the device,assessed up to 100 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients implanted with ECCCO2R
Exclusion Criteria:
* Contra-indication to ECCO2R
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** 3 types of patients : Patients with acute exacerbation of chronic obstructive pulmonary disease (COPD) and acute hypercapnic respiratory failure at high risk to failed noninvasive ventilation Patients with acute exacerbation of chronic obstructive pulmonary disease (COPD) needing invasive ventilation in order to reduce mechanical ventilation duration Patients with ARDS and with the ail to reduce ventilation
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Jean-Luc Diehl, MD
**Phone:** 0033156093201
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Nadia Aissaoui, MD
**Phone:** 0033156093201
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Paris
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Jean-Luc Diehl, MD
- **Phone:** 0033156093201
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Nadia Aissaoui, MD
- **Phone:** 0033156093201
- **Role:** CONTACT
**Country:** France
**Facility:** Assistance Publique - Hopitaux de Paris
**Status:** RECRUITING
**Zip:** 75015
### References Module
#### References
**Citation:** Augy JL, Aissaoui N, Richard C, Maury E, Fartoukh M, Mekontso-Dessap A, Paulet R, Anguel N, Blayau C, Cohen Y, Chiche JD, Gaudry S, Voicu S, Demoule A, Combes A, Megarbane B, Charpentier E, Haghighat S, Panczer M, Diehl JL. A 2-year multicenter, observational, prospective, cohort study on extracorporeal CO2 removal in a large metropolis area. J Intensive Care. 2019 Aug 20;7:45. doi: 10.1186/s40560-019-0399-8. eCollection 2019.
**PMID:** 31452899
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000008171
- Term: Lung Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
- ID: D000002908
- Term: Chronic Disease
- ID: D000020969
- Term: Disease Attributes
- ID: D000010335
- Term: Pathologic Processes
- ID: D000012120
- Term: Respiration Disorders
- ID: D000007235
- Term: Infant, Premature, Diseases
- ID: D000007232
- Term: Infant, Newborn, Diseases
- ID: D000055370
- Term: Lung Injury
### Condition Browse Module - Browse Branches
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC16
- Name: Diseases and Abnormalities at or Before Birth
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M14965
- Name: Respiratory Distress Syndrome
- Relevance: HIGH
- As Found: Respiratory Distress Syndrome
- ID: M14964
- Name: Respiratory Distress Syndrome, Newborn
- Relevance: HIGH
- As Found: Respiratory Distress Syndrome
- ID: M11168
- Name: Lung Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M11170
- Name: Lung Diseases, Obstructive
- Relevance: HIGH
- As Found: Obstructive Pulmonary Disease
- ID: M23449
- Name: Pulmonary Disease, Chronic Obstructive
- Relevance: HIGH
- As Found: Chronic Obstructive Pulmonary Disease
- ID: M28144
- Name: Acute Lung Injury
- Relevance: HIGH
- As Found: Acute Respiratory Distress Syndrome
- ID: M28143
- Name: Lung Injury
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract 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: M14957
- Name: Respiration Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M25869
- Name: Premature Birth
- Relevance: LOW
- As Found: Unknown
- ID: M10279
- Name: Infant, Premature, Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10276
- Name: Infant, Newborn, Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T4927
- Name: Respiratory Distress Syndrome, Infant
- Relevance: HIGH
- As Found: Respiratory Distress Syndrome
- ID: T192
- Name: Acute Respiratory Distress Syndrome
- Relevance: HIGH
- As Found: Acute Respiratory Distress Syndrome
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
- ID: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000008173
- Term: Lung Diseases, Obstructive
- ID: D000029424
- Term: Pulmonary Disease, Chronic Obstructive
- ID: D000012128
- Term: Respiratory Distress Syndrome
- ID: D000012127
- Term: Respiratory Distress Syndrome, Newborn
- ID: D000055371
- Term: Acute Lung Injury
### 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:** NCT04734379
**Acronym:** ROCKIT-1
**Brief Title:** Rho Kinase (ROCK) Inhibitor in Tauopathies - 1
**Official Title:** A Phase 2a Open-Label Preliminary Safety, Tolerability, and Biomarker Study of Oral Fasudil in Patients With the 4-Repeat Tauopathies of Progressive Supranuclear Palsy-Richardson Syndrome or Corticobasal Syndrome.
#### Organization Study ID Info
**ID:** WP-0512-002
#### Organization
**Class:** INDUSTRY
**Full Name:** Woolsey Pharmaceuticals
### Status Module
#### Completion Date
**Date:** 2023-11-30
**Type:** ESTIMATED
#### Expanded Access Info
**Last Known Status:** ACTIVE_NOT_RECRUITING
#### Last Update Post Date
**Date:** 2022-06-03
**Type:** ACTUAL
**Last Update Submit Date:** 2022-05-31
**Overall Status:** UNKNOWN
#### Primary Completion Date
**Date:** 2022-11-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2021-01-22
**Type:** ACTUAL
**Status Verified Date:** 2022-05
#### Study First Post Date
**Date:** 2021-02-02
**Type:** ACTUAL
**Study First Submit Date:** 2021-01-18
**Study First Submit QC Date:** 2021-01-27
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Woolsey Pharmaceuticals
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** A Phase 2a Open-Label Preliminary Safety, Tolerability, and Biomarker Study of Oral Fasudil in Patients with the 4-Repeat Tauopathies of Progressive Supranuclear Palsy-Richardson Syndrome or Corticobasal Syndrome
**Detailed Description:** After consent, participants will undergo screening evaluations, which may occur over the course of up to 6 weeks. Subjects who meet inclusion/exclusion criteria will be enrolled into the study and complete baseline evaluations. Dosing with study drug will begin on Day 1 and continue for 48 weeks. Participants will return to the clinic at Week 1 (7 ± 2 days after the first study drug administration) and at Weeks 12, 24, 36, and 48 for study evaluations, and at Week 52 for post-treatment follow-up evaluations. Plasma biomarker collection will occur at baseline, and Weeks 12, 24, 36, and 48. Cerebrospinal fluid (CSF) Biomarker collection will occur at screening, Week 24 and Week 48. Brain magnetic resonance imaging (MRI) will occur at screening, and Weeks 24 and 48. Safety labs will be collected at each study visit as well as during Week 4.
Adverse events (AEs) will be assessed at all visits and subjects will be contacted one day after the start of treatment (that is, one day after Visit 1), and monthly thereafter including at each visit. Subject will also be contacted one day after Visit 6/last day of dosing with study drug for subjects who discontinue early.
Subjects/caregivers will be queried for study drug compliance one day after the start of treatment (that is, one day after Visit 1), and monthly thereafter.
After completion of the 48-week primary portion of the study, subjects will be given the option to continue open-label treatment for up to an additional 12 months.
### Conditions Module
**Conditions:**
- Progressive Supranuclear Palsy
- Corticobasal Syndrome
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** Open label, single arm
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 15
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Oral fasudil 180 mg/day
**Intervention Names:**
- Drug: Fasudil
**Label:** Treatment
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Treatment
**Description:** Oral fasudil 180 mg/day
**Name:** Fasudil
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Incidence of adverse events \[AEs\] and serious adverse events \[SAEs\] as assessed by clinically significant abnormal physical examination findings; changes in vital signs; 12-lead electrocardiogram \[ECG\]; magnetic resonance imaging \[MRI\]; and hematology, blood chemistry, liver function, and urine tests.
**Measure:** Adverse events
**Time Frame:** 48 weeks
#### Secondary Outcomes
**Description:** Number of participants with changes in concentrations of cerebrospinal fluid (CSF) and plasma phosphorylated tau
**Measure:** Phosphorylated tau
**Time Frame:** 48 weeks
**Description:** Number of participants with changes in biomarkers of neurodegeneration, including neurofilament light chain (NfL), and total tau fragment levels.
**Measure:** Biomarkers of neurodegeneration
**Time Frame:** 48 weeks
**Description:** Number of participants with changes in imaging biomarkers of neurodegeneration, including changes in brain volume (whole brain, ventricles, hippocampus, frontal operculum, pre-central gyri, midbrain, pons and superior cerebellar peduncle) and white matter tract integrity (aslant tract, superior longitudinal fasciculus, and superior cerebellar peduncle) as determined by T1-weighted volumetric magnetic resonance imaging (MRI), diffusion tensor imaging (DTI)
**Measure:** Imaging biomarkers of neurodegeneration
**Time Frame:** 48 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Between 35 and 80 years of age (inclusive).
2. Able to walk at least 10 steps with minimal assistance (stabilization of one arm or use of cane/walker).
3. MRI at Screening is consistent with the underlying neurodegenerative disease of the respective diagnostic cohort (i.e. PSP-RS or CBS), with no large strokes or severe white matter disease.
4. Mini-Mental State Exam (MMSE) at Screening is between 20 and 30 (inclusive).
5. For CBS: Amyloid beta (Aβ) positron emission tomography (PET) scan (florbetapir or equivalent) at Screening is not consistent with underlying Alzheimer's disease (AD). Previous Aβ PET scan negativity (assessed by a certified neuroradiologist) or previous AD CSF biomarker (Aβ/tau level, P-tau181 or Aβ1-40 / Aβ1-42) or plasma AD biomarker (P-tau181 or P-tau217) negativity may be used instead of performing an Aβ PET scan at Screening at the Principal Investigator's (PI's) discretion.
6. The following medications are allowed, but must be stable for 2 months prior to Baseline:
1. FDA-approved AD medications
2. FDA-approved Parkinson's Disease (PD) medications
7. Other prescription medications are allowed as long as the dose is stable for 30 days prior to Baseline. (Note Exclusion Criteria 17 and 18.)
8. Has a reliable study partner who agrees to accompany the participant to visits, and spends at least 5 hours per week with the participant.
9. Signed and dated written informed consent obtained from the participant/legally authorized representative (LAR) and the participant's study partner in accordance with local Institutional Review Board (IRB) regulations.
10. Women of childbearing potential (WCBP) must agree to abstain from sex or use an adequate method of contraception for the duration of the screening period, the study drug treatment period, and for 28 days after the last dose of study drug.
11. Males must agree to abstain from sex with WCBP or use an adequate method of contraception for the duration of the study drug treatment period and for 75 days after.
For PSP-RS Only
12. Meets 2017 consensus criteria for possible or probable progressive supranuclear palsy-Richardson syndrome (PSP-RS).
For CBS Only
13. Meets 2013 consensus criteria for possible or probable corticobasal degeneration (CBD), CBS subtype.
Exclusion Criteria:
1. Meets criteria for probable AD established by the National Institute on Aging and the Alzheimer's Association (NIA-AA).
2. Any other medical condition other than PSP-RS or CBS that could account for cognitive or motor deficits (e.g., active seizure disorder, stroke, vascular dementia, substance abuse or alcoholism).
3. History of a prominent and sustained response to levodopa therapy in the opinion of the PI.
4. Presence of significant cardiovascular, hematologic, renal, or hepatic disease.
5. Suicidal ideation per the Columbia-Suicide Severity Rating Scale (C-SSRS) that in the opinion of the PI would pose a safety risk or interfere with the appropriate interpretation of study data
6. History of major psychiatric illness or untreated depression that in the opinion of the PI would pose a safety risk or interfere with the appropriate interpretation of study data.
7. Neutrophil count \<1,500/mm3, platelets \<100,000/mm3, total bilirubin ≥1.5 x Upper Limit of Normal (ULN), alanine aminotransferase (ALT) ≥3 x ULN, aspartate aminotransferase (AST) ≥3 x ULN, or International Normalized Ratio (INR) \>1.2.
8. Serum creatinine \>1.3 mg/dL.
9. Evidence of any clinically significant findings on screening or baseline evaluations which, in the opinion of the PI would pose a safety risk or interfere with appropriate interpretation of study data.
10. Current or recent history (within four weeks prior to Screening) of a clinically significant bacterial, fungal, or mycobacterial infection.
11. Current clinically significant viral infection.
12. Major surgery within four weeks prior to Screening.
13. Any contraindication for MRI or unable to tolerate MRI scan at Screening.
14. Any contraindication to or unable to tolerate lumbar puncture at Screening, including use of anticoagulant medications such as warfarin. Daily administration of aspirin up to 81mg is not a contraindication, as long as the dose is stable for 30 days prior to Screening.
15. Participants who, in the opinion of the PI, are unable or unlikely to comply with the dosing schedule or study evaluations.
16. Treatment with another investigational drug within 30 days or 5 half-lives of drug before Baseline, whichever is longer. Treatment with investigational drugs other than fasudil while on study will not be allowed.
17. Treatment with systemic corticosteroids within 30 days or 5 half-lives of drug before Baseline, whichever is longer.
18. On more than one of the following drug classes: long-acting nitrates, beta-blockers, or calcium channel blockers.
19. Known hypersensitivity to the inactive ingredients in the study drug (fasudil).
20. Known to be pregnant or lactating; or positive pregnancy test at Screening or Baseline (Day 1) for WCBP.
21. Cancer within 5 years of Screening, except for basal cell carcinoma.
22. History of serum or plasma progranulin level less than one standard deviation below the normal participant mean for the laboratory performing the assay.
23. History or evidence at Screening of known disease-associated mutations in GRN, TBK1, C9ORF72, TARBP, CHMPB2, or VCP genes (FTLD causative gene mutations not associated with underlying tau pathology).
24. Blood pressure \< 90/60.
25. Evidence of orthostatic hypotension.
**Maximum Age:** 80 Years
**Minimum Age:** 35 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** San Francisco
**Country:** United States
**Facility:** University of California Weill Institute for Neurosciences
**State:** California
**Zip:** 94158
#### Overall Officials
**Official 1:**
**Affiliation:** UCSF Weill Institute for Neurosciences
**Name:** Peter Ljubenkov, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000004194
- Term: Disease
- ID: D000010335
- Term: Pathologic Processes
- 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: D000009886
- Term: Ophthalmoplegia
- ID: D000015835
- Term: Ocular Motility Disorders
- ID: D000003389
- Term: Cranial Nerve Diseases
- ID: D000019636
- Term: Neurodegenerative Diseases
- ID: D000010243
- Term: Paralysis
- ID: D000009461
- Term: Neurologic Manifestations
- ID: D000005128
- Term: Eye Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC11
- Name: Eye Diseases
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M16355
- Name: Syndrome
- Relevance: HIGH
- As Found: Syndrome
- ID: M13157
- Name: Paralysis
- Relevance: LOW
- As Found: Unknown
- ID: M16275
- Name: Supranuclear Palsy, Progressive
- Relevance: HIGH
- As Found: Progressive Supranuclear Palsy
- ID: M2649
- Name: Corticobasal Degeneration
- Relevance: HIGH
- As Found: Corticobasal Syndrome
- ID: M23002
- Name: Tauopathies
- Relevance: HIGH
- As Found: Tauopathies
- 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: M12817
- Name: Ophthalmoplegia
- Relevance: LOW
- As Found: Unknown
- ID: M18386
- Name: Ocular Motility Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M6605
- Name: Cranial Nerve Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M21558
- Name: Neurodegenerative Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: M8271
- Name: Eye Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T4741
- Name: Progressive Supranuclear Palsy
- Relevance: HIGH
- As Found: Progressive Supranuclear Palsy
- ID: T1606
- Name: Corticobasal Degeneration
- Relevance: HIGH
- As Found: Corticobasal Syndrome
### Condition Browse Module - Meshes
- ID: D000013494
- Term: Supranuclear Palsy, Progressive
- ID: D000024801
- Term: Tauopathies
- ID: D000088282
- Term: Corticobasal Degeneration
- ID: D000013577
- Term: Syndrome
### Intervention Browse Module - Ancestors
- ID: D000002121
- Term: Calcium Channel Blockers
- ID: D000049990
- Term: Membrane Transport Modulators
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000077264
- Term: Calcium-Regulating Hormones and Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000014665
- Term: Vasodilator Agents
- ID: D000047428
- Term: Protein Kinase Inhibitors
- ID: D000004791
- Term: Enzyme Inhibitors
### Intervention Browse Module - Browse Branches
- Abbrev: ChanBlk
- Name: Channel Blockers
- Abbrev: VaDiAg
- Name: Vasodilator Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: BDCA
- Name: Bone Density Conservation Agents
### Intervention Browse Module - Browse Leaves
- ID: M247557
- Name: Fasudil
- Relevance: HIGH
- As Found: Renal pelvis
- ID: M5381
- Name: Calcium
- Relevance: LOW
- As Found: Unknown
- ID: M5384
- Name: Calcium Channel Blockers
- Relevance: LOW
- As Found: Unknown
- ID: M5398
- Name: Calcium, Dietary
- Relevance: LOW
- As Found: Unknown
- ID: M9789
- Name: Hormones
- Relevance: LOW
- As Found: Unknown
- ID: M17412
- Name: Vasodilator Agents
- 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
### Intervention Browse Module - Meshes
- ID: C000049347
- Term: Fasudil
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT04374279
**Acronym:** RECOVER
**Brief Title:** Trial to Promote Recovery From COVID-19 With Endocrine Therapy
**Official Title:** A Phase II Trial to Promote Recovery From COVID-19 With Endocrine Therapy
#### Organization Study ID Info
**ID:** COV2003
#### Organization
**Class:** OTHER
**Full Name:** Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
#### Secondary ID Infos
**Domain:** JHM IRB
**ID:** IRB00249425
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2022-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-03-05
**Type:** ACTUAL
**Last Update Submit Date:** 2021-03-02
**Overall Status:** WITHDRAWN
#### Primary Completion Date
**Date:** 2022-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2021-04
**Type:** ESTIMATED
**Status Verified Date:** 2021-03
#### Study First Post Date
**Date:** 2020-05-05
**Type:** ACTUAL
**Study First Submit Date:** 2020-05-04
**Study First Submit QC Date:** 2020-05-04
**Why Stopped:** Limited resources.
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Patients with COVID-19 requiring inpatient hospitalization will be randomized to treatment with standard of care or standard of care + bicalutamide. This will be a randomized, open-label study to determine if bicalutamide improves the rate of clinical improvement in patients with COVID-19.
### Conditions Module
**Conditions:**
- COVID-19
- SARS-CoV 2
**Keywords:**
- COVID-19
- Coronavirus
- COVID
- SARS-COV-2
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Patients will be randomized 1:1 to bicalutamide with standard of care, or standard of care alone.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Type:** ACTUAL
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Randomized participants receive bicalutamide 150mg oral for 7 days, plus standard of care
**Intervention Names:**
- Drug: Bicalutamide 150 Mg Oral Tablet
**Label:** Standard of care and bicalutamide
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** Randomized participants receive standard of care only.
**Label:** Standard of care only
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Standard of care and bicalutamide
**Description:** Bicalutamide 150 mg by mouth daily for 7 days
**Name:** Bicalutamide 150 Mg Oral Tablet
**Other Names:**
- Casodex
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Percentage of participants who are discharged from the hospital or if they have had at least a 2-point improvement on the World Health Organization (WHO) Ordinal Scale for Clinical Improvement. The WHO clinical improvement scale has a score range of 0-8 where, 0= uninfected, 1= ambulatory with no limitation of activities; 2= ambulatory with limitations to activities; 3= hospitalized, mild disease, with no oxygen therapy; 4= hospitalized, mild disease, with oxygen by mask or nasal prongs; 5= hospitalized, severe disease, with non-invasive ventilation or high-flow oxygen; 6= hospitalized, severe disease, with intubation and mechanical ventilation; 7= hospitalized, severe disease, with ventilation and additional organ support (pressors, dialysis, ECMO); 8= death
**Measure:** Percentage of participants who have clinical improvement at day 7 after randomization
**Time Frame:** up to 7 days
#### Secondary Outcomes
**Description:** Number of participants deceased for any cause
**Measure:** All-cause mortality
**Time Frame:** 28 days
**Description:** Number of calendar days in the hospital
**Measure:** Duration of hospitalization
**Time Frame:** up to 60 days
**Measure:** Percentage of patients needing upgrade to the intermediate care unit (IMC)
**Time Frame:** up to 60 days
**Description:** Number of calendar days in IMC
**Measure:** Duration of IMC stay
**Time Frame:** up to 60 days
**Measure:** Percentage of patients needing upgrade to the intensive care unit (ICU)
**Time Frame:** up to 60 days
**Description:** Number of calendar days in ICU
**Measure:** Duration of ICU stay
**Time Frame:** up to 60 days
**Measure:** Number of participants requiring mechanical ventilation
**Time Frame:** up to 60 days
**Description:** Number of calendar days requiring mechanical ventilation
**Measure:** Duration of mechanical ventilation
**Time Frame:** up to 60 days
**Description:** Number of participants who are COVID-19 positive, experiencing adverse events as defined by the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
**Measure:** Number of participants experiencing adverse events
**Time Frame:** up to 60 days
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* ≥18 years of age
* COVID-19 infection, confirmed by polymerase chain reaction (PCR) test \<=3 days from enrollment
* Require inpatient hospitalization due to COVID-19 with minimal respiratory symptoms
* Able to provide informed consent
Exclusion Criteria:
* Unable to take oral medication
* Pregnant or breastfeeding
* On non-invasive positive pressure ventilation or mechanical ventilation at time of study entry
* Requiring ≥6L oxygen or respiratory rate ≥30
* Taking bicalutamide, any systemic hormonal therapy, or prophylactic treatment for COVID-19 within one month of study entry
* Known hypersensitivity to bicalutamide or its components.
* A past medical history of cirrhosis or AST/ALT/Alk phos/bilirubin \> 3x the upper limit of normal
* Patients with a clinical history of myocardial infarction or congestive heart failure within 6 months, or with prior echocardiogram showing ejection fraction \< 40%
* Patients currently on coumadin anticoagulants due to the potential for drug-drug interactions.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Baltimore
**Country:** United States
**Facility:** Johns Hopkins Hospital
**State:** Maryland
**Zip:** 21231
#### Overall Officials
**Official 1:**
**Affiliation:** Johns Hopkins University
**Name:** Catherine H Marshall, MD/MPH
**Role:** PRINCIPAL_INVESTIGATOR
### 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: M20490
- Name: Coronavirus Infections
- 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: 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
### Intervention Browse Module - Ancestors
- ID: D000000726
- Term: Androgen Antagonists
- ID: D000006727
- Term: Hormone Antagonists
- ID: D000006730
- Term: Hormones, Hormone Substitutes, and Hormone Antagonists
- ID: D000045505
- Term: Physiological Effects of Drugs
- 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: M231527
- Name: Bicalutamide
- Relevance: HIGH
- As Found: Coronavirus
- ID: M4059
- Name: Androgens
- Relevance: LOW
- As Found: Unknown
- ID: M4057
- Name: Androgen 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: C000053541
- Term: Bicalutamide
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT01225679
**Acronym:** CCHS
**Brief Title:** Late-onset Congenital Central Hypoventilation Syndrome and the Mutation of Phox2B Gene
**Official Title:** Late-onset, Insidious Course and Invasive Treatment of Congenital Central Hypoventilation Syndrome in a Case With the Phox2B Mutation
#### Organization Study ID Info
**ID:** 512947
#### Organization
**Class:** OTHER
**Full Name:** Associação Fundo de Incentivo à Pesquisa
### Status Module
#### Completion Date
**Date:** 2010-09
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2014-02-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2014-02-05
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2010-07
**Type:** ACTUAL
#### Start Date
**Date:** 2010-07
**Status Verified Date:** 2014-02
#### Study First Post Date
**Date:** 2010-10-21
**Type:** ESTIMATED
**Study First Submit Date:** 2010-07-07
**Study First Submit QC Date:** 2010-10-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Associação Fundo de Incentivo à Pesquisa
#### Responsible Party
**Investigator Affiliation:** Associação Fundo de Incentivo à Pesquisa
**Investigator Full Name:** Prof. Dr. Lia Azeredo-Bittencourt
**Investigator Title:** MD, PhD
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Congenital central hypoventilation syndrome (CCHS) is a rare disorder of respiratory control characterized by ventilatory impairment that results in arterial hypoxemia. Although patients typically present this disease as newborns and rarely in later infancy, there have been reports of patients presenting with CCHS in adulthood.
The present study reports a unique familial case in which the father (proband) presented late-onset CCHS with an expansion mutation of the Phox2B gene that was confirmed by genetic analysis. Surprisingly, the proband did not report any manifestation of the disease during childhood, and the disease progressed following an insidious course until adulthood. At the time of diagnosis, he did not present signs of pulmonary hypertension and right-side heart failure. The patient responded well to nocturnal invasive ventilation. In contrast, his son presented CCHS as a newborn with the full complement of symptoms while his daughter did not.
The present report shows that CCHS cases characterized by a mutated Phox2 gene can progress without many symptoms and that the treatment approach used here was efficient for controlling the course of the disease. Furthermore, this case indicates that incomplete penetrance can occur. Genetic screening of family members is mandatory to evaluate the reproductive risk of the disease, especially because asymptomatic mutation carriers may be at high risk to develop the disease and transmit it to the next generation.
**Detailed Description:** Congenital central hypoventilation syndrome (CCHS) is a rare disorder of respiratory control characterized by ventilatory impairment that results in arterial hypoxemia. This condition worse during sleep and occurs in patients with normal mechanical properties of the lung. It is diagnosed in the absence of primary neuromuscular disease, identifiable brainstem lesions, and other sleep disturbances or substance use.
Amiel et al. (2003) identified a mutation in the Phox2B gene associated with CCHS, characterized by 5 to 9 alanine expansions within a 20-residue polyalanine region in exon 3 of the Phox2B gene. Several reports confirmed the findings of Amiel et al., supporting the view that this gene is a master switch for the development of the autonomic nervous system network linked to respiratory control. Transgenic animals carrying the human Phox2B mutation develop a similar phenotype and lack glutamatergic neurons located in the parafacial region in the brainstem, which are involved in breathing control.
Although patients typically present with CCHS as newborns and rarely in later infancy, there have been reports of patients presenting with CCHS in adulthood. In cases of late-onset CCHS, most patients report having had some symptoms since childhood, and they have parents with a history of CCHS. Symptoms of right-side heart failure are generally observed at the time of diagnosis, and nocturnal noninvasive ventilation is frequently indicated.
The present study reports a unique familial case of CCHS in which the father (proband) presented late-onset CCHS linked to a Phox2B gene expansion mutation. The presentation, course of development and treatment response for this patient was unique His son presented CCHS as a newborn, while his daughter did not.
### Conditions Module
**Conditions:**
- Congenital Central Hypoventilation Syndrome
**Keywords:**
- Congenital Central Hypoventilation Syndrome
- Phox2B gene
- invasive ventilation
- genetics
- late-onset
- sleep
- central sleep apnea
### Design Module
#### Bio Spec
**Description:** Human
**Retention:** SAMPLES_WITH_DNA
#### Design Info
**Observational Model:** CASE_ONLY
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 1
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Overnight supervised polysomnography (Embla System®) was performed in a sleep laboratory, which included capnometry. Arterial blood gas analysis was performed by radial arterial puncture. Ventilatory response to progressive hypercapnia was measured using the Read breathing technique. Briefly, subjects rebreathed into an air tight 5-L bag containing a mixture of 8% carbon dioxide (CO2) and 40% oxygen (O2). The spirometer technology used to monitor ventilation was based on a bi-directional rotating vane principle (flow sensitive). A continuous record of CO2 concentration in the expired gas was obtained by a CO2 analyzer within the circuit. The ventilatory hypercapnic drive was calculated from the slope produced by changes in ventilation (L. min-1) and changes in end-tidal PCO2.
**Intervention Names:**
- Device: positive airway pressure, Non-invasive mechanic ventilation
**Label:** polysomnography
### Interventions
#### Intervention 1
**Arm Group Labels:**
- polysomnography
**Description:** Vpap: 16 cm H2O inspiratory and 8 cm H2O expiratory pressures, 20 irpm.
Mechanic ventilation: tidal volume of 850 ml; 16 irpm; inspiratory pressure of 40 mmHg; PEEP: 5 cm H2O.
**Name:** positive airway pressure, Non-invasive mechanic ventilation
**Other Names:**
- There is no other intervention description
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Measure:** Describe the clinical case apresentation
**Time Frame:** Years of evolution
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:Family member
Exclusion Criteria:NA
**Healthy Volunteers:** True
**Minimum Age:** 5 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** MALE
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
**Study Population:** familial case in which the father (proband) presented late-onset CCHS with an expansion mutation of the Phox2B gene that was confirmed by genetic analysis.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** São Paulo
**Country:** Brazil
**Facility:** Disciplina de Medicina e Biologia do Sono, Departamento de Psicobiologia, Universidade Federal de São Paulo
**Zip:** 04024-002
#### Overall Officials
**Official 1:**
**Affiliation:** Universidade Federal de São Paulo/UNIFESP
**Name:** Lia Rita A Bittencourt, PhD
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000004194
- Term: Disease
- ID: D000010335
- Term: Pathologic Processes
- ID: D000012131
- Term: Respiratory Insufficiency
- ID: D000012120
- Term: Respiration Disorders
- ID: D000012140
- Term: Respiratory Tract Diseases
- ID: D000012818
- Term: Signs and Symptoms, Respiratory
- ID: D000012891
- Term: Sleep Apnea Syndromes
- ID: D000001049
- Term: Apnea
- ID: D000020919
- Term: Sleep Disorders, Intrinsic
- ID: D000020920
- Term: Dyssomnias
- ID: D000012893
- Term: Sleep Wake Disorders
- ID: D000009422
- Term: Nervous System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M16355
- Name: Syndrome
- Relevance: HIGH
- As Found: Syndrome
- ID: M4361
- Name: Apnea
- Relevance: LOW
- As Found: Unknown
- ID: M15694
- Name: Sleep Apnea Syndromes
- Relevance: LOW
- As Found: Unknown
- ID: M10090
- Name: Hypoventilation
- Relevance: HIGH
- As Found: Hypoventilation
- ID: M22011
- Name: Sleep Apnea, Central
- Relevance: HIGH
- As Found: Congenital Central Hypoventilation Syndrome
- ID: M14968
- Name: Respiratory Insufficiency
- 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: M15623
- Name: Signs and Symptoms, Respiratory
- 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: T1473
- Name: Congenital Central Hypoventilation Syndrome
- Relevance: HIGH
- As Found: Congenital Central Hypoventilation Syndrome
### Condition Browse Module - Meshes
- ID: D000007040
- Term: Hypoventilation
- ID: D000020182
- Term: Sleep Apnea, Central
- ID: D000013577
- Term: Syndrome
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT03934879
**Acronym:** FitClub
**Brief Title:** Physical Exercise and Contributors to Academic Performance Among Adolescents With ASD (Fit Club Study)
**Official Title:** Physical Exercise and Contributors to Academic Performance Among Adolescents With ASD (Fit Club Study)
#### Organization Study ID Info
**ID:** 16-0185
#### Organization
**Class:** OTHER
**Full Name:** The University of Texas Medical Branch, Galveston
### Status Module
#### Completion Date
**Date:** 2020-12
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-02-01
**Type:** ACTUAL
**Last Update Submit Date:** 2021-01-28
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2018-07
**Type:** ACTUAL
#### Start Date
**Date:** 2016-08
**Type:** ACTUAL
**Status Verified Date:** 2020-04
#### Study First Post Date
**Date:** 2019-05-02
**Type:** ACTUAL
**Study First Submit Date:** 2016-08-08
**Study First Submit QC Date:** 2019-04-30
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** The University of Texas Medical Branch, Galveston
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** This study, Physical Exercise and Contributors to Academic Performance among Adolescents with Autism Spectrum Disorders (ASD), aims to expand our understanding of the impact of regular physical exercise on improvement in academic performance. The investigators will focus on the use of affordable, portable, and achievable interventions that can be easily shared and incorporated into other academic and home settings. The study will examine the use a regular vigorous exercise program for helping students with ASD reduce body mass index and improve executive function, motor performance, sensory responsiveness, and mood. The investigators propose a collaborative arrangement with an area school to conduct an 18-month exploratory pilot study of 30 middle- and high-school aged students (12 to 18 years old) with ASD, who are returning participants or are new to participating in the Fit Club at Gateway Academy. The investigators expect that the changes elicited by participation in this type of exercise program will support the formation of adult life skills, impacting on long-term quality of life for individuals with ASD and children with other conditions.
**Detailed Description:** Detailed Description: Background:
Individuals with autism spectrum disorders (ASD) typically have social impairment, have difficulty making decisions and problem solving (executive function) and have impaired motor performance. As a result, they are less likely to even live independently, be employed, go to college or get married. Few effective interventions have been found to help with the complex problems of people with ASD who are unable to establish independent lives. The investigators plan to begin the examination of using a regular physically challenging exercise program to support development of executive function (EF) and motor skills among children and young adults with ASD to improve academic behaviors and participation in adult activities.
In addition to having social, EF and motor problems, children and young adults with ASD often participate in limited physical activities, enjoy them less than do typically developing (TD) children, are less motivated to participate in physical activities than TD children, experience weight gain from medications, and encounter problems with reduced physical fitness and obesity. Lack of interest or motivation to exercise may make it difficult for them to comply with daily physical activity recommendations. As a result, these students are less likely to be involved in physical activity, enjoy fewer types of leisure activities, and experience limited relationships with peers, which eventually contribute to lower levels of participation in adult activities.
Benefits of Physical Activity:
Physical exercise has been shown to improve cognitive processes in TD individuals. It has a positive influence on symptoms seen in children and adolescents with ASD, including experiencing reductions in stereotypical behaviors, improved sensory skills and social responsiveness, improved concentration and memory, weight reduction, improved motor skills, improvement in executive function and a reduction in repetitive behaviors. Many of these skills are necessary for adult tasks such as driving, test-taking, employment, and engaging in other purposeful adult activities. The mechanism of improvement in these cognitive functions as a result of physical exercise is thought to be caused by increased cerebral blood flow, up-regulation of neuroprotective growth factors, and the cardiovascular benefits of exercise, which lead to an improvement in the delivery of oxygen and nutrients. It is not clear, however, if the amount of effort during exercise is related to the improvement in cognitive functions.
Participation: Participation in activities is how children and young adults develop an understanding of the expectations of society and gain the physical and social skills needed to function and flourish, it plays an important role in a child's or young adult's social development, and it influences long-term mental and physical health.
Mood: Having ASD may lead to psychosocial impairments, including depression, anxiety, stress, and low self-esteem. For example, Shtayermman (2008) reported that 50% of study participants with Asperger syndrome had made a suicide attempt, while Paquette-Smith, Weiss, and Lunsky (2014) determined that "36% suicide attempt rate reported in their sample of 50 adults with Asperger Syndrome was much higher than the national average of 4.6% over a lifetime in the general population". Using the Depression, Anxiety, and Stress Scale (DASS-21), components of psychosocial well-being will be assessed in this cohort of children during this study.
Sensory Responsiveness: Children and young adults with ASD demonstrate unusual sensory responses to stimuli more frequently than do typically developing peers or those with other developmental disorders. In a study comparing children with and without ASD, atypical sensory responsiveness patterns greater than one standard deviation from the mean were found in up to 95% in children with ASD, compared to 12 to 25% of children without ASD in the various sensory domains.
Gateway Academy: For this study, the investigators will partner with Gateway Academy, a private school that utilizes innovative approaches to learning, physical fitness, and social awareness, and enrolls approximately 55 students of middle to high school age with social and academic challenges, the majority of whom have an ASD diagnosis. Gateway Academy developed a Fit Club fitness program seven years ago modeled after an exercise program developed by Ratey. In addition, a second school, closely matched to Gateway Academy functional levels, has communicated an interest in participating in the second stage of this study.
Methodology:
Each year, 10 to 15 new students join Gateway Academy who have not participated in an organized, mandatory exercise intervention (Fit Club). With this study, the investigators plan to examine the impact of the Fit Club intervention by comparing students new to the Fit Club intervention throughout the school year, and also by tracking returning students on a range of factors, including BMI, executive function, motor skills, sleep patterns, and classroom behaviors.
The investigators propose to conduct an 18-month exploratory pilot study of 30 middle- and high-school aged students (12 to 18 years old) with ASD, who participate in, or are new to participating in the Fit Club at Gateway Academy. Engagement in exercise and response to exercise will be constantly monitored for participants. Other participant data will be collected three times, once at baseline, at the end of the school year, and at the beginning of the next school year.
The investigators will adhere to the Fit Club fitness program protocol. All students will rotate through each fitness module, which includes spin class, Pilates, strengthening exercises (weight training), basketball, running and rhythm, and cardio fitness. Students will meet five days per week during their first class of the day for 35 minutes and participate in two randomly assigned modules for two week periods. After 2 weeks, they participate in 2 different modules.
Study Objectives:
Objective 1: To determine how students new to the fitness program compare to their returning peers in BMI, executive function, sensory responsiveness, motor skills, mood, and activity participation.
Objective 2: To quantify the changes in BMI, executive function, sensory responsiveness motor skills, and mood after participation in a fitness program after one and two semesters for new and returning students.
Objective 3: To determine if greater physical effort is correlated with greater improvement in BMI, executive function, sensory responsiveness, motor skills, and mood.
Objective 4: To determine if leisure activity participation patterns vary across ages of students and change after two semesters of participation in a fitness program.
Data Collection phase of the study. Timeline Months 1 \& 2: Identification of participants, Consents, Baseline data collected (Visit 1) Months 3-9: Fit Club Month 9 (Visit 2) Months 10-12: Summer Break Months13-14: School Start data collection (Visit 3) Months14-18: Data analysis and dissemination
Evaluation/Data Analysis:
Data from students will include factors that affect academic performance, including measures of EF, sensory responsiveness, and motor skills. Physiological statistics such as height and weight will be collected to calculate Body Mass Indices (BMI) for each participant over the course of the study. To achieve the greatest validity, assessments have been selected that obtain the perspectives from several sources: parent/LAR report, teacher report and direct observation. Parent, student, and teacher questionnaires will be administered online. All students, teachers, and parents will be able to use computers with access to the internet. Observation assessments will be conducted by graduate occupational therapy students from the University of Texas Medical Branch. A FitBit® activity tracking wristband with a heart rate monitor and wireless syncing capabilities will be worn by participants and will be used to track resting and peak heart rate, calories burned, steps taken, and sleep quality. Outcome constructs and performance measures are listed below.
Study Outcome: Performance Measure ASD Severity: Social Responsiveness Scale, Second Edition, parent and teacher forms (SRS-2), Sensory Responsiveness: Adolescent/Adult Sensory Profile, Motor Performance: Bruininks-Osteretsky Test of Motor Proficiency, Second Edition (BOT-2), Executive Function: Behavior Rating Inventory of Executive Function, parent and teacher forms (BRIEF), Delis-Kaplan Executive Function System (D-KEFS), Participation: Children's Assessment of Participation and Enjoyment \& Preferences for Activities of Children (CAPE/PAC), Life Participation for Parents, Adolescent and Young Adult Activity Card Sort (AYA-ACS), Behavior/Mood: Repetitive Behavior Scale, Depression, Anxiety and Stress Scale (DASS), Effort:Heart Rate and daily steps taken with activity monitoring wristband, Summer Exercise Questionnaire Metabolic Parameters Height and weight scale, Height in inches, Body temperature with no contact thermometer
Significance:
This research has the potential to change policy regarding physical education for students with ASD. If the results of this study show a strong relationship between the level of physical exertion and improvements in factors affecting academic performance, it will suggest adding more physically exerting activities to school curricula for students with ASD. The positive impact of physical exercise has been observed in previous studies, but this study may help to clarify the relationship between effort during exercise and improvements in the factors that support academic performance. The investigators may also gain understanding of the duration and effort of exercise necessary to see improvements in these factors, and whether the benefits are sustained. Examination of regression from non-adherence over the summer will help clarify the necessity of continuous participation. If a relationship is found between effort and the factors supporting academic performance, it will help to better identify options for interventions to improve those factors in students with ASD. Participation data will build a better understanding of leisure activity participation patterns in adolescents with ASD that will help to guide intervention.
### Conditions Module
**Conditions:**
- Autism Spectrum Disorders
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** One school will receive FitClub intervention. Second school will receive regular school activities.
##### 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:** For this study, Gateway Academy students will participate in the FitClub intervention. They will rotate through each fitness module, which includes spin class, Pilates, strengthening exercises (weight training), basketball, running and rhythm, and cardio fitness. Students will meet five days per week during their first class of the day for 35 minutes and participate in two randomly assigned modules for two week periods. After 2 weeks, they participate in 2 different modules. Resting and peak heart rate (during exercise), calories burned and steps taken will be collected during each session.
**Intervention Names:**
- Behavioral: FitClub
**Label:** Gateway Academy
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Other comparable school will be added as a control school, in which regular school activities will be provided.
**Intervention Names:**
- Other: Regular School Activities
**Label:** Control School
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Gateway Academy
**Description:** Participants will rotate through each fitness module, which includes spin class, Pilates, strengthening exercises (weight training), basketball, running and rhythm, and cardio fitness. Students will meet five days per week during their first class of the day for 35 minutes and participate in two randomly assigned modules for two week periods. After 2 weeks, they participate in 2 different modules. Resting and peak heart rate (during exercise), calories burned and steps taken will be collected during each session.
**Name:** FitClub
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- Control School
**Description:** Students will participate in regular school activities.
**Name:** Regular School Activities
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** is a standardized measure of motor proficiency. It generates gender-specific composite subscale scores for: fine manual control, manual coordination, body coordination, strength and agility, and a full motor composite score, and has been normed for children between ages 4 and 21. Participants will be tested at the beginning and end of the school year to detect change in motor proficiency after participating in the intervention.
**Measure:** Change from baseline in Bruininks-Osteretsky Test of Motor Proficiency, Second Edition
**Time Frame:** Initial, 9 months
#### Secondary Outcomes
**Description:** is a card sort assessment of participation in everyday activities developed for individuals between the ages of 18-25. It includes activities in categories of obligatory chores, leisure, social, health, wellness or fitness, education and learning, work, and parenting/caring for children. Participants will be tested at the beginning and end of the school year to detect change in activity participation after participating in the intervention.
**Measure:** Change from baseline in Adolescent and Young Adult Activity Card Sort
**Time Frame:** Initial, 9 months
**Description:** is a self-report, 4-point Likert-scale and a quantitative measure of distress along three dimensions: depression, anxiety and stress. Participants will be tested at the beginning and end of the school year to detect change.
**Measure:** Change from baseline in Depression, Anxiety and Stress Scale
**Time Frame:** Initial, 9 months
**Description:** An empirically derived parent-reported clinical rating scale for measuring the presence and severity of a variety of forms of restricted, repetitive behaviors that are characteristic of children and adults with Autism Spectrum Disorders (ASD). Six subscales are derived from 43 items consisting of: 1) Stereotyped Behavior, 2) Self-injurious Behavior, 3) Compulsive Behavior, 4) Routine Behavior, 5) Sameness Behavior, and 6) Restricted Behavior. This scale will be administered at the beginning and the end of the school year to detect changes in repetitive behavior from participation in the intervention.
**Measure:** Change from baseline in Repetitive Behavior Scale
**Time Frame:** Initial, 9 months
**Description:** is a standardized questionnaire for individuals between the ages of 11 and 65, is comprised of 60 statements rated on a Likert (1) never to (5) always scale. Participants will be complete the form at the beginning and end of the school year to detect change in their sensory responsiveness after participating in the intervention.
**Measure:** Change from baseline in Sensory Profile Adolescent/Adult
**Time Frame:** Initial, 9 months
**Description:** Height and weight will be measured and BMI calculated from that. Height and weight will be measured at the beginning and end of the school year to detect change in BMI after participating in the intervention.
**Measure:** Change from baseline in Body Mass Indices
**Time Frame:** Initial, 9 months
**Description:** FitbitChargeHR® activity tracking wristband with a HR monitor and wireless syncing capabilities will be worn by participants and will be used to track resting and peak HR. Exercise heart rate will be compared between the beginning and the end of the school year to detect changes after participating in the intervention.
**Measure:** Change from baseline in Exercise Heart Rate
**Time Frame:** initial, 9 months
**Description:** is the first nationally standardized set of tests to evaluate higher level cognitive. Participants will be tested at the beginning and end of the school year to detect change in executive function after participating in the intervention.
**Measure:** Change from baseline in Delis-Kaplan Executive Function System
**Time Frame:** Initial, 9 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age 12 - 18 years
* Diagnosis of ASD
* IQ of 60+, will be provided by Gateway Academy with parental consent
* Willingness to participate in study (i.e. signed assent/consent)
* Conversational use of English language
Exclusion Criteria:
* Dual diagnosis of cerebral palsy or any other major neurologic condition
* Uncorrected hearing or vision problems
**Maximum Age:** 18 Years
**Minimum Age:** 12 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Houston
**Country:** United States
**Facility:** Gateway Academy
**State:** Texas
**Zip:** 77092
#### Overall Officials
**Official 1:**
**Affiliation:** University of Texas
**Name:** Claudia L Hilton, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000002659
- Term: Child Development Disorders, Pervasive
- ID: D000065886
- Term: Neurodevelopmental 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: M4623
- Name: Autistic Disorder
- Relevance: LOW
- As Found: Unknown
- ID: M206
- Name: Autism Spectrum Disorder
- Relevance: HIGH
- As Found: Autism Spectrum Disorder
- ID: M5903
- Name: Child Development Disorders, Pervasive
- Relevance: LOW
- As Found: Unknown
- ID: M5902
- Name: Developmental Disabilities
- 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
### Condition Browse Module - Meshes
- ID: D000067877
- Term: Autism Spectrum Disorder
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT02233179
**Brief Title:** The Association Between Unprotected Standing, Walking and Wound Healing in Diabetes
**Official Title:** Body-worn Sensor Technology for Improving Diabetic Care During Activities of Daily Living
#### Organization Study ID Info
**ID:** 0900000701
#### Organization
**Class:** OTHER
**Full Name:** University of Arizona
### Status Module
#### Completion Date
**Date:** 2012-11
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2014-09-08
**Type:** ESTIMATED
**Last Update Submit Date:** 2014-09-03
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2011-08
**Type:** ACTUAL
#### Start Date
**Date:** 2009-06
**Status Verified Date:** 2014-09
#### Study First Post Date
**Date:** 2014-09-08
**Type:** ESTIMATED
**Study First Submit Date:** 2014-08-08
**Study First Submit QC Date:** 2014-09-03
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** Qatar National Research Foundation, Qatar
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Arizona
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The aim of the study was to explore the association between activities of daily living ( measured using a body-worn sensor) on wound healing in diabetic patients. Since this was an exploratory study, there was no study hypothesis.
**Detailed Description:** Diabetes patients with active foot ulcers were recruited and monitored for activities of daily living while wearing an offloading device.
### Conditions Module
**Conditions:**
- Diabetic Foot
**Keywords:**
- Diabetic foot ulcer
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** TRIPLE
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 49
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** An offloading device that can be removed by the patients
**Intervention Names:**
- Device: Removable cast walker
**Label:** Removable Cast Walker
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** A removable cast rendered irremovable using instant total contact cast, so patients cannot remove offloading device.
**Intervention Names:**
- Device: Irremovable cast walker
**Label:** Irremovable Cast Walker
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Removable Cast Walker
**Description:** Offloading device that can be removed by patients.
**Name:** Removable cast walker
**Other Names:**
- Cast walker from Ossur, Reykjavik, Iceland
**Type:** DEVICE
#### Intervention 2
**Arm Group Labels:**
- Irremovable Cast Walker
**Description:** Offloading device that cannot be removed by patients.
**Name:** Irremovable cast walker
**Other Names:**
- Cast walker from Ossur, Reykjavik, Iceland
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Wound size was measured every week for 12 weeks
**Measure:** Wound size
**Time Frame:** 12 weeks
**Description:** Recorded using a body-worn sensor and measured every 4 weeks for 2 days.
**Measure:** Daily Physical Activities
**Time Frame:** 12 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* age 18 or older with non-infected, non-ischemic foot ulcers
* active neuropathic foot ulcer
Exclusion Criteria:
* major foot amputation
* active Charcot arthropathy
* ankle brachial index of 0.5 or less
* history of substance abuse within 6 months
* inability to walk 20m
**Maximum Age:** 68 Years
**Minimum Age:** 37 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Tucson
**Country:** United States
**Facility:** University Medical Center
**State:** Arizona
**Zip:** 85724
#### Overall Officials
**Official 1:**
**Affiliation:** University of Arizona
**Name:** David G Armstrong, DPM, MD, PhD
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000003925
- Term: Diabetic Angiopathies
- ID: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000016523
- Term: Foot Ulcer
- ID: D000007871
- Term: Leg Ulcer
- ID: D000012883
- Term: Skin Ulcer
- ID: D000012871
- Term: Skin Diseases
- ID: D000048909
- Term: Diabetes Complications
- ID: D000003920
- Term: Diabetes Mellitus
- ID: D000004700
- Term: Endocrine System Diseases
- ID: D000003929
- Term: Diabetic Neuropathies
### 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: BC26
- Name: Wounds and Injuries
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: BC10
- Name: Nervous System Diseases
### Condition Browse Module - Browse Leaves
- ID: M7115
- Name: Diabetes Mellitus
- Relevance: LOW
- As Found: Unknown
- ID: M17685
- Name: Wounds and Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M17206
- Name: Ulcer
- Relevance: LOW
- As Found: Unknown
- ID: M19933
- Name: Diabetic Foot
- Relevance: HIGH
- As Found: Diabetic Foot
- ID: M18919
- Name: Foot Ulcer
- Relevance: LOW
- As Found: Unknown
- ID: M7120
- Name: Diabetic Angiopathies
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10883
- Name: Leg Ulcer
- Relevance: LOW
- As Found: Unknown
- ID: M15686
- Name: Skin Ulcer
- Relevance: LOW
- As Found: Unknown
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M26004
- Name: Diabetes Complications
- Relevance: LOW
- As Found: Unknown
- ID: M7862
- Name: Endocrine System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7124
- Name: Diabetic Neuropathies
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000017719
- Term: Diabetic Foot
### Intervention Browse Module - Ancestors
- ID: D000015853
- Term: Cysteine Proteinase Inhibitors
- ID: D000011480
- Term: Protease 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: Infe
- Name: Anti-Infective Agents
- Abbrev: AA
- Name: Amino Acids
### Intervention Browse Module - Browse Leaves
- ID: M40889
- Name: Calpastatin
- Relevance: HIGH
- As Found: Germany
- ID: M14343
- Name: Protease Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M19609
- Name: HIV Protease Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M7951
- Name: Enzyme Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: T4
- Name: Cysteine
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: C000033668
- Term: Calpastatin
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT02480179
**Brief Title:** CNS Modification of Food Craving by Neurofeedback
**Official Title:** CNS Modification of Food Craving by Neurofeedback
#### Organization Study ID Info
**ID:** 1164-14-SMC
#### Organization
**Class:** OTHER_GOV
**Full Name:** Sheba Medical Center
### Status Module
#### Completion Date
**Date:** 2016-04
**Type:** ESTIMATED
#### Expanded Access Info
**Last Known Status:** NOT_YET_RECRUITING
#### Last Update Post Date
**Date:** 2015-06-24
**Type:** ESTIMATED
**Last Update Submit Date:** 2015-06-23
**Overall Status:** UNKNOWN
#### Primary Completion Date
**Date:** 2015-10
**Type:** ESTIMATED
#### Start Date
**Date:** 2015-06
**Status Verified Date:** 2015-06
#### Study First Post Date
**Date:** 2015-06-24
**Type:** ESTIMATED
**Study First Submit Date:** 2015-05-28
**Study First Submit QC Date:** 2015-06-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER_GOV
**Name:** Sheba Medical Center
#### Responsible Party
**Investigator Affiliation:** Sheba Medical Center
**Investigator Full Name:** Dr. Ruth Perchik
**Investigator Title:** Dr.
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The investigators plan to evaluate H.E.G. (Hematoencephalography) modality in brain modulation of appetite and food craving in a randomized controlled study. The H.E.G. will serve as the neurofeedback modality while the functional brain imaging will enable assessment and hopefully validation of changes brain activity related to food craving and self-control. H.E.G. is a relatively new neurofeedback technique which similar to fMRI, is based on changes in blood oxygenation level as a result of regional brain activation. The unique advantage of this technology regarding our enterprise is that it inheritably samples the two brain areas that are in our focus of interest: the superior orbito-frontal cortex (OFC) which Involved in self-control and reward processing, and the anterior cingulate cortex (ACC) which processes cognitive and emotional information. The investigators will combine HRV (Heart rate variability) biofeedback, which is a well-established treatment form in the investigators therapeutic sessions and will correlate functional neuroimaging with behavioral, anthropometric and laboratory data.
The intervention name is: Measurements of blood flow changes within the brain and online visual feedback to the participant by a H.E.R. (Hematoencephalography) N.I,R (Near Infra Red sensor) sensor made by MindMedia, The Netherlands and a NEXUX4 Hardware, Bluetooth unit, Bio Trace Plus software made by MindMedia, The Netherlands.
Hypothesis: The neurofeedback practice sessions are expected to facilitate improved control of blood flow to frontal brain areas, as a marker of brain activity in these areas
**Detailed Description:** CNS Modification of Food Craving by Neurofeedback Study Protocol Research Plan and Methodology
The investigators's goal is to modulate food craving and eating behavior among overweight and obese participants using and interventional neurofeedback program. During the study period, each participant will go through 10 neurofeedback sessions, two sessions per week, over a five-week period. In addition, each participant will go through two functional MRI sessions, the first session, before the neurofeedback intervention, to document baseline neurocognitive response to food stimuli using a specified paradigm and the second - after completion of the neurofeedback series, in order to evaluate changes in C.N.S. response to food.
Subjects: 6 overweight and obese participants will be participate in our pilot study and will go through 2 fMRI sessions, 10 H.E.G. sessions and 3 anthropometric and metabolic evaluations during one year intervention and follow-up.
Study Design: In the investigators's single arm pilot study participants will go through a series of neurofeedback sessions with psychological, anthropomorphic, and laboratory evaluation taken before and after intervention.
Baseline questioners: Baseline assessment will include completion of a combined questionnaire that will address a spectrum eating behavior traits, including hunger and craving, addiction, impulsivity, binge eating, addiction, impulsivity, hedonic eating and externally driven eating14-23.
Anthropomorphic measurements: Height, weight, waist circumference and BMI will be measured before intervention. Weight and calculated BMI will be documented twice more: at week 7-8, soon after accomplishing the Neurofeedback sessions series and at week 12.
The investigators intend to call participants 6 and 12 months after study start and ask for their current weight.
Blood samples: Gut peptides and hormones that are known to parallel weight changes will be measured in the first and last visits including: leptin, morning cortisol, TSH, Ft4 and TT3. In addition, before each fMRI session we will evaluate "satiety profile" by documenting levels of Ghrelin, PYY, c-peptide and insulin.
Functional MRI sessions Experimental Paradigm Based on current knowledge regarding brain areas involved in food craving, the investigators defined two ROIs (regions of interest) that correspond with the introspective tasks in the H.E.G. neurofeedback sessions, one area in the superior orbitofrontal cortex (sOFC.) bilaterally and the second: the anterior cingulated cortex (ACC) bilaterally. Each ROI will be mapped in a block design paradigm (7:22 min) in which visual food stimuli will be shown alternately with neutral visual stimuli (neutral objects) and fixation (8 cycles, 54sec each including 3 blocks, 18s each of fixation, neutral objects, and food stimuli).
For the investigator's specific modulation goal, the suitable in-scanner satiety status is "half satiated". On one hand, hunger activates brain circuits involved in homeostatic appetite while, on the other hand complete satiety will shut down any food craving. For that purpose, participants will be asked to time their meals in order to start the session 1-2 hours after a medium-large meal. The investigators will document in detail the last meal (timing, content, estimated caloric value) and explore correlative parameters in the hormonal profile. Participants will be asked to rate their hunger, satiety, fullness and prospective eating in visual analogue scales: graphic questioners that are commonly used and well validated in eating behavior research field.
fMRI data acquisition: Functional scanning will be performed using a 3 Tesla whole body MRI system (GE EXITE HDxt, most updated version 14 M5) equipped with 8-channel head coil. Each scan will be acquired using a standard gradient echo planar imaging (EPI) sequence. After each volume is acquired, it will be automatically transferred in DICOM format from the MRI scanner computer to a separate computer for in-scan processing.
fMRI data processing: Online RT-fMRI processing will be made possible via a fast connection between the MRI scanner and the analysis/display computer. Turbo-Brain Voyager (TBV) 2.0 software (Brain Innovation, Maastricht, the Netherlands) will be used to perform real-time in-scan processing. TBV is capable of incrementally computing statistical maps based on General Linear Model (GLM) and event-related averages.
Off-line fMRI analysis:
Off-line analysis will be conducted to all data collected. Off-line analysis will be performed using Statistical Parametric Mapping software 8 (SPM8. The Welcome Department of Cognitive Neurology, London, UK). While MarsBar toolbox (the Marseille region of interest toolbox for SPM) will be used for ROI analysis.
Neurofeedback sessions Participants will undergo 10 H.E.G. sessions, twice weekly, over 5 weeks of intervention. They will be instructed to come to sessions in a "half-satiated" condition in order to focus on hedonic/emotional brain circuits involved in eating behavior rather than physiological circuits, based on the "real", physiological hunger. Participants will be given introspective tasks of mindfulness, increased sense of self-control and reduced food craving and will be instructed to attempts augmentation for visual feedback. These tasks correlate with modulation of our ROIs: Increase self-control - is adjusted to increase activity in the superior orbitofrontal cortex (sOFC) whereas suppressing food craving is adjusted to modification of neural activity in the anterior cingulated cortex (ACC) bilaterally. Successive feedback regarding changes in activity in this region will be given analogically with a thermometer with bars above baseline level of activation colored in red while those below baseline colored blue. Thermometer bars are constantly updated with a minimal inherent delay.
### Conditions Module
**Conditions:**
- Obesity
**Keywords:**
- functional MRI
- appetite
- neurofeedback
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 5
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Hematoencephalography bio/neurofeedback for Brain neural activity modulation. H.E.G. (hematoencephalography) based neurofeedback program. No drug use.
**Intervention Names:**
- Device: H.E.G. (hematoencephalography) based neurofeedback
**Label:** single arm pilot feasibility study
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- single arm pilot feasibility study
**Description:** H.E.G. is a relatively new neurofeedback technique which, similar to fMRI is based on differential oxygenated blood supply according to regional brain activity.
**Name:** H.E.G. (hematoencephalography) based neurofeedback
**Other Names:**
- ProComp2 - 2 Channel Biofeedback & Neurofeedback System w/ BioGraph Infiniti Software - T7400M
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Measure:** Increase brain activity in frontal brain areas
**Time Frame:** 7 weeks
#### Secondary Outcomes
**Description:** Activation of superior frontal brain regions and middle temporal regions in response to food stimuli, known to correlate with inhibition, self control and executive functions.
**Measure:** Increased activation of superior frontal brain regions and middle temporal regions in response to food stimuli, in the second fMRI session, perforemed after the neurofeedback sessions, compared to baseline session
**Time Frame:** 7 weeks
**Description:** Increased scores of self control and inhibition and decreased scores of binge eating and emotional eating on questionnaires.
**Measure:** Behavioural measures
**Time Frame:** 12 months
**Description:** weight loss according to follow-up 6 and 12 months after intervention.
**Measure:** Anthropometric measures
**Time Frame:** 12 months
**Measure:** Number of participants with adverse events
**Time Frame:** 12 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
Right handed BMI in the range of 28-35kg/m2
Exclusion Criteria:
* Current or past history of any major psychiatric disorder
* Major medical or neurological disorders
* Exposure to drugs likely to influence cerebral blood flow or neurological function within 3 weeks
* History of drug or alcohol abuse
* General MRI exclusion criteria
**Healthy Volunteers:** True
**Maximum Age:** 50 Years
**Minimum Age:** 20 Years
**Sex:** MALE
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Ruth Percik, MD
**Phone:** 972-3-5302021
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Jenny Cina, Ph.D
**Phone:** 972-3-5308493
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Sheba Medical Center
**Name:** Ruth Percik, MD
**Role:** PRINCIPAL_INVESTIGATOR
### References Module
#### References
**Citation:** Percik R, Cina J, Even B, Gitler A, Geva D, Seluk L, Livny A. A pilot study of a novel therapeutic approach to obesity: CNS modification by N.I.R. H.E.G. neurofeedback. Clin Nutr. 2019 Feb;38(1):258-263. doi: 10.1016/j.clnu.2018.01.023. Epub 2018 Feb 15.
**PMID:** 29428788
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M12701
- Name: Obesity
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT05550779
**Brief Title:** What Makes People Better at Retrieving Proper Names?
**Official Title:** What Makes People Better at Retrieving Proper Names?
#### Organization Study ID Info
**ID:** 2023-023
#### Organization
**Class:** OTHER
**Full Name:** University of Colorado, Colorado Springs
### Status Module
#### Completion Date
**Date:** 2023-03-30
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-04-04
**Type:** ACTUAL
**Last Update Submit Date:** 2023-03-31
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-03-23
**Type:** ACTUAL
#### Start Date
**Date:** 2022-10-01
**Type:** ACTUAL
**Status Verified Date:** 2023-03
#### Study First Post Date
**Date:** 2022-09-22
**Type:** ACTUAL
**Study First Submit Date:** 2022-09-19
**Study First Submit QC Date:** 2022-09-19
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Colorado, Colorado Springs
#### Responsible Party
**Investigator Affiliation:** University of Colorado, Colorado Springs
**Investigator Full Name:** Lori James
**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:** This study is being conducted to learn more about how various personal and situational characteristics are related to the ability to produce names of pictured people. Participants will perform a brief mental exercise, then see 83 celebrity photographs to produce the names of. Participants will also complete other surveys and measures. Collected data will give researchers a better understanding of how different variables relate to proper name production.
**Detailed Description:** This study is being conducted to learn more about how various personal and situational characteristics are related to the ability to produce names of pictured people. Adult participants ages 18-35 and 60-80 will participant in videoconference calls during which they will perform a brief mental exercise, then see 83 celebrity photographs with instructions to name each pictured person. The naming task will be video recorded for later scoring. Participants will also complete other surveys and measures, including some about demographics and other personal characteristics. Participation will take approximately 60-75 minutes. Collected will be de-identified and the aggregate data will give researchers a better understanding about how individual's personality and cognitive traits and the mental exercise performed before the study relate to people's proper name production.
### Conditions Module
**Conditions:**
- Healthy Aging
**Keywords:**
- cognitive aging
- name retrieval
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Participants are randomly assigned to one of two mental exercises before performing a proper name production task and completing other measures.
##### Masking Info
**Masking:** SINGLE
**Masking Description:** Participant do not know which condition they are in. They only know what mental exercise they will do in their assigned condition
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** BASIC_SCIENCE
#### Enrollment Info
**Count:** 102
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants follow instructions on a 10-minute audio clip
**Intervention Names:**
- Behavioral: Mental Exercise
**Label:** Mental Exercise A
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants follow instructions on a 10-minute audio clip
**Intervention Names:**
- Behavioral: Mental Exercise
**Label:** Mental Exercise B
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Mental Exercise A
- Mental Exercise B
**Description:** Participant perform a 10-minute mental exercise
**Name:** Mental Exercise
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** Percent of trials with correct responses and percent of trials that are name retrieval failures will be measured on a task created for this purpose. Specifically, participants will try to provide names that fit photographs, indicating when a name gets stuck on the "tip of their tongue"
**Measure:** Name retrieval performance
**Time Frame:** During the 60-75 minute experimental session
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* fluent speaker of English
* ages 18-35 or 60-80
* lived in the United States for at least 5 years
Exclusion Criteria:
-
**Maximum Age:** 80 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Colorado Springs
**Country:** United States
**Facility:** UCCS
**State:** Colorado
**Zip:** 80918
#### Overall Officials
**Official 1:**
**Affiliation:** University of Colorado, Colorado Springs
**Name:** Lori James, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** De-identified participant data may be posted on a website for open access to other researchers, if the publication outlet requires it. But I do not currently plan to share the data
**IPD Sharing:** NO
## Derived Section
### Misc Info Module
#### Submission Tracking
- Estimated Results First Submit Date: 2023-12-28
##### Submission Infos
- MCP Release N: Unknown
- Release Date: 2023-12-28
- Reset Date: Unknown
- Unrelease Date: Unknown
- Unrelease Date Unknown: Unknown
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT00172679
**Brief Title:** Effects of Tai Chi Exercise on Innate and Adaptive Immune Function
#### Organization Study ID Info
**ID:** 9361701225
#### Organization
**Class:** OTHER
**Full Name:** National Taiwan University Hospital
### Status Module
#### Completion Date
**Date:** 2006-06
#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2007-09-27
**Type:** ESTIMATED
**Last Update Submit Date:** 2007-09-26
**Overall Status:** UNKNOWN
#### Start Date
**Date:** 2005-07
**Status Verified Date:** 2004-12
#### Study First Post Date
**Date:** 2005-09-15
**Type:** ESTIMATED
**Study First Submit Date:** 2005-09-12
**Study First Submit QC Date:** 2005-09-12
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER_GOV
**Name:** National Science Council, Taiwan
#### Lead Sponsor
**Class:** OTHER
**Name:** National Taiwan University Hospital
### Description Module
**Brief Summary:** Tai Chi is a traditional Chinese martial art that has been practiced for many centuries. Improvements in cardiorespiratory function, balance, muscular strength, flexibility in older subjects; preventing falls in the frail elderly; stress reduction, and mood state with Tai Chi practices have been well established. A potential immune response effect of Tai Chi practice is a frequent claim; however, this is an under-researched area. Therefore, in this study, the researchers will examine the effects of Tai Chi on innate and adaptive immune function.
**Detailed Description:** Tai Chi, a traditional Chinese martial art that has been practiced for many centuries, has only recently gained the interest of researchers in Western countries as an alternative form of exercise. Tai Chi combines deep diaphragmatic breathing and relaxation with many fundamental postures that flow imperceptibly and smoothly from one to the other through slow, gentle, and graceful movements. Based on the maximum oxygen consumption (VO2max) measured during the practice, Tai Chi is characterized as a low- to moderate-intensity form of exercise. Tai Chi has been applied as a rehabilitation program in patients with heart failure, hypertension, acute myocardial infarction, arthritis, and multiple sclerosis. Improvements in cardiorespiratory function, balance, muscular strength, flexibility in older subjects; preventing falls in the frail elderly; stress reduction, and mood state with Tai Chi practices have been well established. A potential immune response effect of Tai Chi practice is a frequent claim; however, this is an under-researched area. A nonrandomized controlled study of 60 elderly subjects found that the total number of circulating T cells were significantly higher in the Tai Chi group (who regularly practiced Tai Chi for 4 or more years) than in the untrained group. Irwin et al. demonstrated that older adults with no previous Tai Chi experience after practicing for 15 wks (1-3 times/wk), a nearly 50% increase in varicella zoster virus specific, cell-mediated immunity was found. Thus in this proposed study, we will examine the effects of regular Tai Chi practitioners on innate and adaptive immune function.
### Conditions Module
**Conditions:**
- Healthy
**Keywords:**
- Tai Chi
- NK Cells
- T lymphocytes
- Exercise
### Design Module
#### Design Info
**Observational Model:** DEFINED_POPULATION
**Time Perspective:** OTHER
#### Enrollment Info
**Count:** 30
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Has been practicing Tai Chi Chuan (TCC) for at least 3 days a week for at least 12 months.
Exclusion Criteria:
* Any chronic systemic diseases (e.g., coronary artery disease \[CAD\])
* Has cognitive impairments.
**Healthy Volunteers:** True
**Maximum Age:** 70 Years
**Minimum Age:** 30 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Li-Ying Wang, Ph.D.
**Phone:** 886-223123456
**Phone Ext:** 6683
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Taipei
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Li-Ying Wang, Ph.D.
- **Phone:** 886-223123456
- **Phone Ext:** 6683
- **Role:** CONTACT
**Country:** Taiwan
**Facility:** National Taiwan University Hospital
**Status:** NOT_YET_RECRUITING
**Zip:** 100
**Location 2:**
**City:** Taipei
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Li-Ying Wang, Ph.D.
- **Phone:** 886-2-23123456
- **Phone Ext:** 6683
- **Role:** CONTACT
**Country:** Taiwan
**Facility:** School & Graduate Institute of Physical Therapy, College of Medicine, NTU
**Status:** RECRUITING
**Zip:** 100
#### Overall Officials
**Official 1:**
**Affiliation:** National Taiwan University, College of Medicine
**Name:** Li-Ying Wang, Ph.D.
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT01698879
**Brief Title:** Prospective Study of Mylotarg and G-CSF in Acute Myeloid Leukemia Treatment
**Official Title:** Treatment of de Novo Acute Myeloid Leukemia With the Combination of Idarubicin, Cytarabine, and Gemtuzumab Ozogamicin (Mylotarg ®), Associated or Not Priming With G-CSF. Prospective Study of Efficacy and Toxicity
#### Organization Study ID Info
**ID:** ICOG-07
#### Organization
**Class:** OTHER
**Full Name:** Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias
#### Secondary ID Infos
**ID:** 2007-006295-11
**Type:** EUDRACT_NUMBER
### Status Module
#### Completion Date
**Date:** 2016-09-26
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-01-27
**Type:** ACTUAL
**Last Update Submit Date:** 2021-01-26
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2016-09-14
**Type:** ACTUAL
#### Results First Post Date
**Date:** 2021-01-27
**Type:** ACTUAL
**Results First Submit Date:** 2017-02-13
**Results First Submit QC Date:** 2021-01-26
#### Start Date
**Date:** 2009-10
**Status Verified Date:** 2021-01
#### Study First Post Date
**Date:** 2012-10-03
**Type:** ESTIMATED
**Study First Submit Date:** 2012-07-23
**Study First Submit QC Date:** 2012-10-01
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Acute myeloid leukemia (AML) is a neoplasm of immature hematopoietic cells (blasts) with altered ripening capacity. Due to excessive proliferation, the blasts displace normal hematopoietic cells and bone marrow failure appears. Leukemic cells also infiltrate extramedullary tissues.
Following the standard chemotherapy treatment, the CR rate achieved is around 65-75% for all patients and 15% lower when considering only patients over 65 years. Modifications to the standard regimen consist of replacing the DNR for a cytotoxic one, modifying the dose of ara-C or adding a third drug.
Gemtuzumab ozogamicin (Mylotarg ®) is an immunoconjugate between anti-CD33 antibody and a cytotoxic antitumor antibiotic, calicheamicin. Mylotarg ® antibody specifically binds to CD33, a sialic acid-dependent adhesion protein expressed in over 90% of LMA10. Mylotarg ® selectively transports the cytotoxic agent calicheamicin into leukemic cells and hematopoietic progenitors differentiated from the myelomonocytic line, while respecting the pluripotent hematopoietic stem cells. Calicheamicin is released only after the fixation of the antibody anti-CD33 and its internalization by the cell, after which binds to and damages the DNA.
Mylotarg ® is approved in the U.S. for the treatment of CD33 positive AML in first relapse, for patients older than 60 years non-candidates for other intensive treatment modalities.
Since the efficacy of Mylotarg ® is equivalent and its toxicity profile less than the conventional therapy, it is logical to conduct a phase II trial exploring the role of Mylotarg ® in the early stages of treatment of AML.
Previous experience with gemtuzumab ozogamicin in relapsed patients led to its use combined with induction chemotherapy. The aim was to improve the CR rate reached with the latter and reduce relapse after achieving greater leukemic cytoreduction.
Recent data from the HOVON group support that the administration of G-CSF before and during induction chemotherapy decreases the incidence of relapse in patients with AML, particularly those considered to have intermediate risk.
Everything mentioned above justifies to investigate the combination of GO combined with chemotherapy with IDR and ara-C in standard 3x7 scheme and analyze the effect of sensitization with G-CSF in patients with AML de novo. If the treatment proposed here is effective and presents an acceptable toxicity it should be investigated.
### Conditions Module
**Conditions:**
- Novo Acute Myeloid Leukemia
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 46
**Type:** ACTUAL
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Idarubicin, cytarabine, Mylotarg.
**Intervention Names:**
- Drug: Mylotarg
**Label:** Single arm, three cohorts
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Single arm, three cohorts
**Description:** Cohort 1 version 1.0. GO: 6mg/m\^2 (maximum 10 mg), IV infusion, 2 hours, day 1. Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine: 100 mg/m\^2 IV days 1 to 7, to begin 4 hours after the administration of GO.
Cohort 1.0 version 2.0: GO: 3 mg/m\^2 (maximum 5 mg), IV infusion, 2 hours, day 1. Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine: 100 mg/m\^2 IV days 1 to 7, to begin 4 hours after the administration of GO.
Cohort 2: G-CSF: 150 mcg/m\^2, SC, days 0 to 7. GO: 3 mg/m\^2 (maximum 5 mg), IV infusion, 2 hours, day 1. Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine: 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours later after the administration of GO.
**Name:** Mylotarg
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Rate of patients that have obtained complete remission. Complete remission is defined as, bone marrow normocellular or slightly hypocellular with proportion of blasts \<5%, including the erythroid cell count (and including promonocytes in case of M5), no Auer rods, no extramedullary leukemia, neutrophils and platelets rising. The persistence of minimal residual disease in immunophenotypic study will not invalidate the standard cytogenetic complete remission.
**Measure:** Complete Remission of the Disease
**Time Frame:** 28 days after chemotherapy
#### Secondary Outcomes
**Description:** Hematological toxicity, hepatic and gastrointestinal toxicity, fever and infections, pulmonary complications, duration of hospitalization
**Measure:** Secondary Toxicity to Mylotarg(R)
**Time Frame:** Baseline, weekly during treatment and at month 3 and month 6 after first induction.
**Description:** all deaths occurring after the first administration of MylotargTM until the time of transplantation with no leukemic relapse has occurred, and all deaths in the 6 first months after administration of the second dose of MylotargTM with no leukemic relapse occurred.
**Measure:** Mortality at Induction
**Time Frame:** Weekly during treatment, at third month and at 6 months after last administration of Mylotarg
**Description:** Rate of patients with capacity to obtain hematopoietic progenitor cells (HPC) for autotransplantation. This analysis has not been performed, because data were not available in sites.
**Measure:** Capacity to Obtain Hematopoietic Progenitor Cells (HPC) for Autotransplantation - DATA NOT COLLECTED
**Time Frame:** One month before transplant, expected at 9 months after end of treatment.
**Description:** Rate of patients that have relapse after 6 months of obtained complete remission.
**Measure:** Relapse After 6 Months
**Time Frame:** 6 months from complete remission
**Description:** rate of patients alive within 6 months of obtained complete remission
**Measure:** Survival After 6 Months
**Time Frame:** 6 months after complete remission
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Patients with primary or "de novo" AML, different than promyelocytic or M3 subtype.
2. Age 18 to 70 years.
3. Written informed consent form
Exclusion Criteria:
1. Acute leukemia appeared after a myeloproliferative process or a myelodysplastic syndrome longer than 6 months, AML arising after another cured malignant disease (e.g. Hodgkin's disease), and secondary AML treated with alkylating agents or radiation.
2. Acute promyelocytic leukemia.
3. Relevant history of liver disease. Significant impaired liver function (bilirubin, AST or ALT ≥ 2.5 times the normal value) not attributable to leukemic infiltration.
4. Patients with prior heart failure.
5. Symptomatic chronic respiratory failure.
6. Positive serology for HIV, hepatitis C virus or its surface antigen.
7. Estimated life expectancy less than 3 months, despite treatment.
8. Pregnancy or breastfeeding at the time of inclusion 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:** Badalona
**Country:** Spain
**Facility:** Hospital Germans Trias i Pujol
**State:** Barcelona
**Zip:** 08916
**Location 2:**
**City:** Barcelona
**Country:** Spain
**Facility:** Hospital de la Santa Creu i Sant Pau
**Zip:** 08025
**Location 3:**
**City:** Barcelona
**Country:** Spain
**Facility:** Hospital Clinic Barcelona
**Zip:** 08036
**Location 4:**
**City:** Salamanca
**Country:** Spain
**Facility:** Hospital Clinico Universitario de Salamanca
**Zip:** 37007
**Location 5:**
**City:** Sevilla
**Country:** Spain
**Facility:** Hospital Universitario Virgen del Rocio
**Zip:** 41013
**Location 6:**
**City:** Valencia
**Country:** Spain
**Facility:** Hospital Clínico Universitario de Valencia
**Zip:** 496010
#### Overall Officials
**Official 1:**
**Affiliation:** Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
**Name:** Jordi Sierra, MD
**Role:** STUDY_CHAIR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000009369
- Term: Neoplasms
- 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
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M10945
- Name: Leukemia
- Relevance: HIGH
- As Found: Leukemia
- ID: M10955
- Name: Leukemia, Myeloid
- Relevance: HIGH
- As Found: Myeloid Leukemia
- ID: M18127
- Name: Leukemia, Myeloid, Acute
- Relevance: HIGH
- As Found: Acute Myeloid Leukemia
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
- ID: M9490
- Name: Hematologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T3995
- Name: Myeloid Leukemia
- Relevance: HIGH
- As Found: Myeloid Leukemia
- ID: T182
- Name: Acute Myeloid Leukemia
- Relevance: HIGH
- As Found: Acute Myeloid Leukemia
- ID: T188
- Name: Acute Non Lymphoblastic Leukemia
- Relevance: HIGH
- As Found: Acute Myeloid Leukemia
- ID: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000007938
- Term: Leukemia
- ID: D000007951
- Term: Leukemia, Myeloid
- ID: D000015470
- Term: Leukemia, Myeloid, Acute
### Intervention Browse Module - Ancestors
- ID: D000074322
- Term: Antineoplastic Agents, Immunological
- ID: D000000970
- Term: Antineoplastic Agents
- ID: D000000922
- Term: Immunotoxins
- ID: D000018796
- Term: Immunoconjugates
- 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: M6766
- Name: Cytarabine
- Relevance: LOW
- As Found: Unknown
- ID: M17958
- Name: Idarubicin
- Relevance: LOW
- As Found: Unknown
- ID: M2089
- Name: Gemtuzumab
- Relevance: HIGH
- As Found: Yes
- ID: M1346
- Name: Antineoplastic Agents, Immunological
- Relevance: LOW
- As Found: Unknown
- ID: M4241
- Name: Immunotoxins
- Relevance: LOW
- As Found: Unknown
- ID: M20855
- Name: Immunoconjugates
- Relevance: LOW
- As Found: Unknown
- ID: M10201
- Name: Immunologic Factors
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000079982
- Term: Gemtuzumab
### Misc Info Module
- Version Holder: 2024-05-24
## Results Section
### Adverse Events Module
#### Event Groups
**Group ID:** EG000
**Title:** Cohort 1
**Deaths Num Affected:** 1
**Deaths Num At Risk:** 20
**Description:** Idarubicin, cytarabine, Mylotarg, G-CSF.
Mylotarg: Cohort 1 (20 evaluable patients):
GO: 3 mg/m\^2 (maximum 5 mg), IV infusion, 2 hours, day 1. Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours after the administration of GO.
**ID:** EG000
**Other Num Affected:** 20
**Other Num at Risk:** 20
**Serious Number Affected:** 3
**Serious Number At Risk:** 20
**Title:** Cohort 1
**Group ID:** EG001
**Title:** Cohort 2
**Deaths Num Affected:** 2
**Deaths Num At Risk:** 20
**Description:** Cohort 2 (20 evaluable patients):
G-CSF: 150 mcg/m\^2, SC, days 0 to 7, to begin 12 to 18 hours before treatment with Gemtuzumab. GO: 3 mg/m\^2 (maximum 5 mg), IV infusion, 2 hours, day 1.
Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours later after the administration of GO.
**ID:** EG001
**Other Num Affected:** 19
**Other Num at Risk:** 20
**Serious Number Affected:** 6
**Serious Number At Risk:** 20
**Title:** Cohort 2
**Group ID:** EG002
**Title:** 5 Patients Treated in Trial With Prrotocol Version 1.0
**Deaths Num Affected:** 1
**Deaths Num At Risk:** 5
**Description:** Idarubicin, cytarabine, Mylotarg, G-CSF.
Mylotarg::
GO: 5 mg/m\^2 (maximum 10 mg), IV infusion, 2 hours, day 1. If no adequate response, GO: 3 mg/m\^2 (maximum 5 mg), IV infusion, 2 hours, day 1.
Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours after the administration of GO.
**ID:** EG002
**Other Num Affected:** 3
**Other Num at Risk:** 5
**Serious Number Affected:** 2
**Serious Number At Risk:** 5
**Title:** 5 Patients Treated in Trial With Prrotocol Version 1.0
**Frequency Threshold:** 5
#### Other Events
**Term:** Grade 4 hematologic toxicity
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Blood and lymphatic system disorders
**Source Vocabulary:**
**Term:** G1/2 Hepatic toxicity
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Hepatobiliary disorders
**Source Vocabulary:**
**Term:** G3/G4 Hepatic Toxicity
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Hepatobiliary disorders
**Source Vocabulary:**
**Term:** Grade I/II infectous toxicity
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:**
**Term:** Grade 3 Infectous toxicity
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:**
#### Serious Events
**Term:** Transient Ischemic event
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 20
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 20
**Num Events:** 1
**Group ID:** EG002
**Num At Risk:** 5
**Term:** Septic shock
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
##### Stats
**Group ID:** EG000
**Num At Risk:** 20
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 20
**Num Events:** 1
**Group ID:** EG002
**Num At Risk:** 5
**Term:** Severe respiratory failure
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 20
**Group ID:** EG001
**Num Affected:** 2
**Num At Risk:** 20
**Num Events:** 2
**Group ID:** EG002
**Num At Risk:** 5
**Term:** Toxic megacolon
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
##### Stats
**Group ID:** EG000
**Num At Risk:** 20
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 20
**Num Events:** 1
**Group ID:** EG002
**Num At Risk:** 5
**Term:** Bilateral pneumonia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 20
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 20
**Group ID:** EG002
**Num At Risk:** 5
**Term:** Febrile neutropenia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 20
**Num Events:** 1
**Group ID:** EG001
**Num Affected:** 2
**Num At Risk:** 20
**Num Events:** 2
**Group ID:** EG002
**Num At Risk:** 5
**Term:** Anemia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Blood and lymphatic system disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 20
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 20
**Group ID:** EG002
**Num At Risk:** 5
**Term:** Liver failure
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Hepatobiliary disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 20
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 20
**Num Events:** 1
**Group ID:** EG002
**Num At Risk:** 5
**Term:** Hepatic Toxicity
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Hepatobiliary disorders
##### Stats
**Group ID:** EG000
**Num At Risk:** 20
**Group ID:** EG001
**Num At Risk:** 20
**Group ID:** EG002
**Num Affected:** 2
**Num At Risk:** 5
**Num Events:** 2
**Term:** Neutropenia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Blood and lymphatic system disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 20
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 20
**Group ID:** EG002
**Num At Risk:** 5
**Term:** Acute Pulmonary Edema
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 20
**Num Events:** 1
**Group ID:** EG001
**Num At Risk:** 20
**Group ID:** EG002
**Num At Risk:** 5
**Time Frame:** From October 2008 up to September 2016, 7 years and 11 months.
## Results Section - Baseline Characteristics Module
### Denomination Counts
**Group ID:** BG000
**Value:** 5
**Group ID:** BG001
**Value:** 20
**Group ID:** BG002
**Value:** 20
**Group ID:** BG003
**Value:** 45
**Units:** Participants
### Group
**ID:** BG000
**Title:** Cohort 1, Version 1.0
**Description:** Mylotarg: Cohort 1 version 1.0 (5 evaluable patients):
GO: 6 mg/m\^2 (maximum 10 mg), IV infusion, 2 hours, day 1. Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours after the administration of GO.
If chemo-sensitivity is observed after a first course of treatment (50% or more reduction of blasts compared to baseline) a second identical cycle will be administered.
### Group
**ID:** BG001
**Title:** Cohort 1, Version 2.0
**Description:** Mylotarg: Cohort 1 (20 evaluable patients):
GO: 3 mg/m\^2 (maximum 5 mg), IV infusion, 2 hours, day 1. Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4.
Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours after the administration of GO.
### Group
**ID:** BG002
**Title:** Cohort 2
**Description:** Cohort 2 (20 evaluable patients):
G-CSF: 150 mcg/m\^2, SC, days 0 to 7, to begin 12 to 18 hours before treatment with Gemtuzumab. GO: 3 mg/m\^2 (maximum 5 mg), IV infusion, 2 hours, day 1.
Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours later after the administration of GO.
### Group
**ID:** BG003
**Title:** Total
**Description:** Total of all reporting groups
### Measure
#### Measurement
**Group ID:** BG000
**Lower Limit:** 32
**Upper Limit:** 61
**Value:** 56
#### Measurement
**Group ID:** BG001
**Lower Limit:** 22
**Upper Limit:** 64
**Value:** 49
#### Measurement
**Group ID:** BG002
**Lower Limit:** 24
**Upper Limit:** 69
**Value:** 61
#### Measurement
**Group ID:** BG003
**Lower Limit:** 22
**Upper Limit:** 69
**Value:** 61
**Class Title:**
### Measure
#### Measurement
**Group ID:** BG000
**Value:** 2
#### Measurement
**Group ID:** BG001
**Value:** 9
#### Measurement
**Group ID:** BG002
**Value:** 5
#### Measurement
**Group ID:** BG003
**Value:** 16
**Category Title:** Female
#### Measurement
**Group ID:** BG000
**Value:** 3
#### Measurement
**Group ID:** BG001
**Value:** 11
#### Measurement
**Group ID:** BG002
**Value:** 15
#### Measurement
**Group ID:** BG003
**Value:** 29
**Category Title:** Male
**Class Title:**
### Measure
#### Measurement
**Group ID:** BG000
**Value:** 5
#### Measurement
**Group ID:** BG001
**Value:** 20
#### Measurement
**Group ID:** BG002
**Value:** 20
#### Measurement
**Group ID:** BG003
**Value:** 45
**Class Title:** Spain
### Measure
#### Measurement
**Group ID:** BG000
**Lower Limit:** 2.1
**Upper Limit:** 31.85
**Value:** 13.48
#### Measurement
**Group ID:** BG001
**Lower Limit:** 1
**Upper Limit:** 96.6
**Value:** 7.66
#### Measurement
**Group ID:** BG002
**Lower Limit:** 0.9
**Upper Limit:** 114
**Value:** 6.96
#### Measurement
**Group ID:** BG003
**Lower Limit:** 0.9
**Upper Limit:** 114
**Value:** 6.96
**Class Title:**
### Measure
#### Measurement
**Group ID:** BG000
**Value:** 1
#### Measurement
**Group ID:** BG001
**Value:** 5
#### Measurement
**Group ID:** BG002
**Value:** 3
#### Measurement
**Group ID:** BG003
**Value:** 9
**Category Title:** Favorable
#### Measurement
**Group ID:** BG000
**Value:** 3
#### Measurement
**Group ID:** BG001
**Value:** 13
#### Measurement
**Group ID:** BG002
**Value:** 12
#### Measurement
**Group ID:** BG003
**Value:** 28
**Category Title:** Intermediate
#### Measurement
**Group ID:** BG000
**Value:** 1
#### Measurement
**Group ID:** BG001
**Value:** 2
#### Measurement
**Group ID:** BG002
**Value:** 5
#### Measurement
**Group ID:** BG003
**Value:** 8
**Category Title:** Adverse
**Class Title:**
**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
**Population Description:** The first 5 patients received GO 6mg/m2 but this dose was halted by unacceptable toxicity. Therefore, in Cohort 1 were included 20 patients receiving IA plus 3 mg/m2 GO. Cohort 2 included 20 patients who received treatment as in cohort 1 plus G-CSF priming
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** NUMBER
**Population Description:** One patient has not been evaluated because has not received study treatment.
**Title:** Region of Enrollment
**Unit of Measure:** participants
### Measure 4
**Dispersion Type:** FULL_RANGE
**Parameter Type:** MEDIAN
**Population Description:** The first 5 patients received GO 6mg/m2 but this dose was halted by unacceptable toxicity. Therefore, in Cohort 1 were included 20 patients receiving IA plus 3 mg/m2 GO. Cohort 2 included 20 patients who received treatment as in cohort 1 plus G-CSF priming.
**Title:** Leucocites at diagnosis
**Unit of Measure:** Cells x 10^9/L
### Measure 5
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** 1 patient not evaluable because has not received study treatment.
**Title:** Citogenetic
**Unit of Measure:** Participants
**Population Description:** From cohort 1 version 1.0, one patient did not receive any study treatment (PIS withdrawal), for that reason is not considered for outcome assessment.
## Results Section - More Information Module
### Certain Agreement
**Restriction Type:** GT60
**Restrictive Agreement:** True
### Point of Contact
**Email:** [email protected]
**Organization:** CETLAM
**Phone:** +34 93 434 44 12
**Title:** Dr. Jordi Sierra
## 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:** It has not been evaluated efficacy result of this cohort with unacceptable toxicity profile
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** NA
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 18
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 16
**Title:** Complete Response
##### Category
**Measurements:**
- **Comment:** It has not been evaluated efficacy result of this cohort with unacceptable toxicity profile
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** NA
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 1
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 2
**Title:** Partial Response
##### Category
**Measurements:**
- **Comment:** It has not been evaluated efficacy result of this cohort with unacceptable toxicity profile
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** NA
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 1
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 2
**Title:** Refractory
#### 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:** 100
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 95
**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:** 5
**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:** 10
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 10
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 40
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 5
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 15
**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:** 10
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 25
**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:** 5
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 30
**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:** 0
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 2
**Title:**
#### Outcome Measure 4
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 30
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 59
**Title:**
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 80
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 80
**Title:**
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Rate of patients that have obtained complete remission. Complete remission is defined as, bone marrow normocellular or slightly hypocellular with proportion of blasts \<5%, including the erythroid cell count (and including promonocytes in case of M5), no Auer rods, no extramedullary leukemia, neutrophils and platelets rising. The persistence of minimal residual disease in immunophenotypic study will not invalidate the standard cytogenetic complete remission.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Initial 5 patients included in cohort 1 version 1.0 (closed due toxicity) have been evaluated for safety outcome but not evaluated for efficacy because the treatment is not feasible.
**Reporting Status:** POSTED
**Time Frame:** 28 days after chemotherapy
**Title:** Complete Remission of the Disease
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** Mylotarg: Cohort 1 version 1.0 (5 evaluable patients):
GO: 6 mg/m\^2 (maximum 10 mg), IV infusion, 2 hours, day 1. Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours after the administration of GO.
If chemo-sensitivity is observed after a first course of treatment (50% or more reduction of blasts compared to baseline) a second identical cycle will be administered.
**ID:** OG000
**Title:** Cohort 1, Version 1.0
##### Group
**Description:** Mylotarg: Cohort 1 (20 evaluable patients):
GO: 3 mg/m\^2 (maximum 5 mg), IV infusion, 2 hours, day 1. Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours after the administration of GO.
**ID:** OG001
**Title:** Cohort 1, Version 2.0
##### Group
**Description:** Cohort 2 (20 evaluable patients):
G-CSF: 150 mcg/m\^2, SC, days 0 to 7, to begin 12 to 18 hours before treatment with Gemtuzumab. GO: 3 mg/m\^2 (maximum 5 mg), IV infusion, 2 hours, day 1.
Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours later after the administration of GO.
**ID:** OG002
**Title:** Cohort 2
#### Outcome Measure 2
**Description:** Hematological toxicity, hepatic and gastrointestinal toxicity, fever and infections, pulmonary complications, duration of hospitalization
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** Baseline, weekly during treatment and at month 3 and month 6 after first induction.
**Title:** Secondary Toxicity to Mylotarg(R)
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Initial 5 patients of cohort 1 (closed due toxicity)
**ID:** OG000
**Title:** Cohort 1, Version 1.0
##### Group
**Description:** Idarubicin, cytarabine, Mylotarg
Mylotarg: Cohort 1 (20 evaluable patients):
GO: 3 mg/m\^2 (maximum 5 mg), IV infusion, 2 hours, day 1. Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours after the administration of GO.
**ID:** OG001
**Title:** Cohort 1, Version 2.0
##### Group
**Description:** Cohort 2 (20 evaluable patients):
G-CSF: 150 mcg/m\^2, SC, days 0 to 7, to begin 12 to 18 hours before treatment with Gemtuzumab. GO: 3 mg/m\^2 (maximum 5 mg), IV infusion, 2 hours, day 1.
Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours later after the administration of GO.
**ID:** OG002
**Title:** Cohort 2
#### Outcome Measure 3
**Description:** all deaths occurring after the first administration of MylotargTM until the time of transplantation with no leukemic relapse has occurred, and all deaths in the 6 first months after administration of the second dose of MylotargTM with no leukemic relapse occurred.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Reporting Status:** POSTED
**Time Frame:** Weekly during treatment, at third month and at 6 months after last administration of Mylotarg
**Title:** Mortality at Induction
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Initial 5 patients of cohort 1 (closed due toxicity)
**ID:** OG000
**Title:** Cohort 1, Version 1.0
##### Group
**Description:** Mylotarg: Cohort 1 (20 evaluable patients):
GO: 3 mg/m\^2 (maximum 5 mg), IV infusion, 2 hours, day 1. Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours after the administration of GO.
**ID:** OG001
**Title:** Cohort 1 Version 2.0
##### Group
**Description:** Cohort 2 (20 evaluable patients):
G-CSF: 150 mcg/m\^2, SC, days 0 to 7, to begin 12 to 18 hours before treatment with Gemtuzumab. GO: 3 mg/m\^2 (maximum 5 mg), IV infusion, 2 hours, day 1.
Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours later after the administration of GO.
**ID:** OG002
**Title:** Cohort 2
#### Outcome Measure 4
**Description:** Rate of patients with capacity to obtain hematopoietic progenitor cells (HPC) for autotransplantation. This analysis has not been performed, because data were not available in sites.
**Population Description:** Initial 5 patients included in cohort 1 version 1.0 (closed due toxicity) have been evaluated for safety outcome but not evaluated for efficacy because the treatment is not feasible. This analysis has not been performed because data were not available for any of the cohorts studied.
**Reporting Status:** POSTED
**Time Frame:** One month before transplant, expected at 9 months after end of treatment.
**Title:** Capacity to Obtain Hematopoietic Progenitor Cells (HPC) for Autotransplantation - DATA NOT COLLECTED
**Type:** SECONDARY
##### Group
**Description:** Mylotarg: Cohort 1 version 1.0 (5 evaluable patients):
GO: 6 mg/m\^2 (maximum 10 mg), IV infusion, 2 hours, day 1. Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours after the administration of GO.
If chemo-sensitivity is observed after a first course of treatment (50% or more reduction of blasts compared to baseline) a second identical cycle will be administered.
**ID:** OG000
**Title:** Cohort 1, Version 1.0
##### Group
**Description:** Idarubicin, cytarabine, Mylotarg
Mylotarg: Cohort 1 (20 evaluable patients):
GO: 3 mg/m\^2 (maximum 5 mg), IV infusion, 2 hours, day 1. Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours after the administration of GO.
**ID:** OG001
**Title:** Cohort 1, Version 2.0
##### Group
**Description:** Cohort 2 (20 evaluable patients):
G-CSF: 150 mcg/m\^2, SC, days 0 to 7, to begin 12 to 18 hours before treatment with Gemtuzumab. GO: 3 mg/m\^2 (maximum 5 mg), IV infusion, 2 hours, day 1.
Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours later after the administration of GO.
**ID:** OG002
**Title:** Cohort 2
#### Outcome Measure 5
**Description:** Rate of patients that have relapse after 6 months of obtained complete remission.
**Parameter Type:** NUMBER
**Population Description:** Initial 5 patients included in cohort 1 version 1.0 (closed due toxicity) have been evaluated for safety outcome but not evaluated for efficacy because the treatment is not feasible.
**Reporting Status:** POSTED
**Time Frame:** 6 months from complete remission
**Title:** Relapse After 6 Months
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Idarubicin, cytarabine, Mylotarg.
Mylotarg: Cohort 1 (20 evaluable patients):
GO: 3 mg/m\^2 (maximum 5 mg), IV infusion, 2 hours, day 1. Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours after the administration of GO.
**ID:** OG000
**Title:** Cohort 1, Version 2.0
##### Group
**Description:** Cohort 2 (20 evaluable patients):
G-CSF: 150 mcg/m\^2, SC, days 0 to 7, to begin 12 to 18 hours before treatment with Gemtuzumab. GO: 3 mg/m\^2 (maximum 5 mg), IV infusion, 2 hours, day 1.
Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours later after the administration of GO.
**ID:** OG001
**Title:** Cohort 2
#### Outcome Measure 6
**Description:** rate of patients alive within 6 months of obtained complete remission
**Parameter Type:** NUMBER
**Population Description:** Initial 5 patients included in cohort 1 version 1.0 (closed due toxicity) have been evaluated for safety outcome but not evaluated for efficacy because the treatment is not feasible.
**Reporting Status:** POSTED
**Time Frame:** 6 months after complete remission
**Title:** Survival After 6 Months
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Idarubicin, cytarabine, Mylotarg, G-CSF.
Mylotarg: Cohort 1 (20 evaluable patients):
GO: 3 mg/m\^2 (maximum 5 mg), IV infusion, 2 hours, day 1. Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours after the administration of GO.
**ID:** OG000
**Title:** Cohort 1
##### Group
**Description:** Cohort 2 (20 evaluable patients):
G-CSF: 150 mcg/m\^2, SC, days 0 to 7, to begin 12 to 18 hours before treatment with Gemtuzumab. GO: 3 mg/m\^2 (maximum 5 mg), IV infusion, 2 hours, day 1.
Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours later after the administration of GO.
**ID:** OG001
**Title:** Cohort 2
### Participant Flow Module
#### Group
**Description:** Mylotarg: Cohort 1 version 1.0 (5 evaluable patients):
GO: 6 mg/m\^2 (maximum 10 mg), IV infusion, 2 hours, day 1. Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours after the administration of GO.
If chemo-sensitivity is observed after a first course of treatment (50% or more reduction of blasts compared to baseline) a second identical cycle will be administered.
**ID:** FG000
**Title:** Cohort 1 Version 1.0
#### Group
**Description:** Idarubicin, cytarabine, Mylotarg
Mylotarg: Cohort 1 (20 evaluable patients):
GO: 3 mg/m\^2 (maximum 5 mg), IV infusion, 2 hours, day 1. Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours after the administration of GO.
**ID:** FG001
**Title:** Cohort 1 Version 2.0
#### Group
**Description:** Cohort 2 (20 evaluable patients):
G-CSF: 150 mcg/m\^2, SC, days 0 to 7, to begin 12 to 18 hours before treatment with Gemtuzumab. GO: 3 mg/m\^2 (maximum 5 mg), IV infusion, 2 hours, day 1.
Idarubicin: 12 mg/m\^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine (cytosine arabinoside): 100 mg/m\^2 IV continuous infusion on days 1 to 7, to begin 4 hours later after the administration of GO.
**ID:** FG002
**Title:** Cohort 2
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 6
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 20
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 20
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 5
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 20
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 20
##### Milestone
**Type:** NOT 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
**Has Results:** True |
## Protocol Section
### Identification Module
**NCT ID:** NCT02885779
**Acronym:** ANTATROC
**Brief Title:** Comparison of 2 Techniques of Invasive Mini Surgery: Coelioscopy Mini-trocar and Monotrocar in the Adnexa no Carcinologic Surgery : Forward-looking Observational Study.
**Official Title:** Comparison of 2 Techniques of Invasive Mini Surgery: Coelioscopy Mini-trocar and Monotrocar in the Adnexa no Carcinologic Surgery : Forward-looking Observational Study.
#### Organization Study ID Info
**ID:** ANTATROC-IPC 2015-011
#### Organization
**Class:** OTHER
**Full Name:** Institut Paoli-Calmettes
### Status Module
#### Completion Date
**Date:** 2015-09
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2016-09-01
**Type:** ESTIMATED
**Last Update Submit Date:** 2016-08-26
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2015-09
**Type:** ACTUAL
#### Start Date
**Date:** 2015-05
**Status Verified Date:** 2016-08
#### Study First Post Date
**Date:** 2016-09-01
**Type:** ESTIMATED
**Study First Submit Date:** 2016-08-18
**Study First Submit QC Date:** 2016-08-26
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Institut Paoli-Calmettes
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The advantages of the celioscopy mini--trocar and monotrocar technical are recognized.
There is however no forward-looking or retrospective study comparing the microcomputed-celioscopy (use of microphone) - trocar of 3mm of diameter in access celioscopic pluri--trocar) in the celioscopy monotrocar ( a single intra-umbilical section) in gynecological surgery.
The objective of this preliminary study is to compare both surgical care in terms of morbidity died operating, in adnexa surgeries.
### Conditions Module
**Conditions:**
- Gynecologic Surgical Procedures for Adnexa Surgery in Ovarian Disease
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 16
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patient having an operating indication of adnexa surgery : unilateral or bilateral adnexectomy
**Label:** Patient having an operating indication of adnexa surgery
### Outcomes Module
#### Primary Outcomes
**Description:** consumption of analgesic for pains in immediate operating comment
**Measure:** Immediate post operative pains
**Time Frame:** Up to 1 month
**Description:** consumption of analgesic for pains
**Measure:** Court term post operative pains
**Time Frame:** Up to 2 month
**Description:** consumption of analgesic for pains
**Measure:** Medium term post operative pains
**Time Frame:** Up to 3 month
#### Secondary Outcomes
**Description:** Blood loss
**Measure:** Complications per operating
**Time Frame:** During surgery
**Description:** Addition of trocar
**Measure:** Complications per operating
**Time Frame:** During surgery
**Description:** Duration of hospitalization
**Measure:** Complications post operating
**Time Frame:** Up to 1 month
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria :
* Age \> 18 ans
* OMS = 2
* Patient having an operating indication of adnexa surgery : unilateral or bilateral adnexectomy
Exclusion Criteria:
* Contraindication to coelioscopy intervention
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Operating indication of adnexa surgery : unilateral or bilateral adnexectomy
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Marseille
**Country:** France
**Facility:** Institut Paoli-Calmettes
**State:** Bouches-du-Rhône
**Zip:** 13273
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- 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: D000091662
- Term: Genital Diseases
- ID: D000006058
- Term: Gonadal Disorders
- ID: D000004700
- Term: Endocrine System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M12972
- Name: Ovarian Diseases
- Relevance: HIGH
- As Found: Ovarian Diseases
- 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: M9163
- Name: Gonadal Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M7862
- Name: Endocrine System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000010049
- Term: Ovarian Diseases
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT03644979
**Brief Title:** Skydiving as a Model of Psychological Stress and Its Effect on Intestinal Barrier Function
**Official Title:** Skydiving as a Model of Psychological Stress and Its Effect on Intestinal Barrier Function
#### Organization Study ID Info
**ID:** 2017/313
#### Organization
**Class:** OTHER
**Full Name:** Örebro University, Sweden
### Status Module
#### Completion Date
**Date:** 2018-10-31
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-01-03
**Type:** ACTUAL
**Last Update Submit Date:** 2019-01-02
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2018-10-31
**Type:** ACTUAL
#### Start Date
**Date:** 2018-07-01
**Type:** ACTUAL
**Status Verified Date:** 2019-01
#### Study First Post Date
**Date:** 2018-08-23
**Type:** ACTUAL
**Study First Submit Date:** 2018-08-21
**Study First Submit QC Date:** 2018-08-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Örebro University, Sweden
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** In this study, it will be investigated how psychological stress evoked by skydiving affects the intestinal permeability in 20 healthy subjects. Participants attend two visits: 1) Skydiving visit, 2) Negative control visit. At all visits, saliva samples, blood samples, and faecal samples are collected, and the multi-sugar permeability test is performed. In this test, participants drink a sugar solution and then collect urine for 5 and 24 h. The ratio of the sugars detected in the urine is a reflection of the intestinal permeability. Saliva samples are collected for assessment of cortisol, a stress marker. Blood and faecal samples are collected for assessment of markers of intestinal barrier function and inflammation.
### Conditions Module
**Conditions:**
- Psychological Stress Due to Skydiving
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** CROSSOVER
**Intervention Model Description:** 1) Skydiving visit, 2) Negative control visit
##### Masking Info
**Masking:** NONE
**Primary Purpose:** BASIC_SCIENCE
#### Enrollment Info
**Count:** 20
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Tandem skydiving
**Intervention Names:**
- Other: Skydiving
**Label:** Skydiving
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** No skydiving
**Label:** Negative control
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Skydiving
**Description:** Tandem skydiving (with an experienced instructor)
**Name:** Skydiving
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Measure:** Change in small intestinal permeability after skydiving measured as the urinary lactulose/rhamnose secretion ratio compared to negative control
**Time Frame:** 2-4 weeks
#### Secondary Outcomes
**Measure:** Change in whole gut permeability after skydiving measured as the urinary sucralose/erythritol secretion ratio compared to negative control
**Time Frame:** 2-4 weeks
**Measure:** Change in colonic permeability after skydiving measured as the urinary sucralose/erythritol secretion ratio compared to negative control
**Time Frame:** 2-4 weeks
**Measure:** Change in gastroduodenal permeability after skydiving measured as urinary sucrose excretion
**Time Frame:** 2-4 weeks
**Description:** fatty acid binding proteins, zonulin, claudin-3, 16S rRNA
**Measure:** Change in quantity of intestinal permeability markers in blood after skydiving compared to the negative control
**Time Frame:** 2-4 weeks
**Measure:** Change in salivary cortisol levels after skydiving compared to the negative control
**Time Frame:** 2-4 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Written informed consent prior to any study related procedures
2. Age \> 18 till \<50
3. Novice skydivers (first or second tandem jump)
4. Signed up for tandem skydive
5. Willing to abstain from probiotic products or medications known to alter gastrointestinal function throughout the study
Exclusion Criteria:
1. Abdominal surgery which might influence gastrointestinal function, except appendectomy and cholecystectomy.
2. Current diagnosis of hypertension.
3. Current diagnosis of psychiatric disease.
4. Over 100kg or with a body mass index over 35.
5. Systemic use of steroids in the last 6 weeks.
6. Use of antibiotics or antimicrobial medication in the last month.
7. Daily usage of non-steroidal anti-inflammatory drugs in the last 2 months or incidental use in the last 2 weeks prior to screening.
8. Usage of medications that could affect the barrier function, except oral contraceptives, during the 14 days prior to screening.
9. Diagnosed inflammatory gastrointestinal disease.
10. Regular use of probiotics in the last 6 weeks.
11. Smoking and/or chewable tobacco.
12. Planned changes to current diet or exercise regime.
13. Use of laxatives, anti-diarrhetics, anti-cholinergics within last 4 weeks prior to screening.
14. Use of immunosuppressant drugs within last 4 weeks prior to screening.
15. Women: Pregnancy, lactation.
16. Abuse of alcohol or drugs.
17. Any disease/condition which in the investigator's opinion could interfere with the intestinal barrier function.
18. Any clinically significant disease/condition which in the investigator's opinion could interfere with the results of the trial.
**Healthy Volunteers:** True
**Maximum Age:** 50 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Örebro
**Country:** Sweden
**Facility:** Örebro University
**Zip:** 701 82
### IPD Sharing Statement Module
**Description:** No individual participant data will be shared.
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Roca Rubio MF, Eriksson U, Brummer RJ, Konig J. Short intense psychological stress induced by skydiving does not impair intestinal barrier function. PLoS One. 2021 Jul 8;16(7):e0254280. doi: 10.1371/journal.pone.0254280. eCollection 2021.
**PMID:** 34237102
## 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: Psychological Stress
- 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:** NCT03865979
**Brief Title:** AI ENRICH - AI Detection of ICH
**Official Title:** Automated Detection, Characterization, Triage, and Recruitment of ICH Subjects Using Artificial Intelligence in the ENRICH Trial
#### Organization Study ID Info
**ID:** VIZ-ICH-01
#### Organization
**Class:** INDUSTRY
**Full Name:** Viz.ai, Inc.
### Status Module
#### Completion Date
**Date:** 2022-12
**Type:** ESTIMATED
#### Expanded Access Info
**Last Known Status:** ENROLLING_BY_INVITATION
#### Last Update Post Date
**Date:** 2022-04-27
**Type:** ACTUAL
**Last Update Submit Date:** 2022-04-26
**Overall Status:** UNKNOWN
#### Primary Completion Date
**Date:** 2022-12
**Type:** ESTIMATED
#### Start Date
**Date:** 2020-01-23
**Type:** ACTUAL
**Status Verified Date:** 2022-04
#### Study First Post Date
**Date:** 2019-03-07
**Type:** ACTUAL
**Study First Submit Date:** 2019-03-04
**Study First Submit QC Date:** 2019-03-06
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** Nico Corporation
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Viz.ai, Inc.
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** True
**Is FDA Regulated Drug:** False
**Is Unapproved Device:** True
**Is US Export:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** To evaluate the performance of the Viz RECRUIT software in subjects identified as symptomatic of a stroke event as determined by standard of care imaging assessments and interpretation.
**Detailed Description:** This study will be a multicenter prospective feasibility trial to evaluate the performance of the Viz RECRUIT software. This study will enroll subjects evaluated at each center for stroke via CT imaging. The Viz RECRUIT software will review the CT and notify a specialist if an ICH is detected. It will also evaluate the ICH parameters per study specific guidelines related to the ENRICH Trial and notify a specialist if their ICH meets the study inclusion or exclusion criteria related to cerebral blood flow volume. If an enrolled subject is ultimately included in the ENRICH trial, they will be identified in a prospective cohort of subjects exposed to Viz (intervention arm) will be evaluated per the secondary endpoints to a cohort of subjects retrospectively from the ENRICH Trial (control arm) which were evaluated and enrolled prior to Viz use.
### Conditions Module
**Conditions:**
- Intracerebral Hemorrhage
**Keywords:**
- Artificial Intelligence
- ICH
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** HEALTH_SERVICES_RESEARCH
#### Enrollment Info
**Count:** 5000
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Subject CT images assessed by Viz RECRUIT software in "real time" analysis All subjects in which the Viz RECRUIT software is utilized will be identified per cohort described below per PI confirmation of ENRICH Trial status/Study ID.
Cohort A: Subjects with imaging data Cohort B: Subjects with imaging data and ultimately enrolled as part of the ENRICH Trial
**Intervention Names:**
- Device: Viz RECRUIT
**Label:** Intervention Arm
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** Subjects enrolled as part of the ENRICH Trial prior to Viz RECRUIT software activation
**Label:** Control Arm
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Intervention Arm
**Description:** Viz RECRUIT includes the following modules: Viz ICH, Viz VOLUME, Viz VIEW and Viz HUB
**Name:** Viz RECRUIT
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Rate of concordance of Viz RECRUIT software identification of ICH via Head CT images and standard of care radiologist identification of ICH.
**Measure:** Performance
**Time Frame:** Enrollment
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Subjects with stroke symptoms who undergo CT brain imaging.
Exclusion Criteria:
* Subjects with poor or incomplete CT brain imaging.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Little Rock
**Country:** United States
**Facility:** UAMS Medical Center
**State:** Arkansas
**Zip:** 72205
**Location 2:**
**City:** Evanston
**Country:** United States
**Facility:** Northshore University Health System
**State:** Illinois
**Zip:** 60201
**Location 3:**
**City:** Camden
**Country:** United States
**Facility:** Cooper University Hospital
**State:** New Jersey
**Zip:** 08103
**Location 4:**
**City:** Bronx
**Country:** United States
**Facility:** Montefiore Medical Center
**State:** New York
**Zip:** 10467
**Location 5:**
**City:** Buffalo
**Country:** United States
**Facility:** SUNY Buffalo
**State:** New York
**Zip:** 14203
**Location 6:**
**City:** Danville
**Country:** United States
**Facility:** Geisinger Medical Center
**State:** Pennsylvania
**Zip:** 17822
#### Overall Officials
**Official 1:**
**Affiliation:** The Cooper Health System
**Name:** Brian T Jankowitz, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010335
- Term: Pathologic Processes
- ID: D000020300
- Term: Intracranial Hemorrhages
- 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
### 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
### Condition Browse Module - Browse Leaves
- ID: M5792
- Name: Cerebral Hemorrhage
- Relevance: HIGH
- As Found: Intracerebral Hemorrhage
- ID: M9556
- Name: Hemorrhage
- Relevance: HIGH
- As Found: Hemorrhage
- ID: M22113
- Name: Intracranial Hemorrhages
- 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
### Condition Browse Module - Meshes
- ID: D000002543
- Term: Cerebral Hemorrhage
- ID: D000006470
- Term: Hemorrhage
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT04509479
**Acronym:** NATURE-VALVE
**Brief Title:** National Tunisian Registry of Valvulopathies (NATURE-VALVE)
**Official Title:** National Tunisian Registry of Valvulopathies (NATURE-VALVE)
#### Organization Study ID Info
**ID:** DAC-008-STCCCV
#### Organization
**Class:** OTHER
**Full Name:** Dacima Consulting
### Status Module
#### Completion Date
**Date:** 2022-07-30
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-08-22
**Type:** ACTUAL
**Last Update Submit Date:** 2022-08-19
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2021-03-31
**Type:** ACTUAL
#### Start Date
**Date:** 2020-07-06
**Type:** ACTUAL
**Status Verified Date:** 2022-08
#### Study First Post Date
**Date:** 2020-08-12
**Type:** ACTUAL
**Study First Submit Date:** 2020-08-09
**Study First Submit QC Date:** 2020-08-09
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Tunisian Society of Cardiology and Cardiovascular Surgery
#### Lead Sponsor
**Class:** OTHER
**Name:** Dacima Consulting
#### 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 National Tunisian Registry of Valvulopathies is an observational, prospective and multicenter study aiming to assess the epidemiological, clinical and therapeutic profile of valve disease in tunisian departments of cardiology. Cardiologists from both sectors (public and private) are participating in the study, with 37 investigational centers. Data will be captured electronically by DACIMA Clinical Suite, according to FDA 21 CFR part 11 (Food and Drug Administration 21 Code of Federal Regulations part 11), HIPAA (Health Insurance Portability and Accountability Act) \& ICH (International Conference on Harmonisation) requirements.
### Conditions Module
**Conditions:**
- Valvular Heart Disease
- Valvular Stenosis
- Valvular Insufficiency
**Keywords:**
- Valvular
- Heart
- Aortic
- Mitral
- Tricuspid
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 3637
**Type:** ACTUAL
**Patient Registry:** True
**Study Type:** OBSERVATIONAL
**Target Duration:** 6 Months
### Arms Interventions Module
### Interventions
#### Intervention 1
**Description:** Description of valve replacements
**Name:** Valve replacement
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** Number of subjects with valvular disease (mitral or aortic or tricuspid) and willing to participate at the study
**Measure:** Valvulopathies incidence
**Time Frame:** at inclusion
#### Secondary Outcomes
**Description:** Number of patients with Major adverse cardiovascular events (MACE), including nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death.
**Measure:** Major adverse cardiovascular events (MACE)
**Time Frame:** at 6 months of follow-up
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients originated from Tunisia
* Signed informed consent
* Patients with at least one of the following conditions :
1. moderate to severe native mitral and / or aortic and / or tricuspid native valve disease
2. and / or a history of a previous percutaneous or surgical valve intervention
3. and / or a history of infectious endocarditis
Exclusion Criteria:
* Congenital valve diseases not including bicuspid aortic valve
* Isolated pulmonary valvulopathies
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Patients with valvular disease
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Tunis
**Country:** Tunisia
**Facility:** The Tunisian Society of Cardiology and CardioVascular Surgery
**Zip:** 1053
#### Overall Officials
**Official 1:**
**Affiliation:** Tunisian Society of Cardiology and Cardiovascular Surgery
**Name:** Fathia Mghaieth, MD
**Role:** STUDY_CHAIR
**Official 2:**
**Affiliation:** Tunisian Society of Cardiology and Cardiovascular Surgery
**Name:** Lilia Zakhama, MD
**Role:** STUDY_CHAIR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000002318
- Term: Cardiovascular 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
### Condition Browse Module - Browse Leaves
- ID: M9419
- Name: Heart Diseases
- Relevance: HIGH
- As Found: Heart Disease
- ID: M6475
- Name: Constriction, Pathologic
- Relevance: LOW
- As Found: Unknown
- ID: M9437
- Name: Heart Valve Diseases
- Relevance: HIGH
- As Found: Valvular Heart Disease
### Condition Browse Module - Meshes
- ID: D000006331
- Term: Heart Diseases
- ID: D000006349
- Term: Heart Valve Diseases
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT04319679
**Brief Title:** ESWT for UE Pain in Patients With Cervical Spinal Cord Injury
**Official Title:** The Effects of Extracorporeal Shockwave Therapy (ESWT) for Upper Extremity Pain Related to Spasticity in Patients With Spinal Cord Injury
#### Organization Study ID Info
**ID:** ESWTSCIPain
#### Organization
**Class:** OTHER
**Full Name:** Bundang CHA Hospital
### Status Module
#### Completion Date
**Date:** 2021-04-13
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-04-14
**Type:** ACTUAL
**Last Update Submit Date:** 2021-04-13
**Overall Status:** TERMINATED
#### Primary Completion Date
**Date:** 2021-04-05
**Type:** ACTUAL
#### Start Date
**Date:** 2020-06-05
**Type:** ACTUAL
**Status Verified Date:** 2021-04
#### Study First Post Date
**Date:** 2020-03-24
**Type:** ACTUAL
**Study First Submit Date:** 2020-03-14
**Study First Submit QC Date:** 2020-03-21
**Why Stopped:** Difficulty in recruiting patients
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Bundang CHA Hospital
#### Responsible Party
**Investigator Affiliation:** Bundang CHA Hospital
**Investigator Full Name:** MinYoung Kim, MD, PhD
**Investigator Title:** Principal Professor of Rehabilitation 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 aimed to investigate the efficacy and safety of extracorporeal shockwave therapy (ESWT) for upper extremity pain related to spasticity in patients with spinal cord injury.
**Detailed Description:** 6 times of ESWT (3,000 pulses per time, low energy under 0.3 mJ/m\^2, tolerable range) on forearm area to reduce pain related to spasticity in patients with cervical myelopathy
### Conditions Module
**Conditions:**
- Spastic Tetraplegia
- Pain
- Myelopathy Cervical
**Keywords:**
- Extracorporeal shockwave therapy
- Cervical myelopathy
- Spasticity
- Pain
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 4
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** 3,000 pulses per time, low energy under 0.3 mJ/mm\^2, tolerable range
**Intervention Names:**
- Device: Extracorporeal shockwave therapy
**Label:** Experimental group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Sham therapy
**Intervention Names:**
- Device: Sham therapy
**Label:** Control group
**Type:** SHAM_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Experimental group
**Description:** 6 times during 2 weeks
**Name:** Extracorporeal shockwave therapy
**Type:** DEVICE
#### Intervention 2
**Arm Group Labels:**
- Control group
**Description:** 6 times during 2 weeks
**Name:** Sham therapy
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Pain intensity (0-10, ordinal scale)
**Measure:** Numerical rating scale (NRS)
**Time Frame:** Up to 4 weeks (baseline, after each treatment during 2 weeks, 2 weeks + 1 day, 4 weeks)
#### Secondary Outcomes
**Description:** Spasticity, ordinal scale (0, 1, 1+, 2, 3, 4: higher scores indicate more severe spasticity)
**Measure:** Modified Ashworth scale (MAS)
**Time Frame:** Up to 4 weeks (baseline, after each treatment during 2 weeks, 2 weeks + 1 day, 4 weeks)
**Description:** Passive ROM of elbow, wrist and 3rd finger (in degrees: higher scores indicate larger range)
**Measure:** Range of motion (ROM)
**Time Frame:** Up to 4 weeks (baseline, 1 week, 2 weeks, 2 weeks + 1 day, 4 weeks)
**Description:** Hand grip power (in Kg measured by a dynamometer: higher scores indicate stronger power)
**Measure:** Grasp power
**Time Frame:** Up to 4 weeks (baseline, 2 weeks, 4 weeks)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Spinal cord damage confirmed in the spinal cord image
2. 1 month after spinal cord injury
3. Spasticity of upper extremities
4. Pain in areas below spinal cord injury more than 4 points on the numerical scale (NRS)
5. Cognitive functions that can clearly point out NRS with more than 15 points in the mini mental state examination (MMSE)
6. Age: 20 and older
7. Person who has agreed in writing to decide his or her participation and comply with the precautions
Exclusion Criteria:
1. Pain due to trauma
2. Injection treatments two weeks before participating in the study
3. Severe coagulopathy (excluding antiplatelet use)
4. Impaired cognition
**Minimum Age:** 20 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Seongnam
**Country:** Korea, Republic of
**Facility:** Department of Rehabilitation Medicine, CHA Bundang Medical Center,
**Zip:** 13496
#### Overall Officials
**Official 1:**
**Affiliation:** Department of Rehabilitation Medicine, CHA Bundang Medical Center, CHA University School of Medicine
**Name:** Kyunghoon Min, MD, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** Information that cannot be identified
**Info Types:**
- STUDY_PROTOCOL
**IPD Sharing:** YES
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000020196
- Term: Trauma, Nervous System
- ID: D000014947
- Term: Wounds and Injuries
- ID: D000009461
- Term: Neurologic Manifestations
- ID: D000006402
- Term: Hematologic Diseases
- ID: D000010243
- Term: Paralysis
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC05
- Name: Musculoskeletal Diseases
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: BC15
- Name: Blood and Lymph Conditions
### Condition Browse Module - Browse Leaves
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M12085
- Name: Muscle Spasticity
- Relevance: LOW
- As Found: Unknown
- ID: M15916
- Name: Spinal Cord Injuries
- Relevance: HIGH
- As Found: Spinal Cord Injury
- ID: M5134
- Name: Bone Marrow Diseases
- Relevance: HIGH
- As Found: Myelopathy
- ID: M14632
- Name: Quadriplegia
- Relevance: HIGH
- As Found: Spastic Tetraplegia
- ID: M15915
- Name: Spinal Cord Diseases
- Relevance: HIGH
- As Found: Myelopathy
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17685
- Name: Wounds and Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M22023
- Name: Trauma, Nervous System
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: M9490
- Name: Hematologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M13157
- Name: Paralysis
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000013119
- Term: Spinal Cord Injuries
- ID: D000013118
- Term: Spinal Cord Diseases
- ID: D000011782
- Term: Quadriplegia
- ID: D000001855
- Term: Bone Marrow Diseases
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT04891679
**Acronym:** OMS
**Brief Title:** Induction of Labor by Oral Misoprostol Solution
**Official Title:** A Randomised Control Study of Titrated and Static Oral Misoprostol for Induction of Labor at Term
#### Organization Study ID Info
**ID:** Titrated and Static OMS
#### Organization
**Class:** OTHER
**Full Name:** Christian Medical College and Hospital, Ludhiana, India
### Status Module
#### Completion Date
**Date:** 2018-11-30
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-05-18
**Type:** ACTUAL
**Last Update Submit Date:** 2021-05-13
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2018-11-30
**Type:** ACTUAL
#### Start Date
**Date:** 2017-12-01
**Type:** ACTUAL
**Status Verified Date:** 2021-05
#### Study First Post Date
**Date:** 2021-05-18
**Type:** ACTUAL
**Study First Submit Date:** 2021-05-13
**Study First Submit QC Date:** 2021-05-13
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Christian Medical College and Hospital, Ludhiana, India
#### Responsible Party
**Investigator Affiliation:** Christian Medical College and Hospital, Ludhiana, India
**Investigator Full Name:** Dr. Barbie Sharma
**Investigator Title:** Senior Resident, Department of obstetrics and gynecology
**Type:** PRINCIPAL_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:** AIM: To evaluate effectiveness and safety of titrated oral misoprostol solution (OMS) in comparison with static-dose oral misoprostol solution for induction of labor at term.
Women with singleton live pregnancy at term without any complications who were admitted in labor room for induction of labor were enrolled.
Study involves allocation of selected women in two groups randomly and use of either titrated or static oral misoprostol dose regimen to induce labor. Possible benefits included rapid induction of labor with oral drug regimen which is easier to comply as compared to vaginal regimens. Women were at risk of all the complications associated with induction of labor like labor abnormalities, risk of cesarean section, non reassuring fetal status.
**Detailed Description:** This comparative randomized study was conducted in the Department of Obstetrics and Gynecology, Christian medical college and hospital, Ludhiana for a period of one year beginning from 1st December, 2017 to 30th November, 2018. The study group comprised of all antenatal women admitted in labor room at term for induction of labor. Informed consent was taken for all selected women. Women were subjected to detailed history taking, a complete physical examination including per vaginum examination (to calculate modified bishop's score and to rule out cephalopelvic disproportion), investigations and a NST. Gestational age was established by the first date of the last menstrual period and confirmed by first trimester ultrasound. Presentation was confirmed by palpation and third trimester ultrasound.
Women after randomization were allocated into two groups. The first group (A) was induced with hourly titrated oral misoprostol regimen and the second group (B) received two hourly static oral misoprostol regimen. Once labor had started, vital signs were closely monitored every 2 hours; fetal heart rate (FHR) and uterine activity every 15 minutes during first stage of labor. Per vaginum examination was done 4-hourly or as indicated.
Primary and secondary outcome measures were noted and analyzed to compare safety and efficacy of titrated and oral misoprstol solution.
### Conditions Module
**Conditions:**
- Induction of Labor
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Single center interventional single-blinded randomised controlled trial
##### Masking Info
**Masking:** SINGLE
**Masking Description:** Women were randomized (1:1) into the treatment groups A) Titrated-dose OMS group B) Static dose OMS group; using computer generated number sequence. Allocation concealment was carried out by using opaque envelopes that were distributed by the obstetrics nurse. Whereas study investigators and attending care teams were aware of the allocated arm, patients were kept blinded to the allocation. Study investigators and outcome assessors could not be blinded as the data collection and analysis included outcome measures like timing of oral misoprostol solution doses.
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 264
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Titrated oral misoprostol solution
**Intervention Names:**
- Drug: Oral misoprostol solution (OMS)
**Label:** Group A (Titrated OMS)
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** Static oral misoprostol solution
**Intervention Names:**
- Drug: Oral misoprostol solution (OMS)
**Label:** Group B (Static OMS)
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Group A (Titrated OMS)
- Group B (Static OMS)
**Description:** Based on the WHO labor induction recommendation, and for the purpose of achieving precise oral misoprostol dosage, one misoprostol tablet (200 mcg) was pulverized and dissolved into 200 ml water.90 Thus 1ml of solution had 1mcg of misoprostol. This misoprostol solution could be preserved at room temperature and remained active for 24 hours.
Hourly titrated oral misoprostol solution was given to group A as described by Wang X et al, 2016 as described below.
0 hour= 20ml
1. hour= 20ml
2. hour= 30ml
3. hour= 30ml
4. hour= 30ml
5. hour= 40ml 6.5 hour= 50ml 8.5 hour= 60ml 10.5 hour=60ml
Group B received 25 mcg (25 ml) oral misoprostol solution every 2 hours for a maximum of 12 doses or until the onset of regular uterine activity.
**Name:** Oral misoprostol solution (OMS)
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** The time taken from induction of labor to delivery measured as
1) \<12 hours 2) 12-24 hours 3) 24-48 hours 4) \>48 hours
**Measure:** Interval between induction and delivery
**Time Frame:** From first dose of oral misoprostol solution (titrated/static) to childbirth; upto 5 days
#### Secondary Outcomes
**Description:** Measured as difference between modified bishop's score before induction of labor and at amniotomy/stopping of oral misoprostol solution regimen; minimum 0f 1 to maximum of 7.
**Measure:** Mean change in modified Bishop's score
**Time Frame:** From first dose of oral misoprostol solution to childbirth (intrapartum); upto 5 days
**Description:** Measured as 1-2; 3-4; 5-6; 7-8; \>9
**Measure:** Number of misoprostol doses
**Time Frame:** From first dose of oral misoprostol solution to childbirth (intrapartum); upto 5 days
**Description:** Measured as 1-4 hours; 5-8 hours; 9-12 hours; 13-16 hours; 17-20 hours; 21-24 hours
**Measure:** Time taken to give required doses
**Time Frame:** From first dose of oral misoprostol solution to childbirth (intrapartum); upto 5 days
**Description:** Measured as \</=75mcg; 76-150mcg; 151-225mcg; 226-300mcg; \>301 mcg
**Measure:** Total misoprostol dosage
**Time Frame:** From first dose of oral misoprostol solution to childbirth (intrapartum); upto 5 days
**Description:** In terms of Vaginal delivery/LSCS
**Measure:** Mode of delivery
**Time Frame:** Upto 5 days from first dose of oral misoprostol solution
**Description:** Divided into either of the following:
1. SECONDARY ARREST OF DILATATION
2. MSAF IN EARLY LABOR
3. CTG CATEGORY III
4. FAILED INDUCTION
5. CEPHALOPELVIC DISPROPORTION
6. CORD PROLAPSE
7. DEEP TRANSVERSE ARREST
8. ARREST OF DESCENT OF HEAD
**Measure:** Indication for LSCS
**Time Frame:** Upto 5 days from first dose of oral misoprostol solution
**Description:** Required/Not required
**Measure:** Oxytocin augmentation
**Time Frame:** From first dose of oral misoprostol solution to childbirth (intrapartum); upto 5 days
**Description:** In terms of incidence of either of the following:
1. Incidence of tachysystole
2. Fever- intrapartum and postpartum
3. Puerperal sepsis
4. Uterine rupture
**Measure:** Maternal morbidity
**Time Frame:** From first dose of oral misoprostol solution to dischage from hospital; upto 7 days
**Description:** Measured in terms of incidence of either of the following:
1. Incidence of meconium-stained liquor
2. APGAR scores at 1,5 min
3. NICU stay
**Measure:** Neonatal parameters
**Time Frame:** From childbirth to discharge of the baby; upto 1 month
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Singleton live pregnancy;
2. ≥37 weeks gestation;
3. Cephalic presentation;
4. Reassuring fetal heart rate;
5. Modified Bishop'score
Exclusion Criteria:
1. Hypersensitivity to misoprostol;
2. Uterine scar due to previous cesarean section or other uterine surgery;
3. Grand multipara;
4. Multiple gestations;
5. High risk pregnanacies • preeeclampsia with severe features • significant maternal cardiac,renal, liver disease
6. Any contraindication to induction and vaginal delivery e.g. cephalopelvic disproportion, malpresentation, fetal compromise and ante partum hemorrhage
7. Intrauterine fetal demise
**Gender Based:** True
**Gender Description:** Pregnant females were enrolled for induction of labor in the study.
**Healthy Volunteers:** True
**Maximum Age:** 40 Years
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Ludhiana
**Country:** India
**Facility:** Christian Medical College and Hospital
**State:** Punjab
**Zip:** 141008
#### Overall Officials
**Official 1:**
**Affiliation:** Department of obstetrics and gynecology, Christian Medical College and hospital, Ludhiana
**Name:** SUNITA GOYAL, MBBS, MD
**Role:** STUDY_CHAIR
### IPD Sharing Statement Module
**Access Criteria:** Anyone who wishes to access the data for any purpose. Link will be made available at a later date.
**Description:** IPD that underlie the results reported in the study, after deidentification (text, tables, figures and appendices) will be shared in the excel sheet format.
**Info Types:**
- STUDY_PROTOCOL
- SAP
- ICF
**IPD Sharing:** YES
**Time Frame:** Data will be available beginning immediately and ending 36 months following article publication.
### References Module
#### Available IPDs
**ID:** PATIENT INFORMATION SHEET
**Type:** Informed Consent Form
**URL:** https://figshare.com/s/a6c10a2a4be65f30144b
**ID:** STUDY PROTOCOL
**Type:** Study Protocol
**URL:** https://figshare.com/s/3f978a10eee4e90173bb
#### References
**Citation:** Rouzi AA, Alsahly N, Alamoudi R, Almansouri N, Alsinani N, Alkafy S, Rozzah R, Abduljabbar H. Randomized clinical trial between hourly titrated and 2 hourly static oral misoprostol solution for induction of labor. Am J Obstet Gynecol. 2017 Apr;216(4):405.e1-405.e6. doi: 10.1016/j.ajog.2016.11.1054. Epub 2016 Dec 14.
**PMID:** 27986461
**Citation:** Aduloju OP, Ipinnimo OM, Aduloju T. Oral misoprostol for induction of labor at term: a randomized controlled trial of hourly titrated and 2 hourly static oral misoprostol solution. J Matern Fetal Neonatal Med. 2021 Feb;34(4):493-499. doi: 10.1080/14767058.2019.1610378. Epub 2019 Apr 29.
**PMID:** 31006282
## Derived Section
### Intervention Browse Module - Ancestors
- ID: D000000020
- Term: Abortifacient Agents, Nonsteroidal
- ID: D000000019
- Term: Abortifacient Agents
- ID: D000012102
- Term: Reproductive Control Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000000897
- Term: Anti-Ulcer Agents
- ID: D000005765
- Term: Gastrointestinal Agents
- ID: D000010120
- Term: Oxytocics
### Intervention Browse Module - Browse Branches
- Abbrev: PhSol
- Name: Pharmaceutical Solutions
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Gast
- Name: Gastrointestinal Agents
- Abbrev: Repr
- Name: Reproductive Control Agents
### Intervention Browse Module - Browse Leaves
- ID: M21860
- Name: Pharmaceutical Solutions
- Relevance: LOW
- As Found: Unknown
- ID: M18979
- Name: Misoprostol
- Relevance: HIGH
- As Found: Liquid
- 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: D000016595
- Term: Misoprostol
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT01408979
**Acronym:** MgSO4
**Brief Title:** Effectiveness Study of Short Course of Magnesium Sulfate for Severe Preeclamsia
**Official Title:** Postpartum Prophylaxis With Short Course Magnesium Sulfate in Severe Preeclampsia: a Randomized Clinical Trial
#### Organization Study ID Info
**ID:** MgSO4
#### Organization
**Class:** OTHER
**Full Name:** Instituto Materno Infantil Prof. Fernando Figueira
### Status Module
#### Completion Date
**Date:** 2012-02
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2012-08-22
**Type:** ESTIMATED
**Last Update Submit Date:** 2012-08-20
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2011-12
**Type:** ACTUAL
#### Start Date
**Date:** 2011-08
**Status Verified Date:** 2012-04
#### Study First Post Date
**Date:** 2011-08-03
**Type:** ESTIMATED
**Study First Submit Date:** 2011-08-02
**Study First Submit QC Date:** 2011-08-02
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Instituto Materno Infantil Prof. Fernando Figueira
#### Responsible Party
**Investigator Affiliation:** Instituto Materno Infantil Prof. Fernando Figueira
**Investigator Full Name:** Leila Katz
**Investigator Title:** Obstetrical ICU obstetrical coordinator; MD , PhD
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Magnesium sulfate is the ideal drug for seizures prophilaxis in preeclampsia. The ideal duration of this treatment after delivery is still to be established. The hypothesis is that in stable patients a shorter course of treatment is possible without prejudice to the mother.
**Detailed Description:** Magnesium sulfate (MgSO4) is certainly the ideal drug for prevention and control of eclamptic seizures. However, there is no consensus on the appropriate duration of prophylaxis with this anticonvulsant postpartum.The objective of the present study is to compare effectiveness of 12 hours of magnesium sulfate versus 24 hours (standard treatment) in stable patients with preeclampsia.
### Conditions Module
**Conditions:**
- Severe Preeclampsia
**Keywords:**
- Severe preeclampsia
- magnesium sulfate
- anticonvulsivant
### 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:** 120
**Type:** ACTUAL
**Phases:**
- PHASE4
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients in this group will have magnesium sulfate administered for 12 hours after delivery
**Intervention Names:**
- Drug: Magnesium sulfate 12 hours
**Label:** 12 hours of magnesium sulfate
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Patients in this group will have magnesium sulfate administered for 24 hours after delivery
**Intervention Names:**
- Drug: Magnesium sulfate 24 hours
**Label:** 24 hours of magnesium sulfate
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- 12 hours of magnesium sulfate
**Description:** Magnesium sulfate, 1g/h, (10% solution), for 12 hours
**Name:** Magnesium sulfate 12 hours
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- 24 hours of magnesium sulfate
**Description:** Magnesium sulfate, 1g/h, (10% solution), for 24 hours
**Name:** Magnesium sulfate 24 hours
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Defined as the need to continue therapy for another 12 hours, this will occur when after the first 12 hours of magnesium sulfate therapy the patient has severe hypertension, unsatisfactory diureses or has signs or symptoms of iminent eclampsia.
**Measure:** Need to continue therapy for another 12 hours.
**Time Frame:** 24 hours
#### Secondary Outcomes
**Description:** Patients satisfaction with the duration of therapy
**Measure:** Satisfaction
**Time Frame:** 24 hours
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Pre-eclampsia;
* Puerperium.
Exclusion Criteria:
* Associated maternal diseases;
* Use of illicit drugs or other medications that might interfere with maternal hemodynamics;
* Contraindications to the use of magnesium sulfate: drug hypersensitivity, oliguria with urine output below 25ml/h; anuria (absent urine output), myasthenia gravis.
**Maximum Age:** 50 Years
**Minimum Age:** 11 Years
**Sex:** FEMALE
**Standard Ages:**
- CHILD
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Recife
**Country:** Brazil
**Facility:** IMIP
**State:** Pernambuco
**Zip:** 50.000
#### Overall Officials
**Official 1:**
**Affiliation:** IMIP
**Name:** Melania M Amorim, MD; PhD
**Role:** PRINCIPAL_INVESTIGATOR
### References Module
#### References
**Citation:** Maia SB, Katz L, Neto CN, Caiado BV, Azevedo AP, Amorim MM. Abbreviated (12-hour) versus traditional (24-hour) postpartum magnesium sulfate therapy in severe pre-eclampsia. Int J Gynaecol Obstet. 2014 Sep;126(3):260-4. doi: 10.1016/j.ijgo.2014.03.024. Epub 2014 May 10.
**PMID:** 24890747
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000046110
- Term: Hypertension, Pregnancy-Induced
- 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: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: All
- Name: All Conditions
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M14106
- Name: Pre-Eclampsia
- Relevance: HIGH
- As Found: Preeclampsia
- ID: M7633
- Name: Eclampsia
- Relevance: LOW
- As Found: Unknown
- ID: M10024
- Name: Hypertension
- Relevance: LOW
- As Found: Unknown
- ID: M25635
- Name: Hypertension, Pregnancy-Induced
- 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
- ID: T2019
- Name: Eclampsia
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000011225
- Term: Pre-Eclampsia
### 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: D000000777
- Term: Anesthetics
- ID: D000002492
- Term: Central Nervous System Depressants
- ID: D000000889
- Term: Anti-Arrhythmia Agents
- ID: D000000927
- Term: Anticonvulsants
- ID: D000002121
- Term: Calcium Channel Blockers
- ID: D000049990
- Term: Membrane Transport Modulators
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000077264
- Term: Calcium-Regulating Hormones and Agents
- ID: D000015149
- Term: Tocolytic Agents
- ID: D000012102
- Term: Reproductive Control Agents
### Intervention Browse Module - Browse Branches
- Abbrev: PhSol
- Name: Pharmaceutical Solutions
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: AnArAg
- Name: Anti-Arrhythmia Agents
- Abbrev: ChanBlk
- Name: Channel Blockers
- Abbrev: Analg
- Name: Analgesics
- Abbrev: AntiConv
- Name: Anticonvulsants
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: Repr
- Name: Reproductive Control Agents
- Abbrev: BDCA
- Name: Bone Density Conservation Agents
### Intervention Browse Module - Browse Leaves
- ID: M21860
- Name: Pharmaceutical Solutions
- Relevance: LOW
- As Found: Unknown
- ID: M11270
- Name: Magnesium Sulfate
- Relevance: HIGH
- As Found: Optimal
- ID: M4032
- Name: Analgesics
- Relevance: LOW
- As Found: Unknown
- ID: M4107
- Name: Anesthetics
- Relevance: LOW
- As Found: Unknown
- ID: M4213
- Name: Anti-Arrhythmia Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4246
- Name: Anticonvulsants
- Relevance: LOW
- As Found: Unknown
- ID: M5381
- Name: Calcium
- Relevance: LOW
- As Found: Unknown
- ID: M5384
- Name: Calcium Channel Blockers
- Relevance: LOW
- As Found: Unknown
- ID: M5398
- Name: Calcium, Dietary
- Relevance: LOW
- As Found: Unknown
- ID: M9789
- Name: Hormones
- Relevance: LOW
- As Found: Unknown
- ID: M17869
- Name: Tocolytic Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000008278
- Term: Magnesium Sulfate
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT04005079
**Acronym:** PACCT
**Brief Title:** Pilocarpine After Combined Cataract/Trabectome Surgery
**Official Title:** A Prospective Randomized Control Trial of Pilocarpine Use After Combined Cataract/Trabectome Surgery
#### Organization Study ID Info
**ID:** 2017-8704
#### Organization
**Class:** OTHER
**Full Name:** Montefiore Medical Center
### Status Module
#### Completion Date
**Date:** 2021-01-21
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-04-07
**Type:** ACTUAL
**Last Update Submit Date:** 2022-04-06
**Overall Status:** WITHDRAWN
#### Primary Completion Date
**Date:** 2021-01-21
**Type:** ACTUAL
#### Start Date
**Date:** 2019-06-05
**Type:** ACTUAL
**Status Verified Date:** 2022-04
#### Study First Post Date
**Date:** 2019-07-02
**Type:** ACTUAL
**Study First Submit Date:** 2019-06-28
**Study First Submit QC Date:** 2019-06-28
**Why Stopped:** not performing Trabectomes
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Montefiore Medical Center
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Is US Export:** True
### Description Module
**Brief Summary:** Combined cataract + trabectome surgery is a surgery designed to help lower the intraocular pressure (pressure in the eye) and hopefully reduce the need for topical drops, progression of glaucoma, and/or further glaucoma surgeries. The purpose of this study is to assess whether using pilocarpine, a medication which is FDA approved to induce miosis, (in other words cause the pupil to constrict or become smaller) provides additional benefit to the success of Trabectome and cataract surgery.
**Detailed Description:** Glaucoma is the leading cause of irreversible blindness worldwide, and its treatment consists of lowering intraocular pressure (IOP) to prevent damage to the optic nerve and loss of vision. Microincisional glaucoma surgery (MIGS) have become more popular in recent years as less invasive methods than traditional surgeries that effectively reduce IOP and help reduce the medication burden on patients.There are multiple available MIGS procedures, most of which act by increasing trabecular outflow. One such procedure is the Trabectome, which is usually performed in combination with cataract surgery.
Trabectome is an FDA approved device used to perform a trabeculectomy via an internal approach. A strip of 60-120 degrees of the nasal angle trabecular meshwork and the inner wall of Schlemm's canal are removed providing a direct pathway for aqueous outflow from the anterior chamber into the collector channels\[2\].
Pilocarpine, a parasympathomimetic agent, is a glaucoma medication that works by causing contraction of the ciliary muscle leading to opening of the trabecular meshwork\[3\]. Due to its frequent dosing requirement and large number of ocular and systemic side effects, pilocarpine has largely fallen out of favor for the treatment of primary open angle glaucoma (POAG), except in patients for whom few other alternatives exist. However, pilocarpine is often used after trabectome surgery.
The rationale for its use after Trabectome procedure is for its miotic effect, which theoretically may prevent the formation of peripheral anterior synechiae. Formation of peripheral anterior synechiae can lead to the closure of the cleft that is generated and the possibility of failure of the procedure. While the theoretical benefit of pilocarpine has been proposed, its actual benefit has never been proven.
In this study, the aim is to evaluate whether Trabecome / Cataract surgery without pilocarpine is non-inferior to Trabecome / Cataract surgery procedure followed by treatment with pilocarpine
### Conditions Module
**Conditions:**
- Open Angle Glaucoma
- Ocular Hypertension
**Keywords:**
- Cataract surgery
- Trabectome
- Eye Surgery
- Vision
- Glaucoma Surgery
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** The "Treatment Group" will use 2% pilocarpine in the postoperative period in addition to standard post-operative drops (Prednisolone acetate and Ofloxacin). The "Control Group" will use only Prednisolone acetate and Ofloxacin, without pilocarpine.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Type:** ACTUAL
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** 2% pilocarpine and standard of care post op drops ( Prednisolone acetate and Ofloxacin)
**Intervention Names:**
- Drug: Pilocarpine
- Drug: Ofloxacin
- Drug: Prednisolone
**Label:** Treatment Group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Standard of care post op drops-Prednisolone acetate and Ofloxacin, without pilocarpine
**Intervention Names:**
- Drug: Ofloxacin
- Drug: Prednisolone
**Label:** Control Group
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Treatment Group
**Description:** 2% pilocarpine in the postoperative period in addition to standard postoperative drops (Prednisolone acetate and Ofloxacin)
**Name:** Pilocarpine
**Other Names:**
- Ocu-Carpine
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Control Group
- Treatment Group
**Description:** Standard of care
**Name:** Ofloxacin
**Other Names:**
- Ocuflox
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- Control Group
- Treatment Group
**Description:** Standard of Care
**Name:** Prednisolone
**Other Names:**
- Ocu-Pred
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Percentage of IOP drop at 1 month, 6 months and 1 year after surgery.
**Measure:** Percentage of intraocular lowering from baseline
**Time Frame:** Up to 1 year
**Description:** The number of pre and post procedure drops required to achieve goal IOP at 6 months, 1, 2 and 3 years after combined cataract/trabectome surgery in patients treated with post-op pilocarpine vs control
**Measure:** Number of IOP lowering agents required to achieve goal IOP
**Time Frame:** Up to 3 years
**Description:** Assessment of the rate of progression towards further surgery in patients treated with post-op pilocarpine vs control over a 3 year follow up period
**Measure:** Rate of progression to further glaucoma surgeries.
**Time Frame:** Up to 3 years
#### Secondary Outcomes
**Description:** Most common side effects will be counted - blurry vision, decrease night vision, headaches, browache, nausea, vomiting, diarrhea
**Measure:** Frequency of pilocarpine related side effects
**Time Frame:** Up to 3 years
**Description:** The number of drug discontinuation due to common side effects will be counted
**Measure:** Frequency of drug discontinuation due to pilocarpine related side effects
**Time Frame:** Up to 3 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age Range: 30 to 100 years old
* Patients with ocular hypertension or open angle glaucoma undergoing combined cataract surgery with trabectome in a single surgical center
Exclusion Criteria:
* Patients with previous history of eye surgeries (including laser procedures).
**Healthy Volunteers:** True
**Maximum Age:** 100 Years
**Minimum Age:** 30 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Bronx
**Country:** United States
**Facility:** Montefiore Medical Center
**State:** New York
**Zip:** 10467
#### Overall Officials
**Official 1:**
**Affiliation:** Montefiore Medical Center
**Name:** Wen-Jeng (Melissa) Yao, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Document Section
### Large Document Module
#### Large Docs
- Date: 2018-11-13
- Filename: Prot_SAP_000.pdf
- Has ICF: False
- Has Protocol: True
- Has SAP: True
- Label: Study Protocol and Statistical Analysis Plan
- Size: 137456
- Type Abbrev: Prot_SAP
- Upload Date: 2021-08-11T08:56
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000005128
- Term: Eye Diseases
- ID: D000007905
- Term: Lens 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: M5638
- Name: Cataract
- Relevance: HIGH
- As Found: Cataract
- ID: M10024
- Name: Hypertension
- Relevance: LOW
- As Found: Unknown
- ID: M9013
- Name: Glaucoma
- Relevance: HIGH
- As Found: Glaucoma
- ID: M9014
- Name: Glaucoma, Open-Angle
- Relevance: HIGH
- As Found: Open Angle Glaucoma
- ID: M12731
- Name: Ocular Hypertension
- Relevance: HIGH
- As Found: Ocular Hypertension
- ID: M8271
- Name: Eye Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10917
- Name: Lens Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000005901
- Term: Glaucoma
- ID: D000002386
- Term: Cataract
- ID: D000005902
- Term: Glaucoma, Open-Angle
- ID: D000009798
- Term: Ocular Hypertension
### Intervention Browse Module - Ancestors
- ID: D000000893
- Term: Anti-Inflammatory Agents
- ID: D000005938
- Term: Glucocorticoids
- ID: D000006728
- Term: Hormones
- ID: D000006730
- Term: Hormones, Hormone Substitutes, and Hormone Antagonists
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000018931
- Term: Antineoplastic Agents, Hormonal
- ID: D000000970
- Term: Antineoplastic Agents
- ID: D000001337
- Term: Autonomic Agents
- ID: D000018373
- Term: Peripheral Nervous System Agents
- ID: D000008916
- Term: Miotics
- ID: D000018721
- Term: Muscarinic 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: D000000892
- Term: Anti-Infective Agents, Urinary
- ID: D000000890
- Term: Anti-Infective Agents
- ID: D000000900
- Term: Anti-Bacterial Agents
- ID: D000059005
- Term: Topoisomerase II Inhibitors
- ID: D000059003
- Term: Topoisomerase Inhibitors
- ID: D000004791
- Term: Enzyme Inhibitors
- ID: D000065609
- Term: Cytochrome P-450 CYP1A2 Inhibitors
- ID: D000065607
- Term: Cytochrome P-450 Enzyme Inhibitors
### Intervention Browse Module - Browse Branches
- Abbrev: Infl
- Name: Anti-Inflammatory Agents
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: AnEm
- Name: Antiemetics
- Abbrev: NeuroAg
- Name: Neuroprotective Agents
- Abbrev: Gast
- Name: Gastrointestinal Agents
### Intervention Browse Module - Browse Leaves
- ID: M14120
- Name: Prednisolone
- Relevance: HIGH
- As Found: Vein
- ID: M30370
- Name: Levofloxacin
- Relevance: LOW
- As Found: Unknown
- ID: M17946
- Name: Ofloxacin
- Relevance: HIGH
- As Found: Histopathology
- 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: M13757
- Name: Pilocarpine
- Relevance: HIGH
- As Found: Motivational interview
- ID: M4217
- Name: Anti-Inflammatory 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
- ID: M20795
- Name: Muscarinic 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: M4214
- Name: Anti-Infective Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4222
- Name: Anti-Bacterial 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
### Intervention Browse Module - Meshes
- ID: D000015242
- Term: Ofloxacin
- ID: D000011239
- Term: Prednisolone
- ID: D000010862
- Term: Pilocarpine
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06425679
**Acronym:** ExerMOT4Health
**Brief Title:** Cost-effectiveness and Efficacy of Different Physical Exercise Interventions (ExerMOT4Health)
**Official Title:** Cost-effectiveness and Efficacy of Physical Exercise on Mental and Physical Health in Older Adults: Role of Motivational Strategies and Digital Technology
#### Organization Study ID Info
**ID:** PID2021-123688OB-C31
#### Organization
**Class:** OTHER
**Full Name:** University of Cadiz
### Status Module
#### Completion Date
**Date:** 2025-01-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-17
**Overall Status:** ACTIVE_NOT_RECRUITING
#### Primary Completion Date
**Date:** 2025-01-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-11-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-26
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** Institute of Biomedical research and innovation of Cádiz (INIBICA)
**Class:** OTHER
**Name:** Universidad de Almeria
**Class:** OTHER_GOV
**Name:** Ministerio de Ciencia e Innovación, Spain
**Class:** UNKNOWN
**Name:** Agencia Estatal de Investigación, Spain
**Class:** OTHER
**Name:** European Regional Development Fund
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Cadiz
#### Responsible Party
**Investigator Affiliation:** University of Cadiz
**Investigator Full Name:** Ana Carbonell Baeza
**Investigator Title:** PhD
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Online exercise has increased in popularity during the pandemic, but there is no evidence of its feasibility and benefits in older people and the influence of motivational strategies. The main aims of this project are: i) To analyze the influence of applying or not motivational strategies during different physical exercise interventions (face-to-face and online) on the effect on mental health, physical health and adherence, according to sex/gender; ii) To analyze and compare the cost-effectiveness and efficacy of face-to-face and online exercise interventions on mental health, physical health and adherence, according to sex/gender. Participants will be 104 community-dwelling older adults (60-75 years) who will be randomized assigned to control, supervised face to face, supervised face to face plus motivation, synchronous online supervised exercise or synchronous online supervised exercise groups.
The control group will carry out the usual activities they have been doing, and the intervention groups will participate for 24 weeks in multicomponent exercise intervention. Study assessments will be made before starting the intervention, at the end and after 24 weeks of follow-up. Primary variables will be changes in mental and physical health, assessed by the Trail Making Test, the Yesavage Geriatric Depression Scale, and lower extremity power measured by the sit to stand test. Secondary outcomes will include other parameters of mental and physical health, blood markers, physical activity, and cost-effectiveness analysis. The dropout rate, the attendance at the sessions, the injuries and other adverse events suffered by the participants, and technical incidences produced in the online modality will also be recorded.
The results of this project will provide insight into the mental and physical health effects and feasibility of face-to-face and synchronous online supervised physical exercise interventions, and identify older adults' perceptions of the safety, barriers and facilitators of these interventions for future application and transfer to community settings.
**Detailed Description:** Scientific evidence has demonstrated the effects of multicomponent physical exercise on the mental and physical health of community-dwelling older people. Despite this, the interest of some older people in exercise is low and even a low percentage of older people practice it with sufficient frequency and intensity to obtain benefits in their mental and physical health. Recent studies have demonstrated the importance of using motivational strategies to generate adherence to exercise, but there are still no studies with community-dwelling older adults. Furthermore, the Covid-19 pandemic has shown that face-to-face physical exercise is not always possible, so it is necessary to have alternatives in case situations of social isolation and mobility restrictions return. It is also important to note that many older people have difficulty traveling to a sports center or living in rural environments, which makes it difficult to practice exercise regularly. Online exercise has increased in popularity during the pandemic, but there is no evidence of its feasibility and benefits in older people.
The specific aims of this study are:
1. To analyze the influence of applying or not motivational strategies during supervised face-to-face and synchronous online physical exercise interventions on the effect on mental health, physical health and adherence, according to sex/gender in the community setting.
2. To analyze and compare the cost-effectiveness and efficacy of supervised face-to-face and synchronous online exercise interventions vs usual lifestyle on mental health, physical health and adherence, according to sex/gender in the community setting, in short and long term (follow up).
3. To design and evaluate the feasibility of supervised face-to-face and synchronous online exercise interventions and to identify older adults' perceptions of safety, barriers and facilitators of supervised face-to-face and synchronous online physical exercise interventions for future application and transfer to the community setting.
4. To create audio-visual resources that explain how to implement safe face-to-face and synchronous online supervised physical exercise interventions in older men and women that promote adherence, based on scientific evidence, in the community setting.
Participants (N=104 community-dwelling older adults aged 60-75 years) will be randomized assigned to: 1) control, 2)supervised face to face, 3) supervised face to face plus motivation, 4) synchronous online supervised exercise or 5) synchronous online supervised exercise groups.
The control group will carry out the usual activities they have been doing, and the intervention groups will participate for 24 weeks in 3 sessions/week of multicomponent exercise intervention, being performed from home (online groups) or at a sport center, according to the assigned group. Each session will last 60 minutes and will include 10 warm-up and joint mobility exercises, 1 balance exercise, 7 strength exercises, 2 aerobic exercises, and 6 flexibility exercises.
Study assessments will be made before starting the intervention, at the end and after 24 weeks of follow-up. Primary variables will be changes in mental and physical health, assessed by the Trail Making Test, the Yesavage Geriatric Depression Scale, and lower extremity power measured by the sit-to-stand test. Secondary outcomes will include other parameters of mental and physical health, blood markers, physical activity, and cost-effectiveness analysis. We will also record the dropout rate, the attendance at the sessions, the injuries and other adverse events suffered by the participants, and technical incidences produced in the online modality.
### Conditions Module
**Conditions:**
- Physical Inactivity
- Healthy Aging
- Older Adult
**Keywords:**
- Aging
- Exercise
- Physical activity
- Supervised
- Home-based
- Multidomain training
- Multicomponent training
- Physical health
- Mental health
- Quality of life
- Physical function
- Cost-effectiveness
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 120
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Behavioral: Supervised synchronous online exercise intervention without motivational strategies
**Label:** Supervised synchronous online exercise intervention without motivational strategies
**Type:** EXPERIMENTAL
#### Arm Group 2
**Intervention Names:**
- Behavioral: Supervised synchronous online exercise intervention with motivational strategies
**Label:** Supervised synchronous online exercise intervention with motivational strategies
**Type:** EXPERIMENTAL
#### Arm Group 3
**Intervention Names:**
- Behavioral: Supervised face to face exercise intervention without motivational strategies
**Label:** Supervised face to face exercise intervention without motivational strategies
**Type:** EXPERIMENTAL
#### Arm Group 4
**Intervention Names:**
- Behavioral: Supervised face to face exercise intervention with motivational strategies
**Label:** Supervised face to face exercise intervention with motivational strategies
**Type:** EXPERIMENTAL
#### Arm Group 5
**Description:** Participants will be advised to maintain their usual lifestyle.
**Label:** Control group
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Supervised synchronous online exercise intervention without motivational strategies
**Description:** Participants will carry out an online synchronic supervised physical exercise intervention through their computer/tablet or mobile phone at home. The exercise professional will supervise the participant's execution online. The training program comprises the same exercise structure and is based on the same muscle groups and movements as the supervised face to face groups. The exercise program will be divided into 3 different levels, progressing the difficulty every 8 weeks.. Each level will contain 3 different sessions including 10 warm-up and joint mobility exercises, 1 balance exercise, 7 strength exercises, 2 aerobic exercises, and 6 flexibility exercises. This multicomponent training will be performed 3 times per week (60 min/session) for 24 weeks
**Name:** Supervised synchronous online exercise intervention without motivational strategies
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- Supervised synchronous online exercise intervention with motivational strategies
**Description:** Participants will carry out an online synchronic supervised physical exercise intervention through their computer/tablet or mobile phone at home. The exercise professional will supervise the participant's execution online and will also apply motivational strategies based on self-determination theory. The training program comprises the same exercise structure and is based on the same muscle groups and movements as the supervised face to face groups. The exercise program will be divided into 3 different levels, progressing the difficulty every 8 weeks. Each level will contain 3 different sessions including 10 warm-up and joint mobility exercises, 1 balance exercise, 7 strength exercises, 2 aerobic exercises, and 6 flexibility exercises. This multicomponent training will be performed 3 times per week (60 min/session) for 24 weeks.
**Name:** Supervised synchronous online exercise intervention with motivational strategies
**Type:** BEHAVIORAL
#### Intervention 3
**Arm Group Labels:**
- Supervised face to face exercise intervention without motivational strategies
**Description:** Participants will attend the sports facilities and perform the training in small groups, being supervised by an exercise professional. The training program comprises the same exercise structure and is based on the same muscle groups and movements as the online synchronic supervised groups, but is performed in a sports center. The exercise program will be divided into 3 different levels, progressing the difficulty every 8 weeks. Each level will contain 3 different sessions including 10 warm-up and joint mobility exercises, 1 balance exercise, 7 strength exercises, 2 aerobic exercises and 6 flexibility exercises. This multicomponent training will be performed 3 times per week (60 min/session) for 24 weeks.
**Name:** Supervised face to face exercise intervention without motivational strategies
**Type:** BEHAVIORAL
#### Intervention 4
**Arm Group Labels:**
- Supervised face to face exercise intervention with motivational strategies
**Description:** Participants will attend the sports facilities and perform the training in small groups, being supervised by an exercise professional who will also apply motivational strategies. The training program comprises the same exercise structure and is based on the same muscle groups and movements as the online synchronic supervised groups, but is performed in a sports center.
The exercise program will be divided into 3 different levels, progressing the difficulty every 8 weeks. Each level will contain 3 different sessions including 10 warm-up and joint mobility exercises, 1 balance exercise, 7 strength exercises, 2 aerobic exercises and 6 flexibility exercises. This multicomponent training will be performed 3 times per week (60 min/session) for 24 weeks.
**Name:** Supervised face to face exercise intervention with motivational strategies
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** The Trail-Making Test Part A and B will be administered. Part A is based on number sequencing, participants link numbers from 1 to 25 in ascending order. Part B focuses on alternating numbers and letters in ascending order. The completion time will be registered in seconds (the lower duration, the best performance).
**Measure:** Neuropsychological Performance
**Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48)
**Description:** The short 15-item version of the Yesavage Geriatric Depression Scale will be used. This is a questionnaire used to screen for depression in older people. This scale consists of 15 items with a yes/no answer pattern, being the minimum score 0 and the maximum 15. The cut-off point for Depression is 5 or more.
**Measure:** Depression
**Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48)
**Description:** Lower limb muscle performance will be assessed using the 30-seconds Chair Sit to Stand (30-s CST) test. The number of standing up in 30 seconds will be counted. A higher score, better performance.
**Measure:** Lower-body muscular function
**Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48)
#### Secondary Outcomes
**Description:** Grip strength will be measured with a digital hand-held dynamometer on both arms (Takei TKK5401, Tokyo, Japan).
The test was performed in both standing and sitting positions, in both cases with the arm fully extended. A higher score, better performance.
**Measure:** Upper-body muscular function
**Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48)
**Description:** Maximum gait speed will be evaluated by measuring the time used to walk 3, 4, 6 and 10 meters linear distance at maximum pace without running. Gait speed is calculated by dividing the distance into registered walking time. A higher speed (or lower registered time) better performance.
**Measure:** Maximum walking speed (3, 4, 6 and 10-m)
**Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48).
**Description:** Usual gait speed will be evaluated by measuring the time used to walk 3, 6 and 10 meters linear distance at usual pace. Gait speed is calculated by dividing the distance into registered walking time. A higher speed (or lower registered time) better performance.
**Measure:** Usual walking speed (3, 6 and 10-m)
**Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48).
**Description:** It consists of three parts: the ability to stand with feet together in side-to-side, semi-tandem, and tandem positions (balance), 4-meters walk test (speed), and 5 times sit-to-stand (muscle power). Each part is scored from 0 to 4, with a total SPPB score of 12 points, a higher score, better performance.
**Measure:** Short Physical Performance Battery (SPPB)
**Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48)
**Description:** SFT battery includes 30-second chair stand test (lower-body strength), 30-second arm curl test (upper-body strength), 6-minute walk test (aerobic endurance), Chair sit-and-reach test (lower-body flexibility), Back scratch test (upper-body flexibility) and 8-foot up-and-go test (agility and dynamic balance).
**Measure:** Senior Fitness Test (SFT)
**Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48).
**Description:** Systolic and diastolic blood pressure will be assessed in a seated position, twice, 2 minutes apart, after 5 minutes at rest, using a digital upper arm blood pressure monitor (OMRON M6, Spain). Blood pressure will be assessed at the level of the right atrium, with the participant's back supported and uncrossed legs with both feet on the floor.
**Measure:** Resting blood pressure
**Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48)
**Description:** Heart rate will be assessed in a seated position twice, 2 minutes apart, after 5 minutes at rest, units will be bpm (beats per minute), using a digital upper arm blood pressure monitor (OMRON M6, Spain).
**Measure:** Resting heart rate
**Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48)
**Description:** Height will be measured with a stadiometer (Seca 213, Hamburg, Germany). Body mass will be measured using a body composition analyzer (InBody 770, Biospace, California, USA). The participant will be barefoot and wearing as minimally clothed as possible.
Body mass index will be calculated as body mass (kg) divided by height (m) squared (kg·m-2).
**Measure:** Anthropometry
**Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48).
**Description:** Waist and hip perimeters will be measured in upright position in accordance with the ISAK guidelines with a circumference tape (Lukfin, W606PM) following the standardized protocol, as well as calf perimeter in a sitting position.
**Measure:** Body perimeters
**Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48).
**Description:** Body Composition will be measured using a body composition analyzer (InBody 770, Biospace, California, USA), following the standardized protocol. Fat mass (kg and %), fat free mass (kg and %) and skeletal muscle mass (kg and %) will be obtained.
**Measure:** Body composition
**Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48)
**Description:** The EuroQol-5D questionnaire will be used for assessing the health-related quality of live of the participants, including five dimensions and a visual analogue scale. The 5 dimensions included in the descriptive system are (1) mobility, (2) self-care, (3) usual activities, (4) pain/discomfort, and (5) anxiety/depression. Responses will be coded according to the three-level scale for each dimension. A utility value will be assigned to each combination of responses. This index provides a quantitative measure of each individual's health-related quality of life, where 0 represents the worst possible health and 1 represents the best possible health.The EQ-VAS scale consists of asking participants to indicate their current health status from 0 ("worst imaginable health status") to 100 ("best imaginable health status").
**Measure:** Health-related quality of life
**Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48)
**Description:** The Montreal Cognitive Assessment (MoCA) assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. The total possible score ranged from 0 to 30, and the highest score indicates better performance.
**Measure:** Cognitive Performance- The Montreal Cognitive Assessment
**Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48).
**Description:** The Stroop Color and Word Test (SCWT) is divided into three conditions, the first condition consists of reading color names printed in black ink, in the second condition the participant will read colors printed in an "X", and the third condition consists of naming the ink color instead of reading the word. All conditions contain 100 words, and time is limited to 45 seconds for each condition. The total number of correct words for each condition will be recorded, indicating that the higher the number of correct words, the better the performance.
**Measure:** Cognitive Performance-The Stroop Color and Word Test (SCWT)
**Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48).
**Description:** Digit Span test of the Wechsler Adult Intelligence Scale III (WAIS III). Participants will be asked to recall a list of numbers in the order given (forward or backwards). The test is finished when for the same item, the participant fails two attempts. A total number of correct answers will be registered for each condition, ranging from 0 to 30, with the highest scores being the best performance.
**Measure:** Cognitive Performance- Digit Span test of the Wechsler Adult Intelligence Scale III
**Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48).
**Description:** The test consists of drawing a clock with a given time (11:10). The total score is the sum of the scores given to dial, numbers and clock faces, ranging from 0 to 10 with the highest scores being the best performance.
**Measure:** Cognitive Performance-Clock Drawing Test (CDT).
**Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48).
**Description:** Digit Symbol Substitution Test. The participant will fill in a series of coded symbols for 90 and 120 seconds. The total number of responses as well as errors are recorded. In this test, the higher the score, the better the performance.
**Measure:** Cognitive Performance- Digit Symbol Substitution Test
**Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48).
**Description:** The Zung Anxiety Self-Assessment Scale will be used to assess anxiety symptoms. It consists of 20 items with a 4-point response scale ranging from 1 (not at all or hardly ever) to 4 (most or all of the time), obtaining a maximum score of 80. The higher the score, the higher anxiety.
**Measure:** Anxiety
**Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48)
**Description:** Physical activity and sedentary behavior will be assessed by accelerometry ((Actigraph GT3X, MTI, USA). The devices will be placed on the subject's non-dominant wrist using a watch strap for 8 days.
**Measure:** Physical activity and sedentary behavior patterns assessed by accelerometry.
**Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48).
**Description:** Physical activity and sedentary behavior will be assessed by the International Physical Activity Questionnaire-Short form (IPAQ). This questionnaire ask about the time spent on vigorous, moderate, walking and sitting activities in the last 7 days.
**Measure:** Physical activity and sedentary behavior patterns by questionnaire
**Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48).
**Description:** The number of hours of sleep will be assessed by accelerometry ((Actigraph GT3X, MTI, USA). The devices will be placed on the subject's non-dominant wrist using a watch strap for 8 days.
**Measure:** Sleep assessed by accelerometry
**Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48).
**Description:** The Pittsburgh Sleep Quality Index consists of 19 self-assessed questions and 5 partner-assessed questions. The 19 items are combined to form seven component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction), each with a range of 0 to 3 points. The total score ranges from 0 to 21, where 0 points represents no difficulties and 21 points represents severe difficulties and worse sleep quality.
**Measure:** Sleep assessed by questionnaire
**Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48).
**Description:** Blood samples will be collected in the morning after an overnight fast and at least 24 h after the last exercise session. After collection, tubes will be centrifuged at 3500 rpm for 10 min. Serum obtained for each participant will be stored in aliquots at -80 °C until analysis. Serum BDNF (ng/mL) will be quantified using a sandwich enzyme-linked immunosorbent assay (ELISA). Human BDNF Quantikine Immunoassay (R\&D Systems, Minneapolis, MN) will be performed according to the manufacturer's instructions.
**Measure:** Serum BDNF
**Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48).
**Description:** Blood samples will be collected in the morning after an overnight fast and at least 24 h after the last exercise session. After collection, tubes will be centrifuged at 3500 rpm for 10 min. Serum obtained for each participant will be stored in aliquots at -80 °C until analysis. A commercial enzyme-linked immunosorbent assay (ELISA) will be performed to measure α-klotho serum concentration (pg/ml) according to the manufacturer's protocol (Human soluble α-Klotho Assay Kit JP27998, Immuno-Biological Laboratories Co., Ltd., Gunma, Japan). The quantification will be performed spectrophotometrically using a FLUOstar OPTIMA Microplate Reader (ThermoFisher Scientific, Waltham, MA, USA) and Optima Control software version 2.20.
**Measure:** Serum α-Klotho
**Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48).
**Description:** Glucose, uric acid, urea, creatinine, bilirubin, sodium, potassium, chloride, calcium, phosphorus, total proteins, albumin, cholesterol, cholesterol-HDL, cholesterol-LDL (calculated), triglycerides, aspartate transaminase (AST), alanine transaminase (ALT), gamma-glutamyltransferase (GGT),alkaline phosphatase, lactate dehydrogenase (LDH), creatine kinase (CK,) will be measured using routinary clinical techniques.
**Measure:** Routinary blood serum analysis
**Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48).
**Description:** It consists of the analysis following parameters: red blood cell count, hemoglobin concentration, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, red cell distribution width, white blood cell count, differential white blood cell count, platelet count and mean platelet volume
**Measure:** Hemogram
**Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48).
**Description:** Motivators and barriers to exercise will be measured using the Exercise Benefits/Barriers Scale. It is a 43-item instrument with a four-response Likert-type scale; Twenty-nine items are related to the benefits, while the remaining 14 are barriers. - The total score of the instrument can range from 43 to 172 points, with higher scores indicating a more positive perception of exercise.
**Measure:** Motivators and barriers to exercise
**Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48).
**Description:** The Behavioral Regulation during Exercise Questionnaire (BREQ-3) comprises 23 items (4 for intrinsic regulation, 4 for integrated regulation, 3 for identified regulation, 4 for introjected regulation, 4 for external regulation and 4 for amotivation) that measure the stages of the self-determination theory with respect to motivation to exercise. Participants will answer each item on a 5-point scale ranging from 0 (not true for me) to 4 (very true for me). Higher scores on identified regulation, integrated regulation and intrinsic motivation are generally considered indicative of a more self-determined and healthy motivation towards exercise. On the other hand, higher scores on amotivation, external regulation and introjected regulation generally indicate less self-determined motivation.
**Measure:** Motivation to exercise according to self-determination theory
**Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48)
**Description:** The Basic Psychological Needs in Exercise Scale (BPNES) is composed of 12 items assessing the satisfaction of the three basic psychological needs in physical exercise contexts: competence, autonomy and relationship with others. A 5-point likert scale is used: (1) Do not agree at all, (2) Somewhat agree, (3) Somewhat agree, (4) Strongly agree, and (5) Strongly agree.using : (1) I don't agree at all, (2) I agree a little bit, (3) I somewhat agree, (4) I agree a lot, and (5) I completely agree. For each need, a minimum score of 4 points and a maximum of 20 points can be obtained. The score for the total questionnaire would be a minimum of 12 points and a maximum of 60 points. A higher score reflects a better satisfaction of basic psychological needs.
**Measure:** Basic Psychological Needs in Exercise
**Time Frame:** Baseline (week 0), Post-intervention (week 25) and follow-up (week 48)
**Description:** The Satisfaction with Life Scale is a 5-item instrument with a Likert-type scale ranging from 1 to 5 points, and measures overall subjective happiness through statements in which participants rate themselves. The higher the score, the higher the satisfaction with life.
**Measure:** Satisfaction with Life
**Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48)
**Description:** Age, sex, marital status, educational level, socioeconomic status, employment status, self-rated health, family history of Alzheimer, pathologies diagnosed, number of falls during the previous year, consumption of medicines, and tobacco and alcohol consumption will be determined by this questionnaire
**Measure:** Sociodemographic characteristics questionnaire
**Time Frame:** Baseline (week 0), post-intervention (week 25), and follow-up (week 48)
**Description:** A cost-effectiveness analysis will be performed to assess the expenses associated with each intervention group, utilizing the EQ-5D questionnaire to evaluate changes in health states.The analysis will focus on the following key metrics, the Quality-Adjusted Life-Year (QALY) and the Incremental Cost-Effectiveness Ratio (ICER).
The Cost-Utility analysis examines an intervention's cost-effectiveness by considering expenses and the impact on patients' quality of life. QALYs provide a comprehensive measure of both the quantity and quality of life, calculated by multiplying the utility weights assigned to each health state by the time spent in that state. The cost per QALY gained is determined by dividing the total intervention costs by the total QALYs gained.
The ICER compares the cost-effectiveness of two interventions by evaluating the difference in costs and effects (QALYs gained). A positive ICER indicates that Intervention A is more expensive and less effective than Intervention B
**Measure:** Cost-Effectiveness Analysis
**Time Frame:** Through intervention completion (24 weeks)
**Description:** Adherence to physical training program will be recorded by the trainers. It will be calculated as a percentage (\[sessions completed/total sessions expected\] x 100), where 0 % indicates total non-adherence and 100 % indicates full adherence to the exercise intervention.
**Measure:** Adherence to physical training program
**Time Frame:** Through intervention completion (week 24)
**Description:** During the 24-week follow-up, the investigators will assess through an ad-hoc self-reported questionnaire whether or not participants exercised during the follow up period (24 weeks), the exercise modality performed, if the exercise was supervised center-based and/or unsupervised/supervised home-based, the number of weekly exercise sessions performed, the average time and the subjective intensity perceived (light, moderate or vigorous).
**Measure:** Exercise during follow-up period
**Time Frame:** Follow-up (week 48)
**Description:** Participants in the supervised synchronous online exercise and control groups will record in a diary their falls and adverse events during and outside exercise sessions. In the supervised face to face groups, supervisors will register the incidence of falls during exercise sessions an participants will register them outside the exercise sessions using the diary.
**Measure:** Falls and adverse events
**Time Frame:** Through intervention completion (24 weeks)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* People from both sexes aged 60-75 years.
* Not to have diseases and disabilities that limit to be part of exercise interventions or avoid measurements.
* Not perform supervised moderate to vigorous physical activity \>30 minutes and \>3 days/week.
* To be able to communicate without problems.
* To be able to read and understand the aim of the project and informed consent form.
* To have a smartphone, tablet or computer with internet connection.
Exclusion Criteria:
* Acute or terminal illness.
* Myocardial infarction, coronary artery bypass grafting, angioplasty, angina, or other cardiac conditions in the past year.
* Uncontrolled medical problems that the general practitioner considers would preclude patients from undertaking the exercise program (e.g., acute systemic illness such as pneumonia, acute rheumatoid arthritis, and acute or unstable heart failure).
* Conditions requiring a specialized physical exercise program (e.g., uncontrolled epilepsy, significant neurological disease or impairment, inability to maintain an upright seated position or unable to move independently, multiple sclerosis, cancer, Parkinson's, Alzheimer's, or chronic obstructive pulmonary disease).
* General practitioner-diagnosed hypertension that has not been controlled.
* Uncontrolled Type I or Type II Diabetes.
* History of major psychiatric illness including schizophrenia, generalized anxiety disorder, or depression according to the DSM-5.
* Three or more self-reported falls in the last year.
* Not wanting to complete the study or be assigned to the control group;
* Be participating in another research study that may influence this project.
**Healthy Volunteers:** True
**Maximum Age:** 75 Years
**Minimum Age:** 60 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Almería
**Country:** Spain
**Facility:** Universidad de Almeria
**State:** Almeria
**Zip:** 04120
**Location 2:**
**City:** Puerto Real
**Country:** Spain
**Facility:** University of Cadiz
**State:** Cadiz
**Zip:** 11519
#### Overall Officials
**Official 1:**
**Affiliation:** University of Cadiz
**Name:** Ana Carbonell Baeza, PhD
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** Universidad de Almeria
**Name:** Pablo Jorge Marcos Pardo, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## 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: T6034
- Name: Quality of Life
- Relevance: LOW
- As Found: Unknown
### 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:** NCT06411379
**Brief Title:** Study to Evaluate the Efficacy and Safety of Subcutaneous Sonelokimab Compared With Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
**Official Title:** A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Subcutaneous Sonelokimab in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
#### Organization Study ID Info
**ID:** M1095-HS-302
#### Organization
**Class:** INDUSTRY
**Full Name:** MoonLake Immunotherapeutics AG
#### Secondary ID Infos
**Domain:** Sponsor
**ID:** VELA-2
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2026-06-17
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-13
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-08
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-06-17
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-22
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-13
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-08
**Study First Submit QC Date:** 2024-05-08
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** MoonLake Immunotherapeutics AG
#### 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 study to evaluate the clinical efficacy and safety of sonelokimab administered subcutaneously compared with placebo in the treatment of adult participants with moderate to severe hidradenitis suppurativa. Participants will be randomized 2:1 to either sonelokimab or matching placebo up to Week 16.
### Conditions Module
**Conditions:**
- Hidradenitis Suppurativa
**Keywords:**
- Hidradenitis Suppurativa
- Hidradenitis
- Sweat Gland Diseases
- Skin Diseases
- Skin Diseases, Bacterial
- Suppuration
- Anti-Inflammatory Agents
- Sonelokimab
- Nanobody
- Apocrine Gland Disease
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 400
**Type:** ESTIMATED
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Subjects randomized to this arm will receive sonelokimab from Weeks 0-48.
**Intervention Names:**
- Drug: Sonelokimab
**Label:** sonelokimab
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Subjects randomized to this arm will receive placebo from Weeks 0-16. They will receive sonelokimab from weeks 16-48
**Intervention Names:**
- Drug: Placebo
**Label:** Placebo
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- sonelokimab
**Description:** Sonelokimab
**Name:** Sonelokimab
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Placebo
**Description:** Placebo
**Name:** Placebo
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75), where HiSCR75 is defined as at least a 75% reduction from baseline in abscess and inflammatory nodule (AN) count, with no increase from baseline in abscess or draining fistula count.
**Measure:** Hidradenitis Suppurativa Clinical Response 75
**Time Frame:** Week 16
#### Secondary Outcomes
**Description:** Percentage of participants achieving HiSCR50
**Measure:** Hidradenitis Suppurativa Clinical Response 50
**Time Frame:** Week 16
**Description:** Absolute change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4)
The IHS4 score is calculated as follows: number of nodules (multiplied by 1) + number of abscesses (multiplied by 2) + number of draining tunnels (multiplied by 4). A total score of 3 or less signifies mild, 4 to 10 signifies moderate, and 11 or higher signifies severe disease.
**Measure:** Change in International Hidradenitis Suppurativa Severity Score System
**Time Frame:** Week 16
**Description:** Percentage of participants achieving a DLQI total reduction of ≥4 minimal clinically important difference among participants with a baseline DLQI ≥4
**Measure:** Dermatology Life Quality Index (DLQI)
**Time Frame:** Week 16
**Description:** Percentage of participants achieving at least ≥30% (and ≥50%) reduction and at least 2-unit reduction from Baseline in Numerical Rating Scale (NRS30 \& NRS50) in Patient's Global Assessment of Skin Pain (PGA Skin Pain) among subjects with Baseline NRS ≥3
**Measure:** Reduction from Numerical Rating Scale (NRS30 & NRS50) in Patient's Global Assessment of Skin Pain (PGA Skin Pain)
**Time Frame:** week 16
**Description:** Patient Global Impression - Severity of Illness - Hidradenitis Suppurativa at Week 16
**Measure:** Patient Global Impression - Severity of Illness - Hidradenitis Suppurativa at Week 16
**Time Frame:** Week 16
**Description:** Resolution of draining tunnels (DT100)
**Measure:** Resolution of draining tunnels (DT100)
**Time Frame:** Week 16 and Week 52
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Participants must be at least 18 years of age at the time of signing the informed consent.
2. Participants who are diagnosed with hidradenitis suppurativa as determined by the investigator and have a history of signs and symptoms of hidradenitis suppurativa for at least 6 months before signing the informed consent.
3. Participants who have had an inadequate response to appropriate systemic antibiotics for treatment of hidradenitis suppurativa (or demonstrated intolerance to, or had a contraindication to, systemic antibiotics for treatment of their HS), in the investigator's opinion.
4. Participants who have a total AN count of ≥5.
5. Participants who have HS lesions present in ≥2 distinct anatomical areas, at least one of which must contain single or multiple fistulas (ie, be Hurley Stage II or III).
Exclusion Criteria:
1. Participants with a known hypersensitivity to sonelokimab or any of its excipients.
2. Participants with any other active skin disease or condition that may, in the opinion of the investigator, interfere with the assessment of HS.
3. Participants with underlying conditions that, in the opinion of the investigator, potentially places the participant at unacceptable risk.
4. Participants with current severe or uncontrolled disease(s) that put(s) the participant at increased risk in the investigator's opinion, would preclude the participant from adhering to the protocol or completing the study per protocol.
5. Participants with any other known autoimmune disease or any medical condition that in the opinion of the investigator would interfere with an accurate assessment of clinical symptoms of HS.
6. Participants with a gastrointestinal condition including inflammatory bowel disease or diagnosis of ulcerative colitis or Crohn's disease.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Moonlake Clinical Trial Helpdesk
**Phone:** +41 41 510 8022
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** MoonLake Immunotherapeutics AG
**Name:** Prof Kristian Reich, M.D., Ph.D. (equ.)
**Role:** STUDY_DIRECTOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000013543
- Term: Sweat Gland Diseases
- ID: D000012871
- Term: Skin Diseases
- ID: D000017192
- Term: Skin Diseases, Bacterial
- ID: D000001424
- Term: Bacterial Infections
- ID: D000001423
- Term: Bacterial Infections and Mycoses
- ID: D000007239
- Term: Infections
- ID: D000012874
- Term: Skin Diseases, Infectious
- ID: D000013492
- Term: Suppuration
### Condition Browse Module - Browse Branches
- Abbrev: BC01
- Name: Infections
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
### Condition Browse Module - Browse Leaves
- ID: M16273
- Name: Suppuration
- Relevance: LOW
- As Found: Unknown
- ID: M19762
- Name: Hidradenitis Suppurativa
- Relevance: HIGH
- As Found: Hidradenitis Suppurativa
- ID: M18964
- Name: Hidradenitis
- Relevance: HIGH
- As Found: Hidradenitis
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M19500
- Name: Skin Diseases, Bacterial
- Relevance: LOW
- As Found: Unknown
- ID: M16323
- Name: Sweat Gland 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: M4722
- Name: 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: M15677
- Name: Skin Diseases, Infectious
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000017497
- Term: Hidradenitis Suppurativa
- ID: D000016575
- Term: Hidradenitis
### Intervention Browse Module - Browse Branches
- Abbrev: Infl
- Name: Anti-Inflammatory Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M4217
- Name: Anti-Inflammatory Agents
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT04365179
**Brief Title:** Study of NEROFE, a Novel Hormone-Peptide in Adult Patients With Advanced MDS and AML
**Official Title:** An Open-Label Phase 1b Study of NEROFE, a Novel Hormone-Peptide in Adult Patients With Advanced Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML)
#### Organization Study ID Info
**ID:** 20190675
#### Organization
**Class:** INDUSTRY
**Full Name:** Immune System Key Ltd
### Status Module
#### Completion Date
**Date:** 2022-12-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-07-22
**Type:** ACTUAL
**Last Update Submit Date:** 2022-07-21
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2022-12-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2020-06-18
**Type:** ACTUAL
**Status Verified Date:** 2022-07
#### Study First Post Date
**Date:** 2020-04-28
**Type:** ACTUAL
**Study First Submit Date:** 2020-04-12
**Study First Submit QC Date:** 2020-04-26
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** University of Miami Sylvester Comprehensive Cancer Center
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Immune System Key Ltd
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
### Description Module
**Brief Summary:** This is an open-label Phase 1b study of NEROFE following a traditional 3+3 design to assess safety and to determine the Recommended Phase 2 Dose (RP2D) of NEROFE in patients with MDS or AML. IV NEROFE will be administered three times per week on alternate days. The exact dosage will be determined using the body surface area (BSA) measured on Day 1 of each cycle.
**Detailed Description:** NEROFE monotherapy may be administered for a maximum of 12 cycles provided that the patient tolerates treatment and there is evidence of clinical benefit. If patients are receiving clinical benefit, they may continue past 12 cycles.
Patients will be followed for a minimum of 30 days after the last dose of NEROFE monotherapy.
After this 30 day period, patients will only be followed for the resolution of any ongoing adverse events.
### Conditions Module
**Conditions:**
- Advanced MDS
- AML
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SEQUENTIAL
**Intervention Model Description:** traditional 3+3 design
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 18
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Dose Level - Nerofe Dose
-1 - 6mg/m2
1. - 12 mg/m2
2. - 24 mg/m2
3. - 48 mg/m2
4. - 96 mg/m2
5. - 150mg/m2
**Intervention Names:**
- Drug: Nerofe
**Label:** NEROFE
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- NEROFE
**Description:** Up to 12 cycles of 28 days are planned. If patients are deriving benefit, treatment may continue past 12 cycles.
Cycle 1: During Cycle 1, assigned NEROFE doses will be administered by intravenous (IV) infusion over 1 hour on Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26.
Cycles 2-12: Subsequent cycles will be administered as above, presuming that patients do not meet criteria for study withdrawal during cycle 1.
**Name:** Nerofe
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Bone Marrow samples to measure percentage of blasts (%). Range 0-30% (the higher percentage the worse outcome)
**Measure:** Assessing change in IWG (International Working Group) Criteria to evaluate response to Nerofe Treatment for MDS patients
**Time Frame:** At Screening (Day 1), at cycle 3 (Day 1) at cycle 5 (Day 1), at cycle 7 (Day 1), at cycle 9 (Day 1) at cycle 11 (Day 1) and at End of Treatment Visit. Cycle length is 28 days. Through study completion, an average of 1 year.
**Description:** Complete Blood Count (CBC) to measure hemoglobin (g/dL). Range 4-18 (4 worse outcome and 18 best outcome)
**Measure:** Assessing change in IWG (International Working Group) Criteria to evaluate response to Nerofe Treatment for MDS patients. A calculation of several variables.
**Time Frame:** At every cycle on Day 1, Day 3, Day 8, Day 10, Day 12, D15, Day 17, Day 19, Day 22, Day 24, Day 26 and Day 28 (cycle length is 28 days), and at End of Treatment Visit, through study completion, an average of 1 year.
**Description:** Complete Blood Count (CBC) to measure absolute neutrophil count (x10\^9/L). Range 0-15 (the higher the score the better outcome).
**Measure:** Assessing change in IWG (International Working Group) Criteria to evaluate response to Nerofe Treatment for MDS patients. A calculation of several variables.
**Time Frame:** At every cycle on Day 1, Day 3, Day 8, Day 10, Day 12, D15, Day 17, Day 19, Day 22, Day 24, Day 26 and Day 28 (cycle length is 28 days), and at End of Treatment Visit, through study completion, an average of 1 year.
**Description:** Complete Blood Count (CBC) to measure platelets (x10\^9/L). Range 0-2000 (the higher the score the better outcome).
**Measure:** Assessing change in IWG (International Working Group) Criteria to evaluate response to Nerofe Treatment for MDS patients. A calculation of several variables.
**Time Frame:** At every cycle on Day 1, Day 3, Day 8, Day 10, Day 12, D15, Day 17, Day 19, Day 22, Day 24, Day 26 and Day 28 (cycle length is 28 days), and at End of Treatment Visit, through study completion, an average of 1 year.
**Description:** Complete Blood Count (CBC) to measure cytogenetic abnormalities. Range from very good (0) to very poor (4).
**Measure:** Assessing change in IWG (International Working Group) Criteria to evaluate response to Nerofe Treatment for MDS patients. A calculation of several variables.
**Time Frame:** At every cycle on Day 1, Day 3, Day 8, Day 10, Day 12, D15, Day 17, Day 19, Day 22, Day 24, Day 26 and Day 28 (cycle length is 28 days), and at End of Treatment Visit, through study completion, an average of 1 year.
**Description:** Bone Marrow samples to measure percentage of blasts (%). Range 0-30% (the higher percentage the worse outcome)
**Measure:** Assessing change in ELN 2017 (European Leukemia Net) Criteria to evaluate response to Nerofe Treatment for AML patients
**Time Frame:** At Screening (Day 1), at cycle 3 (Day 1) at cycle 5 (Day 1), at cycle 7 (Day 1), at cycle 9 (Day 1) at cycle 11 (Day 1) and at End of Treatment Visit. Cycle length is 28 days. Through study completion, an average of 1 year.
**Description:** Complete Blood Count (CBC) to measure absolute neutrophil count (x10\^9/L). Range 0-15 (the higher the score the better outcome)
**Measure:** Assessing change in ELN 2017 (European Leukemia Net) Criteria to evaluate response to Nerofe Treatment for AML patients. A calculation of several variables.
**Time Frame:** At every cycle on Day 1, Day 3, Day 8, Day 10, Day 12, D15, Day 17, Day 19, Day 22, Day 24, Day 26 and Day 28 (cycle length is 28 days), and at End of Treatment Visit, through study completion, an average of 1 year.
**Description:** Complete Blood Count (CBC) to to measure platelets (x10\^9/L). Range 0-2000 (the higher the score the better outcome).
**Measure:** Assessing change in ELN 2017 (European Leukemia Net) Criteria to evaluate response to Nerofe Treatment for AML patients. A calculation of several variables.
**Time Frame:** At every cycle on Day 1, Day 3, Day 8, Day 10, Day 12, D15, Day 17, Day 19, Day 22, Day 24, Day 26 and Day 28 (cycle length is 28 days), and at End of Treatment Visit, through study completion, an average of 1 year.
**Description:** Complete Blood Count (CBC) to measure cytogenetic abnormalities. Range from very good (0) to very poor (4).
**Measure:** Assessing change in ELN 2017 (European Leukemia Net) Criteria to evaluate response to Nerofe Treatment for AML patients. A calculation of several variables.
**Time Frame:** At every cycle on Day 1, Day 3, Day 8, Day 10, Day 12, D15, Day 17, Day 19, Day 22, Day 24, Day 26 and Day 28 (cycle length is 28 days), and at End of Treatment Visit, through study completion, an average of 1 year.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Confirmed diagnosis of one of the following:
1. Relapsed/refractory Acute Myelogenous Leukemia (AML) where no alternative life prolonging therapy exists. Adverse genetic risk treatment naïve patients may also be considered eligible if, in the opinion of the investigator, these patients are unlikely to benefit from alternative therapy (e.g., an older patient with adverse risk MDS who progresses to AML after failing treatment for MDS (i.e. hypomethylating agent (HMA) or HMA and Venetoclax and is not a candidate for traditional AML induction chemotherapy).
2. Relapsed/refractory Myelodysplastic Syndrome (MDS) those who fail to achieve a complete remission (CR) with at least 4 cycles of HMA (e.g. decitabine or azacitidine); or those who have progressive disease or have intolerance of HMA therapy after at least 2 cycles. Intolerance to HMA includes those patients forced to stop the HMA after at least 2 cycles due to severe infections/worsening cytopenias and are otherwise considered eligible. Patients with MDS have to have intermediate, high, or very high risk disease by International Prognostic Scoring System - Revised (IPSS-R score).
2. Adult male or female patients 18 years of age or older.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2.
4. Patients must satisfy the following laboratory criteria:
1. Pre-treatment bone marrow staining must demonstrate expression of the ST2 receptor by IHC (low or high expression is allowed).
2. Total bilirubin \< 1.5 x greater upper limit of normal (UNL). Elevated indirect bilirubin associated with post-transfusion hemolysis is allowed.
3. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) must be \< 3 x UNL
4. Creatinine \< 2 x UNL or calculated creatinine clearance \> 40 ml/min; or Estimated Glomerular Filtration Rate (eGFR) \<50 according to MDRD (Modification of Diet in Renal Disease) method.
5. White blood cell count (WBC) \< 25,000/uL before the administration of NEROFE on Cycle 1 Day 1. Use of hydroxyurea to control the level of circulating leukemic blast cell counts is allowed before and during the study.
5. Suitable venous access to allow for all study related blood sampling (safety and research).
6. Estimated life expectancy, in the judgment of the investigator, which will permit receipt of at least 8 weeks of treatment.
7. Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without jeopardy to future medical care.
8. Female patients who are:
1. Postmenopausal for at least one year before the screening visit, OR
2. Surgically sterile, OR
3. If they are of childbearing potential:
Agree to practice one highly effective method and one additional effective (barrier) method of contraception, at the same time, form the time of signing the informed consent through 4 months after the last does of study drug (female and male condoms should not be used together), OR Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence e.g. calendar, ovulation, symptothermal, postovulation methods; withdrawal; spermicides only; and lactational amenorrhea are not acceptable methods of contraception).
9. Male patients even if surgically sterilized (e.g. status post vasectomy), who:
1. Agree to practice effective barrier contraception during the entire study treatment period and through four months after the last dose of study drug (female and male condoms should not be used together), OR
2. Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence e.g. calendar, ovulation, symptothermal, postovulation methods; withdrawal; spermicides only; and lactational amenorrhea are not acceptable methods of contraception).
10. Able to undergo bone marrow examination at screening
Exclusion Criteria:
1. Patients with a diagnosis of acute promyelocytic leukemia (APL).
2. Screening bone marrow slide without staining for ST2 receptor. (Low or High expression by Immunohistochemistry \[IHC\] allowed on study).
3. Therapy with any investigational products, anti-neoplastic therapy, or radiotherapy within 14 days of Cycle 1 Day 1. Patients actively receiving hydroxyurea are eligible and may continue to receive this medication during treatment on this protocol.
4. Candidates for standard and/or potentially curative treatments. (A candidate is defined as a patient that is both eligible and willing to have these treatments.)
5. Major surgery within 30 days of the first dose of any study drug or a scheduled surgery during study period.
6. Grade 2 or higher diarrhea (as defined by NCI CTCAE Version 5.0) despite optimal anti-diarrheal supportive care within 7 days prior to Cycle 1 Day 1.
7. Known cardiopulmonary disease as defined by one of the following:
1. Clinically significant arrhythmia including: history of polymorphic ventricular fibrillation or torsade de pointes; atrial fibrillation \> 7 days and requiring cardioversion in the 4 weeks before screening; incompletely controlled, symptomatic atrial fibrillation. Patients with Afib are permitted to enroll if it is \< Grade 3 for a period of 6 months or greater and the rate is controlled with a stable regimen.
2. Congestive heart failure (New York Heart Association (NYHA) Class III or IV; or Class II with a recent decompensation requiring hospitalization or referral to a heart failure clinic within four weeks of screening; myocardial infarction (MI) and/or revascularization (e.g.
coronary bypass graft/stent) within 6 months of first dose of study drug.;
3. Patients with ischemic heart disease who have had acute coronary syndrome (ACS), MI\< and/or revascularization greater than 6 months before screening and who are without cardiac symptoms may enroll.
4. Moderate to severe aortic and/or mitral valve stenosis or other ongoing valvulopathy;
5. Pulmonary hypertension (symptomatic)
6. Prolonged rate corrected QT (QTc) interval \>480 msec, calculated according to institutional guidelines;
7. Known, active left ventricular ejection fraction (LVEF) \< 50% as assessed by echocardiogram or radionuclide angiography (not required at screening);
8. Known moderate to severe chronic obstructive pulmonary disease (COPD), interstitial lung disease and/or pulmonary fibrosis (e.g., requiring home O2 therapy).
8. Active and uncontrolled infection or severe infectious disease, such as severe pneumonia, meningitis, or septicemia (stable or resolving infection on antibiotics is allowed).
9. Known human immunodeficiency virus (HIV) seropositive.
10. Known Hepatitis B surface antigen seropositive (note: patients who have isolated positive hepatitis B core antibody \[e.g. in the setting of negative hepatitis B surface antigen and negative hepatitis B surface antibody\] must have an undetectable hepatitis viral load).
11. Known or suspected active hepatitis C infection. Patients with treated Hep C treated with a negative viral load are eligible.
12. Females of child bearing potential who refuse to practice two effective methods of contraception at the same time or abstain from heterosexual intercourse from the time of signing consent through four months after the last dose of study drug.
13. Males of child bearing potential who refuse to practice effective barrier methods of contraception at the same time or abstain from heterosexual intercourse from the time of signing consent through four months after the last dose of study drug.
14. Female patients who are both lactating or breastfeeding, or have a positive serum pregnancy test during the screening period or a positive urine pregnancy test on Day 1 before the first dose of study drug.
15. Female patients who intend to donate eggs (ova) during the course of this study or within four months after receiving their last dose of study drug.
16. Male patients who intend to donate sperm during the course of this study or within four months after receiving their last dose of study drug.
17. Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of study procedures.
18. Symptomatic central nervous system (CNS) involvement.
19. Diagnosed or treated for another malignancy within 2 years with evidence of residual disease.
20. Known hepatic cirrhosis or severe pre-existing hepatic impairment.
21. Patients with uncontrolled coagulopathy or bleeding disorder.
22. Use of systemic steroids (prednisone) \>10mg/day or any equivalent corticosteroids within 7 days of Cycle 1 Day 1. Patients on other immunosuppression (such as post-transplant) and also ineligible. Patients with active, uncontrolled GVHD (Graft Versus Host Disease) are also ineligible. Otherwise patients are eligible post-bone marrow transplantation.
23. Life-threatening illnesses unrelated to cancer.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Justin Watts, MD
**Phone:** 305-243-3084
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Amber Thomassen, APRN-BC
**Phone:** 305-243-7042
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Miami
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Justin M Watts, MD
- **Phone:** 305-243-3084
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Amber Thomassen, RN
- **Phone:** 305 243 7042
- **Role:** CONTACT
***Contact 3:***
- **Name:** Justin M Watts, MD
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 4:***
- **Name:** Namrata Chandhok, MD
- **Role:** SUB_INVESTIGATOR
***Contact 5:***
- **Name:** Terrance Bradley, MD
- **Role:** SUB_INVESTIGATOR
**Country:** United States
**Facility:** University of Miami Hospital and Clinics / Sylvester Comprehensive Cancer Center
**State:** Florida
**Status:** RECRUITING
**Zip:** 33136
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC15
- Name: Blood and Lymph Conditions
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M10945
- Name: Leukemia
- Relevance: LOW
- As Found: Unknown
- ID: M10955
- Name: Leukemia, Myeloid
- Relevance: LOW
- As Found: Unknown
- ID: M18127
- Name: Leukemia, Myeloid, Acute
- Relevance: LOW
- As Found: Unknown
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M14164
- Name: Preleukemia
- Relevance: LOW
- As Found: Unknown
- ID: M12145
- Name: Myelodysplastic Syndromes
- Relevance: LOW
- As Found: Unknown
- ID: T3995
- Name: Myeloid Leukemia
- Relevance: LOW
- As Found: Unknown
- ID: T182
- Name: Acute Myeloid Leukemia
- Relevance: LOW
- As Found: Unknown
- ID: T188
- Name: Acute Non Lymphoblastic Leukemia
- Relevance: LOW
- As Found: Unknown
- ID: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
- ID: T3993
- Name: Myelodysplastic Syndromes
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M9789
- Name: Hormones
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT04660279
**Acronym:** VALIDATE
**Brief Title:** Dynamic FDG PET/CT: Optimization and Validation of Data Acquisition
**Official Title:** Dynamic Wholebody FDG PET/CT - Next Generational Functional Imaging: Optimization and Validation of Data Acquisition
#### Organization Study ID Info
**ID:** AarhusUH
#### Organization
**Class:** OTHER
**Full Name:** Aarhus University Hospital
### Status Module
#### Completion Date
**Date:** 2021-12-31
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-02-22
**Type:** ACTUAL
**Last Update Submit Date:** 2022-02-21
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2021-12-31
**Type:** ACTUAL
#### Start Date
**Date:** 2020-01-01
**Type:** ACTUAL
**Status Verified Date:** 2022-02
#### Study First Post Date
**Date:** 2020-12-09
**Type:** ACTUAL
**Study First Submit Date:** 2020-08-19
**Study First Submit QC Date:** 2020-12-08
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Aarhus University Hospital
#### Responsible Party
**Investigator Affiliation:** Aarhus University Hospital
**Investigator Full Name:** André H. Dias
**Investigator Title:** Staff specialist, PhD Student
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Quantification of the metabolic rate of glucose from Dynamic Whole-Body PET examinations requires measurements of the time course of the radioactivity concentrations in arterial blood by blood sampling, and in the tissue of interest by dynamic PET. Invasive arterial blood sampling cannot be part of a standard examination, and therefore the blood samples need to be replaced by activity concentrations derived from the PET images, usually from small volumes in the descending aorta or left ventricle.
Newly developed scanner software (Siemens) allows automated CT-based identification of blood pool regions and extraction of an image-derived blood input function from the corresponding PET data.
However, this automated method needs validation, as it could be prone to systematic errors caused by limited spatial resolution, patient movement, and image reconstruction. We will use invasively measured arterial blood samples as a reference for validation of methods to extract non-invasive PET image-derived input functions and quantify any systematic errors that could propagate to the resulting parametric images.
### Conditions Module
**Conditions:**
- Positron-Emission Tomography
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** DIAGNOSTIC
#### Enrollment Info
**Count:** 20
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** D-WB PET/CT scans + arterial blood sampling.
**Intervention Names:**
- Diagnostic Test: Dynamic Whole-Body parametric PET/CT
**Label:** Validate
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Validate
**Description:** Dynamic whole-body PET/CT imaging protocol
**Name:** Dynamic Whole-Body parametric PET/CT
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** We will perform a correlation of the image derived input function and the input function obtained from blood sampling. This will allow us to confirm that the information obtained by the equipment is accurate enough and can be trusted.
**Measure:** Validation of current parametric reconstruction protocol
**Time Frame:** through study completion, an average of 1 year
**Description:** After we have validated the image derived input function we will use the data we sampled to construct a "normal population" input function that can be applied to the current protocol. This way we will be able to skip the acquisition on the camera of the input function and be able to only scan the patients at a later period, therefor shortening the acquisition protocol to something more manageable in daily clinic.
**Measure:** Time reduction of current parametric reconstruction protocol
**Time Frame:** through study completion, an average of 1 year
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients with a planned clinical standard PET/CT as part of pre-therapeutic staging, response assessment scanning.
* Good performance status, which will allow us to obtain informed consent to draw the required arterial blood samples during the examination, and which will permit patients to lay still in the scanner for at least 70 min.
Exclusion Criteria:
* • Age \< 18 or \> 85 years
* Patients that can not tolerate a PET scan (f.ex: claustrophobia).
**Healthy Volunteers:** True
**Maximum Age:** 85 Years
**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
## Derived Section
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT00766779
**Brief Title:** HCT Versus CT in Elderly AML
**Official Title:** Randomized Phase III Study Comparing Conventional Chemotherapy to Low Dose Total Body Irradiation-Based Conditioning and HCT From Related and Unrelated Donors as Consolidation Therapy for Older Patients With AML in 1st Complete Remission
#### Organization Study ID Info
**ID:** 2007-003514-34
#### Organization
**Class:** NETWORK
**Full Name:** European Society for Blood and Marrow Transplantation
#### Secondary ID Infos
**ID:** EBMT-ALWP01/2008
### Status Module
#### Completion Date
**Date:** 2020-12
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-10-14
**Type:** ACTUAL
**Last Update Submit Date:** 2021-10-06
**Overall Status:** TERMINATED
#### Primary Completion Date
**Date:** 2020-12
**Type:** ACTUAL
#### Start Date
**Date:** 2010-01
**Status Verified Date:** 2021-10
#### Study First Post Date
**Date:** 2008-10-06
**Type:** ESTIMATED
**Study First Submit Date:** 2008-10-03
**Study First Submit QC Date:** 2008-10-03
**Why Stopped:** Recommendation of DMC
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Acute Leukemia French Association
**Class:** OTHER
**Name:** Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias
**Class:** NETWORK
**Name:** European Organisation for Research and Treatment of Cancer - EORTC
**Class:** OTHER
**Name:** French Innovative Leukemia Organisation
**Class:** OTHER
**Name:** HOVON - Dutch Haemato-Oncology Association
**Class:** UNKNOWN
**Name:** East German Study Group of Hematology and Oncology (OSHO)
**Class:** OTHER
**Name:** Swiss Group for Clinical Cancer Research
#### Lead Sponsor
**Class:** NETWORK
**Name:** European Society for Blood and Marrow Transplantation
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** A study comparing conventional chemotherapy to low dose total body irradiation-based conditioning and hematopoietic cell transplantation from related and unrelated donors as consolidation therapy for older Patients with AML in first Complete Remission.
**Detailed Description:** The majority of patients with acute myelogenous leukaemia (AML) enter complete remission following induction therapy, but relapse despite consolidation and maintenance therapy. In response, post-remission treatment has been progressively intensified and results improved either by high-dose post-remission therapy with autologous hematopoietic cell transplantation (HCT) or by allogeneic HCT, which has the highest curative potential for patients with AML. Given the toxicity of dose intensification and of allogeneic HCT, however, only younger patients profit from this treatment approach
### Conditions Module
**Conditions:**
- Acute Myeloid Leukemia
**Keywords:**
- hematopoietic cell transplantation
- Acute Myeloid Leukemia
- first Complete Remission
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 126
**Type:** ACTUAL
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Hematopoietic cell transplantation after Reduced Intensity Conditioning
**Intervention Names:**
- Procedure: hematopoietic cell transplantation
**Label:** Transplant Arm
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The non-transplant treatment approach for consolidation
**Intervention Names:**
- Drug: Non-Transplant treatment approach for consolidation
**Label:** Conventional Chemotherapy
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Transplant Arm
**Description:** low dose total body irradiation-based conditioning and hematopoietic cell transplantation from related and unrelated donors
**Name:** hematopoietic cell transplantation
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- Conventional Chemotherapy
**Description:** Patients will receive the treatment that would be otherwise applied at the local institution. The consolidation or maintenance therapy is according to the study group protocol.
**Name:** Non-Transplant treatment approach for consolidation
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Measure:** To evaluate Leukaemia Free Survival (LFS) after allo HCT in AML/RAEB in complete remission using matched or unrelated donors in comparison to conventional chemotherapy
**Time Frame:** 5 years
#### Secondary Outcomes
**Measure:** To evaluate overall survival, relapse, Treatment Related Mortality (TRM) and complications after HCT
**Time Frame:** 5 Years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age ≥ 60years and ≤ 75 years
* primary or secondary AML as defined by WHO or refractory anemia with excess of blasts (RAEB)
* First complete remission following one or two cycles of induction chemotherapy
* Chemotherapy was administered according to current participating cooperative group protocols
* Karnofsky score ≥ 70
* Written informed consent
Exclusion Criteria:
* AML FAB M3
* HIV positivity
* Participation in another clinical trial without prior consent of the coordinating investigator, patients may exceptionally take part in a further study only if
* The second study exclusively concerns induction therapy
* Consolidation cycle one and two are given according to the accredited study group policy
* No investigational drugs are used post registration for the HCT vs CT in eldery AML study.
* Documentation for the HCT vs CT in eldery AML study is not compromised. Second hand data from foreign study is not accepted
**Maximum Age:** 75 Years
**Minimum Age:** 60 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Melbourne Victoria
**Country:** Australia
**Facility:** The Alfred Hospital
**Location 2:**
**City:** Wien
**Country:** Austria
**Facility:** Hanusch Krankenhaus der Wiener Gebietskrankenkasse
**Location 3:**
**City:** Wien
**Country:** Austria
**Facility:** Medizinische Universität Wien
**Location 4:**
**City:** Antwerpen
**Country:** Belgium
**Facility:** ZNA Stuivenberg - Ziekenhuis Netwerk Antwerpen
**Location 5:**
**City:** Leuven
**Country:** Belgium
**Facility:** UZ Gasthuisberg Leuven
**Location 6:**
**City:** Amiens cedex 1
**Country:** France
**Facility:** Centre Hospitalier Sud Amiens
**Location 7:**
**City:** Caen Cedex 9
**Country:** France
**Facility:** Hopital Femme Enfant Hématologie
**Location 8:**
**City:** Clamart
**Country:** France
**Facility:** Hôpital d'instruction des armées Percy
**Location 9:**
**City:** Clermont-Ferrand
**Country:** France
**Facility:** Centre hospitalier et universitaire (CHU) d´ Estaing
**Location 10:**
**City:** Limoges cedex
**Country:** France
**Facility:** Centre hospitalier et universitaire (CHU) de Limoges
**Location 11:**
**City:** Marseille cedex 9
**Country:** France
**Facility:** Institut Paoli-Calmettes
**Location 12:**
**City:** Nantes cedex 01
**Country:** France
**Facility:** CHU de Nantes, Hôtel Dieu
**Location 13:**
**City:** Nice cedex 2
**Country:** France
**Facility:** Centre Antoine Lacassagne
**Location 14:**
**City:** Nice
**Country:** France
**Facility:** Centre hospitalier et universitaire (CHU) de Nice
**Location 15:**
**City:** Paris 12ème
**Country:** France
**Facility:** Hopital Saint Antoine
**Location 16:**
**City:** Pessac
**Country:** France
**Facility:** CHU du Haut Lévêque
**Location 17:**
**City:** Saint Quentin cedex
**Country:** France
**Facility:** Centre Hospitalier (CH) Saint Quentin
**Location 18:**
**City:** Aachen
**Country:** Germany
**Facility:** University Aachen
**Location 19:**
**City:** Augsburg
**Country:** Germany
**Facility:** II. Medizinische Klinik, Hämatologie/Internistische Onkologie
**Location 20:**
**City:** Berlin
**Country:** Germany
**Facility:** Charité - Campus Benjamin Franklin
**Location 21:**
**City:** Chemnitz
**Country:** Germany
**Facility:** Klinikum Chemnitz gGmbH
**Location 22:**
**City:** Dresden
**Country:** Germany
**Facility:** Universitaetsklinikum Dresden
**Location 23:**
**City:** Greifswald
**Country:** Germany
**Facility:** Klinik für Innere Medizin C
**Location 24:**
**City:** Heidelberg
**Country:** Germany
**Facility:** University of Heidelberg
**Location 25:**
**City:** Jena
**Country:** Germany
**Facility:** Friedrich-Schiller-Universität Jena
**Location 26:**
**City:** Leipzig
**Country:** Germany
**Facility:** University Hospital
**Zip:** 04103
**Location 27:**
**City:** Magdeburg
**Country:** Germany
**Facility:** Universitätsklinikum Magdeburg AöR / Otto-von-Guericke Universität
**Location 28:**
**City:** Münster
**Country:** Germany
**Facility:** University of Münster
**Location 29:**
**City:** Potsdam
**Country:** Germany
**Facility:** Klinikum Ernst von Bergmann gGmbH
**Location 30:**
**City:** Regensburg
**Country:** Germany
**Facility:** University Regensburg
**Location 31:**
**City:** Rostock
**Country:** Germany
**Facility:** Universität Rostock
**Location 32:**
**City:** Stuttgart
**Country:** Germany
**Facility:** Robert-Bosch-Krankenhaus
**Location 33:**
**City:** Tübingen
**Country:** Germany
**Facility:** Universität Tübingen
**Location 34:**
**City:** Würzburg
**Country:** Germany
**Facility:** Allogeneic Stem Cell Transplant Cente
**Location 35:**
**City:** Amsterdam
**Country:** Netherlands
**Facility:** Academisch Ziekenhuis bij de Universiteit Amsterdam
**Location 36:**
**City:** Amsterdam
**Country:** Netherlands
**Facility:** VU University Medical Center Amsterdam
**Location 37:**
**City:** Groningen
**Country:** Netherlands
**Facility:** University Medical Centre Groningen
**Location 38:**
**City:** Maastricht
**Country:** Netherlands
**Facility:** University Hospital Maastricht
**Location 39:**
**City:** Rotterdam
**Country:** Netherlands
**Facility:** Erasmus MC-Daniel den Hoed Cancer Centre
**Zip:** 3008
**Location 40:**
**City:** Utrecht
**Country:** Netherlands
**Facility:** University Medical Centre Utrecht
**Location 41:**
**City:** Zwolle
**Country:** Netherlands
**Facility:** Isala klinieken
**Location 42:**
**City:** Aarau
**Country:** Switzerland
**Facility:** Kantonsspital Aarau
**Location 43:**
**City:** Basel
**Country:** Switzerland
**Facility:** University Hospital
**Zip:** 4031
**Location 44:**
**City:** Bern
**Country:** Switzerland
**Facility:** Inselspital Bern
**Location 45:**
**City:** Geneve
**Country:** Switzerland
**Facility:** Hopitaux Universitaires de Geneve
**Zip:** 1211
**Location 46:**
**City:** Lausanne
**Country:** Switzerland
**Facility:** CHUV Lausanne
**Location 47:**
**City:** Luzern 16
**Country:** Switzerland
**Facility:** Kantonsspital Luzern
**Location 48:**
**City:** Zürich
**Country:** Switzerland
**Facility:** University Hospital Zürich
#### Overall Officials
**Official 1:**
**Affiliation:** EBMT and OSHO
**Name:** Dietger Niederwieser, Prof
**Role:** STUDY_CHAIR
**Official 2:**
**Affiliation:** Stichting Hemato-Oncologie voor Volwassenen Nederland
**Name:** Bob Löwenberg, Prof
**Role:** STUDY_CHAIR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007938
- Term: Leukemia
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000009369
- Term: Neoplasms
- 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
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M10945
- Name: Leukemia
- Relevance: LOW
- As Found: Unknown
- ID: M10955
- Name: Leukemia, Myeloid
- Relevance: HIGH
- As Found: Myeloid Leukemia
- ID: M18127
- Name: Leukemia, Myeloid, Acute
- Relevance: HIGH
- As Found: Acute Myeloid Leukemia
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
- ID: M9490
- Name: Hematologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T3995
- Name: Myeloid Leukemia
- Relevance: HIGH
- As Found: Myeloid Leukemia
- ID: T182
- Name: Acute Myeloid Leukemia
- Relevance: HIGH
- As Found: Acute Myeloid Leukemia
- ID: T188
- Name: Acute Non Lymphoblastic Leukemia
- Relevance: HIGH
- As Found: Acute Myeloid Leukemia
- ID: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000007951
- Term: Leukemia, Myeloid
- ID: D000015470
- Term: Leukemia, Myeloid, Acute
### Misc Info Module
#### Removed Countries
- Country: Italy
- Country: Spain
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT00002379
**Brief Title:** The Safety and Effectiveness of Adefovir Dipivoxil Plus Indinavir Combined With Zidovudine or Lamivudine or Stavudine in HIV-Infected Patients Who Have Not Taken Anti-HIV Drugs
**Official Title:** A Phase II, Stratified, Randomized, Open-Label, Multi-Center Study of the Safety and Efficacy of Adefovir Dipivoxil and Indinavir in Combination With Zidovudine, Lamivudine, or Stavudine for the Treatment of Therapy Naive HIV-Infected Patients With CD4 Cell Counts >= 100 Cells/mm3 and HIV-1 RNA Copy Numbers >= 5,000 Copies/Ml
#### Organization Study ID Info
**ID:** 232D
#### Organization
**Class:** INDUSTRY
**Full Name:** NIH AIDS Clinical Trials Information Service
### Status Module
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2005-06-24
**Type:** ESTIMATED
**Last Update Submit Date:** 2005-06-23
**Overall Status:** COMPLETED
**Status Verified Date:** 1998-10
#### 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:** INDUSTRY
**Name:** Gilead Sciences
### Description Module
**Brief Summary:** To evaluate the safety and tolerance of adefovir dipivoxil and indinavir administered orally in combination with zidovudine, lamivudine, or stavudine in HIV-infected patients with CD4 cell counts \>= 100 cells/mm3 and an HIV-1 RNA baseline copy number \>= 5000 copies/ml. To determine the proportion of patients whose plasma HIV-1 RNA level falls below the level of detection (500 copies/ml) by 20 weeks of study therapy and the average reduction in HIV-1 RNA from baseline through study week 20. To evaluate the durability of the antiviral response through 48 weeks of study in patients who continue on study therapy after week 24.
**Detailed Description:** This protocol is a stratified, randomized, open-label study of the safety and efficacy of adefovir dipivoxil with indinavir as quadruple therapy in combination with zidovudine and lamivudine, or as triple combination administered with either zidovudine or lamivudine or stavudine for 48 weeks in the treatment of HIV-infected patients with CD4 cell counts \>= 100/mm3 and an HIV-1 RNA baseline copy number \>= 5000 copies/ml. Patients will be randomized to adefovir dipivoxil, indinavir, zidovudine, and lamivudine or adefovir dipivoxil, indinavir, and a nucleoside inhibitor (randomly assigned to receive zidovudine, lamivudine, or stavudine) or to indinavir, zidovudine, and lamivudine. Additionally, a daily dose of L-carnitine will be administered to all patients randomized to an arm containing adefovir dipivoxil.
### Conditions Module
**Conditions:**
- HIV Infections
**Keywords:**
- HIV-1
- Drug Therapy, Combination
- Administration, Oral
- Acquired Immunodeficiency Syndrome
- Zidovudine
- Stavudine
- HIV Protease Inhibitors
- CD4 Lymphocyte Count
- Lamivudine
- Indinavir
- RNA, Viral
- Adenine
- Anti-HIV Agents
- Viral Load
### Design Module
#### Design Info
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 100
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
### Interventions
#### Intervention 1
**Name:** Indinavir sulfate
**Type:** DRUG
#### Intervention 2
**Name:** Levocarnitine
**Type:** DRUG
#### Intervention 3
**Name:** Adefovir dipivoxil
**Type:** DRUG
#### Intervention 4
**Name:** Lamivudine
**Type:** DRUG
#### Intervention 5
**Name:** Stavudine
**Type:** DRUG
#### Intervention 6
**Name:** Zidovudine
**Type:** DRUG
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria
Patients must have:
* Laboratory diagnosis of HIV infection (positive HIV antibody test confirmed by Western blot, p24 antigen assay, HIV-1 RNA, or HIV-1 culture).
* An HIV-1 RNA plasma titer \>= 5000 copies/ml within 14-21 days prior to the baseline visit.
* CD4 cell count \>= 100 cells/mm3 within 14-21 days prior to the baseline visit.
* A minimum life expectancy of at least 1 year.
* Signed, informed consent from parent or legal guardian for those patients \< 18 years of age.
Exclusion Criteria
Co-existing Condition:
Patients with any of the following symptoms and conditions are excluded:
* Active, serious infections (other than HIV infection) requiring parenteral antibiotic or antiviral therapy. Patients will be considered recovered from such infectious episodes if at least 2 weeks elapsed following the cessation of parenteral therapy before the baseline visit.
* Exhibiting evidence of a gastrointestinal malabsorption syndrome or chronic nausea or vomiting which may confer an inability to receive an orally administered medication.
* Malignancy other than cutaneous Kaposi's sarcoma (KS) or basal cell carcinoma. Patients with biopsy-confirmed cutaneous KS are eligible, but must not have received any systemic therapy for KS within 4 weeks prior to baseline and are not anticipated to require systemic therapy during the study.
* Any other clinical condition that in the opinion of the investigator would make the patient unsuitable for study or unable to comply with the dosing requirements.
Patients with any of the following prior conditions are excluded:
* A new AIDS-defining event diagnosed within 1 month prior to baseline.
* Any patient who has previously been discontinued from zidovudine, lamivudine, and/or stavudine due to a drug-related toxicity.
* Significant history of peripheral neuropathy.
1. Treatment with immunomodulating agents such as systemic corticosteroids, IL-2, or interferons.
* Saquinavir, ritonavir, nelfinavir, nevirapine, delavirdine, didanosine, dideoxycytidine, interferon alpha, interferon beta, isoniazid, rifampin, investigational agents (except upon Sponsor approval), chemotherapeutic agents (systemic), terfenadine, astemizole, cisapride, triazolam, and midazolam.
1. Prior use of adefovir dipivoxil.
* Prior non-protease antiretroviral therapy (other than antiretroviral vaccines) for greater than 4 cumulative weeks.
* Prior use of any antiretroviral protease inhibitor.
* Immunizations within 30 days of baseline.
* Antiretroviral vaccine therapy within 60 days of baseline.
* Treatment in the 4 weeks prior to baseline, with immunomodulating agents such as systemic corticosteroids, IL-2, or interferons.
* Any other investigational drug within 30 days prior to baseline.
* Any prior therapy that, in the opinion of the investigator, would make the patient unsuitable for study or unable to comply with the dosing requirements.
Patients with current alcohol or substance abuse judged by the investigator to potentially interfere with patient compliance.
**Minimum Age:** 16 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Phoenix
**Country:** United States
**Facility:** Phoenix Body Positive
**State:** Arizona
**Zip:** 85016
**Location 2:**
**City:** Los Angeles
**Country:** United States
**Facility:** AIDS Healthcare Foundation Labs
**State:** California
**Zip:** 90027
**Location 3:**
**City:** San Francisco
**Country:** United States
**Facility:** Davies Med Ctr
**State:** California
**Zip:** 94114
**Location 4:**
**City:** Greenwich
**Country:** United States
**Facility:** Blick Med Associates
**State:** Connecticut
**Zip:** 06830
**Location 5:**
**City:** Washington
**Country:** United States
**Facility:** George Washington Med Ctr
**State:** District of Columbia
**Zip:** 20037
**Location 6:**
**City:** Chicago
**Country:** United States
**Facility:** Cook County Gen Hosp / Division of Infect Diseases
**State:** Illinois
**Zip:** 60612
**Location 7:**
**City:** Baltimore
**Country:** United States
**Facility:** Johns Hopkins Univ School of Medicine
**State:** Maryland
**Zip:** 21287
**Location 8:**
**City:** Brookline
**Country:** United States
**Facility:** Community Research Initiative
**State:** Massachusetts
**Zip:** 02445
**Location 9:**
**City:** New York
**Country:** United States
**Facility:** Community Research Initiative on AIDS
**State:** New York
**Zip:** 10001
**Location 10:**
**City:** New York
**Country:** United States
**Facility:** Saint Vincent's AIDS Ctr
**State:** New York
**Zip:** 10011
**Location 11:**
**City:** Hershey
**Country:** United States
**Facility:** Hershey Med Ctr / Dept of Hematology
**State:** Pennsylvania
**Zip:** 17033
**Location 12:**
**City:** Pawtucket
**Country:** United States
**Facility:** Mem Hosp of Rhode Island
**State:** Rhode Island
**Zip:** 02860
**Location 13:**
**City:** Dallas
**Country:** United States
**Facility:** Univ of Texas Southwestern Med Ctr of Dallas
**State:** Texas
**Zip:** 75235
**Location 14:**
**City:** Seattle
**Country:** United States
**Facility:** Swedish Med Ctr
**State:** Washington
**Zip:** 98122
**Location 15:**
**City:** Ponce
**Country:** Puerto Rico
**Facility:** Hosp Regional de Ponce - Area Vieja
**Zip:** 00731
## 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: M16355
- Name: Syndrome
- 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: M10199
- Name: Immunologic Deficiency Syndromes
- 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: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000015658
- Term: HIV Infections
### Intervention Browse Module - Ancestors
- ID: D000018894
- Term: Reverse Transcriptase Inhibitors
- ID: D000019384
- Term: Nucleic Acid Synthesis Inhibitors
- ID: D000004791
- Term: Enzyme Inhibitors
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000000998
- Term: Antiviral Agents
- ID: D000000890
- Term: Anti-Infective Agents
- ID: D000019380
- Term: Anti-HIV Agents
- ID: D000044966
- Term: Anti-Retroviral Agents
- ID: D000000963
- Term: Antimetabolites
- ID: D000017320
- Term: HIV Protease Inhibitors
- ID: D000084762
- Term: Viral Protease Inhibitors
- ID: D000011480
- Term: Protease Inhibitors
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M21243
- Name: Lamivudine
- Relevance: HIGH
- As Found: Plane
- ID: M19609
- Name: HIV Protease Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M14343
- Name: Protease Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M17920
- Name: Zidovudine
- Relevance: HIGH
- As Found: Intraoperative
- ID: M219518
- Name: Adefovir
- Relevance: HIGH
- As Found: IV bolus
- ID: M341402
- Name: Adefovir dipivoxil
- Relevance: HIGH
- As Found: Vincristine sulfate
- ID: M21350
- Name: Anti-HIV Agents
- Relevance: LOW
- As Found: Unknown
- ID: M20272
- Name: Stavudine
- Relevance: HIGH
- As Found: 007
- ID: M21424
- Name: Indinavir
- Relevance: HIGH
- As Found: Hydromorphone
- ID: M20935
- Name: Reverse Transcriptase Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M7951
- Name: Enzyme Inhibitors
- 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
- ID: M25428
- Name: Anti-Retroviral Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4281
- Name: Antimetabolites
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000019259
- Term: Lamivudine
- ID: D000015215
- Term: Zidovudine
- ID: D000018119
- Term: Stavudine
- ID: C000053001
- Term: Adefovir
- ID: C000106812
- Term: Adefovir dipivoxil
- ID: D000019469
- Term: Indinavir
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT00154479
**Brief Title:** The Correlation Between the Haplotype of Human Leukocyte Antigen (HLA) and Human Papillomavirus
#### Organization Study ID Info
**ID:** 9261701235
#### Organization
**Class:** OTHER
**Full Name:** National Taiwan University Hospital
### Status Module
#### Completion Date
**Date:** 2008-12
#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2006-12-14
**Type:** ESTIMATED
**Last Update Submit Date:** 2006-12-13
**Overall Status:** UNKNOWN
#### Start Date
**Date:** 2003-10
**Status Verified Date:** 2003-10
#### Study First Post Date
**Date:** 2005-09-12
**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:** National Taiwan University Hospital
### Description Module
**Brief Summary:** Cervical cancer is the most frequent neoplasm of women in Taiwan and in the world. It influences about 2,700 women with about 1,000 women dying of cervical cancer each year and in Taiwan. Human papillomaviruses (HPV) have been consistently implicated in causing cervical cancer especially those high-risk types which have been strongly associated with cervical cancer. In recent years, there has been compelling evidence that infection with human papillomavirus (HPV) is a major etiologic factor in the development of cervical intraepithelial neoplasia (CIN) and cervical carcinoma.
As in most virus-induced diseases, an adequate immune response is likely to play a key role in the clearance of HPV infections and HPV-related lesions. This assumption is born out by both epidemiological studies and animal models. Immune-compromised patients such as HIV-infected women, organ transplant recipients, and patients suffering from other forms of malignancies, are at a higher risk of developing CIN lesions and invasive cervical cancer. Moreover, several studies establish the existence of natural HPV E7-specific cytotoxic T lymphocyte (CTL) immunity in humans. Only a minority of women infected with oncogenic HPV types develop CIN or cervical cancer. Indeed, the majority of CIN lesions do not progress or even regress to normal cytology, indicating that other factors such as an inadequate immune function are necessary for the development of progressive CIN lesions and cervical carcinoma.
Consequently, the HLA class I and II phenotypes may be correlated with an effective immune response against HPV-associated cervical lesions. Differences in the recognition of foreign antigens, such as those contributed by alleles at the HLA class I or II loci, might be proposed to affect the risk of developing cervical cancer.
In the present proposal, the investigators would like to examine the HLA class I and II associations among Taiwanese women with cervical neoplasia. The purposes of this proposal are:
1. to address the relationships between the HLA class I and II haplotype, HPV infection, and cervical cancer; and
2. to elucidate the immunologic responses to HPV type 16 in different HLA class I and II haplotypes. It will help the investigators to identify which population of HLA genotypes is more susceptible to HPV infection and progresses to invasive cervical cancer. The results of this research will be very useful for the prevention and screening of cervical cancer in the future.
**Detailed Description:** 1. To survey the incidence of HPV infection in CIN and cervical cancer patients.
Using epidemiologic data drawn from a wide range of countries and population groups, investigators have found evidence of HPV in 90% to 95% of cervical cancers. The incidence of HPV in cervical cancer was 79% in our own report. Besides, 91% of high-grade CIN cases and 50% of low-grade CIN cases could be attributed to HPV infection in Taiwanese women. Because these reports for Taiwanese women were published around 10 years ago, it is important to survey and update the incidence of HPV in CIN and cervical cancer patients in Taiwanese women. We will survey the incidence of HPV infection in 500 cervical cancer patients, 100 patients of CIN and 100 normal population patients.
2. To survey the human leukocyte antigen haplotype in CIN and cervical cancer patients.
HLA class I and II alleles have been reported to associate with the nasopharyngeal carcinoma in Taiwan. Besides, human leukocyte antigen class I and II alleles might interplay in the response to interferon-alpha treatment in Taiwanese patients with chronic hepatitis C virus infection. We will detect the HLA class I and II haplotype first and then correlate them with the CIN and cervical cancer patients.
3. To identify the correlation between HLA class I and II haplotype and HPV infection and CIN and cervical cancer.
We will further survey the correlation between HLA class I and II and the genotypes of HPV in CIN and cervical cancer patients. We will identify which HLA class I and II haplotypes have positive or negative correlation with HPV infection, CIN and cervical cancer. Then we would determine which specific HLA antigens are important in determining the risk of HPV infection, CIN and cervical cancer.
4. To elucidate the immunologic responses to HPV type 16 in HLA2 with different II haplotypes and the role of immunogenetics in the carcinogenesis of cervical cancer.
HPV type 16 has been identified to be the highest incidence of malignant HPV genotypes in cervical cancer. Our laboratory has set up immunologic assays for evaluating the immune responses to HPV type 16. We will survey the immune response to HPV type 16 in those HLA class I and II haplotypes which have positive or negative correlation with the HPV infection and cervical cancer. We would identify which population of HLA genotype are more susceptible to HPV infection and invasive cervical cancer and elucidate the role of immunogenetics in the HPV infection and carcinogenesis of cervical cancer.
### Conditions Module
**Conditions:**
- Cancer of Cervix
**Keywords:**
- Cervical cancer
- Human papillomavirus
- Human leukocyte antigen
- immunologic response
- healthy volunteers
### Design Module
#### Design Info
**Observational Model:** DEFINED_POPULATION
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 700
**Study Type:** OBSERVATIONAL
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Using epidemiologic data drawn from a wide range of countries and population groups, investigators have found evidence of HPV in 90% to 95% of cervical cancers. The incidence of HPV in cervical cancer was 79% in our own report. Besides, 91% of high-grade CIN cases and 50% of low-grade CIN cases could be attributed to HPV infection in Taiwanese women. Because these reports for Taiwanese women were published around 10 years ago. It is important to survey and update the incidence of HPV in CIN and cervical cancer patients in Taiwanese women. We will survey the incidence of HPV infection in 500 cervical cancer patients, 100 patients of CIN and 100 normal population patients.
**Healthy Volunteers:** True
**Maximum Age:** 80 Years
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Wen-Fang Cheng, MD, PhD
**Phone:** 886-2-2312-3456
**Phone Ext:** 5166
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Taipei
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Wen-Fang Cheng, MD, PhD
- **Phone:** 886-2-2312-3456
- **Phone Ext:** 5166
- **Role:** CONTACT
***Contact 2:***
- **Name:** Wen-Fang Cheng, MD, PhD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Taiwan
**Facility:** Wen-Fang Cheng
**Status:** RECRUITING
#### Overall Officials
**Official 1:**
**Affiliation:** National Taiwan University Hospital
**Name:** Wen-Fang Cheng, MD, PhD
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000014594
- Term: Uterine Neoplasms
- ID: D000005833
- Term: Genital Neoplasms, Female
- ID: D000014565
- Term: Urogenital Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000002577
- Term: Uterine Cervical Diseases
- ID: D000014591
- Term: Uterine 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: D000091662
- Term: Genital 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: M5830
- Name: Uterine Cervical Neoplasms
- Relevance: HIGH
- As Found: Cancer of Cervix
- ID: M17342
- Name: Uterine Neoplasms
- 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: M5825
- Name: Uterine Cervical Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17339
- Name: Uterine 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
### Condition Browse Module - Meshes
- ID: D000002583
- Term: Uterine Cervical Neoplasms
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT02970279
**Brief Title:** Reducing Stasis Outcomes for Depression in Group Behavioural Activation Therapy
**Official Title:** Effect of Treatment Augmentations Embedded in Behavioural Activation Group Therapy on Reducing Drop-out and Stasis Rates in Depression
#### Organization Study ID Info
**ID:** Protocol Version 3.0
#### Organization
**Class:** OTHER
**Full Name:** University of Sheffield
### Status Module
#### Completion Date
**Date:** 2017-12
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2018-05-04
**Type:** ACTUAL
**Last Update Submit Date:** 2018-05-01
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2017-12
**Type:** ACTUAL
#### Start Date
**Date:** 2016-12
**Status Verified Date:** 2018-05
#### Study First Post Date
**Date:** 2016-11-21
**Type:** ESTIMATED
**Study First Submit Date:** 2016-11-11
**Study First Submit QC Date:** 2016-11-17
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** Sheffield Health and Social Care NHS Foundation Trust
**Class:** UNKNOWN
**Name:** Howard Morton Trust
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Sheffield
#### Responsible Party
**Investigator Affiliation:** University of Sheffield
**Investigator Full Name:** Melanie Simmonds-Buckley
**Investigator Title:** PhD Research Student
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Depression is one of the most common mental health disorders and it is estimated up to 50% of patients do not respond to evidenced-based psychotherapy treatment, recording a 'stasis' outcome. However, there is limited research understanding this population, meaning a considerable number of people continue to suffer. The purpose of this study is to 1) identify depression stasis prevalence and predictors in an existing evidenced-based group treatment for depression, 2) run a clinical trial to test whether an embedded intervention based on theoretical and clinical practice evidence can help reduce patient depression stasis and drop-out rates and 3) understand what aspect of therapy produces change (or prevents change in stasis). The study will be based on behavioural activation (BA) therapy delivered in an eight-session group format in an Improving Access to Psychological Therapies (IAPT) service in the United Kingdom. BA is one of the most effective psychotherapies available for depression and focuses on helping patients to increase their engagement with valued activities to help break out of the cycle of depression. Firstly, an archived anonymised dataset of routine depression measures from patients who have previously received the existing group BA treatment will be analysed. Secondly, the group BA treatment delivered to patients in 2017 will be enhanced with two treatment augmentations. One augmentation will target stasis outcomes through the addition of specific 'if-then' planning (known as implementation intentions) when setting between-session homework and the other augmentation will target patient drop-out by informing patients about group BA effectiveness and therapy-dose evidence. The stasis outcomes and drop-out rates from the enhanced treatment in the trial will be compared with the archived outcomes to see if the intervention has had an effect and the role of engaging in valued living as a mechanism of change for depression symptoms will be examined. It is hypothesised that a) 50% of patients who have received the existing BA group treatment for depression will have a stasis outcome, b) there will be a significant reduction in depression stasis outcomes and drop-out rate following the enhanced BA group treatment delivered in the trial and c) engagement in valued living will have a mediating effect on outcome for responding patients following the enhanced BA group treatment but the effect will not be present for patients with a stasis outcome.
**Detailed Description:** A one-armed quasi-experimental trial will be used to test the effect of two embedded behavioural activation group (BAG) treatment augmentations on treatment outcomes and to identify a potential outcome mediator for patients with a stasis outcome. A non-randomised design enables data to be collected which reflects routine clinical practice and address stasis outcomes as they occur in real-world services. A matched pairs design will be implemented in the analysis to allow comparison of the enhanced BAG data with historical control data from archived outcomes of the existing treatment (i.e. the baseline data).
Patients who access the Improving Access to Psychological Therapies (IAPT) service in Sheffield, United Kingdom with a primary presenting problem of depression and are referred to BAG will be approached to take part in the study. Patients will be asked to provide informed consent to agree for their weekly routine outcome scores from enhanced BAG to be used in the study.
Enhanced BAG Augmentations
The existing BAG treatment will be enhanced with embedded treatment augmentations. The augmentations will consist of two strands; 1) implementation intentions to directly target reducing stasis and 2) psychoeducation to target reducing drop-out.
Implementation Intentions: The first augmentation will be a top-down theoretically informed 'implementation intentions' enhancement to target reducing the stasis outcome rate. Implementation intentions are specific plans about how, when and where goals will be acted upon, formed using an if-then format in order to effectively implement actions. Patients will be taught to use if-then planning (implementation intentions) to help them complete the between-session which is crucial to producing change in BA.
Dose-Response Psychoeducation: The second augmentation will be a dose-response psychoeducation enhancement aimed at reducing the dropout rate. Patients will be given information based on practice-based evidence about the effectiveness of BAG and dose-response information (minimum number of sessions required to experience change).
Treatment Integrity
Treatment adherence to the protocol will be assessed using a BAG adherence checklist created for this trial. Adherence will be checked and compared using self-report and an expert rater; i) after each session the BAG facilitators will complete the session integrity measure to check self-report adherence and ii) the BAG facilitator lead will observe and rate one session from each course of BAG to provide an expert adherence check.
Data Collection
Data collection for the study will run for a year from January 2017 until December 2017 incorporating six BAG treatment groups.
Data Analysis
The data will be analysed using the intention-to-treat (ITT) principle. The final available measure will be used as the post score or if there is only one score available, it will be assumed there was no change. Patients who do not score above the clinical cut-off for depression (score of ≥10 on Patient Health Questionnaire \[PHQ-9\]) prior to commencing BAG will not be included in the analysis to avoid a floor effect when calculating stasis outcomes.
### Conditions Module
**Conditions:**
- Depression
**Keywords:**
- Behavioural activation
- Psychotherapy, group
- Depression
- Depressive disorder
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 34
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Behavioural activation group (BAG) psychotherapy delivered with two embedded treatment augmentations;
1. Implementation intentions
2. Dose-response psychoeducation
**Intervention Names:**
- Behavioral: Behavioural Activation Group (BAG) Psychotherapy
**Label:** Enhanced Behavioural Activation Groups
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Enhanced Behavioural Activation Groups
**Description:** Behavioural activation (BA) is a psychotherapy intervention based on behaviour theory and operant conditioning. It teaches patients to reduce avoidant depressive behaviours and in turn increase the positive reinforcement they receive from their environment for non-depressive behaviours through the use of activity scheduling and pleasant events. For the trial, BA will be delivered in a group format (BAG) and facilitated by two therapists. BAG treatment will consist of eight weekly sessions, lasting two hours and will follow a manualised treatment protocol. Each session will be based on a different topic relevant to the principles of BA and patients will be given between session work to complete to encourage increased participation in rewarding personally meaningful activities.
**Name:** Behavioural Activation Group (BAG) Psychotherapy
**Type:** BEHAVIORAL
### Outcomes Module
#### Other Outcomes
**Description:** BAG facilitators will complete an therapy adherence checklist (designed for this trial) after each session. An external rater will rate one session of each course of treatment to ensure adherence to the treatment protocol
**Measure:** Behavioural activation group (BAG) therapy adherence
**Time Frame:** Weeks 1-8 (Every treatment session)
#### Primary Outcomes
**Description:** Validated 9-item self-report measure of depressive symptoms
**Measure:** Change in Patient Health Questionnaire (PHQ-9) scores
**Time Frame:** Week 1 (pre-treatment), at every weekly treatment session attended (for 8 weeks) and at week 8 (end of treatment)
#### Secondary Outcomes
**Description:** Number of therapy sessions patients attend in a course of treatment
**Measure:** Patient attendance at treatment sessions
**Time Frame:** Weeks 1-8 (every weekly treatment session - maximum of 8)
**Description:** Validated self-report measure of engagement in valued living
**Measure:** Change in Valued Living Questionnaire (VLQ) score
**Time Frame:** Week 1 (pre-treatment), week 4 (at the 4th treatment session) and at week 8 (end of treatment)
**Description:** Validated 7-item self-report measure of anxiety symptoms
**Measure:** Change in Generalised Anxiety Disorder Assessment (GAD-7) score
**Time Frame:** Week 1 (pre-treatment), at every weekly treatment session attended (for 8 weeks) and at week 8 (end of treatment)
**Description:** Validated self-report measure of functional impairment as a result of mental health problems
**Measure:** Change in Work and Social Adjustment Scale (WSAS) score
**Time Frame:** Week 1 (pre-treatment), at every weekly treatment session attended (for 8 weeks) and at week 8 (end of treatment)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients who access the Sheffield Improving Access to Psychological Therapies (IAPT) service (United Kingdom) with depression as the primary presenting problem
* Patients with co-morbid anxiety symptoms can be included as long as depression is the primary diagnosis
* Are referred to and choose the Behavioural Activation Group (BAG) treatment option
* Able to attend the BAG intervention
* Aged 18 or over
Exclusion Criteria:
* Primary diagnosis that is not depression
* Patients who do not choose BAG as a treatment option
* Aged under 18
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Sheffield
**Country:** United Kingdom
**Facility:** Sheffield Health and Social Care NHS Foundation Trust - Improving Access to Psychological Therapies Service
**State:** South Yorkshire
**Zip:** S3 7ND
#### Overall Officials
**Official 1:**
**Affiliation:** University of Sheffield
**Name:** Melanie K Simmonds-Buckley, BSc
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** University of Sheffield & Sheffield Health and Social Care NHS Foundation Trust
**Name:** Stephen Kellett, DClinPsy
**Role:** PRINCIPAL_INVESTIGATOR
**Official 3:**
**Affiliation:** University of Sheffield
**Name:** Glenn Waller, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** The data will be anonymised and analysed collectively so individual participant data will not be identifiable within any reports or publications.
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Gollwitzer, P. M. (1999). Implementation intentions: Strong effects of simple plans. American Psychologist, 54, 493-503.
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001526
- Term: Behavioral Symptoms
- ID: D000019964
- Term: Mood 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: M7058
- Name: Depression
- Relevance: HIGH
- As Found: Depression
- ID: M7061
- Name: Depressive Disorder
- Relevance: HIGH
- As Found: Depression
- ID: M4818
- Name: Behavioral Symptoms
- Relevance: LOW
- As Found: Unknown
- ID: M21835
- Name: Mood 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: D000003863
- Term: Depression
- ID: D000003866
- Term: Depressive Disorder
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT05058079
**Acronym:** HHLS
**Brief Title:** Hand Holding During Light Sedation for Minimally Invasive Spine Surgery Improves Outcomes
**Official Title:** The Effect of Hand Holding on Patient Satisfaction During for Minimally Invasive Spine Surgery Under Monitored Anesthesia Care. A Single Blinded, Single Center Randomized Controlled Trial
#### Organization Study ID Info
**ID:** 1678933
#### Organization
**Class:** OTHER
**Full Name:** Rhode Island Hospital
### Status Module
#### Completion Date
**Date:** 2022-12-31
**Type:** ESTIMATED
#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2021-09-27
**Type:** ACTUAL
**Last Update Submit Date:** 2021-09-16
**Overall Status:** UNKNOWN
#### Primary Completion Date
**Date:** 2022-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2021-09-20
**Type:** ESTIMATED
**Status Verified Date:** 2021-09
#### Study First Post Date
**Date:** 2021-09-27
**Type:** ACTUAL
**Study First Submit Date:** 2021-09-02
**Study First Submit QC Date:** 2021-09-16
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Rhode Island 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:** The investigators want to determine whether handholding improves patient satisfaction and reduce patient's anxiety during minimally invasive outpatient spine surgery with monitored anesthesia care.
**Detailed Description:** Minimally invasive spine interventions have emerged as a treatment options for patients with previous spine surgery and patients who have never before been operated upon. These procedures can be done safely in patients with advanced comorbid conditions, previous failed major spine procedures, and in patients who have decided to try the least invasive approach to address their lumbo-sacral spine condition in hopes of avoiding more major and potentially morbid procedures. These endoscopic procedures are typically done as outpatients with light sedation, ideally rendering the patient calm but completely cooperative and able to respond in real-time to questions from the surgeon during the procedure. This has implications for the progress and success of the procedure, the safety of the procedure and allows for a short ambulatory hospital stay.
Hand holding has been shown to improve outcomes such as compliance, procedural success and patient comfort with patients undergoing light sedation for a variety of procedures. The purpose of this study is to determine whether adding hand holding to light sedation for minimally invasive spine procedures has a positive impact on patient satisfaction and perioperative outcomes.
### Conditions Module
**Conditions:**
- Spine
- Minimally Invasive
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- CARE_PROVIDER
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 154
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients hand will be held by the anesthesia provider during the procedure. A folded blanket will be over the patient's hand during the procedure and the anesthesia provider will have their hand under the folded blanket holding the patient's hand.
**Intervention Names:**
- Behavioral: Intraoperative Hand Held
**Label:** Hand-held group
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** No physical contact for comfort or reassurance during the procedure. A folded blanket will be over the patient's hand during the procedure and the anesthesia provider will be next to the patient's hand.
**Label:** No hand holding group
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Hand-held group
**Description:** Intraoperative hand holding
**Name:** Intraoperative Hand Held
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** 11-item questionnaire designed to measure the satisfaction with monitored anesthesia care. The Iowa Satisfaction with Anesthesia Scale (ISAS) score is the mean of responses to all 11questions. The score can range from a min of -3 to a maximum of +3. The responses are : -3 = disagree very much, -2 = disagree moderately, -1 = disagree slightly, 1 = agree slightly, 2 = agree moderately, and 3 = agree very much. A score of +3 would imply a totally satisfied patient.
**Measure:** Iowa Satisfaction with Anesthesia Scale (ISAS)
**Time Frame:** 24 hours after the procedure
#### Secondary Outcomes
**Description:** Numerical pain score (0=no pain, 10=worst pain imaginable)
**Measure:** Pain Score
**Time Frame:** Through study completion up to 24 hours after procedure.
**Description:** The 6-item version of the Spielberger 20-item State-Trait Anxiety Inventory (STAI) is a validated short form and correlates well with the standard inventory. It measures state anxiety (how one feels at the moment: "feel questions") and trait anxiety (how one generally feels: "am questions"). It contains six questions with a Likert scale from 1 to 4 (1=not at all, 2=somewhat, 3=moderately so, 4=very much so) The score range is from a minimum of 6 to a maximum of 24. A low score represents no to low anxiety where as a high score represents high anxiety.
**Measure:** State Trait Anxiety Inventory (STAI)
**Time Frame:** Before and 24 hours after the procedure
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* American Society of Anesthesiology physical status 1 to 3
* Outpatient endoscopic spine procedures under light sedation
Exclusion Criteria:
* American Society of Anesthesiology physical status 4 or greater
* Pre-existing neuropathy
* Infection at the site
* Pregnancy
* Patient's refusal or inability to consent
**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:** Joseph Caiati, MD
**Phone:** 401-444-5172
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Mark Kendall, MD
**Phone:** 401-444-4722
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Providence
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Mark Kendall, MD
- **Phone:** 401-444-4722
- **Role:** CONTACT
***Contact 2:***
- **Name:** Albert Telfeian, MD
- **Role:** SUB_INVESTIGATOR
**Country:** United States
**Facility:** Rhode Island Hospital
**State:** Rhode Island
**Status:** RECRUITING
**Zip:** 02903
#### Overall Officials
**Official 1:**
**Affiliation:** Rhode Island Hospital
**Name:** Joseph Caiati, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Kwon WA, Lee JW, Seo HK, Oh TH, Park SC, Jeong HJ, Seo IY. Hand-Holding during Cystoscopy Decreases Patient Anxiety, Pain, and Dissatisfaction: A Pilot Randomized Controlled Trial. Urol Int. 2018;100(2):222-227. doi: 10.1159/000485745. Epub 2017 Dec 22.
**PMID:** 29275402
**Citation:** Dexter F, Candiotti KA. Multicenter assessment of the Iowa Satisfaction with Anesthesia Scale, an instrument that measures patient satisfaction with monitored anesthesia care. Anesth Analg. 2011 Aug;113(2):364-8. doi: 10.1213/ANE.0b013e318217f804. Epub 2011 Apr 25.
**PMID:** 21519043
**Citation:** Yanes AF, Weil A, Furlan KC, Poon E, Alam M. Effect of Stress Ball Use or Hand-holding on Anxiety During Skin Cancer Excision: A Randomized Clinical Trial. JAMA Dermatol. 2018 Sep 1;154(9):1045-1049. doi: 10.1001/jamadermatol.2018.1783.
**PMID:** 30027283
## 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:** NCT03557879
**Acronym:** NGS-NSHL
**Brief Title:** Exome Analysis in Hearing Impaired Patients
**Official Title:** Exome Analysis on Hearing Impaired Patients
#### Organization Study ID Info
**ID:** UF96802
#### Organization
**Class:** OTHER
**Full Name:** University Hospital, Montpellier
### Status Module
#### Completion Date
**Date:** 2019-06-01
**Type:** ESTIMATED
#### Expanded Access Info
**Last Known Status:** ACTIVE_NOT_RECRUITING
#### Last Update Post Date
**Date:** 2018-06-15
**Type:** ACTUAL
**Last Update Submit Date:** 2018-06-14
**Overall Status:** UNKNOWN
#### Primary Completion Date
**Date:** 2018-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2018-06-04
**Type:** ACTUAL
**Status Verified Date:** 2018-06
#### Study First Post Date
**Date:** 2018-06-15
**Type:** ACTUAL
**Study First Submit Date:** 2018-06-04
**Study First Submit QC Date:** 2018-06-14
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University Hospital, Montpellier
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Hearing impairment is the most frequent sensory deficit in humans and affects one newborn out of 500. The prevalence rises to 3,5/1000 in teenagers due to retarded forms. Most of hearing impairments (about two thirds) have a genetic origin, with recessive, dominant or X-linked mode of inheritance. Some rare forms can be linked to mitochondrial DNA. Molecular diagnosis (i.e. defining the molecular basis of the disease, genes and precise DNA variants) is essential for the follow-up of patients and families.
The project intends to perform exome sequencing on 30 samples of families presenting with hearing impairment. Families have been included based on the genetic origin of the hearing impairment (familial cases) and the exclusion of the involvement of 74 known deafness genes. Exome sequencing (sequencing of the coding regions of all known genes, about 22,000) in these cases may underly new gene/disease relationships.
**Detailed Description:** Exome sequencing will be performed of 10 trios that each include two affected and one non affected members of a family. Filtering of variants will be performed based on frequency. For each trio, data will be analysed in parallel to follow segregation of the variant(s) in candidate genes. The selected candidate genes will be further characterized in order to ascertain their involvement in hearing function.
Finally, once these new genes are well defined as "deafness genes" , their screening will be added to existing diagnostic panels.
### Conditions Module
**Conditions:**
- Hearing Impairment
**Keywords:**
- Hearing impairment
- familial
### Design Module
#### Bio Spec
**Description:** Blood samples
**Retention:** SAMPLES_WITH_DNA
#### Design Info
**Observational Model:** FAMILY_BASED
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 30
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Samples from families presenting with familial hearing impairment, underlying the genetic basis, for whom 74 deafness genes have already been excluded (no evidence of pathogenic genotype)
**Intervention Names:**
- Genetic: Exome sequencing
**Label:** Hearing impaired families
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Hearing impaired families
**Description:** DNA extracted from samples will undergo exome sequencing, i.e. sequencing of the coding regions of all known human genes (about 22,000)
**Name:** Exome sequencing
**Type:** GENETIC
### Outcomes Module
#### Primary Outcomes
**Description:** Description: a candidate gene would present a genotype (combination of DNA variants) compatible with the transmission mode and several lines of evidence of the pathogenic effect of the DNA variants
**Measure:** identification of candidate genes
**Time Frame:** 1 day
#### Secondary Outcomes
**Description:** Quality assessment of the exome sequencing
**Measure:** Quality assessment of the exome sequencing
**Time Frame:** 1 day
**Description:** Quality assessment of the bioinformatics pipelines used
**Measure:** Quality assessment of the bioinformatics pipelines used
**Time Frame:** 1 day
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Families presenting with familial hearing impairment, underlying the genetic basis, for whom 74 deafness genes have already been excluded (no evidence of pathogenic genotype)
Exclusion criteria:
- sporadic cases of hearing impairment, or resolved familial cases
**Minimum Age:** 5 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
**Study Population:** Hearing impaired patients and relatives
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Montpellier
**Country:** France
**Facility:** Uhmontpellier
**Zip:** 34295
#### Overall Officials
**Official 1:**
**Affiliation:** University Hospital, Montpellier
**Name:** Anne Françoise ROUX
**Role:** STUDY_DIRECTOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000006311
- Term: Hearing Disorders
- ID: D000004427
- Term: Ear Diseases
- ID: D000010038
- Term: Otorhinolaryngologic Diseases
- ID: D000012678
- Term: Sensation Disorders
- ID: D000009461
- Term: Neurologic Manifestations
- ID: D000009422
- Term: Nervous System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC09
- Name: Ear, Nose, and Throat Diseases
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M24420
- Name: Hearing Loss
- Relevance: HIGH
- As Found: Hearing Impairment
- ID: M6840
- Name: Deafness
- Relevance: HIGH
- As Found: Hearing Impairment
- ID: M9400
- Name: Hearing Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M7601
- Name: Ear Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12961
- Name: Otorhinolaryngologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15490
- Name: Sensation Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000034381
- Term: Hearing Loss
- ID: D000003638
- Term: Deafness
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT00696579
**Brief Title:** Bacillus of Calmette and Guerin (BCG) Versus Gemcitabine For Intravesical Therapy In High Risk Superficial Bladder Cancer
**Official Title:** BCG vs. Gemcitabine For Intravesical Therapy In High Risk Superficial Bladder Cancer: A Randomized Prospective Study
#### Organization Study ID Info
**ID:** EC_ML_003
#### Organization
**Class:** OTHER
**Full Name:** University Of Perugia
### Status Module
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2008-06-12
**Type:** ESTIMATED
**Last Update Submit Date:** 2008-06-10
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2008-03
#### Start Date
**Date:** 2004-01
**Status Verified Date:** 2008-06
#### Study First Post Date
**Date:** 2008-06-12
**Type:** ESTIMATED
**Study First Submit Date:** 2008-06-10
**Study First Submit QC Date:** 2008-06-10
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University Of Perugia
### Oversight Module
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** A significant number of patients with high risk superficial bladder cancer has progression to invasive disease. No consensus exists regarding the optimal treatment to decrease the recurrence and progression rate. The aim of this research is to evaluate the safety, tolerability and efficacy of adjuvant intravesical gemcitabine vs. BCG in the treatment of high-risk superficial bladder cancer
**Detailed Description:** This was a prospective, randomized study conducted from 2004 to 2006 at a single tertiary urban teaching University Urological Department regarding sixty-four patients with high-risk superficial bladder cancer (pT1, and/or G3 and/or CIS), who were assigned to interventions (gemcitabine or BCG) by using random allocation 1:1. Group A, 32 patients, were treated weekly (6 weekly instillations) with BCG dose 5 x 108 CFU and then maintenance therapy at 3-6-12-18-24-30-36 months; Group B, 32 patients, received gemcitabine 2 gr/instillation on a weekly basis (6 weekly instillations), followed by maintenance therapy at 3-6-12-18-24-30-36 months.
### Conditions Module
**Conditions:**
- Bladder Cancer
**Keywords:**
- BCG
- Gemcitabine
- Intravesical
- Therapy
- Superficial
- Transitional
- Cell carcinoma
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 64
**Type:** ACTUAL
**Phases:**
- PHASE1
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Group A received BCG instillation 14 days after II look-TURB:6 weekly instillations of Tice-strain BCG (Organon Teknika Corp.) as induction chemotherapy, with a dose of 5 x 108 CFU diluted in 50 mL of saline held in the bladder for 2 hours.
**Intervention Names:**
- Drug: BCG
**Label:** A
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** 14 days after II look-TURB the patients received 6 weekly instillations of Gemcitabine (Gemzar, Eli Lilly SpA), using a dose of 2000 mg diluted in 50 mL of saline held in the bladder for 2 hours
**Intervention Names:**
- Drug: gemcitabine
**Label:** 2
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- A
**Description:** 6 weekly instillations of Tice-strain BCG (Organon Teknika Corp.) as induction chemotherapy, with a dose of 5 x 108 CFU diluted in 50 mL of saline held in the bladder for 2 hours.
**Name:** BCG
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- 2
**Description:** 14 days after II look-TURB the patients received 6 weekly instillations of Gemcitabine (Gemzar, Eli Lilly SpA), using a dose of 2000 mg diluted in 50 mL of saline held in the bladder for 2 hours
**Name:** gemcitabine
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Measure:** The primary outcome measure consists of evaluation of recurrence and progression rates as they were detected by follow-up tools. Interval before recurrence and progression were also considered primary end-points
#### Secondary Outcomes
**Measure:** Secondary endpoints were tolerability, as detected by number of patients who dropped out the study, and safety as the recording of adverse events.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Primary diagnosis of high risk superficial bladder cancer according to EAU guidelines (http://www.eortc.be/tools/bladdercalculator/),
* Having never been treated with other intravesical chemotherapeutic agents,
* And to consent to participate to the study
Exclusion Criteria:
* Concomitant tumours;
* Urinary tract infections (UTI);
* Altered function of the liver, kidneys and/or bone marrow;
* Major cardiovascular diseases;
* Life expectancy of less than 1 year;
* Intravesical chemotherapy in the previous 3 months or immunotherapy in the previous 6 months;
* Systemic chemotherapy and pelvic radiotherapy prior to TURB, and any condition that in the judgment of the investigators would interfere with the subject's ability to provide informed consent, comply with study instructions, place the subject at increased risk, or which might confound interpretation of study results.
**Maximum Age:** 75 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Perugia
**Country:** Italy
**Facility:** 1. Department of Medical-Surgical Specialties and Public Health, Section of Urology and Andrology, University of Perugia - Italy
**Zip:** 06100
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000014571
- Term: Urologic Neoplasms
- ID: D000014565
- Term: Urogenital Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- 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
### Condition Browse Module - Browse Leaves
- ID: M5534
- Name: Carcinoma
- Relevance: LOW
- As Found: Unknown
- ID: M5030
- Name: Urinary Bladder Neoplasms
- Relevance: HIGH
- As Found: Bladder Cancer
- 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
### Condition Browse Module - Meshes
- ID: D000001749
- Term: Urinary Bladder 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: M2985
- Name: Gemcitabine
- Relevance: HIGH
- As Found: Activity
- ID: M4793
- Name: BCG Vaccine
- Relevance: LOW
- As Found: Unknown
- 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
|
## Protocol Section
### Identification Module
**NCT ID:** NCT04989179
**Acronym:** PMPS
**Brief Title:** Incidence and Factors Affecting the Development and Outcome of Post Mastectomy Pain Syndrome
**Official Title:** Incidence and Factors Affecting the Development and Outcome of Post Mastectomy Pain Syndrome - A Multi-centre Prospective Cohort Study.
#### Organization Study ID Info
**ID:** PMPS 1
#### Organization
**Class:** OTHER
**Full Name:** Singapore General Hospital
### Status Module
#### Completion Date
**Date:** 2022-09
**Type:** ESTIMATED
#### Expanded Access Info
**Last Known Status:** NOT_YET_RECRUITING
#### Last Update Post Date
**Date:** 2021-08-04
**Type:** ACTUAL
**Last Update Submit Date:** 2021-07-25
**Overall Status:** UNKNOWN
#### Primary Completion Date
**Date:** 2022-09
**Type:** ESTIMATED
#### Start Date
**Date:** 2021-08
**Type:** ESTIMATED
**Status Verified Date:** 2021-07
#### Study First Post Date
**Date:** 2021-08-04
**Type:** ACTUAL
**Study First Submit Date:** 2021-07-07
**Study First Submit QC Date:** 2021-07-25
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Singapore General 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:** Phase 1 of this multi-centre, prospective study aims to obtain a precise estimate of the local incidence of PMPS and identify biopsychosocial risk factors contributing to the development of PMPS. Recognition of the impact of PMPS on function and mood and quality of life in cancer survivors, and identification of risk factors would help physicians institute appropriate pre-operative counselling and preventive measures to reduce the development of PMPS. The investigators aim to follow up on the long-term multi-dimensional effects of PMPS, and continue to develop and validate a risk prediction model for patients at risk of PMPS in the next phase of the study.
**Detailed Description:** Post-mastectomy pain syndrome (PMPS) has been reported to occur in 25-60% of patients following surgeries for breast cancer, the highest occurring cancer in women worldwide. There is a lack of an accepted standard definition of PMPS which has resulted in the wide range of estimates of its occurrence. While there has been much research interest in this condition, there is still a paucity of standardized and effective treatment at this point, and our understanding of this condition, its exact incidence and risk factors, is still incomplete.
The local incidence of PMPS after breast cancer surgery is presently unknown and often under-reported, although breast cancer surgery is common and is carried out in almost all Singhealth institutions. Risk factors for PMPS in the local context may differ from that postulated in the West due to cultural, racial and societal differences. Breast cancer has a high survival rate, with data from the CONCORD-2 study showing a 5-year survival rate of ≥85%in developed countries. Despite high survival rates in cancer survivors, PMPS has been shown to have a negative impact on the quality of recovery(QoR), patient satisfaction, and can be severe enough causing the diminished quality of life (QoL) including poor sleep, long-term disability, mood disorders and interference with activities of daily living (ADL).
Despite widespread recognition of PMPS, it is often untreated or undertreated. Some possible reasons suggested for inadequate management of PMPS are the lack of quality information about optimal treatment, and incomplete understanding of the mechanisms and risk factors for chronic pain development and prognosis. There is therefore a knowledge gap in the understanding of risk factors leading to PMPS, the lack of a validated risk prediction model for development of PMPS, and hence limiting the institution of preventive analgesia in high risk patients. It is therefore timely to conduct a local multi-centre, prospective study to look at the local incidence of PMPS after breast surgery, the multi-dimensional effects of PMPS on the patient as well as to identify modifiable biopsychosocial risk factors leading to PMPS.
### Conditions Module
**Conditions:**
- Breast Cancer
- Post-mastectomy Pain Syndrome
### Design Module
#### Bio Spec
**Description:** blood sampling
**Retention:** SAMPLES_WITH_DNA
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** CROSS_SECTIONAL
#### Enrollment Info
**Count:** 200
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Outcomes Module
#### Primary Outcomes
**Description:** Hypothesized to result from damage to major peripheral nerves during surgery. The International Association for the Study of Pain (IASP) defines PMPS as persistent pain soon after mastectomy/lumpectomy affecting the anterior thorax, axilla, and/or medial upper arm. The primary outcome will be the local incidence of PMPS at 4 months follow-up after surgery.
**Measure:** Precise estimate of the local incidence and clinical/functional impact of PMPS
**Time Frame:** 4 months
#### Secondary Outcomes
**Description:** Describe patient, anaesthetic and surgical factors (both modifiable and unmodifiable) contributing to the development of PMPS.
**Measure:** Identify risk factors of PMPS
**Time Frame:** 4 months
**Description:** Identified risk factors can help to identify patients at risk of developing PMPS which then allows clinicians to institute prevention measures such as pre-operative counselling and preventive analgesics for high-risk patients with multiple risk factors
**Measure:** Describe factors likely to prevent or reduce the development of PMPS after breast cancer surgery
**Time Frame:** 4months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age 21-80 years old
* Provided consent for the study
* Types of breast surgery included: single or bilateral site mastectomies, with or without axillary clearance, wide excision with axillary clearance, radical mastectomies with or without flap surgery.
Exclusion Criteria:
1. Age below 21 or above 80 years old
2. Male patients
3. Cognitive impairment/ uncommunicative patients.
**Gender Based:** True
**Gender Description:** Only female patients will be recruited as breast cancer in male is very rare.
**Maximum Age:** 80 Years
**Minimum Age:** 21 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Surgeons at the breast clinic listing patients for surgery will inform patients of the study. The clinical research coordinators will approach the potential study participants referred by the study team members and other attending pain clinicians.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Diana Chan, MBBS/MMED (Anaesthesia), MCI
**Phone:** +6594372568
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Singapore
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Diana Chan Xin Hui
- **Phone:** 94372568
- **Role:** CONTACT
**Country:** Singapore
**Facility:** Singapore General hospital
**Zip:** 169608
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Larsson IM, Ahm Sorensen J, Bille C. The Post-mastectomy Pain Syndrome-A Systematic Review of the Treatment Modalities. Breast J. 2017 May;23(3):338-343. doi: 10.1111/tbj.12739. Epub 2017 Jan 30.
**PMID:** 28133848
**Citation:** Tait RC, Zoberi K, Ferguson M, Levenhagen K, Luebbert RA, Rowland K, Salsich GB, Herndon C. Persistent Post-Mastectomy Pain: Risk Factors and Current Approaches to Treatment. J Pain. 2018 Dec;19(12):1367-1383. doi: 10.1016/j.jpain.2018.06.002. Epub 2018 Jun 30.
**PMID:** 29966772
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000004194
- Term: Disease
- ID: D000010335
- Term: Pathologic Processes
- ID: D000001523
- Term: Mental Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
### Condition Browse Module - Browse Leaves
- ID: M5220
- Name: Breast Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M16355
- Name: Syndrome
- Relevance: HIGH
- As Found: Syndrome
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M15803
- Name: Somatoform Disorders
- Relevance: HIGH
- As Found: Pain Syndrome
- 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: D000013577
- Term: Syndrome
- ID: D000013001
- Term: Somatoform Disorders
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06263179
**Brief Title:** Feasibility of Aerobic Exercise for Recovery From Work-related Concussion
**Official Title:** Feasibility of Aerobic Exercise for Recovery From Work-related Concussion
#### Organization Study ID Info
**ID:** STUDY00007706
#### Organization
**Class:** OTHER
**Full Name:** State University of New York at Buffalo
#### Secondary ID Infos
**ID:** UL1TR001412
**Link:** https://reporter.nih.gov/quickSearch/UL1TR001412
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2024-12-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-04-08
**Type:** ACTUAL
**Last Update Submit Date:** 2024-04-04
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-10-14
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-04
#### Study First Post Date
**Date:** 2024-02-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-01-29
**Study First Submit QC Date:** 2024-02-14
### Sponsor Collaborators Module
#### Collaborators
**Class:** NIH
**Name:** National Center for Advancing Translational Sciences (NCATS)
#### Lead Sponsor
**Class:** OTHER
**Name:** State University of New York at Buffalo
#### Responsible Party
**Investigator Affiliation:** State University of New York at Buffalo
**Investigator Full Name:** Jacob I. McPherson
**Investigator Title:** Clinical Assistant Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** There is a lot of research on how to treat people with sport-related concussion. There has not been a lot of research on the treatment of injured workers with concussion. An exercise program has been developed for people with sport-related concussion. It is suspected that this program may be helpful for injured workers with concussion too. This study will test the effect of this exercise in injured workers with concussion.
**Detailed Description:** Participants who are diagnosed with a concussion and agree to participant in the study will complete a demographics form and other relevant questionnaires. They will then perform a graded exertion test (the Buffalo Concussion Treadmill Test \[BCTT\]) at the clinic, this takes approximately 15 minutes. Participants will then be prescribed the individualized THRAE based on the results from the BCTT and will be sent home with a commercial heart rate monitor. Participants will perform exercises at home on their free time 4-5 days per week. Participants will return to the clinic weekly to be re-examined by the study physician and obtain a new heart rate prescription for the first six weeks until clinical recovery or the intervention period ends (6-weeks).
### Conditions Module
**Conditions:**
- Concussion, Brain
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** Target Heartrate Aerobic Exercise
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 40
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants will be asked to complete the Buffalo Concussion Treadmill Test (BCTT), a safe graded exercise test that is used to identify concussion-related exertion intolerance. Participants will wear a heart rate (HR) monitor for the collection of continuous HR data. The test is stopped when a participant's symptoms increase subjectively by an intensity of 3 points or more from the pre-exercise value on a scale from 0-10, or they report being physically exhausted. Their HR at the time of test termination constitutes the HR threshold (HRt). An individualized THRAE program will be prescribed based on 80% of the HRt on the BCTT. Participants will be given a Polar HR monitor to wear while performing their THRAE prescription, which will be performed at home for 20 minutes, 4-5 days per week, for 6 weeks or until medically cleared from their concussion.
**Intervention Names:**
- Behavioral: Target Heartrate Aerobic Exercise
**Label:** Target Heartrate Aerobic Exercise (THRAE)
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Target Heartrate Aerobic Exercise (THRAE)
**Description:** Exercise program
**Name:** Target Heartrate Aerobic Exercise
**Type:** BEHAVIORAL
### Outcomes Module
#### Other Outcomes
**Description:** At each weekly follow-up meeting participants will be asked about any adverse events including injuries or other negative events.
**Measure:** Rate of adverse Events as assessed by questioning the participant
**Time Frame:** Up to week 6
#### Primary Outcomes
**Description:** Adherence to Target Heartrate Aerobic Exercise (THRAE) program as measured by counting exercise sessions completed.
**Measure:** Adherence to Target Heartrate Aerobic Exercise (THRAE) program as measured by counting the number and duration of exercise sessions completed.
**Time Frame:** Up to 6 weeks
#### Secondary Outcomes
**Description:** The Post-Concussion Symptom Scale (PCSS) is a validated 22-item self-report symptom questionnaire. Scores range from 0-132 with greater scores indicating increased symptom burden.
**Measure:** Change in post-concussive symptom burden as measured by the Post-Concussion Symptom Scale
**Time Frame:** Baseline, week 1, week 2, week 3, week 4, week 5, week 6
**Description:** The Patient Health Questionnaire-9 (PHQ-9) is used for rating the severity of depression among participants. Scores range from 0-27. Higher scores indicate increased severity of depression.
**Measure:** Change in Patient Health Questionnaire-9 (PHQ-9)
**Time Frame:** Baseline, up to week 6
**Description:** The Generalized Anxiety Disorder-7 (GAD-7) is used to measure the severity of anxiety among participants. Scores range from 0-21. Higher scores indicate increased severity of anxiety.
**Measure:** Change in Generalized Anxiety Disorder-7 (GAD-7)
**Time Frame:** Baseline, up to week 6
**Description:** The Primary Care Post Traumatic Stress Disorder (PTSD) Screen for DSM-5 (PC-PTSD-5) is used to measure probable PTSD among participants. Scores range from 0-5. Higher scores indicate increased probability of PTSD.
**Measure:** Primary Care Post Traumatic Stress Disorder (PTSD) Screen for DSM-5 (PC-PTSD-5)
**Time Frame:** Baseline
**Description:** The Patient-Reported Outcomes Measurement Information System Global Health-10 (PROMIS-10) is used to measure general healthcare-related quality of life, including global physical health and global mental health. Both global physical health and global mental health have raw scores ranging from 4-20. Higher scores reflect higher participant ratings for global physical and mental health. This measure will be used to assess change in global physical and mental health between the initial and final visits.
**Measure:** Change in Patient-Reported Outcomes Measurement Information System Global Health-10 (PROMIS-10)
**Time Frame:** Baseline, up to week 6
**Description:** The Work Climate Questionnaire - 6-Item Version is used for assessing participants' perceptions regarding the degree of autonomy supportiveness of their work managers or employers. Scores range of 6-42. Higher scores indicate a greater degree of perceived autonomy supportiveness.
**Measure:** Work Climate Questionnaire - 6-Item Version
**Time Frame:** Baseline
**Description:** The Basic Psychological Needs Satisfaction and Frustration Scale (BPNSFS) is used to assess participant satisfaction or frustration with the psychological needs for autonomy, competence, and relatedness. The scale involves 6 subscales, including autonomy satisfaction, autonomy frustration, relatedness satisfaction, relatedness frustration, competence satisfaction, and competence frustration. Each subscale has scores ranging from 4-20. Higher scores indicate higher participant perceptions of the psychological need satisfaction or frustration reflected in the subscale. This measure will be used to assess change in psychological needs satisfaction and psychological needs frustration between the initial and final visits.
**Measure:** Change in Basic Psychological Needs Satisfaction and Frustration Scale (BPNSFS)
**Time Frame:** Baseline, up to week 6
**Description:** Time to return to work as measured by difference between date of injury and date the participant is medically cleared to return to work
**Measure:** Time to return to work measured in days
**Time Frame:** Up to week 6
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Aged 18-40
* Received a concussion at work and are engaged with the workers compensation program
* Within 3 weeks of concussive injury
Exclusion Criteria:
* 3-point or less difference between current and pre-injury symptoms as measured by the Post-Concussion Symptom Inventory (PCSI)
* Moderate or severe TBI
* Injury involving loss of consciousness for \>30 minutes or post-traumatic amnesia \> 24 hours
* Pre-existing conditions or presence of polytrauma that prevent participation in active testing and/or rehabilitation
* History of more than 3 diagnosed concussions
* Active substance abuse/dependence
* Report of injury mechanism occurring due to physical assault
* Unwillingness to perform intervention
* Limited English proficiency.
**Maximum Age:** 40 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Jacob McPherson, PhD
**Phone:** 7168296734
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Christopher Stavisky, PhD
**Phone:** (716)829-6805
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** SUNY Buffalo
**Name:** Jacob McPherson
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Sharma B, Nowrouzi-Kia B, Mollayeva T, Kontos P, Grigorovich A, Liss G, Gibson B, Mantis S, Lewko J, Colantonio A. Work-related traumatic brain injury: A brief report on workers perspective on job and health and safety training, supervision, and injury preventability. Work. 2019;62(2):319-325. doi: 10.3233/WOR-192866.
**PMID:** 30829642
**Citation:** Leddy JJ, Haider MN, Ellis MJ, Mannix R, Darling SR, Freitas MS, Suffoletto HN, Leiter J, Cordingley DM, Willer B. Early Subthreshold Aerobic Exercise for Sport-Related Concussion: A Randomized Clinical Trial. JAMA Pediatr. 2019 Apr 1;173(4):319-325. doi: 10.1001/jamapediatrics.2018.4397.
**PMID:** 30715132
**Citation:** Leddy JJ, Master CL, Mannix R, Wiebe DJ, Grady MF, Meehan WP, Storey EP, Vernau BT, Brown NJ, Hunt D, Mohammed F, Mallon A, Rownd K, Arbogast KB, Cunningham A, Haider MN, Mayer AR, Willer BS. Early targeted heart rate aerobic exercise versus placebo stretching for sport-related concussion in adolescents: a randomised controlled trial. Lancet Child Adolesc Health. 2021 Nov;5(11):792-799. doi: 10.1016/S2352-4642(21)00267-4. Epub 2021 Oct 1.
**PMID:** 34600629
**Citation:** de Koning ME, Scheenen ME, van der Horn HJ, Timmerman ME, Hageman G, Roks G, Spikman JM, van der Naalt J. Prediction of work resumption and sustainability up to 1 year after mild traumatic brain injury. Neurology. 2017 Oct 31;89(18):1908-1914. doi: 10.1212/WNL.0000000000004604. Epub 2017 Oct 6.
**PMID:** 28986414
**Citation:** Kristman VL, Cote P, Van Eerd D, Vidmar M, Rezai M, Hogg-Johnson S, Wennberg RA, Cassidy JD. Prevalence of lost-time claims for mild traumatic brain injury in the working population: improving estimates using workers compensation databases. Brain Inj. 2008 Jan;22(1):51-9. doi: 10.1080/02699050701849991.
**PMID:** 18183509
**Citation:** Smith CK, Wuellner S, Marcum J. Racial and ethnic disparities in workers' compensation claims rates. PLoS One. 2023 Jan 17;18(1):e0280307. doi: 10.1371/journal.pone.0280307. eCollection 2023.
**PMID:** 36649295
## Document Section
### Large Document Module
#### Large Docs
- Date: 2024-01-26
- Filename: ICF_000.pdf
- Has ICF: True
- Has Protocol: False
- Has SAP: False
- Label: Informed Consent Form
- Size: 252809
- Type Abbrev: ICF
- Upload Date: 2024-01-29T12:18
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000070642
- Term: Brain Injuries, Traumatic
- ID: D000001930
- Term: Brain Injuries
- ID: D000001927
- Term: Brain Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000006259
- Term: Craniocerebral Trauma
- ID: D000020196
- Term: Trauma, Nervous System
- ID: D000016489
- Term: Head Injuries, Closed
- ID: D000014947
- Term: Wounds and Injuries
- ID: D000014949
- Term: Wounds, Nonpenetrating
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M5201
- Name: Brain Concussion
- Relevance: HIGH
- As Found: Concussion, Brain
- ID: M5207
- Name: Brain Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M628
- Name: Brain Injuries, Traumatic
- 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: M17685
- Name: Wounds and Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M9349
- Name: Craniocerebral Trauma
- Relevance: LOW
- As Found: Unknown
- ID: M22023
- Name: Trauma, Nervous System
- Relevance: LOW
- As Found: Unknown
- ID: M18892
- Name: Head Injuries, Closed
- Relevance: LOW
- As Found: Unknown
- ID: M17687
- Name: Wounds, Nonpenetrating
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001924
- Term: Brain Concussion
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT03781479
**Brief Title:** Controlled Trial to Evaluate Amifampridine Phosphate in Spinal Muscular Atrophy Type 3 Patients
**Official Title:** A Randomized, Placebo-Controlled, Crossover Study to Evaluate the Safety and Efficacy of Amifampridine Phosphate in Ambulatory Patients With Spinal Muscular Atrophy (SMA) Type 3
#### Organization Study ID Info
**ID:** SMA-001
#### Organization
**Class:** INDUSTRY
**Full Name:** Catalyst Pharmaceuticals, Inc.
### Status Module
#### Completion Date
**Date:** 2020-07-23
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-06-01
**Type:** ACTUAL
**Last Update Submit Date:** 2021-05-28
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2020-07-23
**Type:** ACTUAL
#### Results First Post Date
**Date:** 2021-06-01
**Type:** ACTUAL
**Results First Submit Date:** 2021-04-06
**Results First Submit QC Date:** 2021-05-28
#### Start Date
**Date:** 2019-01-21
**Type:** ACTUAL
**Status Verified Date:** 2021-05
#### Study First Post Date
**Date:** 2018-12-20
**Type:** ACTUAL
**Study First Submit Date:** 2018-12-18
**Study First Submit QC Date:** 2018-12-18
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Catalyst Pharmaceuticals, Inc.
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** A two-period, two-treatment, crossover study to evaluate the safety, tolerability and efficacy of amifampridine phosphate in ambulatory patients diagnosed with spinal muscular atrophy (SMA) Type 3.
**Detailed Description:** This randomized (1:1), double-blind, placebo-controlled, 2-period, 2-treatment, crossover, outpatient study is designed to evaluate the safety, tolerability and efficacy of amifampridine phosphate in ambulatory patients diagnosed with SMA Type 3. The study is planned to include approximately 12 male and female SMA Type 3 patients. The planned duration of participation for each patient is approximately 2 months, based upon length of dose titration and excluding the screening period, which can last up to 14 days. Patients should only be taking the assigned investigational product (amifampridine phosphate 10 mg tablets or matching placebo tablets), no new therapies are permitted during the study.
### Conditions Module
**Conditions:**
- Muscular Atrophy, Spinal
**Keywords:**
- Type 3
### 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:** 13
**Type:** ACTUAL
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Oral tablets, 30 to 80 mg per day in divided doses 3 to 4 times a day for 4 weeks
**Intervention Names:**
- Drug: Amifampridine Phosphate
- Drug: Placebo Oral Tablet
**Label:** Amifampridine Phosphate - Placebo
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Oral tablets, 30 to 80 mg per day in divided doses 3 to 4 times a day for 4 weeks
**Intervention Names:**
- Drug: Amifampridine Phosphate
- Drug: Placebo Oral Tablet
**Label:** Placebo - Amifampridine Phosphate
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Amifampridine Phosphate - Placebo
- Placebo - Amifampridine Phosphate
**Description:** Amifampridine phosphate tablets 10 mg will be provided in round, white-scored tablets, and containing amifampridine phosphate formulated to be the equivalent of 10 mg amifampridine base per tablet.
**Name:** Amifampridine Phosphate
**Other Names:**
- 3,4 diaminopyridine phosphate
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Amifampridine Phosphate - Placebo
- Placebo - Amifampridine Phosphate
**Description:** Placebo Oral Tablet
**Name:** Placebo Oral Tablet
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Hammersmith Functional Motor Scale Expanded (HFMSE) assesses motor function by functional item in order of progressive difficulty, with higher values showing higher function abilities. Each item is scored on a scale of 0-2 with 2 representing item achieved unaided and 0 representing inability to achieve item. Each item was assessed by the patient at Screening, the first (Day 1) and last day (Day 0) of the Run-in period, during Period 1 at Day 7 and Day 14, and during Period 2 at Day 21 and Day 28. The total HFMSE score was calculated as the sum of each item score, with a maximum score of 66 (all items achieved unaided) and minimum score of 0 (all items failed). Change from baseline (CFB) will be assessed from Day 0 to Day 28. A mixed effects liner model was fit with the HFMSE change from baseline (CFB) scores at Day 28 as a response and treatment, sequence, and treatment by sequence as fixed effect terms and patient as a random effect.
**Measure:** Hammersmith Functional Motor Scale Expanded (HFMSE) Summary Statistics and Mixed Model Analysis
**Time Frame:** Screening, the first (Day 1) and last day (Day 0) of the Run-in period, during Period 1 at Day 7 and Day 14, and during Period 2 at Day 21 and Day 28
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Willing and able to provide written informed consent after the nature of the study has been explained and before the start of any research-related procedures.
2. Male or female between the ages of 6 and 50 years.
3. Genetically confirmed diagnosis of SMA Type 3.
4. Able to walk independently for at least 30 meters.
5. Not taking Nusinersen for the treatment of SMA (Nusinersen should be stopped at least 6 months before screening). Salbutamol is permitted only if the dose has been stable during the 6 months before screening.
6. Able to swallow oral medication.
7. Female patients of childbearing potential must have a negative pregnancy test (serum human chorionic gonadotropin \[HCG\] at Screening); and must practice an effective, reliable contraceptive regimen during the study and for up to 30 days following discontinuation of treatment.
8. Ability to participate in the study based on overall health of the patient and disease prognosis, as applicable, in the opinion of the Investigator; and able to comply with all requirements of the protocol, including completion of study questionnaires.
Exclusion Criteria:
1. Epilepsy and currently on medication for epilepsy.
2. Concomitant use of medicinal products with a known potential to cause QTc prolongation.
3. Patients with long QT syndromes.
4. An electrocardiogram (ECG) within 6 months before starting treatment that shows clinically significant abnormalities, in the opinion of the Investigator.
5. Breastfeeding or pregnant at Screening or planning to become pregnant at any time during the study.
6. Treatment with an investigational drug (other than amifampridine), device, or biological agent within 6 months prior to Screening or while participating in this study.
7. Surgery for scoliosis or joint contractures within the previous 6 months.
8. Any medical condition that, in the opinion of the Investigator, might interfere with the patient's participation in the study, poses an added risk for the patient, or confound the assessment of the patient.
9. History of drug allergy to any pyridine-containing substances or any amifampridine excipient(s).
10. Less than a 3-point improvement in HFSME from start of the Open label Run -in period to end of Run-in (Day 0).
**Maximum Age:** 50 Years
**Minimum Age:** 6 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Milano
**Country:** Italy
**Facility:** Neurological Institute Carlo Besta
**State:** Lombardy
**Zip:** 20133
#### Overall Officials
**Official 1:**
**Affiliation:** Carlo Besta Institute, Milan, Italy
**Name:** Lorenzo Maggi, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Bonanno S, Giossi R, Zanin R, Porcelli V, Iannacone C, Baranello G, Ingenito G, Iyadurai S, Stevic Z, Peric S, Maggi L. Amifampridine safety and efficacy in spinal muscular atrophy ambulatory patients: a randomized, placebo-controlled, crossover phase 2 trial. J Neurol. 2022 Nov;269(11):5858-5867. doi: 10.1007/s00415-022-11231-7. Epub 2022 Jun 28.
**PMID:** 35763114
## Document Section
### Large Document Module
#### Large Docs
- Date: 2019-09-27
- Filename: Prot_000.pdf
- Has ICF: False
- Has Protocol: True
- Has SAP: False
- Label: Study Protocol
- Size: 2833864
- Type Abbrev: Prot
- Upload Date: 2021-04-06T12:26
- Date: 2020-05-11
- Filename: SAP_001.pdf
- Has ICF: False
- Has Protocol: False
- Has SAP: True
- Label: Statistical Analysis Plan
- Size: 973511
- Type Abbrev: SAP
- Upload Date: 2021-04-06T12:27
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000020763
- Term: Pathological Conditions, Anatomical
- ID: D000020879
- Term: Neuromuscular Manifestations
- ID: D000009461
- Term: Neurologic Manifestations
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000013118
- Term: Spinal Cord Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000016472
- Term: Motor Neuron Disease
- ID: D000019636
- Term: Neurodegenerative Diseases
- ID: D000009468
- Term: Neuromuscular 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: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M12090
- Name: Muscular Atrophy
- Relevance: HIGH
- As Found: Muscular Atrophy
- ID: M12091
- Name: Muscular Atrophy, Spinal
- Relevance: HIGH
- As Found: Muscular Atrophy, Spinal
- ID: M4589
- Name: Atrophy
- Relevance: HIGH
- As Found: Atrophy
- ID: M22519
- Name: Pathological Conditions, Anatomical
- Relevance: LOW
- As Found: Unknown
- ID: M22619
- Name: Neuromuscular Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: M15915
- Name: Spinal Cord Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M18879
- Name: Motor Neuron Disease
- Relevance: LOW
- As Found: Unknown
- ID: M4024
- Name: Amyotrophic Lateral Sclerosis
- Relevance: LOW
- As Found: Unknown
- ID: M21558
- Name: Neurodegenerative Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12411
- Name: Neuromuscular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T5342
- Name: Spinal Muscular Atrophy
- Relevance: HIGH
- As Found: Spinal Muscular Atrophy
- ID: T5347
- Name: Spinal Muscular Atrophy Type 3
- Relevance: LOW
- As Found: Unknown
- ID: T349
- Name: Amyotrophic Lateral Sclerosis
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000009133
- Term: Muscular Atrophy
- ID: D000009134
- Term: Muscular Atrophy, Spinal
- ID: D000001284
- Term: Atrophy
### Intervention Browse Module - Ancestors
- ID: D000009465
- Term: Neuromuscular Agents
- ID: D000018373
- Term: Peripheral Nervous System Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000026902
- Term: Potassium Channel Blockers
- ID: D000049990
- Term: Membrane Transport Modulators
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
### Intervention Browse Module - Browse Branches
- Abbrev: ChanBlk
- Name: Channel Blockers
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M1902
- Name: Amifampridine
- Relevance: HIGH
- As Found: Drain removal
- ID: M23171
- Name: Potassium Channel Blockers
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000077770
- Term: Amifampridine
### Misc Info Module
#### Submission Tracking
##### First MCP Info
###### Post Date
- Date: 2021-05-03
- Type: ACTUAL
- Version Holder: 2024-05-24
## Results Section
### Adverse Events Module
**Description:** Serious classification based on the FDA regulatory definition of a serious AE.
#### Event Groups
**Group ID:** EG000
**Title:** Amifampridine
**Deaths Num At Risk:** 12
**Description:** Treatment administered to the patient at the time of onset of the AE.
**ID:** EG000
**Other Num Affected:** 5
**Other Num at Risk:** 12
**Serious Number At Risk:** 12
**Title:** Amifampridine
**Group ID:** EG001
**Title:** Placebo
**Deaths Num At Risk:** 12
**Description:** Treatment administered to the patient at the time of onset of the AE.
**ID:** EG001
**Other Num Affected:** 3
**Other Num at Risk:** 12
**Serious Number At Risk:** 12
**Title:** Placebo
**Frequency Threshold:** 5
#### Other Events
**Term:** Hypoaesthesia oral
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (19.0)
**Term:** Paraesthesia oral
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (19.0)
**Term:** Fatigue
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA (19.0)
**Term:** Gait disturbance
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA (19.0)
**Term:** Influenza like illness
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA (19.0)
**Term:** Influenza
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA (19.0)
**Term:** Fall
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Injury, poisoning and procedural complications
**Source Vocabulary:** MedDRA (19.0)
**Term:** Transaminases increased
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:** MedDRA (19.0)
**Term:** Muscular weakness
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Musculoskeletal and connective tissue disorders
**Source Vocabulary:** MedDRA (19.0)
**Term:** Headache
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
**Source Vocabulary:** MedDRA (19.0)
**Term:** Paraesthesia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
**Source Vocabulary:** MedDRA (19.0)
**Term:** Intranasal Paraesthesia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
**Source Vocabulary:** MedDRA (19.0)
**Time Frame:** Serious adverse events (SAEs) were recorded for each patient from the time informed consent was obtained at Screening and continued through four weeks after the last visit or at the early discontinuation visit, for a total of approximately 14 weeks. Non-serious AEs were recorded for each patient after the first administration of study drug through the termination visit or at the early termination visit, for a total of approximately 10 weeks.
## Results Section - Baseline Characteristics Module
### Denomination Counts
**Group ID:** BG000
**Value:** 6
**Group ID:** BG001
**Value:** 6
**Group ID:** BG002
**Value:** 1
**Group ID:** BG003
**Value:** 13
**Units:** Participants
### Group
**ID:** BG000
**Title:** Amifampridine Phosphate - Placebo
**Description:** Each patient participated in an open-label unblinded drug escalation/treatment run-in phase for up to 4 weeks until stable dose and frequency of amifampridine phosphate was achieved for 7 days. After this phase, half of the subjects were randomized to receive amifampridine in Period 1 and then crossed over to receive placebo in Period 2. Each randomized treatment period was 14 days in duration.
Dosing was up to 80 mg per day and frequency was between 3-4 times per day. Amifampridine Phosphate: Amifampridine phosphate tablets 10 mg were provided in round, white-scored tablets, and contained amifampridine phosphate formulated to be the equivalent of 10 mg amifampridine base per tablet.
Placebo: A placebo equivalent was provided as tablets indistinguishable from the amifampridine phosphate tablets. The placebo was administered consistent with the dose and dose regimen of amifampridine phosphate.
### Group
**ID:** BG001
**Title:** Placebo - Amifampridine Phosphate
**Description:** Each patient participated in an open-label unblinded drug escalation/treatment run-in phase for up to 4 weeks until stable dose and frequency of amifampridine phosphate was achieved for 7 days. After this phase, half of the subjects were randomized to receive placebo in Period 1 and then crossed over to receive amifampridine in Period 2. Each randomized treatment period was 14 days in duration.
Dosing was up to 80 mg per day and frequency was between 3-4 times per day. Placebo: A placebo equivalent was provided as tablets indistinguishable from the amifampridine phosphate tablets. The placebo was administered consistent with the dose and dose regimen of amifampridine phosphate.
Amifampridine Phosphate: Amifampridine phosphate tablets 10 mg were provided in round, white-scored tablets, and contained amifampridine phosphate formulated to be the equivalent of 10 mg amifampridine base per tablet.
### Group
**ID:** BG002
**Title:** Not Randomized
**Description:** Patients receiving amifampridine during the open-label run-in period but were not randomized to receive treatment.
### Group
**ID:** BG003
**Title:** Total
**Description:** Total of all reporting groups
### Measure
#### Measurement
**Group ID:** BG000
**Spread:** 8.5
**Value:** 37.2
#### Measurement
**Group ID:** BG001
**Spread:** 13.5
**Value:** 30.2
#### Measurement
**Group ID:** BG002
**Value:** 45.0
#### Measurement
**Group ID:** BG003
**Spread:** 11.3
**Value:** 34.5
**Class Title:**
### Measure
#### Measurement
**Group ID:** BG000
**Value:** 4
#### Measurement
**Group ID:** BG001
**Value:** 1
#### Measurement
**Group ID:** BG002
**Value:** 0
#### Measurement
**Group ID:** BG003
**Value:** 5
**Category Title:** Female
#### Measurement
**Group ID:** BG000
**Value:** 2
#### Measurement
**Group ID:** BG001
**Value:** 5
#### Measurement
**Group ID:** BG002
**Value:** 1
#### Measurement
**Group ID:** BG003
**Value:** 8
**Category Title:** Male
**Class Title:**
### Measure
#### Measurement
**Group ID:** BG000
**Value:** 0
#### Measurement
**Group ID:** BG001
**Value:** 0
#### Measurement
**Group ID:** BG002
**Value:** 0
#### Measurement
**Group ID:** BG003
**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:** 0
#### Measurement
**Group ID:** BG003
**Value:** 1
**Category Title:** Asian
#### Measurement
**Group ID:** BG000
**Value:** 0
#### Measurement
**Group ID:** BG001
**Value:** 0
#### Measurement
**Group ID:** BG002
**Value:** 0
#### Measurement
**Group ID:** BG003
**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
#### Measurement
**Group ID:** BG003
**Value:** 0
**Category Title:** Black or African American
#### Measurement
**Group ID:** BG000
**Value:** 6
#### Measurement
**Group ID:** BG001
**Value:** 5
#### Measurement
**Group ID:** BG002
**Value:** 1
#### Measurement
**Group ID:** BG003
**Value:** 12
**Category 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
**Category Title:** More than one race
#### Measurement
**Group ID:** BG000
**Value:** 0
#### Measurement
**Group ID:** BG001
**Value:** 0
#### Measurement
**Group ID:** BG002
**Value:** 0
#### Measurement
**Group ID:** BG003
**Value:** 0
**Category Title:** Unknown or Not Reported
**Class Title:**
### Measure
#### Measurement
**Group ID:** BG000
**Spread:** 9.3
**Value:** 64.7
#### Measurement
**Group ID:** BG001
**Spread:** 11.8
**Value:** 67.8
#### Measurement
**Group ID:** BG002
**Value:** 76.9
#### Measurement
**Group ID:** BG003
**Spread:** 10.2
**Value:** 67.0
**Class Title:**
### Measure
#### Measurement
**Group ID:** BG000
**Spread:** 9.0
**Value:** 169.3
#### Measurement
**Group ID:** BG001
**Spread:** 6.1
**Value:** 174.8
#### Measurement
**Group ID:** BG002
**Value:** 170.0
#### Measurement
**Group ID:** BG003
**Spread:** 7.6
**Value:** 171.9
**Class Title:**
### Measure
#### Measurement
**Group ID:** BG000
**Spread:** 1.4
**Value:** 22.5
#### Measurement
**Group ID:** BG001
**Spread:** 4.3
**Value:** 22.3
#### Measurement
**Group ID:** BG002
**Value:** 26.6
#### Measurement
**Group ID:** BG003
**Spread:** 3.1
**Value:** 22.7
**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:** COUNT_OF_PARTICIPANTS
**Title:** Race (NIH/OMB)
**Unit of Measure:** Participants
### Measure 4
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Weight
**Unit of Measure:** kg
### Measure 5
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Height
**Unit of Measure:** cm
### Measure 6
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** BMI
**Unit of Measure:** kg/m^2
**Population Description:** The analysis of baseline characteristics included all patients in the Safety population, who are those patients who enrolled and received at least one dose of amifampridine. Patients who began the Run-in period regardless of whether they were randomized to double blind medication on Day 0 belong to the Safety population.
## Results Section - More Information Module
### Certain Agreement
### Point of Contact
**Email:** [email protected]
**Organization:** Catalyst Pharmaceuticals, Inc.
**Phone:** 3054203200
**Title:** Gary Ingenito
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** 0.22
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.37
**CI Upper Limit Comment:**
**Dispersion Type:**
**Dispersion Value:**
**Estimate Comment:** Results show the LSMeans for the estimated difference between treatments along with a 95% confidence interval for this difference.
**Group Description:** A mixed effects liner model was fit with the HFMSE change from baseline (CFB) scores at Day 28 as a response and treatment, sequence, and treatment by sequence as fixed effect terms and patient as a random effect.
**Non-Inferiority Comment:**
**Non-Inferiority Type:** OTHER
**Other Analysis Description:**
**P-Value:** 0.0083
**P-Value Comment:**
**Parameter Type:** Mean Difference (Net)
**Parameter Value:** 0.792
**Statistical Comment:**
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:**
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 0.326
- **Upper Limit:**
- **Value:** 0.208
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 0.326
- **Upper Limit:**
- **Value:** -0.583
**Title:**
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Hammersmith Functional Motor Scale Expanded (HFMSE) assesses motor function by functional item in order of progressive difficulty, with higher values showing higher function abilities. Each item is scored on a scale of 0-2 with 2 representing item achieved unaided and 0 representing inability to achieve item. Each item was assessed by the patient at Screening, the first (Day 1) and last day (Day 0) of the Run-in period, during Period 1 at Day 7 and Day 14, and during Period 2 at Day 21 and Day 28. The total HFMSE score was calculated as the sum of each item score, with a maximum score of 66 (all items achieved unaided) and minimum score of 0 (all items failed). Change from baseline (CFB) will be assessed from Day 0 to Day 28. A mixed effects liner model was fit with the HFMSE change from baseline (CFB) scores at Day 28 as a response and treatment, sequence, and treatment by sequence as fixed effect terms and patient as a random effect.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** The analysis of primary outcome data was based on the Full Analysis Set population, which included all randomized patients who received at least one dose of study medication (amifampridine or placebo) and had at least one post-treatment efficacy assessment. Patients are compared for efficacy according to the treatment to which they were randomized, regardless of the treatment actually received.
**Reporting Status:** POSTED
**Time Frame:** Screening, the first (Day 1) and last day (Day 0) of the Run-in period, during Period 1 at Day 7 and Day 14, and during Period 2 at Day 21 and Day 28
**Title:** Hammersmith Functional Motor Scale Expanded (HFMSE) Summary Statistics and Mixed Model Analysis
**Type:** PRIMARY
**Unit of Measure:** Overall Score
##### Group
**Description:** Each patient will participate in an open-label unblinded drug escalation/treatment run-in phase for up to 4 weeks until stable dose and frequency of amifampridine phosphate is achieved for 7 days. After this phase, half of the subjects were randomized to receive amifampridine in Period 1 and then crossed over to receive placebo in Period 2 and the other were randomized to receive placebo in Period 1 and then crossed over to receive amifampridine in Period 2.
Each randomized treatment period is 14 days in duration.
Dosing was up to 80 mg per day and frequency was between 3-4 times per day.
Amifampridine Phosphate: Amifampridine phosphate tablets 10 mg were provided in round, white-scored tablets, and contained amifampridine phosphate formulated to be the equivalent of 10 mg amifampridine base per tablet.
Placebo: A placebo equivalent was provided as tablets indistinguishable from the amifampridine phosphate tablets. The placebo was administered consistent with the dose and dose regimen of amifampridine phosphate.
The Amifampridine study arm includes all patients in the FAS population who received Amifampridine during the treatment period, regardless of which Period the treatment was administered.
**ID:** OG000
**Title:** Amifampridine Phosphate
##### Group
**Description:** Each patient will participate in an open-label unblinded drug escalation/treatment run-in phase for up to 4 weeks until stable dose and frequency of amifampridine phosphate is achieved for 7 days. After this phase, half of the subjects were randomized to receive amifampridine in Period 1 and then crossed over to receive placebo in Period 2 and the other were randomized to receive placebo in Period 1 and then crossed over to receive amifampridine in Period 2.
Each randomized treatment period is 14 days in duration.
Dosing was up to 80 mg per day and frequency was between 3-4 times per day.
Amifampridine Phosphate: Amifampridine phosphate tablets 10 mg were provided in round, white-scored tablets, and contained amifampridine phosphate formulated to be the equivalent of 10 mg amifampridine base per tablet.
Placebo: A placebo equivalent was provided as tablets indistinguishable from the amifampridine phosphate tablets. The placebo was administered consistent with the dose and dose regimen of amifampridine phosphate.
The Placebo study arm includes all patients in the FAS population who received Placebo during the treatment period, regardless of which Period the treatment was administered.
**ID:** OG001
**Title:** Placebo
### Participant Flow Module
#### Group
**Description:** Each patient participated in an open-label unblinded drug escalation/treatment run-in phase for up to 4 weeks until stable dose and frequency of amifampridine phosphate was achieved for 7 days. After this phase, half of the subjects were randomized to receive amifampridine in Period 1 and then crossed over to receive placebo in Period 2. Each randomized treatment period was 14 days in duration.
Dosing was up to 80 mg per day and frequency was between 3-4 times per day.
Amifampridine Phosphate: Amifampridine phosphate tablets 10 mg were provided in round, white-scored tablets, and contained amifampridine phosphate formulated to be the equivalent of 10 mg amifampridine base per tablet.
Placebo: A placebo equivalent was provided as tablets indistinguishable from the amifampridine phosphate tablets. The placebo was administered consistent with the dose and dose regimen of amifampridine phosphate.
**ID:** FG000
**Title:** Amifampridine Phosphate - Placebo
#### Group
**Description:** Each patient participated in an open-label unblinded drug escalation/treatment run-in phase for up to 4 weeks until stable dose and frequency of amifampridine phosphate was achieved for 7 days. After this phase, half of the subjects were randomized to receive placebo in Period 1 and then crossed over to receive amifampridine in Period 2. Each randomized treatment period was 14 days in duration.
Dosing was up to 80 mg per day and frequency was between 3-4 times per day.
Placebo: A placebo equivalent was provided as tablets indistinguishable from the amifampridine phosphate tablets. The placebo was administered consistent with the dose and dose regimen of amifampridine phosphate.
Amifampridine Phosphate: Amifampridine phosphate tablets 10 mg were provided in round, white-scored tablets, and contained amifampridine phosphate formulated to be the equivalent of 10 mg amifampridine base per tablet.
**ID:** FG001
**Title:** Placebo - Amifampridine Phosphate
#### Group
**Description:** Patients receiving amifampridine during the open-label run-in period but were not randomized to receive treatment.
**ID:** FG002
**Title:** Not Randomized
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 6
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 6
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 1
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 6
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 6
###### Achievement
**Group ID:** FG002
**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:** 1
**Pre-Assignment Details:** A screening visit was conducted to ensure that each patient met inclusion/exclusion criteria for the study. Those patients successfully completing screening had procedures/assessments conducted at the start of the Run-in period (Day 1, before starting study medication) and during Run-in, until stable dose and frequency of amifampridine was established for at least 7 days, and at least a 3-point improvement in HFMSE score was achieved from start of Run-in to be eligible for randomization (Day 0).
**Recruitment Details:** The study was conducted from 14 January 2019 - 17 September 2020 at two sites in Europe.
**Has Results:** True |
## Protocol Section
### Identification Module
**NCT ID:** NCT01005979
**Brief Title:** A Phase I Trial Using Cyclophosphamide, Rituximab and Revlimid (CR2) for the Treatment of Relapsed/Refractory B-Cell Chronic Lymphocytic Leukemia (B-CLL) and Small Lymphocytic Lymphoma (SLL)
**Official Title:** A Phase I Trial Using Cyclophosphamide, Rituximab and Revlimid (CR2) for the Treatment of Relapsed/Refractory B-Cell Chronic Lymphocytic Leukemia (B-CLL) and SLL
#### Organization Study ID Info
**ID:** IRB00024085
#### Organization
**Class:** OTHER
**Full Name:** Emory University
#### Secondary ID Infos
**Domain:** Other
**ID:** WCI1642-09
**Type:** OTHER
### Status Module
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2014-08-13
**Type:** ESTIMATED
**Last Update Submit Date:** 2014-08-12
**Overall Status:** TERMINATED
#### Primary Completion Date
**Date:** 2012-10
**Type:** ACTUAL
#### Start Date
**Date:** 2010-07
**Status Verified Date:** 2014-08
#### Study First Post Date
**Date:** 2009-11-01
**Type:** ESTIMATED
**Study First Submit Date:** 2009-09-30
**Study First Submit QC Date:** 2009-10-30
**Why Stopped:** Slow Accrual
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** Celgene Corporation
#### Lead Sponsor
**Class:** OTHER
**Name:** Emory University
#### Responsible Party
**Investigator Affiliation:** Emory University
**Investigator Full Name:** Christopher R. Flowers
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The purpose of this study is to determine the maximum tolerated dose (MTD), safety and toxicity when cyclophosphamide, rituximab and lenalidomide (Revlimid) are combined for the treatment of relapsed/refractory of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).
### Conditions Module
**Conditions:**
- Leukemia, Lymphocytic, Chronic, B-Cell
- Chronic Lymphocytic Leukemia
- Lymphoma, Small Lymphocytic
**Keywords:**
- Leukemia, Lymphocytic, Chronic, B-Cell
- Chronic Lymphocytic Leukemia
- Lymphoma, Small Lymphocytic
- Lymphoma
- Leukemia
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 6
**Type:** ACTUAL
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Drug: Lenalidomide, Rituximab, and Cyclophosphamide
**Label:** A
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- A
**Description:** COHORT 1: Cyclophosphamide 250 mg/m2 day 1, 2 and 3, Rituximab 500 mg/m2 i.v. day 1, Lenalidomide 2.5 mg/day starting day 8-28 of Cycle 1 and then daily on Days 1-28 of subsequent cycles
COHORT 2: Cyclophosphamide 250mg/m2 day 1, 2 and 3. Rituximab 500 mg.m2 i.v. daY Lenalidomide 5 mg/day starting day 8 -28 of Cycle 1 and then daily on Days 1-28 of subsequent cycles
COHORT 3: Cyclophosphamide 250mg/m2 day 1, 2 and 3, Rituximab 500 mg.m2 i.v. day 1, Lenalidomide 10 mg/day starting day 8 -28 of Cycle 1 and then daily on Days 1-28 of subsequent cycles
COHORT 4: Cyclophosphamide 250mg/m2 day 1, 2 and 3, Rituximab 500 mg.m2 i.v. day 1, Lenalidomide 15 mg/day starting day 8 -28 of Cycle 1 and then daily on Days 1-28 of subsequent cycles
Patients will receive a total of 6-8 cycles.
**Name:** Lenalidomide, Rituximab, and Cyclophosphamide
**Other Names:**
- Revlimid
- Rituxan
- Mab Thera
- Endoxan
- Cytoxan
- Neosar
- Procytox
- Revimmune
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Measure:** The primary endpoint is to determine the maximum tolerated dose of lenalidomide in combination with cyclophosphamide and rituximab for the treatment of CLL or SLL.
**Time Frame:** Day 28 of the first cycle of chemotherapy
#### Secondary Outcomes
**Measure:** Assess response criteria, including complete response rate, survival at 1 year, time to progression, duration of response, and eradication of minimal residual disease.
**Time Frame:** Response will be measured after 4 cycles, at the end of treatment and then every 3 months post treatment.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Understand and voluntarily sign an informed consent form.
2. Age ≥ 18 years at the time of signing the informed consent form.
3. Able to adhere to the study visit schedule and other protocol requirements.
4. Relapsed/refractory B-cell CLL or SLL
5. All previous cancer therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least 2 weeks prior to treatment in this study.
6. Patients must have received at least one prior therapy and must meet the NCI Working Group (NCI WG) Criteria for treatment of B-CLL as described in Appendix D.
7. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 at study entry (see Appendix C).
8. Laboratory test results within these ranges (unless related to CLL involvement):
* Absolute neutrophil count ≥ 1000 /mm3
* Platelet count ≥ 50,000/mm³
* Serum creatinine ≤ 1.5 mg/dL. Serum creatinine \> 1.5 mg/dL requires creatinine clearance of ≥ 60 mL/min by Cockroft-Gault formula.
* Total bilirubin ≤ 1.5 mg/dL
* Aspartate aminotransferase (AST) (SGOT) and alanine aminotransferase (ALT) (SGPT) ≤ 2 x upper limit of normal (ULN) or ≤ 5 x ULN if hepatic metastases are present.
9. Disease free of second malignancies for ≥ 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "insitu" of the cervix or breast.
10. Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 milli-International Units (mIU)/mL within 10 - 14 days prior to and again within 24 hours of starting lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure. See Appendix A: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods, AND also Appendix B: Education and Counseling Guidance Document.
11. Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to acetylsalicylic acid \[ASA\] may use warfarin or low molecular weight heparin).
Exclusion Criteria:
1. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
2. Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
3. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
4. Evidence of laboratory tumor lysis syndrome (TLS) by Cairo-Bishop criteria (Appendix J) (subjects may be enrolled upon correction of electrolyte abnormalities).
5. Use of any other experimental drug or therapy within 28 days of baseline.
6. Known hypersensitivity to thalidomide.
7. The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
8. Any prior use of lenalidomide.
9. Concurrent use of other anti-cancer agents or treatments.
10. Known positive for HIV or infectious hepatitis, type A, B or C.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Atlanta
**Country:** United States
**Facility:** Emory University Winship Cancer Institute
**State:** Georgia
**Zip:** 30322
#### Overall Officials
**Official 1:**
**Affiliation:** Emory University Winship Cancer Institute
**Name:** Rajni Sinha, MD
**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: D000015448
- Term: Leukemia, B-Cell
- ID: D000002908
- Term: Chronic Disease
- ID: D000020969
- Term: Disease Attributes
- ID: D000010335
- Term: Pathologic Processes
### 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: 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: Lymphocytic Leukemia
- ID: M18116
- Name: Leukemia, Lymphocytic, Chronic, B-Cell
- Relevance: HIGH
- As Found: Leukemia, Lymphocytic, Chronic, B-Cell
- ID: M11220
- Name: Lymphoma
- Relevance: HIGH
- As Found: 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: M9490
- Name: Hematologic Diseases
- 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: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
- ID: T1308
- Name: Chronic Lymphocytic Leukemia
- Relevance: HIGH
- As Found: Chronic Lymphocytic Leukemia
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: HIGH
- As Found: Chronic
- ID: T3543
- Name: Lymphosarcoma
- Relevance: HIGH
- As Found: Lymphoma
### Condition Browse Module - Meshes
- ID: D000008223
- Term: Lymphoma
- ID: D000007938
- Term: Leukemia
- ID: D000007945
- Term: Leukemia, Lymphoid
- ID: D000015451
- Term: Leukemia, Lymphocytic, Chronic, B-Cell
### Intervention Browse Module - Ancestors
- ID: D000007166
- Term: Immunosuppressive Agents
- ID: D000007155
- Term: Immunologic Factors
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000018501
- Term: Antirheumatic Agents
- ID: D000018906
- Term: Antineoplastic Agents, Alkylating
- ID: D000000477
- Term: Alkylating Agents
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000000970
- Term: Antineoplastic Agents
- ID: D000019653
- Term: Myeloablative Agonists
- ID: D000074322
- Term: Antineoplastic Agents, Immunological
- ID: D000020533
- Term: Angiogenesis Inhibitors
- ID: D000043924
- Term: Angiogenesis Modulating Agents
- ID: D000006133
- Term: Growth Substances
- ID: D000006131
- Term: Growth Inhibitors
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: ARhu
- Name: Antirheumatic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M6727
- Name: Cyclophosphamide
- Relevance: HIGH
- As Found: Cycle
- ID: M373
- Name: Rituximab
- Relevance: HIGH
- As Found: Healthy
- ID: M1725
- Name: Lenalidomide
- Relevance: HIGH
- As Found: Respiratory
- ID: M10212
- Name: Immunosuppressive Agents
- 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: M20942
- Name: Antineoplastic Agents, Alkylating
- Relevance: LOW
- As Found: Unknown
- ID: M3820
- Name: Alkylating Agents
- Relevance: LOW
- As Found: Unknown
- ID: M1346
- Name: Antineoplastic Agents, Immunological
- 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
### Intervention Browse Module - Meshes
- ID: D000003520
- Term: Cyclophosphamide
- ID: D000069283
- Term: Rituximab
- ID: D000077269
- Term: Lenalidomide
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT03485079
**Acronym:** PM-SCD CHINA
**Brief Title:** A Prospective,Multiple Center,Cohort Study of Prediction Model on Sudden Cardiac Death and Devices Development by Automatic Analysis From 24h Electrocardiogram in China
**Official Title:** A Prospective, Multiple Center, Cohort Study of Prediction Model on Sudden Cardiac Death and Devices Development by Automatic Analysis From 24h Electrocardiogram in China
#### Organization Study ID Info
**ID:** [2018]SYSEC-KY-KS-025
#### Organization
**Class:** OTHER
**Full Name:** Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
### Status Module
#### Completion Date
**Date:** 2022-12-31
**Type:** ESTIMATED
#### Expanded Access Info
**Last Known Status:** ENROLLING_BY_INVITATION
#### Last Update Post Date
**Date:** 2018-04-02
**Type:** ACTUAL
**Last Update Submit Date:** 2018-03-25
**Overall Status:** UNKNOWN
#### Primary Completion Date
**Date:** 2022-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2018-04-10
**Type:** ESTIMATED
**Status Verified Date:** 2018-03
#### Study First Post Date
**Date:** 2018-04-02
**Type:** ACTUAL
**Study First Submit Date:** 2018-03-20
**Study First Submit QC Date:** 2018-03-25
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Chinese Academy of Medical Sciences, Fuwai Hospital
**Class:** OTHER
**Name:** Fudan University
**Class:** OTHER
**Name:** The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
**Class:** OTHER
**Name:** Ruijin Hospital
#### Lead Sponsor
**Class:** OTHER
**Name:** Jingfeng Wang
#### Responsible Party
**Investigator Affiliation:** Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
**Investigator Full Name:** Jingfeng Wang
**Investigator Title:** secretary of the party committee
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** This study is a prospective, multicenter, cohort study. The study will be completed in three phases.
The first phase aims to establish SCD PW marker and PW score scoring system
1. Use big data processing techniques to find out the differences between survivors with ventricular arrhythmias and normal controls. Find out the SCD Pre-warning ECG Marker (PW marker).
2. Establish SCD Pre-warning risk score system according to traditional SCD risk factors, clinical characteristics of patients and abnormal electrocardiogram indicators.
3. According to the established SCD PW marker and PW score scoring system, the original group of patients are classified and scored. After five years of follow-up with sustained ventricular tachycardia or ventricular fibrillation as the primary end point and sudden cardiac death as the secondary endpoint, Kaplan-Meier are used to calculate the mortality rate of sudden cardiac death and Kaplan-Meier survival analysis. The COX proportional hazards regression model is used to further determine and evaluate the SCD predictive value of PW marker and PW score risk factor scoring system.
The second phase is to validate the established PW marker and PW score system models and evaluate the SCD predictive value of it. This stage is divided into two parts:
1. Patients enrolled in traditional high-risk ventricular arrhythmia, will be divided into PW marker positive group and PW marker negative group and join in a 5-year follow-up. Kaplan-Meier is used to calculate the mortality rate of sudden cardiac death and Kaplan-Meier survival analysis is performed to further verify the early warning effect of PW marker on SCD.
2. Patients will be divide into three groups including the low-risk group, middle-risk group and high-risk group according to the PW score risk factor scoring system and join in a 5-year follow-up. Kaplan-Meier is used to calculate the mortality rate of sudden cardiac death, and Kaplan-Meier survival analysis is used to further verify the early warning effect of PW score scoring system on SCD.
The third stage is the development stage of SCD early warning equipment. This stage will conduct clinical translational medical studies of PW marker and PW score based on the previous study and develop PW marker and PW score as portable SCD warning device and/or mobile phone APP which will be applied to the clinic for early warning diagnosis of SCD.
**Detailed Description:** This study is a prospective, multicenter, cohort study. The study will be completed in three phases.
The first phase is a prospective, multi-center, cohort study of the SCD early warning model. This phase is divided into three parts:
1. Use big data processing techniques to find out the differences between survivors with ventricular arrhythmias and normal controls. Find out the SCD Pre-warning ECG Marker (PW marker), and determine the reasonable threshold of its early warning.
2. Establish SCD Pre-warning risk score system according to traditional SCD risk factors, clinical characteristics of patients and abnormal electrocardiogram indicators.
3. According to the established SCD PW marker and PW score scoring system, the original group of patients are classified and scored. After five years of follow-up with sustained ventricular tachycardia or ventricular fibrillation as the primary end point and sudden cardiac death as the secondary endpoint, Kaplan-Meier are used to calculate the mortality rate of sudden cardiac death and Kaplan-Meier survival analysis. The COX proportional hazards regression model is used to further determine and evaluate the SCD predictive value of PW marker and PW score risk factor scoring system.
The second phase is a prospective, multicenter, high-risk cohort study of SCD. It is used to validate the established PW marker and PW score system models and evaluate the SCD predictive value of it.
This stage is divided into two parts:
1. Patients enrolled in traditional high-risk ventricular arrhythmia, will be divided into PW marker positive group and PW marker negative group and join in a 5-year follow-up with sustained ventricular tachycardia or ventricular fibrillation as the primary end point and sudden cardiac death as the secondary endpoint. Kaplan-Meier is used to calculate the mortality rate of sudden cardiac death and Kaplan-Meier survival analysis is performed to further verify the early warning effect of PW marker on SCD.
2. Patients will be divide into three groups including the low-risk group, middle-risk group and high-risk group according to the PW score risk factor scoring system and join in a 5-year follow-up with sustained ventricular tachycardia or ventricular fibrillation as the primary end point and sudden cardiac death as the secondary endpoint. Kaplan-Meier is used to calculate the mortality rate of sudden cardiac death, and Kaplan-Meier survival analysis is used to further verify the early warning effect of PW score scoring system on SCD.
The third stage is the development stage of SCD early warning equipment. This stage will conduct clinical translational medical studies of PW marker and PW score based on the previous study and develop PW marker and PW score as portable SCD warning device and/or mobile phone APP which will be applied to the clinic for early warning diagnosis of SCD.
### Conditions Module
**Conditions:**
- Sudden Cardiac Death
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 2200
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Outcomes Module
#### Primary Outcomes
**Description:** Use big data processing techniques to find out the differences between survivors with ventricular arrhythmias and normal controls
**Measure:** SCD Pre-warning ECG Marker (PW marker)
**Time Frame:** baseline
**Description:** Five years of follow-up with sustained ventricular tachycardia or ventricular fibrillation as the primary end point
**Measure:** rate of sustained ventricular tachycardia or ventricular fibrillation
**Time Frame:** baseline and 5 years later
**Description:** Five years of follow-up with sudden cardiac death as the secondary endpoint
**Measure:** rate of sudden cardiac death
**Time Frame:** baseline and 5 years later
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* 1. Patients with recorded ventricular tachycardia, ventricular fibrillation or cardiac arrest meet one of the following conditions:
1. survivors with cardiac arrest(including correct electrotherapy of ICD with ATP and electrical cardioversion)owing to non-reversible causes of ventricular fibrillation or hemodynamically unstable sustained ventricular tachycardia.
2. Patients who suffer the underlying organic heart disease with spontaneous sustained ventricular tachycardia (including correct ICD therapy including ATP and cardioversion)
1. more than 40 days after myocardial infarction , LVEF ≤ 0.35 with grade II or III cardiac function or more than 40 days after myocardial infarction, LVEF ≤ 0.30, with grade I cardiac function;
2. non-ischemic cardiomyopathy, grade II or III heart function, LVEF ≤ 0.35;
3. hereditary arrhythmia diseases: a group inherited diseases including long QT syndrome, short QT syndrome and Brugada syndrome, etc with arrhythmia, syncope and sudden death as the main clinical manifestations and cardiac gene mutation which encodes ion channels and their regulatory protein as the reason.
long QT syndrome: electrocardiogram on the surface indicates QTc longer than 440 ms, accompanied by rapid ventricular arrhythmia, clinical symptoms of syncope and sudden death, without organic heart disease, except for acquired QT extension caused by electrolyte disorder and medication.
short QT syndrome: electrocardiogram on the surface indicates QTc less than 300 ms, accompanied by rapid ventricular arrhythmia, clinical manifestations of syncope and sudden death, without organic heart disease, except for acquired etiology such as electrolyte disturbance and sympathetic stimulation.
brugada syndrome: electrocardiogram on the surface suggests that the ST segment of leads V1-V3 is descending or saddle-shaped, accompanied by right bundle branch block, rapid ventricular arrhythmia, syncope, and sudden death without organic heart disease and ST-T changes due to other factors.
catecholamine sensitive ventricular tachycardia: healthy individuals with no cardiac structural abnormalities and normal QTc suffer typical bidirectional, polymorphic ventricular tachycardia during exercise treadmill test or intravenous isoproterenol injection.
4. hypertrophic cardiomyopathy: asymmetric ventricular septum hypertrophy\> 15mm, or symmetrical hypertrophy ventricular septum thickness / left ventricular posterior wall thickness \< 1.3 and left ventricular diastolic compliance decreased with or without left intraventricular or outflow obstruction confirmed by examination (including echocardiography, left ventricular angiography, cardiac MRI or cardiac CT, etc.).Heart changes caused by hypertension, aortic stenosis and other diseases need to be excluded.
Note: The above arrhythmia must be clearly recorded, including course records, nursing records, electrocardiogram, Holter, bedside ECG monitoring, telemetry ECG monitoring, portable ECG recorder, implanted device with program control data, including ECG Event recorders, pacemakers,ICDs, etc.
* 2.health checkers:physical examination patients without history of structural heart disease such as coronary heart disease or cardiomyopathy
* 3.patients or health checkers can learn to use microelectrocardiograph device after simple technical training;
* 4.patients or legal representatives or health checkers are willing and able to sign informed consent
Exclusion Criteria:
* 1.people who are pregnant or ready to become pregnant
* 2.people who are unable or unwilling to follow the study protocol and complete follow-up
* 3.people with uncontrolled hyperthyroidism and hypothyroidism, severe infection, severe hepatic and renal insufficiency (ALT≧3 times, or/and eGFR≦30mL/min calculated by any formula), malignancy, etc.
* 4.people with all kinds of idiopathic ventricular tachycardia diagnosed by electrocardiogram or electrophysiological examination, including idiopathic ventricular tachycardia in special parts such as left posterior branch, left anterior branch, right ventricular outflow tract, left ventricular outflow tract, etc.
* 5.people with various structural heart diseases, including various congenital heart diseases, rheumatic or senile heart valve disease
* 6.people with acute or subacute infective endocarditis, acute viral myocarditis
* 7.people with pulmonary arterial hypertension caused by right ventricular dysfunction alone, by UCG or right heart catheter examination PASP ≧ 40mmHg
* 8.people with severe electrolyte imbalance, acid-base imbalance
* 9.people with cardiac arrest caused by various severe bradyarrhythmias
* 10.people with known allergic reactions to adhesives or hydrogels
* 11.people whose skin cannot be pasted by electrode beacuse of a recent surgery.
* 12.people who are participating in other clinical trials and may affect the data collection of this study
* 13.people who have other situations that are not suitable for joining the group
Exit criteria:
* 1.people participating in the study can withdraw from the study at any time
* 2.people ask researchers for their desire to terminate the study
* 3.if the study jeopardizes the patient's health, the researcher can decide at any time to let the patient withdraw from the study.
**Healthy Volunteers:** True
**Maximum Age:** 75 Years
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Patients with recorded ventricular tachycardia, ventricular fibrillation or cardiac arrest and patients with traditional high-risk ventricular arrhythmia or health checkers in Sun Yat-sen Memorial Hospital, Sun Yat-sen University. Informed consent must be obtained for all of the included people.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Guangzhou
**Country:** China
**Facility:** Sun Yat-sen Memorial Hospital of Sun Yat-sen University
**State:** Guangdong
#### Overall Officials
**Official 1:**
**Affiliation:** Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
**Name:** Jingfeng Wang, M.D.,Ph.D.
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010335
- Term: Pathologic Processes
- ID: D000006323
- Term: Heart Arrest
- ID: D000006331
- Term: Heart Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000003645
- Term: Death, Sudden
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC14
- Name: Heart and Blood Diseases
### Condition Browse Module - Browse Leaves
- ID: M6845
- Name: Death
- Relevance: HIGH
- As Found: Cardiac Death
- ID: M19118
- Name: Death, Sudden, Cardiac
- Relevance: HIGH
- As Found: Sudden Cardiac Death
- ID: M6847
- Name: Death, Sudden
- Relevance: LOW
- As Found: Unknown
- ID: M9411
- Name: Heart Arrest
- Relevance: LOW
- As Found: Unknown
- ID: M9419
- Name: Heart Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000016757
- Term: Death, Sudden, Cardiac
- ID: D000003643
- Term: Death
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT05008679
**Brief Title:** The Effects of Neuraminidase Inhibitor Oseltamivir in Patients With Chronic Heart Failure
**Official Title:** The Effects of Neuraminidase Inhibitor Oseltamivir in Patients With Chronic Heart Failure: an Open Label, Randomized, Blank-controlled Study.
#### Organization Study ID Info
**ID:** TJ-HF-NI
#### Organization
**Class:** OTHER
**Full Name:** Tongji Hospital
### Status Module
#### Completion Date
**Date:** 2024-01-25
**Type:** ESTIMATED
#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2021-08-17
**Type:** ACTUAL
**Last Update Submit Date:** 2021-08-14
**Overall Status:** UNKNOWN
#### Primary Completion Date
**Date:** 2023-02-25
**Type:** ESTIMATED
#### Start Date
**Date:** 2021-02-25
**Type:** ACTUAL
**Status Verified Date:** 2021-08
#### Study First Post Date
**Date:** 2021-08-17
**Type:** ACTUAL
**Study First Submit Date:** 2021-08-14
**Study First Submit QC Date:** 2021-08-14
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Tongji Hospital
#### Responsible Party
**Investigator Affiliation:** Tongji Hospital
**Investigator Full Name:** Dao Wen Wang
**Investigator Title:** Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Heart failure (HF) is a complex syndrome with increasing incidence and high rates of mortality and hospitalization. Although inhibitors of angiotensin converting enzyme (ACE), β-blockers and aldosterone-receptor blockers have improved the treatment of heart failure, mortality of HF remains unacceptably high.
Recently, we identified a key metabolite N-acetylneuraminic acid (Neu5Ac) increased in the plasma of patients with heart failure. Also, elevated plasma Neu5Ac, independent of other traditional risk factors, is associated with poor prognosis in patients with HF in long-term follow up. Neu5Ac levels, the most common sialic acid in mammals, generated from sialylated glycoconjugates by neuraminidase. Neu5Ac and its regulatory enzyme neuraminidase play a key role in heart failure. We found neuraminidase inhibitor could reduce Neu5Ac levels and improve heart failure in mice model, providing opportunity for a novel therapeutic strategy in HF. Neuraminidase inhibitor oseltamivir is also an old anti-influenza drug. Using oseltamivir may be a new therapeutic strategy in heart failure.
Based on above information, we designed the randomized, open-label, blank-controlled study in patients with chronic HF to receive either oseltamivir or placebo, in addition to standard HF therapy to Identify the effect of oseltamivir on serum Neu5Ac level in patients with heart failure and assess the clinic outcomes of level in patients with heart failure using oseltamivir.
### Conditions Module
**Conditions:**
- Heart Failure
**Keywords:**
- heart failure
- Neuraminidase inhibitor
- oseltamivir
- Neu5Ac
- NTproBNP
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 388
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** patients with heart failure to receive standard HF therapy
**Label:** Control
**Type:** NO_INTERVENTION
#### Arm Group 2
**Description:** patients with heart failure to receive oseltamivir (at a dose of 75 mg twice daily) for 1 month in addition to standard HF therapy
**Intervention Names:**
- Drug: Oseltamivir
**Label:** Oseltamivir
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Oseltamivir
**Description:** at a dose of 75 mg twice daily
**Name:** Oseltamivir
**Other Names:**
- Neuraminidase Inhibitor
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Reduction of NT-proBNP level at 1 month treatment of Oseltamivir
**Measure:** NT-proBNP
**Time Frame:** 1 month
#### Secondary Outcomes
**Description:** Cardiac systolic function assessed by ejection fraction using echocardiography
**Measure:** EF (ejection fraction)
**Time Frame:** 1month, 6 months
**Description:** NYHA Classification after treatment of Oseltamivir
**Measure:** NYHA Classification
**Time Frame:** 1month, 6 months
**Description:** Minnesota Heart Failure Quality of life assessment after treatment of Oseltamivir
**Measure:** Quality of life assessment
**Time Frame:** 1month, 6 months
**Description:** 6-minute walk test after treatment of Oseltamivir
**Measure:** 6-minute walk test
**Time Frame:** 1month, 6 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. 18 of age or older, regardless of gender;
2. Patients with NYHA II-IV, LVEF less than 40%;
3. Levels of NT-proBNP more than 450 pg/ml
4. Willing to participate in this study and sign an informed consent, and receive follow-up contact for at least 6 months.
Exclusion Criteria:
1. Onset of acute myocardial infarction within the last 1 month;
2. Had cardiac surgery or onset of cerebrovascular accident within the last 6 months;
3. Plan to have cardiac transplantation or CRT, or already having CRT therapy;
4. Females with pregnancy or plan to have pregnancy;
5. Have participate in any other clinical trial within the last 3 months;
6. Severe neurological disorders (Alzheimer's disease, progressive stage of Parkinson's syndrome), disabilities of lower limbs or deaf-mute;
7. had a history of tumour, or precancerous lesions confirmed by pathological tests (ductal carcinoma in situ, cervical dysplasia, etc.);
8. had malignant tumours (by physical examinations, X-ray, type-B ultrasonic imaging or other methods), or had hyperplastic glands or adenoma which possess endocrine activity and affect cardiac or endocrine functions (pheochromocytoma, goitre, etc.);
9. The subjects who refuse to comply with the items of the research protocol;
10. The subjects who are not available to fulfil the follow-up plan (due to project management or other reasons), according to the judgement of researchers.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Li Ni, Phd
**Phone:** 862783662479
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Wuhan
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Li Ni, PHD
- **Phone:** +862783662479
- **Role:** CONTACT
**Country:** China
**Facility:** Tongji Hospital
**State:** Hubei
**Status:** RECRUITING
**Zip:** 430030
#### Overall Officials
**Official 1:**
**Affiliation:** Tongji Hospital
**Name:** Dao Wen Wang, Phd
**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
### Condition Browse Module - Meshes
- ID: D000006333
- Term: Heart Failure
### Intervention Browse Module - Ancestors
- ID: D000000998
- Term: Antiviral Agents
- ID: D000000890
- Term: Anti-Infective Agents
- ID: D000004791
- Term: Enzyme Inhibitors
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Infe
- Name: Anti-Infective Agents
### Intervention Browse Module - Browse Leaves
- ID: M4673
- Name: Azacitidine
- Relevance: LOW
- As Found: Unknown
- ID: M27146
- Name: Oseltamivir
- Relevance: HIGH
- As Found: Self-help
- ID: M4314
- Name: Antiviral Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4214
- Name: Anti-Infective Agents
- Relevance: LOW
- As Found: Unknown
- ID: M7951
- Name: Enzyme Inhibitors
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000053139
- Term: Oseltamivir
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT05739279
**Brief Title:** Sarcopenia and Related Factors in Lipedema
**Official Title:** Evaluation of Sarcopenia and Associated Factors in Patients With Lipedema
#### Organization Study ID Info
**ID:** 7416-GOA
#### Organization
**Class:** OTHER
**Full Name:** Dokuz Eylul University
### Status Module
#### Completion Date
**Date:** 2024-05
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-02-20
**Type:** ACTUAL
**Last Update Submit Date:** 2024-02-18
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-04
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-01-01
**Type:** ACTUAL
**Status Verified Date:** 2024-02
#### Study First Post Date
**Date:** 2023-02-22
**Type:** ACTUAL
**Study First Submit Date:** 2023-02-12
**Study First Submit QC Date:** 2023-02-12
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Dokuz Eylul University
#### Responsible Party
**Investigator Affiliation:** Dokuz Eylul University
**Investigator Full Name:** Nihan ERDINC GUNDUZ
**Investigator Title:** Assistant Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
### Description Module
**Brief Summary:** Lipedema is a common disease of subcutaneous adipose tissue. The most common complaint of patients with swelling in the affected extremity is pain. In addition, patients with lipedema may experience conditions that can greatly affect the health and quality of life of the individual, such as loss of muscle strength and exercise capacity, and deterioration in activity levels of daily living. It is still unknown whether the decrease in muscle strength in patients with lipedema is part of this condition or whether decreased activity levels lead to decreased muscle strength.
Sarcopenia is an important health problem characterized by age-related loss of muscle mass and muscle function. The relationship between muscle weakness and sarcopenia in patients with lipedema has not been investigated before. Early recognition of possible sarcopenia and functional limitations in these patients may be important to increase the ability of patients to participate in physical activity as part of their conservative management.
There is no study in the literature investigating sarcopenia in patients with a diagnosis of lipedema. The aim of this study is to evaluate patients with a diagnosis of lipedema in terms of sarcopenia. In addition, the relationship between sarcopenia and age, body mass index, exercise frequency, lipedema type, and stage will be investigated in patients diagnosed with lipedema.
**Detailed Description:** Lipedema is a chronic progressive condition in women characterized by a disproportionate increase in subcutaneous adipose tissue, accompanied by pain in the legs and sometimes the arms. It was first described in the 1940s and was expressed as fluid accumulation in the wide legs and legs due to subcutaneous fat deposition in the hips and lower extremities. Lipedema is characterized by bilateral enlargement from the hip to the ankle, often sparing the foot, due to abnormal deposition of subcutaneous fat, often with mild edema. The fact that many patients have pain and sensitivity has led to the use of the term painful fat syndrome. The disease usually begins at or just after puberty. Although some lipoedema patients are obese or overweight, the patients often have a normal appearance from the waist up and there is a disproportionate appearance between their trunk and lower extremities. Protection of the hands and feet is typical. This disease, which almost always affects women, has rarely been defined in men due to hormonal disorders or concomitant diseases such as cirrhosis. Although its prevalence is not known exactly, it is thought to be a much more common disease than expected because it is confused with other diseases such as obesity, venous insufficiency, and lymphedema and is a frequently missed diagnosis. Although the results of the studies vary, it has been reported that it is seen at a minimum rate of 1:72.000 or 11% of women affected by this disease.
The pathophysiology of lipoedema is multifactorial, and causes such as increased permeability and capillary fragility due to microangiopathy in adipose tissue, adipocyte necrosis due to hypoxia, and macrophage migration are prioritized. In addition, lymphatic drainage through HIF-1 (hypoxia-inducible factor 1), VEGF (Vascular Endothelial Growth Factor), and FFA (Free Fatty Acid) increases and endothelial barrier function are affected, resulting in impaired vascular circulation due to fluid extravasation and fat accumulation. are held. Estrogen has effects on peripheral and central mechanisms and fat metabolism. The decrease in lipolysis in the femoral region and the increase in lipedema during periods of hormonal changes such as pregnancy, menopause, and oral contraceptive use suggest that hormonal mechanisms are effective on the disease. Preoptic and arcuate nuclei in the hypothalamus; It is involved in lipid mobilization and distribution of white adipose tissue and forms a pathway through ER α (estrogen receptor alpha) and its mediator CART (Cocaine and Amphetamine Regulatory Transcript). Disruption in this regulation pathway also results in regional adipose tissue deposition. There is a family history of 15-64% of the patients, and genetics is thought to be significantly effective. Pedigree studies indicate X-dominant or autosomal-dominant inheritance.
Lipedema usually presents with bilateral extremity swelling that begins in the post-adolescent period, is progressive, does not respond to diet and exercise, does not improve with elevation, and is spontaneous or painful to touch. Patients describe easy bruising with touch or minor trauma. Typically, the hands or feet are not involved, although this may involve the hip and gluteal region. On examination, the skin is often of normal color and texture, and oily hypertrophy may feel soft and pasty. Bruises caused by minor traumas can be observed during the examination. It does not leave pitting after long-term pressure is applied with the finger, and the Stemmer sign, which is observed by compressing the skin on the dorsum of the foot, is negative. Evaluation of these two findings is important in differentiating it from lymphedema. Lipedema consists of 5 major types:
* Type 1 pelvis, gluteal region, and hips,
* Type 2 extending from the gluteal region to the knees and with fat folds in the inner parts of the knees,
* Type 3 extending from the gluteal region to the ankles,
* Type 4 located in arms,
* Type 5 is defined as the presence of isolated swelling in the lower part of the legs.
Types 1-3 are the 3 most common. Lipedema can be seen in 3 stages. In stage 1, the skin surface is normal, the subcutaneous tissue is enlarged, and small nodules are present on palpation. In stage 2, the skin surface is irregular, and large fat nodules are seen. In stage 3, the skin contour is lobulated due to the increase in adipose tissue, and large nodules and deformities are observed. Some sources state the form of lipedema accompanied by lymphedema is stage 4, and this is called lipo lymphedema.
The diagnosis is made clinically, and the history and physical examination can be supported by assistive imaging techniques. The skin and subcutaneous tissue can be examined qualitatively and quantitatively by ultrasonography, computed tomography, or magnetic resonance imaging.
Sarcopenia is an important health problem characterized by age-related loss of muscle mass and muscle function. It is a harbinger of physical fragility and limitation of movement. Muscle wasting is mainly due to the loss of type II muscle fibers, and progressive motor neuron loss is thought to be the primary underlying factor. Anterior thigh muscles atrophy earlier and loss of anterior thigh muscle function may therefore be a precursor finding.
Experts in the sarcopenia special interest group (ISarcoPRM) under the umbrella of the International Society for Physical and Rehabilitation Medicine (ISPRM) have developed a new algorithm based on regional measurements and functional assessments of the anterior thigh muscle, which is initially and most frequently affected in sarcopenia.
The iSarcoPRM has proposed a new measurement that uses anterior thigh muscle measurements for early assessment and rapid diagnosis of low muscle mass and confirmation of sarcopenia. Accordingly, STAR- (sonographic thigh adjustment ratio) sonographic thigh adjustment ratio is found by dividing anterior thigh muscle thickness by body mass index. Using two standard deviation values of healthy young adults, the threshold values for the sonographic thigh fit ratio were found to be 1.4 and 1.0 for male and female subjects, respectively.
As sarcopenia diagnostic criteria;
* STAR- (sonographic thigh adjustment ratio) sonographic thigh adjustment ratio below 1.4 and 1.0 for men and women, respectively
* For muscle strength measurement, hand grip strength is below 32 and 19 kg for men and women, respectively
* It is recommended that the 5-repeat stand-up test (CST (chair stand test)) be longer than 12 seconds.
It has been suggested that walking speed (6 meters) ≤0.8 m/s or inability to get up from a chair without support (limited movement) should be the primary outcome, not part of the diagnostic criteria.
Although pain is the most common complaint of patients with lipoedema along with swelling in the involved extremity, conditions such as loss of muscle strength and exercise capacity, and deterioration in daily life activity levels, can greatly affect the health and quality of life of the individual, can also be seen.
These patients have thickening of the lower extremities beginning in adolescence; limited exercise, dietary changes, or swelling of the affected extremities; they have a medical history that includes limitations in functionality such as fatigue, family history, inability to work, and loss of activity level.
It is still unknown whether the decrease in muscle strength in patients with lipoedema is part of this condition or whether decreased activity levels lead to decreased muscle strength. The relationship between muscle weakness and sarcopenia in these patients has not been investigated before. Early recognition of possible sarcopenia and functional limitations in this patient group may be important to increase the ability of patients to participate in physical activity as a part of conservative management. There is no study in the literature investigating sarcopenia in patients with a diagnosis of lipedema. This study aims to evaluate patients with a diagnosis of lipedema in terms of sarcopenia.
### Conditions Module
**Conditions:**
- Lipedema
- Sarcopenia
- Musculoskeletal Diseases
**Keywords:**
- Lipedema
- Sarcopenia
- Musculoskeletal Diseases
### Design Module
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** CROSS_SECTIONAL
#### Enrollment Info
**Count:** 102
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients between the ages of 18-85, diagnosed with lipedema, accepted to participate in the study, and at the appropriate sociocultural level to participate in the study are included in this group.
**Intervention Names:**
- Diagnostic Test: STAR-Sonographic Thigh Adjustment Ratio
- Diagnostic Test: Hand Grip Strength
- Diagnostic Test: Chair Stand Test
- Diagnostic Test: 6 Meter Gait Speed
**Label:** Lipedema Group
#### Arm Group 2
**Description:** Those between the ages of 18-85, in an age group similar to the lipoedema group, who agreed to participate in the study, and who were at the appropriate sociocultural level to participate in the study are included in this group.
**Intervention Names:**
- Diagnostic Test: STAR-Sonographic Thigh Adjustment Ratio
- Diagnostic Test: Hand Grip Strength
- Diagnostic Test: Chair Stand Test
- Diagnostic Test: 6 Meter Gait Speed
**Label:** Control Group
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Control Group
- Lipedema Group
**Description:** With ultrasonography, anterior thigh muscle thickness on the dominant extremity side will be measured at a 50% level between the anterior superior iliac spine and the upper pole of the patella in the supine position. The STAR-sonographic thigh adjustment ratio will be calculated by dividing the anterior thigh muscle thickness (mm) by the body mass index.
**Name:** STAR-Sonographic Thigh Adjustment Ratio
**Type:** DIAGNOSTIC_TEST
#### Intervention 2
**Arm Group Labels:**
- Control Group
- Lipedema Group
**Description:** Hand grip strength will be measured with a Jamar dynamometer used in the second grip position, in a sitting position with shoulders adducted and neutrally rotated, elbows flexed to 90°, and forearms/wrists in the neutral position. Three repetitive measurements will be made from the dominant side and the maximum value obtained for analysis will be taken.
**Name:** Hand Grip Strength
**Type:** DIAGNOSTIC_TEST
#### Intervention 3
**Arm Group Labels:**
- Control Group
- Lipedema Group
**Description:** For the 5-repeat stand-up test, patients will be asked to get up from a chair without an armrest and sit (at the start) five times as fast as possible with their arms crossed over their chest.
**Name:** Chair Stand Test
**Type:** DIAGNOSTIC_TEST
#### Intervention 4
**Arm Group Labels:**
- Control Group
- Lipedema Group
**Description:** For walking speed measurements, patients will be asked to stand with both feet touching the starting line and walk at their normal speed on a 6-meter track after the command. The time between the start and end will be measured with a stopwatch and converted to meters/second. Three consecutive measurements will be made for both and average values will be taken for the analyses.
**Name:** 6 Meter Gait Speed
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** With ultrasonography, anterior thigh muscle thickness on the dominant extremity side will be measured at a 50% level between the anterior superior iliac spine and the upper pole of the patella in the supine position. The STAR-sonographic thigh adjustment ratio will be calculated by dividing the anterior thigh muscle thickness (mm) by the body mass index.
**Measure:** STAR-Sonographic Thigh Adjustment Ratio
**Time Frame:** Day 1
**Description:** Hand grip strength will be measured with a Jamar dynamometer used in the second grip position, in a sitting position with shoulders adducted and neutrally rotated, elbows flexed to 90°, and forearms/wrists in the neutral position. Three repetitive measurements will be made from the dominant side and the maximum value obtained for analysis will be taken.
**Measure:** Hand Grip Strength
**Time Frame:** Day 1
**Description:** For the 5-repeat stand-up test, patients will be asked to get up from a chair without an armrest and sit (at the start) five times as fast as possible with their arms crossed over their chest.
**Measure:** Chair Stand Test
**Time Frame:** Day 1
#### Secondary Outcomes
**Description:** For walking speed measurements, patients will be asked to stand with both feet touching the starting line and walk at their normal speed on a 6-meter track after the command. The time between the start and end will be measured with a stopwatch and converted to meters/second. Three consecutive measurements will be made for both and average values will be taken for the analyses
**Measure:** 6 Meter Gait Speed
**Time Frame:** Day 1
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* between the ages of 18-85
* with a diagnosis of lipoedema
* who agreed to participate in the study
* having a sociocultural level suitable for participation in the study
* healthy volunteers in a similar age group for the control group
Exclusion Criteria:
* with chronic venous insufficiency and/or lymphedema
* with Parkinson's disease, previous stroke, cerebellar diseases, multiple sclerosis, major depression, neuromuscular diseases, history of major orthopedic surgery, severe hip/knee osteoarthritis, rheumatological diseases, malignancies, advanced heart/liver/renal failure, visual impairment, and vestibular diseases, and those who use any assistive device to walk
* who are illiterate and have cognitive impairment that will prevent them from giving written consent will not be included in the study
**Healthy Volunteers:** True
**Maximum Age:** 85 Years
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Descriptive, cross-sectional, case-control
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Nihan Erdinc Gunduz, M.D.
**Phone:** +905063992614
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Izmir
**Contacts:**
***Contact 1:***
- **Name:** Nihan Erdinc Gunduz
- **Role:** CONTACT
**Country:** Turkey
**Facility:** Department of Physical Medicine and Rehabilitation, Medical Faculty of Dokuz Eylül University, İzmir, Turkey
**Status:** RECRUITING
#### Overall Officials
**Official 1:**
**Affiliation:** Dokuz Eylul University
**Name:** Nihan Erdinc Gunduz, M.D.
**Role:** STUDY_DIRECTOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009133
- Term: Muscular Atrophy
- ID: D000020879
- Term: Neuromuscular Manifestations
- ID: D000009461
- Term: Neurologic Manifestations
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000001284
- Term: Atrophy
- ID: D000020763
- Term: Pathological Conditions, Anatomical
- ID: D000003240
- Term: Connective Tissue Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC05
- Name: Musculoskeletal Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
### Condition Browse Module - Browse Leaves
- ID: M12097
- Name: Musculoskeletal Diseases
- Relevance: HIGH
- As Found: Musculoskeletal Diseases
- ID: M28396
- Name: Sarcopenia
- Relevance: HIGH
- As Found: Sarcopenia
- ID: M30472
- Name: Lipedema
- Relevance: HIGH
- As Found: Lipedema
- ID: M12090
- Name: Muscular Atrophy
- Relevance: LOW
- As Found: Unknown
- ID: M4589
- Name: Atrophy
- Relevance: LOW
- As Found: Unknown
- ID: M22619
- Name: Neuromuscular Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: M22519
- Name: Pathological Conditions, Anatomical
- Relevance: LOW
- As Found: Unknown
- ID: M6464
- Name: Connective Tissue Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000009140
- Term: Musculoskeletal Diseases
- ID: D000055948
- Term: Sarcopenia
- ID: D000065134
- Term: Lipedema
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT04333979
**Brief Title:** The Effect of Drain Use on Patient Comfort in Laparoscopic Sleeve Gastrectomy
**Official Title:** Effect of Drain Usage on Patient Comfort on Laparoscopic Sleeve Gastrectomy
#### Organization Study ID Info
**ID:** 2016-181
#### Organization
**Class:** OTHER
**Full Name:** Inonu University
### Status Module
#### Completion Date
**Date:** 2017-06-22
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2020-04-03
**Type:** ACTUAL
**Last Update Submit Date:** 2020-04-02
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2017-06-22
**Type:** ACTUAL
#### Start Date
**Date:** 2016-12-09
**Type:** ACTUAL
**Status Verified Date:** 2020-04
#### Study First Post Date
**Date:** 2020-04-03
**Type:** ACTUAL
**Study First Submit Date:** 2019-01-08
**Study First Submit QC Date:** 2020-04-02
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Inonu University
#### Responsible Party
**Investigator Affiliation:** Inonu University
**Investigator Full Name:** Ersin Gündoğan
**Investigator Title:** Doctor- lecturer-Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Introduction Laparoscopic sleeve gastrectomy surgeon; Have become increasingly morbid obesity treatment methods with improvements in minimally invasive surgery. Ensuring patient comfort and early return to life are the criteria that should be given priority in this treatment method. The purpose of this study is to determine the use of drain, which closely affects these criteria; And the effect on patient comfort.
**Detailed Description:** Question the necessity of routine use of drain in Laparoscopic sleeve gastrectomy surgeon
### Conditions Module
**Conditions:**
- Obesity, Morbid
**Keywords:**
- obesity
- VAS
- Pain
- Laparoscopy
- Sleeve
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 50
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Effects of drainage
**Intervention Names:**
- Other: Drainage
**Label:** Drain replacement
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Effects of not using drain
**Label:** Drain not placed
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Drain replacement
**Description:** Using drain after operation
**Name:** Drainage
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** self reported pain intensity morning. item is scored 0-10 ( 0: no pain- 10: pain as bad as can be)
**Measure:** Pain Intensity measure
**Time Frame:** 6 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Morbid obese patients
Exclusion Criteria:
* - Cirrhotic patients, those under 18 years of age, additional intraabdominal surgeries during Laparoscopic sleeve gastrectomy and those who had previously undergone obesity surgery (revision surgery) were excluded
**Healthy Volunteers:** True
**Maximum Age:** 65 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### 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: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M12701
- Name: Obesity
- Relevance: LOW
- As Found: Unknown
- ID: M12702
- Name: Obesity, Morbid
- Relevance: HIGH
- As Found: Obesity, Morbid
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- 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
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT05778279
**Brief Title:** Role of New High Resolution Ultrasonographic Modalities for Diagnosis of Fetal Nervous System Anomalies
**Official Title:** Role of New High Resolution Ultrasonographic Modalities for Diagnosis of Fetal Nervous System Anomalies
#### Organization Study ID Info
**ID:** woman's Health University H
#### Organization
**Class:** OTHER
**Full Name:** Woman's Health University Hospital, Egypt
### Status Module
#### Completion Date
**Date:** 2026-02-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-04-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-04-23
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2026-01-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-09-30
**Type:** ESTIMATED
**Status Verified Date:** 2024-04
#### Study First Post Date
**Date:** 2023-03-21
**Type:** ACTUAL
**Study First Submit Date:** 2023-01-20
**Study First Submit QC Date:** 2023-03-18
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Woman's Health University Hospital, Egypt
#### Responsible Party
**Investigator Affiliation:** Woman's Health University Hospital, Egypt
**Investigator Full Name:** Professor Atef Darwish
**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 fetal CNS screening examination during the mid-trimester scan in low-risk pregnancies should include evaluation of the fetal head and spine, using transabdominal sonography. Evaluation of two axial planes allows visualization of the relevant cerebral structures to assess the anatomic integrity of the fetal brain.These planes are commonly referred to as the transventricular and transcerebellar planes. A third plane, the so-called transthalamic plane, is frequently added, mostly for the purpose of biometry. Structures that should be noted in the routine examination include the lateral ventricles, the cerebellum, the cisterna magna, and the cavum septi pellucidi (CSP). Head shape and brain texture should also be noted on these views.
**Detailed Description:** The neural system malformation is one of the more common congenital anomalies encountered in pregnancy. They represent about 0.3-1 percent of all live births. During a prenatal anomaly scan, detection of CNS malformations is important, especially since these anomalies have a poor prognosis and are also associated with genetic syndromes or chromosomal anomalies. Such malformations have clinical importance because they are associated with high rates of morbidity and mortality, influencing the neurocognitive and motor development of the survivors, who may have lifelong sequelae. Thus, it's extremely important to assess the fetal CNS during the prenatal period in order to identify any changes in its development and give appropriate advice to parents regarding pregnancy follow-up. Also, it is vital to explore options for fetal therapy and the timing/type of delivery, as well as postnatal treatment and prognosis.
The fetal CNS screening examination during the mid-trimester scan in low-risk pregnancies should include evaluation of the fetal head and spine, using transabdominal sonography. Evaluation of two axial planes allows visualization of the relevant cerebral structures to assess the anatomic integrity of the fetal brain.These planes are commonly referred to as the transventricular and transcerebellar planes. A third plane, the so-called transthalamic plane, is frequently added, mostly for the purpose of biometry. Structures that should be noted in the routine examination include the lateral ventricles, the cerebellum, the cisterna magna, and the cavum septi pellucidi (CSP). Head shape and brain texture should also be noted on these views.
### Conditions Module
**Conditions:**
- Ultrasound Therapy; Complications
- Anomaly
- Central Nervous System Diseases
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 150
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
### Interventions
#### Intervention 1
**Description:** High-resolution ultrasonography to detect fetal CNS anomalies
**Name:** High-resolution ultrasonography
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** tO DETECT PREVELANCE OF FETAL BRAIN CONGENITAL ANOMALIES UTILIZING STANDARD THREE-AXIAL VIEW (TRANSTHALAMIC, TRANSVENTRICULAR AND TRANSCEREBELLER ) WITH 2D ULTRASONOGRAPHY .
**Measure:** PREVELANCE OF FETAL BRAIN ANOMALIES UTILIZING THREE-AXIAL VIEW WITH 2D ULTRASONOGRAPHY .
**Time Frame:** 2 years
**Description:** PREVELANCE OF FETAL BRAIN ANOMALIES UTILIZING ADDITIONAL 2 VIEWS (TRANCALVERIAL AND TRANSGENU AND SPELNIUM) TO THE STANDARD THREE-AXIAL VIEW WITH 2D ULTRASONOGRAPHY .
**Measure:** PREVELANCE OF FETAL BRAIN ANOMALIES UTILIZING ADDITIONAL 2 VIEWS TO THE STANDARD THREE-AXIAL VIEW WITH 2D ULTRASONOGRAPHY .
**Time Frame:** 2 years
**Description:** PREVELANCE OF FETAL NERVOUS SYSTEM ANOMALIES UTILIZING 3D ULTRASONOGRAPHY BY SURFACE 3 D, MULTIPLANNER AND MULTISLICE VIEWS .
**Measure:** PREVELANCE OF FETAL NERVOUS SYSTEM ANOMALIES UTILIZING 3D ULTRASONOGRAPHY .
**Time Frame:** 2 YEARS
### Eligibility Module
**Eligibility Criteria:** 1. Inclusion criteria:
2. Suspicion of CNS or spinal malformation at routine screening ultrasound
3. Suspicion of CNS or spinal malformation at nuchal translucency scan
4. Family history of inheritable CNS spinal malformations
5. Previous pregnancy complicated by fetal brain or spinal malformation
6. Fetus with congenital heart disease
7. Monochorionic twins
8. Suspected congenital intrauterine infection Exposure to teratogens known to affect neurogenesis
Exclusion Criteria:
* Low risk pregnancy
**Maximum Age:** 28 Years
**Minimum Age:** 20 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** FEMALE
**Standard Ages:**
- ADULT
**Study Population:** all pregnant women with gestational age between 20 and 28 weeks coming to outpatient clinic for antenatal care with one or more of the following inclusion criteria will be included in this study.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Dina Darwish, MRCOG
**Phone:** 0201001572723
**Role:** CONTACT
**Contact 2:**
**Name:** Atef Darwish
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Assiut
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Atef MM Darwish, MD PhD
- **Phone:** 0201001572723
- **Role:** CONTACT
**Country:** Egypt
**Facility:** Woman's Health University Hospital
**Status:** RECRUITING
**Zip:** 71111
#### Overall Officials
**Official 1:**
**Affiliation:** Woman's Health University Hospital
**Name:** Dina Darwish, MRCOG
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC16
- Name: Diseases and Abnormalities at or Before Birth
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
### Condition Browse Module - Browse Leaves
- ID: M12
- Name: Congenital Abnormalities
- Relevance: HIGH
- As Found: Anomalies
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: HIGH
- As Found: Central Nervous System Diseases
- ID: M12365
- Name: Nervous System Malformations
- Relevance: HIGH
- As Found: Nervous System Anomalies
### Condition Browse Module - Meshes
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009421
- Term: Nervous System Malformations
- ID: D000000013
- Term: Congenital Abnormalities
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT03824379
**Brief Title:** Magnesium Supplementation in Diabetic Nephropathy
**Official Title:** The Impact of Magnesium Supplementation on the Clinical Outcome of Patients of Diabetic Nephropathy
#### Organization Study ID Info
**ID:** PHCL932
#### Organization
**Class:** OTHER
**Full Name:** Ain Shams University
### Status Module
#### Completion Date
**Date:** 2020-03-01
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-01-12
**Type:** ACTUAL
**Last Update Submit Date:** 2021-01-11
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2020-03-01
**Type:** ACTUAL
#### Start Date
**Date:** 2019-06-01
**Type:** ACTUAL
**Status Verified Date:** 2021-01
#### Study First Post Date
**Date:** 2019-01-31
**Type:** ACTUAL
**Study First Submit Date:** 2019-01-26
**Study First Submit QC Date:** 2019-01-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Ain Shams University
#### Responsible Party
**Investigator Affiliation:** Ain Shams University
**Investigator Full Name:** Nihal Mohamed Halawa
**Investigator Title:** clinical Pharmacist
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Higher prevalence of hypomagnesaemia in diabetic patients with nephropathy was compared to those without nephropathy. Serum magnesium levels were significantly inversely correlated with serum creatinine and U-A/C ratio, and positively correlated with glomerular filtration rate (GFR).
Hence, Magnesium supplementation using magnesium salts could be a good approach to improve the cardiovascular complications, insulin resistance index, lipid profile and kidney function in diabetic nephropathy patients.
**Detailed Description:** Diabetic nephropathy is a serious kidney-related complication of type 1 diabetes and type 2 diabetes. It is also called diabetic kidney disease. Up to 40 percent of people with diabetes eventually develop kidney disease. Over time, elevated blood sugar associated with uncontrolled diabetes causes high blood pressure which in turn damages the kidneys by increasing kidney filtration pressure. Complications of diabetic nephropathy include heart and blood vessel disease (cardiovascular disease), fluid retention and hyperkalemia. Magnesium (Mg) is the fourth most abundant cation in the body and the second most important intracellular cation. It plays an essential role in biological systems as co-factor for more than 300 essential enzymatic reactions such as signal transduction, energy metabolism, vascular processes and bone metabolism. Normal serum Mg concentrations ranges from 0.7 to 1.1 mmol/L (1.4-2.0 mEq/L or 1.7-2.4 mg/dL). Outcome studies in the general population have indicated potential associations between low serum Mg levels and atherosclerosis, hypertension, diabetes, and left ventricular hypertrophy, as well as both CVD mortality and all-cause mortality. Low SMg levels (1.4-1.9 mg/dL; 0.58-0.78 mM) were independently associated with all-cause death in patients with prevalent CKD. Higher prevalence of hypomagnesaemia in diabetic patients with nephropathy compared to those without nephropathy. Serum magnesium levels were significantly inversely correlated with serum creatinine and U-A/C ratio, and positively correlated with glomerular filtration rate (GFR). Magnesium deficiency promotes hydroxyapatite formation and calcification of vascular smooth muscle cells . It is closely related to insulin resistance and metabolic syndrome. A lower Mg level is directly associated with a faster deterioration of renal function in T2DM patients. Moreover, hypomagnesemia is associated with the long-term micro- and macrovascular complications of T2DM. A dysregulation of mineral metabolism, reflected by altered levels of magnesium and FGF-23, correlates with an increased urinary albumin to creatinine ratio (UACR) in type 2 diabetic patients with CKD stages 2-4. Also, a link between hypomagnesemia and atherogenic dyslipidemia alterations exists; a significantly raised total cholesterol and LDL and non-HDL in patients with CKD are observed, suggesting a link to increased cardiovascular risk in CKD patients. Increasing magnesium levels could attenuate the cardiovascular risk derived from hyperphosphatemia, hence the CKD progression. Current literature suggests that Mg may have a protective effect on the CV system. Mg supplementation improves the insulin resistance index and beta-cell function, and decreases hemoglobin A1c levels in type 2 DM patients. In animal models of vascular calcification VC, dietary supplementation with magnesium results in marked reduction in VC and mortality, improved mineral metabolism, including lowering of PTH, as well as improvement in renal function. Hence, Magnesium supplementation using magnesium salts could be a good approach to improve the cardiovascular complications, insulin resistance index, lipid profile and kidney function in diabetic nephropathy patients.
### Conditions Module
**Conditions:**
- Diabetic Nephropathies
**Keywords:**
- magnesium
- diabetic nephropathy
- osteocalcin
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** prospective randomized controlled open label study
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 60
**Type:** ACTUAL
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** 30 patients will receive the standard therapy (anti-diabetic ) + magnesium supplement
**Intervention Names:**
- Dietary Supplement: Magnesium citrate
- Drug: Antidiabetic
**Label:** Magnesium arm
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** 30 patients will receive the standard therapy (anti-diabetic)
**Intervention Names:**
- Drug: Antidiabetic
**Label:** Control
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Magnesium arm
**Description:** magnesium citrate equivalent 20-30 mmol elemental magnesium
**Name:** Magnesium citrate
**Type:** DIETARY_SUPPLEMENT
#### Intervention 2
**Arm Group Labels:**
- Control
- Magnesium arm
**Description:** insulin or oral hypoglycemics
**Name:** Antidiabetic
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Evaluation of the extent of cardiovadcular events
**Measure:** Change of Human Serum Osteocalcin level
**Time Frame:** Change from baseline Human Serum Osteocalcin level at 12 weeks
#### Secondary Outcomes
**Description:** Evaluation of Glycemic Status
**Measure:** Serum Insulin
**Time Frame:** Samples will be measured at baseline and after 12 weeks
**Description:** (HOMA-IR), developed by Matthews et al. will be used to assess insulin resistance. The following formula will be used in its calculation: HOMA IR = (fasting glucose mg/dl × fasting insulin μU/ml)/22.5 × 18. A normal value was considered to be \<2.5
**Measure:** The homeostasis model assessment-estimated insulin resistance (HOMA-IR)
**Time Frame:** Assessed at baseline and after 12 weeks
**Description:** Evaluation of Glycemic Status
**Measure:** Hemoglobin A1c level
**Time Frame:** Samples will be measured at baseline and after 12 weeks
**Description:** Evaluation of Glycemic Status
**Measure:** Fasting and Post Prandial Blood Sugar level
**Time Frame:** Samples will be measured at baseline and after 12 weeks
**Description:** Evaluation of kidney function
**Measure:** Serum creatinine
**Time Frame:** Samples will be measured at baseline and after 12 weeks
**Description:** Evaluation of kidney function
**Measure:** Blood Urea Nitrogen Concentration
**Time Frame:** Samples will be measured at baseline and after 12 weeks
**Description:** Evaluation of kidney function. GFR (mL/min/1.73 m2) = 175 × (Scr)-1.154 × (Age)-0.203 × (0.742 if female) × (1.212 if African American)
**Measure:** eGFR using the MDRD equation
**Time Frame:** Samples will be measured at baseline and after 12 weeks
**Description:** Evaluation of SMg level
**Measure:** Serum Magnesium
**Time Frame:** Samples will be measured at baseline, 6 weeks and 12 weeks
**Description:** Serum Low-density Lipoprotein Cholesterol (LDL-C), High-density Lipoprotein Cholesterol (HDL-C), Total Cholesterol, Triglycerides
**Measure:** Evaluation of Lipid profile
**Time Frame:** Samples will be measured at baseline and after 12 weeks
**Description:** Fatigue Assessment using Fatigue Severity Scale (FSS). It is a 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle in a variety of disorders.
\> 4 points indicates no fatigue 4 points or more indicates increasing fatigue
**Measure:** Fatigue Assessment
**Time Frame:** Assessed at baseline and after 12 weeks
**Description:** Quality of Life (QoL) assessment using D-39 Questionnaire
**Measure:** Quality of Life (QoL) Assessment: D-39 Questionnaire
**Time Frame:** Assessed at baseline and after 12 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Age ≥ 18 years.
2. Type I or II diabetic patientCKD stage 3 ( eGFR = 30 - 59 ml/min) or stage 4 ( eGFR 15-29 ml/min)
3. Proteinuria 30-300 mg/dl (microalbuminuria)
4. Low SMg levels (1.4-1.9 mg/dL; 0.58-0.78 mM) to normal (1.7-2.4 mg/dL; 0.7 -1.1 mmol/L; 1.4-2.0 mEq/L).
5. Life expectancy \>12 months.
6. Women of child-bearing age should be using contraceptives as Hormonal contraceptive or Intra-uterine device.
Exclusion Criteria:
1. Kidney donor recipient.
2. Current treatment with Mg supplements.
3. Any condition impairing intestinal absorption of Mg (e.g: chronic pancreatitis, short bowel syndrome)
4. Active malignancy.
5. Pregnancy or breastfeeding.
6. Cardiac Arrythmias.
7. Allergy towards the Mg supplement.
8. Participation in other interventional trials.
**Maximum Age:** 85 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Cairo
**Country:** Egypt
**Facility:** Ain Shams University Hospitals
**State:** Abbasseia
**Zip:** 12345
#### Overall Officials
**Official 1:**
**Affiliation:** Faculty of Pharmacy - Ain Shams University
**Name:** Nihal Halawa
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000014570
- Term: Urologic Diseases
- ID: D000052776
- Term: Female Urogenital Diseases
- ID: D000005261
- Term: Female Urogenital Diseases and Pregnancy Complications
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000052801
- Term: Male Urogenital Diseases
- ID: D000048909
- Term: Diabetes Complications
- ID: D000003920
- Term: Diabetes Mellitus
- ID: D000004700
- Term: Endocrine System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: All
- Name: All Conditions
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
### Condition Browse Module - Browse Leaves
- ID: M10698
- Name: Kidney Diseases
- Relevance: HIGH
- As Found: Nephropathy
- ID: M7123
- Name: Diabetic Nephropathies
- Relevance: HIGH
- As Found: Diabetic Nephropathy
- ID: M17319
- Name: Urologic 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: M27095
- Name: Male Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7115
- Name: Diabetes Mellitus
- Relevance: LOW
- As Found: Unknown
- ID: M26004
- Name: Diabetes Complications
- Relevance: LOW
- As Found: Unknown
- ID: M7862
- Name: Endocrine System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000007674
- Term: Kidney Diseases
- ID: D000003928
- Term: Diabetic Nephropathies
### Intervention Browse Module - Ancestors
- ID: D000002400
- Term: Cathartics
- ID: D000005765
- Term: Gastrointestinal 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
- Abbrev: AnCoag
- Name: Anticoagulants
- Abbrev: Gast
- Name: Gastrointestinal Agents
- Abbrev: Ot
- Name: Other Dietary Supplements
- Abbrev: Mi
- Name: Mineral
### Intervention Browse Module - Browse Leaves
- ID: M10365
- Name: Insulin
- Relevance: LOW
- As Found: Unknown
- ID: M10054
- Name: Hypoglycemic Agents
- Relevance: HIGH
- As Found: Omegaven
- ID: M173166
- Name: Insulin, Globin Zinc
- Relevance: LOW
- As Found: Unknown
- ID: M21320
- Name: Citric Acid
- Relevance: LOW
- As Found: Unknown
- ID: M1837
- Name: Sodium Citrate
- Relevance: LOW
- As Found: Unknown
- ID: M209491
- Name: Magnesium citrate
- Relevance: HIGH
- As Found: Adolescence
- 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
- ID: T382
- Name: Citrate
- Relevance: HIGH
- As Found: Free
- ID: T342
- Name: Magnesium Supplement
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000007004
- Term: Hypoglycemic Agents
- ID: C000110422
- Term: Magnesium citrate
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT05249179
**Brief Title:** Comparison of the Effects of Oral Stimulation and Non-nutritive Sucking Practices
**Official Title:** Comparison of the Effects of Oral Stimulation and Non-nutritive Sucking Practices on the Transition to Full Oral Feeding in Infants With a Gestational Age of 26-32 Weeks
#### Organization Study ID Info
**ID:** E2-21-883
#### Organization
**Class:** OTHER
**Full Name:** Ankara City Hospital Bilkent
### Status Module
#### Completion Date
**Date:** 2024-08-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-02-21
**Type:** ACTUAL
**Last Update Submit Date:** 2022-02-18
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-01-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2022-04-01
**Type:** ESTIMATED
**Status Verified Date:** 2021-12
#### Study First Post Date
**Date:** 2022-02-21
**Type:** ACTUAL
**Study First Submit Date:** 2021-12-11
**Study First Submit QC Date:** 2022-02-18
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Ankara City Hospital Bilkent
#### 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 study, it was aimed to compare the effects of oral stimulation and non-nutritive sucking practices on the transition to full oral feeding in babies with a gestational age of 26-32 weeks. Non-oral feeding methods are frequently used in babies born prematurely since sucking and sucking-swallowing coordination have not yet developed. While some premature babies gain the sucking and swallowing reflexes faster, some of them cannot develop this reflex for a long time, so the length of hospital stay is prolonged. All infants who can be fed completely enterally (PMA \>29 weeks) will be randomized into 4 groups as oral stimulation (group 1), pacifier (group 2), oral stimulation + pacifier (group 3), and control group by using a stratified blocked randomization method with a block size of 4. Stratification on GA (26-27, 28-29, 30-32 weeks GA) was used to ensure that the groups had similar gestational age distribution. The time of the patients to start breastfeeding and the length of hospital stay (days) will be compared.
### Conditions Module
**Conditions:**
- Premature
- Nutrition Disorders
- Sucking Behavior
**Keywords:**
- Sucking
- Oral stimulation
- Premature baby
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 140
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The group that will receive oral stimulation with the Backman method once a day from the 29th week
**Intervention Names:**
- Other: Oral stimulation
**Label:** Group 1 (Oral stimulation)
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The group that will be given a pacifier three times a day from the 29th week
**Intervention Names:**
- Other: Pacifier
**Label:** Group 2 (Pacifier)
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Starting from the 29th week, the group will be given a pacifier three times a day and a Backman oral stimulation will be applied once a day.
**Intervention Names:**
- Other: Pacifier
- Other: Oral stimulation
**Label:** Group 3 (oral stimulation + pacifier)
**Type:** EXPERIMENTAL
#### Arm Group 4
**Description:** The group fed enterally by tube in routine practice, in which no intervention will be made.
**Label:** Group 4 (Enteral feeding by tube)
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Group 2 (Pacifier)
- Group 3 (oral stimulation + pacifier)
**Description:** Preterm infants in Groups 2 and 3 will suck a pacifier 3 times a day (09:00, 12:00, 15:00) for 3 minutes before feeding and then they will be fed with the O/G feeding tube.
**Name:** Pacifier
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Group 1 (Oral stimulation)
- Group 3 (oral stimulation + pacifier)
**Description:** Infants in groups 1 and 3 will receive a prefeeding oral stimulation program once a day, 15 to 30 minutes before a tube feeding. Oral stimulation programs will be delivered by trained nurses or pediatric physical therapies. Nurses will be trained to deliver the stimulation program to the infants, by a member from the pediatric physical therapies medical staff, before the beginning of the study. Based on Backman's principles, the pre-feeding oral stimulation program consisted of a 12-minute stimulation program that included stroking the cheeks, lips, gums, and tongue.
**Name:** Oral stimulation
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The effect of oral stimulation and/or pacifier use on full oral feeding time in premature infants.
**Measure:** Full oral feeding time (postmenstruel week)
**Time Frame:** 2 years
**Description:** The effect of oral stimulation and/or pacifier use on hospital stay in premature infants
**Measure:** Hospital stay (days)
**Time Frame:** 2 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Preterm babies born between 26-32 weeks (including 26 and 32 weeks)
Exclusion Criteria:
* Babies with congenital anomalies
* Babies born with asphyxia
* Babies with major GIS anomalies
* Babies who have undergone major GIS surgery
**Maximum Age:** 6 Months
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Mustafa S Akin, Specialist
**Phone:** +90 555 876 05 85
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Ankara Bilkent Central Hospital, Neonatal Unit
**Name:** Nilgün Altuntas, Proff
**Role:** STUDY_DIRECTOR
**Official 2:**
**Affiliation:** Ankara Bilkent Central Hospital, Neonatal Unit
**Name:** Suna S Oguz, Proff
**Role:** STUDY_DIRECTOR
**Official 3:**
**Affiliation:** Ankara Bilkent Central Hospital, Neonatal Unit
**Name:** Mustafa S Akin, Specialist
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**Description:** No agreement yet to share with other researchers
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
### Condition Browse Module - Browse Leaves
- ID: M12684
- Name: Nutrition Disorders
- Relevance: HIGH
- As Found: Nutrition Disorders
- ID: M25869
- Name: Premature Birth
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000009748
- Term: Nutrition Disorders
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT04691479
**Acronym:** PIMA1-JO-PR
**Brief Title:** Adherence and Quality of Life of CPAP for Obstructive Sleep Apnea
**Official Title:** Adherence and Quality of Life of CPAP for Obstructive Sleep Apnea With an Intervention Based on Stratification and Personalization of Care Plans: a Randomized Controlled Trial
#### Organization Study ID Info
**ID:** PIMA1-3450
#### Organization
**Class:** INDUSTRY
**Full Name:** Air Liquide Healthcare Spain
#### Secondary ID Infos
**Domain:** Ethics Committee for Clinical Research
**ID:** 3450
**Type:** REGISTRY
### Status Module
#### Completion Date
**Date:** 2018-11-20
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2020-12-31
**Type:** ACTUAL
**Last Update Submit Date:** 2020-12-29
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2018-09-11
**Type:** ACTUAL
#### Start Date
**Date:** 2018-03-10
**Type:** ACTUAL
**Status Verified Date:** 2020-12
#### Study First Post Date
**Date:** 2020-12-31
**Type:** ACTUAL
**Study First Submit Date:** 2020-12-21
**Study First Submit QC Date:** 2020-12-29
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Hospital Universitari Joan XXIII de Tarragona.
**Class:** OTHER
**Name:** Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Air Liquide Healthcare Spain
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** A multicentre, randomized controlled trial (RCT) design.The control group followed the usual treatment, while the intervention group (PIMA) followed the treatment with an adapted and flexible care plan depending on socio-demographic, clinical and psychological variables. The treatment plan includes different channels (home, telephone, care center), a continuous evaluation, and the use of the motivational interview in each of the interventions with the patient. The main outcome was adherence. Secondary outcomes were quality of life, emotional state, activities, social relationships, perceived competence and motivation.
**Detailed Description:** The aim of this trial was to determine adherence to CPAP and health- related outcomes in patients with OSA via a comprehensive and multidisciplinary program based on stratification and individualized care plans, including the motivational interview.
A multicentre, randomized controlled trial (RCT) design was used. The control group followed the usual treatment, while the intervention group (PIMA) followed the treatment with an adapted and flexible care plan depending on socio-demographic, clinical and psychological variables. The treatment plan includes different channels (home, telephone, care center), a continuous evaluation, and the use of the motivational interview in each of the interventions with the patient. The main outcome was adherence. Secondary outcomes were quality of life, emotional state, activities, social relationships, perceived competence and motivation.
### Conditions Module
**Conditions:**
- Sleep Apnea, Obstructive
**Keywords:**
- CPAP
- Sleep Apnea
- Adherence
- Quality of Life
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Masking Description:** After confirming their participation in the study, the patient was randomly assigned to one group or another, receiving the treatment as established in the protocol according to group.
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 129
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** 1. Educational and training program using motivational interview technical.
2. Stratification labels: to determine the personalized intervention plan are obtained from two types of variables: personal and modulation variables. For psychological variables the Perceived Competence Evaluation Questionnaire validated in Adherence to CPAP in OSA (CEPCA) is used. Drowsiness is obtained through the administration of the Epworth Somnolence Test, and the apnoea-hypopnea index is taken from the patient's clinical history.
3. Segmentation: With the psychological and clinical variables, in this first visit, "predictive" information is obtained on how the patient's adherence will be: high adherence, moderate adherence or low adherence.
4. Taking this information into account, the care plan will start considering how the patient is and their situation with respect to adherence. Depending on their evolution, the care plan is adapted. For patients with low adherence, telemonitoring is used.
**Intervention Names:**
- Behavioral: Motivational Interview (MI) & Adherence Follow-Up
**Label:** PIMAGroup
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The patients followed the standard of care, which consists of starting therapy in the hospital, where the nurse performed training in the use of CPAP equipment, mask adjustment, and safety and maintenance instructions. For follow-up, the patient was always referred to the Hospital, with a frequency established by the Spanish Society of Pulmonology and Thoracic Surgery (Day 30, Day 90 and Day 180). The follow-up procedure consisted of reviewing the CPAP hour meter and resolving any incidents that may have arisen, with the necessary corrective actions (change of mask, positive reinforcement, and explanation of specific aspects).
**Intervention Names:**
- Behavioral: Adherence Follow-Up
**Label:** Control
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- PIMAGroup
**Description:** 1. MEntA: Educational \& Training Program
2. Stratification: Identification of Personal Variables (Age, Level of study, Work status, preference of care attention, digital behaviour)
3. Adherence evaluation: Evaluation of Perceived Competence, Quality of Life, Mood, Activities, Social relations and Social Support
4. Identification of Care plan and Schedule next visits
5. Follow-up D30-D60-D90-D180 depending of the care plan, through the channel that belong for each care plan
**Name:** Motivational Interview (MI) & Adherence Follow-Up
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- Control
**Description:** The nurse takes the compliance of the CPAP device, and ask to the patient if he had some problems.
**Name:** Adherence Follow-Up
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** Number of hours of use of CPAP per night
**Measure:** Adherence (changes)
**Time Frame:** Day 90, Day 180
**Description:** Residual sleepiness after use of CPAP. Epworth Sleepiness Scale. Minimum score: 0; Maximum: 24. Higher scores=worse outcome
**Measure:** Somnolence (changes)
**Time Frame:** Day 1, Day 90, Day 180
**Description:** Self-Efficacy in the CPAP treatment. Perceived Competence Evaluation Questionnaire. Minimum score: 0; Maximum score 13. Higher score= Better outcome.
**Measure:** Perceived Competence (changes)
**Time Frame:** Day 1, Day 90, Day 180
#### Secondary Outcomes
**Description:** Well-Being of the patient related to sleep apnea. Analogical Well-Being in Sleep Apnea Scale. Mininum score: 0; Maximum score: 10. Higher score= better outcome.
**Measure:** Quality of Life (Changes)
**Time Frame:** Day 1, Day 90, Day 180
**Description:** Emotional status related to sleep apnea. Ad hoc question. Minimum score: 0; maximum score: 3. Higher score: Better outcome.
**Measure:** Mood (Changes)
**Time Frame:** Day 1, Day 90, Day 180
**Description:** Improving general activity after use CPAP. Ad hoc question. Minimum score: 0; maximum score: 3. Higher score: Better outcome.
**Measure:** Activities (Changes)
**Time Frame:** Day 1, Day 90, Day 180
**Description:** Improving general social relations after use CPAP. Ad hoc question. Minimum score: 0; maximum score: 3. Higher score: Better outcome.
**Measure:** Social Relations (Changes)
**Time Frame:** Day 1, Day 90, Day 180
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Older than 18 years
* Diagnosis of OSA confirmed by sleep studies with polygraphy (PS) and / or polysomnography (PSG)
Exclusion Criteria:
* Subjects with obesity-related hypoventilation
* Severe COPD (chronic obstructive pulmonary disease)
* Cognitive disorders and those unable to understand the consent to participate
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Madrid
**Country:** Spain
**Facility:** David Rudilla
**Zip:** 28020
#### Overall Officials
**Official 1:**
**Affiliation:** Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
**Name:** Pedro Landete, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Access Criteria:** Researchers and reviewers
**Description:** Publication of results in two phases:
* National Congress in Portugal
* Publication in Research Journal
**Info Types:**
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
**IPD Sharing:** YES
**Time Frame:** At the moment we are presenting the results in a journal for publication. The data may be requested from any of the researchers, and may be consulted online, the data being 100% anomized. Data accessibility will be in the next 36 months after publication.
## Document Section
### Large Document Module
#### Large Docs
- Date: 2018-02-14
- Filename: Prot_SAP_ICF_000.pdf
- Has ICF: True
- Has Protocol: True
- Has SAP: True
- Label: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
- Size: 736145
- Type Abbrev: Prot_SAP_ICF
- Upload Date: 2020-12-29T07:45
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012120
- Term: Respiration Disorders
- ID: D000012140
- Term: Respiratory Tract Diseases
- ID: D000012818
- Term: Signs and Symptoms, Respiratory
- ID: D000020919
- Term: Sleep Disorders, Intrinsic
- ID: D000020920
- Term: Dyssomnias
- ID: D000012893
- Term: Sleep Wake Disorders
- ID: D000009422
- Term: Nervous System Diseases
### 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
### Condition Browse Module - Browse Leaves
- ID: M4361
- Name: Apnea
- Relevance: HIGH
- As Found: Apnea
- ID: M15694
- Name: Sleep Apnea Syndromes
- Relevance: HIGH
- As Found: Sleep Apnea
- ID: M22010
- Name: Sleep Apnea, Obstructive
- Relevance: HIGH
- As Found: Sleep Apnea, Obstructive
- 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: M15623
- Name: Signs and Symptoms, Respiratory
- 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: T6034
- Name: Quality of Life
- Relevance: HIGH
- As Found: Quality of Life
### Condition Browse Module - Meshes
- ID: D000001049
- Term: Apnea
- ID: D000012891
- Term: Sleep Apnea Syndromes
- ID: D000020181
- Term: Sleep Apnea, Obstructive
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT03332979
**Acronym:** ELPAS
**Brief Title:** Experiencing Loss and Planning Ahead Study
**Official Title:** Experiencing Loss and Planning Ahead Study (ELPAS): Caring for a Relative or Friend With Dementia
#### Organization Study ID Info
**ID:** 17/0477
#### Organization
**Class:** OTHER
**Full Name:** University College, London
### Status Module
#### Completion Date
**Date:** 2020-02-01
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2020-10-19
**Type:** ACTUAL
**Last Update Submit Date:** 2020-10-15
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2019-01-31
**Type:** ACTUAL
#### Results First Post Date
**Date:** 2020-10-19
**Type:** ACTUAL
**Results First Submit Date:** 2020-03-25
**Results First Submit QC Date:** 2020-10-15
#### Start Date
**Date:** 2018-01-11
**Type:** ACTUAL
**Status Verified Date:** 2020-10
#### Study First Post Date
**Date:** 2017-11-06
**Type:** ACTUAL
**Study First Submit Date:** 2017-11-01
**Study First Submit QC Date:** 2017-11-01
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Alzheimer's Society
#### Lead Sponsor
**Class:** OTHER
**Name:** University College, London
#### 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 course of dementia over many years, gradual losses and uncertain life expectancy can lead to grief amongst family and friend carers. This study aims to examine the relationship between carers' feelings of grief before the death of a person with dementia and how well carers are prepared for that death. The study involves completing questionnaires with 150 carers of people with dementia (at home or in a care home). Twenty of these carers will be purposively selected to complete additional semi-structured questions to further explore the research questions. The questionnaires will examine whether being prepared for end of life is linked to having lower levels of grief. Preparation will be measured by important factors shown in research including: knowledge of dementia progression; knowledge of the person with dementia's end of life preferences; communication with healthcare professionals; family support; and having a Power of Attorney or advance directives. The study is part of a larger study that will also involve surveys with service providers and developing a resource for carers. The study will provide important insights into how we can better support grieving carers and help them plan and prepare for end of life care.
**Detailed Description:** Grief is often felt before the death of a friend or relative with dementia. Grief before the death can be triggered by losses associated with dementia causing carers to experience sorrow, anger, yearning and acceptance that can wax and wane from diagnosis to the end of life. It occurs due to the lengthy and uncertain disease trajectory; compromised communication between the person with dementia and family and friends; and changes in relationship quality and carer freedom. Between 47-71% of family and friends of people with dementia (referred here as 'carers') experience grief before the death and 20% experience complicated grief after the death. Higher grief prior to death is associated with complicated grief after death, so emotional support during care rather than solely after the death may be beneficial.
Preparation for end of life has medical, psychosocial, spiritual and practical components, including having a family member or healthcare professional to help make decisions, knowing what to expect about the terminal condition and having finances in place. Good communication with healthcare providers to discuss prognosis, treatments, cultural, spiritual and practical issues; and dealing with family conflict is critical. Preparation for end of life is associated with a lower likelihood of complicated grief in bereavement but has not been explored in the context of grief before the death. Preparation for end of life is influenced by socioeconomic factors associated with health literacy. In the UK a third of older adults have difficulty interpreting basic health information. Despite the potential benefits of end of life discussions with carers, there are many barriers to such discussions. Carers struggle to formalise in writing future wishes on behalf of the person with dementia and professionals tend to be reluctant to initiate end of life discussions. Family conflict can deter end of life decision making. Factors reflecting preparation for end of life are potentially modifiable suggesting that improving preparation could reduce grief before the death.
This study aims to examine the relationship between family and friend carers' feelings of grief before the death of a person with dementia and how well carers are prepared for that death. The hypothesis that will be tested is that modifiable factors indicating preparation for end of life are associated with lower grief before the death in carers of people with dementia. The modifiable factors reflecting preparation for end of life include: carers' having a good knowledge of dementia progression; high health literacy; a lasting (enduring) Power of Attorney; knowing the end of life wishes of the person with dementia; being satisfied with support from their social network.
Knowing which modifiable factors reflecting preparation for end of life are most closely associated with grief before the death will inform the development of a resource for carers with the potential to reduce carer distress during the lifetime of the person with dementia, bringing benefits for the person with dementia as well as their carer. It will enable discussions to ensure care at the end of life is planned and in accordance with the person's wishes; and may reduce the prevalence of complicated grief after the death of the person with dementia.
Secondary objectives are to: examine the prevalence and severity of grief before the death in carers of people with dementia; identify which modifiable factors reflecting preparation for end of life are most strongly related to grief before the death; examine the extent to which carers feel prepared for the future and end-of-life care for their relative with dementia; explore whether carers recognize grief during caring and what supports they think would be helpful; identify unmet needs for information about end of life symptoms and emotional support for carers; and explore how carers experience and cope with changes in grief over time.
This is a cross-sectional study using mixed methods. One hundred and fifty carers of people with a diagnosis of dementia will be recruited to take part in the study. They will take part in a quantitative interview with a range of questionnaires. Participants will be recruited through community and healthcare services and via the Join Dementia Research Register in the United Kingdom. Eligible carers will be sent invitations to participate. Flyers in these services or presentations at family meetings of these services are other potential avenues for recruitment. Participants will provide written consent prior to the interview.
A sub-sample of carers will be asked whether they would also like to take part in an additional qualitative semi-structured interview to enable more in-depth exploration of some of the secondary objectives. The interview will explore the dynamic and changing nature of grief over time, how carers identify with the concept of grief and whether they consider they are going through a grief experience. It will also examine what supports they have found helpful and what they perceive to be unmet information and support needs and possible programs/resources that might address these needs. Qualitative interviews will be audio-recorded with permission from the participant on an encrypted digital recorder and then transcribed verbatim by the research team. Participants will be purposively selected to take part in these interviews to provide a mix of responses representing male and female participants, adult child and spouse participants, different ethnicity as well as carers of people at different severity of dementia. We will aim to interview carers until saturation of data is reached. We envisage this will be between 15-20 carers. Once we have achieved saturation we will cease inviting carers to take part in this component of the study.
For the quantitative analysis, multivariable regression analysis will be used to explore the impact of the five modifiable factors reflecting preparation for end of life on the primary outcome of pre-death grief. We will control for potential confounding variables including: dementia severity, relationship type (spouse/partner, a child or another relationship), gender, care home status (whether or not the person with dementia is living at home or in a care home), and religiosity. There are ten potential co-variates to be included in the model. A sample of 15 participants per co-variate is preferable while ten may be sufficient. We will aim to recruit 150 participants for an adequately powered analysis.
For the qualitative analysis audio-recording will be transcribed verbatim and entered into NVivo qualitative software package (QSR International) to support data coding. Data will be thematically analysed by coding chunks of text and grouping these codes into themes and sub-themes that address the study objectives. Two researchers will independently code and analyse each interview independently and then compare codes and themes to ensure rigour in analysis. Discrepancies will be discussed until consensus on themes is reached. Interviews will be coded as collected to enable subsequent interviews to draw on and explore themes arising. While we aim to recruit carers from a mix of categories (gender, relationship type and dementia severity) we will not be able to make comparisons between groups because of the small numbers representing each group (eg there may be only one male son caring for someone with mild dementia). The themes identified will help to draw out individual experiences in relation to carer grief and access to supports to supplement and expand the quantitative data.
### Conditions Module
**Conditions:**
- Grief
**Keywords:**
- pre-death grief
- palliative care
- dementia
- caregiver
- preparation for end of life
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 150
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Outcomes Module
#### Primary Outcomes
**Description:** Marwit-Meuser Caregiver Grief Inventory Short Form (MMCGI-SF) (Marwit and Meuser 2005). 18 items with a score range from 18-90. Higher scores indicate higher levels of grief from carers of people with dementia.
**Measure:** Pre-death Grief in Dementia Caregiving
**Time Frame:** Baseline
#### Secondary Outcomes
**Description:** Dementia Knowledge Assessment Scale (Annear, Toye et al. 2015). Possible score range 0-50 with a higher score indicating better knowledge of dementia.
**Measure:** Knowledge of How Dementia Progresses
**Time Frame:** Baseline
**Description:** Two categorical questions will be used: 'Have you had discussions with the person with dementia regarding their wishes at the end of life? (yes/no). Do you feel you have a good understanding of their wishes for end of life care? (yes/not sure/no).
**Measure:** Knowledge of the Person With Dementia's End of Life Preferences
**Time Frame:** Baseline
**Description:** Binary variable - either have or do not have any form of advance plan (such as Power of Attorney, Advance decisions to refuse treatment, Do Not attempt Resuscitation, Advance Care plan) in place for the person with dementia.
**Measure:** Advance Decisions in Place for Person With Dementia
**Time Frame:** Baseline
**Description:** Health Literacy Questionnaire (Osborne et al. 2013) Subscale 1 'Feeling understood and supported by healthcare providers' a Average score of 4 items leading to a range of 1-4 with higher scores indicating areas of strength.
**Measure:** Communication With Healthcare Providers
**Time Frame:** Baseline
**Description:** Health Literacy Questionnaire (Osborne, Batterham et al. 2013) Sub-scale examines satisfaction with support for health from social network. Score is calculated as an average of the 5 items of the subscale leading to a score range of 1-4 with higher scores indicating that a person's social system provides them with all the support they want or need.
**Measure:** Social Support for Health Subscale of the Health Literacy Questionnaire
**Time Frame:** Baseline
**Description:** Carer report of their relative/friend's severity of dementia using the Clinical Dementia Rating scale (Morris 1993). This scale leads to scores 5 possible scores; 0=no dementia, 0.5=questionable dementia, 1=mild dementia, 2=moderate dementia and 3=severe dementia.
**Measure:** Dementia Severity
**Time Frame:** Baseline
**Description:** Duke University Religion Index (Koenig and Büssing 2010). Using the subscale 'Intrinsic religiosity' which assesses degree of personal religious commitment or motivation which has been more strongly associated with protecting from psychological distress. Possible score range is 0-12 with a higher score indicating a stronger personal religious commitment/motivation.
**Measure:** Intrinsic Religiosity
**Time Frame:** Baseline
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Carers of people with dementia providing practical, social, emotional or supervisory support to a friend or family member. This will include carers of people with dementia living at home or in a care home. Carers will be 18 years of age or over and living in England. The person they care for will have received a formal diagnosis of any dementia related disease.
Exclusion Criteria:
* Carers who are not able to communicate in English or who do not have capacity to provide informed written consent.
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Community sample. Carers will be recruited via a range of services (memory services/clinics, care homes, Admiral Nurses \[specialist dementia nurses\] and branches of the Alzheimer's Society). Recruitment will also occur through the Join Dementia Research website which is an online register where people living in the United Kingdom can express an interest in participating in dementia research and be invited to take part in studies based on matched eligibility criteria.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** London
**Country:** United Kingdom
**Facility:** University College London
**Zip:** W1T 7NF
#### Overall Officials
**Official 1:**
**Affiliation:** University College, London
**Name:** Kirsten J Moore, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
### References Module
#### References
**Citation:** Almack K, Cox K, Moghaddam N, Pollock K, Seymour J. After you: conversations between patients and healthcare professionals in planning for end of life care. BMC Palliat Care. 2012 Sep 17;11:15. doi: 10.1186/1472-684X-11-15.
**PMID:** 22985010
**Citation:** Annear MJ, Toye CM, Eccleston CE, McInerney FJ, Elliott KE, Tranter BK, Hartley T, Robinson AL. Dementia Knowledge Assessment Scale: Development and Preliminary Psychometric Properties. J Am Geriatr Soc. 2015 Nov;63(11):2375-81. doi: 10.1111/jgs.13707. Epub 2015 Oct 27.
**PMID:** 26503020
**Citation:** Barry LC, Kasl SV, Prigerson HG. Psychiatric disorders among bereaved persons: the role of perceived circumstances of death and preparedness for death. Am J Geriatr Psychiatry. 2002 Jul-Aug;10(4):447-57.
**PMID:** 12095904
**Citation:** Bostock S, Steptoe A. Association between low functional health literacy and mortality in older adults: longitudinal cohort study. BMJ. 2012 Mar 15;344:e1602. doi: 10.1136/bmj.e1602.
**PMID:** 22422872
**Citation:** Braun V, Clarke V. Using thematic analysis in psychology. Qualitative Research in Psychology 3(2): 77-101, 2006.
**Citation:** Chan D, Livingston G, Jones L, Sampson EL. Grief reactions in dementia carers: a systematic review. Int J Geriatr Psychiatry. 2013 Jan;28(1):1-17. doi: 10.1002/gps.3795. Epub 2012 Mar 8.
**PMID:** 22407743
**Citation:** Dening KH, Jones L, Sampson EL. Preferences for end-of-life care: a nominal group study of people with dementia and their family carers. Palliat Med. 2013 May;27(5):409-17. doi: 10.1177/0269216312464094. Epub 2012 Nov 5.
**PMID:** 23128905
**Citation:** Hebert RS, Dang Q, Schulz R. Preparedness for the death of a loved one and mental health in bereaved caregivers of patients with dementia: findings from the REACH study. J Palliat Med. 2006 Jun;9(3):683-93. doi: 10.1089/jpm.2006.9.683.
**PMID:** 16752974
**Citation:** Hebert RS, Prigerson HG, Schulz R, Arnold RM. Preparing caregivers for the death of a loved one: a theoretical framework and suggestions for future research. J Palliat Med. 2006 Oct;9(5):1164-71. doi: 10.1089/jpm.2006.9.1164.
**PMID:** 17040154
**Citation:** Hebert RS, Schulz R, Copeland V, Arnold RM. What questions do family caregivers want to discuss with health care providers in order to prepare for the death of a loved one? An ethnographic study of caregivers of patients at end of life. J Palliat Med. 2008 Apr;11(3):476-83. doi: 10.1089/jpm.2007.0165.
**PMID:** 18363491
**Citation:** Hirschman KB, Kapo JM, Karlawish JH. Identifying the factors that facilitate or hinder advance planning by persons with dementia. Alzheimer Dis Assoc Disord. 2008 Jul-Sep;22(3):293-8. doi: 10.1097/WAD.0b013e318169d669.
**PMID:** 18580595
**Citation:** Lindauer A, Harvath TA. Pre-death grief in the context of dementia caregiving: a concept analysis. J Adv Nurs. 2014 Oct;70(10):2196-207. doi: 10.1111/jan.12411. Epub 2014 Apr 7.
**PMID:** 24702153
**Citation:** Marwit SJ, Meuser TM. Development of a short form inventory to assess grief in caregivers of dementia patients. Death Stud. 2005 Apr;29(3):191-205. doi: 10.1080/07481180590916335.
**PMID:** 15816111
**Citation:** Osborne RH, Batterham RW, Elsworth GR, Hawkins M, Buchbinder R. The grounded psychometric development and initial validation of the Health Literacy Questionnaire (HLQ). BMC Public Health. 2013 Jul 16;13:658. doi: 10.1186/1471-2458-13-658.
**PMID:** 23855504
**Citation:** Petty NJ, Thomson OP, Stew G. Ready for a paradigm shift? Part 2: introducing qualitative research methodologies and methods. Man Ther. 2012 Oct;17(5):378-84. doi: 10.1016/j.math.2012.03.004. Epub 2012 Apr 3.
**PMID:** 22480949
**Citation:** Romero MM, Ott CH, Kelber ST. Predictors of grief in bereaved family caregivers of person's with Alzheimer's disease: a prospective study. Death Stud. 2014 Jul-Dec;38(6-10):395-403. doi: 10.1080/07481187.2013.809031. Epub 2013 Oct 18.
**PMID:** 24666146
**Citation:** Sampson EL, Jones L, Thune-Boyle IC, Kukkastenvehmas R, King M, Leurent B, Tookman A, Blanchard MR. Palliative assessment and advance care planning in severe dementia: an exploratory randomized controlled trial of a complex intervention. Palliat Med. 2011 Apr;25(3):197-209. doi: 10.1177/0269216310391691. Epub 2011 Jan 12.
**PMID:** 21228087
**Citation:** Schulz R, Boerner K, Klinger J, Rosen J. Preparedness for death and adjustment to bereavement among caregivers of recently placed nursing home residents. J Palliat Med. 2015 Feb;18(2):127-33. doi: 10.1089/jpm.2014.0309. Epub 2014 Dec 3.
**PMID:** 25469737
**Citation:** Schulz R, Mendelsohn AB, Haley WE, Mahoney D, Allen RS, Zhang S, Thompson L, Belle SH; Resources for Enhancing Alzheimer's Caregiver Health Investigators. End-of-life care and the effects of bereavement on family caregivers of persons with dementia. N Engl J Med. 2003 Nov 13;349(20):1936-42. doi: 10.1056/NEJMsa035373.
**PMID:** 14614169
**Citation:** Steinhauser KE, Christakis NA, Clipp EC, McNeilly M, Grambow S, Parker J, Tulsky JA. Preparing for the end of life: preferences of patients, families, physicians, and other care providers. J Pain Symptom Manage. 2001 Sep;22(3):727-37. doi: 10.1016/s0885-3924(01)00334-7.
**PMID:** 11532586
**Citation:** Tabachnick, B. G. and L. S. Fidell (1989). Using Multivariate Statistics, 2nd Edition. New York, Harper & Row.
**Citation:** Morris JC. The Clinical Dementia Rating (CDR): current version and scoring rules. Neurology. 1993 Nov;43(11):2412-4. doi: 10.1212/wnl.43.11.2412-a. No abstract available.
**PMID:** 8232972
**Citation:** Koenig HG, Büssing A. The Duke University Religion Index (DUREL): A Five-Item Measure for Use in Epidemological Studies. Religions 1: 78-85, 2010.
**Citation:** Moore KJ, Crawley S, Vickerstaff V, Cooper C, King M, Sampson EL. Is preparation for end of life associated with pre-death grief in caregivers of people with dementia? Int Psychogeriatr. 2020 Jun;32(6):753-763. doi: 10.1017/S1041610220000289. Epub 2020 Apr 3.
**PMID:** 32241317
## Document Section
### Large Document Module
#### Large Docs
- Date: 2017-10-02
- Filename: Prot_SAP_000.pdf
- Has ICF: False
- Has Protocol: True
- Has SAP: True
- Label: Study Protocol and Statistical Analysis Plan
- Size: 454750
- Type Abbrev: Prot_SAP
- Upload Date: 2019-11-05T09:23
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- 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: M6904
- Name: Dementia
- Relevance: LOW
- As Found: Unknown
- ID: M6845
- Name: Death
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-24
## Results Section
### Adverse Events Module
#### Event Groups
**Group ID:** EG000
**Title:** All Study Participants
**Deaths Num At Risk:** 150
**Description:** All Study Participants/ Usual care
**ID:** EG000
**Other Num at Risk:** 150
**Serious Number At Risk:** 150
**Title:** All Study Participants
**Frequency Threshold:** 0
**Time Frame:** One interview
## Results Section - Baseline Characteristics Module
### Denomination Counts
**Group ID:** BG000
**Value:** 150
**Units:** Participants
### Group
**ID:** BG000
**Title:** All Study Participants
**Description:** All Study Participants/Usual care
### Measure
#### Measurement
**Group ID:** BG000
**Spread:** 12.1
**Value:** 63.0
**Class Title:**
### Measure
#### Measurement
**Group ID:** BG000
**Value:** 116
**Category Title:** Female
#### Measurement
**Group ID:** BG000
**Value:** 34
**Category Title:** Male
**Class Title:**
### Measure
#### Measurement
**Group ID:** BG000
**Value:** 131
**Category Title:** White British
#### Measurement
**Group ID:** BG000
**Value:** 9
**Category Title:** White Other
#### Measurement
**Group ID:** BG000
**Value:** 3
**Category Title:** Mixed race- White and Asian
#### Measurement
**Group ID:** BG000
**Value:** 3
**Category Title:** Asian/Asian British - Indian
#### Measurement
**Group ID:** BG000
**Value:** 1
**Category Title:** Asian/Asian British - Pakistani
#### Measurement
**Group ID:** BG000
**Value:** 1
**Category Title:** African
#### Measurement
**Group ID:** BG000
**Value:** 2
**Category Title:** Declined to answer
**Class Title:** Ethnicity
### Measure
#### Measurement
**Group ID:** BG000
**Value:** 150
**Class Title:** United Kingdom
### Measure
#### Measurement
**Group ID:** BG000
**Value:** 17
**Class Title:** Single
#### Measurement
**Group ID:** BG000
**Value:** 124
**Class Title:** Married/cohabitating
#### Measurement
**Group ID:** BG000
**Value:** 8
**Class Title:** Divorced/separated
#### Measurement
**Group ID:** BG000
**Value:** 1
**Class Title:** Widowed
### Measure
#### Measurement
**Group ID:** BG000
**Value:** 70
**Class Title:** Spouse/partner
#### Measurement
**Group ID:** BG000
**Value:** 72
**Class Title:** Adult child
#### Measurement
**Group ID:** BG000
**Value:** 8
**Class Title:** Other
### Measure
#### Measurement
**Group ID:** BG000
**Value:** 70
**Class Title:** Urban Major Conurbation
#### Measurement
**Group ID:** BG000
**Value:** 61
**Class Title:** Urban City and Town
#### Measurement
**Group ID:** BG000
**Value:** 1
**Class Title:** Urban City and Town in a sparse setting
#### Measurement
**Group ID:** BG000
**Value:** 9
**Class Title:** Rural Town and Fringe
#### Measurement
**Group ID:** BG000
**Value:** 5
**Class Title:** Rural Village
#### Measurement
**Group ID:** BG000
**Value:** 3
**Class Title:** Rural Hamlets and Isolated Dwellings
#### Measurement
**Group ID:** BG000
**Value:** 1
**Class Title:** Missing
### Measure
#### Measurement
**Group ID:** BG000
**Value:** 5
**Class Title:** 1
#### Measurement
**Group ID:** BG000
**Value:** 9
**Class Title:** 2
#### Measurement
**Group ID:** BG000
**Value:** 9
**Class Title:** 3
#### Measurement
**Group ID:** BG000
**Value:** 17
**Class Title:** 4
#### Measurement
**Group ID:** BG000
**Value:** 15
**Class Title:** 5
#### Measurement
**Group ID:** BG000
**Value:** 11
**Class Title:** 6
#### Measurement
**Group ID:** BG000
**Value:** 15
**Class Title:** 7
#### Measurement
**Group ID:** BG000
**Value:** 17
**Class Title:** 8
#### Measurement
**Group ID:** BG000
**Value:** 22
**Class Title:** 9
#### Measurement
**Group ID:** BG000
**Value:** 29
**Class Title:** 10
#### Measurement
**Group ID:** BG000
**Value:** 1
**Class Title:** Missing
### Measure
#### Measurement
**Group ID:** BG000
**Value:** 98
**Class Title:** Yes
#### Measurement
**Group ID:** BG000
**Value:** 52
**Class Title:** No
### Measure
#### Measurement
**Group ID:** BG000
**Value:** 147
**Class Title:** Emotional support
#### Measurement
**Group ID:** BG000
**Value:** 54
**Class Title:** ADLs
#### Measurement
**Group ID:** BG000
**Value:** 144
**Class Title:** IADL
#### Measurement
**Group ID:** BG000
**Value:** 114
**Class Title:** Supervision
### Measure
#### Measurement
**Group ID:** BG000
**Spread:** 4
**Value:** 16.2
**Class Title:**
### Measure
#### Measurement
**Group ID:** BG000
**Value:** 82
**Class Title:** Male
#### Measurement
**Group ID:** BG000
**Value:** 68
**Class Title:** Female
### Measure
#### Measurement
**Group ID:** BG000
**Spread:** 9.7
**Value:** 80.3
**Class Title:**
### Measure
#### Measurement
**Group ID:** BG000
**Value:** 70
**Class Title:** Yes
#### Measurement
**Group ID:** BG000
**Value:** 70
**Class Title:** No
#### Measurement
**Group ID:** BG000
**Value:** 9
**Class Title:** Other
#### Measurement
**Group ID:** BG000
**Value:** 1
**Class Title:** Missing
**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:** COUNT_OF_PARTICIPANTS
**Title:** Race/Ethnicity, Customized
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
### Measure 5
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Marital status
**Unit of Measure:** Participants
### Measure 6
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Relationship to person with dementia
**Unit of Measure:** Participants
### Measure 7
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Rurality
**Unit of Measure:** Participants
### Measure 8
**Description:** Deprivation (IMD deciles) 1= most deprived 10= least deprived
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Deprivation
**Unit of Measure:** Participants
### Measure 9
**Description:** Question asked: Do you currently work for pay
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Employment status
**Unit of Measure:** Participants
### Measure 10
**Description:** Participants could select as many options were appropriate. ADL: Activities of daily living. IADL: Instrumental activities of daily living ie shopping
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Support provided by carer
**Unit of Measure:** Participants
### Measure 11
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Years of education
**Unit of Measure:** years
### Measure 12
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Person with dementia gender
**Unit of Measure:** Participants
### Measure 13
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Person with dementia age
**Unit of Measure:** years
### Measure 14
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Does the person with dementia require constant supervision
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
**PI Sponsor Employee:** True
### Point of Contact
**Email:** [email protected]
**Organization:** Marie Curie Palliative Care Research Department, Division of Psychiatry, University College London
**Phone:** 020 7679 9488
**Title:** Dr Kirsten Moore
## 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:**
**Non-Inferiority Comment:** Multivariable regression analysis will be used to enable us to explore the impact of modifiable factors reflecting preparation for end of life on the MMCGI-SF.
**Non-Inferiority Type:** OTHER
**Other Analysis Description:** Multivariable regression will be used to explore preparation for end of life on the MMCGI-SF. The analyses will use the MMCGI-SF as the dependent variable with five predictor variables (dementia knowledge \[DKAS\], Social support \[HLQ1\], Communication with healthcare professionals \[HLW4\], advance decisions and knowledge of end of life wishes of person with dementia. There will also be 10 confounders included in the model (gender of caregiver, living arrangement of person with dementia \[at home of a care home\], aged of person with dementia, dementia severity \[CDR\], change in closeness, religiosity \[DURAL\], deprivation and relationship of the carer to the person with dementia).
**P-Value:** <0.05
**P-Value Comment:**
**Parameter Type:**
**Parameter Value:**
**Statistical Comment:**
**Statistical Method:** Regression, Linear
**Tested Non-Inferiority:**
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
### Outcome Measure 6
### Outcome Measure 7
### Outcome Measure 8
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 4.7
- **Upper Limit:**
- **Value:** 57.6
**Title:**
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 7.0
- **Upper Limit:**
- **Value:** 34.8
**Title:**
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 110
**Title:** Yes
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 29
**Title:** Not sure
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 11
**Title:** No
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 63
**Title:** Yes
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 8
**Title:** Not sure
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 79
**Title:** No
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 0.7
- **Upper Limit:**
- **Value:** 2.7
**Title:**
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 0.6
- **Upper Limit:**
- **Value:** 2.7
**Title:**
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 4
**Title:** Questionable dementia
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 34
**Title:** Mild dementia
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 64
**Title:** Moderate dementia
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 48
**Title:** Severe dementia
#### Outcome Measure 8
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 4.3
- **Upper Limit:**
- **Value:** 6.6
**Title:**
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Marwit-Meuser Caregiver Grief Inventory Short Form (MMCGI-SF) (Marwit and Meuser 2005). 18 items with a score range from 18-90. Higher scores indicate higher levels of grief from carers of people with dementia.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Baseline
**Title:** Pre-death Grief in Dementia Caregiving
**Type:** PRIMARY
**Unit of Measure:** score on a scale
##### Group
**Description:** All Study Participants/Usual care
**ID:** OG000
**Title:** All Study Participants
#### Outcome Measure 2
**Description:** Dementia Knowledge Assessment Scale (Annear, Toye et al. 2015). Possible score range 0-50 with a higher score indicating better knowledge of dementia.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Baseline
**Title:** Knowledge of How Dementia Progresses
**Type:** SECONDARY
**Unit of Measure:** score on a scale
##### Group
**Description:** All Study Participants/Usual care
**ID:** OG000
**Title:** All Study Participants
#### Outcome Measure 3
**Description:** Two categorical questions will be used: 'Have you had discussions with the person with dementia regarding their wishes at the end of life? (yes/no). Do you feel you have a good understanding of their wishes for end of life care? (yes/not sure/no).
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Reporting Status:** POSTED
**Time Frame:** Baseline
**Title:** Knowledge of the Person With Dementia's End of Life Preferences
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** All Study Participants/Usual care
**ID:** OG000
**Title:** All Study Participants
#### Outcome Measure 4
**Description:** Binary variable - either have or do not have any form of advance plan (such as Power of Attorney, Advance decisions to refuse treatment, Do Not attempt Resuscitation, Advance Care plan) in place for the person with dementia.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Reporting Status:** POSTED
**Time Frame:** Baseline
**Title:** Advance Decisions in Place for Person With Dementia
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** All Study Participants/Usual care
**ID:** OG000
**Title:** All Study Participants
#### Outcome Measure 5
**Description:** Health Literacy Questionnaire (Osborne et al. 2013) Subscale 1 'Feeling understood and supported by healthcare providers' a Average score of 4 items leading to a range of 1-4 with higher scores indicating areas of strength.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Baseline
**Title:** Communication With Healthcare Providers
**Type:** SECONDARY
**Unit of Measure:** score on a scale
##### Group
**Description:** All Study Participants/Usual care
**ID:** OG000
**Title:** All Study Participants
#### Outcome Measure 6
**Description:** Health Literacy Questionnaire (Osborne, Batterham et al. 2013) Sub-scale examines satisfaction with support for health from social network. Score is calculated as an average of the 5 items of the subscale leading to a score range of 1-4 with higher scores indicating that a person's social system provides them with all the support they want or need.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Baseline
**Title:** Social Support for Health Subscale of the Health Literacy Questionnaire
**Type:** SECONDARY
**Unit of Measure:** score on a scale
##### Group
**Description:** All Study Participants/Usual care
**ID:** OG000
**Title:** All Study Participants
#### Outcome Measure 7
**Description:** Carer report of their relative/friend's severity of dementia using the Clinical Dementia Rating scale (Morris 1993). This scale leads to scores 5 possible scores; 0=no dementia, 0.5=questionable dementia, 1=mild dementia, 2=moderate dementia and 3=severe dementia.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Reporting Status:** POSTED
**Time Frame:** Baseline
**Title:** Dementia Severity
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** All Study Participants/Usual care
**ID:** OG000
**Title:** All Study Participants
#### Outcome Measure 8
**Description:** Duke University Religion Index (Koenig and Büssing 2010). Using the subscale 'Intrinsic religiosity' which assesses degree of personal religious commitment or motivation which has been more strongly associated with protecting from psychological distress. Possible score range is 0-12 with a higher score indicating a stronger personal religious commitment/motivation.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Baseline
**Title:** Intrinsic Religiosity
**Type:** SECONDARY
**Unit of Measure:** score on a scale
##### Group
**Description:** All Study Participants/Usual care
**ID:** OG000
**Title:** All Study Participants
### Participant Flow Module
#### Group
**Description:** All Study Participants/Usual care
**ID:** FG000
**Title:** All Study Participants
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 150
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 150
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
**Recruitment Details:** 11/01/2018-31/01/2019 Carers were recruited via a number of avenues including; 9 NHS hospital trusts across England who acted as Participant Identification Centres, the Join Dementia Research (JDR) website and through Alzheimer's Society avenues such as the Alzheimer's Society research network and the Care and Cure magazine.
**Has Results:** True |
## Protocol Section
### Identification Module
**NCT ID:** NCT05242679
**Brief Title:** Effect of Myofascial Release With Tennis Ball on Spasticity and Motor Functions
**Official Title:** Effect of Myofascial Release With Tennis Ball on Spasticity and Upper Limb Motor Functions in Patients With Chronic Stroke
#### Organization Study ID Info
**ID:** GSTIESC/23/16
#### Organization
**Class:** OTHER
**Full Name:** King Saud University
### Status Module
#### Completion Date
**Date:** 2017-10-23
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-03-04
**Type:** ACTUAL
**Last Update Submit Date:** 2022-02-16
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2017-08-08
**Type:** ACTUAL
#### Start Date
**Date:** 2016-11-21
**Type:** ACTUAL
**Status Verified Date:** 2022-02
#### Study First Post Date
**Date:** 2022-02-16
**Type:** ACTUAL
**Study First Submit Date:** 2022-02-06
**Study First Submit QC Date:** 2022-02-06
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** King Saud University
#### Responsible Party
**Investigator Affiliation:** King Saud University
**Investigator Full Name:** Masood Khan
**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:** Impaired motor function and upper extremity spasticity are common concerns in patients after stroke. It is essential to plan therapeutic techniques to recover from the stroke. The objective of this study was to investigate the effects of myofascial release with the tennis ball on spasticity and motor functions of the upper extremity in patients with chronic stroke.
**Detailed Description:** Myofascial release is a therapeutic technique that aims to improve flexibility and sliding between layers of soft tissues, reduce the severity of muscle activity pain, and improve functional performance. A previous study included myofascial release with a tennis ball in the lower extremity in patients with chronic stroke and reported improved balance. Different other unique therapeutic interventions have been proposed over the past two decades for stroke management; however, myofascial release with a tennis ball has not been included in them. Therefore, the present study aimed to examine the effects of myofascial release with a tennis ball on spasticity and motor functions of the upper limb in patients with chronic stroke.
Participants were equally divided into two groups viz. experimental and control, with 11 participants in each group.
### Conditions Module
**Conditions:**
- Stroke
**Keywords:**
- Myofascial release
- Chronic stroke
- Motor functions
- Spasticity
- modified Ashworth scale
- Fugl-Meyer assessment scale
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Two-arm parallel pre-test-post-test experimental design.
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 22
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants were treated with a conventional physiotherapy program along with myofascial release with a tennis ball.
**Intervention Names:**
- Other: Myofascial release technique along with conventional physiotherapy exercises
**Label:** Myofascial Release Group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** A conventional physiotherapy program was provided including range of motion/flexibility exercises, strength training, postural control, functional mobility exercises, lower limb functional exercises, and gait training.
**Intervention Names:**
- Other: Conventional physiotherapy exercises
**Label:** Conventional Physiotherapy Group
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Myofascial Release Group
**Description:** Myofascial release technique was performed using a tennis ball along with conventional physiotherapy exercises.
**Name:** Myofascial release technique along with conventional physiotherapy exercises
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Conventional Physiotherapy Group
**Description:** Conventional physiotherapy exercises were performed including the range of motion/flexibility exercises, strength training, postural control, functional exercises, and gait training.
**Name:** Conventional physiotherapy exercises
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Spasticity measured using Modified Ashworth scale - Scores range from 0 to 4, where lower scores represent normal muscle tone and higher scores represent spasticity.
**Measure:** Spasticity
**Time Frame:** 4 weeks.
**Description:** Upper limb motor functions measured using Fugl-Meyer Assessment Scale - Scores range from 0-66, where lower score represent poor performance of upper extremity and higher scores represents good performance of upper extremity
**Measure:** Upper limb motor functions
**Time Frame:** 4 weeks.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Unilateral stroke,
* Hemiplegia with upper extremity dysfunctions of more than 6 months and less than 2 years of duration
* modified Ashworth scale of grade 1-3,
* Mini-Mental State Exam (MMSE) \>24 suggesting intact cognition,
* full passive range of motion of the shoulder, elbow, wrist, and hand joints
* voluntary control by Brunnstrom of grade 3-5 for shoulder, elbow, and wrist joints
Exclusion Criteria:
* circulatory problems such as deep vein thrombosis,
* impaired sensation over the affected upper limb,
* recently injured area/open wounds,
* arthritic or any other musculoskeletal condition of the upper extremity, shoulder instability based on the posterior or anterior apprehension test, and positive sulcus test,
* history of brain surgery after stroke,
* Botox injection in the past four months,
* medically unstable patients,
* patients who have had multiple strokes.
**Maximum Age:** 65 Years
**Minimum Age:** 40 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Riyadh
**Country:** Saudi Arabia
**Facility:** King Saud University
**Zip:** 11433
#### Overall Officials
**Official 1:**
**Affiliation:** King Saud University
**Name:** Masood Khan, M.P.Th
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Parikh RJ, Sutaria JM, Ahsan M, Nuhmani S, Alghadir AH, Khan M. Effects of myofascial release with tennis ball on spasticity and motor functions of upper limb in patients with chronic stroke: A randomized controlled trial. Medicine (Baltimore). 2022 Aug 5;101(31):e29926. doi: 10.1097/MD.0000000000029926.
**PMID:** 35945719
## Derived Section
### Condition Browse Module - Ancestors
- 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: D000009135
- Term: Muscular Diseases
- ID: D000009140
- Term: Musculoskeletal Diseases
- ID: D000009122
- Term: Muscle Hypertonia
- ID: D000020879
- Term: Neuromuscular Manifestations
- ID: D000009461
- Term: Neurologic Manifestations
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC05
- Name: Musculoskeletal Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M22306
- Name: Stroke
- Relevance: HIGH
- As Found: Stroke
- ID: M12085
- Name: Muscle Spasticity
- Relevance: HIGH
- As Found: Spasticity
- 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: M12092
- Name: Muscular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12097
- Name: Musculoskeletal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12079
- Name: Muscle Hypertonia
- Relevance: LOW
- As Found: Unknown
- ID: M22619
- Name: Neuromuscular Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000009128
- Term: Muscle Spasticity
- ID: D000020521
- Term: Stroke
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT02203279
**Brief Title:** Evaluation of Three Hard Relining Materials in Complete Dentures
**Official Title:** Evaluation of Three Hard Relining Materials in Complete Dentures: An In-vivo Study
#### Organization Study ID Info
**ID:** UDDS-RemPro-02-2014
#### Organization
**Class:** OTHER
**Full Name:** Damascus University
### Status Module
#### Completion Date
**Date:** 2015-09
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2015-09-29
**Type:** ESTIMATED
**Last Update Submit Date:** 2015-09-26
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2015-08
**Type:** ACTUAL
#### Start Date
**Date:** 2014-07
**Status Verified Date:** 2015-09
#### Study First Post Date
**Date:** 2014-07-29
**Type:** ESTIMATED
**Study First Submit Date:** 2014-07-28
**Study First Submit QC Date:** 2014-07-28
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Damascus University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Purpose: The purpose of this study is to evaluate three hard relining materials after 3 and 6 months of use with mandibular complete dentures. The effect of hard relining materials on supporting tissues and patients' satisfaction will also be assessed.
Materials and Methods: 36 complete edentulous patients who already have maxillary dentures and complaining of instable mandibular dentures will be invited to participate in this study. Mandibular dentures will be relined randomly by one of three relining materials: two chairside relining materials (Tokuyama Rebase II Fast, Tokuyama Dental Co, Japan), and (Flexacryl Hard, Lang Co, USA) and one heat cured acrylic resin (Vertex, Dental technology Co, Holland).
The color stability of relining material, peeling, and the effect on supporting tissue will be assessed by two separate prosthodontists after 3 and 6 months of follow up. In addition, patients will be asked to grade there overall satisfaction on a Visual Analogue Scale (VAS) ranging from 0 to 100.
**Detailed Description:** Relining denture is a process of resurfacing the tissue side of a denture to make it fit more accurately Direct relining of removable dentures with hard chair-side reline materials is suitable for improving the fit of the denture bases to the supporting tissues. Chairside reline materials are more convenient than those processed in a laboratory because the direct method is faster and does not cause clinically significant dimensional changes of the reline resin. However, when autopolymerized reline resins are used with a direct method, several problems can occur as burning sensation caused by monomers, an exothermic heat reaction and an unpleasant odor.
There are three types of hard relining chair-side materials: Dual-polymerized Visible light-polymerized as Triad DuaLine, Light Liner (Hard), Astron LC (Hard).Visible light-polymerized as Lightdon-U, Triad Hi-Flow Reline Material, Triad VLC Reline Material. Finally, autopolymerized as New Truline, Tokuyama Rebase II (Fast) , GC Reline. Other concerns related to direct reline materials include patient tolerance (taste, temperature, odor), color stability, durability and ease of handling and polishing.
Few studies evaluated the effect of disinfection solutions on relining materials properties as roughness and hardness. In one study, disinfectant solutions caused a decrease in hardness, whereas with roughness, the materials tested showed a statistically significant increase, except for Tokuyama. Depending on the examined relining materials, some materials have increased and the others have decreased surface roughness after immersion in disinfecting solutions or microwave disinfection.
All previous laboratory studies concentrated on the effects of disinfection on relining materials properties as roughness, hardness, color change. However, the clinical studies did not compare chemically cured and heat cured relining materials and their effects on supporting tissue. The aim of this study is to evaluate the clinical performance of two -chemically cured- and heat cured denture relining material after 3 and 6 months of use. In addition, the effect of hard relining materials on supporting tissues, and patients' satisfaction has not been evaluated yet.
### Conditions Module
**Conditions:**
- Complete Mandibular Dentures With Poor Retention
**Keywords:**
- Chair-side hard relining
- complete denture
- patients' satisfaction
- supporting tissues
- autopolymerized reline resins
- heat cured relining material
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 36
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The direct chair-side relining materiel 'Rebase II Fast' will be used.
**Intervention Names:**
- Other: Rebase II Fast
**Label:** Rebase II Fast
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The direct chair-side relining material Flexacryl will be used
**Intervention Names:**
- Other: Flexacryl
**Label:** Flexacryl
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Vertex is a heat-cured resin material which is going to be used for indirect relining
**Intervention Names:**
- Other: Vertex
**Label:** Vertex
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Rebase II Fast
**Description:** It is going to be used a direct relining material
**Name:** Rebase II Fast
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Flexacryl
**Description:** This is going to be used as a second direct relining material
**Name:** Flexacryl
**Type:** OTHER
#### Intervention 3
**Arm Group Labels:**
- Vertex
**Description:** This is going to be used as an indirect relining material
**Name:** Vertex
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** According to a clinical examination by two prosthodontists, the supporting alveolar mucosa will be given one of the following levels:
Class I: The presence of reddish soft tissues extending to more than half of the area of the supporting mucosa or the presence of large areas of movable tissues.
Class II: The presence of irritated soft tissues extending to about third of the area of the supporting mucose or the presence of some areas of movable tissues at the top of the alveolar ridge.
Class III: The soft tissues appear in general as normal and fixed except for small isolated areas.
Class IV: The soft tissues appear normal and fixed without any signs of irritation or denture-induced injuries.
**Measure:** Supporting Alveolar Mucosa Status_3
**Time Frame:** This will be measured at three months following relining
**Description:** According to a clinical examination by two prosthodontists, the supporting alveolar mucosa will be given one of the following levels:
Class I: The presence of reddish soft tissues extending to more than half of the area of the supporting mucosa or the presence of large areas of movable tissues.
Class II: The presence of irritated soft tissues extending to about third of the area of the supporting mucose or the presence of some areas of movable tissues at the top of the alveolar ridge.
Class III: The soft tissues appear in general as normal and fixed except for small isolated areas.
Class IV: The soft tissues appear normal and fixed without any signs of irritation or denture-induced injuries.
**Measure:** Supporting Alveolar Mucosa Status_6
**Time Frame:** This variable will be assessed at six months following relining
**Description:** The color stability variable has four degrees on clinical examination:
1. no change
2. simple
3. medium
4. large
**Measure:** Color Stability_3
**Time Frame:** This will be assessed at three moths following relining
#### Secondary Outcomes
**Description:** The color stability variable has four degrees on clinical examination:
no change simple medium large
**Measure:** Color Stability_6
**Time Frame:** This be assessed at six months following relining
**Description:** This variable is going to be inspected clinically and it has two categories:
1. peeling more than 4 mm
2. peeling less than 4 mm
**Measure:** Peeling_3
**Time Frame:** This variable is going to be assessed at three months following relining
**Description:** This variable is going to be inspected clinically and it has two categories:
1. peeling more than 4 mm
2. peeling less than 4 mm
**Measure:** Peeling_6
**Time Frame:** This variable is going to be assessed at six months following relining
**Description:** Patient's satisfaction: patients will be asked to grade there overall satisfaction on a visual analogue scale (VAS) ranging from 0 to 100.
**Measure:** Satisfaction_3
**Time Frame:** This is going to be measured at three months following relining
**Description:** Patient's satisfaction: patients will be asked to grade there overall satisfaction on a visual analogue scale (VAS) ranging from 0 to 100.
**Measure:** Satisfaction_6
**Time Frame:** This is going to be measured at six months following relining
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age between 45-80 year,
* complete maxillary and lower dentures
* Mandibular dentures with poor retention
Exclusion Criteria:
* Patients with good stability of mandibular dentures.
* Partial maxillary edentulous patients
**Maximum Age:** 78 Years
**Minimum Age:** 47 Years
**Sex:** MALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Damascus
**Country:** Syrian Arab Republic
**Facility:** Department of Removable Prosthodontics, University of Damascus Dental School
**Zip:** DM20AM18
#### Overall Officials
**Official 1:**
**Affiliation:** PhD student, Department of Removable Prosthodontics, University of Damascus Dental School, Damascus
**Name:** Omar Teriaky, DDS MSc
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** Associate Professor, Removable Prosthodontics Department, University of Damascus Dental School, Damascus
**Name:** Muhannad Alssadi, DDS MSc PhD
**Role:** STUDY_DIRECTOR
### References Module
#### References
**Citation:** Al Rifaiy MQ. Shear bond strength between light polymerized hard reline resin and denture base resin subjected to long term water immersion. Saudi Dent J. 2012 Jan;24(1):23-7. doi: 10.1016/j.sdentj.2011.10.004. Epub 2011 Nov 20.
**PMID:** 23960524
**Citation:** Arima T, Murata H, Hamada T. Analysis of composition and structure of hard autopolymerizing reline resins. J Oral Rehabil. 1996 May;23(5):346-52. doi: 10.1111/j.1365-2842.1996.tb00863.x.
**PMID:** 8736448
**Citation:** Pinto Lde R, Acosta EJ, Tavora FF, da Silva PM, Porto VC. Effect of repeated cycles of chemical disinfection on the roughness and hardness of hard reline acrylic resins. Gerodontology. 2010 Jun;27(2):147-53. doi: 10.1111/j.1741-2358.2009.00282.x. Epub 2009 Jun 8.
**PMID:** 19508322
**Citation:** Haywood J, Basker RM, Watson CJ, Wood DJ. A comparison of three hard chairside denture reline materials. Part I. Clinical evaluation. Eur J Prosthodont Restor Dent. 2003 Dec;11(4):157-63.
**PMID:** 14737792
**Citation:** Hong G, Murata H, Li Y, Sadamori S, Hamada T. Influence of denture cleansers on the color stability of three types of denture base acrylic resin. J Prosthet Dent. 2009 Mar;101(3):205-13. doi: 10.1016/S0022-3913(09)60032-9.
**PMID:** 19231574
**Citation:** Machado AL, Breeding LC, Vergani CE, da Cruz Perez LE. Hardness and surface roughness of reline and denture base acrylic resins after repeated disinfection procedures. J Prosthet Dent. 2009 Aug;102(2):115-22. doi: 10.1016/S0022-3913(09)60120-7.
**PMID:** 19643225
**Citation:** Machado AL, Giampaolo ET, Vergani CE, Souza JF, Jorge JH. Changes in roughness of denture base and reline materials by chemical disinfection or microwave irradiation: surface roughness of denture base and reline materials. J Appl Oral Sci. 2011 Oct;19(5):521-8. doi: 10.1590/s1678-77572011000500015.
**PMID:** 21986658
**Citation:** Matsumura H, Tanoue N, Kawasaki K, Atsuta M. Clinical evaluation of a chemically cured hard denture relining material. J Oral Rehabil. 2001 Jul;28(7):640-4. doi: 10.1046/j.1365-2842.2001.00701.x.
**PMID:** 11422696
**Citation:** Murata H, Seo RS, Hamada T, Polyzois GL, Frangou MJ. Dynamic mechanical properties of hard, direct denture reline resins. J Prosthet Dent. 2007 Oct;98(4):319-26. doi: 10.1016/S0022-3913(07)60105-X.
**PMID:** 17936130
**Citation:** Ogle RE, Sorensen SE, Lewis EA. A new visible light-cured resin system applied to removable prosthodontics. J Prosthet Dent. 1986 Oct;56(4):497-506. doi: 10.1016/0022-3913(86)90397-5.
**PMID:** 3463760
**Citation:** Wyatt CC, Harrop TJ, MacEntee MI. A comparison of physical characteristics of six hard denture reline materials. J Prosthet Dent. 1986 Mar;55(3):343-6. doi: 10.1016/0022-3913(86)90117-4.
**PMID:** 3457166
## Derived Section
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT02655679
**Brief Title:** An Ascending Multiple Dose Study of VTP-38543 in Adult Participants With Mild to Moderate Atopic Dermatitis
**Official Title:** A Randomized, Double-Blind, Vehicle-Controlled Ascending Multiple Dose and Clinical Proof-Of-Concept Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VTP-38543 in Adult Patients With Mild to Moderate Atopic Dermatitis
#### Organization Study ID Info
**ID:** VTP-38543-001
#### Organization
**Class:** INDUSTRY
**Full Name:** Vitae Pharmaceuticals, Inc.
### Status Module
#### Completion Date
**Date:** 2016-09-09
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-02-15
**Type:** ACTUAL
**Last Update Submit Date:** 2019-01-18
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2016-09-09
**Type:** ACTUAL
#### Results First Post Date
**Date:** 2019-02-15
**Type:** ACTUAL
**Results First Submit Date:** 2019-01-18
**Results First Submit QC Date:** 2019-01-18
#### Start Date
**Date:** 2015-12-15
**Type:** ACTUAL
**Status Verified Date:** 2019-01
#### Study First Post Date
**Date:** 2016-01-14
**Type:** ESTIMATED
**Study First Submit Date:** 2016-01-11
**Study First Submit QC Date:** 2016-01-12
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Vitae Pharmaceuticals, Inc.
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary clinical efficacy of VTP-38543 administered as a cream, twice-daily, for 28 days in otherwise healthy adult male and female participants with mild to moderate atopic dermatitis.
**Detailed Description:** This is a randomized, double-blind, vehicle-controlled study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary clinical efficacy of VTP-38543 following twice-daily, every twelve hours (Q12h) administration for 28 days in otherwise healthy adult male and female participants with mild to moderate atopic dermatitis.
Evaluation of three ascending doses in three dose panels is planned for this trial. Dose Panel 1 (VTP-38543 0.05%) and Panel 2 (VTP-38543 0.15%) will each enroll 30 participants and randomize 20 to VTP-38543 and 10 to matching vehicle control (Vehicle without Transcutol®P). Dose Panel 3 (VTP-38543 1%) will enroll 40 participants and randomize 20 to VTP-38543 and 20 to matching vehicle control (Vehicle with Transcutol®P). A total of approximately 100 participants will participate in the trial.
### Conditions Module
**Conditions:**
- Dermatitis, Atopic
**Keywords:**
- Eczema
### 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:** 104
**Type:** ACTUAL
**Phases:**
- PHASE1
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** VTP-38543 0.05% administered topically every 12 hours for 28 days.
**Intervention Names:**
- Drug: VTP-38543
**Label:** VTP-38543 0.05%
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** VTP-38543 0.15% administered topically every 12 hours for 28 days.
**Intervention Names:**
- Drug: VTP-38543
**Label:** VTP-38543 0.15%
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Vehicle without Transcutol®P administered topically every 12 hours for 28 days.
**Intervention Names:**
- Other: Vehicle without Transcutol®P
**Label:** Vehicle without Transcutol®P
**Type:** PLACEBO_COMPARATOR
#### Arm Group 4
**Description:** VTP-38543 1% administered topically every 12 hours for 28 days.
**Intervention Names:**
- Drug: VTP-38543
**Label:** VTP-38543 1%
**Type:** EXPERIMENTAL
#### Arm Group 5
**Description:** Vehicle with Transcutol®P administered topically every 12 hours for 28 days.
**Intervention Names:**
- Other: Vehicle with Transcutol®P
**Label:** Vehicle with Transcutol®P
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- VTP-38543 0.05%
- VTP-38543 0.15%
- VTP-38543 1%
**Description:** VTP-38543 topical cream
**Name:** VTP-38543
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Vehicle with Transcutol®P
**Description:** Vehicle matching VTP-38543 cream with Transcutol®P
**Name:** Vehicle with Transcutol®P
**Other Names:**
- Transcutol®P is Diethylene Glycol Monoethyl Ether, NF.
**Type:** OTHER
#### Intervention 3
**Arm Group Labels:**
- Vehicle without Transcutol®P
**Description:** Vehicle matching VTP-38543 cream without Transcutol®P
**Name:** Vehicle without Transcutol®P
**Other Names:**
- Transcutol®P is Diethylene Glycol Monoethyl Ether, NF.
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** An Adverse Event is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The number of participants with AEs related to treatment are reported.
**Measure:** Number of Participants With Treatment-related Adverse Events (AEs)
**Time Frame:** Baseline (Day 0) to Day 35
**Description:** Clinical Laboratory tests included chemistry, hematology and urinalysis tests collected during the study. The investigator determined if the changes in laboratory results were clinically significant.
**Measure:** Number of Participants With Clinically Significant Changes in Clinical Laboratory Values
**Time Frame:** Baseline (Day 0) to Day 35
**Description:** Vital signs included blood pressure, pulse, respiration rate and body temperature. The investigator determined if the changes in vital sign results were clinically significant.
**Measure:** Number of Participants With Clinically Significant Changes in Vital Signs
**Time Frame:** Baseline (Day 0) to Day 35
**Description:** A standard 12-lead ECG was performed. The investigator determined if the changes in ECG results were clinically significant.
**Measure:** Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values
**Time Frame:** Baseline (Day 0) to Day 35
#### Secondary Outcomes
**Measure:** Maximum Plasma Concentration (Cmax) for VTP-38543-001
**Time Frame:** Day 0 (pre-dose, 1, 2, 4, 6, 9, and 12 hours post first dose), and Day 27 (pre-dose, 1, 2, 4, 6, 9, 12, 24, 48, and 72 hours post last dose)
**Measure:** Time to Maximum Plasma Concentrations (Tmax) for VTP-38543
**Time Frame:** Day 0 (pre-dose, 1, 2, 4, 6, 9, and 12 hours post first dose), and Day 27 (pre-dose, 1, 2, 4, 6, 9, 12, 24, 48, and 72 hours post last dose)
**Measure:** Area Under the Plasma Concentration Versus Time Curve, From Time 0 to the Last Measurable Concentration (AUClast) for VTP-38543
**Time Frame:** Day 0 (pre-dose, 1, 2, 4, 6, 9, and 12 hours post first dose), and Day 27 (pre-dose, 1, 2, 4, 6, 9, 12, 24, 48, and 72 hours post last dose)
**Measure:** Area Under the Plasma Concentration Versus Time Curve, From Time 0 to 12 Hours (AUC0-12hr) for VTP-38543
**Time Frame:** Day 0 (pre-dose, 1, 2, 4, 6, 9, and 12 hours post first dose), and Day 27 (pre-dose, 1, 2, 4, 6, 9, 12, 24, 48, and 72 hours post last dose)
**Measure:** Elimination Half-life (t½) for VTP-38543
**Time Frame:** Day 0 (pre-dose, 1, 2, 4, 6, 9, and 12 hours post first dose), and Day 27 (pre-dose, 1, 2, 4, 6, 9, 12, 24, 48, and 72 hours post last dose)
**Description:** Percent BSA was estimated using the palmar surface of the participant's hand up to the proximal interphalangeal joint, including the thumb, to approximate 1% of the participant's BSA. The overall BSA affected by atopic dermatitis was evaluated from 0 to 100% and divided by 5 for a maximum of 20. A negative percentage change indicates improvement.
**Measure:** Percentage Change From Baseline in Total Body Surface Area (BSA)
**Time Frame:** Baseline (Day 0) to Day 28
**Description:** The investigator assessed the participant's atopic dermatitis using the 5-point IGA where 0=clear (Minor, residual discoloration, no erythema or induration/papulation, no oozing/crusting) to 4=Severe disease (Deep/bright red erythema with severe induration/papulation with oozing/crusting). A negative percentage change indicates improvement.
**Measure:** Percentage Change From Baseline in Investigator Global Assessments (IGA) Score
**Time Frame:** Baseline (Day 0) to Day 28
**Description:** The investigator assessed severity of atopic dermatitis (AD) using scoring atopic dermatitis (SCORAD) score obtained from different individual scales. 6-items: erythema, edema/papulation, oozing/crusts, excoriation, lichenification, and dryness were graded on a 4-point scale where 0=Absent to 3=Severe. The individual scores were added together to get a score of 0 to 18 that was multiplied by 3.5 for a score of 0 to 63. The overall BSA affected by AD (0 to 100 %) was divided by 5 for a score 0 to 20. The participant used a 10-point Visual Analog Scale (VAS) to evaluate loss of sleep and the occurrence of pruritus averaged over the last 3 days where 0=None to Worst Imaginable. The sum of the 2 VAS scores was 0 to 20. The above measures were added together for a total possible SCORAD score of 0 (best) to 103 (worst). A negative percentage change indicates improvement.
**Measure:** Percentage Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score
**Time Frame:** Baseline (Day 0) to Day 28
**Description:** The investigator assessed four body regions: Head and neck, Upper extremities, Trunk including axillae and groin, and Lower extremities including buttocks. Each body region was scored based on BSA where 0=No involvement to 6=90-100%. Each body region was assessed for erythema, infiltration/papulation, excoriation and lichenification using a 4-point scale where 0=None to 3=Severe. EASI total score was determined by combining the individual scores for each of the 4 body regions. The total for each region was calculated by \[erythema + infiltration+ excoriation + lichenification \* area involvement \* a constant (constants Head and Neck=0.1, Upper Limbs=0.2, Trunk=0.3, Lower Limbs=0.4)\]. The EASI total score was determined by combining the individual scores for each of the 4 body regions for a total possible score of 0 (best) to 72 (worst). A negative percentage change indicates improvement.
**Measure:** Percentage Change From Baseline Eczema Area and Severity Index (EASI)
**Time Frame:** Baseline (Day 0) to Day 28
**Description:** The participant used a 10-point VAS to assess the occurrence of pruritus (itchy skin) over the last 3 days where 0= None to 10=Worst Imaginable for a total possible score of 0 to 10. A negative percentage change indicates improvement.
**Measure:** Percentage Change From Baseline in Pruritus VAS Score
**Time Frame:** Baseline (Day 0) to Day 28
**Description:** The participant used a 10-point VAS to evaluate loss of sleep averaged over the last 3 days where 0= None to 10=Worst imaginable for a total possible score of 0 to 10. A negative percentage change indicates improvement.
**Measure:** Percentage Change From Baseline in VAS Sleep Score
**Time Frame:** Baseline (Day 0) to Day 28
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Mild to moderate atopic dermatitis with a minimum of 3 to a maximum of 15% body surface area (BSA) involvement
* Investigator Global Assessments (IGA) score of 2 or 3
* Body Mass Index (BMI) = 18 - 35 kg/m\^2
* Negative Pregnancy test for females
Exclusion Criteria:
* Treatment for atopic dermatitis with systemic medications, topical agents, and parenteral biological/monoclonal antibody agents, within specific time period prior to dosing.
* Organ dysfunction or any clinically significant deviation from normal in vital signs, physical examinations, labs, and Electrocardiogram (ECG) findings
* Major surgery within 3 months of Screening
* Use of prescription drugs, sedative antihistamine, medical devices for treatment of atopic dermatitis (AD), and topical products containing urea and/or ceramides within 14 prior to dosing
* Excessive sun exposures, use of tanning booths or other ultraviolet (UV) light sources 4 weeks prior to dosing
**Maximum Age:** 65 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** West Dundee
**Country:** United States
**Facility:** Dundee Dermatology
**State:** Illinois
**Zip:** 60118
**Location 2:**
**City:** Fort Gratiot
**Country:** United States
**Facility:** Hamzavi Dermatology
**State:** Michigan
**Zip:** 48059
**Location 3:**
**City:** New York
**Country:** United States
**Facility:** Skin Specialty Dermatology
**State:** New York
**Zip:** 10155
**Location 4:**
**City:** Raleigh
**Country:** United States
**Facility:** Wake Research Associates, LLC
**State:** North Carolina
**Zip:** 27612
**Location 5:**
**City:** Philadelphia
**Country:** United States
**Facility:** Paddington Testing Company, Inc
**State:** Pennsylvania
**Zip:** 19103
**Location 6:**
**City:** Calgary
**Country:** Canada
**Facility:** Kirk Barber Research
**State:** Alberta
**Zip:** T2G1B1CA
**Location 7:**
**City:** Edmonton
**Country:** Canada
**Facility:** Stratica Medical Inc
**State:** Alberta
**Zip:** T5K 1X3
**Location 8:**
**City:** Markham
**Country:** Canada
**Facility:** Lynderm Research Inc
**State:** Ontario
**Zip:** L3P 1X2
**Location 9:**
**City:** Richmond Hill
**Country:** Canada
**Facility:** The Center for Dermatology / Institution
**State:** Ontario
**Zip:** L4B 1A5
**Location 10:**
**City:** Windsor
**Country:** Canada
**Facility:** Windsor Clinical Research Inc
**State:** Ontario
**Zip:** N8W 5L7
**Location 11:**
**City:** Drummondville
**Country:** Canada
**Facility:** Dr Isabelle Delorme Inc
**State:** Quebec
**Zip:** J2B 5L4
**Location 12:**
**City:** Montreal
**Country:** Canada
**Facility:** Innovaderm Research
**State:** Quebec
**Zip:** H2K4L5
#### Overall Officials
**Official 1:**
**Affiliation:** Allergan
**Name:** Christy Harutunian
**Role:** STUDY_DIRECTOR
### References Module
#### References
**Citation:** Czarnowicki T, Dohlman AB, Malik K, Antonini D, Bissonnette R, Chan TC, Zhou L, Wen HC, Estrada Y, Xu H, Bryson C, Shen J, Lala D, Ma'ayan A, McGeehan G, Gregg R, Guttman-Yassky E. Effect of short-term liver X receptor activation on epidermal barrier features in mild to moderate atopic dermatitis: A randomized controlled trial. Ann Allergy Asthma Immunol. 2018 Jun;120(6):631-640.e11. doi: 10.1016/j.anai.2018.03.013. Epub 2018 Mar 19.
**PMID:** 29567358
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012871
- Term: Skin Diseases
- ID: D000012873
- Term: Skin Diseases, Genetic
- ID: D000030342
- Term: Genetic Diseases, Inborn
- ID: D000017443
- Term: Skin Diseases, Eczematous
- ID: D000006969
- Term: Hypersensitivity, Immediate
- ID: D000006967
- Term: Hypersensitivity
- ID: D000007154
- Term: Immune System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC16
- Name: Diseases and Abnormalities at or Before Birth
- Abbrev: BC20
- Name: Immune System Diseases
### Condition Browse Module - Browse Leaves
- ID: M7067
- Name: Dermatitis
- Relevance: HIGH
- As Found: Dermatitis
- ID: M7655
- Name: Eczema
- Relevance: LOW
- As Found: Unknown
- ID: M7071
- Name: Dermatitis, Atopic
- Relevance: HIGH
- As Found: Dermatitis, Atopic
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15676
- Name: Skin Diseases, Genetic
- Relevance: LOW
- As Found: Unknown
- ID: M23686
- Name: Genetic Diseases, Inborn
- Relevance: LOW
- As Found: Unknown
- ID: M19712
- Name: Skin Diseases, Eczematous
- 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
### Condition Browse Module - Meshes
- ID: D000003876
- Term: Dermatitis, Atopic
- ID: D000003872
- Term: Dermatitis
### Intervention Browse Module - Ancestors
- ID: D000018685
- Term: Anesthetics, Inhalation
- ID: D000018681
- Term: Anesthetics, General
- ID: D000000777
- Term: Anesthetics
- ID: D000002492
- Term: Central Nervous System Depressants
- ID: D000045505
- Term: Physiological Effects of Drugs
### 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: M8134
- Name: Ether
- Relevance: HIGH
- As Found: Brainstem
- ID: M4107
- Name: Anesthetics
- Relevance: LOW
- As Found: Unknown
- ID: M20765
- Name: Anesthetics, Inhalation
- Relevance: LOW
- As Found: Unknown
- ID: M20761
- Name: Anesthetics, General
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000004986
- Term: Ether
### Misc Info Module
- Version Holder: 2024-05-24
## Results Section
### Adverse Events Module
**Description:** Safety population, all randomized participants who received at least one dose of study medication, was used to determine the number of participants for Serious Adverse Events and Other Adverse Events.
#### Event Groups
**Group ID:** EG000
**Title:** VTP- 38543 0.05%
**Deaths Num At Risk:** 20
**Description:** VTP-38543 0.05% administered topically every 12 hours for 28 days.
**ID:** EG000
**Other Num Affected:** 10
**Other Num at Risk:** 20
**Serious Number At Risk:** 20
**Title:** VTP- 38543 0.05%
**Group ID:** EG001
**Title:** VTP- 38543 0.15%
**Deaths Num At Risk:** 19
**Description:** VTP-38543 0.15% administered topically every 12 hours for 28 days.
**ID:** EG001
**Other Num Affected:** 12
**Other Num at Risk:** 19
**Serious Number At Risk:** 19
**Title:** VTP- 38543 0.15%
**Group ID:** EG002
**Title:** Vehicle Without Transcutol®P
**Deaths Num At Risk:** 20
**Description:** Vehicle without Transcutol®P administered topically every 12 hours for 28 days.
**ID:** EG002
**Other Num Affected:** 12
**Other Num at Risk:** 20
**Serious Number At Risk:** 20
**Title:** Vehicle Without Transcutol®P
**Group ID:** EG003
**Title:** VTP-38543 1%
**Deaths Num At Risk:** 24
**Description:** VTP-38543 1% administered topically every 12 hours for 28 days.
**ID:** EG003
**Other Num Affected:** 8
**Other Num at Risk:** 24
**Serious Number At Risk:** 24
**Title:** VTP-38543 1%
**Group ID:** EG004
**Title:** Vehicle With Transcutol®P
**Deaths Num At Risk:** 20
**Description:** Vehicle with Transcutol®P administered topically every 12 hours for 28 days.
**ID:** EG004
**Other Num Affected:** 6
**Other Num at Risk:** 20
**Serious Number At Risk:** 20
**Title:** Vehicle With Transcutol®P
**Frequency Threshold:** 0
#### Other Events
**Term:** Diarrhoea
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA 18.1
**Term:** Hypothyroidism
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Endocrine disorders
**Source Vocabulary:** MedDRA 18.1
**Term:** Dyspepsia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA 18.1
**Term:** Tooth impacted
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA 18.1
**Term:** Application site pain
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA 18.1
**Term:** Application site pruritus
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA 18.1
**Term:** Administration site pruritus
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA 18.1
**Term:** Chest pain
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA 18.1
**Term:** Chills
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA 18.1
**Term:** Cellulitis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA 18.1
**Term:** Post procedural infection
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA 18.1
**Term:** Upper respiratory tract infection
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA 18.1
**Term:** Procedural dizziness
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Injury, poisoning and procedural complications
**Source Vocabulary:** MedDRA 18.1
**Term:** Arthropod bite
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Injury, poisoning and procedural complications
**Source Vocabulary:** MedDRA 18.1
**Term:** Post procedural contusion
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Injury, poisoning and procedural complications
**Source Vocabulary:** MedDRA 18.1
**Term:** Sunburn
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Injury, poisoning and procedural complications
**Source Vocabulary:** MedDRA 18.1
**Term:** Aspartate aminotransferase increased
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:** MedDRA 18.1
**Term:** Blood creatine phosphokinase increased
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:** MedDRA 18.1
**Term:** Decreased appetite
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
**Source Vocabulary:** MedDRA 18.1
**Term:** Arthralgia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Musculoskeletal and connective tissue disorders
**Source Vocabulary:** MedDRA 18.1
**Term:** Back pain
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Musculoskeletal and connective tissue disorders
**Source Vocabulary:** MedDRA 18.1
**Term:** Musculoskeletal pain
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Musculoskeletal and connective tissue disorders
**Source Vocabulary:** MedDRA 18.1
**Term:** Headache
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
**Source Vocabulary:** MedDRA 18.1
**Term:** Oropharyngeal pain
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
**Source Vocabulary:** MedDRA 18.1
**Term:** Pruritus
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
**Source Vocabulary:** MedDRA 18.1
**Term:** Dermatitis atopic
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
**Source Vocabulary:** MedDRA 18.1
**Term:** Eczema
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
**Source Vocabulary:** MedDRA 18.1
**Term:** Urticaria
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
**Source Vocabulary:** MedDRA 18.1
**Term:** Nasopharyngitis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA 18.1
**Term:** Application site reaction
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA 18.1
**Term:** Fatigue
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA 18.1
**Term:** Ligament sprain
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Injury, poisoning and procedural complications
**Source Vocabulary:** MedDRA 18.1
**Term:** Chest discomfort
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA 18.1
**Term:** Leukopenia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Blood and lymphatic system disorders
**Source Vocabulary:** MedDRA 18.1
**Term:** Dry eye
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Eye disorders
**Source Vocabulary:** MedDRA 18.1
**Term:** Body tinea
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA 18.1
**Term:** Otitis media acute
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA 18.1
**Time Frame:** First dose of study drug to the last visit (Up to Day 35)
## Results Section - Baseline Characteristics Module
### Denomination Counts
**Group ID:** BG000
**Value:** 20
**Group ID:** BG001
**Value:** 19
**Group ID:** BG002
**Value:** 20
**Group ID:** BG003
**Value:** 24
**Group ID:** BG004
**Value:** 20
**Group ID:** BG005
**Value:** 103
**Units:** Participants
### Group
**ID:** BG000
**Title:** VTP- 38543 0.05%
**Description:** VTP-38543 0.05% administered topically every 12 hours for 28 days.
### Group
**ID:** BG001
**Title:** VTP- 38543 0.15%
**Description:** VTP-38543 0.15% administered topically every 12 hours for 28 days.
### Group
**ID:** BG002
**Title:** Vehicle Without Transcutol®P
**Description:** Vehicle without Transcutol®P administered topically every 12 hours for 28 days.
### Group
**ID:** BG003
**Title:** VTP-38543 1%
**Description:** VTP-38543 1% administered topically every 12 hours for 28 days.
### Group
**ID:** BG004
**Title:** Vehicle With Transcutol®P
**Description:** Vehicle with Transcutol®P administered topically every 12 hours for 28 days.
### Group
**ID:** BG005
**Title:** Total
**Description:** Total of all reporting groups
### Measure
#### Measurement
**Group ID:** BG000
**Spread:** 15.79
**Value:** 36.2
#### Measurement
**Group ID:** BG001
**Spread:** 13.39
**Value:** 36.8
#### Measurement
**Group ID:** BG002
**Spread:** 11.59
**Value:** 30.8
#### Measurement
**Group ID:** BG003
**Spread:** 10.51
**Value:** 35.7
#### Measurement
**Group ID:** BG004
**Spread:** 11.73
**Value:** 30.9
#### Measurement
**Group ID:** BG005
**Spread:** 12.67
**Value:** 34.1
**Class Title:**
### Measure
#### Measurement
**Group ID:** BG000
**Value:** 13
#### Measurement
**Group ID:** BG001
**Value:** 11
#### Measurement
**Group ID:** BG002
**Value:** 8
#### Measurement
**Group ID:** BG003
**Value:** 14
#### Measurement
**Group ID:** BG004
**Value:** 9
#### Measurement
**Group ID:** BG005
**Value:** 55
**Category Title:** Female
#### Measurement
**Group ID:** BG000
**Value:** 7
#### Measurement
**Group ID:** BG001
**Value:** 8
#### Measurement
**Group ID:** BG002
**Value:** 12
#### Measurement
**Group ID:** BG003
**Value:** 10
#### Measurement
**Group ID:** BG004
**Value:** 11
#### Measurement
**Group ID:** BG005
**Value:** 48
**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
**Population Description:** Safety population included randomized participants who received at least one dose of study medication.
## Results Section - More Information Module
### Certain Agreement
**Other Details:** A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
**Restriction Type:** OTHER
**Restrictive Agreement:** True
### Point of Contact
**Email:** [email protected]
**Organization:** Allergan
**Phone:** 714-246-4500
**Title:** Therapeutic Area, 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
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 1
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 3
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 2
- **Comment:**
- **Group ID:** OG003
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 6
- **Comment:**
- **Group ID:** OG004
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 2
**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
- **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 3
**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 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
- **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 5
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 1.16
- **Upper Limit:**
- **Value:** 0.546
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 0.175
- **Upper Limit:**
- **Value:** 0.221
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:** 3.29
- **Upper Limit:**
- **Value:** 2.34
**Title:**
**Denomination:**
- **Group ID:** OG000
- **Value:** 6
- **Group ID:** OG001
- **Value:** 4
- **Group ID:** OG002
- **Value:** 6
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 5.35
- **Upper Limit:**
- **Value:** 2.81
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 1.68
- **Upper Limit:**
- **Value:** 2.28
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:** 12.7
- **Upper Limit:**
- **Value:** 13.4
**Title:**
**Denomination:**
- **Group ID:** OG000
- **Value:** 5
- **Group ID:** OG001
- **Value:** 4
- **Group ID:** OG002
- **Value:** 4
**Units:** Participants
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:** 2
- **Spread:**
- **Upper Limit:** 9
- **Value:** 5.5
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:** 2
- **Spread:**
- **Upper Limit:** 9
- **Value:** 9
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:** 2
- **Spread:**
- **Upper Limit:** 9
- **Value:** 4
**Title:**
**Denomination:**
- **Group ID:** OG000
- **Value:** 6
- **Group ID:** OG001
- **Value:** 4
- **Group ID:** OG002
- **Value:** 6
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:** 0
- **Spread:**
- **Upper Limit:** 4
- **Value:** 1
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:** 2
- **Spread:**
- **Upper Limit:** 24
- **Value:** 6.5
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:** 4
- **Spread:**
- **Upper Limit:** 9
- **Value:** 4
**Title:**
**Denomination:**
- **Group ID:** OG000
- **Value:** 5
- **Group ID:** OG001
- **Value:** 4
- **Group ID:** OG002
- **Value:** 4
**Units:** Participants
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 4.23
- **Upper Limit:**
- **Value:** 2.27
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 1.41
- **Upper Limit:**
- **Value:** 1.35
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:** 28.2
- **Upper Limit:**
- **Value:** 20.0
**Title:**
**Denomination:**
- **Group ID:** OG000
- **Value:** 6
- **Group ID:** OG001
- **Value:** 4
- **Group ID:** OG002
- **Value:** 6
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 257
- **Upper Limit:**
- **Value:** 129
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 77.5
- **Upper Limit:**
- **Value:** 104
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:** 798
- **Upper Limit:**
- **Value:** 720
**Title:**
**Denomination:**
- **Group ID:** OG000
- **Value:** 5
- **Group ID:** OG001
- **Value:** 4
- **Group ID:** OG002
- **Value:** 4
**Units:** Participants
#### Outcome Measure 8
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 4.23
- **Upper Limit:**
- **Value:** 2.27
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 1.41
- **Upper Limit:**
- **Value:** 1.35
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:** 28.2
- **Upper Limit:**
- **Value:** 20.0
**Title:**
**Denomination:**
- **Group ID:** OG000
- **Value:** 6
- **Group ID:** OG001
- **Value:** 4
- **Group ID:** OG002
- **Value:** 6
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 44.8
- **Upper Limit:**
- **Value:** 23.6
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 18.2
- **Upper Limit:**
- **Value:** 22.2
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:** 144
- **Upper Limit:**
- **Value:** 144
**Title:**
**Denomination:**
- **Group ID:** OG000
- **Value:** 5
- **Group ID:** OG001
- **Value:** 4
- **Group ID:** OG002
- **Value:** 4
**Units:** Participants
#### Outcome Measure 9
**Class:**
##### Category
**Measurements:**
- **Comment:** t1/2 was not achieved at Day 0.
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** NA
- **Upper Limit:**
- **Value:** NA
- **Comment:** t1/2 was not achieved at Day 0.
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** NA
- **Upper Limit:**
- **Value:** NA
- **Comment:** t1/2 was not achieved at Day 0.
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:** NA
- **Upper Limit:**
- **Value:** NA
**Title:**
**Denomination:**
- **Group ID:** OG000
- **Value:** 6
- **Group ID:** OG001
- **Value:** 4
- **Group ID:** OG002
- **Value:** 6
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 14.5
- **Upper Limit:**
- **Value:** 58.6
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 12.2
- **Upper Limit:**
- **Value:** 47.2
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:** 349
- **Upper Limit:**
- **Value:** 246
**Title:**
**Denomination:**
- **Group ID:** OG000
- **Value:** 5
- **Group ID:** OG001
- **Value:** 4
- **Group ID:** OG002
- **Value:** 4
**Units:** Participants
#### Outcome Measure 10
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 29.233
- **Upper Limit:**
- **Value:** -39.09
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 52.978
- **Upper Limit:**
- **Value:** -9.46
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:** 55.588
- **Upper Limit:**
- **Value:** -17.39
- **Comment:**
- **Group ID:** OG003
- **Lower Limit:**
- **Spread:** 48.063
- **Upper Limit:**
- **Value:** -9.44
- **Comment:**
- **Group ID:** OG004
- **Lower Limit:**
- **Spread:** 29.398
- **Upper Limit:**
- **Value:** -28.51
**Title:**
#### Outcome Measure 11
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 25.36
- **Upper Limit:**
- **Value:** -12.7
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 34.96
- **Upper Limit:**
- **Value:** -16.7
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:** 32.46
- **Upper Limit:**
- **Value:** -19.4
- **Comment:**
- **Group ID:** OG003
- **Lower Limit:**
- **Spread:** 34.79
- **Upper Limit:**
- **Value:** -6.1
- **Comment:**
- **Group ID:** OG004
- **Lower Limit:**
- **Spread:** 20.47
- **Upper Limit:**
- **Value:** -13.2
**Title:**
#### Outcome Measure 12
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 30.1085
- **Upper Limit:**
- **Value:** -23.473
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 34.7270
- **Upper Limit:**
- **Value:** -17.300
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:** 35.6572
- **Upper Limit:**
- **Value:** -24.453
- **Comment:**
- **Group ID:** OG003
- **Lower Limit:**
- **Spread:** 32.2743
- **Upper Limit:**
- **Value:** -14.483
- **Comment:**
- **Group ID:** OG004
- **Lower Limit:**
- **Spread:** 26.0370
- **Upper Limit:**
- **Value:** -18.630
**Title:**
#### Outcome Measure 13
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 29.832
- **Upper Limit:**
- **Value:** -36.26
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 66.519
- **Upper Limit:**
- **Value:** -9.16
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:** 46.549
- **Upper Limit:**
- **Value:** -26.99
- **Comment:**
- **Group ID:** OG003
- **Lower Limit:**
- **Spread:** 58.819
- **Upper Limit:**
- **Value:** -12.52
- **Comment:**
- **Group ID:** OG004
- **Lower Limit:**
- **Spread:** 36.323
- **Upper Limit:**
- **Value:** -27.10
**Title:**
#### Outcome Measure 14
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 112.105
- **Upper Limit:**
- **Value:** 4.20
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 48.771
- **Upper Limit:**
- **Value:** -20.07
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:** 47.715
- **Upper Limit:**
- **Value:** -26.75
- **Comment:**
- **Group ID:** OG003
- **Lower Limit:**
- **Spread:** 42.232
- **Upper Limit:**
- **Value:** -25.80
- **Comment:**
- **Group ID:** OG004
- **Lower Limit:**
- **Spread:** 54.612
- **Upper Limit:**
- **Value:** -34.68
**Title:**
#### Outcome Measure 15
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 61.845
- **Upper Limit:**
- **Value:** -29.40
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 78.382
- **Upper Limit:**
- **Value:** -19.74
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:** 113.782
- **Upper Limit:**
- **Value:** 2.73
- **Comment:**
- **Group ID:** OG003
- **Lower Limit:**
- **Spread:** 53.672
- **Upper Limit:**
- **Value:** -29.98
- **Comment:**
- **Group ID:** OG004
- **Lower Limit:**
- **Spread:** 39.259
- **Upper Limit:**
- **Value:** -30.85
**Title:**
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** An Adverse Event is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The number of participants with AEs related to treatment are reported.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Safety population included randomized participants who received at least one dose of study medication.
**Reporting Status:** POSTED
**Time Frame:** Baseline (Day 0) to Day 35
**Title:** Number of Participants With Treatment-related Adverse Events (AEs)
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** VTP-38543 0.05% administered topically every 12 hours for 28 days.
**ID:** OG000
**Title:** VTP-38543 0.05%
##### Group
**Description:** VTP-38543 0.15% administered topically every 12 hours for 28 days.
**ID:** OG001
**Title:** VTP-38543 0.15%
##### Group
**Description:** Vehicle without Transcutol®P administered topically every 12 hours for 28 days.
**ID:** OG002
**Title:** Vehicle Without Transcutol®P
##### Group
**Description:** VTP-38543 1% administered topically every 12 hours for 28 days.
**ID:** OG003
**Title:** VTP-38543 1%
##### Group
**Description:** Vehicle with Transcutol®P administered topically every 12 hours for 28 days.
**ID:** OG004
**Title:** Vehicle With Transcutol®P
#### Outcome Measure 2
**Description:** Clinical Laboratory tests included chemistry, hematology and urinalysis tests collected during the study. The investigator determined if the changes in laboratory results were clinically significant.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Safety population included randomized participants who received at least one dose of study medication.
**Reporting Status:** POSTED
**Time Frame:** Baseline (Day 0) to Day 35
**Title:** Number of Participants With Clinically Significant Changes in Clinical Laboratory Values
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** VTP-38543 0.05% administered topically every 12 hours for 28 days.
**ID:** OG000
**Title:** VTP-38543 0.05%
##### Group
**Description:** VTP-38543 0.15% administered topically every 12 hours for 28 days.
**ID:** OG001
**Title:** VTP-38543 0.15%
##### Group
**Description:** Vehicle without Transcutol®P administered topically every 12 hours for 28 days.
**ID:** OG002
**Title:** Vehicle Without Transcutol®P
##### Group
**Description:** VTP-38543 1% administered topically every 12 hours for 28 days.
**ID:** OG003
**Title:** VTP-38543 1%
##### Group
**Description:** Vehicle with Transcutol®P administered topically every 12 hours for 28 days.
**ID:** OG004
**Title:** Vehicle With Transcutol®P
#### Outcome Measure 3
**Description:** Vital signs included blood pressure, pulse, respiration rate and body temperature. The investigator determined if the changes in vital sign results were clinically significant.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Safety population included randomized participants who received at least one dose of study medication.
**Reporting Status:** POSTED
**Time Frame:** Baseline (Day 0) to Day 35
**Title:** Number of Participants With Clinically Significant Changes in Vital Signs
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** VTP-38543 0.05% administered topically every 12 hours for 28 days.
**ID:** OG000
**Title:** VTP-38543 0.05%
##### Group
**Description:** VTP-38543 0.15% administered topically every 12 hours for 28 days.
**ID:** OG001
**Title:** VTP-38543 0.15%
##### Group
**Description:** Vehicle without Transcutol®P administered topically every 12 hours for 28 days.
**ID:** OG002
**Title:** Vehicle Without Transcutol®P
##### Group
**Description:** VTP-38543 1% administered topically every 12 hours for 28 days.
**ID:** OG003
**Title:** VTP-38543 1%
##### Group
**Description:** Vehicle with Transcutol®P administered topically every 12 hours for 28 days.
**ID:** OG004
**Title:** Vehicle With Transcutol®P
#### Outcome Measure 4
**Description:** A standard 12-lead ECG was performed. The investigator determined if the changes in ECG results were clinically significant.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Safety population included randomized participants who received at least one dose of study medication.
**Reporting Status:** POSTED
**Time Frame:** Baseline (Day 0) to Day 35
**Title:** Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** VTP-38543 0.05% administered topically every 12 hours for 28 days.
**ID:** OG000
**Title:** VTP-38543 0.05%
##### Group
**Description:** VTP-38543 0.15% administered topically every 12 hours for 28 days.
**ID:** OG001
**Title:** VTP-38543 0.15%
##### Group
**Description:** Vehicle without Transcutol®P administered topically every 12 hours for 28 days.
**ID:** OG002
**Title:** Vehicle Without Transcutol®P
##### Group
**Description:** VTP-38543 1% administered topically every 12 hours for 28 days.
**ID:** OG003
**Title:** VTP-38543 1%
##### Group
**Description:** Vehicle with Transcutol®P administered topically every 12 hours for 28 days.
**ID:** OG004
**Title:** Vehicle With Transcutol®P
#### Outcome Measure 5
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Pharmacokinetic (PK) population included all participants with available plasma concentration data with profiles adequate to determine PK parameters. Number analyzed is the number of participants with serial sampling data available at the given timepoint.
**Reporting Status:** POSTED
**Time Frame:** Day 0 (pre-dose, 1, 2, 4, 6, 9, and 12 hours post first dose), and Day 27 (pre-dose, 1, 2, 4, 6, 9, 12, 24, 48, and 72 hours post last dose)
**Title:** Maximum Plasma Concentration (Cmax) for VTP-38543-001
**Type:** SECONDARY
**Unit of Measure:** ng/mL
##### Group
**Description:** VTP-38543 0.05% administered topically every 12 hours for 28 days.
**ID:** OG000
**Title:** VTP-38543 0.05%
##### Group
**Description:** VTP-38543 0.15% administered topically every 12 hours for 28 days.
**ID:** OG001
**Title:** VTP-38543 0.15%
##### Group
**Description:** VTP-38543 1% administered topically every 12 hours for 28 days.
**ID:** OG002
**Title:** VTP-38543 1%
#### Outcome Measure 6
**Dispersion Type:** Full Range
**Parameter Type:** MEDIAN
**Population Description:** PK population included all participants with available plasma concentration data with profiles adequate to determine PK parameters. Number analyzed is the number of participants with serial sampling data available at the given timepoint.
**Reporting Status:** POSTED
**Time Frame:** Day 0 (pre-dose, 1, 2, 4, 6, 9, and 12 hours post first dose), and Day 27 (pre-dose, 1, 2, 4, 6, 9, 12, 24, 48, and 72 hours post last dose)
**Title:** Time to Maximum Plasma Concentrations (Tmax) for VTP-38543
**Type:** SECONDARY
**Unit of Measure:** hour
##### Group
**Description:** VTP-38543 0.05% administered topically every 12 hours for 28 days.
**ID:** OG000
**Title:** VTP-38543 0.05%
##### Group
**Description:** VTP-38543 0.15% administered topically every 12 hours for 28 days.
**ID:** OG001
**Title:** VTP-38543 0.15%
##### Group
**Description:** VTP-38543 1% administered topically every 12 hours for 28 days.
**ID:** OG002
**Title:** VTP-38543 1%
#### Outcome Measure 7
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** PK population included all participants with available plasma concentration data with profiles adequate to determine PK parameters. Number analyzed is the number of participants with serial sampling data available at the given timepoint.
**Reporting Status:** POSTED
**Time Frame:** Day 0 (pre-dose, 1, 2, 4, 6, 9, and 12 hours post first dose), and Day 27 (pre-dose, 1, 2, 4, 6, 9, 12, 24, 48, and 72 hours post last dose)
**Title:** Area Under the Plasma Concentration Versus Time Curve, From Time 0 to the Last Measurable Concentration (AUClast) for VTP-38543
**Type:** SECONDARY
**Unit of Measure:** ng*hr/mL
##### Group
**Description:** VTP-38543 0.05% administered topically every 12 hours for 28 days.
**ID:** OG000
**Title:** VTP-38543 0.05%
##### Group
**Description:** VTP-38543 0.15% administered topically every 12 hours for 28 days.
**ID:** OG001
**Title:** VTP-38543 0.15%
##### Group
**Description:** VTP-38543 1% administered topically every 12 hours for 28 days.
**ID:** OG002
**Title:** VTP-38543 1%
#### Outcome Measure 8
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** PK population included all participants with available plasma concentration data with profiles adequate to determine PK parameters. Number analyzed is the number of participants with serial sampling data available at the given timepoint.
**Reporting Status:** POSTED
**Time Frame:** Day 0 (pre-dose, 1, 2, 4, 6, 9, and 12 hours post first dose), and Day 27 (pre-dose, 1, 2, 4, 6, 9, 12, 24, 48, and 72 hours post last dose)
**Title:** Area Under the Plasma Concentration Versus Time Curve, From Time 0 to 12 Hours (AUC0-12hr) for VTP-38543
**Type:** SECONDARY
**Unit of Measure:** ng*hr/mL
##### Group
**Description:** VTP-38543 0.05% administered topically every 12 hours for 28 days.
**ID:** OG000
**Title:** VTP-38543 0.05%
##### Group
**Description:** VTP-38543 0.15% administered topically every 12 hours for 28 days.
**ID:** OG001
**Title:** VTP-38543 0.15%
##### Group
**Description:** VTP-38543 1% administered topically every 12 hours for 28 days.
**ID:** OG002
**Title:** VTP-38543 1%
#### Outcome Measure 9
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** PK Population included all participants with available plasma concentration data with profiles adequate to determine PK parameters. Number analyzed is the number of participants with serial sampling data available at the given timepoint.
**Reporting Status:** POSTED
**Time Frame:** Day 0 (pre-dose, 1, 2, 4, 6, 9, and 12 hours post first dose), and Day 27 (pre-dose, 1, 2, 4, 6, 9, 12, 24, 48, and 72 hours post last dose)
**Title:** Elimination Half-life (t½) for VTP-38543
**Type:** SECONDARY
**Unit of Measure:** hour
##### Group
**Description:** VTP-38543 0.05% administered topically every 12 hours for 28 days.
**ID:** OG000
**Title:** VTP-38543 0.05%
##### Group
**Description:** VTP-38543 0.15% administered topically every 12 hours for 28 days.
**ID:** OG001
**Title:** VTP-38543 0.15%
##### Group
**Description:** VTP-38543 1% administered topically every 12 hours for 28 days.
**ID:** OG002
**Title:** VTP-38543 1%
#### Outcome Measure 10
**Description:** Percent BSA was estimated using the palmar surface of the participant's hand up to the proximal interphalangeal joint, including the thumb, to approximate 1% of the participant's BSA. The overall BSA affected by atopic dermatitis was evaluated from 0 to 100% and divided by 5 for a maximum of 20. A negative percentage change indicates improvement.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Modified intent-to-treat (mITT) population included all participants who were randomized and who received at least one dose of study medication and with a Baseline and Day 28 value for efficacy parameters.
**Reporting Status:** POSTED
**Time Frame:** Baseline (Day 0) to Day 28
**Title:** Percentage Change From Baseline in Total Body Surface Area (BSA)
**Type:** SECONDARY
**Unit of Measure:** percentage change in total BSA
##### Group
**Description:** VTP-38543 0.05% administered topically every 12 hours for 28 days.
**ID:** OG000
**Title:** VTP-38543 0.05%
##### Group
**Description:** VTP-38543 0.15% administered topically every 12 hours for 28 days.
**ID:** OG001
**Title:** VTP-38543 0.15%
##### Group
**Description:** Vehicle without Transcutol®P administered topically every 12 hours for 28 days.
**ID:** OG002
**Title:** Vehicle Without Transcutol®P
##### Group
**Description:** VTP-38543 1% administered topically every 12 hours for 28 days.
**ID:** OG003
**Title:** VTP-38543 1%
##### Group
**Description:** Vehicle with Transcutol®P administered topically every 12 hours for 28 days.
**ID:** OG004
**Title:** Vehicle With Transcutol®P
#### Outcome Measure 11
**Description:** The investigator assessed the participant's atopic dermatitis using the 5-point IGA where 0=clear (Minor, residual discoloration, no erythema or induration/papulation, no oozing/crusting) to 4=Severe disease (Deep/bright red erythema with severe induration/papulation with oozing/crusting). A negative percentage change indicates improvement.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** mITT population included all participants who were randomized and who received at least one dose of study medication and with a Baseline and Day 28 value for efficacy parameters.
**Reporting Status:** POSTED
**Time Frame:** Baseline (Day 0) to Day 28
**Title:** Percentage Change From Baseline in Investigator Global Assessments (IGA) Score
**Type:** SECONDARY
**Unit of Measure:** percentage change in IGA score
##### Group
**Description:** VTP-38543 0.05% administered topically every 12 hours for 28 days.
**ID:** OG000
**Title:** VTP-38543 0.05%
##### Group
**Description:** VTP-38543 0.15% administered topically every 12 hours for 28 days.
**ID:** OG001
**Title:** VTP-38543 0.15%
##### Group
**Description:** Vehicle without Transcutol®P administered topically every 12 hours for 28 days.
**ID:** OG002
**Title:** Vehicle Without Transcutol®P
##### Group
**Description:** VTP-38543 1% administered topically every 12 hours for 28 days.
**ID:** OG003
**Title:** VTP-38543 1%
##### Group
**Description:** Vehicle with Transcutol®P administered topically every 12 hours for 28 days.
**ID:** OG004
**Title:** Vehicle With Transcutol®P
#### Outcome Measure 12
**Description:** The investigator assessed severity of atopic dermatitis (AD) using scoring atopic dermatitis (SCORAD) score obtained from different individual scales. 6-items: erythema, edema/papulation, oozing/crusts, excoriation, lichenification, and dryness were graded on a 4-point scale where 0=Absent to 3=Severe. The individual scores were added together to get a score of 0 to 18 that was multiplied by 3.5 for a score of 0 to 63. The overall BSA affected by AD (0 to 100 %) was divided by 5 for a score 0 to 20. The participant used a 10-point Visual Analog Scale (VAS) to evaluate loss of sleep and the occurrence of pruritus averaged over the last 3 days where 0=None to Worst Imaginable. The sum of the 2 VAS scores was 0 to 20. The above measures were added together for a total possible SCORAD score of 0 (best) to 103 (worst). A negative percentage change indicates improvement.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** mITT population included all participants who were randomized and who received at least one dose of study medication and with a Baseline and Day 28 value for efficacy parameters.
**Reporting Status:** POSTED
**Time Frame:** Baseline (Day 0) to Day 28
**Title:** Percentage Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score
**Type:** SECONDARY
**Unit of Measure:** percentage change in SCORAD score
##### Group
**Description:** VTP-38543 0.05% administered topically every 12 hours for 28 days.
**ID:** OG000
**Title:** VTP-38543 0.05%
##### Group
**Description:** VTP-38543 0.15% administered topically every 12 hours for 28 days.
**ID:** OG001
**Title:** VTP-38543 0.15%
##### Group
**Description:** Vehicle without Transcutol®P administered topically every 12 hours for 28 days.
**ID:** OG002
**Title:** Vehicle Without Transcutol®P
##### Group
**Description:** VTP-38543 1% administered topically every 12 hours for 28 days.
**ID:** OG003
**Title:** VTP-38543 1%
##### Group
**Description:** Vehicle with Transcutol®P administered topically every 12 hours for 28 days.
**ID:** OG004
**Title:** Vehicle With Transcutol®P
#### Outcome Measure 13
**Description:** The investigator assessed four body regions: Head and neck, Upper extremities, Trunk including axillae and groin, and Lower extremities including buttocks. Each body region was scored based on BSA where 0=No involvement to 6=90-100%. Each body region was assessed for erythema, infiltration/papulation, excoriation and lichenification using a 4-point scale where 0=None to 3=Severe. EASI total score was determined by combining the individual scores for each of the 4 body regions. The total for each region was calculated by \[erythema + infiltration+ excoriation + lichenification \* area involvement \* a constant (constants Head and Neck=0.1, Upper Limbs=0.2, Trunk=0.3, Lower Limbs=0.4)\]. The EASI total score was determined by combining the individual scores for each of the 4 body regions for a total possible score of 0 (best) to 72 (worst). A negative percentage change indicates improvement.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** mITT population included all participants who were randomized and who received at least one dose of study medication and with a Baseline and Day 28 value for efficacy parameters.
**Reporting Status:** POSTED
**Time Frame:** Baseline (Day 0) to Day 28
**Title:** Percentage Change From Baseline Eczema Area and Severity Index (EASI)
**Type:** SECONDARY
**Unit of Measure:** percentage change in EASI
##### Group
**Description:** VTP-38543 0.05% administered topically every 12 hours for 28 days.
**ID:** OG000
**Title:** VTP-38543 0.05%
##### Group
**Description:** VTP-38543 0.15% administered topically every 12 hours for 28 days.
**ID:** OG001
**Title:** VTP-38543 0.15%
##### Group
**Description:** Vehicle without Transcutol®P administered topically every 12 hours for 28 days.
**ID:** OG002
**Title:** Vehicle Without Transcutol®P
##### Group
**Description:** VTP-38543 1% administered topically every 12 hours for 28 days.
**ID:** OG003
**Title:** VTP-38543 1%
##### Group
**Description:** Vehicle with Transcutol®P administered topically every 12 hours for 28 days.
**ID:** OG004
**Title:** Vehicle With Transcutol®P
#### Outcome Measure 14
**Description:** The participant used a 10-point VAS to assess the occurrence of pruritus (itchy skin) over the last 3 days where 0= None to 10=Worst Imaginable for a total possible score of 0 to 10. A negative percentage change indicates improvement.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** mITT population included all participants who were randomized and who received at least one dose of study medication and with a Baseline and Day 28 value for efficacy parameters.
**Reporting Status:** POSTED
**Time Frame:** Baseline (Day 0) to Day 28
**Title:** Percentage Change From Baseline in Pruritus VAS Score
**Type:** SECONDARY
**Unit of Measure:** percentage change in pruritis VAS score
##### Group
**Description:** VTP-38543 0.05% administered topically every 12 hours for 28 days.
**ID:** OG000
**Title:** VTP-38543 0.05%
##### Group
**Description:** VTP-38543 0.15% administered topically every 12 hours for 28 days.
**ID:** OG001
**Title:** VTP-38543 0.15%
##### Group
**Description:** Vehicle without Transcutol®P administered topically every 12 hours for 28 days.
**ID:** OG002
**Title:** Vehicle Without Transcutol®P
##### Group
**Description:** VTP-38543 1% administered topically every 12 hours for 28 days.
**ID:** OG003
**Title:** VTP-38543 1%
##### Group
**Description:** Vehicle with Transcutol®P administered topically every 12 hours for 28 days.
**ID:** OG004
**Title:** Vehicle With Transcutol®P
#### Outcome Measure 15
**Description:** The participant used a 10-point VAS to evaluate loss of sleep averaged over the last 3 days where 0= None to 10=Worst imaginable for a total possible score of 0 to 10. A negative percentage change indicates improvement.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** mITT population included all participants who were randomized and who received at least one dose of study medication and with a Baseline and Day 28 value for efficacy parameters.
**Reporting Status:** POSTED
**Time Frame:** Baseline (Day 0) to Day 28
**Title:** Percentage Change From Baseline in VAS Sleep Score
**Type:** SECONDARY
**Unit of Measure:** percentage change in VAS sleep score
##### Group
**Description:** VTP-38543 0.05% administered topically every 12 hours for 28 days.
**ID:** OG000
**Title:** VTP-38543 0.05%
##### Group
**Description:** VTP-38543 0.15% administered topically every 12 hours for 28 days.
**ID:** OG001
**Title:** VTP-38543 0.15%
##### Group
**Description:** Vehicle without Transcutol®P administered topically every 12 hours for 28 days.
**ID:** OG002
**Title:** Vehicle Without Transcutol®P
##### Group
**Description:** VTP-38543 1% administered topically every 12 hours for 28 days.
**ID:** OG003
**Title:** VTP-38543 1%
##### Group
**Description:** Vehicle with Transcutol®P administered topically every 12 hours for 28 days.
**ID:** OG004
**Title:** Vehicle With Transcutol®P
### Participant Flow Module
#### Group
**Description:** VTP-38543 0.05% administered topically every 12 hours for 28 days.
**ID:** FG000
**Title:** VTP- 38543 0.05%
#### Group
**Description:** VTP-38543 0.15% administered topically every 12 hours for 28 days.
**ID:** FG001
**Title:** VTP- 38543 0.15%
#### Group
**Description:** Vehicle without Transcutol®P administered topically every 12 hours for 28 days.
**ID:** FG002
**Title:** Vehicle Without Transcutol®P
#### Group
**Description:** VTP-38543 1% administered topically every 12 hours for 28 days.
**ID:** FG003
**Title:** VTP-38543 1%
#### Group
**Description:** Vehicle with Transcutol®P administered topically every 12 hours for 28 days.
**ID:** FG004
**Title:** Vehicle With Transcutol®P
#### Period
**Title:** Overall Study
##### 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:** 0
###### Reason
**Group ID:** FG004
**Number of Subjects:** 0
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
###### Reason
**Group ID:** FG003
**Number of Subjects:** 3
###### Reason
**Group ID:** FG004
**Number of Subjects:** 1
##### Withdraw
**Type:** Inability to Comply with the Protocol
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### 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:** 0
##### 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:** 1
###### Reason
**Group ID:** FG003
**Number of Subjects:** 1
###### Reason
**Group ID:** FG004
**Number of Subjects:** 0
##### Withdraw
**Type:** Other Miscellaneous Reasons
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### 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:** 0
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 21
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 19
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 20
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 24
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 20
##### Milestone
**Type:** Received Study Drug (Safety Population)
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 20
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 19
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 20
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 24
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 20
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 18
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 16
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 19
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 20
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 19
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 3
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 3
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 1
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 4
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 1
**Has Results:** True |
## Protocol Section
### Identification Module
**NCT ID:** NCT01732679
**Acronym:** SINs
**Brief Title:** Sunnaas International Network´s Stroke Study
**Official Title:** A Prospective Multicenter Study of Stroke Rehabilitation in Seven Countries: Norway, China, USA, Russia, Israel, Palestine, and Sweden.
#### Organization Study ID Info
**ID:** SINs stroke study
#### Organization
**Class:** OTHER
**Full Name:** Sunnaas Rehabilitation Hospital
### Status Module
#### Completion Date
**Date:** 2016-10
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-04-25
**Type:** ACTUAL
**Last Update Submit Date:** 2017-04-24
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2014-12
**Type:** ACTUAL
#### Start Date
**Date:** 2012-09
**Status Verified Date:** 2017-04
#### Study First Post Date
**Date:** 2012-11-26
**Type:** ESTIMATED
**Study First Submit Date:** 2012-11-08
**Study First Submit QC Date:** 2012-11-23
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER_GOV
**Name:** China Rehabilitation Research Center
**Class:** UNKNOWN
**Name:** Sichuan 81 Rehabilitation Center, Chengdu
**Class:** UNKNOWN
**Name:** NYU Langoon medical center; The Rusk Institute of Rehabilitation Medicine, New York
**Class:** OTHER
**Name:** City outpatient clinics №2,Petrozavodsk, Petrozavodsk
**Class:** OTHER_GOV
**Name:** Sheba Medical Center
**Class:** OTHER
**Name:** Al-Wafa Rehabilitation Hospital
**Class:** UNKNOWN
**Name:** Bethlehem Arab Society for Rehabilitation, Betlehem
**Class:** OTHER
**Name:** Sahlgrenska University Hospital, Sweden
#### Lead Sponsor
**Class:** OTHER
**Name:** Sunnaas Rehabilitation Hospital
#### Responsible Party
**Investigator Affiliation:** Sunnaas Rehabilitation Hospital
**Investigator Full Name:** Birgitta Langhammer
**Investigator Title:** Associate professor/ project manager
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** A descriptive study of the stroke rehabilitation content in specialized clinics in seven countries: procedures for admission to rehabilitation, services available and provided to patients, as well as duration of the stay and discharge routines. An observational study of changes in regard to the physical function, quality of life and psycho-social factors in stroke patients before and after specialized rehabilitation
**Detailed Description:** The descriptive study is two folded:
1) Description of the rehabilitation centers and the content the respective clinic presents as specialized rehabilitation.
A description of the expected change this input will result in in form of patients change in ADL and life satisfaction, with repeated measurements:
2a) reports of change in activities of daily living from baseline, to one fixed time (18-22 days in rehab),at discharge (which will vary),6 and 12 months post discharge (relatively fixed time) .
2b) reports of possible change in life satisfaction at baseline, discharge, 6 and 12 months after discharge.
Since the times for admission is expected to vary, which will be described under 1),we also want to measure if and how this difference might influence results. Therefore a fixed measure is inserted between admission and discharge. we have added a "relatively" fixed date at 6 months post stroke in order to see if change of function from specialized rehabilitation will differ in a longitudinal perspective, and if possible to see if the difference in time to admission (time from debut till admission in specialized rehabilitation)might influence results.
3) description of psycho- social factors at 6 and 12 months post discharge
### Conditions Module
**Conditions:**
- Cerebral Stroke
**Keywords:**
- stroke, rehabilitation, multidisciplinary, description
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 230
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** specialized rehabilitation in a multidisciplinary team, Sunnaas International Network
**Intervention Names:**
- Other: rehabilitation
**Label:** stroke patients
### Interventions
#### Intervention 1
**Arm Group Labels:**
- stroke patients
**Description:** Description of specialized rehabilitation and Influence on activities, life satisfaction, psycho social aspects 6 and 12 months post discharge
**Name:** rehabilitation
**Other Names:**
- multidisciplinary specialised rehabilitation
**Type:** OTHER
### Outcomes Module
#### Other Outcomes
**Description:** NIHSS is a clinical stroke assessment tool to evaluate and document neurological status in acute stroke patients.
The timeframe for discharge will vary with the different clinics since this is one of the differences expected.
Length of stay is one of the outcomes
**Measure:** National Institutes of health stroke scale (NIHSS)
**Time Frame:** patients will be tested baseline and at discharge
**Description:** it is an evaluation of the degree of disability or dependence in the daily activities of people who have suffered a stroke
**Measure:** Modified Rankin Scale
**Time Frame:** patients will be followed 6 months from baseline testing
**Description:** A semi - structured interview, with focus on the psycho-social situation 6 months after rehabilitation, will be performed. Questions will focus on the work-, financial situation, what sort of follow-up services, recreational- and social activities are available, and what is considered the major change of life after stroke.
**Measure:** Description of the psycho- social situation
**Time Frame:** 6 months after discharge
**Description:** a questionaire where the participants are required to describe the services available, methods used in rehabilitation, intensity of training, procedures for intake and discharge
**Measure:** description of institution
**Time Frame:** baseline
**Description:** questionnaire regarding demographic data; age, gender, civil status, comorbidity, medication
**Measure:** registration data
**Time Frame:** baseline
#### Primary Outcomes
**Description:** Changes in Activities of daily living are monitored as an indirect evaluation of how the specialized rehabilitation may influence patients' outcomes.
**Measure:** activities of daily living
**Time Frame:** patients will be followed 6 months from baseline testing
#### Secondary Outcomes
**Description:** LiSat-11 consists of patients estimations of satisfaction with life as a whole as well as satisfaction in ten specific domains: vocation, economy, leisure, contacts, sexual life, activities of daily living (ADL), family life, partner relationship, somatic health, psychological health
**Measure:** The Life Satisfaction checklist (LiSat-11)
**Time Frame:** patients will be followed 6 months from baseline testing
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* primary diagnosis of stroke, in need of specialized comprehensive rehabilitation, voluntary participation
Exclusion Criteria:
* sub-arachnoid hæmorrhage, tumor or other severe medical condition in combination with stroke that will influence outcomes
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** stroke patients in need of specialised comprehensive rehabilitation
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** New York
**Country:** United States
**Facility:** Rusk Institute
**State:** New York
**Location 2:**
**City:** Chengdu
**Country:** China
**Facility:** Sichuan 81 rehabilitation center
**State:** Sichuan
**Location 3:**
**City:** Beijing
**Country:** China
**Facility:** China Research rehabilitation center
**Location 4:**
**City:** Tel Aviv
**Country:** Israel
**Facility:** Sheba medical center
**Location 5:**
**City:** Nesoddtangen
**Country:** Norway
**Facility:** Sunnaas rehabilitation Hospital
**Location 6:**
**City:** Betlehem
**Country:** Palestinian Territory, occupied
**Facility:** Betlehem arab society rehabilitation
**State:** Palestine
**Location 7:**
**City:** Gaza
**Country:** Palestinian Territory, occupied
**Facility:** El Wafa rehabilitation center
**Location 8:**
**City:** Petrozavodsk
**Country:** Russian Federation
**Facility:** Petrozavodsk
**Location 9:**
**City:** Gothenburgh
**Country:** Sweden
**Facility:** Sahlgrenska university hospital
#### Overall Officials
**Official 1:**
**Affiliation:** Sunnaas rehabilitation hospital, University of Oslo
**Name:** Johan K Stanghelle, PhD, MD
**Role:** STUDY_DIRECTOR
## Derived Section
### Condition Browse Module - Ancestors
- 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
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M22306
- Name: Stroke
- Relevance: HIGH
- As Found: Stroke
- 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
### Condition Browse Module - Meshes
- ID: D000020521
- Term: Stroke
### Misc Info Module
#### Removed Countries
- Country: Palestinian Territories, Occupied
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT01467479
**Brief Title:** A Study to Treat Subjects With Telaprevir, Ribavirin, and Peginterferon Who Are Coinfected With HIV and Hepatitis C Virus (HCV)
**Official Title:** An Open Label,Phase 3 Study of Telaprevir in Combination With Peginterferon Alfa 2a (Pegasys®) and Ribavirin (Copegus®) in Subjects Coinfected With Genotype 1 Hepatitis C Virus and Human Immunodeficiency Virus Type 1(HCV/HIV-1)
#### Organization Study ID Info
**ID:** VX11-950-115
#### Organization
**Class:** INDUSTRY
**Full Name:** Vertex Pharmaceuticals Incorporated
### Status Module
#### Completion Date
**Date:** 2014-02
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2015-03-17
**Type:** ESTIMATED
**Last Update Submit Date:** 2015-03-03
**Overall Status:** TERMINATED
#### Primary Completion Date
**Date:** 2014-02
**Type:** ACTUAL
#### Results First Post Date
**Date:** 2015-03-17
**Type:** ESTIMATED
**Results First Submit Date:** 2015-03-03
**Results First Submit QC Date:** 2015-03-03
#### Start Date
**Date:** 2011-12
**Status Verified Date:** 2015-03
#### Study First Post Date
**Date:** 2011-11-08
**Type:** ESTIMATED
**Study First Submit Date:** 2011-11-03
**Study First Submit QC Date:** 2011-11-07
**Why Stopped:** It was decided by Sponsor on 13 January 2014 to terminate study early at primary efficacy endpoint as part of a decision to modify drug development plan.
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Vertex Pharmaceuticals Incorporated
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The purpose of this study is to treat human immunodeficiency virus (HIV) and Hepatitis C Virus (HCV) co-infected subjects with telaprevir, pegylated interferon alfa-2a (Peg-IFN-alfa-2a), and ribavirin (RBV) to achieve undetectable hepatitis C virus ribonucleic acid (HCV RNA) 12 weeks after the last planned dose of study drug.
### Conditions Module
**Conditions:**
- Hepatitis C
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 185
**Type:** ACTUAL
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants who were receiving atazanavir/ritonavir (ATV/r) based highly active antiretroviral therapy (HAART) at baseline, received Telaprevir (T)1125 milligram (mg) tablet twice daily for 12 weeks in combination with pegylated interferon alfa 2a (P) (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (R) (RBV) tablet orally twice daily at a dose of 800 milligram per day (mg/day) for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
**Intervention Names:**
- Drug: Telaprevir
- Drug: Ribavirin
- Biological: Pegylated Interferon Alfa-2a
- Drug: Highly Active Antiretroviral Therapy (HAART)
**Label:** T/PR + HAART Regimen (ATV/r-Based)
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants who were receiving efavirenz (EFV) based highly active antiretroviral therapy (HAART) at baseline, received Telaprevir (T)1125 milligram (mg) tablet three times a day for 12 weeks in combination with pegylated interferon alfa 2a (P) (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (R) (RBV) tablet orally twice daily at a dose of 800 milligram per day (mg/day) for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
**Intervention Names:**
- Drug: Telaprevir
- Drug: Ribavirin
- Biological: Pegylated Interferon Alfa-2a
- Drug: Highly Active Antiretroviral Therapy (HAART)
**Label:** T/PR + HAART Regimen (EFV-Based)
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Participants who were receiving raltegravir (RAL) based highly active antiretroviral therapy (HAART) at baseline, received Telaprevir (T)1125 milligram (mg) tablet twice daily for 12 weeks in combination with pegylated interferon alfa 2a (P) (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (R) (RBV) tablet orally twice daily at a dose of 800 milligram per day (mg/day) for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
**Intervention Names:**
- Drug: Telaprevir
- Drug: Ribavirin
- Biological: Pegylated Interferon Alfa-2a
- Drug: Highly Active Antiretroviral Therapy (HAART)
**Label:** T/PR + HAART Regimen (RAL-Based)
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- T/PR + HAART Regimen (ATV/r-Based)
- T/PR + HAART Regimen (EFV-Based)
- T/PR + HAART Regimen (RAL-Based)
**Description:** Tablet
**Name:** Telaprevir
**Other Names:**
- VX-950
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- T/PR + HAART Regimen (ATV/r-Based)
- T/PR + HAART Regimen (EFV-Based)
- T/PR + HAART Regimen (RAL-Based)
**Description:** Tablet
**Name:** Ribavirin
**Other Names:**
- Copegus®
- RBV
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- T/PR + HAART Regimen (ATV/r-Based)
- T/PR + HAART Regimen (EFV-Based)
- T/PR + HAART Regimen (RAL-Based)
**Description:** Subcutaneous Injection
**Name:** Pegylated Interferon Alfa-2a
**Other Names:**
- Pegasys®
- Peg-IFN-Alfa-2a
**Type:** BIOLOGICAL
#### Intervention 4
**Arm Group Labels:**
- T/PR + HAART Regimen (ATV/r-Based)
- T/PR + HAART Regimen (EFV-Based)
- T/PR + HAART Regimen (RAL-Based)
**Description:** Atazanavir/ritonavir (ATV/r) based HAART, Efavirenz (EFV) based HAART, or Raltegravir (RAL) based HAART, as per standard practice. HAART medications were not considered study drugs.
**Name:** Highly Active Antiretroviral Therapy (HAART)
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** SVR 12 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (\<lower limit of quantification) at 12 weeks after last planned dose of study drug. The plasma hepatitis C virus ribonucleic acid (HCV RNA) level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL).
**Measure:** Percentage of Participants With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12)
**Time Frame:** 12 weeks after last planned dose of study drug (up to Week 60)
#### Secondary Outcomes
**Description:** SVR 24 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (\<lower limit of quantification) at 24 weeks after last planned dose of study drug. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL).
**Measure:** Percentage of Participants With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR 24)
**Time Frame:** 24 weeks after last planned dose of study drug (up to Week 72)
**Description:** The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. RVR was defined as undetectable HCV RNA (\<lower limit of quantification) 4 weeks after the start of study treatment.
**Measure:** Percentage of Participants With Rapid Viral Response (RVR)
**Time Frame:** Week 4
**Description:** The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. eRVR was defined as undetectable HCV RNA (\<lower limit of quantification) at both 4 weeks and 12 weeks after the start of study treatment.
**Measure:** Percentage of Participants With Extended Rapid Viral Response (eRVR)
**Time Frame:** Week 4 and Week 12
**Description:** The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. Percentage of participants with undetectable HCV RNA (\<lower limit of quantification) at EOT (up to Week 48) are reported. Data for this outcome was not planned to be reported by prior response.
**Measure:** Percentage of Participants With Undetectable HCV RNA at End of Treatment (EOT)
**Time Frame:** EOT (up to Week 48)
**Description:** AE: any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event.
**Measure:** Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
**Time Frame:** Up to Week 52
**Description:** Cmax, Cmin, and Cavg were reported for atazanavir (ATV), efavirenz (EFV), raltegravir (RAL), and telaprevir.
**Measure:** Maximum (Cmax), Minimum (Cmin), and Average Plasma Concentration (Cavg)
**Time Frame:** Day -14 to Day -1 and Week 1 for ATV, EFV, and RAL; Week 1 for telaprevir
**Description:** Sequence analysis of the HCV NS3-4A region was performed to monitor telaprevir-resistant variants. HCV RNA was isolated from the plasma, amplified by reverse transcription-polymerase chain reaction (RT-PCR), and sequenced (sequencing assay limit of detection HCV RNA \>=1000 IU/mL). Results of this outcome measure were to be reported for overall participants instead of by HAART treatment.
**Measure:** Number of Participants With Telaprevir Resistant HCV Variant at Non-Structural Viral Protein 3-4A (NS3-4A) Region
**Time Frame:** Baseline, follow-up (Week 96)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Participants must have chronic, genotype 1a or 1b, hepatitis C with HCV RNA greater than (\>) 1000 international units per milliliter (IU/mL)
* Population A: HCV Pegylated interferon (Peg-IFN)/RBV treatment naive (received no prior HCV therapy)or Peg-IFN/RBV prior treatment with relapse
* Population B: Peg-IFN/RBV prior null or partial responder
* Participants must not have achieved undetectable HCV RNA 24 weeks after the last planned dose of study drug (SVR24) after at least 1 prior course of Peg IFN/RBV therapy of standard duration
* Participant must have positive HIV antibody at Screening
* Participant must have a diagnosis of HIV-1 infection \>6 months before Screening
* Participants should be taking 1 of the following permissible highly active antiretroviral therapy (HAART) regimens for HIV continuously for 12 weeks prior to screening:
* Atripla® or equivalent components (efavirenz, tenofovir, emtricitabine)
* Efavirenz plus Epzicom® (abacavir, lamivudine) or equivalent components
* Boosted atazanavir (atazanavir with ritonavir) plus Truvada® (tenofovir, emtricitabine) or equivalent components
* Boosted atazanavir plus Epzicom®, or equivalent components
* Raltegravir plus Truvada®, or equivalent components
* Raltegravir plus Epzicom®, or equivalent components
* Cluster of differentiation 4 (CD4) counts and human immunodeficiency virus Type 1 (HIV-1) ribonucleic acid (RNA) meeting acceptable criteria at Screening as specified in the protocol
* Laboratory values within acceptable ranges at Screening as specified in the protocol
Exclusion Criteria:
* Subjects anticipating a need to switch HAART regimens within 14 weeks after Day 1 or any switches occurring 12 weeks prior to Day 1
* Use of azidothymidine (AZT), didanosine (ddI) or stavudine (d4T) nucleosides
* Contraindications to any planned HAART component as per the respective drug labeling information
* Contraindications to Peg-IFN or RBV
* Evidence of hepatic decompensation
* Clinical suspicion of acute hepatitis
* Any other cause of liver disease in addition to hepatitis C
* History of organ transplantation (except cornea and skin)
* Autoimmune-mediated disease
* Participated in any investigational drug study within 90 days before Day 1
* Previous treatment with an HCV protease inhibitor
**Maximum Age:** 65 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Birmingham
**Country:** United States
**Facility:** Alabama
**State:** Alabama
**Location 2:**
**City:** Bakersfield
**Country:** United States
**Facility:** California
**State:** California
**Location 3:**
**City:** Beverly Hills
**Country:** United States
**Facility:** California
**State:** California
**Location 4:**
**City:** Coronado
**Country:** United States
**Facility:** California
**State:** California
**Location 5:**
**City:** Los Angeles
**Country:** United States
**Facility:** California
**State:** California
**Location 6:**
**City:** Oakland
**Country:** United States
**Facility:** California
**State:** California
**Location 7:**
**City:** Palo Alto
**Country:** United States
**Facility:** California
**State:** California
**Location 8:**
**City:** Sacremento
**Country:** United States
**Facility:** California
**State:** California
**Location 9:**
**City:** San Diego
**Country:** United States
**Facility:** California
**State:** California
**Location 10:**
**City:** San Francisco
**Country:** United States
**Facility:** California
**State:** California
**Location 11:**
**City:** New Haven
**Country:** United States
**Facility:** Connecticut
**State:** Connecticut
**Location 12:**
**City:** Washington DC
**Country:** United States
**Facility:** DC
**State:** District of Columbia
**Location 13:**
**City:** Washington
**Country:** United States
**Facility:** Washington, DC
**State:** District of Columbia
**Location 14:**
**City:** Bay Pines
**Country:** United States
**Facility:** Florida
**State:** Florida
**Location 15:**
**City:** Jacksonville
**Country:** United States
**Facility:** Florida
**State:** Florida
**Location 16:**
**City:** Miami
**Country:** United States
**Facility:** Florida
**State:** Florida
**Location 17:**
**City:** Orlando
**Country:** United States
**Facility:** Florida
**State:** Florida
**Location 18:**
**City:** West Palm Beach
**Country:** United States
**Facility:** Florida
**State:** Florida
**Location 19:**
**City:** Atlanta
**Country:** United States
**Facility:** Georgia
**State:** Georgia
**Location 20:**
**City:** Decatur
**Country:** United States
**Facility:** Georgia
**State:** Georgia
**Location 21:**
**City:** Chicago
**Country:** United States
**Facility:** Illinois
**State:** Illinois
**Location 22:**
**City:** Portland
**Country:** United States
**Facility:** Maine
**State:** Maine
**Location 23:**
**City:** Baltimore
**Country:** United States
**Facility:** Maryland
**State:** Maryland
**Location 24:**
**City:** Lutherville
**Country:** United States
**Facility:** Maryland
**State:** Maryland
**Location 25:**
**City:** Springfield
**Country:** United States
**Facility:** Massachusetts
**State:** Massachusetts
**Location 26:**
**City:** Detroit
**Country:** United States
**Facility:** Michigan
**State:** Michigan
**Location 27:**
**City:** Minneapolis
**Country:** United States
**Facility:** Minnesota
**State:** Minnesota
**Location 28:**
**City:** Kansas City
**Country:** United States
**Facility:** Missouri
**State:** Missouri
**Location 29:**
**City:** Saint Louis
**Country:** United States
**Facility:** Missouri
**State:** Missouri
**Location 30:**
**City:** Newark
**Country:** United States
**Facility:** New Jersey
**State:** New Jersey
**Location 31:**
**City:** Santa Fe
**Country:** United States
**Facility:** New Mexico
**State:** New Mexico
**Location 32:**
**City:** Bronx
**Country:** United States
**Facility:** New York
**State:** New York
**Location 33:**
**City:** New York
**Country:** United States
**Facility:** New York
**State:** New York
**Location 34:**
**City:** Rochester
**Country:** United States
**Facility:** New York
**State:** New York
**Location 35:**
**City:** Durham
**Country:** United States
**Facility:** North Carolina
**State:** North Carolina
**Location 36:**
**City:** Cincinnati
**Country:** United States
**Facility:** Ohio
**State:** Ohio
**Location 37:**
**City:** Cleveland
**Country:** United States
**Facility:** Ohio
**State:** Ohio
**Location 38:**
**City:** Portland
**Country:** United States
**Facility:** Oregon
**State:** Oregon
**Location 39:**
**City:** Philadelphia
**Country:** United States
**Facility:** Pennsylvania
**State:** Pennsylvania
**Location 40:**
**City:** Providence
**Country:** United States
**Facility:** Rhode Island
**State:** Rhode Island
**Location 41:**
**City:** Columbia
**Country:** United States
**Facility:** South Carlonia
**State:** South Carolina
**Location 42:**
**City:** Dallas
**Country:** United States
**Facility:** Texas
**State:** Texas
**Location 43:**
**City:** Houston
**Country:** United States
**Facility:** Texas
**State:** Texas
**Location 44:**
**City:** Salt Lake City
**Country:** United States
**Facility:** Utah
**State:** Utah
**Location 45:**
**City:** Richmond
**Country:** United States
**Facility:** Virginia
**State:** Virginia
**Location 46:**
**City:** Seattle
**Country:** United States
**Facility:** Washington
**State:** Washington
**Location 47:**
**City:** Edmonton
**Country:** Canada
**Facility:** Edmonton
**State:** Alberta
**Location 48:**
**City:** Vancouver
**Country:** Canada
**Facility:** Vancouver
**State:** British Columbia
**Location 49:**
**City:** Hamilton
**Country:** Canada
**Facility:** Hamilton
**State:** Ontario
**Location 50:**
**City:** Toronto
**Country:** Canada
**Facility:** Toronto
**State:** Ontario
**Location 51:**
**City:** Montreal
**Country:** Canada
**Facility:** Montreal
**State:** Quebec
**Location 52:**
**City:** Bonn
**Country:** Germany
**Facility:** Bonn
**Location 53:**
**City:** Essen
**Country:** Germany
**Facility:** Essen
**Location 54:**
**City:** Hamburg
**Country:** Germany
**Facility:** Hamburg
**Location 55:**
**City:** Munchen
**Country:** Germany
**Facility:** Munchen
**Location 56:**
**City:** San Juan
**Country:** Puerto Rico
**Facility:** Puerto Rico
**Location 57:**
**City:** Badalona
**Country:** Spain
**Facility:** Spain
**Location 58:**
**City:** Barcelona
**Country:** Spain
**Facility:** Barcelona
**Location 59:**
**City:** Madrid
**Country:** Spain
**Facility:** Madrid
#### Overall Officials
**Official 1:**
**Affiliation:** Vertex Pharmaceuticals Incorporated
**Name:** Medical Monitor
**Role:** STUDY_DIRECTOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000008107
- Term: Liver Diseases
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000006525
- Term: Hepatitis, Viral, Human
- ID: D000014777
- Term: Virus Diseases
- ID: D000007239
- Term: Infections
- ID: D000004769
- Term: Enterovirus Infections
- ID: D000010850
- Term: Picornaviridae Infections
- ID: D000012327
- Term: RNA Virus Infections
- ID: D000086982
- Term: Blood-Borne Infections
- ID: D000003141
- Term: Communicable Diseases
- ID: D000018178
- Term: Flaviviridae Infections
### Condition Browse Module - Browse Branches
- Abbrev: BC01
- Name: Infections
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M9592
- Name: Hepatitis A
- Relevance: HIGH
- As Found: Hepatitis
- ID: M9591
- Name: Hepatitis
- Relevance: HIGH
- As Found: Hepatitis
- ID: M3522
- Name: Acquired Immunodeficiency Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M18250
- Name: HIV Infections
- Relevance: LOW
- As Found: Unknown
- ID: M17522
- Name: Virus Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M9611
- Name: Hepatitis C
- Relevance: HIGH
- As Found: Hepatitis C
- ID: M10199
- Name: Immunologic Deficiency Syndromes
- Relevance: LOW
- As Found: Unknown
- ID: M11107
- Name: Liver 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: M9610
- Name: Hepatitis, Viral, Human
- 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: M7930
- Name: Enterovirus Infections
- Relevance: LOW
- As Found: Unknown
- ID: M13745
- Name: Picornaviridae Infections
- Relevance: LOW
- As Found: Unknown
- ID: M15149
- Name: RNA Virus Infections
- Relevance: LOW
- As Found: Unknown
- ID: M2593
- Name: Blood-Borne Infections
- Relevance: LOW
- As Found: Unknown
- ID: M20324
- Name: Flaviviridae Infections
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000006506
- Term: Hepatitis A
- ID: D000006526
- Term: Hepatitis C
- ID: D000006505
- Term: Hepatitis
### Intervention Browse Module - Ancestors
- ID: D000000970
- Term: Antineoplastic Agents
- ID: D000000998
- Term: Antiviral Agents
- ID: D000000890
- Term: Anti-Infective Agents
- ID: D000000963
- Term: Antimetabolites
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000007155
- Term: Immunologic Factors
- ID: D000045505
- Term: Physiological Effects of Drugs
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: ANeo
- Name: Antineoplastic Agents
### Intervention Browse Module - Browse Leaves
- ID: M21394
- Name: Ritonavir
- Relevance: LOW
- As Found: Unknown
- ID: M10407
- Name: Interferons
- Relevance: HIGH
- As Found: Recurrent
- ID: M340137
- Name: Efavirenz
- Relevance: LOW
- As Found: Unknown
- ID: M19243
- Name: Interferon-alpha
- Relevance: HIGH
- As Found: Status
- ID: M15083
- Name: Ribavirin
- Relevance: HIGH
- As Found: Bevacizumab
- ID: M247369
- Name: Peginterferon alfa-2a
- Relevance: HIGH
- As Found: Releasing
- ID: M1685
- Name: Interferon alpha-2
- Relevance: HIGH
- As Found: Observation
- ID: M25428
- Name: Anti-Retroviral Agents
- Relevance: HIGH
- As Found: Skeletal
- ID: M333
- Name: Raltegravir Potassium
- Relevance: LOW
- As Found: Unknown
- ID: M415
- Name: Atazanavir Sulfate
- 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
- ID: M4281
- Name: Antimetabolites
- Relevance: LOW
- As Found: Unknown
- ID: M10201
- Name: Immunologic Factors
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000007372
- Term: Interferons
- ID: D000012254
- Term: Ribavirin
- ID: D000016898
- Term: Interferon-alpha
- ID: D000077190
- Term: Interferon alpha-2
- ID: C000100416
- Term: Peginterferon alfa-2a
- ID: D000044966
- Term: Anti-Retroviral Agents
### Misc Info Module
#### Removed Countries
- Country: Mexico
- Version Holder: 2024-05-24
## Results Section
### Adverse Events Module
**Description:** Adverse events were planned to be reported as per HAART treatment.
#### Event Groups
**Group ID:** EG000
**Title:** T/PR + HAART Regimen (ATV/r-Based)
**Description:** Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
**ID:** EG000
**Other Num Affected:** 54
**Other Num at Risk:** 54
**Serious Number Affected:** 7
**Serious Number At Risk:** 54
**Title:** T/PR + HAART Regimen (ATV/r-Based)
**Group ID:** EG001
**Title:** T/PR + HAART Regimen (EFV-Based)
**Description:** Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
**ID:** EG001
**Other Num Affected:** 66
**Other Num at Risk:** 69
**Serious Number Affected:** 8
**Serious Number At Risk:** 69
**Title:** T/PR + HAART Regimen (EFV-Based)
**Group ID:** EG002
**Title:** T/PR + HAART Regimen (RAL-Based)
**Description:** Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
**ID:** EG002
**Other Num Affected:** 56
**Other Num at Risk:** 59
**Serious Number Affected:** 9
**Serious Number At Risk:** 59
**Title:** T/PR + HAART Regimen (RAL-Based)
**Frequency Threshold:** 0
#### Other Events
**Term:** Nausea
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Diarrhoea
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Vomiting
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Anorectal discomfort
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Anal pruritus
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Haemorrhoids
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Dry mouth
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Constipation
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Abdominal pain
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Cheilitis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Gastrooesophageal reflux disease
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Aphthous stomatitis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Dyspepsia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Abdominal pain upper
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Proctalgia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Rectal haemorrhage
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Flatulence
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Oral pain
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Abdominal discomfort
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Anal ulcer
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Gastritis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Gingival pain
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Glossodynia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Haematochezia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Loose tooth
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Toothache
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Abdominal distension
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Abnormal faeces
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Anal fissure
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Anorectal disorder
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Chapped lips
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Dental caries
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Dysphagia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Eructation
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Faeces discoloured
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Faeces hard
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Frequent bowel movements
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Gastrointestinal tract irritation
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Gingival bleeding
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Lip dry
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Mouth ulceration
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Odynophagia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Oesophageal pain
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Oral discomfort
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Oral mucosal erythema
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Palatal disorder
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Rectal fissure
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Retching
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Sensitivity of teeth
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Stomatitis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Tongue disorder
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Tongue eruption
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Fatigue
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Influenza like illness
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Pyrexia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Chills
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Asthenia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Injection site reaction
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Irritability
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Pain
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Injection site erythema
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Malaise
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Injection site bruising
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Injection site rash
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Crying
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Feeling hot
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Thirst
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Chest discomfort
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Chest pain
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Cyst
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Feeling abnormal
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Gait disturbance
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Injection site pruritus
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Local swelling
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Localised oedema
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Oedema peripheral
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Sluggishness
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Temperature intolerance
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Xerosis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Pruritus
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Rash
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Alopecia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Dry skin
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Pruritus generalised
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Rash pruritic
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Eczema
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Rash papular
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Night sweats
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Rash erythematous
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Rash maculo-papular
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Erythema
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Acne
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Dermatitis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Hyperhidrosis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Macule
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Photosensitivity reaction
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Rash morbilliform
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Skin fissures
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Angioedema
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Cold sweat
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Dermatitis acneiform
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Dermatitis contact
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Dermatosis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Erythema multiforme
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Nail disorder
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Neurodermatitis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Pigmentation disorder
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Psoriasis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Rash generalised
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Seborrhoea
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Seborrhoeic dermatitis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Skin disorder
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Skin exfoliation
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Skin hypopigmentation
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Skin lesion
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Skin mass
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Headache
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Dizziness
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Dysgeusia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Disturbance in attention
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Paraesthesia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Hypoaesthesia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Dizziness postural
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Syncope
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Hypersomnia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Memory impairment
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Migraine
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Neuropathy peripheral
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Somnolence
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Tremor
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Ageusia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Allodynia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Amnesia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Burning sensation
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Head discomfort
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Hyperaesthesia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Lethargy
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Parosmia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Peripheral sensory neuropathy
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Presyncope
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Sciatica
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Sensory disturbance
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Anaemia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Blood and lymphatic system disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Neutropenia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Blood and lymphatic system disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Thrombocytopenia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Blood and lymphatic system disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Lymphadenopathy
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Blood and lymphatic system disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Pancytopenia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Blood and lymphatic system disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Haemolytic anaemia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Blood and lymphatic system disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Lymph node pain
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Blood and lymphatic system disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Lymphoid tissue hyperplasia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Blood and lymphatic system disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Lymphopenia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Blood and lymphatic system disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Insomnia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Psychiatric disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Depression
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Psychiatric disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Mood swings
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Psychiatric disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Anxiety
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Psychiatric disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Sleep disorder
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Psychiatric disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Abnormal dreams
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Psychiatric disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Affect lability
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Psychiatric disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Anger
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Psychiatric disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Restlessness
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Psychiatric disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Anxiety disorder
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Psychiatric disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Bipolar disorder
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Psychiatric disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Bruxism
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Psychiatric disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Depressed mood
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Psychiatric disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Hallucination
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Psychiatric disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Libido decreased
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Psychiatric disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Mood altered
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Psychiatric disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Panic disorder
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Psychiatric disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Stress
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Psychiatric disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Suicidal ideation
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Psychiatric disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Myalgia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Musculoskeletal and connective tissue disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Arthralgia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Musculoskeletal and connective tissue disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Back pain
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Musculoskeletal and connective tissue disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Pain in extremity
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Musculoskeletal and connective tissue disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Bone pain
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Musculoskeletal and connective tissue disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Muscle spasms
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Musculoskeletal and connective tissue disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Neck pain
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Musculoskeletal and connective tissue disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Flank pain
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Musculoskeletal and connective tissue disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Joint stiffness
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Musculoskeletal and connective tissue disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Joint swelling
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Musculoskeletal and connective tissue disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Muscle haemorrhage
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Musculoskeletal and connective tissue disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Musculoskeletal pain
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Musculoskeletal and connective tissue disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Musculoskeletal stiffness
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Musculoskeletal and connective tissue disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Osteopenia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Musculoskeletal and connective tissue disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Osteoporosis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Musculoskeletal and connective tissue disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Pain in jaw
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Musculoskeletal and connective tissue disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Rhabdomyolysis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Musculoskeletal and connective tissue disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Spinal osteoarthritis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Musculoskeletal and connective tissue disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Upper respiratory tract infection
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA (16.1)
**Term:** Folliculitis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA (16.1)
**Term:** Influenza
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA (16.1)
**Term:** Sinusitis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA (16.1)
**Term:** Bronchitis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA (16.1)
**Term:** Oral candidiasis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA (16.1)
**Term:** Pharyngitis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA (16.1)
**Term:** Tooth infection
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA (16.1)
**Term:** Urinary tract infection
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA (16.1)
**Term:** Cellulitis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA (16.1)
**Term:** Hordeolum
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA (16.1)
**Term:** Nasopharyngitis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA (16.1)
**Term:** Onychomycosis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA (16.1)
**Term:** Otitis media
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA (16.1)
**Term:** Pneumonia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA (16.1)
**Term:** Abscess jaw
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA (16.1)
**Term:** Abscess limb
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA (16.1)
**Term:** Abscess soft tissue
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA (16.1)
**Term:** Body tinea
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA (16.1)
**Term:** Campylobacter gastroenteritis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA (16.1)
**Term:** Candida infection
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA (16.1)
**Term:** Cardiac valve vegetation
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA (16.1)
**Term:** Eye infection
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA (16.1)
**Term:** Furuncle
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA (16.1)
**Term:** Gastroenteritis viral
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA (16.1)
**Term:** Gingivitis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA (16.1)
**Term:** Injection site pustule
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA (16.1)
**Term:** Mycoplasma infection
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA (16.1)
**Term:** Oral herpes
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA (16.1)
**Term:** Otitis externa
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA (16.1)
**Term:** Respiratory syncytial virus infection
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA (16.1)
**Term:** Rhinitis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA (16.1)
**Term:** Sepsis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA (16.1)
**Term:** Staphylococcal skin infection
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA (16.1)
**Term:** Tinea cruris
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA (16.1)
**Term:** Tooth abscess
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA (16.1)
**Term:** Urethritis chlamydial
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA (16.1)
**Term:** Urethritis gonococcal
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA (16.1)
**Term:** Vulvovaginal candidiasis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA (16.1)
**Term:** Decreased appetite
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Hypokalaemia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Dehydration
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Diabetes mellitus
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Hypophosphataemia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Abnormal loss of weight
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Acidosis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Gout
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Hyperamylasaemia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Hyperlipasaemia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Hypertriglyceridaemia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Hyperuricaemia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Hypoalbuminaemia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Hyponatraemia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Dyspnoea
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Cough
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Dyspnoea exertional
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Epistaxis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Oropharyngeal pain
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Wheezing
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Respiratory tract congestion
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Rhinorrhoea
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Nasal congestion
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Sneezing
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Dry throat
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Hiccups
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Increased viscosity of nasal secretion
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Oropharyngeal plaque
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Pharyngeal oedema
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Productive cough
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Sinus congestion
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Throat irritation
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Throat tightness
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Upper-airway cough syndrome
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Weight decreased
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:** MedDRA (16.1)
**Term:** Neutrophil count decreased
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:** MedDRA (16.1)
**Term:** Blood uric acid increased
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:** MedDRA (16.1)
**Term:** CD4 lymphocytes decreased
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:** MedDRA (16.1)
**Term:** Gamma-glutamyltransferase increased
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:** MedDRA (16.1)
**Term:** Blood bilirubin increased
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:** MedDRA (16.1)
**Term:** Activated partial thromboplastin time prolonged
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:** MedDRA (16.1)
**Term:** Alanine aminotransferase increased
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:** MedDRA (16.1)
**Term:** Aspartate aminotransferase increased
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:** MedDRA (16.1)
**Term:** Blood creatine increased
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:** MedDRA (16.1)
**Term:** Blood creatine phosphokinase increased
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:** MedDRA (16.1)
**Term:** Blood glucose increased
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:** MedDRA (16.1)
**Term:** Blood lactate dehydrogenase increased
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:** MedDRA (16.1)
**Term:** Blood triglycerides increased
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:** MedDRA (16.1)
**Term:** Creatinine renal clearance decreased
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:** MedDRA (16.1)
**Term:** Electrocardiogram QT prolonged
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:** MedDRA (16.1)
**Term:** Electrocardiogram abnormal
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:** MedDRA (16.1)
**Term:** Eosinophil count increased
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:** MedDRA (16.1)
**Term:** Glomerular filtration rate decreased
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:** MedDRA (16.1)
**Term:** Haematocrit decreased
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:** MedDRA (16.1)
**Term:** Haemoglobin decreased
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:** MedDRA (16.1)
**Term:** International normalised ratio increased
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:** MedDRA (16.1)
**Term:** Lipase increased
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:** MedDRA (16.1)
**Term:** Liver function test abnormal
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:** MedDRA (16.1)
**Term:** Neutrophil count increased
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:** MedDRA (16.1)
**Term:** Prothrombin time prolonged
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:** MedDRA (16.1)
**Term:** Reticulocyte count decreased
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:** MedDRA (16.1)
**Term:** Weight increased
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:** MedDRA (16.1)
**Term:** Photophobia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Eye disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Vision blurred
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Eye disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Dry eye
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Eye disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Ocular hyperaemia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Eye disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Visual impairment
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Eye disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Abnormal sensation in eye
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Eye disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Blepharitis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Eye disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Conjunctivitis allergic
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Eye disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Eye discharge
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Eye disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Eye inflammation
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Eye disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Eye pruritus
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Eye disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Hypermetropia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Eye disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Lacrimation increased
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Eye disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Ocular icterus
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Eye disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Palpitations
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Cardiac disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Tachycardia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Cardiac disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Atrioventricular block first degree
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Cardiac disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Bundle branch block left
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Cardiac disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Mitral valve incompetence
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Cardiac disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Myocardial ischaemia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Cardiac disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Sinus tachycardia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Cardiac disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Tricuspid valve incompetence
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Cardiac disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Ventricular extrasystoles
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Cardiac disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Dysuria
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Renal and urinary disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Pyuria
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Renal and urinary disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Enuresis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Renal and urinary disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Haematuria
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Renal and urinary disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Nephropathy
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Renal and urinary disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Nocturia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Renal and urinary disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Pollakiuria
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Renal and urinary disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Polyuria
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Renal and urinary disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Renal failure acute
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Renal and urinary disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Urinary incontinence
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Renal and urinary disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Arthropod bite
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Injury, poisoning and procedural complications
**Source Vocabulary:** MedDRA (16.1)
**Term:** Contusion
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Injury, poisoning and procedural complications
**Source Vocabulary:** MedDRA (16.1)
**Term:** Excoriation
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Injury, poisoning and procedural complications
**Source Vocabulary:** MedDRA (16.1)
**Term:** Fall
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Injury, poisoning and procedural complications
**Source Vocabulary:** MedDRA (16.1)
**Term:** Joint dislocation
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Injury, poisoning and procedural complications
**Source Vocabulary:** MedDRA (16.1)
**Term:** Joint injury
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Injury, poisoning and procedural complications
**Source Vocabulary:** MedDRA (16.1)
**Term:** Laceration
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Injury, poisoning and procedural complications
**Source Vocabulary:** MedDRA (16.1)
**Term:** Ligament sprain
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Injury, poisoning and procedural complications
**Source Vocabulary:** MedDRA (16.1)
**Term:** Transfusion reaction
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Injury, poisoning and procedural complications
**Source Vocabulary:** MedDRA (16.1)
**Term:** Erectile dysfunction
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Reproductive system and breast disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Benign prostatic hyperplasia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Reproductive system and breast disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Genital hypoaesthesia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Reproductive system and breast disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Haematospermia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Reproductive system and breast disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Menstruation irregular
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Reproductive system and breast disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Sexual dysfunction
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Reproductive system and breast disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Testicular pain
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Reproductive system and breast disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Jaundice
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Hepatobiliary disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Cholelithiasis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Hepatobiliary disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Hot flush
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Vascular disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Flushing
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Vascular disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Peripheral coldness
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Vascular disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Thrombosis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Vascular disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Hypothyroidism
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Endocrine disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Hypogonadism
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Endocrine disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Cerumen impaction
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Ear and labyrinth disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Ear pruritus
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Ear and labyrinth disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Hyperacusis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Ear and labyrinth disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Colour blindness
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Congenital, familial and genetic disorders
**Source Vocabulary:** MedDRA (16.1)
**Term:** Seasonal allergy
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Immune system disorders
**Source Vocabulary:** MedDRA (16.1)
#### Serious Events
**Term:** Anaemia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Blood and lymphatic system disorders
**Source Vocabulary:** MedDRA (16.1)
##### Stats
**Group ID:** EG000
**Num At Risk:** 54
**Group ID:** EG001
**Num Affected:** 3
**Num At Risk:** 69
**Group ID:** EG002
**Num Affected:** 4
**Num At Risk:** 59
**Term:** Neutropenia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Blood and lymphatic system disorders
**Source Vocabulary:** MedDRA (16.1)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 54
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 69
**Group ID:** EG002
**Num Affected:** 1
**Num At Risk:** 59
**Term:** Leukocytosis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Blood and lymphatic system disorders
**Source Vocabulary:** MedDRA (16.1)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 54
**Group ID:** EG001
**Num At Risk:** 69
**Group ID:** EG002
**Num At Risk:** 59
**Term:** Diarrhoea
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (16.1)
##### Stats
**Group ID:** EG000
**Num At Risk:** 54
**Group ID:** EG001
**Num At Risk:** 69
**Group ID:** EG002
**Num Affected:** 1
**Num At Risk:** 59
**Term:** Mallory-Weiss syndrome
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (16.1)
##### Stats
**Group ID:** EG000
**Num At Risk:** 54
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 69
**Group ID:** EG002
**Num At Risk:** 59
**Term:** Rectal haemorrhage
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (16.1)
##### Stats
**Group ID:** EG000
**Num At Risk:** 54
**Group ID:** EG001
**Num At Risk:** 69
**Group ID:** EG002
**Num Affected:** 1
**Num At Risk:** 59
**Term:** Vomiting
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Gastrointestinal disorders
**Source Vocabulary:** MedDRA (16.1)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 54
**Group ID:** EG001
**Num At Risk:** 69
**Group ID:** EG002
**Num At Risk:** 59
**Term:** Escherichia urinary tract infection
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA (16.1)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 54
**Group ID:** EG001
**Num At Risk:** 69
**Group ID:** EG002
**Num At Risk:** 59
**Term:** Pneumonia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA (16.1)
##### Stats
**Group ID:** EG000
**Num At Risk:** 54
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 69
**Group ID:** EG002
**Num At Risk:** 59
**Term:** Psoas abscess
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Infections and infestations
**Source Vocabulary:** MedDRA (16.1)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 54
**Group ID:** EG001
**Num At Risk:** 69
**Group ID:** EG002
**Num At Risk:** 59
**Term:** Dyspnoea exertional
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
**Source Vocabulary:** MedDRA (16.1)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 54
**Group ID:** EG001
**Num At Risk:** 69
**Group ID:** EG002
**Num At Risk:** 59
**Term:** Pneumonitis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
**Source Vocabulary:** MedDRA (16.1)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 54
**Group ID:** EG001
**Num At Risk:** 69
**Group ID:** EG002
**Num At Risk:** 59
**Term:** Pulmonary embolism
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Respiratory, thoracic and mediastinal disorders
**Source Vocabulary:** MedDRA (16.1)
##### Stats
**Group ID:** EG000
**Num At Risk:** 54
**Group ID:** EG001
**Num At Risk:** 69
**Group ID:** EG002
**Num Affected:** 1
**Num At Risk:** 59
**Term:** Non-cardiac chest pain
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA (16.1)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 54
**Group ID:** EG001
**Num At Risk:** 69
**Group ID:** EG002
**Num At Risk:** 59
**Term:** Pyrexia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA (16.1)
##### Stats
**Group ID:** EG000
**Num At Risk:** 54
**Group ID:** EG001
**Num At Risk:** 69
**Group ID:** EG002
**Num Affected:** 1
**Num At Risk:** 59
**Term:** Flank pain
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Musculoskeletal and connective tissue disorders
**Source Vocabulary:** MedDRA (16.1)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 54
**Group ID:** EG001
**Num At Risk:** 69
**Group ID:** EG002
**Num At Risk:** 59
**Term:** Rhabdomyolysis
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Musculoskeletal and connective tissue disorders
**Source Vocabulary:** MedDRA (16.1)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 54
**Group ID:** EG001
**Num At Risk:** 69
**Group ID:** EG002
**Num At Risk:** 59
**Term:** Syncope
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Nervous system disorders
**Source Vocabulary:** MedDRA (16.1)
##### Stats
**Group ID:** EG000
**Num At Risk:** 54
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 69
**Group ID:** EG002
**Num Affected:** 1
**Num At Risk:** 59
**Term:** Renal cyst
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Renal and urinary disorders
**Source Vocabulary:** MedDRA (16.1)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 54
**Group ID:** EG001
**Num At Risk:** 69
**Group ID:** EG002
**Num At Risk:** 59
**Term:** Renal failure acute
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Renal and urinary disorders
**Source Vocabulary:** MedDRA (16.1)
##### Stats
**Group ID:** EG000
**Num At Risk:** 54
**Group ID:** EG001
**Num At Risk:** 69
**Group ID:** EG002
**Num Affected:** 1
**Num At Risk:** 59
**Term:** Vertigo
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Ear and labyrinth disorders
**Source Vocabulary:** MedDRA (16.1)
##### Stats
**Group ID:** EG000
**Num At Risk:** 54
**Group ID:** EG001
**Num At Risk:** 69
**Group ID:** EG002
**Num Affected:** 1
**Num At Risk:** 59
**Term:** Basedow's disease
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Endocrine disorders
**Source Vocabulary:** MedDRA (16.1)
##### Stats
**Group ID:** EG000
**Num At Risk:** 54
**Group ID:** EG001
**Num At Risk:** 69
**Group ID:** EG002
**Num Affected:** 1
**Num At Risk:** 59
**Term:** Retinopathy
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Eye disorders
**Source Vocabulary:** MedDRA (16.1)
##### Stats
**Group ID:** EG000
**Num At Risk:** 54
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 69
**Group ID:** EG002
**Num At Risk:** 59
**Term:** Clavicle fracture
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Injury, poisoning and procedural complications
**Source Vocabulary:** MedDRA (16.1)
##### Stats
**Group ID:** EG000
**Num At Risk:** 54
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 69
**Group ID:** EG002
**Num At Risk:** 59
**Term:** Hepatic enzyme increased
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Investigations
**Source Vocabulary:** MedDRA (16.1)
##### Stats
**Group ID:** EG000
**Num At Risk:** 54
**Group ID:** EG001
**Num Affected:** 1
**Num At Risk:** 69
**Group ID:** EG002
**Num At Risk:** 59
**Term:** Hypokalaemia
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Metabolism and nutrition disorders
**Source Vocabulary:** MedDRA (16.1)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 54
**Group ID:** EG001
**Num At Risk:** 69
**Group ID:** EG002
**Num At Risk:** 59
**Term:** Adenocarcinoma
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)
**Source Vocabulary:** MedDRA (16.1)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 54
**Group ID:** EG001
**Num At Risk:** 69
**Group ID:** EG002
**Num At Risk:** 59
**Term:** Anxiety
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Psychiatric disorders
**Source Vocabulary:** MedDRA (16.1)
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 54
**Group ID:** EG001
**Num At Risk:** 69
**Group ID:** EG002
**Num At Risk:** 59
**Term:** Rash
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
**Source Vocabulary:** MedDRA (16.1)
##### Stats
**Group ID:** EG000
**Num At Risk:** 54
**Group ID:** EG001
**Num At Risk:** 69
**Group ID:** EG002
**Num Affected:** 1
**Num At Risk:** 59
**Term:** Skin lesion
**Assessment Type:** SYSTEMATIC_ASSESSMENT
**Organ System:** Skin and subcutaneous tissue disorders
**Source Vocabulary:** MedDRA (16.1)
##### Stats
**Group ID:** EG000
**Num At Risk:** 54
**Group ID:** EG001
**Num At Risk:** 69
**Group ID:** EG002
**Num Affected:** 1
**Num At Risk:** 59
**Time Frame:** Baseline up to Week 52
## Results Section - Baseline Characteristics Module
### Denomination Counts
**Group ID:** BG000
**Value:** 54
**Group ID:** BG001
**Value:** 69
**Group ID:** BG002
**Value:** 59
**Group ID:** BG003
**Value:** 182
**Units:** Participants
### Group
**ID:** BG000
**Title:** T/PR + HAART Regimen (ATV/r-Based)
**Description:** Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
### Group
**ID:** BG001
**Title:** T/PR + HAART Regimen (EFV-Based)
**Description:** Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
### Group
**ID:** BG002
**Title:** T/PR + HAART Regimen (RAL-Based)
**Description:** Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
### Group
**ID:** BG003
**Title:** Total
**Description:** Total of all reporting groups
### Measure
#### Measurement
**Group ID:** BG000
**Spread:** 8.81
**Value:** 50.4
#### Measurement
**Group ID:** BG001
**Spread:** 8.84
**Value:** 49.6
#### Measurement
**Group ID:** BG002
**Spread:** 9.58
**Value:** 48.4
#### Measurement
**Group ID:** BG003
**Spread:** 9.06
**Value:** 49.5
**Class Title:**
### Measure
#### Measurement
**Group ID:** BG000
**Value:** 6
#### Measurement
**Group ID:** BG001
**Value:** 9
#### Measurement
**Group ID:** BG002
**Value:** 15
#### Measurement
**Group ID:** BG003
**Value:** 30
**Category Title:** Female
#### Measurement
**Group ID:** BG000
**Value:** 48
#### Measurement
**Group ID:** BG001
**Value:** 60
#### Measurement
**Group ID:** BG002
**Value:** 44
#### Measurement
**Group ID:** BG003
**Value:** 152
**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
**Population Description:** The Full Analysis Set (FAS), included all randomized participants who received at least 1 dose of study drug.
## Results Section - More Information Module
### Certain Agreement
**Other Details:** PI is free to publish results of the study after (1) the first multi-center publication, (2) if the sponsor elects not to publish the results, or (3) 18 months after close of the study, whichever occurs first. Proposed publications are to be submitted to the sponsor for review and comment for a period of at least 45 days (which may be extended under certain circumstances related to protection of intellectual property); the sponsor cannot require changes to the proposed publications.
**Restriction Type:** OTHER
**Restrictive Agreement:** True
### Limitations and Caveats
**Description:** It was decided by Sponsor on 13 January 2014 to terminate the study early at the primary efficacy endpoint (SVR12) as part of a decision to modify the drug development plan. Eligible participants completed virologic follow-up after termination.
### Point of Contact
**Email:** [email protected]
**Organization:** Vertex Pharmaceuticals Incorporated
**Phone:** 617-341-6777
**Title:** Medical Monitor
## 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
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 66.7
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 59.0
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 61.3
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 75.0
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 54.5
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 100
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 40
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 36.4
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 40
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 14.3
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 87.5
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 55.6
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 53.7
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 58.0
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 57.6
**Title:**
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 65.2
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 57.9
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 51.7
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 75.0
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 54.5
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 100
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 33.3
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 22.2
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 35.7
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 14.3
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 75.0
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 55.6
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 50.9
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 54.5
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 51.8
**Title:**
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 50.0
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 53.8
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 74.2
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 62.5
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 72.7
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 100
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 26.7
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 54.5
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 53.3
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 42.9
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 50.0
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 44.4
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 44.4
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 56.5
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 66.1
**Title:**
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 50.0
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 53.8
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 61.3
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 62.5
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 72.7
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 100
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 26.7
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 54.5
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 53.3
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 14.3
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 50.0
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 44.4
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 40.7
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 56.5
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 59.3
**Title:**
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 55.6
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 63.8
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 61.0
**Title:**
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 100
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 95.7
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 94.9
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 13.0
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 11.6
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 15.3
**Title:**
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 1580
- **Upper Limit:**
- **Value:** 2870
- **Comment:** Data not reported as no participant was evaluable for this parameter from this reporting group
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** NA
- **Upper Limit:**
- **Value:** NA
- **Comment:** Data not reported as no participant was evaluable for this parameter from this reporting group
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:** NA
- **Upper Limit:**
- **Value:** NA
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 635
- **Upper Limit:**
- **Value:** 991
- **Comment:** Data not reported as no participant was evaluable for this parameter from this reporting group
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** NA
- **Upper Limit:**
- **Value:** NA
- **Comment:** Data not reported as no participant was evaluable for this parameter from this reporting group
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:** NA
- **Upper Limit:**
- **Value:** NA
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 647
- **Upper Limit:**
- **Value:** 1100
- **Comment:** Data not reported as no participant was evaluable for this parameter from this reporting group
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** NA
- **Upper Limit:**
- **Value:** NA
- **Comment:** Data not reported as no participant was evaluable for this parameter from this reporting group
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:** NA
- **Upper Limit:**
- **Value:** NA
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 1570
- **Upper Limit:**
- **Value:** 2820
- **Comment:** Data not reported as no participant was evaluable for this parameter from this reporting group
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** NA
- **Upper Limit:**
- **Value:** NA
- **Comment:** Data not reported as no participant was evaluable for this parameter from this reporting group
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:** NA
- **Upper Limit:**
- **Value:** NA
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 636
- **Upper Limit:**
- **Value:** 1280
- **Comment:** Data not reported as no participant was evaluable for this parameter from this reporting group
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** NA
- **Upper Limit:**
- **Value:** NA
- **Comment:** Data not reported as no participant was evaluable for this parameter from this reporting group
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:** NA
- **Upper Limit:**
- **Value:** NA
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 685
- **Upper Limit:**
- **Value:** 1320
- **Comment:** Data not reported as no participant was evaluable for this parameter from this reporting group
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** NA
- **Upper Limit:**
- **Value:** NA
- **Comment:** Data not reported as no participant was evaluable for this parameter from this reporting group
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:** NA
- **Upper Limit:**
- **Value:** NA
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:** Data not reported as no participant was evaluable for this parameter from this reporting group
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** NA
- **Upper Limit:**
- **Value:** NA
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 2600
- **Upper Limit:**
- **Value:** 3800
- **Comment:** Data not reported as no participant was evaluable for this parameter from this reporting group
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:** NA
- **Upper Limit:**
- **Value:** NA
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:** Data not reported as no participant was evaluable for this parameter from this reporting group
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** NA
- **Upper Limit:**
- **Value:** NA
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 1900
- **Upper Limit:**
- **Value:** 2560
- **Comment:** Data not reported as no participant was evaluable for this parameter from this reporting group
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:** NA
- **Upper Limit:**
- **Value:** NA
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:** Data not reported as no participant was evaluable for this parameter from this reporting group
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** NA
- **Upper Limit:**
- **Value:** NA
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 1680
- **Upper Limit:**
- **Value:** 2150
- **Comment:** Data not reported as no participant was evaluable for this parameter from this reporting group
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:** NA
- **Upper Limit:**
- **Value:** NA
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:** Data not reported as no participant was evaluable for this parameter from this reporting group
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** NA
- **Upper Limit:**
- **Value:** NA
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 2450
- **Upper Limit:**
- **Value:** 3340
- **Comment:** Data not reported as no participant was evaluable for this parameter from this reporting group
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:** NA
- **Upper Limit:**
- **Value:** NA
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:** Data not reported as no participant was evaluable for this parameter from this reporting group
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** NA
- **Upper Limit:**
- **Value:** NA
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 1880
- **Upper Limit:**
- **Value:** 2290
- **Comment:** Data not reported as no participant was evaluable for this parameter from this reporting group
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:** NA
- **Upper Limit:**
- **Value:** NA
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:** Data not reported as no participant was evaluable for this parameter from this reporting group
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** NA
- **Upper Limit:**
- **Value:** NA
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 1400
- **Upper Limit:**
- **Value:** 1920
- **Comment:** Data not reported as no participant was evaluable for this parameter from this reporting group
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:** NA
- **Upper Limit:**
- **Value:** NA
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:** Data not reported as no participant was evaluable for this parameter from this reporting group
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** NA
- **Upper Limit:**
- **Value:** NA
- **Comment:** Data not reported as no participant was evaluable for this parameter from this reporting group
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** NA
- **Upper Limit:**
- **Value:** NA
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:** 1880
- **Upper Limit:**
- **Value:** 1900
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:** Data not reported as no participant was evaluable for this parameter from this reporting group
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** NA
- **Upper Limit:**
- **Value:** NA
- **Comment:** Data not reported as no participant was evaluable for this parameter from this reporting group
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** NA
- **Upper Limit:**
- **Value:** NA
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:** 198
- **Upper Limit:**
- **Value:** 196
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:** Data not reported as no participant was evaluable for this parameter from this reporting group
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** NA
- **Upper Limit:**
- **Value:** NA
- **Comment:** Data not reported as no participant was evaluable for this parameter from this reporting group
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** NA
- **Upper Limit:**
- **Value:** NA
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:** 429
- **Upper Limit:**
- **Value:** 483
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:** Data not reported as no participant was evaluable for this parameter from this reporting group
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** NA
- **Upper Limit:**
- **Value:** NA
- **Comment:** Data not reported as no participant was evaluable for this parameter from this reporting group
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** NA
- **Upper Limit:**
- **Value:** NA
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:** 1970
- **Upper Limit:**
- **Value:** 2320
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:** Data not reported as no participant was evaluable for this parameter from this reporting group
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** NA
- **Upper Limit:**
- **Value:** NA
- **Comment:** Data not reported as no participant was evaluable for this parameter from this reporting group
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** NA
- **Upper Limit:**
- **Value:** NA
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:** 435
- **Upper Limit:**
- **Value:** 281
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:** Data not reported as no participant was evaluable for this parameter from this reporting group
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** NA
- **Upper Limit:**
- **Value:** NA
- **Comment:** Data not reported as no participant was evaluable for this parameter from this reporting group
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** NA
- **Upper Limit:**
- **Value:** NA
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:** 539
- **Upper Limit:**
- **Value:** 643
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 1180
- **Upper Limit:**
- **Value:** 3160
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 1670
- **Upper Limit:**
- **Value:** 3780
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:** 868
- **Upper Limit:**
- **Value:** 3470
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 863
- **Upper Limit:**
- **Value:** 1650
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 961
- **Upper Limit:**
- **Value:** 1750
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:** 741
- **Upper Limit:**
- **Value:** 1840
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 907
- **Upper Limit:**
- **Value:** 2320
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 1290
- **Upper Limit:**
- **Value:** 2430
- **Comment:**
- **Group ID:** OG002
- **Lower Limit:**
- **Spread:** 643
- **Upper Limit:**
- **Value:** 2520
**Title:**
#### Outcome Measure 8
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 2
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 11
**Title:**
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** SVR 12 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (\<lower limit of quantification) at 12 weeks after last planned dose of study drug. The plasma hepatitis C virus ribonucleic acid (HCV RNA) level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL).
**Parameter Type:** NUMBER
**Population Description:** Safety Set included all participants who received at least 1 dose of study drug. Here, n = participants evaluable for specified category for each arm, respectively.
**Reporting Status:** POSTED
**Time Frame:** 12 weeks after last planned dose of study drug (up to Week 60)
**Title:** Percentage of Participants With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12)
**Type:** PRIMARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
**ID:** OG000
**Title:** T/PR + HAART Regimen (ATV/r-Based)
##### Group
**Description:** Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
**ID:** OG001
**Title:** T/PR + HAART Regimen (EFV-Based)
##### Group
**Description:** Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
**ID:** OG002
**Title:** T/PR + HAART Regimen (RAL-Based)
#### Outcome Measure 2
**Description:** SVR 24 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (\<lower limit of quantification) at 24 weeks after last planned dose of study drug. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL).
**Parameter Type:** NUMBER
**Population Description:** Safety set. Here number of participants analyzed = participants evaluable for this measure and n = participants evaluable for specified categories, for each arm, respectively.
**Reporting Status:** POSTED
**Time Frame:** 24 weeks after last planned dose of study drug (up to Week 72)
**Title:** Percentage of Participants With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR 24)
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
**ID:** OG000
**Title:** T/PR + HAART Regimen (ATV/r-Based)
##### Group
**Description:** Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
**ID:** OG001
**Title:** T/PR + HAART Regimen (EFV-Based)
##### Group
**Description:** Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
**ID:** OG002
**Title:** T/PR + HAART Regimen (RAL-Based)
#### Outcome Measure 3
**Description:** The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. RVR was defined as undetectable HCV RNA (\<lower limit of quantification) 4 weeks after the start of study treatment.
**Parameter Type:** NUMBER
**Population Description:** Safety set. Here, n = participants evaluable for specified category for each arm, respectively.
**Reporting Status:** POSTED
**Time Frame:** Week 4
**Title:** Percentage of Participants With Rapid Viral Response (RVR)
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
**ID:** OG000
**Title:** T/PR + HAART Regimen (ATV/r-Based)
##### Group
**Description:** Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
**ID:** OG001
**Title:** T/PR + HAART Regimen (EFV-Based)
##### Group
**Description:** Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
**ID:** OG002
**Title:** T/PR + HAART Regimen (RAL-Based)
#### Outcome Measure 4
**Description:** The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. eRVR was defined as undetectable HCV RNA (\<lower limit of quantification) at both 4 weeks and 12 weeks after the start of study treatment.
**Parameter Type:** NUMBER
**Population Description:** Safety set. Here, n = participants evaluable for specified category for each arm, respectively.
**Reporting Status:** POSTED
**Time Frame:** Week 4 and Week 12
**Title:** Percentage of Participants With Extended Rapid Viral Response (eRVR)
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
**ID:** OG000
**Title:** T/PR + HAART Regimen (ATV/r-Based)
##### Group
**Description:** Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
**ID:** OG001
**Title:** T/PR + HAART Regimen (EFV-Based)
##### Group
**Description:** Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
**ID:** OG002
**Title:** T/PR + HAART Regimen (RAL-Based)
#### Outcome Measure 5
**Description:** The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. Percentage of participants with undetectable HCV RNA (\<lower limit of quantification) at EOT (up to Week 48) are reported. Data for this outcome was not planned to be reported by prior response.
**Parameter Type:** NUMBER
**Population Description:** Full analysis set included all participants who received at least 1 dose of study drug.
**Reporting Status:** POSTED
**Time Frame:** EOT (up to Week 48)
**Title:** Percentage of Participants With Undetectable HCV RNA at End of Treatment (EOT)
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
**ID:** OG000
**Title:** T/PR + HAART Regimen (ATV/r-Based)
##### Group
**Description:** Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
**ID:** OG001
**Title:** T/PR + HAART Regimen (EFV-Based)
##### Group
**Description:** Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
**ID:** OG002
**Title:** T/PR + HAART Regimen (RAL-Based)
#### Outcome Measure 6
**Description:** AE: any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event.
**Parameter Type:** NUMBER
**Population Description:** Safety set.
**Reporting Status:** POSTED
**Time Frame:** Up to Week 52
**Title:** Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
**ID:** OG000
**Title:** T/PR + HAART Regimen (ATV/r-Based)
##### Group
**Description:** Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
**ID:** OG001
**Title:** T/PR + HAART Regimen (EFV-Based)
##### Group
**Description:** Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
**ID:** OG002
**Title:** T/PR + HAART Regimen (RAL-Based)
#### Outcome Measure 7
**Description:** Cmax, Cmin, and Cavg were reported for atazanavir (ATV), efavirenz (EFV), raltegravir (RAL), and telaprevir.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Full Analysis set.Here, n = participants evaluable for specified category for each arm, respectively.
**Reporting Status:** POSTED
**Time Frame:** Day -14 to Day -1 and Week 1 for ATV, EFV, and RAL; Week 1 for telaprevir
**Title:** Maximum (Cmax), Minimum (Cmin), and Average Plasma Concentration (Cavg)
**Type:** SECONDARY
**Unit of Measure:** nanogram per milliliter (ng/mL)
##### Group
**Description:** Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
**ID:** OG000
**Title:** T/PR + HAART Regimen (ATV/r-Based)
##### Group
**Description:** Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
**ID:** OG001
**Title:** T/PR + HAART Regimen (EFV-Based)
##### Group
**Description:** Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
**ID:** OG002
**Title:** T/PR + HAART Regimen (RAL-Based)
#### Outcome Measure 8
**Description:** Sequence analysis of the HCV NS3-4A region was performed to monitor telaprevir-resistant variants. HCV RNA was isolated from the plasma, amplified by reverse transcription-polymerase chain reaction (RT-PCR), and sequenced (sequencing assay limit of detection HCV RNA \>=1000 IU/mL). Results of this outcome measure were to be reported for overall participants instead of by HAART treatment.
**Parameter Type:** NUMBER
**Population Description:** Full analysis set. Here number of participants analyzed = participants who were evaluable for this measure and n = participants evaluable for specified categories.
**Reporting Status:** POSTED
**Time Frame:** Baseline, follow-up (Week 96)
**Title:** Number of Participants With Telaprevir Resistant HCV Variant at Non-Structural Viral Protein 3-4A (NS3-4A) Region
**Type:** SECONDARY
**Unit of Measure:** participants
##### Group
**Description:** Participants who were receiving either ATV/r based HAART or EFV based HAART or RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily or 1125 mg three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their respective HAART, as per standard practice and investigator discretion.
**ID:** OG000
**Title:** T/PR + HAART Regimen
### Participant Flow Module
#### Group
**Description:** Participants who were receiving atazanavir/ritonavir (ATV/r) based HAART at baseline, received Telaprevir (T)1125 milligram (mg) tablet twice daily for 12 weeks in combination with pegylated interferon alfa 2a (P) (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (R) (RBV) tablet orally twice daily at a dose of 800 milligram per day (mg/day) for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
**ID:** FG000
**Title:** T/PR + HAART Regimen (ATV/r-Based)
#### Group
**Description:** Participants who were receiving efavirenz (EFV) based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
**ID:** FG001
**Title:** T/PR + HAART Regimen (EFV-Based)
#### Group
**Description:** Participants who were receiving raltegravir (RAL) based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
**ID:** FG002
**Title:** T/PR + HAART Regimen (RAL-Based)
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** No Study Medication
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 2
##### Withdraw
**Type:** Adverse Event
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 2
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
##### Withdraw
**Type:** Death
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 1
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
###### Reason
**Group ID:** FG001
**Number of Subjects:** 5
###### Reason
**Group ID:** FG002
**Number of Subjects:** 3
##### Withdraw
**Type:** Withdrawal of Consent
###### Reason
**Group ID:** FG000
**Number of Subjects:** 3
###### Reason
**Group ID:** FG001
**Number of Subjects:** 7
###### Reason
**Group ID:** FG002
**Number of Subjects:** 7
##### Withdraw
**Type:** Study Terminated by Sponsor
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 3
###### Reason
**Group ID:** FG002
**Number of Subjects:** 3
##### Withdraw
**Type:** Other
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 55
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 69
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 61
##### Milestone
**Type:** Treated
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 54
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 69
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 59
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 46
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 52
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 45
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 9
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 17
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 16
**Pre-Assignment Details:** Efficacy analyses were reported as per highly active antiretroviral therapy (HAART) treatment (reporting arms) and also separately as per prior response (in categories) (Treatment-Naive, Prior Relapser, Prior Null Responder, Prior Partial Responder as well as for Total Participants), unless otherwise specified.
**Recruitment Details:** Study included Treatment-Naïve (no prior hepatitis C virus \[HCV\] therapy); Prior Relapser (prior HCV treatment with pegylated interferon alfa/ribavirin \[Peg-IFN/RBV\] and experienced viral relapse); and Prior Null/Partial Responder (prior HCV treatment with Peg-IFN/RBV and had null/partial response) participants.
**Has Results:** True |
## Protocol Section
### Identification Module
**NCT ID:** NCT03217279
**Acronym:** TYBRA
**Brief Title:** Needs Assessment and Quality of Life of Stroke Patients and Their Caregivers
**Official Title:** Typology of Needs and Quality of Life of Stroke Patients and Their Caregivers
#### Organization Study ID Info
**ID:** 69HCL17_0444
#### Organization
**Class:** OTHER
**Full Name:** Hospices Civils de Lyon
### Status Module
#### Completion Date
**Date:** 2018-09-14
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-08-20
**Type:** ACTUAL
**Last Update Submit Date:** 2019-08-19
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2018-02-14
**Type:** ACTUAL
#### Start Date
**Date:** 2017-11-02
**Type:** ACTUAL
**Status Verified Date:** 2019-08
#### Study First Post Date
**Date:** 2017-07-14
**Type:** ACTUAL
**Study First Submit Date:** 2017-07-06
**Study First Submit QC Date:** 2017-07-11
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Hospices Civils de Lyon
#### 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 incidence of Stroke in France is about 150 000 per year. Stroke represents the leading cause of long-term disability. The specificity of stroke is the sequelae polymorphism that can occurs: physical disability, cognitive deficit and sensitive trouble. Then this large extend of sequelae may have a different impact on daily life. Therefore, we have to consider the individual's own resources and in his whole environment to face the situation. We suppose that each situation, each post-stroke disability will have a different social impact in stroke survivors and their caregivers. Nowadays, Barthel Index and Rankin scale are the standards for the assessment of the stroke impact on survivors' daily life. However, what is the real impact of an activity limitation in daily life? How consider the psychosocial impact of stroke only with functional indicators? For this study we will consider handicap and disability in a societal way. In fact, the WHO developed in 2001 the International Classification of functioning, disability and health that allows to bring the concept of participation restriction, this is to say the consequences of a disability in the real life. The ICF allows to bring a conceptual framework of participation restriction.
Psychosocial consequences of stroke are relatively unknown especially in France. According to our hypothesis, patients with major disabilities and their caregivers will experience more psychosocial consequences and participation restriction in terms of emotional health, quality of life and burden. Also, we hypothesize that stroke severity, the typology of disabilities (motor, cognitive and sensorial) will have a different impact on patients and proxys' lifes in terms of psychosocial consequences, participation restriction and quality of life.
TYBRA study is a prospective multicentric cohort study that mixes qualitative and quantitative approaches. The first aim of the quantitative approach is to explore factors related to patients and their caregivers at 6 months that predict participation restriction at 12 months post-stroke. The first aim of the qualitative study is to explore the experience of stroke in minor stroke patients and their proxys.
### Conditions Module
**Conditions:**
- Stroke Patients and Their Caregivers
**Keywords:**
- stroke-participation
- restriction-needs-cohort-patients-caregivers
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 396
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Outcomes Module
#### Primary Outcomes
**Description:** Patients will receive at home questionnaires about the psychosocial consequences of stroke for them and their caregivers at 6 months and 12 months post stroke.
Scale 2.0 at 12 months. The variable "participation" will be dichotomized in two scores : \<50 and \>50. A score \<50 means that the person presents a significate participation restriction.
**Measure:** Change from 6-month participation restriction at 12 months.
**Time Frame:** At 6 and 12 months post-stroke
**Description:** Semi-structured interviews with stroke patients and their proxys.
**Measure:** Change from 6-month experience of minor stroke for patients and their proxys at 12 months.
**Time Frame:** Interviews at 6 and 12 months post-stroke
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Quantitative study : (patients included in Stroke 69 cohort study)
* Diagnosis of stroke confirmed by a neurologist or by an emergency doctor after brain imaging (CT or MRI scan)
* Patients admitted to an emergency department or a neurovascular unit in Rhône department whatever their geographical origin
* Concerning proxys : Caregivers of patients included in Stroke 69 cohort study and eligible to TYBRA study.
Qualitative study : (patients included in Stroke 69 cohort study)
* Patients included in Stroke 69 cohort study with a diagnosis of stroke confirmed by brain imaging
* Minor stroke (Rankin \<1)
* Proxys of minor stroke patients
Exclusion Criteria:
* Patients institutionalized before stroke and/or at 6 months and/or at 12 months
* Patients who have major cognitive trouble
* Stroke during hospitalisation
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Hemorrhagic or ischemic stroke patients and their caregivers.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Lyon
**Country:** France
**Facility:** Hospices Civils de Lyon
**Zip:** 69003
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- 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
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- 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: M22306
- Name: Stroke
- Relevance: HIGH
- As Found: Stroke
- 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: T6034
- Name: Quality of Life
- Relevance: HIGH
- As Found: Quality of Life
### Condition Browse Module - Meshes
- ID: D000020521
- Term: Stroke
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT01921179
**Brief Title:** Rehabilitation of Executive Functioning in Veterans With PTSD and Mild TBI
**Official Title:** Rehabilitation of Executive Functioning in Veterans With PTSD and Mild TBI
#### Organization Study ID Info
**ID:** D1111-I
#### Organization
**Class:** FED
**Full Name:** VA Office of Research and Development
### Status Module
#### Completion Date
**Date:** 2018-12-30
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2020-02-17
**Type:** ACTUAL
**Last Update Submit Date:** 2020-02-03
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2018-12-30
**Type:** ACTUAL
#### Results First Post Date
**Date:** 2020-02-17
**Type:** ACTUAL
**Results First Submit Date:** 2020-01-17
**Results First Submit QC Date:** 2020-02-03
#### Start Date
**Date:** 2013-07-31
**Type:** ACTUAL
**Status Verified Date:** 2020-02
#### Study First Post Date
**Date:** 2013-08-13
**Type:** ESTIMATED
**Study First Submit Date:** 2013-08-02
**Study First Submit QC Date:** 2013-08-08
### 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:** One of the most pressing concerns within the VA currently is the provision of interventions that address the cognitive as well as emotional problems faced by Veterans with concurrent mild TBI and PTSD. One purpose of this study is to learn more about how PTSD and mild brain injury influences how people think, act, and feel. This may include how people pay attention, keep information in memory, organize plans for achieving important goals, and manage stress. Another purpose of this research is to learn more about the effects of cognitive training on the thinking, behavior, and emotions of individuals with PTSD and mild brain injury - both in the short- and long-term. With this research, the investigators hope to better understand and treat cognitive and emotional difficulties that can occur due to PTSD and mild brain injury.
**Detailed Description:** The overall aim of this proposal is to investigate the potential short and long term effectiveness of a cognitive training program Goal-Oriented Attentional Self-regulation (GOALS) that targets executive control functions in Veterans with co-morbid posttraumatic stress disorder (PTSD), history of mild traumatic brain injury (mTBI), and cognitive difficulties. Both PTSD and a history of mild TBI are prevalent in Veterans from the Operation Enduring Freedom (OEF) and Operation Iraqi Freedom (OIF) conflicts, with reported rates for each disorder ranging from 14 - 22%. Both PTSD and TBI have been associated with cognitive dysfunction which may lead to functional impairment and poor community reintegration. PTSD can be highly debilitating not only due to emotional dysregulation, but also due to deficits in the cognitive control processes.
Goal-Oriented Attentional Self-Regulation (GOALS) is a therapist administered cognitive rehabilitation training that targets executive control functions of applied mindfulness-based attention regulation and goal management, and links them to participant-defined real-life goals. In a prior study with individuals with chronic brain injury, this training has improved cognitive performance in areas of complex attention / executive function, memory, complex functional task performance, and daily functioning. Furthermore, functional MRI results after training indicated significantly enhanced modulation of neural processing in extrastriate cortex and changes in prefrontal cortex. Preliminary results from a recently completed study with Veterans with a history of chronic TBI also support improvements post GOALS on neuropsychological measures of attention and executive function, performance on complex 'real-life' tasks, and self-report measures of functional performance. Furthermore, participants also showed improvement on the emotional regulation self-report measures. These findings suggest that improving cognitive control may also improve functioning in other domains such as emotional regulation and functional performance in daily life.
In a randomized, controlled intervention study design, 42 Veterans with a diagnosis of PTSD, history of mTBI and residual cognitive difficulties will participate in experimental (GOALS), and/or active comparison (Brain Health Education - EDU) interventions matched for time and intensity. Participants will be randomized to start with either 5 weeks of GOALS or EDU training. Those who begin with EDU will cross-over to GOALS, while those begin with GOALS will have 5 weeks of self-driven practice only. Both groups will participate in pre and post intervention measurements at baseline, weeks 5 and 10. Long-term follow-up will be at 6 months. Pre- and post-intervention measurements will include performance on untrained: neuro-cognitive tests assessing targeted and non-targeted cognitive domains, complex functional task performance in low structure 'real-world' setting, and self-report measures of emotional regulation and daily functioning.
### Conditions Module
**Conditions:**
- Post Traumatic Stress Disorder
- Mild Traumatic Brain Injury, Concussion
**Keywords:**
- Post Traumatic Stress Disorder,
- Mild Traumatic Brain Injury
- Concussion
- Cognitive Rehabilitation
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 76
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Goal-Oriented Attentional Regulation (GOALS) will involve 5-weeks of training (20 hours of group training (2 hour sessions, 2 days per week), 3 hours of individual training (1 hour at the beginning, halfway through and at the end of training), and approximately 20 hours of home practice). Some subjects will only receive the GOALS intervention.
**Intervention Names:**
- Behavioral: GOALS (Goal-Oriented Attentional Regulation)
**Label:** GOALS (Goal-Oriented Attentional Regulation)
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Brain Health Education (EDU) will involve 5-weeks of training (20 hours of group training (2 hour sessions, 2 days per week), 3 hours of individual training (1 hour at the beginning, halfway through and at the end of training), and approximately 20 hours of homework). The EDU intervention involves education on brain health and functioning in a classroom format, with study materials for homework. Some subjects will start with EDU and then cross-over to the GOALS.
**Intervention Names:**
- Behavioral: EDU (Brain Health Education)
**Label:** EDU (Brain Health Education)
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- GOALS (Goal-Oriented Attentional Regulation)
**Description:** Goal-Oriented Attentional Regulation (GOALS) will involve 5-weeks of training (20 hours of group training (2 hour sessions, 2 days per week), 3 hours of individual training (1 hour at the beginning, halfway through and at the end of training), and approximately 20 hours of home practice). Some subjects will only receive the GOALS intervention.
**Name:** GOALS (Goal-Oriented Attentional Regulation)
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- EDU (Brain Health Education)
**Description:** Brain Health Education (EDU) will involve 5-weeks of training (20 hours of group training (2 hour sessions, 2 days per week), 3 hours of individual training (1 hour at the beginning, halfway through and at the end of training), and approximately 20 hours of homework). The EDU intervention involves education on brain health and functioning in a classroom format, with study materials for homework. Some subjects will start with EDU and then cross-over to the GOALS.
**Name:** EDU (Brain Health Education)
**Other Names:**
- EDU
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** Attention and Executive Function Overall Domain Z Score (primary neuropsychological outcome measure) is calculated as the average of z scores of following tests: Letter Number Sequencing, Auditory Consonant Trigrams, Digit Vigilance, Trails B, DKEFS Stroop Inhibition, DKEFS Stroop Inhibition-Switching, DKEFS Verbal Fluency Switching, DKEFS Visual Fluency Switching.
(The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the population mean. Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population)
**Measure:** Change in Performance on Neurocognitive Measure of Attention and Executive Function Post GOALS Intervention vs EDU Control Training
**Time Frame:** baseline, 5 weeks
**Description:** Attention and Executive Function Overall Domain Z Score (primary neuropsychological outcome measure) is calculated as the average of z scores of following tests: Letter Number Sequencing, Auditory Consonant Trigrams, Digit Vigilance, Trails B, DKEFS Stroop Inhibition, DKEFS Stroop Inhibition-Switching, DKEFS Verbal Fluency Switching, DKEFS Visual Fluency Switching.
(The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the population mean. Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population)
**Measure:** Long Term Follow-up After GOALS Training - Change in Performance on Neurocognitive Measures of Attention and Executive Function 6+ Months Post GOALS Intervention Relative to Baseline
**Time Frame:** baseline, 6+ months after GOALS training
#### Secondary Outcomes
**Description:** Goal Processing Scale Overall Performance score (Primary functional performance outcome ) is calculated as the average of the 8 sub-domain scores including: Planning, Initiation, Maintenance of Attention, Self-Monitoring, Sequencing and Switching Attention, Flexible Problem Solving, Memory, and Execution. Minimum value is 0, maximum value is 10. Higher scores indicate better outcome.
**Measure:** Change in Performance on Complex Functional Task -Goal Processing Scale Post GOALS Intervention vs EDU Control Training
**Time Frame:** baseline; 5 weeks
**Description:** Goal Processing Scale Overall Performance score (Primary functional performance outcome ) is calculated as the average of the 8 sub-domain scores including: Planning, Initiation, Maintenance of Attention, Self-Monitoring, Sequencing and Switching Attention, Flexible Problem Solving, Memory, and Execution. Minimum value is 0, maximum value is 10. Higher scores indicate better outcome
**Measure:** Long Term Follow-up After GOALS Training - Change in Performance on Complex Functional Task -Goal Processing Scale 6+ Months Post GOALS Intervention Relative to Baseline
**Time Frame:** baseline, 6 months post GOALS training
**Description:** Overall psychological distress will be assessed with Profile of Mood States (POMS) questionnaire Total Mood Disturbance Z Score (primary emotional regulation outcome measure).
(The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the population mean. Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population)
**Measure:** Change on Self Report Measures of Emotional Regulation GOALS Post Intervention vs EDU Control Training
**Time Frame:** baseline, 5 weeks
**Description:** Overall psychological distress is assessed with Profile of Mood States (POMS) questionnaire Total Mood Disturbance Z Score (primary emotional regulation outcome measure)
(The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the population mean. Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population)
**Measure:** Long Term Follow-up Change on Self Report Measures of Emotional Regulation 6+ Months Post GOALS Intervention
**Time Frame:** baseline, 6 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Diagnosis of PTSD
* History of mild TBI, including concussion \> 6 months ago
* Cognitive difficulties affecting daily functioning
* Age 18-75
* Veteran
* At least 12th grade education or equivalent
Exclusion Criteria:
* Amnesic/Severe memory problems
* Active Substance Abuse/Dependence
* Medical condition that may affect mental status/disrupt study participation
* Active psychotropic medication changes
* Participation in evidence-based PTSD treatment
**Maximum Age:** 75 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Martinez
**Country:** United States
**Facility:** Martinez Outpatient Clinic and Community Living Center, Martinez, CA
**State:** California
**Zip:** 94553
**Location 2:**
**City:** San Francisco
**Country:** United States
**Facility:** San Francisco VA Medical Center, San Francisco, CA
**State:** California
**Zip:** 94121
#### Overall Officials
**Official 1:**
**Affiliation:** San Francisco VA Medical Center, San Francisco, CA
**Name:** Tatjana Novakovic-Agopian, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** Following study completion and publication of results we will explore available mechanisms for data sharing
**IPD Sharing:** YES
### References Module
#### References
**Citation:** Novakovic-Agopian T, Chen AJ, Rome S, Abrams G, Castelli H, Rossi A, McKim R, Hills N, D'Esposito M. Rehabilitation of executive functioning with training in attention regulation applied to individually defined goals: a pilot study bridging theory, assessment, and treatment. J Head Trauma Rehabil. 2011 Sep-Oct;26(5):325-38. doi: 10.1097/HTR.0b013e3181f1ead2.
**PMID:** 21169860
**Citation:** Chen AJ, Novakovic-Agopian T, Nycum TJ, Song S, Turner GR, Hills NK, Rome S, Abrams GM, D'Esposito M. Training of goal-directed attention regulation enhances control over neural processing for individuals with brain injury. Brain. 2011 May;134(Pt 5):1541-54. doi: 10.1093/brain/awr067. Epub 2011 Apr 22.
**PMID:** 21515904
**Citation:** Novakovic-Agopian T, Chen AJ, Rome S, Rossi A, Abrams G, D'Esposito M, Turner G, McKim R, Muir J, Hills N, Kennedy C, Garfinkle J, Murphy M, Binder D, Castelli H. Assessment of subcomponents of executive functioning in ecologically valid settings: the goal processing scale. J Head Trauma Rehabil. 2014 Mar-Apr;29(2):136-46. doi: 10.1097/HTR.0b013e3182691b15.
**PMID:** 23076096
**Citation:** Novakovic-Agopian T, Kornblith E, Abrams G, Burciaga-Rosales J, Loya F, D'Esposito M, Chen AJW. Training in Goal-Oriented Attention Self-Regulation Improves Executive Functioning in Veterans with Chronic Traumatic Brain Injury. J Neurotrauma. 2018 Dec 1;35(23):2784-2795. doi: 10.1089/neu.2017.5529. Epub 2018 Jul 23.
**PMID:** 29717652
## Document Section
### Large Document Module
#### Large Docs
- Date: 2014-11-13
- Filename: Prot_SAP_000.pdf
- Has ICF: False
- Has Protocol: True
- Has SAP: True
- Label: Study Protocol and Statistical Analysis Plan: Full Protocol
- Size: 328202
- Type Abbrev: Prot_SAP
- Upload Date: 2019-12-29T04:19
- Date: 2014-11-18
- Filename: ICF_001.pdf
- Has ICF: True
- Has Protocol: False
- Has SAP: False
- Label: Informed Consent Form
- Size: 134593
- Type Abbrev: ICF
- Upload Date: 2019-12-29T04:21
- Date: 2019-03-26
- Filename: Prot_002.pdf
- Has ICF: False
- Has Protocol: True
- Has SAP: False
- Label: Study Protocol: Study Protocol Summary Abstract
- Size: 169321
- Type Abbrev: Prot
- Upload Date: 2019-12-29T04:23
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001927
- Term: Brain Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000006259
- Term: Craniocerebral Trauma
- ID: D000020196
- Term: Trauma, Nervous System
- ID: D000014947
- Term: Wounds and Injuries
- ID: D000068099
- Term: Trauma and Stressor Related Disorders
- ID: D000001523
- Term: Mental Disorders
- ID: D000016489
- Term: Head Injuries, Closed
- ID: D000014949
- Term: Wounds, Nonpenetrating
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC26
- Name: Wounds and Injuries
### Condition Browse Module - Browse Leaves
- ID: M16103
- Name: Stress Disorders, Post-Traumatic
- Relevance: HIGH
- As Found: Post Traumatic Stress Disorder
- ID: M5207
- Name: Brain Injuries
- Relevance: HIGH
- As Found: Brain Injury
- ID: M628
- Name: Brain Injuries, Traumatic
- Relevance: HIGH
- As Found: Traumatic Brain Injury
- ID: M24916
- Name: Stress Disorders, Traumatic
- Relevance: HIGH
- As Found: Traumatic Stress Disorder
- ID: M5201
- Name: Brain Concussion
- Relevance: HIGH
- As Found: Mild Traumatic Brain Injury
- ID: M5204
- Name: Brain Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17685
- Name: Wounds and Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M9349
- Name: Craniocerebral Trauma
- Relevance: LOW
- As Found: Unknown
- ID: M22023
- Name: Trauma, Nervous System
- Relevance: LOW
- As Found: Unknown
- ID: M222
- Name: Trauma and Stressor Related 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: M18892
- Name: Head Injuries, Closed
- Relevance: LOW
- As Found: Unknown
- ID: M17687
- Name: Wounds, Nonpenetrating
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001930
- Term: Brain Injuries
- ID: D000070642
- Term: Brain Injuries, Traumatic
- ID: D000001924
- Term: Brain Concussion
- ID: D000040921
- Term: Stress Disorders, Traumatic
- ID: D000013313
- Term: Stress Disorders, Post-Traumatic
### Misc Info Module
- Version Holder: 2024-05-24
## Results Section
### Adverse Events Module
**Description:** Potential risks were minimal. The research procedures involved presented no physical risk and minimal psychological risk to the subjects. The primary risk was the potential for anxiety or boredom associated with completing behavioral assessments and training interventions.
#### Event Groups
**Group ID:** EG000
**Title:** GOALS (Goal-Oriented Attentional Regulation)
**Deaths Num At Risk:** 37
**Description:** Goal-Oriented Attentional Regulation (GOALS) executive training involved 5-weeks of training (20 hours of group training (2 hour sessions, 2 days per week), 3 hours of individual training, and approximately 20 hours of home practice. Participants randomized to the GOALS intervention, did no receive EDU training.
**ID:** EG000
**Other Num at Risk:** 37
**Serious Number At Risk:** 37
**Title:** GOALS (Goal-Oriented Attentional Regulation)
**Group ID:** EG001
**Title:** EDU (Brain Health Education)
**Deaths Num At Risk:** 22
**Description:** Brain Health Education (EDU) involved 5-weeks of training (20 hours of group training , 3 hours of individual training ,and approximately 20 hours of homework). The EDU intervention involves education on brain health and functioning in a classroom format, with study materials for homework.
Some subjects who completed EDU training during the randomized phase, completed the additional 5 weeks of GOALS.
**ID:** EG001
**Other Num at Risk:** 22
**Serious Number At Risk:** 22
**Title:** EDU (Brain Health Education)
**Frequency Threshold:** 1
**Time Frame:** baseline to 6 month follow-up
## Results Section - Baseline Characteristics Module
### Denomination Counts
**Group ID:** BG000
**Value:** 21
**Group ID:** BG001
**Value:** 19
**Group ID:** BG002
**Value:** 40
**Units:** Participants
### Group
**ID:** BG000
**Title:** GOALS (Goal-Oriented Attentional Regulation)
**Description:** Goal-Oriented Attentional Regulation (GOALS) executive training involved 5-weeks of training (20 hours of group training (2 hour sessions, 2 days per week), 3 hours of individual training, and approximately 20 hours of home practice.
Participants randomized to GOALS intervention, did no receive EDU training after completion of GOALS.
### Group
**ID:** BG001
**Title:** EDU (Brain Health Education)
**Description:** Brain Health Education (EDU) involved 5-weeks of training (20 hours of group training , 3 hours of individual training ,and approximately 20 hours of homework). The EDU intervention involves education on brain health and functioning in a classroom format, with study materials for homework.
Some subjects who completed EDU training during the randomized phase, completed additional 5 weeks of GOALS training.
### Group
**ID:** BG002
**Title:** Total
**Description:** Total of all reporting groups
### Measure
#### Measurement
**Group ID:** BG000
**Spread:** 13.95
**Value:** 42.1
#### Measurement
**Group ID:** BG001
**Spread:** 14.86
**Value:** 47.53
#### Measurement
**Group ID:** BG002
**Spread:** 14.74
**Value:** 45.08
**Class Title:**
### Measure
#### Measurement
**Group ID:** BG000
**Value:** 1
#### Measurement
**Group ID:** BG001
**Value:** 4
#### Measurement
**Group ID:** BG002
**Value:** 5
**Category Title:** Female
#### Measurement
**Group ID:** BG000
**Value:** 20
#### Measurement
**Group ID:** BG001
**Value:** 15
#### Measurement
**Group ID:** BG002
**Value:** 35
**Category Title:** Male
**Class Title:**
### Measure
#### Measurement
**Group ID:** BG000
**Value:** 2
#### Measurement
**Group ID:** BG001
**Value:** 0
#### Measurement
**Group ID:** BG002
**Value:** 2
**Class Title:** Asian
#### Measurement
**Group ID:** BG000
**Value:** 1
#### Measurement
**Group ID:** BG001
**Value:** 1
#### Measurement
**Group ID:** BG002
**Value:** 2
**Class Title:** Native Hawaiian or Pacific Islander
#### Measurement
**Group ID:** BG000
**Value:** 2
#### Measurement
**Group ID:** BG001
**Value:** 2
#### Measurement
**Group ID:** BG002
**Value:** 4
**Class Title:** Black
#### Measurement
**Group ID:** BG000
**Value:** 14
#### Measurement
**Group ID:** BG001
**Value:** 14
#### Measurement
**Group ID:** BG002
**Value:** 28
**Class Title:** White
#### Measurement
**Group ID:** BG000
**Value:** 2
#### Measurement
**Group ID:** BG001
**Value:** 1
#### Measurement
**Group ID:** BG002
**Value:** 3
**Class Title:** More than one race
#### Measurement
**Group ID:** BG000
**Value:** 0
#### Measurement
**Group ID:** BG001
**Value:** 1
#### Measurement
**Group ID:** BG002
**Value:** 1
**Class Title:** Hispanic or Latino
### Measure
#### Measurement
**Group ID:** BG000
**Value:** 21
#### Measurement
**Group ID:** BG001
**Value:** 19
#### Measurement
**Group ID:** BG002
**Value:** 40
**Class Title:** United States
### Measure
#### Measurement
**Group ID:** BG000
**Spread:** 0.72
**Value:** -0.39
#### Measurement
**Group ID:** BG001
**Spread:** 0.77
**Value:** -0.38
#### Measurement
**Group ID:** BG002
**Spread:** 0.72
**Value:** -0.39
**Class Title:**
### Measure
#### Measurement
**Group ID:** BG000
**Spread:** 1.48
**Value:** 7.17
#### Measurement
**Group ID:** BG001
**Spread:** 1.44
**Value:** 7.31
#### Measurement
**Group ID:** BG002
**Spread:** 1.39
**Value:** 7.27
**Class Title:**
### Measure
#### Measurement
**Group ID:** BG000
**Spread:** 1.57
**Value:** -1.69
#### Measurement
**Group ID:** BG001
**Spread:** 1.06
**Value:** -1.94
#### Measurement
**Group ID:** BG002
**Spread:** 1.34
**Value:** -1.81
**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:** COUNT_OF_PARTICIPANTS
**Title:** Race/Ethnicity, Customized
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Region of Enrollment
**Unit of Measure:** Participants
### Measure 5
**Description:** Attention and Executive Function Overall Domain Z Score is calculated as the average of z scores of following tests: Letter Number Sequencing, Auditory Consonant Trigrams, Digit Vigilance, Trails B, DKEFS Stroop Inhibition, DKEFS Stroop Inhibition-Switching, DKEFS Verbal Fluency Switching, DKEFS Visual Fluency Switching.
(The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the population mean. Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population)
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Attention/Executive Function Overall Z Score
**Unit of Measure:** z score
### Measure 6
**Description:** Goal Processing Scale Overall Performance score (Primary functional performance outcome ) is calculated as the average of the 8 sub-domain scores including: Planning, Initiation, Maintenance of Attention, Self-Monitoring, Sequencing and Switching Attention, Flexible Problem Solving, Memory, and Execution. Minimum value is 0, maximum value is 10. Higher scores indicate better outcome.
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Goal Processing Scale (GPS) Overall Performance Score
**Unit of Measure:** score on a scale
### Measure 7
**Description:** Overall psychological distress will be assessed with Profile of Mood States (POMS) questionnaire Total Mood Disturbance Z Score (primary emotional regulation outcome measure).
(The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the population mean. Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population)
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Profile of Mood States (POMS)-Total Mood Disturbance Score
**Unit of Measure:** z score
## Results Section - More Information Module
### Certain Agreement
### Limitations and Caveats
**Description:** One important limitation of this study is a relatively small sample size, which may have also resulted in our interaction analyses being under powered, possibly leading to failure to detect true effects of group on outcomes
### Point of Contact
**Email:** [email protected]
**Organization:** San Francisco VA HCS
**Phone:** 415-753-3888
**Title:** Dr Tatjana Novakovic-Agopian
## 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:**
**Non-Inferiority Comment:** A repeated measures MANOVA was used to compare the impact of GOALS training versus the BHE training on neurocognitive performance Attention and Executive Function Overall Domain Z Score
**Non-Inferiority Type:** EQUIVALENCE
**Other Analysis Description:**
**P-Value:** <0.01
**P-Value Comment:**
**Parameter Type:**
**Parameter Value:**
**Statistical Comment:**
**Statistical Method:** ANOVA
**Tested Non-Inferiority:**
### 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:**
**Non-Inferiority Comment:** A repeated measure multivariate analysis of variance (MANOVA) was used to compare neurocognitive performance on Overall Attention /Executive Function overall score at baseline and at 6+ month post-GOALS training follow-up
**Non-Inferiority Type:** EQUIVALENCE
**Other Analysis Description:**
**P-Value:** <0.001
**P-Value Comment:**
**Parameter Type:**
**Parameter Value:**
**Statistical Comment:** Repeated measure MANOVA was used to compare performance on neurocognitive domain scores at baseline and at 6+ month follow-up post-GOALS training
**Statistical Method:** ANOVA
**Tested Non-Inferiority:**
### 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:**
**Non-Inferiority Comment:** A repeated measures MANOVA was used to compare the impact of GOALS training versus the BHE training on functional performance
**Non-Inferiority Type:** EQUIVALENCE
**Other Analysis Description:**
**P-Value:** >0.05
**P-Value Comment:**
**Parameter Type:**
**Parameter Value:**
**Statistical Comment:** A repeated measures MANOVA was used to compare the impact of GOALS training versus the BHE training on functional performance
**Statistical Method:** ANOVA
**Tested Non-Inferiority:**
### 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:** A repeated measure multivariate analysis of variance (MANOVA) was used to compare performance on Goal Processing Scale Overall domain scores at baseline and 6+ month post-GOALS training follow-up
**Non-Inferiority Type:** EQUIVALENCE
**Other Analysis Description:**
**P-Value:** <0.001
**P-Value Comment:**
**Parameter Type:**
**Parameter Value:**
**Statistical Comment:**
**Statistical Method:** ANOVA
**Tested Non-Inferiority:**
### 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:**
**Non-Inferiority Comment:** A repeated measures MANOVA was used to compare the impact of GOALS training versus the BHE training on emotional regulation measures - POMS Total score
**Non-Inferiority Type:** EQUIVALENCE
**Other Analysis Description:**
**P-Value:** <0.05
**P-Value Comment:**
**Parameter Type:**
**Parameter Value:**
**Statistical Comment:** A repeated measures MANOVA was used to compare the impact of GOALS versus the BHE training on emotional regulation measures - POMS Total score
**Statistical Method:** ANOVA
**Tested Non-Inferiority:**
### 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:**
**Non-Inferiority Comment:** A repeated measure multivariate analysis of variance (MANOVA) was used to compare participants' self-report on POMS Total Mood Disturbance overall score at baseline and 6+ month post-GOALS training follow-up
**Non-Inferiority Type:** EQUIVALENCE
**Other Analysis Description:**
**P-Value:** <0.01
**P-Value Comment:**
**Parameter Type:**
**Parameter Value:**
**Statistical Comment:**
**Statistical Method:** ANOVA
**Tested Non-Inferiority:**
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 0.68
- **Upper Limit:**
- **Value:** -0.03
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 0.72
- **Upper Limit:**
- **Value:** -0.39
**Title:**
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 0.78
- **Upper Limit:**
- **Value:** -0.2
**Title:**
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 1.10
- **Upper Limit:**
- **Value:** 8.10
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 1.04
- **Upper Limit:**
- **Value:** 7.60
**Title:**
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 1.20
- **Upper Limit:**
- **Value:** 8.23
**Title:**
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 1.82
- **Upper Limit:**
- **Value:** -1.37
- **Comment:**
- **Group ID:** OG001
- **Lower Limit:**
- **Spread:** 0.94
- **Upper Limit:**
- **Value:** -2.09
**Title:**
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 1.40
- **Upper Limit:**
- **Value:** -1.01
**Title:**
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Attention and Executive Function Overall Domain Z Score (primary neuropsychological outcome measure) is calculated as the average of z scores of following tests: Letter Number Sequencing, Auditory Consonant Trigrams, Digit Vigilance, Trails B, DKEFS Stroop Inhibition, DKEFS Stroop Inhibition-Switching, DKEFS Verbal Fluency Switching, DKEFS Visual Fluency Switching.
(The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the population mean. Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population)
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Out of 21 participants who completed GOALS, 3 participants did not complete one or more neuropsychological tests
**Reporting Status:** POSTED
**Time Frame:** baseline, 5 weeks
**Title:** Change in Performance on Neurocognitive Measure of Attention and Executive Function Post GOALS Intervention vs EDU Control Training
**Type:** PRIMARY
**Unit of Measure:** z score
##### Group
**Description:** Goal-Oriented Attentional Regulation (GOALS) executive training involved 5-weeks of training (20 hours of group training, 3 hours of individual training, and approximately 20 hours of home practice. GOALS is therapist administered cognitive rehabilitation training that targets executive control functions of applied mindfulness-based attention regulation and problem solving applied to participant-defined real-life goals.
Participants randomized to the GOALS intervention, did no receive EDU training after completion of GOALS.
**ID:** OG000
**Title:** GOALS (Goal-Oriented Attentional Regulation)
##### Group
**Description:** Brain Health Education (EDU) involved 5-weeks of training (20 hours of group training), 3 hours of individual training, and approximately 20 hours of homework). The EDU intervention is therapist administered, and involves education on brain health and functioning in a classroom format, with study materials for homework.
Participants randomized to EDU intervention were offered to participate in GOALS training after completion of EDU training.
**ID:** OG001
**Title:** EDU (Brain Health Education)
#### Outcome Measure 2
**Description:** Attention and Executive Function Overall Domain Z Score (primary neuropsychological outcome measure) is calculated as the average of z scores of following tests: Letter Number Sequencing, Auditory Consonant Trigrams, Digit Vigilance, Trails B, DKEFS Stroop Inhibition, DKEFS Stroop Inhibition-Switching, DKEFS Verbal Fluency Switching, DKEFS Visual Fluency Switching.
(The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the population mean. Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population)
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** baseline, 6+ months after GOALS training
**Title:** Long Term Follow-up After GOALS Training - Change in Performance on Neurocognitive Measures of Attention and Executive Function 6+ Months Post GOALS Intervention Relative to Baseline
**Type:** PRIMARY
**Unit of Measure:** z score
##### Group
**Description:** Goal-Oriented Attentional Regulation (GOALS) executive training involved 5-weeks of training (20 hours of group training (2 hour sessions, 2 days per week), 3 hours of individual training, and approximately 20 hours of home practice. Participants randomized to the GOALS intervention, did no receive EDU training.
**ID:** OG000
**Title:** GOALS (Goal-Oriented Attentional Regulation)
#### Outcome Measure 3
**Description:** Goal Processing Scale Overall Performance score (Primary functional performance outcome ) is calculated as the average of the 8 sub-domain scores including: Planning, Initiation, Maintenance of Attention, Self-Monitoring, Sequencing and Switching Attention, Flexible Problem Solving, Memory, and Execution. Minimum value is 0, maximum value is 10. Higher scores indicate better outcome.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Out of 21 participants who completed GOALS training 3 participants did not complete one or more sub-tests of GPS.
Out of 19 participants who completed EDU training 2 participants did not complete one or more sub-tests of GPS
**Reporting Status:** POSTED
**Time Frame:** baseline; 5 weeks
**Title:** Change in Performance on Complex Functional Task -Goal Processing Scale Post GOALS Intervention vs EDU Control Training
**Type:** SECONDARY
**Unit of Measure:** score on a scale
##### Group
**Description:** Goal-Oriented Attentional Regulation (GOALS) executive training involved 5-weeks of training (20 hours of group training, 3 hours of individual training, and approximately 20 hours of home practice. GOALS is therapist administered cognitive rehabilitation training that targets executive control functions of applied mindfulness-based attention regulation and problem solving applied to participant-defined real-life goals.
Participants randomized to the GOALS intervention, did no receive EDU training after completion of GOALS.
**ID:** OG000
**Title:** GOALS (Goal-Oriented Attentional Regulation)
##### Group
**Description:** Brain Health Education (EDU) involved 5-weeks of training (20 hours of group training), 3 hours of individual training, and approximately 20 hours of homework). The EDU intervention is therapist administered, and involves education on brain health and functioning in a classroom format, with study materials for homework.
Participants randomized to EDU intervention were offered to participate in GOALS training after completion of EDU training.
**ID:** OG001
**Title:** EDU (Brain Health Education)
#### Outcome Measure 4
**Description:** Goal Processing Scale Overall Performance score (Primary functional performance outcome ) is calculated as the average of the 8 sub-domain scores including: Planning, Initiation, Maintenance of Attention, Self-Monitoring, Sequencing and Switching Attention, Flexible Problem Solving, Memory, and Execution. Minimum value is 0, maximum value is 10. Higher scores indicate better outcome
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** baseline, 6 months post GOALS training
**Title:** Long Term Follow-up After GOALS Training - Change in Performance on Complex Functional Task -Goal Processing Scale 6+ Months Post GOALS Intervention Relative to Baseline
**Type:** SECONDARY
**Unit of Measure:** score on a scale
##### Group
**Description:** Goal-Oriented Attentional Regulation (GOALS) executive training involved 5-weeks of training (20 hours of group training (2 hour sessions, 2 days per week), 3 hours of individual training, and approximately 20 hours of home practice. Participants randomized to the GOALS intervention, did no receive EDU training.
**ID:** OG000
**Title:** GOALS (Goal-Oriented Attentional Regulation)
#### Outcome Measure 5
**Description:** Overall psychological distress will be assessed with Profile of Mood States (POMS) questionnaire Total Mood Disturbance Z Score (primary emotional regulation outcome measure).
(The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the population mean. Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population)
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Out of 21 participants who completed GOALS training 3 participants did not complete one or more questions on POMS Out of 19 participants who completed EDU training 2 participants did not complete one or more questions on POMS
**Reporting Status:** POSTED
**Time Frame:** baseline, 5 weeks
**Title:** Change on Self Report Measures of Emotional Regulation GOALS Post Intervention vs EDU Control Training
**Type:** SECONDARY
**Unit of Measure:** z score
##### Group
**Description:** Goal-Oriented Attentional Regulation (GOALS) executive training involved 5-weeks of training (20 hours of group training, 3 hours of individual training, and approximately 20 hours of home practice. GOALS is therapist administered cognitive rehabilitation training that targets executive control functions of applied mindfulness-based attention regulation and problem solving applied to participant-defined real-life goals.
Participants randomized to the GOALS intervention, did no receive EDU training after completion of GOALS.
**ID:** OG000
**Title:** GOALS (Goal-Oriented Attentional Regulation)
##### Group
**Description:** Brain Health Education (EDU) involved 5-weeks of training (20 hours of group training), 3 hours of individual training, and approximately 20 hours of homework). The EDU intervention is therapist administered, and involves education on brain health and functioning in a classroom format, with study materials for homework.
Participants randomized to EDU intervention were offered to participate in GOALS training after completion of EDU training.
**ID:** OG001
**Title:** EDU (Brain Health Education)
#### Outcome Measure 6
**Description:** Overall psychological distress is assessed with Profile of Mood States (POMS) questionnaire Total Mood Disturbance Z Score (primary emotional regulation outcome measure)
(The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the population mean. Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population)
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** baseline, 6 months
**Title:** Long Term Follow-up Change on Self Report Measures of Emotional Regulation 6+ Months Post GOALS Intervention
**Type:** SECONDARY
**Unit of Measure:** z score
##### Group
**Description:** Goal-Oriented Attentional Regulation (GOALS) executive training involved 5-weeks of training (20 hours of group training (2 hour sessions, 2 days per week), 3 hours of individual training, and approximately 20 hours of home practice. Participants randomized to the GOALS intervention, did no receive EDU training.
**ID:** OG000
**Title:** GOALS (Goal-Oriented Attentional Regulation)
### Participant Flow Module
#### Group
**Description:** Goal-Oriented Attentional Regulation (GOALS) executive training involved 5-weeks of training (20 hours of group training (2 hour sessions, 2 days per week), 3 hours of individual training, and approximately 20 hours of home practice. Participants randomized to the GOALS intervention, did no receive EDU training.
**ID:** FG000
**Title:** GOALS (Goal-Oriented Attentional Regulation)
#### Group
**Description:** Brain Health Education (EDU) will involve 5-weeks of training (20 hours of group training (2 hour sessions, 2 days per week), 3 hours of individual training (1 hour at the beginning, halfway through and at the end of training), and approximately 20 hours of homework). The EDU intervention involves education on brain health and functioning in a classroom format, with study materials for homework. Some subjects will start with EDU and then cross-over to the GOALS.
**ID:** FG001
**Title:** EDU (Brain Health Education)
#### Period
**Title:** 5 Week Randomized GOALS vs EDU Training
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 3
###### Reason
**Group ID:** FG001
**Number of Subjects:** 3
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 24
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 22
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 21
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 19
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 3
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 3
#### Period
**Title:** Long Term Follow-up After GOALS Training
##### Withdraw
**Type:** Lost to Follow-up
###### 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:** 34
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 32
###### 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:** 0
**Pre-Assignment Details:** Out of 76 enrolled participants: 12 were excluded after in person screening for not meeting inclusion criteria CAPS diagnosis of PTSD (n=11), or substance abuse (n=1); 8 participants left study after consent for scheduling, medical/family issues; and 10 left study during baseline assessment (were not randomized)
46 participants were randomized
**Has Results:** True |
## Protocol Section
### Identification Module
**NCT ID:** NCT02174679
**Brief Title:** 68Ga DOTATATE PET/CT in Neuroendocrine Tumors (Expanded Access)
**Official Title:** 68Ga-DOTATATE Imaging in Neuroendocrine Tumors
#### Organization Study ID Info
**ID:** DOTATATE12-001920EA
#### Organization
**Class:** OTHER
**Full Name:** Jonsson Comprehensive Cancer Center
#### Secondary ID Infos
**Domain:** CTRP
**ID:** NCI-2016-01796
**Type:** OTHER
**Domain:** Jonsson Comprehensive Cancer Center
**ID:** JCCCID324
**Type:** OTHER
### Status Module
#### Last Update Post Date
**Date:** 2020-07-27
**Type:** ACTUAL
**Last Update Submit Date:** 2020-07-23
**Overall Status:** NO_LONGER_AVAILABLE
**Status Verified Date:** 2019-05
#### Study First Post Date
**Date:** 2014-06-25
**Type:** ESTIMATED
**Study First Submit Date:** 2014-06-20
**Study First Submit QC Date:** 2014-06-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Jonsson Comprehensive Cancer Center
#### Responsible Party
**Type:** SPONSOR
### Description Module
**Brief Summary:** To evaluate 68Ga-DOTATATE PET/CT for staging of patients with carcinoid, neuroendocrine tumors, medullary thyroid cancer and other cancers expressing somatostatin receptors.
**Detailed Description:** This is an expanded access study with a total of 300 participants with NET and suspected SSTR positive tumors. Eligible participants will undergo baseline assessments at enrollment. Study participants will receive 68Ga-DOTATATE and will undergo a PET/CT imaging study. All patients referred by Oncologists will be screened by a UCLA Nuclear Medicine physician and then accepted for scanning if clinically appropriate.
### Conditions Module
**Conditions:**
- Carcinoid Cancer
- Neuroendocrine Tumors
- Medullary Thyroid Cancer
- Cancers Expressing Somatostatin Receptors
### Design Module
**Study Type:** EXPANDED_ACCESS
### Arms Interventions Module
### Interventions
#### Intervention 1
**Description:** Patients with somatostatin receptor positive tumors will be evaluated with 68Ga-DOTATATE PET/CT.
**Name:** 68Ga DOTATATE
**Other Names:**
- 68Ga DOTATATE PET/CT Scan
**Type:** DRUG
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Older than 18 years the time of radiotracer administration
* Provides written informed consent
* Known diagnosis of NET or suspected SSTR positive tumors Women of childbearing age must have a negative pregnancy test at screening/baseline
* Able to remain still for duration of each imaging procedure (about 30 minutes)
Exclusion Criteria:
* Less than 18 years-old at the time of radiotracer administration
* Pregnant or nursing
* Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
* Any additional medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Los Angeles
**Country:** United States
**Facility:** UCLA Hospital
**State:** California
**Zip:** 90095
#### Overall Officials
**Official 1:**
**Affiliation:** University of California, Los Angeles
**Name:** Johannes Czernin, MD
**Role:** PRINCIPAL_INVESTIGATOR
### References Module
#### References
**Citation:** Modlin IM, Kidd M, Hinoue T, Lye KD, Murren J, Argiris A. Molecular strategies and 111in-labelled somatostatin analogues in defining the management of neuroendocrine tumour disease: a new paradigm for surgical management. Surgeon. 2003 Jun;1(3):137-43. doi: 10.1016/s1479-666x(03)80092-6.
**PMID:** 15570748
**Citation:** Modlin IM, Latich I, Zikusoka M, Kidd M, Eick G, Chan AK. Gastrointestinal carcinoids: the evolution of diagnostic strategies. J Clin Gastroenterol. 2006 Aug;40(7):572-82. doi: 10.1097/00004836-200608000-00003.
**PMID:** 16917396
**Citation:** Graham MM, Menda Y. Radiopeptide imaging and therapy in the United States. J Nucl Med. 2011 Dec;52 Suppl 2:56S-63S. doi: 10.2967/jnumed.110.085746.
**PMID:** 22144556
**Citation:** Virgolini I, Ambrosini V, Bomanji JB, Baum RP, Fanti S, Gabriel M, Papathanasiou ND, Pepe G, Oyen W, De Cristoforo C, Chiti A. Procedure guidelines for PET/CT tumour imaging with 68Ga-DOTA-conjugated peptides: 68Ga-DOTA-TOC, 68Ga-DOTA-NOC, 68Ga-DOTA-TATE. Eur J Nucl Med Mol Imaging. 2010 Oct;37(10):2004-10. doi: 10.1007/s00259-010-1512-3.
**PMID:** 20596866
**Citation:** Buchmann I, Henze M, Engelbrecht S, Eisenhut M, Runz A, Schafer M, Schilling T, Haufe S, Herrmann T, Haberkorn U. Comparison of 68Ga-DOTATOC PET and 111In-DTPAOC (Octreoscan) SPECT in patients with neuroendocrine tumours. Eur J Nucl Med Mol Imaging. 2007 Oct;34(10):1617-26. doi: 10.1007/s00259-007-0450-1. Epub 2007 May 23.
**PMID:** 17520251
**Citation:** Calais J, Czernin J, Eiber M, Fendler WP, Gartmann J, Heaney AP, Hendifar AE, Pisegna JR, Hecht JR, Wolin EM, Slavik R, Gupta P, Quon A, Schiepers C, Allen-Auerbach MS, Herrmann K. Most of the Intended Management Changes After 68Ga-DOTATATE PET/CT Are Implemented. J Nucl Med. 2017 Nov;58(11):1793-1796. doi: 10.2967/jnumed.117.192450. Epub 2017 May 4.
**PMID:** 28473600
#### See Also Links
**Label:** UCLA Ahmanson Translational Imaging Division
**URL:** http://pet.ucla.edu
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009369
- Term: Neoplasms
- 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
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: All
- Name: All Conditions
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M20495
- Name: Neuroendocrine Tumors
- Relevance: HIGH
- As Found: Neuroendocrine Tumors
- ID: M16718
- Name: Thyroid Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M16723
- Name: Thyroid Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M5533
- Name: Carcinoid Tumor
- 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: T4091
- Name: Neuroendocrine Tumor
- Relevance: HIGH
- As Found: Neuroendocrine Tumors
- ID: T5651
- Name: Thyroid Cancer, Medullary
- Relevance: HIGH
- As Found: Medullary Thyroid Cancer
- ID: T948
- Name: Carcinoid Tumor
- Relevance: LOW
- As Found: Unknown
- ID: T4092
- Name: Neuroepithelioma
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000018358
- Term: Neuroendocrine Tumors
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M15806
- Name: Somatostatin
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT04382079
**Brief Title:** Honey Products for Cancer Patients With Oral Mucositis: a Randomized Controlled Trial
**Official Title:** Effects of Honey and Propolis on Head and Neck Cancer Patients With Oral Mucositis: a Randomized Controlled Trial
#### Organization Study ID Info
**ID:** N202001041
#### Organization
**Class:** OTHER
**Full Name:** Taipei Medical University
### Status Module
#### Completion Date
**Date:** 2022-04-15
**Type:** ESTIMATED
#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2020-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2020-05-22
**Overall Status:** UNKNOWN
#### Primary Completion Date
**Date:** 2021-04-15
**Type:** ESTIMATED
#### Start Date
**Date:** 2020-04-08
**Type:** ACTUAL
**Status Verified Date:** 2020-04
#### Study First Post Date
**Date:** 2020-05-11
**Type:** ACTUAL
**Study First Submit Date:** 2020-05-03
**Study First Submit QC Date:** 2020-05-06
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Taipei Medical University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The investigators plan to conduct a 3-year pioneering care research project for mucositis in cancer patients. These include: (1) an analysis of the incidence and severity of mucositis, severity, treatment methods, and treatment costs; (2) an RCT comparing the effectiveness of honey, Taiwan green propolis, and usual care in mucositis of cancer patients; (3) monitoring of related symptom changes using a smart bracelet device; (4) a measurement of IL-1, IL-6, IL-10, and TNF in saliva and (4) modeling of the trend of mucositis for alertness and search of essential parameters of the complications.
**Detailed Description:** Mucositis is common among cancer patients receiving radiotherapy and chemotherapy. A total of 80-100% of the patients are suffering from the mucositis pain; their regular dieting is disturbed, nutritional status deteriorated, and even treatment discontinued. Some self-paid medications like glutamine have been used to prevent mucositis before and during radiotherapy/chemotherapy. However, the cost of glutamine is relatively high (NT15,000 month/person) and its treatment efficacy and side effects are still to be determined. Randomized controlled trials (RCTs) and experiments have shown that honey and propolis may be used for the management of mucositis. Taiwan is a country of rich agriculture with unique bee products among which the longan honey demonstrates the most significant antibacterial effects; the green propolis has also been proved to comprise antibacterial, anti-inflammatory, and antioxidant effects. However, none of these propolis products have been specifically trialed for the management of mucositis of cancer patients.
Bee products have been concerned as potential sources of natural antioxidants such as flavonoids, phenolic acids, and terpenoids. Their potential treatment effects have caught the attention of the medical community. Accumulating evidence is supporting the use of bee products in mucositis caused by chemotherapy, radiotherapy, or both. However, systematic review and meta-analysis have suggested a low quality of the included RCTs, and this affects the applicability of the evidence in the real clinical scenario.
The investigators plan to conduct a 3-year pioneering care research project for mucositis in cancer patients. These include: (1) an analysis of the incidence and severity of mucositis, severity, treatment methods, and treatment costs; (2) an RCT comparing the effectiveness of honey, Taiwan green propolis, and usual care in mucositis of cancer patients; (3) monitoring of related symptom changes using a smart bracelet device; (4) a measurement of IL-1, IL-6, IL-10, and TNF in saliva and (4) modeling of the trend of mucositis for alertness and search of essential parameters of the complications. In the first year, our project will focus on the analysis of the incidence and severity of mucositis, treatment methods, and treatment costs. In the second year, the planned RCT will be carried out and changes in heart rate, stress, and fatigue of the patients are to be collected using the smart bracelet. In the third year, the investigators will conduct a deep machine learning of the clinical and serial test data to predict the changes in symptoms. The modeling is anticipated to provide important parameter combinations that assist the alerting of possible severe complications. The overall findings of this project shall the strategical references for applying bee products in the prevention and treatment of mucositis in cancer patients.
### Conditions Module
**Conditions:**
- Oral Mucositis
**Keywords:**
- head and neck cancer
- mucositis
- honey
- Taiwanese green propolis
- intelligent care
### 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:** 150
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Honey, 10 grams per pack, calories 33.4 calories, protein 0.05 grams, fat 0.07 grams, fructose + glucose 7.0 grams, sodium 0 mg.
Usage is three times a day after three meals. After oral care is required before use, use 10 grams of longan honey, circulate in the oral cavity for at least 30 seconds, and slowly swallow. Do not eat, drink, or gargle within 30 minutes of use.
**Intervention Names:**
- Dietary Supplement: honey
**Label:** honey
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Oil-soluble green propolis, propolis 100 mg / mL, dilute green propolis 200 times with edible oil, drink 0.5 mL each time, 3 times a day (a total of 50 mg).
Usage: three times a day, after three meals. After oral care is required before use, draw about 0.5ml of green propolis into the mouth, circulate in the oral cavity for at least 30 seconds, and slowly swallow. Do not eat, drink or gargle within 30 minutes of use.
**Intervention Names:**
- Dietary Supplement: propolis
**Label:** propolis
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Routine care to encourage oral care three times a day.
**Label:** control
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- honey
**Description:** Since the patient received radiation therapy, Taiwan Longan Honey has been used for a total of eight weeks.
Understand the changes of oral mucositis and various symptoms during this period
**Name:** honey
**Type:** DIETARY_SUPPLEMENT
#### Intervention 2
**Arm Group Labels:**
- propolis
**Description:** Since the patient received radiation therapy, Taiwan green propolis has been used for a total of eight weeks.
Understand the changes of oral mucositis and various symptoms during this period
**Name:** propolis
**Type:** DIETARY_SUPPLEMENT
### Outcomes Module
#### Primary Outcomes
**Description:** measurement tool: National Cancer Institute Common Terminology Criteria for Adverse Events and The World Health Organization grading system
**Measure:** oral mucositis
**Time Frame:** twelve weeks
#### Secondary Outcomes
**Description:** measurement tool:Numerical Rating Scale,for pain status, range from 0 to 10, 10 was the most pain, 0 was no pain.
**Measure:** Numerical Rating Scale
**Time Frame:** twelve weeks
**Description:** measurement tool: Xerostomia Questionnaire
**Measure:** Xerostomia
**Time Frame:** twelve weeks
**Description:** measurement tool : Functional Assessment of Cancer Therapy Scale- Head and Neck, for patient's Quality of life (QoL), range from 0 to 100, score 100 means better outcome.
**Measure:** Functional Assessment of Cancer Therapy Scale- Head and Neck
**Time Frame:** twelve weeks
**Description:** measurement tool: Brief-Fatigue Inventory, range 0 to 10, 10 was the worst fatigue.
**Measure:** fatigue--Brief-Fatigue Inventory
**Time Frame:** Brief-Fatigue Inventory for two weeks.
**Description:** measurement tool: Visual Analogue Scale for fatigue, range 0 to 10, 10 was the worst fatigue.
**Measure:** fatigue--Visual Analogue Scale
**Time Frame:** Visual Analogue Scale for fatigue for twelve weeks.
**Description:** The patient collected this saliva before the start of radiotherapy, on the 7th, 14th, 21st day and at the end of radiation therapy, a total of 5 tubes of saliva at a time
**Measure:** IL-1, IL-6, IL-10,TNF
**Time Frame:** radiotherapy on Day 0, on the 7th, 14th, 21st day and on an average of 28 st day.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* age≧20 years old
* diagnosed as head and neck cancer patients
* Plan to Receive radiation therapy
* Consciousness, ability to complete research assessment and willing to participate in research
* Patients can be communicated in Mandarin and Taiwanese, and complete the questionnaire on their own or with the help of researchers.
Exclusion Criteria:
* History of allergic to honey, propolis, various pollen, alcohol
* People with mental disorders or cognitive dysfunction
* Diabetes mellitus
* Critical of end of life patient
**Maximum Age:** 100 Years
**Minimum Age:** 20 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Tsai-Wei Huang, PhD
**Phone:** +88627361661
**Phone Ext:** 6350
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Taipei county
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Tsai-Wei Huang, PhD
- **Phone:** +88627361661
- **Phone Ext:** 6350
- **Role:** CONTACT
***Contact 2:***
- **Name:** Shao-Ching Jen, BS
- **Role:** SUB_INVESTIGATOR
**Country:** Taiwan
**Facility:** Taipei Medical University
**Status:** RECRUITING
**Zip:** 110
#### Overall Officials
**Official 1:**
**Affiliation:** Taipei Medical University
**Name:** Tsai-Wei Huang, PhD
**Role:** STUDY_CHAIR
### IPD Sharing Statement Module
**Access Criteria:** Professor Huang will review the application to share IPD.
**Description:** oral mucositis severity, fatigue, pain, quality of life
**Info Types:**
- STUDY_PROTOCOL
- CSR
**IPD Sharing:** YES
**Time Frame:** Before radiotherapy, until 12 weeks later
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000005759
- Term: Gastroenteritis
- ID: D000005767
- Term: Gastrointestinal Diseases
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000009059
- Term: Mouth Diseases
- ID: D000009057
- Term: Stomatognathic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: All
- Name: All Conditions
- Abbrev: BC07
- Name: Mouth and Tooth Diseases
- Abbrev: BC06
- Name: Digestive System Diseases
### Condition Browse Module - Browse Leaves
- ID: M9348
- Name: Head and Neck Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M16070
- Name: Stomatitis
- Relevance: HIGH
- As Found: Oral Mucositis
- ID: M26955
- Name: Mucositis
- Relevance: HIGH
- As Found: Mucositis
- ID: M8875
- Name: Gastroenteritis
- 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: M12019
- Name: Mouth Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12017
- Name: Stomatognathic Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000052016
- Term: Mucositis
- ID: D000013280
- Term: Stomatitis
### 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
- Abbrev: Ot
- Name: Other Dietary Supplements
### Intervention Browse Module - Browse Leaves
- ID: M14295
- Name: Propolis
- Relevance: HIGH
- As Found: Depleted
- ID: M4214
- Name: Anti-Infective Agents
- Relevance: LOW
- As Found: Unknown
- ID: T364
- Name: Bee Products
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000011429
- Term: Propolis
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT02320279
**Brief Title:** The Fetal EKG Study
**Official Title:** The Fetal EKG Study
#### Organization Study ID Info
**ID:** South Shore Fetal EKG study
#### Organization
**Class:** INDUSTRY
**Full Name:** Mindchild Medical Inc.
### Status Module
#### Completion Date
**Date:** 2023-12
**Type:** ESTIMATED
#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2021-11-16
**Type:** ACTUAL
**Last Update Submit Date:** 2021-11-12
**Overall Status:** UNKNOWN
#### Primary Completion Date
**Date:** 2023-12
**Type:** ESTIMATED
#### Start Date
**Date:** 2013-10
**Status Verified Date:** 2021-11
#### Study First Post Date
**Date:** 2014-12-19
**Type:** ESTIMATED
**Study First Submit Date:** 2014-12-16
**Study First Submit QC Date:** 2014-12-18
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Mindchild Medical Inc.
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The objective is to contribute data to ongoing research activities focused on identification of EKG waveform changes in the context of clinical conditions and maternal medication use. Additionally, to develop the capacity to measure contractions more accurately and more reliably using skin-surface electrodes.
**Detailed Description:** Specific Aim 1: To develop a technique for the quantitative analysis of fetal heart-rate (FHR) data recorded during labor using advanced mathematical techniques, including pattern-recognition analysis.
* Specific Aim 2: To develop the capacity to measure fetal cardiac data using EKG sensors applied to the maternal abdomen during labor.
* Specific Aim 3: To validate prenatal non-invasive measurement of the fetal QTc interval.
* Specific Aim 4: To develop and validate the capacity to measure uterine contractions using the uterine EMG signal recorded from maternal skin-surface electrodes.
* Specific Aim 5: Collect clinical data related to medication usage and hypoxia.
### Conditions Module
**Conditions:**
- Labor
**Keywords:**
- Fetal Heart Rate
- Fetal EKG
- FHR tracing
- fetal R-waves
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 900
**Type:** ESTIMATED
**Patient Registry:** True
**Study Type:** OBSERVATIONAL
**Target Duration:** 1 Day
### Arms Interventions Module
#### Arm Group 1
**Description:** Pregnant women, women in labor, and women who are admitted to labor and delivery for scheduled c-sections will form the eligible population for recruitment into our study.
**Intervention Names:**
- Device: Fetal Heart Rate Monitor
**Label:** Women in labor
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Women in labor
**Description:** Use of a system that monitors fetal heart rate through use of fetal EKG read using abdominal electrodes
**Name:** Fetal Heart Rate Monitor
**Other Names:**
- Mindchild Meridian Fetal Heart Rate System
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Quantitative analysis of fetal heart-rate data recorded during labor using advanced mathetmatical techniques, including pattern-recognition analysis using EKG electrodes applied to the maternal abdomen.
**Measure:** Quantitative FHR
**Time Frame:** During Labor
#### Secondary Outcomes
**Description:** Uterine contractions will be identified by analyzing data from surface electrodes to identify patterns consistent with uterine muscle coordinated shortening. These data will be compared to data from either the external tocometer or the internal IUPC. Cross correlation analysis will be used to compare the two signals and validate the analysis of uterine EMG signal.
**Measure:** Uterine contractions
**Time Frame:** During labor
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Women who are pregnant or in labor who are having their fetus' heart rate monitored continuously and able to consent
* 18 years old or older.
* Gestational age of 24-42 weeks.
* Any method of fetal heart rate monitoring.
* Pregnant women in labor as well as women who are not in labor.
* Pregnant women who are admitted to labor and delivery for scheduled c-sections.
Exclusion Criteria:
* Women unable to consent
* Women under sedation or systemic anesthesia, and women who have diminished cognitive capacity
* Women in extremis (in severe pain, etc.)
* Women who are using the Mindchild device for clinical monitoring.
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Pregnant women, women in labor, and women who are admitted to labor and delivery for scheduled c-sections will form the eligible population for recruitment into our study. These women will be identified by a study staff-member who will ask on-call physicians, midwives, and nurses working on Labor and Delivery
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Adam Wolfberg, MD
**Phone:** 781-624-8000
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** South Weymouth
**Contacts:**
***Contact 1:***
- **Name:** Adam Wolfberg, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** South Shore Hospital
**State:** Massachusetts
**Status:** RECRUITING
**Zip:** 02190
#### Overall Officials
**Official 1:**
**Affiliation:** South Shore Hospital
**Name:** Adam Wolfberg, MD
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06330779
**Acronym:** TAY-CAP
**Brief Title:** Trauma-adapted Yoga in Child & Adolescent Psychiatry.
**Official Title:** Trauma-adapted Yoga in Child & Adolescent Psychiatry: A Multicenter Study.
#### Organization Study ID Info
**ID:** UWest
#### Organization
**Class:** OTHER
**Full Name:** University West, Sweden
### Status Module
#### Completion Date
**Date:** 2028-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-03-26
**Type:** ACTUAL
**Last Update Submit Date:** 2024-03-19
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2027-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2025-01-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-03
#### Study First Post Date
**Date:** 2024-03-26
**Type:** ACTUAL
**Study First Submit Date:** 2024-03-07
**Study First Submit QC Date:** 2024-03-19
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** Västra Götalands Region
**Class:** OTHER_GOV
**Name:** Region Stockholm
**Class:** UNKNOWN
**Name:** Region Skåne
**Class:** UNKNOWN
**Name:** Region Värmland
**Class:** UNKNOWN
**Name:** Region Östra Gotland
**Class:** UNKNOWN
**Name:** Region Örebro
#### Lead Sponsor
**Class:** OTHER
**Name:** University West, Sweden
#### 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 randomized clinical trial is to evaluate the efficacy of trauma-adapted yoga as a complementary intervention to care as usual in child and adolescents psychiatry clinics, in the population of adolescents with the diagnosis of ADHD and/or PTSD. We hypothesize that trauma-adapted yoga (TAY) is an effective non-pharmacological intervention for adolescent with ADHD and/or PTSD. Aims: (1) Validate the impact of TAY on the mental health \& quality of life of adolescents with ADHD and/or PTSD. (2) Investigate the feasibility of online TAY for continued self-care. (3) Explore adolescents' experiences \& parental perspectives on TAY in their treatment. (4) Explore healthcare professionals' experience on the integration of TAY into clinical practice.
Within and between group (yoga group vs waiting list) analyses will be performed.
**Detailed Description:** Study Summary
Introduction:
There is growing interest in applying yoga and mindfulness techniques to children and adolescents, although research in this area remains limited. Existing studies suggest that yoga can reduce stress, improve mood, enhance resilience, and boost self-regulation skills in school settings. Additionally, these approaches hold promise for improving mental health in clinical child and adolescent populations.
Study Aim:
The aim of this study is to evaluate the impact of trauma-adapted yoga (TAY) as a complement to care as usual in Child and Adolescent Psychiatry (CAP) clinics in the USA and Sweden. The study hypothesizes that eight weeks of TAY practice will reduce negative affect states and pain intensity/frequency, while improving emotional and behavioral control, attention, and resilience. It is expected that TAY will enhance the success of other ongoing treatments in CAP, foster improved well-being, and provide patients with self-care tools.
Importance of the Study:
The study's results are crucial for developing evidence-based care for children and adolescents with mental disorders and filling gaps in knowledge about yoga's efficacy as a treatment method.
Participants:
Adolescents aged 12-18 in contact with CAP clinics who have received a diagnosis of PTSD and/or ADHD are eligible. Inclusion criteria include understanding English or Swedish, while exclusion criteria involve ongoing substance use, active manic periods, psychotic disorders, suicidality, cognitive impairment, and serious physical illnesses.
Study Design:
The study adopts a Randomized Control Trial (RCT) design. Participants undergo pre-intervention assessment, followed by random assignment to either the yoga group or a control group. The yoga group attends weekly TAY sessions for eight weeks, while the control group waits. Assessments are conducted post-intervention and at a follow-up point. The study aims to include 174-180 adolescents.
Intervention:
TAY classes span eight weeks, incorporating physical movements, balance exercises, adapted breathing practices, trauma-informed mindfulness guidance, and guided progressive muscle relaxation. Participants have the option to continue yoga practice online after the intervention.
Assessment:
Assessment includes self-reported measures using validated instruments, such as the Child PTSD Symptom Scale, Positive/Negative Affect, Pain assessment, Child and Youth Resilience Measure, and Self-Directedness. Guardian-reported measures include the SNAP-IV and PedsQL-Fam inventory. Patient records provide additional data.
Qualitative Component:
After the intervention, individual interviews gather qualitative information on participants', guardians', and staff's experiences of yoga and its health effects.
This study aims to provide valuable insights into the potential benefits of trauma-adapted yoga for adolescents in CAP clinics, contributing to the advancement of evidence-based care in this population.
### Conditions Module
**Conditions:**
- ADHD
- PTSD
- Quality of Life
- Self-Control
- Pain
- Affect
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
##### Masking Info
**Masking:** NONE
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 180
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** 8 weeks ,once a week, instructor led trauma-adapted yoga intervention.
**Intervention Names:**
- Other: Trauma-adapted yoga
**Label:** Yoga-group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Waiting list
**Label:** Controll
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Yoga-group
**Description:** Trauma-adapted-yoga (TAY) classes The classes, which span eight weeks with a once-a-week frequency, each last approximately 45-50 minutes. These small group classes are structured in a semi-circle arrangement to create a sense of security and empowerment for the participants. The teaching approach is trauma-sensitive, characterized by its inviting nature, provision of choices when facing challenges (A-B choices), and direction toward tangible physical sensations to enhance interoceptive awareness. Each yoga session follows a structured sequence of activities designed to promote participants' well-being and physiological awareness.
Online TAY classes After eight weeks, adolescents in the yoga group can continue their practice online. Exclusive to previous in-person participants, they'll receive a link for recorded classes and they will have the possibility to contact their health care contact any time.
**Name:** Trauma-adapted yoga
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Child PTSD Symptom Scale: 27-item self-report version rates each item from 0 (not at all) to 4 (6 or more times a week/almost always) based on the frequency and severity of the reported symptom experienced during the last month. The total severity score ranges from 0 to 80 and is calculated by summing the ratings of the first 20 items.
The CPSS-5 also yields subscale scores for intrusion (Items 1-5), avoidance (Items 6-7), changes in cognition and mood (Items 8-14), and increased arousal and reactivity (Items15-20). Finally, seven items assess impairment of endorsed symptoms on daily functioning pertinent to youth (e.g., fun things you want to do, doing your chores, relationships with your friends). The respondent rates these items on a scale of 0 (not at all) to 4 (6 or more times a week/almost always), resulting in an impairment score that ranges from 0 to 28.
**Measure:** Negative experience score CPSS-5-S
**Time Frame:** 8 weeks
**Description:** Parent-rated ADHD score, SNAP-IV: The SNAP-IV consists of a total of 26 questions, divided into two subscales: one for inattention symptoms and one for hyperactivity-impulsivity symptoms. Each subscale contains 9 items, and there are 8 additional questions that provide an overall assessment of impairment. Higher score indicates higher problem load.
**Measure:** Inattention, impulsivity score
**Time Frame:** 8 weeks
**Description:** social, ecological, psychological, and emotional resilience: The Child and Youth Resilience Measure-Revised-Adapted Swedish (CYRM-R-AS) is a self-report measures of social ecological and psychological, emotional resilience. In addition to an overall score of resilience, scores can be derived for the three subscales of the measures personal, caregiver and psychological/emotional resilience. The CYRM-R (simplified) is suitable for youth aged 10-23 with difficulties to comprehend text or sustain attention. Its 23 items can be scored on 3- point Likert scales. The items in the measure are all positively worded and therefore scoring involves simple summing of responses. It can be used to evaluate the efficacy of interventions to build and maintain resilience. Three sub-scales can be created . Higher scores indicate better outcome.
**Measure:** Resilience score
**Time Frame:** 8 weeks
#### Secondary Outcomes
**Description:** Pain frequency, intensity and location: The Pain assessment instrument uses verbal and numerical assessment scales, where the participant describes their pain during the last month using words (no pain; mild pain; moderate pain; severe pain; very severe pain; unbearable pain) and using numbers between 0 and 10, where 0 (zero) represents no pain, and 10 represents the worst possible pain. Primary and secondary pain localization is described in free text by the participant. Higher scores indicate increased problem load
**Measure:** Pain frequency and intensity
**Time Frame:** 8 weeks
**Description:** Positive and Negative affect state: The Positive Affect and Negative Affect-Extended (PANAS-X) instrument consists of 30 items and captures the valence (positive and negative) and the arousal (high or low) of the mood descriptors during the last month.
The following are examples for all four categories. Positive activated: active, enthusiastic, excited, inspired, and proud; Positive deactivated: at ease, serene, calm, relaxed, and content; Negative activated: afraid, scared, hostile, guilty, and ashamed; Negative deactivated: tired, sluggish, drowsy, dull, and bored.
HIgher scores indicate dominance of the specific subscale in affect state.
**Measure:** affect
**Time Frame:** 8 weeks
**Description:** Self-control, responsibility: Self-Directedness character domain of the J-TCI (Junior Temperament and Character Inventory, Cloninger et al., Swedish version: Kerekes et al.) has been used to measure changes in this domain during the last month. Has been used for 9-15-year-old adolescents in Sweden. Self-directedness, or self-determination, refers to a tendency to achieve personal goals and values. Includes 20 questions and dichotomic responses (Yes/No). Higher scores indicate better outcome.
**Measure:** Self-directednes
**Time Frame:** 8 weeks
**Description:** PedsQL and PedsQL FIM: The 23-item PedsQL™ 4.0 Generic Core Scales encompass:
* 1) Physical Functioning (8 items),
* 2) Emotional Functioning (5 items),
* 3) Social Functioning (5 items), and
* 4) School Functioning (5 items), and were developed through focus groups, cognitive interviews, pre-testing, and field-testing measurement development protocols.
The Parent-reported Health-Related Quality of Life of the Child (PedsQL-Fam) inventory is an assessment tool designed to measure the health-related quality of life (HRQOL) of children from the perspective of their parents or caregivers. It includes questions about different aspects of the child's functioning and well-being, 25 items. Higher scores indicate better outcome
**Measure:** Quality of life score
**Time Frame:** 8 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Adolescents who have received a diagnosis (not under evaluation) of PTSD and/or ADHD
* Understanding English or Swedish languages.
Exclusion Criteria:
* Ongoing substance use,
* active manic periods,
* psychotic disorders,
* suicidality,
* cognitive impairment.
* serious physical illness prohibiting participation in physical activities.
**Maximum Age:** 18 Years
**Minimum Age:** 12 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Nóra Kerekes, Ph.D
**Phone:** +46739013403
**Role:** CONTACT
### IPD Sharing Statement Module
**Info Types:**
- STUDY_PROTOCOL
- SAP
- ICF
**IPD Sharing:** YES
**Time Frame:** After completion of data collection and analyses, and after we coudl publish the results in peer reviewed scientific journals
### References Module
#### See Also Links
**Label:** The project's home page that includes this study as well.
**URL:** https://www.yogatocare.com/
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
### Condition Browse Module - Browse Leaves
- ID: M17685
- Name: Wounds and Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: T6034
- Name: Quality of Life
- Relevance: HIGH
- As Found: Quality of Life
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT02957279
**Brief Title:** Dendritic Cells-Derived Exosomes in Human Sepsis
**Official Title:** A Cohort Study to Investigate the Impacts of Peripheral Blood Dendritic Cells-Derived Exosomes at Early Phase on the Prognosis in Human Sepsis
#### Organization Study ID Info
**ID:** 20161103
#### Organization
**Class:** OTHER
**Full Name:** Jinling Hospital, China
### Status Module
#### Completion Date
**Date:** 2017-10
**Type:** ESTIMATED
#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2016-11-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2016-11-04
**Overall Status:** UNKNOWN
#### Primary Completion Date
**Date:** 2017-09
**Type:** ESTIMATED
#### Start Date
**Date:** 2016-11
**Status Verified Date:** 2016-11
#### Study First Post Date
**Date:** 2016-11-06
**Type:** ESTIMATED
**Study First Submit Date:** 2016-11-04
**Study First Submit QC Date:** 2016-11-04
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Jinling Hospital, China
#### Responsible Party
**Investigator Affiliation:** Jinling Hospital, China
**Investigator Full Name:** Jianan Ren
**Investigator Title:** President of department of surgery, Jinling Hospital
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The amount of peripheral blood exosomes has been confirmed to change in the endotoxin-induced infection. The primary objectives of this study are to compare the changes of peripheral blood dendritic cell-derived exosomes in the patients with sepsis and the healthy controls.
**Detailed Description:** This is a prospective, single-centered, clinical cohort study.
### Conditions Module
**Conditions:**
- Sepsis
**Keywords:**
- sepsis
- exosomes
- dendritic cell
### Design Module
#### Bio Spec
**Description:** peripheral venous blood
**Retention:** SAMPLES_WITH_DNA
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 50
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The patients were admitted to the Jinling Hospital, who met the diagnosis of sepsis(Sepsis 3.0).
**Intervention Names:**
- Drug: Antibiotics
**Label:** Sepsis group
#### Arm Group 2
**Description:** Healthy volunteers.
**Label:** Healthy control group
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Sepsis group
**Description:** In the sepsis group, antibiotics were used when needed.
**Name:** Antibiotics
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Measure:** Amount of dendritic cell-derived exosomes
**Time Frame:** The first 4 hour after admission
#### Secondary Outcomes
**Measure:** Compositions of microRNA in the dendritic cell-derived exosomes
**Time Frame:** The first 4 hour after admission
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients were selected with the diagnostic standard "Sepsis 3.0".
* Healthy volunteers do not have serious illness.
Exclusion Criteria:
* Patients or volunteers do not agree to provide written informed consent and / or can not be legally authorized to provide informed consent.
* Patients give up treatments.
* Patients or volunteers withdrew from the study.
**Healthy Volunteers:** True
**Maximum Age:** 65 Years
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Patients were admitted to Jinling Hospital from November, 2016.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Jianan Ren, MD
**Phone:** 862580860108
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Yuan Li, MD
**Phone:** 8615751866716
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Nanjing
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Jianan Ren, MD
- **Phone:** 862580860108
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Yuan Li, MD
- **Phone:** 8615751866716
- **Role:** CONTACT
**Country:** China
**Facility:** Jinling Hospital, Medical School of Nanjing University
**State:** Jiangsu
**Status:** RECRUITING
**Zip:** 210002
#### Overall Officials
**Official 1:**
**Affiliation:** Jinling Hospital, Medical School of Nanjing University
**Name:** Jianan Ren, MD
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007239
- Term: Infections
- ID: D000018746
- Term: Systemic Inflammatory Response Syndrome
- ID: D000007249
- Term: Inflammation
- ID: D000010335
- Term: Pathologic Processes
### 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: M20864
- Name: Sepsis
- Relevance: HIGH
- As Found: Sepsis
- ID: M16869
- Name: Toxemia
- Relevance: HIGH
- As Found: Sepsis
- ID: M10283
- Name: Infections
- Relevance: LOW
- As Found: Unknown
- ID: M6368
- Name: Communicable Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M20818
- Name: Systemic Inflammatory Response Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M10293
- Name: Inflammation
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000018805
- Term: Sepsis
- ID: D000014115
- Term: Toxemia
### 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: M4222
- Name: Anti-Bacterial Agents
- Relevance: HIGH
- As Found: Initial
- 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:** NCT00795379
**Brief Title:** Testing the Use of Interoceptive Exposure to Reduce Barriers to Psychotherapy
**Official Title:** Testing the Use of Interoceptive Exposure to Reduce Barriers to Psychotherapy
#### Organization Study ID Info
**ID:** MIRECC 5-1006
#### Organization
**Class:** FED
**Full Name:** G.V. (Sonny) Montgomery VA Medical Center
### Status Module
#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2008-11-21
**Type:** ESTIMATED
**Last Update Submit Date:** 2008-11-20
**Overall Status:** UNKNOWN
#### Primary Completion Date
**Date:** 2009-11
**Type:** ESTIMATED
#### Start Date
**Date:** 2008-11
**Status Verified Date:** 2008-11
#### Study First Post Date
**Date:** 2008-11-21
**Type:** ESTIMATED
**Study First Submit Date:** 2008-11-19
**Study First Submit QC Date:** 2008-11-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** FED
**Name:** G.V. (Sonny) Montgomery VA Medical Center
#### Responsible Party
**Old Name Title:** Kevin S. Del Ben, Ph.D. Assistant Professor
**Old Organization:** G.V. (Sonny) Montgomery VA Medical Center
### Oversight Module
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** To assess the effectiveness of Interoceptive Exposure (IE) as a treatment to reduce negative cognitions and arousal in a veteran sample during an anxiety-inducing situation (i.e., the Trier Social Stressor Task - an analogue to the anxiety of undergoing exposure-based treatment). After completing the initial screening, qualifying participants will complete a pre-intervention assessment at UMC (structured clinical interview, self-report measures, and a treatment-engagement analogue exercise). Half of the participants will be randomized into either supportive counseling or to the treatment protocol at GVSMVAMC consisting of four sessions of Interoceptive Exposure over a four week period targeting interoceptive stimuli. Veterans will be assessed a second time at UMC after treatment (5 to 6 weeks after the first assessment). Participants will include approximately 40 male OEF/OIF veterans with combat-related PTSD recruited from the Trauma Recovery Program (TRP) and Post-deployment Clinic at the G.V. (Sonny) Montgomery VAMC (GVSMVAMC). Following the pre-intervention assessment, veterans will be randomized into one of two groups. Half of the veterans (n = 20) will receive received four weeks of supportive counseling while the other half will receive four weeks of Interoceptive Exposure (IE). The proposed study examines anxiety sensitivity (AS) as a possible barrier to treatment engagement in exposure therapy for PTSD. AS is a dispositional cognitive characteristic defined as the fear of sensations directly related to autonomic arousal that arises from the belief that these sensations have harmful consequences. Interoceptive Exposure (IE) is an intervention that: 1) helps individuals with high AS increase their tolerance to the somatic sensations of arousal; and 2) promotes an adaptive appraisal of fear-related sensations The current study will use a social stressor task to assess the affect of IE on AS and avoidance among veterans who have PTSD, thereby increasing the likelihood that a veteran will enter into, and remain in, treatment for PTSD.
### Conditions Module
**Conditions:**
- Anxiety
**Keywords:**
- Psychotherapy
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 40
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants will complete an at home four-week, intervention targeting their negative cognitions triggered by physical sensations. The goal of IE is to purposefully induce bodily sensations related to autonomic arousal so that participants can learn that those sensations are not harmful. IE and Cognitive restructuring have been found to be superior to progressive muscle relaxation as a way to avoid aversive autonomic sensations.
**Intervention Names:**
- Behavioral: Interoceptive Exposure
**Label:** IE
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** waitlist control
**Label:** 2
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- IE
**Description:** Exposure to internal stimuli.
**Name:** Interoceptive Exposure
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Measure:** Anxiety Sensitivity Index-3
**Time Frame:** 2 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Interested OEF/OIF veterans with a reported history of combat-related trauma, probable PTSD diagnosis (score above 44 on the PTSD Checklist), scores above 28 on the Anxiety Sensitivity Index (ASI), and who have been medically cleared will be invited to participate (study personnel will assist the participant in getting clearance from their primary care physician or TRP staff).
Exclusion Criteria:
* Veterans will be excluded if they are judged to have medical conditions that might limit cooperation or compromise the integrity of the self-report or psychophysiological data (e.g., uncontrolled blood pressure, severe asthma, dementia, psychotic disorder, acute mania, current substance abuse, or taking medications that would reduce physiological responding). Veterans who are currently receiving (or who are scheduled to begin) individual exposure-based treatment for PTSD will be excluded from the study. As this project is designed as a pilot study, no exclusions will be made based on previous treatment or previous treatment refusal; however, treatment history data will be collected.
**Healthy Volunteers:** True
**Maximum Age:** 65 Years
**Minimum Age:** 18 Years
**Sex:** MALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Kevin S Del Ben, Ph.D.
**Phone:** 601-984-5807
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Jackson
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Kevin S Del Ben, Ph.D.
- **Phone:** 601-984-5807
- **Role:** CONTACT
**Country:** United States
**Facility:** G.V. (Sonny) Montgomery VAMC
**State:** Mississippi
**Status:** RECRUITING
**Zip:** 39216
## 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: M4324
- Name: Anxiety Disorders
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT04532879
**Brief Title:** HygiRelief Procedure and HygiSample Evaluation for Functional Constipation
**Official Title:** HygiRelief Procedure and HygiSample Evaluation for Patients Diagnosed With Rome IV Functional Constipation Previously Managed With Linzess
#### Organization Study ID Info
**ID:** HGP-0009
#### Organization
**Class:** INDUSTRY
**Full Name:** HyGIeaCare, Inc.
### Status Module
#### Completion Date
**Date:** 2022-06
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-09-17
**Type:** ACTUAL
**Last Update Submit Date:** 2021-09-10
**Overall Status:** WITHDRAWN
#### Primary Completion Date
**Date:** 2022-03
**Type:** ESTIMATED
#### Start Date
**Date:** 2021-09
**Type:** ESTIMATED
**Status Verified Date:** 2021-09
#### Study First Post Date
**Date:** 2020-08-31
**Type:** ACTUAL
**Study First Submit Date:** 2020-08-20
**Study First Submit QC Date:** 2020-08-26
**Why Stopped:** decided not to do the study due to Covid staffing restrictions
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** HyGIeaCare, Inc.
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** True
**Is FDA Regulated Drug:** False
**Is US Export:** True
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This study has a single center, prospective, open label design. The population will include patients diagnosed with Rome IV Functional Constipation who are at the time of study enrollment being managed with a stable dose of Linzess. They will stop taking their Linzess, undergo monitoring of bowel habits for 2 weeks, have a HygiRelief procedure and then undergo an additional 2 weeks of bowel habit monitoring.
**Detailed Description:** After undergoing a 5-7 day Linzess washout period, patients will record their bowel habits in a daily diary for 2 weeks. Patients will have the HygiRelief procedure with a HygiSample evaluation, then they will record their bowel habits in a daily diary for 2 weeks following the HygiRelief procedure.
HygiSamples (stool samples) will be collected throughout the HygiRelief procedure and the samples will be sent for microbiome evaluation.
Patients will complete multiple questionnaires - Happiness Scale, Hospital Anxiety and Depression Scale (HADS), and a personal assessment which includes the Constipation Symptom Score and Adverse Event Screening. These will be completed at Baseline, after the 2 week PRE-HygiRelief period, and after the 2 week POST-HygiRelief period.
### Conditions Module
**Conditions:**
- Rome IV Functional Constipation
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** Prospective, single center, open label. Patients will serve as their own control by comparing their bowel habits using a specific diary 2 weeks after the Linzess washout period to the 2 weeks after their HygiRelief procedure.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Bowel habits before and after the HygiRelief procedure will be assessed.
Samples will be sent for microbiome evaluation.
**Intervention Names:**
- Device: HygiPrep (HyGIeaCare System)
**Label:** All patients enrolled
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- All patients enrolled
**Description:** Controlled gravity-based high-volume colon irrigation
**Name:** HygiPrep (HyGIeaCare System)
**Other Names:**
- HygiSample (stool collection for microbiome evaluation)
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Evaluate the clinical effectiveness of the HygiRelief procedure to relieve functional constipation in patients previously managed with a stable dose of Lizess
**Measure:** Assess change in bowel movements PRE and POST HygiRelief procedure
**Time Frame:** 12 months
#### Secondary Outcomes
**Description:** Samples will be evaluated for their microbiological and biochemical content, as well as to identify microbiome changes throughout the colon
**Measure:** Assess colon effluent samples (HygiSample) collected during the HygiRelief procedure
**Time Frame:** 12 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Patient's age is between 18 and 80 years old
2. Patient diagnosed with Rome IV Functional Constipation (Attachment C2)
3. Patient is currently managed with Linzess and willing to stop taking it for study duration
Exclusion Criteria:
1. Patient has functional bowel disorders characterized by alternating bowel habits (diarrhea/constipation)
2. Patient has any other condition that, in the opinion of the investigator, may adversely affect the compliance or safety of the patient or would limit the patient's ability to complete the study
3. Patient has any of the contraindications listed below:
1. Cardiac: Congestive heart failure (NYHA class III or IV or EF \<50%)
2. GI: Intestinal perforation, carcinoma of the rectum, fissures or fistula, severe hemorrhoids, abdominal hernia, recent colon, rectal, or abdominal surgery
3. GU: Renal insufficiency (CC \< 60 ml/min/173m2), cirrhosis with ascites
4. Abdominal surgery within the last 6 months
5. Pregnancy
4. Patient took antibiotics within two months of starting the study
**Maximum Age:** 80 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012817
- Term: Signs and Symptoms, Digestive
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M6472
- Name: Constipation
- Relevance: HIGH
- As Found: Constipation
- ID: M15622
- Name: Signs and Symptoms, Digestive
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003248
- Term: Constipation
### Intervention Browse Module - Browse Branches
- Abbrev: Gast
- Name: Gastrointestinal Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: HB
- Name: Herbal and Botanical
### Intervention Browse Module - Browse Leaves
- ID: M252449
- Name: Linaclotide
- Relevance: LOW
- As Found: Unknown
- ID: T120
- Name: Cola
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT04216979
**Brief Title:** Palmer's Point Versus The Umbilicus As Routine Primary Entry Site In Gynecologic Laparoscopy
**Official Title:** Palmer's Point Versus The Umbilicus As Routine Primary Entry Site In Gynecologic Laparoscopy
#### Organization Study ID Info
**ID:** 5806-15-12-2019
#### Organization
**Class:** OTHER_GOV
**Full Name:** Zagazig University
### Status Module
#### Completion Date
**Date:** 2020-07-30
**Type:** ESTIMATED
#### Expanded Access Info
**Last Known Status:** ACTIVE_NOT_RECRUITING
#### Last Update Post Date
**Date:** 2020-07-17
**Type:** ACTUAL
**Last Update Submit Date:** 2020-07-16
**Overall Status:** UNKNOWN
#### Primary Completion Date
**Date:** 2020-07-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2019-12-15
**Type:** ACTUAL
**Status Verified Date:** 2020-01
#### Study First Post Date
**Date:** 2020-01-03
**Type:** ACTUAL
**Study First Submit Date:** 2019-12-19
**Study First Submit QC Date:** 2020-01-01
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER_GOV
**Name:** Zagazig University
#### Responsible Party
**Investigator Affiliation:** Zagazig University
**Investigator Full Name:** basem mohamed hamed khalil
**Investigator Title:** lecturer of obstetrics and gynecology/ MD ob/gyn
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** we will compare the classic method of using the umbilicus as the primary entry site in gynecological laparoscopy with Palmar's point
**Detailed Description:** All these cases will undergo:
1. History taking Patients are randomly arranged in 2 groups Group (A):- Palmer's point is the primary entry site. The stomach will be emptied of secretions and air following endotracheal intubation. (This is most easily performed using a nasogastric tube.) The left upper quadrant will be inspected for scars and the upper abdomen palpated for hepatomegaly or splenomegaly. A 10-mm incision will be made over Palmer's point. Veress needle first will be used for insufflation and tests of safety will be considered.
A 10-mm port will be held vertically and the layers observed via a 10-mm laparoscope. A gentle rotating action in a vertical direction was used to allow the bladeless tip to separate the tissues.
The layers of the abdominal wall seen at Palmer's point are as follows:
* skin,
* subcutaneous fat,
* external oblique aponeurosis,
* internal oblique aponeurosis,
* transversalis muscle fibres,
* (sometimes) extraperitoneal fat,
* peritoneum. Once the peritoneum will be breached, the introducer will be carefully removed from the port. The laparoscope will be then reintroduced.
An extra 360° check was then performed to exclude a through-and-through bowel injury. The umbilicus was then inspected and any adhesions cleared using one or more 5-mm ports inserted under direct vision. At the end of the operation, the skin was closed using a single subcuticular suture Group (B):- The umbilicus is the primary entry site. First of all, the umbilicus is well cleaned with a piece of gauze with betadine or alcohol then small incision is done (10mm) in the umbilicus, veress needle is then inserted and tests of safety of intraperotineal insufflation are considered. 10 mm port is then introduced with gentle rotating action in a vertical direction to allow the bladeless tip to separate the tissues.
The layers of the abdominal wall seen at Palmer's point are as follows:
* skin
* linea alba
* peritoneum. Once the peritoneum is breached, the trocar will be carefully removed from the port. The laparoscope will then reintroduced.
An extra 360° check was then performed to exclude a through-and-through bowel injury. At the end of the operation, the skin will be closed using a single subcuticular suture
### Conditions Module
**Conditions:**
- Gynecologic Disease
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- INVESTIGATOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 96
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients are randomly arranged in 2 groups Group (A):- Palmer's point is the primary entry site. Group (B):- The umbilicus is the primary entry site.
**Intervention Names:**
- Procedure: laparoscopy entry policy
**Label:** randomization
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** these are the patient with palmars point as primary entry site
**Intervention Names:**
- Procedure: laparoscopy entry policy
**Label:** group A
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** these are the patient with umbilicus as primary entry site
**Intervention Names:**
- Procedure: laparoscopy entry policy
**Label:** group B
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- group A
- group B
- randomization
**Description:** Patients will be randomly arranged in 2 groups Group (A):- Palmer's point is the primary entry site.
Group (B):- The umbilicus is the primary entry site.
**Name:** laparoscopy entry policy
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** the surgeon will calculate the time of surgery for similar cases in both groups and will compare between both groups according to the time factor
**Measure:** Time assessed by the difference in using the umbilicus method as the primary entry site in gynecological laparoscopy with Palmar's point
**Time Frame:** 6 months
**Description:** we will compare the number of participants with vascular or intestinal injuries in both procedures
**Measure:** complications that occur in using the umbilicus method as the primary entry site in gynecological laparoscopy in comparison with Palmar's point
**Time Frame:** 6 months
**Description:** questionnaire will be done to ask the surgeon about the degree of coordination and smoothness of using the surgeon his both hands in laparoscopy
**Measure:** coordination of the surgeon movement by the difference in using the umbilicus method as the primary entry site in gynecological laparoscopy in comparison with Palmar's point
**Time Frame:** 6 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients listed for diagnostic or operative laparoscopy.
Exclusion Criteria:
* • Splenomegaly
* Hepatomegaly
* previous left upper quadrant surgery.
* midline laparotomy
* umbilical surgery
* presence of umbilical hernia
**Healthy Volunteers:** True
**Maximum Age:** 60 Years
**Minimum Age:** 10 Years
**Sex:** FEMALE
**Standard Ages:**
- CHILD
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Zagazig
**Country:** Egypt
**Facility:** Zagazig University
**State:** East
**Zip:** 44511
**Location 2:**
**City:** Zagazig
**Country:** Egypt
**Facility:** Zagazig
**State:** East
**Zip:** 44511
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000052776
- Term: Female Urogenital Diseases
- ID: D000005261
- Term: Female Urogenital Diseases and Pregnancy Complications
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000091662
- Term: Genital Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M8943
- Name: Genital Diseases, Female
- Relevance: HIGH
- As Found: Gynecologic Disease
- 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
### Condition Browse Module - Meshes
- ID: D000005831
- Term: Genital Diseases, Female
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT05414279
**Brief Title:** Validation of Capillary Serum Sodium Levels
**Official Title:** Validation of Serum Sodium Levels Through Capillary Blood Collection Via Finger Prick Compared to Standard Venous Blood Sampling
#### Organization Study ID Info
**ID:** BC-09422
#### Organization
**Class:** OTHER
**Full Name:** University Hospital, Ghent
### Status Module
#### Completion Date
**Date:** 2021-10-05
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-06-10
**Type:** ACTUAL
**Last Update Submit Date:** 2022-06-07
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2021-09-29
**Type:** ACTUAL
#### Start Date
**Date:** 2021-04-30
**Type:** ACTUAL
**Status Verified Date:** 2022-06
#### Study First Post Date
**Date:** 2022-06-10
**Type:** ACTUAL
**Study First Submit Date:** 2022-06-07
**Study First Submit QC Date:** 2022-06-07
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University Hospital, Ghent
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Prospective interventional study to determine sodium levels in capillary blood via finger prick. The goal is to determine if this technique is suitable and equal to a standard venous blood collection for the analysis of blood sodium levels.The purpose is to compare both sodium levels to determine if they are equal so the technique can be used in a clinical setting for people who need regular blood collections for the determination of sodium, for example after the start of desmopressin use.
**Detailed Description:** Currently, serum sodium levels are determined by standard venous blood sampling. This method is invasive, painful and a relatively large amount of blood is drawn (5ml). Repeated blood draws are necessary in certain patient groups. If sodium values can be determined on a capillary blood sample instead of a classic venous blood sample, the total blood volume will be smaller. In addition, in the future, the aim is to perform capillary blood sampling at home and to send the sample by courier, thus saving the patient a trip to the doctor's office or a nurse at home.
The aim of this prospective interventional study is to validate the sodium values on a capillary blood sample obtained via fingerstick (250µL). To demonstrate that the obtained values are reliable and clinically useful they will be compared one-on-one with the sodium values determined on a standard venous blood sample. Since it is important to validate a broad range of sodium values, a heterogeneous study population is chosen to obtain sufficient variation.
Patients admitted to the Urology department at UZ Gent will be informed verbally and in writing about the content and purpose of the study. If they are interested in participating, they will be asked to sign the consent form. At the moment the already planned venous blood collection, a capillary blood sample will be taken as well via a finger prick. A number of blood drops (250 µL) are collected in a standard Lithium-Heparin tube and will be collected by lab Maenhout for further analysis. The venous blood sample, which is taken as part of the therapy/diagnosis (independent of the study, standard of care) during admission, is analyzed by the clinical lab of UZ Gent.
The sodium values from the capillary blood draw will be compared with the values from the venous blood draw, with each patient acting as their own control. There is no need to have the venous blood samples analyzed by Labo Maenhout, as the clinical lab of UZ Gent uses the same technique for sodium determination (indirect determination) as Labo Maenhout.
The sodium values obtained through capillary and venous blood sampling will be statistically analyzed using a Passing-Bablok regression model.
### Conditions Module
**Conditions:**
- Nocturia
**Keywords:**
- nocturia
- Desmopressin
- Hyponatremia
- Blood chemical analysis
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** BASIC_SCIENCE
#### Enrollment Info
**Count:** 100
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** From each patient a capillary and venous blood sample will be taken in order to determine the sodium level
**Intervention Names:**
- Diagnostic Test: Sodium determination
**Label:** Capillary and venous sodium
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Capillary and venous sodium
**Description:** Through a single finger prick 10 drops of capillary blood will be drawn. The venous blood sample will be taken through a standard venipuncture. Both samples will be send to the lab for indirect sodium determination
**Name:** Sodium determination
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** the agreement between capillary and venous sodium measurements, measured by the intra-class correlation coefficient
**Measure:** Difference in sodium level between capillary and venous blood samples
**Time Frame:** 1 hour
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Above 18 years or older
* admitted to the urology ward
Exclusion Criteria:
* none
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Ghent
**Country:** Belgium
**Facility:** Ghent University Hospital
**State:** East-Fanders
**Zip:** 9000
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000059411
- Term: Lower Urinary Tract Symptoms
- ID: D000020924
- Term: Urological Manifestations
### Condition Browse Module - Browse Branches
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M10060
- Name: Hyponatremia
- Relevance: LOW
- As Found: Unknown
- ID: M27158
- Name: Nocturia
- Relevance: HIGH
- As Found: Nocturia
- ID: M29464
- Name: Lower Urinary Tract Symptoms
- Relevance: LOW
- As Found: Unknown
- ID: M22659
- Name: Urological Manifestations
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000053158
- Term: Nocturia
### Intervention Browse Module - Browse Branches
- Abbrev: NaAg
- Name: Natriuretic Agents
- Abbrev: Coag
- Name: Coagulants
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M7089
- Name: Deamino Arginine Vasopressin
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT00493779
**Acronym:** DECADES
**Brief Title:** A Study to Evaluate the Discontinuation Effect of Clopidogrel After Drug Eluting Stent Implantation in Non-diabetic Patients
**Official Title:** An Exploratory, Multi-Center, Open-Label, Single-Arm Study to Evaluate the Discontinuation Effect of Clopidogrel After Drug Eluting Stent (DECADES) on Inflammatory and Platelet Activation Markers in Subjects Who Are Receiving Low Dose Acetylsalicylic Acid (ASA)
#### Organization Study ID Info
**ID:** CV149-208
#### Organization
**Class:** INDUSTRY
**Full Name:** Bristol-Myers Squibb
#### Secondary ID Infos
**ID:** Eudract number: 2007-000713-11
### Status Module
#### Completion Date
**Date:** 2008-06
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2010-08-10
**Type:** ESTIMATED
**Last Update Submit Date:** 2010-08-03
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2008-06
**Type:** ACTUAL
#### Results First Post Date
**Date:** 2009-08-11
**Type:** ESTIMATED
**Results First Submit Date:** 2009-06-05
**Results First Submit QC Date:** 2009-08-10
#### Start Date
**Date:** 2007-10
**Status Verified Date:** 2010-06
#### Study First Post Date
**Date:** 2007-06-28
**Type:** ESTIMATED
**Study First Submit Date:** 2007-06-27
**Study First Submit QC Date:** 2007-06-27
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** Sanofi
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Bristol-Myers Squibb
#### Responsible Party
**Old Name Title:** Study Director
**Old Organization:** Bristol-Myers Squibb
### Description Module
**Brief Summary:** The purpose of the study is to look at the biomarkers of inflammation and platelet activation in patients with drug eluting stents implanted approximately 12 months ago on aspirin and statin, for a 4-week period after the routine discontinuation of clopidogrel
### Conditions Module
**Conditions:**
- Antiplatelet Aggregation
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
#### Enrollment Info
**Count:** 103
**Type:** ACTUAL
**Phases:**
- PHASE4
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Effect of Clopidogrel withdrawal on biomarkers will be assessed via blood draws
**Intervention Names:**
- Procedure: Blood Collection
**Label:** 1
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- 1
**Description:** 4 weeks
**Name:** Blood Collection
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** Based on ANCOVA models performed on log scale controlling for site \& natural logarithm of baseline soluble CD40 Ligand value. Percent changes from baseline can be interpreted as the difference of biomarker timepoint value minus baseline value divided by baseline value. Positive percent change might indicate possible enhanced platelet activation.
**Measure:** Adjusted Mean Percent Changes From Baseline in Soluble CD40 Ligand (sCD40L)
**Time Frame:** Week 1, Week 2, Week 3, Week 4 (primary timepoint)
#### Secondary Outcomes
**Description:** Based on ANCOVA models performed on log scale controlling for site and natural logarithm of baseline Plasma Soluble P-selectin value. Percent changes from baseline can be interpreted as difference of biomarker timepoint value minus baseline value divided by baseline value. Positive percent change is known to be mediated by increases in sCD40L.
**Measure:** Adjusted Mean Percent Changes From Baseline in Plasma Soluble P-Selectin
**Time Frame:** Week 1, Week 2, Week 3, Week 4
**Description:** ANCOVA models performed on log scale controlling for site \& natural logarithm of baseline hs-CRP. Back-transformed mean percent changes are presented. Percent changes from baseline can be interpreted as difference of biomarker timepoint value - baseline value ÷ baseline value. Since there is no measure of platelet inhibition or overall thrombogenicity assay presented here, a negative percent change for this measure can not be judged on its own as indicating improvement.
**Measure:** Adjusted Mean Percent Changes From Baseline in Hs-CRP
**Time Frame:** Week 1, Week 2, Week 3, Week 4
**Description:** An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a patient or clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.
**Measure:** Adverse Events (AE) / Serious Adverse Events (SAE)Deaths, and AEs Leading to Discontinuation of Follow-up
**Time Frame:** Throughout 4-week follow-up period
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Subjects with one or more drug-eluting stents of any type who are coming to the end of their 12 months of clopidogrel (75 mg daily) treatment
* Subjects receiving low dose ASA
* Subjects receiving a statin
* Current medication regimen (including ASA and statins) must have been stable for three (3) months. i.e. no initiation of new prescription medication or change in dosage of any previously initiated medication within three (3) months of entering this study
* Subjects with no clinical history of diabetes mellitis
* Men and women, ages 18 years or older
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Paris
**Country:** France
**Facility:** Local Institution
**Zip:** 75013
**Location 2:**
**City:** Mainz
**Country:** Germany
**Facility:** Local Institution
**Zip:** 55101
**Location 3:**
**City:** Nieuwegein
**Country:** Netherlands
**Facility:** Local Institution
**Zip:** 3435 CM
**Location 4:**
**City:** Rotterdam
**Country:** Netherlands
**Facility:** Local Institution
**Zip:** 3015 GD
**Location 5:**
**City:** Glasgow
**Country:** United Kingdom
**Facility:** Local Institution
**State:** Central
**Zip:** G11 6NT
**Location 6:**
**City:** Southampton
**Country:** United Kingdom
**Facility:** Local Institution
**State:** Hampshire
**Zip:** SO16 6YD
#### Overall Officials
**Official 1:**
**Affiliation:** Bristol-Myers Squibb
**Name:** Bristol-Myers Squibb
**Role:** STUDY_DIRECTOR
### References Module
#### References
**Citation:** Wykrzykowska JJ, Warnholtz A, de Jaeger P, Curzen N, Oldroyd KG, Collet JP, Ten Berg JM, Rademaker T, Goedhart D, Lissens J, Kint PP, Serruys PW. Effect of clopidogrel discontinuation at 1 year after drug eluting stent placement on soluble CD40L, P-selectin and C-reactive protein levels: DECADES (Discontinuation Effect of Clopidogrel After Drug Eluting Stent): a multicenter, open-label study. J Thromb Thrombolysis. 2009 Nov;28(4):410-7. doi: 10.1007/s11239-009-0354-y.
**PMID:** 19504052
## Derived Section
### Intervention Browse Module - Browse Branches
- Abbrev: PlAggInh
- Name: Platelet Aggregation Inhibitors
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Antipy
- Name: Antipyretics
- Abbrev: Infl
- Name: Anti-Inflammatory Agents
- Abbrev: ARhu
- Name: Antirheumatic Agents
- Abbrev: FiAg
- Name: Fibrinolytic Agents
- Abbrev: Analg
- Name: Analgesics
### Intervention Browse Module - Browse Leaves
- ID: M1669
- Name: Clopidogrel
- Relevance: LOW
- As Found: Unknown
- ID: M4548
- Name: Aspirin
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-24
## Results Section
### Adverse Events Module
#### Event Groups
**Group ID:** EG000
**Title:** Clopidogrel Withdrawal Population
**Description:** All enrolled participants in whom clopidogrel treatment was discontinued.
**ID:** EG000
**Other Num at Risk:** 98
**Serious Number Affected:** 2
**Serious Number At Risk:** 98
**Title:** Clopidogrel Withdrawal Population
**Frequency Threshold:** 5
#### Serious Events
**Term:** Non-cardiac chest pain
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** General disorders
**Source Vocabulary:** MedDRA 10.0
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 98
**Term:** Angina unstable
**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT
**Organ System:** Cardiac disorders
**Source Vocabulary:** MedDRA 10.0
##### Stats
**Group ID:** EG000
**Num Affected:** 1
**Num At Risk:** 98
## Results Section - Baseline Characteristics Module
### Denomination Counts
**Group ID:** BG000
**Value:** 98
**Units:** Participants
### Group
**ID:** BG000
**Title:** Clopidogrel Withdrawal Population
**Description:** All enrolled participants in whom clopidogrel treatment was discontinued.
### Measure
#### Measurement
**Group ID:** BG000
**Spread:** 8.5
**Value:** 63.3
**Class Title:**
### Measure
#### Measurement
**Group ID:** BG000
**Lower Limit:** 44
**Upper Limit:** 81
**Value:** 63
**Class Title:**
### Measure
#### Measurement
**Group ID:** BG000
**Value:** 20
**Category Title:** Female
#### Measurement
**Group ID:** BG000
**Value:** 78
**Category Title:** Male
**Class Title:**
### Measure
#### Measurement
**Group ID:** BG000
**Value:** 93
**Class Title:** Caucasian
#### Measurement
**Group ID:** BG000
**Value:** 5
**Class Title:** Asian Oriental
### Measure
#### Measurement
**Group ID:** BG000
**Spread:** 2.052
**Value:** 1.70
**Class Title:**
### Measure
#### Measurement
**Group ID:** BG000
**Spread:** 14.898
**Value:** 44.59
**Class Title:**
### Measure
#### Measurement
**Group ID:** BG000
**Spread:** 186.513
**Value:** 223.76
**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
**Dispersion Type:** FULL_RANGE
**Parameter Type:** MEDIAN
**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:** NUMBER
**Title:** Race/Ethnicity, Customized
**Unit of Measure:** participants
### Measure 5
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Mean Baseline High Sensitivity C-Reactive Protein (hs-CRP)
**Unit of Measure:** mg/L
### Measure 6
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Mean Baseline Plasma Soluble P-Selectin
**Unit of Measure:** ng/mL
### Measure 7
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Mean Baseline Soluble CD40 Ligand
**Unit of Measure:** ng/L
## Results Section - More Information Module
### Certain Agreement
**Other Details:** Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
**Restriction Type:** OTHER
**Restrictive Agreement:** True
### Limitations and Caveats
**Description:** The open-label and exploratory nature of this small study and the absence of control group inherently limit the interpretability of the results.
### Point of Contact
**Email:** [email protected]
**Organization:** Bristol-Myers Squibb
**Title:** BMS Study Director
## 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:** 1.53
- **Upper Limit:**
- **Value:** 44.59
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 2.38
- **Upper Limit:**
- **Value:** 9.00
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 2.11
- **Upper Limit:**
- **Value:** 11.10
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 2.69
- **Upper Limit:**
- **Value:** 3.63
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 2.76
- **Upper Limit:**
- **Value:** 1.90
**Title:**
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 19.14
- **Upper Limit:**
- **Value:** 223.76
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 10.37
- **Upper Limit:**
- **Value:** 35.04
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 10.76
- **Upper Limit:**
- **Value:** 38.88
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 9.68
- **Upper Limit:**
- **Value:** 32.74
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 11.07
- **Upper Limit:**
- **Value:** 39.42
**Title:**
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 0.21
- **Upper Limit:**
- **Value:** 1.70
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 6.76
- **Upper Limit:**
- **Value:** -20.59
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 6.78
- **Upper Limit:**
- **Value:** -22.89
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 8.22
- **Upper Limit:**
- **Value:** -19.32
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:** 8.48
- **Upper Limit:**
- **Value:** -17.70
**Title:**
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 0
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 20
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 0
**Title:**
**Class:**
##### Category
**Measurements:**
- **Comment:**
- **Group ID:** OG000
- **Lower Limit:**
- **Spread:**
- **Upper Limit:**
- **Value:** 2
**Title:**
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Based on ANCOVA models performed on log scale controlling for site and natural logarithm of baseline Plasma Soluble P-selectin value. Percent changes from baseline can be interpreted as difference of biomarker timepoint value minus baseline value divided by baseline value. Positive percent change is known to be mediated by increases in sCD40L.
**Dispersion Type:** Standard Error
**Parameter Type:** MEAN
**Population Description:** Number of patients in the biomarker analysis population having baseline Plasma Soluble P-selectin value (n=95) and at least one post-clopidogrel withdrawal measurement for Plasma Soluble P-selectin value. No imputation technique for missing values was applied.
**Reporting Status:** POSTED
**Time Frame:** Week 1, Week 2, Week 3, Week 4
**Title:** Adjusted Mean Percent Changes From Baseline in Plasma Soluble P-Selectin
**Type:** SECONDARY
**Unit of Measure:** percent change
##### Group
**Description:** All participants in the Clopidogrel Withdrawal Population having a baseline and at least one post clopidogrel withdrawal measurement for any of the 3 biomarkers collected.
**ID:** OG000
**Title:** Biomarker Analysis Population
#### Outcome Measure 2
**Description:** Based on ANCOVA models performed on log scale controlling for site \& natural logarithm of baseline soluble CD40 Ligand value. Percent changes from baseline can be interpreted as the difference of biomarker timepoint value minus baseline value divided by baseline value. Positive percent change might indicate possible enhanced platelet activation.
**Dispersion Type:** Standard Error
**Parameter Type:** MEAN
**Population Description:** Number of participants in the biomarker analysis population having a baseline soluble CD40 Ligand value (n=95) and at least one post-clopidogrel withdrawal measurement for soluble CD40 Ligand value. No imputation technique for missing values was applied.
**Reporting Status:** POSTED
**Time Frame:** Week 1, Week 2, Week 3, Week 4 (primary timepoint)
**Title:** Adjusted Mean Percent Changes From Baseline in Soluble CD40 Ligand (sCD40L)
**Type:** PRIMARY
**Unit of Measure:** percent change
##### Group
**Description:** All participants in the Clopidogrel Withdrawal Population having a baseline and at least one post clopidogrel withdrawal measurement for any of the 3 biomarkers collected.
**ID:** OG000
**Title:** Biomarker Analysis Population
#### Outcome Measure 3
**Description:** ANCOVA models performed on log scale controlling for site \& natural logarithm of baseline hs-CRP. Back-transformed mean percent changes are presented. Percent changes from baseline can be interpreted as difference of biomarker timepoint value - baseline value ÷ baseline value. Since there is no measure of platelet inhibition or overall thrombogenicity assay presented here, a negative percent change for this measure can not be judged on its own as indicating improvement.
**Dispersion Type:** Standard Error
**Parameter Type:** MEAN
**Population Description:** Number of patients in the biomarker analysis population having baseline hs-CRP value and at least one post clopidogrel withdrawal measurement for hs-CRP value. No imputation technique for missing values was applied.
**Reporting Status:** POSTED
**Time Frame:** Week 1, Week 2, Week 3, Week 4
**Title:** Adjusted Mean Percent Changes From Baseline in Hs-CRP
**Type:** SECONDARY
**Unit of Measure:** percent change
##### Group
**Description:** All participants in the Clopidogrel Withdrawal Population having a baseline and at least one post clopidogrel withdrawal measurement for any of the 3 biomarkers collected.
**ID:** OG000
**Title:** Biomarker Analysis Population
#### Outcome Measure 4
**Description:** An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a patient or clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.
**Parameter Type:** NUMBER
**Population Description:** All enrolled patients in whom clopidogrel treatment was discontinued.
**Reporting Status:** POSTED
**Time Frame:** Throughout 4-week follow-up period
**Title:** Adverse Events (AE) / Serious Adverse Events (SAE)Deaths, and AEs Leading to Discontinuation of Follow-up
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** All enrolled participants in whom clopidogrel treatment was discontinued.
**ID:** OG000
**Title:** Clopidogrel Withdrawal Population
### Participant Flow Module
#### Group
**Description:** All enrolled participants in whom clopidogrel treatment was discontinued.
**ID:** FG000
**Title:** Clopidogrel Withdrawal Population
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Logistical issue at site
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 98
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 97
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 1
**Pre-Assignment Details:** 103 subjects who were enrolled and treated with clopidogrel, were enrolled, of which 98 subjects had discontinued clopidogrel treatment and entered follow-up phase (study phase).
**Has Results:** True |
## Protocol Section
### Identification Module
**NCT ID:** NCT00462579
**Brief Title:** Risk Factors for Carbapenem-resistant Acinetobacter Baumannii
**Official Title:** Risk Factors for Carbapenem-resistant Acinetobacter Baumannii
#### Organization Study ID Info
**ID:** PRO07040057
#### Organization
**Class:** OTHER
**Full Name:** University of Pittsburgh
### Status Module
#### Completion Date
**Date:** 2017-06
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2018-06-12
**Type:** ACTUAL
**Last Update Submit Date:** 2018-06-11
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2017-06
**Type:** ACTUAL
#### Start Date
**Date:** 2007-04
**Type:** ACTUAL
**Status Verified Date:** 2018-06
#### Study First Post Date
**Date:** 2007-04-19
**Type:** ESTIMATED
**Study First Submit Date:** 2007-04-17
**Study First Submit QC Date:** 2007-04-18
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Pittsburgh
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** It has been demonstrated that panresistant strains of Acinetobacter species may be selected by antibiotic use \[4\], may be transmitted from person to person \[5\], and may be passed via environmental contamination \[6\]. Surveillance for panresistant Acinetobacter species should be a priority, given the lack of antibiotic options for the treatment of these infections. There are currently no data on the antibiotic susceptibility of Acinetobacter species or on the rates of panresistant organisms. The elucidation of potential risk factors for resistant strains of Acinetobacter is therefore an important task, and the use of alternative antibiotics should be considered in ICUs where these strains are endemic.
**Detailed Description:** The elucidation of potential risk factors for resistant strains of Acinetobacter is therefore an important task, and the use of alternative antibiotics should be considered in ICUs where these strains are endemic.he following information will be collected: age, sex, occupation, hospital location at the time of positive culture (ER, medical ward, ICU etc), date of positive culture, prior hospitalization, receipt of outpatient dialysis, home care or other regular medical care (eg, outpatient chemotherapy), presence of invasive devices, receipt of antibiotics, including their type and whether they were adequate for the resistance profile of the organism, prior positive microbiologic cultures, time and location of positive cultures, underlying diseases and severity of illness, presence of urinary or intravascular devices, recent immunomodulative therapies or radiation therapy, physical exam findings, laboratory and radiographical data, antimicrobial usage within 30 days of onset of the infection, microbiological data and resistance patterns, choice of antibiotics once organism identified, bacteriological outcomes, laboratory results, demographic information, medications, clinical outcome,gender, height, weight, ethnicity, and past medical history. We will collect information retrospectively.
### Conditions Module
**Conditions:**
- Acinetobacter Infections
**Keywords:**
- carbapenem-resistant acinetobacter baumannii
- positive culture
- positive culture for carbapenem-resistant acinetobacter
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 100
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Outcomes Module
#### Primary Outcomes
**Description:** health status
**Measure:** dead or alive
**Time Frame:** end of study
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Positive cultures of carbapenem-resistant acinetobacter baumannii
Exclusion Criteria:
* Not meeting inclusion criteria
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** carbapenem-resistant acinetobacter baumannii positive cultures
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Pittsburgh
**Country:** United States
**Facility:** UPMC
**State:** Pennsylvania
**Zip:** 15213
#### Overall Officials
**Official 1:**
**Affiliation:** University of Pittsburgh Medical Center
**Name:** David L Paterson, MD
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000045828
- Term: Moraxellaceae 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
### 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: M3511
- Name: Acinetobacter Infections
- Relevance: HIGH
- As Found: Acinetobacter Infections
- 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
### Condition Browse Module - Meshes
- ID: D000000151
- Term: Acinetobacter Infections
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT00861679
**Acronym:** ALL SCT BFM
**Brief Title:** Therapy Protocol Acute Lymphoblastic Leukemia Stem Cell Transplantation International
**Official Title:** Therapy Protocol ALL SCT BFM International-open, Multicenter, Controlled, Prospective Study for Therapy and Therapy Optimisation in Patients With Acute Lymphoblastic Leukemia (ALL) and an Indication for Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
#### Organization Study ID Info
**ID:** ALL-SCT-BFM-0321-08-HMO-CTIL
#### Organization
**Class:** OTHER
**Full Name:** Hadassah Medical Organization
### Status Module
#### Completion Date
**Date:** 2014-09
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-03-29
**Type:** ACTUAL
**Last Update Submit Date:** 2021-03-24
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2009-09
**Type:** ACTUAL
#### Start Date
**Date:** 2007-01
**Status Verified Date:** 2009-03
#### Study First Post Date
**Date:** 2009-03-13
**Type:** ESTIMATED
**Study First Submit Date:** 2009-03-12
**Study First Submit QC Date:** 2009-03-12
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Hadassah Medical Organization
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** To evaluate whether HSCT from matched family or unrelated donors (MD) is equivalent to the HSCT from matched sibling donors (MSD). To evaluate the efficacy of HSCT from mismatched family or unrelated donors (MMD) as compared to HSCT from MSD/MD. To determine whether therapy has been carried out according to the main HSCT protocol recommendations. The standardisation of the treatment options during HSCT from different donor types aims at the achievement of an optimal comparison of survival after HSCT with survival after chemotherapy only. To prospectively evaluate and compare the incidence of acute and chronic GvHD after HSCT from MSD, from MD and from MMD.
### Conditions Module
**Conditions:**
- Acute Lymphoblastic Leukemia
**Keywords:**
- HSCT
- ALL
- GvHD
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 552
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** HSCT from matched family or unrelated donors(MD) to matched related donors.
**Intervention Names:**
- Procedure: Transplantation with Stem Cells from Umbilical Cord
**Label:** HSCT from matched family or unrelated donors(MD)
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- HSCT from matched family or unrelated donors(MD)
**Description:** According to results from published experiences in children following suggestions are given:
1. Number of Cells:
* Number of nucleated cells infused exceed 2,5x10\*7/kg recipient BW or
* Number of nucleated cells collected exceed 3x10\*7/kg BW
* Number of CD34+ cells infused exceed 2x10\*5/kg Recipient BW
2. GVHD-prophylaxis:
• MSD: CSA 3 mg/kg as described in the protocol + Prednisolone 1 mg/kg (day O to day 15, then tapering until day 28)
• UD: as above + additional immunosuppression according to local protocols; ATG might increase risk of infectious complication and might be replaced by other drugs according to local protocols.
3. HLA-matching for unrelated CB: a matched UB is defined by 6/6 HLA matches (A, B antigenic medium resolution and DRB1 allelic) and allocate to the transplantation group "MD". Less than 6/6 HLA matches allocate the patient to the "MMD" group.
4. If many choices available ABO- major incompatibility should be avoided.
**Name:** Transplantation with Stem Cells from Umbilical Cord
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Measure:** event-free and overall survival after allogeneic HSCT, occurrence of acute and chronic Graft-versus-Host-Disease (GvHD), occurrence and course of late effects after chemotherapy with subsequent allogeneic HSCT
**Time Frame:** 11 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
all patients with ALL (except for patients with B-ALL) who fulfil the following criteria:
* age at time of initial diagnosis or relapse diagnosis, respectively
≤18 years
* indication for allogeneic HSCT
* complete remission (CR) is achieved before SCT
* written consent of the parents (legal guardian) and, if indicated, the minor patient via "Informed Consent Form"
* no pregnancy
* no secondary malignancy
* no previous HSCT
* HSCT is performed in a study participating centre.
Exclusion Criteria:
* not signed inform consent of the parents (legal guardian)
* pregnancy
* secondary malignancy
* previous HSCT
**Maximum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Petach Tikvah
**Country:** Israel
**Facility:** Schneider Children's Medical Center of Israel
**Zip:** 49202
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000009369
- Term: Neoplasms
- ID: D000006402
- Term: Hematologic Diseases
- 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: All
- Name: All Conditions
- Abbrev: BC20
- Name: Immune System 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: M27585
- Name: Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Relevance: HIGH
- As Found: Acute Lymphoblastic Leukemia
- ID: M11220
- Name: Lymphoma
- Relevance: LOW
- As Found: Unknown
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
- ID: M9490
- Name: Hematologic Diseases
- 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: 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: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
- ID: T3543
- Name: Lymphosarcoma
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000007938
- Term: Leukemia
- ID: D000054198
- Term: Precursor Cell Lymphoblastic Leukemia-Lymphoma
- ID: D000007945
- Term: Leukemia, Lymphoid
### Intervention Browse Module - Browse Branches
- Abbrev: Infl
- Name: Anti-Inflammatory Agents
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: AnEm
- Name: Antiemetics
- Abbrev: NeuroAg
- Name: Neuroprotective Agents
- Abbrev: Gast
- Name: Gastrointestinal Agents
### Intervention Browse Module - Browse Leaves
- ID: M14120
- Name: Prednisolone
- 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
### Misc Info Module
- Version Holder: 2024-05-24
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06157879
**Brief Title:** Measuring Electrical Properties of Breast Tissues
**Official Title:** Measuring Electrical Properties of Breast Tissues
#### Organization Study ID Info
**ID:** HREBA.CC-22-0112
#### Organization
**Class:** OTHER
**Full Name:** University of Calgary
### Status Module
#### Completion Date
**Date:** 2026-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-04-18
**Type:** ACTUAL
**Last Update Submit Date:** 2024-04-16
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-01
**Type:** ESTIMATED
**Status Verified Date:** 2023-10
#### Study First Post Date
**Date:** 2023-12-06
**Type:** ACTUAL
**Study First Submit Date:** 2023-11-06
**Study First Submit QC Date:** 2023-11-27
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** Wave View Imaging
**Class:** OTHER
**Name:** Alberta Innovates Health Solutions
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Calgary
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The goal of this observational study is to use a low-powered microwave imaging system to provide insight into the correlation of electrical properties of breast tissue at microwave frequencies and breast density obtained from mammograms in healthy women between the ages of 18 and 74. The main questions it aims to answer : • Is there a correlation between the electrical properties of breast tissue and breast density obtained from mammograms? Both breasts of each participant will be scanned by the microwave imaging system six times in total.
**Detailed Description:** A new approach to imaging that uses low-power microwaves to scan the breast has been developed. Since the imaging system uses low power, there is no risk of tissue heating. The imaging system places the sensors in contact with the breast and does not require compression. The research team at the University of Calgary has previously developed microwave imaging systems that have been tested on volunteers and patients. This included repeated scanning of a group of volunteers to evaluate the consistency of the approach. The information collected from experiences scanning volunteers and patients have been reviewed and translated into a next-generation imaging system design. Aspects of this system have been further improved by Wave View Imaging, which is a company formed by members of the University's research team.
The proposed study involves collecting electrical property measurements of breast tissues and comparing these measurements to clinical information. The investigators also aim to compare regions of interest in the microwave scans with regions of interest in the mammograms. This includes regions dominated by fibroglandular tissues, as well as regions of interest that correspond to anomalies identified in the mammograms
The plan is to scan both breasts of up to 200 volunteers. Each volunteer will participate in a single scanning session. Breast tissue composition (VOLPARA score) will be compared with the microwave properties and registration of mammograms with microwave images will be performed for a more detailed comparison.
### Conditions Module
**Conditions:**
- Healthy
- Breast
**Keywords:**
- women
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 200
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Healthy volunteers
**Intervention Names:**
- Device: WVI-MIS-01-2022
**Label:** WVI-MIS-01-2022
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- WVI-MIS-01-2022
**Description:** Microwave scans
**Name:** WVI-MIS-01-2022
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** The electrical properties will be estimated for each volunteer and an image that maps these properties will be created.
**Measure:** Measurement of electrical properties of breast tissue
**Time Frame:** 18 months
#### Secondary Outcomes
**Description:** Comparison of the microwave images and mammograms in 2 ways: VOLPARA scores versus average electrical properties and comparison of regions of interest in both images
**Measure:** Correlation between the electrical properties of breast tissue and breast density
**Time Frame:** 18 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Must have had a previous mammogram in the last 2 years
Exclusion Criteria:
* Participants currently undergoing chemotherapy and/or radiation treatment.
* Participants with breast implants.
* Participants who are breast or breastfeeding.
* Participants with active breast infections.
* Participants with nipple piercings (unless they can be removed prior to scanning).
* Participants with an implanted electronic device.
* Participants with physical limitations that prevent them from placing their breasts in the scanner.
**Healthy Volunteers:** True
**Maximum Age:** 74 Years
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Anita Garland
**Phone:** 4037031664
**Role:** CONTACT
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Smith, K., et al. "Microwave Imaging of the Breast: Consistency of Measurements Over Time." IEEE Journal of Electromagnetics, RF and Microwaves in Medicine and Biology, vol. 6, no. 1, 2022, pp. 61-67, https://doi.org/10.1109/JERM.2021.3099014.
**Citation:** Smith K, Bourqui J, Wang Z, Besler B, Lesiuk M, Roumeliotis M, Quirk S, Grendarova P, Pinilla J, Price S, Docktor B, Fear E. Microwave imaging for monitoring breast cancer treatment: A pilot study. Med Phys. 2023 Nov;50(11):7118-7129. doi: 10.1002/mp.16756. Epub 2023 Oct 6.
**PMID:** 37800880
## Derived Section
### Misc Info Module
- Version Holder: 2024-05-24
|