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## Protocol Section
### Identification Module
**NCT ID:** NCT06422442
**Brief Title:** Information Processing Biases in Adults Who Stutter
**Official Title:** Information Processing Biases in Adults Who Stutter: Behavioral and Eye-tracking Indices of Threat-related Attention Allocation
#### Organization Study ID Info
**ID:** R21DC020557
**Link:** https://reporter.nih.gov/quickSearch/R21DC020557
**Type:** NIH
#### Organization
**Class:** OTHER
**Full Name:** University of Memphis
### Status Module
#### Completion Date
**Date:** 2026-06-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-15
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-10-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-09-11
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** University of Alabama, Tuscaloosa
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Memphis
#### 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 clinical trial is to examine whether stuttering is associated with a tendency to attend more quickly or for longer durations to threat-related information in the environment (threat-related attention bias). The main questions it aims to answer are:
Do adults who stutter, relative to adults who do not stutter, attend to threat-related stimuli more than neutral information? Are attentional biases observed across different types of threat or are they specific to threats related to stuttering experiences? Do measures of attention bias explain individual differences in psychological reactions among adults who stutter?
**Detailed Description:** The goal of the project is to examine threat-related attentional processes associated with stuttering. In Aim 1, investigators will establish differences in attention bias (AB) in adults who do and do not stutter and the processing stage at which differences emerge. In Aim 2, investigators will compare AB effects across different categories of threat stimuli to determine whether threat-related AB in adults who stutter is general or disorder-specific. In Aim 3, the investigators examine the role of AB as a causal factor mediating effects of individual risk-factors (related to temperament and attention control) on stuttering impact and anticipation. Participants will include 35 adults who stutter and 35 adults who stutter between the ages of 18-30 years, all meeting specified eligibility criteria. All participants will complete three experimental tasks for measuring AB: (1) a free-viewing task, (2) dot-probe task, and (3) emotional Stroop task. Study procedures will be administered over two sessions (2-2.5 hours each) scheduled within three weeks of each other. Key outcomes will include reaction time and eye-tracking measures, which will be used to extract multiple AB indices. Data will be analyzed via mixed-effects regression analysis with a random intercept for subject and maximal converging random-slopes structure. Age, gender, socioeconomic status and various measures used for inclusion purposes will be included as covariates. Mediation analyses will assess four relationships (Temperament -\> Stuttering impact, Temperament -\> Anticipation, Attention control -\> Stuttering impact, and Attention control -\> Anticipation), with AB as the mediator variable in each analysis.
### Conditions Module
**Conditions:**
- Stuttering, Adult
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Masking Description:** Individuals reviewing and coding data will not be aware of group status or diagnoses for participants.
**Primary Purpose:** BASIC_SCIENCE
#### Enrollment Info
**Count:** 80
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** All participants complete three tasks in which they view threat-related and neutral stimuli (words or faces)
**Intervention Names:**
- Behavioral: Threat-related stimulus exposure
**Label:** Eye tracking tasks
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Eye tracking tasks
**Description:** Participants will view threat-related stimuli (words or faces) paired with nonthreat matches in three related experimental paradigms.
**Name:** Threat-related stimulus exposure
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** A) A key outcome measure from the dot-probe task will consist of RTs for congruent trials (in which probe appears in the location of threat stimulus) vs. incongruent trials (probe replaces neutral stimulus). (B) Key outcome measure from the emotional Stroop will include RT for threat vs. neutral words.
**Measure:** Reaction time (RT) measures
**Time Frame:** Trial duration (maximum of 10 seconds)
**Description:** This primary (and most reliable) index of AB will be extracted from eye movement data and represents the total duration of all fixations to areas of interest with threat stimuli for each trial of the free-viewing task.
**Measure:** Total dwell time on threat
**Time Frame:** Trial duration (8 seconds)
#### Secondary Outcomes
**Description:** Additional indices of AB will be extracted from eye movement data and examined in exploratory manner: (1) probability of first fixation to an area of of interest (AOI), (2) first fixation latency, (3) first fixation duration, 4) first-run dwell time (representing summed duration of all fixations to an AOI from the first fixation until the AOI is exited), and (5) second-run dwell time (summed duration of all fixations within an AOI from the second time the AOI is entered until it is exited).
**Measure:** Eye tracking indices of AB
**Time Frame:** Trial duration (8 seconds)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Speaks English as their primary language
* Normal hearing (based on pure tone screening)
* Normal or corrected vision (based on report)
* Normal color vision (based on Ishihara Test, Concise Edition)
* Nonverbal intelligence within at least average range based on Test of Nonverbal Intelligence, 4th Edition
* Expressive language within at least average range score based on Expressive One-Word Picture Vocabulary Test
Additional inclusion criteria for adults who stutter:
* Self-identification as a person who stutters
* Score of at least 11 (mild stuttering) on Stuttering Severity Index, 4th Edition
Exclusion Criteria:
* Reported significant medical history
* Psychological or emotional disorder
* History of frank neurological injury
* Known speech, language, or learning disorder(s) other than stuttering
* Reading difficulties
* Score within clinically significant range for ADHD on Adults ADHD Self-Rating Scale
* Score within clinically significant range for depression on Beck Depression Inventory
* Score within clinically significant range for anxiety on State-Trait Anxiety Inventory
**Healthy Volunteers:** True
**Maximum Age:** 65 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Memphis
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Naomi Eichorn, PhD
- **Phone:** 901-678-5825
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Edina Bene
- **Phone:** (901) 678-2573
- **Role:** CONTACT
**Country:** United States
**Facility:** University of Memphis
**State:** Tennessee
**Status:** RECRUITING
**Zip:** 38152
### IPD Sharing Statement Module
**Description:** Data will be made freely and publicly available on OSF (https://osf.io) together with our publications, with prior Institutional Review Board approval. Archived data will also be made available to other researchers upon request (by emailing the PI) and without cost. A signed data-sharing agreement will be required for researchers to access data; the agreement will stipulate that shared data must be used solely for the purpose of research, must not be transferred to or shared with others, must not be manipulated for the purpose of identifying subjects, and that the planned research must be reviewed and approved by an Institutional Review Board.
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000013064
- Term: Speech Disorders
- ID: D000007806
- Term: Language Disorders
- ID: D000003147
- Term: Communication Disorders
- ID: D000019954
- Term: Neurobehavioral Manifestations
- ID: D000009461
- Term: Neurologic Manifestations
- ID: D000009422
- Term: Nervous System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
### Condition Browse Module - Browse Leaves
- ID: M16132
- Name: Stuttering
- Relevance: HIGH
- As Found: Stuttering
- ID: M15864
- Name: Speech Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M10823
- Name: Language Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M6374
- Name: Communication Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M21826
- Name: Neurobehavioral Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000013342
- Term: Stuttering
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06422429
**Brief Title:** Study on the Regulatory Effects of Personalized Innovative Youtiao Intervention on Nutritional Health
**Official Title:** Study on the Regulatory Effects of Personalized Innovative Youtiao Intervention on Nutritional Health
#### Organization Study ID Info
**ID:** RCT_PI Youtiao
#### Organization
**Class:** OTHER
**Full Name:** Zhejiang University
### Status Module
#### Completion Date
**Date:** 2025-12-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-17
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-09-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2025-03-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-01
#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-01-17
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Yu Zhang
#### Responsible Party
**Investigator Affiliation:** Zhejiang University
**Investigator Full Name:** Yu Zhang
**Investigator Title:** professor
**Type:** SPONSOR_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 investigate the effects of personalized innovative fritters on the nutritional health of overweight and obese individuals aged 40 to 70 years. The main questions it aims to answer are:
* How does consuming personalized innovative fritters affect the nutritional health of overweight and obese individuals?
* What is the mechanism underlying the impact of personalized innovative oil bars on nutritional health?
Participants will be randomly assigned to one of two groups: a trial group consuming personalized innovative fritters and a control group consuming traditional fritters with equal energy content. Over the course of 6 months, participants will undergo two phases of intervention separated by a two-month washout period. During the intervention, participants will be assessed comprehensively for sensory ratings and nutritional health status through biological indicators, physical examinations, and other relevant measures.
Researchers will compare the trial group to the control group to determine if personalized innovative fritters lead to improvements in nutritional health compared to traditional fritters.
**Detailed Description:** Participants entered the trial with a 1-week equilibration period during which baked and fried foods were prohibited. The test group will consume personalised innovative Youtiao and the control group will uniformly consume traditional Youtiao of equal energy, 45 g 4 times per week for 8 weeks, during which time we will periodically measure biological indicators and collect biological samples to gain insight into the effects of the personalised innovative Youtiao on the participants. After completion of the 8-week intervention, a washout phase is entered. During this phase, participants will no longer ingest the Youtiao to see how they trend after stopping the intervention. Participants then enter the second phase of the trial, where the intervention process described above is continued with appropriate consumption adjustments based on the initial results of the first phase of the intervention.
### Conditions Module
**Conditions:**
- Metabolism and Nutrition Disorder
### 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:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** traditional Youtiao
**Intervention Names:**
- Drug: Traditional deep-fried Youtiao
**Label:** Control group
**Type:** PLACEBO_COMPARATOR
#### Arm Group 2
**Description:** Personalised and innovative Youtiao
**Intervention Names:**
- Drug: PI Youtiao
**Label:** Intervention group
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Control group
**Description:** 45g 4 times a week for 4 months
**Name:** Traditional deep-fried Youtiao
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Intervention group
**Description:** 45g 4 times a week for 4 months
**Name:** PI Youtiao
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** The investigators will measure HbA1c in blood samples before and after treatment.
**Measure:** Change in HbA1c
**Time Frame:** 6 months
**Description:** The investigators will measure fasting plasma glucose levels in blood samples before and after treatment.
**Measure:** Change in blood glucose from baseline
**Time Frame:** 6 months
#### Secondary Outcomes
**Description:** The investigators will measure Triglycerides (TG), total cholesterol (TC), LDL-C, and HDL-C levels in blood samples before and after treatment.
**Measure:** Change in blood lipids from baseline
**Time Frame:** 6 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age between 40-70 years old (women need to be menopausal);
* BMI\>24 kg/m2;
* Consumption of fritters more than once a week.
Exclusion Criteria:
* history of diabetes mellitus, cardiovascular disease, dyslipidaemia, renal disease, -
* liver disease or cancer;
* surgical treatment within 3 months;
* allergy/intolerance to the study food or any of its ingredients;
* breastfeeding or pregnancy;
* \>10% weight loss in the past 6 months;
* smoking or alcohol abuse;
* participation in another clinical study within the past 6 months
**Maximum Age:** 70 Years
**Minimum Age:** 40 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Yu Zhang, PHD
**Phone:** 86-0571-88982211
**Role:** CONTACT
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M12684
- Name: Nutrition Disorders
- Relevance: HIGH
- As Found: Nutrition Disorders
### Condition Browse Module - Meshes
- ID: D000009748
- Term: Nutrition Disorders
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06422416
**Brief Title:** [Trial of device that is not approved or cleared by the U.S. FDA]
**Official Title:** [Trial of device that is not approved or cleared by the U.S. FDA]
#### Organization Study ID Info
**ID:** 5047
#### Organization
**Full Name:** [Redacted]
### Status Module
**Delayed Posting:** True
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** WITHHELD
#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module
#### Lead Sponsor
**Name:** [Redacted]
#### Responsible Party
**Old Name Title:** [Redacted]
**Old Organization:** [Redacted]
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06422403
**Acronym:** VALUE-CHECK
**Brief Title:** A Value-Driven Study on Reducing Immune Checkpoint Inhibitor Dosing Frequency in Advanced Cancers
**Official Title:** A Value-Driven Study on Reducing Immune Checkpoint Inhibitor Dosing Frequency in Advanced Cancers: Phase 2 Randomized Trial (VALUE-CHECK)
#### Organization Study ID Info
**ID:** 2024/00217
#### Organization
**Class:** OTHER
**Full Name:** National University Hospital, Singapore
### Status Module
#### Completion Date
**Date:** 2029-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-15
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2029-03-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-01
#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** National University Hospital, Singapore
#### 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:** This study is a prospective, open label, multi-centre phase 2 trial which assesses the efficacy and safety of standard dosing compared to extended dosing interval of nivolumab, atezolizumab or pembrolizumab in advanced/unresectable gastric/gastroesophageal junction/oesphageal adenocarcinomas with PDL1 CPS ≥5%, hepatocellular carcinoma andnon-small cell lung cancer with PDL1 TPS≥50% with no prior treatment. The investigators hypothesize that nivolumab, pembrolizumab and atezolizumab can be used efficiently at extended dosing intervals, compared to their approved labels with comparable clinical outcome.
**Detailed Description:** This study aims to assess the noninferiority of progression free survival of standard dosing compared to extended dosing interval of nivolumab, pembrolizumab and atezolizumab in advanced/unresectable gastric/gastroesophageal junction/oesphageal adenocarcinomas with PDL1 CPS ≥5%, hepatocellular carcinoma, non-small cell lung cancer with PDL1 TPS≥50% and locally advanced/metastatic head and neck squamous cell carcinoma with PDL1 CPS ≥1% that have no prior treatment.
Secondary Objective To investigate the safety, overall survival (OS) of ICI at extended dosing interval of the standard versus extended dosing interval groups.
Exploratory endpoints We would detect minimal residual disease (MRD) using multiomics and compare the progress of the disease or the outcome of patients besides clinical assessments.
### Conditions Module
**Conditions:**
- Carcinoma, Hepatocellular
- Gastric Adenocarcinoma
- GastroEsophageal Cancer
- Oesophageal Cancer
- Non-small Cell Lung Cancer
- Head and Neck Squamous Cell Carcinoma
**Keywords:**
- Nivolumab
- Atezolizumab
- Pembrolizumab
- Extended dosing interval
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** This study is a prospective, open label, multi-centre phase 2 trial
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 310
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Nivolumab, XELOX/FOLFOX
**Intervention Names:**
- Drug: Standard of Care - A
**Label:** Cohort A (SOC)
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** Nivolumab, XELOX/FOLFOX
**Intervention Names:**
- Drug: Extended Dosing Interval - A
**Label:** Cohort A (EDI)
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Bevacizumab, Atezolizumab
**Intervention Names:**
- Drug: Standard of Care - B
**Label:** Cohort B (SOC)
**Type:** ACTIVE_COMPARATOR
#### Arm Group 4
**Description:** Bevacizumab, Atezolizumab
**Intervention Names:**
- Drug: Extended Dosing Interval - B
**Label:** Cohort B (EDI)
**Type:** EXPERIMENTAL
#### Arm Group 5
**Description:** Pembrolizumab
**Intervention Names:**
- Drug: Standard of Care - C
**Label:** Cohort C (SOC)
**Type:** ACTIVE_COMPARATOR
#### Arm Group 6
**Description:** Pembrolizumab
**Intervention Names:**
- Drug: Extended Dosing Interval - C
**Label:** Cohort C (EDI)
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Cohort A (EDI)
**Description:** Nivolumab 360mg 6 weekly (up to 2 years) + XELOX Nivolumab 240mg 4 weekly (up to 2 years) + FOLFOX
**Name:** Extended Dosing Interval - A
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Cohort B (EDI)
**Description:** Bevacizumab + Atezolizumab 1200mg 6 weekly (up to 2 years)
**Name:** Extended Dosing Interval - B
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- Cohort C (EDI)
**Description:** Pembrolizumab 200mg 6 weekly (up to 2 years)
**Name:** Extended Dosing Interval - C
**Type:** DRUG
#### Intervention 4
**Arm Group Labels:**
- Cohort A (SOC)
**Description:** Nivolumab 360mg 3 weekly (up to 2 years) + XELOX Nivolumab 240mg 2 weekly (up to 2 years) + FOLFOX
**Name:** Standard of Care - A
**Type:** DRUG
#### Intervention 5
**Arm Group Labels:**
- Cohort B (SOC)
**Description:** Bevacizumab + Atezolizumab 1200mg 3 weekly (up to 2 years)
**Name:** Standard of Care - B
**Type:** DRUG
#### Intervention 6
**Arm Group Labels:**
- Cohort C (SOC)
**Description:** Pembrolizumab 200mg 3 weekly (up to 2 years)
**Name:** Standard of Care - C
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** PFS is defined as the time from date of first dosing until the date of objective disease progression as defined by Response Evaluation Criteria in Solid Tumor (RECIST 1.1) or death (by any cause in the absence of progression).
**Measure:** Progression-free survival (PFS)
**Time Frame:** Up to 2 years
#### Secondary Outcomes
**Description:** As defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
**Measure:** Number of participant with treatment related haematological and non-haematological toxicities
**Time Frame:** Up to 2 years
**Description:** Percentage of patients who have at least one confirmed response of 'complete response' or 'partial response' as defined by Response Evaluation Criteria in Solid Tumor (RECIST 1.1), that is confirmed at least 4 weeks later
**Measure:** Objective response rate
**Time Frame:** Up to 2 years
**Description:** Duration of response will be defined as the time from the date of first documented response, that is subsequently confirmed until the date of documented progression or death in the absence of disease progression, the end of response should coincide with the date of progression or death from any cause used for the PFS endpoint.
**Measure:** Duration of Response
**Time Frame:** Up to 2 years
**Description:** Disease control rate is defined as the proportion of patients with a best overall response of CR = complete response, PR = partial response, or SD = stable disease, as defined by Response Evaluation Criteria in Solid Tumor (RECIST 1.1)
**Measure:** Disease control rate
**Time Frame:** Up to 2 years
**Description:** Overall survival will be assessed based on the date of first dose and survival status at the time of analysis.
**Measure:** Overall survival
**Time Frame:** Up to 2 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Provision of informed consent prior to any study-specific procedure
2. Patients with one of the following:
* Cohort A: Previously untreated locally advanced/metastatic HER2 -ve gastric/gastroesophageal junction/esophageal (PDL1 CPS ≥5% adenocarcinomas not amenable to curative surgery or radiotherapy who are above to begin platinum double and nivolumab.
* Cohort B: Previously untreated locally advanced/metastatic Child's A hepatocellular carcinoma not amenable to curative surgery or radiotherapy who are above to begin atezolizumab and bevacizumab.
* Cohort C: Previously untreated locally advanced/metastatic lung adenocarcinoma (PDL1 TPS≥50%, EGFR/ALK wildtype) not amenable to curative surgery or radiotherapy who are above to begin pembrolizumab monotherapy
3. Measurable disease per RECIST 1.1 criteria
4. ECOG Performance status is 0-2
5. Normal organ and bone marrow function measured within 28 days before the study as defined below:
* Haemoglobin ≥ 8.0 g/dL and no blood transfusions in the 28 days prior to entry
* Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L
* No features suggestive of MDS/AML on peripheral blood smear
* White blood cells (WBC) \> 3x10\^9/L
* Platelet count ≥ 100 x 10\^9/L
* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)
* AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional upper limit of normal unless liver metastases are present in which case it must be ≤ 5x ULN
* Serum creatinine ≤ 1.5 x institutional upper limit of normal (ULN)
6. A life expectancy ≥ 12 weeks in all patients.
7. Females in childbearing age should be using adequate contraceptive measures, should not be breastfeeding and their pregnancy test prior to the start of treatment must be negative. Evidence of non-child-bearing potential is fulfilled by one of the following criteria at screening:
8. The post-menopausal period defined as age ≥50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments
9. Women \<50 years old they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with LH and FSH levels in the post-menopausal range.
10. Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not a tubal ligatio
11. Male patients should be willing to use barrier contraception
12. The patient is willing to comply with the protocol during the study including undergoing treatment and scheduled visits and examinations including follow up.
13. At least one lesion, not previously irradiated, that can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes which must have short axis ≥ 15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and is considered suitable for accurate repeated measurements
Exclusion Criteria:
1. Patients who have previously received immune checkpoint inhibitors or investigational monoclonal antibody therapy.
2. Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≥ 5 years
3. Unstable spinal cord compression/brain metastases unless asymptomatic and not requiring steroids for at least 2 weeks prior to the start of study treatment. For patients with brain metastases, gamma knife or stereotactic brain surgery is allowed prior to study treatment.
4. Major surgery within 4 weeks of starting study treatment and patients must have recovered from any effects of any major surgery. Minor surgery is allowed.
5. Severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which based on investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardise compliance with the protocol, or having active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic conditions is not required.
6. Autoimmune disorders
7. Males and females of reproductive potential who are not using an effective method of contraception and females who are pregnant or breastfeeding or have a positive serum pregnancy test prior to study entry
8. 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
9. Previous allogeneic bone marrow transplant.
**Maximum Age:** 99 Years
**Minimum Age:** 21 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Wei Peng Yong
**Phone:** +65 6908 2222
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Singapore
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Wei Peng Yong
- **Phone:** +65 6908 2222
- **Role:** CONTACT
**Country:** Singapore
**Facility:** Department of Hematology-Oncology, National University Hospita
#### Overall Officials
**Official 1:**
**Affiliation:** National University Hospital, Singapore
**Name:** Wei Peng Yong
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009375
- Term: Neoplasms, Glandular and Epithelial
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000009369
- Term: Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000002294
- Term: Carcinoma, Squamous Cell
- ID: D000000230
- Term: Adenocarcinoma
- ID: D000006258
- Term: Head and Neck Neoplasms
- ID: D000008113
- Term: Liver Neoplasms
- ID: D000004067
- Term: Digestive System Neoplasms
- 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: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M5534
- Name: Carcinoma
- Relevance: HIGH
- As Found: Carcinoma
- ID: M5550
- Name: Carcinoma, Squamous Cell
- Relevance: LOW
- As Found: Unknown
- ID: M3585
- Name: Adenocarcinoma
- Relevance: LOW
- As Found: Unknown
- ID: M9613
- Name: Carcinoma, Hepatocellular
- Relevance: HIGH
- As Found: Carcinoma, Hepatocellular
- ID: M11172
- Name: Lung Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M5546
- Name: Carcinoma, Non-Small-Cell Lung
- Relevance: LOW
- As Found: Unknown
- ID: M1689
- Name: Squamous Cell Carcinoma of Head and Neck
- Relevance: HIGH
- As Found: Head and Neck Squamous Cell Carcinoma
- ID: M12320
- Name: Neoplasms, Glandular and Epithelial
- Relevance: LOW
- As Found: Unknown
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
- ID: M9348
- Name: Head and Neck Neoplasms
- 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: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M11107
- Name: Liver Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T2141
- Name: Esophageal Cancer
- Relevance: HIGH
- As Found: Oesophageal Cancer
### Condition Browse Module - Meshes
- ID: D000002277
- Term: Carcinoma
- ID: D000077195
- Term: Squamous Cell Carcinoma of Head and Neck
- ID: D000006528
- Term: Carcinoma, Hepatocellular
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M246
- Name: Bevacizumab
- Relevance: LOW
- As Found: Unknown
- ID: M349416
- Name: Pembrolizumab
- Relevance: LOW
- As Found: Unknown
- ID: M1854
- Name: Nivolumab
- Relevance: LOW
- As Found: Unknown
- ID: M349417
- Name: Atezolizumab
- Relevance: LOW
- As Found: Unknown
- ID: M2342
- Name: Immune Checkpoint Inhibitors
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06422390
**Brief Title:** PRP for Rotator Cuff Tears
**Official Title:** Platelet - Rich Plasma Injections for Rotator Cuff Tears
#### Organization Study ID Info
**ID:** 24-8331
#### Organization
**Class:** OTHER
**Full Name:** Scripps Clinic
### Status Module
#### Completion Date
**Date:** 2025-07
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-15
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-06
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Scripps Clinic
#### Responsible Party
**Investigator Affiliation:** Scripps Clinic
**Investigator Full Name:** Laika Nur
**Investigator Title:** Clinical Assistant Professor of Orthopedic Surgery - Division of Sports Medicine
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Is US Export:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Regenerative medicine, specifically orthobiologics is a hot topic in the community and in Sports Medicine. Riding the hype curve of a new treatment can be great when offering new procedures to patients. However, as the excitement regarding potential benefits of orthobiologics grows, it is valuable to grow the body of literature on their safety and efficacy in various musculoskeletal conditions. Furthering the body of data regarding which musculoskeletal conditions may benefit most from these treatments and which may not can help guide physicians on when to incorporate orthobiologics into clinical practice. More robust data can help physicians guide patients and patient expectations when discussing treatment options.
Platelet rich plasma (PRP) in musculoskeletal medicine is most commonly used to treat tendinopathies and degenerative joint disease. The American Medical Society for Sports Medicine released a position statement in November of 2021 summarizing meta-analysis and systemic review data evaluating efficacy and major adverse events of PRP for tendinopathy and osteoarthritis1. At this time, the most robust data exists for lateral epicondylopathy as multiple randomized controlled trials demonstrate positive response to PRP. Gluteus medius tendinopathy and plantar fasciaopathy similarly have positive data. In Achilles tendinopathy, well designed RCTs have shown no difference between PRP and saline injections. These data should help guide physicians in responsible use and patient counseling.
Data from Hurley et al. suggest PRP may augment rotator cuff repair with improved rates of healing and reduced overall pain. However, there are limited high quality studies on the efficacy of PRP alone in partial rotator cuff tear. Partial rotator cuff tear is a common musculoskeletal complaint that can be treated with conservative measures such as physical therapy and corticosteroid injection. It can also be treated with surgical intervention if those modalities provide incomplete or inadequate pain relief and functional restoration. This study aims to evaluate if PRP is an efficacious treatment modality for partial rotator cuff tear.
### Conditions Module
**Conditions:**
- Rotator Cuff Tears
**Keywords:**
- PRP
### Design Module
#### Design Info
**Observational Model:** CASE_ONLY
**Time Perspective:** CROSS_SECTIONAL
#### Enrollment Info
**Count:** 76
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Adult patients with symptomatic partial rotator cuff tear of one rotator cuff tendon diagnosed on imaging with MRI or ultrasound.
**Intervention Names:**
- Biological: Platelet - Rich Plasma
**Label:** PRP Injection
#### Arm Group 2
**Description:** Adult patients with symptomatic partial rotator cuff tear of one rotator cuff tendon diagnosed on imaging with MRI or ultrasound.
**Label:** Placebo
### Interventions
#### Intervention 1
**Arm Group Labels:**
- PRP Injection
**Description:** Platelet - Rich Plasma is a biologic injection created from the patient's own blood. 52cc of the patient's blood is drawn then mixed with 8cc of anticoagulant. The blood mixture will be spun down using a centrifuge that can separate the platelet-rich plasma from the other contents in the blood. Once the centrifuge process is complete the Platelet - Rich Plasma is ready to be used.
**Name:** Platelet - Rich Plasma
**Type:** BIOLOGICAL
### Outcomes Module
#### Primary Outcomes
**Description:** Primary outcome: Improvement in patients' subjective pain and function as measured by the American Shoulder and Elbow Surgeons (ASES) score at 6 weeks, 12 weeks, 6 months, and 1 year.
**Measure:** Improvement of pain and function
**Time Frame:** June 2024 to June 2025
#### Secondary Outcomes
**Description:** Secondary Outcome: Improvement in visual analog scale (VAS) pain scores at 6 weeks, 12 weeks, 6 months, and 1 year. Additional secondary outcomes: Patients' perception of overall improvement with their shoulder, patient satisfaction with outcome, tendon healing assessed by ultrasound evaluation, progression to surgical management or other intervention such as corticosteroid injections (CSI), and association between volume of PRP and outcomes.
**Measure:** Improvement in VAS scores and patient satisfaction
**Time Frame:** June 2024 to June 2025
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Adult patients with symptomatic partial rotator cuff tear of one rotator cuff tendon diagnosed on imaging with MRI or ultrasound.
Exclusion Criteria:
* Patients who have had any an intervention within the past three months (CSI, PRP, prolotherapy), patient with previous surgical interventions on the same rotator cuff. Patients on aspirin who cannot discontinue medication for five weeks total. Patients who decline to discontinue anti-inflammatory medications or supplements for five weeks total. After identifying appropriate study participants and obtaining consent, participants will be randomized to either injection with sterile water without anesthetic or PRP injection without anesthetic. All injections will occur using US-guidance for placement of injection into tear. All participants will be asked to avoid NSAIDs, anti-inflammatory supplements for at least one week prior to injection and four weeks after injection. PRP patients will have 60cc of whole blood drawn and processed using Arthrex system using leukocyte poor protocol. This typically yields between 1-3cc of PRP. Volume of PRP will be noted by RN. Syringe will be occluded by RN performing draw and processing of PRP prior to procedure by MD. Injection will be performed using ultrasound guidance for proper placement into torn tendon. The placebo group will have 5-10cc of whole blood drawn and discarded to maintain double blind protocol prior to injection. 2cc sterile water will be drawn and syringe occluded by RN prior to procedure. Injection will be performed using ultrasound guidance for proper placement into torn tendon by MD. A power analysis showed that 33 patients will be needed in each group to detect a 20% improvement in ASES total scores by 6 months. We plan to enroll an additional 5 patients to each group in case any patients fail to return to all follow-up visits. Patients will complete the ASES and VAS at their procedure visit and all follow up visits (6 weeks, 12 weeks, 6 months, and 1 year). If participants miss in person follow up visits, these will be completed via phone or myscripps message with staff. Participates will also select their perceived percentage overall improvement at follow up visits. At 6 week follow up, patients will be encouraged to restart physical therapy or home exercise program in both groups.
**Maximum Age:** 90 Years
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Patients who are 18 years or older but 90 years or younger with a diagnosis of a symptomatic partial rotator cuff tear of one rotator cuff tendon.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Emily Martin, MBt
**Phone:** 858-554-7011
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Julie McCauley, MPh(c)
**Phone:** 858-554-7122
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** La Jolla
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Program Director, Clinical Research
- **Phone:** 858-554-7122
- **Role:** CONTACT
***Contact 2:***
- **Name:** Laika Nur, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Scripps Clinic - Torrey Pines
**State:** California
**Zip:** 92037
#### Overall Officials
**Official 1:**
**Affiliation:** Scripps Clinic Medical Group
**Name:** Laika Nur, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Finnoff JT, Awan TM, Borg-Stein J, Harmon KG, Herman DC, Malanga GA, Master Z, Mautner KR, Shapiro SA. American Medical Society for Sports Medicine Position Statement: Principles for the Responsible Use of Regenerative Medicine in Sports Medicine. Clin J Sport Med. 2021 Nov 1;31(6):530-541. doi: 10.1097/JSM.0000000000000973.
**PMID:** 34704973
**Citation:** Reilly P, Macleod I, Macfarlane R, Windley J, Emery RJ. Dead men and radiologists don't lie: a review of cadaveric and radiological studies of rotator cuff tear prevalence. Ann R Coll Surg Engl. 2006 Mar;88(2):116-21. doi: 10.1308/003588406X94968.
**PMID:** 16551396
**Citation:** Giovannetti de Sanctis E, Franceschetti E, De Dona F, Palumbo A, Paciotti M, Franceschi F. The Efficacy of Injections for Partial Rotator Cuff Tears: A Systematic Review. J Clin Med. 2020 Dec 25;10(1):51. doi: 10.3390/jcm10010051.
**PMID:** 33375716
**Citation:** Kwong CA, Woodmass JM, Gusnowski EM, Bois AJ, Leblanc J, More KD, Lo IKY. Platelet-Rich Plasma in Patients With Partial-Thickness Rotator Cuff Tears or Tendinopathy Leads to Significantly Improved Short-Term Pain Relief and Function Compared With Corticosteroid Injection: A Double-Blind Randomized Controlled Trial. Arthroscopy. 2021 Feb;37(2):510-517. doi: 10.1016/j.arthro.2020.10.037. Epub 2020 Oct 28.
**PMID:** 33127554
**Citation:** Fitzpatrick J, Bulsara M, Zheng MH. The Effectiveness of Platelet-Rich Plasma in the Treatment of Tendinopathy: A Meta-analysis of Randomized Controlled Clinical Trials. Am J Sports Med. 2017 Jan;45(1):226-233. doi: 10.1177/0363546516643716. Epub 2016 Jul 21.
**PMID:** 27268111
**Citation:** Prodromos CC, Finkle S, Prodromos A, Chen JL, Schwartz A, Wathen L. Treatment of Rotator Cuff Tears with platelet rich plasma: a prospective study with 2 year follow-up. BMC Musculoskelet Disord. 2021 May 29;22(1):499. doi: 10.1186/s12891-021-04288-4.
**PMID:** 34051761
**Citation:** DeLong JM, Russell RP, Mazzocca AD. Platelet-rich plasma: the PAW classification system. Arthroscopy. 2012 Jul;28(7):998-1009. doi: 10.1016/j.arthro.2012.04.148.
**PMID:** 22738751
**Citation:** Kesikburun S, Tan AK, Yilmaz B, Yasar E, Yazicioglu K. Platelet-rich plasma injections in the treatment of chronic rotator cuff tendinopathy: a randomized controlled trial with 1-year follow-up. Am J Sports Med. 2013 Nov;41(11):2609-16. doi: 10.1177/0363546513496542. Epub 2013 Jul 26.
**PMID:** 23893418
**Citation:** Sung CM, Hah YS, Kim JS, Nam JB, Kim RJ, Lee SJ, Park HB. Cytotoxic effects of ropivacaine, bupivacaine, and lidocaine on rotator cuff tenofibroblasts. Am J Sports Med. 2014 Dec;42(12):2888-96. doi: 10.1177/0363546514550991. Epub 2014 Oct 8.
**PMID:** 25296645
**Citation:** Honda H, Gotoh M, Kanazawa T, Nakamura H, Ohta K, Nakamura K, Shiba N. Effects of lidocaine on torn rotator cuff tendons. J Orthop Res. 2016 Sep;34(9):1620-7. doi: 10.1002/jor.23153. Epub 2016 Feb 11.
**PMID:** 26742649
**Citation:** Chen X, Jones IA, Park C, Vangsness CT Jr. The Efficacy of Platelet-Rich Plasma on Tendon and Ligament Healing: A Systematic Review and Meta-analysis With Bias Assessment. Am J Sports Med. 2018 Jul;46(8):2020-2032. doi: 10.1177/0363546517743746. Epub 2017 Dec 21.
**PMID:** 29268037
**Citation:** Rossi LA, Piuzzi N, Giunta D, Tanoira I, Brandariz R, Pasqualini I, Ranalletta M. Subacromial Platelet-Rich Plasma Injections Decrease Pain and Improve Functional Outcomes in Patients With Refractory Rotator Cuff Tendinopathy. Arthroscopy. 2021 Sep;37(9):2745-2753. doi: 10.1016/j.arthro.2021.03.079. Epub 2021 Apr 20.
**PMID:** 33892072
**Citation:** Thepsoparn M, Thanphraisan P, Tanpowpong T, Itthipanichpong T. Comparison of a Platelet-Rich Plasma Injection and a Conventional Steroid Injection for Pain Relief and Functional Improvement of Partial Supraspinatus Tears. Orthop J Sports Med. 2021 Sep 1;9(9):23259671211024937. doi: 10.1177/23259671211024937. eCollection 2021 Sep.
**PMID:** 34485587
**Citation:** Snow M, Hussain F, Pagkalos J, Kowalski T, Green M, Massoud S, James S. The Effect of Delayed Injection of Leukocyte-Rich Platelet-Rich Plasma Following Rotator Cuff Repair on Patient Function: A Randomized Double-Blind Controlled Trial. Arthroscopy. 2020 Mar;36(3):648-657. doi: 10.1016/j.arthro.2019.09.026. Epub 2019 Nov 27.
**PMID:** 31784365
**Citation:** Chen X, Jones IA, Togashi R, Park C, Vangsness CT Jr. Use of Platelet-Rich Plasma for the Improvement of Pain and Function in Rotator Cuff Tears: A Systematic Review and Meta-analysis With Bias Assessment. Am J Sports Med. 2020 Jul;48(8):2028-2041. doi: 10.1177/0363546519881423. Epub 2019 Nov 19.
**PMID:** 31743037
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012421
- Term: Rupture
- ID: D000014947
- Term: Wounds and Injuries
- ID: D000070599
- Term: Shoulder Injuries
- ID: D000013708
- Term: Tendon Injuries
### Condition Browse Module - Browse Branches
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M15241
- Name: Rupture
- Relevance: LOW
- As Found: Unknown
- ID: M22785
- Name: Lacerations
- Relevance: LOW
- As Found: Unknown
- ID: M624
- Name: Rotator Cuff Injuries
- Relevance: HIGH
- As Found: Rotator Cuff Tears
- ID: M17685
- Name: Wounds and Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M602
- Name: Shoulder Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M16479
- Name: Tendon Injuries
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000070636
- Term: Rotator Cuff Injuries
### Intervention Browse Module - Browse Branches
- Abbrev: AnCoag
- Name: Anticoagulants
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M4244
- Name: Anticoagulants
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06422377
**Brief Title:** A Study Evaluating Soticlestat in Participants With Dravet Syndrome or Lennox-Gastaut Syndrome Who Have Been Exposed to Fenfluramine
**Official Title:** An Open-label, Nonrandomized, Phase 3 Study to Evaluate the Efficacy and Safety of Soticlestat in Participants With Dravet Syndrome or Lennox-Gastaut Syndrome Who Have Been Exposed to Fenfluramine
#### Organization Study ID Info
**ID:** TAK-935-3004
#### Organization
**Class:** INDUSTRY
**Full Name:** Takeda
#### Secondary ID Infos
**Domain:** EU CTIS
**ID:** 2023-504104-29
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2027-01-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-15
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2027-01-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-04-25
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Takeda
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Is US Export:** False
### Description Module
**Brief Summary:** The purpose of this study is to check how soticlestat impacts symptoms of Dravet syndrome \[DS\] and Lennox-Gastaut syndrome \[LGS\] in participants who have been exposed to fenfluramine.
**Detailed Description:** The drug being tested in this study is called soticlestat. Soticlestat is being tested to treat people who have DS or LGS and have been exposed to fenfluramine. This study will assess the efficacy and safety of soticlestat in addition to standard care in the treatment of DS or LGS.
The study will enroll approximately 45 patients. This study comprises a screening period of up to 6 weeks, a 4-week titration period, a 48-week maintenance period, a taper period of up to 1 week and a follow-up safety visit. Participants will be enrolled to receive soticlestat along with the standard of care:
• Soticlestat 100-300 mg
Participants will receive oral administration of soticlestat Dose 1 (days 1 to 7), Dose 2 (days 8 to 14), and Dose 3 (Days 15 to 28) with a minimum dose of 100 mg to a maximum dose of 300 mg depending on participant's body weight in the titration period followed by maintenance period up to end of treatment (up to approximately 52 weeks). Percent change from baseline in convulsive in participants with DS and major motor drop (MMD) in participants with LGS seizure frequency per 28 days during the initial 12 weeks of the maintenance period will be assessed.
This multi-center trial will be conducted in the United Kingdom and Europe. The overall time to participate in this study is approximately 60 weeks. Participants will make multiple visits to the clinic and will be followed up for safety by visiting the clinic or by telephone approximately 2 weeks after the last dose of the study drug.
### Conditions Module
**Conditions:**
- Dravet Syndrome (DS)
- Lennox-Gastaut Syndrome (LGS)
**Keywords:**
- Drug Therapy
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 45
**Type:** ESTIMATED
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants with DS or LGS will receive soticlestat, mini-tablets, at the starting dose of 100 mg to 300 mg, administered orally with or without food (oral or enteral feeds), twice daily (BID) based on body weight up to 4 weeks in Titration Period. Participants will continue to receive the dose that they are on at the end of the titration period, for first 12 weeks in the Maintenance Period. The dose can be adjusted in the maintenance period as per the body weight after the initial 12 weeks. Dose will be tapered down if participants decide to discontinue the treatment. Total duration of the treatment will be up to approximately 52 weeks.
**Intervention Names:**
- Drug: Soticlestat
**Label:** Soticlestat
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Soticlestat
**Description:** Soticlestat tablets or mini-tablets
**Name:** Soticlestat
**Other Names:**
- TAK-935
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Measure:** Percent Change from Baseline in Convulsive Seizure Frequency per 28 days During First 12 Weeks of Maintenance Period for DS Participants
**Time Frame:** Baseline to Week 12 of Maintenance Period
**Measure:** Percent Change from Baseline in Major Motor Drop (MMD) Seizure Frequency per 28 days During First 12 Weeks of Maintenance Period for LGS Participants
**Time Frame:** Baseline to Week 12 of Maintenance Period
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. The participant has been exposed to fenfluramine (currently on or used previously).
2. The participant has a clinical diagnosis of LGS and a history of, on average, ≥12 MMD seizures in the last 90 days immediately before screening based on historical information, and the participant has ≥4 MMD seizures during a minimum of 4 weeks of seizure data collection during the prospective baseline period.
3. The participant is currently taking 0 to 5 antiseizure treatments (eg. antiseizure medications \[ASMs\], vagus nerve stimulation \[VNS\], ketogenic diet) at stable doses.
Exclusion Criteria:
1. The participant is currently enrolled in a clinical study involving an investigational product or treatment device (ie, not approved in that country, other than soticlestat), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. Note: Compatibility will be determined on the basis of consultation with the sponsor/designee.
2. The participant has a known hypersensitivity to any component of the soticlestat formulation.
3. Participants aged ≥6 years who have positive answers on item numbers 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) before dosing are excluded. This scale will only be administered to participants aged ≥6 years at the time of enrollment or participants who turn 6 after enrollment.
**Maximum Age:** 65 Years
**Minimum Age:** 2 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Takeda Contact
**Phone:** +1-877-825-3327
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Dianalund
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Site Contact
- **Phone:** +4558264200
- **Role:** CONTACT
***Contact 2:***
- **Name:** Cathrine Elisabeth Gjerulfsen
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Denmark
**Facility:** Epilepsihospitalet Filadelfia
**State:** Zealand
**Status:** RECRUITING
**Zip:** 4293
**Location 2:**
**City:** Cardiff
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Site Contact
- **Phone:** +442920715434
- **Role:** CONTACT
***Contact 2:***
- **Name:** Khalid Hamandi
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United Kingdom
**Facility:** University Hospital of Wales
**State:** Wales
**Status:** RECRUITING
**Zip:** CF14 4XW
#### Overall Officials
**Official 1:**
**Affiliation:** Takeda
**Name:** Study Director
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**Access Criteria:** IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
**Description:** Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
**Info Types:**
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
**IPD Sharing:** YES
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000004194
- Term: Disease
- ID: D000010335
- Term: Pathologic Processes
- ID: D000004829
- Term: Epilepsy, Generalized
- ID: D000004827
- Term: Epilepsy
- ID: D000001927
- Term: Brain Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000073376
- Term: Epileptic Syndromes
- ID: D000030342
- Term: Genetic Diseases, Inborn
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC16
- Name: Diseases and Abnormalities at or Before Birth
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M16355
- Name: Syndrome
- Relevance: HIGH
- As Found: Syndrome
- ID: M30593
- Name: Lennox Gastaut Syndrome
- Relevance: HIGH
- As Found: Lennox-Gastaut Syndrome
- ID: M7983
- Name: Epilepsy
- Relevance: LOW
- As Found: Unknown
- ID: M7987
- Name: Epilepsies, Myoclonic
- Relevance: HIGH
- As Found: Dravet Syndrome
- ID: M7985
- Name: Epilepsy, Generalized
- 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: M1165
- Name: Epileptic Syndromes
- Relevance: LOW
- As Found: Unknown
- ID: M23686
- Name: Genetic Diseases, Inborn
- Relevance: LOW
- As Found: Unknown
- ID: T1938
- Name: Dravet Syndrome
- Relevance: HIGH
- As Found: Dravet Syndrome
- ID: T1024
- Name: CDKL5 Deficiency Disorder
- Relevance: HIGH
- As Found: Dravet Syndrome
- ID: T3371
- Name: Lennox-Gastaut Syndrome
- Relevance: HIGH
- As Found: Lennox-Gastaut Syndrome
### Condition Browse Module - Meshes
- ID: D000004831
- Term: Epilepsies, Myoclonic
- ID: D000065768
- Term: Lennox Gastaut Syndrome
- ID: D000013577
- Term: Syndrome
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M8414
- Name: Fenfluramine
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06422364
**Brief Title:** Assessment of the Safety and Efficacy of Weighted Wearable Blankets in Healthy Infants During Sleep
**Official Title:** Assessment of the Safety and Efficacy of Weighted Wearable Blankets in Healthy Infants During Sleep
#### Organization Study ID Info
**ID:** 21638
#### Organization
**Class:** OTHER
**Full Name:** Indiana University
### Status Module
#### Completion Date
**Date:** 2025-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-15
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-04-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-26
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** Dreamland Baby Co.
#### Lead Sponsor
**Class:** OTHER
**Name:** Indiana University
#### Responsible Party
**Investigator Affiliation:** Indiana University
**Investigator Full Name:** Harish Rao
**Investigator Title:** Assistant Professor of Clinical Pediatrics
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** True
**Is FDA Regulated Drug:** False
**Is Unapproved Device:** True
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The goal of this clinical trial is to assess the risk of an infant overheating and/or experiencing lowered respiration via measurement of vital signs in a controlled clinical environment while wearing a weighted wearable blanket in male/female infant healthy volunteers, 0-12 months of age.
The main questions it aims to answer are:
Primary Objective: To pilot an investigation on the impact of weighted wearable blankets on vital signs and infant movement in healthy infants during nap polysomnogram.
Secondar Objective: To investigate the efficacy of weighted wearable blankets on sleep patterns in healthy infants during overnight sleep.
**Detailed Description:** To date, there is no evaluation of the safety or efficacy of weighted wearable blankets on healthy infants during overnight use in the peer-reviewed scientific literature. These are the conditions in which these products are used by consumers, with infants sleeping unobserved throughout the night. Given the rising popularity in the use of weighted wearable blankets in infants and the risk speculated, a study of the potential impact of weighted wearable blankets on infant vital signs is warranted.
Study Design: Direct observational pilot study of the safety of weighted wearable blankets on a minimum (10) healthy infants aged 0-12 months with nap polysomnogram. Participants will be placed in a weighted wearable blanket, in accordance with their age/weight/height, by their parent or caregiver under the supervision of a member of the study team. After being put to sleep on their back, the participant will remain in the weighted wearable blanket until completion of the nap polysomnogram.
There are stopping parameters (outlined elsewhere) that will be used for this study. If any of the stopping parameters are met, the weighted blanket will be opened to assess if the weighted blanket is responsible for the change. If determined yes, the weighted blanket will be removed and the nap polysomnogram will be terminated.
### Conditions Module
**Conditions:**
- Sleep
**Keywords:**
- Sleep
- Healthy
- Infant
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 10
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Weighted wearable blanket, provided by Dreamland Baby Co.
**Intervention Names:**
- Device: Weighted Wearable Blanket provided by Dreamland Baby Co.
**Label:** Pilot
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Pilot
**Description:** All infants will be placed in a weighted wearable blanket, provided by Dreamland Baby Co., and complete a nap polysomnogram.
**Name:** Weighted Wearable Blanket provided by Dreamland Baby Co.
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Measured by EKG
**Measure:** Heart Rate
**Time Frame:** Day 1, during polysomnogram, up to 8 hours
**Description:** Measured by Respiratory effort belts
**Measure:** Respiratory Rate
**Time Frame:** Day 1, during polysomnogram, up to 8 hours
**Description:** Manually measured by ear thermometer
**Measure:** Body Temperature
**Time Frame:** Day 1, during polysomnogram, up to 8 hours
**Description:** Measured by pulse oximetry
**Measure:** Oxygen Saturation
**Time Frame:** Day 1, during polysomnogram, up to 8 hours
**Description:** The clinical technician will be asked to report any observed infant movements during the polysomnogram. The technician will report either Yes or No to this question.
**Measure:** Number of Infants with Observed Head Movement
**Time Frame:** Day 1, during polysomnogram, up to 8 hours
**Description:** The clinical technician will be asked to report any observed infant movements during the polysomnogram. The technician will report either Yes or No to this question.
**Measure:** Number of Infants with Observed Arm Movement
**Time Frame:** Day 1, during polysomnogram, up to 8 hours
**Description:** The clinical technician will be asked to report any observed infant movements during the polysomnogram. The technician will report either Yes or No to this question.
**Measure:** Number of Infants with Observed Body Movement
**Time Frame:** Day 1, during polysomnogram, up to 8 hours
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Ability of parent, caregiver or legal guardian/representative to understand a written informed consent document and choose to participate in the study
* 0-12 months of age
* Weight greater than or equal to 8 pounds
* Gestational age 37 weeks or greater
* Health status: healthy infant without underlying cardiac, neurological, or pulmonary disorders
* Infant is naive to a weighted wearable blanket
Exclusion Criteria:
* Health status: medical diagnosis associated with underlying cardiac, neurological, or pulmonary disorder
* Weight \< 8 pounds
* Gestational age \< 37 weeks
* Gestational use of marijuana, alcohol, or illicit drugs
* Home environment: use of cigarettes, vaping, e-cigarettes, or marijuana
* Infant is not naive to a weighted wearable blanket
**Healthy Volunteers:** True
**Maximum Age:** 12 Months
**Minimum Age:** 1 Day
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Lori Trotter, RN
**Phone:** 317-278-7121
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Lisa Bendy, BA
**Phone:** 317-278-7152
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Indianapolis
**Contacts:**
***Contact 1:***
- **Name:** Harish Rao, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Riley Hospital for Children at Indiana University Health
**State:** Indiana
**Status:** RECRUITING
**Zip:** 46202
#### Overall Officials
**Official 1:**
**Affiliation:** Riley Hospital for Children at Indiana University Health
**Name:** Harish Rao, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M5114
- Name: Body Weight
- Relevance: HIGH
- As Found: Weighted
### Condition Browse Module - Meshes
- ID: D000001835
- Term: Body Weight
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06422351
**Brief Title:** Clinical Trial to Evaluate the Efficacy of Gene Therapy for Pyruvate Kinase Deficiency
**Official Title:** A Phase 2 Clinical Trial to Evaluate the Efficacy of the Infusion of Autologous CD34+ Cells Transduced With a Lentiviral Vector Carrying the Codon Optimized Red Cell Pyruvate Kinase (coRPK) Gene in Subjects With Pyruvate Kinase Deficiency
#### Organization Study ID Info
**ID:** RP-L301-0124
#### Organization
**Class:** INDUSTRY
**Full Name:** Rocket Pharmaceuticals Inc.
### Status Module
#### Completion Date
**Date:** 2029-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-11
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-08
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Rocket Pharmaceuticals Inc.
#### 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 an open-label Phase II trial to evaluate the efficacy of a hematopoietic cell-based gene therapy for patients with Pyruvate Kinase Deficiency (PKD).
**Detailed Description:** Autologous hematopoietic stem cells from mobilized peripheral blood will be transduced ex vivo (outside the body) with a lentiviral vector carrying a correct copy of the deficient PKLR (Pyruvate Kinase L/R) gene. The corrected stem cells will be infused intravenously back into the patient to correct the hematological manifestations of the disease.
### Conditions Module
**Conditions:**
- Pyruvate Kinase Deficiency
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 10
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** RP-L301 is a gene therapy product containing autologous genetically modified CD34+ hematopoietic stem cells containing the corrected PKLR (Pyruvate Kinase L/R) gene
**Intervention Names:**
- Biological: RP-L301
**Label:** Participant Group/Arm
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Participant Group/Arm
**Description:** Autologous genetically modified CD34+ hematopoietic stem cells containing the corrected PKLR (Pyruvate Kinase L/R) gene
**Name:** RP-L301
**Other Names:**
- Intervention/Treatment
**Type:** BIOLOGICAL
### Outcomes Module
#### Primary Outcomes
**Description:** Hemoglobin (Hb) level increase of ≥1.5g/dL at 12 months post-infusion, compared to baseline.
**Measure:** Improvement in Anemia
**Time Frame:** 12 months post-infusion
#### Secondary Outcomes
**Description:** Time to Hemoglobin level increase of ≥1.5g/dL post-infusion, compared to baseline.
**Measure:** Durability Improvement anemia sustained
**Time Frame:** 24 months post-infusion
**Description:** Hemoglobin level within normal range (≥ lower limit of normal) at 12 months post-infusion.
**Measure:** Resolution of anemia
**Time Frame:** 12 months post-infusion
**Description:** * a: ≥50% reduction in Pyruvate Kinase Deficiency (PKD)-related Red Blood Cells (RBC) transfusion requirements in the 12 months post-infusion, relative to the annualized event rate for 24 months prior to enrollment; or,
* b: Absence of PKD-related RBC transfusion requirements in the 12 months post-infusion.
**Measure:** Reduction of transfusion requirements
**Time Frame:** 12 months post-infusion
**Description:** Improvements in bilirubin, each evaluated at 12 months post-infusion, compared to baseline.
**Measure:** Improvements of hemolysis parameters (bilirubin)
**Time Frame:** 12 months post-infusion
**Description:** Improvements in Lactate Dehydrogenase (LDH), each evaluated at 12 months post-infusion, compared to baseline.
**Measure:** Improvements of hemolysis parameters (Lactate Dehydrogenase (LDH))
**Time Frame:** 12 months post-infusion
**Description:** Improvements in erythropoietin, each evaluated at 12 months post-infusion, compared to baseline.
**Measure:** Improvements of hemolysis parameters (erythropoietin)
**Time Frame:** 12 months post-infusion
**Description:** Improvements in reticulocyte, each evaluated at 12 months post-infusion, compared to baseline.
**Measure:** Improvements of hemolysis parameters (reticulocyte)
**Time Frame:** 12 months post-infusion
**Description:** Genetic correction demonstrated by vector copy number (VCN) of 0.1 in Peripheral Blood mononuclear cells, evaluated at 12 months post-infusion.
**Measure:** Peripheral blood genetic correction
**Time Frame:** 12 months post-infusion
**Description:** Improvement in fatigue as compared with baseline, as assessed by:
* Age ≥18: FACIT Fatigue; or,
* Age \<18: PROMIS Fatigue Short Form 10a
**Measure:** Improvement in fatigue
**Time Frame:** 12 months post-infusion
**Description:** Improvement in Pyruvate Kinase Deficiency symptoms, compared with baseline, as assessed by:
* PROMIS Dyspnea Severity SF10; or,
* Dyspnea severity
**Measure:** Improvement in dyspnea
**Time Frame:** 12 months post-infusion
**Description:** Improvement in Pyruvate Kinase Deficiency symptoms, compared with baseline, as assessed by:
* jaundice severity evaluated at 12 months post-infusion; or,
* and jaundice severity
**Measure:** Improvement in jaundice
**Time Frame:** 12 months post-infusion
**Description:** Incidence, type, severity, frequency, time to onset, and duration of treatment emergent adverse events (TEAEs), serious adverse events (SAEs), clinical laboratory abnormalities, and adverse events of special interest (AESIs).
**Measure:** Safety and tolerability of RP-L301
**Time Frame:** 24 months post-infusion
**Description:** Hemoglobin (Hb) level within normal range (≥ lower limit of normal).
**Measure:** Evaluate durable resolution of anemia
**Time Frame:** 24 months post-infusion
**Description:** 1. ≥50% reduction in Pyruvate Kinase Deficiency (PKD)-related Red Blood Cell (RBC) transfusion requirements in the 24 months post-infusion, relative to the annualized event rate for 24 months prior to enrollment; or,
2. Absence of PKD-related RBC transfusion requirements in the 24 months post-infusion.
**Measure:** Evaluate durable resolution of transfusion requirements (where relevant).
**Time Frame:** 24 months post-infusion
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria
1. Pyruvate Kinase Deficiency (PKD) diagnosis with a confirmed PK-LR mutation
2. Significant anemia defined as:
* Hemoglobin (Hb) levels \<9.5 g/dL documented during 2 or more assessments in the 12 months prior to screening and either:
1. at least 6 Red Blood Cell (RBC) transfusion episodes over the 12- month period prior to screening or
2. at least 3 Red Blood Cell (RBC) transfusion episodes each year for 2 years prior to screening; or
* Hemoglobin (Hb) levels \<8.5 g/dL irrespective of transfusions (documented during 2 or more assessments during the prior 2 years); or
* Hemoglobin (Hb) levels \<10.0 g/dL irrespective of transfusions (documented during 2 or more assessments during the prior 2 years) and the presence of either:
* Fatigue or energy-related symptoms limiting activities of daily living (The National Cancer Institute Common Terminology Criteria for Adverse Events v 5.0 (NCI CTCAE v5.0 grade 3)); or
* Fatigue or energy-related symptoms limiting activities of daily living (The National Cancer Institute Common Terminology Criteria for Adverse Events v 5.0 (NCI CTCAE v5.0 grade 2)) not responsive to available medical therapy; or
* Icterus limiting social interactions, education or work activities and not responsive to available medical therapy;
3. Subject age: age ≥8 years and ≤55 years
4. Prior splenectomy
5. Adequate cardiac, pulmonary, renal and hepatic function, as detailed in relevant exclusion criteria
6. Availability of detailed medical records, including accurate transfusion history and blood count assessments, for the prior 2 years
7. Willing and able to read and correctly understand the patient information sheet and provide consent (or informed assent for minors) regarding study participation, willing and able to comply with all study-related procedures including follow-up visits.
8. Negative serum pregnancy test for female subjects of childbearing potential.
Exclusion Criteria
1. Presence of other known causes of hemolysis (in addition to Pyruvate Kinase Deficiency (PKD)). Patients with concurrent G6PD deficiency diagnosed during pre-study evaluation may be considered for eligibility if in the opinion of the Investigator, the hemolytic anemia is the result of PKD and the Glucose-6-phosphate dehydrogenase (G6PD) deficiency is considered an incidental finding.
2. A venous thromboembolic event (VTE; i.e., pulmonary embolism or deep vein thrombosis) or arteriothromboembolic event (ATE; including unstable angina, myocardial infarction, stroke or transient ischemic attack) during the prior 12 months.
3. Evidence of bridging fibrosis, cirrhosis or active hepatitis on liver biopsy.
1. Liver biopsy is required when liver iron concentration (LIC) is ≥15 mg/g on T2\* magnetic resonance imaging (MRI) of liver.
2. If a liver biopsy has been performed less than 6 months prior to enrollment, it does not need to be repeated.
4. Cardiac T2\* \<10 ms by magnetic resonance imaging (MRI) or left ventricular ejection fraction (LVEF) \<45% by echocardiogram or multiple gated acquisition scan (MUGA).
5. Any evidence of severe iron overload beyond parameters stipulated in exclusion criteria 3 and 4 that, per Investigator discretion, warrants exclusion.
6. Significant medical conditions including documented HIV (human immunodeficiency virus) infection, active viral hepatitis, poorly controlled hypertension, pulmonary hypertension, cardiac arrhythmia or congestive heart failure; or arteriothromboembolic events (ATEs) (including stroke or myocardial infarction) within the 12 prior months.
7. Active hematologic or solid organ malignancy, not including non-melanoma skin cancer or another carcinoma in situ. Patients with previously resected solid organ malignancies or definitively treated hematologic malignancies may be eligible if there has been no evidence of active malignancy during the prior 3 years.
8. Uncontrolled seizure disorder.
9. Hepatic dysfunction as defined by Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2.5× the upper limit normal (ULN).
10. Renal dysfunction defined as serum creatinine \>upper limit normal (ULN). Patients with creatinine above ULN may be eligible pending documentation of a glomerular filtration rate ≥60 mL/min/1.73m2 as calculated by Modification of Diet in Renal Disease equation (Stevens 2006), or 24-hour urine collection.
11. Pulmonary dysfunction as defined by either:
1. Need for supplemental oxygen during the prior 2 weeks (in absence of acute infection) OR
2. Clinically significant pulmonary disease that may impair ability to tolerate study procedures and treatments.
12. Any medical or other contraindication for leukapheresis as determined by the treating Investigator.
13. Any medical or psychiatric condition that in the opinion of the Investigator renders the patient unfit for trial participation or at higher than acceptable risk for participation.
14. Poor functional status evidenced by Karnofsky Index \<70 in subjects ≥16 years old and Lansky Play-Performance Scale \<70 in subjects \<16 years old.
15. Participation in another clinical trial with an investigational drug within 14 days before the informed consent signature. Participation in observational studies is allowed. Patients who are receiving mitapivat in non-investigational settings are eligible provided they discontinue mitapivat at least 90 days prior to the start of mobilization.
16. Pregnant women or women with a positive serum pregnancy test at screening or breast feeding or planning to become pregnant within the next 24 months. Female participants or female partners of male participants not willing to use highly effective contraceptive methods during the complete study period.
17. Previous allogeneic or other hematopoietic stem cell transplant.
**Maximum Age:** 55 Years
**Minimum Age:** 8 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Rocket Clinical Trials
**Phone:** 646-627-0033
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Palo Alto
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Ami Shah, MD
- **Phone:** 650-497-8953
- **Role:** CONTACT
***Contact 2:***
- **Name:** Ami J. Shah, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Stanford University
**State:** California
**Zip:** 94305
**Location 2:**
**City:** Madrid
**Country:** Spain
**Facility:** Hospital Infantil Universitario Niño Jesús
**Zip:** 28009
**Location 3:**
**City:** Madrid
**Country:** Spain
**Facility:** Hospital Universitario Fundación Jiménez Díaz
#### Overall Officials
**Official 1:**
**Affiliation:** Stanford University
**Name:** Ami Shah, MD
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** Hospital Infantil Universitario Niño Jesús
**Name:** Julian Sevilla Navarro, MD, PhD
**Role:** PRINCIPAL_INVESTIGATOR
**Official 3:**
**Affiliation:** Hospital Universitario Fundación Jiménez Díaz
**Name:** José Luis López Lorenzo, MD
**Role:** PRINCIPAL_INVESTIGATOR
**Official 4:**
**Affiliation:** Rocket Pharmaceuticals Inc.
**Name:** Elieen Nicoletti, MD
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000000745
- Term: Anemia, Hemolytic, Congenital
- ID: D000000743
- Term: Anemia, Hemolytic
- ID: D000000740
- Term: Anemia
- ID: D000006402
- Term: Hematologic Diseases
- ID: D000030342
- Term: Genetic Diseases, Inborn
- ID: D000002239
- Term: Carbohydrate Metabolism, Inborn Errors
- ID: D000008661
- Term: Metabolism, Inborn Errors
- ID: D000008659
- Term: Metabolic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC15
- Name: Blood and Lymph Conditions
- Abbrev: All
- Name: All Conditions
- Abbrev: BC16
- Name: Diseases and Abnormalities at or Before Birth
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M4070
- Name: Anemia
- Relevance: LOW
- As Found: Unknown
- ID: M4076
- Name: Anemia, Hemolytic, Congenital Nonspherocytic
- Relevance: HIGH
- As Found: Pyruvate Kinase Deficiency
- ID: M9547
- Name: Hemolysis
- Relevance: LOW
- As Found: Unknown
- ID: M4073
- Name: Anemia, Hemolytic
- Relevance: LOW
- As Found: Unknown
- ID: M4075
- Name: Anemia, Hemolytic, Congenital
- Relevance: LOW
- As Found: Unknown
- ID: M18016
- Name: Pyruvate Metabolism, Inborn Errors
- Relevance: HIGH
- As Found: Pyruvate Kinase Deficiency
- ID: M11641
- Name: Metabolism, Inborn Errors
- Relevance: LOW
- As Found: Unknown
- ID: M9490
- Name: Hematologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M23686
- Name: Genetic Diseases, Inborn
- Relevance: LOW
- As Found: Unknown
- ID: M5498
- Name: Carbohydrate Metabolism, Inborn Errors
- Relevance: LOW
- As Found: Unknown
- ID: M11639
- Name: Metabolic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T4852
- Name: Pyruvate Kinase Deficiency
- Relevance: HIGH
- As Found: Pyruvate Kinase Deficiency
### Condition Browse Module - Meshes
- ID: D000000746
- Term: Anemia, Hemolytic, Congenital Nonspherocytic
- ID: D000015323
- Term: Pyruvate Metabolism, Inborn Errors
### Intervention Browse Module - Browse Branches
- Abbrev: Ot
- Name: Other Dietary Supplements
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: T424
- Name: Pyruvate
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06422338
**Brief Title:** A Rapid Triage Test to Improve Risk-stratification of Febrile Children (EChiLiBRiST, Clinical Trial 1, Outpatients)
**Official Title:** A Multi-country, Two-arm, Open-label, Superiority, Randomised Controlled Trial to Study the Performance of a Rapid Triage Test Compared to Standard of Care (IMCI-based) to Guide Admission/Discharge Decisions During the First Clinical Assessment of Children With Fever
#### Organization Study ID Info
**ID:** EChiLiBRiST CT1
#### Organization
**Class:** OTHER
**Full Name:** Barcelona Institute for Global Health
### Status Module
#### Completion Date
**Date:** 2027-03-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-12-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-12-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Barcelona Institute for Global Health
#### 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 overall aim of the study is to provide evidence that introducing soluble triggering receptor expressed on myeloid cells-1 (sTREM-1) evaluation at triaging (first clinical assessment), in combination with IMCI-based guidelines (SoC), is a viable strategy to enhance rapid and accurate identification of febrile children at increased risk of life-threatening infections compared to IMCI-based strategies alone (SoC), and to demonstrate whether this results in enhanced decisions of admission/referral vs discharge, and enhanced overall health outcome of children with acute fever in sub-Saharan Africa.
**Detailed Description:** This is a multi-country, open label, two-arm, parallel-group, superiority, individually randomised clinical trial involving 2,606 febrile children per country (two countries, total n=5212). The trial will compare the performance of a point-of-care rapid triage test (POC-RTT) based on sTREM-1 levels (i.e. B-Triage) (in combination with IMCI-based strategies, which are the SoC) to appropriately support admission/referral vs discharge decisions during the first clinical assessment of febrile children aged 2-\<60 months compared to the standard of care based on IMCI guidelines.
Febrile children meeting the study eligibility criteria will be randomly allocated (1:1) to one of the two triaging approaches (arms): 1) IMCI-based standard of care (SoC); or 2) IMCI-enhanced by sTREM-1 levels (SoC + sTREM-1 POC). Blood will be collected from all participants and only those randomised to the intervention arm (arm 2) will have sTREM-1 levels determined at the POC using B-Triage device.
At baseline, all children will undergo two clinical assessments. Primary composite endpoint of "appropriateness of discharge" will be based on the first clinical assessment, which is more representative of real-world clinical practice. However, the ultimate decision on admission/referral vs discharge will be based on the second clinical assessment, which will ensure the safest possible clinical practice in the context of a clinical trial.
1. At baseline, during the first clinical assessment, all participants will be evaluated following the SoC based on IMCI guidelines, which will guide management decisions, including clinical diagnosis and treatment. This IMCI-guideline based evaluation during this first clinical assessment will be conducted by a health worker as per routine clinical practice in the outpatient departments of each study site.
1. In the participants randomised to the control arm, decision of admission/referral vs discharge home will be informed by IMCI-based evaluation alone (SoC).
2. In the participants randomised to the intervention arm, decision of admission/referral vs discharge home will be informed by IMCI-based evaluation enhanced by sTREM-1 levels (SoC + sTREM-1 POC). Clinicians will be instructed to admit for further observation any child with sTREM-1 levels equal or superior to 200 pg/mL, as these patients are at moderate or high risk of adverse outcomes and death. On the other hand, children with sTREM-1 levels below 200 pg/mL will be eligible for discharge home at the criteria of the clinician, considering the signs and symptoms found, and based on IMCI guidelines. Hence, should clinicians in charge deem that any of these children still require admission, they will be instructed to continue with the admission regardless of sTREM-1 levels.
The study intervention will be implemented during the first clinical assessment, and consequently, primary composite endpoint of "appropriateness of discharge" will be based on the decision of admission/referral vs discharge home during this first clinical assessment, which is more representative of routine clinical practice in each study site.
2. All randomised participants will be also evaluated by an independent study physician in a second clinical assessment, for the implementation of a systematised clinical evaluation (IMCI-based) to uncover any danger signs or severity criteria potentially missed or misinterpreted during the first assessment. This second assessment will also include clinical variables of the clinical scores Paediatric Early Warning Score (ED-PEWS), Lactate enhanced-quick Sequential Organ Failure Assessment (LqSOFA) and Logistic Organ Dysfunction Score (LODS), as well as temperature and oxygen saturation measures. Hence, study clinicians during this second clinical assessment might be able to uncover more symptoms and signs that are admission criteria due to the tools available in the context of this clinical trial. Initially discharged patients from both arms showing a danger sign or other severity criteria during this second assessment will be admitted, as well as those from the intervention arm with sTREM-1 high-risk (red light) and moderate-risk (yellow light) levels, in case that the first clinician might not have adhered to the protocol during the first assessment. On the other hand, this second assessment will not overturn the decision of the first clinician if admission has been decided in case of sTREM-1 levels below 200 pg/mL (green light, low-risk).
This second clinical assessment will guide the ultimate decision on admission/referral vs discharge in order to ensure the safest possible clinical practice in the context of a clinical trial.
Moreover, those participants with respiratory symptoms will be eligible for the respiratory tract infection (RTI) sub-study, where digital lung auscultations, a mid-turbinate nasal swab and a saliva sample will be collected.
Throughout the study, all participants will receive treatment as per the routine clinical practice and SoC for each diagnosis at each study site, administered by clinical staff routinely working in the participating facilities.
All participants will have follow-up evaluations by study clinicians on days 3 and 7 post-enrolment, or at any time in-between in case of clinical deterioration according to caregivers' evaluation. All participants will be also followed-up on day 28 for an interview to follow-up on serious adverse events (SAEs), as well as to collect information on secondary consultations and hospitalisation, or death. A follow-up extra visit at day 91 (month 3) can be conducted for an interview to ask for hospitalisation or death.
### Conditions Module
**Conditions:**
- Infectious Disease
- Febrile Illness
- Child, Only
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 5212
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** IMCI-guidelines (standard of care) + Point-Of-Care Rapid Triage Test (POC-RTT) based on sTREM-1 quantification
**Intervention Names:**
- Other: IMCI-enhanced by sTREM-1 levels (SoC + sTREM-1 POC)
**Label:** IMCI-enhanced by sTREM-1 levels (SoC + sTREM-1 POC)
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** IMCI-guidelines (standard of care)
**Label:** IMCI alone
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- IMCI-enhanced by sTREM-1 levels (SoC + sTREM-1 POC)
**Description:** IMCI-guidelines (standard of care) + Point-Of-Care Rapid Triage Test (POC-RTT) based on sTREM-1 quantification
**Name:** IMCI-enhanced by sTREM-1 levels (SoC + sTREM-1 POC)
**Type:** OTHER
### Outcomes Module
#### Other Outcomes
**Description:** Proportion of secondary consultations or admissions on day 91 (month 3) among the two study arms
**Measure:** Secondary consultations or admission
**Time Frame:** Up to day 91
**Description:** Proportion of mortality on day 91 (month 3) among the two study arms.
**Measure:** Mortality
**Time Frame:** Up to day 91
#### Primary Outcomes
**Description:** The primary outcome is the proportion of "appropriateness of discharge" according to the first clinical assessment of febrile children aged 2-\<60 months compared among the 2 study arms.
Inappropriate discharge is defined as a composite of (fulfilling at least one of the following):
1. Presence at baseline of World Health Organization (WHO)-proposed danger signs in discharged children; OR
2. Presence of WHO-proposed danger signs on day 3 post-discharge; OR
3. Requirement for additional visit at the health facility or admission at day 7; OR
4. Death on day 7 post-discharge. The absence of any of these endpoints will be considered an appropriate discharge.
**Measure:** Appropriateness of discharge
**Time Frame:** Up to day 7
#### Secondary Outcomes
**Description:** Proportion of secondary consultations or admissions on day 7 and day 28 among the two study arms.
**Measure:** Secondary consultations or admissions
**Time Frame:** Up to day 28
**Description:** Proportion of mortality on day 7 and day 28 among the two study arms.
**Measure:** Mortality
**Time Frame:** Up to day 28
**Description:** Proportion of referrals of mild infections to higher level facilities at day 7 and day 28 among the two study arms.
**Measure:** Referrals to higher level facilities
**Time Frame:** Up to day 28
**Description:** Proportion of participants diagnosed with severe disease as described in IMCI (i.e. very severe diseases, severe pneumonia, severe dehydration, severe persistent diarrhoea, very severe febrile diseases, severe complicated measles, complicated severe acute malnutrition, mastoiditis, and severe anaemia), at day 3 and day 7 among the two study arms.
**Measure:** Severe disease
**Time Frame:** Up to day 7
**Description:** Median time to symptoms resolution among the two study arms until day 28.
**Measure:** Symptoms duration
**Time Frame:** Up to day 28
**Description:** Median length of hospital stay among the two study arms until day 28
**Measure:** Hospital stay length
**Time Frame:** Up to day 28
**Description:** Proportion of serious adverse events (SAEs) at day 3, day 7, and day 28, among the two study arms.
**Measure:** Serious adverse events
**Time Frame:** Up to day 28
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age ≥2 months and \<60 months
* Written informed consent from the child's parent or caregiver
* History of fever for ≤7 days OR hypothermia (i.e., axillary temperature \<35.5ºC) OR suspected severe infection (e.g., in children with moderate or severe acute malnutrition).
* Lives within the catchment area of the study facility and must intend to continue to reside there for the duration of the study
* For the RTI sub-study only: presence of respiratory symptoms compatible with RTI.
Exclusion Criteria:
* Weight less than 2.5kg
* Main reason for consultation is an injury, trauma or acute poisoning
* Enrolled in another clinical trial testing a new drug
* Enrolled in a vaccine trial in the last 3 months.
* Any other condition determined by the investigators that makes it unlikely that the participant would complete the study
**Maximum Age:** 60 Months
**Minimum Age:** 2 Months
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Quique Bassat, Prof
**Phone:** 93 227 92 12
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Barbara Baro, PhD
**Phone:** 93 227 92 12
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Barcelona Institute for Global Health
**Name:** Quique Bassat, Prof
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Access Criteria:** On request to any interested professional
**Description:** This clinical trial, as part of the wider EChiLiBRiST project, is committed to European Union-funded Horizon 2021 aims to improve and maximize access to and reuse of research data generated by the Project.
Biological samples and data will be shared using material and data transfer agreements with the collaborating institutions.
The full protocol will be available on request to any interested professional and may be published in peer-reviewed journals or deposited in an online repository. A fully de-identified data set of the complete patient-level data will be available for sharing purposes as soon as the the analysis is completed and no later than five years after the publication of the trial.
**Info Types:**
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
**IPD Sharing:** YES
**Time Frame:** A fully de-identified data set of the complete patient-level data will be available for sharing purposes as soon as the data analysis is completed and no later than five years after the publication of the trial.
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000020969
- Term: Disease Attributes
- ID: D000010335
- Term: Pathologic Processes
- ID: D000001832
- Term: Body Temperature Changes
- ID: D000018882
- Term: Heat Stress Disorders
- ID: D000014947
- Term: Wounds and Injuries
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: All
- Name: All Conditions
- Abbrev: BC01
- Name: Infections
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
### Condition Browse Module - Browse Leaves
- ID: M2454
- Name: Hyperthermia
- Relevance: HIGH
- As Found: Febrile
- ID: M8464
- Name: Fever
- Relevance: HIGH
- As Found: Febrile
- ID: M10283
- Name: Infections
- Relevance: HIGH
- As Found: Infectious Disease
- ID: M6368
- Name: Communicable Diseases
- Relevance: HIGH
- As Found: Infectious Disease
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
- ID: M5111
- Name: Body Temperature Changes
- Relevance: LOW
- As Found: Unknown
- ID: M20924
- Name: Heat Stress Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M24916
- Name: Stress Disorders, Traumatic
- Relevance: LOW
- As Found: Unknown
- ID: M17685
- Name: Wounds and Injuries
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003141
- Term: Communicable Diseases
- ID: D000007239
- Term: Infections
- ID: D000084462
- Term: Hyperthermia
- ID: D000005334
- Term: Fever
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06422325
**Brief Title:** Two Way Crossover Closed Loop Study Insulin vs Insulin and Pramlintide
**Official Title:** A Crossover Study to Evaluate Insulin/Pramlintide Versus Insulin Alone Delivery Strategy
#### Organization Study ID Info
**ID:** 25279
#### Organization
**Class:** OTHER
**Full Name:** Oregon Health and Science University
### Status Module
#### Completion Date
**Date:** 2024-12-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-15
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-11-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Oregon Health and Science University
#### Responsible Party
**Investigator Affiliation:** Oregon Health and Science University
**Investigator Full Name:** Leah Wilson
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** True
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The purpose of this study is to test how well a new investigational closed loop system manages your blood sugar with the ability to deliver insulin and pramlintide. Pramlintide is a drug that is used with mealtime insulin to control blood sugar in people who have diabetes. It works by slowing down the movement of food through the stomach which prevents blood sugar from rising too high after a meal. The closed loop system will receive glucose values from the Dexcom G6 CGM and automatically send commands to one Omnipod for insulin and one Omnipod for pramlintide delivery.
**Detailed Description:** Participants will undergo two 12.5 hour clinic visits. Participants will complete a training on how to start the Dexcom G6 sensor at home. Participants will start the G6 sensor the day before each study visit. For one visit, the system will use insulin only for managing blood sugar. For the other study, the system will use both insulin and pramlintide. The order of the visits will be randomly chosen. For 3 days before the insulin and pramlintide visit, participants will dose with pramlintide before each meal. During the visits, participants will wear one or two Omnipods to delivery insulin and insulin/pramlintide and a Dexcom G6 CGM. The CGM system will provide sensor glucose data every 5 minutes. Sensor glucose data will be wirelessly transmitted via Bluetooth Low Energy (BTLE) from the Dexcom G6 to the smartphone master controller every 5 minutes. The smartphone will communicate via BTLE to an Omnipod for insulin delivery. The closed loop system will receive activity data through a Polar M600 watch worn by the participant. Participants will eat breakfast and lunch in clinic.
### Conditions Module
**Conditions:**
- Type 1 Diabetes
**Keywords:**
- automated insulin delivery systems
- glucose sensor
- pramlintide
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 35
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants will use the closed loop system with insulin only for managing blood sugar during the 12.5 hour study. Insulin will be administered by an Omnipod. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
**Intervention Names:**
- Device: MPC closed-loop system in insulin only mode
**Label:** Insulin Only Arm
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants will use the closed loop system with insulin and pramlintide for managing blood sugar during the 12.5 hour study. Insulin and pramlintide will be administered by two Omnipods. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
**Intervention Names:**
- Device: MPC closed-loop system in insulin/pramlintide mode
**Label:** Insulin and Pramlintide Arm
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Insulin Only Arm
**Description:** The Model Predictive Control (MPC) insulin infusion algorithm contains a model within the controller that takes as an input the aerobic metabolic expenditure in addition to the CGM and meal in puts. The algorithm uses heart rate and accelerometer data collected on the patient's body to calculate metabolic expenditure (METs). The METs then acts on the model for the insulin dynamics, whereby more energy expenditure and longer duration exercise can lead to a more substantial effect of insulin on the CGM. The MPC also has missed meal insulin bolus detection where the system will calculate the amount of insulin that was missed for a meal. The missed meal boluses can be delivered automatically without any input from the user. This feature can also be disabled. The device in this mode will administer insulin continuously for managing blood sugar.
**Name:** MPC closed-loop system in insulin only mode
**Type:** DEVICE
#### Intervention 2
**Arm Group Labels:**
- Insulin and Pramlintide Arm
**Description:** The Model Predictive Control (MPC) insulin infusion algorithm contains a model within the controller that takes as an input the aerobic metabolic expenditure in addition to the CGM and meal in puts. The algorithm uses heart rate and accelerometer data collected on the patient's body to calculate metabolic expenditure (METs). The METs then acts on the model for the insulin dynamics, whereby more energy expenditure and longer duration exercise can lead to a more substantial effect of insulin on the CGM. The MPC also has missed meal insulin bolus detection where the system will calculate the amount of insulin that was missed for a meal. The missed meal boluses can be delivered automatically without any input from the user. This feature can also be disabled. The device in this mode will administer both insulin and pramlintide continuously for managing blood sugar. The system will deliver pramlintide in a fixed ratio to insulin at 6 mcg of pramlintide delivered for every 1 unit of insulin.
**Name:** MPC closed-loop system in insulin/pramlintide mode
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Incremental area under the curve (iAUC) of postprandial glucose as measured by the Dexcom G6 CGM in the 6 hours following the start of first meal. iAUC (mg/dL\*min) will be calculated using a trapezoidal method, which sums all CGM values in the 6 hour period following the meal above the starting glucose.
**Measure:** Incremental area under the curve of postprandial glucose following the first meal
**Time Frame:** 6 hours following first meal
**Description:** Assess the percent of time that the Dexcom G6 reported sensor glucose values between 70-180 mg/dl using Dexcom sensor in the 6 hours following the start of the first meal.
**Measure:** Percent of time with sensed glucose between 70 - 180 mg/dl following first meal
**Time Frame:** 6 hours following first meal
#### Secondary Outcomes
**Description:** Incremental area under the curve (iAUC) of postprandial glucose as measured by the Dexcom G6 CGM in the 6 hours following the start of second meal. iAUC (mg/dL\*min) will be calculated using a trapezoidal method, which sums all CGM values in the 6 hour period following the meal above the starting glucose.
**Measure:** Incremental area under the curve of postprandial glucose following the second meal
**Time Frame:** 6 hours following second meal
**Description:** Assess the percent of time that the Dexcom G6 reported sensor glucose values between 70-180 mg/dl using Dexcom sensor in the 6 hours following the start of the second meal.
**Measure:** Percent of time with sensed glucose between 70 - 180 mg/dl following second meal
**Time Frame:** 6 hours following second meal
**Description:** Net area under the curve (netAUC) of postprandial glucose as measured by CGM in the 6 hours following the start of first meal. netAUC (mg/dL\*min) will be calculated using a trapezoidal method, which sums all CGM values in the 6 hour period following the meal above the starting glucose and subtracts CGM values below the starting glucose.
**Measure:** Net area under the curve of postprandial glucose following the first meal
**Time Frame:** 6 hours following first meal
**Description:** Net area under the curve (netAUC) of postprandial glucose as measured by CGM in the 6 hours following the start of second meal. netAUC (mg/dL\*min) will be calculated using a trapezoidal method, which sums all CGM values in the 6 hour period following the meal above the starting glucose and subtracts CGM values below the starting glucose.
**Measure:** Net area under the curve of postprandial glucose following the second meal
**Time Frame:** 6 hours following second meal
**Description:** Net area under the curve (netAUC) of postprandial glucose as measured by CGM over the 12 hour study visit. netAUC (mg/dL\*min) will be calculated using a trapezoidal method, which sums all CGM values above the starting glucose and subtracts CGM values below the starting glucose.
**Measure:** Net area under the curve of postprandial glucose
**Time Frame:** 12 hour clinic visit
**Description:** Assess the percent of time that the Dexcom G6 reported sensor glucose values less than 70 mg/dl using Dexcom sensor in the 6 hours following the start of the first meal.
**Measure:** Percent of time with sensed glucose <70 mg/dL following first meal
**Time Frame:** 6 hours following first meal
**Description:** Assess the percent of time that the Dexcom G6 reported sensor glucose values less than 70 mg/dl using Dexcom sensor in the 6 hours following the start of the second meal.
**Measure:** Percent of time with sensed glucose <70 mg/dL following second meal
**Time Frame:** 6 hours following second meal
**Description:** Assess the percent of time that the Dexcom G6 reported sensor glucose values less than 70 mg/dl using Dexcom sensor.
**Measure:** Percent of time with sensed glucose <70 mg/dL
**Time Frame:** 12 hour clinic visit
**Description:** Assess the percent of time that the Dexcom G6 reported sensor glucose values between 70-140 mg/dl using Dexcom sensor in the 6 hours following the start of the first meal.
**Measure:** Percent of time with sensed glucose between 70-140 mg/dL following first meal
**Time Frame:** 6 hours following first meal
**Description:** Assess the percent of time that the Dexcom G6 reported sensor glucose values between 70-140 mg/dl using Dexcom sensor in the 6 hours following the start of the second meal.
**Measure:** Percent of time with sensed glucose between 70-140 mg/dL following second meal
**Time Frame:** 6 hours following second meal
**Description:** Assess the percent of time that the Dexcom G6 reported sensor glucose values between 70-140 mg/dl using Dexcom sensor.
**Measure:** Percent of time with sensed glucose between 70-140 mg/dL
**Time Frame:** 12 hour clinic visit
**Description:** Assess mean sensed glucose from the Dexcom G6 sensor in the 6 hours following the start of the first meal.
**Measure:** Mean sensed glucose following first meal
**Time Frame:** 6 hours following first meal
**Description:** Assess mean sensed glucose from the Dexcom G6 sensor in the 6 hours following the start of the second meal.
**Measure:** Mean sensed glucose following second meal
**Time Frame:** 6 hours following second meal
**Description:** Assess mean sensed glucose from the Dexcom G6 sensor.
**Measure:** Mean sensed glucose
**Time Frame:** 12 hour clinic visit
**Description:** Assess the percent of time that the Dexcom G6 reported sensor glucose values less than 54 mg/dl using Dexcom sensor in the 6 hours following the start of the first meal.
**Measure:** Percent of time with sensed glucose <54 mg/dL following first meal
**Time Frame:** 6 hours following first meal
**Description:** Assess the percent of time that the Dexcom G6 reported sensor glucose values less than 54 mg/dl using Dexcom sensor in the 6 hours following the start of the second meal.
**Measure:** Percent of time with sensed glucose <54 mg/dL following second meal
**Time Frame:** 6 hours following second meal
**Description:** Assess the percent of time that the Dexcom G6 reported sensor glucose values less than 54 mg/dl using Dexcom sensor.
**Measure:** Percent of time with sensed glucose <54 mg/dL
**Time Frame:** 12 hour clinic visit
**Description:** Assess the percent of time that the Dexcom G6 reported sensor glucose values greater than 180 mg/dl using Dexcom sensor in the 6 hours following the start of the first meal.
**Measure:** Percent of time with sensed glucose >180 mg/dL following first meal
**Time Frame:** 6 hours following first meal
**Description:** Assess the percent of time that the Dexcom G6 reported sensor glucose values greater than 180 mg/dl using Dexcom sensor in the 6 hours following the start of the second meal.
**Measure:** Percent of time with sensed glucose >180 mg/dL following second meal
**Time Frame:** 6 hours following second meal
**Description:** Assess the percent of time that the Dexcom G6 reported sensor glucose values greater than 180 mg/dl using Dexcom sensor.
**Measure:** Percent of time with sensed glucose >180 mg/dL
**Time Frame:** 12 hour clinic visit
**Description:** Assess the percent of time that the Dexcom G6 reported sensor glucose values greater than 250 mg/dl using Dexcom sensor in the 6 hours following the start of the first meal.
**Measure:** Percent of time with sensed glucose >250 mg/dL following first meal
**Time Frame:** 6 hours following first meal
**Description:** Assess the percent of time that the Dexcom G6 reported sensor glucose values greater than 250 mg/dl using Dexcom sensor in the 6 hours following the start of the second meal.
**Measure:** Percent of time with sensed glucose >250 mg/dL following second meal
**Time Frame:** 6 hours following second meal
**Description:** Assess the percent of time that the Dexcom G6 reported sensor glucose values greater than 250 mg/dl using Dexcom sensor.
**Measure:** Percent of time with sensed glucose >250 mg/dL
**Time Frame:** 12 hour clinic visit
**Description:** Assess the mean amount of insulin delivered (in units and units/kg) in the 6 hours following the first meal.
**Measure:** Mean amount of insulin delivered following first meal
**Time Frame:** 6 hours following the first meal
**Description:** Assess the mean amount of insulin delivered (in units and units/kg) in the 6 hours following the second meal.
**Measure:** Mean amount of insulin delivered following second meal
**Time Frame:** 6 hours following the second meal
**Description:** Assess the mean amount of insulin delivered (in units and units/kg).
**Measure:** Mean amount of insulin delivered
**Time Frame:** 12 hour clinic visit
**Description:** Assess the mean amount of pramlintide delivered (in mcg and mcg/kg) in the 6 hours following the first meal.
**Measure:** Mean amount of pramlintide delivered following first meal
**Time Frame:** 6 hours following the first meal
**Description:** Assess the mean amount of pramlintide delivered (in mcg and mcg/kg) in the 6 hours following the second meal.
**Measure:** Mean amount of pramlintide delivered following second meal
**Time Frame:** 6 hours following the second meal
**Description:** Assess the mean amount of pramlintide delivered (in mcg and mcg/kg).
**Measure:** Mean amount of pramlintide delivered
**Time Frame:** 12 hour clinic visit
**Description:** Assess the coefficient of variation based on the Dexcom sensor values across both study arms in the 6 hours following the first meal.
**Measure:** Coefficient of variation following first meal
**Time Frame:** 6 hours following the first meal
**Description:** Assess the coefficient of variation based on the Dexcom sensor values across both study arms in the 6 hours following the second meal.
**Measure:** Coefficient of variation following second meal
**Time Frame:** 6 hours following the second meal
**Description:** Assess the coefficient of variation based on the Dexcom sensor values across both study arms.
**Measure:** Coefficient of variation
**Time Frame:** 12 hour clinic visit
**Description:** Assess low blood glucose index based on the Dexcom sensor values for the 6 hours following the first meal.
**Measure:** Low Blood Glucose Index (LBGI) following the first meal
**Time Frame:** 6 hours following the first meal
**Description:** Assess low blood glucose index based on the Dexcom sensor values for the 6 hours following the second meal.
**Measure:** Low Blood Glucose Index (LBGI) following the second meal
**Time Frame:** 6 hours following the second meal
**Description:** Assess low blood glucose index based on the Dexcom sensor values.
**Measure:** Low Blood Glucose Index (LBGI)
**Time Frame:** 12 hour clinic visit
**Description:** Assess high blood glucose index based on the Dexcom sensor values for the 6 hours following the first meal.
**Measure:** High Blood Glucose Index (HBGI) following the first meal
**Time Frame:** 6 hours following the first meal
**Description:** Assess high blood glucose index based on the Dexcom sensor values for the 6 hours following the second meal.
**Measure:** High Blood Glucose Index (HBGI) following the second meal
**Time Frame:** 6 hours following the second meal
**Description:** Assess high blood glucose index based on the Dexcom sensor values.
**Measure:** High Blood Glucose Index (HBGI)
**Time Frame:** 12 hour clinic visit
**Description:** Assess the number of adverse events probably or possibly associated with pramlintide administration.
**Measure:** Adverse events related to pramlintide
**Time Frame:** 4 days of pramlintide use
**Description:** Assess discomfort level due to gastrointestinal issues by participant rating from 0-10 with 1 being no discomfort and 10 being worst possible discomfort 6 hours after the first meal.
**Measure:** Baxter Retching Faces (BARF)/VAS scale for gastrointestinal issues after the first meal
**Time Frame:** 6 hours following first meal
**Description:** Assess gastrointestinal issues by participant rating from 0-10 with 1 being no discomfort and 10 being worst possible discomfort 6 hours after the second meal as reported using the BARF/VAS scale.
**Measure:** Baxter Retching Faces (BARF)/VAS scale for gastrointestinal issues after the second meal
**Time Frame:** 6 hours following second meal
**Description:** Assess the average duration of gastrointestinal issues reported by the participant at 6 hours after the first meal as reported by participant.
**Measure:** Mean duration of gastrointestinal issues after the first meal
**Time Frame:** 6 hours following first meal
**Description:** Assess the average duration of gastrointestinal issues reported by the participant at 6 hours after the second meal as reported by participant.
**Measure:** Mean duration of gastrointestinal issues after the second meal
**Time Frame:** 6 hours following second meal
**Description:** Assess the number of rescue carbohydrate treatments (defined as 15 grams of carbohydrate intake) needed to treat hypoglycemia.
**Measure:** Episodes of carbohydrate intake to treat hypoglycemia
**Time Frame:** 12 hour clinic visit
**Description:** Assess the number of episodes of hypoglycemia defines as CGM \< 70 mg/dl for 10 minutes or more.
**Measure:** Episodes of hypoglycemia
**Time Frame:** 12 hour clinic visit
**Description:** Assess the number of provider-administered insulin injections due to hyperglycemia.
**Measure:** Number of provider-administered insulin injections
**Time Frame:** 12 hour clinic visit
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Diagnosis of type 1 diabetes mellitus for at least 1 year.
* Participants 18 to 70 years of age.
* Current use of an insulin pump for at least 3 months with stable insulin pump settings for \>2 weeks OR current use of multiple day injection insulin therapy with stable doses for \>2 weeks.
* Uses a carbohydrate ratio, at lease occasionally, to dose meal time insulin.
* HbA1c ≤ 10.5% at screening.
* Total daily insulin requirement is less than 139 units/day.
* Willingness to follow all study procedures, including attending all clinic visits.
* Willingness to sign informed consent and HIPAA documents.
Exclusion Criteria:
* Individual of childbearing potential who is pregnant or intending to become pregnant or breast-feeding, or is not using adequate contraceptive methods. Acceptable contraception includes birth control pill / patch / vaginal ring, Depo-Provera, Norplant, an IUD, the double barrier method (the woman uses a diaphragm and spermicide and the man uses a condom), or abstinence.
* Any cardiovascular disease, defined as a clinically significant EKG abnormality at the time of screening or any history of: stroke, heart failure, myocardial infarction, angina pectoris, or coronary arterial bypass graft or angioplasty. Diagnosis of 2nd or 3rd degree heart block or any non-physiological arrhythmia judged by the investigator to be exclusionary.
* Renal insufficiency (GFR \< 60 ml/min, using the MDRD equation as reported by the OHSU laboratory).
* Liver failure, cirrhosis, or any other liver disease that compromises liver function as determined by the investigator.
* History of severe hypoglycemia during the past 3 months prior to screening visit or hypoglycemia unawareness as judged by the investigator. Participants will complete a hypoglycemia awareness questionnaire. Participants will be excluded for four or more R responses.
* History of diabetes ketoacidosis during the prior 3 months prior to screening visit, as diagnosed on hospital admission or as judged by the investigator.
* Adrenal insufficiency.
* Any active infection requiring treatment (example soft tissue infection requiring antibiotics).
* Known or suspected abuse of alcohol, narcotics, or illicit drugs.
* Seizure disorder.
* Active foot ulceration.
* Major surgical operation within 30 days prior to screening.
* Use of an investigational drug within 30 days prior to screening.
* Chronic usage of any immunosuppressive medication (such as cyclosporine, azathioprine, sirolimus, or tacrolimus).
* Bleeding disorder, treatment with warfarin, or platelet count below 50,000.
* Allergy to aspart insulin.
* Allergy to pramlintide.
* Current administration of oral or parenteral corticosteroids.
* Any life-threatening disease, including malignant neoplasms and medical history of malignant neoplasms within the past 5 years prior to screening (except basal and squamous cell skin cancer).
* Current use of any medication intended to lower glucose other than insulin or pramlintide (ex. use of liraglutide, metformin).
* Gastroparesis
* Diets consisting of less than 50 grams of carbohydrates per day.
* Dietary restrictions or allergies to the study meals
* Any clinically significant disease or disorder which in the opinion of the Investigator may jeopardize the participant's safety or compliance with the protocol.
**Maximum Age:** 70 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Leah Wilson, MD
**Phone:** 503-494-3273
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Deborah Branigan
**Phone:** 503-418-9070
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Oregon Health and Science University
**Name:** Leah Wilson, MD
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000003920
- Term: Diabetes Mellitus
- ID: D000044882
- Term: Glucose Metabolism Disorders
- ID: D000008659
- Term: Metabolic Diseases
- ID: D000004700
- Term: Endocrine System Diseases
- ID: D000001327
- Term: Autoimmune Diseases
- ID: D000007154
- Term: Immune System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC20
- Name: Immune System Diseases
### Condition Browse Module - Browse Leaves
- ID: M7115
- Name: Diabetes Mellitus
- Relevance: LOW
- As Found: Unknown
- ID: M7117
- Name: Diabetes Mellitus, Type 1
- Relevance: HIGH
- As Found: Type 1 Diabetes
- ID: M11639
- Name: Metabolic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M25403
- Name: Glucose Metabolism Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M7862
- Name: Endocrine System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M4629
- Name: Autoimmune Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003922
- Term: Diabetes Mellitus, Type 1
### Intervention Browse Module - Ancestors
- ID: D000007004
- Term: Hypoglycemic Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
### Intervention Browse Module - Browse Branches
- Abbrev: Hypo
- Name: Hypoglycemic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Micro
- Name: Micronutrients
### Intervention Browse Module - Browse Leaves
- ID: M10365
- Name: Insulin
- Relevance: HIGH
- As Found: Day 1
- ID: M173166
- Name: Insulin, Globin Zinc
- Relevance: HIGH
- As Found: Day 1
- ID: M250016
- Name: Pramlintide
- Relevance: HIGH
- As Found: Sore
- ID: M17768
- Name: Zinc
- Relevance: LOW
- As Found: Unknown
- ID: M10054
- Name: Hypoglycemic Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000007328
- Term: Insulin
- ID: C000557859
- Term: Insulin, Globin Zinc
- ID: C000105254
- Term: Pramlintide
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06422312
**Brief Title:** A Study Comparing a Disposable Flexible Cystoscope With Reusable Scopes in Adult Patients.
**Official Title:** Clinical Investigation to Evaluate the Effectiveness of the Redpine Disposable Scope Compared to Standard Reusable Scope for Flexible Cystoscopy.
#### Organization Study ID Info
**ID:** USA001
#### Organization
**Class:** INDUSTRY
**Full Name:** Guangzhou Red Pine Medical Instrument Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2025-07
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-15
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** University of Texas Southwestern Medical Center
**Class:** OTHER
**Name:** University of Washington
**Class:** OTHER
**Name:** Penn State University
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Guangzhou Red Pine Medical Instrument Co., Ltd.
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** True
**Is FDA Regulated Drug:** False
**Is US Export:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This study will compare the time required for a cystoscopy procedure in adult participants using the Redpine® Rflex endo(trademark) High-Definition Cystoscope or the site's standard of care reusable flexible cystoscope in participants requiring urethral stent removal.
**Detailed Description:** This randomized study will compare the cumulative procedure time between cystoscopy performed with the Redpine® Rflex endo(trademark) High-Definition Cystoscope and the site's standard of care reusable flexible cystoscope in adult study participants requiring cystoscopy for visualization of and/or intervention on the urinary bladder. The study will evaluate the user experience and product performance during cystoscopic procedures. Participant experience, tolerance to the procedure, and any differences in adverse events between disposable and reusable scope will be evaluated. The hypothesis is that the RedPine cystoscope will perform as well as reusable scopes and will have a shorter cumulative procedure time.
### Conditions Module
**Conditions:**
- Bladder Cancer
- Bladder Stone
- Bladder Outlet Obstruction
- Renal Stone
- Renal Disease
**Keywords:**
- cystoscopy
- urinary stint removal
- bladder biopsy
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** HEALTH_SERVICES_RESEARCH
#### Enrollment Info
**Count:** 140
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants in this arm will receive cystoscopy using the clinic's standard of care flexible reusable cystoscope of the urologist's choice.
**Intervention Names:**
- Device: Cystoscopy with RedPine flexible disposable cystoscope
**Label:** Control
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** Participants in this arm will receive cystoscopy using the Redpine® Rflex endoTMHD Cysto scope.
**Intervention Names:**
- Device: Cystoscopy with RedPine flexible disposable cystoscope
**Label:** Intervention
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Control
- Intervention
**Description:** Use of a flexible cystoscope to visualize the urethra and bladder, take biopsies, and remove stents.
**Name:** Cystoscopy with RedPine flexible disposable cystoscope
**Other Names:**
- Cystoscopy with standard of care flexible reusable scope
**Type:** DEVICE
### Outcomes Module
#### Other Outcomes
**Description:** Safety will be assessed based on the incidence rates of adverse events based on the seriousness and relatedness to the device and/or procedure.
1. All urologic adverse events, both device and procedure related, during the cystoscopy procedure through 7 (+/- 3) days post-procedure.
2. All reported device and/or procedural related adverse events through 7 (+/- 3) days post- procedure
3. All Serious Adverse Events (SAEs) through 7 (+/- 3) days post-procedure
**Measure:** Safety Endpoints
**Time Frame:** 4 to 10 days
#### Primary Outcomes
**Description:** To compare the Cumulative Procedure Time between cystoscopy performed with the Redpine® Rflex endo(trademark) High Definition (endoTMHD) Cysto scope and the site's Standard of Care reusable flexible cystoscope as measured by:
* Scope preparation for procedure
* Actual procedure time (insertion of cystoscope to complete bladder examination) and
* Time to dispose of or prepare for reprocessing of cystoscopy equipment.
**Measure:** Cumulative Procedure Time
**Time Frame:** 30 minutes
#### Secondary Outcomes
**Description:** Physician satisfaction, rated on a five-point scale. i) Ease of insertion ii) Ability to visualize anatomical landmarks and/or urothelium changes iii) Perception of image quality iv) Maneuverability in the bladder v) Scope articulation with tools in the working channel vi) Visualization while tools are in the working channel
**Measure:** User experience and product performance during cystoscopic procedures
**Time Frame:** within 24 hours
**Description:** Participants will be interviewed using a questionnaire.
**Measure:** Participant comfort during the procedure
**Time Frame:** 30 minutes
**Description:** Rate of conversion to a reusable cystoscope for those subjects randomized to the REDPINE cystoscope.
**Measure:** RedPine Cystoscope Conversion Rate
**Time Frame:** 30 minutes
**Description:** Device failure leading to a serious adverse event (SAE), termination of the procedure, or conversion to a reusable cystoscope.
**Measure:** Device Failure Rate
**Time Frame:** 30 minutes
**Description:** Device malfunction including any device-related issue or observation whether it leads to an SAE, termination of the procedure or conversion to a reusable cystoscope.
**Measure:** Device Malfunction Rate
**Time Frame:** 30 minutes
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Male or female, aged at least 18 years old
2. Patient undergoing routine flexible cystoscopy
3. No active urinary tract infection
4. Subject is willing and able to sign informed consent and HIPAA authorization.
Exclusion Criteria:
1. Known unpassable urethral stricture
2. Febrile patient with active urinary tract infection (UTI)
3. Subjects with acute infection (acute urethritis, acute prostatitis, acute epididymitis)
4. Subject with severe coagulopathy
5. Subject is pregnant or female with reproductive capability who is unwilling to have a pre-procedure pregnancy test and use birth control.
**Maximum Age:** 120 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Greg Lips
**Phone:** 800-570-4962
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Daniel S Laferriere, MS
**Phone:** 5037586788
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Hershey
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Suzanne L Boltz, B.S.
- **Phone:** 717-531-0003
- **Phone Ext:** 287502
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Amogh Pande, M.S.
- **Phone:** 717-531-5930
- **Role:** CONTACT
**Country:** United States
**Facility:** Pennsylvania State University
**State:** Pennsylvania
**Zip:** 17033
**Location 2:**
**City:** Dallas
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Brett Johnson, MD
- **Phone:** 214-645-8765
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Sonobia Garrett, BS
- **Phone:** 214-645-8482
- **Role:** CONTACT
***Contact 3:***
- **Name:** Brett Johnson, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** UT Southwestern Medical Center
**State:** Texas
**Zip:** 75390
#### Overall Officials
**Official 1:**
**Affiliation:** UT Southwestern Medical Center
**Name:** Yair Lotan, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Samplaski MK, Jones JS. Two centuries of cystoscopy: the development of imaging, instrumentation and synergistic technologies. BJU Int. 2009 Jan;103(2):154-8. doi: 10.1111/j.1464-410X.2008.08244.x. Epub 2008 Dec 8.
**PMID:** 19076146
**Citation:** O'Sullivan DC, Chilton CP. Flexible cystoscopy. Br J Hosp Med. 1994 Apr 6-19;51(7):340-5.
**PMID:** 8081563
**Citation:** Poulton LJ, Joyce AD. Flexible cystoscopy: Training and Assessment Guideline. Br Assoc Urol Nurses. 2012;(November).
**Citation:** Pillai PL, Sooriakumaran P. Flexible cystoscopy: a revolution in urological practice. Br J Hosp Med (Lond). 2009 Oct;70(10):583-5. doi: 10.12968/hmed.2009.70.10.44626.
**PMID:** 19966704
**Citation:** Kadi N, Menezes P. ABC of flexible cystoscopy for junior trainee and general practitioner. Int J Gen Med. 2011;4:593-6. doi: 10.2147/IJGM.S20267. Epub 2011 Aug 19.
**PMID:** 21887113
**Citation:** Steinberg. Cystoscopy in Bladder Carcinoma [Internet]. Medscape. 2015 [cited 2018 Jan 18]. Available from: https://emedicine.medscape.com/article/1950345-overview
**Citation:** Doizi S, Kamphuis G, Giusti G, Palmero JL, Patterson JM, Proietti S, Straub M, de la Rosette J, Traxer O. First clinical evaluation of a new single-use flexible cystoscope dedicated to double-J stent removal (Isiris): a European prospective multicenter study. World J Urol. 2017 Aug;35(8):1269-1275. doi: 10.1007/s00345-016-1986-0. Epub 2016 Dec 17.
**PMID:** 27988848
## 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: D000001745
- Term: Urinary Bladder Diseases
- ID: D000014570
- Term: Urologic Diseases
- ID: D000052801
- Term: Male Urogenital Diseases
- ID: D000002137
- Term: Calculi
- ID: D000020763
- Term: Pathological Conditions, Anatomical
- ID: D000052878
- Term: Urolithiasis
- ID: D000014545
- Term: Urinary Calculi
- ID: D000014524
- Term: Urethral Obstruction
- ID: D000014522
- Term: Urethral Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: All
- Name: All Conditions
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M10698
- Name: Kidney Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5030
- Name: Urinary Bladder Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M10693
- Name: Kidney Calculi
- Relevance: LOW
- As Found: Unknown
- ID: M27126
- Name: Nephrolithiasis
- Relevance: LOW
- As Found: Unknown
- ID: M5399
- Name: Calculi
- Relevance: LOW
- As Found: Unknown
- ID: M5029
- Name: Urinary Bladder Neck Obstruction
- Relevance: HIGH
- As Found: Bladder Outlet Obstruction
- ID: M5025
- Name: Urinary Bladder Calculi
- Relevance: HIGH
- As Found: Bladder Stone
- ID: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27093
- Name: Female Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14127
- Name: Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M8399
- Name: Female Urogenital Diseases and Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M5026
- Name: Urinary Bladder Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17319
- Name: Urologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27095
- Name: Male Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M22519
- Name: Pathological Conditions, Anatomical
- Relevance: LOW
- As Found: Unknown
- ID: M27103
- Name: Urolithiasis
- Relevance: LOW
- As Found: Unknown
- ID: M17295
- Name: Urinary Calculi
- Relevance: LOW
- As Found: Unknown
- ID: M17274
- Name: Urethral Obstruction
- Relevance: LOW
- As Found: Unknown
- ID: M17272
- Name: Urethral Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001748
- Term: Urinary Bladder Neck Obstruction
- ID: D000001744
- Term: Urinary Bladder Calculi
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06422299
**Brief Title:** Developing and Testing an Online Intervention for Alcohol and Cannabis Misuse and Healthy Relationship Skills Among Young Adult Couples
**Official Title:** Developing and Testing an Online Intervention for Decreasing Alcohol and Cannabis Misuse and Increasing Healthy Relationship Skills Among Young Adult Couples: A Comprehensive Mixed-methods Approach
#### Organization Study ID Info
**ID:** STUDY00017992
#### Organization
**Class:** OTHER
**Full Name:** University of Washington
#### Secondary ID Infos
**ID:** K23AA031034-01
**Link:** https://reporter.nih.gov/quickSearch/K23AA031034-01
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2027-08-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2027-08-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2026-07-15
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-02-08
**Study First Submit QC Date:** 2024-05-18
### Sponsor Collaborators Module
#### Collaborators
**Class:** NIH
**Name:** National Institutes of Health (NIH)
**Class:** NIH
**Name:** National Institute on Alcohol Abuse and Alcoholism (NIAAA)
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Washington
#### Responsible Party
**Investigator Affiliation:** University of Washington
**Investigator Full Name:** Katherine Walukevich-Dienst
**Investigator Title:** Acting Assistant Professor, School of Medicine
**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 develop and test a brief online intervention to reduce alcohol and cannabis misuse and improve healthy relationship skills among young adult couples. The main questions it aims to answer are:
* Will the intervention be feasible and acceptable to young adult couples?
* Will the intervention demonstrate initial efficacy in reducing risky substance use and increasing relationship functioning?
Eligible couples will complete a virtual baseline session and be randomized to intervention condition (online intervention with 3-5 weeks of self-paced modules) or control condition (no intervention). Couples will complete two follow-up surveys (post-assessment - approximately 5 weeks after baseline, 3-month). Couples in the control condition will be offered the intervention after 3-month follow-up.
Researchers will compare intervention and control groups to see if there there is a difference between the groups on substance misuse and relationship functioning at post-assessment and 3-month follow-up.
### Conditions Module
**Conditions:**
- Alcohol Drinking
- Cannabis Use
- Couples
**Keywords:**
- alcohol use, cannabis use, couples, healthy relationships, young adults
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** A novel, brief online intervention for young adults community couples who engage in alcohol and cannabis co-use.
**Intervention Names:**
- Behavioral: Online, couples-based intervention
**Label:** Online, couples-based intervention
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Couples in the control condition will not receive an intervention.
**Label:** Assessment-only control
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Online, couples-based intervention
**Description:** During Phase 1 of the present study, the intervention will be iteratively developed using a rigorous, user-centered design approach through integration of knowledge gained from Phase 1 dyadic analyses and qualitative interviews, and existing gold-standard treatments for substance use among couples, including Integrative Behavioral Couples Therapy (IBCT; Christensen \& Doss, 2016) and Behavioral Couples Therapy for Alcohol (ABCT; McCrady et al, 1995) and substance use brief interventions for young adults (Halladay, et al., 2019; Tanner-Smith et al., 2015).
**Name:** Online, couples-based intervention
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** Alcohol use - number of days in the past month participant engaged in heavy episodic drinking (4+/5+ drinks in one occasion for women/men) and high intensity drinking (8+/10+ drinks in one occasion for women/men)
**Measure:** Heavy episodic and high intensity drinking
**Time Frame:** Screening, baseline, approximately 5 weeks after baseline, 3-month followup
**Description:** Alcohol use - Average total drinks per week will be calculated as the sum of the total number of drinks reported.
**Measure:** Daily Drinking Questionnaire (DDQ)
**Time Frame:** Screening, baseline, approximately 5 weeks after baseline, 3-month followup
**Description:** Cannabis use - Average total hours high from cannabis per week will be calculated as the sum of the total hours high reported
**Measure:** Daily Marijuana Questionnaire (DMQ)
**Time Frame:** Screening, baseline, approximately 5 weeks after baseline, 3-month followup
**Description:** Cannabis use intensity - Average number of times used cannabis per day will be calculated as the mean number of times participant reports using cannabis per each day of a typical week in the past month
**Measure:** Intensity of Marijuana Use
**Time Frame:** Screening, baseline, approximately 5 weeks after baseline, 3-month followup
**Description:** Healthy relationship self-efficacy - 3 items assessing perceived intervention impacts on healthy relationship self-efficacy scored 0=strongly disagree to 5=strongly agree. Scores will be summed, total scores will range from 0 to 15, with higher scores indicating greater healthy relationship self-efficacy
**Measure:** Perceived Program Effects on Healthy Relationship Self-Efficacy items
**Time Frame:** Screening, baseline, approximately 5 weeks after baseline, 3-month followup
**Description:** Relationship satisfaction - sum of 4 items ranges from 0 to 21, higher scores indicate greater relationship satisfaction
**Measure:** Couples Satisfaction Index
**Time Frame:** Screening, baseline, approximately 5 weeks after baseline, 3-month followup
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Both partners in the couple are 18-29 years old
* In a committed romantic relationship (e.g., dating seriously, cohabiting, married) with each other for at least 3 months
* Face-to-face contact their partner at least 5 days per week
* Live in Washington State
* Have a valid email address and access to a cell phone
* Report alcohol and cannabis co-use at least three times in the past month
* Willingness to: complete online surveys during the allotted time frames, receive text messages and emails from the project, complete a baseline session, and participate during the same time period as their partner
Exclusion Criteria:
* Couples who endorse any perpetration or receipt of severe interpersonal aggression during screening will be excluded and provided with resources
**Healthy Volunteers:** True
**Maximum Age:** 29 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Katherine Walukevich-Dienst, PhD
**Phone:** 508-282-0413
**Role:** CONTACT
**Contact 2:**
**Name:** Hana Basu, BA
**Phone:** 425-372-6459
**Role:** CONTACT
### References Module
#### References
**Citation:** Patrick ME. A Call for Research on High-Intensity Alcohol Use. Alcohol Clin Exp Res. 2016 Feb;40(2):256-9. doi: 10.1111/acer.12945. No abstract available.
**PMID:** 26842244
**Citation:** Collins RL, Parks GA, Marlatt GA. Social determinants of alcohol consumption: the effects of social interaction and model status on the self-administration of alcohol. J Consult Clin Psychol. 1985 Apr;53(2):189-200. doi: 10.1037//0022-006x.53.2.189. No abstract available.
**PMID:** 3998247
**Citation:** Lee CM, Kilmer JR, Neighbors C, Atkins DC, Zheng C, Walker DD, Larimer ME. Indicated prevention for college student marijuana use: a randomized controlled trial. J Consult Clin Psychol. 2013 Aug;81(4):702-9. doi: 10.1037/a0033285. Epub 2013 Jun 10.
**PMID:** 23750464
**Citation:** Patrick ME, Veliz PT, Terry-McElrath YM. High-intensity and simultaneous alcohol and marijuana use among high school seniors in the United States. Subst Abus. 2017 Oct-Dec;38(4):498-503. doi: 10.1080/08897077.2017.1356421. Epub 2017 Jul 20.
**PMID:** 28726580
**Citation:** Scott ME, Moore KA, Fish H, Benedetti A, Erikson S. OPRE Report #2015-65a. Prepared by Child Trends. Washington, DC: Office of Planning, Research and Evaluation, Administration for Children and Families, U.S. Department of Health and Human Services. 2015. https://www.acf.hhs.gov/sites/default/files/documents/b_hmre_recommended_outcome_measures_for_adolescents_508_0.pdf
**Citation:** Funk JL, Rogge RD. Testing the ruler with item response theory: increasing precision of measurement for relationship satisfaction with the Couples Satisfaction Index. J Fam Psychol. 2007 Dec;21(4):572-83. doi: 10.1037/0893-3200.21.4.572.
**PMID:** 18179329
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000019966
- Term: Substance-Related Disorders
- ID: D000064419
- Term: Chemically-Induced Disorders
- ID: D000001523
- Term: Mental Disorders
- ID: D000004327
- Term: Drinking Behavior
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
- Abbrev: BC25
- Name: Substance Related Disorders
### Condition Browse Module - Browse Leaves
- ID: M3774
- Name: Alcohol Drinking
- Relevance: HIGH
- As Found: Alcohol Drinking
- ID: M5449
- Name: Marijuana Abuse
- Relevance: HIGH
- As Found: Cannabis
- ID: M21837
- Name: Substance-Related Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M30302
- Name: Chemically-Induced Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M7502
- Name: Drinking Behavior
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000002189
- Term: Marijuana Abuse
- ID: D000000428
- Term: Alcohol Drinking
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M3777
- Name: Ethanol
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06422286
**Brief Title:** Efficacy of Low-level Laser Acupuncture and Microcurrent Electrical Stimulation on Gag Reflex on Children
**Official Title:** Efficacy of Low-level Laser Acupuncture and Microcurrent Electrical Stimulation on Gag Reflex on Children During Taking Dental Impression
#### Organization Study ID Info
**ID:** 0800_11/2023
#### Organization
**Class:** OTHER
**Full Name:** Alexandria University
### Status Module
#### Completion Date
**Date:** 2024-12-16
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-18
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-08-16
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-04-16
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-24
**Study First Submit QC Date:** 2024-05-18
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Alexandria University
#### Responsible Party
**Investigator Affiliation:** Alexandria University
**Investigator Full Name:** Marwa Baraka
**Investigator Title:** Lecturer, Pediatric dentistry department
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** the aim of the current study is to evaluate the effectiveness of the laser acupuncture in comparison to the electroacupuncure for controlling gag reflex in children
**Detailed Description:** the study will select children who are suffering from gag reflex that can affect their dental appointments negatively. they will be diagnosed then randomly distributed to one of the 3 groups of the study gag reflex and anxiety will be measured before and after the intervention then the results will be compared.
### Conditions Module
**Conditions:**
- Gagging
**Keywords:**
- gag reflex
- dental anxiety
- low-level laser
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 63
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The laser device with wavelength 940 nm, energy 4J, and 3-4 mm away from the tissue is applied on PC6 acupoint without causing pain to the patient for 1 minute.
Immediately after the laser acupuncture, an alginate impression is going to be taken.
**Intervention Names:**
- Device: low-level laser
**Label:** children allocated to low-level laser
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** A meridian acupuncture pen with AA battery will be applied on PC6 for one minute.
Immediately after using the meridian pen, an alginate impression is going to be taken.
**Intervention Names:**
- Biological: microcurrent stimulation
**Label:** children allocated to microcurrent electrical stimulation
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** A meridian acupuncture pen will be deactivated by the operator. Then an alginate impression is going to be taken.
**Intervention Names:**
- Device: placebo
**Label:** placebo control group
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- children allocated to low-level laser
**Description:** children will be allocated to the device then the gag reflex will be re-evaluated
**Name:** low-level laser
**Type:** DEVICE
#### Intervention 2
**Arm Group Labels:**
- children allocated to microcurrent electrical stimulation
**Description:** children will be allocated to the device then the gag reflex will be re-evaluated
**Name:** microcurrent stimulation
**Other Names:**
- meridian pen
**Type:** BIOLOGICAL
#### Intervention 3
**Arm Group Labels:**
- placebo control group
**Description:** children will be allocated to a deactivated meridian pen
**Name:** placebo
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** the difference in gagging preventive index before and after the intervention
**Measure:** gagging prevetive index
**Time Frame:** immediately after the intervention
#### Secondary Outcomes
**Description:** dental anxiety will be measured before and after the intervention using pulse oximeter
**Measure:** anxiety
**Time Frame:** immediately after the intervention
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* children free of any systemic disease or special health care needs
* children with score 2 or 3 according to the frankle behavioral rating scale
* a full arch maxillary alginate impression is needed
* moderate to severe gagging according to the gagging severity index
* written informed consent of the legal guardian
Exclusion Criteria:
* children taking anti-emetic drugs
* children sensitive to alginate
**Maximum Age:** 9 Years
**Minimum Age:** 6 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** sara salim, master
**Phone:** 01026643894
**Role:** CONTACT
**Contact 2:**
**Name:** marwa baraka, PHD
**Phone:** 01000804757
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Alexandria
**Country:** Egypt
**Facility:** Alexandria University
**Status:** RECRUITING
#### Overall Officials
**Official 1:**
**Affiliation:** Alexandria University
**Name:** sawsan hafez, PHD
**Role:** STUDY_CHAIR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012817
- Term: Signs and Symptoms, Digestive
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M4324
- Name: Anxiety Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M8802
- Name: Gagging
- Relevance: HIGH
- As Found: Gag Reflex
- ID: M15622
- Name: Signs and Symptoms, Digestive
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000005683
- Term: Gagging
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06422273
**Brief Title:** Protest Trial: TXA vs Saline
**Official Title:** Prophylactic Use of Tranexamic Acid Versus Saline to Prevent Bleeding During Transbronchial Biopsy in Lung Transplant Recipients- A Randomized Double-Blind Trial (Protest Trial)
#### Organization Study ID Info
**ID:** 2024-0552
#### Organization
**Class:** OTHER
**Full Name:** Spectrum Health Hospitals
### Status Module
#### Completion Date
**Date:** 2026-04-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-17
**Overall Status:** ENROLLING_BY_INVITATION
#### Primary Completion Date
**Date:** 2025-04-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-04-16
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Spectrum Health Hospitals
#### Responsible Party
**Investigator Affiliation:** Spectrum Health Hospitals
**Investigator Full Name:** Sheila Krishnan
**Investigator Title:** Principle Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** To determine if endobronchial (topical) tranexamic acid used prophylactically prior to performing transbronchial biopsies in lung transplant recipients reduces bleeding risk.
**Detailed Description:** Tranexamic acid (TXA) is an antifibrinolytic agent. It forms a reversible complex that displaces plasminogen from fibrin resulting in inhibition of fibrinolysis. It also inhibits proteolytic activity of plasmin. TXA is frequently used in clinical practice and can be administered via multiple delivery methods, including intravenous, nebulized, and topical. It has been shown to reduce blood loss in a variety of clinical settings without significant adverse effects. It has also been evaluated for prophylactic use with mixed results in reducing bleeding. In our current general pulmonary practice, topical TXA is used variably by pulmonologists during bronchoscopy for post-biopsy bleeding or pulmonary hemorrhage.
The purpose of this research study is to determine if prophylactic topical TXA can reduce bleeding risk in lung transplant patients who undergo transbronchial biopsies. A finding of reduced bleeding would be significant as it could improve clinical outcomes, allow for improved diagnostic yield of biopsy samples, and improve patient experience. It therefore has the potential to change clinical practice and standardize bronchoscopy procedures.
### Conditions Module
**Conditions:**
- Lung Transplant; Complications
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** The study design will be a single-center, randomized, double-blinded, placebo-controlled study. The control group will receive topical saline (placebo) and the experimental treatment group will receive topical Tranexamic acid (TXA active drug).
##### Masking Info
**Masking:** TRIPLE
**Masking Description:** The investigational pharmacist will be responsible for randomizing on the day of bronchoscopy to placebo or Tranexamic acid in a 1:1 fashion using REDCap software. The pharmacist will be the only individual aware of the randomization assignment. All other study personnel will be blinded to the randomization assignment.
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 94
**Type:** ESTIMATED
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Tranexamic acid used prophylactically prior to performing transbronchial biopsies in lung transplant recipients.
**Intervention Names:**
- Drug: Tranexamic Acid
**Label:** TXA
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Topical Saline (placebo) administered as endobronchial topical application.
**Intervention Names:**
- Other: Saline (placebo)
**Label:** Saline
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- TXA
**Description:** Endobronchial (topical) tranexamic acid used prophylactically prior to performing transbronchial biopsies in lung transplant recipients
**Name:** Tranexamic Acid
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Saline
**Description:** Topical Saline (placebo) administered as endobronchial topical application prior to performing transbronchial biopsies in lung transplant recipients.
**Name:** Saline (placebo)
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Bleeding severity will be documented in the following categories: none, mild, moderate, severe and massive
**Measure:** Bleeding Risk
**Time Frame:** up to 1 hour
#### Secondary Outcomes
**Description:** Procedure times will be recorded for both the tranexamic acid and the control saline group.
**Measure:** Procedure time Reduction
**Time Frame:** up to 1 hour
**Description:** This will be measured by the number of pieces of tissue from the pathology report
**Measure:** Greater yield in tissue samples
**Time Frame:** up to 1 hour
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Single or double lung transplant recipients
2. Patients \>18 years old
3. Willingness and ability to sign an informed consent for study participation
Exclusion Criteria:
1. Platelet count (\<50k/uL)
2. INR (\>1.6)
3. Active bleeding
4. Decompensated liver disease
5. History of uremic bleeding or BUN \>50
6. Severe pulmonary hypertension (mean PA pressure \>40 mmHg on RHC or estimated PA systolic pressure \>62 mmHg on TTE within one year of procedure)
7. Known bleeding disorder
8. Allergy to TXA
9. Prior history of severe TBBx-related airway bleeding requiring admission or advanced maneuvers for hemostasis (examples including intubation, bronchial artery embolization, surgical intervention)
10. Contraindications to topical TXA
11. Pregnancy
12. Vulnerable populations
13. Adults of limited English proficiency/non-English speakers
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Grand Rapids
**Country:** United States
**Facility:** Spectrum Health Hospitals
**State:** Michigan
**Zip:** 49503
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Document Section
### Large Document Module
#### Large Docs
- Date: 2024-02-20
- Filename: Prot_SAP_000.pdf
- Has ICF: False
- Has Protocol: True
- Has SAP: True
- Label: Study Protocol and Statistical Analysis Plan
- Size: 375346
- Type Abbrev: Prot_SAP
- Upload Date: 2024-05-16T12:12
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M9556
- Name: Hemorrhage
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Ancestors
- ID: D000000933
- Term: Antifibrinolytic Agents
- ID: D000050299
- Term: Fibrin Modulating Agents
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000006490
- Term: Hemostatics
- ID: D000003029
- Term: Coagulants
### Intervention Browse Module - Browse Branches
- Abbrev: Coag
- Name: Coagulants
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M16902
- Name: Tranexamic Acid
- Relevance: HIGH
- As Found: Stage IV
- ID: M4252
- Name: Antifibrinolytic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M9576
- Name: Hemostatics
- Relevance: LOW
- As Found: Unknown
- ID: M6259
- Name: Coagulants
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000014148
- Term: Tranexamic Acid
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06422260
**Brief Title:** Four-unit Implant Supported Fixed Partial Dentures Fabricated From Different Materials
**Official Title:** Clinical and Radiographic Outcomes of Four-unit Implant Supported Fixed Partial Dentures Fabricated From Different Materials
#### Organization Study ID Info
**ID:** ADMNF-0030324
#### Organization
**Class:** OTHER
**Full Name:** Menoufia University
### Status Module
#### Completion Date
**Date:** 2025-01-29
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-17
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-07-22
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-01-19
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-08
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Menoufia University
#### Responsible Party
**Investigator Affiliation:** Menoufia University
**Investigator Full Name:** Mohammed El-Sawy
**Investigator Title:** lecturer, Department of prosthodontics, principle investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Implant supported superstructure is necessary for long term success and durability of the implant itself in terms of stresses distribution and fracture strength capability. Stresses falling on an implant are too much greater than those applied on a tooth structure with a periodontal ligament offering a degree of elasticity. The important mechanical and physical properties of materials used for the fabrication of dental prostheses include adequate flexural and tensile strength and modulus of elasticity, maximum fracture resistance, optimal bond strength and adequate polishability.
**Detailed Description:** One objective of implant dentistry is to provide excellent esthetics and soft-tissue profiles in the esthetic zone. Esthetic requirements have focused primarily on the position, inclination, shape, and color of the restoration. However, the peri-implant soft tissue also plays a major role in the esthetics of an implant-supported restoration especially in the anterior region.
### Conditions Module
**Conditions:**
- Prosthesis Survival
- Bone Loss
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Patient Registry:** True
**Study Type:** OBSERVATIONAL
**Target Duration:** 4 Years
### Arms Interventions Module
#### Arm Group 1
**Description:** Evaluation of biological response and clinical performance of the fixed partial denture anterior bridge constructed from PFM
**Intervention Names:**
- Other: Prosthesis superstructure
**Label:** Porcelin fused to metal (PFM) group
#### Arm Group 2
**Description:** Evaluation of biological response and clinical performance of the fixed partial denture anterior bridge constructed from ceramics
**Intervention Names:**
- Other: Prosthesis superstructure
**Label:** Zirconia group
#### Arm Group 3
**Description:** Evaluation of biological response and clinical performance of the fixed partial denture anterior bridge constructed from PEEK
**Intervention Names:**
- Other: Prosthesis superstructure
**Label:** Polyetheretherketone (PEEK) group
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Polyetheretherketone (PEEK) group
- Porcelin fused to metal (PFM) group
- Zirconia group
**Description:** Prosthesis superstructure for 2 implant supported short span fixed bride constructed from different materials
**Name:** Prosthesis superstructure
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Measurement of alveolar bone loss around implants.
**Measure:** Bone loss
**Time Frame:** 4 years
#### Secondary Outcomes
**Description:** Such as fracture of the prosthesis.
**Measure:** Clinical performance of the prosthesis superstructure
**Time Frame:** 4 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* No systemic diseases that might alter the tissue response to implantation.
* Mobility grade 3 at the site of the 4 lateral incisors.
* sufficient available inter-arch space
* normal maxillomandibular relation.
* no temporomandibular joint
Exclusion Criteria:
* Grade 1 or 2 mobility at the incisor's region.
* Patients with systematic diseases that contraindicate implant placement.
**Maximum Age:** 50 Years
**Minimum Age:** 30 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
**Study Population:** 60 participants who needed an implant-supported fixed partial denture (FPD) in the esthetic zone.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Mohammed A. El-Sawy, PhD
**Phone:** 01061314522
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Mohammed T. Khater, PhD
**Phone:** 01003854552
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Mansoura
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Mohammed A. El-Sawy
- **Phone:** 161314522
- **Role:** CONTACT
**Country:** Egypt
**Facility:** Mohammed A. El-Sawy
**Status:** RECRUITING
**Zip:** 12345
#### Overall Officials
**Official 1:**
**Affiliation:** Menoufia University
**Name:** Mohammed A. El-Sawy, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** The result can be shared upon request from the corresponding author
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000011183
- Term: Postoperative Complications
- ID: D000010335
- Term: Pathologic Processes
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M14338
- Name: Prosthesis Failure
- Relevance: HIGH
- As Found: Prosthesis Survival
- ID: M14065
- Name: Postoperative Complications
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000011475
- Term: Prosthesis Failure
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06422247
**Brief Title:** Observational Study in Japanese Patients With Peripheral T-Cell Lymphoma Who Received Second-Line Therapy
**Official Title:** Observational Study in Japanese Patients With Peripheral T-Cell Lymphoma Who Received Second-Line Therapy
#### Organization Study ID Info
**ID:** CA073-1019
#### Organization
**Class:** INDUSTRY
**Full Name:** Bristol-Myers Squibb
### Status Module
#### Completion Date
**Date:** 2025-04-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-15
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-04-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-14
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Bristol-Myers Squibb
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
### Description Module
**Brief Summary:** The purpose of this study is to describe the therapeutic practices and the prognosis of patients with relapsed or refractory peripheral T-cell lymphoma in Japan
### Conditions Module
**Conditions:**
- Peripheral T-cell Lymphoma
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 300
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Drug: Systemic therapy
**Label:** Relapsed or refractory peripheral T-cell lymphoma initiating second-line systemic therapy
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Relapsed or refractory peripheral T-cell lymphoma initiating second-line systemic therapy
**Description:** Approved peripheral T-cell lymphoma systemic treatments prescribed by the treating physician
**Name:** Systemic therapy
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Measure:** Overall survival (OS)
**Time Frame:** From baseline until date of death from any cause or last known alive date, assessed up to 6 years
#### Secondary Outcomes
**Measure:** Participant baseline demographics
**Time Frame:** Baseline
**Measure:** Participant baseline clinical characteristics
**Time Frame:** Baseline
**Measure:** Participant treatment sequence from initial diagnosis
**Time Frame:** From date of initial diagnosis until death from any cause or last known alive date, assessed up to 6 years
**Measure:** Frequency of treatment regimen by treatment line
**Time Frame:** End date of each treatment-line of therapy, assessed up to 6 years
**Measure:** Time to next treatment line or death (TTNT)
**Time Frame:** From date of first-line therapy initiation until death from any cause or last known alive date, assessed up to 6 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Male or female participants with a confirmed diagnosis of the specific subtypes of peripheral T-cell lymphoma (PTCL) according to The World Health Organization (WHO) classification of lymphoid neoplasm, 4th edition defined by WHO and International Agency for Research on Cancer (IARC).
* Participates aged ≥18 years of age at diagnosis of PTCL.
* Participates who have been treated with a systemic therapy for PTCL and have initiated a systemic therapy as a second-line therapy for relapsed or refractory PTCL between April 1, 2018 and March 31, 2023.
Exclusion Criteria:
* Participates who have medical history of peripheral T-cell lymphoma (PTCL) treatment by unapproved drug in Japan as of 31 March 2024 or off-label drug for PTCL in Japan as of 31 March 2024.
* Participates who have medical history of participation to a separately defined registration study for regulatory approval in PTCL.
* Participates who have medical history of PTCL treatment in a separately defined clinical study with intervention by on-label regimen for PTCL.
* Participates judged to be inappropriate for enrollment in this study by the site investigator.
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Adult participants with peripheral T-cell lymphoma in Japan initiating second-line systemic therapy
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** BMS Study Connect Contact Center www.BMSStudyConnect.com
**Phone:** 855-907-3286
**Role:** CONTACT
**Contact 2:**
**Name:** First line of the email MUST contain NCT # and Site #.
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Minato-ku
**Country:** Japan
**Facility:** Mebix, Inc
**State:** Tokyo
**Status:** RECRUITING
**Zip:** 105-0001
#### Overall Officials
**Official 1:**
**Affiliation:** Bristol-Myers Squibb
**Name:** Bristol-Myers Squibb
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### 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:** https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000009369
- Term: Neoplasms
- ID: D000008232
- Term: Lymphoproliferative Disorders
- ID: D000008206
- Term: Lymphatic Diseases
- ID: D000007160
- Term: Immunoproliferative Disorders
- ID: D000007154
- Term: Immune System Diseases
- ID: D000008228
- Term: Lymphoma, Non-Hodgkin
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC15
- Name: Blood and Lymph Conditions
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M11220
- Name: Lymphoma
- Relevance: HIGH
- As Found: Lymphoma
- ID: M18829
- Name: Lymphoma, T-Cell
- Relevance: HIGH
- As Found: T-cell Lymphoma
- ID: M18833
- Name: Lymphoma, T-Cell, Peripheral
- Relevance: HIGH
- As Found: Peripheral T-cell Lymphoma
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
- ID: M11225
- Name: Lymphoproliferative Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M11203
- Name: Lymphatic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10206
- Name: Immunoproliferative Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M11222
- Name: Lymphoma, Non-Hodgkin
- Relevance: LOW
- As Found: Unknown
- ID: T3543
- Name: Lymphosarcoma
- Relevance: HIGH
- As Found: Lymphoma
- ID: T4496
- Name: Peripheral T-cell Lymphoma
- Relevance: HIGH
- As Found: Peripheral T-cell Lymphoma
### Condition Browse Module - Meshes
- ID: D000008223
- Term: Lymphoma
- ID: D000016399
- Term: Lymphoma, T-Cell
- ID: D000016411
- Term: Lymphoma, T-Cell, Peripheral
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06422234
**Brief Title:** Effect of Exergame-Based Exercise on Hamstring and Quadriceps Isokinetic Muscle Parameters
**Official Title:** Effect of Exergame-Based Exercise on Hamstring and Quadriceps Isokinetic Muscle Parameters, Balance and Explosive Power
#### Organization Study ID Info
**ID:** ACetinkaya001
#### Organization
**Class:** OTHER
**Full Name:** Halic University
### Status Module
#### Completion Date
**Date:** 2024-06-03
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-17
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-05-27
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-04-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-08
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Medipol University
#### Lead Sponsor
**Class:** OTHER
**Name:** Halic University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** The aim of this study is to investigate the effects of two different exercise methods (video-based game exercise group and real (non-game) exercise group) to increase knee strength in healthy individuals on muscle strength, balance and lower extremity functional parameters. In our study, it will be revealed which technique will have what effect in the strengthening, which will be done by taking certain criteria into consideration. Participants will be randomized into three different groups. Two groups, except the control group, will exercise three times a week for 6 weeks. All participants will be assessment twice in total, at the beginning of the study and 6 weeks later. It is thought that the results obtained here will contribute to the literature.
**Detailed Description:** The study was planned to include individuals studying at Halic University, who met the inclusion criteria and volunteered to participate in the study. Evaluated participants will be randomly assigned to three different groups (control group, video-based game exercise group, real game-free exercise group). The sealed envelope method will be used in randomization. All evaluations by the same physiotherapist will be performed twice, before exercise and after 6 weeks of exercise. Both exercise groups will practice under the supervision of a physiotherapist. The control group will not exercise and will only be evaluated twice. At the end of the study, those in the control group will be able to participate in any exercise group they want for 6 weeks.
### Conditions Module
**Conditions:**
- Exergaming
- Sedentary Behavior
- Muscle Strength
**Keywords:**
- Exergaming
- Muscle Strength Dynamometer
- Physical Inactivity
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 45
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants will exercise 3 days a week for 6 weeks with the Ring Fit Adventure game on Nintendo Switch. The exergames to be played are selected by the physiotherapist and become more difficult as the weeks progress.
**Intervention Names:**
- Other: Exergame
**Label:** Exergame Group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The games selected for the exergame group will be held in a real environment, without games, 3 days a week for 6 weeks.
**Intervention Names:**
- Other: Game-free Exercise
**Label:** Game-free Exercise Group
**Type:** ACTIVE_COMPARATOR
#### Arm Group 3
**Description:** Participants in this group will continue their normal life routines and the evaluations will be repeated 6 weeks after the first evaluation.
**Label:** Control Group
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Exergame Group
**Description:** Video-based game exercises will be performed 3 days a week for 6 weeks. Participants will be taught how to play the games before starting the game called Ring Fit Adventure, one of the Nintendo Switch games. Among the games within Ring Fit, games that aim to increase lower extremity muscle strength, core stabilization and balance have been selected, and game types and number of repetitions are changed every week.
**Name:** Exergame
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Game-free Exercise Group
**Description:** All activities in the exergame group were done without games and screens. The progression of the exercises proceeds in the same way as the other group.
**Name:** Game-free Exercise
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Biodex System 4 device will be used to evaluate quadriceps and hamstring isokinetic muscle strength. All tests were planned to be performed on the dominant and non-dominant sides of the participants. Isokinetic muscle strength test will be performed in concentric/concentric mode at speeds of 60°/sec, 90°/sec, 240°/sec in concentric strength test. Isokinetic test will be performed at 0° extension and 90° flexion joint range of motion. Before the isokinetic test, the participant will have 2 repetitions at 60°/sec for adaptation, and then 5 repetitions for the test. After the participant rests for 120 seconds, the participant will first have 4 repetitions for adaptation and then 15 repetitions for the test at 240°/sec. During the tests, the participant will be verbally motivated by the same person. .As a result of the tests, quadriceps and hamstring peak torque (PT) values will be recorded.
**Measure:** Isokinetic Evaluation-Peak Torque
**Time Frame:** at baseline and at week 6
**Description:** Biodex System 4 device will be used to evaluate quadriceps and hamstring isokinetic muscle strength. All tests were planned to be performed on the dominant and non-dominant sides of the participants. Isokinetic muscle strength test will be performed in concentric/concentric mode at speeds of 60°/sec, 90°/sec, 240°/sec in concentric strength test. Isokinetic test will be performed at 0° extension and 90° flexion joint range of motion. Before the isokinetic test, the participant will have 2 repetitions at 60°/sec for adaptation, and then 5 repetitions for the test. After the participant rests for 120 seconds, the participant will first have 4 repetitions for adaptation and then 15 repetitions for the test at 240°/sec. During the tests, the participant will be verbally motivated by the same person. As a result of the tests, peak torque/body weight (PT/VA) values will be recorded.
**Measure:** Isokinetic Evaluation-Peak Torque / Body Weight
**Time Frame:** at baseline and at week 6
**Description:** Biodex System 4 device will be used to evaluate quadriceps and hamstring isokinetic muscle strength. All tests were planned to be performed on the dominant and non-dominant sides of the participants. Isokinetic muscle strength test will be performed in concentric/concentric mode at speeds of 60°/sec, 90°/sec, 240°/sec in concentric strength test. Isokinetic test will be performed at 0° extension and 90° flexion joint range of motion. Before the isokinetic test, the participant will have 2 repetitions at 60°/sec for adaptation, and then 5 repetitions for the test. After the participant rests for 120 seconds, the participant will first have 4 repetitions for adaptation and then 15 repetitions for the test at 240°/sec. During the tests, the participant will be verbally motivated by the same person. As a result of the tests, Hamstring/Quadriceps (H/Q) values will be recorded.
**Measure:** Isokinetic Evaluation-Peak Torque / Hamstring/Quadriceps (H/Q)
**Time Frame:** at baseline and at week 6
**Description:** Biodex System 4 device will be used to evaluate quadriceps and hamstring isokinetic muscle strength. All tests were planned to be performed on the dominant and non-dominant sides of the participants. Isokinetic muscle strength test will be performed in concentric/concentric mode at speeds of 60°/sec, 90°/sec, 240°/sec in concentric strength test. Isokinetic test will be performed at 0° extension and 90° flexion joint range of motion. Before the isokinetic test, the participant will have 2 repetitions at 60°/sec for adaptation, and then 5 repetitions for the test. After the participant rests for 120 seconds, the participant will first have 4 repetitions for adaptation and then 15 repetitions for the test at 240°/sec. During the tests, the participant will be verbally motivated by the same person. As a result of the tests, total work values will be recorded.
**Measure:** Isokinetic Evaluation-Peak Torque / Total Work
**Time Frame:** at baseline and at week 6
#### Secondary Outcomes
**Description:** Individuals' joint position sense of the knee joint will be evaluated at 30°, 45° and 75° knee flexion angles using the Biodex System 4 device. While the individual's eyes are closed, the knee joint will be brought to the targeted angle by the researcher, and the subject will be asked to stay in this position for 5 seconds and perceive this angular position. Afterwards, the individuals' knee angle will be flexed to 90° and they will be asked to bring the knee joint to the targeted angle. The test will be repeated three times and the average of the deviation degrees from the targeted angle in the three tests will be recorded regardless of the direction of movement. The less deviation from the target angle, the better the sense of proprioception.
**Measure:** Proprioception Assessment
**Time Frame:** at baseline and at week 6
**Description:** It is asked to jump to maximum height from the double-leg squat position. Between jumps, 15 to 30 seconds of listening time is given for recovery. Athletes are asked to perform 3 repetitions and the average of the values is recorded. The jump height is recorded in centimeters. The EZEJUMP (vertical jump testing system) System will be used for this test.The higher the jump height, the better the performance.
**Measure:** Vertical Jump Test
**Time Frame:** at baseline and at week 6
**Description:** It is asked to open his legs shoulder-width apart, and without taking a step, he jumps forward, gaining momentum with his arms. The distance between the starting line and the heel closest to this line is recorded as the score. The jump distance is recorded in centimeters Three attempts are made and the best score is noted. The higher the jump distance, the better the performance.
**Measure:** Standing long jump
**Time Frame:** at baseline and at week 6
**Description:** While the individual tries to balance on a 15 cm long, 4 cm wide wooden plate prepared in the dimensions specified in the literature, the number of times he falls in 1 minute will be recorded. He stands on the bench with his dominant foot lengthwise, bends his free foot backwards and holds it with his hand on the same side. The other arm is released to maintain balance. During this period, the stopwatch will be stopped during each fall and the individual will be waited to get into position again. As the number of falls decreases during one minute, static balance performance increases.
**Measure:** Flamingo Balance Test
**Time Frame:** at baseline and at week 6
**Description:** The maximum distance that a person can travel while balancing on one leg in three directions is recorded in centimeters. At the furthest point they lie down, the person is asked to lightly touch the ground and balance standing again. The test is completed by moving clockwise or counterclockwise. While stretching, your hands are asked to be on the iliac crests. A trial tour is conducted before the test. The average of the subject's three attempts in each direction is taken, the result is divided by the leg length and multiplied by 100. Increasing the distance a person can reach with the other leg while remaining in balance indicates that dynamic balance performance increases.
**Measure:** Modified Star Balance Test
**Time Frame:** at baseline and at week 6
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Being a woman between the ages of 18-25
* Being a 1st or 2nd year physiotherapy and rehabilitation student or a student in any department other than sports sciences
* Being sedentary or underweight according to fit score
* Being at normal values according to body mass index
* Full knee flexion-extension joint range of motion
* Volunteering to participate in the study
Exclusion Criteria:
* Knee pain, history of injury in the last 6 months,
* Doing regular physical activity in the last 6 months,
* Neurological, cardiorespiratory, musculoskeletal, endocrine, renal, metabolic and other related disease(s) that will prevent the performance of exercises
* History of lower extremity orthopedic surgery
* Chronic use of medications or anti-inflammatory drugs
**Gender Based:** True
**Healthy Volunteers:** True
**Maximum Age:** 25 Years
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Ayşenur Çetinkaya, MSc
**Phone:** +905077218827
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Devrim Tarakcı, Asst. Prof.
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Istanbul
**Contacts:**
***Contact 1:***
- **Name:** Ayşenur Çetinkaya, MSc
- **Role:** CONTACT
***Contact 2:***
- **Name:** Ayşenur Çetinkaya, MSc
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 3:***
- **Name:** Devrim Tarakcı, Asst. Prof.
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Turkey
**Facility:** Halic University
**State:** Eyüpsultan
**Status:** RECRUITING
**Zip:** 34060
#### Overall Officials
**Official 1:**
**Affiliation:** Halic University
**Name:** Ayşenur Çetinkaya, MSc
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06422221
**Brief Title:** An Oral Doxycycline Regimen to Prevent Bacteremia Following Dental Procedures
**Official Title:** An Oral Doxycycline Regimen to Prevent Bacteremia Following Dental Procedures
#### Organization Study ID Info
**ID:** Doxycycline Regimen
#### Organization
**Class:** OTHER
**Full Name:** University of Santiago de Compostela
### Status Module
#### Completion Date
**Date:** 2025-06-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-18
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-01-15
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-14
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-18
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Hospital Clinico Universitario de Santiago
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Santiago de Compostela
#### Responsible Party
**Investigator Affiliation:** University of Santiago de Compostela
**Investigator Full Name:** Pedro DIz DIos
**Investigator Title:** Full Professor
**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:** Although controversy exists regarding the efficacy of antibiotic prophylaxis for patients at risk of infective endocarditis, expert committees continue to publish recommendations for antibiotic prophylactic regimens. The last American Heart Association (AHA) and European Society of Cardiology (ESC) guidelines include several important changes, highlighting that clindamycin (CLI) is no longer recommended as an alternative to amoxicillin in those allergic to penicillin. This new project aims to evaluate the effectiveness of oral doxycycline in preventing post-dental extraction bloodstream infection.
**Detailed Description:** PURPOSE: Despite the controversy about the risk of developing bacterial endocarditis of oral origin, numerous Expert Committees in different countries continue to publish prophylactic regimens. To date, the literature is unclear about the role of antimicrobial prophylaxis in the prevention of bacteremia following dental procedures. The aim of this study is to evaluate the efficacy of prophylactic dosage with oral doxycycline (DXC) in the prevention of bacteremia following dental extractions.
SELECTION OF THE STUDY GROUP AND STUDY DESIGN: The study group will comprise patients who, for behavioral reasons (autism, learning disabilities, phobias, etc.), will undergo dental extractions under general anesthesia in the Santiago de Compostela University Hospital (Santiago de Compostela, Spain). 150 patients will be selected and will be randomly distributed into 3 study groups: control group (receiving no prophylaxis), CLI group (receiving 600 mg oral CLI) and DXC group (receiving 100 mg oral DXC).
COLLECTION OF SAMPLES FOR BLOOD CULTURE: To determine the prevalence of bacteremia, a peripheral venous blood sample (10 ml) will be drawn from each patient. Samples will be inoculated in BACTEC plus (Becton Dickinson and Company, Sparks, MD) aerobic and anaerobic blood culture bottles, and will be processed in the Bactec 9240 (Becton Dickinson).
MICROBIOLOGICAL ANALYSIS OF BLOOD CULTURES: A Gram stain will be performed on each positive blood culture. The positive blood cultures in the aerobic media will be subcultured on blood agar and chocolate agar in an atmosphere of 5 to 10% carbon monoxide and on MacConkey agar under aerobic conditions. The same protocol will be used for the positive blood cultures in the anaerobic media, with subculture on Schaedler agar and incubation in an anaerobic atmosphere. The bacteria isolated will be identified by using the battery of biochemical tests provided with the Vitek system for Gram-positive bacteria, Neisseria spp., Haemophilus spp., and obligate anaerobic bacteria. The viridans group streptococci will be classified into five groups, the Streptococcus mitis, S. anginosus, S. salivarius, S. mutans, and S. bovis groups, by applying the Ruoff criteria. Facklam's criteria will be used to identify unusual Streptococcus spp. and other Gram-positive cocci in chains.
The subculture and further identification of the isolated bacteria will be performed by conventional microbiological techniques. The collection, handling, and transport of the blood samples for blood culture will be performed according to the recommendations of the Spanish Society of Infectious Diseases and Clinical Microbiology.
### Conditions Module
**Conditions:**
- Bacteremia
- Endocarditis
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Masking Description:** Single
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 150
**Type:** ESTIMATED
**Phases:**
- PHASE4
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Receiving no prophylaxis
**Label:** No Intervention
**Type:** NO_INTERVENTION
#### Arm Group 2
**Description:** Receiving 600 mg oral Clindamycin 1 hour before general anesthesia and before any dental manipulation
**Intervention Names:**
- Drug: Clindamycin
**Label:** Clindamycin
**Type:** ACTIVE_COMPARATOR
#### Arm Group 3
**Description:** Receiving 100 mg oral Doxycycline 1 hour before general anesthesia and before any dental manipulation
**Intervention Names:**
- Drug: Doxycycline
**Label:** Doxycycline
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Clindamycin
**Description:** Receiving 600 mg oral Clindamycin 1 hour before general anesthesia and before any dental manipulation
**Name:** Clindamycin
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Doxycycline
**Description:** Receiving 100 mg oral Doxycycline 1 hour before general anesthesia and before any dental manipulation
**Name:** Doxycycline
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Positive cultures
**Measure:** Bacteremia in participants receiving a prophylactic dosage with oral doxycyclin
**Time Frame:** Changes from baseline in prevalence of bacteremia at 30 seconds and 15 minutes after the final dental extraction
#### Secondary Outcomes
**Description:** Positive cultures
**Measure:** Bacteremia in participants receiving a prophylactic dosage with oral clindamycin
**Time Frame:** Changes from baseline in prevalence of bacteremia at 30 seconds and 15 minutes after the final dental extraction
**Description:** Positive cultures
**Measure:** Bacteremia in participants receiving no prophylaxis
**Time Frame:** Changes from baseline in prevalence of bacteremia at 30 seconds and 15 minutes after the final dental extraction
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Subjects must have at least 10 teeth.
* Subjects must have the need for a dental extraction under general anesthesia (for behavioral reasons).
* Subjects will be recruited regardless of the extent and severity of their dental and/or periodontal disease.
Exclusion Criteria:
* Age under 18 years
* Body weight under 40 kg
* Receipt of antibiotics in the previous 3 months
* Routine use of oral antiseptics
* A history of allergy or intolerance to doxycycline
* A history of allergy or intolerance to cindamycin
* Any type of congenital or acquired immunodeficiency
* Any known risk factor for bacterial endocarditis
* Any known risk factor for prolonged bleeding
**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:** JAVIER Feijoo
**Phone:** +34636962202
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Pedro Diz Dios
**Phone:** +34617864293
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Santiago De Compostela
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Javier Fernandez Feijoo
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Pedro Diz Dios
- **Role:** CONTACT
**Country:** Spain
**Facility:** Santiago de Compostela University Hospital
**State:** A Coruña
**Zip:** 15782
#### Overall Officials
**Official 1:**
**Affiliation:** Santiago de Compostela University
**Name:** Pedro Diz Dios
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Access Criteria:** On request
**Description:** IPD will be available on request
**Info Types:**
- CSR
**IPD Sharing:** YES
**Time Frame:** By the end of the study (for 1 year)
### References Module
#### References
**Citation:** Diz Dios P. Infective endocarditis prophylaxis. Oral Dis. 2014 May;20(4):325-8. doi: 10.1111/odi.12221. Epub 2014 Jan 13.
**PMID:** 24373017
**Citation:** Valdes C, Tomas I, Alvarez M, Limeres J, Medina J, Diz P. The incidence of bacteraemia associated with tracheal intubation. Anaesthesia. 2008 Jun;63(6):588-92. doi: 10.1111/j.1365-2044.2008.05449.x.
**PMID:** 18477269
**Citation:** Pineiro A, Tomas I, Blanco J, Alvarez M, Seoane J, Diz P. Bacteraemia following dental implants' placement. Clin Oral Implants Res. 2010 Sep;21(9):913-8. doi: 10.1111/j.1600-0501.2010.01928.x.
**PMID:** 20701619
**Citation:** Diz Dios P, Tomas Carmona I, Limeres Posse J, Medina Henriquez J, Fernandez Feijoo J, Alvarez Fernandez M. Comparative efficacies of amoxicillin, clindamycin, and moxifloxacin in prevention of bacteremia following dental extractions. Antimicrob Agents Chemother. 2006 Sep;50(9):2996-3002. doi: 10.1128/AAC.01550-05.
**PMID:** 16940094
**Citation:** Limeres Posse J, Alvarez Fernandez M, Fernandez Feijoo J, Medina Henriquez J, Lockhart PB, Chu VH, Diz Dios P. Intravenous amoxicillin/clavulanate for the prevention of bacteraemia following dental procedures: a randomized clinical trial. J Antimicrob Chemother. 2016 Jul;71(7):2022-30. doi: 10.1093/jac/dkw081. Epub 2016 Mar 29.
**PMID:** 27029851
**Citation:** Relvas M, Diz P, Seoane J, Tomas I. Oral Health Scales: design of an oral health scale of infectious potential. Med Oral Patol Oral Cir Bucal. 2013 Jul 1;18(4):e664-70. doi: 10.4317/medoral.18427.
**PMID:** 23524418
**Citation:** Martins CC, Lockhart PB, Firmino RT, Kilmartin C, Cahill TJ, Dayer M, Occhi-Alexandre IGP, Lai H, Ge L, Thornhill MH. Bacteremia following different oral procedures: Systematic review and meta-analysis. Oral Dis. 2024 Apr;30(3):846-854. doi: 10.1111/odi.14531. Epub 2023 Mar 29.
**PMID:** 36750413
**Citation:** Thornhill MH, Gibson TB, Yoon F, Dayer MJ, Prendergast BD, Lockhart PB, O'Gara PT, Baddour LM. Endocarditis, invasive dental procedures, and antibiotic prophylaxis efficacy in US Medicaid patients. Oral Dis. 2024 Apr;30(3):1591-1605. doi: 10.1111/odi.14585. Epub 2023 Apr 27.
**PMID:** 37103475
**Citation:** Diniz Freitas M, Alvarez Fernandez M, Vasallo Vidal FJ, Limeres Posse J, Diz Dios P, Fernandez Feijoo J. Oral amoxicillin/clavulanate for the prevention of bacteremia following dental extractions. Oral Dis. 2023 Jul;29(5):2272-2276. doi: 10.1111/odi.14221. Epub 2022 May 13.
**PMID:** 35467064
**Citation:** Dayer MJ, Jones S, Prendergast B, Baddour LM, Lockhart PB, Thornhill MH. Incidence of infective endocarditis in England, 2000-13: a secular trend, interrupted time-series analysis. Lancet. 2015 Mar 28;385(9974):1219-28. doi: 10.1016/S0140-6736(14)62007-9. Epub 2014 Nov 18.
**PMID:** 25467569
**Citation:** Lean SSH, Jou E, Ho JSY, Jou EGL. Prophylactic antibiotic use for infective endocarditis: a systematic review and meta-analysis. BMJ Open. 2023 Aug 22;13(8):e077026. doi: 10.1136/bmjopen-2023-077026.
**PMID:** 37607797
**Citation:** Dayer MJ, Thornhill M, Baddour LM. Antibiotic prophylaxis for patients at risk of infective endocarditis: an increasing evidence base? Br J Cardiol. 2023 Feb 21;30(1):6. doi: 10.5837/bjc.2023.006. eCollection 2023.
**PMID:** 37705833
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001424
- Term: Bacterial Infections
- ID: D000001423
- Term: Bacterial Infections and Mycoses
- ID: D000007239
- Term: Infections
- ID: D000018805
- Term: Sepsis
- ID: D000018746
- Term: Systemic Inflammatory Response Syndrome
- ID: D000007249
- Term: Inflammation
- ID: D000010335
- Term: Pathologic Processes
- 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: BC01
- Name: Infections
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M7858
- Name: Endocarditis
- Relevance: HIGH
- As Found: Endocarditis
- ID: M18877
- Name: Bacteremia
- Relevance: HIGH
- As Found: Bacteremia
- ID: M4722
- Name: Bacterial Infections
- 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: M12136
- Name: Mycoses
- Relevance: LOW
- As Found: Unknown
- ID: M4721
- Name: Bacterial Infections and Mycoses
- Relevance: LOW
- As Found: Unknown
- ID: M20864
- Name: Sepsis
- Relevance: LOW
- As Found: Unknown
- ID: M16869
- Name: Toxemia
- Relevance: LOW
- As Found: Unknown
- ID: M20818
- Name: Systemic Inflammatory Response Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M10293
- Name: Inflammation
- Relevance: LOW
- As Found: Unknown
- ID: M9419
- Name: Heart Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000016470
- Term: Bacteremia
- ID: D000004696
- Term: Endocarditis
### Intervention Browse Module - Ancestors
- ID: D000000900
- Term: Anti-Bacterial Agents
- ID: D000000890
- Term: Anti-Infective Agents
- ID: D000000962
- Term: Antimalarials
- ID: D000000981
- Term: Antiprotozoal Agents
- ID: D000000977
- Term: Antiparasitic Agents
- ID: D000011500
- Term: Protein Synthesis Inhibitors
- ID: D000004791
- Term: Enzyme Inhibitors
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
### Intervention Browse Module - Browse Leaves
- ID: M7493
- Name: Doxycycline
- Relevance: HIGH
- As Found: Signs
- ID: M4107
- Name: Anesthetics
- Relevance: LOW
- As Found: Unknown
- ID: M6214
- Name: Clindamycin
- Relevance: HIGH
- As Found: Letrozole
- ID: M220697
- Name: Clindamycin palmitate
- Relevance: HIGH
- As Found: Letrozole
- ID: M231711
- Name: Clindamycin phosphate
- Relevance: HIGH
- As Found: Letrozole
- ID: M4222
- Name: Anti-Bacterial Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4214
- Name: Anti-Infective Agents
- Relevance: LOW
- As Found: Unknown
- 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: M7951
- Name: Enzyme Inhibitors
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000004318
- Term: Doxycycline
- ID: D000002981
- Term: Clindamycin
- ID: C000000489
- Term: Clindamycin palmitate
- ID: C000007084
- Term: Clindamycin phosphate
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06422208
**Brief Title:** Autologous iPSC-Derived Dopamine Neuron Transplantation for Parkinson's Disease
**Official Title:** A Phase 1 Clinical Trial of Autologous iPSC-Derived Dopamine Neuron Transplantation for Parkinson's Disease
#### Organization Study ID Info
**ID:** 2023P003609
#### Organization
**Class:** OTHER
**Full Name:** Mclean Hospital
#### Secondary ID Infos
**ID:** U01NS109463
**Link:** https://reporter.nih.gov/quickSearch/U01NS109463
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2027-08
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-08
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module
#### Collaborators
**Class:** NIH
**Name:** National Institute of Neurological Disorders and Stroke (NINDS)
#### Lead Sponsor
**Class:** OTHER
**Name:** Penelope J. Hallett, Ph.D.
#### Responsible Party
**Investigator Affiliation:** Mclean Hospital
**Investigator Full Name:** Penelope J. Hallett, Ph.D.
**Investigator Title:** Associate Professor
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** This research study is evaluating an investigational cell product called autologous induced pluripotent stem cell (iPSC)-derived dopamine neurons. This research study is a single-center Phase 1 clinical trial, which will test the safety of injecting the investigational cell product into the brain of subjects with Parkinson's disease.
**Detailed Description:** The goal of this research study is to test a new treatment for Parkinson's disease. Parkinson's disease is a progressive disease that causes people to lose specific brain cells called midbrain dopamine neurons. When these dopamine neurons are lost, it leads to a lack of dopamine in the brain. When there is not enough dopamine, people with Parkinson's disease experience problems with their movement. This trial will test whether new dopamine neurons made from blood cells from subjects with Parkinson's disease are safe when surgically injected into the area of the brain affected (called the putamen) of the same subjects (called autologous transplantation). The trial will assess the safety of the injected cells and will also measure the effects of the transplanted autologous dopamine neurons on Parkinson's disease symptoms.
### Conditions Module
**Conditions:**
- Parkinson Disease
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 6
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Biological: Autologous midbrain dopamine neurons
**Label:** Autologous midbrain dopamine neurons
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Autologous midbrain dopamine neurons
**Description:** The autologous midbrain dopamine neurons are a experimental cryopreserved cell product derived from human autologous induced pluripotent stem cells. The autologous midbrain dopamine neurons will be surgically administered into the putamen, unilaterally, in a single surgical session.
**Name:** Autologous midbrain dopamine neurons
**Type:** BIOLOGICAL
### Outcomes Module
#### Primary Outcomes
**Description:** To assess the safety of autologous transplantation of cryopreserved midbrain dopamine neurons into the putamen of subjects with Parkinson's disease by measuring (1) the incidence of serious adverse events at 12 months and 18 months post-transplantation and (2) the incidence and severity of all intervention emergent adverse events.
**Measure:** Safety: number and severity of adverse events and serious adverse events
**Time Frame:** Baseline to 12 months post-transplant and baseline to 18 months post-transplant
#### Secondary Outcomes
**Description:** Change in Movement Disorder Society Unified Parkinson's Disease Rating Scale (UPDRS) motor (Part III) compared to the baseline. UPDRS Part III assesses motor function and is measured in both "Off" and "On" states. UPDRS Part III score range: 0-132. A lower score is associated with milder Parkinson's disease motor symptoms.
**Measure:** Change in UPDRS Part III
**Time Frame:** 18 months following transplantation
**Description:** Change in ON time without troublesome dyskinesia is measured using a Parkinson's disease patient diary card.
**Measure:** Change in ON time without troublesome dyskinesia
**Time Frame:** 18 months following transplantation
**Description:** Change in OFF time is measured using a Parkinson's disease patient diary card.
**Measure:** Change in OFF time
**Time Frame:** 18 months following transplantation
**Description:** Change in Levodopa Equivalent Daily Dose (LEDD) which measures Parkinson's medications.
**Measure:** Change in baseline Levodopa Equivalent Daily Dose
**Time Frame:** 18 months following transplantation
**Description:** The Unified Dyskinesia Rating Scale evaluates dyskinesia in patients with Parkinson's disease (range 0-104). A lower score indicates less dyskinesia.
**Measure:** Change in Unified Dyskinesia Rating Scale
**Time Frame:** 18 months following transplantation
**Description:** Change in Movement Disorder Society Unified Parkinson's Disease Rating Scale (UPDRS) Part II, which assesses the motor aspects of experiences of daily living in the week prior to the visit. Score range: 0-52. A lower score is associated with less disability.
**Measure:** Change in UPDRS Part II
**Time Frame:** 18 months following transplantation
**Description:** Change in Montreal Cognitive Assessment (MoCA), which measures various aspects of cognitive function. Score range 0-30. A higher score is associated with better cognitive function.
**Measure:** Change in MoCA
**Time Frame:** 18 months following transplantation
**Description:** DaTscan (SPECT neuroimaging for dopamine transporter, DAT) imaging is performed to assess changes in dopamine neuron function in the putamen (the transplanted area of the brain).
**Measure:** Change in DaTscan
**Time Frame:** Baseline to 18 months following transplantation
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Males and females between ages 55 to eighty.
* Diagnosis of Parkinson's disease with motor symptoms by neurologist according to Movement Disorder Society (MDS) 2015 Clinical Diagnostic Criteria for Parkinson's disease.
* Diagnosis of Parkinson's disease for at least 5 years.
* Dopamine drug responsiveness demonstrated by a positive "on/off" test with at least a 30% improvement on UPDRS III (motor) scale.
* No gross abnormalities on MRI, including hydrocephalus or extensive white matter disease.
* No significant cognitive impairment (Montreal Cognitive Assessment).
* No significant untreated depression (Beck Depression Inventory 2).
* Up to date cancer screening per primary MD.
* Able to understand trial requirements and intervention procedures and provide written informed consent.
Exclusion Criteria:
* History of intracranial surgeries.
* Any previous thalamotomy, pallidotomy or deep brain stimulation.
* Atypical Parkinsonism (Parkinsonism-Plus syndrome, secondary parkinsonism, hereditary parkinsonism)
* History of psychiatric disorders including schizophrenia or psychosis likely to compromise with ability to comply with trial protocol requirements.
* Prior history of intracerebral, subdural, or epidural hemorrhage.
* History of malignancy within 5 years.
* Inability to have an MRI.
* Life expectancy \< 6 months due to concomitant illnesses.
* Ingestion of investigational drug or recipient of investigational procedure within 6 months prior to trial.
* Subjects with active cardiovascular and cerebrovascular disease within 6 months prior to signing the informed consent form:
1. History of severe heart failure (congestive heart failure of New York Heart Association Class II or above or left ventricular ejection fraction \< 35% by any examination method), unstable angina pectoris and myocardial infarction
2. Severe arrhythmia
3. History of cardiovascular surgery (cardiac, vascular stent surgery, angioplasty);
4. History of stroke or transient ischemic attack
5. History of subarachnoid hemorrhage
6. Subjects with major vascular diseases (aortic aneurysm, aortic dissecting aneurysm, internal carotid artery stenosis)
* Hypertensive subjects with poorly controlled blood pressure (defined as blood pressure above 160/100 mmHg despite treatment with antihypertensive drugs) and subjects with severe postural hypotension.
* Abnormal pre-operative coagulation labs.
* Any necessary chronic anticoagulation medication in use (not including antiplatelet therapy and chronic NSAID).
* Diabetic subjects with poorly controlled blood glucose (glycosylated hemoglobin \> 9.0%, or fasting plasma glucose (FPG) ≥ 11.1 mmol/L).
* Active infectious disease. Subjects known to have tested positive for HIV, Human T-lymphotropic Virus, Hepatitis B Virus, Hepatitis C Virus, Cytomegalovirus (IgM \> IgG) and/or syphilis will be evaluated by an expert as to subject eligibility based on the subject's infectious status.
* Any illness which, in the Investigator's judgment, will interfere with the subject's ability to comply with the protocol, compromise subject safety, or interfere with the interpretation of the trial results.
* Active clinical infection being treated by antibiotics within one week of enrollment.
* Known drug or alcohol dependence or any other clinical factors or conditions (for example, history of seizures) which will interfere with the trial conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate.
* Unwilling and/or not able to give written informed consent.
**Maximum Age:** 80 Years
**Minimum Age:** 55 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Penelope Hallett, Ph.D.
**Phone:** 617-732-6564
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Boston
**Country:** United States
**Facility:** Brigham & Women's Hospital
**State:** Massachusetts
**Zip:** 02215
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Osborn TM, Hallett PJ, Schumacher JM, Isacson O. Advantages and Recent Developments of Autologous Cell Therapy for Parkinson's Disease Patients. Front Cell Neurosci. 2020 Apr 3;14:58. doi: 10.3389/fncel.2020.00058. eCollection 2020.
**PMID:** 32317934
**Citation:** Hallett PJ, Deleidi M, Astradsson A, Smith GA, Cooper O, Osborn TM, Sundberg M, Moore MA, Perez-Torres E, Brownell AL, Schumacher JM, Spealman RD, Isacson O. Successful function of autologous iPSC-derived dopamine neurons following transplantation in a non-human primate model of Parkinson's disease. Cell Stem Cell. 2015 Mar 5;16(3):269-74. doi: 10.1016/j.stem.2015.01.018. Epub 2015 Feb 26.
**PMID:** 25732245
**Citation:** Hallett PJ, Cooper O, Sadi D, Robertson H, Mendez I, Isacson O. Long-term health of dopaminergic neuron transplants in Parkinson's disease patients. Cell Rep. 2014 Jun 26;7(6):1755-61. doi: 10.1016/j.celrep.2014.05.027. Epub 2014 Jun 6.
**PMID:** 24910427
**Citation:** Cooper O, Hallett P, Isacson O. Using stem cells and iPS cells to discover new treatments for Parkinson's disease. Parkinsonism Relat Disord. 2012 Jan;18 Suppl 1(0 1):S14-6. doi: 10.1016/S1353-8020(11)70007-4.
**PMID:** 22166414
**Citation:** Hargus G, Cooper O, Deleidi M, Levy A, Lee K, Marlow E, Yow A, Soldner F, Hockemeyer D, Hallett PJ, Osborn T, Jaenisch R, Isacson O. Differentiated Parkinson patient-derived induced pluripotent stem cells grow in the adult rodent brain and reduce motor asymmetry in Parkinsonian rats. Proc Natl Acad Sci U S A. 2010 Sep 7;107(36):15921-6. doi: 10.1073/pnas.1010209107. Epub 2010 Aug 23.
**PMID:** 20798034
**Citation:** Cooper O, Astradsson A, Hallett P, Robertson H, Mendez I, Isacson O. Lack of functional relevance of isolated cell damage in transplants of Parkinson's disease patients. J Neurol. 2009 Aug;256 Suppl 3:310-6. doi: 10.1007/s00415-009-5242-z.
**PMID:** 19711122
**Citation:** Mendez I, Vinuela A, Astradsson A, Mukhida K, Hallett P, Robertson H, Tierney T, Holness R, Dagher A, Trojanowski JQ, Isacson O. Dopamine neurons implanted into people with Parkinson's disease survive without pathology for 14 years. Nat Med. 2008 May;14(5):507-9. doi: 10.1038/nm1752. Epub 2008 Apr 6.
**PMID:** 18391961
**Citation:** Fink JS, Schumacher JM, Ellias SL, Palmer EP, Saint-Hilaire M, Shannon K, Penn R, Starr P, VanHorne C, Kott HS, Dempsey PK, Fischman AJ, Raineri R, Manhart C, Dinsmore J, Isacson O. Porcine xenografts in Parkinson's disease and Huntington's disease patients: preliminary results. Cell Transplant. 2000 Mar-Apr;9(2):273-8. doi: 10.1177/096368970000900212.
**PMID:** 10811399
**Citation:** Schumacher JM, Ellias SA, Palmer EP, Kott HS, Dinsmore J, Dempsey PK, Fischman AJ, Thomas C, Feldman RG, Kassissieh S, Raineri R, Manhart C, Penney D, Fink JS, Isacson O. Transplantation of embryonic porcine mesencephalic tissue in patients with PD. Neurology. 2000 Mar 14;54(5):1042-50. doi: 10.1212/wnl.54.5.1042.
**PMID:** 10720272
**Citation:** Mendez I, Sanchez-Pernaute R, Cooper O, Vinuela A, Ferrari D, Bjorklund L, Dagher A, Isacson O. Cell type analysis of functional fetal dopamine cell suspension transplants in the striatum and substantia nigra of patients with Parkinson's disease. Brain. 2005 Jul;128(Pt 7):1498-510. doi: 10.1093/brain/awh510. Epub 2005 May 4.
**PMID:** 15872020
**Citation:** Wernig M, Zhao JP, Pruszak J, Hedlund E, Fu D, Soldner F, Broccoli V, Constantine-Paton M, Isacson O, Jaenisch R. Neurons derived from reprogrammed fibroblasts functionally integrate into the fetal brain and improve symptoms of rats with Parkinson's disease. Proc Natl Acad Sci U S A. 2008 Apr 15;105(15):5856-61. doi: 10.1073/pnas.0801677105. Epub 2008 Apr 7.
**PMID:** 18391196
**Citation:** Cooper O, Hargus G, Deleidi M, Blak A, Osborn T, Marlow E, Lee K, Levy A, Perez-Torres E, Yow A, Isacson O. Differentiation of human ES and Parkinson's disease iPS cells into ventral midbrain dopaminergic neurons requires a high activity form of SHH, FGF8a and specific regionalization by retinoic acid. Mol Cell Neurosci. 2010 Nov;45(3):258-66. doi: 10.1016/j.mcn.2010.06.017. Epub 2010 Jul 24.
**PMID:** 20603216
## 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 - Ancestors
- ID: D000002316
- Term: Cardiotonic Agents
- ID: D000013566
- Term: Sympathomimetics
- ID: D000001337
- Term: Autonomic Agents
- ID: D000018373
- Term: Peripheral Nervous System Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000015259
- Term: Dopamine Agents
- ID: D000018377
- Term: Neurotransmitter Agents
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000020011
- Term: Protective Agents
### Intervention Browse Module - Browse Branches
- Abbrev: CaAg
- Name: Cardiotonic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M7473
- Name: Dopamine
- Relevance: HIGH
- As Found: Eligibility criteria
- ID: M5572
- Name: Cardiotonic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M16345
- Name: Sympathomimetics
- 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: M21869
- Name: Protective Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000004298
- Term: Dopamine
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06422195
**Brief Title:** Dynamic Needle Tip Positioning Modification Technique in Short Axis Approach
**Official Title:** Does the Dynamic Needle Tip Positioning Modification Technique in Short Axis Approach (DNTP - SA) Provides a Faster Ultrasound-guided Arterial Cannulation Than Long Axis (LA) Approach: A Prospective Randomized Controlled Study
#### Organization Study ID Info
**ID:** 36197/12/22
#### Organization
**Class:** OTHER
**Full Name:** Tanta University
### Status Module
#### Completion Date
**Date:** 2024-09-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-19
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-09-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-19
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-18
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Tanta University
#### Responsible Party
**Investigator Affiliation:** Tanta University
**Investigator Full Name:** Maram Ibrahim Elmazny
**Investigator Title:** Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** The aim of the present study is to compare between Dynamic Needle Tip Positioning Modification Technique in Short Axis Approach (DNTP - SA) and Long Axis (LA) Approach for Ultrasound-guided Arterial Cannulation as regard time to successful arterial cannula insertion as well as the success rate in the first trial of insertion, number of attempts till successful arterial line placemen, complications, and operators' satisfaction.
**Detailed Description:** Intraoperative Arterial cannulation is recently frequently required especially in high-risk patients or patients with expected major fluid shift.
The most common site for arterial cannulation is the radial artery because of ease of accessibility, dual blood supply to the hand via the ulnar artery, and a low rate of complications. Complications from arterial cannulation include thrombosis, hematoma formation, edema and vasospasm.
Two approaches are basically identified for ultrasound-guided radial artery cannulation, i.e., short-axis out-of-plane (SA-OOP) and long-axis in-plane (LA-IP) techniques.
The dynamic needle tip positioning (DNTP) technique uses the short-axis view of the radial artery with gradual advancing of the needle till reaching the radial artery. Meanwhile, the ultrasound probe is being moved proximally in advance of the needle tip until it disappears from the ultrasound image. The cannula then advanced in the direction of the artery
### Conditions Module
**Conditions:**
- Dynamic Needle Tip Positioning
- Short Axis
- Arterial Cannulation
- Long Axis
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- OUTCOMES_ASSESSOR
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 164
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Ultrasound guided radial artery cannulation by Dynamic Needle Tip Positioning Technique in Short Axis Approach (DNTP - SA) will be performed by an experienced anesthesiologist who has no subsequent role in the study. The ultrasound transducer is oriented transversely to the radial artery at the wrist, and the vessel appears as a circular anechoic structure in the ultrasound screen with gradual advancing of the needle till reaching the radial artery. Meanwhile, the ultrasound probe is being moved proximally in advance of the needle tip until it disappears from the ultrasound image. The cannula then advanced in the direction of the artery.
**Intervention Names:**
- Other: Dynamic Needle Tip Positioning Technique in Short Axis Approach (DNTP - SA)
**Label:** Dynamic Needle Tip Positioning Technique in Short Axis Approach (DNTP - SA)
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Ultrasound guided radial artery cannulation in Long Axis Approach (LA) will be performed by an experienced anesthesiologist who has no subsequent role in the study. In the LA-IP approach, an ultrasound probe is placed parallel to the radial artery and the artery appears as a tubular anechoic structure in ultrasound.
**Intervention Names:**
- Other: Long Axis Approach (LA)
**Label:** Long Axis Approach (LA)
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Dynamic Needle Tip Positioning Technique in Short Axis Approach (DNTP - SA)
**Description:** Ultrasound guided radial artery cannulation by Dynamic Needle Tip Positioning Technique in Short Axis Approach (DNTP - SA) will be performed by an experienced anesthesiologist who has no subsequent role in the study. The ultrasound transducer is oriented transversely to the radial artery at the wrist, and the vessel appears as a circular anechoic structure in the ultrasound screen with gradual advancing of the needle till reaching the radial artery. Meanwhile, the ultrasound probe is being moved proximally in advance of the needle tip until it disappears from the ultrasound image. The cannula then advanced in the direction of the artery.
**Name:** Dynamic Needle Tip Positioning Technique in Short Axis Approach (DNTP - SA)
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Long Axis Approach (LA)
**Description:** Ultrasound guided radial artery cannulation in Long Axis Approach (LA) will be performed by an experienced anesthesiologist who has no subsequent role in the study. In the LA-IP approach, an ultrasound probe is placed parallel to the radial artery and the artery appears as a tubular anechoic structure in ultrasound.
**Name:** Long Axis Approach (LA)
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Time to achieve successful cannulation will be measured from initial skin puncture until the catheter is placed into the radial artery.
**Measure:** Time to achieve successful cannulation
**Time Frame:** Immediately after catheterization
#### Secondary Outcomes
**Description:** The success rate in the first trial of insertion between the two different approaches will be assessed.
**Measure:** The success rate
**Time Frame:** Immediately after catheterization
**Description:** Number of attempts till successful arterial cannula insertion will be recorded.
**Measure:** Number of attempts till successful arterial cannula insertion
**Time Frame:** Immediately after catheterization
**Description:** Complications including edema, hematoma, vasospasm, ischemia, thrombosis and nerve injury will be recorded.
**Measure:** Incidence of complications
**Time Frame:** 24 hours postoperatively
**Description:** Operators' satisfaction (Level of operators' satisfaction will be assessed with a Scale from 1-5)
**Measure:** Operators' satisfaction
**Time Frame:** Immediately after catheterization
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age between 18 and 70 years.
* Both sexes.
* American Society of Anesthesiologists physical status II-IV.
* Patients scheduled for elective surgery procedure that requires the use of invasive arterial pressure monitoring, as determined by the attending anesthesiologist.
Exclusion Criteria:
* Emergency patients or with Hemodynamic instability.
* Patients who have cellulitis or infection at the site of insertion.
* Patients with a positive modified Allen test.
* Raynaud disease or any Peripheral vascular disease.
* Patients with Multiple previous radial artery interventional therapies in the previous 30 days.
* Patients scheduled for Surgery at site of insertion like forearm flap.
* Refusal to participate by the patient.
**Maximum Age:** 70 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Maram I Elmazny, MD
**Phone:** 00201014137093
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Tanta
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Maram I Elmazny, MD
- **Phone:** 00201014137093
- **Role:** CONTACT
***Contact 2:***
- **Name:** Sarah A Afifi, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Egypt
**Facility:** Tanta University
**State:** El-Gharbia
**Status:** RECRUITING
**Zip:** 31527
### IPD Sharing Statement Module
**Access Criteria:** The data will be available upon a reasonable request from the corresponding author.
**Description:** The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
**Info Types:**
- STUDY_PROTOCOL
**IPD Sharing:** YES
**Time Frame:** After the end of study for one year.
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06422182
**Brief Title:** Erector Spinae Plane Block in Radical Cystectomy
**Official Title:** Ultrasound-Guided Erector Spinae Plane Block in Radical Cystectomy: A Randomized Controlled Study
#### Organization Study ID Info
**ID:** 2112-301-058
#### Organization
**Class:** OTHER
**Full Name:** Kafrelsheikh University
### Status Module
#### Completion Date
**Date:** 2024-01-15
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-19
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2024-01-15
**Type:** ACTUAL
#### Start Date
**Date:** 2021-07-25
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-18
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Kafrelsheikh University
#### Responsible Party
**Investigator Affiliation:** Kafrelsheikh University
**Investigator Full Name:** Tarek Ezzat Abd El Galil
**Investigator Title:** Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Kafrelsheikh University, Egypt
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** The aim of this research is to study and compare the efficacy and safety of bilateral single injection erector spinae plane block (ESPB) compared with intravenous patient-controlled analgesia (IV-PCA) in managing postoperative pain after radical cystectomy.
**Detailed Description:** Radical cystectomy (RC) is one of the most challenging surgical techniques in Urology. Acute postsurgical pain is frequently detrimental in a patient's recovery and quality of life.
Intravenous patient-controlled analgesia (IV-PCA) is one of the most commonly used strategies in clinical practice for controlling postoperative pain. It involves continuous administration of a programmed dose of analgesics, while also allowing patients to receive additional, need-based doses.
One such avenue is the erector spinae plane block (ESPB), a novel analgesic technique first described in 2016 by Forero et al. Although the mechanism of action of the ESPB is unknown, a proposed mechanism is via blockade of the dorsal and ventral rami of thoracic/lumbar spinal nerves. ESPB has been used as analgesia in rib fractures and other thoracic procedures as well as in abdominal surgeries.
### Conditions Module
**Conditions:**
- Erector Spinae Plane Block
- Radical Cystectomy
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 60
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients received ultrasound guided bilateral single shot erector spinae pane block (ESPB) at Th10 level with 20 mL 0.25% bupivacaine after the end of surgery.
**Intervention Names:**
- Drug: Bupivacain 25% (Erector Spinae Plane Block)
**Label:** Erector Spinae Plane Block group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Patients received Intravenous patient-controlled analgesia (IV-PCA) by morphine
**Intervention Names:**
- Drug: Morphine (Intravenous patient-controlled analgesia)
**Label:** Intravenous patient-controlled analgesia group
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Erector Spinae Plane Block group
**Description:** Patients received ultrasound guided bilateral single shot erector spinae pane block (ESPB) at Th10 level with 20 mL 0.25% bupivacaine after the end of surgery.
**Name:** Bupivacain 25% (Erector Spinae Plane Block)
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Intravenous patient-controlled analgesia group
**Description:** Patients received intravenous patient-controlled analgesia (IV-PCA) by morphine
**Name:** Morphine (Intravenous patient-controlled analgesia)
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Bolus dose of IV morphine (3mg) was provided as a rescue analgesia when the numeric rating scale (NRS) ≥ 4.
**Measure:** Total morphine consumption
**Time Frame:** 48 hours postoperatively
#### Secondary Outcomes
**Description:** Time from end of surgery to first dose of morphine administrated.
**Measure:** The time of first rescue analgesia
**Time Frame:** 48 hours postoperatively
**Description:** Pain assessment will be done at rest and during coughing or movement by numeric rating scale (NRS) from 0 to 10 where 0 means no pain and 10 being worst pain) at PACU, 2, 4, 8, 12, 16 24, 36 and 48 postoperative.
**Measure:** Degree of pain
**Time Frame:** 48 hours postoperatively
**Description:** Side effects such as hypotension, bradycardia, respiratory depression (respiratory rate \<10/minute), urinary retention and postoperative nausea and vomiting (PONV) will be recorded and managed.
**Measure:** Incidence of side effects
**Time Frame:** 48 hours postoperatively
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age of the patient between 21 to 65 years.
* Both sexes.
* Body mass index (BMI): 20 - 40 kg/m2.
* American Society of Anesthesiologists (ASA) physical status II-III.
* Elective radical cystectomy.
Exclusion Criteria:
* Patient refusal.
* Psychiatric and cognitive disorders.
* Local infection at the site of injection.
* Allergy to study medications.
* Anatomic abnormalities.
* Inability to comprehend or participate in pain scoring system.
**Maximum Age:** 65 Years
**Minimum Age:** 21 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Kafr Ash Shaykh
**Country:** Egypt
**Facility:** Kafrelsheikh University
**State:** Kafrelsheikh
**Zip:** 33516
### IPD Sharing Statement Module
**Access Criteria:** The data will be available upon a reasonable request from the corresponding author.
**Description:** The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
**Info Types:**
- STUDY_PROTOCOL
**IPD Sharing:** YES
**Time Frame:** After the end of study for one year.
## Derived Section
### Intervention Browse Module - Ancestors
- ID: D000000779
- Term: Anesthetics, Local
- ID: D000000777
- Term: Anesthetics
- ID: D000002492
- Term: Central Nervous System Depressants
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000018689
- Term: Sensory System Agents
- ID: D000018373
- Term: Peripheral Nervous System Agents
- ID: D000000701
- Term: Analgesics, Opioid
- ID: D000009294
- Term: Narcotics
- ID: D000000700
- Term: Analgesics
### Intervention Browse Module - Browse Branches
- Abbrev: Analg
- Name: Analgesics
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M11982
- Name: Morphine
- Relevance: HIGH
- As Found: Screening
- ID: M5315
- Name: Bupivacaine
- Relevance: HIGH
- As Found: Following
- ID: M4107
- Name: Anesthetics
- Relevance: LOW
- As Found: Unknown
- ID: M4109
- Name: Anesthetics, Local
- Relevance: LOW
- As Found: Unknown
- ID: M4032
- Name: Analgesics
- Relevance: LOW
- As Found: Unknown
- ID: M4033
- Name: Analgesics, Opioid
- Relevance: LOW
- As Found: Unknown
- ID: M12245
- Name: Narcotics
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000009020
- Term: Morphine
- ID: D000002045
- Term: Bupivacaine
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06422169
**Brief Title:** Interventistic Clinical Investigation on the Use of Medical Device in Subjects With Mild-moderate Osteoarticular Pain
**Official Title:** Interventistic Monocentric Pre-market Clinical Investigation on the Use of Medical Device "ArToFILL" in Subjects With Mild-moderate Osteoarticular Pain
#### Organization Study ID Info
**ID:** ARTO/09/2023
#### Organization
**Class:** INDUSTRY
**Full Name:** PromoPharma spa
### Status Module
#### Completion Date
**Date:** 2025-05-08
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-17
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-03-08
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-08
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-08
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** PromoPharma spa
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Evaluation of the performance and safety of ArToFILL in subjects with mild to moderate osteoarticular pain
**Detailed Description:** Monocenter, prospective, open label, interventional clinical investigation evaluating the performance and safety of 3 intra-articular injections of ArToFILL for the treatment of mild-moderate osteoarticular pain.
### Conditions Module
**Conditions:**
- Osteoarthritis, Knee
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 35
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** One vial for intra-articular infiltration every 7 days, for three consecutive weeks. After the injection it is necessary to keep the infiltrated joint at rest for at least 24 hours. In addition, as with all invasive joint treatments, the patient is advised to avoid any physical activity 2-3 days after the injection. Do not repeat the treatment before 7 days from the previous one.
**Intervention Names:**
- Device: ArToFILL
**Label:** Artofill
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Artofill
**Description:** ArToFILL is an injectable medical device (class III) intended for use as a temporary filler in joints. It is a sterile, non-pyrogenic, colorless and transparent hyaluronic acid gel of non-animal origin. ArToFILL is a hydrogel consisting of a mixture of two different molecular weights of hyaluronic acid, for a total HA concentration of 2.7 %.
**Name:** ArToFILL
**Type:** DEVICE
### Outcomes Module
#### Other Outcomes
**Description:** Investigator Global Assessment of Safety (IGAS): using the 4- point scale:1= very good safety, 2 =good safety, 3 = moderate safety and 4 = poor safety.
Counting the number of files used for the patient confirmed by the number of traceability labels detached and kept by the Investigator
**Measure:** Evaluation of the safety and tolerability of treatment of medical device.
**Time Frame:** 180 days
**Description:** Evaluation of reported adverse effects/incidents, monitoring of concomitant treatments, and the possible intake of rescue medication, assessment of patient compliance with the medical device in the study,
**Measure:** Evaluation of the safety and tolerability of treatment of medical device.
**Time Frame:** Up to 180 days
#### Primary Outcomes
**Description:** Assessment of pain reduction using the visual analogue scale (VAS) ranging from 0 to 100 mm (where 0 = absent and 100 = strongest pain)
**Measure:** Reduction ≥ of 15 points on VAS scale, at the Study Termination Visit compared to baseline
**Time Frame:** Up to 180 days
#### Secondary Outcomes
**Description:** Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score. The total score is the result of the sum of 3 groups of questions with 5 possible answers (between 0 and 4, where 0=none and 4=extreme) for the self-assessment of:
* pain:five questions (score from 0 to 20);
* joint stiffness: two questions (score from 0 to 8);
* functional limitations: 17 questions (score from 0 to 68).
**Measure:** Clinical improvement assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
**Time Frame:** Up to 180 days
**Description:** The variation of the ROM joint excursion used for the analysis of the joint excursion (flexion-extension), will be calculated as the difference between maximum width and minimum width of the angular profile on the basis of the following formula: ROMα = max (α) - min (α) (flexion-extension)
**Measure:** Improved range of motion (ROM) of the knee joint
**Time Frame:** Up to 180 days
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patient (males and females) aged between 18 and 84 years (limits included);
* Patient able to understand the nature and purpose of the study, including possible risks and side effects;
* Patient able to provide written Informed Consent, in accordance with good clinical practice and current legislation;
* Pain ≥ 40 mm on the VAS score in the target knee for at least 2 months;
* Patient with knee osteoarthritis assessed radiographically, grade 1 to 3 according to the Kellgren-Lawrence scale (K-L);
* Body Mass Index (BMI) ≤ 35;
* Patient who will benefit from this treatment;
* Patient available for the entire study period;
* Patient able to cooperate and meet the requirements of the clinical investigation plan.
Exclusion Criteria:
* Patient with knee osteoarthritis, assessed radiographically, grade 4 by the K-L scale;
* Patient presenting ongoing inflammation/infection at the level of the joint being investigated;
* Patient with abundant intra-articular effusion;
* Patient with symptoms of viral or bacterial infections or similar;
* Patient with insertion point of the joint infected or in the presence of a skin disease;
* Simultaneous treatment with disinfectants containing quaternary ammonium salts or chlorhexidine;
* Patient with known or potential allergy or hypersensitivity and/or history of allergic reactions to one of the components of the medical device;
* Concomitant treatments with thrombolytic or anticoagulant therapies, for less than 2 weeks prior to the screening visit;
* Intra-articular treatments carried out in the last 3 months (9 months if with products containing hyaluronic acid) of the target joint;
* Topical treatments of the target joint in progress or performed within 1 week of the screening visit;
* Taking NSAIDs and/or paracetamol as rescue treatment for more than two consecutive days;
* Surgical interventions of prosthetic replacement in the target joint;
* Physiotherapy and instrumental physical therapy treatments for the target joint performed in the last 2 weeks prior to the screening visit, and during the study period;
* Participation in another clinical trial within 60 days prior to the screening visit;
* Evidence of severe or uncontrolled systemic disease or any other significant disorder (e.g. haemophilia, bleeding disorders etc.); which do not allow participation in the study or could compromise the results.
* Patients who are pregnant or breastfeeding;
* Subject unable to follow clinical investigation procedures and follow-up visits;
* Any other medical condition which could influence participation in the clinical investigation or compromise its results.
**Maximum Age:** 84 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Michele Vecchio
**Phone:** +39 0953782702
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Catania
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Michele Vecchio
- **Phone:** +39 0953782702
- **Role:** CONTACT
***Contact 2:***
- **Name:** Michele Vecchio
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Italy
**Facility:** U.O. Recupero e riabilitazione funzionale P.O. "G.Rodolico", Azienda Ospedaliero Universitaria Policlinico "G. Rodolico - San Marco"
**Status:** RECRUITING
#### Overall Officials
**Official 1:**
**Affiliation:** Azienda Ospedaliero Universitaria Policlinico "G. Rodolico - San Marco", P.O. "G. Rodolico"
**Name:** Michele Vecchio
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010003
- Term: Osteoarthritis
- 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: BC23
- Name: Symptoms and General Pathology
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
### Condition Browse Module - Browse Leaves
- ID: M22168
- Name: Osteoarthritis, Knee
- Relevance: HIGH
- As Found: Osteoarthritis, Knee
- ID: M12926
- Name: Osteoarthritis
- Relevance: LOW
- As Found: Unknown
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M4476
- Name: Arthritis
- Relevance: LOW
- As Found: Unknown
- ID: M10621
- Name: Joint Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12097
- Name: Musculoskeletal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15045
- Name: Rheumatic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6323
- Name: Collagen Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000020370
- Term: Osteoarthritis, Knee
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M9878
- Name: Hyaluronic Acid
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06422156
**Acronym:** Nim-PC-28
**Brief Title:** SBRT Combined With Nimotuzumab and Mono-chemotherapy in Locally Advanced Pancreatic Cancer
**Official Title:** A Prospective, Multicenter, Single Arm Study of SBRT Combined With Nimotuzumab and Mono-chemotherapy in the Treatment of Locally Advanced Pancreatic Cancer
#### Organization Study ID Info
**ID:** M2023639
#### Organization
**Class:** OTHER
**Full Name:** Peking University Third Hospital
### Status Module
#### Completion Date
**Date:** 2026-06-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-17
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-06-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2023-11
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-03-17
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Biotech Pharmaceutical Co., Ltd.
#### Lead Sponsor
**Class:** OTHER
**Name:** Peking University Third Hospital
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** This is a prospective, multicenter, single arm clinical study. The main purpose of the study is to evaluate the clinical efficacy and safety of SBRT combined with Nimotuzumab and mono-chemotherapy in the treatment of locally advanced pancreatic cancer (LAPC).
**Detailed Description:** This clinical study is designed as a prospective, multicenter, single arm study to evaluate the clinical efficacy and safety of SBRT combined with nimotuzumab and mono-chemotherapy in the treatment of locally advanced pancreatic cancer (LAPC). All eligible patients will receive SBRT with doses ranging from 35-40 Gy in five fractions, intravenous nimotuzumab 400mg weekly or 600mg on day 1 and 8 of a 21-day cycle, and mono-chemotherapy (Gemcitabine, S-1 or capecitabine) until disease progression, death, unacceptable toxicity, or consent withdrawal. The main endpoint is progression-free survival (PFS).
### Conditions Module
**Conditions:**
- Advanced Pancreatic Cancer
**Keywords:**
- advanced pancreatic cancer
- stereotactic body radiation therapy (SBRT)
- Nimotuzumab
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 73
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** All eligible patients will receive SBRT combined with nimotuzumab and mono-chemotherapy.
**Intervention Names:**
- Radiation: Stereotactic body radiation
- Drug: Nimotuzumab
- Drug: mono-chemotherapy
**Label:** SBRT+Nimotuzumab+ mono-chemotherapy
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- SBRT+Nimotuzumab+ mono-chemotherapy
**Description:** Patients will receive SBRT with doses ranging from 35-40 Gy in five fractions.
**Name:** Stereotactic body radiation
**Other Names:**
- SBRT
**Type:** RADIATION
#### Intervention 2
**Arm Group Labels:**
- SBRT+Nimotuzumab+ mono-chemotherapy
**Description:** Patients will receive Nimotuzumab 400 mg weekly or Nimotuzumab 600mg on day 1 and 8 of a 21-day cycle until disease progression.
**Name:** Nimotuzumab
**Other Names:**
- h-R3
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- SBRT+Nimotuzumab+ mono-chemotherapy
**Description:** Patients will receive mono-chemotherapy (Gemcitabine, S-1 or capecitabine) until disease progression.
**Name:** mono-chemotherapy
**Other Names:**
- chemotherapy
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** PFS, defined as the time from the beginning of treatment to disease progression or all-cause death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
**Measure:** progression-free survival (PFS)
**Time Frame:** Up to 12 months
#### Secondary Outcomes
**Description:** The time from the beginning of treatment to death due to any cause.
**Measure:** overall survival (OS)
**Time Frame:** Up to 12 months
**Description:** Objective response rate (ORR), including complete response (CR) and partial response (PR). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), at least a 30% decrease in the sum of the longest diameter of target lesions.
**Measure:** Objective response rate (ORR)
**Time Frame:** Up to 12 months
**Description:** Disease control rate (DCR), including complete response (CR) and partial response (PR) and stable disease(SD). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT/MRI: CR, disappearance of all target lesions; PR, at least a 30% decrease in the sum of the longest diameter of target lesions. SD, neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (PD, defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions).
**Measure:** Disease control rate (DCR)
**Time Frame:** Up to 12 months
**Description:** The proportion of patients with pain relief after treatment to the total number enrolled.
**Measure:** Pain relief rate
**Time Frame:** Up to 12 months
**Description:** Frequency and severity of adverse events.
**Measure:** adverse events
**Time Frame:** Up to 30 days after last administration
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* 1. Age 18-75 years old, gender unlimited;
* 2. Histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC);
* 3. Locally advanced pancreatic cancer (according to the NCCN criteria), unresectable or surgically declined;
* 4. The maximum diameter of the primary tumor was \< 5.0cm;
* 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
* 6. No prior radiotherapy (upper abdomen) or tumor systemic therapy;
* 7. Adequate organ and bone marrow function, defined as follows: absolute neutrophil count (ANC)≥1.5×10\^9/L; hemoglobin≥9.0 g/dL; platelets≥75×10\^9/L; serum total bilirubin (TBIL)≤1.5×ULN; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times the upper limit of normal (ULN); serum creatinine≤1.5×ULN;
* 8. Left ventricular ejection fraction ≥50%;
* 9. Fertile subjects are willing to take contraceptive measures during the study period;
* 10. Woman who are breastfeeding during the study period or within 150 days after the last treatment;
* 11. Survival was expected to be ≥3 months;
* 12.Good compliance and signed informed consent voluntarily.
Exclusion Criteria:
* 1. Tumor invasion of gastrointestinal tract;
* 2. Woman who are pregnant or breastfeeding;
* 3. History of other malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix) within the past 5 years;
* 4. History of uncontrolled epilepsy, central nervous system disease, or mental disorder, which may influence the signing of informed consent or affect the patient's adherence;
* 5.Serious heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more, severe congestive heart failure or severe arrhythmia requiring medical intervention, or a history of myocardial infarction within the past 12 months;
* 6. Patients requiring immunosuppressive;
* 7.Accompanied by active infections, or a major hematological, renal, metabolic, gastrointestinal, endocrine, or metabolic disorder determined by the investigator, or other serious uncontrolled concomitant disease;
* 8. Known allergy to prescription or any component of the prescription used in this study;
* 9. Immunodeficiency, including HIV infection or other acquired immunodeficiency, or a history of organ transplantation, or other immune-related disorders requiring medical intervention;
* 10. Patients with acute and chronic tuberculosis infection;
* 11. Received Chinese herbal medicines or immune-modulators for anti-tumor within 2 weeks prior to initial administration;
* 12.History of noninfectious pneumonia requiring glucocorticoid therapy or current interstitial lung disease within 1 year prior to initial administration;
* 13. Received any other form of immunosuppressive therapy within 7 days prior to the initial of study administration;
* 14. Participated in other clinical trials within 4 weeks, or received another investigational drugs or investigational device within 4 weeks prior to the initial administration;
* 15.Other reasons that are not suitable to participate in this study according to the researcher's judgment.
**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:** Bin Qiu, MD
**Phone:** +86 010-82265968
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Peking University Third Hospital
**Name:** Junjie Wang, Dr
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000004067
- Term: Digestive System Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000004701
- Term: Endocrine Gland Neoplasms
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000010182
- Term: Pancreatic Diseases
- ID: D000004700
- Term: Endocrine System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M13110
- Name: Pancreatic Neoplasms
- Relevance: HIGH
- As Found: Pancreatic Cancer
- ID: M8886
- Name: Gastrointestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M7256
- Name: Digestive System Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M7863
- Name: Endocrine Gland Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M13102
- Name: Pancreatic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7862
- Name: Endocrine System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T4387
- Name: Pancreatic Cancer
- Relevance: HIGH
- As Found: Pancreatic Cancer
### Condition Browse Module - Meshes
- ID: D000010190
- Term: Pancreatic Neoplasms
### Intervention Browse Module - Ancestors
- ID: D000074322
- Term: Antineoplastic Agents, Immunological
- ID: D000000970
- Term: Antineoplastic Agents
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M2985
- Name: Gemcitabine
- Relevance: LOW
- As Found: Unknown
- ID: M377
- Name: Capecitabine
- Relevance: LOW
- As Found: Unknown
- ID: M288889
- Name: Nimotuzumab
- Relevance: HIGH
- As Found: Details
- ID: M1346
- Name: Antineoplastic Agents, Immunological
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: C000501466
- Term: Nimotuzumab
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06422143
**Brief Title:** Pembrolizumab With or Without Maintenance Sacituzumab Tirumotecan (Sac-TMT; MK-2870) in Metastatic Squamous Non-small Cell Lung Cancer (NSCLC) [MK-2870-023]
**Official Title:** Phase 3 Study of Pembrolizumab in Combination With Carboplatin/Taxane (Paclitaxel or Nab-paclitaxel) Followed by Pembrolizumab With or Without Maintenance MK-2870 in the First-line Treatment of Metastatic Squamous Non-small Cell Lung Cancer
#### Organization Study ID Info
**ID:** 2870-023
#### Organization
**Class:** INDUSTRY
**Full Name:** Merck Sharp & Dohme LLC
#### Secondary ID Infos
**Domain:** EU CT
**ID:** 2023-510128-66
**Type:** OTHER
**Domain:** UTN
**ID:** U1111-1301-2790
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2031-02-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-15
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2029-01-12
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-02
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Merck Sharp & Dohme 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:** This is a phase 3 study of pembrolizumab in combination with carboplatin/taxane (paclitaxel or nab-paclitaxel) followed by pembrolizumab with or without maintenance sacituzumab tirumotecan (sac-TMT; MK-2870) in first-line treatment of metastatic squamous non-small cell lung cancer. It is hypothesized that pembrolizumab with maintenance sacituzumab tirumotecan is superior to pembrolizumab without sacituzumab tirumotecan maintenance with respect to overall survival (OS).
**Detailed Description:** All participants undergo an initial induction phase of four cycles, each cycle consisting of a 3-week cycle of pembrolizumab q3w + carboplatin q3w + paclitaxel q3w or nabpaclitaxel weekly. Participants are then randomly assigned to pembrolizumab maintenance vs. pembrolizumab + sac-TMT maintenance.
### Conditions Module
**Conditions:**
- Non-small Cell Lung Cancer
- NSCLC
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Participants are allocated to a single induction arm, then assigned randomly to one of 2 maintenance arms.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 851
**Type:** ESTIMATED
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** During the Induction phase, participants receive pembrolizumab 200 mg q3w for 4 cycles, carboplatin AUC 6 (mg/mL/min) q3w for 4 cycles, and paclitaxel 200 mg/m2 q3w for 4 cycles or nab-paclitaxel 100 mg/m2 weekly for 4 cycles. During the Maintenance phase, participants receive sac-TMT 4 mg/kg infusion every 2 weeks (q2w) after receipt of an antihistamine, H2 receptor antagonist, acetaminophen (or equivalent), and dexamethasone (or equivalent) until discontinuation criteria is met for sac-TMT; and pembrolizumab 400 mg every 6 weeks (q6w) for 96 weeks.
**Intervention Names:**
- Biological: Pembrolizumab
- Biological: sac-TMT
**Label:** Maintenance Arm 1: Pembrolizumab + sac-TMT
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** During the induction phase, participants receive pembrolizumab 200 mg q3w for 4 cycles, carboplatin AUC 6 (mg/mL/min) q3w for 4 cycles, and paclitaxel 200 mg/m2 q3w for 4 cycles or nab-paclitaxel 100 mg/m2 weekly for 4 cycles. During the Maintenance phase, participants receive pembrolizumab 400 mg q6w for 96 weeks.
**Intervention Names:**
- Biological: Pembrolizumab
**Label:** Maintenance Arm 2: Pembrolizumab Monotherapy
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Maintenance Arm 1: Pembrolizumab + sac-TMT
- Maintenance Arm 2: Pembrolizumab Monotherapy
**Description:** Intravenous (IV) infusion
**Name:** Pembrolizumab
**Other Names:**
- KEYTRUDA®
- MK-3475
- SCH 900475
**Type:** BIOLOGICAL
#### Intervention 2
**Arm Group Labels:**
- Maintenance Arm 1: Pembrolizumab + sac-TMT
**Description:** IV infusion
**Name:** sac-TMT
**Other Names:**
- MK-2870
- Sacituzumab tirumotecan
**Type:** BIOLOGICAL
### Outcomes Module
#### Primary Outcomes
**Description:** OS is the time from randomization to death due to any cause.
**Measure:** Overall survival (OS)
**Time Frame:** Up to ~79 months
#### Secondary Outcomes
**Description:** PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
**Measure:** Progression-Free Survival (PFS)
**Time Frame:** Up to ~79 months
**Description:** An AE is 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 ≥1 adverse event (AE)
**Time Frame:** Up to ~79 months
**Description:** An AE is 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 discontinuing from study therapy due to AE(s)
**Time Frame:** Up to ~79 months
**Description:** European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) is a 30-item scale to assess the overall quality of life in cancer patients. The global health status and QoL scores are based on participant responses to items 29 ("How would you rate your overall health during past week?") and 30 ("How would you rate your overall quality of life during the week?") that are scored on a 7-point scale (1 = "Very poor" to 7 = "Excellent"). Higher scores indicate better overall health status.
**Measure:** Change in Score from Baseline to a Predefined Timepoint in Participant-Reported Global health status/Quality of Life (QoL) Score (EORTC QLQ-C30 Items 29 and 30)
**Time Frame:** Baseline and up to ~79 months
**Description:** EORTC QLQ-C30 is a 30-item scale to assess the overall quality of life of cancer patients. The dyspnea score is based on participant responses to item 8 ("Were you short of breath?") that is scored on a 4-point scale (1 = 'Not at All' to 4 = 'Very Much'). Higher scores indicate worse dyspnea symptoms.
**Measure:** Change in Score from Baseline to a Predefined Timepoint in Participant-Reported Dyspnea (EORTC QLQ-C30 Item 8)
**Time Frame:** Baseline and up to ~79 months
**Description:** EORTC QLQ-C13 is a 13-item addendum to EORTC QLQ-C30 to assess the overall quality of life of lung cancer patients. The cough score is based on participant responses to item 31 ("How much did you cough?") that is scored on a 4-point scale (1 = 'Not at All' to 4 = 'Very Much'). Higher scores indicate worse cough.
**Measure:** Change in Score from Baseline to a Predefined Timepoint in Participant-Reported Cough (EORTC QLQ-LC13 Item 31)
**Time Frame:** Baseline and up to ~79 months
**Description:** EORTC QLQ-C13 is a 13-item addendum to EORTC QLQ-C30 to assess the overall quality of life of lung cancer patients. The chest pain score is based on participant responses to item 40 e (1 = "Not at All" to 4 = "Very Much").
**Measure:** Change in Score from Baseline to a Predefined Timepoint in Participant-Reported Chest Pain (EORTC QLQ-LC13 Item 40)
**Time Frame:** Baseline and up to ~79 months
**Description:** EORTC QLQ-C30 is a 30-item scale to assess the overall quality of life in cancer patients. TTD in global health status and QoL scores are based on participant responses to items 29 ("How would you rate your overall health during past week?") and 30 ("How would you rate your overall quality of life during the week?") that are scored on a 7-point scale (1 = "Very poor" to 7 = "Excellent"). Higher scores indicate better overall health status.
**Measure:** Time to First Deterioration (TTD) in Global Health Status/QoL Scores (EORTC QLQ-C30 Items 29 and 30)
**Time Frame:** Up to ~79 months
**Description:** EORTC QLQ-C30 is a 30-item scale to assess the overall quality of life of cancer patients. TTD in dyspnea score is based on participant responses to item 8 ("Were you short of breath?") that is scored on a 4-point scale (1 = 'Not at All' to 4 = 'Very Much'). Higher scores indicate worse dyspnea symptoms.
**Measure:** TTD in Dyspnea Score (EORTC QLQ-C30 Item 8)
**Time Frame:** Up to ~79 months
**Description:** EORTC QLQ-C13 is a 13-item addendum to EORTC QLQ-C30 to assess the overall quality of life of lung cancer patients. TTD in cough score is based on participant responses to item 31 ("How much did you cough?") that is scored on a 4-point scale (1 = 'Not at All' to 4 = 'Very Much'). Higher scores indicate worse cough.
**Measure:** TTD in Cough (EORTC QLQ-LC13 Item 31)
**Time Frame:** Up to ~79 months
**Description:** EORTC QLQ-C13 is a 13-item addendum to EORTC QLQ-C30 to assess the overall quality of life of lung cancer patients. TTD in chest pain score is based on participant responses to item 40 ("Have you had pain in your chest?") that is scored on a 4-point scale (1 = 'Not at All' to 4 = 'Very Much'). Higher scores indicate worse chest pain.
**Measure:** TTD in Chest Pain (EORTC QLQ-LC13 Item 40)
**Time Frame:** Up to ~79 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Histologically or cytologically confirmed diagnosis of squamous squamous non-small cell lung cancer (NSCLC) \[Stage IV: M1a, M1b, M1c, American Joint Committee on Cancer Staging Manual, version 8\]
* Measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology
* Has life expectancy ≥3 months
* Has Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1 assessed within 7 days prior to allocation
* Archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated has been provided
* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
* Participants who are hepatitis B surface antigen (HBsAg)-positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load before allocation
* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
* Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to ≤ Grade 1 or baseline (participants with endocrine-related AEs who are adequately treated with hormone replacement are eligible)
* Has adequate organ function
* For Maintenance only (prior to randomization): is without disease progression of their NSCLC, as determined by BICR using RECIST 1.1 after completion of study-specified Induction with an evaluable scan at Week 12
* For Maintenance only (prior to randomization): has ECOG PS of 0 or 1 as assessed at the Prerandomization Visit
* For Maintenance only (prior to randomization): all AEs (with the exception of alopecia, Grade 2 fatigue, and Grade ≤2 endocrine-related AEs requiring treatment or hormone replacement) have recovered
* For Maintenance only (prior to randomization): has adequate organ function
Exclusion Criteria:
* Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements
* Grade ≥2 peripheral neuropathy
* History of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing
* Active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease
* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QTcF interval to \>480 ms, and other serious cardiovascular and cerebrovascular diseases within 6 months before study intervention
* HIV-infected participants who have been newly diagnosed or with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
* Received prior systemic anticancer therapy for their metastatic NSCLC
* Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxic Tlymphocyte-associated protein 4, OX-40, CD137) \[Note: Prior treatment with chemotherapy and/or radiation as a part of neoadjuvant or adjuvant therapy or chemoradiation therapy for nonmetastatic NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC.\]
* Received prior treatment with a TROP2-targeted antidrug conjugate (ADC)
* Received prior systemic anticancer therapy including investigational agents within 4 weeks before allocation
* Received radiation therapy to the lung that is \>30 Gray within 6 months of start of study intervention
* Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids
* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
* Active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease
* Participants who have not adequately recovered from major surgery or have ongoing surgical complications
* Received prior treatment with a topoisomerase I inhibitor-containing ADC
* Is currently receiving a strong inducer/inhibitor of CYP3A4 that cannot be discontinued for the duration of the study (the required washout period before starting sac-TMT is 2 weeks)
* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
* Has known CNS metastases/carcinomatous meningitis (participants with previously treated brain metastases may participate provided they are clinically stable for t least 2 weeks and, have no evidence of new or enlarging brain metastases and also are off steroids 3 days prior to dosing with study medication. Subjects with known untreated, asymptomatic brain metastases \[ie, no neurological symptoms, no requirements for corticosteroids, no or minimal surrounding edema, and no lesion \>1.5 cm\] may participate but will require regular imaging of the brain as a site of disease)
* Severe hypersensitivity (≥Grade 3) to study intervention and/or any of its excipients or to another biologic therapy
* Active autoimmune disease that has required systemic treatment in the past 2 years (replacement therapy \[eg, thyroxine, insulin, or physiologic corticosteroid\] is allowed)
* History of (noninfectious)pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
* Active infection requiring systemic therapy
* History of allogeneic tissue/solid organ transplant
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### IPD Sharing Statement Module
**Description:** http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
**IPD Sharing:** YES
**URL:** http://engagezone.msd.com/ds_documentation.php
### References Module
#### See Also Links
**Label:** Merck Clinical Trials Information
**URL:** https://www.merckclinicaltrials.com/
## 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: D000074322
- Term: Antineoplastic Agents, Immunological
- ID: D000000970
- Term: Antineoplastic Agents
- ID: D000082082
- Term: Immune Checkpoint 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: Infl
- Name: Anti-Inflammatory Agents
- Abbrev: AnEm
- Name: Antiemetics
- Abbrev: Gast
- Name: Gastrointestinal Agents
- Abbrev: Antipy
- Name: Antipyretics
- Abbrev: Analg
- Name: Analgesics
### Intervention Browse Module - Browse Leaves
- ID: M19537
- Name: Paclitaxel
- Relevance: LOW
- As Found: Unknown
- ID: M231
- Name: Albumin-Bound Paclitaxel
- Relevance: LOW
- As Found: Unknown
- ID: M18650
- Name: Carboplatin
- Relevance: LOW
- As Found: Unknown
- ID: M349416
- Name: Pembrolizumab
- Relevance: HIGH
- As Found: Mg/m2
- ID: M7102
- Name: Dexamethasone
- Relevance: LOW
- As Found: Unknown
- ID: M235549
- Name: Dexamethasone acetate
- Relevance: LOW
- As Found: Unknown
- ID: M2340
- Name: Acetaminophen
- Relevance: LOW
- As Found: Unknown
- ID: M9709
- Name: Histamine Antagonists
- Relevance: LOW
- As Found: Unknown
- ID: M9710
- Name: Histamine H1 Antagonists
- Relevance: LOW
- As Found: Unknown
- ID: M147959
- Name: Taxane
- Relevance: LOW
- As Found: Unknown
- ID: M9711
- Name: Histamine H2 Antagonists
- Relevance: LOW
- As Found: Unknown
- ID: M1346
- Name: Antineoplastic Agents, Immunological
- Relevance: LOW
- As Found: Unknown
- ID: M2342
- Name: Immune Checkpoint Inhibitors
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: C000582435
- Term: Pembrolizumab
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06422130
**Acronym:** MATCHLESS
**Brief Title:** Ningbo Maternity-Child Linked Database Study
**Official Title:** Ningbo Maternity-Child Linked Database Study(MATCHLESS): Using Electronic Health Records to Improve Maternal and Child Health Care and Outcomes in China
#### Organization Study ID Info
**ID:** NBU-2023-240
#### Organization
**Class:** OTHER
**Full Name:** Ningbo University
### Status Module
#### Completion Date
**Date:** 2026-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-17
**Overall Status:** ACTIVE_NOT_RECRUITING
#### Primary Completion Date
**Date:** 2021-12-31
**Type:** ACTUAL
#### Start Date
**Date:** 2016-10-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-08
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** Ningbo Health Information Center
#### Lead Sponsor
**Class:** OTHER
**Name:** Ningbo University
#### Responsible Party
**Investigator Affiliation:** Ningbo University
**Investigator Full Name:** Liya Liu
**Investigator Title:** Associate Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** With the implementation of China's two-child policy and a marked increase in adverse pregnancy outcomes, leveraging electronic health records (EHR) to enhance maternal and child healthcare and outcomes in China has emerged as a novel strategy to tackle this pivotal demographic and health challenge. Given the mature construction of the information platform and the well-established maternal and child health service system in Ningbo, this study utilized the Ningbo Maternal and Child Health Electronic Monitoring Information Management System and the Ningbo Regional Health Information Platform to conduct the Ningbo maternity-child linked database study (MATCHLESS), which involved over 300,000 mother-child pairs in China. MATCHLESS not only allows for longitudinal follow-up of pregnant women and their offspring but also expands its scope from prenatal exposure to long-term outcomes through data linkage. The longitudinal scope of MATCHLESS facilitates the elucidation of the relationship and etiological significance of early-life exposures and adverse pregnancy outcomes. It also permits the exploration of the health trajectory of women and children over their life-course.
During the past 5 years (October 2016 to December 2021), a substantial amount of maternal and child health data has been recorded in MATCHLESS, including socio-demographics, health care services and medications, as well as clinical outcome events. Additionally, it contains longitudinal measurements on risk factors for adverse pregnancy outcomes, which provides a robust foundation for future real-world studies of dynamic predictive models. This study was approved by the Ethics Review Committee of the Ningbo University Health Science Center. Considering the safety, privacy, and confidentiality concerns surrounding the storage and processing of personal EHR data, the responsibility for data storage and management is undertaken by the Health Commission of Ningbo. Researchers are required to submit applications to the local health department, and all studies undergo ethical review and research registration procedures to access EHR data for health research purposes.
### Conditions Module
**Conditions:**
- Pregnant Women
- Children
**Keywords:**
- Population-based healthcare database
- Longitudinal study
- Ambispective Cohort
- Pregnant women and offspring
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 325596
**Type:** ACTUAL
**Patient Registry:** True
**Study Type:** OBSERVATIONAL
**Target Duration:** 10 Years
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Other: Pregnant women and their offspring without intervention
**Label:** Pregnant women and their offspring
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Pregnant women and their offspring
**Description:** Pregnant women and their offspring with those exposures of interest determined in specific research based on the database
**Name:** Pregnant women and their offspring without intervention
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Regular contractions accompanied by cervical change at less than 37 weeks' gestation.
Or, the following diagnose in the electronic health records according to the International Classification of Diseases 10th Revision (ICD-10) : O60.
**Measure:** Incidence of preterm birth
**Time Frame:** Up to 42 weeks
**Description:** New onset hypertension (\>140 mm Hg systolic or \>90 mm Hg diastolic) after 20 weeks of pregnancy and the coexistence of one or both of the following new-onset conditions: proteinuria (urine protein:creatinine ratio ≥30 mg/mmol, or albumin: creatinine ratio ≥8 mg/mmol, or ≥1 g/L \[2+\] on dipstick testing), other maternal organ dysfunction, including features such as renal or liver involvement, neurological or haematological complications, or uteroplacental dysfunction (such as fetal growth restriction, abnormal umbilical artery Doppler waveform analysis, or stillbirth).
Or, the following diagnose in the electronic health records according to the International Classification of Diseases 10th Revision (ICD-10) : O14.
**Measure:** Incidence of pre-eclampsia
**Time Frame:** Up to 42 weeks
**Description:** The occurrence of new-onset, generalized, tonic-clonic seizures or coma in a patient with preeclampsia or gestational hypertension.
Or, the following diagnose in the electronic health records according to the International Classification of Diseases 10th Revision (ICD-10) : O15.
**Measure:** Incidence of eclampsia
**Time Frame:** Up to 42 weeks
**Description:** Impaired Glucose Tolerance (IGT) with onset or first recognition during pregnancy.
Or, the following diagnose in the electronic health records according to the International Classification of Diseases 10th Revision (ICD-10) : O24.4.
**Measure:** Incidence of gestational diabetes mellitus
**Time Frame:** Up to 42 weeks
**Description:** Weight at birth of \< 2500 g.
Or, at least one of the following diagnoses in the electronic health records according to the International Classification of Diseases 10th Revision (ICD-10) : P07.0, P07.1.
**Measure:** Incidence of low birth weight
**Time Frame:** Up to 42 weeks
**Description:** Less than the tenth birth weight centile using INTERGROWTH-21st.
Or, the following diagnose in the electronic health records according to the International Classification of Diseases 10th Revision (ICD-10) : P05.
**Measure:** Incidence of small for gestational age
**Time Frame:** Up to 42 weeks
**Description:** The following diagnose in the electronic health records according to the International Classification of Diseases 10th Revision (ICD-10) : F84.
**Measure:** Incidence of autism
**Time Frame:** Up to 10 years
**Description:** Birth defects such as congenital malformations of the nervous system, congenital malformations of eye, ear, face and neck, congenital malformations of the circulatory system, congenital malformations of the respiratory system, or other birth defects.
Or, at least one of the following diagnoses in the electronic health records according to the International Classification of Diseases 10th Revision (ICD-10) : Q00-Q99.
**Measure:** Incidence of birth defects
**Time Frame:** Up to 10 years
**Description:** Blood loss exceeding 500 mL following vaginal birth and 1000 mL following cesarean.
Or, the following diagnose in the electronic health records according to the International Classification of Diseases 10th Revision (ICD-10) : O72.
**Measure:** Incidence of postpartum hemorrhage
**Time Frame:** Within 24 hours after delivery
**Description:** Death of a fetus that has reached a birth weight of 500 g, or if birth weight is unavailable, gestational age of 22 weeks or crown-to-heel length of 25 cm.
Or, at least one of the following diagnoses in the electronic health records according to the International Classification of Diseases 10th Revision (ICD-10) : Z37.1, Z37.3, Z37.4, Z37.7.
**Measure:** Incidence of stillbirth
**Time Frame:** Up to 42 weeks
**Description:** Uterine rupture is confirmed by laparotomy.
Or, at least one of the following diagnoses in the electronic health records according to the International Classification of Diseases 10th Revision (ICD-10) : O71.0, O71.1, O34.5, O62.4.
**Measure:** Incidence of ruptured uterus
**Time Frame:** Up to 42 weeks
**Description:** Death of women while pregnant or within 42 days of termination of pregnancy irrespective of the site and size of pregnancy but related to or aggravated by the pregnancy or its management but not from accidental or incidental causes.
**Measure:** Incidence of maternal death
**Time Frame:** Up to 52 weeks
**Description:** Deaths among live births during the first 28 completed days of life.
**Measure:** Incidence of neonatal death
**Time Frame:** Within 28 days after delivery
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Pregnant women and their offspring who registered at the Ningbo maternal and child health electronic monitoring information management system.
Exclusion Criteria:
* None.
**Gender Based:** True
**Gender Description:** All pregnant women and their offspring registered at the Ningbo maternal and child health electronic monitoring information management system were enrolled.
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** FEMALE
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
**Study Population:** Pregnant women and their offspring who registered at the Ningbo maternal and child health electronic monitoring information management system.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Ningbo
**Country:** China
**Facility:** Ningbo University
**State:** Zhejiang
**Zip:** 315000
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06422117
**Brief Title:** Efficacy and Safety of HSK16149 Capsule in the Treatment of Moderate and Severe Central Neuropathic Pain in China
**Official Title:** A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of HSK16149 Capsule in the Treatment of Moderate to Severe Central Neuropathic Pain in China
#### Organization Study ID Info
**ID:** HSK16149-305
#### Organization
**Class:** INDUSTRY
**Full Name:** Haisco Pharmaceutical Group Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2027-08-07
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-17
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2027-07-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-30
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-16
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Haisco Pharmaceutical Group Co., Ltd.
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** To evaluate the efficacy and safety of HSK16149 capsule in the treatment of moderate to severe central neuropathic pain compared with placebo.
### Conditions Module
**Conditions:**
- Central Neuropathic Pain
### 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:** 408
**Type:** ESTIMATED
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Oral administration of 20mg twice daily for 12 weeks can be adjusted to 40mg twice daily based on the efficacy and tolerability of the subject
**Intervention Names:**
- Drug: HSK16149 20mg-40mg BID
**Label:** HSK16149 20mg-40mg bid
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Placebo,Oral,2 capsules, twice daily for 12 weeks
**Intervention Names:**
- Drug: Placebo
**Label:** Placebo
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- HSK16149 20mg-40mg bid
**Description:** Oral, 20mg, BID, adjustable to 40mg, BID based on tolerability and efficacy;
**Name:** HSK16149 20mg-40mg BID
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Placebo
**Description:** Placebo, oral, 2 capsules twice daily
**Name:** Placebo
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Changes in mean pain intensity (ADPS) at week 12 between HSK16149 and placebo were compared from baseline;The pain NRS score divides a straight line into 10 segments, with 0 to 10 indicating pain (a total of 11 points), 0 indicating no pain, and 10 indicating the most intense pain. The pain NRS scores of the past 7 days were collected and the average value was used as the ADPS score.
**Measure:** The changes of pain scores after treatment in HSK16149 group and placebo group were compared with baseline
**Time Frame:** week12
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Voluntarily sign an informed consent form;
2. Able to read and complete survey questionnaires;
3. Male or female patients aged ≥ 18 years old;
4. The subject has a medical history and symptoms related to central neuropathic pain, including spinal cord related neuropathic pain (subject enrollment ≥ 50%), post-stroke central neuropathic pain, Parkinson's disease pain, and multiple sclerosis pain, and must meet the following criteria: a) pain duration ≥ 3 months; b) Characteristics that conform to neuropathic pain: DN4 scale score ≥ 4 points;
5. During screening visits, patients were assessed to have an average pain visual analogue scale (VAS) score of ≥ 40 mm over the past 24 hours.
Exclusion Criteria:
1. The presence of other painful diseases that may affect the evaluation of neuropathic pain;
2. Patients with spinal cord injury or stroke whose condition is unstable and is expected to require surgical treatment;
3. There is a chronic systemic disease that the investigator has assessed may affect the participant's participation in the study；
4. Meet any of the following laboratory test results: a) Hematology: WBC\<3×109/L, N\< 1.5 ×109/L, PLT\< 75 ×109/L, or HB\< 90 g/L; b) Liver function: ALT or AST\> 2.5 × ULN; Or TBIL\> 1.5 × ULN; c) eGFR\< 60 mL/min/1.73 m2; d) Creatine kinase \> 2.0 × ULN;
5. Women who are pregnant, planning to become pregnant during the study period, or breastfeeding; Women who do not wish to use reliable contraceptive methods (including condoms, spermicides, or Iuds) for 28 days after signing up for the ICF from the beginning to the last trial drug administration, or who plan to use progesterone contraceptives during this period;
6. Mechanical operators engaged in high-altitude work, motor vehicle driving and other dangerous activities during the study period;
7. Participated in any other clinical study within 30 days prior to screening;
8. The investigator determined that there were other conditions that were not suitable for study participation.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010523
- Term: Peripheral Nervous System Diseases
- ID: D000009468
- Term: Neuromuscular Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000010146
- Term: Pain
- ID: D000009461
- Term: Neurologic Manifestations
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M12381
- Name: Neuralgia
- Relevance: HIGH
- As Found: Neuropathic Pain
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M13432
- Name: Peripheral Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12411
- Name: Neuromuscular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000009437
- Term: Neuralgia
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06422104
**Brief Title:** Neuromodulation Therapy for Task-Specific Dystonia
**Official Title:** Development of Mechanistically Informed Therapy for Task-Specific Dystonia Using Noninvasive Neuromodulation
#### Organization Study ID Info
**ID:** Pro00094131
#### Organization
**Class:** OTHER
**Full Name:** Duke University
### Status Module
#### Completion Date
**Date:** 2023-01-13
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-17
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-01-13
**Type:** ACTUAL
#### Start Date
**Date:** 2018-08-23
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-24
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Doris Duke Charitable Foundation
**Class:** OTHER
**Name:** Dystonia Coalition
**Class:** OTHER
**Name:** Dystonia Study Group
**Class:** NIH
**Name:** National Center for Advancing Translational Sciences (NCATS)
#### Lead Sponsor
**Class:** OTHER
**Name:** Duke University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** True
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** This study aims to apply a non-invasive brain stimulation technology called repetitive Transcranial Magnetic Stimulation (rTMS) in patients with focal hand dystonia (FHD). The goal of the study is to identify which cortical target (premotor cortex (PMC) or primary somatosensory cortex (PSC)) will show benefit after active rTMS compared to sham rTMS. A secondary goal of the study is to understand if 10 Hz rTMS can show behavioral benefit compared to sham rTMS. The study will evaluate rTMS response using measures if writing on a sensor tablet, examiner and patient dystonia rating scales and brain imaging scan (functional MRI) to understand brain changes after rTMS. Safety measures include adherence to TMS guidelines and thorough medical screening to prevent seizures.
**Detailed Description:** The primary objective of this study is to develop rTMS for FHD. The focus is to assess whether stimulating the PMC or PSC will show greater improvement in writing behavior. This research builds upon prior studies that have demonstrated improvement in behavior after rTMS to PMC and PSC. The study includes five sequential visits:
* Visit 1 behavior writing measures and dystonia rating scales.
* Visit 2 includes task-based functional MRI brain scans to develop cortical target for rTMS sessions.
* Visits 3, 4, and 5: FHD participants receive 10 Hz rTMS to PMC, PSC and sham rTMS to PMC in a cross over design with at minimum one week of washout between sessions. Participants complete behavior writing measures and rating scales on same day before and after each TMS session and an fMRI after each TMS session. Up to 5 Healthy Volunteers were recruited to help develop the TMS visits.
The information in this record reflects Visits 2-5
### Conditions Module
**Conditions:**
- Isolated Focal Hand Dystonia
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
**Intervention Model Description:** Double-blind cross-over design with participants receiving TMS at two cortical locations.
##### Masking Info
**Masking:** DOUBLE
**Masking Description:** The TMS intensity and cortical location delivered at each TMS visit will be masked
**Who Masked:**
- PARTICIPANT
- OUTCOMES_ASSESSOR
**Primary Purpose:** BASIC_SCIENCE
#### Enrollment Info
**Count:** 12
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** 10 Hz rTMS to premotor cortex
**Intervention Names:**
- Device: Repetitive transcranial magnetic stimulation
**Label:** 10 Hz rTMS to premotor cortex
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** 10 Hz rTMS to primary somatosensory cortex
**Intervention Names:**
- Device: Repetitive transcranial magnetic stimulation
**Label:** 10 Hz rTMS to primary somatosensory cortex
**Type:** ACTIVE_COMPARATOR
#### Arm Group 3
**Description:** 0.7 Hz rTMS to premotor cortex
**Intervention Names:**
- Device: Repetitive transcranial magnetic stimulation
**Label:** 0.7 Hz rTMS to premotor cortex
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- 0.7 Hz rTMS to premotor cortex
- 10 Hz rTMS to premotor cortex
- 10 Hz rTMS to primary somatosensory cortex
**Description:** 10 Hz repetitive TMS will be delivered for 20 minutes per session and 0.7 Hz for 20 minutes per session
**Name:** Repetitive transcranial magnetic stimulation
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Measure:** Feasibility of accurately delivering TMS during the task of writing as measured by number of participants who completed the TMS sessions
**Time Frame:** Visit 3 (week 1), Visit 4 (week 2), Visit 5 (week 3)
#### Secondary Outcomes
**Measure:** Safety, as measured by TMS acute side effects
**Time Frame:** Visit 3 (week 1), Visit 4 (week 2), Visit 5 (week 3)
**Description:** Using change in peak accelerations to assess writing behavior and further develop this writing behavior assessment tool throughout the study.
**Measure:** Feasibility, as measured by change in behavioral writing measure
**Time Frame:** Visit 3 (week 1), Visit 4 (week 2), Visit 5 (week 3)
**Description:** using functional magnetic resonance imaging of the brain
**Measure:** Change in brain connectivity in the motor network
**Time Frame:** Visit 3 (week 1), Visit 4 (week 2), Visit 5 (week 3)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Healthy Control Participants:
1. 18yrs and older
2. Left or Right hand dominance
3. Age-matched to Focal Hand dystonia patients
4. Must be able to sign informed consent
5. Must be literate
* Focal Hand dystonia Patients:
1. 18yrs and older
2. Left or Right hand dominance
3. Diagnosed with Writer's Cramp dystonia in left or right hand
4. Must be able to sign informed consent
5. Must be literate
Exclusion Criteria:
Healthy Control Participants (visits 2, 3, 4, and 5) and Focal Hand dystonia Patients (visits 2, 3, 4, and 5):
1. Other neurological movement disorders diagnoses including other types of dystonia, Parkinsonism, or essential tremor
2. Botulinum toxin injections within 3 months of research study
3. Medications with effects on the central nervous system including anticholinergic, benzodiazepines, and muscle relaxants among others within 1 week of the study
4. No physical or occupational therapy of the upper extremities
5. Any contraindications to MRI (ie: metal in body or implanted medical devices, etc)
6. Any contraindication on TMS adult safety screening (TASS form) including seizure history, pregnancy, brain injury, cranial metal implants, known structural brain lesion
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Durham
**Country:** United States
**Facility:** Duke University Health System
**State:** North Carolina
**Zip:** 27705
#### Overall Officials
**Official 1:**
**Affiliation:** Duke Health
**Name:** Noreen Bukhari-Parlakturk, MD PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Mulcahey PJ, Peterchev AV, Calakos N, Bukhari-Parlakturk N. Transcranial magnetic stimulation: the road to clinical therapy for dystonia. Dystonia. 2023 August; 2.
**Citation:** Bukhari-Parlakturk N, Mulcahey PJ, Lutz M, Ghazi R, Huang Z, Dannhauer M, Simsek Z, Groves S, Lipp M, Fei M, Tran T, Wood E, Beynel L, Scott B, Termsarasab P, Petty C, Al-Khalidi HR, Voyvodic J, Appelbaum LG, Davis S, Michael A, Peterchev AV, Calakos N. Functional MRI-guided personalized TMS decreases basal ganglia activity and improves focal hand dystonia. International Organization of Human Brain Mapping Conference. Montreal, Canada. July 22-26, 2023. virtual poster presentation.
**Citation:** Bukhari-Parlakturk N, Mulcahey PJ, Lutz M, Ghazi R, Huang Z, Dannhauer M, Simsek Z, Groves S, Lipp M, Fei M, Tran T, Wood E, Beynel L, Scott B, Termsarasab P, Petty C, Al-Khalidi HR, Voyvodic J, Appelbaum LG, Davis S, Michael A, Peterchev AV, Calakos N. Functional MRI-guided personalized TMS decreases basal ganglia activity and improves focal hand dystonia. International Dystonia Symposium. Dublin, Ireland. June 1-3, 2023. poster presentation.
**Citation:** Bukhari-Parlakturk N, Lutz MW, Al-Khalidi HR, Unnithan S, Wang JE, Scott B, Termsarasab P, Appelbaum LG, Calakos N. Suitability of Automated Writing Measures for Clinical Trial Outcome in Writer's Cramp. Mov Disord. 2023 Jan;38(1):123-132. doi: 10.1002/mds.29237. Epub 2022 Oct 13.
**PMID:** 36226903
**Citation:** Dannhauer M, Huang Z, Beynel L, Wood E, Bukhari-Parlakturk N, Peterchev AV. TAP: targeting and analysis pipeline for optimization and verification of coil placement in transcranial magnetic stimulation. J Neural Eng. 2022 Apr 21;19(2):10.1088/1741-2552/ac63a4. doi: 10.1088/1741-2552/ac63a4.
**PMID:** 35377345
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000020820
- Term: Dyskinesias
- ID: D000009461
- Term: Neurologic Manifestations
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000009069
- Term: Movement Disorders
- ID: D000002493
- Term: Central Nervous System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M7595
- Name: Dystonia
- Relevance: HIGH
- As Found: Dystonia
- ID: M22575
- Name: Dystonic Disorders
- Relevance: HIGH
- As Found: Dystonia
- ID: M22574
- Name: Dyskinesias
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: M12029
- Name: Movement Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T2358
- Name: Focal Task-specific Dystonia
- Relevance: HIGH
- As Found: Task-Specific Dystonia
### Condition Browse Module - Meshes
- ID: D000004421
- Term: Dystonia
- ID: D000020821
- Term: Dystonic Disorders
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06422091
**Brief Title:** [Trial of device that is not approved or cleared by the U.S. FDA]
**Official Title:** [Trial of device that is not approved or cleared by the U.S. FDA]
#### Organization Study ID Info
**ID:** ET2-ASF
#### Organization
**Full Name:** [Redacted]
### Status Module
**Delayed Posting:** True
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-15
**Overall Status:** WITHHELD
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module
#### Lead Sponsor
**Name:** [Redacted]
#### Responsible Party
**Old Name Title:** [Redacted]
**Old Organization:** [Redacted]
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06422078
**Acronym:** AIR POWER
**Brief Title:** A Non-interventional, Prospective Study With Benralizumab
**Official Title:** A Non-interventional, Prospective Study With Benralizumab to Investigate Clinical Outcome Based on Standard of Care Medication in Real-life
#### Organization Study ID Info
**ID:** D3250R00124
#### Organization
**Class:** INDUSTRY
**Full Name:** AstraZeneca
### Status Module
#### Completion Date
**Date:** 2026-06-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-15
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-06-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-30
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** AstraZeneca
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This is a prospective, non-interventional, single-arm, multicenter study to investigate asthma control, and health-related quality of life (HRQL), lung function and asthma medication intake in severe eosinophilic asthma patients treated with benralizumab in a real-life setting in Germany.
**Detailed Description:** This is a prospective observational study to investigate the asthma control and health realted quality of life (HRQL) of benralizumab treated patients in routine clinical practice, their asthma medication intake, and their changes in asthma medication during the study, up to 52 weeks.
The asthma control will be analyzed by using the Asthma Control Test (ACT) and the Asthma Impairment and Risk Questionnaire (AIRQ®) at different timepoints during the study period either collected by the investigator or self-reported by the patient. In addition, health realted quality of life will be assessed at baseline and routine follow-up visits using the mini Asthma Quality of Life Questionnaire (miniAQLQ) which is collected by the investigator. To investigate the medication intake and assess the changes in asthma medication, the patients will record their weekly medication intake in a paper-based or an electronic medication diary throughout the study.
### Conditions Module
**Conditions:**
- Asthma, Bronchial
**Keywords:**
- benralizumab
- severe eosinophilic asthma
- quality of life
- asthma control
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 300
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Outcomes Module
#### Primary Outcomes
**Description:** To assess asthma control in patients initiating treatment with benralizumab over time.
The ACT includes 5 questions. The score can range from 5 (worst control) to 25 (best control). Scores between 20 and 25 indicate well-controlled asthma, and scores lower than 20 indicate patients with not-well controlled asthma.
**Measure:** Change in Asthma Control Test (ACT) total score in patients from baseline to week 12, 24 and 52 after first benralizumab dose
**Time Frame:** From baseline to week 12, 24 and 52
**Description:** To assess asthma control in patients initiating treatment with benralizumab. Responders are defined as patients with well-controlled asthma (ACT score ≥20).
**Measure:** Proportion of responders at baseline, week 12, 24 and 52 after first benralizumab dose, using ACT
**Time Frame:** At baseline, week 12, 24 and 52
**Description:** To assess prescribed daily ICS dose of benralizumab treated patients over time. Doses of medication will be converted to equivalents to be able to make comparisons.
**Measure:** Change in daily doses of prescribed inhaled corticosteroids (ICS) intake from baseline to week 12, 24 and 52 after first benralizumab dose
**Time Frame:** From baseline to week 12, 24 and 52
**Description:** To assess patient-reported daily ICS dose of benralizumab treated patients over time. Doses of medication will be converted to equivalents to be able to make comparisons.
**Measure:** Change in daily doses of patient-reported inhaled corticosteroids (ICS) intake from baseline to week 12, 24 and 52 after first benralizumab dose
**Time Frame:** From baseline to week 12, 24 and 52
**Description:** To assess prescribed daily ICS dose of benralizumab treated patients with ICS dose reduction.
**Measure:** Reduction (in percentage) in prescribed daily ICS dose intake from baseline to week 52 after first benralizumab dose
**Time Frame:** From baseline to week 52
**Description:** To assess patient-reported daily ICS dose of benralizumab treated patients with ICS dose reduction.
**Measure:** Reduction (in percentage) in patient-reported daily ICS dose intake from baseline to week 52 after first benralizumab dose
**Time Frame:** From baseline to week 52
#### Secondary Outcomes
**Description:** To describe the proportion of patients who meet any individual criteria for remission.
Criteria for remission are defined as no exacerbation, no prescribed use of oral corticosteroids (OCS) for asthma, ACT score ≥20, and stable lung function).
**Measure:** Proportion of patients meeting any individual criteria for remission at baseline, week 24 and 52 after first benralizumab dose
**Time Frame:** At baseline, week 24 and 52
**Description:** To describe the proportion of patients who meet all criteria for remission after initiation of benralizumab treatment.
**Measure:** Proportion of patients fulfilling all the criteria for remission at baseline, week 24 and 52 after first benralizumab dose
**Time Frame:** At baseline, week 24 and 52
**Description:** To assess diaries reported asthma control in patients initiating treatment with benralizumab using the AIRQ® score.
The AIRQ® includes 10 questions (7 assessing symptom impairment and 3 assessing risk) concerning patient medication use, asthma symptoms, medical visits, and tests. The AIRQ® can predict the risk for exacerbations and assess the quality of life of asthma patients.
AIRQ® score: well-controlled (0-1 points), not well-controlled (2-4 points) and very poorly controlled (≥5 points) asthma
**Measure:** Total Asthma Impairment and Risk Questionnaire® (AIRQ®) score reduction from baseline to every 4 weeks after first benralizumab dose
**Time Frame:** From baseline to week 52
**Description:** To assess diaries reported asthma control in patients initiating treatment with benralizumab using the ACT score.
**Measure:** Total ACT score reduction from baseline to every 4 weeks after first benralizumab dose
**Time Frame:** From baseline to week 52
**Description:** To describe patient-reported health-related quality of life (HRQL) in patients initiating treatment with benralizumab using the miniAQLQ.
The miniAQLQ is composed of 15 questions covering 4 different domains, namely symptoms, activities, emotions, and environment experienced during the previous 2 weeks. The score in each item can vary from 1 to 7, with a higher score indicating better quality of life (QoL). The mean score is calculated as the total score divided by the number of items, and the domain scores are calculated as the total score divided by the number of items for respective domain. A change in score of ≥0.5 can be considered clinically important
**Measure:** Change in total Mini Asthma Quality of Life Questionnaire (miniAQLQ) score from baseline to week 12, 24, and 52 after first benralizumab dose
**Time Frame:** From baseline to week 12, 24 and 52
**Description:** To describe the proportion of patients regarding prescribed standard-of-care (SOC) asthma medication dose change in patients initiating treatment with benralizumab.
**Measure:** Change in daily doses of prescribed relevant background medication from baseline to week 12, 24 and 52 after first benralizumab dose
**Time Frame:** From baseline to week 12, 24 and 52
**Description:** To describe the proportion of patients regarding prescribed increased SOC asthma medication dose in patients initiating treatment with benralizumab.
**Measure:** Proportion of patients with increased daily dose of relevant background medication from baseline to week 12, 24 and 52 after first benralizumab dose
**Time Frame:** From baseline to week 12, 24 and 52
**Description:** To describe the proportion of patients regarding prescribed decreased SOC asthma medication dose in patients initiating treatment with benralizumab.
**Measure:** Proportion of patients with decreased daily dose of relevant background medication from baseline to week 12, 24 and 52 after first benralizumab dose
**Time Frame:** From baseline to week 12, 24 and 52
**Description:** To describe the proportion of patients regarding prescribed equal SOC asthma medication dose in patients initiating treatment with benralizumab.
**Measure:** Proportion of patients with equal daily dose of relevant background medication from baseline to week 12, 24 and 52 after first benralizumab dose
**Time Frame:** From baseline to week 12, 24 and 52
**Description:** To assess the annualized asthma exacerbation rate in patients initiating treatment with benralizumab.
**Measure:** Annualized exacerbation rate assessed at baseline, week 12, 24 and 52 after first benralizumab dose
**Time Frame:** From baseline to week 12, 24 and 52
**Description:** To describe the proportion of patients without asthma exacerbations in patients initiating treatment with benralizumab.
**Measure:** Proportion of patients without exacerbations at baseline, week 12, 24 and 52 after first benralizumab dose
**Time Frame:** From baseline to week 12, 24 and 52
**Description:** To describe the FEV1 and FVC levels in patients initiating treatment with benralizumab.
From FEV1 and FVC the Tiffenau-Index will be calculated as follows: FEV1/FVC
**Measure:** Level of lung function parameters - forced expiratory volume in the first second (FEV1) and forced vital capacity (FVC) at baseline, week 12, 24 and 52 after first benralizumab dose
**Time Frame:** At baseline, week 12, 24 and 52
**Description:** To describe the level of RV in patients initiating treatment with benralizumab.
**Measure:** Level of lung function parameters - residual volume (RV) at baseline, week 12, 24 and 52 after first benralizumab dose
**Time Frame:** At baseline, week 12, 24 and 52
**Description:** To describe the level of TLC in patients initiating treatment with benralizumab.
**Measure:** Level of lung function parameters - total lung capacity (TLC) at baseline, week 12, 24 and 52 after first benralizumab dose
**Time Frame:** At baseline, week 12, 24 and 52
**Description:** To describe the level of sRtot in patients initiating treatment with benralizumab.
**Measure:** Level of lung function parameters - total specific airway resistance (sRtot) at baseline, week 12, 24 and 52 after first benralizumab dose
**Time Frame:** At baseline, week 12, 24 and 52
**Description:** To describe the level of DLCO in patients initiating treatment with benralizumab.
**Measure:** Level of diffusing capacity of the lungs for carbon monoxide (DLCO) at baseline, week 12, 24 and 52 after first benralizumab dose
**Time Frame:** At baseline, week 12, 24 and 52
**Description:** To describe the level of eosinophils in patients initiating treatment with benralizumab.
Measured in cells per microliter.
**Measure:** Level of biomarkers - eosinophils at baseline, week 12, 24 and 52 after first benralizumab dose
**Time Frame:** At baseline, week 12, 24 and 52
**Description:** To describe the level of total IgE in patients initiating treatment with benralizumab.
Total IgE, measured in international units per milliliter (IU/ml).
**Measure:** Level of biomarkers - total immunglobulin E (IgE) at baseline, week 12, 24 and 52 after first benralizumab dose
**Time Frame:** At baseline, week 12, 24 and 52
**Description:** To describe the level of FeNO in patients initiating treatment with benralizumab.
Measured in parts per billion (ppb).
**Measure:** Level of biomarkers - fractional exhaled nitric oxide (FeNO) at baseline, week 12, 24 and 52 after first benralizumab dose
**Time Frame:** At baseline, week 12, 24 and 52
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Male or female patients aged 18 years or older
* Confirmed diagnosis of severe eosinophilic asthma (defined according to the European Respiratory Society and American Thoracic Society and local German guidelines) treated with high-dose inhaled corticosteroids (ICS) plus long-acting beta agonists (LABA)
* Prescribed treatment with benralizumab according to label and local market reimbursement criteria
* Benralizumab treatment was not part of the study decision and treatment decision was met prior and independently of the study
* Patients must be able and willing to read and comprehend written instructions
* After full explanation, patients must have signed an informed consent form (ICF) indicating that they understand the purpose of, and the procedures required for the study and are willing to participate in the study
* Patients must be willing to report asthma patient-reported outcomes (PROs) every 4 weeks and medication intake weekly
Exclusion Criteria:
* Patients who participate in an observational trial that might, in the investigators' opinion, influence the assessment for current study; or participated in a randomized clinical trial in the last 3 months
* History of anaphylaxis to any biologic therapy
* Prior treatment with any asthma biologic therapy within the last 6 months
* Concurrent biologic therapy
* Helminth parasitic infection diagnosed within 24 weeks prior to the date informed consent was obtained that had not been treated with, or had failed to respond to standard of care (SOC) therapy
* Any other pulmonary disease than asthma that, in the investigator's point of view, would have an impact on the interpretation of results
* An acute or chronic condition that, in the investigator's point of view, would limit the patient's ability to complete questionnaires or participate in this study or impact the interpretations of results
* Current or history of malignancy within 5 years before the enrolment date with the following exceptions:
* In-situ carcinoma of the cervix where curative therapy has been completed and patients are in remission for at least 12 months prior to enrolment date
* Basal cell or superficial squamous skin cancer
* Pregnancy or lactation period (status to be proactively asked by the investigator)
* Any condition, that, in the opinion of the investigator, could jeopardize the safety of the patient
**Maximum Age:** 120 Years
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** The study population will consist of adult patients, who were diagnosed with severe eosinophilic asthma treated by pulmonary specialists, for whom the indication to start benralizumab therapy was received independently of study participation.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** AstraZeneca Clinical Study Information Center
**Phone:** 1-877-240-9479
**Role:** CONTACT
### IPD Sharing Statement Module
**Access Criteria:** When a request has been approved, AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
**Description:** Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
**IPD Sharing:** YES
**Time Frame:** AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
**URL:** https://vivli.org/
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001982
- Term: Bronchial Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
- ID: D000008173
- Term: Lung Diseases, Obstructive
- ID: D000008171
- Term: Lung Diseases
- ID: D000012130
- Term: Respiratory Hypersensitivity
- ID: D000006969
- Term: Hypersensitivity, Immediate
- ID: D000006967
- Term: Hypersensitivity
- ID: D000007154
- Term: Immune System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC15
- Name: Blood and Lymph Conditions
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
### Condition Browse Module - Browse Leaves
- ID: M4556
- Name: Asthma
- Relevance: HIGH
- As Found: Asthma, Bronchial
- ID: M14511
- Name: Pulmonary Eosinophilia
- 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: M10018
- Name: Hypersensitivity
- Relevance: LOW
- As Found: Unknown
- ID: M14967
- Name: Respiratory Hypersensitivity
- Relevance: LOW
- As Found: Unknown
- ID: M10020
- Name: Hypersensitivity, Immediate
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T6034
- Name: Quality of Life
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001249
- Term: Asthma
### Intervention Browse Module - Browse Branches
- Abbrev: Resp
- Name: Respiratory System Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M287399
- Name: Benralizumab
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06422065
**Brief Title:** [Trial of device that is not approved or cleared by the U.S. FDA]
**Official Title:** [Trial of device that is not approved or cleared by the U.S. FDA]
#### Organization Study ID Info
**ID:** SRF-21625
#### Organization
**Full Name:** [Redacted]
### Status Module
**Delayed Posting:** True
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** WITHHELD
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module
#### Lead Sponsor
**Name:** [Redacted]
#### Responsible Party
**Old Name Title:** [Redacted]
**Old Organization:** [Redacted]
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06422052
**Brief Title:** Epidemiological Investigation of Helicobacter Pylori-infected Patients and the Effect of Eradication Treatment on Dyspepsia Symptoms
**Official Title:** Epidemiological Investigation of Helicobacter Pylori-infected Patients and the Effect of Eradication Treatment on Dyspepsia Symptoms
#### Organization Study ID Info
**ID:** rjhy20240504
#### Organization
**Class:** OTHER
**Full Name:** Shanghai Jiao Tong University School of Medicine
### Status Module
#### Completion Date
**Date:** 2025-05-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-14
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-05-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-03-11
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Shanghai Jiao Tong University School of Medicine
#### Responsible Party
**Investigator Affiliation:** Shanghai Jiao Tong University School of Medicine
**Investigator Full Name:** Hong Lu, MD
**Investigator Title:** Medical Doctor of Division of Gastroenterology and Hepatology of Renji Hospital,Professor of Medicine
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The objectives of this multicenter, prospective, observational study were to investigate the incidence of dyspeptic symptoms in patients with Helicobacter pylori (H. pylori) infection and to continuously follow up the remission of dyspeptic symptoms after H. pylori eradication, so as to provide reference for the clinical diagnosis and treatment strategies of patients with H. pylori infection and dyspeptic symptoms.
### Conditions Module
**Conditions:**
- Helicobacter Pylori Infection
- Dyspepsia
**Keywords:**
- Helicobacter Pylori Infection
- Dyspepsia
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 2242
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Other: Epidemiological questionnaire and Functional Dyspepsia Symptom Diary（FDSD）
**Label:** Dyspepsia with Helicobacter pylori infection
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Dyspepsia with Helicobacter pylori infection
**Description:** H. pylori infection was confirmed by 13C/ 14C-breath test and/or rapid urease test under endoscopy and histopathological examination. Epidemiological questionnaire and Functional Dyspepsia Symptom Diary (FDSD) were used to investigate basic information and assess dyspeptic symptoms. Patients with dyspepsia who successfully eradicated Helicobacter pylori infection will be followed up for dyspeptic symptoms after 2 months and 6 months to evaluate the relief of dyspeptic symptoms.
**Name:** Epidemiological questionnaire and Functional Dyspepsia Symptom Diary（FDSD）
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Proportion of patients with Helicobacter pylori infection with dyspeptic symptoms
**Measure:** the incidence of dyspepsia in patients with Helicobacter pylori infection
**Time Frame:** Time 0 when finished the Epidemiological questionnaire and Functional Dyspepsia Symptom Diary
**Description:** The Functional Dyspepsia Symptom Diary (FDSD) will be used to evaluate the dyspepsia symptoms of the patients
**Measure:** Relief of Helicobacter pylori related dyspepsia
**Time Frame:** Patients with dyspepsia who have successfully eradicated Helicobacter pylori infection will be followed up for dyspepsia symptoms after 2 months and after 6 months to assess the remission of dyspepsia symptoms
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Male or female patients aged 15-80 years
* H. pylori infection diagnosed by 13C/ 14C-UBT (\> 2 times the cutoff value) and/or gastroscopy (rapid urease strong positive and histological positive)
* Treatment-naive patients with Helicobacter pylori
* Ability and willingness to participate in the study and to sign and give informed consent
Exclusion Criteria:
* Under 18 or over 80 years old
* Organic digestive diseases, such as active peptic ulcer, gastroesophageal reflux, gastrointestinal bleeding, acute/chronic pancreatitis, acute/chronic cholecystitis, gallstones, intestinal obstruction, inflammatory bowel disease, etc.
* Combined with melena, hematemesis, anemia, emaciation and other alarm symptoms
* Pregnant and lactating women
* History of cancer
* History of subtotal gastrectomy
* Severe organ dysfunction of heart, liver, kidney, lung and other important organs and congenital diseases, such as grade IV heart failure, liver failure, uremia, respiratory failure, hemophilia, Wilson's disease, etc.
**Maximum Age:** 80 Years
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** The study population targets male and female patients aged 15-80 who have not previously been treated for Helicobacter pylori and have been diagnosed via 13C/14C urea breath test or gastroscopy. Participants must be willing and able to give informed consent. Exclusions include individuals under 18 or over 80, those with organic digestive diseases, pregnant or nursing women, those with a history of cancer or partial gastrectomy, and individuals with severe organ dysfunction or congenital diseases. Also excluded are those with symptoms like melena, hematemesis, anemia, or cachexia.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Hong Lu, MD
**Phone:** +8613611958022
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Chongqing
**Contacts:**
***Contact 1:***
- **Name:** Qiang Wu
- **Phone:** +8618223960853
- **Role:** CONTACT
**Country:** China
**Facility:** The People's Hospital of Kaizhou District, CQ
**State:** Chongqing
**Status:** RECRUITING
**Location 2:**
**City:** Xiamen
**Contacts:**
***Contact 1:***
- **Name:** Jinyan Zhang
- **Phone:** +8615160042319
- **Role:** CONTACT
**Country:** China
**Facility:** The First Affiliated Hospital of Xiamen University
**State:** Fujian
**Status:** RECRUITING
**Location 3:**
**City:** Wuwei
**Contacts:**
***Contact 1:***
- **Name:** Xiaoyun Ma
- **Phone:** +8613639359150
- **Role:** CONTACT
**Country:** China
**Facility:** The People's Hospital of Wuwei
**State:** Gansu
**Status:** RECRUITING
**Location 4:**
**City:** Qinzhou
**Contacts:**
***Contact 1:***
- **Name:** Meimei Zeng
- **Phone:** +8615107774335
- **Role:** CONTACT
**Country:** China
**Facility:** The First People's Hospital of Qinzhou
**State:** Guangxi
**Status:** RECRUITING
**Location 5:**
**City:** Baotou
**Contacts:**
***Contact 1:***
- **Name:** Qiang Liu
- **Phone:** +86 15174918099
- **Role:** CONTACT
**Country:** China
**Facility:** Baotou Central Hospital
**State:** Inner Mongolia
**Status:** RECRUITING
**Location 6:**
**City:** Dalian
**Contacts:**
***Contact 1:***
- **Name:** Lina Liang
- **Phone:** +8618098875591
- **Role:** CONTACT
**Country:** China
**Facility:** The First Affiliated Hospital of Dalian Medical University
**State:** Liaoning
**Status:** RECRUITING
**Location 7:**
**City:** Shanghai
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Hong Lu, MD
- **Phone:** +8613611958022
- **Role:** CONTACT
**Country:** China
**Facility:** Renji Hospital, School of Medicine, Shanghai Jiao Tong University
**State:** Shanghai
**Status:** RECRUITING
**Zip:** 200127
**Location 8:**
**City:** Shanghai
**Contacts:**
***Contact 1:***
- **Name:** Qi Liao
- **Phone:** +8613512128067
- **Role:** CONTACT
**Country:** China
**Facility:** Shanghai Construction Group Hospital
**State:** Shanghai
**Status:** RECRUITING
**Location 9:**
**City:** Chengdu
**Contacts:**
***Contact 1:***
- **Name:** Yan Ou
- **Phone:** +8615008228212
- **Role:** CONTACT
**Country:** China
**Facility:** West China Fourth Hospital, Sichuan University
**State:** Sichuan
**Status:** RECRUITING
**Location 10:**
**City:** Kashgar
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Jilin Wang
- **Phone:** +8613761853016
- **Role:** CONTACT
**Country:** China
**Facility:** The Second People's Hospital of Kashgar, Xinjiang
**State:** Xinjiang
**Status:** RECRUITING
**Location 11:**
**City:** Kunming
**Contacts:**
***Contact 1:***
- **Name:** Zhouhua Li
- **Phone:** +8613769108442
- **Role:** CONTACT
**Country:** China
**Facility:** Second People's Hospital of Jinning District, Kunming City
**State:** Yunnan
**Status:** RECRUITING
**Location 12:**
**City:** Ningbo
**Contacts:**
***Contact 1:***
- **Name:** Shuliang Zhao
- **Phone:** +057458993397
- **Role:** CONTACT
**Country:** China
**Facility:** Ningbo Hangzhou Bay Hospital
**State:** Zhejiang
**Status:** RECRUITING
**Location 13:**
**City:** Ningbo
**Contacts:**
***Contact 1:***
- **Name:** Shan Yu
- **Phone:** +8613456521442
- **Role:** CONTACT
**Country:** China
**Facility:** The People's Hospital of Shengzhou
**State:** Zhejiang
**Status:** RECRUITING
### 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
- Abbrev: BC01
- Name: Infections
### Condition Browse Module - Browse Leaves
- ID: M7589
- Name: Dyspepsia
- Relevance: HIGH
- As Found: Dyspepsia
- ID: M10283
- Name: Infections
- Relevance: LOW
- As Found: Unknown
- ID: M6368
- Name: Communicable Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15622
- Name: Signs and Symptoms, Digestive
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000004415
- Term: Dyspepsia
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06422039
**Brief Title:** Bioavailability and Food Effects of HRS-7535 Tablets With Different Formulating Processes in Healthy Subjects
**Official Title:** A Clinical Study to Evaluate the Relative Bioavailability of HRS-7535 Tablets of Different Formulating Processes and the Effects of Food on New Formulates (Single Center, Random, Open, Cross)
#### Organization Study ID Info
**ID:** HRS-7535-103
#### Organization
**Class:** INDUSTRY
**Full Name:** Shandong Suncadia Medicine Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2024-06-15
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-14
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-06-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-15
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Shandong Suncadia Medicine Co., Ltd.
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** This study was designed as a a single-center, randomized, open, interleaved (3-cycle, 3-sequence) trial. It is planned to enroll 18 healthy subjects.
### Conditions Module
**Conditions:**
- Type 2 Diabetes Mellitus
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
**Intervention Model Description:** This study was an open, fixed-sequence clinical trial in healthy adult subjects
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 18
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Drug: HRS-7535（D）Tablets
- Drug: HRS-7535（C）Tablets
**Label:** Treatment group A
**Type:** EXPERIMENTAL
#### Arm Group 2
**Intervention Names:**
- Drug: HRS-7535（D）Tablets
- Drug: HRS-7535（C）Tablets
**Label:** Treatment group B
**Type:** EXPERIMENTAL
#### Arm Group 3
**Intervention Names:**
- Drug: HRS-7535（D）Tablets
- Drug: HRS-7535（C）Tablets
**Label:** Treatment group C
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Treatment group A
- Treatment group B
- Treatment group C
**Description:** One HRS-7535（D）Tablet is administered to healthy subjects.
**Name:** HRS-7535（D）Tablets
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Treatment group A
- Treatment group B
- Treatment group C
**Description:** Two HRS-7535（C）Tablets is administered to healthy subjects.
**Name:** HRS-7535（C）Tablets
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Measure:** PK parameters：Cmax
**Time Frame:** 0 hour to 72 hours after the last dosing
**Measure:** PK parameters：AUC0-t
**Time Frame:** 0 hour to 72 hours after the last dosing
**Measure:** PK parameters：AUC0-∞
**Time Frame:** 0 hour to 72 hours after the last dosing
**Measure:** Relative bioavailability of HRS-7535 (D) tablets compared to HRS-7535 (C) tablets following a high-fat meal
**Time Frame:** 0 hour to 72 hours after the last dosing
**Measure:** Relative bioavailability of HRS-7535 (D) tablets under both fasting and fed (high fat meal) status
**Time Frame:** 0 hour to 72 hours after the last dosing
#### Secondary Outcomes
**Measure:** PK parameters：Tmax
**Time Frame:** 0 hour to 72 hours after the last dosing
**Measure:** PK parameters： t1/2
**Time Frame:** 0 hour to 72 hours after the last dosing
**Measure:** PK parameters： CL/F
**Time Frame:** 0 hour to 72 hours after the last dosing
**Measure:** PK parameters： V/F
**Time Frame:** 0 hour to 72 hours after the last dosing
**Measure:** Incidence and severity of adverse events (AEs)
**Time Frame:** from screening to 72 hours after the last dosing
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Able and willing to provide a written informed consent;
2. Male or female aged 18-45 at screening (both inclusive);
3. Male weight ≥ 50 kg, female weight ≥ 45 kg, and body mass index (BMI) : 18-30 kg/m2 (including both ends of the value);
4. Subjects (including male subjects) are willing to have no birth plan and voluntarily adopt effective contraceptive measures and no sperm donation plan from Signed informed consent to the last two weeks after the administration of no fertility plan and no sperm donation, egg donation plan, and agree to take effective contraceptive measures.
Exclusion Criteria:
1. Those who had a smoking history in the 3 months before screening (average daily smoking \> 5 cigarettes), or could not stop using any tobacco products during the test;
2. Those who consumed an average of more than 25 g of alcohol per day (e.g., 750 mL beer, 250 mL wine, or 50 mL liquor) in the three months prior to screening, or who could not abstain during the trial period;
3. Consumed any beverage or food containing grapefruit in the 7 days prior to screening; Or consumed any beverage or food containing methylxanthine within 2 days prior to screening, such as coffee, tea, cola, chocolate, etc.
4. Allergy, or suspected allergy to any ingredient in HRS-7535 preparation;
5. A history of drug abuse in the past five years or use of drugs in the three months prior to the test; Or a positive urine drug test;
6. A history of any clinically serious disease or disease or condition that the investigator believes may affect the test results, including but not limited to circulatory, endocrine, nervous, digestive, urinary, or blood, immune, psychiatric, or metabolic disorders;
7. Abnormalities with QTcF \> 450 ms detected by 12-lead electrocardiogram at screening or baseline and judged by investigators to be clinically significant;
8. Vital signs, physical examination, laboratory examination, abdominal ultrasound or chest imaging examination at the time of screening or at baseline suggest abnormalities that the investigators have determined to be clinically significant;
9. Positive hepatitis B surface antigen (HBsAg), positive antibodies against hepatitis C virus (HCV), positive antibodies against human immunodeficiency virus (HIV), or positive antibodies against syphilis within 4 weeks prior to screening;
10. Use of any prescription, over-the-counter, herbal or dietary supplements (excluding regular vitamins) in the 2 weeks prior to screening;
11. Participants in clinical trials of any other drug or medical device within the 3 months prior to screening or within the 5 half-life of the drug (based on whether the drug was administered or used, excluding placebo);
12. Received BCG vaccine within 12 months prior to screening; Vaccination or exposure to other live or attenuated vaccines (other than COVID-19 vaccines) within 3 months prior to screening; Or who plan to be vaccinated during the trial;
13. Patients who have had any surgery in the 3 months prior to screening, have not recovered from surgery, or are likely to have surgery or hospitalization plans during the trial period;
14. Blood donation (or blood loss) and blood donation (or blood loss) ≥400 mL within 3 months before screening, or receiving blood transfusion;
15. Positive results of serum pregnancy test (serum beta-HCG test) during screening period or baseline examination in women;
16. The woman had any form of pregnancy (including spontaneous abortion, delivery, ectopic pregnancy, etc.) in the 3 months prior to the screening, or was breastfeeding at the time of the screening visit;
17. Women use the following contraceptive methods during screening visits: medicated extended-release Iuds, extended-release contraceptives (subcutaneous implants, vaginal rings, microspheres and microcapsules); Use of long-acting contraceptive injections before screening (medroxyprogesterone acetate should be prohibited 3 months before screening, other injections should be prohibited 1 month before screening), use of oral contraceptives 2 months before screening, and use of contraceptive patches 1 month before screening; Special cases are judged by the researcher;
18. Subjects have conditions that, as determined by the investigator, affect drug absorption, distribution, metabolism, and excretion, or reduce adherence, or other factors that make participation in the study inappropriate.
**Healthy Volunteers:** True
**Maximum Age:** 45 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Sheng Feng
**Phone:** +86-0518-82342973
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Chang Shu
**Phone:** +86-0518-82342973
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Hefei
**Contacts:**
***Contact 1:***
- **Name:** Wei Hu, Doctor
- **Role:** CONTACT
**Country:** China
**Facility:** The Second Hospital of Anhui Medical Uniersity
**State:** Anhui
**Zip:** 230601
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000003920
- Term: Diabetes Mellitus
- ID: D000044882
- Term: Glucose Metabolism Disorders
- ID: D000008659
- Term: Metabolic Diseases
- ID: D000004700
- Term: Endocrine System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M7115
- Name: Diabetes Mellitus
- Relevance: LOW
- As Found: Unknown
- ID: M7119
- Name: Diabetes Mellitus, Type 2
- Relevance: HIGH
- As Found: Type 2 Diabetes Mellitus
- ID: M11639
- Name: Metabolic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M25403
- Name: Glucose Metabolism Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M7862
- Name: Endocrine System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T4202
- Name: Oculocerebral Syndrome With Hypopigmentation
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003924
- Term: Diabetes Mellitus, Type 2
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06422026
**Brief Title:** Evaluated the Efficacy and Safety of APCP on Hair Health
**Official Title:** A 24 Week, Randomized, Double Blind, Placebo Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of APCP on Hair Health
#### Organization Study ID Info
**ID:** AP-PV-2022-02
#### Organization
**Class:** INDUSTRY
**Full Name:** Amorepacific Corporation
### Status Module
#### Completion Date
**Date:** 2024-04-30
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2024-01-30
**Type:** ACTUAL
#### Start Date
**Date:** 2023-03-16
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Amorepacific Corporation
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This study is designed to evaluate the efficacy and safety of APCP in promoting hair health in adult with mild to moderate hair damage, compared to a placebo control.
### Conditions Module
**Conditions:**
- Hair Damage
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** QUADRUPLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 150
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Dietary Supplement: APCP I
**Label:** APCP I
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Intervention Names:**
- Dietary Supplement: APCP II
**Label:** APCP II
**Type:** ACTIVE_COMPARATOR
#### Arm Group 3
**Intervention Names:**
- Dietary Supplement: Placebo
**Label:** Placebo
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- APCP I
**Description:** Each subject takes one active bottle per day for 24 weeks. Each bottle contains APCP 3 g.
**Name:** APCP I
**Type:** DIETARY_SUPPLEMENT
#### Intervention 2
**Arm Group Labels:**
- APCP II
**Description:** Each subject takes one active bottle per day for 24 weeks. Each bottle contains APCP 4 g.
**Name:** APCP II
**Type:** DIETARY_SUPPLEMENT
#### Intervention 3
**Arm Group Labels:**
- Placebo
**Description:** Each subject takes one active bottle per day for 24 weeks.
**Name:** Placebo
**Type:** DIETARY_SUPPLEMENT
### Outcomes Module
#### Primary Outcomes
**Description:** Hair tensile strength measured by UTM(Universal Testing Machine) etc.
**Measure:** Change from baseline in hair tensile strength
**Time Frame:** Baseline, 24 week
#### Secondary Outcomes
**Description:** Hair gloss measured by Glossymeter etc.
**Measure:** Change from baseline in hair gloss
**Time Frame:** Baseline, 24 week
**Description:** Hair density measured by Folliscope
**Measure:** Change from baseline in hair density
**Time Frame:** Baseline, 24 week
**Description:** Hair volume measured by I Max-plus
**Measure:** Change from baseline in hair volume
**Time Frame:** Baseline, 24 week
**Description:** Satisfaction surveys are evaluated on a 10-point scale. Survey items are evaluated on a scale from '0 - Not at all' to '10 - Very much so' (although scoring may be reversed depending on the question).
**Measure:** Change from baseline in satisfaction survey
**Time Frame:** Baseline, 24 week
**Description:** scalp moisture measured by DermaLab Hydration Pin Probe
**Measure:** Change from baseline in scalp moisture
**Time Frame:** Baseline, 24 week
**Description:** scalp percutaneous moisture loss measured by Tewameter TM Nano
**Measure:** Change from baseline in scalp percutaneous moisture loss
**Time Frame:** Baseline, 24 week
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Glossy scores according to the visual evaluation classification method correspond to 1 point or more and 3 points or less and a total hair damage score of less than 18 points evaluated according to exposure to risk factors
* A person capable of maintaining the same hair shape and color during this human body application test
* A person who has agreed to participate in this human application test before the start of the human application test and filled out the Informed Consent Form
Exclusion Criteria:
* A person currently being treated for infectious diseases and malignant tumors, including severe cardiovascular system, immune system, respiratory system, hepatometer, kidney and urology system, nervous system, musculoskeletal system, psychosis, skin, etc
* As of Visit 1, those who currently have dull dermatitis, scalp psoriasis, and scalp infection
* A person who plans to manage and operate hair supplies, hair products during this human body application test
* A person who has taken oral Dutasteride or Finasteride within 6 months of visit 1
* A person who has applied topical hair growth agents, wool, and hair growth agents for the last 1 month (30 days) or more as of Visit 1
* Those who have been administered systemic steroids, cell death agents, vasodilators, antihypertensive agents, antiepileptic agents, beta receptor blockers, bronchodilators, diuretics, Cimetidine, Diazoxide, Cyclosporine, and Ketoconazole for the last 1 month or more (30 days)
* A person who has applied topical steroids to the scalp for the last 1 month (30 days) or more as of Visit 1
* A person who has participated in other interventional clinical trials (including human application tests) within one month (30 days) of visit 1 or plans to participate in other interventional clinical trials (including human application tests) after the start of this human application test
* A person who is pregnant or who has a plan to become pregnant during the nursing mother or during this human body application test
* A person who is sensitive to or allergic to food ingredients for this human body application test
* A person who is deemed inappropriate by the tester for other reasons
**Healthy Volunteers:** True
**Maximum Age:** 60 Years
**Minimum Age:** 19 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Seoul
**Country:** Korea, Republic of
**Facility:** Yonsei University Health System, Severance Hospital
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06422013
**Brief Title:** Clinical Study to Evaluate the Body Fat Reducing Effect and Safety of GTB1
**Official Title:** A Randomized, Double-blind, Placebo-controlled, Parallel-design Clinical Study to Evaluate the Body Fat Reducing Effect and Safety of Lactiplantibacillus Plantarum APsulloc 331261(GTB1)
#### Organization Study ID Info
**ID:** AP-PV-2022-01
#### Organization
**Class:** INDUSTRY
**Full Name:** Amorepacific Corporation
### Status Module
#### Completion Date
**Date:** 2023-12-08
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-12-08
**Type:** ACTUAL
#### Start Date
**Date:** 2022-10-28
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Amorepacific Corporation
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This study was conducted to investigate the effects of daily supplementation of GTB1 on decrease of body fat.
**Detailed Description:** This study was a 12 week, randomized, double-blind, placebo-controlled human trial. 100 subjects were randomly divided into GTB1 group and placebo group. It is to evaluate the changes in the displayed evaluation items when taking GTB1 once a day, in comparison with taking a placebo.
### Conditions Module
**Conditions:**
- Body Fat
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** QUADRUPLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 100
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Once-daily, once a packet, for 12 week
**Intervention Names:**
- Dietary Supplement: GTB1
**Label:** GTB1
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** Once-daily, once a packet, for 12 week
**Intervention Names:**
- Dietary Supplement: Placebo
**Label:** Placebo
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- GTB1
**Description:** oral administration of GTB1 powder packet once daily
**Name:** GTB1
**Type:** DIETARY_SUPPLEMENT
#### Intervention 2
**Arm Group Labels:**
- Placebo
**Description:** oral administration of placebo powder packet once daily
**Name:** Placebo
**Type:** DIETARY_SUPPLEMENT
### Outcomes Module
#### Primary Outcomes
**Description:** Measurement is made using dual-energy X-ray absorptiometry(DEXA)
**Measure:** Changes of percent body fat(trunk, total ect.)
**Time Frame:** Baseline, Week 12
#### Secondary Outcomes
**Description:** Measurement of the target area is made using dual-energy X-ray absorptiometry (DEXA)
**Measure:** Changes of fat free mass(trunk, total ect.)
**Time Frame:** Baseline, Week 12
**Description:** Measurement of the target area is made using computed tomography (CT)
**Measure:** Changes of total abdominal fat area, visceral fat area and subcutaneous fat area
**Time Frame:** Baseline, Week 12
**Description:** Measurement of waist and hip circumference is performed following the WHO guideline
**Measure:** Changes of waist, hip circumference and waist/hip circumference ratio
**Time Frame:** Baseline, Week 12
**Description:** Indicator of lipid metabolism(i.e., Total cholesterol, Triglyceride, LDL-cholesterol, HDL-cholesterol)
**Measure:** Changes of indicator of lipid metabolism
**Time Frame:** Baseline, Week 12
**Description:** Obesity-related hormone indexes(Adiponectin, Leptin etc.). As blood adiponectin levels increase, blood leptin concentrations decrease, indicating a positive change.
**Measure:** Changes of obesity-related hormone index
**Time Frame:** Baseline, Week 12
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Males and females aged between 19\~65 years at the screening
* Participants who were BMI 25.0\~34.9 kg/m\^2 (Excluding those who need to take or be prescribed medication that affects fat reduction, if the BMI is between 30.0\~34.9 kg/m\^2)
* Participants who have a waist circumference of 90 cm for men and 85 cm or more for women
* Participants who have fully understood the information provided about the study voluntarily decided to participate and agreed to comply with precautions
Exclusion Criteria:
* Participants who decrease 10% more of weight within 3 months period to the screening
* Participants who have undergone surgical procedures (such as gastrectomy) for weight loss
* Participants who have a history of malignant tumors within 5 years prior to participating in the clinical study
* Participants who have a systolic blood pressure of 160 mmHg or higher, or a diastolic blood pressure of 100 mmHg or higher (those who are stably controlling their blood pressure with medication can participate)
* Participants who are taking beta-blockers or diuretics as part of their hypertension treatment
* Patients who have been diagnosed with Type 1 or Type 2 diabetes and are taking oral hypoglycemic agents and insulin
* Participants who have taken antibiotics within 4 weeks prior to the screening examination
* Participants who have taken health functional foods, herbal medicine, or general foods for the purpose of weight loss within 4 weeks prior to the screening visit
* Participants with clinically significant acute or chronic diseases of the cardiovascular system, endocrine system, immune system, respiratory system, liver biliary system, kidney and urinary system, neuropsychiatry system, musculoskeletal system, inflammatory and hematologic, gastrointestinal diseases, and other diseases requiring treatment
* Participants with a past history of gastrointestinal diseases (e.g., Crohn's disease) or gastrointestinal surgery (but, excluding simple cecal surgery and hernia surgery) that can affect the absorption of products of the human trial
* Participants who have participated in other clinical study within 3 months prior to the screening examination
* Women who are pregnant or breastfeeding
* Women who may become pregnant and have not used appropriate contraceptives
* Participants who show the following relevant results in a Laboratory test
* Aspartate Transaminase (AST), Alanine Transaminase (ALT) \> Reference range 3 times upper limit
* Serum Creatinine \> 2.0 mg/dl
* Participants who the principal investigator judged inappropriate for the participant in this study because of a laboratory test result, etc.
**Healthy Volunteers:** True
**Maximum Age:** 65 Years
**Minimum Age:** 19 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Jeonju
**Country:** Korea, Republic of
**Facility:** Jeonbuk National University Hospital
**State:** Jeollabuk-do
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06422000
**Brief Title:** Effect of Pentoxifylline Versus Probiotic on Preterm Neonates With Necrotizing Enterocolitis
**Official Title:** Pentoxifylline Versus Probiotic as Adjuvant Therapy for Preterm Neonates With Necrotizing Enterocolitis
#### Organization Study ID Info
**ID:** pentoxifylline probiotic NEC
#### Organization
**Class:** OTHER
**Full Name:** Tanta University
### Status Module
#### Completion Date
**Date:** 2023-12-30
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-14
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-11-01
**Type:** ACTUAL
#### Start Date
**Date:** 2022-06-30
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2022-11-11
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Tanta University
#### Responsible Party
**Investigator Affiliation:** Tanta University
**Investigator Full Name:** Alaa Mohamed Ahmed Rowisha
**Investigator Title:** clinical pharmacist
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** The aim of this study is to evaluate the effectiveness of pentoxifylline versus probiotics supplementation as adjuvant therapy for preterm neonates with necrotizing enterocolitis.
**Detailed Description:** This randomized clinical trial includes 75 preterm infants who met the inclusion criteria for stage I and stage II NEC. Patients are allocated randomly into three groups (each included 25 neonates); group I (traditional therapy group) received antibiotics according to culture and sensitivity results, group II (pentoxifylline group) received antibiotics and IV pentoxifylline at a dose of 30 mg/ Kg given over 6 hours daily until discharge from the unit, and group III (probiotics group) received antibiotics and probiotics sachets supplementation in a dose of 100 mg mixed with 10 ml sterile water and given by Ryle tube once daily until discharge. The serum level of high-mobility group box protein 1 (HMGB-1), intestinal fatty acid binding proteins (I-FABP), and total antioxidant capacity (TAC) were measured on admission and at discharge.
### Conditions Module
**Conditions:**
- Necrotizing Enterocolitis
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 75
**Type:** ACTUAL
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** will include 25 preterm neonates with NEC who will receive traditional therapy of NEC including antibiotics and normal incubator care measures
**Label:** control group (group I)
**Type:** NO_INTERVENTION
#### Arm Group 2
**Description:** will include 25 preterm neonates with NEC who will receive traditional therapy of NEC in association with IV pentoxifylline at a dose of 30 mg/kg given over 6 hours daily (Schüller et al., 2020) until discharge from the unit after clinical and laboratory improvement .
**Intervention Names:**
- Drug: Pentoxifylline
**Label:** pentoxifylline group (group II)
**Type:** ACTIVE_COMPARATOR
#### Arm Group 3
**Description:** will include 25 preterm neonates with NEC who will receive traditional therapy of NEC in association with probiotics sachets supplementation, in the form of lyophilized lactic acid bacteria each Aluminium stick pack contains 100 mg ( Meyer et al., 2020) Probio Tec BB12-Blend 30- IF\* (SANDOZ®.) mixed with 10 ml sterile water and given by Ryle tube once daily until discharge from the unit after clinical and laboratory improvement .
**Intervention Names:**
- Drug: Probiotic Formula
**Label:** probiotic group (group III)
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- pentoxifylline group (group II)
**Description:** Pentoxifylline 30 mg/kg given over 6 hours daily
**Name:** Pentoxifylline
**Other Names:**
- group 2 (Pentoxifylline group)
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- probiotic group (group III)
**Description:** probiotics sachets supplementation, in the form of lyophilized lactic acid bacteria each Aluminium stick pack contains 100 mg ( Meyer et al., 2020) Probio Tec BB12-Blend 30- IF\* (SANDOZ®.) mixed with 10 ml sterile water and given by Ryle tube once daily until discharge from the unit after clinical and laboratory improvement .
**Name:** Probiotic Formula
**Other Names:**
- group 3 (Probiotic group)
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** record mortality rate in each group during treatment
**Measure:** Mortality rate
**Time Frame:** 2 months
**Description:** record any complications or side effects of the treating drugs
**Measure:** complications and side effects
**Time Frame:** 2 months
**Description:** Change in serum C-reactive protein at baseline and after 2 months
**Measure:** Inflammatory parameter
**Time Frame:** 2 months
#### Secondary Outcomes
**Description:** blood sample will be collected at baseline and after 2 months
**Measure:** change in serum high-mobility group box protein 1 (HMGB1)
**Time Frame:** 2 months
**Description:** blood sample will be collected at baseline and after 2 months
**Measure:** change in serum Intestinal fatty acid binding protein (I-FABP).
**Time Frame:** 2 months
**Description:** Blood sample will be collected at baseline and after 2 months
**Measure:** change in serum total antioxidant capacity (TAC)
**Time Frame:** 2 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Male and female preterm neonates less than 37 weeks gestational age
* Suffering from necrotizing enterocolitis (NEC), according to Modified Bell's system which was first proposed by Bell et al., 1978 as stage I (suspected), II (proven) .
* Diagnosis of NEC depends on; history, physical examination, laboratory and radiographic findings .
* Signs and symptoms of NEC (at least three or more ), including; unstable temperature, apnea, increased residual milk in stomach, mid abdominal distension, vomiting coffee-like substances, bloody stool
* Laboratory findings including; thrombocytopenia, hypernatremia, metabolic acidosis, neutropenia and leukocytosis.
* Anterior posterior abdominal radiograph is used for diagnosis in which pneomatosis intestinalis in stage II NEC
Exclusion Criteria:
* Term and post term neonates
* Neonates with congenital infections
* Neonates with major congenital anomalies
* Neonates with stage III NEC
**Maximum Age:** 37 Weeks
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Tanta
**Country:** Egypt
**Facility:** Tanta University
**State:** El Gharbia
#### Overall Officials
**Official 1:**
**Affiliation:** professor and head of clinical pharmacy department, faculty of Pharmact, Tanta University, Egypt
**Name:** Sahar Hegazy, MD
**Role:** STUDY_DIRECTOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000005759
- Term: Gastroenteritis
- ID: D000005767
- Term: Gastrointestinal Diseases
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000007410
- Term: Intestinal Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: All
- Name: All Conditions
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M25869
- Name: Premature Birth
- Relevance: LOW
- As Found: Unknown
- ID: M7922
- Name: Enterocolitis
- Relevance: HIGH
- As Found: Enterocolitis
- ID: M22151
- Name: Enterocolitis, Necrotizing
- Relevance: HIGH
- As Found: Necrotizing Enterocolitis
- ID: M8875
- Name: Gastroenteritis
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10444
- Name: Intestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T4055
- Name: Necrotizing Enterocolitis
- Relevance: HIGH
- As Found: Necrotizing Enterocolitis
### Condition Browse Module - Meshes
- ID: D000004760
- Term: Enterocolitis
- ID: D000020345
- Term: Enterocolitis, Necrotizing
### Intervention Browse Module - Ancestors
- ID: D000010726
- Term: Phosphodiesterase Inhibitors
- ID: D000004791
- Term: Enzyme Inhibitors
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000010975
- Term: Platelet Aggregation Inhibitors
- ID: D000011837
- Term: Radiation-Protective Agents
- ID: D000020011
- Term: Protective Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000014665
- Term: Vasodilator Agents
- ID: D000016166
- Term: Free Radical Scavengers
- ID: D000000975
- Term: Antioxidants
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: VaDiAg
- Name: Vasodilator Agents
- Abbrev: PlAggInh
- Name: Platelet Aggregation Inhibitors
- Abbrev: Ot
- Name: Other Dietary Supplements
### Intervention Browse Module - Browse Leaves
- ID: M4222
- Name: Anti-Bacterial Agents
- Relevance: LOW
- As Found: Unknown
- ID: M13342
- Name: Pentoxifylline
- Relevance: HIGH
- As Found: Format
- ID: M4224
- Name: Antibiotics, Antitubercular
- Relevance: LOW
- As Found: Unknown
- ID: M13629
- Name: Phosphodiesterase Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M7951
- Name: Enzyme Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M13865
- Name: Platelet Aggregation Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M21869
- Name: Protective Agents
- Relevance: LOW
- As Found: Unknown
- ID: M14684
- Name: Radiation-Protective Agents
- Relevance: LOW
- As Found: Unknown
- ID: M17412
- Name: Vasodilator Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4292
- Name: Antioxidants
- Relevance: LOW
- As Found: Unknown
- ID: T355
- Name: Acidophilus
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000010431
- Term: Pentoxifylline
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06421987
**Brief Title:** Cardiopulmonary Function and Cerebral Blood Flow in Hodgkin Lymphoma Survivors
**Official Title:** Cardiopulmonary Function and Cerebral Blood Flow in Hodgkin Lymphoma Survivors
#### Organization Study ID Info
**ID:** HODNIRS
#### Organization
**Class:** OTHER
**Full Name:** St. Jude Children's Research Hospital
### Status Module
#### Completion Date
**Date:** 2027-03
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-14
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-03
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-01
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** St. Jude Children's Research Hospital
#### 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:** SURVIVORS
Study participants are being asked to take part in this research study called HODNIRS because the participant is a survivor of Hodgkin Lymphoma (HL) treated with chest radiation and bleomycin at St. Jude Children's Research Hospital. The study is being done to help investigators understand the link between long term effects of chest radiation and bleomycin for HL and brain function in survivors.
Primary Objective To evaluate dynamic changes in CBF and oxygenation during exercise with Near Infrared Spectroscopy (NIRS) in HL survivors and non-cancer controls matched for age, sex, race, and ethnicity. .
Secondary Objectives To examine the degree of CO2 clearance (DLCO/ETCO2) during rest and exercise in Hodgkin Lymphoma (HL) survivors compared to non-cancer controls matched for age, sex, race, and ethnicity.
CONTROLS
Volunteers are being asked to take part in this research study because they are non-first degree relative or friend of someone who received treatment for a childhood cancer or similar illness at St. Jude Children's Research Hospital or are an employee/affiliate of St. Jude Children's Research Hospital and have agreed to be a St. Jude Life Cohort Study (SJLIFE) community control.
**Detailed Description:** NIRS is a portable, non-invasive, brain imaging device that uses low levels of non-ionizing light to record variations in blood flow in the brain. The NIRS is wearable and can read blood flow to the brain during physical activity.
### Conditions Module
**Conditions:**
- Hodgkin Lymphoma, Adult
### Design Module
#### Design Info
**Observational Model:** CASE_CROSSOVER
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 100
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** A survivor of Hodgkin Lymphoma (HL) treated with chest radiation and bleomycin at St. Jude Children's Research Hospital.
and Control: Voluntarily taking part in this study because you are a relative, friend or employee of St. Jude Children's Research Hospital.
**Intervention Names:**
- Device: Near Infrared Spectroscopy (NIRS)
**Label:** SURVIVOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- SURVIVOR
**Description:** NIRS is a portable, non-invasive, brain imaging device.
**Name:** Near Infrared Spectroscopy (NIRS)
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** a non-invasive imaging technology that is used to measure regional or global cerebral tissue oxygenation and cerebral blood flow (CBF) during exercise. NIRS takes advantage of the fact that oxygenated blood and de-oxygenated blood absorb light differently. By measuring the reflected light from blood, the concentration of both oxygenated hemoglobin (HbO2) and deoxygenated hemoglobin (HbdO2) using the modified Beer-Lambert Law can be calculated.
**Measure:** Near-Infrared Spectroscopy (NIRS)
**Time Frame:** Baseline
#### Secondary Outcomes
**Description:** Cardiopulmonary Exercise Testing (CPX) will be performed with the goal of maximal exertion. Participants are monitored with 12-lead electrocardiogram (ECG) and serial blood pressure measurements during and after exercise, and during recovery. Study participants whose physical performance does not permit walking safely on the treadmill, will perform CPX on a bicycle or upper extremity ergometer using a comparable testing protocol.
Oxygen consumption during CPX- Oxygen will be measured at baseline and continuously during CPX. Total minute ventilation (respiratory rate X tidal volume; l/min), and ventilatory reserve (l/min) will be used to assess the ability of the pulmonary system to respond to exercise.
**Measure:** Cardiopulmonary Exercise Testing (CPX)
**Time Frame:** Baseline
**Description:** As part of the St. Jude Life (SJLIFE) study visit, participants will complete PFT's performed in a single laboratory according to the American Thoracic Society Task Force Guidelines. Pulmonary Function Tests (PFTs) will include:
1. Forced vital capacity (FVC) - measured in liters
2. Forced expiratory volume in 1 second (FEV1) - measured in liters/per second
3. FEV1/FVC ratio - measurement will be a percent.
4. DLCO capacity of lung to transfer carbon monoxide - measured in mL/min/mm Hg.
These measurements will be compared with those predicted for the participant's age, race, sex, and height.
**Measure:** Pulmonary Function Testing
**Time Frame:** Baseline
**Description:** - As part of the SJLIFE study visit, participants will complete neurocognitive testing (Wechsler Abbreviated Scale of Intelligence; Connors Continuous Performance; California Verbal Learning; Coding Digital Symbol; Grooved Pegboard; Trail Making; Verbal Fluence; Visual Selective; Digital Span; and Rey Complex). All tests are converted to z-scores (1.0 z-score is 1 standard deviation lower than the mean).
**Measure:** Neurocognitive Outcomes
**Time Frame:** Baseline
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
HL Survivors
* Completed bleomycin and/or thoracic radiation therapy for HL at SJCRH.
* \<21-years old at diagnosis; currently ≥18-years of age and ≥2-years post therapy.
* SJLIFE or ACT/SJLIFE participants
* English language proficiency.
Community Controls
* SJLIFE control.
* ≥18-years of age at the time of enrollment with age sampling to broadly match the HL survivors.
Exclusion Criteria:
HL Survivors
* History of cranial or total-body irradiation therapy.
* History of intrathecal or high dose intravenous antimetabolite therapy.
* History of head injury or diagnosis of a genetic disorder associated with cognitive impairment.
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** All participants who meet eligibility criteria and consent to enrollment on the study.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Nicholas Phillips, PhD
**Phone:** 866-278-5833
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Memphis
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Nicholas Phillips, PhD
- **Phone:** 866-278-5833
- **Role:** CONTACT
***Contact 2:***
- **Name:** Nicholas Phillips, PhD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** St. Jude Children's Research Hospital
**State:** Tennessee
**Zip:** 38105
#### Overall Officials
**Official 1:**
**Affiliation:** St. Jude
**Name:** Nicholas Phillips, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### See Also Links
**Label:** St. Jude Children's Research Hospital
**URL:** http://www.stjude.org
**Label:** Clinical Trials Open at St. Jude
**URL:** http://www.stjude.org/protocols
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000009369
- Term: Neoplasms
- ID: D000008232
- Term: Lymphoproliferative Disorders
- ID: D000008206
- Term: Lymphatic Diseases
- ID: D000007160
- Term: Immunoproliferative Disorders
- ID: D000007154
- Term: Immune System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC15
- Name: Blood and Lymph Conditions
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M11220
- Name: Lymphoma
- Relevance: HIGH
- As Found: Lymphoma
- ID: M9751
- Name: Hodgkin Disease
- Relevance: HIGH
- As Found: Hodgkin 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: T3543
- Name: Lymphosarcoma
- Relevance: HIGH
- As Found: Lymphoma
- ID: T2817
- Name: Hodgkin Lymphoma
- Relevance: HIGH
- As Found: Hodgkin Lymphoma
### Condition Browse Module - Meshes
- ID: D000008223
- Term: Lymphoma
- ID: D000006689
- Term: Hodgkin Disease
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M5042
- Name: Bleomycin
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06421974
**Brief Title:** Effectiveness of Robotic Surgery for Right Colon Cancer
**Official Title:** A Prospective, Multicenter, Randomized Controlled Trial of the Effectiveness of Robotic Versus Laparoscopic Surgery for Right Colon Cancer
#### Organization Study ID Info
**ID:** SRRS-ERSRCC
#### Organization
**Class:** OTHER
**Full Name:** Sir Run Run Shaw Hospital
### Status Module
#### Completion Date
**Date:** 2027-05-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-14
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-05-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-03
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Zhejiang University
**Class:** OTHER
**Name:** Second Affiliated Hospital, School of Medicine, Zhejiang University
**Class:** OTHER
**Name:** Zhejiang Cancer Hospital
**Class:** OTHER
**Name:** Zhejiang Provincial People's Hospital
**Class:** OTHER
**Name:** First Affiliated Hospital of Wenzhou Medical University
**Class:** OTHER
**Name:** Ningbo No. 1 Hospital
#### Lead Sponsor
**Class:** OTHER
**Name:** Sir Run Run Shaw Hospital
#### Responsible Party
**Investigator Affiliation:** Sir Run Run Shaw Hospital
**Investigator Full Name:** Zhangfa Song
**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:** This study aims to explore through a multi-center, randomized controlled clinical study whether robot-assisted radical resection of right colon cancer is superior to laparoscopic surgery in terms of surgical quality and oncological prognosis.
**Detailed Description:** The incidence rate of colorectal cancer has risen to the second place in my country, highlighting its significant impact on public health. It is a high-incidence malignant tumor that seriously threatens the health of our people. Surgery is the core treatment method for curing colorectal cancer. With the promotion of multidisciplinary comprehensive treatment models, in-depth understanding of abdominal and pelvic anatomy, and innovations in surgical instruments and techniques, colorectal cancer surgery is gradually developing in the direction of minimally invasive and organ function preservation. This advancement not only improves the safety and effectiveness of surgery, but also improves patients' postoperative quality of life. Laparoscopic surgery has obvious minimally invasive advantages in the treatment of right colon cancer. Compared with traditional laparotomy, laparoscopic surgery has the advantages of less trauma, less postoperative pain, faster recovery, and shorter hospital stay.
Since Hohenberger proposed the concept of complete mesocolic excision (CME), the principle of CME has become a key technique in colon cancer surgery, which emphasizes thorough lymph node dissection and precise tumor resection. In radical resection of right colon cancer, CME technology ensures complete resection of surrounding tissue by performing surgery along the natural anatomical plane of blood vessels and nerve plexuses, thereby reducing the local recurrence rate of the tumor. A retrospective cohort study of 1395 cases included in the Danish Colorectal Cancer Study Group showed that the 4-year disease-free survival rate of patients of all stages after CME surgery was 85.8% (95% CI 81.4-90.1), and that after non-CME surgery, the 4-year disease-free survival rate was 85.8% (95% CI 81.4-90.1). The 4-year disease-free survival rate was 75.9% (95% CI 72.2-79.7) (log-rank p=0.0010), which preliminarily proved that the CME principle can significantly improve the disease recurrence-free survival (DFS) rate. This method aims to achieve better tumor cure results through more extensive and complete resection.
However, with the continuous innovation of surgical instruments and technologies, laparoscopic surgery is also facing some challenges. Laparoscopic surgery often provides a two-dimensional field of view, which may limit the surgeon's depth perception and accuracy when performing complex procedures. In addition, the operating rods of traditional laparoscopic tools are relatively long and the operating space is limited, which may lead to difficulties in gesture amplification and fine motor control during surgery, resulting in certain defects in surgical operation accuracy and visual field stability.
The robot-assisted surgical system provides a new technical platform for improving the quality of surgical operations with its enhanced visual capabilities, stable field of view and flexibility of surgical instruments. The stability of the three-dimensional stereo vision system and camera platform can significantly improve the surgical field of view, while the high flexibility of the robotic arm optimizes surgical operations. Existing clinical studies show that compared with traditional laparoscopic surgery, robot-assisted surgical systems have potential advantages in reducing the proportion of conversions to laparotomy, reducing the occurrence of postoperative complications, and shortening postoperative recovery time.
When considering the economic burden of robotic-assisted surgical systems relative to conventional laparoscopic surgery, more rigorous and quantitative evidence is necessary to assess their economic benefits in daily clinical practice. Although robot-assisted surgical systems offer operational advantages, their high equipment investment and maintenance costs remain a major obstacle to their adoption. Therefore, a comprehensive cost-effectiveness analysis, combined with an assessment of surgical outcomes, patient recovery, and long-term health-related quality, is critical to determine its suitability in the healthcare system. The REAL randomized controlled study led by Professor Xu Jianmin compared the surgical quality and long-term tumor prognosis of robot-assisted surgery and conventional laparoscopic surgery in patients with middle and low rectal cancer. The primary endpoint of the study was the 3-year local recurrence rate, while the secondary endpoints focused on the positive circumferential margin rate and the 30-day postoperative complication rate. The short-term secondary endpoint data that have been published so far are encouraging. However, there is still a lack of multicenter randomized controlled clinical studies on the long-term oncological outcomes of robotic surgery for right colon cancer.
This study aims to compare the 3-year disease recurrence-free survival (DFS) between robot-assisted radical right hemicolectomy (RA-LSRHC) and conventional laparoscopic radical right hemicolectomy (LSRHC) through a multicenter, randomized controlled study. The non-inferiority in terms of surgery provides high-quality evidence-based medical evidence for robot-assisted right colon cancer surgery, further optimizes treatment strategies, and improves patients' quality of life.
### Conditions Module
**Conditions:**
- Colon Cancer
- Robotic Surgery
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 610
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Robot-assisted right colon cancer radical resection group, referred to as robotic surgery group
**Intervention Names:**
- Procedure: DaVinci si or xi system
**Label:** Robotic surgery for right colon cancer
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Laparoscopic right colon cancer radical resection group, referred to as laparoscopic surgery group
**Intervention Names:**
- Procedure: laparoscopic radical resection
**Label:** laparoscopic surgery for right colon cancer
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Robotic surgery for right colon cancer
**Description:** In this study, subjects were randomly divided into an experimental group (robot-assisted radical resection of right colon cancer group, referred to as robotic surgery group) and a control group (laparoscopic radical resection of right colon cancer group, referred to as laparoscopic surgery group).
**Name:** DaVinci si or xi system
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- laparoscopic surgery for right colon cancer
**Description:** In this study, subjects were randomly divided into an experimental group (robot-assisted radical resection of right colon cancer group, referred to as robotic surgery group) and a control group (laparoscopic radical resection of right colon cancer group, referred to as laparoscopic surgery group).
**Name:** laparoscopic radical resection
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** The time from randomization to first tumor recurrence/metastasis or death from any cause was defined as the time of last follow-up for patients lost to follow-up(Patients still alive at the end of the study, the end of follow-up).
**Measure:** 3-year disease-free survival rate
**Time Frame:** From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
#### Secondary Outcomes
**Description:** Perioperative complications were classified according to the Clavien-Dindo system, including intraoperative, short-term and long-term postoperative complications.
**Measure:** 30-day perioperative complications
**Time Frame:** up to 1 month.
**Description:** 5-year overall survival rate
**Measure:** Overall survival
**Time Frame:** 5-year
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Age 18-75 years old.
2. ASA classification ≤ Level III.
3. Colon adenocarcinoma was confirmed by colonoscopy and biopsy pathology.
4. Transabdominal enhanced CT showed that the distal and proximal ends of the primary tumor were located in the right colon (cecum to the proximal 1/3 of the transverse colon).
5. Preoperative clinical stage: TanyNanyM0.
6. The patient's condition meets the indications for robotic surgery and is willing to accept the robotic surgery treatment plan.
7. Voluntarily participate in this study and sign the informed consent form. If the subject is unable to read and sign the informed consent form due to incapacity or other reasons, his or her guardian must be responsible for the informed process and sign the informed consent form. If the subject is unable to read the informed consent form (such as illiterate subjects), a witness must witness the informed process and sign the informed consent form.
Exclusion Criteria:
1. Preoperative examination indicates synchronous multiple primary colorectal cancers or other diseases requiring intestinal segmental resection.
2. The results of preoperative imaging examination or intraoperative exploration suggest: 1) The tumor involves surrounding organs and requires combined organ resection; 2) There is distant metastasis; 3) R0 resection cannot be performed.
3. Additional radical surgery after emr and esd surgery.
4. Have a history of any other malignant tumor or familial adenomatous polyposis in the past 5 years, except for cured cervical carcinoma in situ, basal cell carcinoma, papillary thyroid carcinoma or cutaneous squamous cell carcinoma.
5. Combined intestinal obstruction, intestinal perforation, intestinal bleeding, etc. require emergency surgery.
6. Patients who are not suitable for or cannot tolerate robotic or laparoscopic surgery.
7. Pregnant or lactating women.
8. Patients with a history of mental illness.
9. Patients who have received neoadjuvant treatment before surgery.
10. MDT discusses patients who are not suitable for entering the study.
11. Patients who refuse to undergo either robotic or laparoscopic surgery.
**Maximum Age:** 75 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Hanzhou
**Country:** China
**Facility:** Sir Run Run Shao hospital
**State:** Zhejiang
**Zip:** 310012
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000015179
- Term: Colorectal Neoplasms
- ID: D000007414
- Term: Intestinal Neoplasms
- ID: D000005770
- Term: Gastrointestinal Neoplasms
- ID: D000004067
- Term: Digestive System Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000005767
- Term: Gastrointestinal Diseases
- ID: D000003108
- Term: Colonic Diseases
- ID: D000007410
- Term: Intestinal 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: M6338
- Name: Colonic Neoplasms
- Relevance: HIGH
- As Found: Colon Cancer
- ID: M17890
- Name: Colorectal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M10448
- Name: Intestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8886
- Name: Gastrointestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M7256
- Name: Digestive System Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System 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
### Condition Browse Module - Meshes
- ID: D000003110
- Term: Colonic Neoplasms
### Intervention Browse Module - Browse Branches
- Abbrev: HB
- Name: Herbal and Botanical
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: T120
- Name: Cola
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06421961
**Brief Title:** Agreement Study on AI-assisted Smartphone-based Monitoring Tool for Difficult-to-heal Ischemic Leg Ulcers
**Official Title:** Digital Techniques for Measuring Chronic Leg Ulcers in Peripheral Arterial Disease: Aspects of Measurement Precision and Evaluation of Wound Treatment
#### Organization Study ID Info
**ID:** AW-trail20240409
#### Organization
**Class:** OTHER
**Full Name:** Sahlgrenska University Hospital, Sweden
### Status Module
#### Completion Date
**Date:** 2026-04-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-17
**Overall Status:** ENROLLING_BY_INVITATION
#### Primary Completion Date
**Date:** 2025-04-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-15
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-15
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Sahlgrenska University Hospital, Sweden
#### Responsible Party
**Investigator Affiliation:** Sahlgrenska University Hospital, Sweden
**Investigator Full Name:** Louise Koch-Nielsen
**Investigator Title:** Specialist nurse, 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:** The purpose of the project is to investigate the agreement with Bland-Altman plots between an AI-supported automatic digital measurement method of wound area and depth and existing manual measurement methods in patients with arterial ulcers on the lower leg. The expectation is that the digital measurement tool can provide healthcare providers with better opportunities to objectively monitor and detect changes in the wound healing process in patients with peripheral arterial disease.
### Conditions Module
**Conditions:**
- Chronic Limb-Threatening Ischemia
**Keywords:**
- Wound Healing
- Artificial Intelligence
- Digital Technology
### Design Module
#### Design Info
**Observational Model:** OTHER
**Time Perspective:** OTHER
#### Enrollment Info
**Count:** 223
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Outcomes Module
#### Primary Outcomes
**Description:** The size of the wound will be determined using three different measurement techniques, with images captured during a single session.
1. Traditional Method for Area Measurement: This method utilizes a Canon EOS 700D camera and a 10 cm ruler for reference. The area is calculated using Picsara software, yielding results in square centimeters (cm²).
2. SeeWound Method Version 1.6.4 for Area Measurement with reference card: This technique employs a specialized app to calculate the wound area in square centimeters (cm²) with the reference card.
2. SeeWound Method Version 1.6.4 for Research: This app utilizes lidar technology to measure the area in square centimeters (cm²).
**Measure:** Assessing the agreement between two methods of measuring the size of arterial wounds.
**Time Frame:** Wounds will be sequentially included until we achieve a sample size of 223 wounds within an estimated timeframe of 52 weeks.
**Description:** The Depth of the wound will be determined using two different measurement techniques, with measurement taken during a single session.
1. Manual Depth Measurement with a Cotton Swab: A cotton swab is inserted into the wound to measure its depth. The measurement is taken at the deepest point and recorded in millimeters (mm).
2. SeeWound Method Version 1.6.4 for Research: This app utilizes lidar technology to measure the depth of the wound in millimeters (mm).
**Measure:** Assessing the agreement between two methods of measuring the depth of arterial wounds.
**Time Frame:** Wounds will be sequentially included until we achieve a sample size of 223 wounds within an estimated timeframe of 52 weeks.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Adults with peripheral arterial disease.
* Arterial or arteriovenous ulcers on lower leg
* Age \<18
Exclusion Criteria:
* Adults with non-ischemic ulcers,
* Purely venous ulcers,
* Purely traumatic wounds,
* Wounds resulting from non-atherosclerotic chronic vascular conditions of the lower extremity (e.g.,vasculitis, Buerger disease, radiation arteritis),
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Patienten seeking care and being diagnos with peripheral arterial disease and having hard to heal wounds on lower leg or foot.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Gothenburg
**Country:** Sweden
**Facility:** Sahlgrenska University Hospital
#### Overall Officials
**Official 1:**
**Affiliation:** Sahlgrenska Academy
**Name:** Monica Ms Pettersson, PhD
**Role:** STUDY_DIRECTOR
**Official 2:**
**Affiliation:** Sahlgrenska University Hospital, Sweden
**Name:** Joakim Mr Nordanstig, PhD
**Role:** STUDY_CHAIR
**Official 3:**
**Affiliation:** Karolinska Institutet
**Name:** Sara Ms Haile, PhD
**Role:** STUDY_CHAIR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007511
- Term: Ischemia
- ID: D000010335
- Term: Pathologic Processes
- ID: D000012883
- Term: Skin Ulcer
- ID: D000012871
- Term: Skin Diseases
- ID: D000058729
- Term: Peripheral Arterial Disease
- ID: D000050197
- Term: Atherosclerosis
- ID: D000001161
- Term: Arteriosclerosis
- ID: D000001157
- Term: Arterial Occlusive Diseases
- ID: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000016491
- Term: Peripheral Vascular Diseases
- ID: D000002908
- Term: Chronic Disease
- ID: D000020969
- Term: Disease Attributes
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M10543
- Name: Ischemia
- 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: M29213
- Name: Peripheral Arterial Disease
- Relevance: LOW
- As Found: Unknown
- ID: M18894
- Name: Peripheral Vascular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M2714
- Name: Chronic Limb-Threatening Ischemia
- Relevance: HIGH
- As Found: Chronic Limb-Threatening Ischemia
- ID: M10883
- Name: Leg Ulcer
- Relevance: HIGH
- As Found: Leg Ulcers
- ID: M15686
- Name: Skin Ulcer
- Relevance: LOW
- As Found: Unknown
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M26188
- Name: Atherosclerosis
- Relevance: LOW
- As Found: Unknown
- ID: M4469
- Name: Arteriosclerosis
- Relevance: LOW
- As Found: Unknown
- ID: M4465
- Name: Arterial Occlusive Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6147
- Name: Chronic Disease
- Relevance: LOW
- As Found: Unknown
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000089802
- Term: Chronic Limb-Threatening Ischemia
- ID: D000007871
- Term: Leg Ulcer
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06421948
**Brief Title:** Linperlisib Combined With Chidamide in Patients With PTCL
**Official Title:** PI3Kδ Inhibitor Linperlisib Combined With HDAC Inhibitor Chidamide Versus CHOP in Patients With Peripheral T-cell Lymphoma: a Multicenter, Open Label, Phase Ib/II Study
#### Organization Study ID Info
**ID:** HNSZLYYML08
#### Organization
**Class:** OTHER_GOV
**Full Name:** Henan Cancer Hospital
### Status Module
#### Completion Date
**Date:** 2026-05-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-14
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-01-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-06
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER_GOV
**Name:** Yanyan Liu
#### Responsible Party
**Investigator Affiliation:** Henan Cancer Hospital
**Investigator Full Name:** Yanyan Liu
**Investigator Title:** Professor
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** The goal of this clinical trial is to determine the maximum tolerated dose (MTD) of PI3Kδ inhibitor linperlisib when combined with fixed dose of HDAC inhibitor chidamide in participants with peripheral T-cell lymphoma (PTCL), and to compare the combination of linperlisib and chidamide to standard CHOP (cyclophosphamide, doxorubicin/epirubicin, vincristine, and prednisone) regimen chemotherapy in the frontline treatment of PTCL to see which therapy is better.
**Detailed Description:** In the phase Ib trial, participants with newly diagnosed or relapsed/refractory PTCL will receive fixed dose of chidamide (20 mg, twice a week) and escalating dose of linperlisib (40 mg, 60 mg, or 80 mg, once a day), to find out the optimal dose of linperlisib.
In the phase II trial, participants with newly diagnosed PTCL will be randomized into experimental arm (arm A) to receive linperlisib in combination with chidamide, or control arm (arm B) to receive standard CHOP regimen chemotherapy.
Interim efficacy assessment will be performed after three cycles of treatment. Responded participants will receive another three cycles of treatment. After a total of 6 cycles of treatment, participants can choose autologous hematopoietic stem cell transplantation, maintenance treatment with linperlisib and/or chidamide, or watch and wait.
### Conditions Module
**Conditions:**
- Peripheral T-cell Lymphoma
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 100
**Type:** ESTIMATED
**Phases:**
- PHASE1
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants will receive a combination of linperlisib in combination with chidamide orally.
**Intervention Names:**
- Drug: Linperlisib and chidamide
**Label:** Orally administered, targeted therapy
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants will receive standard CHOP regimen chemotherapy including cyclophosphamide, doxorubicin/epirubicin, vincristine, and prednisone.
**Intervention Names:**
- Drug: cyclophosphamide, doxorubicin/epirubicin, vincristine, and prednisone
**Label:** Intravenously chemotherapy
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Orally administered, targeted therapy
**Description:** A combination of linperlisib and chidamide will be administered for 6 cycles in patients responded to treatment.
**Name:** Linperlisib and chidamide
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Intravenously chemotherapy
**Description:** A combination of cyclophosphamide, doxorubicin/epirubicin, vincristine, and prednisone (CHOP) will be administered for 6 cycles in patients responded to treatment.
**Name:** cyclophosphamide, doxorubicin/epirubicin, vincristine, and prednisone
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Complete response rate
**Measure:** CRR
**Time Frame:** Through study completion, an average of 3 years
#### Secondary Outcomes
**Description:** Progression-free survival
**Measure:** PFS
**Time Frame:** 12 months
**Description:** Overall survival
**Measure:** OS
**Time Frame:** 12 months
**Description:** Adverse event
**Measure:** AE
**Time Frame:** Through study completion, an average of 3 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age 18-75 years at the time of inclusion (Age 18-80 years for phase Ib study)
* Patients with a newly diagnosed and histologically confirmed PTCL (phase Ib study includes both newly diagnosed and relapsed/refractory PTCL). Anaplastic large cell lymphoma and NK/T-cell lymphoma are not included.
* ECOG PS 0-2 at protocol entry
* Estimated life expectancy of 6 months or longer
* Measurable disease
* Hemoglobin ≥ 8 g/dL (≥5 mmol/l); Platelets ≥ 75 x 10E9/L; Absolute neutrophil count ≥ 1.0 x 10E9/L; Platelets ≥ 50 x 10E9/L permitted if documented bone marrow involvement; Serum bilirubin ≤ 1.5 x upper limit of normal (ULN); Serum glutamic-oxaloacetic transaminase (AST) and/or serum glutamic-pyruvic transaminase (ALT) ≤ 2.5 x ULN, or ≤ 5 x ULN if elevation is due to hepatic involvement by lymphoma; Serum creatinine ≤ 1.5 x ULNb; left ventricular ejection fraction (LVEF) ≥ 50%
* Women of childbearing potential must use safe anticonception (e.g. contraceptive pills, intrauterine devices etc.) during the study and 12 months after the last administration of study drugs; Male patients must use contraception for the duration of the study and 6 months after the last administration of study drugs if his partner is of childbearing potential
* Written informed consent
Exclusion Criteria:
* Patients previously treated with PI3K inhibitor
* Patients previously treated with chidamide (phase Ib study is not limited by this item)
* Suspected or documented central nervous system involvement by lymphoma
* Patients with positive HIV and/or active hepatitis B and/or hepatitis C infection
* Patients with active, uncontrolled infections
* Unwillingness or inability to comply with the protocol
* Deemed 'unfit' by the treating physician
* Pregnant and/or breastfeeding women
* Concurrent severe and/or uncontrolled medical disease which is not lymphoma-related
* Patients with contraindications to chemotherapy
* Known hypersensitivity to one or more of the study drugs
**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:** Yanyan Liu
**Phone:** 86 037165587791
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Zheng Yan
**Phone:** 86 13598097015
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Zhengzhou
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Yanyan Liu
- **Phone:** 86-037165587791
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Zheng Yan
- **Phone:** 86+13598097015
- **Role:** CONTACT
**Country:** China
**Facility:** Affiliated Cancer Hospital of Zhengzhou University
**State:** Henan
**Status:** RECRUITING
**Zip:** 450008
#### Overall Officials
**Official 1:**
**Affiliation:** A
**Name:** Yanyan Liu
**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: D000008228
- Term: Lymphoma, Non-Hodgkin
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC15
- Name: Blood and Lymph Conditions
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M11220
- Name: Lymphoma
- Relevance: HIGH
- As Found: Lymphoma
- ID: M18829
- Name: Lymphoma, T-Cell
- Relevance: HIGH
- As Found: T-cell Lymphoma
- ID: M18833
- Name: Lymphoma, T-Cell, Peripheral
- Relevance: HIGH
- As Found: Peripheral T-cell Lymphoma
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
- ID: M11225
- Name: Lymphoproliferative Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M11203
- Name: Lymphatic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10206
- Name: Immunoproliferative Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M11222
- Name: Lymphoma, Non-Hodgkin
- Relevance: LOW
- As Found: Unknown
- ID: T3543
- Name: Lymphosarcoma
- Relevance: LOW
- As Found: Unknown
- ID: T4496
- Name: Peripheral T-cell Lymphoma
- Relevance: HIGH
- As Found: Peripheral T-cell Lymphoma
### Condition Browse Module - Meshes
- ID: D000008223
- Term: Lymphoma
- ID: D000016399
- Term: Lymphoma, T-Cell
- ID: D000016411
- Term: Lymphoma, T-Cell, Peripheral
### Intervention Browse Module - Ancestors
- ID: 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: 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: ANeo
- Name: Antineoplastic Agents
- Abbrev: ARhu
- Name: Antirheumatic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Infl
- Name: Anti-Inflammatory Agents
- Abbrev: Infe
- Name: Anti-Infective Agents
### Intervention Browse Module - Browse Leaves
- ID: M6727
- Name: Cyclophosphamide
- Relevance: HIGH
- As Found: Cycle
- ID: M14121
- Name: Prednisone
- Relevance: HIGH
- As Found: Outcomes
- ID: M7492
- Name: Doxorubicin
- Relevance: HIGH
- As Found: Cognitive
- ID: M227339
- Name: Liposomal doxorubicin
- Relevance: LOW
- As Found: Unknown
- ID: M17495
- Name: Vincristine
- Relevance: HIGH
- As Found: Volume
- ID: M17954
- Name: Epirubicin
- Relevance: HIGH
- As Found: Questions
- ID: M28511
- Name: Histone Deacetylase 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: 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: 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: D000004317
- Term: Doxorubicin
- ID: D000014750
- Term: Vincristine
- ID: D000015251
- Term: Epirubicin
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06421935
**Brief Title:** M9466 as Single Agent or in Combination With Tuvusertib in Advanced Solid Tumors (DDRiver 501)
**Official Title:** An Open Label, Multicenter, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Profile of the PARP1 Inhibitor M9466 as a Single Agent and in Combination With the ATR Inhibitor Tuvusertib in Participants With Advanced Solid Tumors (DDRiver 501)
#### Organization Study ID Info
**ID:** MS202659_0001
#### Organization
**Class:** INDUSTRY
**Full Name:** EMD Serono
#### Secondary ID Infos
**Domain:** EU CTR
**ID:** 2024-513492-41-00
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2026-03-26
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-14
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-03-09
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** Merck KGaA, Darmstadt, Germany
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** EMD Serono Research & Development Institute, Inc.
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
### Description Module
**Brief Summary:** The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamic, and preliminary clinical activity of M9466 as monotherapy or in combination with tuvusertib in participants with advanced solid tumors. Study details include: Study/Treatment Duration: Participants will be treated until disease progression, death, discontinuation, or End of Study. Visit Frequency: Every week in the first 2 cycles, followed by every 3 weeks in the subsequent cycles. An End of Treatment Visit and Safety Follow-up/Discontinuation Visit are scheduled after the treatment period.
### Conditions Module
**Conditions:**
- Advanced Solid Tumor
**Keywords:**
- PARP inhibitor
- castration-resistant prostate cancer
- ovarian cancer
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 70
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Drug: M9466
- Drug: Tuvusertib
**Label:** M9466 plus Tuvusertib
**Type:** EXPERIMENTAL
#### Arm Group 2
**Intervention Names:**
- Drug: M9466
**Label:** M9466 Monotherapy
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- M9466 Monotherapy
- M9466 plus Tuvusertib
**Description:** Participants will be administered M9466 orally.
**Name:** M9466
**Other Names:**
- HRS-1167;
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- M9466 plus Tuvusertib
**Description:** Participants will be administered Tuvusertib orally.
**Name:** Tuvusertib
**Other Names:**
- Substance code MSC2584415A; also known as M1774, VXc-400, or VR 1363004
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Measure:** Module 1 Part A1: Number of Participants With Treatment-Emergent Adverse Events (TEAE), and Treatment-related AEs
**Time Frame:** Time from first treatment up to 30 days after end of study intervention (approximately assessed up to 20 months)
**Measure:** Module 1 Part A1: Number of Participants with Dose Limiting Toxicity (DLT)-like events
**Time Frame:** Day 1 up to Day 21 of Cycle 1 (each cycle is of 21 days)
**Measure:** Module 2 Part A1: Pharmacokinetic (PK) Plasma Concentrations of M9466
**Time Frame:** Day 1, Day 8 and Day 15
#### Secondary Outcomes
**Measure:** Module 1 Part A1: Pharmacokinetic (PK) Plasma Concentrations of M9466 and Tuvusertib
**Time Frame:** Day 1, Day 8 and Day 15
**Measure:** Module 1 Part A1: Objective Response (OR) According to Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 as Assessed by Investigator
**Time Frame:** Time from first treatment to planned assessment at 12 months
**Measure:** Module 1 Part A1: Effect of M9466 in combination with tuvusertib on QTc interval as determined by Digital ECGs
**Time Frame:** Time from first treatment to planned assessment at 12 months
**Measure:** Module 2 Part A1: Number of Participants With Treatment-Emergent Adverse Events (TEAE), and Treatment-Related AEs
**Time Frame:** Time from first treatment up to 30 days after end of study intervention (approximately assessed up to 20 months)
**Measure:** Module 2 Part A1: Number of Participants with Abnormalities in Digital Electrocardiogram (ECG) Measures
**Time Frame:** Time from first treatment up to 30 days after end of study intervention (approximately assessed up to 20 months)
**Measure:** Module 2 Part A1: Pharmacokinetic (PK) Plasma Concentrations of M9466 and Tuvusertib
**Time Frame:** Day 1, Day 8 and Day 15
**Measure:** Module 2 Part A1: Relative Changes in Pharmacodynamic Markers In Paired Tumor Biopsies
**Time Frame:** Day 1, Day 8 and Day 15
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Module 1 Part A1 and Module 2 Part A1: Locally advanced or metastatic disease that is refractory to standard therapy or for which no standard therapy is judged appropriate by the Investigator
* Eastern Cooperative Oncology Group Performance Status less than or equal to (\<=) 1
* Life expectancy of more than 6 months
* Have adequate hematologic function
* Participants who received chemotherapy, extensive radiotherapy, biological therapy (e.g. antibodies) or investigational agents will have a washout period of 4 weeks (6 weeks for nitrosourea, mitomycin-C) or 5 half-lives whichever is shorter, prior to starting study intervention with M9466 (± tuvusertib)
* Other protocol defined inclusion criteria could apply
Exclusion Criteria:
* Persistence of Adverse Events related to any prior treatments that have not recovered to Grade less than 1 by NCI Common Terminology Criteria for Adverse Events- v5.0 unless AEs are clinically nonsignificant and/or stable on supportive therapy in the opinion of the Investigator (e.g. neuropathy or alopecia)
* Participant has a history of malignancy within 5 years before the date of enrollment (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, benign prostate neoplasm/hypertropia, or malignancy that in the opinion of the Investigator, with concurrence of the Sponsor's Medical Monitor, is considered cured with minimal risk of recurrence within 3 years)
* Participants with known brain metastases, except if clinically controlled, which is defined as individuals with Central Nervous System (CNS) tumors that have been treated, are asymptomatic and who have discontinued steroids (for the treatment of CNS tumors) for more than 28 days
* Serious Gastrointestinal bleeding within 3 months, refractory nausea and vomiting, uncontrolled diarrhea, known malabsorption, significant small bowel resection or gastric bypass surgery, use of feeding tubes, other chronic gastrointestinal disease (including exocrine pancreatic insufficiency requiring pancreatic enzyme replacement therapy), and/or other situations that may preclude adequate absorption of oral medications
* Cerebrovascular accident or stroke
* Other protocol defined exclusion criteria could apply
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** US Medical Information
**Phone:** 888-275-7376
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Communication Center
**Phone:** +49 6151 72 5200
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Rockland
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Please Contact U.S. Medical Information
- **Phone:** 888-275-7376
- **Role:** CONTACT
**Country:** United States
**Facility:** Please Contact U.S. Medical Information
**State:** Massachusetts
**Zip:** 02370
**Location 2:**
**City:** Darmstadt
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Please Contact the Communication Center
- **Phone:** +49 6151 72 5200
- **Role:** CONTACT
**Country:** Germany
**Facility:** Please Contact the Communication Center
**Zip:** 64293
#### Overall Officials
**Official 1:**
**Affiliation:** EMD Serono Research & Development Institute, Inc.
**Name:** Medical Responsible
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**Description:** We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and the European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21
**IPD Sharing:** NO
### References Module
#### See Also Links
**Label:** Trial Awareness and Transparency website
**URL:** https://clinicaltrials.emdgroup.com/en
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M12974
- Name: Ovarian Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M14335
- Name: Prostatic Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M1704
- Name: Carcinoma, Ovarian Epithelial
- Relevance: LOW
- As Found: Unknown
- ID: T4352
- Name: Ovarian Cancer
- Relevance: LOW
- As Found: Unknown
- ID: T4354
- Name: Ovarian Epithelial Cancer
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000009369
- Term: Neoplasms
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M205
- Name: Poly(ADP-ribose) Polymerase Inhibitors
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06421922
**Brief Title:** Effect of Different Dietary Therapies on Intestinal Barrier Integrity in Patients With Irritable Bowel Syndrome
**Official Title:** The Effects of Supplementation of Diet With Fiber or Probiotic Yogurt on the Intestinal Barrier Integrity in Individuals With Constipation-predominant Irritable Bowel Syndrome
#### Organization Study ID Info
**ID:** 50687469-799
#### Organization
**Class:** OTHER_GOV
**Full Name:** Gulhane Training and Research Hospital
#### Secondary ID Infos
**Domain:** TUEK
**ID:** 50687469-799
**Type:** OTHER_GRANT
### Status Module
#### Completion Date
**Date:** 2020-06-07
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2019-10-15
**Type:** ACTUAL
#### Start Date
**Date:** 2019-06-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-08
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER_GOV
**Name:** Gulhane Training and Research Hospital
#### Responsible Party
**Investigator Affiliation:** Gulhane Training and Research Hospital
**Investigator Full Name:** Emine Nuket Unsal
**Investigator Title:** PhD, Dietitian, Head of Clinical Nutrition Department
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This study aims to evaluate the effects of different dietary treatments on intestinal integrity in female subjects aged 19-50 years previously diagnosed with constipation-predominant irritable bowel syndrome (IBS). At the Gülhane Training and Research Hospital's gastroenterology clinic in Ankara, Turkey, a randomized controlled experiment was carried out. 60 individuals with IBS were randomly divided into three groups. Group 1 was assigned to a regular constipation diet, group 2 to a constipation diet rich in soluble fibers, and group 3 to a constipation diet with probiotic yogurt supplementation. Every individual was monitored for eight weeks. Plasma zonulin level was used to measure intestinal integrity both before and after treatment.
**Detailed Description:** This was a non-pharmacological randomized controlled trial conducted at Ankara Gülhane Training and Research Hospital Gastroenterology Polyclinic between June 2019 and March 2020. Participants of this study were women aged 19 to 50 years with a diagnosis of IBS according to the Rome IV criteria (2017).
The sample size was calculated with G\*Power software. With an estimated power of 90%, a Type I error of 0.05, and an effect size of f=0.25, the total sample size required was 54, consisting of 18 participants in each group. The sample size was calculated using G\*Power software. The total sample size, with an estimated strength of 90%, Type I error of 0.05, and effect size f = 0.25, was 54, consisting of 18 participants in each group. 60 participants were targeted due to compensation for potential drop-out from protocol.
Using random assignment software, participants were divided into three groups at random for parallel group randomized trials. Group 1 received a standard constipation diet; Group 2 received a soluble fiber-rich constipation diet; and Group 3 received a probiotic yogurt-supplemented constipation diet. The three groups-regular constipation diet, constipation diet high in soluble fiber, and constipation diet fortified with probiotic yogurt-were coded R 1-2, F 1-2, and P 1-2 to protect patient confidentiality. Twice a week, two liters of water, two servings of vegetables, and three servings of fruits, and legumes were the staples of the constipation diet. For the first four weeks, Group 2's constipation diet included 1 sachet of soluble fiber (resistant starch) (5 g/day), and in the second week, 2 sachets of soluble fiber (10 g/day) were added. It happens after four weeks. In Group 3, the yogurt ingested before lunch was supplemented with the IBS-specific strain "Bifidobacterium Infantis 35624 (B. Infantis 35624)". For eight weeks, there was a follow-up.
All data were collected by face-to-face survey method. At the first visit, sociodemographic characteristics and three-day food consumption were recorded. Food consumption was recorded for 3 days, 2 days on weekdays, and 1 day on weekends. Serum Zonulin level and biochemical tests were evaluated at the beginning of the diet and the 8th week. Serum Zonulin level was measured using the "BT Lab Human Zonulin ELISA Kit" (China, E1117). Daily energy and nutrient amounts taken from the diet were analyzed using the Nutrition Information System 8 (BeBis 8) computer package program.
IBM SPSS Statistics 22.00 program was used to analyze the data obtained. The normal distribution of the data was evaluated with the Shapiro-Wilk test. To increase clarity and ensure consistency with other studies, continuous variables are presented as mean ± standard deviation. Spearman rank correlation coefficients are a way to represent correlations between continuous variables. Analysis of variance or the Kruskal Wallis test was used to compare groups. Wilcoxon signed-rank test was used to compare groups within the same group from baseline to week eight. The significance threshold of p\<0.05 was determined.
### Conditions Module
**Conditions:**
- Irritable Bowel Syndrome-IBS
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 60
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Group 1 received a regular constipation diet (n=21)
**Intervention Names:**
- Dietary Supplement: Group 1 received a regular constipation diet
**Label:** Group 1-regular constipation diet
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** group 2 received a constipation diet rich in soluble fiber (n=17)
**Intervention Names:**
- Dietary Supplement: Group 2 received a constipation diet rich in soluble fiber
**Label:** Group 2-soluble fiber
**Type:** ACTIVE_COMPARATOR
#### Arm Group 3
**Description:** group 3 received a constipation diet with added probiotic yogurt (n=22).
**Intervention Names:**
- Dietary Supplement: Group 3 received a constipation diet supplemented with probiotic yogurt.
**Label:** Group 3-probiotic yogurt
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Group 1-regular constipation diet
**Description:** Group 1 received only regular constipation diet, the constipation diet included 2 litres of water, 2 portions of vegetables, 3 portions of fruits and legumes 2 times a week. Followed 8 weeks.
**Name:** Group 1 received a regular constipation diet
**Type:** DIETARY_SUPPLEMENT
#### Intervention 2
**Arm Group Labels:**
- Group 2-soluble fiber
**Description:** Soluble fiber (resistant starch) (5 g/day) was added to the constipation diet in group 2 as 1 sachet/day (5 g/day) during the initial 4 weeks and 2 sachets/day (10 g/day) in the following 4 weeks.
**Name:** Group 2 received a constipation diet rich in soluble fiber
**Type:** DIETARY_SUPPLEMENT
#### Intervention 3
**Arm Group Labels:**
- Group 3-probiotic yogurt
**Description:** "Bifidobacterium İnfantis 35624 (B. İnfantis 35624)\" strain, which is specific to IBS, was added to yogurt in group 3, consumed before the lunch. The follow-up period was 8 weeks.
**Name:** Group 3 received a constipation diet supplemented with probiotic yogurt.
**Type:** DIETARY_SUPPLEMENT
### Outcomes Module
#### Primary Outcomes
**Description:** The primary outcome was the change in blood Zonulin level after adding probiotic yogurt to a regular constipation diet instead of soluble fiber. Serum zonulin levels were analysed to evaluate the effect of dietary compliance on intestinal barrier integrity. Lower serum zonulin levels indicate a better intestinal barrier integrity.
**Measure:** Serum Zonulin level
**Time Frame:** 0-8 weeks
#### Secondary Outcomes
**Description:** The secondary outcomes were changes in fasting blood glucose, cholesterol, blood triglyceride, LDL cholesterol and CRP levels after adding probiotic yogurt to a regular constipation diet instead of soluble fiber.
**Measure:** Other biomarkers (fasting blood glucose, cholesterol, blood triglyceride, LDL cholesterol and CRP)
**Time Frame:** 0-8 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Women aged 19-50 years who were diagnosed with IBS according to Rome IV criteria
* Any metabolic disease (diabetes, heart disease, etc.), cancer and autoimmune no history of chronic diseases such as illness
* Not being pregnant or lactating
* Body mass index (BMI) of 18.5-29.9 kg/m2
Exclusion Criteria:
* Chronic disease history such as cancer and autoimmune diseases
* Probiotics use or nutritional supplement use (vitamins, minerals) in the last 6 months.
* Pregnancy.
**Gender Based:** True
**Maximum Age:** 50 Years
**Minimum Age:** 19 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Ankara
**Country:** Turkey
**Facility:** GulhaneTRH
**State:** Keçiören
**Zip:** 06010
#### Overall Officials
**Official 1:**
**Affiliation:** Gulhane Training and Research Hospital
**Name:** Emine Nuket Unsal, Phd
**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: D000003109
- Term: Colonic Diseases, Functional
- ID: D000003108
- Term: Colonic Diseases
- ID: D000007410
- Term: Intestinal Diseases
- ID: D000005767
- Term: Gastrointestinal Diseases
- ID: D000004066
- Term: Digestive System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC06
- Name: Digestive System Diseases
### Condition Browse Module - Browse Leaves
- ID: M16355
- Name: Syndrome
- Relevance: HIGH
- As Found: Syndrome
- ID: M6472
- Name: Constipation
- Relevance: LOW
- As Found: Unknown
- ID: M25118
- Name: Irritable Bowel Syndrome
- Relevance: HIGH
- As Found: Irritable Bowel Syndrome
- ID: M6336
- Name: Colonic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6337
- Name: Colonic Diseases, Functional
- Relevance: LOW
- As Found: Unknown
- ID: M10444
- Name: Intestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000043183
- Term: Irritable Bowel Syndrome
- ID: D000013577
- Term: Syndrome
### Intervention Browse Module - Browse Branches
- Abbrev: Ot
- Name: Other Dietary Supplements
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: T367
- Name: Bifidobacterium
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06421909
**Acronym:** mindmenopaus
**Brief Title:** Mindfulness-based Educational Intervention on Anxiety, Depression, Stress and Quality of Life on Menopausal Woman
**Official Title:** Effect of Mindfulness-based Educational Intervention on Anxiety, Depression, Stress and Quality of Life on Menopausal Woman.
#### Organization Study ID Info
**ID:** 99-b
#### Organization
**Class:** OTHER
**Full Name:** Alexandria University
### Status Module
#### Completion Date
**Date:** 2024-08-28
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-15
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-06-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-04-18
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Alexandria University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Mindfulness-based educational intervention is a structured program that incorporates principles of mindfulness to help individuals develop greater awareness and acceptance of their thoughts, feelings, and bodily sensations. The intervention typically includes mindfulness meditation practices, cognitive-behavioral techniques, and educational components about stress management and emotional regulation. By fostering a non-judgmental and present-focused attitude, participants learn to manage their symptoms more effectively and improve their overall quality of life.
**Detailed Description:** Menopause is a significant transitional phase in a woman's life, often accompanied by various physical, emotional, and psychological challenges. Common issues during menopause include anxiety, depression, stress, and a decreased quality of life. Addressing these concerns holistically is crucial for improving overall well-being. Mindfulness-based educational interventions have gained recognition for their effectiveness in enhancing mental health and quality of life by promoting awareness and acceptance of present experiences. This study investigates the impact of a mindfulness-based educational intervention on anxiety, depression, stress, and quality of life in menopausal women.
### Conditions Module
**Conditions:**
- Menopause
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 120
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Behavioral: mindfulness-based educational intervention
**Label:** mindfulness-based educational intervention group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Label:** non-intervention group
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- mindfulness-based educational intervention group
**Description:** Mindfulness-based educational intervention is a structured program that incorporates principles of mindfulness to help individuals develop greater awareness and acceptance of their thoughts, feelings, and bodily sensations. The intervention typically includes mindfulness meditation practices, cognitive-behavioral techniques, and educational components about stress management and emotional regulation. By fostering a non-judgmental and present-focused attitude, participants learn to manage their symptoms more effectively and improve their overall quality of life.
**Name:** mindfulness-based educational intervention
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Measure:** menopausal women who participate in the mindfulness-based educational intervention will experience significant reductions in anxiety inventory score ( total score range from 10 to 50, a lower score of less than 20) than those who not entered
**Time Frame:** three months
#### Secondary Outcomes
**Measure:** menopausal women who participate in the mindfulness-based educational intervention will experience reductions in stress scale score ( total score range from 10 to 50, a lower score of less than 20) than those who not entered
**Time Frame:** three months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* in age of menopause
Exclusion Criteria:
* age of menarche
* older than 70 years old
**Healthy Volunteers:** True
**Maximum Age:** 70 Years
**Minimum Age:** 50 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Alexandria
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** mohamed H atta
- **Phone:** 2026609088
- **Role:** CONTACT
**Country:** Egypt
**Facility:** Alexandria university
**State:** Al Iskandariyah
**Status:** RECRUITING
**Zip:** 21913
## 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: M7061
- Name: Depressive Disorder
- Relevance: LOW
- As Found: Unknown
- ID: M7058
- Name: Depression
- Relevance: LOW
- As Found: Unknown
- ID: M4324
- Name: Anxiety Disorders
- Relevance: LOW
- As Found: Unknown
- ID: T6034
- Name: Quality of Life
- Relevance: HIGH
- As Found: Quality of Life
- ID: T6036
- Name: Menopause
- Relevance: HIGH
- As Found: Menopause
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06421896
**Acronym:** METgeriatri
**Brief Title:** Motivational Enhancement Therapy's Impact on d COPD Outcomes in Geriatric Patient
**Official Title:** Exploring the Motivational Enhancement Therapy's Impact on Motivation, Resilience, Anxiety Reduction, and COPD Outcomes in Geriatric Patient
#### Organization Study ID Info
**ID:** 85-a
#### Organization
**Class:** OTHER
**Full Name:** Alexandria University
### Status Module
#### Completion Date
**Date:** 2024-10-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-15
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-09-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Alexandria 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:** Motivational Enhancement Therapy (MET) is a systematic intervention that focuses on eliciting and strengthening a person's intrinsic motivation to change. MET is rooted in motivational interviewing principles, emphasizing empathy, autonomy, and the evocation of the patient's own motivations for change. The therapy typically involves several sessions where therapists help patients identify personal goals, explore ambivalence towards change, and develop actionable plans to achieve their desired outcomes.
**Detailed Description:** Chronic Obstructive Pulmonary Disease (COPD) is a leading cause of morbidity and mortality worldwide, particularly among the elderly. Managing COPD effectively in geriatric patients requires addressing not only the physiological aspects of the disease but also the psychological and motivational factors that can influence treatment adherence and overall well-being. Motivational Enhancement Therapy (MET) is a counseling approach designed to help individuals enhance their motivation to change and engage in healthier behaviors. This study explores the impact of MET on motivation, resilience, anxiety reduction, and COPD outcomes in geriatric patients.
### Conditions Module
**Conditions:**
- COPD
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 100
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** COPD geriatric patients who receive motivational Enhancement Therapy
**Intervention Names:**
- Behavioral: motivational Enhancement Therapy
**Label:** experimental group: geriatric who receive motivational Enhancement Therapy
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** COPD geriatric patients who don't receive motivational Enhancement Therapy
**Label:** non- experimental group
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- experimental group: geriatric who receive motivational Enhancement Therapy
**Description:** Motivational Enhancement Therapy (MET) is a systematic intervention that focuses on eliciting and strengthening a person's intrinsic motivation to change. MET is rooted in motivational interviewing principles, emphasizing empathy, autonomy, and the evocation of the patient's own motivations for change. The therapy typically involves several sessions where therapists help patients identify personal goals, explore ambivalence towards change, and develop actionable plans to achieve their desired outcomes.
**Name:** motivational Enhancement Therapy
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** primary objective
**Measure:** COPD geriatric patients who entered motivational Enhancement Therapy will demonstrate a higher score in resilience scale ( ( total score range from 15 to 75, a higher score of more than 50)than those who not entered
**Time Frame:** three months
#### Secondary Outcomes
**Description:** secondary
**Measure:** OPD geriatric patients who entered motivational Therapy will demonstrate a lower score in anxiety inventory ( total score range from 10 to 50, a lower score of more than 20)than those who not entered
**Time Frame:** three months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* more than 60 years
Exclusion Criteria:
* more than 80 years
**Maximum Age:** 80 Years
**Minimum Age:** 60 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Alexandria
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** mohamed H atta
- **Phone:** 2026609088
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Phone Ext:** atta
- **Role:** CONTACT
***Contact 3:***
- **Name:** mohamed H atta
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Egypt
**Facility:** Alexandria university
**State:** Al Iskandariyah
**Status:** RECRUITING
**Zip:** 21913
### 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: M4324
- Name: Anxiety Disorders
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06421883
**Acronym:** probiotic
**Brief Title:** Study the Effect of Probiotic Supplementation on Trimethylamine-N-Oxide Plasma Level in Hemodialysis Patients
**Official Title:** The Potential Impact of Probiotic Supplementation on Trimethylamine-N-Oxide Plasma Level in End Stage Renal Disease Patients Undergoing Hemodialysis
#### Organization Study ID Info
**ID:** Interventional clinical trial
#### Organization
**Class:** OTHER
**Full Name:** Al-Azhar University
### Status Module
#### Completion Date
**Date:** 2024-10-15
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-17
**Overall Status:** ENROLLING_BY_INVITATION
#### Primary Completion Date
**Date:** 2024-06-15
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-03-15
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Al-Azhar University
#### Responsible Party
**Investigator Affiliation:** Al-Azhar University
**Investigator Full Name:** Nehal Kamal Bazid
**Investigator Title:** Principal investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** The goal of this clinical trial is to learn if probiotic has an effect on Trimethylamine-N-Oxide Plasma Level in plasma, which represent strong risk factor for Atherosclerosis in end stage renal disease patients who undergoing hemodialysis the main questions to answer are : Does probiotic lower Trimethylamine-N-Oxide concentration? does probiotic participating in decreasing risk of atherosclerosis in end stage renal disease patients undergoing hemodialysis ? research will compare between patients who are taking probiotic and control group (taking no drug) participants will take probiotic for 3 months visit the clinic once every 2 weeks for checkups and tests
All Patients will be subjected to the following:
1. Informed consent.
2. Demographics and history taking: Using Patient Data sheet.
3. Laboratory evaluation including:
Kidney function tests: blood urea,serum creatinine, albumin ,uric acid. Complete blood count (CBC).
C-reactive protein (CRP).
**Detailed Description:** Chronic Kidney Disease (CKD) is considered as a major public health problem as it can lead to end-stage kidney failure, which requires replacement therapy. A prompt and accurate diagnosis, along with the appropriate treatment, can delay CKD's progression End-stage renal disease (ESRD) is associated with significant alterations in cardiovascular function; homeostasis of body fluid, electrolytes, and acid-base equilibrium; bone metabolism, erythropoiesis; and blood coagulation. The prevalence of ESRD is increasing rapidly worldwide, as is the number of patients requiring surgery under general anesthesia. Patients with ESRD have significantly higher risks of perioperative morbidity and mortality due to multiple comorbidities Trimethylamine N-oxide (TMAO) is a gut microbiota metabolite derived from trimethylamine containing nutrient precursors such as choline, L-carnitine, and betaine. An increasing number of clinical studies have demonstrated a strong relationship between elevated plasma TMAO levels and adverse cardiovascular events. It is commonly agreed that TMAO acts as both an independent risk factor and a prognostic index for patients with cardiovascular disease , TMAO is considered as a potential biomarker and/or therapeutic target for diagnosis and treatment of patients with cardiovascular disease Probiotic work as antagonist for those strains which are responsible for the synthesis of TMAO precursor molecules in the gut and modulate miRNAs associated with the genes which are responsible for TMA lyases and ultimately play a role in conversion of diet precursor into TMA Control group: 40 patients will receive their standard therapy only. Intervention group (probiotic group): 40 patients will receive probiotic 5 billion unit per day with their standard therapy for 3 months
### Conditions Module
**Conditions:**
- End Stage Renal Disease
**Keywords:**
- hemodialysis
- probiotic
- Trimethylamine-N-Oxide
- TMAO
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Patients will be randomized into two groups each group includes 40 patients:
Control group: 40 patients will receive their standard therapy only. Intervention group (probiotic group): 40 patients will receive probiotic 5 billion unit per day with their standard therapy for 3 months.
##### Masking Info
**Masking:** NONE
**Masking Description:** (Open Label)
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 80
**Type:** ESTIMATED
**Phases:**
- PHASE2
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Experimental probiotic group patients will receive probiotic 5 billion unit per day with their standard therapy collect blood sample and measure TMAO at baseline and after 3 months
**Intervention Names:**
- Dietary Supplement: Lactobacillus containing probiotic
**Label:** Experimental probiotic group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** No Intervention: control group patients will receive their standard therapy only collect blood sample and measure TMAO at baseline and after 3 months
**Label:** control group
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Experimental probiotic group
**Description:** Patients will be randomized into two groups each group includes 40 patients:
Control group: 40 patients will receive their standard therapy only. Intervention group (probiotic group): 40 patients will receive probiotic 5 billion unit per day with their standard therapy for 3 months.
**Name:** Lactobacillus containing probiotic
**Other Names:**
- probiotic
**Type:** DIETARY_SUPPLEMENT
### Outcomes Module
#### Primary Outcomes
**Description:** probiotic is expected to lower Trimethylamine-N-Oxide Plasma Level in dialysis patients
**Measure:** change in Trimethylamine-N-Oxide Plasma Level
**Time Frame:** 3 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients who diagnosed as End Stage Renal Disease with hemodialysis
* Aged 18 years or older.
* Both sexes.
* No known contraindications to therapy with probiotic
* Patients who accept to participate in the study.
Exclusion Criteria:
* Pregnant and breast-feeding women
* History of severe allergic reactions to the study medication.
* Current medication regimen including probiotic
* chronic liver disease
* Patients receiving chronic anti-inflammatory therapy
* Non-compliant patients: those who did not adhere to the medications during the study.
**Maximum Age:** 60 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Cairo
**Country:** Egypt
**Facility:** Al Azhar University
### 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: D000051436
- Term: Renal Insufficiency, Chronic
- ID: D000051437
- Term: Renal Insufficiency
- ID: D000002908
- Term: Chronic Disease
- ID: D000020969
- Term: Disease Attributes
- ID: D000010335
- Term: Pathologic Processes
### Condition Browse Module - Browse Branches
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M10698
- Name: Kidney Diseases
- Relevance: HIGH
- As Found: Renal Disease
- ID: M10699
- Name: Kidney Failure, Chronic
- Relevance: HIGH
- As Found: End Stage Renal Disease
- ID: M26718
- Name: Renal Insufficiency
- Relevance: LOW
- As Found: Unknown
- 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: M26717
- Name: Renal Insufficiency, Chronic
- Relevance: LOW
- As Found: Unknown
- ID: M6147
- Name: Chronic Disease
- Relevance: LOW
- As Found: Unknown
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000007674
- Term: Kidney Diseases
- ID: D000007676
- Term: Kidney Failure, Chronic
### Intervention Browse Module - Browse Branches
- Abbrev: Ot
- Name: Other Dietary Supplements
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: T355
- Name: Acidophilus
- Relevance: HIGH
- As Found: Next
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06421870
**Brief Title:** Renoprotective Effects of Dapagliflozin Versus Pentoxiphylline in Chronic Kidney Disease Patients
**Official Title:** Renoprotective Effects of Dapagliflozin Versus Pentoxiphylline in Chronic Kidney Disease Patients
#### Organization Study ID Info
**ID:** MD277/2023
#### Organization
**Class:** OTHER
**Full Name:** Ain Shams University
### Status Module
#### Completion Date
**Date:** 2025-07
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-15
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-05
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-03-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Ain Shams University
#### Responsible Party
**Investigator Affiliation:** Ain Shams University
**Investigator Full Name:** nahla mohamed elsayed teama
**Investigator Title:** Assistant Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Is US Export:** False
### Description Module
**Brief Summary:** Kidneys have a vital role in glucose homeostasis by various mechanisms, one of the major mechanisms is through SGLT2. This role was commonly overlooked till development of the new SGLT2 inhibitors. (Ni, L., et al 2020) The SGLT2 inhibitor class of glucose-lowering agents has recently shown beneficial effects to reduce the onset and progression of renal complications in people with and without diabetes, through slow the decline in glomerular filtration rate (GFR), delaying the onset of microalbuminuria and slow or reverse the progression of proteinuria. (Nespoux, J., \& Vallon, V. 2020) The drug pentoxifylline is a methyl-xanthine derivative and a nonselective phosphodiesterase inhibitor with anti-inflammatory, antiproliferative and antifibrotic actions currently indicated for peripheral artery disease. (Panchapakesan U et al.,2018) Chronic kidney disease is a progressive disorder in which patients are treated according to complications presented such as hypocalcemia, hyperkalemia, anemia and metabolic acidosis.
**Detailed Description:** It is only in recent years that the attention was drawn on the key role of the kidney in glucose homeostasis. Nevertheless, along with the liver, the kidney has a key role in ensuring the energy needs during fasting periods. This organ has a vital role in absorbing the entire quantity of the filtered glucose. Having a glomerular filtration rate of 180 litres per day, it filters approximately 180 grams of glucose per day, bringing its contribution in maintaining normal fasting plasma glucose (FPG) levels. (Cersosimo, E.et al 2014) The reabsorption of glucose is ensured by the sodium-glucose cotransporter (SGLT) 2, responsible for the reabsorption of 90% of glucose, and SGLT1, that reabsorbs the remaining glucose. (Mota, M., et al 2015) Glomerular hyperfiltration is a common pathway of kidney injury both in diabetic and non-diabetic settings and is associated with progression of kidney function decline. (Hoogeveen, E. K. 2022) Sodium-glucose co-transporter-2 (SGLT2) inhibitors are glucose-lowering agents that eliminate excess glucose through a glucosuric effect by reducing glucose reabsorption from the renal filtrate (Thomson, S. C., et al. 2019) It is indicated that the expression of high mobility group box 1 (HMGB1) increased in patients with kidney disease, and may result in renal injury through the activation of nuclear factor- κB (NF- κB) and an increase in receptor for advanced glycation end products (RAGE) expression. It is suggested that Dapagliflozin achieves its reno-protective status through its antioxidative stress and anti-inflammatory action via inhibition of the HMGB1 - RAGE - NF- κB signalling pathway. (Yao, D et al., 2018) SGLT2 is found almost exclusively in the luminal membranes of epithelial cells lining the first and second segments of the proximal tubules, where it mediates reabsorption of most (typically ≥ 90%) of filtered glucose. (Mudaliar S, et al. 2015) By inhibiting SGLT2 beneficial kidney effects are thought to be mediated by various mechanisms, including restoration of tubule-glomerular feedback leading to a reduction in intraglomerular pressure and hyperfiltration. Both conditions are considered core components of the pathophysiology contributing to progression of diabetic as well as nondiabetic CKD. Reductions in intraglomerular pressure, as shown by agents blocking the renin-angiotensin system, are frequently accompanied by a hemodynamic acute decrease in GFR, which is reversible after treatment cessation. (Wanner et al., 2018).
Common drug side effects of dapagliflozin include urinary tract infections, cystitis, hypotension, dehydration and female genital mycotic infections. Hypoglycemic episodes were reported in 6% to 10% of patients who administer dapagliflozin concurrently with insulin and insulin secretagogues. (Anderson SL et al., 2014) Pentoxifylline (PTF) is a synthetic dimethylxanthine derivative that modulates the rheological properties of blood and has both anti-oxidant and anti-inflammatory properties. PTF has been investigated for its possible use in diverse conditions, including osteoradionecrosis, diabetic kidney disease, and generally any condition associated with fibrosis. (Wen WX et al., 2017) PTF reduces levels of inflammatory markers: high-sensitivity C-reactive protein (hs-CRP), serum fibrinogen and TNF-α, this could reduce albuminuria and slow renal disease progression. (de Morales AM et al, 2019)
Thus, we need to evaluate the effect of Dapagliflozin versus Pentoxifylline on GFR among CKD non-diabetic patients.
### Conditions Module
**Conditions:**
- Chronic Kidney Diseases
**Keywords:**
- Dapagliflozin
- Chronic kidney disease
- Pentoxiphylline
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 210
**Type:** ESTIMATED
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** 70 patients will take dapagliflozin 10 mg per day for 1 year in addition to standard management for chronic kidney disease
**Intervention Names:**
- Drug: Dapagliflozin 10mg Tab
**Label:** Dapagliflozin arm
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** 70 patients will take pentoxifylline 400 mg twice daily for 1 year in addition to standard management for chronic kidney disease
**Intervention Names:**
- Drug: Pentoxifylline 400 MG
**Label:** Pentoxiphylline arm
**Type:** ACTIVE_COMPARATOR
#### Arm Group 3
**Description:** 70 patients won't take either dapagliflozin or pentoxiphylline but they will continue their standard management for chronic kidney disease
**Label:** Control
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Dapagliflozin arm
**Description:** Patients will be given dapagliflozin 10 mg once daily
**Name:** Dapagliflozin 10mg Tab
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Pentoxiphylline arm
**Description:** Patients will be given pentoxyifylline 400 mg twice daily
**Name:** Pentoxifylline 400 MG
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** eGFR will be based on serum creatinine and will be calculated by CKD-EPI 2021
**Measure:** Change in estimated glomerular filtration rate
**Time Frame:** 1 year
**Description:** Proteinuria quantification done by urine protein to creatinine ratio
**Measure:** Change in proteinuria
**Time Frame:** 1 year
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* CKD stage 2 and 3
Exclusion Criteria:
* Diabetes mellitus
* History of recurrent or recent genitourinary infections
* Immunosuppressive medications
* Malignancy
**Maximum Age:** 60 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Mohamed A Mohamed, MSc
**Phone:** 1119090018
**Phone Ext:** +20
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Cairo
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Mohamed A Mohamed, MSc
- **Phone:** 1119090018
- **Phone Ext:** +20
- **Role:** CONTACT
**Country:** Egypt
**Facility:** Ain Shams University
**Status:** RECRUITING
**Zip:** 1181
#### Overall Officials
**Official 1:**
**Affiliation:** Ain Shams University
**Name:** Saeed A Saeed, Professor
**Role:** STUDY_DIRECTOR
### References Module
#### References
**Citation:** Ni L, Yuan C, Chen G, Zhang C, Wu X. SGLT2i: beyond the glucose-lowering effect. Cardiovasc Diabetol. 2020 Jun 26;19(1):98. doi: 10.1186/s12933-020-01071-y.
**PMID:** 32590982
**Citation:** Nespoux J, Vallon V. Renal effects of SGLT2 inhibitors: an update. Curr Opin Nephrol Hypertens. 2020 Mar;29(2):190-198. doi: 10.1097/MNH.0000000000000584.
**PMID:** 31815757
**Citation:** Panchapakesan U, Pollock C. Drug repurposing in kidney disease. Kidney Int. 2018 Jul;94(1):40-48. doi: 10.1016/j.kint.2017.12.026. Epub 2018 Apr 6.
**PMID:** 29628139
**Citation:** Cersosimo E, Solis-Herrera C, Triplitt C. Inhibition of renal glucose reabsorption as a novel treatment for diabetes patients. J Bras Nefrol. 2014 Jan-Mar;36(1):80-92. doi: 10.5935/0101-2800.20140014.
**PMID:** 24676619
**Citation:** DeFronzo RA, Davidson JA, Del Prato S. The role of the kidneys in glucose homeostasis: a new path towards normalizing glycaemia. Diabetes Obes Metab. 2012 Jan;14(1):5-14. doi: 10.1111/j.1463-1326.2011.01511.x.
**PMID:** 21955459
## 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: D000051437
- Term: Renal Insufficiency
- ID: D000002908
- Term: Chronic Disease
- ID: D000020969
- Term: Disease Attributes
- ID: D000010335
- Term: Pathologic Processes
### Condition Browse Module - Browse Branches
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M10698
- Name: Kidney Diseases
- Relevance: HIGH
- As Found: Kidney Disease
- ID: M26717
- Name: Renal Insufficiency, Chronic
- Relevance: HIGH
- As Found: Chronic Kidney Disease
- ID: M26718
- Name: Renal Insufficiency
- Relevance: LOW
- As Found: Unknown
- 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: M6147
- Name: Chronic Disease
- Relevance: LOW
- As Found: Unknown
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: HIGH
- As Found: Chronic
### Condition Browse Module - Meshes
- ID: D000007674
- Term: Kidney Diseases
- ID: D000051436
- Term: Renal Insufficiency, Chronic
### Intervention Browse Module - Ancestors
- ID: D000077203
- Term: Sodium-Glucose Transporter 2 Inhibitors
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000007004
- Term: Hypoglycemic Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000010726
- Term: Phosphodiesterase Inhibitors
- ID: D000004791
- Term: Enzyme Inhibitors
- ID: D000010975
- Term: Platelet Aggregation Inhibitors
- ID: D000011837
- Term: Radiation-Protective Agents
- ID: D000020011
- Term: Protective Agents
- ID: D000014665
- Term: Vasodilator Agents
- ID: D000016166
- Term: Free Radical Scavengers
- ID: D000000975
- Term: Antioxidants
### Intervention Browse Module - Browse Branches
- Abbrev: Hypo
- Name: Hypoglycemic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: VaDiAg
- Name: Vasodilator Agents
- Abbrev: PlAggInh
- Name: Platelet Aggregation Inhibitors
### Intervention Browse Module - Browse Leaves
- ID: M348449
- Name: Dapagliflozin
- Relevance: HIGH
- As Found: 0.9
- ID: M13342
- Name: Pentoxifylline
- Relevance: HIGH
- As Found: Format
- ID: M1691
- Name: Sodium-Glucose Transporter 2 Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M10054
- Name: Hypoglycemic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M13629
- Name: Phosphodiesterase Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M7951
- Name: Enzyme Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M13865
- Name: Platelet Aggregation Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M21869
- Name: Protective Agents
- Relevance: LOW
- As Found: Unknown
- ID: M14684
- Name: Radiation-Protective Agents
- Relevance: LOW
- As Found: Unknown
- ID: M17412
- Name: Vasodilator Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4292
- Name: Antioxidants
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: C000529054
- Term: Dapagliflozin
- ID: D000010431
- Term: Pentoxifylline
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06421857
**Brief Title:** Hemostatic Measures During Laparoscopic Cystectomy for Endometrioma
**Official Title:** Bipolar Coagulation Versus Suturing During Laparoscopic Endometriotic Cystectomy
#### Organization Study ID Info
**ID:** ASU Hemostasis
#### Organization
**Class:** OTHER
**Full Name:** Ain Shams Maternity Hospital
### Status Module
#### Completion Date
**Date:** 2024-05-01
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-15
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2024-05-01
**Type:** ACTUAL
#### Start Date
**Date:** 2023-09-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Ain Shams Maternity Hospital
#### Responsible Party
**Investigator Affiliation:** Ain Shams Maternity Hospital
**Investigator Full Name:** Nagat Hesham Abdelhai Mohammed
**Investigator Title:** postgraduate student
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** laparoscopic excision of ovarian endometriotic cysts is generally recommended because it has been associated with a higher spontaneous conception rate, residual ovarian function after the procedure may be affected
### Conditions Module
**Conditions:**
- Endometrioma
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 48
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** after ovarian cystectomy for endometrioma, separate sutures were applied if there was significant bleeding
**Intervention Names:**
- Procedure: suturing
**Label:** suturing
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** after ovarian cystectomy for endometrioma, the inner wall was coagulated using bipolar electrocoagulation if there was significant bleeding
**Intervention Names:**
- Procedure: bipolar electrocoagulation
**Label:** bipolar electrocoagulation
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- suturing
**Description:** laparoscopic cystectomy for endometrioma and hemostasis was done using suturing
**Name:** suturing
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- bipolar electrocoagulation
**Description:** laparoscopic cystectomy for endometrioma and hemostasis was done bipolar electrocoagulation
**Name:** bipolar electrocoagulation
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** measuring AMH level
**Measure:** ovarian reserve
**Time Frame:** 6 weeks after procedure
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* 18 to 35 years
* unilateral endometriotic cyst
Exclusion Criteria:
anovulatory women women with decreased ovarian reserve women receiving hormonal treatment three months prior to surgery women with any contraindication to laparoscopy women with previous ovarian surgery possible ovarian malignancy.
**Maximum Age:** 35 Years
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Cairo
**Country:** Egypt
**Facility:** Ain Shams university
**Zip:** 11566
#### Overall Officials
**Official 1:**
**Affiliation:** Ain Shams University
**Name:** Osama Kamel, MD
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- 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: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M7877
- Name: Endometriosis
- Relevance: HIGH
- As Found: Endometrioma
- 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: D000004715
- Term: Endometriosis
### Intervention Browse Module - Browse Branches
- Abbrev: Coag
- Name: Coagulants
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M9576
- Name: Hemostatics
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06421844
**Brief Title:** A Prospective Study: Smart Phone Application for Measure Serum Bilirubin Through Sclera Images
**Official Title:** A Prospective Study: A Computer Vision Model on a Smartphone Platform for Real-time Evaluation of Serum Bilirubin Through Sclera Images
#### Organization Study ID Info
**ID:** KY20242031-F-1
#### Organization
**Class:** OTHER
**Full Name:** Air Force Military Medical University, China
### Status Module
#### Completion Date
**Date:** 2024-07-10
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-15
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-06-20
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-04-20
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Air Force Military Medical University, China
#### Responsible Party
**Investigator Affiliation:** Air Force Military Medical University, China
**Investigator Full Name:** Yanglin Pan
**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 primary efficacy endpoints are the standard deviation and coefficient of determination (R2) between predicted and actual values for the bilirubin regression model, and the grading accuracy for the jaundice severity classification model. The secondary efficacy endpoint is the mean percentage error between predicted and actual bilirubin values. There are no relevant safety risks.
Statistical differences for categorical variables (e.g., jaundice grading evaluation indicators) will be analyzed using the chi-square test or Fisher's exact probability test. For continuous variables (e.g., bilirubin prediction evaluation indicators), t-tests (normal distribution) or non-parametric tests (non-normal distribution) will be used. The 95% confidence interval for jaundice grading accuracy will be calculated using the Wilson method.
The study duration is estimated to be 3 months.
### Conditions Module
**Conditions:**
- Jaundice
- Deep Learning
- Hyperbilirubinemia
- Sclera
**Keywords:**
- Smart phone
- Hyperbilirubinemia
- Real-time
- Deep learning
- Sclera
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 270
**Type:** ESTIMATED
**Patient Registry:** True
**Study Type:** OBSERVATIONAL
**Target Duration:** 2 Weeks
### Arms Interventions Module
#### Arm Group 1
**Description:** The cohort consists of at least 270 subjects consecutively enrolled from the Department of Gastroenterology at Xijing Hospital. The subjects will be followed prospectively over a period of time to collect data on their age, medical information, scleral images, and liver function test results. The cohort includes patients with various liver diseases and varying degrees of jaundice severity.
**Label:** Real-Time Scleral Jaundice Evaluation in Gastroenterology Cohort
### Outcomes Module
#### Primary Outcomes
**Description:** Standard deviation and mean average percentage error between predicted and actual bilirubin levels for the bilirubin regression model.
**Measure:** Loss of predicted bilirubin levels
**Time Frame:** Immediately after test completion
**Description:** Classification accuracy for the jaundice severity grading model
**Measure:** Classification accuracy
**Time Frame:** Immediately after test completion
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
Age 14 years or older. Subjects who are visiting the Gastroenterology Department of Xijing Hospital and will undergo liver function tests on the same day. The disease spectrum of the subjects mainly includes pancreatitis, pancreatic tumors, hepatobiliary stones, biliary tumors, and colonic polyps.
Exclusion Criteria:
Subjects with diseases that may cause abnormal changes in scleral color, such as glaucoma, Wilson's disease, pterygium, or scleritis.
Subjects who have recently consumed a large amount of carotenoid-rich foods (such as oranges or carrots).
Subjects who are unable to provide informed consent.
Elimination Criteria:
Subjects with incomplete scleral exposure due to limited eye movement or excessive tension during external eye examination.
Subjects who are unable to understand the instructions for eye rotation during scleral examination or are unable to cooperate due to reasons such as poor hearing.
**Healthy Volunteers:** True
**Minimum Age:** 14 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
**Study Population:** Study Population Description:
The study will include a total of 270 patients, both male and female, aged 14 years and above. The participants should not have any pre-existing conditions that may affect the color of their sclera. They should be able to follow instructions and complete the scleral imaging procedure. The patient population will primarily consist of individuals undergoing treatment for colorectal polyps, pancreatitis, pancreatic tumors, hepatobiliary stones, or biliary tract tumors.
Screening Procedure:
Potential participants will be screened using oral queries to assess their eligibility based on the inclusion and exclusion criteria. A brief ocular examination will be performed to rule out any apparent ocular surface disorders. Eligible participants will be provided with a detailed explanation of the study objectives, procedures, and potential risks and benefits. Written informed consent will be obtained from all participants prior to enrollment in the study.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Yanglin Pan, MD
**Phone:** 86-13991811225
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Xi'an
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Yanglin Pan
- **Phone:** 13991811225
- **Role:** CONTACT
***Contact 2:***
- **Name:** Xintain Yang
- **Role:** SUB_INVESTIGATOR
**Country:** China
**Facility:** First Affiliated Hospital of Air Force Military Medical University
**State:** Shaanxi
**Status:** RECRUITING
**Zip:** 710032
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Bang JY, Navaneethan U, Hasan M, Hawes R, Varadarajulu S. Stent placement by EUS or ERCP for primary biliary decompression in pancreatic cancer: a randomized trial (with videos). Gastrointest Endosc. 2018 Jul;88(1):9-17. doi: 10.1016/j.gie.2018.03.012. Epub 2018 Mar 21.
**PMID:** 29574126
**Citation:** Inamori G, Kamoto U, Nakamura F, Isoda Y, Uozumi A, Matsuda R, Shimamura M, Okubo Y, Ito S, Ota H. Neonatal wearable device for colorimetry-based real-time detection of jaundice with simultaneous sensing of vitals. Sci Adv. 2021 Mar 3;7(10):eabe3793. doi: 10.1126/sciadv.abe3793. Print 2021 Mar.
**PMID:** 33658197
**Citation:** Bian Y, Zheng Z, Fang X, Jiang H, Zhu M, Yu J, Zhao H, Zhang L, Yao J, Lu L, Lu J, Shao C. Artificial Intelligence to Predict Lymph Node Metastasis at CT in Pancreatic Ductal Adenocarcinoma. Radiology. 2023 Jan;306(1):160-169. doi: 10.1148/radiol.220329. Epub 2022 Sep 6.
**PMID:** 36066369
**Citation:** Wu HL, Yao LW, Shi HY, Wu LL, Li X, Zhang CX, Chen BR, Zhang J, Tan W, Cui N, Zhou W, Zhang JX, Xiao B, Gong RR, Ding Z, Yu HG. Validation of a real-time biliopancreatic endoscopic ultrasonography analytical device in China: a prospective, single-centre, randomised, controlled trial. Lancet Digit Health. 2023 Nov;5(11):e812-e820. doi: 10.1016/S2589-7500(23)00160-7. Epub 2023 Sep 27.
**PMID:** 37775472
**Citation:** Park JH, Yang MJ, Kim JS, Park B, Kim JH, Sunwoo MH. Deep-Learning-Based Smartphone Application for Self-Diagnosis of Scleral Jaundice in Patients with Hepatobiliary and Pancreatic Diseases. J Pers Med. 2021 Sep 18;11(9):928. doi: 10.3390/jpm11090928.
**PMID:** 34575705
**Citation:** Xiao W, Huang X, Wang JH, Lin DR, Zhu Y, Chen C, Yang YH, Xiao J, Zhao LQ, Li JO, Cheung CY, Mise Y, Guo ZY, Du YF, Chen BB, Hu JX, Zhang K, Lin XS, Wen W, Liu YZ, Chen WR, Zhong YS, Lin HT. Screening and identifying hepatobiliary diseases through deep learning using ocular images: a prospective, multicentre study. Lancet Digit Health. 2021 Feb;3(2):e88-e97. doi: 10.1016/S2589-7500(20)30288-0.
**PMID:** 33509389
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010335
- Term: Pathologic Processes
- ID: D000012877
- Term: Skin Manifestations
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M10595
- Name: Jaundice
- Relevance: HIGH
- As Found: Jaundice
- ID: M9983
- Name: Hyperbilirubinemia
- Relevance: HIGH
- As Found: Hyperbilirubinemia
- ID: M15680
- Name: Skin Manifestations
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000007565
- Term: Jaundice
- ID: D000006932
- Term: Hyperbilirubinemia
### Intervention Browse Module - Browse Branches
- Abbrev: Hemat
- Name: Hematinics
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M11110
- Name: Liver Extracts
- Relevance: LOW
- As Found: Unknown
- ID: M4949
- Name: Bilirubin
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06421831
**Brief Title:** Evaluation of Safety and Efficacy of Gene Therapy Drug in the Treatment of Spinal Muscular Atrophy (SMA) Type 3 Patients
**Official Title:** A Multi-center, Open Label, Single-arm, Dose Ascending Clinical Trial for Evaluation of Safety and Efficacy of Gene Therapy Drug GC101 in the Treatment of Spinal Muscular Atrophy (SMA) Type 3 Patients
#### Organization Study ID Info
**ID:** JLJY-GC101-SMA-010
#### Organization
**Class:** INDUSTRY
**Full Name:** GeneCradle Inc
### Status Module
#### Completion Date
**Date:** 2028-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-14
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2026-12
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-10
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** GeneCradle Inc
#### 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 study will evaluate safety and efficacy of intrathecal delivery of GC101 gene therapy drug as a treatment of spinal muscular atrophy Type 3 (SMA 3) patients.
**Detailed Description:** The purpose of this trial is to evaluate safety and efficacy of gene therapy drug GC101 in SMA 3 patients. Open-label, dose-escalation clinical trials of GC101 will be conducted in multiple centers in China.
GC101 will be administrated intrathecally. Short-term safety will be evaluated in 52 weeks and enter long-term follow-up study of 5 years at will. Patients will be tested at baseline and followed up at various time points.
The primary analysis for efficacy will be assessed at 12 months after treatment with GC101 on the changes from baseline HFMSE (Hammersmith Functional Motor Scale Expanded) and RULM（Revised Upper Limb Module) scores for patients of age ≥ 6 years old.
### Conditions Module
**Conditions:**
- Spinal Muscular Atrophy Type 3
**Keywords:**
- SMA type 3
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 21
**Type:** ESTIMATED
**Phases:**
- PHASE1
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** 1.2x10\^14 vg/person of GC101 delivered one-time intrathecally
**Intervention Names:**
- Genetic: GC101
**Label:** single dose cohort
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- single dose cohort
**Description:** Self-complementary AAV9 carrying a codon-optimized SMN coding sequence(coSMN1) driven by CMV enhancer and chicken β-actin promoter
**Name:** GC101
**Type:** GENETIC
### Outcomes Module
#### Other Outcomes
**Measure:** The proportion of patients whose Clinical Global Impression (CGI) is improved at Month 12
**Time Frame:** 52 weeks
**Measure:** The proportion of patients whose Motor Function Measure (MFM) is improved or maintained at Month 12
**Time Frame:** 52 weeks
**Measure:** Change from baseline of Forced Vital Capacity (FVC) at Month 12 ( for patients > 6 years)
**Time Frame:** 52 weeks
**Measure:** Change from baseline of Forced Expiratory Volume in 1 Second (FEV1) at Month 12 ( for patients > 6 years)
**Time Frame:** 52 weeks
**Measure:** Change from baseline of Maximal Inspiratory Pressure (MIP) at Month 12 ( for patients > 6 years)
**Time Frame:** 52 weeks
**Measure:** Change from baseline of Maximal Expiratory Pressure (MEP) at Month 12 ( for patients > 6 years)
**Time Frame:** 52 weeks
**Description:** The 6MWT is used for ambulatory participants with SMA and measures the total distance walked in 6 minutes.
**Measure:** Change from baseline of 6 minutes walk test (6MWT) at Month 12 (for ambulatory patients)
**Time Frame:** 52 weeks
**Description:** The SMA Independence Scale (SMAIS) is a self-reported questionnaire to assess the amount of assistance patients require to perform daily activities. Higher SMAIS scores indicate greater independence.
(range: 0-44).
**Measure:** Change from baseline of SMA Independence Scale (SMAIS) at Month 12
**Time Frame:** 52 weeks
#### Primary Outcomes
**Description:** Frequency of treatment-related adverse events (AEs), serious adverse events (SAEs), and changes from baseline in relevant clinical laboratory tests
**Measure:** Incidence of Treatment-Emergent Adverse Events
**Time Frame:** 52 weeks
**Description:** HFMSE consists of 33 activities that can be scored one of three ways: 0 for unable to perform, 1 for performs with modification/adaptation, and 2 for performs without modification.
**Measure:** Change from baseline on Hammersmith Functional Motor Scale - Expanded (HFMSE) scores at Month 12
**Time Frame:** 52 weeks
#### Secondary Outcomes
**Description:** HFMSE ≥3 points：minimal clinically important differences (MCID) were considered for the outcomes:
**Measure:** The proportion of patients whose HFMSE improvement ≥ 3 points at Month 12
**Time Frame:** 52 weeks
**Description:** RULM is a 20-item evaluation of upper limb function primarily used for those with SMA who are non-ambulatory (young children through adults).
**Measure:** Change from baseline on Revised Upper Limb Module (RULM) scores at Month 12
**Time Frame:** 52 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* ≥2 years of age on the day of signing the informed consent form;
* Genetic and clinical diagnosis of type 3 SMA with bi-allelic deletion of SMN1 of 5qSMA;
* Hammersmith Functional Motor Scale - Expanded (HFMSE) score is between 10 and 54 at screening;
* Female patients of childbearing age who are pregnant or lactating, as well as all enrolled patients （both male and female), should take effective contraceptive measures within 6 months after the treatment;
* Patients or patient's legal guardian(s) must be able to understand the purpose and risks of the study and voluntarily provide signed and dated informed consent prior to any study-related procedures being performed.
Exclusion Criteria:
* Patient who has participated in any previous gene therapy research trials;
* Patient who has AAV9 neutralizing antibody titer ≥1:200;
* Patient who has received Nusinersen within 120 days and Risdiplam within 15 days before treatment;
* Patient who requires invasive or non-invasive ventilatory support averaging≥16 hours/day at screening;
* SMN2 copy numbers \>4；
* Patient who needs nasal or gastric tube feeding for eating;
* Patient who is positive for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen, hepatitis C antibody, or treponema pallidum antibody;
* Known allergy or hypersensitivity to prednisolone or other glucocorticosteroids or their excipients
* Severe contractures at screening that interfere with either the ability to attain/demonstrate functional measures or with the ability to receive intrathecal (IT) dosing;
* Patient who has other serious diseases, such as severe cardiovascular and cerebrovascular diseases, digestive system diseases, urinary system diseases, endocrine system diseases, hematological diseases, immune system diseases, nervous system diseases (including but not limited to epilepsy, meningitis, history of convulsions or seizures, cerebrospinal fluid circulation disorders), and mental illnesses, etc.;
* Patient with previous injuries (such as upper or lower limb fractures) or surgical operations that have not fully recovered or reached a stable state;
* Vaccination no longer than 2 weeks before treatment;
* Patient who has any other condition that, in the opinion of the investigator, makes the subject unsuitable for participation in the study.
**Minimum Age:** 2 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** GeneCradle, Inc China
**Phone:** +8613501380583
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Beijing
**Contacts:**
***Contact 1:***
- **Name:** Kang Zhang
- **Role:** CONTACT
***Contact 2:***
- **Name:** Zaiqiang Zhang
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 3:***
- **Name:** Yajie Wang
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** China
**Facility:** Beijing Tiantan Hospital, Capital Medical University
**State:** Beijing
**Status:** RECRUITING
### IPD Sharing Statement Module
**IPD Sharing:** NO
## 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: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M4589
- Name: Atrophy
- Relevance: HIGH
- As Found: Atrophy
- ID: M12090
- Name: Muscular Atrophy
- Relevance: HIGH
- As Found: Muscular Atrophy
- ID: M12091
- Name: Muscular Atrophy, Spinal
- Relevance: HIGH
- As Found: Spinal Muscular 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: HIGH
- As Found: Spinal Muscular Atrophy Type 3
- 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
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06421818
**Brief Title:** Effect and Mechanism of Baitouweng Decoction for Large Intestine Damp-heat Syndrome of Ulcerative Colitis
**Official Title:** Formula-to-Syndrome Effect and Pharmacomicrobiomics Mechanism of Colon Delivery of Baitouweng Decoction for Treating Large Intestine Damp-heat Syndrome of Ulcerative Colitis
#### Organization Study ID Info
**ID:** BTW-RCT
#### Organization
**Class:** OTHER
**Full Name:** The Second Hospital of Nanjing Medical University
### Status Module
#### Completion Date
**Date:** 2026-12-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2026-12-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Heilongjiang University of Chinese Medicine
#### Lead Sponsor
**Class:** OTHER
**Name:** The Second Hospital of Nanjing Medical University
#### Responsible Party
**Investigator Affiliation:** The Second Hospital of Nanjing Medical University
**Investigator Full Name:** Faming Zhang
**Investigator Title:** chief physician, PhD
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Baitouweng Decoction is traditionally used to treat large intestine damp-heat syndrome of ulcerative colitis (UC) by oral administration and rectal enema.The project applicant's invention of transendoscopic entral tubing (TET) has been used in Baitouweng Decoction for the treatment of UC across the whole colon, however, the efficacy have not been reported and the underlying mechanism is still unclear. Compared with oral and rectal enema, Baitouweng Decoction by colon TET can improve the therapeutic effect by increasing the concentration of drugs in the whole colon, which need to be verified. This project will reveal the prescription effect and drug-microbiome interaction mechanism of whole colon repeated administration of Baitouweng Decoction in the treatment of UC through clinical randomized controlled studies, deep intestinal dynamic sampling, integrated analysis of multi-omics and TCM prescription metabolomics studies, and provide key scientific basis for the establishment of a new approach of whole colon repeated administration of TCM and a new strategy for the treatment of UC.
**Detailed Description:** A multi-center randomized controlled study will be conducted to compare the efficacy differences and multi-omics changes of colon TET, rectal enema and oral Baitouweng Decoction in the control of intestine damp-heat syndrome of UC. Moreover，a group of patients was designed to receive blank carrier solution through colon TET tube. After the study, the patients in this group were given compensation treatment of fecal microbiota transplantation as an ethical protection measure.The colonic TET will be implanted into the intestine and the whole colon will be covered with Baitouweng Decoction. The treatment period is 10 days. The primary outcome measure is the changes of fecal calprotectin before and after oral, colonic TET and rectal enema administration. And the secondary outcomes measure are the changes of disease condition, Mayo score and safety. Deep intestine fluid, stool, blood and urine samples were collected before and after treatment to study the changes of microbiomes, metabolomics and immunoomics. Identify the difference of the key material basis of Baitouweng Decoction and analyze its mechanism comprehensively. The key beneficial and harmful bacteria were identified by comprehensive analysis. A total of not less than 144 subjects are expected to be included and divided into colonic TET treatment group, colonic TET placebo group, rectal enema group, and oral group according to a ratio of 1:1:1:1.
### Conditions Module
**Conditions:**
- Ulcerative Colitis
**Keywords:**
- Baitouweng Decoction
- Formula-to-Syndrome Effect
- Ulcerative colitis
- Pharmacomicrobiomics
- Colon delivery
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** QUADRUPLE
**Masking Description:** For groups receiving Baitouweng Decoction by oral administration and rectal edema，the interventions are single-blind to investigators and outcomes assessor. For groups receiving Baitouweng Decoction or placebo by colonic TET, the interventions are double-blind to participants, care provider, investigators and outcomes assessor.
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 144
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Baitouweng Decoction is administered through the colonic TET.
**Intervention Names:**
- Drug: Baitouweng Tang
**Label:** Colonic TET treatment group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The same volume of placebo as the colonic TET treatment group was administered through the colonic TET.
**Intervention Names:**
- Other: Placebo
**Label:** Colonic TET placebo group
**Type:** PLACEBO_COMPARATOR
#### Arm Group 3
**Description:** Baitouweng Decoction is administered through rectal enema.
**Intervention Names:**
- Drug: Baitouweng Tang
**Label:** Rectal enema group
**Type:** ACTIVE_COMPARATOR
#### Arm Group 4
**Description:** Baitouweng Decoction is administered through oral.
**Intervention Names:**
- Drug: Baitouweng Tang
**Label:** Oral group
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Colonic TET treatment group
- Oral group
- Rectal enema group
**Description:** Baitouweng Decoction is composed of four herbs: Baitouweng, Rhizoma coptidis, Phellodendri huangbai and Qin Pi.
**Name:** Baitouweng Tang
**Other Names:**
- Baitouweng Decoction
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Colonic TET placebo group
**Description:** The same volume and color as Baitouweng Decoction.
**Name:** Placebo
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** To compare the concentration of fecal calprotecin before and after oral, colonic TET and rectal enema administration.
**Measure:** The concentration of fecal calprotecin.
**Time Frame:** Baseline; Day 15; Day 53
#### Secondary Outcomes
**Description:** To compare the change of Mayo score before and after oral, colonic TET and rectal enema administration. The Mayo score included the number of bowel movements, blood in the stool, endoscopic findings and overall physician evaluation. The total score was 12 points. The higher the score, the higher the degree of disease activity.
**Measure:** The change of Mayo score.
**Time Frame:** Baseline; Day 15; Day 22; Day 53; Day 99.
**Description:** The number of adverse reactions that are associated with Baitouweng Decoction reported by subjects from the start of treatment to the end of follow-up.
**Measure:** Incidence of Treatment-Emergent Adverse Events
**Time Frame:** Day 15; Day 22; Day 53; Day 99.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Patients diagnosed with ulcerative colitis;
2. The patients are in mild to moderate active stage with Mayo score of 3-8.
3. Patients with damp-heat syndrome of large intestine according to TCM syndrome differentiation: according to the expert consensus on integrated traditional Chinese and Western medicine diagnosis and treatment of UC, the main symptoms are diarrhea, mucopurulent and bloody stool, abdominal pain, and tenesmus. Secondary symptoms: anal burning, body heat is not Yang, dry mouth and bitter mouth, short red urine. Tongue pulse: tongue red fur yellow greasy, pulse slippery number. The determination of the above 8 syndromes can be made if there are 2 main symptoms and 1-2 secondary symptoms. The tongue pulse is for reference only.
4. The patients who can tolerate Baitouweng Decoction;
5. The patients who tolerance to colonoscopy and TET;
6. The patients who know and agree to participate in the clinical trial.
Exclusion Criteria:
1. The patients are complicated with other diseases that may cause diarrhea, such as infectious colitis, radiation enteritis, Crohn's disease, etc.
2. Patients with heart, brain, lung, liver, kidney and other serious diseases;
3. Patients do not cooperate to complete the clinical trial process;
4. Other cases considered unsuitable for inclusion.
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Faming Zhang, PhD
**Phone:** 02558509670
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Bota Cui
**Phone:** 02558509883
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Nanjing
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Faming Zhang, PhD
- **Phone:** 086-025-58509883
- **Role:** CONTACT
**Country:** China
**Facility:** Department of Microbiota Medicine & Medical Centre for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
**State:** Jiangsu
**Status:** RECRUITING
#### Overall Officials
**Official 1:**
**Affiliation:** The Second Hospital of Nanjing Medical University
**Name:** Faming Zhang, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Wang W, Lu G, Wu X, Wen Q, Zhang F. Colonic Transendoscopic Enteral Tubing Is a New Pathway to Microbial Therapy, Colonic Drainage, and Host-Microbiota Interaction Research. J Clin Med. 2023 Jan 18;12(3):780. doi: 10.3390/jcm12030780.
**PMID:** 36769429
**Citation:** Zhang X, Zhang L, Chan JCP, Wang X, Zhao C, Xu Y, Xiong W, Chung WC, Liang F, Wang X, Miao J, Bian Z. Chinese herbal medicines in the treatment of ulcerative colitis: a review. Chin Med. 2022 Apr 4;17(1):43. doi: 10.1186/s13020-022-00591-x.
**PMID:** 35379276
**Citation:** Gou H, Su H, Liu D, Wong CC, Shang H, Fang Y, Zeng X, Chen H, Li Y, Huang Z, Fan M, Wei C, Wang X, Zhang X, Li X, Yu J. Traditional Medicine Pien Tze Huang Suppresses Colorectal Tumorigenesis Through Restoring Gut Microbiota and Metabolites. Gastroenterology. 2023 Dec;165(6):1404-1419. doi: 10.1053/j.gastro.2023.08.052. Epub 2023 Sep 12.
**PMID:** 37704113
**Citation:** Wei P, He Q, Liu T, Zhang J, Shi K, Zhang J, Liu S. Baitouweng decoction alleviates dextran sulfate sodium-induced ulcerative colitis by suppressing leucine-related mTORC1 signaling and reducing oxidative stress. J Ethnopharmacol. 2023 Mar 25;304:116095. doi: 10.1016/j.jep.2022.116095. Epub 2022 Dec 26.
**PMID:** 36581160
**Citation:** Gu X, Miao Z, Wang Y, Yang Y, Yang T, Xu Y. New Baitouweng decoction combined with fecal microbiota transplantation alleviates DSS-induced colitis in rats by regulating gut microbiota metabolic homeostasis and the STAT3/NF-kappaB signaling pathway. BMC Complement Med Ther. 2022 Nov 24;22(1):307. doi: 10.1186/s12906-022-03766-z.
**PMID:** 36424592
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000004194
- Term: Disease
- ID: D000010335
- Term: Pathologic Processes
- ID: D000005759
- Term: Gastroenteritis
- ID: D000005767
- Term: Gastrointestinal Diseases
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000003108
- Term: Colonic Diseases
- ID: D000007410
- Term: Intestinal Diseases
- ID: D000015212
- Term: Inflammatory Bowel Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC06
- Name: Digestive System Diseases
### Condition Browse Module - Browse Leaves
- ID: M16355
- Name: Syndrome
- Relevance: HIGH
- As Found: Syndrome
- ID: M6320
- Name: Colitis
- Relevance: HIGH
- As Found: Colitis
- ID: M6321
- Name: Colitis, Ulcerative
- Relevance: HIGH
- As Found: Ulcerative Colitis
- ID: M17206
- Name: Ulcer
- Relevance: HIGH
- As Found: Ulcerative
- ID: M8875
- Name: Gastroenteritis
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System 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: M17917
- Name: Inflammatory Bowel Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003092
- Term: Colitis
- ID: D000003093
- Term: Colitis, Ulcerative
- ID: D000013577
- Term: Syndrome
- ID: D000014456
- Term: Ulcer
### Intervention Browse Module - Browse Branches
- Abbrev: HB
- Name: Herbal and Botanical
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: T120
- Name: Cola
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06421805
**Acronym:** MTDPUMCH
**Brief Title:** Establishing Prospective Mediastinal Tumor Database of PUMCH
**Official Title:** A Single-center, Prospective, and Observational Study on Population Characteristics, Pathological Features, and Prognostic Factors of Patients With Mediastinal Tumor: Establishing Mediastinal Tumor Database of PUMCH.
#### Organization Study ID Info
**ID:** MTDPUMCH
#### Organization
**Class:** OTHER
**Full Name:** Peking Union Medical College Hospital
### Status Module
#### Completion Date
**Date:** 2045-12-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-14
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2044-12-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2012-01-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-20
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Peking Union Medical College Hospital
#### Responsible Party
**Investigator Affiliation:** Peking Union Medical College Hospital
**Investigator Full Name:** Xuehan Gao
**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:** This study aims to prospectively document the population characteristics, imaging findings, pathological features, prognostic factors, etc., of patients with mediastinal tumors. Clinical information will be structured and processed, and it is recommended to establish a mediastinal tumors database at Peking Union Medical College Hospital. The goal is to provide support for the quality of diagnosis and treatment, clinical protocols, and medical decision-making related to mediastinal tumors.
**Detailed Description:** Mediastinal tumors encompass a variety of tumors originating in the mediastinum, comprising both benign and malignant tumors, those invading mediastinal structures during disease progression, or metastases from malignant tumors originating elsewhere in the body. Based on their relationship with the pericardium, mediastinal tumors can be categorized into anterior mediastinal tumors, commonly including thymomas, retrosternal goiters, teratomas, and germ cell tumors; middle mediastinal tumors, which often include bronchogenic cysts, lymphomas, malignant lymphomas, pericardial cysts, lipomas, and esophageal cysts; and posterior mediastinal tumors, where neurogenic tumors and neurofibromas are prevalent. Mediastinal tumors are relatively rare compared to other solid tumors and exhibit complex pathological types. Consequently, conducting prospective randomized controlled clinical trials is challenging, and the significant treatment disparities among different types of mediastinal tumors affect patient survival outcomes. Clinicians often have limited understanding of some complex mediastinal tumors due to the lack of quality and reliable diagnostic and treatment standards or survival data. Therefore, establishing a specialized database for mediastinal tumor research holds great practical significance for the effective development of clinical practice.
Tumor registration databases in North America and Europe have been established earlier, with wide coverage and relatively mature development. For example, the National Cancer Database (NCDB) in the United States is the largest tumor registration database globally, with over 1500 hospitals reporting tumor data to it, covering approximately 70% of newly diagnosed cancer cases. The Surveillance, Epidemiology, and End Results (SEER) database is a public health database based on tumor populations in some states and counties in the United States (17 regional registration centers). It has been registering data since 1973, covering tumor monitoring, epidemiology, and prognosis information. Both databases have high coverage and reasonable registration and verification systems, providing a wealth of high-level evidence for the formulation of tumor prevention and control strategies.
In China, the development in this field started relatively late. To integrate resources, deeply explore data information, and further improve the diagnosis and treatment level and patient management level of mediastinal tumors in China, it is necessary to establish a scientifically standardized specialized mediastinal tumor database.
### Conditions Module
**Conditions:**
- Thymic Epithelial Tumor
- Teratoma
- Thymic Cyst
- Retrosternal Goitre
- Germ Cell Tumor
- Lymphoma
- Schwannoma
**Keywords:**
- mediastinal tumors
- database
- thymic epithelial tumor
### Design Module
#### Bio Spec
**Description:** After obtaining informed consent from the patients, tumor tissue specimens will be stored in the sample repository of PUMCH at -80 degrees Celsius.
**Retention:** SAMPLES_WITH_DNA
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 2000
**Type:** ESTIMATED
**Patient Registry:** True
**Study Type:** OBSERVATIONAL
**Target Duration:** 20 Years
### Arms Interventions Module
#### Arm Group 1
**Description:** mediastinal tumors_thymoma
**Label:** thymoma
#### Arm Group 2
**Description:** mediastinal tumors_teratomas
**Label:** teratoma
#### Arm Group 3
**Description:** mediastinal tumors_germ cell tumors
**Label:** germ cell tumor
#### Arm Group 4
**Description:** mediastinal tumor_lymphoma
**Label:** lymphoma
#### Arm Group 5
**Description:** mediastinal tumor_NETs, including neuroendocrine tumours and neuroendocrine carcinomas.
**Label:** mediastinal neuroendocrine tumors (NETs)
#### Arm Group 6
**Description:** mediastinal tumor_neurinoma
**Label:** neurinoma
#### Arm Group 7
**Description:** mediastinal tumor_thymic carcinoma
**Label:** thymic carcinoma
#### Arm Group 8
**Description:** mediastinal tumors_other tumors
**Label:** others
### Outcomes Module
#### Primary Outcomes
**Description:** Overall survival of patients with mediastinal tumors
**Measure:** Overall survival (OS)
**Time Frame:** From date of enrollment until the date of death from any cause, assessed up to 20 years
#### Secondary Outcomes
**Description:** Progression free survival of patients with mediastinal tumors
**Measure:** Progression free survival (PFS)
**Time Frame:** From date of enrollment until the date of first documented progression, assessed up to 20 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Clinical or pathological diagnosis of mediastinal tumors;
2. Written consent is able to obtained.
Exclusion Criteria:
1. Incomplete clinicopathological information.
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
**Study Population:** Patients diagnosed with mediastinal tumors clinically or pathologically.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Xuehan Gao, MD
**Phone:** +86 18801341299
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Yeye Chen, MD
**Phone:** 13671338819
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Beijing
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Xuehan Gao, MD
- **Phone:** 18801341299
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Yeye Chen, MD
- **Phone:** 13671338819
- **Role:** CONTACT
***Contact 3:***
- **Name:** Xuehan Chen, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** China
**Facility:** Peking Union Medical College Hospital
**State:** Beijing
**Status:** RECRUITING
**Zip:** 100730
#### Overall Officials
**Official 1:**
**Affiliation:** Peking Union Medical College Hospital
**Name:** Shanqing Li, Prof.
**Role:** STUDY_CHAIR
### IPD Sharing Statement Module
**Description:** The research results have not been published.
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009373
- Term: Neoplasms, Germ Cell and Embryonal
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000018358
- Term: Neuroendocrine Tumors
- ID: D000017599
- Term: Neuroectodermal Tumors
- ID: D000009463
- Term: Neuroma
- ID: D000018317
- Term: Nerve Sheath Neoplasms
- ID: D000009380
- Term: Neoplasms, Nerve Tissue
- ID: D000013899
- Term: Thoracic Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000008477
- Term: Mediastinal Diseases
- ID: D000013896
- Term: Thoracic Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
- ID: D000003560
- Term: Cysts
### 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: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M11220
- Name: Lymphoma
- Relevance: LOW
- As Found: Unknown
- ID: M16494
- Name: Teratoma
- Relevance: HIGH
- As Found: Teratoma
- ID: M12386
- Name: Neurilemmoma
- Relevance: HIGH
- As Found: Schwannoma
- ID: M11462
- Name: Mediastinal Neoplasms
- Relevance: HIGH
- As Found: Mediastinal Tumor
- ID: M9147
- Name: Goiter
- Relevance: LOW
- As Found: Unknown
- ID: M6765
- Name: Cysts
- Relevance: LOW
- As Found: Unknown
- ID: M11459
- Name: Mediastinal Cyst
- Relevance: HIGH
- As Found: Thymic Cyst
- 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: M20495
- Name: Neuroendocrine Tumors
- Relevance: LOW
- As Found: Unknown
- ID: M19845
- Name: Neuroectodermal Tumors
- Relevance: LOW
- As Found: Unknown
- ID: M20388
- Name: Neuroectodermal Tumors, Primitive
- Relevance: LOW
- As Found: Unknown
- ID: M12406
- Name: Neuroma
- Relevance: LOW
- As Found: Unknown
- ID: M20461
- Name: Nerve Sheath Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M12325
- Name: Neoplasms, Nerve Tissue
- Relevance: LOW
- As Found: Unknown
- ID: M16658
- Name: Thoracic Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M11460
- Name: Mediastinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M16655
- Name: Thoracic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T3543
- Name: Lymphosarcoma
- Relevance: LOW
- As Found: Unknown
- ID: T2475
- Name: Germ Cells Tumors
- Relevance: HIGH
- As Found: Germ cell tumor
- ID: T5139
- Name: Schwannoma
- Relevance: HIGH
- As Found: Schwannoma
- ID: T5647
- Name: Thymic Epithelial Tumor
- Relevance: HIGH
- As Found: Thymic Epithelial Tumor
- ID: T4091
- Name: Neuroendocrine Tumor
- Relevance: LOW
- As Found: Unknown
- ID: T4092
- Name: Neuroepithelioma
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000009369
- Term: Neoplasms
- ID: D000013724
- Term: Teratoma
- ID: D000009442
- Term: Neurilemmoma
- ID: D000008479
- Term: Mediastinal Neoplasms
- ID: D000008476
- Term: Mediastinal Cyst
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06421792
**Acronym:** POISON
**Brief Title:** PrOtamIne doSing clOt imagiNg (POISON) Study
**Official Title:** Scanning Electron Microscopy (SEM) and Confocal Imaging of Clot in Two Different Protamine Environments (PrOtamIne doSing clOt imagiNg (POISON) Study)
#### Organization Study ID Info
**ID:** T03024
#### Organization
**Class:** OTHER_GOV
**Full Name:** Papworth Hospital NHS Foundation Trust
### Status Module
#### Completion Date
**Date:** 2024-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-14
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-08
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-21
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** University of Oxford
**Class:** OTHER
**Name:** University of Liverpool
**Class:** OTHER_GOV
**Name:** Medical Research Council
#### Lead Sponsor
**Class:** OTHER_GOV
**Name:** Papworth Hospital NHS Foundation Trust
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The proposed study involves using two different high-resolution microscopic imaging techniques to examine the health and platelet invasion of clot in patients who were given 1:1 protamine / heparin and compare this to clot from patients who had heparin reversed using the PRODOSE algorithm. Patients will be treated according to the routine clinical practice of their individual care team.
**Detailed Description:** Sample collection at RPH
Patients will have a total of 14ml of blood taken during the procedure.
The first 7ml will be taken after induction of anaesthesia along with routine blood gas and coagulation sampling through the routinely indwelling arterial catheter. The initial sample must be taken before any heparin has been administered. This will be used to fill 2 x 3.5ml citrated (green top) blood tubes. These will be clearly labelled as "pre-heparin" with a Tissue Bank ID number.
The second 7ml will be taken 5 minutes after heparin has been reversed with protamine after cessation of cardiopulmonary bypass. It will again be taken at the same time as routine sampling for blood gas and coagulation studies. Analog to the first sample, it will again be divided and used to fill 2 x 3.5ml citrated (green top) blood tubes. These will be clearly labelled as "post-protamine" with the same ID number and whether "1:1" or a "PRODOSE algorithm determined" protamine: heparin ratio was used.
In keeping with clinical routine, ROTEM coagulation testing and full blood counts will be requested as seen necessary by the clinical team.
The samples will be sent to Royal Papworth Hospital (RPH) Tissue Bank for initial processing. Samples need to be processed within 4 hours of blood draw.
After initial processing, samples will be sent for confocal imaging to the MRC Laboratory of Molecular Biology (LMB) and for SEM imaging to the University of Oxford respectively.
Clinical data to be collected (to be completed by anaesthetic team).
1. Demographic information: Age / Gender / Weight / Height / Medication history;
2. Type of surgery;
3. Cardiac drug history and antiplatelets / anticoagulants and timing;
4. Coagulation tests (ACT / ROTEM) at the following points: a) Pre-heparin, b) Post-heparin, pre-CPB, c) Throughout CPB, c) Post-protamine;
5. Full blood count at the following points: a) Pre-surgery and date of sample, b) Post-protamine; 6) CPB and x-clamp times, nadir temperature
### Conditions Module
**Conditions:**
- Cardiac Surgery
### Design Module
#### Design Info
**Observational Model:** OTHER
**Time Perspective:** OTHER
#### Enrollment Info
**Count:** 20
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** 10 patients receiving standard reversal with 1:1 protamine / heparin ratio
**Label:** Standard
#### Arm Group 2
**Description:** 10 patients who had heparin reversed using the PRODOSE algorithm anticipated (average protamine / heparin ratio 0.6:1).
**Label:** PRODOSE Algorithm
### Outcomes Module
#### Primary Outcomes
**Description:** The proposed study involves using two different high-resolution microscopic imaging techniques to examine the health and platelet invasion of clot in patients who were given 1:1 protamine / heparin and compare this to clot from patients who had heparin reversed using the PRODOSE algorithm.
This is an observational study in which differences between images of clot obtained from samples from the two patient groups and before and after cardiopulmonary bypass will be described.
**Measure:** High-resolution microscopic images (Scanning Electron Microscopy and Confocal Imaging)
**Time Frame:** Pre Heparin and Post Protamine [5 minutes after heparin has been reversed]
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* undergoing elective, uncomplicated single procedure cardiac surgery with anticipated CPB duration \< 120 min
* with all anticoagulant drugs stopped at least 5 days before surgery, apart from aspirin
* with normal full blood count and clotting screen pre-OP.
Exclusion Criteria:
* emergency surgery
* inability to stop anticoagulants except aspirin for 5 days pre-OP
* complex surgery with anticipated CPB duration \> 120min
* operations planned to be done at temperature on CPB \< 34 degrees
* operations requiring deep hypothermic circulatory arrest, solid organ transplantation
* know blood dyscrasia
* intra-operative blood or blood product transfusion or post-operative coagulopathy
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
**Study Population:** Patients undergoing elective, uncomplicated single procedure cardiac surgery with anticipated CPB duration \< 120 min
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Cambridge
**Country:** United Kingdom
**Facility:** Royal Papworth Hospital NHS Foundation Trust
**State:** Cambridgeshire
**Zip:** CB23 3RE
### IPD Sharing Statement Module
**Description:** Small observational study so IPD not relevant
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Miles LF, Burt C, Arrowsmith J, McKie MA, Villar SS, Govender P, Shaylor R, Tan Z, De Silva R, Falter F. Optimal protamine dosing after cardiopulmonary bypass: The PRODOSE adaptive randomised controlled trial. PLoS Med. 2021 Jun 7;18(6):e1003658. doi: 10.1371/journal.pmed.1003658. eCollection 2021 Jun.
**PMID:** 34097705
## Derived Section
### Intervention Browse Module - Browse Branches
- Abbrev: FiAg
- Name: Fibrinolytic Agents
- Abbrev: AnCoag
- Name: Anticoagulants
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Coag
- Name: Coagulants
### Intervention Browse Module - Browse Leaves
- ID: M9579
- Name: Heparin
- Relevance: LOW
- As Found: Unknown
- ID: M46053
- Name: Calcium heparin
- Relevance: LOW
- As Found: Unknown
- ID: M14342
- Name: Protamines
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06421779
**Brief Title:** The Effect of Virtual Reality (VR) on Skin Prick Test Related Pain and Fear in Children
**Official Title:** A Game-Like Skin Testing Experience: The Effect of Virtual Reality (VR) on Skin Prick Test Related Pain and Fear in Children (Randomized Controlled Trial)
#### Organization Study ID Info
**ID:** ADUPIA-CSAHIN-1
#### Organization
**Class:** OTHER
**Full Name:** Aydin Adnan Menderes University
### Status Module
#### Completion Date
**Date:** 2024-07
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-19
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-06
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-03-22
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Aydin Adnan Menderes University
#### Responsible Party
**Investigator Affiliation:** Aydin Adnan Menderes University
**Investigator Full Name:** Cihangir Sahin
**Investigator Title:** Research Assistant Medical Doctor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** This study aims to show the effect of VR on skin prick test-related pain and fear in children. The investigators will compare the effect of VR on skin prick test-induced pain and fear in children applying to the Pediatric Allergy outpatient clinic with controls who underwent skin prick test without the use of VR.
**Detailed Description:** Pain and fear during interventional procedures in pediatric patients are some of the most difficult problems in hospitals. While bad experiences in childhood can lead to increased sensitivity to pain, sleep problems, social learning difficulties, phobias, pre-treatment anxiety disorders, and treatment resistance; increases the risk of anxiety and depression in adulthood.
Skin prick test is the gold standard diagnostic method most frequently used in Pediatric Allergy clinics for the detection of allergens with high sensitivity, specificity, and reliability. The numerous pricking procedures performed during the skin test may turn into a painful and frightening experience for children.
Virtual reality (VR) is often accomplished using a special headset or glasses and can create for children a virtual world separate from their current physical environment, effectively distracting them from the possible pain and fear experience.
There is no study in the literature investigating the effect of VR on skin prick test-related pain and fear in children. This study aims to show the effect of VR on skin prick test-related pain and fear in children. The investigators will compare the effect of VR on skin prick test-induced pain and fear in children applying to the Pediatric Allergy outpatient clinic with controls who underwent skin prick test without the use of VR.
The hypotheses of this study were to:
H1: The virtual reality (VR) group will experience less pain due to the skin prick test than the control group.
H2: The virtual reality (VR) group will experience less fear due to the skin prick test than the control group.
Study Design:
This study is a parallel group randomized controlled trial planned to be conducted in the skin testing unit of a tertiary reference center of a pediatric allergy outpatient clinic between March and June 2024. The CONSORT guideline will be followed in the study. Fifty children between the ages of 4 and 10 years, who decided to undergo skin prick testing, will be randomized into two groups: using VR (VR group, n = 25) and not using VR (Control group; n = 25) by block randomization method. The reason for choosing this age group is that this age group is the common validation age range of the Wong-Baker FACES Pain Rating Scale (WB-FACES) and Child Fear Scale (CFS), which the investigators will use in the evaluation of pain and fear, in the Turkish children. At the same time, children in this age group are curious about technology and open to collaboration.
Sample Size and Randomization:
The number of patients was determined by taking the data obtained from the reference study titled "The Effect of Three Different Methods on Venipuncture Pain and Anxiety in Children: Distraction Cards, Virtual Reality, and Buzzy® (Randomized Controlled Trial)". Power analysis was performed based on self-report data of the WB-FACES Pain Rating scale in the study. According to the calculation by G\*Power 3.1.9.7, the effect size was determined as 0.92, the alpha margin of error was 0.05, the statistical power was 80%, and it was determined that at least 19 participants in each group were required to conduct the study. The analysis showed that a total sample size of 38 participants would be sufficient to detect significant differences. In light of the potential losses of 10% that may occur during the study, the investigators planned to include at least 21 participants in both groups to obtain a total of 42 participants.
In the literature, the studies show that gender and age affect pain and fear associated with invasive procedures in children. Therefore, gender (girls and boys) and age group (4-6 years (preschool) and 7-10 years (school age)) variables were used for block randomization. Blocks were repeated 5 times in each group. 25 participants were assigned to each of the VR and Control groups. A blocked randomization list was developed using an online randomization tool. The investigators were not blinded to group allocation because they performed the randomization themselves.
Ethics:
The study was approved by the local research ethics committee of our institution (2024/66). All participants will take part voluntarily, and personal written informed consent will be obtained from the parents of all participants, and verbal consent will be obtained from the participants before participation.
Data Collection Tools:
Data will be collected with a case report form created using WB-FACES and CFS. Both scales are suitable for personal, parent, and researcher evaluation. In our study, children's personal, parent, and researcher reporting data will be evaluated for both scales. Investigator reporting data will be evaluated by a specialist nurse trained on the scales.
Wong-Baker FACES Pain Rating Scale (WB-FACES):
The Wong-Baker FACES Pain Rating Scale (WB-FACES) was developed in 1981 and revised in 1983. WB-FACES is a reliable scale that has been validated for the Turkish population. The scale is used to diagnose pain in children ages 3-18 years. It consists of six facial expressions, each representing increasing degree of pain scored from 0 to 5 from left to right (0 = very happy face/no pain, 5 = a crying face/worst pain imaginable). High scores indicate low pain tolerance. The child is asked to rate his/her pain by asking "Can you show me the face that shows how you feel right now?".
Children's Fear Scale (CFS):
The Child Fear Scale (CFS) was developed in 2011. It was adapted into Turkish in 2018, by studying it with children aged 4-10 years. It consists of five facial expressions representing a range from neutral=0 to extreme fear=4.
Virtual Reality (VR):
Virtual reality (VR) allows the user to visit a three-dimensional world, isolating them from real life. VR is an advanced technology that offers a 360-degree visual and audio simulation that surrounds the user and allows them to look in all directions. In this study, VR intervention will be performed using a smartphone (Samsung Galaxy S23 Ultra, Qualcomm Snapdragon 8 Gen 2 processor, 12 GB RAM, Android 14 version, One UI 6.0 version, Dynamic AMOLED 1440x3088 QHD+ Pixel Screen, Stereo Dual Speakers), VR glasses (Schulzz VRG Pro) and a VR underwater experience video (2160p resolution video suitable for VR format) that will attract the attention of age groups.
Procedure:
Each child will be admitted to the skin testing unit with his/her parents. The skin testing unit has the same environmental conditions (seat, temperature, light, noise, etc.). Participants will be randomly selected into groups. The researcher will inform the participants and parents about the skin prick test and scales (WB-FACES and CFS). Before the procedure, all participants will be asked verbally about their baseline fear status due to the skin prick test.
Participants in the VR group will put on VR glasses for approximately two minutes before the skin prick test and watch a VR underwater experience video throughout the procedure. Participants in the control group will undergo a routine skin prick test procedure. The VR intervention and skin prick testing will terminate at the same time. The researcher will use a case report form to collect data for participants and their parents. Immediately after the procedure, participants will describe their pain levels with WB-FACES and their fear levels with CFS. Meanwhile, a volunteer parent and a specialist nurse will observe the children's behavior and perform the WB-FACES and CFS evaluations separately. The data collection process will be planned to be completed in approximately ten minutes.
Skin prick test:
Skin prick tests will be performed over the same period by a volunteer nurse with at least 5 years of experience. All participants will undergo the same aeroallergen skin test panel. Skin prick tests will be performed using a prick test applicator (MedBlue One, Türkiye) on the flexural aspect of the forearm by standard guidelines using standardized glycerinated extracts (1% weight/volume) from LOFARMA (Milan, Italy).
Statistical analysis:
SPSS version 23.0 statistical software (IBM SPSS Inc., Chicago, IL, USA) will be used for statistical analysis. Categorical variables will be presented as numbers (%), and continuous variables will be presented as mean±SD and median values (interquartile range-IQR). Univariate analyses including categorical data will be performed using the χ2 test. If data exhibit normality according to the Shapiro-Wilk normality test, parametric values will be analyzed using the Student's t-test, and non-parametric variables will be analyzed using the Mann-Whitney U test. P\<0.05 value was considered statistically significant.
### Conditions Module
**Conditions:**
- Pain
- Fear
- Fear of Pain
- Child, Only
- Allergy
**Keywords:**
- Skin Prick Test
- Virtual Reality
- Pain
- Fear
- Child
- Allergy
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** A Prospective parallel group randomized controlled trial.
##### Masking Info
**Masking:** SINGLE
**Masking Description:** Children aged 4 to 10 years for whom a skin prick test has been decided.
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 50
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Children in the VR group put on VR glasses for approximately two minutes before the skin prick test and watched a VR underwater experience video throughout the procedure.
**Intervention Names:**
- Behavioral: Virtual reality (VR)
**Label:** Experimental: VR
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Children in the control group underwent a routine skin prick test procedure. Control group children did not receive any distraction techniques.
**Label:** No Intervention: Control
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Experimental: VR
**Description:** Children watch underwater experience video by wearing the virtual reality glass during the skin prick test.
**Name:** Virtual reality (VR)
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** Wong-Baker FACES (WB-FACES) Pain Rating Scale used. The Wong-Baker FACES Pain Rating Scale (WB-FACES) was developed in 1981 and revised in 1983. WB-FACES is a reliable scale that has been validated for the Turkish population. The scale is used to diagnose pain in children ages 3-18 years. It consists of six facial expressions, each representing increasing degree of pain scored from 0 to 5 from left to right (0 = very happy face/no pain, 5 = a crying face/worst pain imaginable). High scores indicate low pain tolerance. The child is asked to rate his/her pain by asking "Can you show me the face that shows how you feel right now?".
**Measure:** Skin prick test-related pain
**Time Frame:** Through painful procedure completion, an average of 10 minutes.
**Description:** The Child Fear Scale (CFS) used. The Child Fear Scale (CFS) was developed in 2011. It was adapted into Turkish in 2018, by studying it with children aged 4-10 years. It consists of five facial expressions representing a range from neutral=0 to extreme fear=4.
**Measure:** Skin prick test-related fear
**Time Frame:** Through fearful procedure completion, an average of 10 minutes.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* being between the ages of 4-10 years
* requirement of skin prick test due to allergic diseases
Exclusion Criteria:
* having chronic diseases (except allergic diseases)
* vision, hearing, and speech disorders
* psychiatric and neurological diseases
* mental status disorder, learning and perception disorder
* a history of pre-procedure sedative, analgesic or narcotic drug use within 24 hours
* a history of active infection
* those who are scheduled to undergo a skin test other than an aeroallergen panel
* contra-indicated conditions for skin prick testing such as dermographism, severe eczema, being under drugs (immunosuppressive drugs, antihistamine, steroid, etc)
**Healthy Volunteers:** True
**Maximum Age:** 10 Years
**Minimum Age:** 4 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Cihangir Sahin
**Phone:** +905544113216
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Aydin
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Cihangir Sahin
- **Phone:** +905544113216
- **Role:** CONTACT
**Country:** Turkey
**Facility:** Aydin Adnan Menderes University, School of Medicine, Department of Pediatric Immunology and Allergy
**Status:** RECRUITING
**Zip:** 09100
#### Overall Officials
**Official 1:**
**Affiliation:** Aydin Adnan Menderes University, Department of Pediatric Immunology and Allergy, Aydin, Türkiye
**Name:** Cihangir Sahin
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007154
- Term: Immune System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M10018
- Name: Hypersensitivity
- Relevance: HIGH
- As Found: Allergy
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000006967
- Term: Hypersensitivity
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06421766
**Brief Title:** Retrospective Study of Outcomes With 3 mm Implant for Percutaneous BAHS Procedures
**Official Title:** Retrospective Study of Outcomes With 3 mm Implant for Percutaneous Bone-anchored Hearing System (BAHS) Procedures
#### Organization Study ID Info
**ID:** BC122
#### Organization
**Class:** INDUSTRY
**Full Name:** Oticon Medical
### Status Module
#### Completion Date
**Date:** 2024-09
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-14
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-09
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-03-08
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-23
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Oticon Medical
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** True
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** This retrospective study is conducted to gain more knowledge on use and complications of 3mm long implants used in percutaneous (through the skin) bone-anchored hearing system (BAHS) surgeries in adults. Patients included have already been treated and recieved an implant with the wide diameter (Ø: 4.5 mm) design, either of 3- or 4mm length. The main purpose of the study is to investigate implant survival three months after implantation.
**Detailed Description:** BAHS systems are intended for patients with conductive or mixed hearing loss, and for patients with single-sided deafness. In BAHS surgery, an implant - coupled to a skin-penetrating abutment - is implanted in the bone behind the ear and is later loaded with a sound processor. The sound processor transforms sound waves to sound vibrations that are transferred through the skull bone to the inner ear(s)/cochlea. Thus, sound can be transmitted directly to the cochlea and bypass any problems in the ear canal or middle ear. Today, more than 400,000 implantations have been made around the world and the long-term success rate of BAHS surgery is high, with a low rate of major complications.
Over the years, both implant design and surgical techniques have developed, with improved patient outcomes as a result. Wider diameter implants, 4.5mm in diameter, increased the implant stability and have become standard. The implants exist in two different lengths, 3- and 4mm, to accomodate for different bone thickness. The shorter implant has primarily been used for (young) children and for adults with thinner bone. The aim of this restrospective study is to investigate the outcomes after implantation of a 3mm implant in an adult population.
### Conditions Module
**Conditions:**
- Hearing Loss
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 240
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients recieving a 3mm long implant
**Intervention Names:**
- Device: BAHS
**Label:** 3mm implant
#### Arm Group 2
**Description:** Patients recieving a 4mm long implant
**Intervention Names:**
- Device: BAHS
**Label:** 4mm implant
### Interventions
#### Intervention 1
**Arm Group Labels:**
- 3mm implant
- 4mm implant
**Description:** Implantation of a percutaneous bone-anchored hearing system
**Name:** BAHS
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Implant in place in skull bone at 3 months (Yes/No).
**Measure:** Implant survival
**Time Frame:** 3 months after implant surgery
#### Secondary Outcomes
**Description:** Implant in place in skull bone at end of observation (Yes/No).
**Measure:** Implant survival
**Time Frame:** Through study completion, with minimum 3 months
**Description:** Assessment of intraoperative events during surgery by the investigator. Will be presented in a frequency table.
**Measure:** Number and type of intraoperative events
**Time Frame:** During surgery
**Description:** Assessment of postoperative events during the initial postoperative period (0-3 months) by the investigator. Will be presented in a frequency table.
**Measure:** Number and type of postoperative events
**Time Frame:** Up to 3 months
**Description:** Time from surgery to sound processor loading
**Measure:** Time to sound processor loading
**Time Frame:** Up to 3 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Adult patient (≥19 years) receiving percutaneous BAHS treatment using an implant with the wide diameter (Ø: 4.5 mm) design.
Exclusion Criteria:
* Patient undergoing re-implantation due to previous failure of osseointegration or other spontaneous implant loss.
* Patient undergoing conversions from passive transcutaneous devices (i.e. BAHA Attract) to active percutaneous devices (using an abutment), using the same implant for attachment.
**Minimum Age:** 19 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Patients that have already obtained surgical intervention with a percutaneous bone anchored hearing system.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Sara Svensson, PhD
**Phone:** +46735042041
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Nicole Amichetti, PhD
**Phone:** +1 609-366-0424
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Birmingham
**Contacts:**
***Contact 1:***
- **Name:** Dennis G Pappas, MD
- **Role:** CONTACT
**Country:** United States
**Facility:** Alabama Ear Specialists
**State:** Alabama
**Status:** RECRUITING
**Zip:** 25233
#### Overall Officials
**Official 1:**
**Affiliation:** Alabama Ear Specialists
**Name:** Dennis G Pappas, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## 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 Loss
- ID: M6840
- Name: Deafness
- Relevance: LOW
- As Found: Unknown
- 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
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06421753
**Acronym:** SDSS_UMS
**Brief Title:** Efficiency of Spatially Distributed Sequential Stimulation (Sdss) for Functional Electrical Stimulation (FES) of Upper Motor Neuron Syndrome (UMR) Patients
**Official Title:** Efficiency of Spatially Distributed Sequential Stimulation (Sdss) for Functional Electrical Stimulation (FES) of Upper Motor Neuron Syndrome (UMR) Patients
#### Organization Study ID Info
**ID:** 2024-01-VR
#### Organization
**Class:** OTHER
**Full Name:** UGECAM Rhône-Alpes
### Status Module
#### Completion Date
**Date:** 2024-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-17
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-07-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-14
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** UGECAM Rhône-Alpes
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** To determine whether Spatially Distributed Sequential Functional Electrical Stimulation is more effective than Standard Electrical Stimulation During Functional Electrical Stimulation in Upper Motor Neuron Patients
**Detailed Description:** Design: SCED (single case experimental design) prospective, monocentric, comparative interventional study (SDSS versus SES) Population: patients with motor deficit due to upper motor neuron syndrome Setting: Neurologic Rehabilitation Unit Interventions: 3 FES cycling sessions separated by 48h of rest. Each session is comprised of 2 phases separated by 20 minutes of rest. Each phase is comprised of a 3 minutes passive cycling warm-up, followed by 3 minutes of electrically stimulated cycling.
Participants will be evaluated before and during the training.
### Conditions Module
**Conditions:**
- Upper Motor Neuron Disease
**Keywords:**
- functional electrical stimulation
- muscle fatigue
- rehabilitation
- spinal cord injury
- stroke
- multiple sclerosis
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
**Intervention Model Description:** SCED : Single Case Experimental Design Each patient is his own control Patient will be randomised to receive FES-cycling with SDSS or standard electrical stimulation
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 10
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Interventions: 3 FES cycling sessions separated by 48h of rest. Each session is comprised of 2 phases separated by 20 minutes of rest. Each phase is comprised of a 3 minutes passive cycling warm-up, followed by 3 minutes of electrically stimulated cycling.
**Intervention Names:**
- Device: SDSS
**Label:** Spatially Distributed Sequential Functional Electrical Stimulation
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Each session begins with a 3-minute warm-up phase, followed by a 3-minute stimulation phase. The motor rotates the legs at 50 rpm during both phases. The type of stimulation used in the first phase is chosen randomly. After a 20-minute break, the second warm-up and stimulation phases are carried out. During the second session, the order of the stimulation phases is reversed.
**Intervention Names:**
- Device: Standard Electrical Stimulation During Functional Electrical Stimulation
**Label:** Standard Electrical Stimulation During Functional Electrical Stimulation
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Spatially Distributed Sequential Functional Electrical Stimulation
**Description:** Each session begins with a 3-minute warm-up phase, followed by a 3-minute stimulation phase. The motor rotates the legs at 50 rpm during both phases. The type of stimulation used in the first phase is chosen randomly. After a 20-minute break, the second warm-up and stimulation phases are carried out During the second session, the order of the stimulation phases is reversed.
**Name:** SDSS
**Type:** DEVICE
#### Intervention 2
**Arm Group Labels:**
- Standard Electrical Stimulation During Functional Electrical Stimulation
**Description:** Each session begins with a 3-minute warm-up phase, followed by a 3-minute stimulation phase. The motor rotates the legs at 50 rpm during both phases. The type of stimulation used in the first phase is chosen randomly. After a 20-minute break, the second warm-up and stimulation phases are carried out During the second session, the order of the stimulation phases is reversed.
**Name:** Standard Electrical Stimulation During Functional Electrical Stimulation
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** The subjects are installed on a Hepha Bike electrostimulation bike, equipped with force-torque measuring pedals (ICS_RM, Sensix, France), synchronized with a MotiMove-8 stimulator. The average quadriceps power (watts) during the first and last 30 seconds of each stimulation phase, as well as the total average power (Pm) are calculated.
**Measure:** Average quadriceps power output (watts) measured during 3 minutes of FES cycling
**Time Frame:** during sessions of FES cycling
#### Secondary Outcomes
**Description:** Dry electrode then hydrogel electrode are placed on the quadriceps' motor point The amplitude of stimulation is increased in steps of 3 mA followed by 5 seconds of rest for subsequent trains until the subject feels a burning sensation. the stimulation threshold (mA) is compared between dry and hydrogel electrode
**Measure:** Evaluate the comfort of dry and hydrogel based functional electrical stimulation electrodes
**Time Frame:** before the first session of FES cycling
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
Patients with Upper Motor Neuron syndrome:
* adult (\> 18 years)
* motor deficit due to an acquired traumatic or neurodegenerative motor deficiency of the central nervous system (MRC\<4/5)
* stable clinical condition, particularly on the cardiovascular level (recent assessment by a cardiologist with stress test)
* non denervated muscles
* tolerant to muscle electrical stimulation
* having given written consent
* able to cycle 30 minutes with FES-cycling
Exclusion Criteria:
* major cognitive comprehension disorders that could compromise understanding of the protocol and the smooth running of the study
* cardiac pacemaker and other contraindications relating to the use of electrostimulation (in particularly "deep vein thrombosis")
* spasticity of the lower limbs making flexion/extension movement difficult
* participation in another study
* pregnancy
* people with the following legal and administrative states or situations:
* people placed under judicial protection;
* persons deprived of their liberty, persons subject to psychiatric care and persons admitted to a health or social establishment for purposes other than that of clinical investigation;
* unemancipated minors;
* people who are not affiliated to a social security scheme or beneficiaries of such a scheme
**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:** julie di marco, MD
**Phone:** 01133472532161
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** sarah finel
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Saint didier au mont d'or
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** julie di marco, MD
- **Phone:** 01133472532161
- **Role:** CONTACT
***Contact 2:***
- **Name:** julie di marco, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** France
**Facility:** SMR Val Rosay
**Status:** RECRUITING
**Zip:** 69370
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000019636
- Term: Neurodegenerative Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000009468
- Term: Neuromuscular Diseases
- ID: D000013118
- Term: Spinal Cord Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000057177
- Term: TDP-43 Proteinopathies
- ID: D000057165
- Term: Proteostasis Deficiencies
- ID: D000008659
- Term: Metabolic 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: BC23
- Name: Symptoms and General Pathology
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M22306
- Name: Stroke
- Relevance: LOW
- As Found: Unknown
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M15916
- Name: Spinal Cord Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M12060
- Name: Multiple Sclerosis
- Relevance: LOW
- As Found: Unknown
- ID: M15415
- Name: Sclerosis
- Relevance: LOW
- As Found: Unknown
- ID: M18879
- Name: Motor Neuron Disease
- Relevance: HIGH
- As Found: Motor Neuron Disease
- ID: M4024
- Name: Amyotrophic Lateral Sclerosis
- Relevance: HIGH
- As Found: Motor Neuron Disease
- ID: M8364
- Name: Fatigue
- 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: M15915
- Name: Spinal Cord Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M28759
- Name: TDP-43 Proteinopathies
- Relevance: LOW
- As Found: Unknown
- ID: M28747
- Name: Proteostasis Deficiencies
- Relevance: LOW
- As Found: Unknown
- ID: M11639
- Name: Metabolic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T349
- Name: Amyotrophic Lateral Sclerosis
- Relevance: HIGH
- As Found: Motor Neuron Disease
- ID: T4699
- Name: Primary Lateral Sclerosis
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000016472
- Term: Motor Neuron Disease
- ID: D000000690
- Term: Amyotrophic Lateral Sclerosis
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06421740
**Acronym:** REACH-AD
**Brief Title:** An Observational Study to Assess Real-World Use of Upadacitinib Tablets in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis in China
**Official Title:** REal-world Utilization and Treatment Target ACHievement With Upadacitinib in Adolescents and Adults With Moderate to Severe Atopic Dermatitis in China
#### Organization Study ID Info
**ID:** P24-965
#### Organization
**Class:** INDUSTRY
**Full Name:** AbbVie
### Status Module
#### Completion Date
**Date:** 2026-06-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-15
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-06-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-20
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** AbbVie
#### 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:** Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin.
Upadacitinib is an approved drug for treating AD. Approximately 1000 adolescents and adult participants who are prescribed upadacitinib by their physician in accordance with local label will be enrolled in up to 40 sites in China.
Participants will receive oral upadacitinib tablets as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed up for approximately 12 months.
There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.
### Conditions Module
**Conditions:**
- Atopic Dermatitis
**Keywords:**
- Upadacitinib
- Rinvoq
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 1000
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants will receive upadacitinib as prescribed by their physician according to local label.
**Label:** Upadacitinib
### Outcomes Module
#### Primary Outcomes
**Description:** Dose change includes: Changed dose, dose escalation or dose tapering.
**Measure:** Number of participants with a dose change
**Time Frame:** 12 Months
**Description:** Interruption: Upadacitinib is temporarily interrupted due to atopic dermatitis disease condition, economic, tolerance, AE, or personal reasons, and the investigator considers there is still possibility of Upadacitinib re-initiating within the patient's study follow-up period.
Discontinuation: Upadacitinib is permanently discontinued for safety or any other reasons, and the investigator considers Upadacitinib will not be used again, at least within the participant's study follow-up period.
**Measure:** Number of participants with interruption or permanent discontinuation
**Time Frame:** 12 Months
**Description:** The participants missed medication, regardless of reason, or incompliance with the prescription as per medical advice are to be recorded in the eDiary, choosing the reason: "Forgot, Self-reduction of medication, interruption because of AE, interruption not due to safety/tolerability, for other reasons".
If no eDiary entries are found within 30 days before the visit, the participant will need to complete the following question in ePRO: timely Upadacitinib intake per medical advice in past 30 days (yes/no); if "no", days-off-drug, intentionally or accidentally, and if "intentionally", reason for incompliance with medical prescription.
**Measure:** Number of participants with Upadacitinib drug compliance
**Time Frame:** 12 Months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Adolescents (body weight \>= 40 kg at the Baseline Visit for patients between \>= 12 and \< 18 years of age) and adults at the time of enrollment.
* Clinical diagnosis of moderate to severe atopic dermatitis at the time of enrollment.
* UPA treatment is indicated for AD and prescribed as per Chinese label / SmPC.
* The decision to prescribe UPA is made prior to and independent of study participation.
* The participant should not be treated with UPA prior to this study.
* Participants who are willing and able to participate in the collection of patient-reported data, including ePROs and eDiary via apps.
* The participant (legal representative for adolescents) voluntarily signed an informed consent before any study-related activities are conducted.
Exclusion Criteria:
* The participant is currently participating in interventional research (not including noninterventional study, observational study, or registry participation).
* Any circumstances that the investigator believes may limit the patient's participation and compliance with study procedures.
**Minimum Age:** 12 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
**Study Population:** Adolescent and adult Chinese participants with atopic dermatitis (AD) who are prescribed Upadacitinib by their physician according to their local label.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Judy Yu
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** AbbVie
**Name:** ABBVIE INC.
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
### References Module
#### See Also Links
**Label:** Related Info
**URL:** https://www.abbvieclinicaltrials.com/study/?id=P24-965
## 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: BC16
- Name: Diseases and Abnormalities at or Before Birth
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M7071
- Name: Dermatitis, Atopic
- Relevance: HIGH
- As Found: Atopic Dermatitis
- ID: M7067
- Name: Dermatitis
- Relevance: HIGH
- As Found: Dermatitis
- ID: M7655
- Name: Eczema
- Relevance: HIGH
- As Found: Atopic Dermatitis
- 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
- ID: D000004485
- Term: Eczema
### Intervention Browse Module - Browse Branches
- Abbrev: ARhu
- Name: Antirheumatic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M275493
- Name: Upadacitinib
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06421727
**Brief Title:** Rehabilitation Of Balance Function In Patients With Persistent Postural Perceptual Dizziness.
**Official Title:** Rehabilitation Of Balance Function In Patients With Persistent Postural Perceptual Dizziness: A Longitudinal Study
#### Organization Study ID Info
**ID:** Soh-Med-24-01-06MD
#### Organization
**Class:** OTHER
**Full Name:** Sohag University
### Status Module
#### Completion Date
**Date:** 2026-03-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-17
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-01-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-30
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-20
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Sohag University
#### Responsible Party
**Investigator Affiliation:** Sohag University
**Investigator Full Name:** Nada Mostafa Abdelhamid
**Investigator Title:** Assistant lecturer
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Rehabilitation Of Balance Function In Patients With Persistent Postural Perceptual Dizziness: A longitudinal Study
**Detailed Description:** this study will be conducted to show the long term effect of combined vestibular rehabilitation incorporating optokinetic stimulation and virtual reality exercises on persistent postural perceptual dizziness patients.
Aim:1.Evaluate the balance control function in patients with persistent postural perceptual dizziness using computerized dynamic posturography.
2.To study effect of rehabilitation using optokinetic stimulation and virtual reality on persistent postural perceptual dizziness patients.
3.To follow up patients after the vestibular rehabilitation therapy to study the persistence of improvement" if any" in patients with persistent postural perceptual dizziness .
Type of the study : prospective cohort and longitudinal study. Sources of data : Audio-vestibular medicine unit , Sohag University Hospital. Study group : consists of 36 patients age ranged from 18-65 years suffering from symptoms of persistent postural perceptual vertigo.
All subjects will be submitted to:
A- Detailed medical history, full history of dizziness. B-Acoustic impedance test. C-Basic audiological evaluation. D- Vestibular assessment.
### Conditions Module
**Conditions:**
- Persistent Postural Perceptual Dizziness
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** combined vestibular rehabilitation incorporating optokinetic stimulation and virtual reality exercises on persistent postural perceptual dizziness patients.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 36
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** combined vestibular rehabilitation incorporating optokinetic stimulation and virtual reality exercises (by device Virtual reality system(Meta Quest 2_Advanced All-In-One Virtual Reality Headset_ 128 GB)) on persistent postural perceptual dizziness patients.
**Intervention Names:**
- Other: Rehabilitation by optokinetic stimulation and virtual reality exercises .
**Label:** Rehabilitation by optokinetic stimulation and virtual reality exercises .
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Rehabilitation by optokinetic stimulation and virtual reality exercises .
**Description:** Rehabilitation by optokinetic stimulation and virtual reality exercises(by deviceVirtual reality system(Meta Quest 2_Advanced All-In-One Virtual Reality Headset_ 128 GB)).
**Name:** Rehabilitation by optokinetic stimulation and virtual reality exercises .
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Improvement of dizziness measured by Computerized dynamic posturography:6 conditions, the maximum handicap score 0/6 and the minimum 6/6.
**Measure:** Rehabilitation Of Balance Function In Patients With Persistent Postural Perceptual Dizziness : A longitudinal Study
**Time Frame:** 2 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age: from 18 years to 65 years old.
* Gender: males and females.
* Can withstand and willing to undergo repeated vestibular rehabilitation therapy .\*No history of any disease required to give treatment that could affect results.
Exclusion Criteria:
* Neurological disorders, paresis, paralysis, motor disorder, ataxia, brain mass, multiple sclerosis and stroke with grade 4 muscle power or below.
* Otological disorders e.g. middle ear pathology (chronic suppurative otitis media, Tumor).
* Psychiatric disorders e.g. Schizophrenia and endogenous depression.
* Severely ill patients who would not tolerate vestibular rehabilitation therapy .
**Healthy Volunteers:** True
**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:** nada elhakeem
**Phone:** 01000401121
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** mostafa yossif
**Phone:** 01001313395
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** sohag university hospital
**Name:** Maha Ahmed
**Role:** STUDY_CHAIR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012678
- Term: Sensation Disorders
- ID: D000009461
- Term: Neurologic Manifestations
- ID: D000015837
- Term: Vestibular Diseases
- ID: D000007759
- Term: Labyrinth Diseases
- ID: D000004427
- Term: Ear Diseases
- ID: D000010038
- Term: Otorhinolaryngologic Diseases
- 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: M17462
- Name: Vertigo
- Relevance: HIGH
- As Found: Dizziness
- ID: M7420
- Name: Dizziness
- Relevance: HIGH
- As Found: Dizziness
- ID: M15490
- Name: Sensation Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: M18387
- Name: Vestibular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10779
- Name: Labyrinth Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10782
- Name: Labyrinthitis
- 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
### Condition Browse Module - Meshes
- ID: D000014717
- Term: Vertigo
- ID: D000004244
- Term: Dizziness
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06421714
**Brief Title:** A Study of the Safety, Tolerability, and Pharmacokinetics of Orally Administered Venglustat and Itraconazole in Healthy Adult Male Participants
**Official Title:** A Phase I, Single-Center, Open-Label, Two-Period, Single Sequence, Two Treatment Drug-Drug Interaction Study of GZ/SAR402671 (Venglustat) and Itraconazole in Healthy Male Subjects
#### Organization Study ID Info
**ID:** INT14339
#### Organization
**Class:** INDUSTRY
**Full Name:** Sanofi
#### Secondary ID Infos
**ID:** 2014-002550-39
**Type:** EUDRACT_NUMBER
### Status Module
#### Completion Date
**Date:** 2018-10-14
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-17
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2018-10-14
**Type:** ACTUAL
#### Start Date
**Date:** 2018-08-16
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Genzyme, a Sanofi Company
#### 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 assess in healthy adult male participants the effects of itraconazole on the pharmacokinetics of venglustat and to assess the safety and tolerability of venglustat with and without coadministration of itraconazole. The maximum duration for participants from screening is between 32 to 62 days.
**Detailed Description:** Total study duration for participants is up to 62 days including screening up to 28 days, 1 day of treatment in period 1, washout of 7 days, 13 days of treatment in period 2, and follow up period 10-14 days after last dose.
### Conditions Module
**Conditions:**
- Healthy Volunteers
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 8
**Type:** ACTUAL
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The first period will include a single dose administration of venglustat followed by a second period including a multiple dose administration of itraconazole for 12 days and a second single dose administration of venglustat on the 6th day of itraconazole administration
**Intervention Names:**
- Drug: Venglustat
- Drug: Itraconazole
**Label:** Venglustat and Itraconazole
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Venglustat and Itraconazole
**Description:** Pharmaceutical form:Capsule-Route of administration:Oral
**Name:** Venglustat
**Other Names:**
- GZ/SAR402671
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Venglustat and Itraconazole
**Description:** Pharmaceutical form:Capsule-Route of administration:Oral
**Name:** Itraconazole
**Other Names:**
- ITZ
- Sporanox
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Measure:** Area under the plasma concentration versus time curve (AUC) of venglustat
**Time Frame:** Multiple time points up to 21 days
**Measure:** Area under the plasma concentration versus time curve calculated from time zero to the real time (tlast) (AUClast) of venglustat
**Time Frame:** Multiple time points up to 21 days
#### Secondary Outcomes
**Measure:** Maximum plasma concentration observed (Cmax) of venglustat
**Time Frame:** Multiple time points up to 21 days
**Measure:** Plasma concentration observed just before treatment administration during repeated dosing (Ctrough) of venglustat
**Time Frame:** Multiple time points up to 21 days
**Measure:** Time to reach Cmax (tmax) of venglustat
**Time Frame:** Multiple time points up to 21 days
**Measure:** Terminal half-life (t1/2) of venglustat
**Time Frame:** Multiple time points up to 21 days
**Measure:** Maximum plasma concentration observed (Cmax) of itraconazole
**Time Frame:** Multiple time points up to 21 days
**Measure:** Plasma concentration observed just before treatment administration during repeated dosing (Ctrough) of itraconazole
**Time Frame:** Multiple time points up to 21 days
**Measure:** Time to reach Cmax (tmax) of itraconazole
**Time Frame:** Multiple time points up to 21 days
**Measure:** Area under the plasma concentration versus time curve calculated over the dosing interval (12 h) (AUC0-12) of itraconazole
**Time Frame:** Multiple time points up to 21 days
**Measure:** Maximum plasma concentration observed (Cmax) of hydroxyitraconazole
**Time Frame:** Multiple time points up to 21 days
**Measure:** Plasma concentration observed just before treatment administration during repeated dosing (Ctrough) of hydroxyitraconazole
**Time Frame:** Multiple time points up to 21 days
**Measure:** Time to reach Cmax (tmax) of hydroxyitraconazole
**Time Frame:** Multiple time points up to 21 days
**Measure:** Area under the plasma concentration versus time curve over the dosing interval (12 h) (AUC0-12) of hydroxyitraconazole
**Time Frame:** Multiple time points up to 21 days
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria: -Male participants, between 18 and 55 years of age, inclusive.
* Body weight between 50.0 and 100.0 kg, inclusive, body mass index between 18.0 and 30.0 kg/m2, inclusive.
* Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).
* Normal vital signs, electrocardiogram, and laboratory parameters.
* Having given written informed consent prior to undertaking any study-related procedure.
* Not under any administrative or legal supervision.
* Male participant, whose partners are of childbearing potential (including lactating women), must accept to use, during sexual intercourse, a double contraception method according to the following algorithm: (condom) plus (spermicide or intra-uterine device or hormonal contraceptive) from the inclusion up to 4 months after the last dosing.
* Male participant, whose partners are pregnant, must use, during sexual intercourse, a condom from the inclusion up to 4 months after the last dosing.
* Male participant has agreed not to donate sperm from the inclusion up to 4 months after the last dosing. Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply:
* Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness.
* Frequent headaches and/or migraine, recurrent nausea and/or vomiting (for vomiting only: more than twice a month).
* Blood donation, any volume, within 2 months before inclusion.
* Symptomatic postural hypotension excluding vasovagal episode associated with a blood draw.
* Presence or history of clinically significant drug hypersensitivity, or allergic disease diagnosed and treated by a physician.
* History or presence of drug or alcohol abuse (alcohol consumption more than 40 g per day on a regular basis).
* Smoking regularly more than 5 cigarettes or equivalent per week, unable to stop smoking during the study (occasional smoker can be enrolled). Excessive consumption of beverages containing xanthine bases (more than 4 cups or glasses per day).
* Any medication (including St John's Wort) within 14 days before inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of the medication, with the exception of hormonal contraception or menopausal hormone replacement therapy; any vaccination within the last 28 days and any biologics (antibody or its derivatives) given within 4 months before inclusion.
* Positive result on any of the following tests: hepatitis B surface (HBs Ag) antigen, anti hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency Virus 1 and 2 antibodies (anti-HIV1 and anti HIV2 Ab).
* Positive result on urine drug screen or urine alcohol test.
* Any contraindications to itraconazole, according to the applicable labeling.
**Healthy Volunteers:** True
**Maximum Age:** 55 Years
**Minimum Age:** 18 Years
**Sex:** MALE
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Austin
**Country:** United States
**Facility:** PPD
**State:** Texas
**Zip:** 78744
### IPD Sharing Statement Module
**Description:** Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
**IPD Sharing:** YES
## Derived Section
### Intervention Browse Module - Ancestors
- ID: D000000935
- Term: Antifungal Agents
- ID: D000000890
- Term: Anti-Infective Agents
- ID: D000058888
- Term: 14-alpha Demethylase Inhibitors
- ID: D000065607
- Term: Cytochrome P-450 Enzyme Inhibitors
- ID: D000004791
- Term: Enzyme Inhibitors
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000065088
- Term: Steroid Synthesis Inhibitors
- ID: D000006727
- Term: Hormone Antagonists
- ID: D000006730
- Term: Hormones, Hormone Substitutes, and Hormone Antagonists
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000065692
- Term: Cytochrome P-450 CYP3A 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: M20133
- Name: Itraconazole
- Relevance: HIGH
- As Found: Part A
- ID: M349697
- Name: Venglustat
- Relevance: HIGH
- As Found: Cigarette use
- ID: M256158
- Name: Hydroxyitraconazole
- 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: M7951
- Name: Enzyme Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M30537
- Name: Cytochrome P-450 Enzyme Inhibitors
- 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: M30564
- Name: Cytochrome P-450 CYP3A Inhibitors
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000017964
- Term: Itraconazole
- ID: C000608118
- Term: Venglustat
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06421701
**Brief Title:** Anti-CD19 CAR-NK Cells in Refractory/Relapsed Systemic Lupus Erythematosus
**Official Title:** A Clinical Study of Anti-CD19 CAR-NK Cells in the Treatment of Refractory/Relapsed Systemic Lupus Erythematosus
#### Organization Study ID Info
**ID:** 2024-0530
#### Organization
**Class:** OTHER
**Full Name:** Second Affiliated Hospital, School of Medicine, Zhejiang University
### Status Module
#### Completion Date
**Date:** 2026-05-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-17
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-08-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Second Affiliated Hospital, School of Medicine, Zhejiang 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:** This study is a single-center, open-label, single-arm, dose-escalation trial. The aim of this study is to investigate the safety and efficacy of anti-CD19 CAR-NK cells in patients with refractory/relapsed systemic lupus erythematosus.
### Conditions Module
**Conditions:**
- Systemic Lupus Erythematosus
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 10
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** To evaluate the safety and efficacy of anti-CD19 CAR-NK cells in patients with refractory/relapsed systemic lupus erythematosus. All subjects will receive fludarabine/cyclophosphamide lymphodepletion followed by anti-CD19 CAR-NK cells infusion on Day 0, 7, and 14.
**Intervention Names:**
- Drug: anti-CD19 CAR-NK cells
**Label:** anti-CD19 CAR-NK cells
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- anti-CD19 CAR-NK cells
**Description:** Patients will receive Fludarabine (25 mg/m2 per day) and Cyclophosphamide (500mg/m2 per day) on day -5, -4, and -3. Doses of 2×10\^6/kg, 3×10\^6/kg, 4×10\^6/kg anti-CD19 CAR-NK cells will be infused in each group on Day 0, 7, and 14 using the "3 + 3" dose-escalation strategy.
**Name:** anti-CD19 CAR-NK cells
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** DLT definition is dose-limiting toxicity.
**Measure:** The proportion of subjects with DLT
**Time Frame:** Within 28 days after anti-CD19 CAR-NK cells infusion
**Description:** Incidence and severity of AEs and SAEs, including changes in laboratory values, ECG and vital signs as assessed by CTCAE v5.0.
**Measure:** The proportion of subjects with adverse events
**Time Frame:** 12 months
#### Secondary Outcomes
**Description:** Proportion of patients with SRI-4 response: including SELENA-SLEDAI ≥4-Point improvement, BILAG 2004 with no new A domain score AND no more than 1 new B domain scores, PGA with No worsening (\<0.3-point increase).
**Measure:** Proportion of subjects with Systemic Lupus Erythematosus Responder Index-4 (SRI-4) response
**Time Frame:** 4, 8, 12, 16, 20, 24, 36 and 52 weeks after infusion
**Description:** The Definition of Remission in SLE (DORIS) is a standardized criterion to clearly define what constitutes remission in patients with systemic lupus erythematosus.
**Measure:** Proportion of participants achieving definition of remission in SLE (DORIS) remission
**Time Frame:** 4, 8, 12, 16, 20, 24, 36 and 52 weeks after infusion
**Description:** The Lupus Low Disease Activity State (LLDAS) is a clinical treatment target designed for patients with systemic lupus erythematosus. It represents a state where the disease activity is kept at a low level, aiming to minimize symptoms and prevent long-term damage caused by the disease.
**Measure:** Proportion of participants achieving Lupus Low Disease Activity State (LLDAS)
**Time Frame:** 4, 8, 12, 16, 20, 24, 36 and 52 weeks after infusion
**Description:** Assessment of SLEDAI-2000 from baseline administration at various timepoints up to month 12 follow up visit.
**Measure:** Changes in the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2000) score from baseline
**Time Frame:** Within 12 months after anti-CD19 CAR-NK cell infusion
**Description:** Assessment of SELENA-SLEDAI from baseline administration at various timepoints up to month 12 follow up visit.
**Measure:** Changes in the Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) - Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) score from baseline
**Time Frame:** Within 12 months after anti-CD19 CAR-NK cell infusion
**Description:** Assessment of BILAG-2004 from baseline administration at various timepoints up to month 12 follow up visit.
**Measure:** Changes in the British Isles Lupus Assessment Group 2004 index (BILAG-2004) from baseline
**Time Frame:** Within 12 months after anti-CD19 CAR-NK cell infusion
**Description:** Assessment of PGA from baseline administration at various timepoints up to month 12 follow up visit.
**Measure:** Changes in the Physician Global Assessment (PGA) from baseline
**Time Frame:** Within 12 months after anti-CD19 CAR-NK cell infusion
**Description:** Assessment of 24h proteinuria or urine protein creatinine ratio (UPCR) from baseline administration at various timepoints up to month 12 follow up visit.
**Measure:** Change in proteinuria measured by 24h proteinuria or urine protein creatinine ratio (UPCR) from baseline
**Time Frame:** Within 12 months after anti-CD19 CAR-NK cell infusion
**Description:** Assessment of ANA from baseline administration at various timepoints up to month 12 follow up visit.
**Measure:** Changes in level of anti-nuclear antibody (ANA) in peripheral blood from baseline
**Time Frame:** Within 12 months after anti-CD19 CAR-NK cell infusion
**Description:** Assessment of C3 and C4 from baseline administration at various timepoints up to month 12 follow up visit.
**Measure:** Changes in levels of complement C3 and C4 in peripheral blood from baseline
**Time Frame:** Within 12 months after anti-CD19 CAR-NK cell infusion
**Description:** CMAX is defined as the highest concentration of anti-CD19 CAR-NK cell expansion in the peripheral blood.
**Measure:** CMAX of anti-CD19 CAR-NK cells
**Time Frame:** 3 months
**Description:** TMAX is defined as the time to reach the highest concentration of anti-CD19 CAR-NK cell expansion in the peripheral blood.
**Measure:** TMAX of anti-CD19 CAR-NK cells
**Time Frame:** 3 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Voluntarily participate in this clinical study, sign an informed consent form, have good compliance, and cooperate with follow-up;
* Age range from 18 to 65 years old, regardless of gender;
* Fulfilling the 2019 ACR/EULAR classification criteria of SLE;
* Presence of anti-dsDNA or anti-Sm antibodies and decreased C3 or C4 levels;
* SELENA-SLEDAI≥8；
* Subject has ≥ 1 organ system with BILAG-2004 Class A mobility score or ≥ 2 organ systems with BILAG-2004 Class B mobility score prior to screening;
* Routine treatment is ineffective or the disease relapses after remission. Definition of routine treatment: use more than two drugs, including glucocorticoid (more than 1mg/kg/d), and any two or more of the following immunomodulatory drugs for more than 6 months: cyclophosphamide, mycophenolate mofetil, azathioprine, methotrexate, leflunomide, tacrolimus, ciclosporin, and biological agents, including rituximab, belizumab, or telitacicept；
* Hemoglobin ≥ 85g/L; white blood cell count ≥ 3 × 10\^9/L；neutrophil count ≥ 1.5 × 10\^9/L; platelets ≥ 50 × 10\^9/L;
* The functions of important organs are basically normal: ALT ≤ 2 × ULN; AST ≤ 2 × ULN; eGFR ≥ 60ml/min/1.73m2; total bilirubin ≤2.0 mg/dL; cardiac function: left ventricular ejection fraction (LVEF) ≥ 50%; non-oxygenated blood oxygen saturation \>94%; prothrombin time (PT) ≤ 1.5 × ULN；international standardized ratio (INR) ≤ 1.5 × ULN；
* Females of childbearing potential must use effective contraception during the study. In addition, subjects must not donate eggs during the study and for at least 90 days after the last dose of study treatment；
Exclusion Criteria:
* History of severe allergy or known hypersensitivity to any of the active ingredients of the cell product；
* Pregnant (or lactating) women;
* Severe lupus nephritis (defined as serum creatinine \> 2.5 mg/dL or 221 μmol/L), treatment with hemodialysis within 8 weeks prior to screening；
* Other lupus crises, such as active central nervous system lupus, severe hemolytic anemia, severe thrombocytopenic purpura, severe agranulocytosis, severe myocardial damage, severe lupus pneumonia or pulmonary hemorrhage, severe lupus hepatitis, and severe vasculitis within 8 weeks prior to screening；
* Combined with other autoimmune diseases requiring systemic therapy;
* Clinically significant central nervous system diseases or pathological changes not caused by lupus prior to screening, including but not limited to: cerebrovascular accident, aneurysm, epilepsy, convulsions/convulsions, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis;
* Abnormal test results for hepatitis B or C indicate the presence of an active or chronic infection, including positive HBsAg or positive HBcAb with HBV DNA levels exceeding the normal upper limit，positive hepatitis C antibody and detectable HCV RNA；positive serology for human immunodeficiency virus (HIV) or a known history of HIV infection；
* Cytomegalovirus DNA levels and EB (Epstein-Barr) virus DNA levels in the peripheral blood exceeding the normal upper limits；
* Active or latent tuberculosis；
* Presence of uncontrollable bacterial, fungal, viral or other infections, requiring antibiotic therapy;
* Acquired and congenital immunodeficiency diseases；
* IgA deficiency;
* Other uncontrolled diseases: acute or chronic diseases that are clinically unstable or have not been effectively controlled and are not related to SLE；
* History of malignant diseases such as malignant tumors, except for adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, superficial bladder cancer, breast cancer;
* Any active skin disease that may interfere with the study assessment of SLE, including but not limited to psoriasis, dermatomyositis, systemic sclerosis, non-LE cutaneous lupus manifestations (eg, cutaneous vascular disease, periungual telangiectasia, fingertip sclerosis, rheumatoid nodules, erythema multiforme, leg ulcers) or drug-induced lupus；
* Prior treatment with cell therapy or any prior gene therapy product；
* Contraindication to cyclophosphamide in combination with fludarabine;
* Prior CD19-targeted therapy;
* Received live vaccine treatment within 4 weeks prior to screening;
* Subjects who have undergone major surgery within 8 weeks prior to screening, or who are scheduled to have surgery during the trial；
* Have received B-cell targeted therapy within 4 weeks prior to screening;
* Have received immunosuppressants within 1 week prior to screening;
* Have received plasmapheresis or intravenous immunoglobulin within 3 months prior to screening;
* Have participated in other clinical studies within 3 months prior to screening;
* History of vital organ transplantation (eg, heart, lung, kidney, liver) or hematopoietic stem cell/or bone marrow transplantation；
* Situations in which investigators consider it inappropriate to participate in the study.
**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:** Huaxiang Wu, PhD
**Phone:** 86-13757118395
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Hangzhou
**Contacts:**
***Contact 1:***
- **Name:** Huaxiang Wu, PhD
- **Phone:** 86-13757118395
- **Role:** CONTACT
**Country:** China
**Facility:** The Second Affiliated Hospital of Zhejiang University School of Medicine
**Zip:** 310016
#### Overall Officials
**Official 1:**
**Affiliation:** Second Affiliated Hospital, School of Medicine, Zhejiang University
**Name:** Huaxiang Wu
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000003240
- Term: Connective Tissue Diseases
- ID: D000001327
- Term: Autoimmune Diseases
- ID: D000007154
- Term: Immune System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M11177
- Name: Lupus Erythematosus, Systemic
- Relevance: HIGH
- As Found: Systemic Lupus Erythematosus
- ID: M6464
- Name: Connective Tissue Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M4629
- Name: Autoimmune Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000008180
- Term: Lupus Erythematosus, Systemic
### 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: LOW
- As Found: Unknown
- ID: M283230
- Name: Fludarabine
- Relevance: LOW
- As Found: Unknown
- ID: M225513
- Name: Fludarabine phosphate
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06421688
**Brief Title:** Effect of Vitamin C on Postoperative Pulmonary Complications After Intracranial Tumor Surgery
**Official Title:** Effect of Vitamin C on Postoperative Pulmonary Complications After Intracranial: a Randomized, Double-blind, Placebo-controlled Study
#### Organization Study ID Info
**ID:** YXLL-KY-2024(039)
#### Organization
**Class:** OTHER
**Full Name:** Qianfoshan Hospital
### Status Module
#### Completion Date
**Date:** 2025-06
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-17
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-05
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Qianfoshan Hospital
#### Responsible Party
**Investigator Affiliation:** Qianfoshan Hospital
**Investigator Full Name:** Dong Wang
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Is US Export:** False
### Description Module
**Brief Summary:** The goal of this clinical trial is to investigate the effect of perioperative administration of vitamin C on postoperative pulmonary complications, with the aim of providing a safe and effective medication regimen for the prevention and treatment of postoperative pulmonary complications in patients undergoing surgery for craniocerebral tumors. The main questions it aims to answer are:
1. To determine whether vitamin C can reduce pulmonary complications after surgery for intracranial tumors.
2. Does intraoperative vitamin C improve the prognosis of surgical patients
Researchers will compare vitamin C to a placebo (saline) to see if vitamin C is effective for postoperative lung complications in patients undergoing surgery for cranial tumors.
1. Participants will be intravenously pumped with vitamin C for two hours after induction of anesthesia.
2. Participants will have intraoperative plasma sampling and recording of ventilator parameters, monitor parameters and perioperative data.
3. Participants will be followed up until discharge from the hospital to record symptoms and adverse events, and will be called at six months to check on their prognosis.
**Detailed Description:** Neurosurgery has a high incidence of postoperative pulmonary complications, increasing patient costs and affecting patient prognosis. Neurosurgery often requires hyperventilation to reduce intracranial pressure, so methods to reduce postoperative pulmonary complications such as small tidal volumes cannot be used routinely, and larger tidal volumes often result in injury to pulmonary endothelial cells, which leads to increased permeability of the pulmonary microvasculature, resulting in mechanically ventilated lung injury. Of course surgical injuries and mechanical ventilation can also cause oxidative stress injury to the lungs. Vitamin C is a common antioxidant drug and cofactor in the synthesis of many substances in the body, and many studies have shown that vitamin C prevents the increase in endothelial barrier permeability due to many causes. During the COVID-19 epidemic, vitamin C is seen as an important adjunct in preventing and ameliorating symptoms of COVID-19 patients. not only that, but vitamin C also assisted in postoperative analgesia and promote incision healing, so investigators would like to observe that by giving vitamin C during the surgery is able to prevent the occurrence of postoperative pulmonary complications or improve the prognosis of participants.
### Conditions Module
**Conditions:**
- Ascorbic Acid
- Neurosurgical Procedures
- Humans
- Ventilator-Induced Lung Injury
- Postoperative Complications
### 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:** 86
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients received 50 mg/kg of Ascorbic acid after induction of anesthesia
**Intervention Names:**
- Drug: Ascorbic acid
**Label:** Ascorbic acid group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Patients receive 50ml saline after induction of anesthesia
**Intervention Names:**
- Drug: Saline
**Label:** Control comparator group
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Ascorbic acid group
**Description:** After participants underwent induction of anesthesia, Ascorbic acid (Vitamin C Injection) was administered at a dosage of 50 mg/kg, diluted to 50 ml using saline, with a total amount not exceeding 4 g; pumping was performed using a micro pump at a rate of 25 ml/h.
**Name:** Ascorbic acid
**Other Names:**
- vitamin C
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Control comparator group
**Description:** After participants underwent induction of anesthesia, 50 ml of saline was used and pumped using a micro pump at a rate of 25 ml/h.
**Name:** Saline
**Other Names:**
- saline (medicine)
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** This will be assessed using the Postoperative Pulmonary Complications Score, which ranges from 0 to 5, with a score of ≥3 being considered positive for postoperative pulmonary complications. It was assessed every day before discharge and the highest score that occurred was recorded.
**Measure:** incidence of postoperative pulmonary complications
**Time Frame:** About 10 days
#### Secondary Outcomes
**Description:** Plasma levels of neuron-specific enolase, unit is ng/ml
**Measure:** Neuron-specific enolase levels
**Time Frame:** Post operative day 1
**Description:** Length of time between participant's completion of surgery and discharge
**Measure:** Length of hospitalization
**Time Frame:** About 10 days
**Description:** PaO2/FiO2, in millimeters of mercury
**Measure:** Oxygenation index
**Time Frame:** One hour postoperative
**Description:** Patient's postoperative pain level; Using a "Pain Visual Analogue Scale", a 10-centimeter-long ruler was used, with 0 indicating no pain and 10 representing the most intense pain that was intolerable. During the test, the participant points to the scale that best represents the level of pain, and the researcher assigns the participant a score based on the location of the point.
**Measure:** Pain scores
**Time Frame:** 1 day, 3 days, 7 days postoperative
**Description:** lung compliance in Milliliter/ centimeter water column
**Measure:** pulmonary compliance
**Time Frame:** Last hour of surgery.
**Description:** The level of Interleukin-6 in the blood, in nanograms per liter
**Measure:** Interleukin-6
**Time Frame:** 1 day, 3 days, 7 days postoperative
**Description:** Blood levels of superoxide dismutase, in units per milliliter
**Measure:** superoxide dismutase (SOD)
**Time Frame:** 1 day, 3 days, 7 days postoperative
**Description:** Postoperative body temperature in degrees Celsius
**Measure:** body temperature
**Time Frame:** 1 day, 3 days, 7 days postoperative
**Description:** Systolic and diastolic blood pressure，In millimeters of mercury
**Measure:** blood pressure
**Time Frame:** About 10 days
**Description:** Plasma levels of brain-specific cardiolipin
**Measure:** Brain-specific cardiolipin
**Time Frame:** About 3 days
**Description:** Levels of neutrophils in the blood, measured in units per liter.
**Measure:** neutrophil
**Time Frame:** About 10 days
**Description:** Level of C-reactive protein in the blood in milligrams per liter
**Measure:** C-reactive protein
**Time Frame:** 1 day, 3 days, 7 days postoperative
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Patients who need craniotomy treatment due to intracranial tumors;
2. age 18-75 years old;
3. American Society of Anesthesiologists classification: 1\~3;
4. Patients and their families agree to participate in the study and sign the informed consent form.
Exclusion Criteria:
1. Patients with severe pulmonary infection or respiratory failure prior to surgery;
2. Patients with previous history of neurological or psychiatric diseases;
3. Patients with cardiac, hepatic and renal insufficiency;
4. patients who are receiving parenteral nutrition;
5. pregnant patients;
6. Patients ruled out by medication instructions;
7. Patients who require emergency surgery;
8. patients with combination of other malignant tumors;
9. patients who have participated in other clinical studies of drugs within 3 months.
**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:** Dong Wang, M.D
**Phone:** 18353173516
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Linquan Shao
**Phone:** 15864548531
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Jinan
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Dong Wang, Doctor of Medicine(M.D.)
- **Phone:** +86-18353173516
- **Role:** CONTACT
**Country:** China
**Facility:** The First Affiliated Hospital of Shandong First Medical University
**State:** Shandong
**Zip:** 250000
#### Overall Officials
**Official 1:**
**Affiliation:** The First Affiliated Hospital of Shandong First Medical University
**Name:** Dong Wang, M.D
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** Individual Participant Data(IPD) will be available when this trial is finished and the article have been published
**IPD Sharing:** UNDECIDED
### References Module
#### References
**Citation:** Sogame LC, Vidotto MC, Jardim JR, Faresin SM. Incidence and risk factors for postoperative pulmonary complications in elective intracranial surgery. J Neurosurg. 2008 Aug;109(2):222-7. doi: 10.3171/JNS/2008/109/8/0222.
**PMID:** 18671633
**Citation:** May JM, Harrison FE. Role of vitamin C in the function of the vascular endothelium. Antioxid Redox Signal. 2013 Dec 10;19(17):2068-83. doi: 10.1089/ars.2013.5205. Epub 2013 May 29.
**PMID:** 23581713
**Citation:** Holford P, Carr AC, Jovic TH, Ali SR, Whitaker IS, Marik PE, Smith AD. Vitamin C-An Adjunctive Therapy for Respiratory Infection, Sepsis and COVID-19. Nutrients. 2020 Dec 7;12(12):3760. doi: 10.3390/nu12123760.
**PMID:** 33297491
**Citation:** Wang D, Wang M, Zhang H, Zhu H, Zhang N, Liu J. Effect of Intravenous Injection of Vitamin C on Postoperative Pulmonary Complications in Patients Undergoing Cardiac Surgery: A Double-Blind, Randomized Trial. Drug Des Devel Ther. 2020 Aug 11;14:3263-3270. doi: 10.2147/DDDT.S254150. eCollection 2020.
**PMID:** 32848365
**Citation:** Costa Leme A, Hajjar LA, Volpe MS, Fukushima JT, De Santis Santiago RR, Osawa EA, Pinheiro de Almeida J, Gerent AM, Franco RA, Zanetti Feltrim MI, Nozawa E, de Moraes Coimbra VR, de Moraes Ianotti R, Hashizume CS, Kalil Filho R, Auler JO Jr, Jatene FB, Gomes Galas FR, Amato MB. Effect of Intensive vs Moderate Alveolar Recruitment Strategies Added to Lung-Protective Ventilation on Postoperative Pulmonary Complications: A Randomized Clinical Trial. JAMA. 2017 Apr 11;317(14):1422-1432. doi: 10.1001/jama.2017.2297.
**PMID:** 28322416
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010335
- Term: Pathologic Processes
- ID: D000008171
- Term: Lung Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
- ID: D000013898
- Term: Thoracic Injuries
- ID: D000014947
- Term: Wounds and Injuries
### Condition Browse Module - Browse Branches
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M28143
- Name: Lung Injury
- Relevance: HIGH
- As Found: Lung Injury
- ID: M14065
- Name: Postoperative Complications
- Relevance: HIGH
- As Found: Postoperative Complications
- ID: M28152
- Name: Ventilator-Induced Lung Injury
- Relevance: HIGH
- As Found: Ventilator-Induced Lung Injury
- ID: M11168
- Name: Lung Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M16657
- Name: Thoracic Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M17685
- Name: Wounds and Injuries
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000055370
- Term: Lung Injury
- ID: D000055397
- Term: Ventilator-Induced Lung Injury
- ID: D000011183
- Term: Postoperative Complications
### Intervention Browse Module - Ancestors
- ID: D000014815
- Term: Vitamins
- ID: D000018977
- Term: Micronutrients
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000000975
- Term: Antioxidants
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000020011
- Term: Protective Agents
### Intervention Browse Module - Browse Branches
- Abbrev: Micro
- Name: Micronutrients
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: Vi
- Name: Vitamins
### Intervention Browse Module - Browse Leaves
- ID: M17558
- Name: Vitamins
- Relevance: LOW
- As Found: Unknown
- ID: M4513
- Name: Ascorbic Acid
- Relevance: HIGH
- As Found: Sorafenib
- ID: M4107
- Name: Anesthetics
- 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: M4292
- Name: Antioxidants
- Relevance: LOW
- As Found: Unknown
- ID: M21869
- Name: Protective Agents
- Relevance: LOW
- As Found: Unknown
- ID: T437
- Name: Ascorbic Acid
- Relevance: HIGH
- As Found: Sorafenib
- ID: T477
- Name: Vitamin C
- Relevance: HIGH
- As Found: Adjusted
### Intervention Browse Module - Meshes
- ID: D000001205
- Term: Ascorbic Acid
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06421675
**Acronym:** EMBRACE
**Brief Title:** Outpatient and Intermittent Dosing of Elranatamab in Relapsed/Refractory Multiple Myeloma
**Official Title:** A Study of Elranatamab Management With Outpatient and Intermittent Dosing in Relapsed/Refractory Multiple Myeloma
#### Organization Study ID Info
**ID:** OCOG-2023-EMBRACE
#### Organization
**Class:** OTHER
**Full Name:** Ontario Clinical Oncology Group (OCOG)
### Status Module
#### Completion Date
**Date:** 2028-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-14
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-12
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-03-11
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** Pfizer
#### Lead Sponsor
**Class:** OTHER
**Name:** Ontario Clinical Oncology Group (OCOG)
#### 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 phase II study of single agent elranatamab in patients with relapsed and/or refractory multiple myeloma (MM) who have previously received at least three classes of therapeutic agents and are refractory to the last line of treatment. The primary objective of this study is to improve the tolerability and safety of elranatamab in patients with relapsed and/or refractory multiple myeloma by evaluating an outpatient and intermittent dosing strategy.
**Detailed Description:** This is a multi-centre, single arm, phase II study of single agent elranatamab in patients with relapsed and/or refractory multiple myeloma (MM) who have previously received at least three classes of therapeutic agents and are refractory to the last line of treatment. Potential study participants must have documented evidence of refractory or progressive disease during or within 60 days (measured from the end of the last cycle) of completing treatment with the last anti-myeloma drug regimen used just prior to study entry. Study participants will receive SC administration of elranatamab until disease progression, unacceptable toxicity or death. The primary short term outcome is hospitalization rate within the first 2 weeks of Cycle 1 of treatment; the primary long term outcome is rate of grade 3+ infections within the first 24 months of treatment. Study participants will be followed for survival for 36 months from the date of enrollment. A total of 40 study participants will be enrolled across approximately 5 Canadian clinical trial sites.
### Conditions Module
**Conditions:**
- Refractory Multiple Myeloma
**Keywords:**
- relapsed
- refractory
- multiple myeloma
- elranatamab
- cytokine release syndrome
- immune effector-cell associated neurotoxicity
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** Multi-center, single-arm, phase II study of single-agent elranatamab in patients with relapsed and/or refractory multiple myeloma.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 40
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The administration of two step-up elranatamab doses (12 mg and 32 mg) and full dose 76 mg. The dosing interval for the first 6 cycles (each cycle q28 days) is every week, cycles 7-12 are bi-weekly. The dosing interval will increase to q4 weeks (cycle 13+) according to IMWG dose-response criteria of \>= VGPR. Further dosing interval increase to q8weeks (cycles 19+) will be done among participants based on response criteria IMWG of \>= CR.
**Intervention Names:**
- Drug: Elranatamab injection
**Label:** Elranatamab injection
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Elranatamab injection
**Description:** Elranatamab (Elrexfio) is a humanized bispecific antibody that targets both BCMA-expressing multiple myeloma (MM) cells and CD3-expressing T cells.
**Name:** Elranatamab injection
**Other Names:**
- Elrexio
**Type:** DRUG
### Outcomes Module
#### Other Outcomes
**Description:** BCMA levels in blood and their relationship to clinical response and progression.
**Measure:** Exploratory outcome BCMA expression (biologic tumor characteristics)
**Time Frame:** 36 months
**Description:** Feasibility, adherence and satisfaction of remote patient monitoring during the first 9 days of treatment using an outpatient remote monitoring device
**Measure:** Feasibility, adherence and satisfaction of remote patient monitoring
**Time Frame:** First 9 days of treatment.
**Description:** Patient satisfaction with the use of the remote monitoring device will be captured using a single, 5-point likert scale question, asked when the device is returned.
**Measure:** Patient satisfaction with the use of the remote monitoring device
**Time Frame:** First 9 days of treatment.
#### Primary Outcomes
**Description:** Hospitalization rate, defined as the number of patients who are hospitalized within the first 2 weeks of Cycle 1 of treatment, due to any cause, divided by the number of patients who are treated with elranatamab.
**Measure:** Hospitalization rate
**Time Frame:** 2 weeks
**Description:** Rate of grade 3+ infections as grade by NCI CTCAE v5 within the first 24 months of treatment, defined as the number of patients who experience a grade 3+ infection within 24 months of treatment, divided by the number of patients who are treated with elranatamab.
**Measure:** Rate of grade 3+ infections
**Time Frame:** 24 months
#### Secondary Outcomes
**Description:** Overall response rate, defined by the IMWG criteria.
**Measure:** Overall response rate.
**Time Frame:** 36 months
**Description:** PFS, defined as the time from the date of first dose until confirmed PD per IMWG criteria or death due to any cause, whichever occurs first.
**Measure:** Progression free survival.
**Time Frame:** 36 months
**Description:** DOR is defined, for participants with an overall response per IMWG criteria, as the time from the first documentation of overall response that is subsequently confirmed, until confirmed PD per IMWG criteria, or death due to any cause, whichever occurs first.
**Measure:** Duration of response.
**Time Frame:** 36 months
**Description:** TTR is defined, for participants with an overall response per IMWG criteria, as the time from the date of first dose to the first documentation of overall response that is subsequently confirmed.
**Measure:** Time to response.
**Time Frame:** 36 months
**Description:** AEs will be graded according to NCI CTCAE Version 5. CRS and ICANS will be assessed. AEs will be characterized by type, frequency, severity, timing, seriousness, and relationship to elranatamab. AEs will be presented with and without regard to causality based on the investigator's judgment. The frequency of overall toxicity, categorized by toxicity Grades 1 through 5, will be described. Additional summaries will be provided for AEs that are observed with higher frequency and for AESIs (including CRS and ICANS).
**Measure:** Adverse Events
**Time Frame:** 36 months
**Description:** Clinical laboratory data will be classified by grade according to NCI CTCAE version 5.0 and will be analyzed using summary statistics. The worst on-treatment grades during the treatment period will be summarized.
**Measure:** Clinical laboratory data
**Time Frame:** 36 months.
**Description:** OS, defined from the date of study registration to the date or death due to any cause.
**Measure:** Overall survival
**Time Frame:** 36 months
**Description:** Frailty will be measured using the IMWG frailty score and the time for the 4-meter walk test will be recorded.
**Measure:** Patient Frailty
**Time Frame:** To the time of disease progression.
**Description:** Frequency and timing hospitalization will be recorded during the first two weeks of the study treatment.
**Measure:** Frequency and Timing of Hospitalization
**Time Frame:** 2 weeks.
**Description:** QoL during treatment measured using the EORTC QOL Questionnaire-C30 instrument EORTC QLQ-C30
**Measure:** Patient Quality of Life
**Time Frame:** To the time of disease progression.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Relapsed and/or refractory MM defined as:
1. Documented evidence of progressive disease (PD) after achieving at least minimal response (MR) for ≥ 1 cycle during a previous MM treatment (i.e., relapsed MM).
2. Disease progression during or within 60 days from the end of the most recent MM treatment (i.e., refractory MM).
2. Measurable disease based on IMWG criteria, defined as at least one of the following, documented within 28 days before enrollment:
1. Serum M-protein ≥ 0.5 g/dl.
2. Urine M-protein excretion ≥ 200 mg/24 h.
3. Serum-free light chains (FLC) assay: Involved FLC level ≥ 10 mg/dl (≥ 100 mg/l) AND an abnormal serum-free light chain ratio (\< 0.26 or \> 1.65) only for patients without measurable serum or urine M protein.
3. Receipt of at least three prior classes of drugs either in separate regimens or as combinations.
The three classes are defined as:
An immunomodulatory drug (lenalidomide or pomalidomide), a proteasome inhibitor (bortezomib, ixazomib, carfilzomib), and an anti-CD38 drug (daratumumab or isatuximab).
4. At least 18 years of age.
5. Eastern Cooperative Oncology Group (ECOG) performance status score of ≤2.
Exclusion Criteria:
Medical conditions
1. Active plasma cell leukemia (either 20% of peripheral white blood cells or \> 2.0 × 109/L circulating plasma cells by standard differential).
2. Amyloidosis.
3. POEMS syndrome (Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal plasma cell disorder, Skin Changes).
4. Monoclonal gammopathy of unknown significance or smoldering multiple myeloma.
5. Solitary plasmacytoma.
6. Stem cell transplant within 12 weeks prior to enrollment or active graft versus host disease.
7. History of prior treatment with a BCMA targeting agent.
Laboratory Parameters
8. Laboratory results within 28 days as per below prior to enrollment:
* Absolute neutrophil count (ANC) ≤ 1.0 x 109 /L) (use of growth factor is permitted if completed at least 7 days prior to enrollment).
* Platelet count ≤ 25 x 109 /L (transfusion support permitted if completed at least 7 days prior to enrollment).
* Hemoglobin ≤ 8.0 g/dL (transfusion support permitted if completed at least 7 days prior to enrollment, concurrent erythropoietin stimulating agents allowed).
* Serum AST and ALT \> 2.5 x upper limit of normal (ULN).
* Creatinine clearance \< 30 mL/min (according to the Cockcroft Gault formula, by 24-hour urine collection for creatinine clearance, or according to local institutional standard method).
* Total bilirubin \> 2.0 x ULN (≥ 3.0 unless known to have Gilbert's disease).
Support Requirement
9. As this protocol requires outpatient administration, the patient will be excluded if they cannot agree to the following for the first 9 days post-first dose of drug administration:
1. Staying within 60 minutes of travel distance to their trial-based hospital.
2. Must have a caregiver/support person who will stay with the patient.
3. Patient and/or their caregiver/support person agree to monitor and record oral temperature q8 hours.
4. Patients must agree that if they have an oral temperature of (≥38°C), they must report to the study team within 1 hour and can come to the hospital for admission within 2 hours.
Other co-morbidities
10. Impaired cardiovascular function or clinically significant cardiovascular diseases, defined as any of the following within 6 months before enrollment:
* Acute myocardial infarction or acute coronary syndromes (eg, unstable angina, coronary artery bypass graft, coronary angioplasty or stenting, symptomatic pericardial effusion).
* Clinically significant cardiac arrhythmias (eg, uncontrolled atrial fibrillation or uncontrolled paroxysmal supraventricular tachycardia).
* Thromboembolic or cerebrovascular events (eg, transient ischemic attack, cerebrovascular accident, deep vein thrombosis \[unless associated with a central venous access complication\], or pulmonary embolism).
* Prolonged QT syndrome (or triplicate average QTcF \>470 msec at screening).
11. Ongoing Grade ≥2 peripheral sensory or motor neuropathy.
12. History of Guillain-Barre Syndrome (GBS) or GBS variants, or history of any Grade ≥3 peripheral motor polyneuropathy.
13. Unresolved acute effects of any prior therapy for MM in the last three months to either baseline severity or NCI CTCAE ≤Grade 1.
14. Active HBV, HCV, SARS-CoV2, HIV, or any active, uncontrolled bacterial, fungal, or viral infection.
15. Any other active malignancy within 2 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.
16. Any serious and/or unstable pre-existing medical, psychiatric disorder, or other conditions (including lab abnormalities), or surgical (major surgery within 14 days prior to enrollment) that could interfere with the patient's safety, obtaining informed consent or compliance to the study procedures.
17. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to elranatamab or any of the components of the study treatment.
Concomitant Medications
18. Treatment with a chemotherapeutic or anti-MM drug within the last 28 days or 5 half-lives (whichever is shorter) prior to enrollment or are currently enrolled in another interventional clinical study.
19. Receipt of any other therapy to treat cancer (including radiation, biologics, cellular therapies, and/or steroids at doses \> 20 mg dexamethasone or equivalent) within 14 days prior to the enrollment.
20. Receipt of any live vaccine within 30 days prior to enrollment or expected need of live vaccination during study participation. (Administration of locally approved non-live vaccine can be done as per local guidelines during the screening and/or treatment period including the COVID-19 mRNA vaccine. Elranatamab should be administered ± 7 days from the SARS-CoV-2 vaccine administration).
Pregnancy and Contraception
21. Pregnancy or lactating female or inability of female patients of childbearing potential (FCBP) to meet contraception requirements (see Section 5.1.3.).
Informed Consent
22. Inability to provide signed, informed consent.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Emilio Aguirre, CRA,HIT,CHIM
**Phone:** 905-527-2299
**Phone Ext:** 42650
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Sharon Nason
**Phone:** 905-527-2299
**Phone Ext:** 42622
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Calgary
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Nazir Jacques Bahlis, MD
- **Phone:** 403-944-1880
- **Role:** CONTACT
**Country:** Canada
**Facility:** Arnie Charbonneau Cancer Institute
**State:** Alberta
**Zip:** T2N 4Z6
**Location 2:**
**City:** Edmonton
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Irwindeep Sandhu, MD
- **Phone:** 780-432-8757
- **Role:** CONTACT
**Country:** Canada
**Facility:** Cross Cancer Institute
**State:** Alberta
**Zip:** T6G 1Z2
**Location 3:**
**City:** Vancouver
**Contacts:**
***Contact 1:***
- **Name:** Christopher Venner, MD
- **Phone:** 604-877-6000
- **Role:** CONTACT
**Country:** Canada
**Facility:** Vancouver Cancer Center
**State:** British Columbia
**Zip:** V5Z 1L3
**Location 4:**
**City:** Hamilton
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Hira Mian, MD
- **Phone:** 905-387-9495
- **Role:** CONTACT
**Country:** Canada
**Facility:** Juravinski Cancer Center
**State:** Ontario
**Zip:** L8V 1C3
**Location 5:**
**City:** Ottawa
**Contacts:**
***Contact 1:***
- **Name:** Arleigh Robertson McCurdy, MD
- **Phone:** 613-737-8899
- **Phone Ext:** 71281
- **Role:** CONTACT
**Country:** Canada
**Facility:** Ottawa Hospital
**State:** Ontario
**Zip:** K1H 8L6
#### Overall Officials
**Official 1:**
**Affiliation:** McMaster University
**Name:** Hira Mian, MD
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** OCOG - McMaster University
**Name:** Jim Wright, MD
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000009369
- Term: Neoplasms
- ID: D000020141
- Term: Hemostatic Disorders
- ID: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000010265
- Term: Paraproteinemias
- ID: D000001796
- Term: Blood Protein Disorders
- ID: D000006402
- Term: Hematologic Diseases
- ID: D000006474
- Term: Hemorrhagic Disorders
- ID: D000008232
- Term: Lymphoproliferative Disorders
- ID: D000007160
- Term: Immunoproliferative Disorders
- ID: D000007154
- Term: Immune System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: BC15
- Name: Blood and Lymph Conditions
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC25
- Name: Substance Related Disorders
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M12058
- Name: Multiple Myeloma
- Relevance: HIGH
- As Found: Multiple Myeloma
- ID: M27588
- Name: Neoplasms, Plasma Cell
- Relevance: HIGH
- As Found: Multiple Myeloma
- ID: M2157
- Name: Cytokine Release Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M22080
- Name: Neurotoxicity Syndromes
- Relevance: LOW
- As Found: Unknown
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
- ID: M21977
- Name: Hemostatic Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M5059
- Name: Blood Coagulation Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M13178
- Name: Paraproteinemias
- Relevance: LOW
- As Found: Unknown
- ID: M5077
- Name: Blood Protein Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M9490
- Name: Hematologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M9560
- Name: Hemorrhagic Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M11225
- Name: Lymphoproliferative Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M10206
- Name: Immunoproliferative Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T3947
- Name: Multiple Myeloma
- Relevance: HIGH
- As Found: Multiple Myeloma
- ID: T4120
- Name: Neurotoxicity Syndromes
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000009101
- Term: Multiple Myeloma
- ID: D000054219
- Term: Neoplasms, Plasma Cell
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M20194
- Name: Antibodies, Bispecific
- Relevance: LOW
- As Found: Unknown
- ID: M4225
- Name: Antibodies
- Relevance: LOW
- As Found: Unknown
- ID: M10184
- Name: Immunoglobulins
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06421662
**Brief Title:** The Role of Attachment Training in Mother-infant Attachment
**Official Title:** The Effect of Attachment Training Given to Pregnant Women on Mother Infant Attachment
#### Organization Study ID Info
**ID:** mother-infant attachment
#### Organization
**Class:** OTHER
**Full Name:** Saglik Bilimleri Universitesi
### Status Module
#### Completion Date
**Date:** 2024-03-04
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2024-01-01
**Type:** ACTUAL
#### Start Date
**Date:** 2023-08-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Saglik Bilimleri Universitesi
#### Responsible Party
**Investigator Affiliation:** Saglik Bilimleri Universitesi
**Investigator Full Name:** GÜVEN BEKTEMUR
**Investigator Title:** Assoc.Prof.
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The study aimed to investigate the effect of attachment training given to pregnant women on mother-infant attachment.Primiparous pregnant women between 28.-38. weeks were randomized into two groups. Pregnant women in the study group were given attachment training for 15 days and the effect of the training on mother-infant attachment was investigated by using the mother-infant attachment scale at postpartum week 8 in comparison with the control group.
**Detailed Description:** Pregnant women between 28th and 38th weeks of gestational age who applied to an outpatient clinic of a training and research hospital were randomized into two groups. The study group was trained online by a psychologist on attachment in two sessions. In order to measure the level of attachment knowledge before and after the training, a test form prepared by the researcher based on the literature and expert opinion was applied as pre-test and post-test. In the 8th week after delivery, "Maternal Attachment Inventory" developed by Mary Muller in 1994 and Turkish validity and reliability study was conducted by Şirin and Kavlak. Maternal Attachment Inventory, Each item contains direct expressions and is always scored as follows: (a)= 4 points, frequently (b)= 3 points, sometimes (c)= 2 points, and never (d)= 1 point. A general score is obtained from the sum of all items. A high score indicates a high level of maternal attachment. The total score from the scale ranges from a minimum of 26 to a maximum of 104
### Conditions Module
**Conditions:**
- Mother-Infant Interaction
- Infant Development
- Maternal Behavior
**Keywords:**
- infant
- maternal attachment
- attachment training
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 60
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Thirty pregnant women between 28th and 38th gestational weeks who applied to the outpatient clinic of a training and research hospital were included in the study group. During the training, 7 participants were excluded due to premature birth.
**Intervention Names:**
- Behavioral: Attachment Training
**Label:** Study Group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Thirty-one pregnant women between 28th and 38th gestational weeks who applied to the outpatient clinic of a training and research hospital were included in the control group. The control group was administered only the "Maternal Attachment Inventory " developed by Mary Muller in 1994 and the Turkish validity and reliability study was conducted by Şirin and Kavlak at the 8th week after birth.
**Label:** Control Group
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Study Group
**Description:** The study group was trained online by a psychologist on attachment in two sessions. In order to measure the level of attachment knowledge before and after the training, a test form prepared by the researcher based on the literature and expert opinion was used as pre-test and post-test. In the 8th week after delivery, "Maternal Attachment Inventory " developed by Mary Muller in 1994 and Turkish validity and reliability study was conducted by Şirin and Kavlak.
**Name:** Attachment Training
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** Maternal Attachment Inventory (MAI) Each item contains direct expressions and is always scored as follows: (a)= 4 points, frequently (b)= 3 points, sometimes (c)= 2 points, and never (d)= 1 point. A general score is obtained from the sum of all items. A high score indicates a high level of maternal attachment. The total score from the scale ranges from a minimum of 26 to a maximum of 104.
**Measure:** Maternal Attachment
**Time Frame:** 10 minutes
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* 18-40 years old with a primiparous pregnancy,
* 28 to 38 weeks of gestation,
* At least primary school graduate,
* Who can use the internet actively and can receive planned training online,
* Can speak and understand Turkish like a native speaker,
* Expectant mothers who voluntarily accepted the study.
Exclusion Criteria:
* Transferring the pregnant woman to another hospital for follow-up and treatment
* Those who cannot use active internet and will not be able to receive online education
* Not completing the post-test after the training
* Not completing the postpartum maternal attachment scale
* Expectant mothers receiving psychiatric treatment
* Those with risky pregnancies
* Any congenital anomaly in the baby
* Unwanted baby status
* Withdrawal of the candidate from the study
**Gender Based:** True
**Gender Description:** Primiparous pregnant women
**Maximum Age:** 40 Years
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Istanbul
**Country:** Turkey
**Facility:** University of Health Sciences
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06421649
**Acronym:** PRONTO
**Brief Title:** Investigating the Role of Adjuvant Proton Beam Therapy in Patients With Parotid Carcinoma
**Official Title:** An Evaluative Commissioning Study to Investigate the Role of Adjuvant Proton Beam Radiotherapy in Patients With Localised Parotid Carcinoma
#### Organization Study ID Info
**ID:** CFTSp218 (01)
#### Organization
**Class:** OTHER
**Full Name:** The Christie NHS Foundation Trust
### Status Module
#### Completion Date
**Date:** 2029-01-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2028-01-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-25
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Royal Marsden NHS Foundation Trust
**Class:** OTHER
**Name:** University College London Hospitals
#### Lead Sponsor
**Class:** OTHER
**Name:** The Christie NHS Foundation Trust
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Proton Beam Therapy (PBT) is an advanced radiotherapy technique. There are two National Health Service (NHS) PBT treatment centres in the UK, one in Manchester and one in London. The NHS is committed to ensuring the best use of this limited resource by investigating which patients will benefit from PBT treatment.
Evaluative Commissioning in Protons (ECIP) is a programme of studies that explore the role of PBT for patients with different types of cancer. They are funded by NHS England. ECIP studies are not randomised studies, which means that all eligible patients will be offered proton therapy. Any patient in the United Kingdom (UK) can be referred, and for patients that need to travel far to their nearest centre, accommodation will be available.
The main benefit of PBT, compared with photon radiotherapy, is the predicted reduction in radiation dose to surrounding healthy tissues. With photon radiotherapy, some radiation passes beyond the target area, affecting healthy tissues and causing side-effects. With PBT, the radiation dose stops within the target area, causing less damage to surrounding tissues, and limiting side effects.
PRONTO is a study within the ECIP programme exploring whether PBT can reduce treatment side effects for patients with salivary gland cancers who need radiotherapy following surgery. Whilst radiotherapy is associated with good cancer control, it commonly causes problematic side-effects such as loss of taste and dry mouth. These can be permanent and can negatively affect someone's quality of life. PRONTO's main aim is to see if PBT can reduce the loss of taste following radiotherapy.
Participants in PRONTO will be closely monitored by the medical team and with questionnaires. The patient experience will be compared to what we would expect with standard photon radiotherapy.
**Detailed Description:** Malignant parotid tumours are uncommon. Whilst 85% of salivary gland tumours originate in the parotid gland, only 20-25% of these are malignant, representing only 3-6% of head and neck cancers. This is about 650 patients/year in the UK.
Standard treatment for local disease is with surgical resection followed by adjuvant radiotherapy for patients with high-risk features. Local control and 5-year survival rates are good, at \>70% and \>80% respectively, but radiotherapy is associated with considerable toxicity. More than 70% of patients receiving photon therapy experience significant dysgeusia (taste loss/alteration). This can be permanent, is associated with weight loss, diminished appetite, dry mouth, and negatively impact on Quality of Life (QoL).
The putative benefit of proton beam radiotherapy (PBT) relates to its characteristic deposition in the body, which limits the radiation dose received by surrounding healthy tissues. We hypothesise that irradiating the post-operative parotid bed with PBT rather than Intensity Modulated Radiation Therapy (IMRT), will reduce the dose delivered to the Organs at Risk (OAR), in particular the oral cavity (OC), leading to a reduction in acute and long term taste loss/alteration. The advantageous physical properties of PBT may also improve other side effects including fatigue, mucositis, nausea \& vomiting and potentially hearing problems, as well as overall QoL.
Radiotherapy planning studies:
Radiation planning studies have repeatedly shown statistically significant reductions in the dose delivered to healthy tissues including: the oral cavity, brainstem, spinal cord, contralateral parotid, ipsilateral and contralateral submandibular glands and ipsilateral temporal lobe. In particular, radiotherapy doses to the oral cavity are significantly reduced, typically to below 10 Gray (Gy). No routinely contoured OAR or region of interest was consistently found to have higher doses planning with protons, although skin dose may be higher.
Clinical Trials:
Whilst there are no randomised control trials comparing protons and photons for this cohort. However, there is some clinical evidence that the use of PBT leads to clinically meaningful improvements in the side effects experienced by patients. One study compared acute toxicities between matched groups receiving either protons or photons, demonstrating statistically significant reductions in dysgeusia, fatigue, mucositis and nausea and vomiting in patients undergoing proton treatment. In other studies, PBT is associated with very low toxicity level, such as less than 30% of patients experiencing any dysgeusia. This compares favourably to photon experience, such as in the phase 3 randomised controlled trial 'A Multicentre Randomised Study of Cochlear Sparing Intensity Modulated Radiotherapy Versus Conventional Radiotherapy in Patients with Parotid Tumours' (COSTAR) where approximately 60% of patients reported dysgeusia in the Head \& Neck 35 (HN35) questionnaire at 1 year. The PRONTO study is powered to identify a clinically meaningful reduction in taste dysfunction of at least 20%.
Whilst late toxicities are also likely under-reported in the retrospective international data, the published literature to date is very reassuring. The mean dose to the ipsilateral temporal lobe is reportedly reduced, and reflected in low levels of subsequent headache, fatigue and/or memory change. Similarly, whilst poorly captured, low levels of hearing dysfunction or otalgia have also been reported following PBT.
There is no rationale at all that cancer outcomes, either local control or overall survival, will be worse with PBT than photon treatment. In studies to date, local control (approximately 95%) and overall survival (89%-96%) has been excellent, and comparative to known photon experience.
### Conditions Module
**Conditions:**
- Parotid Cancer
**Keywords:**
- proton beam therapy
- protons
- evaluative commissioning
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** Evaluative commissioning study. This is a single arm, non-randomised study.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 97
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** All patients will be offered radical adjuvant proton beam therapy to a dose of 60-66 Gray (Gy) in 30-33 fractions delivered Monday to Friday over 6-6.5 weeks.
**Intervention Names:**
- Radiation: Proton Beam Therapy
**Label:** Proton Beam Therapy
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Proton Beam Therapy
**Description:** All patients will be offered radical adjuvant proton beam therapy to a dose of 60-66 Gray (Gy) in 30-33 fractions delivered Monday to Friday over 6-6.5 weeks.
**Name:** Proton Beam Therapy
**Type:** RADIATION
### Outcomes Module
#### Primary Outcomes
**Description:** Taste dysfunction as recorded on the European Organisation for the Research \& Treatment of Cancer (EORTC) Head \& Neck 43 (HN43) patient reported questionnaire.
43 questions with a Likert scale of 1 - 4 Higher score may mean a worse outcome
**Measure:** Taste dysfunction
**Time Frame:** 12 months
#### Secondary Outcomes
**Description:** Using the CTCAE toxicity grade Grades 1 - 5 Higher score may mean a worse outcome
**Measure:** Clinician reported acute and late toxicity using Common Terminology Criteria for Adverse Events (CTCAE) grades
**Time Frame:** up to 24 months
**Description:** Using the LENT-SOMA scale A multiple item scoring system composed of four domains; subjective, objective, management and analytic.
Grades 0-4 Higher score may mean a worse outcome
**Measure:** Clinician reported acute and late toxicity using Late Effects Normal Tissue - Subjective Objective Management Analytic (LENT-SOMA) scale
**Time Frame:** up to 24 months
**Description:** Using pure tone audiometry to measure hearing changes Loss of hearing may mean a worse outcome
**Measure:** Clinician reported acute and late toxicity - measurement of hearing changes
**Time Frame:** up to 24 months
**Description:** Using the EORTC QLQ-C30 30 questions using a Likert scale of 1-4 Higher score may mean a worse outcome
**Measure:** Patient reported acute and late toxicity using European Organisation for the Research & Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 module questionnaire
**Time Frame:** up to 24 months
**Description:** Using the EORTC HN43 patient reported questionnaire 43 questions using a Likert scale of 1-4 Higher score may mean a worse outcome
**Measure:** Patient reported acute and late toxicity using European Organisation for the Research & Treatment of Cancer (EORTC) Head & Neck 43 (HN43) patient reported questionnaire.
**Time Frame:** up to 24 months
**Description:** Using the UW-QoL questionnaire Most questions are scored on a Likert scale, 0=worst, 100=best Lower score may mean worse outcomes
**Measure:** Patient reported acute and late toxicity using University of Washington Quality of Life (UW-QoL) questionnaire
**Time Frame:** up to 24 months
**Description:** Using the GHABP questionnaire Possible values for response options (0=not applicable, 5=cannot manage at all) Higher score may mean worse outcomes
**Measure:** Patient reported acute and late toxicity using Glasgow hearing Aid Benefit Profile (GHABP) questionnaire
**Time Frame:** up to 24 months
**Description:** This will be measured as time to recurrence (measured in months from completion of treatment) and location of recurrence (within the primary nodal regional or distant spread)
**Measure:** Loco-regional tumour control
**Time Frame:** up to 24 months
**Description:** This will be measured in months from completion of treatment to death
**Measure:** Overall survival
**Time Frame:** up to 24 months
**Description:** Number of patients referred to and participating in the study annually
**Measure:** Patient participation in the study each year
**Time Frame:** up to 24 months
**Description:** Review the number of patients completing radiotherapy and the number of patients completing follow up on the study as per protocol.
**Measure:** Study completion rates
**Time Frame:** up to 24 months
**Description:** Patients will be re-planned with photon radiotherapy, the dose distribution differences between the treatment proton plans and photon plans will be recorded in particular the dose to the oral cavity
**Measure:** Oral cavity radiation dose
**Time Frame:** 12 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. ≥ 18 years old.
2. Histologically confirmed primary malignant tumours of parotid gland.
3. Requiring post-operative radiotherapy to the parotid bed, with a dose equivalent of at least 60 Gray (Gy) in 2 Gy / fraction.
4. Treatment delivered with radical intent.
5. All patients must be suitable to attend regular follow-up, audiograms, toxicity monitoring, and be available for long term follow-up.
6. Willingness to comply with the protocol, including travel to the proton centre for Intensity Modulated Proton Therapy (IMPT) treatment.
7. Written informed consent.
Exclusion Criteria:
1. Previous radiotherapy to the head and neck region;
2. Parotid tumours requiring primary radiation or those with gross residual disease;
3. Metastases from squamous cell carcinoma of the head and neck to the parotid gland;
4. Benign tumours requiring post operative radiotherapy;
5. Previous or concurrent illness, which in the investigators opinion would interfere with either completion of therapy or follow-up;
6. Patients requiring or receiving neoadjuvant, concomitant or planned adjuvant chemotherapy.
7. Patients who are eligible for PBT under routine commissioning
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Romelie Rieu
**Phone:** 0044 1619187172
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Sally Falk
**Phone:** 0044 1619187172
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Royal Marsden NHS Foundation Trust
**Name:** Chris Nutting
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Romesser PB, Cahlon O, Scher E, Zhou Y, Berry SL, Rybkin A, Sine KM, Tang S, Sherman EJ, Wong R, Lee NY. Proton beam radiation therapy results in significantly reduced toxicity compared with intensity-modulated radiation therapy for head and neck tumors that require ipsilateral radiation. Radiother Oncol. 2016 Feb;118(2):286-92. doi: 10.1016/j.radonc.2015.12.008. Epub 2016 Feb 8.
**PMID:** 26867969
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009369
- Term: Neoplasms
- ID: D000012468
- Term: Salivary Gland Neoplasms
- ID: D000009062
- Term: Mouth Neoplasms
- ID: D000006258
- Term: Head and Neck Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009059
- Term: Mouth Diseases
- ID: D000009057
- Term: Stomatognathic Diseases
- ID: D000010305
- Term: Parotid Diseases
- ID: D000012466
- Term: Salivary Gland Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: All
- Name: All Conditions
- Abbrev: BC07
- Name: Mouth and Tooth Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M5534
- Name: Carcinoma
- Relevance: LOW
- As Found: Unknown
- ID: M13220
- Name: Parotid Neoplasms
- Relevance: HIGH
- As Found: Parotid Cancer
- ID: M15287
- Name: Salivary Gland Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M12022
- Name: Mouth Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M9348
- Name: Head and Neck Neoplasms
- 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: M13218
- Name: Parotid Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15285
- Name: Salivary Gland Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T4265
- Name: Oral Cancer
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000010307
- Term: Parotid Neoplasms
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06421636
**Acronym:** FERVENT-1
**Brief Title:** A Study to Test the Safety, Tolerability, and Efficacy of an Antibody, REGN7999, Injected Under the Skin for the Treatment of Iron Overload in Adult Participants With Non-Transfusion Dependent β-thalassemia, Using MRI Scans to Measure Iron Levels in the Body
**Official Title:** A PHASE 2, TWO-PART, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF SUBCUTANEOUSLY ADMINISTERED REGN7999 (AN INHIBITOR OF TMPRSS6) IN PARTICIPANTS WITH IRON OVERLOAD DUE TO NON-TRANSFUSION DEPENDENT β-THALASSEMIA
#### Organization Study ID Info
**ID:** R7999-BThal-2350
#### Organization
**Class:** INDUSTRY
**Full Name:** Regeneron Pharmaceuticals
#### Secondary ID Infos
**Domain:** EU CT Number
**ID:** 2023-508604-37-00
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2028-01-24
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-14
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2028-01-24
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-09-25
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Regeneron 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:** This study is researching an experimental drug called REGN7999 (called "study drug"). The study is focused on patients with non-transfusion dependent beta-thalassemia. The aim of the study is to see how safe and effective the study drug is.
The study is looking at several other research questions, including:
* Whether the study drug lowers extra iron levels in the body
* What side effects may happen from taking the study drug
* How much study drug is in the blood at different times
* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)
### Conditions Module
**Conditions:**
- Non-transfusion Dependent Beta-thalassemia (NTDT)
**Keywords:**
- Beta-thalassemia
- Resultant Iron overload (IOL)
### 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:** 95
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Randomized 2:2:1
**Intervention Names:**
- Drug: REGN7999
**Label:** Part A High Dose
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Randomized 2:2:1
**Intervention Names:**
- Drug: REGN7999
**Label:** Part A Low Dose
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Randomized 2:2:1
**Intervention Names:**
- Drug: Placebo
**Label:** Part A Placebo
**Type:** PLACEBO_COMPARATOR
#### Arm Group 4
**Description:** Randomized 2:2:1
**Intervention Names:**
- Drug: REGN7999
**Label:** Part B High Dose
**Type:** EXPERIMENTAL
#### Arm Group 5
**Description:** Randomized 2:2:1
**Intervention Names:**
- Drug: REGN7999
**Label:** Part B Low Dose
**Type:** EXPERIMENTAL
#### Arm Group 6
**Description:** Randomized 2:2:1
**Intervention Names:**
- Drug: Placebo
**Label:** Part B Placebo
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Part A High Dose
- Part A Low Dose
- Part B High Dose
- Part B Low Dose
**Description:** Administered subcutaneous (SC)
**Name:** REGN7999
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Part A Placebo
- Part B Placebo
**Description:** Administered SC
**Name:** Placebo
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Measure:** Change in Liver iron concentration (LIC) by R2* magnetic resonance imaging (MRI)
**Time Frame:** Baseline to week 24
**Measure:** Incidence of Treatment-emergent adverse events (TEAEs)
**Time Frame:** Up to week 72
**Measure:** Severity of Treatment-emergent adverse events (TEAEs)
**Time Frame:** Up to week 72
#### Secondary Outcomes
**Measure:** Achievement of ≥20% reduction in LIC by R2* MRI
**Time Frame:** Baseline to week 52
**Measure:** Change in hemoglobin
**Time Frame:** Baseline to week 24
**Measure:** Change in LIC by R2* MRI
**Time Frame:** Baseline to week 52
**Measure:** Percent change in LIC by R2* MRI
**Time Frame:** Baseline to week 24 and week 52
**Measure:** Achievement of ≥20% reduction in LIC by R2* MRI
**Time Frame:** Baseline to week 24
**Measure:** Change in hemoglobin over time
**Time Frame:** Up to week 56
**Measure:** Achievement of ≥1.5 g/dL increase in hemoglobin for two consecutive assessments in the absence of red blood cell (RBC) transfusions
**Time Frame:** Baseline to week 56
**Measure:** Number of RBC transfusions required
**Time Frame:** Baseline to week 72
**Measure:** Achievement of transfusion independence
**Time Frame:** Baseline to week 72
**Measure:** Change in RBC counts over time
**Time Frame:** Baseline to week 56
**Measure:** Concentrations of REGN7999 in serum over time
**Time Frame:** Up to week 56
**Measure:** Incidence of anti-drug antibody (ADA) to REGN7999 over time
**Time Frame:** Up to week 56
**Measure:** Titer of ADA to REGN7999 over time
**Time Frame:** Up to week 56
### Eligibility Module
**Eligibility Criteria:** Key Inclusion Criteria:
1. Clinical diagnosis of NTDT as described in the protocol
2. IOL, defined as LIC ≥ 5 mg Fe/g DW as measured by R2\* MRI at screening
3. Serum ferritin ≥ 300 ng/mL as described in the protocol
Key Exclusion Criteria:
1. Hemoglobin ≤ 8 g/dL
2. Any RBC transfusion within approximately 8 weeks prior to screening as described in the protocol
3. For Part A only: Any ICT use in approximately 12 weeks prior to screening as described in the protocol
4. For Part B only: If on ICT, any change in Iron chelation therapy (ICT) dose in approximately 12 weeks prior to screening as described in the protocol
5. Any use of luspatercept or mitapivat in 6 months prior to screening as described in the protocol
6. Absolute contraindication to MRI
Note: Other protocol-defined Inclusion/ Exclusion Criteria apply
**Maximum Age:** 60 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Clinical Trials Administrator
**Phone:** 844-734-6643
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Regeneron Pharmaceuticals
**Name:** Clinical Trial Management
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**Access Criteria:** Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
**Description:** All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
**Info Types:**
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
- ANALYTIC_CODE
**IPD Sharing:** YES
**Time Frame:** When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.
**URL:** https://vivli.org/
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000000745
- Term: Anemia, Hemolytic, Congenital
- ID: D000000743
- Term: Anemia, Hemolytic
- ID: D000000740
- Term: Anemia
- ID: D000006402
- Term: Hematologic Diseases
- ID: D000006453
- Term: Hemoglobinopathies
- ID: D000030342
- Term: Genetic Diseases, Inborn
- ID: D000019189
- Term: Iron Metabolism Disorders
- ID: D000008659
- Term: Metabolic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC15
- Name: Blood and Lymph Conditions
- Abbrev: BC16
- Name: Diseases and Abnormalities at or Before Birth
- Abbrev: All
- Name: All Conditions
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M16557
- Name: Thalassemia
- Relevance: HIGH
- As Found: Thalassemia
- ID: M19408
- Name: beta-Thalassemia
- Relevance: HIGH
- As Found: Beta Thalassemia
- ID: M21178
- Name: Iron Overload
- Relevance: HIGH
- As Found: Iron Overload
- ID: M4070
- Name: Anemia
- Relevance: LOW
- As Found: Unknown
- ID: M9547
- Name: Hemolysis
- Relevance: LOW
- As Found: Unknown
- ID: M4073
- Name: Anemia, Hemolytic
- Relevance: LOW
- As Found: Unknown
- ID: M4075
- Name: Anemia, Hemolytic, Congenital
- Relevance: LOW
- As Found: Unknown
- ID: M9490
- Name: Hematologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M9539
- Name: Hemoglobinopathies
- Relevance: LOW
- As Found: Unknown
- ID: M23686
- Name: Genetic Diseases, Inborn
- Relevance: LOW
- As Found: Unknown
- ID: M11639
- Name: Metabolic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M21177
- Name: Iron Metabolism Disorders
- Relevance: LOW
- As Found: Unknown
- ID: T5622
- Name: Thalassemia
- Relevance: HIGH
- As Found: Thalassemia
- ID: T737
- Name: Beta-thalassemia
- Relevance: HIGH
- As Found: Beta Thalassemia
### Condition Browse Module - Meshes
- ID: D000013789
- Term: Thalassemia
- ID: D000017086
- Term: beta-Thalassemia
- ID: D000019190
- Term: Iron Overload
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Micro
- Name: Micronutrients
### Intervention Browse Module - Browse Leaves
- ID: M4225
- Name: Antibodies
- Relevance: LOW
- As Found: Unknown
- ID: M10184
- Name: Immunoglobulins
- Relevance: LOW
- As Found: Unknown
- ID: M10533
- Name: Iron
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06421623
**Acronym:** MINIPAS
**Brief Title:** Preserving Autonomy Through Foot Health: a Study on the Acceptability of a Program Including Various Workshops for the Elderly
**Official Title:** Préserver Son Autonomie Par la santé du Pied : Etude d'acceptabilité d'un Programme Incluant différents Ateliers Chez Les Personnes âgées
#### Organization Study ID Info
**ID:** RIPH2-FUNDENBERGER-MINIPAS
#### Organization
**Class:** OTHER
**Full Name:** Centre Hospitalier Emile Roux
#### Secondary ID Infos
**Domain:** ID-RCB
**ID:** 2024-A00086-41
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2024-07-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** ACTIVE_NOT_RECRUITING
#### Primary Completion Date
**Date:** 2024-07-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-04-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-03-12
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Centre Hospitalier Emile Roux
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Every year in France, 2 million falls by people over 65 are responsible for 10,000 deaths, the leading cause of accidental death, and more than 130,000 hospitalizations.
The investigators will combine minimalist footwear, plantar massage, and workshops to re-learn walking and posture. The main objective of this study is to verify the acceptability and feasibility of this program among the elderly.
**Detailed Description:** Study participants will benefit from a plantar massage session (5-10 min massage performed by a podiatrist) and one posture and walking workshop per week, also supervised by the podiatrist. Minimalist shoes have been purchased by the centers and used during the workshops. They will also be available to participants outside the workshops for the duration of the study.
### Conditions Module
**Conditions:**
- Falling
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 59
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Study participants will benefit from a plantar massage session (5-10 min foot massage) and one posture and walking workshop per week, supervised by a trained health professional. Minimalist shoes have been purchased by the centers and used during the workshops. They will also be available to participants outside the workshops for the duration of the study.
**Intervention Names:**
- Other: Program Including Various Workshops aiming to preserve elderly's autonomy through foot health
**Label:** Workshops aiming to preserve elderly's autonomy through foot health
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Workshops aiming to preserve elderly's autonomy through foot health
**Description:** Combination of minimalist footwear, foot massages, and workshops to re-learn walking and posture
**Name:** Program Including Various Workshops aiming to preserve elderly's autonomy through foot health
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Participant acceptability will be assessed by workshop attendance rates.
**Measure:** The acceptability of foot health workshops conducted by a podiatrist with elderly people
**Time Frame:** At the end of the 12 weeks program
#### Secondary Outcomes
**Description:** In centimeters (cm)
**Measure:** Foot Length measurement
**Time Frame:** Before and immediately after the intervention
**Description:** Thanks to the stabilometry platform
**Measure:** The distance of the center of gravity from the center
**Time Frame:** Before and immediately after the intervention
**Description:** Thanks to the stabilometry platform
**Measure:** Measurement of bearing surface and force distribution in static position
**Time Frame:** Before and immediately after the intervention
**Description:** Measured by the Weight-Bearing Lunge Test
**Measure:** Joint capacity for ankle flexion and extension
**Time Frame:** Before and immediately after the intervention
**Description:** Numerical scale from 0 to 10 (0 meaning no fear and 10 the worst fear imaginable)
**Measure:** Fear of falling scale
**Time Frame:** Before and immediately after the intervention
**Description:** Timed up and go test
**Measure:** The risk of falling
**Time Frame:** Before and immediately after the intervention
**Description:** Numerical scale from 0 to 10 (0 meaning no pain and 10 the worst pain imaginable)
**Measure:** Foot pain scale
**Time Frame:** Before and immediately after the intervention
**Measure:** Number and type of foot disorders
**Time Frame:** Before and immediately after the intervention
**Description:** To evaluate participants' perception of the minimalist footwear and the various workshops (foot massage and walking)
**Measure:** A specifically made satisfaction questionnaire
**Time Frame:** Immediately after the intervention
**Measure:** Number of hours shoes used
**Time Frame:** Immediately after the intervention
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* People over 65 years of age
* Able to walk independently with or without a walking aid (cane, walker, etc.)
* Persons affiliated with a social security system or assimilated
* Persons (participants, guardians, or curators where applicable) who have been informed and have given their written consent to participate in the study.
Exclusion Criteria:
* People with a contraindication to wearing minimalist shoes
* Persons unable to participate in the various workshops
* Refusal to participate in research
* Persons under court protection
* Persons unable to walk
* Persons with any other contraindication at the investigator's discretion
**Minimum Age:** 65 Years
**Sex:** ALL
**Standard Ages:**
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Beaulieu
**Country:** France
**Facility:** EHPAD "Foyer Notre-Dame"
**Zip:** 43800
**Location 2:**
**City:** Brives-Charensac
**Country:** France
**Facility:** EHPAD "Vert-Bocage"
**Zip:** 43700
**Location 3:**
**City:** Le Puy En Velay
**Country:** France
**Facility:** Ssiad " Amadom43 "
**Zip:** 43000
**Location 4:**
**City:** Le Puy-en-Velay
**Country:** France
**Facility:** Ehpad Nazareth
**Zip:** 43000
**Location 5:**
**City:** Vals Pres Le Puy
**Country:** France
**Facility:** EHPAD Foyer " Saint-Dominique "
**Zip:** 43750
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06421610
**Brief Title:** OPC5: Pressurized IntraThoracic Aerosol Chemotherapy (PITAC) in Patients With Malignant Pleural Effusion.
**Official Title:** Implementation and Evaluation of Pressurized Intrathoracic Aerosol Chemotherapy (PITAC) for the Treatment of Patients With Malignant Pleural Effusion. A Danish Phase I Study (OPC5 Study)
#### Organization Study ID Info
**ID:** PITAC-OPC5
#### Organization
**Class:** OTHER
**Full Name:** Odense University Hospital
### Status Module
#### Completion Date
**Date:** 2024-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-14
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-09-15
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2023-04-26
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Odense University Hospital
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** This study will monitor and evaluate patient and personnel safety and toxicity during the implementation and evaluation of Pressurized IntraThoracic Aerosol Chemotherapy (PITAC) directed treatment. Furthermore, this study will focus on Quality of Life questionnaires, LENT score, and evaluate pain and breathlessness using af visual analogue scales (VAS).
**Detailed Description:** This is a safety and feasibility study of repeated (minimum two procedures) PITAC directed treatments, and the primary outcome is the number of patients with medical adverse events (AEs) according to the Common Terminology Criteria for Adverse Events (CTCAE) and/or surgical complications according to the Clavien-Dindo classification. This study will include consecutive MPE patients until 20 patients have completed at least two PITAC´s. The PITAC directed treatment will be performed in 4 week intervals. Bedside ultrasound, VAS-pain and VAS-breathlessness, and Quality of Life questionnaires will be performed at baseline, one month follow-up and three months follow-up.
Patients with MPE who are eligible for surgery are identified during the multidisciplinary tumor (MDT) conference at the Department of Surgery, Odense University Hospital (OUH), and included based on predefined in- and exclusion criteria. Patients with MPE from non-colorectal or -appendix cancer will be treated with a combination of cisplatin and doxorubicin. Patients with MPE from colorectal or appendix cancer will be treated with oxaliplatin.
In brief, The PITAC procedure is the application of aerosolized chemotherapy into the pleural cavity using thoracoscopy. PITAC is performed in the prone or lateral position. A double lumen endotracheal tube is used to allow exclusion of the ipsilateral lung, but this is not (always) necessary with the patient in the prone position. The first trocar is placed guided by ultrasound, and after safe positioning a second trocar can be inserted guided by video thoracoscopy. The chemotherapy is applied to the pleural cavity through a nebulizer inserted through one of the trocars and linked to a high-pressure injector. After five minutes the chemotherapy has been delivered to the pleural cavity, and after an additional 30 minutes of simple diffusion, the intrathoracic air saturated with chemotherapy is evacuated through a series of filters.
The patients are monitored for a minimum of one day and will after each PITAC directed treatment be screened for adverse events.
### Conditions Module
**Conditions:**
- Malignant Pleural Effusion
- Pleural Neoplasms
- Quality of Life
- Chemotherapy Effect
- Chemotherapeutic Toxicity
- Pleural Carcinomatosis
- Pleural Cavity Effusion
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** Cohort study
##### Masking Info
**Masking:** NONE
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 20
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Malignant Pleural Effusion (MPE) from colorectal or appendix cancer will be treated with Pressurized IntraThoracic Aerosol Chemotherapy (PITAC) using oxaliplatin 92 mg/m2 in 150 ml dextrose. MPE from non-colorectal or -appendix cancer will be treated with PITAC using cisplatin 10.5 mg/m2 in 150 ml saline and 2.1 mg/m2 in 50 ml saline.
PITAC is performed with a intrapleural pressure of 12 mmHg and the aerosolised chemotherapy will be nebulized at a maximum pressure of 300 PSI and a flow-rate of 0.5-1.8 ml/min. The PITAC directed treatment will be planned with 4 week intervals and patients may receive bi-directional systemic chemotherapy simultaneously.
**Intervention Names:**
- Drug: PITAC
**Label:** PITAC
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- PITAC
**Description:** Cisplatin, oxaliplatin and doxorubicin are standard, commercially available intravenous cytostatic drugs in oncologic treatment with alkylating and topoisomerase inhibitor effect, respectively. Based on the available data and experience from 11 PITAC procedures at OPC, PITAC with cisplatin, oxaliplatin and doxorubicin for intrapleural administration is expected to be well tolerated with a minimal of nausea, subcutaneous emphysema and transient chest pains.
**Name:** PITAC
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Number of patients with medical adverse events (AEs) according to the Common Terminology Criteria for Adverse Events (CTCAE) version 6.0 defined as CTCAE ≥ 4 within 30 days after the procedure.
**Measure:** Medical adverse events
**Time Frame:** 30 days from PITAC directed treatment
**Description:** Number of patients with surgical complications according to the Clavien-Dindo classification defined as Clavien-Dindo ≥ 3b within 30 days after the procedure.
**Measure:** Surgical complications
**Time Frame:** 30 days from PITAC directed treatment
#### Secondary Outcomes
**Description:** To evaluate the number of patients completing three PITAC treatments
**Measure:** Number of patients completing three PITAC treatments
**Time Frame:** 12 months
**Description:** To macroscopically evaluate the extent of visible pleural metastasis (PLM) during PITAC directed therapy via the new PLM-score based on size of lesions (LS).
LS 0 No tumor seen LS1 Tumor up to 0.5 cm LS2 Tumor up to 5.0 cm LS3 Tumor \> 5.0 cm or confluence
**Measure:** Extent of visible pleural metastasis
**Time Frame:** 12 months
**Description:** To evaluate Pleural Regression Grade Score (Ple-RGS) in biopsies from visible pleural metastasis Ple-RGS is a modification of the Peritoneal Regression Grading score (PRGS). Ple-RGS 1: Complete histological response Ple-RGS 2: Regressive changes are predominant over cancer cells (major response) Ple-RGS 3: Cancer cells are predominant over regressive changes (minor response) Ple-RGS 4: No response
**Measure:** Pathology on pleural metastasis biopsies
**Time Frame:** 12 months
**Description:** To evaluate cytology on MPE during PITAC directed therapy. The cells will be graded according to a five-tiered score: malignant cells, suspicious cells, atypical cells, no malignant cells and other
**Measure:** Cytology on malignant pleural effusion fluid
**Time Frame:** 12 months
**Description:** To evaluate the LENT score after each PITAC directed therapy. Low risk: 0-1 Moderate risk: 2-4 High risk: 5-7
**Measure:** LENT score
**Time Frame:** 12 months
**Description:** Quantify the length of stay (LOS) (surgery = day 0)
**Measure:** Length of Stay (LOS)
**Time Frame:** 12 months
**Description:** Assess personnel safety by measuring of platinum traces in the operating room.
**Measure:** Personnel safety (environmental)
**Time Frame:** 12 months
**Description:** Assess personnel safety by measuring of platinum traces in blood samples from surgeons and/or OR nurses.
**Measure:** Personnel safety (biological)
**Time Frame:** 12 months
**Description:** To evaluate lung function by saturation (SAT) before PITAC directed treatment (day 0) and at discharge (day 1), day 30 and 3 months after the last PITAC directed treatment
**Measure:** Lung function evaluation by SAT
**Time Frame:** 12 months
**Description:** To evaluate breathlessness using visual analogue scales (VAS-breath) before PITAC directed treatment (day 0) and at discharge (day 1), day 30, and 3 months after the last PITAC directed treatment
**Measure:** Breathlessness
**Time Frame:** 12 months
**Description:** To evaluate pain using visual analogue scales (VAS-pain) before PITAC directed treatment (day 0) and at discharge (day 1), day 30, and 3 months after the last PITAC directed treatment
**Measure:** Pain assessment
**Time Frame:** 12 months
**Description:** To evaluate the quality of life with EORTC-QLQ-C30 at baseline, day 30 and 3 months after the last PITAC directed treatment
**Measure:** Quality of Life questionnaires
**Time Frame:** 12 months
**Description:** To calculate the change in volume of drained MPE from 2 months before the first PITAC treatment to three months after the last PITAC treatment
**Measure:** Change in MPE volume
**Time Frame:** 12 months
**Description:** To assess long-term complications 3 months after the third PITAC directed treatment
**Measure:** Long term complications
**Time Frame:** 12 months
**Description:** Median overall survival
**Measure:** Survival
**Time Frame:** 12 months
**Description:** To evaluate lung function by Forced Expired Volume in the first second (FEV1) before PITAC directed treatment (day 0) and at discharge (day 1), day 30 and 3 months after the last PITAC directed treatment
**Measure:** Lung function evaluation by FEV1
**Time Frame:** 12 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Symptomatic MPE visible with bedside ultrasound
* Histologically or cytologically verified malignancy
* Status CT-scan not older than four weeks
* MPE requiring at least one drainage procedure
* Drained ≥ 14 days before the first PITAC directed treatment
* Bidirectional systemic chemotherapy or immunotherapy ≥ 14 days before the first PITAC directed treatment or no simultaneous systemic chemotherapy or immunotherapy
* ECOG Performance status 0-2
* Life expectancy ≥ 3 months
* Age ≥ 18 years
* Danish-speaking and reading patients
* Written informed consent according to the local Ethics Committee requirements
Exclusion Criteria:
* A history of allergic reaction to cisplatin or other platinum containing compounds or doxorubicin
* Renal impairment, defined as GFR \< 40 ml/min (Cockcroft-Gault Equation)
* Myocardial insufficiency, defined as NYHA class \> 2
* Impaired liver function defined as bilirubin ≥1.5
* Fertility, pregnancy and lactation: Female subjects will be considered of non-reproductive potential if they are either a, b or c:
1. postmenopausal (defined as at least 12 months with no menses without an alternative medical cause; in women \< 45 years of age 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. In the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.
2. have had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy or bilateral tubal ligation/occlusion, at least 6 weeks prior to screening.
3. have a congenital or acquired condition that prevents childbearing. Previous intrathoracic chemotherapy, intrathoracic antibody treatment or chemical pleurodesis
* Any other condition or therapy, which in the investigator´s opinion may pose a risk to the patient or interfere with the study objects
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Pernille Schjødt Hansen, Student
**Phone:** +45 65411857
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Odense
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Martin Graversen, MD
- **Phone:** +45 30549497
- **Role:** CONTACT
***Contact 2:***
- **Name:** Martin Graversen, MD, Ph.D.
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Denmark
**Facility:** Odense PIPAC Center, Department of Surgery, Odense University Hospital
**Status:** RECRUITING
**Zip:** 5000
### IPD Sharing Statement Module
**Description:** Publications and presentations will be based on patient data, but the database is not open to other researchers.
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010995
- Term: Pleural Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
- ID: D000009375
- Term: Neoplasms, Glandular and Epithelial
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000009369
- Term: Neoplasms
- ID: D000012142
- Term: Respiratory Tract Neoplasms
- ID: D000013899
- Term: Thoracic Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
### Condition Browse Module - Browse Leaves
- ID: M18563
- Name: Pleural Effusion, Malignant
- Relevance: HIGH
- As Found: Malignant Pleural Effusion
- ID: M13886
- Name: Pleural Effusion
- Relevance: HIGH
- As Found: Pleural Effusion
- ID: M13887
- Name: Pleural Neoplasms
- Relevance: HIGH
- As Found: Pleural Neoplasms
- ID: M5534
- Name: Carcinoma
- Relevance: HIGH
- As Found: Carcinomatosis
- ID: M13885
- Name: Pleural Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12320
- Name: Neoplasms, Glandular and Epithelial
- Relevance: LOW
- As Found: Unknown
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
- ID: M14979
- Name: Respiratory Tract Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M16658
- Name: Thoracic Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: T6034
- Name: Quality of Life
- Relevance: HIGH
- As Found: Quality of Life
### Condition Browse Module - Meshes
- ID: D000002277
- Term: Carcinoma
- ID: D000016066
- Term: Pleural Effusion, Malignant
- ID: D000010997
- Term: Pleural Neoplasms
- ID: D000010996
- Term: Pleural Effusion
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M6182
- Name: Cisplatin
- Relevance: LOW
- As Found: Unknown
- ID: M1674
- Name: Oxaliplatin
- Relevance: LOW
- As Found: Unknown
- ID: M7492
- Name: Doxorubicin
- Relevance: LOW
- As Found: Unknown
- ID: M227339
- Name: Liposomal doxorubicin
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06421597
**Acronym:** RIGID
**Brief Title:** Identifying Individuals at Risk of Glucocorticoid-Induced Impairment of Bone Disease
**Official Title:** Identifying Individuals at Risk of Glucocorticoid-Induced Impairment of Bone Disease
#### Organization Study ID Info
**ID:** 2023-506949-27-00
#### Organization
**Class:** OTHER
**Full Name:** Odense University Hospital
### Status Module
#### Completion Date
**Date:** 2025-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-14
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-12
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-03
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Hospital of South West Jutland
**Class:** OTHER
**Name:** University of Ulm
**Class:** OTHER
**Name:** University of Birmingham
#### Lead Sponsor
**Class:** OTHER
**Name:** Odense University Hospital
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Previous studies have shown that there is a large inter-individual variability in the degree of bone loss during glucocorticoid treatment, and while some patients experience extensive bone loss other patients' bone mass remains stable. The aim of the study is to find a biomarker that can be used to identify individuals at risk of glucocorticoid-induced bone loss. The study will include 36 healthy volunteers, that will be randomized to receive either glucocorticoid treatment or placebo. During the study blood samples, bone marrow samples, bone tissue samples, and adipose tissue samples are taken and a mixed meal test is performed.
### Conditions Module
**Conditions:**
- Osteoporosis Secondary
### 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:** 36
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Drug: Prednisolone
**Label:** Prednisolone group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Intervention Names:**
- Drug: Placebo
**Label:** Placebo group
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Prednisolone group
**Description:** prednisoline 25 mg/day for seven days
**Name:** Prednisolone
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Placebo group
**Description:** Placebo treatment for seven days
**Name:** Placebo
**Type:** DRUG
### Outcomes Module
#### Other Outcomes
**Description:** Untargeted proteomics will be used to try to identify a biomarker for individuals at risk of glucocorticoid induced bone loss
**Measure:** Biomarker
**Time Frame:** Baseline
#### Primary Outcomes
**Description:** Changes in the level of the bone turnover marker P1NP in peripheral blood from baseline to day 8
**Measure:** Procollagen type 1 N-terminal propeptide (P1NP)
**Time Frame:** Baseline to day 8
#### Secondary Outcomes
**Description:** Changes in the level of the bone turnover marker CTX in peripheral blood from baseline to day 8 and 15
**Measure:** Collagen 1 cross link C-terminal telopeptide (CTX)
**Time Frame:** Baseline to day 8 and 15
**Description:** Changes in the level of the bone turnover marker P1NP in peripheral blood from baseline to day 15
**Measure:** P1NP (baseline to day 15)
**Time Frame:** Baseline to day 15
**Description:** Changes in the levels of glucocorticoid metabolites in blood from baseline to day 8
**Measure:** Concentration of Glucocorticoid metabolites
**Time Frame:** Baseline to day 8
**Description:** Changes in gene expression in abdominal and gluteal subcutaneous adipose tissue from baseline to day 8
**Measure:** Adipose tissue
**Time Frame:** Baseline to day 8
**Description:** Changes in gene expression in bone tissue from baseline to day 8
**Measure:** Bone tissue
**Time Frame:** Baseline to day 8
**Description:** Changes in glucose levels during a mixed meal test from baseline to day 8
**Measure:** Glucose
**Time Frame:** Baseline to day 8
**Description:** Changes in c-peptid levels during a mixed meal test from baseline to day 8
**Measure:** C-peptid
**Time Frame:** Baseline to day 8
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Men and women aged 18-50 years.
Exclusion Criteria:
* Uncontrolled thyrotoxicosis
* Chronic kidney disease (eGFR \<30)
* Known Cushing's syndrome
* Previous gastric bypass and/or known ongoing malabsorption
* Severe covid-19 in the last 3 month (defined as needing dexamethasone treatment)
* Use of oral or inhaled glucocorticoids within the past year
* Menopause (defined as 1 year without menstrual bleeding)
* Pregnancy (defined as elevated HCG)
* Ongoing infection
* Allergy to prednisolone or one of the excipients
* Systematic fungal infections
* Vaccination with living or weaken viral or bacterial vaccines in patient who or immunocompromised. In these cases, prednisolone treatment should not be administered two weeks before and after vaccination
* Not able to provide informed consent (e.g., dementia, not able to understand Danish).
**Healthy Volunteers:** True
**Maximum Age:** 50 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Catharina Vind Nielsen, MD
**Phone:** +45 21351124
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Esbjerg
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Catharina Vind Nielsen, MD
- **Phone:** +45 21351124
- **Role:** CONTACT
**Country:** Denmark
**Facility:** Hospital of South West Jutland
**Zip:** 6700
**Location 2:**
**City:** Odense C
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Catharina Vind Nielsen, MD
- **Phone:** +45 21351124
- **Role:** CONTACT
**Country:** Denmark
**Facility:** Odense University Hospital
**Zip:** 5000
#### Overall Officials
**Official 1:**
**Affiliation:** Odense University Hospital
**Name:** Morten Frost, MD
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** Hospital of South West Jutland
**Name:** Claus Bogh Juhl, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** Individual participant data will not be shared with other researchers other than collaborators. Since the data contains personal information from the study participants
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001851
- Term: Bone Diseases, Metabolic
- ID: D000009140
- Term: Musculoskeletal Diseases
- ID: D000008659
- Term: Metabolic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC05
- Name: Musculoskeletal Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
### Condition Browse Module - Browse Leaves
- ID: M5126
- Name: Bone Diseases
- Relevance: HIGH
- As Found: Bone Disease
- ID: M12307
- Name: Neoplasm Metastasis
- Relevance: LOW
- As Found: Unknown
- ID: M12947
- Name: Osteoporosis
- Relevance: HIGH
- As Found: Osteoporosis
- 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
- ID: D000001847
- Term: Bone Diseases
### 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
### 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: HIGH
- As Found: 1.5
- ID: M9047
- Name: Glucocorticoids
- Relevance: LOW
- As Found: Unknown
- ID: M11749
- Name: Methylprednisolone
- Relevance: LOW
- As Found: Unknown
- ID: M1833
- Name: Methylprednisolone Acetate
- Relevance: LOW
- As Found: Unknown
- ID: M11750
- Name: Methylprednisolone Hemisuccinate
- Relevance: LOW
- As Found: Unknown
- ID: M229449
- Name: Prednisolone acetate
- Relevance: LOW
- As Found: Unknown
- ID: M211887
- Name: Prednisolone hemisuccinate
- Relevance: LOW
- As Found: Unknown
- ID: M248881
- Name: Prednisolone phosphate
- Relevance: LOW
- As Found: Unknown
- ID: M4217
- Name: Anti-Inflammatory Agents
- Relevance: LOW
- As Found: Unknown
- ID: M9789
- Name: Hormones
- Relevance: LOW
- As Found: Unknown
- ID: M9788
- Name: Hormone Antagonists
- Relevance: LOW
- As Found: Unknown
- ID: M20966
- Name: Antineoplastic Agents, Hormonal
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000011239
- Term: Prednisolone
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06421584
**Acronym:** SURGTEACH
**Brief Title:** Evaluating the Role of SURGical TElementoring in Acquisition of Surgical Skills of Laparoscopic Cholecystectomy. SURGTEACH Trial
**Official Title:** Laparoscopic Cholecystectomy - A Randomized Controlled Trial Evaluating The Role Of Surgical Telementoring In Acquisition of Surgical Skills
#### Organization Study ID Info
**ID:** Nordlandssykehuset
#### Organization
**Class:** OTHER
**Full Name:** Nordlandssykehuset HF
### Status Module
#### Completion Date
**Date:** 2025-11-20
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-14
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-10-20
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-20
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-11
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** Olympus
#### Lead Sponsor
**Class:** OTHER
**Name:** Nordlandssykehuset HF
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Surgical telementoring (ST) has the potential to become an integrated part of everyday surgical teaching practice. Its educational benefits require investigation.
This is a randomized controlled trial evaluating ST in a clinical setting. Laparoscopic cholecystectomy will be performed by eligible surgical residents randomized to the intervention group or the control group. The control group being guided by traditional onsite mentoring and the intervention group being telementored by a distantly located telementor during ongoing procedure. The primary outcome will be the video recorded GOALS-score (Global Operative Assessment of Laparoscopic Skills) and NOTSS-score (Non Technical Surgical Skills) assessment of each procedure while secondary outcomes will be satisfaction scores of the involved residents and mentors.
**Detailed Description:** Background:
Developing surgical skills among residents takes time and resources. Surgical practice is increasingly driven by efficacy and hospital economics. Operating room surgical education might conflict with these goals. The identified factors need optimizing surgical resident training. Surgical telementoring (ST) seems natural in surgery. Some ST-systems are cost-effective and safe. Despite recent technical breakthroughs and growing experience with telemedicine in the health sector, data on educational outcomes is still being determined.
Objective:
ST will be evaluated for efficiency and safety as a skill development tool for laparoscopic cholecystectomy. In this randomized controlled trial, surgical residents will be randomly assigned in a 1:1 ratio to the intervention group (real-time telementoring and postoperative coaching) or the control group (traditional intraoperative hands-on teaching). The research follows CONSORT, SPIRIT 2013 statements and the intention to treat principle (ITT).
The study is approved by the Norwegian ethical committee (REK HELSE NORD 32592) and the data protection officer (PVO) at Nordland Hospital trust Bodø (NLSH Bodø).
Two groups of residents will be allocated. The control group will follow the traditional hands-on surgical training method. In the intervention group, an expert surgeon will telementor the surgical residents. General surgery trainees in years 1-6 who have completed more than five laparoscopic abdominal surgeries are eligible. Stratification according to previous experience of the mentee will be made. All residents must agree with the mentor on surgical communication. This model uses LapcoNor principles for intraoperative communication and the GROW-model as an educational model. The GOALS score is the primary trial outcome. It consists of a five-item global rating scale for laparoscopic surgical skills. Each item may be scored from 1 to 5, where 1 is the lowest and five is the highest. The max score is 25. We hypothesize that the intervention group will enhance clinical skills by 3-5 points on the GOALS score compared to the control group. To attain 0.8 statistical power, a p-value of less than 0.05, and a 20% dropout rate, 12 residents per group are needed.
In addition to the GOALS-score assessment of video records, the NOTSS-score evaluating non-surgical technical skills will be assessed. The NOTSS score is based on 4 categories where each category consists of 3 elements. Each element may be graded from 1 to 4 , where 1 is the lowest and 4 is the highest. The highest achievable score is 48.
The higher the score, the better the outcome for both scoring systems.
Results:
Lapco TT courses were given to all telementors and onsite consulting surgeons before the trial start. In December 2023, the Medprescence (c) telementoring system was installed in three local hospitals. Residents, consultant surgeons, and telementors learned Medprescence setup and use. Surgical residents will be recruited once this research protocol is evaluated and accepted for publication to accommodate any necessary changes before the study begins. Starting recruitment in spring 2024 is feasible. This would allow data analysis by end of 2024 and publication in an international peer-reviewed journal by spring 2025.
Conclusions:
The SURGTEACH trial is the first randomized trial of telementoring for surgical education. The surgical education system and surgeon supply are limited globally and locally. Due to geographical and educational barriers, the Norwegian healthcare system requires support in educating enough surgeons. Therefore, surgical education must evolve, and surgical telementoring may help solve these challenges. This research may give high quality evidence to improve surgical education, especially in rural hospitals.
### Conditions Module
**Conditions:**
- Surgical Education
- Surgical Telementoring
**Keywords:**
- Competency based surgical education
- Surgical telementoring
- Laparoscopic cholecystectomy
- Randomized controlled clinical trial
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** This randomized controlled trial (RCT) was designed as a superiority trial to demonstrate the superiority of telementored resident skill learning in the operating room (OR) compared to standard training methods.
##### Masking Info
**Masking:** DOUBLE
**Masking Description:** Mentors and telementors performing the GOALS-assessment of the video records are blinded to the temporal order of the performed procedures by the residents in both groups.
**Who Masked:**
- PARTICIPANT
- OUTCOMES_ASSESSOR
**Primary Purpose:** HEALTH_SERVICES_RESEARCH
#### Enrollment Info
**Count:** 24
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The residents randomized to the control arm will receive traditional intra operative guidance by the mentor holding the laparoscopic camera during the procedure.
**Label:** Control group
**Type:** NO_INTERVENTION
#### Arm Group 2
**Description:** The residents randomized to the intervention arm will receive telementored guidance. This guidance is provided by telecommunication setup allowing the remotely located mentor to see the live footage of the laparoscopic procedure and to verbally communicate with the resident performing the surgical procedure.
**Intervention Names:**
- Device: Surgical telementoring
**Label:** Interventional arm
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Interventional arm
**Description:** The intervention group receives intraoperative guidance by telementoring. The telementor is remotely located but able to see the real-time footage of the ongoing procedure and simultaneously verbally communicate with the operating resident wearing a headset during surgery. Additionally, feedback by telestration may be given to the operating resident if required. This involves graphic annotations on a still picture of the ongoing surgery which the telementor may design if required.
**Name:** Surgical telementoring
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** GOALS-score is a validated scoring system for laparoscopic surgical skills. Each performed procedure in the control group and the intervention group will be divided into 5 key-steps and each step will be scored by the 5 involved mentors and telementors. The video records of the procedures will be edited by the main author into 5 key-steps. Each recorded procedure will not exceed 1hours duration. All five procedures by each resident will be edited and presented to 5 mentors/telementors for GOALS-score assessment. Total GOALS-score will be calculated by adding the scores of each key-step.
Every resident in each of the 2 groups will perform 5 consecutive procedures within 3-5 consecutive days. The GOALS-assessment will be required with 1 week after presenting the procedures to the 5 mentors/telementors
**Measure:** GOALS-score (Global Operative Assessment of Laparoscopic Skills)
**Time Frame:** Each resident in both the intervention group and the control group will be scheduled to perform 5 consecutive laparoscopic cholecystectomies within 3-5 days.
**Description:** Assessing non-surgical technical skills by assessment of 4 categories (Situation awareness, Decision making, Communication and teamwork and Leadership. Each category consists of 3 elements. Each category is rated from 1-4 and each of the 3 elements within each category is rated from 1-4. Each recorded and edited video record of the 5 consecutive laparoscopic procedures by the residents in both groups will be presented to mentors/telementors (5 members) for NOTSS-score assessment. The NOTSS-assessment will be required with 1 week after presenting the procedures to the 5 mentors/telementors.
**Measure:** NOTSS-score (Non-technical surgical skills)
**Time Frame:** Each resident in both the intervention group and the control group will be scheduled to perform 5 consecutive laparoscopic cholecystectomies within 3-5 days.
#### Secondary Outcomes
**Description:** Each resident (both groups) will be given a predetermined form for self-reported satisfaction score. Resident satisfaction survey was based on a 5-point Likert scale. 7 statements are to be assessed with answers ranging from 1= strong disagreement with the statement and 5=strong agreement with the statement. 5 is the best outcome for each statement and 35 is the best overall result for the survey.
**Measure:** Satisfaction score of residents in the control group and the intervention group.
**Time Frame:** 5 subsequent procedures will be performed by each resident within a periode of 3-5 days. Satisfaction score form will be asked for within 1 hour after each procedure.
**Description:** Each mentor and telementor (both groups)will be given a predetermined form for self-reported satisfaction score. The mentor/telementor satisfaction survey was based on a 5-point Likert scale. 7 statements are to be assessed with answers ranging from 1= strong disagreement with the statement and 5=strong agreement with the statement. 5 is the best outcome for each statement and 35 is the best overall result for the survey.
**Measure:** Satisfaction score of mentors (control group) and telementors (intervention group)
**Time Frame:** Each mentor and telementor will be given a satisfaction score form to fill out within 1 hour after each procedure.
### Eligibility Module
**Eligibility Criteria:** Inclusion criteria for residents in control- and intervention group:
* General surgery residents in years 1 to 6 of their specialty education having performed more than five laparoscopic procedures.
* Stratification according to experience will be made for the subject in the control arm and in the intervention arm.
* Having passed the prerequisite mandatory national course of general laparoscopic principles.
* All residents had to undergo agreement with the mentor about communication model during surgery. This model is derived from LapcoNor principals (11). Residents in the intervention group underwent an additional introduction to the principals of communication through telementoring at the OR. They were introduced to the telementoring equipment.
Inclusion criteria for on-site mentors (control group) and telementors (intervention group): • - Consultant surgeon with more than 3 years of experience with independently performing laparoscopic cholecystectomies.
* Having acquaintance with assessment of videos for GOALS-score (12)
* Both telementors and on-site mentors had to show certificate of having done the national LapCo-Nor "train the trainer" course and followed standardized norms of communication with the mentee during surgical mentoring thus diminishing bias of communicative difference.
Inclusion criteria for included patients:
* Gallstone disease without clinical history of cholecystitis
* BMI \< 38
* No previous history of upper abdominal laparotomy
* No previous history of percutaneous gallbladder drainage
* Patient provided informed consent.
**Healthy Volunteers:** True
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Khayam Butt, Medical doctor
**Phone:** 004799560985
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Knut-Magne Augestad, Professor
**Phone:** 004797499442
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Bodø
**Country:** Norway
**Facility:** NordlandssykehusetHF
**State:** Nordland
**Zip:** 8004
#### Overall Officials
**Official 1:**
**Affiliation:** Head of research department
**Name:** Petter Øien, PhD
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**Access Criteria:** All raw data will be shared on request.
**Description:** Video records of the procedures will be stripped for patient-ID and stored anonymously on a secured website. Each video will be given an URL-address. The study secretary will have the key enabling recognition of each video to the specific patient and performing surgeon. The anonymous video records will be made available for each of the 5 mentors/telementors after being edited and labelled with key-steps of the procedure. Blinded GOALS- and NOTSS-assessment by the mentors/telementors will be performed. The assessment results will be collected by the study secretary on a questback scheme handed out in advance to the evaluators. The study secretary possesses the key enabling recognition of the video records according to patient-ID and performing residents. An Excel file with the results will be constructed by the study secretary and the data analysis will be commenced. The video records and the Excel file, constituting the raw data, will be available as IPD for sharing.
**Info Types:**
- STUDY_PROTOCOL
- SAP
- ICF
**IPD Sharing:** YES
**Time Frame:** Data will be available as it is collected. Videorecords of the procedures by the residents are planned to be finished by end of November 2024. The video records will be stored continuously and the website will be availabe at the starting point. The GOALS-scores and NOTSS-scores will be collected continuously as the video records are edited and presented to the mentors (control arm) and the telementors (intervention arm)
### References Module
#### References
**Citation:** Holmer H, Lantz A, Kunjumen T, Finlayson S, Hoyler M, Siyam A, Montenegro H, Kelley ET, Campbell J, Cherian MN, Hagander L. Global distribution of surgeons, anaesthesiologists, and obstetricians. Lancet Glob Health. 2015 Apr 27;3 Suppl 2:S9-11. doi: 10.1016/S2214-109X(14)70349-3. No abstract available.
**PMID:** 25926323
**Citation:** Vickers AJ, Bianco FJ, Gonen M, Cronin AM, Eastham JA, Schrag D, Klein EA, Reuther AM, Kattan MW, Pontes JE, Scardino PT. Effects of pathologic stage on the learning curve for radical prostatectomy: evidence that recurrence in organ-confined cancer is largely related to inadequate surgical technique. Eur Urol. 2008 May;53(5):960-6. doi: 10.1016/j.eururo.2008.01.005. Epub 2008 Jan 14.
**PMID:** 18207316
**Citation:** Zorn KC, Gautam G, Shalhav AL, Clayman RV, Ahlering TE, Albala DM, Lee DI, Sundaram CP, Matin SF, Castle EP, Winfield HN, Gettman MT, Lee BR, Thomas R, Patel VR, Leveillee RJ, Wong C, Badlani GH, Rha KH, Eggener SE, Wiklund P, Mottrie A, Atug F, Kural AR, Joseph JV; Members of the Society of Urologic Robotic Surgeons. Training, credentialing, proctoring and medicolegal risks of robotic urological surgery: recommendations of the society of urologic robotic surgeons. J Urol. 2009 Sep;182(3):1126-32. doi: 10.1016/j.juro.2009.05.042. Epub 2009 Jul 21.
**PMID:** 19625032
**Citation:** Strasberg SM, Hertl M, Soper NJ. An analysis of the problem of biliary injury during laparoscopic cholecystectomy. J Am Coll Surg. 1995 Jan;180(1):101-25. No abstract available.
**PMID:** 8000648
**Citation:** Yun Kyung Jung et al: What is the safe training to educate the laparoscopic cholecystectomy for surgical residents in early learning curve ? J. Minim Invasive Surg 2016; 19(2): 70-74
**Citation:** Doarn CR. Telemedicine in tomorrow's operating room: a natural fit. Semin Laparosc Surg. 2003 Sep;10(3):121-6. doi: 10.1177/107155170301000305.
**PMID:** 14551654
**Citation:** Ohinmaa A, Vuolio S, Haukipuro K, Winblad I. A cost-minimization analysis of orthopaedic consultations using videoconferencing in comparison with conventional consulting. J Telemed Telecare. 2002;8(5):283-9. doi: 10.1177/1357633X0200800507.
**PMID:** 12396857
**Citation:** Schulam PG, Docimo SG, Saleh W, Breitenbach C, Moore RG, Kavoussi L. Telesurgical mentoring. Initial clinical experience. Surg Endosc. 1997 Oct;11(10):1001-5. doi: 10.1007/s004649900511.
**PMID:** 9381336
**Citation:** Augestad KM, Bellika JG, Budrionis A, Chomutare T, Lindsetmo RO, Patel H, Delaney C; Mobile Medical Mentor (M3) Project. Surgical telementoring in knowledge translation--clinical outcomes and educational benefits: a comprehensive review. Surg Innov. 2013 Jun;20(3):273-81. doi: 10.1177/1553350612465793. Epub 2012 Oct 30.
**PMID:** 23117447
**Citation:** Wood D. No surgeon should operate alone: how telementoring could change operations. Telemed J E Health. 2011 Apr;17(3):150-2. doi: 10.1089/tmj.2011.9986. No abstract available.
**PMID:** 21500973
**Citation:** Hanna GB, Mackenzie H, Miskovic D, Ni M, Wyles S, Aylin P, Parvaiz A, Cecil T, Gudgeon A, Griffith J, Robinson JM, Selvasekar C, Rockall T, Acheson A, Maxwell-Armstrong C, Jenkins JT, Horgan A, Cunningham C, Lindsey I, Arulampalam T, Motson RW, Francis NK, Kennedy RH, Coleman MG; on behalfofLapco program. Laparoscopic Colorectal Surgery Outcomes Improved After National Training Program (LAPCO) for Specialists in England. Ann Surg. 2022 Jun 1;275(6):1149-1155. doi: 10.1097/SLA.0000000000004584. Epub 2020 Oct 19.
**PMID:** 33086313
**Citation:** Vassiliou MC, Feldman LS, Andrew CG, Bergman S, Leffondre K, Stanbridge D, Fried GM. A global assessment tool for evaluation of intraoperative laparoscopic skills. Am J Surg. 2005 Jul;190(1):107-13. doi: 10.1016/j.amjsurg.2005.04.004.
**PMID:** 15972181
**Citation:** Mackenzie H, Cuming T, Miskovic D, Wyles SM, Langsford L, Anderson J, Thomas-Gibson S, Valori R, Hanna GB, Coleman MG, Francis N. Design, delivery, and validation of a trainer curriculum for the national laparoscopic colorectal training program in England. Ann Surg. 2015 Jan;261(1):149-56. doi: 10.1097/SLA.0000000000000437.
**PMID:** 24374538
**Citation:** Manatakis DK, Antonopoulou MI, Tasis N, Agalianos C, Tsouknidas I, Korkolis DP, Dervenis C. Critical View of Safety in Laparoscopic Cholecystectomy: A Systematic Review of Current Evidence and Future Perspectives. World J Surg. 2023 Mar;47(3):640-648. doi: 10.1007/s00268-022-06842-0. Epub 2022 Dec 6.
**PMID:** 36474120
**Citation:** Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
**PMID:** 15273542
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06421571
**Acronym:** GR-CTCL_CL
**Brief Title:** The Mechanism of Action of Chlormethine (CL) Gel in the Treatment of MF-CTCL Adult Patients
**Official Title:** A Greek, Prospective Non-interventional Study Investigating the Effectiveness and the Mechanism of Action of Chlormethine (CL) Gel in the Treatment of MF-CTCL Adult Patients
#### Organization Study ID Info
**ID:** 441/05-08-2020
#### Organization
**Class:** OTHER
**Full Name:** National and Kapodistrian University of Athens
### Status Module
#### Completion Date
**Date:** 2025-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-14
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-02
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-02-21
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-03-26
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** Recordati Rare Diseases
#### Lead Sponsor
**Class:** OTHER
**Name:** National and Kapodistrian University of Athens
#### Responsible Party
**Investigator Affiliation:** National and Kapodistrian University of Athens
**Investigator Full Name:** Evangelia Papadavid
**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:** Chlormethine is a topical alkylating agent whose role in MF-CTCL has been extensively studied over the last 40 years. While its efficacy is well established, many safety concerns have been raised due to high rates of delayed cutaneous hypersensitivity to aqueous solutions that limit the prolonged use of chlormethine in clinical practice. It has been shown that complete response to topical chlormethine is associated with lower risk of disease progression. Accordingly, clinical data from the investigators' clinic confirm that chlormethine gel is a safe and effective treatment, which be used in early and advanced stages of cutaneous lymphomas. Based investigators' clinical and biological results , the investigators like to further investigate the change in the percentage as well as the profile of malignant and inflammatory cells by CyTOF analysis and further investigate the pathways (eg OX40, PDL1) involved in this process.
**Detailed Description:** 1. RATIONALE Chlormethine is a topical alkylating agent whose role in MF-CTCL has been extensively studied over the last 40 years. While its efficacy is well established, many safety concerns have been raised due to high rates of delayed cutaneous hypersensitivity to aqueous solutions that limit the prolonged use of chlormethine in clinical practice. It has been shown that complete response to topical chlormethine is associated with lower risk of disease progression. Accordingly, the clinical data confirm that chlormethine gel is a safe and effective treatment, which be used in early and advanced stages of cutaneous lymphomas. In a study of 23 patients with stage IA-IIB mycosis fungoides from investigators' center an overall response of 65.22% at 9 months of treatment with topical chlormethine was recorded. Moreover in a recent multicenter greek study that included 58 patients with stage IA-IIB mycosis fungoides an overall response rate of 80.8% at 9 months of treatment was achieved. In the same study better response in patients with patches in comparison to plaques or tumors was also depicted. Unfortunately, the occurrence of skin drug reactions was the leading cause of treatment discontinuation in studies evaluating chlormethine irrespective of drug formulation, negatively affecting the achievement of a therapeutic response. In investigators' study, severe dermatitis was one of the main causes of treatment discontinuation, occuring in 15.5% of patients.
Taper of application frequency (as per SmPC) and topical steroid use represent strategies allowing the management of dermatitis in order to maintain patients on CL gel treatment and prevent treatment discontinuation. The presence or severity of dermatitis in the study population was not associated with ORR, indicating that the development of dermatitis did not affect the likelihood of response. It has previously been suggested that dermatitis may be a prognostic indicator for clinical response. These data highlight the unmet need to explain the significance of dermatitis after topical chlomethine application and the immunological changes behind and how these affect the clinical response. Additionally by standardizing a CyTOF technique in CTCL samples from skin biopsies of CTCL patients, investigators established the methodology for identification and enumeration of different cells populations in situ and their interactions with tumor microenvironment. Investigators' preliminary data demonstrated that the evaluation of MF-CTCL patients' immune profile revealed differences in cell proportion pinpointing the heterogeneity that characterizes different stages of MF.
Based on investigators' clinical and biological results investigators would like to further examine the change in the percentage as well as the profile of malignant and inflammatory cells by CyTOF analysis and further investigate the pathways (eg OX40, PDL1) involved in this process.
2. STUDY DESIGN 2.1 Study Description The proposed study is a non-interventional, prospective (data collection), open-label, single-arm study. Data collection will be done prospectively. The management of patients will be done in the classic framework of the management of adult patients with MF-CTCL in principal investigator's university hospital.
3. RESEARCH OBJECTIVES (CLINICAL, BIOLOGICAL AND PATIENT-REPORTED OUTCOMES - QUALITY OF LIFE) 3.1 Clinical objectives
3.1.1 Effectiveness of CL gel treatment in routine medical practice in MF patients by:
• Evaluation of clinical response by mSWAT
* Duration of response (defined as the interval from the time measurement criteria for CR and PR are first met until the first date that progressive disease is documented), time to next treatment (TNTT: defined as the time from the time the next treatment is recorded)
* Correlation between dermatitis occurrence and clinical response
* quality of life of the patients
* Chlormethine gel tube consumption
* safety and tolerability of the treatment with CL gel: frequency of skin side effects 3.2 Biological objectives For this part of the study the percentage change of malignant and inflammatory cells, profile of inflammatory (new and existing) and malignant cells in all MF patients treated with chlormethine gel (with or without dermatitis), cytokines and signaling pathways at a single cell level will be also measured.
3.2.1 Assessments Dermatitis occurrence (before any topical steroids application) Clinical response (at least score \>50% improvement from baseline) At months 6 and 12
* Evaluation of the impact of chlormethine gel treatment on malignant and inflammatory cells
* Evaluation of the impact of chlormethine gel treatment exhibits on the profile of Th1/Th2 cytokines (ELISA)
* Evaluation of the impact that CL gel treatment exerts on the JAK/STAT, NF-κB AKT, MAP signaling pathways (Western Blotting) 3.3 Patient-Reported Outcomes - quality of life (SKINDEX-29) Quality of Life (QoL) change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Disease-Related Symptom Scales of the SKINDEX-29 at every visit.
3.4 Study Population MF patients treated with CL gel as monotherapy. Study design is presented in figure below.
This study will include 40 patients treated with CL gel as monotherapy.
Patients will discontinue study treatment permanently if the following condition is met:
• Patients are still unable to tolerate CL gel treatment at reduced frequency with co-administration of corticosteroids.
All patients will be assessed every month for the first three months, and every 3 months thereafter (at months 6, 9, 12), as per current clinical practice.
In case of dermatitis, the patient is encouraged to continue treatment with reduced frequency at every other day or every third day. Steroids will be used only if the reduced schedule is not sufficient. A temporary treatment interruption might occur for a period of 2 weeks and then treatment can be restarted.
3.5 Research objectives (detailed) Clinical, biological and patient quality of life 3.5.1 Clinical objective
• Effectiveness of CL gel treatment in routine medical practice in MF patients: Overall Response Rate (ORR), defined as the proportion of patients who achieved a CR or PR (at least score \>50% improvement from baseline), in all patients determined by mSWAT, within 12 months of the start of CL gel treatment.
* Duration of response (RD), time to next treatment (TNTT) in the framework of the trial
* safety and tolerability of the drug: Frequency of skin side effects with a focus on dermatitis, the time to occurrence and duration of dermatitis as well as the percentage of patients with dermatitis remaining on treatment at the end of the study
* Correlation between dermatitis occurrence and clinical response (ORR in patients experiencing or not dermatitis during treatment by chlormethine gel)
* quality of life of the patients (using Skindex-29 tool) receiving CL gel for at baseline and at the end of treatment
* Chlormethine gel tube consumption estimated from medical prescription and patients' statement 3.6 Biological objectives
For this part of the study the percentage change of malignant and inflammatory cells, profile of inflammatory (new and existing) and malignant cells in all MF patients treated with chlormethine gel (with or without dermatitis), cytokines and signaling pathways at a single cell level will be also measured at:
* Baseline
o Dermatitis occurrence (before any topical steroids application)
* Clinical response (at least score \>50% improvement from baseline)
* At months 6 and 12
* Evaluation of the impact of chlormethine gel treatment on malignant and inflammatory cells using mass cytometry (CyTOF)
* Evaluation of the impact of chlormethine gel treatment exhibits on the profile of Th1/ Th2 cytokines (ELISA)
* Evaluation of the impact that CL gel treatment exerts on the JAK/STAT, NF-κB, AKT, MAP signalling pathways (western blot analysis)
Skin histology description, immunohistochemistry and PCR are used in clinical routine practice to assess malignant T cells and clonality.
The exploratory study will use both blood samples and skin biopsies taken as per routine management of the patients tests for the study of • CL gel mechanism of action (1)
• the pathophysiology of dermatitis after CL gel application (2)
We will correlate the above with the clinical effectiveness of CL gel treatment (3) as well as dermatitis occurrence and clinical response in MF patients (4).
More specifically
• the profile of malignant cells and inflammatory, by characterizing the immune cells deriving from single cell suspensions from biopsies and/or PBMCs by mass cytometry
The signaling pathways involved, such as JAK/STAT, NF-κB, AKT, MAP kinases by identifying the phosphorylation status of implicated proteins by Western blot analyses
3.7 Patient-Reported Outcomes - quality of life (SKINDEX-29) Definition: Quality of Life (QoL) change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Disease-Related Symptom Scales of the SKINDEX-29 at every visit.
The Skindex-29 is a skin disease-specific questionnaire that comprehensively assesses the effects of skin diseases on patient's quality of life. It was specifically developed to detect changes throughout time, as well as differences among patients with different skin diseases. The questionnaire covers areas considered crucial in an instrument designed to evaluate quality of life, such as: degree of symptoms, psychosocial functioning, and emotional status. The 29-item version is a refinement of a previous 61-item version. It was originally written in English and has already been translated and validated in other languages. The Skindex-29 inquiries about how often (Never, Rarely, Sometimes, Often, All the time) during the previous four weeks the patient experienced the effect described in each item. Seven items address the Symptoms domain, ten items the Emotional domain, and twelve items the Functioning domain. All responses are transformed to a linear scale of 100 varying from 0 (no effect) to 100 (effect experienced all the time). Skindex scores are reported as three scale scores, corresponding to the three domains; a scale score is the average of a patient's responses to items in a given domain.
Five distinct categories for the Symptoms scale, and four for the Emotions and Functioning scales have been categorized as summarized in the table below:
Emotional Symptoms Functioning Very little \<6 \<4 \<4 Mild 6-24.9 4-10.9 4-10.9 Moderate 25-49.9 11-25.9 11-32.9 Severe ≥50 26-49.9 ≥33 Extreme ≥50
### Conditions Module
**Conditions:**
- Mycosis Fungoides
### Design Module
#### Bio Spec
**Description:** Skin biopsies and blood from MF-CTCL patients
**Retention:** SAMPLES_WITH_DNA
#### Design Info
**Observational Model:** OTHER
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 40
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Outcomes Module
#### Primary Outcomes
**Description:** Number of participants with treatment-related adverse events as assessed by CTCAEv4.0.
**Measure:** Clinical objectives: Number of participants with treatment-related adverse events as assessed by CTCAEv4.0.
**Time Frame:** 12 months
**Description:** Clinical response mSWAT (at least score ≥50% improvement from baseline) every month for the first three months, and every 3 months thereafter (at months 6, 9, 12), as per current clinical practice
**Measure:** Clinical objectives: Clinical response mSWAT
**Time Frame:** 12 months
**Description:** Dermatitis occurrence (before any topical steroids application)
**Measure:** Clinical objectives: Dermatitis occurrence
**Time Frame:** 12 months
**Description:** Determine and compare immune cells vs malignant cells at single cell level
**Measure:** Biological objectives: Evaluation of the impact of chlormethine gel treatment on malignant and inflammatory cells
**Time Frame:** 12 months
**Description:** Evaluation of the impact of chlormethine gel treatment exhibits on the profile of Th1/Th2 cytokines (ELISA)
**Measure:** Biological objectives:Evaluation of the impact of chlormethine gel treatment exhibits on the profile of cytokines
**Time Frame:** 12 months
**Description:** Evaluation of the impact that CL gel treatment exerts on the JAK/STAT, NF-κB AKT, MAP signaling pathways (Western Blotting)
**Measure:** Biological objectives:Evaluation of the impact that CL gel treatment exerts on the major signaling pathways
**Time Frame:** 12 months
**Description:** Questionnaires of Quality of Life
**Measure:** Patient-Reported Outcomes
**Time Frame:** 12 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* MF-CTCL early-stage diagnosed patients, or late-stage patients that relapse without current active tumoral disease who still have patches and/or plaques.
* Age ≥ 18 years
* Patients naïve from CL gel treatment
* Early-stage patients who will be using CL as monotherapy: at enrolment without any concomitant MF treatment
* Early-stage patients if treated with other topical or systemic (late or early-stage patients) at enrolment, then a 2 week for topical steroids (and/or other topical treatment) and 4 weeks for systemic treatments wash out period will be required
* Women of child bearing potential must have a negative serum pregnancy test within 3 days prior enrolment.
* Women of child bearing potential should use adequate birth control measures, during the study treatment period until 30 days after treatment
* Women who are breast feeding should discontinue nursing prior to the first application of study treatment and until 30 days after the last study treatment
* Before patient enrolment, written informed consent must be given according to ICH/GCP
Exclusion Criteria:
* - Patients diagnosed with stage III and IV, unless they meet the inclusion criteria for late stage disease (see above)
* Patients with multiple active tumors - progressive disease
* Patients with concomitant and chronic use of topical or systemic corticosteroids for the treatment of any other disease
* Patients treated with concomitant topical (except chlormethine gel) and/or systemic MF treatments who have missed the wash-out period (2 weeks for topical treatment and 4 weeks for systemic treatment)
* Acute flare or atopic dermatitis or other dermatosis in the last 3 weeks
* Pregnant and breast-feeding women
* Patients unable to comply with study procedures (e.g. provide written consent, fill in the questionnaires, geographical condition potentially hampering compliance with the study protocol and follow-up schedule).
* Known hypersensitivity to any component of the CL gel formulation
* Concurrent or planned local or systemic anti-CTCL therapies
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** MF-CTCL patients, from outpatient PCL clinic from Attikon University Hospital, who will be candidates for topical treatment with chlormethine gel will be informed and invited to participate in this prospective data collection. All clinical and biological investigations (including blood samplings and biopsies) will be prescribed and arranged as part of standard routine clinical practice at PCL center.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Athens
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Evangelia Papadavid
- **Phone:** +302105832458
- **Role:** CONTACT
***Contact 2:***
- **Name:** Evangelia Papadavid
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Greece
**Facility:** 1 Rimini Street, ATTIKON University Hospital
**Status:** RECRUITING
**Zip:** 12462
### References Module
#### References
**Citation:** Inturi S, Tewari-Singh N, Agarwal C, White CW, Agarwal R. Activation of DNA damage repair pathways in response to nitrogen mustard-induced DNA damage and toxicity in skin keratinocytes. Mutat Res. 2014 May-Jun;763-764:53-63. doi: 10.1016/j.mrfmmm.2014.04.002. Epub 2014 Apr 13.
**PMID:** 24732344
**Citation:** Lessin SR, Duvic M, Guitart J, Pandya AG, Strober BE, Olsen EA, Hull CM, Knobler EH, Rook AH, Kim EJ, Naylor MF, Adelson DM, Kimball AB, Wood GS, Sundram U, Wu H, Kim YH. Topical chemotherapy in cutaneous T-cell lymphoma: positive results of a randomized, controlled, multicenter trial testing the efficacy and safety of a novel mechlorethamine, 0.02%, gel in mycosis fungoides. JAMA Dermatol. 2013 Jan;149(1):25-32. doi: 10.1001/2013.jamadermatol.541.
**PMID:** 23069814
**Citation:** Kim EJ, Guitart J, Querfeld C, Girardi M, Musiek A, Akilov OE, Angello JT, Bailey WL, Geskin LJ. The PROVe Study: US Real-World Experience with Chlormethine/Mechlorethamine Gel in Combination with Other Therapies for Patients with Mycosis Fungoides Cutaneous T-Cell Lymphoma. Am J Clin Dermatol. 2021 May;22(3):407-414. doi: 10.1007/s40257-021-00591-x. Epub 2021 Mar 3. Erratum In: Am J Clin Dermatol. 2022 May;23(3):425.
**PMID:** 33656660
**Citation:** Kim YH, Liu HL, Mraz-Gernhard S, Varghese A, Hoppe RT. Long-term outcome of 525 patients with mycosis fungoides and Sezary syndrome: clinical prognostic factors and risk for disease progression. Arch Dermatol. 2003 Jul;139(7):857-66. doi: 10.1001/archderm.139.7.857.
**PMID:** 12873880
**Citation:** Kim YH, Martinez G, Varghese A, Hoppe RT. Topical nitrogen mustard in the management of mycosis fungoides: update of the Stanford experience. Arch Dermatol. 2003 Feb;139(2):165-73. doi: 10.1001/archderm.139.2.165.
**PMID:** 12588222
**Citation:** Koumourtzis M, Lampadaki K, Dalamaga M, Papadavid E. Chlormethine Gel is Efficient and Safe in Mycosis Fungoides Skin Lesions. Acta Derm Venereol. 2022 Jun 9;102:adv00730. doi: 10.2340/actadv.v102.1095.
**PMID:** 35199177
**Citation:** Lampadaki K, Koumourtzis M, Karagianni F, Marinos L, Papadavid E. Chlormethine Gel in Combination with Other Therapies in the Treatment of Patients with Mycosis Fungoides Cutaneous T Cell Lymphoma: Three Case Reports. Adv Ther. 2021 Jun;38(6):3455-3464. doi: 10.1007/s12325-021-01721-x. Epub 2021 Apr 30.
**PMID:** 33928511
**Citation:** Papadavid E, Koumourtzis M, Nikolaou V, Lampadaki K, Marinos L, Patsatsi A, Georgiou E, Dalamaga M, Stratigos A. Chlormethine gel is effective for the treatment of skin lesions in patients with early- and late-stage mycosis fungoides in clinical practice. J Eur Acad Dermatol Venereol. 2022 Oct;36(10):1751-1757. doi: 10.1111/jdv.18183. Epub 2022 May 12.
**PMID:** 35470483
**Citation:** Ramsay DL, Parnes RE, Dubin N. Response of mycosis fungoides to topical chemotherapy with mechlorethamine. Arch Dermatol. 1984 Dec;120(12):1585-90.
**PMID:** 6508330
**Citation:** Querfeld C, Scarisbrick JJ, Assaf C, Guenova E, Bagot M, Ortiz-Romero PL, Quaglino P, Bonizzoni E, Hodak E. Post hoc Analysis of a Randomized, Controlled, Phase 2 Study to Assess Response Rates with Chlormethine/Mechlorethamine Gel in Patients with Stage IA-IIA Mycosis Fungoides. Dermatology. 2022;238(2):347-357. doi: 10.1159/000516138. Epub 2021 Jun 4.
**PMID:** 34091453
**Citation:** Pavlidis A, Karagianni F, Vetsika EK, Koumourtzis M, Lampadaki K, Piperi C, Pappa V, Papadavid E. Bio-P-10 - Evaluation of the role of different cell populations in mycosis fungoides microenvironment as a tool for biomarker identification for disease progression and individualized therapy. EJC 2021:156(S1);S40-S41
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001423
- Term: Bacterial Infections and Mycoses
- ID: D000007239
- Term: Infections
- ID: D000016410
- Term: Lymphoma, T-Cell, Cutaneous
- ID: D000016399
- Term: Lymphoma, T-Cell
- ID: D000008228
- Term: Lymphoma, Non-Hodgkin
- ID: D000008223
- Term: Lymphoma
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000009369
- Term: Neoplasms
- ID: D000008232
- Term: Lymphoproliferative Disorders
- ID: D000008206
- Term: Lymphatic Diseases
- ID: D000007160
- Term: Immunoproliferative Disorders
- ID: D000007154
- Term: Immune System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC01
- Name: Infections
- Abbrev: All
- Name: All Conditions
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC15
- Name: Blood and Lymph 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: M12136
- Name: Mycoses
- Relevance: HIGH
- As Found: Mycosis
- ID: M12137
- Name: Mycosis Fungoides
- Relevance: HIGH
- As Found: Mycosis Fungoides
- ID: M4722
- Name: Bacterial Infections
- 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: M4721
- Name: Bacterial Infections and Mycoses
- Relevance: LOW
- As Found: Unknown
- ID: M11220
- Name: Lymphoma
- Relevance: LOW
- As Found: Unknown
- ID: M18829
- Name: Lymphoma, T-Cell
- Relevance: LOW
- As Found: Unknown
- ID: M18832
- Name: Lymphoma, T-Cell, Cutaneous
- Relevance: LOW
- As Found: Unknown
- ID: M11222
- Name: Lymphoma, Non-Hodgkin
- Relevance: LOW
- As Found: Unknown
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
- ID: M11225
- Name: Lymphoproliferative Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M11203
- Name: Lymphatic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10206
- Name: Immunoproliferative Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T3986
- Name: Mycosis Fungoides
- Relevance: HIGH
- As Found: Mycosis Fungoides
- ID: T3543
- Name: Lymphosarcoma
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000009181
- Term: Mycoses
- ID: D000009182
- Term: Mycosis Fungoides
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M11449
- Name: Mechlorethamine
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06421558
**Brief Title:** Impact of Direct Current Electrical Stimulation on Treatment of Lumbosacral Radiculopathy
**Official Title:** Impact of Direct Current Neuromuscular Electrical Stimulation on Physical Therapy Treatment of Lumbosacral Radiculopathy
#### Organization Study ID Info
**ID:** Pro00077736
#### Organization
**Class:** INDUSTRY
**Full Name:** NeuFit - Neurological Fitness and Education
### Status Module
#### Completion Date
**Date:** 2025-08-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-14
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-05-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-04-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-08
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** NeuFit - Neurological Fitness and Education
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** True
**Is FDA Regulated Drug:** False
**Is US Export:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This study will compare two methods of electrical stimulation (alternating current and direct current) as an adjunctive therapy to treating lumbosacral radiculopathy. Both types of electrical stimulation have been used in clinical practice for physical therapy, however direct current stimulation is much less common and there is less known about its impact on physical therapy outcomes. The aim of this project is to show the efficacy of a novel device, the Neubie direct current device, compared to traditional TENS unit in clinical physical therapy treatment of radiculopathy. Outcomes measured will include: pain intensity, functional status, neurological status, electrophysiological changes and patient satisfaction.
**Detailed Description:** To determine the efficacy of direct current electrical stimulation (the Neubie device) on long-term symptoms and severity of lumbosacral and thoracic radiculopathy, participants will enroll in a 6-week treatment regimen at one of 9 Hands-On Physical Therapy associated clinic sites listed included in application. The first session will consist of an intake evaluation session that will include: Visual Analogue Scale (VAS) for pain, Oswestry Disability Index questionnaire to assess functional disability, Straight Leg Raise Test to address nerve root irritation or compression, and Electrophysiological evaluation to determine the nerve function. These tests will serve as baseline (and a within subject control) for the intervention.
Participants will then undergo a specialized radiculopathy protocol that includes traditional PT therapy as well as treatment with the Neubie (or traditional electrical stimulation) both during PT exercises and as additional treatment after sessions. Subjects receive an evaluation session that includes Visual Analogue Scale (VAS) for pain, Oswestry Disability Index questionnaire to assess functional disability, Straight Leg Raise Test to address nerve root irritation or compression, and Electrophysiological evaluation to determine the nerve function.
The experimental group subjects follow with 12 sessions of physical therapy over a 6-week period which include 30 min of various physical therapy exercises with the Neubie.
The control group subjects follow with 12 sessions of physical therapy over a 6-week period which include: a 30-min of various physical therapy exercises with TENS application.
At the end of the 12 sessions of treatment, subjects receive a final evaluation session that includes Visual Analogue Scale (VAS) for pain, Oswestry Disability Index questionnaire to assess functional disability, Straight Leg Raise Test to address nerve root irritation or compression, Electrophysiological evaluation to determine the nerve function, and a patient satisfaction questionnaire to assess patient satisfaction with the treatment. Participants will receive 12 treatments over 6 weeks. Measurement of these variables will provide both quantitative and qualitative data on the severity of radiculopathy symptoms (see "Tools for data collection" below).
### Conditions Module
**Conditions:**
- Radiculopathy Lumbar
- Radiculopathy Sacral
- Radiculopathy Multiple Sites
**Keywords:**
- electrical stimulation
- direct current
- e-stim
- neubie
- emg
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Study will be divided into two randomly assigned groups - control and experimental. Control group will receive traditional e-stim treatment with TENS plus physical therapy. Experimental group will receive direct current e-stim treatment with the Neubie device plus physical therapy.
##### Masking Info
**Masking:** SINGLE
**Masking Description:** Outcomes will be assessed by clinicians at Hands on Diagnostics locations. Assessors will be blinded to which intervention participant has received.
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 150
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The experimental group subjects follow with 12 sessions of physical therapy over a 6-week period which include 30 min of various physical therapy exercises with the Neubie.
**Intervention Names:**
- Device: Neubie Direct Current Electrical Stimulation Device
**Label:** Neubie Direct Current Electrical Stimulation Device
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The control group subjects follow with 12 sessions of physical therapy over a 6-week period which include: a 30-min of various physical therapy exercises with TENS application.
**Intervention Names:**
- Device: Transcutaneous Electrical Stimulation
**Label:** Transcutaneous Electrical Stimulation
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Neubie Direct Current Electrical Stimulation Device
**Description:** Direct Current Electrical Stimulation Device that uses electrodes non-invasively on the skin to stimulate muscle fibers.
**Name:** Neubie Direct Current Electrical Stimulation Device
**Type:** DEVICE
#### Intervention 2
**Arm Group Labels:**
- Transcutaneous Electrical Stimulation
**Description:** Transcutaneous Electrical Nerve Stimulation device - uses alternating current delivered through electrodes on the skin.
**Name:** Transcutaneous Electrical Stimulation
**Other Names:**
- TENS
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Electrodes on the skin release tiny electric shocks to stimulate nerves; the amplitude of the nerve signal will be measured for the H-Reflex.
**Measure:** H-Reflex
**Time Frame:** Pre-intervention
**Description:** Electrodes on the skin release tiny electric shocks to stimulate nerves; the amplitude of the nerve signal will be measured for the H-Reflex.
**Measure:** H-Reflex
**Time Frame:** 6 weeks
**Description:** EMG detection of presence of degree of spontaneous electrical activity such as fibrillation potentials and positive sharp waves of muscles innervated by L4, L5, and S1 nerve roots
**Measure:** EMG detection of spontaneous electrical activity
**Time Frame:** Pre-intervention
**Description:** EMG detection of presence of degree of spontaneous electrical activity such as fibrillation potentials and positive sharp waves of muscles innervated by L4, L5, and S1 nerve roots
**Measure:** EMG detection of spontaneous electrical activity
**Time Frame:** 6 weeks
**Description:** Straight Leg Raise Test degrees of movement
**Measure:** Straight Leg Raise Test
**Time Frame:** Pre-intervention
**Description:** Straight Leg Raise Test degrees of movement
**Measure:** Straight Leg Raise Test
**Time Frame:** 6 weeks
**Description:** Oswestry Disability Index Questionnaire Score
**Measure:** Oswestry Disability Index
**Time Frame:** Pre-intervention
**Description:** Oswestry Disability Index Questionnaire Score
**Measure:** Oswestry Disability Index
**Time Frame:** 6 weeks
**Description:** Visual Analog Score for pain
**Measure:** Visual Analog Score
**Time Frame:** Pre-intervention
**Description:** Visual Analog Score for pain
**Measure:** Visual Analog Score
**Time Frame:** 6 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Must show evidence of lumbo-sacral radiculopathy as determined by EMG and straight leg raise test.
* Must be able to attend weekly sessions for the 6-week period of the study (no extended travel)
* Must be at least 18 years old.
Exclusion Criteria:
* Currently pregnant
* Cardiac pacemaker
* Active or recent cancer
* Active or recent blood clots
* History of epilepsy
* Open wounds
* Spinal fusion surgery
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Dimitrios Kostopoulos, MD, PhD, DPT
**Phone:** 9175382242
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Ramona von Leden, PhD
**Phone:** 5303832292
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Escondido
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Dimitrios Kostopolous
- **Role:** CONTACT
**Country:** United States
**Facility:** NCEPT Physical Therapy
**State:** California
**Status:** RECRUITING
**Zip:** 92025
**Location 2:**
**City:** Cape Coral
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Dimitrios Kostopolous
- **Role:** CONTACT
**Country:** United States
**Facility:** APEX Physical Therapy
**State:** Florida
**Status:** RECRUITING
**Zip:** 33991
**Location 3:**
**City:** Clearwater
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Dimitrios Kostopolous
- **Role:** CONTACT
**Country:** United States
**Facility:** Catalyst Physical Therapy
**State:** Florida
**Status:** RECRUITING
**Zip:** 33756
**Location 4:**
**City:** Fort Myers
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Dimitrios Kostopolous
- **Role:** CONTACT
**Country:** United States
**Facility:** APEX Physical Therapy
**State:** Florida
**Status:** RECRUITING
**Zip:** 33908
**Location 5:**
**City:** Gainesville
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Dimitrios Kostopolous
- **Role:** CONTACT
**Country:** United States
**Facility:** Kinetix Haile Plantation
**State:** Florida
**Status:** RECRUITING
**Zip:** 32608
**Location 6:**
**City:** Gainesville
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Dimitrios Kostopolous
- **Role:** CONTACT
**Country:** United States
**Facility:** Kinetix Arbor Greens - Jonesville
**State:** Florida
**Status:** RECRUITING
**Zip:** 32669
**Location 7:**
**City:** Portland
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Dimitrios Kostopolous
- **Role:** CONTACT
**Country:** United States
**Facility:** Adams Physical Therapy Services
**State:** Indiana
**Status:** RECRUITING
**Zip:** 47371
**Location 8:**
**City:** Bardstown
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Dimitrios Kostopolous
- **Role:** CONTACT
**Country:** United States
**Facility:** KORT Bardstown
**State:** Kentucky
**Status:** RECRUITING
**Zip:** 40004
**Location 9:**
**City:** Shepherdsville
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Dimitrios Kostopolous
- **Role:** CONTACT
**Country:** United States
**Facility:** KORT Sheperdsville
**State:** Kentucky
**Status:** RECRUITING
**Zip:** 40165
**Location 10:**
**City:** Astoria
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Dimitrios Kostopoulos, MD, PhD, DPT
- **Phone:** 917-538-2242
- **Role:** CONTACT
**Country:** United States
**Facility:** Hands On Physical Therpay
**State:** New York
**Status:** RECRUITING
**Zip:** 11106
**Location 11:**
**City:** Deer Park
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Dimitrios Kostopolous
- **Role:** CONTACT
**Country:** United States
**Facility:** WellHealth Physical Therapy
**State:** New York
**Status:** RECRUITING
**Zip:** 11729
**Location 12:**
**City:** Hicksville
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Dimitrios Kostopolous
- **Role:** CONTACT
**Country:** United States
**Facility:** WellHealth Physical Therapy
**State:** New York
**Status:** RECRUITING
**Zip:** 11801
**Location 13:**
**City:** Queens Village
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Dimitrios Kostopolous, MD, PhD, DPT
- **Phone:** 917-538-2242
- **Role:** CONTACT
**Country:** United States
**Facility:** Hands On Physical Therapy of Queens Village
**State:** New York
**Status:** RECRUITING
**Zip:** 11428
**Location 14:**
**City:** Edmond
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Dimitrios Kostopolous
- **Role:** CONTACT
**Country:** United States
**Facility:** Courcier Clinic
**State:** Oklahoma
**Status:** RECRUITING
**Zip:** 73013
**Location 15:**
**City:** El Paso
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Dimi Kostopolous
- **Role:** CONTACT
**Country:** United States
**Facility:** Spine & Rehab Specialists
**State:** Texas
**Status:** RECRUITING
**Zip:** 79925
**Location 16:**
**City:** El Paso
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Dimitrios Kostopoulos
- **Role:** CONTACT
**Country:** United States
**Facility:** Spine & Rehab Specialists
**State:** Texas
**Status:** RECRUITING
**Zip:** 79936
#### Overall Officials
**Official 1:**
**Affiliation:** NeuFit - Neurological Fitness and Education
**Name:** Ramona von Leden, PhD
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Berry JA, Elia C, Saini HS, Miulli DE. A Review of Lumbar Radiculopathy, Diagnosis, and Treatment. Cureus. 2019 Oct 17;11(10):e5934. doi: 10.7759/cureus.5934.
**PMID:** 31788391
**Citation:** Tarulli AW, Raynor EM. Lumbosacral radiculopathy. Neurol Clin. 2007 May;25(2):387-405. doi: 10.1016/j.ncl.2007.01.008.
**PMID:** 17445735
**Citation:** Sharma H, Lee SW, Cole AA. The management of weakness caused by lumbar and lumbosacral nerve root compression. J Bone Joint Surg Br. 2012 Nov;94(11):1442-7. doi: 10.1302/0301-620X.94B11.29148.
**PMID:** 23109619
**Citation:** Lewis R, Williams N, Matar HE, Din N, Fitzsimmons D, Phillips C, Jones M, Sutton A, Burton K, Nafees S, Hendry M, Rickard I, Chakraverty R, Wilkinson C. The clinical effectiveness and cost-effectiveness of management strategies for sciatica: systematic review and economic model. Health Technol Assess. 2011 Nov;15(39):1-578. doi: 10.3310/hta15390. No abstract available.
**PMID:** 22078311
**Citation:** Aono H, Iwasaki M, Ohwada T, Okuda S, Hosono N, Fuji T, Yoshikawa H. Surgical outcome of drop foot caused by degenerative lumbar diseases. Spine (Phila Pa 1976). 2007 Apr 15;32(8):E262-6. doi: 10.1097/01.brs.0000259922.82413.72.
**PMID:** 17426622
**Citation:** Girardi FP, Cammisa FP Jr, Huang RC, Parvataneni HK, Tsairis P. Improvement of preoperative foot drop after lumbar surgery. J Spinal Disord Tech. 2002 Dec;15(6):490-4. doi: 10.1097/00024720-200212000-00010.
**PMID:** 12468976
**Citation:** Bauer P, Krewer C, Golaszewski S, Koenig E, Muller F. Functional electrical stimulation-assisted active cycling--therapeutic effects in patients with hemiparesis from 7 days to 6 months after stroke: a randomized controlled pilot study. Arch Phys Med Rehabil. 2015 Feb;96(2):188-96. doi: 10.1016/j.apmr.2014.09.033. Epub 2014 Oct 18.
**PMID:** 25449195
**Citation:** Glaser JA, Baltz MA, Nietert PJ, Bensen CV. Electrical muscle stimulation as an adjunct to exercise therapy in the treatment of nonacute low back pain: a randomized trial. J Pain. 2001 Oct;2(5):295-300. doi: 10.1054/jpai.2001.25523.
**PMID:** 14622808
**Citation:** Sluka KA, Walsh D. Transcutaneous electrical nerve stimulation: basic science mechanisms and clinical effectiveness. J Pain. 2003 Apr;4(3):109-21. doi: 10.1054/jpai.2003.434.
**PMID:** 14622708
**Citation:** Peters EJ, Armstrong DG, Wunderlich RP, Bosma J, Stacpoole-Shea S, Lavery LA. The benefit of electrical stimulation to enhance perfusion in persons with diabetes mellitus. J Foot Ankle Surg. 1998 Sep-Oct;37(5):396-400; discussion 447-8. doi: 10.1016/s1067-2516(98)80048-3.
**PMID:** 9798171
**Citation:** Gilcreast DM, Stotts NA, Froelicher ES, Baker LL, Moss KM. Effect of electrical stimulation on foot skin perfusion in persons with or at risk for diabetic foot ulcers. Wound Repair Regen. 1998 Sep-Oct;6(5):434-41. doi: 10.1046/j.1524-475x.1998.60505.x.
**PMID:** 9844163
**Citation:** da Silva MP, Liebano RE, Rodrigues VA, Abla LE, Ferreira LM. Transcutaneous electrical nerve stimulation for pain relief after liposuction: a randomized controlled trial. Aesthetic Plast Surg. 2015 Apr;39(2):262-9. doi: 10.1007/s00266-015-0451-6. Epub 2015 Feb 10.
**PMID:** 25665520
**Citation:** Ordog GJ. Transcutaneous electrical nerve stimulation versus oral analgesic: a randomized double-blind controlled study in acute traumatic pain. Am J Emerg Med. 1987 Jan;5(1):6-10. doi: 10.1016/0735-6757(87)90281-6.
**PMID:** 3545246
**Citation:** Zhao M, Bai H, Wang E, Forrester JV, McCaig CD. Electrical stimulation directly induces pre-angiogenic responses in vascular endothelial cells by signaling through VEGF receptors. J Cell Sci. 2004 Jan 26;117(Pt 3):397-405. doi: 10.1242/jcs.00868. Epub 2003 Dec 16.
**PMID:** 14679307
**Citation:** Kanno S, Oda N, Abe M, Saito S, Hori K, Handa Y, Tabayashi K, Sato Y. Establishment of a simple and practical procedure applicable to therapeutic angiogenesis. Circulation. 1999 May 25;99(20):2682-7. doi: 10.1161/01.cir.99.20.2682.
**PMID:** 10338463
**Citation:** Thakral G, Kim PJ, LaFontaine J, Menzies R, Najafi B, Lavery LA. Electrical stimulation as an adjunctive treatment of painful and sensory diabetic neuropathy. J Diabetes Sci Technol. 2013 Sep 1;7(5):1202-9. doi: 10.1177/193229681300700510.
**PMID:** 24124947
**Citation:** Wang TJ, Sung K, Wilburn M, Allbright J. Russian Stimulation/Functional Electrical Stimulation in the Treatment of Foot Drop Resulting from Lumbar Radiculopathy: A Case Series. Innov Clin Neurosci. 2019 May 1;16(5-6):46-49.
**PMID:** 31440402
**Citation:** Martimbianco ALC, Porfirio GJ, Pacheco RL, Torloni MR, Riera R. Transcutaneous electrical nerve stimulation (TENS) for chronic neck pain. Cochrane Database Syst Rev. 2019 Dec 12;12(12):CD011927. doi: 10.1002/14651858.CD011927.pub2.
**PMID:** 31830313
**Citation:** Reichstein L, Labrenz S, Ziegler D, Martin S. Effective treatment of symptomatic diabetic polyneuropathy by high-frequency external muscle stimulation. Diabetologia. 2005 May;48(5):824-8. doi: 10.1007/s00125-005-1728-0. Epub 2005 Apr 14.
**PMID:** 15830180
**Citation:** DeSantana JM, Walsh DM, Vance C, Rakel BA, Sluka KA. Effectiveness of transcutaneous electrical nerve stimulation for treatment of hyperalgesia and pain. Curr Rheumatol Rep. 2008 Dec;10(6):492-9. doi: 10.1007/s11926-008-0080-z.
**PMID:** 19007541
**Citation:** Doucet BM, Griffin L. High-versus low-frequency stimulation effects on fine motor control in chronic hemiplegia: a pilot study. Top Stroke Rehabil. 2013 Jul-Aug;20(4):299-307. doi: 10.1310/tsr2004-299.
**PMID:** 23893829
**Citation:** Najafi B, Talal TK, Grewal GS, Menzies R, Armstrong DG, Lavery LA. Using Plantar Electrical Stimulation to Improve Postural Balance and Plantar Sensation Among Patients With Diabetic Peripheral Neuropathy: A Randomized Double Blinded Study. J Diabetes Sci Technol. 2017 Jul;11(4):693-701. doi: 10.1177/1932296817695338. Epub 2017 Feb 1.
**PMID:** 28627217
**Citation:** Chandrasekaran S, Davis J, Bersch I, Goldberg G, Gorgey AS. Electrical stimulation and denervated muscles after spinal cord injury. Neural Regen Res. 2020 Aug;15(8):1397-1407. doi: 10.4103/1673-5374.274326.
**PMID:** 31997798
**Citation:** Zehr EP, Collins DF, Chua R. Human interlimb reflexes evoked by electrical stimulation of cutaneous nerves innervating the hand and foot. Exp Brain Res. 2001 Oct;140(4):495-504. doi: 10.1007/s002210100857.
**PMID:** 11685403
## Document Section
### Large Document Module
#### Large Docs
- Date: 2024-03-29
- Filename: Prot_SAP_000.pdf
- Has ICF: False
- Has Protocol: True
- Has SAP: True
- Label: Study Protocol and Statistical Analysis Plan
- Size: 186037
- Type Abbrev: Prot_SAP
- Upload Date: 2024-04-08T16:34
## 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: BC10
- Name: Nervous System Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M14689
- Name: Radiculopathy
- Relevance: HIGH
- As Found: Radiculopathy
- ID: M13432
- Name: Peripheral Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12411
- Name: Neuromuscular Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000011843
- Term: Radiculopathy
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06421545
**Acronym:** RT-D ADRD
**Brief Title:** Resilient Together for Dementia
**Official Title:** Resilient Together for Dementia: A Live Video Resiliency Dyadic Intervention for Persons With Dementia and Their Care-partners Early After Diagnosis
#### Organization Study ID Info
**ID:** GCO 23-0519
#### Organization
**Class:** OTHER
**Full Name:** Icahn School of Medicine at Mount Sinai
#### Secondary ID Infos
**ID:** 1K23AG075188-01A1
**Link:** https://reporter.nih.gov/quickSearch/1K23AG075188-01A1
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2024-09
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-14
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-09
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-04-19
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-30
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module
#### Collaborators
**Class:** NIH
**Name:** National Institute on Aging (NIA)
#### Lead Sponsor
**Class:** OTHER
**Name:** Icahn School of Medicine at Mount Sinai
#### Responsible Party
**Investigator Affiliation:** Icahn School of Medicine at Mount Sinai
**Investigator Full Name:** Sarah Bannon
**Investigator Title:** Assistant Professor
**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:** The proposed study will establish the feasibility, acceptability and credibility of a novel live video dyadic resiliency intervention, Resilient Together for Dementia (RT-D), aimed at preventing chronic emotional distress and preserving quality of life among dyads at risk for chronic emotional distress early after a diagnosis of Alzheimer's disease or a related dementia (ADRD).
**Detailed Description:** Both persons living with dementia (PWDs) and their spousal care-partners experience high levels of clinically elevated emotional distress, which can become chronic without treatment and negatively impact the health, quality of life, communication, and care-planning of both partners. A tailored dyadic intervention, such as the proposed Resilient Together for Dementia, delivered over live video to this at risk population during the window of opportunity when PWDs can participate has the potential to prevent chronic emotional distress and preserve quality of life for PWDs and their loved ones.
In the Intervention Phase (Aims 2 and 3), an open pilot (N=5 dyads) of the newly developed RT-D followed by exit interviews will be conducted to explore the initial feasibility and acceptability of the adapted protocol and to further refine the intervention content, materials, and procedures (Aim 2; NIA Stage 1A). Next, a pilot feasibility randomized control trial (RCT; Aim 3; NIA Stage 1B; N=50 dyads) will be conducted of the refined RT-D versus a minimally enhanced educational control (MEUC). Primary outcomes will be feasibility, credibility, and acceptability markers to inform a hybrid efficacy effectiveness R01 (year 4) of RT-D vs. MEUC (NIA Stage III). In this subsequent R01, the researcher will examine RT-D's impact on emotional distress and quality of life outcomes and test mechanisms of change (individual and interpersonal resiliency skills) through mediation and moderation. The researcher will revise the approach if feasibility benchmarks are not met.
### Conditions Module
**Conditions:**
- Alzheimer's Disease and Related Dementias
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 10
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Persons living with dementia (PWDs) and their spousal care-partners
**Intervention Names:**
- Behavioral: Resilient Together for Dementia
**Label:** Open Pilot RT-D Dyads
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Open Pilot RT-D Dyads
**Description:** A novel live video dyadic resiliency intervention
**Name:** Resilient Together for Dementia
**Other Names:**
- RT-D
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** Feasibility of recruitment - Recruitment will be monitored by screening clinic visits for potentially eligible individuals and review recruitment progress in weekly meetings to promote completion within the study time frame. Recruitment will be monitored but will not set official benchmarks and modify procedures after each dyad.
**Measure:** Proportion of potential eligible participants
**Time Frame:** After each dyad completion, throughout study of 1.5-2 months
#### Secondary Outcomes
**Description:** Feasibility of screening - the portion of individuals who undergo screening that screen eligible and ineligible, and the reasons for ineligibility with detailed descriptions will be monitored and will review progress in weekly team meetings. Screening will be monitored but will not set official benchmarks and modify procedures after each dyad.
**Measure:** Proportion of participants screened
**Time Frame:** After each dyad completion, throughout study of 1.5-2 months
**Description:** Feasibility of consent by keeping a record of all individuals who complete screening that consent, refuse to consent, and the reasons for refusal will be monitored and will review progress in weekly team meetings. Feasibility of consent will be monitored but will not set official benchmarks and modify procedures after each dyad.
**Measure:** Proportion of participants who consent or not consent to participate
**Time Frame:** After each dyad completion, throughout study of 1.5-2 months
**Description:** Feasibility of treatment -The number of sessions that enrolled dyads attend as well as missed sessions, treatment dropouts, and reasons for non attendance will be monitored and will review progress in weekly meetings. Feasibility of treatment will be monitored but will not set official benchmarks and modify procedures after each dyad.
**Measure:** Proportion of sessions participants attend
**Time Frame:** After each dyad completion, throughout study of 1.5-2 months
**Description:** Change in emotional distress assessed with the Hospital Anxiety and Depression Anxiety Scale which is a 14-items scale with responses scored from 0-3, scores for each subscale (anxiety and depression) from 0 (normal) to 21 (severe symptoms). Scores for the entire scale is 0 to 42, with higher score indicating more distress.
**Measure:** Change in Hospital Anxiety and Depression Scale (HADS)
**Time Frame:** Baseline and 6 weeks (post-intervention)
### Eligibility Module
**Eligibility Criteria:** PWD inclusion criteria are:
* Recent (\~1 month) chart documented ADRD diagnosis,
* ADRD symptom onset after age 65 ,
* cognitive assessment scores and symptoms consistent with early stage dementia, as determined by the Clinical Dementia Rating Scale scores of .5 or 1.0
* cognitive awareness of his/her problems (as determined by the treating neurologist), and
* ability to understand study and research protocol, as determined by a standardized teach-back method assessment84.
Additional inclusion criteria for dyads are:
* English speaking adults (18 years or older),
* dyad lives together,
* at least one partner endorses clinically significant emotional distress during screening (\>7 on Hospital Anxiety and Depression scale subscales)
Exclusion Criteria:
* patient is deemed inappropriate by the neurology team,
* either partner has a co-occurring terminal illness,
* patient was diagnosed with forms of dementia with clinical profiles that would preclude participation (e.g., Frontotemporal Dementia- behavioral variant), as determined by treatment team.
**Minimum Age:** 65 Years
**Sex:** ALL
**Standard Ages:**
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Sarah M Bannon, PhD
**Phone:** 212-241-0787
**Role:** CONTACT
**Contact 2:**
**Name:** Sydney M McCage, MA
**Phone:** 212-241-6866
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** New York
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Sarah Bannon, PhD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Sarah Bannon
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Brain Injury Research Center at Mount Sinai
**State:** New York
**Status:** RECRUITING
**Zip:** 10029
#### Overall Officials
**Official 1:**
**Affiliation:** Icahn School of Medicine at Mount Sinai
**Name:** Sarah Bannon
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Access Criteria:** Anyone who wishes to access the data. Any purpose. Data are available indefinitely at (Link tbd).
**Description:** All of the individual participant data collected during the trial, after deidentification.
**Info Types:**
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
- ANALYTIC_CODE
**IPD Sharing:** YES
**Time Frame:** Immediately following publication. No end date.
## 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: D000024801
- Term: Tauopathies
- ID: D000019636
- Term: Neurodegenerative Diseases
- ID: D000019965
- Term: Neurocognitive Disorders
- ID: D000001523
- Term: Mental Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M6904
- Name: Dementia
- Relevance: HIGH
- As Found: Dementia
- ID: M3885
- Name: Alzheimer Disease
- Relevance: HIGH
- As Found: Alzheimer's Disease
- 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: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000000544
- Term: Alzheimer Disease
- ID: D000003704
- Term: Dementia
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06421532
**Acronym:** Clear-Brain
**Brief Title:** Stimulating Amyloid Clearance in Cerebral Amyloid Angiopathy
**Official Title:** A Partial Randomised Clinical Trial Investigating Stimulation of the Glymphatic System by Either Deepening Sleep With Lower-sodium Oxybate or Inhibiting Cortical Spreading Depressions With Non-invasive Vagus Nerve Stimulation, or Both, in Patients With Cerebral Amyloid Angiopathy (CAA)
#### Organization Study ID Info
**ID:** P23.100
#### Organization
**Class:** OTHER
**Full Name:** Leiden University Medical Center
### Status Module
#### Completion Date
**Date:** 2026-08-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-14
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-08-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-08
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** The Dutch Brain Foundation (funding)
#### Lead Sponsor
**Class:** OTHER
**Name:** Leiden University Medical Center
#### Responsible Party
**Investigator Affiliation:** Leiden University Medical Center
**Investigator Full Name:** RolfFronczek
**Investigator Title:** principal investigator and neurologist
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Is US Export:** True
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** A pre-post study will be conducted to assess whether treatment with LXB, nVNS or a combination of both interventions can enhance the clearance of Aβ in patients with CAA. A total of 60 subjects, 30 with sCAA and 30 with D-CAA, will be randomly assigned to receive LXB, or both interventions. The primary outcome measure will be the morning levels of Aβ40 and Aβ42 in cerebrospinal fluid (CSF) before and after the intervention. The investigators will assess disease progression with (non-)haemorrhagic imaging markers on 7-Tesla Magnetic Resonance Imaging (7-T MRI) as a secondary outcome. Additionally, the activity of the glymphatic system by means of fluid dynamics will be assessed using 7-T MRI.
### Conditions Module
**Conditions:**
- Cerebral Amyloid Angiopathy
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** pre-post study with additional randomisation
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Deepening sleep
**Intervention Names:**
- Drug: XYWAV
**Label:** Low-sodium oxybate (LXB)
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Inhibiting cortical spreading depolarisations
**Intervention Names:**
- Device: gammaCore Sapphire
**Label:** Non-invasive vagus nerve stimulation (nVNS)
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Deepening sleep and inhibiting cortical spreading depolarisations
**Intervention Names:**
- Drug: XYWAV
- Device: gammaCore Sapphire
**Label:** Combination of both
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Combination of both
- Low-sodium oxybate (LXB)
**Description:** Daily before bedtime for 3 months
**Name:** XYWAV
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Combination of both
- Non-invasive vagus nerve stimulation (nVNS)
**Description:** Twice daily for 3 months
**Name:** gammaCore Sapphire
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Difference between before and after intervention
**Measure:** Amyloid-beta 40 and 42 in cerebrospinal fluid
**Time Frame:** 3 months
#### Secondary Outcomes
**Description:** Intracerebral haemorrhages, cerebral microbleeds, cortical superficial siderosis, white matter hyperintensities, perivascular spaces, cerebrovascular reactivity
**Measure:** Disease progression with (non-)haemorrhagic imaging markers on 7-T MRI
**Time Frame:** 2x 3 months
**Description:** Levels of amyloid-beta 38, 43, t-tau and p-tau181 in CSF and levels of amyloid-beta 40 and 42 in serum.
**Measure:** Other liquid biomarkers
**Time Frame:** 3 months
**Description:** CSF motion
**Measure:** Activity of the glymphatic system by means of fluid dynamics on 7-T MRI
**Time Frame:** 2x 3 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients with D-CAA with a proven amyloid precursor protein (APP) mutation or a history of ≥1 lobar intracerebral haemorrhage (ICH) and a positive family history for D-CAA in ≥1 first degree relative
* Age ≥30 years old
* ≤ 2 symptomatic ICH (occurrence of ICH at least \> 1 year ago) or presence of ≥ 1 haemorrhagic marker (cortical superficial siderosis, cerebral microbleeds) or non-haemorrhagic marker (white matter hyperintensities, enlarged perivascular spaces).
* When presymptomatic, patients are aware that they have D-CAA
* Probable sporadic CAA (sCAA) according to the Modified Boston criteria 2.0
* Age ≥50 years old
* ≤ 2 symptomatic ICH (occurrence of ICH at least \> 1 year ago)
* Provisional CAA when the criteria for probable sCAA are not met due to presence of deep haemorrhagic lesions but there are mostly lobar microbleeds (MBs) and cortical superficial siderosis (cSS) present or a ratio of 10 times more lobar MBs than deep MBs without cSS.
* Age ≥50 years old
* ≤ 2 symptomatic ICH (occurrence of ICH at least \> 1 year ago)
* Participants able to read and understand the patient information folder and who freely provide written informed consent
Exclusion Criteria:
* Modified Rankin Score ≥ 4
* A life expectancy of less than six months
* Pregnancy/breast feeding
* Contraindications for lumbar puncture
* Unwillingness to refrain from consuming \> 1 alcohol unit per day and not later than 8 pm, during the intervention period.
Contraindications for using LXB:
* Sleep apnea; patients will be screened with respiratory polygraphy before inclusion and screening by questionnaire during intervention with LXB.
* Restless legs (RLS) needing active treatment with RLS medication.
* Currently suffering from severe depression and using medication or receiving cognitive therapy.
* Porphyria
* Succinic semialdehyde dehydrogenase (SSADH-)deficiency
* Use of opiates, barbiturates, sedatives (dexmedetomidine, temazepam, oxazepam, midazolam)
* Use certain medication before inclusion:
* When benzodiazepine is used: a two nights washout before the intervention (T3) will be started, is needed.
* When LXB or SXB is used before inclusion: one week washout before inclusion and no use of LXB or SXB during inclusion except for the intervention dose.
Contraindications for lumbar puncture:
* Compression of the spinal cord
* Signs and symptoms of increased intracranial pressure
* Local infections of the skin at the puncture site
* Coagulopathy or thrombocytopenia (\<100)
* (Use of acetylsalicylic acid, NSAIDs, COX2 inhibitors or prophylactic low-molecular-weight heparin are no contraindications for lumbar puncture.)
* Participants deemed at risk for brain replacement due to known aqueduct stenosis, Arnold chiari malformations.
* Participants with a lumbo-sacral neural tube defect or who have a ventriculo-atrial or ventriculo-peritoneal drain.
Contraindications for nVNS:
* An active implantable medical device such as a pacemaker, deep brain stimulator, or any implanted electronic device.
* A recent (\< 1 month) brain infarction or transient ischemic attack due to a symptomatic stenosis or dissection of the carotid artery (in these patients the other side will be stimulated unless a significant stenosis or dissection on the other side is present as well).
* If someone knows to have a structural abnormality e.g. lymphadenopathy, previous surgery or abnormal anatomy (in these patients the other side will be stimulated)
* Metal cervical spine hardware or metallic implant near the stimulation site
* Cervical vagotomy (in these patients the other side will be stimulated)
Contraindications for 7 Tesla MRI as determined by the 7 Tesla safety committee. Examples of possible contra-indications are:
* Claustrophobia
* Pacemakers and defibrillators
* Nerve stimulators
* Intracranial clips
* Intraorbital or intraocular metallic fragments
* Cochlear implants
* Ferromagnetic implants
* Hydrocephalus pump
* Intra-uterine device
* Permanent make-up
* Tattoos above the shoulders
Specific contraindications for checkerboard functional Magnetic Resonance Imaging (fMRI):
* Seizure within prior year
* Photosensitive epilepsy
* Non-correctable visual impairment
**Minimum Age:** 30 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Sanne Schriemer, MD
**Phone:** +31715261825
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Rolf Fronczek, PhD
**Role:** CONTACT
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000057165
- Term: Proteostasis Deficiencies
- ID: D000008659
- Term: Metabolic Diseases
- ID: D000002539
- Term: Cerebral Arterial Diseases
- ID: D000020765
- Term: Intracranial Arterial Diseases
- 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: D000020739
- Term: Brain Diseases, Metabolic, Inborn
- ID: D000001928
- Term: Brain Diseases, Metabolic
- ID: D000059345
- Term: Cerebral Small Vessel Diseases
- ID: D000028226
- Term: Amyloidosis, Familial
- ID: D000008661
- Term: Metabolism, Inborn Errors
- ID: D000030342
- Term: Genetic Diseases, Inborn
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: BC16
- Name: Diseases and Abnormalities at or Before Birth
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M7061
- Name: Depressive Disorder
- Relevance: LOW
- As Found: Unknown
- ID: M7058
- Name: Depression
- Relevance: LOW
- As Found: Unknown
- ID: M4021
- Name: Amyloidosis
- Relevance: HIGH
- As Found: Amyloid
- ID: M19026
- Name: Cerebral Amyloid Angiopathy
- Relevance: HIGH
- As Found: Cerebral Amyloid Angiopathy
- ID: M23333
- Name: Cerebral Amyloid Angiopathy, Familial
- Relevance: HIGH
- As Found: Cerebral Amyloid Angiopathy
- ID: M28747
- Name: Proteostasis Deficiencies
- Relevance: LOW
- As Found: Unknown
- ID: M11639
- Name: Metabolic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5788
- Name: Cerebral Arterial Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M22521
- Name: Intracranial Arterial Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5810
- Name: Cerebrovascular Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M5204
- Name: Brain Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5205
- Name: Brain Diseases, Metabolic
- Relevance: LOW
- As Found: Unknown
- ID: M22498
- Name: Brain Diseases, Metabolic, Inborn
- Relevance: LOW
- As Found: Unknown
- ID: M29437
- Name: Cerebral Small Vessel Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M23329
- Name: Amyloidosis, Familial
- Relevance: LOW
- As Found: Unknown
- ID: M11641
- Name: Metabolism, Inborn Errors
- Relevance: LOW
- As Found: Unknown
- ID: M23686
- Name: Genetic Diseases, Inborn
- Relevance: LOW
- As Found: Unknown
- ID: T2740
- Name: Hereditary Cerebral Hemorrhage With Amyloidosis
- Relevance: HIGH
- As Found: Cerebral Amyloid Angiopathy
### Condition Browse Module - Meshes
- ID: D000016657
- Term: Cerebral Amyloid Angiopathy
- ID: D000028243
- Term: Cerebral Amyloid Angiopathy, Familial
- ID: D000000686
- Term: Amyloidosis
### Intervention Browse Module - Browse Branches
- Abbrev: AdjAn
- Name: Adjuvants, Anesthesia
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M15780
- Name: Sodium Oxybate
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06421519
**Brief Title:** Different Levels of BiPAP
**Official Title:** Crossover Study of the Work of Breathing at Different Levels of BiPAP Settings in Neonates
#### Organization Study ID Info
**ID:** IRAS 327794
#### Organization
**Class:** OTHER
**Full Name:** King's College Hospital NHS Trust
### Status Module
#### Completion Date
**Date:** 2024-08-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-08-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-22
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** King's College Hospital NHS Trust
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Some infants with breathing problems at birth may need to be connected to a machine to help support their breathing. The purpose of this study is to optimise the level of breathing support on Bi level continuous airway pressure (BiPAP), a support which gives two levels of support (pressure) to premature infants.
The study is investigating which upper pressure gives the best support, that is results in the baby having to breathe less hard (work of breathing).
Researchers will measure the work of breathing using a small catheter. Infants will receive three different upper pressures of BiPAP with the same baseline pressure for 20 minutes each. In between each upper level they will receive the standard upper pressure for 20 minutes.
**Detailed Description:** Bilevel continuous positive airway pressure (BiPAP) is a type of non-invasive respiratory support which can be used as breathing support in neonates requiring some pressure support to help their breathing. BiPAP provides cycles of higher and lower pressure levels at set intervals, usually with a baseline pressure constant of 5cm H2O.
In the UK, other forms of non-invasive ventilation, such as NIPPV and NIV-NAVA, have been shown to be efficacious, however they are expensive. BiPAP may therefore provide a viable and cost-effective alternative. Currently there are no written guidelines about BiPAP use.
The investigators aim to identify the most efficacious BiPAP settings for preterm infants as primary support and post-extubation as well as in those with evolving BPD. Infants will be studied at three different upper pressure settings for a period of 20 minutes each. The work of breathing will be measured from small pressure transducers situated on a thin catheter, the size of a feeding tube. The catheter will be passed through the mouth and positioned so the tip is in the stomach. Simultaneous measurements for work of breathing using transcutaneous diaphragm electromyography will also be taken. Following the study the infant will subsequently be nursed on the breathing support type associated with the lower work of breathing.
The investigators aim to recruit 21 patients, with 7 in each arm of the trial. Sample size was derived using previous study results in which the SD of the PTPdi was 78cmH2Os/min in 40 preterm infants of 28-34 weeks gestation and a clinically significant difference of 133cmH2Os/min was observed between infants on SNIPPV against high flow NIV support. To detect such a difference with 90% power and 5% significance, 7 infants would be required in each group, that is 21 infants in total in 3 groups.
The parents of potential participants will be approached by the clinical team initially, subsequently the research fellow will provide them with the study information. Responsibility for recording and dating oral, electronic, and written informed consent or advice will be with the researchers identified in the formal delegation log.
Full analyses will be detailed in a statistical analysis plan (SAP), which will be finalised prior to the end of data collection Any exploratory analyses of sub-groups that are of clinical interest will be pre-specified in the SAP. Any deviations from the original SAP will be described and justified in protocol and/or in final report, as appropriate. This trial will be reported according to the CONSORT guidelines for clinical trials (Consolidated Standards Of Reporting Trials statement). Statistical significance will be at 5% level, and analyses will be conducted in STATA. A summary of the planned statistical analysis is included here:
* Descriptive statistics will be used to describe infant demographics. Standard statistical summaries e.g. medians and ranges or means and variances, or proportions and percentages, dependent on the distribution of the outcomes.
* The main analysis will investigate work of breathing at baseline and at each of the 3 upper BiPAP pressure settings. Data will be assessed for normality. If data is not normally distributed, non-parametric statistics will be used. 95% confidence intervals will be reported throughout. Missing data will be described with reasons given where available.
Data collected during the study will be handled and stored in accordance with the General Data Protection Regulation and Data Protection Act (2018), which requires data to be de-identified as soon as it is practical to do so. All data will be completely anonymised for purposes of analysis and any subsequent reports or publications. For the purposes of ongoing data management, once randomised, individual patients will only be identified by trial numbers.
Data will be downloaded from ventilators and pressure transducers to excel using secure password encrypted USB device Data will be uploaded on password protected servers only and anonymised at the point of entry.
Data will be anonymised and identified by a unique identification number (Trial number) only. A trial enrolment log at the sites will list the ID numbers.
Paper study documents will be held at the trial site in a secure location for the duration of the trial. All essential documents will be retained until children reach 25 years old, as per protocol.
A statement of permission to access source data by study staff and for regulatory and audit purposes will be included within the primary care givers consent form with explicit explanation as part of the consent process and Participant Information Sheet.
In principle, anonymised data will be made available for meta-analysis and if requested by other authorised researchers and journals for publication purposes. Requests for access to data will be reviewed by the Chief Investigator.
Each adverse event will be assessed for severity, causality, seriousness and expectedness. All adverse events will be recorded in the medical records in the first instance. All adverse events will be recorded with clinical symptoms and accompanied with a simple, brief description of the event, including dates as appropriate. All serious adverse events will be recorded in the medical records and the CRF.
The Chief Investigator will ensure there are adequate quality and number of monitoring activities conducted by the study team. This will include adherence to the protocol, procedures for consenting and ensure adequate data quality.
### Conditions Module
**Conditions:**
- Bronchopulmonary Dysplasia
**Keywords:**
- Biphasic continuous positive airway pressure (BiPAP)
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
**Intervention Model Description:** Infants receive receive three upper pressures of BiPAP: 7, 10 or 13cmH2O for a period of 20 minutes each. Additionally, there will be a control period of 20 minutes between each upper pressure with a baseline pressure constant of 5cmH2O. The order in which they receive the levels of respiratory support will be randomised using an excel random number generator. This allows each infant to be used as their own control, minimising the impact of any underlying confounding factors. The results on each pressure setting will be meaned and compared to each other
##### Masking Info
**Masking:** DOUBLE
**Masking Description:** During the study the infant and their parents will not be aware of which pressures they are on. Due to the nature of the study it is not possible to blind the care provider who in this case is the investigator since they need to manipulate the ventilator settings. However, data analysis with be done using anonymous data and the investigator will be blinded to which pressure settings were used.
**Who Masked:**
- PARTICIPANT
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 21
**Type:** ESTIMATED
**Phases:**
- PHASE1
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Infants \<34 weeks gestational age who require non-invasive respiratory support who may go on to require invasive ventilation.
**Intervention Names:**
- Other: BiPAP setting
**Label:** Pre-term infants requiring primary respiratory support before intubation
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Infants \<34 weeks gestational age who were previously invasively ventilated and are currently being weaned onto non-invasive respiratory support and eventually into self-ventilating in room air.
**Intervention Names:**
- Other: BiPAP setting
**Label:** Pre-term infants requiring respiratory support after extubation
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Infants \<34 weeks gestational age who have an ongoing need for non-invasive respiratory support after seven days of life and are likely to develop bronchopulmonary dysplasia.
**Intervention Names:**
- Other: BiPAP setting
**Label:** Pre-term infants requiring respiratory support after seven days
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Pre-term infants requiring primary respiratory support before intubation
- Pre-term infants requiring respiratory support after extubation
- Pre-term infants requiring respiratory support after seven days
**Description:** Infants in this arm of the study will each rotate through three different BiPAP settings. The following BiPAP settings will be used:
13cmH2O / 5cmH2O, 10cmH2O / 5cmH2O, 7cmH2O / 5cmH2O
**Name:** BiPAP setting
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Oesophageal (Poes) and gastric pressures(Pgas) will be measured using a catheter with dual pressure tipped transducers (Gaeltec, Dunvegan, Scotland, UK). Transdiaphragmatic pressure (PTPdi) will be calculated by digital subtraction of the oesophageal from the gastric pressure and tidal volume obtained by digital integration of the flow signal by the acquisition software. The mean PTPdi will be calculated from 20 consecutive breaths to measure work of breathing.
**Measure:** Work of breathing
**Time Frame:** Over the last 5 minutes of the 20 minute study period on each setting of BiPAP
**Description:** Transcutaneous diaphragm electromyography (EMG) will be monitored using a portable 16-channel digital physiological amplifier (Dipha-16; Inbiolab, Groningen, the Netherlands) and three surface electrodes (Kendall H59P cloth electrodes; Covidien, Massachusetts) placed on the infant's abdomen. The device wirelessly transmits to a bedside computer running Polybench (Applied Biosignals, Weener, Germany). Work of breathing will be calculated using the voltages measured from a 5 minute period of recording.
**Measure:** Work of breathing
**Time Frame:** Over the last 5 minutes of the 20 minute study period on each setting of BiPAP
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Preterm infants born \<34 weeks of gestation at KCH requiring primary respiratory support before intubation, after extubation or requiring respiratory support after seven days
* Infants aged between 2 days and 2 months at time of study
Exclusion Criteria:
* Infants with congenital abnormalities of the respiratory system.
* Infants with blood-culture confirmed sepsis.
* Recent gastrointestinal surgery (within 7 days)
* Non-English speakers
**Maximum Age:** 2 Months
**Minimum Age:** 2 Days
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Oishi Sikdar
**Phone:** 07901931550
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** London
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Oishi Sikdar
- **Phone:** 07901931550
- **Role:** CONTACT
***Contact 2:***
- **Name:** Theodore Dassios
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 3:***
- **Name:** Oishi Sikdar
- **Role:** SUB_INVESTIGATOR
**Country:** United Kingdom
**Facility:** King's College Hospital
**Status:** RECRUITING
**Zip:** SE5 9RS
#### Overall Officials
**Official 1:**
**Affiliation:** King's College Hospital NHS Trust
**Name:** Theodore Dassios
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** In principle, anonymised data will be made available for meta-analysis and if requested by other authorised researchers and journals for publication purposes. Requests for access to data will be reviewed by the Chief Investigator.
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000055397
- Term: Ventilator-Induced Lung Injury
- ID: D000055370
- Term: Lung Injury
- ID: D000008171
- Term: Lung Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
- ID: D000007235
- Term: Infant, Premature, Diseases
- ID: D000007232
- Term: Infant, Newborn, Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: BC16
- Name: Diseases and Abnormalities at or Before Birth
- Abbrev: All
- Name: All Conditions
- 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: M5273
- Name: Bronchopulmonary Dysplasia
- Relevance: HIGH
- As Found: Bronchopulmonary Dysplasia
- ID: M27137
- Name: Respiratory Aspiration
- Relevance: LOW
- As Found: Unknown
- ID: M28143
- Name: Lung Injury
- Relevance: LOW
- As Found: Unknown
- ID: M28152
- Name: Ventilator-Induced Lung Injury
- 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: 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: T874
- Name: Bronchopulmonary Dysplasia
- Relevance: HIGH
- As Found: Bronchopulmonary Dysplasia
### Condition Browse Module - Meshes
- ID: D000001997
- Term: Bronchopulmonary Dysplasia
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06421506
**Brief Title:** Less Invasive Surfactant Administration in Late Preterm or Early Term Born Infants
**Official Title:** Does Less Invasive Surfactant Administration (LISA) During High-flow Nasal Cannula Oxygen Treatment Reduces the Need for Invasive Ventilation in Late Preterm and Term Born Infants With Respiratory Distress?
#### Organization Study ID Info
**ID:** 324607
#### Organization
**Class:** OTHER
**Full Name:** King's College Hospital NHS Trust
### Status Module
#### Completion Date
**Date:** 2026-09
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-09
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** Chiesi Limited
#### Lead Sponsor
**Class:** OTHER
**Name:** King's College Hospital NHS Trust
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The aim of this study is to see if giving less invasive surfactant administration (LISA) during high-flow nasal cannula (HFNC) oxygen treatment reduces the need for invasive ventilation in babies with breathing problems born 2-6 weeks early.
Less invasive surfactant administration is where surfactant (a naturally produced substance which helps open up the tiny air sacs in the lungs making it easier for babies to breathe) is given into the lungs by putting a small tube into the windpipe through the mouth whilst the baby is awake. The surfactant is given slowly and breathed in.
High flow nasal cannula is a form of non-invasive support where a machine delivers warmed, moist oxygen and air through short tubes in the nose.
The investigators will be assessing whether a lower percentage of neonates need invasive ventilation within 72 hrs from birth when they have had LISA during HFNC treatment, compared to when they don't receive this treatment.
The investigators will also be looking at the length of neonatal unit stay and the cost of the stay. The investigators will also be measuring the lung function of the babies before and after they receive LISA.
**Detailed Description:** This study is looking at babies born 2- 6 weeks early who have breathing problems soon after birth. Some babies need to go onto a breathing machine (ventilator) or require 'non-invasive' breathing support. Either a machine delivers warmed, moist oxygen + air through short tubes in the nose (humidified high flow nasal cannula, HHFNC) or a machine delivers oxygen and air via a small mask which fits over the nose (continuous positive airway pressure, CPAP). Mechanical ventilation via a ventilator, although life-saving, can cause problems such as infection and lung injury and, therefore, whenever possible baby's breathing is supported with 'non-invasive' methods. The use of CPAP in more mature babies may also cause discomfort or lung collapse, whereas use of HHFNC may avoid those problems. The lungs of healthy full-term babies naturally produce a substance called surfactant that helps open up the tiny air sacs in the lungs and makes it easier for them to breathe. Babies born early or those with problems at birth, do not have enough of their own surfactant or it does not work properly, causing difficulty in taking in oxygen. A natural, animal-derived surfactant medication can be given into the lungs, using a small tube put into the windpipe through the mouth. This is done routinely in ventilated babies born prematurely. More recently, a technique called 'Less invasive surfactant administration (LISA)' has been developed that allows us to give surfactant to babies who are receiving 'non-invasive' breathing support (ie HHFNC) and, thus, avoiding the complications related to mechanical ventilation. A small tube is passed into the windpipe whilst the baby is awake and breathing (supported on HHFNC or CPAP) and the surfactant is slowly given and breathed into the lungs. At the moment, there have been no research studies assessing the use of LISA in more mature infants receiving HHFNC as 'non-invasive' respiratory support.
In this study the investigators want to determine if in babies born between 34 and 38+6 weeks gestation who have breathing problems and receive HHFNC oxygen treatment with LISA within 24 hours of birth will reduce the need for mechanical ventilation. The investigators will also be looking a the length on neonatal unit stay, and the cost of the stay. Lung function of the babies before and after they receive LISA will be measured.
There will be no change in the management of babies taking part in the study. Use of HHFNC, administration of LISA and respiratory monitoring is all part of routine practice. The investigators are asking for consent to analyse the routine monitoring that will be undertaken before, during and after the surfactant administration and follow up on the outcome of the baby after they have had the LISA procedure.
Surfactant is routinely used in babies and there are no extra risks from taking part in this study. HHFNC is routinely used to support babies of this gestational age who require respiratory support. There are no known or expected risks from using HHFNC with LISA but as of yet there have been no studies using this combination.
Giving surfactant may help to avoid mechanical ventilation and its side effects, but this has not been studied before in these gestational ages, hence the need for this study. Theoretically giving surfactant with HHFNC should aid even distribution of surfactant throughout the lungs whilst protecting the lungs from potential damage caused by other forms of non-invasive support such as CPAP but again there is not yet evidence supporting this.
The study will be running at King's College Hospital on the Neonatal Intensive Care Unit at the Denmark hill site and at the Local Neonatal Unit at the Princess Royal Hospital site. The study has received ethical approval and is due to commence imminently (May 2024). The study is aiming to recruit 245 patients which is estimated to take 2yrs and 4 months.
The study is funded by Chiesi Limited. The chief investigator for the study is Theodore Dassios: [email protected]
### Conditions Module
**Conditions:**
- Respiratory Distress Syndrome
- Preterm Pregnancy
- Surfactant Deficiency Syndrome Neonatal
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** This will be a prospective single centre study with a treatment arm and a control group.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 245
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Infants between 34-38+6 weeks gestation will receive surfactant via less invasive administration whilst on high flow nasal cannula oxygen treatment. They will have respiratory function monitoring before and after LISA.
**Intervention Names:**
- Procedure: Less invasive surfactant administration during high flow nasal cannula treatment
**Label:** Neonates given LISA during HFNC treatment
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Infants between 34-38+6 will receive routine care and will not receive surfactant unless intubated.
**Label:** Neonates not given LISA
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Neonates given LISA during HFNC treatment
**Description:** Surfactant distilled through a small tube inserted into the windpipe via the mouth whilst the baby is awake and supported with HFNC.
**Name:** Less invasive surfactant administration during high flow nasal cannula treatment
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** The percentage of babies requiring more respiratory support and therefore needing invasive ventilation within 72 hrs from birth. The percentage from the intervention group will be compared with the control group
**Measure:** The percentage of neonates needing invasive ventilation within 72 hours from birth
**Time Frame:** 72 hours from birth
#### Secondary Outcomes
**Description:** The duration of stay on the neonatal unit will be compared between the babies receiving the intervention, and those who are not.
**Measure:** The length of neonatal unit stay
**Time Frame:** The length of time the neonate is in hospital, up to 20 weeks
**Description:** Standard NHS tariffs will be used to calculate the total cost of the stay for the babies in the intervention vs control group.
**Measure:** The cost of stay as estimated via standard NHS tariffs according to level of care
**Time Frame:** The length of time the neonate is in hospital, up to 20 weeks
**Description:** The following lung function parameter: tidal volume will be measured for all babies receiving LISA.
**Measure:** The lung function parameters two minutes before and two minutes after the administration of LISA
**Time Frame:** The first 24 hours of life
**Description:** The following lung function parameter: respiratory rate will be measured for all babies receiving LISA.
**Measure:** The lung function parameters two minutes before and two minutes after the administration of LISA
**Time Frame:** The first 24 hours of life
**Description:** The following lung function parameter: fraction of inspired oxygen (FiO2) will be measured for all babies receiving LISA.
**Measure:** The lung function parameters two minutes before and two minutes after the administration of LISA
**Time Frame:** The first 24 hours of life
**Description:** The following lung function parameter: End Tidal CO2 (ETCO2) will be measured for all babies receiving LISA.
**Measure:** The lung function parameters two minutes before and two minutes after the administration of LISA
**Time Frame:** The first 24 hours of life
**Description:** The following lung function parameter: ratio of oxygen saturations/ fractions of inspired oxygen (SpO2/ FiO2 ratio) will be measured for all babies receiving LISA.
**Measure:** The lung function parameters two minutes before and two minutes after the administration of LISA
**Time Frame:** The first 24 hours of life
**Description:** Lung function parameter: ratio SpO2/FiO2 will be measured two hours after LISA administration for all babies receiving LISA
**Measure:** The SpO2/FiO2 ratio will be measured two hours after LISA administration
**Time Frame:** The first 24 hours of life
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Infants born at 34+0 to 38+6 weeks of gestation, requiring resuscitation at birth, but who achieve regular spontaneous breathing and have a heart rate over 100 beats per minute while receiving non-invasive support.
* Infants enrolled in the Surfon trial, born at 34+0 to 38+6 weeks of gestation, who are less than or equal to 24 hours old and exhibit signs of respiratory distress, defined as an FiO2 greater or equal to 0.30 but less than 0.45 needed to maintain an SpO2 greater than or equal to 92% or a clinically significant work of breathing regardless of the FiO2 and a clinical decision to provide non-invasive respiratory support.
Exclusion Criteria:
* Infants requiring intubation at birth
* Infants with severe congenital anomalies.
**Maximum Age:** 38 Weeks
**Minimum Age:** 34 Weeks
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Eleanor Jeffreys, MBBS
**Phone:** +447519 974813
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** King's College London
**Name:** Theodore Dassios, PHD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** The General Data Protection Regulation and Data Protection Act 2018 will be adhered to. Data will be anonymised before being entered into a secure database. Each participant will be issued a unique study identifier number when enrolled and this will be used on all data collection forms. Patient paper data will be stored in a locked filing cabinet in a room that is only accessible to the research team and that is based on the Neonatal Intensive Care Unit facilities at King's College Hospital. De-identified electronic patient data will be stored on encrypted computers or memory stick devices.
On completion, the data will be analysed and a final report prepared that could be accessed via the sponsor. The study will be presented at research meetings at King's College Hospital. Anonymised study data will be presented at conferences and published by the investigators in peer reviewed journals. Participants will be notified of the outcome of the study via provision of the publication.
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Herting E, Hartel C, Gopel W. Less invasive surfactant administration (LISA): chances and limitations. Arch Dis Child Fetal Neonatal Ed. 2019 Nov;104(6):F655-F659. doi: 10.1136/archdischild-2018-316557. Epub 2019 Jul 11.
**PMID:** 31296694
**Citation:** Shetty S, Egan H, Cornuaud P, Kulkarni A, Duffy D, Greenough A. Less Invasive Surfactant Administration in Very Prematurely Born Infants. AJP Rep. 2021 Jul;11(3):e119-e122. doi: 10.1055/s-0041-1735632. Epub 2021 Sep 22.
**PMID:** 34567837
**Citation:** Smithhart W, Wyckoff MH, Kapadia V, Jaleel M, Kakkilaya V, Brown LS, Nelson DB, Brion LP. Delivery Room Continuous Positive Airway Pressure and Pneumothorax. Pediatrics. 2019 Sep;144(3):e20190756. doi: 10.1542/peds.2019-0756. Epub 2019 Aug 9.
**PMID:** 31399490
**Citation:** Spence KL, Murphy D, Kilian C, McGonigle R, Kilani RA. High-flow nasal cannula as a device to provide continuous positive airway pressure in infants. J Perinatol. 2007 Dec;27(12):772-5. doi: 10.1038/sj.jp.7211828. Epub 2007 Aug 30.
**PMID:** 17762844
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000004194
- Term: Disease
- ID: D000010335
- Term: Pathologic Processes
- ID: D000007752
- Term: Obstetric Labor, Premature
- 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
- ID: D000008171
- Term: Lung Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
- ID: D000012120
- Term: Respiration Disorders
- ID: D000007235
- Term: Infant, Premature, Diseases
- ID: D000007232
- Term: Infant, Newborn, Diseases
### 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: 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: Surfactant Deficiency Syndrome Neonatal
- ID: M16355
- Name: Syndrome
- Relevance: HIGH
- As Found: Syndrome
- ID: M25869
- Name: Premature Birth
- Relevance: HIGH
- As Found: Preterm
- ID: M10772
- Name: Obstetric Labor, Premature
- 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
- ID: M11168
- Name: Lung Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14957
- Name: Respiration Disorders
- 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: Surfactant Deficiency Syndrome Neonatal
- ID: T192
- Name: Acute Respiratory Distress Syndrome
- Relevance: HIGH
- As Found: Respiratory Distress Syndrome
### Condition Browse Module - Meshes
- ID: D000012128
- Term: Respiratory Distress Syndrome
- ID: D000012127
- Term: Respiratory Distress Syndrome, Newborn
- ID: D000047928
- Term: Premature Birth
- ID: D000013577
- Term: Syndrome
### Intervention Browse Module - Ancestors
- ID: D000019141
- Term: Respiratory System Agents
### Intervention Browse Module - Browse Branches
- Abbrev: Resp
- Name: Respiratory System Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M14517
- Name: Pulmonary Surfactants
- Relevance: HIGH
- As Found: DPP
- ID: M21137
- Name: Respiratory System Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000011663
- Term: Pulmonary Surfactants
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06421493
**Acronym:** MATER
**Brief Title:** Role of the Maternal Microbiota on the Immune Response and Metabolism During Hypertensive Disorders
**Official Title:** Role of the Maternal Microbiota on the Immune Response and Metabolism During Hypertensive Disorders
#### Organization Study ID Info
**ID:** 0004622
#### Organization
**Class:** OTHER
**Full Name:** Istituto Clinico Humanitas
### Status Module
#### Completion Date
**Date:** 2025-06-06
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-14
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-06-06
**Type:** ESTIMATED
#### Start Date
**Date:** 2020-06-06
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-07
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
#### Lead Sponsor
**Class:** OTHER
**Name:** Istituto Clinico Humanitas
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Preeclampsia (PE) is a significant cause of maternal and fetal morbidity and mortality, characterized by high blood pressure and proteinuria during pregnancy. It has two main phenotypes: one linked to placental damage and the other to metabolic factors like obesity. Early identification of high-risk groups is crucial, though there's ongoing disagreement over its classification. Research suggests a potential connection between maternal gut bacteria and PE, offering avenues for improved prevention strategies. This study aims to investigate the differences in maternal gut microbiota between these two PE phenotypes.
**Detailed Description:** Preeclampsia (PE) is one of the leading causes of maternal and fetal morbidity and mortality. It is defined as the presence of systolic blood pressure (SBP) ≥ 140 and diastolic blood pressure (DBP) ≥ 90 on two consecutive measurements six hours apart, associated with proteinuria \>300 mg/24 h or 2++ detected by urine dipstick or the presence of organ damage or intrauterine growth restriction. Preeclampsia complicates 3-8% of pregnancies and is responsible for more than 76,000 maternal deaths annually.
Scientific evidence suggests the existence of two distinct phenotypes of the disease: preeclampsia due to placental damage and preeclampsia on a metabolic basis. The former phenotype recognizes altered invasion of the maternal endometrium by the trophoblast as its pathogenesis, where defective trophoblast invasion leads to the development of preeclampsia often associated with early presentation in pregnancy, intrauterine growth restriction (IUGR), and the need for delivery at low gestational ages. The latter phenotype recognizes a metabolic basis, which represents about 4% of hypertensive disorders of pregnancy (HDP), and is dependent on maternal predisposition in patients with visceral obesity and metabolic syndrome.
Evidence suggests that maternal risk factors for metabolic dysfunction may lead to late placental dysfunction in pregnancy. Metabolic-based preeclampsia manifests in patients with pre-existing low-grade inflammation related to truncal obesity and metabolic syndrome, compounded by pregnancy-related inflammation and insulin resistance.
Today, starting as early as the first trimester of pregnancy, maternal cardiovascular and hemodynamic function can be assessed using a non-invasive and safe method for both the mother and fetus through the USCOM (Ultra Sonic Cardiac Output Monitor) system. This system provides real-time data on numerous central and peripheral hemodynamic parameters.
There is still disagreement among scientific societies regarding the classification of preeclampsia and its possible different clinical phenotypes, making personalized clinical approaches to this condition challenging. However, early identification of high-risk groups is becoming increasingly important for diagnostic follow-up and therapeutic strategies based on pathogenesis.
Recently, a screening method at 11-13 weeks of gestation has been developed to predict 75% of pregnancies that will develop preterm preeclampsia (\<37 weeks of gestation) based on a risk calculation algorithm combining weight and height measurements, mean arterial pressure measured with automated devices, blood sampling for PLGF measurement, and Doppler ultrasound measurement of the mean pulsatility index (PI) of the uterine arteries.
However, this screening method can only predict a portion of patients who will develop preeclampsia before 37 weeks and who may benefit from aspirin intake if administered at doses \>100mg and before 16 weeks. Predicting and effectively preventing preeclampsia that occurs after 37 weeks remains the subject of debate and scientific research.
Among emerging etiopathogenetic hypotheses, numerous scientific publications suggest that alterations in maternal immunity and immune tolerance are the basis of hypertensive disorders in pregnancy. Recent discoveries suggest that changes in maternal intestinal microbiota may underlie these immune alterations. Alterations in gut microbiota diversity and composition, known as "dysbiosis," can influence systemic immune responses and metabolic disturbances such as gestational diabetes and preeclampsia, posing risks of metabolic alterations in the neonate.
Based on these premises, this study aims to define the characteristics of maternal intestinal microbiota in the two different clinical phenotypes of preeclampsia: placental preeclampsia associated with growth restriction and metabolic-based preeclampsia associated with a fetus of appropriate weight for gestational age.
### Conditions Module
**Conditions:**
- Preeclampsia
**Keywords:**
- microbiome
- immune system
- metabolome
### Design Module
#### Bio Spec
**Description:** The protocol involves analyzing the maternal microbiota and metabolome from fecal samples and blood samples collected from women who have consented to the study.
The blood will be centrifuged to separate the plasma from the cellular fraction. The isolated plasma will be frozen at -80°C for subsequent metabolomic and microbiota analyses, while the cells will be resuspended in phosphate-buffered saline (PBS) in equal volume to the isolated plasma. focal material will be stored at -80°C.
**Retention:** SAMPLES_WITH_DNA
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 300
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Age \> 18 years Singleton pregnancy Live fetus at 11-13 weeks of gestation Pregnancies complicated by hypertensive disorders (HDP) and fetal growth restriction (FGR) Women with pregnancies complicated by HDP and a fetus with appropriate weight for gestational age (AGAf) Women with pregnancies complicated solely by early fetal growth restriction (before 34 weeks) Women with pregnancies complicated solely by late fetal growth restriction (after 34 weeks) Women identified as high-risk in first-trimester screening for preeclampsia Women identified as high-risk in first-trimester screening for fetal growth restriction
**Label:** Case group
#### Arm Group 2
**Description:** Age \> 18 years Singleton pregnancy Feto vivo a 11-13 settimane di gravidanza Low-risk pregnancies in first-trimester screening for preeclampsia and fetal growth restriction, with physiological follow-up visits until delivery (homogeneous control sample)
**Label:** Controls
### Outcomes Module
#### Primary Outcomes
**Description:** Study of the characteristics of the microbiota in fecal samples from women with pregnancies complicated by hypertensive disorders, with or without fetal growth restriction.
**Measure:** Study of the Characteristics of Maternal Gut Microbiota in Women with Pregnancies Complicated by Hypertensive Disorders, with or without Fetal Growth Restriction.
**Time Frame:** through study completion, an average of 1 year
**Description:** Study of the characteristics of the metabolites in fecal and blood samples from women with pregnancies complicated by hypertensive disorders, with or without fetal growth restriction.
**Measure:** Study of the Characteristics of Metabolome, in Women with Pregnancies Complicated by Hypertensive Disorders, with or without Fetal Growth Restriction.
**Time Frame:** through study completion, an average of 1 year
**Description:** Study of the characteristics of NK and B cells in blood samples from women with pregnancies complicated by hypertensive disorders, with or without fetal growth restriction.
**Measure:** Study of the Characteristics of NK and B Cells in Women with Pregnancies Complicated by Hypertensive Disorders, with or without Fetal Growth Restriction.
**Time Frame:** through study completion, an average of 1 year
#### Secondary Outcomes
**Description:** Assessment of Changes in Maternal Microbiota, in High-Risk Patients in the First Trimester for Preeclampsia or Fetal Growth Restriction
**Measure:** Study of the Characteristics of Microbiota in Women with Pregnancies
**Time Frame:** through study completion, an average of 1 year
**Description:** Assessment of Changes in Maternal Metabolites in High-Risk Patients in the First Trimester for Preeclampsia or Fetal Growth Restriction
**Measure:** Study of the Evolution of Metabolome in Women with Pregnancies
**Time Frame:** through study completion, an average of 1 year
**Description:** Assessment of Changes in B and NK Cells in High-Risk Patients in the First Trimester for Preeclampsia or Fetal Growth Restriction
**Measure:** Study of the Evolution of NK and B Cells in Women with Pregnancies
**Time Frame:** through study completion, an average of 1 year
**Description:** The diet record will be obtained through a validated questionnaire on dietary habits and lifestyle. Spearman correlation of α-diversity microbiota measures and dietary intake will be performed.
**Measure:** Evaluation of a Possible Correlation Between Dietary Habits and Maternal Gut Microbiota
**Time Frame:** through study completion, an average of 1 year
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age \> 18 years
* Singleton pregnancy
* Live fetus at 11-13 weeks of gestation
* Pregnancies complicated by hypertensive disorders (HDP) and fetal growth restriction (FGR) Women with pregnancies complicated by HDP and a fetus with appropriate weight for gestational age (AGAf)
* Women with pregnancies complicated solely by early fetal growth restriction (before 34 weeks)
* Women with pregnancies complicated solely by late fetal growth restriction (after 34 weeks)
* Women identified as high-risk in first-trimester screening for preeclampsia Women identified as high-risk in first-trimester screening for fetal growth restriction
* Low-risk pregnancies in first-trimester screening for preeclampsia and fetal growth restriction, with physiological follow-up visits until delivery (homogeneous control sample)
Exclusion Criteria:
* Multiple pregnancies
* Pregnancies complicated by major fetal abnormalities identified during the 11-13 week gestational assessment
* Women who are unconscious or severely ill, women with learning difficulties, and those with severe psychiatric disorders
* Age \<18 years
* Women who have not provided informed consent for the study
* Women with HIV, HBV, HCV infection
* Women with a history of leukemia and lymphoma
* Women with immunodeficiency
* Women who have used corticosteroids or other immunosuppressants in the last 3 months
**Gender Based:** True
**Gender Description:** Pregnant women
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Women with pregnancies complicated by hypertensive disorders associated with or without fetal growth restriction in the second and third trimesters, and women identified as high-risk for the development of preeclampsia from the first trimester of pregnancy, will be offered the opportunity to participate in the study.
To obtain a control sample, equal participation (1:1 ratio) of pregnant women identified as low-risk in first-trimester screening for preeclampsia and fetal growth restriction, who will undergo physiological follow-up visits until delivery, will also be requested. Recruitment of controls will follow an alternating principle: high risk-low risk-high risk-low risk.
Patients will be followed up at defined intervals, varying depending on the underlying condition. High-risk patients and controls will be seen once per trimester if the pregnancy remains uncomplicated.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Pieve Emanuele
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Silvia Giugliano, PhD
- **Phone:** +390282243190
- **Role:** CONTACT
***Contact 2:***
- **Name:** Silvia Giugliano, PhD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Italy
**Facility:** Humanitas University
**State:** Milan
**Status:** RECRUITING
**Zip:** 20072
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## 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
- ID: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M10024
- Name: Hypertension
- Relevance: HIGH
- As Found: Hypertensive Disorders
- ID: M14106
- Name: Pre-Eclampsia
- Relevance: HIGH
- As Found: Preeclampsia
- ID: M7633
- Name: Eclampsia
- 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: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T2019
- Name: Eclampsia
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000011225
- Term: Pre-Eclampsia
- ID: D000006973
- Term: Hypertension
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06421480
**Brief Title:** Using Machine Learning to Detect Risky Behavior in Psychiatric Clinics
**Official Title:** Detecting Risky Behaviors and Providing a Safe Environment in Patients Receiving Inpatient Treatment in a Psychiatric Clinic Using Machine Learning Model
#### Organization Study ID Info
**ID:** İstanbulMedeniyet
#### Organization
**Class:** OTHER
**Full Name:** Istanbul Medeniyet University
### Status Module
#### Completion Date
**Date:** 2024-08-20
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-08-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-20
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-20
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Istanbul Medeniyet University
#### Responsible Party
**Investigator Affiliation:** Istanbul Medeniyet University
**Investigator Full Name:** CEYDA ÖZTÜRK AKDENİZ
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The aim of this study is to ensure the safety of patients in a psychiatric clinic and to detect risky behaviors by using machine learning method. Risky behaviors are defined as behaviors that are personally, socially and developmentally undesirable and endanger life and health.Patient safety and maintaining a safe environment are among the primary duties of healthcare professionals. Suicide is the most important evidence-based risk factor, especially among individuals with psychiatric illnesses, and is one of the most important factors that threaten patient safety. At the end of this study, it is aimed to detect risky behaviors of patients before they harm themselves and to enable healthcare professionals to make early intervention for these behaviors, thus supporting a safe treatment environment, with the computer system that has been trained with the machine learning model installed in the clinics.
**Detailed Description:** The aim of this study is to detect risky behaviors of patients in a psychiatric clinic using machine learning method. Risky behavior; It is defined as behaviors that are personally, socially and developmentally undesirable and endanger life and health. Patient safety and ensuring a safe environment are among the primary duties of healthcare professionals. Suicide is the most important evidence-based risk factor, especially in individuals with psychiatric illnesses, and is one of the most important factors that threaten patient safety. Suicide attempt is a crisis situation frequently encountered in clinics. It is known that the rate of suicide attempts increases 5-10 times in hospitalized patients. In clinics with inpatients, suicide attempts as well as other risky behaviors are frequently encountered.
Preventing risky behavior and providing a safe environment in psychiatric clinics is an important issue in our country and in the world. In order to detect risky behaviors and ensure patient/employee safety, there are measures to monitor patients with cameras in psychiatric clinics within the scope of quality standards in health. However, these measures are not sufficient to completely solve the problem. In psychiatric clinics, patient monitoring is provided by a nurse who constantly monitors the camera images placed in the rooms on the computer screen. The low number of nurses, especially on night shifts, makes camera monitoring difficult during night shifts and poses a problem in terms of patient safety. Constant monitoring of monitors by the nurse reduces the time spent with the patient and increases the workload. Additionally, when screen monitoring is not done, risky behaviors cannot be detected. Therefore, new methods need to be developed to ensure a safe environment in psychiatric clinics. In this sense, the machine learning method, which is increasingly used in artificial intelligence and data analysis, is a specialized sub-branch of artificial intelligence algorithms that tries to derive meaningful results/predictions from existing data. Machine learning method is frequently used in the field of health, and psychiatry is one of these fields. The main purpose of this study is to detect risky and high-risk behaviors of patients treated in a psychiatric clinic using machine learning method and to ensure that patients receive treatment in a safer environment.
### Conditions Module
**Conditions:**
- Machine Learning
- Dangerous Behavior
**Keywords:**
- psychiatric clinic
- machine learning
- risky behavior
### Design Module
#### Design Info
**Observational Model:** OTHER
**Time Perspective:** CROSS_SECTIONAL
#### Enrollment Info
**Count:** 1
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
### Interventions
#### Intervention 1
**Description:** Using machine learning, the computer will be trained to detect suicide and violent behavior. Cameras will be placed in patient rooms. These cameras will transfer the image to the computer. The computer will process these images and detect suicidal and violent behavior early. A warning will appear on the computer screen
**Name:** Detecting Risky Behaviors and Providing a Safe Environment in Patients Receiving Inpatient Treatment in a Psychiatric Clinic Using Machine Learning Model
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Detection of suicide and violent behaviors using machine learning method
**Measure:** Targeted Output
**Time Frame:** 01.05.2024-01.08.2024
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* It is suitable for all adult patients receiving inpatient treatment in psychiatric clinics. It is designed for the room where patients sleep.
Exclusion Criteria:
* People under the age of 18 will be excluded from the study
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
**Study Population:** The population of the study was theater and drama actors who randomly exhibited suicidal and violent behavior, using an empty room in a psychiatric clinic for training and testing the machine learning model. The number of actors is 4-5 people
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** ceyda öztürk akdeniz, 1
**Phone:** 05394124524
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Istanbul
**Country:** Turkey
**Facility:** Detecting Risky Behaviors and Providing a Safe Environment in Patients Receiving Inpatient Treatment in a Psychiatric Clinic Using Machine Learning Model
**Zip:** 34000
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06421467
**Brief Title:** Insulin Injection Practices in Spain
**Official Title:** Insulin Injection Practices in People With Diabetes in Spain
#### Organization Study ID Info
**ID:** EPID-ES
#### Organization
**Class:** OTHER
**Full Name:** Fundación para la Investigación del Hospital Clínico de Valencia
### Status Module
#### Completion Date
**Date:** 2024-10
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-14
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-10
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-01-19
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** Novo Nordisk A/S
#### Lead Sponsor
**Class:** OTHER
**Name:** Fundación para la Investigación del Hospital Clínico de Valencia
#### Responsible Party
**Investigator Affiliation:** Fundación para la Investigación del Hospital Clínico de Valencia
**Investigator Full Name:** Francisco Javier Ampudia Blasco
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** In this era of pharmaceutical and technological advancements, gaining insights into prevalent insulin administration practices under real-life conditions becomes pivotal for healthcare professionals. The investigators aim to explore insulin injection habits through an online survey among a broad, unselected group of participants with type 1 and type 2 diabetes undergoing daily prandial and/or basal insulin treatment. Eligible participants will access and complete the survey at their convenience after providing online informed consent within the study period
**Detailed Description:** HYPOTHESIS The study hypothesis posits that there is significant variability in the practices of insulin administration among patients with diabetes using daily insulin injections. This diversity in administration practices may have a notable impact on the overall efficacy of treatment regimens and the successful management of the disease, thereby emphasizing the need for a comprehensive understanding of these practices to enhance patient outcomes and optimize diabetes care.
OBJECTIVES The main objective of the study is to comprehensively assess and characterize the diverse insulin administration practices among individuals with diabetes using injections, focusing on both prandial and basal insulin. By employing an online survey methodology and targeting a broad demographic through a diabetes information platform Canal Diabetes, the investigators aim to gain valuable insights into the variability, challenges, and overall patterns of insulin administration. The findings will contribute to a better understanding of real-world practices, facilitating improvements in patient guidance and optimizing diabetes care strategies.
STUDY DESIGN The study follows a cross-sectional observational design, allowing the investigators to capture a snapshot of the current insulin administration practices via an online questionnaire among the diverse population of diabetes patients using multiple insulin injections.
STUDY PROCEDURE AND SCHEDULE The study, focusing on insulin administration practices among participants with diabetes using multiple insulin injections, will employ a two-month online survey accessible on the designated online platform Canal Diabetes. Recruitment efforts through the diabetes information platform Canal Diabetes will inform eligible participants about the study's voluntary nature, emphasizing response confidentiality. Participants meeting the criteria, will access and complete the online informed consent and survey at their convenience within the designated two-month period. Post-survey, collected data will be securely stored and anonymized for subsequent analysis.
STUDY DURATION The anticipated duration of this study will be 4 months, with subject recruitment set to begin in July 2024 and aiming for the completion of statistical analysis by the 31st of October 2024.
GOOD CLINICAL PRACTICE The procedures set out in this study protocol, pertaining to the conduct, evaluation, and documentation of this study, are designed to ensure that the sponsor and investigator (in this case the same person) comply with the principle of the good clinical practice guidelines and the Declaration of Helsinki in the conduct, evaluation and documentation of this study. The study will also be carried out in keeping with local legal requirements.
SUBJECTS INFORMATION AND INFORMED CONSENT Prior to taking the online questionnaire, participants will be required to provide explicit consent to participate in the study. An online informed consent document, encompassing details about the study and the consent form, will be prepared and supplied to participants. This document will be presented in a language accessible to participants, and clear contact information will be provided for any questions that may arise.
ENSURING DATA CONFIDENTIALITY The study database will not contain any information that could allow the individual identification of the study participants. The data obtained will be used exclusively for the purposes described in this research project. The information will be treated as confidential and will be stored and processed in accordance with the provisions of EU Regulation 2016/679 of the European Parliament and the Council of 27 April 2016 on the protection of personal data and the free movement of such data, as well as Organic Law 3/2018 of December.
### Conditions Module
**Conditions:**
- Diabetes
### Design Module
#### Design Info
**Observational Model:** CASE_ONLY
**Time Perspective:** CROSS_SECTIONAL
#### Enrollment Info
**Count:** 400
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Outcomes Module
#### Primary Outcomes
**Description:** Number of total insulin injections per day
**Measure:** Number of total insulin injections
**Time Frame:** through study completion, an average of 16 weeks
**Description:** Number of prandial insulin injections per day
**Measure:** Number of prandial insulin injections
**Time Frame:** through study completion, an average of 16 weeks
**Description:** Number of basal insulin injections per day
**Measure:** Number of basal insulin injections
**Time Frame:** through study completion, an average of 16 weeks
**Description:** Timing of prandial insulin injection: before meals, during meals, after meals, or at some point during the day
**Measure:** Timing of prandial insulin injection
**Time Frame:** through study completion, an average of 16 weeks
**Description:** If insulin administration occurs before starting the meal: time interval (minutes)
**Measure:** Time interval before prandial insulin injection
**Time Frame:** through study completion, an average of 16 weeks
**Description:** If insulin administration occurs after the meal: time interval (minutes)
**Measure:** Time interval after prandial insulin injection
**Time Frame:** through study completion, an average of 16 weeks
**Description:** Insulin overdosing when correcting abnormal glucose values (Y/N)
**Measure:** Insulin overdosing
**Time Frame:** through study completion, an average of 16 weeks
**Description:** Insulin overdosing when correcting abnormal glucose values (Y/N)
**Measure:** Insulin underdosing
**Time Frame:** through study completion, an average of 16 weeks
**Description:** Insulin administration site: abdomen, thigh, arm
**Measure:** Insulin administration site
**Time Frame:** through study completion, an average of 16 weeks
**Description:** Injection site rotation: (Yes/No)
**Measure:** Site rotation
**Time Frame:** through study completion, an average of 16 weeks
**Description:** Frequency in the change of the insulin needle
**Measure:** Change of the insulin needle
**Time Frame:** through study completion, an average of 16 weeks
**Description:** Use of smart pens (Y/N)
**Measure:** Use of smart pens
**Time Frame:** through study completion, an average of 16 weeks
**Description:** Type of prandial insulin used
**Measure:** Type of prandial insulin
**Time Frame:** through study completion, an average of 16 weeks
**Description:** Daily dose of prandial insulin (IU/kg)
**Measure:** Daily dose of prandial insulin
**Time Frame:** through study completion, an average of 16 weeks
**Description:** Type of basal insulin used
**Measure:** Type of basal insulin
**Time Frame:** through study completion, an average of 16 weeks
**Description:** Daily dose of basal insulin (IU/kg)
**Measure:** Daily dose of basal insulin
**Time Frame:** through study completion, an average of 16 weeks
**Description:** Last HbA1c value
**Measure:** Last HbA1c
**Time Frame:** through study completion, an average of 16 weeks
**Description:** Date of last HbA1c value
**Measure:** Date of last HbA1c
**Time Frame:** through study completion, an average of 16 weeks
**Description:** Diabetic ketoacidosis (DKA) in the last year (Y/N)
**Measure:** Diabetic ketoacidosis
**Time Frame:** through study completion, an average of 16 weeks
**Description:** Severe hypoglycemic episodes in the last year (Y/N)
**Measure:** Hypoglycemic episodes
**Time Frame:** through study completion, an average of 16 weeks
**Description:** Hyperglycemic episodes with medical support in the last year (Y/N)
**Measure:** Hyperglycemic episodes
**Time Frame:** through study completion, an average of 16 weeks
**Description:** Age of diabetes onset (years/months)
**Measure:** Age of diabetes onset
**Time Frame:** through study completion, an average of 16 weeks
**Description:** Self-monitoring of capillary blood glucose (SMBG) (Y/N)
**Measure:** Self-monitoring of capillary glucose
**Time Frame:** through study completion, an average of 16 weeks
**Description:** Continuous glucose monitoring (CGM) in real-time or intermittently scanned (Y/N)
**Measure:** Glucose monitoring in real-time or intermittently scanned
**Time Frame:** through study completion, an average of 16 weeks
**Description:** Lack of daily glucose monitoring (Y/N)
**Measure:** Lack of daily glucose monitoring
**Time Frame:** through study completion, an average of 16 weeks
**Description:** Lack of correction based on glucose values (Y/N)
**Measure:** Lack of correction based on glucose values
**Time Frame:** through study completion, an average of 16 weeks
**Description:** If CGM user, CGM parameters from the last 28 days: Time in Range (%TIR)
**Measure:** Time in Range (%TIR)
**Time Frame:** through study completion, an average of 16 weeks
**Description:** If CGM user, CGM parameters from the last 28 days: Time Below Range (%TbR)
**Measure:** Time Below Range (%TbR)
**Time Frame:** through study completion, an average of 16 weeks
**Description:** If CGM user, CGM parameters from the last 28 days: Time Above Range (%TaR)
**Measure:** Time Above Range (%TaR)
**Time Frame:** through study completion, an average of 16 weeks
**Description:** If CGM user, CGM parameters from the last 28 days: mean glucose (mg/dL)
**Measure:** Mean glucose (mg/dL)
**Time Frame:** through study completion, an average of 16 weeks
**Description:** If CGM user, CGM parameters from the last 28 days: coefficient of variation of continuous glucose sensor values (CV)
**Measure:** Coefficient of variation of continuous glucose sensor values (CV)
**Time Frame:** through study completion, an average of 16 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Individuals aged 18 or above
* Individuals diagnosed with diabetes (type 1 or type 2 diabetes)
* Individuals receiving multiple daily doses of insulin
Exclusion Criteria:
* Individuals utilizing continuous subcutaneous insulin infusion
* Individuals engaging in sensor-augmented pump therapy
* Individuals using automatic insulin delivery systems
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Individuals aged 18 or above, diagnosed with either Type 1 or Type 2 diabetes, who actively incorporate insulin injections-both prandial and basal-into their treatment plan, with a minimum requirement of at least one injection of prandial insulin and/or basal insulin.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Ana Palanca
**Phone:** 961973517
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** F. Javier Ampudia-Blasco
**Phone:** 961973500
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Valencia
**Country:** Spain
**Facility:** INCLIVA
**Zip:** 46010
#### Overall Officials
**Official 1:**
**Affiliation:** HCUV-INCLIVA
**Name:** F. Javier Ampudia-Blasco
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M7115
- Name: Diabetes Mellitus
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Browse Branches
- Abbrev: Hypo
- Name: Hypoglycemic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M10365
- Name: Insulin
- Relevance: LOW
- As Found: Unknown
- ID: M173166
- Name: Insulin, Globin Zinc
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06421454
**Brief Title:** Clinical Trial for the Evaluation of Melatonin in the Treatment of Pressure Ulcers
**Official Title:** Clinical Trial for the Evaluation of Melatonin in the Treatment of Pressure Ulcers
#### Organization Study ID Info
**ID:** PHM-2021-001
#### Organization
**Class:** OTHER
**Full Name:** Fundacion Rioja Salud
### Status Module
#### Completion Date
**Date:** 2025-11-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-14
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-06-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-09-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2021-12-03
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** Pharmamel S.L.
**Class:** OTHER
**Name:** Universidad de Granada
**Class:** OTHER_GOV
**Name:** Instituto de Salud Carlos III
#### Lead Sponsor
**Class:** OTHER
**Name:** Fundacion Rioja Salud
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Is US Export:** False
### Description Module
**Brief Summary:** Melatonin has been shown to prevent cellular damage produced by oxidative stress or in situations of ischaemia, inhibiting the synthesis of oxidants and pro inflammatory factors such as pro-inflammatory cytokines, substances which are present in pressure ulcers and can affect the healing process, slowing it down. Melatonin gel has also been shown to prevent ulcers in the oral mucosa due to radiotherapy. Therefore, the hypothesis for this study is that the melatonin cream provides greater ulcer area reduction than standard pressure ulcer treatment.
**Detailed Description:** Melatonin has been shown to prevent cellular damage produced by oxidative stress or in situations of ischaemia, inhibiting the synthesis of oxidants and pro inflammatory factors such as pro-inflammatory cytokines, substances which are present in pressure ulcers and can affect the healing process, slowing it down. Melatonin gel has also been shown to prevent ulcers in the oral mucosa due to radiotherapy. Therefore, the hypothesis for this study is that the melatonin cream provides greater ulcer area reduction than standard pressure ulcer treatment.
In order to o determine the efficacy of melatonin in healing pressure ulcer it has been designed a multicentre, single-blind, randomized clinical trial comparing melatonin cream as an experimental pressure ulcer treatment versus control group with standard treatment based on moist environment wound healing with a time frame of 8 weeks. In order to assess the healing rate, changes in Resvech 2.0 scale scores will be measured, as well as the ulcer surface reduction. To avoid variability in measuring ulcer surface, it will be done by using software HELCOS after taking a photograph of the wound weekly. An intention-to-treat analysis will be carried out. The t-test or Mann-Whitney will be used to check difference of means in the reduction of the area of the ulcer and variation in the Resvech 2.0 scale. Survival curves will be used to check possible differences in the follow-up time until epithelization.
### Conditions Module
**Conditions:**
- Pressure Ulcer
**Keywords:**
- melatonin, ischemia
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- INVESTIGATOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 50
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Ulcers will be treated daily with melatonin cream for 8 weeks
**Intervention Names:**
- Drug: Melatonin
**Label:** Melatonin
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Ulcers will be treated daily with hydrogel for 8 weeks
**Intervention Names:**
- Drug: Hydrogel
**Label:** Control
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Melatonin
**Description:** Pressure Ulcer will be treated with a melatonin cream daily
**Name:** Melatonin
**Other Names:**
- Mel13Rx
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Control
**Description:** Pressure ulcer will be treated with hydrogel daily as a comparator
**Name:** Hydrogel
**Other Names:**
- Intransite
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Percentage of completely epithelialized ulcers
**Measure:** Epithelialisation
**Time Frame:** Up to 8 weeks
#### Secondary Outcomes
**Description:** Percentage of reduction in pressure ulcer area
**Measure:** Pressure ulcer area
**Time Frame:** Up to 8 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Present at least one category II, III or IV pressure ulcer according to National Group for the Study and Assessment of Pressure Ulcers (GNEAUPP) classification.
* Ulcer area between 1 and 100 cm2.
* People over 18 years of age who have freely given their informed consent in writing of their own volition or it has been given on their behalf by a legal guardian
Exclusion Criteria:
* Ulcer of category I, non-classifiable or affecting internal tissues, but with no break in the skin
* People currently undergoing chemotherapy treatment or who have done so in the previous 6 months
* People with a presumed life expectancy of less than 6 months or in palliative care.
**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:** Marco Aldonza-Torres
**Phone:** +34 848 4229505
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Fundacion Rioja Salud
**Name:** Marco Aldonza -Torres
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010335
- Term: Pathologic Processes
- ID: D000012883
- Term: Skin Ulcer
- ID: D000012871
- Term: Skin Diseases
### Condition Browse Module - Browse Branches
- 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: M10543
- Name: Ischemia
- Relevance: LOW
- As Found: Unknown
- ID: M6870
- Name: Pressure Ulcer
- Relevance: HIGH
- As Found: Pressure Ulcer
- ID: M17206
- Name: Ulcer
- Relevance: HIGH
- As Found: Ulcer
- ID: M15686
- Name: Skin Ulcer
- Relevance: LOW
- As Found: Unknown
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003668
- Term: Pressure Ulcer
- ID: D000014456
- Term: Ulcer
### Intervention Browse Module - Ancestors
- ID: D000000975
- Term: Antioxidants
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000020011
- Term: Protective Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000002492
- Term: Central Nervous System Depressants
### 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: M11533
- Name: Melatonin
- Relevance: HIGH
- As Found: Profile
- ID: M4292
- Name: Antioxidants
- Relevance: LOW
- As Found: Unknown
- ID: M21869
- Name: Protective Agents
- Relevance: LOW
- As Found: Unknown
- ID: T410
- Name: Melatonin
- Relevance: HIGH
- As Found: Profile
### Intervention Browse Module - Meshes
- ID: D000008550
- Term: Melatonin
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06421441
**Brief Title:** The Effect of Self-Management Skills Training Given to Nursing Students According to Peer Education Module on Problematic Internet Use and Academic Procrastination Behavior
**Official Title:** The Effect of Self-Management Skills Training Given to Nursing Students According to Peer Education Module on Problematic Internet Use and Academic Procrastination Behavior
#### Organization Study ID Info
**ID:** 1919B012203792
#### Organization
**Class:** OTHER
**Full Name:** Istanbul Aydın University
### Status Module
#### Completion Date
**Date:** 2024-04-15
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-19
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2024-01-15
**Type:** ACTUAL
#### Start Date
**Date:** 2023-09-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2023-01-30
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** The Scientific and Technological Research Council of Turkey
#### Lead Sponsor
**Class:** OTHER
**Name:** Istanbul Aydın University
#### Responsible Party
**Investigator Affiliation:** Istanbul Aydın University
**Investigator Full Name:** Cennet Ciriş Yıldız
**Investigator Title:** Dr. Faculty Member
**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 study is to evaluate the effect of self-management skills training given with the peer education module on the problematic internet use and academic procrastination behavior of nursing students. .
**Detailed Description:** A total of 12 hours of self-management skills training will be given to the peer groups, two days a week for three weeks, two lesson hours a day (60 min. + 60 min.).The effect of self-management skills training on problematic internet use and academic procrastination behavior of nursing students will be evaluated.
### Conditions Module
**Conditions:**
- Problem Behavior
- Problematic Internet Use
- Academic Procrastination Behavior
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Group 1: Experimental group (Education group) Goup 2: Control group
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 175
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Experimental group (Education group)
**Intervention Names:**
- Other: Self Management Skills Training
**Label:** Experimental
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Control group
**Label:** Control group
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Experimental
**Description:** Nursing students will be given self-management skills training for a total of 12 hours, two days a week, two hours a day (60 min. + 60 min.) for three weeks.
**Name:** Self Management Skills Training
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** It was developed in order to reveal the healthy and unhealthy usage levels of the Internet. The total score varies between 27 and 135. This scale aims to reveal healthy and unhealthy internet usage levels. In this context, high scores that can be obtained from the scale should be considered as a sign that individuals' internet use has become unhealthy, the internet has a negative impact on their lives, and may create a tendency towards a pathology such as addiction.
**Measure:** Problematic Internet Use Scale
**Time Frame:** Before training, immediately in the first and third months after training
**Description:** It was developed to determine students' academic procrastination behaviors. The highest score that can be obtained from the scale is 95 and the lowest score is 19. A high score from the scale indicates that students are academic procrastinators.
**Measure:** Academic Procrastination Scale
**Time Frame:** Before training, immediately in the first and third months after training.
### Eligibility Module
**Eligibility Criteria:** Research Inclusion Criteria;
* Being 18 years or older,
* Volunteering to participate in the study,
* Using the internet for an average of 2 hours or more per day,
* Not having any communication problems,
* To continue self-management skills training.
Criteria for Exclusion from the Research;
* Having any communication barrier,
* Not continuing self-management skills training.
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Istanbul
**Country:** Turkey
**Facility:** Istanbul Aydın Üniversity
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## 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: M85
- Name: Problem Behavior
- Relevance: HIGH
- As Found: Problem Behavior
- ID: M4818
- Name: Behavioral Symptoms
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000066553
- Term: Problem Behavior
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06421428
**Acronym:** LEI
**Brief Title:** Lived Experienced Incontinence Lived Experienced Incontinence - LEI
**Official Title:** Urinary Incontinence: Lived Experience of Adult Women. A Phenomenological Study
#### Organization Study ID Info
**ID:** LEI
#### Organization
**Class:** OTHER
**Full Name:** IRCCS San Raffaele
### Status Module
#### Completion Date
**Date:** 2025-10-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-14
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-10-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-09-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Università Vita-Salute San Raffaele
#### Lead Sponsor
**Class:** OTHER
**Name:** IRCCS San Raffaele
#### Responsible Party
**Investigator Affiliation:** IRCCS San Raffaele
**Investigator Full Name:** Sara Trapani
**Investigator Title:** Principal Investigator, Midwife (RM), PhD student
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Study Description: Scientific literature demonstrated the negative influence of Urinary Incontinence (UI) on the quality of life connected to the physical, psychological, and social health of women.
However, a limited number of studies investigated in depth the emotional experience of women affected by this disorder, their behaviors, and their experiences in managing the problem. Health professionals need to understand these aspects to offer the best care, also taking into account women's cultural and territorial differences. Research conducted on the topic in the Italian context is lacking, therefore the present study aims to explore, in a Northern Italian context, the experience of adult women affected by UI.
Study Design: Qualitative phenomenological study (observational, cross-sectional, monocenter) Objective: To explore, in a Northern Italian context, the experience of women aged ≥ 18 years affected by Urinary Incontinence (UI) Study Population: Women ≥ 18 years old, not pregnant nor having given birth for less than 40 days, suffering from urinary incontinence who access the Pelvic Floor Rehabilitation Outpatient Clinic of the San Raffaele Hospital in Milan.
Sample Size: Women who have already had at least a couple of pelvic floor rehabilitation meetings at the outpatient clinic of the San Raffaele Hospital in Milan, within the time frame foreseen by the study. These subjects represent a precious resource and are considered "more informative for the researcher" as they testify to the emotions and daily life that influence the symptoms of urinary incontinence, but they are also able to narrate their experience of re-education of the pelvic floor.
It is assumed that approximately 20 women will be involved to reach data saturation.
Statistical Design: The interviews will be analyzed with the hermeneutic-phenomenological IPA (Interpretative phenomenological analysis) method, which involves the identification of units of meaning, categories and themes in accordance with the language of the speakers. The analysis of qualitative data will be made possible thanks to the use of data management software (NViVO). The socio-demographic data collected will be presented with absolute and relative frequencies
### Conditions Module
**Conditions:**
- Urinary Incontinence
- Experience, Life
### Design Module
#### Design Info
**Observational Model:** OTHER
**Time Perspective:** CROSS_SECTIONAL
#### Enrollment Info
**Count:** 20
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The population under investigation will be made up of women aged ≥ 18 years (excluding pregnant women and women who have given birth less than 40 days) suffering from urinary incontinence and who understand and speak in the Italian language. Will be enrolled on a voluntary basis women who have already had at least a couple of pelvic floor rehabilitation meetings at the outpatient clinic of the San Raffaele Hospital in Milan, within the time frame foreseen by the study, because they are also able to narrate their experience of re-education of the pelvic floor.
**Intervention Names:**
- Other: LEI Interview
- Other: LEI Survey
**Label:** Women's single sample
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Women's single sample
**Description:** In accordance with the IPA (Interpretative phenomenological analysis) methodology, a semi-structured interview outline will be defined, aimed at understanding the lived experiences of women ("lived experience") during their coexistence with urinary incontinence and during the treatment process.
The screwdriver questions were formulated starting from the reference literature and will be discussed in a focus group composed of a uro-gynecologist, two midwives, a nurse, an expert in qualitative methodology. The final screwdriver questions resulting from the focus group will be tested on a small group of women.
**Name:** LEI Interview
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Women's single sample
**Description:** Some sociodemographic data identified from the reference literature will be collected in paper form immediately at the end of each interview, for the description of the sample. The data will concern: age, nationality, marital status, level of education, number of children, menopause, social relationships, level of information, period of onset of symptoms, type of symptomatology, frequency of episodes of urinary incontinence, quantity of urinary leakage, uro-gynecological pathological history.
**Name:** LEI Survey
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** To explore, in a Northern Italian context, the experience of women aged ≥ 18 years affected by Urinary Incontinence (UI) through a semi-structured interview (open questions).
Specifically, the topics addressed in the interview will be:
* Emotions and daily life of women with UI (i.e. subjective meaning of UI, lifestyle changes, women's mood)
* Behavioral strategies implemented to deal with the problem (i.e. choice to give up leisure activities, society's attention to the problem, tools and sources of information)
* Perceptions regarding UI treatment plan (i.e. health expectations and desires, decision-making process that led to undertaking the treatment)
**Measure:** LEI (Lived Experience Incontinence) Interview
**Time Frame:** Baseline
#### Secondary Outcomes
**Description:** To collect some sociodemographic data regarding women affected by UI: age, nationality, marital status, level of education, number of children, menopause, social relationships, level of information, period of onset of symptoms, type of symptomatology, frequency of episodes of urinary incontinence, quantity of urinary leakage, uro-gynecological pathological history.
**Measure:** LEI (Lived Experience Incontinence) survey
**Time Frame:** Baseline
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Female sex
2. Age ≥ 18 years old
3. Urinary Incontinence
4. Informed consent signed
5. Comprehension of written and spoken Italian language
6. Female patients of the pelvic floor rehabilitation outclinic at San Raffaele Hospital
Exclusion Criteria:
1. Male sex
2. Young age (\< 18 years)
3. Pregnancy
4. Puerperium (up to 40 days post-partum)
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** The population under investigation will be made up of women aged ≥ 18 years (excluding pregnant women and women who have given birth less than 40 days) suffering from urinary incontinence and who understand and speak in the Italian language. Will be enrolled on a voluntary basis women who have already had at least a couple of pelvic floor rehabilitation meetings at the outpatient clinic of the San Raffaele Hospital in Milan, within the time frame foreseen by the study, because they are also able to narrate their experience of re-education of the pelvic floor.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Sara Trapani
**Phone:** 3389879403
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Giulia Villa
**Phone:** 0291751779
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Milan
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Sara Trapani
- **Phone:** 3389879403
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Giulia Villa
- **Phone:** 0291751779
- **Role:** CONTACT
***Contact 3:***
- **Name:** Massimo Candiani
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 4:***
- **Name:** Stefano Salvatore
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 5:***
- **Name:** Duilio F. Manara
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 6:***
- **Name:** Stefania Rinaldi
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 7:***
- **Name:** Ilaria Baini
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 8:***
- **Name:** Giulia Villa
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 9:***
- **Name:** Sara Trapani
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Italy
**Facility:** IRCCS Ospedale San Raffaele
**Zip:** 20132
#### Overall Officials
**Official 1:**
**Affiliation:** Director of Center for Nursing Research and Innovation (CeNRI)
**Name:** Duilio F. Manara
**Role:** STUDY_CHAIR
**Official 2:**
**Affiliation:** Director of U.O. Obstetrics and Gynecology
**Name:** Massimo Candiani
**Role:** STUDY_CHAIR
**Official 3:**
**Affiliation:** U.O. Obstetrics and Gynecology
**Name:** Stefano Salvatore
**Role:** STUDY_CHAIR
**Official 4:**
**Affiliation:** U.O. Obstetrics and Gynecology
**Name:** Stefania Rinaldi
**Role:** STUDY_CHAIR
**Official 5:**
**Affiliation:** U.O. Obstetrics and Gynecology
**Name:** Ilaria Baini
**Role:** STUDY_CHAIR
**Official 6:**
**Affiliation:** Center for Nursing Research and Innovation (CeNRI)
**Name:** Giulia Villa
**Role:** STUDY_CHAIR
**Official 7:**
**Affiliation:** U.O. Obstetrics and Gynecology
**Name:** Sara Trapani
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- 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: D000091642
- Term: Urogenital Diseases
- ID: D000052801
- Term: Male Urogenital Diseases
- ID: D000059411
- Term: Lower Urinary Tract Symptoms
- ID: D000020924
- Term: Urological Manifestations
- ID: D000001526
- Term: Behavioral Symptoms
- ID: D000019960
- Term: Elimination Disorders
- ID: D000001523
- Term: Mental Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
### Condition Browse Module - Browse Leaves
- ID: M17299
- Name: Urinary Incontinence
- Relevance: HIGH
- As Found: Urinary Incontinence
- ID: M7936
- Name: Enuresis
- Relevance: HIGH
- As Found: Urinary Incontinence
- ID: M27171
- Name: Nocturnal Enuresis
- 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: 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: M29464
- Name: Lower Urinary Tract Symptoms
- Relevance: LOW
- As Found: Unknown
- ID: M22659
- Name: Urological Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: M4818
- Name: Behavioral Symptoms
- Relevance: LOW
- As Found: Unknown
- ID: M21832
- Name: Elimination 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: D000014549
- Term: Urinary Incontinence
- ID: D000004775
- Term: Enuresis
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06421415
**Brief Title:** Long Term Effect of AIT in Children
**Official Title:** Long Term Effect of AIT in Children
#### Organization Study ID Info
**ID:** HCA-AIT
#### Organization
**Class:** OTHER
**Full Name:** Odense University Hospital
### Status Module
#### Completion Date
**Date:** 2037-05-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2036-12-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Odense University Hospital
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The present study will investigate the long term effect of allergen immunotherapy in a real-life study in children with allergy undergoing subcutaneous or sublingual immunotherapy with grass pollen, birch, house dust mites or venom.
**Detailed Description:** The study will include children aged 5- 18 years who are treated with immunotherapy at Hans Christian Andersen Children' Hospital, Odense University Hospital.
Informed consent to be registered in a database and to receive a questionnaire 5 and 10 years after end of treatment are obtained before start of immunotherapy.
Base line data include information from the patient record: symptoms, medication, blood test and skin prick test results. During treatment effect, medication use, lung function and adverse events are monitored systematically once a year.
The questionnaires 5 and 10 years after end of treatment will focus on allergy symptoms, use of medication and asthma symptoms.
### Conditions Module
**Conditions:**
- Allergy in Children
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 100
**Type:** ESTIMATED
**Patient Registry:** True
**Study Type:** OBSERVATIONAL
**Target Duration:** 14 Years
### Arms Interventions Module
### Interventions
#### Intervention 1
**Description:** Patients will be treated as usual. The study is an observation of the long term effect of the treatment
**Name:** Allergen Immunotherapy Extract
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Medication use for allergy and asthma and the patient's experience of effect of the AIT on a scale from 0-4 (0= no effect, 1= modest effect, 2= some effect, 3= good effect, 4= very good effect)
**Measure:** Effect of immunotherapy 5 years after end of treatment
**Time Frame:** 5 years
#### Secondary Outcomes
**Description:** Medication use for allergy and asthma and the patient's experience of effect of the AIT on a scale from 0-4 (0= no effect, 1= modest effect, 2= some effect, 3= good effect, 4= very good effect)
**Measure:** Effect of immunotherapy 10 years after end of treatment
**Time Frame:** 10 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria: treated with allergen immunotherapy at HCA Children'sHospital, Odense University Hospital -
Exclusion Criteria: received less than 12 months of treatment with allergen immunotherapy
-
**Maximum Age:** 18 Years
**Minimum Age:** 4 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
**Study Population:** Children with moderate to severe allergy to grass pollen, birch, house dust mites or venom who are prescribed allergen immunotherapy
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Josefine Gradman, PhD
**Phone:** 0045 29241375
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Odense
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Josefine Gradman
- **Phone:** 004529241375
- **Role:** CONTACT
**Country:** Denmark
**Facility:** Hans Christian Andersen Children's Hospital
**State:** Odense C
**Status:** RECRUITING
**Zip:** 5000
**Location 2:**
**City:** Odense
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Josefine Gradman, PhD
- **Phone:** 0045 29241375
- **Role:** CONTACT
**Country:** Denmark
**Facility:** Hans Christian Andersen Children's Hospital
**Status:** RECRUITING
**Zip:** 5000
#### Overall Officials
**Official 1:**
**Affiliation:** Odense University Hospital
**Name:** Josefine Gradman, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M10018
- Name: Hypersensitivity
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Ancestors
- ID: D000007155
- Term: Immunologic Factors
- ID: D000045505
- Term: Physiological Effects of Drugs
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M2853
- Name: Immunomodulating Agents
- Relevance: HIGH
- As Found: Immediately
- ID: M10201
- Name: Immunologic Factors
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000091369
- Term: Immunomodulating Agents
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06421402
**Brief Title:** K-HEALTH in AIR - Barcelona Pilot - Cohort
**Official Title:** Knowledge for Improving Indoor Air Quality and Health: Follow up of 200 High-risk Chronic Respiratory Patients During 24 Months.
#### Organization Study ID Info
**ID:** HCB/2023/0126
#### Organization
**Class:** OTHER
**Full Name:** Institut d'Investigacions Biomèdiques August Pi i Sunyer
#### Secondary ID Infos
**Domain:** HaDEA
**ID:** 101057693
**Type:** OTHER_GRANT
### Status Module
#### Completion Date
**Date:** 2026-08-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-14
**Overall Status:** ENROLLING_BY_INVITATION
#### Primary Completion Date
**Date:** 2025-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-10-13
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-29
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Hospital Clinic of Barcelona
#### Lead Sponsor
**Class:** OTHER
**Name:** Institut d'Investigacions Biomèdiques August Pi i Sunyer
#### Responsible Party
**Investigator Affiliation:** Institut d'Investigacions Biomèdiques August Pi i Sunyer
**Investigator Full Name:** Josep Roca Torrent
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The study protocol is part of the European (EU) project "Knowledge for improving indoor AIR quality and HEALTH" (K-HEALTHinAIR, 2022-2026 - registry 101057693), which focuses on enhancing our understanding of how poor indoor air quality (IAQ) affects human health. Specifically, the project aims to identify IAQ determinants of adverse health events and to explore the development of cost-effective strategies for the precise monitoring and improvement, of IAQ across Europe.
With the current study protocol, the Barcelona Pilot, at the Integrated Health District of Barcelona-Esquerra (AISBE, 520 k citizens), is conducting a cohort study over a two-year period (January 2024 to December 2025) to explore the relationships between IAQ (assessment of chemical pollutants in patients' homes) and health status (acute episodes) in multimorbid patients with chronic respiratory diseases (asthma and Chronic Obstructive Pulmonary Disease - COPD) over a two-year period.
The protocol investigates the effectiveness of customized interventions across four critical areas: i) Advanced lung function testing, ii) Continuous IAQ monitoring, iii) Advanced digital support to innovative clinical processes, and iv) Predictive modeling for early identification and management of exacerbations. The ultimate objective is to design and evaluate an innovative integrated care service aiming at enhancing both IAQ and the management of multimorbid patients with chronic obstructive respiratory diseases, with focus on COPD and severe asthma.
**Detailed Description:** The study is structured as a comprehensive two-phase approach. From January to December 2024 (Phase I) the protocol focuses on the assessment, and refinement, of the four core components of the study: i) Enhanced lung function testing, ii) IAQ home monitoring, iii) Advanced digital support to innovative clinical processes, and iv) Predictive modelling for early detection and management of exacerbations. The main outcome at the end of Phase I is the design of an innovative integrated care service aiming at enhanced management of exacerbations and reduction of unplanned hospitalizations in high-risk patients.
From January to December 2025 (Phase II), the protocol aims to refine the novel clinical process, including the four core components alluded to above, as well as to evaluate the potential for healthcare value generation and scalability/transferability of the new integrated care service.
PHASE I (2024):
1. Enhanced Lung Function Testing: Adoption of oscillometry (forced oscillation technique) to measure respiratory system resistance and reactance, as a complementary tool of forced spirometry, exploring its potential for patients' monitoring and management of exacerbations.
2. Continuous Monitoring of IAQ at patients' homes: Assessment of advanced monitoring systems in patients' homes to continuously track air quality parameters, enabling the identification of environmental triggers linked to respiratory exacerbations.
3. Advanced Digital Support to innovative clinical processes with a two-fold aim: i) patient's empowerment for self-management of his/her condition, and ii) enhancing the role of the nurse case manager for early detection and management of exacerbations promoting share care agreements between the patient and the reference doctor (primary care physician and/or specialist). To this end, adoption of an Adaptive Case Management (ACM) Approach constitutes a key element.
4. Predictive Modeling: Development, and refinement, of machine learning-based modelling for early detection and management exacerbations. Key input data in the modelling approach will be: i) Clinical information (symptoms, Patient Reported Outcome Measures - PROMs), ii) Lung function testing, and iii) Patient's self-capturing physiological data through wrist sensors (health rate, heart rate variability and physical activity). Moreover, the impact of IAQ monitoring in the modelling will be explored.
The implementation, and refinement, of the four components alluded to above, as well as the design of the novel integrated care service, will be done with active engagement of patients, healthcare professionals, and other stakeholders in a co-design process using the Plan-Do-Study-Act (PDSA) methodology. Two PDSA cycles, with a six-month duration each, will be undertaken during 2024.
PHASE II (2025):
From January to December 2025, two additional PDSA cycles (six-month duration each) are planned to cover the following objectives:
1. Refinement of the novel integrated care service for enhanced management of exacerbations, as well as the implementation and continuous assessment of the four core components described in PHASE I.
2. Assessment of the outcomes of the novel integrated care service using the Quintuple Aim framework, that is, considering: i) Healthcare outcomes, ii) PROMs/Patient Reported Expirence Measures (PREMs), iii) healthcare professionals' engagement, iv) operational costs, and v) assessing equity. Comparison with conventional care will be done using a propensity score matching to elaborate a control group.
3. Evaluation of the process of deployment of the service using the Consolidated Framework for Implementation Research (CFIR) to identify barriers/facilitators for achieving a sustainable adoption, target candidates for the novel service, as well as potential for service transferability to other sites.
At the end of PHASE II, a mature service design ready for adoption should be available. Besides fulfilment of the objectives of K-Health in Air, the key lessons learned in the two-years period should provide novel insights for enhanced management of chronic patients with multimorbid conditions.
(Enclosed find: i) the Patient's Informed Consent approved by the Ethics Committee, as well as ii) the study protocol approved by the Ethics Committee of the Hosptial Clínic de Barcelona (HCB-2023-0126)).
### Conditions Module
**Conditions:**
- Severe Asthma
- COPD
**Keywords:**
- Prevention of Unplanned Hospital Admissions
- Nurse Case Manager
- COPD
- Severe Asthma
- Integrated Care
- Digital support
- Indoor Air Quality
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 200
**Type:** ESTIMATED
**Patient Registry:** True
**Study Type:** OBSERVATIONAL
**Target Duration:** 24 Months
### Arms Interventions Module
#### Arm Group 1
**Description:** The INTERVENTION (PHASE I, 2024) will have four components: i) Assessment of Lung Function Testing, ii) Monitoring of IAQ at patients' homes (and analysis of the relationships between IAQ and health events), iii) Evaluation of advanced digital support to a novel clinical process to enhance early identification and management of exacerbations (questionnaires, chat, patients' self-capturing sensors, and iv) Development, and refinement, of machine learning-based predictive modelling for supporting clinical decision making.
During PHASE II (2025), the INTERVENTION will consist of the assessment (Quintuple Aim) of the novel integrated care service, as well as the evaluation of its potential for scalability (CFIR).
See inclusion/exclusion criteria and planned measurements in the enclosed documents.
**Intervention Names:**
- Other: Air quality monitoring at patient's home
- Other: Questionnaires: Baseline & every six months
- Diagnostic Test: Lung function Testing: Baseline & every six months & during exacerbations
- Other: EMR & registry data
- Device: Communication channel - Health Circuit Mobile App (Herranz C. JMIR 2023)
- Device: Physiological data - Beat One Watch
- Device: Patient Empowerment
- Other: Characteristics of exacerbations
**Label:** Follow-up 200 high-risk chronic respiratory outpatients for 2 years.
#### Arm Group 2
**Description:** The control group will be introduced in Phase II (2025) to estimate the potential for healthcare value generation of the novel integrated care service. It will include patients with equivalent characteristics who receive standard of care practice, without the interventions carried out in the cohort group.
The control group will be shaped using 1-to-1 propensity score matching techniques. Data from the control group will be obtained from electronic medical records and registry information. In a randomly selected subset of 50 individuals from the control group a Quintuple Aim assessment will be done.
**Intervention Names:**
- Other: EMR & registry data
**Label:** Control Group
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Follow-up 200 high-risk chronic respiratory outpatients for 2 years.
**Description:** Indoor Air Quality:
- MICA-INBIOT system: temperature (ºC), humidity (%), CO2 (ppm), total Volatile Organic Ccompounds (VOCs) (ppb), Formaldehyde (µg/m3); and Particulate Matter (PM) 1/2.5/4/10 (µg/m3)
Outdoor Air Quality:
- Aeris Weather platform: NO, NO2, NOx, SO2, SO3, CO, and PM10, all expressed in µg/m3
**Name:** Air quality monitoring at patient's home
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Follow-up 200 high-risk chronic respiratory outpatients for 2 years.
**Description:** General surveys:
* PROMs: ICHOM Adult Set; encompassing Patient Reported Outcomes Measurement Information System (PROMIS 10), World Health Organization Wellbeing Index (WHO 5) and World Health Organization Disability Assessment Schedule (WHO-DAS 12) questionnaires.
* PREMs: Patient-Reported Indicator Survey (PaRIS)
Disease specific questionaires:
* COPD: COPD Assessment Test (CAT); modified Medical Research Council (mMRC) Dyspnea scale.
* Asthma: Asthma Control Test (ACT); Test of Adherence to Inhalers (TAI-12); Asthma Quality of Life Questionnaire (mini AQLQ); Sino-Nasal Outcome Test (SNOT-22).
**Name:** Questionnaires: Baseline & every six months
**Type:** OTHER
#### Intervention 3
**Arm Group Labels:**
- Follow-up 200 high-risk chronic respiratory outpatients for 2 years.
**Description:** * Forced Spirometry: Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 second (FEV1)
* Forced Oscillation Technique: Impedance, resistance and reactance.
Ancillary measurements: Systemic arterial pressure and pulse oximetry.
**Name:** Lung function Testing: Baseline & every six months & during exacerbations
**Type:** DIAGNOSTIC_TEST
#### Intervention 4
**Arm Group Labels:**
- Control Group
- Follow-up 200 high-risk chronic respiratory outpatients for 2 years.
**Description:** Electronic Medical Records (EMRs): Updated every twelve months to track clinical events from Hospital and Primary Care databases.
Registry data: from the Catalan Health Surveillance System (CHSS).
**Name:** EMR & registry data
**Type:** OTHER
#### Intervention 5
**Arm Group Labels:**
- Follow-up 200 high-risk chronic respiratory outpatients for 2 years.
**Description:** Health Circuit: chat, short questionnaires (Likert scale). As needed.
**Name:** Communication channel - Health Circuit Mobile App (Herranz C. JMIR 2023)
**Type:** DEVICE
#### Intervention 6
**Arm Group Labels:**
- Follow-up 200 high-risk chronic respiratory outpatients for 2 years.
**Description:** Enhanced with real-time physiological data tracking (heart rate, steps walked and Heart Rate Variability (HRV))
**Name:** Physiological data - Beat One Watch
**Type:** DEVICE
#### Intervention 7
**Arm Group Labels:**
- Follow-up 200 high-risk chronic respiratory outpatients for 2 years.
**Description:** Mobile App Health Circuit: follow-up of the personalized action plan agreed with the patient \& reference doctor
**Name:** Patient Empowerment
**Type:** DEVICE
#### Intervention 8
**Arm Group Labels:**
- Follow-up 200 high-risk chronic respiratory outpatients for 2 years.
**Description:** Health Circuit: home-based oscillometry, daily disease-specific questionnaire during the acute episode and continuous assessment of physiological variables.
**Name:** Characteristics of exacerbations
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Number of unplanned hospital admissions.
This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. Assessed in all individuals
**Measure:** Changes in use of healthcare resources - Unplanned hospital admissions
**Time Frame:** During 2025
**Description:** Number and severity of exacerbations.
This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. Assessed in all individuals
**Measure:** Changes in use of healthcare resources - Exacerbations
**Time Frame:** During 2025
**Description:** Number of emergency room visits.
This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. Assessed in all individuals
**Measure:** Changes in use of healthcare resources - Emergency room visits
**Time Frame:** During 2025
**Description:** Number of primary care visits.
This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. Assessed in all individuals
**Measure:** Changes in use of healthcare resources - Primary care visits.
**Time Frame:** During 2025
#### Secondary Outcomes
**Description:** Healthcare costs in €
This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. Assessed in all individuals
**Measure:** Healthcare costs
**Time Frame:** During 2025
**Description:** Enjoyment of life: ICEpop CAPability measure for Older people (ICECAP-O)
Scored on a scale from 0 to 1, where 0 represents no capability and 1 represents full capability.
This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. It will be collected across the entire intervention group and in a randomly selected subset of 50 patients from the control group.
**Measure:** Patient reported experience (PREMs) - Enjoyment of life
**Time Frame:** During 2025
**Description:** Resilience: Brief Resilience Scale (BRS)
Scores range from 1 to 5, with higher scores indicating greater resilience.
This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. It will be collected across the entire intervention group and in a randomly selected subset of 50 patients from the control group.
**Measure:** Patient reported experience (PREMs) - Resilience
**Time Frame:** During 2025
**Description:** Physical functioning: 36-Item Short Form Survey (SF-36)
Scores range from 0 to 100, where a higher score indicates better health status.
This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. It will be collected across the entire intervention group and in a randomly selected subset of 50 patients from the control group.
**Measure:** Patient reported experience (PREMs) - Physical functioning
**Time Frame:** During 2025
**Description:** Continuity of care: Nijmegen Continuity Questionnaire (NCQ)
Scores ranging on a Likert scale from 1 to 5.
This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. It will be collected across the entire intervention group and in a randomly selected subset of 50 patients from the control group.
**Measure:** Patient reported experience (PREMs) - Continuity of care
**Time Frame:** During 2025
**Description:** Physiological wellbeing: Mental Health Inventory-5 (MHI-5)
Scored on a scale of 0 to 100, where higher scores indicate better mental health.
This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. It will be collected across the entire intervention group and in a randomly selected subset of 50 patients from the control group.
**Measure:** Patient reported experience (PREMs) - Physiological wellbeing
**Time Frame:** During 2025
**Description:** Social Participation: Impact on Participation and Autonomy (IPA)
Uses a scoring system based on a Likert scale ranging from 0 to 4 where higher scores indicate greater impairment in participation and autonomy.
This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. It will be collected across the entire intervention group and in a randomly selected subset of 50 patients from the control group.
**Measure:** Patient reported experience (PREMs) - Social Participation
**Time Frame:** During 2025
**Description:** Person-centeredness: Patient Perceptions of Patient-Centeredness Questionnaire (P3CEQ)
Typically uses a Likert scale from 1 to 5, with higher scores indicating better perceptions of patient-centeredness.
This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. It will be collected across the entire intervention group and in a randomly selected subset of 50 patients from the control group.
**Measure:** Patient reported experience (PREMs) - Person-centeredness
**Time Frame:** During 2025
**Description:** Asthma symptoms: Asthma Control Test (ACT)
5 questions, each scored from 1 (poor control of asthma) to 5 (complete control of asthma). Higher scores indicate better asthma control.
This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. It will be collected across the entire intervention group and in a randomly selected subset of 50 patients from the control group.
\*Depending on whether the primary disorder is asthma or COPD
**Measure:** Patient reported outcomes (PROMs) - Asthma symptoms
**Time Frame:** During 2025
**Description:** Functional problems related to asthma: Asthma Quality of Life Questionnaire (miniAQLQ)
Designed to measure the functional problems (physical, emotional, social, and occupational) that are most troublesome to adults with asthma. It includes a series of questions scored from 1 (maximum impairment) to 7 (no impairment), with higher scores indicating better quality of life.
This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. It will be collected across the entire intervention group and in a randomly selected subset of 50 patients from the control group.
\*Depending on whether the primary disorder is asthma or COPD
**Measure:** Patient reported outcomes (PROMs) - Functional problems related to asthma
**Time Frame:** During 2025
**Description:** COPD symptoms: COPD Assessment Test (CAT)
Each question is scored from 0 (no impact) to 5 (maximum impact), with the total score ranging from 0 (less impact) to 40 (more impact), indicating the severity of COPD.
This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. It will be collected across the entire intervention group and in a randomly selected subset of 50 patients from the control group.
\*Depending on whether the primary disorder is asthma or COPD
**Measure:** Patient reported outcomes (PROMs) - COPD symptoms
**Time Frame:** During 2025
**Description:** Dyspnea: Modified Medical Research Council (mMRC) Dyspnea Scale.
It ranges from 0 (no breathlessness except with strenuous exercise) to 4 (too breathless to leave the house or breathless when dressing/undressing), with higher scores indicating more severe dyspnea.
This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. It will be collected across the entire intervention group and in a randomly selected subset of 50 patients from the control group.
\*Depending on whether the primary disorder is asthma or COPD
**Measure:** Patient reported outcomes (PROMs) - Dyspnea
**Time Frame:** During 2025
**Description:** Sino-Nasal symptoms: Sino-Nasal Outcome Test (SNOT-22)
22 items, each scored from 0 (no problem) to 5 (problem as bad as it can be). The total score can thus range from 0 (no sinus-related health problems) to 110 (severe sinus-related health problems).
This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. It will be collected across the entire intervention group and in a randomly selected subset of 50 patients from the control group.
\*Depending on whether the primary disorder is asthma or COPD
**Measure:** Patient reported outcomes (PROMs) - Sino-Nasal symptoms
**Time Frame:** During 2025
**Description:** Adherence to inhalers: Test of Adherence to Inhalers (TAI-12)
12-item questionnaire used to assess a patient's adherence to inhaler medication in respiratory diseases. Each item is scored on a 5-point scale, with higher scores indicating better adherence. The total score ranges from 12 (poor adherence) to 60 (excellent adherence).
This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. It will be collected across the entire intervention group and in a randomly selected subset of 50 patients from the control group.
\*Depending on whether the primary disorder is asthma or COPD
**Measure:** Patient reported outcomes (PROMs) - Adherence to inhalers
**Time Frame:** During 2025
**Description:** Access to the service across different population groups: age, ethnicity, gender, socioeconomic status.
This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. Assessed in all individuals
**Measure:** Equity of the intervention
**Time Frame:** During 2025
**Description:** Model accuracy, sensitivity, specificity, positive predictive value, negative predictive value, and area under the receiver operating characteristic (ROC) curve
**Measure:** Performance of Predictive Modeling for Enhanced Management of Exacerbations
**Time Frame:** During 2025
**Description:** Customer Satisfaction: Net Promoter Score (NPS)
Measures customer loyalty and satisfaction. It is derived from asking customers a single question on a 0-10 scale
Assessed in the intervention group only.
**Measure:** Performance of the digital support in terms of robustness and usability - Customer Satisfaction
**Time Frame:** During 2025
**Description:** Usability: System Usability Scale (SUS)
Scored on a scale of 0 to 100, scores above 80 is an indicator of excellent usability, while a score below 60 could be problematic and suggests that the design needs improvements.
Assessed in the intervention group only.
**Measure:** Performance of the digital support in terms of robustness and usability - Usability
**Time Frame:** During 2025
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Aged Maximum 85 years
* Diagnosed with chronic obstructive pulmonary conditions such as COPD or treatment-resistant asthma.
* Exhibiting a high burden of co-morbidities, assessed above the 80th percentile of the regional risk stratification pyramid using Adjusted Morbidity Groups (AMG) scoring.
* Residing in Barcelona-Esquerra, except for treatment-resistant asthma patients, live in any district of the city of Barcelona.
Exclusion Criteria:
* Dementia.
* Inability to perform independent daily activities.
**Maximum Age:** 85 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
**Study Population:** The study is recruiting 80% of participants from seven AISBE primary care facilities, each serving around 20,000 people. Recruitment leverages Catalan Health Surveillance System data to identify potential participants and link them with their primary care physicians, who engage with patients to assess participation willingness and ensure contact throughout follow-up. Initial contact involves a phone call from a nurse case manager to introduce the project and set up a home visit.
The remaining 20% of the cohort, consisting of patients with treatment-resistant asthma, are recruited from the outpatient Severe Asthma Clinics at Hospital Clínic de Barcelona, using a similar approach.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Barcelona
**Country:** Spain
**Facility:** Fundació de Recerca Clínic Barcelona - Institut d'Investigació Biomèdica August Pi I Sunyer (FRCB-IDIBAPS)
**Zip:** 08036
#### Overall Officials
**Official 1:**
**Affiliation:** Institut d'Investigació Biomèdica August Pi I Sunyer (FRCB-IDIBAPS)
**Name:** JOSEP ROCA TORRENT, MD, PHD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** During the entirety of the project, it is not allowed to disseminate data. Nonetheless, should a formal request be submitted, it may be permissible to disclose certain elements of the information, albeit not in its totality.
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Herranz C, Martin-Moreno Banegas L, Dana Muzzio F, Siso-Almirall A, Roca J, Cano I. A Practice-Proven Adaptive Case Management Approach for Innovative Health Care Services (Health Circuit): Cluster Randomized Clinical Pilot and Descriptive Observational Study. J Med Internet Res. 2023 Jun 14;25:e47672. doi: 10.2196/47672.
**PMID:** 37314850
**Citation:** Herranz C. A Co-Creation Process Toward Sustainable Adoption of Integrated Care for Prevention of Unplanned Hospitalizations. medRxiv. Published online January 1, 2023:2023.08.03.23293537. doi:10.1101/2023.08.03.23293537
**Citation:** Veneroni C, Valach C, Wouters EFM, Gobbi A, Dellaca RL, Breyer MK, Hartl S, Sunanta O, Irvin CG, Schiffers C, Pompilio PP, Breyer-Kohansal R. Diagnostic Potential of Oscillometry: A Population-based Approach. Am J Respir Crit Care Med. 2024 Feb 15;209(4):444-453. doi: 10.1164/rccm.202306-0975OC.
**PMID:** 37972230
**Citation:** Yamagami H, Tanaka A, Kishino Y, Mikuni H, Kawahara T, Ohta S, Yamamoto M, Suzuki S, Ohnishi T, Sagara H. Association between respiratory impedance measured by forced oscillation technique and exacerbations in patients with COPD. Int J Chron Obstruct Pulmon Dis. 2017 Dec 22;13:79-89. doi: 10.2147/COPD.S146669. eCollection 2018.
**PMID:** 29317813
**Citation:** Wu CT, Li GH, Huang CT, Cheng YC, Chen CH, Chien JY, Kuo PH, Kuo LC, Lai F. Acute Exacerbation of a Chronic Obstructive Pulmonary Disease Prediction System Using Wearable Device Data, Machine Learning, and Deep Learning: Development and Cohort Study. JMIR Mhealth Uhealth. 2021 May 6;9(5):e22591. doi: 10.2196/22591.
**PMID:** 33955840
**Citation:** Herranz C. An Adaptive Case Management Approach to Prevent Unplanned Hospital Admissions in a Care Continuum Scenario. Published online 2023.
#### See Also Links
**Label:** EU PROJECT K-HEALTH IN AIR
**URL:** https://k-healthinair.eu/
**Label:** IDIBAPS Members of \"Mecanismes fisiopatològics de les malalties respiratòries\"
**URL:** https://www.clinicbarcelona.org/ca/idibaps/arees-i-programes/biopatologia-i-bioenginyeria-respiratoria-cardiovascular-i-renal/mecanismes-fisiopatologics-de-les-malalties-respiratories/membres
## Document Section
### Large Document Module
#### Large Docs
- Date: 2023-11-30
- Filename: Prot_000.pdf
- Has ICF: False
- Has Protocol: True
- Has SAP: False
- Label: Study Protocol
- Size: 1027016
- Type Abbrev: Prot
- Upload Date: 2024-04-29T12:42
- Date: 2023-11-08
- Filename: ICF_001.pdf
- Has ICF: True
- Has Protocol: False
- Has SAP: False
- Label: Informed Consent Form
- Size: 232490
- Type Abbrev: ICF
- Upload Date: 2024-05-07T03:43
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001982
- Term: Bronchial Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
- ID: D000008173
- Term: Lung Diseases, Obstructive
- ID: D000008171
- Term: Lung Diseases
- ID: D000012130
- Term: Respiratory Hypersensitivity
- ID: D000006969
- Term: Hypersensitivity, Immediate
- ID: D000006967
- Term: Hypersensitivity
- ID: D000007154
- Term: Immune System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M4556
- Name: Asthma
- Relevance: HIGH
- As Found: Asthma
- ID: M5258
- Name: Bronchial Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M11168
- Name: Lung Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M11170
- Name: Lung Diseases, Obstructive
- Relevance: LOW
- As Found: Unknown
- ID: M10018
- Name: Hypersensitivity
- Relevance: LOW
- As Found: Unknown
- ID: M14967
- Name: Respiratory Hypersensitivity
- Relevance: LOW
- As Found: Unknown
- ID: M10020
- Name: Hypersensitivity, Immediate
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001249
- Term: Asthma
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M8681
- Name: Formaldehyde
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06421389
**Brief Title:** Precise Endoscopic Application of Tranexamic Acid and Sucralfate in Gastrointestinal Bleeding: A Randomized Controlled Trial
**Official Title:** Precise Endoscopic Application of Tranexamic Acid and Sucralfate in Gastrointestinal Bleeding: A Randomized Controlled Trial
#### Organization Study ID Info
**ID:** B-BR-113-014
#### Organization
**Class:** OTHER
**Full Name:** National Cheng-Kung University Hospital
### Status Module
#### Completion Date
**Date:** 2025-07-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-14
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-07-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-15
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** National Cheng-Kung University Hospital
#### Responsible Party
**Investigator Affiliation:** National Cheng-Kung University Hospital
**Investigator Full Name:** Hsueh-Chien Chiang
**Investigator Title:** Attending physician
**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:** Background and Aim: Gastrointestinal bleeding (GIB) is a common problem in the hospital. GIB can be divided into upper GIB, small bowel bleeding, and lower GIB. Endoscopic hemostasis includes epinephrine injection, hemoclipping, heat probe coagulation, and Argon plasma coagulation. Although the successful hemostasis rate is high, recurrent bleeding can occur, ranging from 10% to 50% according to the bleeding etiology. Therefore, how to reduce the rebleeding of GIB is an important clinical issue.
Methods: This is a randomized clinical trial. Patients with gastrointestinal bleeding for endoscopy screening and treatment at National Cheng Kung University Hospital were enrolled. The study will recruit 60 patients. After randomization, 30 patients will be classified into the intervention group and 30 into the control group. The participants will receive standard endoscopic hemostasis by either local injection of diluted epinephrine, heater probe coagulation, hemoclipping, or band ligation. After then, we will spray 2g of sucralfate powder and 1g of tranexamic acid through duodenoscopy precisely on the bleeding site in the intervention group. All enrolled patients will be monitored for rebleeding for 28 days after the first endoscopy.
**Detailed Description:** Gastrointestinal bleeding (GIB) is a common problem in the hospital. The annual rate of hospitalization for any type of GI hemorrhage is estimated to be 350 hospital admissions/100,000 population. GIB can be divided into upper GIB, small bowel bleeding, and lower GIB. Approximately 50% of admissions for GIB are for UGI bleeding (from the esophagus, stomach, and duodenum), 40% are for LGI bleeding (from the colon and anorectum), and 10% are for small intestine bleeding. Ulceration bleeding, variceal bleeding, angiodysplasia, Dieulafoy lesion, and tumor bleeding are common cause for UGIB, while diverticulosis, colitis, angioectasia, cancer bleeding, and polypectomy ulcer attribute to the LGIB. GI endoscopy can identify the bleeding site and permit therapeutic hemostasis in most patients with GI bleeding.
Endoscopic hemostasis includes epinephrine injection, hemoclipping, heat probe coagulation, and Argon plasma coagulation. Although the successful hemostasis rate is high, recurrent bleeding can occur, ranging from 10% to 50% according to the bleeding etiology. Therefore, how to reduce the rebleeding of GIB is an important clinical issue.
Tranexamic acid (TXA) is a well-known antifibrinolytic agent that inhibits fibrin degradation by binding to tissue plasminogen, thereby preventing blood clot lysis and reducing bleeding. A recent study evaluating the effect of topical tranexamic acid (TXA) powder on bleeding peptic ulcers demonstrated that the precise endoscopic administration of TXA powder can enhance the stop-bleeding effect.
Sucralfate, a complex of aluminum hydroxide and sucrose octa sulfate, can bind to the wound base. This protective barrier can prevent the wound from further environmental injury. Sucralfate has been widely used for wounds and ulcer treatment, e.g., skin wounds, oral ulcers, and peptic ulcers. With the protective effect of the papilla mucosa, sucralfate can cover the wound and has the potential to avoid further environmental damage. In combination with TXA powder in stabilizing the clotting, we expect the rebleeding event will reduce. Therefore, this study aimed to investigate whether the combination therapy of topical administration of TXA and sucralfate after standard endoscopic hemostasis can reduce the rebleeding event.
Furthermore, the adhesion time of the hemostasis powder at the bleeding site is also an unknown issue. High-dose barium enema use provides better clinical outcomes for initial hemostasis and long-term prevention of rebleeding than conservative therapy in LGIB. In combination of barium, the position of hemostasis powder can be identified by Xray.
Subjects and protocols Participants will be recruited from the volunteers with gastrointestinal bleeding at National Cheng Kung University Hospital. Eligible participants include patients aged ≥ 18 years who accept endoscopy for GIB, including hematemesis, Tarry stool, or bloody stool. Patient consent forms will be given and explained to all patients before the endoscopy. Exclusion criteria include patients with no need of endoscopic hemostasis, allergy to sucralfate, tranexamic acid, or barium, pregnancy, and patients with hollow organ perforation. After patient enrollment, we will randomize the patient into either the intervention group or control group by sealed envelope randomization method.
After the standard endoscopic hemostasis by either epinephrine injection, hemoclipping, heat coagulation, or band ligation, we will randomly assign the patients to either a control or an intervention group. After then, we will spray 2g of sucralfate powder, 1g of tranexamic acid powder, and 1g of barium through the endoscopy precisely on the bleeding site in the intervention group.
Blood tests As ward routine for bleeding patient, a blood sample is obtained to measure creatinine, albumin, total bilirubin, hemoglobin, platelet, prothrombin time (PT), and activated partial thromboplastin time (APTT). All lab data are checked by the central laboratory of the National Cheng Kung University Hospital.
### Conditions Module
**Conditions:**
- Bleed Ulcer
**Keywords:**
- Bleeding ulcer
- Sulcralfate
- Tranexamic acid
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** All patients will receive the standard endoscopic hemostasis by either epinephrine injection, hemoclipping, heat coagulation, or band ligation. After then, patients in intervention group will receive 2g of sucralfate powder, 1g of tranexamic acid powder, and 1g of barium spray through the endoscopy precisely on the bleeding site.
**Intervention Names:**
- Drug: Tranexamic Acid Powder
**Label:** Intervention group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** All patients will receive the standard endoscopic hemostasis by either epinephrine injection, hemoclipping, heat coagulation, or band ligation.
**Label:** Control group
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Intervention group
**Description:** 2g of sucralfate powder, 1g of tranexamic acid powder, and 1g of barium will be sprayed through the endoscopy precisely on the bleeding site
**Name:** Tranexamic Acid Powder
**Other Names:**
- sucralfate powder
- barrium sulfate powder
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Recurrent bleeding was defined as remarkable hematochezia or Tarry stool with endoscopic evidence of the same site bleeding.
**Measure:** the recurrent rate of GI bleeding during the study period
**Time Frame:** 28 days
#### Secondary Outcomes
**Description:** rebleeding requiring transarterial embolization or emergency surgery
**Measure:** the rate of rebleeding requiring transarterial embolization or emergency surgery
**Time Frame:** 28 days
**Description:** length of hospitalization
**Measure:** length of hospitalization
**Time Frame:** 28 days
**Description:** all-cause mortality
**Measure:** all-cause mortality rate
**Time Frame:** 28 days
**Description:** adverse events from powder spray, such as perforation or thrombotic events
**Measure:** adverse events rate from powder spray
**Time Frame:** 28 days
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Eligible participants include patients aged ≥ 18 years who accept endoscopy for GIB, including hematemesis, Tarry stool, or bloody stool
Exclusion Criteria:
* no need of endoscopic hemostasis
* allergy to sucralfate, tranexamic acid, or barium
* pregnancy
* patients with hollow organ perforation
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Hsueh-Chien Chiang, M.D.
**Phone:** 062353535
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Xi-Zhang Lin, M.D.
**Phone:** 062353535
**Role:** CONTACT
### IPD Sharing Statement Module
**Description:** The IPD will be shared once the trial completed and study published
**IPD Sharing:** UNDECIDED
### References Module
#### References
**Citation:** Saydam SS, Molnar M, Vora P. The global epidemiology of upper and lower gastrointestinal bleeding in general population: A systematic review. World J Gastrointest Surg. 2023 Apr 27;15(4):723-739. doi: 10.4240/wjgs.v15.i4.723.
**PMID:** 37206079
**Citation:** Chiang HC, Chen PJ, Yang EH, Hsieh MT, Shih IC, Cheng HC, Chang WL, Chen WY, Chiu HC, Kuo HY, Tsai WC, Lo YN, Yang KC, Chiang CM, Chen WC, Huang KK, Tseng HH, Chen CY, Lin XZ, Chuang CH. Precise application of topical tranexamic acid to enhance endoscopic hemostasis for peptic ulcer bleeding: a randomized controlled study (with video). Gastrointest Endosc. 2023 Nov;98(5):755-764. doi: 10.1016/j.gie.2023.06.013. Epub 2023 Jun 24.
**PMID:** 37356632
**Citation:** Masuelli L, Tumino G, Turriziani M, Modesti A, Bei R. Topical use of sucralfate in epithelial wound healing: clinical evidences and molecular mechanisms of action. Recent Pat Inflamm Allergy Drug Discov. 2010 Jan;4(1):25-36. doi: 10.2174/187221310789895649.
**PMID:** 19832693
**Citation:** Nagata N, Niikura R, Shimbo T, Ishizuka N, Yamano K, Mizuguchi K, Akiyama J, Yanase M, Mizokami M, Uemura N. High-dose barium impaction therapy for the recurrence of colonic diverticular bleeding: a randomized controlled trial. Ann Surg. 2015 Feb;261(2):269-75. doi: 10.1097/SLA.0000000000000658. Erratum In: Ann Surg. 2016 Mar;263(3):e58.
**PMID:** 25569028
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010335
- Term: Pathologic Processes
- ID: D000005767
- Term: Gastrointestinal Diseases
- ID: D000004066
- Term: Digestive System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC06
- Name: Digestive System Diseases
### Condition Browse Module - Browse Leaves
- ID: M9556
- Name: Hemorrhage
- Relevance: HIGH
- As Found: Bleeding
- ID: M9557
- Name: Gastrointestinal Hemorrhage
- Relevance: HIGH
- As Found: Gastrointestinal Bleeding
- ID: M17206
- Name: Ulcer
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000006471
- Term: Gastrointestinal Hemorrhage
- ID: D000006470
- Term: Hemorrhage
### Intervention Browse Module - Ancestors
- ID: D000000933
- Term: Antifibrinolytic Agents
- ID: D000050299
- Term: Fibrin Modulating Agents
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000006490
- Term: Hemostatics
- ID: D000003029
- Term: Coagulants
- ID: D000000897
- Term: Anti-Ulcer Agents
- ID: D000005765
- Term: Gastrointestinal Agents
### Intervention Browse Module - Browse Branches
- Abbrev: VaCoAg
- Name: Vasoconstrictor Agents
- Abbrev: Resp
- Name: Respiratory System Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Coag
- Name: Coagulants
- Abbrev: Gast
- Name: Gastrointestinal Agents
### Intervention Browse Module - Browse Leaves
- ID: M7992
- Name: Epinephrine
- Relevance: LOW
- As Found: Unknown
- ID: M16902
- Name: Tranexamic Acid
- Relevance: HIGH
- As Found: Stage IV
- ID: M16179
- Name: Sucralfate
- Relevance: HIGH
- As Found: Adjunct Therapy
- ID: M9576
- Name: Hemostatics
- Relevance: LOW
- As Found: Unknown
- ID: M30371
- Name: Racepinephrine
- Relevance: LOW
- As Found: Unknown
- ID: M211043
- Name: Epinephryl borate
- Relevance: LOW
- As Found: Unknown
- ID: M4252
- Name: Antifibrinolytic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M6259
- Name: Coagulants
- Relevance: LOW
- As Found: Unknown
- ID: M4188
- Name: Antacids
- Relevance: LOW
- As Found: Unknown
- ID: M4219
- Name: Anti-Ulcer Agents
- Relevance: LOW
- As Found: Unknown
- ID: M8881
- Name: Gastrointestinal Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000013392
- Term: Sucralfate
- ID: D000014148
- Term: Tranexamic Acid
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06421376
**Brief Title:** Induction Chemoimmunotherapy Combined With Chemoradiotherapy in Esophageal Cancer
**Official Title:** Efficacy and Safety of Inductive Chemoimmunotherapy Followed by Chemoradiotherapy With or Without Surgery in Locally Advanced Esophageal Squamous Cell Cancer: a Single-arm, Prospective, Phase II Trial
#### Organization Study ID Info
**ID:** NCC4475
#### Organization
**Class:** OTHER
**Full Name:** Cancer Institute and Hospital, Chinese Academy of Medical Sciences
### Status Module
#### Completion Date
**Date:** 2027-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-14
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2026-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Cancer Institute and Hospital, Chinese Academy of Medical Sciences
#### Responsible Party
**Investigator Affiliation:** Cancer Institute and Hospital, Chinese Academy of Medical Sciences
**Investigator Full Name:** Jianjun Qin
**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:** Although unprecedented advances have been made in the field of esophageal cancer in recent decades, the prognosis for patients with locally advanced esophageal squamous cell carcinoma (ESCC) remains extremely poor, accounting for 30-40% of overall survival at 5 year. In recent years, multimodal treatments have proven to be an appropriate therapeutic approach for locally advanced ESCC. Recently, immunotherapy developed rapidly. The purpose of this study was to observe the efficacy and safety of cardonilizumab combined with chemoradiotherapy in the treatment of locally advanced ESCC.
### Conditions Module
**Conditions:**
- Esophageal Cancer
- Immunotherapy
- Induction Therapy
- Chemoradiotherapy
- Surgery
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** In this group, the patients were given 2 cycles of inductive therapy of cardonilizumab combined with chemotherapy, followed by concurrent chemoradiotherapy with two cycles of nab-paclitaxel and cisplatin plus radiotherapy of 50-50.4 Gy. After clinical evaluation, surgery was feasible for a part of patients.
**Intervention Names:**
- Drug: Cardonilizumab
- Radiation: Chemoradiotherapy ±immunotherapy
- Procedure: Radical surgery
**Label:** Inductive chemoimmunotherapy+chemoradiotherapy±surgery
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Inductive chemoimmunotherapy+chemoradiotherapy±surgery
**Description:** Two cycles of Inductive therapy： nab-paclitaxel 250mg/ m2+cisplatin 75mg/ m2+Cardonilizumab 10mg/kg，ivgtt，3 weeks per cycle for 2 cycles
**Name:** Cardonilizumab
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Inductive chemoimmunotherapy+chemoradiotherapy±surgery
**Description:** Chemoradiotherapy ± immunotherapy：
* PTV: 50-50.4Gy/1.8-2Gy/25-28fractions ②nab-paclitaxel 100mg+cisplatin 25mg/ m2, d1, every 7 days for 3-5 weeks ③Cardonilizumab 10mg/kg，ivgtt，3 weeks per cycle for 2 cycles
**Name:** Chemoradiotherapy ±immunotherapy
**Type:** RADIATION
#### Intervention 3
**Arm Group Labels:**
- Inductive chemoimmunotherapy+chemoradiotherapy±surgery
**Description:** Surgery was evaluated after concurrent chemoradiotherapy according to patients willing and the surgeons' assessment. If patients were accessed with unresectable disease after radiotherapy or refused to receive surgery, Cardonilizumab would be administered for 2 years or until disease progression.
**Name:** Radical surgery
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** Time from treatment initiation to locoregional or distant recurrence, or death from any cause.
**Measure:** Event-free survival
**Time Frame:** 1-year
#### Secondary Outcomes
**Description:** The 1-year OS rate was defined as the proportion of patients who still alive within one year from treatment initiation.
**Measure:** Overall survival
**Time Frame:** 1-year
**Description:** In terms of adverse events of radiation, chemotherapy and immunotherapy
**Measure:** Adverse events
**Time Frame:** 1-year
**Description:** The 1-year rate was defined as the proportion of patients who did not have any locoregional recurrence from treatment initiation.
**Measure:** Locoregional recurrence free survival
**Time Frame:** 1-year
**Description:** The 1-year rate was defined as the proportion of patients who did not have any distant metastasis from treatment initiation.
**Measure:** Distant metastasis free survival
**Time Frame:** 1-year
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* 18-80 years old；
* Eligible patients were histologically confirmed esophageal squamous cell carcinoma;
* Eligible patients were proven locally advanced ESCC (cT1-2N1-3M0-1, cT3/T4N0-3M0-1, M1 was limited to supraclavicular lymph node metastasis）diagnosed by computed tomography \[CT\] and/or endoscopic ultrasonography \[EUS\] according to the American Joint Committee on Cancer (AJCC) 8th edition staging system；
* ECOG PS score: 0\~1；
* Main organs and bone marrow function are normal: routine blood tests: hemoglobin (Hb) ≥100g/L ; absolute neutrophil count (NEUT)≥1.5×109/L; platelets (PLT) ≥100×109/L; white blood cell (WBC)≥3.5×109/L,biochemical examination: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5×UNL; serum total bilirubin (TBIL) ≤1.5×UNL; serum creatinine ( Cr) 1.0×1.5UNL, and BUN≤1.0×UNL;
Exclusion Criteria:
* Those combined with other primary malignant tumors other than esophageal cancer (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
* patients who had previously received other treatments
* At the time of diagnosis, there were distant and hematogenous metastases beyond the supraclavicular lymph node region, including retroperitoneal multiple lymph node metastasis, bone metastasis, brain metastasis, lung metastasis, liver metastasis, malignant pleural effusion and ascites
* Those who already have esophageal perforation or are at high risk of esophageal perforation
* Patients whose tumors invade close to large blood vessels and are at risk of bleeding in the
* there are active infections, such as active tuberculosis and hepatitis
* There are contraindications to immunotherapy.
* Pregnant or lactating women and women of childbearing age do not take reliable contraceptive measures
* Combined with serious cardiovascular diseases, such as uncontrolled heart failure, coronary heart disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or a history of myocardial infarction within the past 6 months; and those combined with other uncontrolled acute and chronic diseases such as hypertension and diabetes.
* Violation of inclusion and exclusion criteria, or other reasons that the researcher believes cannot continue the study of drug treatment.
**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:** Xin Wang, M.D.
**Phone:** +861013311583220
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Anyang
**Contacts:**
***Contact 1:***
- **Name:** Xiaomin Wang, M.D.
- **Role:** CONTACT
**Country:** China
**Facility:** Anyang Cancer Hospital
**State:** Henan
**Status:** NOT_YET_RECRUITING
**Location 2:**
**City:** Xinxiang
**Contacts:**
***Contact 1:***
- **Name:** Xiaomei Liu, M.D.
- **Role:** CONTACT
**Country:** China
**Facility:** The First Affiliated Hospital of Xinxiang Medical University
**State:** Henan
**Status:** NOT_YET_RECRUITING
**Location 3:**
**City:** Beijing
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Xin Wang, MD
- **Phone:** +861013311583220
- **Role:** CONTACT
**Country:** China
**Facility:** Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)
**Status:** RECRUITING
**Zip:** 100021
#### Overall Officials
**Official 1:**
**Affiliation:** Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)
**Name:** Xin Wang
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000005770
- Term: Gastrointestinal Neoplasms
- ID: D000004067
- Term: Digestive System Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000006258
- Term: Head and Neck Neoplasms
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000004935
- Term: Esophageal Diseases
- ID: D000005767
- Term: Gastrointestinal Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: All
- Name: All Conditions
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M5550
- Name: Carcinoma, Squamous Cell
- Relevance: LOW
- As Found: Unknown
- ID: M1733
- Name: Esophageal Squamous Cell Carcinoma
- Relevance: LOW
- As Found: Unknown
- ID: M8088
- Name: Esophageal Neoplasms
- Relevance: HIGH
- As Found: Esophageal Cancer
- ID: M8886
- Name: Gastrointestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M7256
- Name: Digestive System Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M9348
- Name: Head and Neck Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8085
- Name: Esophageal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T2141
- Name: Esophageal Cancer
- Relevance: HIGH
- As Found: Esophageal Cancer
### Condition Browse Module - Meshes
- ID: D000004938
- Term: Esophageal Neoplasms
### Intervention Browse Module - Ancestors
- ID: D000007155
- Term: Immunologic Factors
- ID: D000045505
- Term: Physiological Effects of Drugs
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M19537
- Name: Paclitaxel
- Relevance: LOW
- As Found: Unknown
- ID: M231
- Name: Albumin-Bound Paclitaxel
- Relevance: LOW
- As Found: Unknown
- ID: M6182
- Name: Cisplatin
- Relevance: LOW
- As Found: Unknown
- ID: M2853
- Name: Immunomodulating Agents
- Relevance: HIGH
- As Found: Immediately
- ID: M10201
- Name: Immunologic Factors
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000091369
- Term: Immunomodulating Agents
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06421363
**Acronym:** CAPRICI
**Brief Title:** Continuity of Care Between Primary Care Cardiology and Specialty Services for Patients With Chronic Ischemic Heart Disease
**Official Title:** Continuity of Care Between Primary Care Cardiology and Specialty Services for Patients With Chronic Ischemic Heart Disease
#### Organization Study ID Info
**ID:** CORONARIA 1/2023
#### Organization
**Class:** OTHER
**Full Name:** Hospital Clinico Universitario de Santiago
### Status Module
#### Completion Date
**Date:** 2027-08-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-14
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-06-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-24
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Jose Seijas Amigo
#### Responsible Party
**Investigator Affiliation:** Hospital Clinico Universitario de Santiago
**Investigator Full Name:** Jose Seijas Amigo
**Investigator Title:** PhD MS Pharmacy. Head of Clinical Trial Unit of Cardiology
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** 1.1. Background Cardiovascular disease (CVD) remains the leading cause of death in our country for over four decades. The pathophysiology of CVD begins with various cardiovascular risk factors (CRFs) and their poor management, leading to subclinical lesions in target organs such as albuminuria or left ventricular hypertrophy, which may evolve into CVD. This progression is referred to as the cardiovascular continuum. Patients with chronic cardiovascular conditions require comprehensive periodic health monitoring in primary care (PC), including lifestyle advice and an assessment of comorbidities. Risk factors linked to disease progression are monitored and managed, along with medication reconciliation and planning follow-up care. Such activities, especially post-COVID, help maintain clinical stability and organize healthcare demand, reducing unnecessary interventions and costs. In Galicia, continuity of care programs for ischemic heart disease focus on optimizing service delivery at appropriate levels, including electronic consultations that improve healthcare accessibility, outcomes, and cost-effectiveness. Introducing Inclisiran for chronic CVD patients post-acute coronary syndrome (ACS) hospitalization might streamline care continuity, reducing healthcare costs and improving outcomes.
1.2. Purpose The disruption of care continuity in patients post-ACS increases their risk of mortality and hospitalizations due to coronary complications and comorbidities, as well as emergency visits and unplanned healthcare interactions, thus elevating healthcare costs. We propose reorganizing care continuity for ACS patients by establishing a PC pathway with scheduled semi-annual visits to assess overall and cardiovascular health and to evaluate patient prognosis and healthcare resource utilization.
2. Objectives 2.1. Primary Objectives The main goal is to evaluate whether a follow-up program incorporating Inclisiran treatment in patients with chronic coronary syndrome can optimize follow-up (reducing unscheduled visits to PC and hospital emergency departments), improve control of risk factors (like physical activity, adherence to a Mediterranean diet, lipid profiles, blood pressure, glycemic profile, and renal function), and decrease direct economic costs.
2.2. Secondary Objectives The secondary objectives include analyzing adherence to prescribed chronic pharmacological treatment, factors driving higher demand among patients with chronic coronary syndrome, reasons for emergency visits, hospital admissions, and causes of mortality among these patients.
3. Methodology 3.1. Study Design A pilot, multicentric, analytical intervention study will be conducted involving five health centers in the Santiago de Compostela health area, with specific inclusion and exclusion criteria outlined. The study will monitor patients over 27 months, following a detailed protocol.
### Conditions Module
**Conditions:**
- Ischemic Heart Disease
- Acute Coronary Syndrome
**Keywords:**
- inclisiran
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 50
**Type:** ESTIMATED
**Phases:**
- PHASE4
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Label:** CONTROL GROUP
**Type:** NO_INTERVENTION
#### Arm Group 2
**Intervention Names:**
- Drug: Inclisiran
**Label:** INTERVENTIONAL GROUP
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- INTERVENTIONAL GROUP
**Description:** Implementation of a follow-up program that incorporates Inclisiran treatment in patients with a history of chronic coronary syndrome
**Name:** Inclisiran
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Number of unplanned visits for patients with chronic coronary syndrome in family medicine, nursing, telemedicine, and hospital consultations during follow-up.
**Measure:** Change in Unplanned Medical Visits
**Time Frame:** 2 YEARS
**Description:** Change in adherence to the Mediterranean diet using the validated questionnaire PREDIMED. The test consists of 14 questions, in which the higher the score, the better the relationship with a healthy life.
TOTAL SCORE: \< 9 low adherence \>= 9 good adherence to the Mediterranean diet
**Measure:** Variation in Adherence to the Mediterranean Diet
**Time Frame:** 2 YEARS
**Description:** Change in LDL cholesterol levels in mg/dL from baseline to follow-up. Unit of Measure: mg/dL
**Measure:** Change in Lipid Profile.
**Time Frame:** 2 YEARS
**Description:** Change in systolic/diastolic blood pressure (specify how it's measured, e.g., mmHg).
Unit of Measure: mmHg.
**Measure:** Change in Blood Pressure
**Time Frame:** 2 YEARS
#### Secondary Outcomes
**Description:** Adherence to medication, measured as the proportion of days covered (PDC) based on the total number of days medications were supplied through the electronic prescription system.
Unit of Measure: Percentage (%) Calculation of the PDC for a specific drug: The numerator represents the total number of days a drug was supplied between the first and last electronic prescription picked up (a + b + c + d). The denominator represents the total number of days in the interval (from x to t). PDC: proportion of days covered.
**Measure:** Adherence to Medication
**Time Frame:** 2 YEARS
**Description:** Outcome Measure: Number of hospital emergency attendances during the study period.
Unit of Measure: Number of attendances.
**Measure:** Emergency Room Attendances
**Time Frame:** 2 YEARS
**Description:** Hospital Admissions Description: Number of hospital admissions related to cardiovascular disease Unit of Measure: Number of admissions Mortality Description: Number of deaths and primary cause during the study period. Unit of Measure: Number of admissions
**Measure:** Patient Prognosis
**Time Frame:** 2 YEARS
**Description:** Physical Activity Description: Change in physical activity, assessed via a validated questionnaire SF-36 Unit of Measure: Score on the questionnaire.
Scale Details:
Full Scale Name: Short Form (36) Health Survey Scale Range: The SF-36 scale typically ranges from 0 to 100. Interpretation: Higher scores indicate a better quality of life and health status.
**Measure:** Change in Patient Risk Factors
**Time Frame:** 2 YEARS
**Description:** Costs associated with unplanned medical visits, adherence, hospitalizations, and medication adherence.
Unit of Measure: Cost (currency)
**Measure:** Cost Analysis
**Time Frame:** 2 YEARS
**Description:** Outcome Measure: Number of unplanned nursing consultations in primary care.
Unit of Measure: Number of consultations.
**Measure:** Healthcare Organization 1
**Time Frame:** 2 years
**Description:** Outcome Measure: Number of unplanned family doctor consultations in primary care.
Unit of Measure: Number of consultations.
**Measure:** Healthcare Organization 2
**Time Frame:** 2 yeras
**Description:** Outcome Measure: Number of attendances at continuous care points in primary care.
Unit of Measure: Number of attendances.
**Measure:** Healthcare Organization 3
**Time Frame:** 2 years
**Description:** Outcome Measure: Number of telemedicine hospital consultations.
Unit of Measure: Number of consultations.
**Measure:** Healthcare Organization 4
**Time Frame:** 2 yeras
**Description:** Outcome Measure: Number of in-person hospital consultations.
Unit of Measure: Number of consultations.
**Measure:** Healthcare Organization 5
**Time Frame:** 2 years
**Description:** Outcome Measure: Number of hospital emergency attendances.
Unit of Measure: Number of attendances.
**Measure:** Healthcare Organization 5
**Time Frame:** 2 years
**Description:** Outcome Measure: Lab samples results.
Unit of Measure: Specific measure (e.g., mg/dL for cholesterol).
**Measure:** Lab samples results
**Time Frame:** 2 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Age ≥18 years
2. Prior diagnosis of chronic coronary disease
At least one of the following:
1. Type 2 diabetes mellitus
2. Familial hypercholesterolemia
3. Recurrent coronary disease
4. Chronic kidney disease
3. Currently undergoing pharmacological treatment with high-potency statins, with or without ezetimibe. The allowed statins and daily doses are:
1. Atorvastatin 80mg
2. Rosuvastatin 20mg
3. Rosuvastatin 40mg
4. Patients on other statins or lower doses are acceptable if there has been documented intolerance to the specified molecules and doses.
4. Blood analysis with a lipid profile in the last 6 months and with the current treatment showing LDL levels \>100mg/dl.
Exclusion Criteria:
1. Not receiving statins in the therapeutic regimen.
2. Concomitant treatment with PCSK9 inhibitors.
3. Pregnancy, breastfeeding, or a desire to conceive by the patient.
4. Patients who, in the opinion of the investigator, are unable to adequately follow up in the chronic care program under routine clinical practice.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** SERGIO CINZA SANJURJO, PHD MD
**Phone:** +34915002171
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** JOSE SEIJAS AMIGO, PhD MS Pharm
**Phone:** +34981955764
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** A Estrada
**Contacts:**
***Contact 1:***
- **Name:** DANIEL REY ALDANA
- **Role:** CONTACT
***Contact 2:***
- **Name:** DANIEL REY ALDANA
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Spain
**Facility:** Cenro de Salud de La Estrada
**State:** A Coruña
**Location 2:**
**City:** Ames
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** SERGIO CINZA
- **Role:** CONTACT
***Contact 2:***
- **Name:** SERGIO CINZA SANJURJO
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 3:***
- **Name:** ANDREA GRELA BEIROA
- **Role:** SUB_INVESTIGATOR
**Country:** Spain
**Facility:** Centro de Salud de Milladoiro
**State:** A Coruña
**Location 3:**
**City:** Ribeira
**Contacts:**
***Contact 1:***
- **Name:** ISABEL REGO
- **Role:** CONTACT
***Contact 2:***
- **Name:** ISABEL REGO
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 3:***
- **Name:** ANA SUAREZ DIOS
- **Role:** SUB_INVESTIGATOR
**Country:** Spain
**Facility:** Centro de Salud de Ribeira
**State:** A Coruña
**Location 4:**
**City:** Santiago De Compostela
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** JOSE RAMON GONZALEZ JUNATEY
- **Phone:** +34981950000
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** JOSE SEIJAS AMIGO
- **Phone:** +34981955764
- **Role:** CONTACT
***Contact 3:***
- **Name:** JOSE RAMON GONZALEZ JUANATEY
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 4:***
- **Name:** JOSE SEIJAS AMIGO
- **Role:** SUB_INVESTIGATOR
***Contact 5:***
- **Name:** PILAR MAZON RAMOS
- **Role:** SUB_INVESTIGATOR
***Contact 6:***
- **Name:** PALOMA SEMPERE
- **Role:** SUB_INVESTIGATOR
***Contact 7:***
- **Name:** FRANCISCO REYES SANTÍAS
- **Role:** SUB_INVESTIGATOR
**Country:** Spain
**Facility:** Hospital Clinico Univesitario de Santiago de Compostela
**State:** A Coruña
**Zip:** 15706
**Location 5:**
**City:** Melide
**Contacts:**
***Contact 1:***
- **Name:** MONICA BARRAL CARREGAL
- **Role:** CONTACT
***Contact 2:***
- **Name:** MONICA BARRAL CARREGAL
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Spain
**Facility:** Centro de Salud de Melide
**Location 6:**
**City:** Pontevedra
**Contacts:**
***Contact 1:***
- **Name:** TERESA FERREIRO
- **Role:** CONTACT
***Contact 2:***
- **Name:** TERESA FERREIRO
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Spain
**Facility:** Centro de Salud A Cañiza
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010335
- Term: Pathologic Processes
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000014652
- Term: Vascular Diseases
- ID: D000003327
- Term: Coronary Disease
- ID: D000001161
- Term: Arteriosclerosis
- ID: D000001157
- Term: Arterial Occlusive Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M10543
- Name: Ischemia
- Relevance: HIGH
- As Found: Ischemic
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M6546
- Name: Coronary Artery Disease
- Relevance: HIGH
- As Found: Ischemic Heart Disease
- ID: M9419
- Name: Heart Diseases
- Relevance: HIGH
- As Found: Heart Disease
- ID: M19506
- Name: Myocardial Ischemia
- Relevance: HIGH
- As Found: Ischemic Heart Disease
- ID: M27545
- Name: Acute Coronary Syndrome
- Relevance: HIGH
- As Found: Acute Coronary Syndrome
- ID: M6549
- Name: Coronary Disease
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M4469
- Name: Arteriosclerosis
- Relevance: LOW
- As Found: Unknown
- ID: M4465
- Name: Arterial Occlusive Diseases
- Relevance: LOW
- As Found: Unknown
- ID: 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: D000006331
- Term: Heart Diseases
- ID: D000054058
- Term: Acute Coronary Syndrome
- ID: D000017202
- Term: Myocardial Ischemia
- ID: D000003324
- Term: Coronary Artery Disease
- ID: D000007511
- Term: Ischemia
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06421350
**Brief Title:** Closed Loop Spinal Cord Stimulation for Complex Regional Pain Syndrome
**Official Title:** Efficacy of Closed-Loop Spinal Cord Stimulation for Complex Regional Pain Syndrome
#### Organization Study ID Info
**ID:** 24-8347
#### Organization
**Class:** OTHER
**Full Name:** Scripps Health
### Status Module
#### Completion Date
**Date:** 2026-06
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-15
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-06
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-08
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Scripps Health
#### Responsible Party
**Investigator Affiliation:** Scripps Health
**Investigator Full Name:** David Hiller, MD
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** True
**Is FDA Regulated Drug:** False
**Is US Export:** False
### Description Module
**Brief Summary:** The primary purpose of this study is to determine the differences in response to treatment of complex regional pain syndrome with a closed-loop spinal cord stimulator if applied in the early phases (acute or subacute) versus the chronic phase.
**Detailed Description:** After being informed about the study and the potential risks, all patients given written informed consent will be organized into group 1 (acute or subacute) and group 2 (chronic). They will undergo a trial period with a temporary spinal cord stimulator for 7 days. After the trial period, if the provider determines the device improved the patient's pain and function, the permanent device will be implanted. The patient will fill out an outcomes packet at baseline, end of trial period, 3 months and 6 months. There will also be a blood draw to evaluate prolactin levels, which are associated with stress and pain, at baseline, end of trial period, and 3 months.
### Conditions Module
**Conditions:**
- Complex Regional Pain Syndromes
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 32
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants diagnosed with acute and subacute phases of CRPS will be assigned to this group.
**Intervention Names:**
- Device: Spinal Cord Stimulation Device
**Label:** Acute and Subacute Phases of CRPS
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants diagnosed with chronic CRPS will be assigned to this group.
**Intervention Names:**
- Device: Spinal Cord Stimulation Device
**Label:** Chronic Phase of CRPS
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Acute and Subacute Phases of CRPS
- Chronic Phase of CRPS
**Description:** The closed-loop spinal cord stimulation mechanism uses dynamic adjusting stimulation parameters based on real-time physiologic response and is uniquely positioned to mitigate the aberrant inflammatory and neurosensory processing and autonomic dysfunction driving CRPS and its progression between phases.
**Name:** Spinal Cord Stimulation Device
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** (CRPS SS) This will be determined at baseline by the provider based on his diagnosis of the patient's condition, being acute and subacute or chronic. This is based on the presence or absence of 16 clinically-assessed signs and symptoms, and complements the diagnostic criteria for CRPS. A higher score indicates greater severity of the condition. This will be followed up at the 7 day trial period, 3 months and 6 months post procedure by evaluation.
**Measure:** Change in Complex Regional Pain Syndrome Severity Scores
**Time Frame:** Baseline, 7 day trial period, 3 months, 6 months
**Description:** Spinal cord stimulation device parameters will be collected to determine if a lower voltage is required to treat acute phase of complex regional pain syndrome as compared to later phases. This will be conducted at follow up visits and analyzed by the medical device representative. The data will be pulled and analyzed to determine the activation point for each patient. This will be captured at the 7 day trial period, 3 months, and 6 months.
**Measure:** Change in Target Activation Amplitude Levels by the Spinal Cord Stimulation Device
**Time Frame:** 7 day trial period, 3 months, and 6 months.
#### Secondary Outcomes
**Description:** We plan to include a physiological marker of pain response by assessing serum prolactin levels, which are linked to dopamine levels in the brain. We will use prolactin as a convenient marker of abnormal dopamine levels due to chronic pain and the response to spinal cord stimulation treatment as an objective quantifiable metric of success with treatment. We will collect this via blood draw at our lab at baseline, at the 7 day trial period, and 3 months.
**Measure:** Change in Prolactin Levels
**Time Frame:** Baseline, 7 day trial period, and 3 months
**Description:** (VAS) This will be used to determine the pain intensity the patient is experiencing. It will be on a scale from 0-10, 0 being no pain and 10 being the worst pain.
**Measure:** Visual Analogue Pain Scale
**Time Frame:** Baseline, 7 day trial period, 3 months, and 6 months
**Description:** (EQ-5D-5L) Used to capture quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. A lower score would indicate a severe score and the patient has a low quality of life. The patient also rates how good or bad their health is on a scale of 0-100, 100 being the best health and 0 being the worst health they could imagine.
**Measure:** Quality of Life Questionnaire
**Time Frame:** Baseline, 7 day trial period, 3 months, and 6 months
**Description:** (PROMIS-29v2.1) Used to assess pain intensity using a single 0-10 numeric rating item and seven health domains: physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance.
**Measure:** Patient Reported Outcomes Measurement Information System-29 v 2.1
**Time Frame:** Baseline, 7 day trial period, 3 months, and 6 months
**Description:** (GAD-7) Used for the screening and severity measuring of generalized anxiety disorder. It consists of seven items the patients rate based on their experiences over the past two weeks. Each item is scored from 0 (none) to 3 (every day). The cumulative score, ranging from 0-21, indicates the severity of GAD symptoms, with higher scores corresponding to greater anxiety levels.
**Measure:** General Anxiety Disorder-7
**Time Frame:** Baseline, 7 day trial period, 3 months and 6 months.
**Description:** (PHQ-9) Used for screening and measuring the severity of depression. A higher score would indicate the patient has a worse outcome.
**Measure:** Patient Health Questionnaire-9
**Time Frame:** Baseline, 7 day trial period, 3 months, 6 months
**Description:** (SF-MPQ-2) Used to rate the intensity of each type of pain and related symptoms. A higher score means the patient has a worse outcome. They rate their pain and symptoms on a scale of 0-10, with a 0 being no pain and 10 being the worst pain.
**Measure:** Short-Form McGill Pain Questionnaire-2
**Time Frame:** Baseline, 7 day trial period, 3 months, 6 months
**Description:** (PCS) Used to assess catastrophic thinking related to pain among adults with or without chronic pain. A higher score would mean the patient has a worse outcome.
**Measure:** Pain Catastrophizing Scale
**Time Frame:** Baseline, 7 day trial period, 3 months, 6 months
**Description:** (PGIC) Used to measure the patient's belief about the effectiveness of the treatment. A higher score would reflect the patient believes the treatment is not effective and they have been doing much worse.
**Measure:** Patient Global Impression of Change
**Time Frame:** 7 day trial period, 3 months and 6 months
**Description:** Used to track amount of pain medication taken by the patient on a daily basis or what they are taking and when they are taking it.
**Measure:** Amount of Pain Medication Consumed by Patient
**Time Frame:** Baseline, 7 day trial period, 3 months and 6 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* 18 years or older
* neuromodulation naive patients with unilateral CRPS type 1 or type 2 (defined by Budapest Criteria)
* pre-procedure psychological clearance
Exclusion Criteria:
* younger than 18 years
* prior neuromodulation including spinal cord stimulation
* prior dorsal root ganglion stimulation
* prior peripheral nervous system stimulation
* anatomical obstacles to dorsal column lead placement
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Julie C McCauley
**Phone:** 585-554-7122
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Roslyn M Kackman
**Phone:** 858-554-7122
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** La Jolla
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Julie C McCauley
- **Phone:** 585-554-7122
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Roslyn M Kackman
- **Phone:** 858-554-7122
- **Role:** CONTACT
***Contact 3:***
- **Name:** David B Hiller, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Scripps Clinic Torrey Pines
**State:** California
**Zip:** 92037
#### Overall Officials
**Official 1:**
**Affiliation:** Physician
**Name:** David B Hiller, 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: D000001523
- Term: Mental Disorders
- ID: D000001342
- Term: Autonomic Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000010523
- Term: Peripheral Nervous System Diseases
- ID: D000009468
- Term: Neuromuscular 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
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M16355
- Name: Syndrome
- Relevance: HIGH
- As Found: Syndrome
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M22653
- Name: Complex Regional Pain Syndromes
- Relevance: HIGH
- As Found: Complex Regional Pain Syndrome
- ID: M14861
- Name: Reflex Sympathetic Dystrophy
- Relevance: HIGH
- As Found: Complex Regional Pain Syndrome
- 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
- ID: M4643
- Name: Autonomic Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27979
- Name: Primary Dysautonomias
- Relevance: LOW
- As Found: Unknown
- ID: M13432
- Name: Peripheral Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12411
- Name: Neuromuscular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T1440
- Name: Complex Regional Pain Syndrome
- Relevance: HIGH
- As Found: Complex Regional Pain Syndrome
### Condition Browse Module - Meshes
- ID: D000020918
- Term: Complex Regional Pain Syndromes
- ID: D000012019
- Term: Reflex Sympathetic Dystrophy
- ID: D000013577
- Term: Syndrome
- ID: D000013001
- Term: Somatoform Disorders
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06421337
**Acronym:** PROMISE-GLOB
**Brief Title:** BraiN20® Medical Device in Suspected Acute Stroke Patients
**Official Title:** Somatosensory Evoked Potential (SEP) N20 Monitoring With BraiN20® Medical Device for Prediction of Functional Independence Defined as Rankin Scale Score 0-2 in Global Patients With Suspected Acute Stroke.
#### Organization Study ID Info
**ID:** PROMISE GLOBAL CIP V2.0
#### Organization
**Class:** OTHER
**Full Name:** Fundació Institut Germans Trias i Pujol
### Status Module
#### Completion Date
**Date:** 2025-03-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-17
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-03-15
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-15
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Alicia Martínez Piñeiro
#### Responsible Party
**Investigator Affiliation:** Fundació Institut Germans Trias i Pujol
**Investigator Full Name:** Alicia Martínez Piñeiro
**Investigator Title:** Principal Investigator
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Time is Brain company (http://www.tibtimeisbrain.com/about_us/) developed BraiN20®, a medical device to assess the presence and characteristics of the N20 signal of SEP. Investigators have demonstrated a high prognostic accuracy of N20 on functional recovery of patients with acute ischemic stroke (AIS) due to large vessel occlusion (LVO) undergoing endovascular thrombectomy (EVT), the gold standard treatment. The aim if this new project is to validate BraiN20® in global patients presenting with suspected acute ischemic or hemorrhagic stroke in three comprehensive stroke centers in Spain. The primary objective is to establish the predictive performance of the presence of the N20 SEP over functional recovery as the primary outcome measure (likelihood of having a modified Rankin Scale (mRS) score 0-2 at 3 months evaluated by blinded independent raters). The effect will be measured by the metrics sensitivity, specificity, and predictive values, and compared with clinical and imaging predictive models by Receiving Operating Characteristics (ROC) curve analysis in the global population, stroke subtype and stroke mimics. Secondary aims are: 1) to determine the area under the curve (AUC) of the presence of the N20 SEP as biomarker of functional recovery in small subcortical infarctions and in patients with cortical infarctions and no large vessel occlusion; 2) to characterize N20 SEP signal in hemorrhagic stroke and stroke mimics; and 3) to evaluate the discriminant capacity of an explanatory new algorithm combining pre-hospital clinical variables and N20-SEP signal characteristics between ischemic, hemorrhagic and stroke mimics.
This project would represent the first pilot study to validate the ability of BraiN20® to predict the functional recovery in the different types of acute stroke but also its ability to discriminate between stroke subtypes. Thus, BraiN20® monitoring could arise as a paradigm shift in acute stroke management, since it would standardize and accelerate patient triage, enable real time monitoring, increase access to EVT treatment and improve its outcome The trial is sponsored by Time is Brain S.L. and started in March 2024. Primary endpoint results are expected by the end of the 2024.
BraiN20® could be a useful medical device aiding stroke subtype diagnosis and functional recovery.
**Detailed Description:** The likelihood of a favourable outcome of acute stroke is critically dependent on patients presenting promptly after symptom onset and on hospitals providing immediate access to the gold standard treatment: the EVT. The current clinical stroke management is complex, time-consuming, requires different hospital settings with specialized equipment, and diagnostic is based on momentaneous snapshot providing brain imaging and clinical scores, without real-time monitoring tools. In addition, the current standard of care is unfavourable to patients localized far from a Comprehensive Stroke Center (CSC), especially for those living in rural regions. Thus, 50% undergoing EVT do not respond to the treatment because their brain tissue has been already irreversibly damaged.
Thus, neurologists from the Germans Trias I Pujol CSC (Barcelona, Spain) started a new research line by introducing a new diagnostic approach based on neurophysiological techniques to optimize the selection of patients benefiting from EVT and improve its outcome. In 2018, the Somatosensory Evoked Potentials MonItoring During Acute Ischemic Stroke (PROMISE) clinical trial confirmed in a large cohort (n=228) that the N20 SEP determined before EVT increases 30% the diagnostic accuracy of salvageable brain compared to the technologies currently used.
Time is Brain S.L. (TiB) was founded in July 2020 by neurologists from Germans Trias I Pujol CSC to develop BraiN20®, a medical device to assess presence and characteristics of N20 SEP signal from AIS onset and during the entire stroke patient journey. It promises to be an accurate, relatively inexpensive, userfriendly device to quickly determine N20 signal of the SEPs. This technology is safe and non-invasive and therefore may be especially useful at the pre-hospital stage of stroke patients, monitoring brain viability in-hospital and in particular in the angio-room guiding therapeutic strategies.
PROMISE20 (Somatosensory Evoked Potentials Monitoring in Patients with Acute Ischemic Stroke and Large Anterior Vessel Occlusion Undergoing Endovascular Thrombectomy. A Clinical Validation of the BraiN20® Medical Device) (NCT06149754) is underway.
The primary aim is to prove that the percentage of patients with optimal or good reliability of the BraiN20® Medical Device automatic recording of N20 is higher than 75% (i.e., the lower limit of the one-sided 95% confidence interval is higher or equal to 75%), assuming a true proportion equal to 87.5%, according to the classification by two expert physicians blind to BraiN20® reading results.
While the usefulness of N20 SEP in AIS patients undergoing EVT has already been demonstrated, the predictive performance of BraiN20® is unknown in other stroke subtypes and stroke mimics. This project aims to validate for the first time BraiN20® monitoring in global patients presenting with suspected acute ischemic or hemorrhagic stroke. The accomplishments so far make a strongly believe that BraiN20® will enable a step improvement and become the cornerstone of the acute stroke patient journey
The study will investigate the ability of the BraiN20® medical device to detect and characterize N20 signal in a global population of suspected stroke patients.
The primary objective is to establish the predictive performance of the presence of N20 SEP registered by BraiN20® over functional recovery (primary outcome) (likelihood of having a mRS score 0-2 at 90 days evaluated by blinded independent raters). The effect will be measure by the metrics sensitivity, specificity and predictive values, and compared with clinical and imaging predictive models by ROC curve analysis in the global population, stroke subtypes and stroke mimics.
Secondary aims are:
* to determine the area under the AUC of the N20 amplitude predicting functional recovery in small subcortical infarctions and in patients with spontaneous LVO revascularization.
* to characterize N20 signal in intracranial hemorrhage (ICH) and stroke mimics.
* to evaluate the discriminant capacity of an explanatory new algorithm combining prehospital clinical variables and N20 signal characteristics between ischemic stroke, ICH and stroke mimics.
* to characterize N20 signal in posterior ischemic strokes and basilar occlusion.
Safety outcomes related to BraiN20® monitoring are:
* Frequency of patients in whom N20+ recording prior to treatment disappears after specific treatment such as thrombectomy procedure, or surgical treatment.
* Mortality at day 7.
* Tolerability of the BraiN20® monitoring.
* Number of consumables used with mean and standard deviation
PROMISE-GLOB is a prospective, interventional, single arm, multi-center, open trial with blinded evaluation of the primary endpoint of a cohort of patients with suspected acute stroke admitted in the emergency department of a CSC. The study will be performed in consecutive patients fulfilling eligibility criteria in three comprehensive stroke centers in Spain.
Patients will be studied and managed according to local protocols. No special recommendations are given, but protocols must define criteria for acute medical treatment, intravenous thrombolysis, endovascular thrombectomy, hemicraniectomy and surgical evacuation of ICH. Regarding diagnostic tools, computed tomography (CT), CT angiography (CTA), magnetic resonance (MR) or MR angiography (MRA) and ultrasound will be used at discretion of investigators for a required classification of stroke subtype or stroke mimics.
SEP monitoring with the BraiN20® medical device will be performed as soon as possible after admission preferably before IV thrombolysis as long as it does not entail a delay in the acute emergency therapies. In patients undergoing EVT or surgical therapies, baseline SEP monitoring should be performed before these procedures, and repeated at the end of them. SEP monitoring should also be repeated in case of neurologic deterioration ≥ 4 points in the National Institute of Health Stroke Scale (NIHSS) within the first 24 hours.
Patients' cohort will be followed up to 90 days after inclusion. mRS score will be determined at day 7 or discharge and at day 90 by a local investigator blind to the BraiN20® recordings, both face to face or by telephone interview. There are no specific study interventions. Patients will be discharged at home, other centers or admitted at acute stroke units (or intensive care units if needed) and treated following the European Stroke Organization guidelines.
SEP monitoring will be carried out using the BraiN20® medical device and appropriate electrodes. SEP of both median nerves will be recorded, transferred, and stored to the internal card for their evaluation. BraiN20® Medical Device provides an automatic reading of the presence and feature of a N20 response both ipsilateral and contralateral (as control) to the cerebral hemisphere affected by the stroke and do not require specific training. Furthermore, the device provides an outcome prediction (percentage of likelihood of having mRS ≤ 2 day 7 and 90 after stroke onset) based on an internal algorithm. BraiN20® measures one N20 wave per 33 seconds. Scalp electrodes are easily embedded on a headband and the wrist electrodes on a glove.
SEP recording will be done in the emergency room or in the angiography or surgical room (if required). Examiners will be physicians or nurses in charge of the patient. N20 recordings will be stored in the device for review at the end of the trial. It is recommended to obtain three recordings of the N20 response to confirm its presence or absence and exclude a noisy registration in the affected side (this takes approximately 3 min). Presence of the N20 response in the contralateral side will be used as control to rule out technical issues or the effect of other conditions that could affect the SEPs recordings.
At admission at the Emergency Unit, patients with suspected acute stroke will be immediately attended by neurologists. NIHSS will be evaluated, blood will be drawn for baseline analysis and CT/CTA neuroimaging performed if indicated by local protocols. Anytime during these procedures BraiN20® electrodes will be placed and three N20 recordings obtained from each brain side (stroke side and control hemisphere). Serum glucose, body temperature and blood pressure will be controlled following the American Stroke Association guidelines. Alberta Stroke Program Early CT (ASPECT) score, ICH volume (AxBxC/2) and location will be measured by local investigators on baseline CT. Informed consent either, oral, signed or deferred will be obtained.
Stroke subtype will be classified according to the Oxfordshire Community Stroke Project (OCSP) complemented with neuroimaging findings as total anterior cerebral infarction (TACI), partial anterior cerebral infarction (PACI), posterior cerebral infarction (POCI) and lacunar infarction (LACI); in addition deep ICH and lobar ICH. Stroke etiology following the classification of the Cerebrovascular Diseases Study Group of the Spanish Neurological Society as small vessel disease, large artery atherosclerosis (extracranial or intracranial), atrial fibrillation (AF) or other cardioembolic diseases, Unknown, Other (e.i. arterial dissection) and stroke mimic.
A specific case record form (CRF) will be generated for each eligible patient. The completion of the CRF will be made by authorized site personnel. A copy of the CRF will be kept in the hospital records and the original will be collected by the sponsor. The investigator must ensure the accuracy, completeness and timeliness of data reported in the CRF. The sponsor will test all data for completeness, consistency, and plausibility, and produce queries for erroneous, incomplete and missing data. Any necessary queries will be sent to the investigator by email. Periodic monitoring visits will be made by the sponsor throughout the investigation to ensure that the investigator's obligations are being fulfilled. The database will be keep anonymized and confidentially at the sponsor workplace for centralized monitoring of the electronic records. Resolved queries will be returned to the sponsor by email. If answers are incomplete or discrepant with other data, re-queries may be necessary.
No a priori sample size calculation has been done because it is unknown the potential predictive capacity of BraiN20® in a non-selected stroke population. This population has not been previously studied and this pilot study aims to establish the proof of concept for a future phase III design. The study period is limited to 8-12 months inclusion in three stroke centers and 500 evaluable patients are expected. This sample size is appropriate for including more than 100 patients in each stroke subtype. Patients that do not fulfil eligibility criteria will be replaced in order to obtain 500 evaluable patients.
No risk or benefit for patients is expected in the trial since it is an study without any specific decision-making based on the BraiN20® results. Any device malfunction or unexpected characteristics will be registered, and the device unit discarded (returned to Time is Brain, S.L. for inspection).
### Conditions Module
**Conditions:**
- Acute Stroke
**Keywords:**
- Somatosensory evoked potentials
- Acute stroke ischemic
- Acute stroke hemorrhagic
- Stroke mimics
- Prognosis
- Functional recovery
- Medical device
- Diagnostic
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Masking Description:** Outcome will be evaluated by an independent assessor blinded to the monitoring results at the acute phase
**Primary Purpose:** DIAGNOSTIC
#### Enrollment Info
**Count:** 500
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Subjects presenting at emergency departments of participating hospitals with suspected acute stroke within 24 hours from symptom onset with or without stroke code activation
**Intervention Names:**
- Device: BraiN20(R)
**Label:** Study group
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Study group
**Description:** SEP monitoring will be carried out using the BraiN20® medical device and appropriate electrodes. SEP of both median nerves will be recorded, transferred, and stored to the internal card for their evaluation. BraiN20® Medical Device provides an automatic reading of the presence and feature of a N20 response both ipsilateral and contralateral (as control) to the cerebral hemisphere affected by the stroke and do not require specific training. Furthermore, the device provides an outcome prediction (percentage of likelihood of having mRS ≤ 2 day 7 and 90 after stroke onset) based on an internal algorithm.
BraiN20® measures one N20 wave per 33 seconds. Scalp electrodes are easily embedded on a headband and the wrist electrodes on a glove.
**Name:** BraiN20(R)
**Type:** DEVICE
### Outcomes Module
#### Other Outcomes
**Description:** Comfortability of the patients during the 3-5 minutes of monitoring
**Measure:** Tolerability of the BraiN20® monitoring
**Time Frame:** At admission within 24 hours from stroke onset
#### Primary Outcomes
**Description:** Functional recovery is defined by modified Rankin Scale score 0-2 (min 0, no disability; max 6, death) at day 90 after stroke. Modified Rankin Scale score will be measured by blinded local raters according to a structured interview at day 7 or before discharge and at day 90 by telephone interview or face to face. Two cohort groups are defined:
Stroke functional recovery: mRS lower or equal than 2 at 90 ± 15 days. Stroke functional dependence: mRS higher than 2 at 90 ± 15 days.
**Measure:** Functional recovery at 3 months
**Time Frame:** Day 90
#### Secondary Outcomes
**Description:** Amplitude, latency and wave characteristics of the N20 response will be used to make a new algorithm able to discriminate between ischemic, hemorrhagic and stroke mimics.
**Measure:** N20 signal characteristics
**Time Frame:** At admission within 24 hours from stroke onset
**Description:** Evaluation of the severity of the focal neurologic deficit (NIHSS: min 0, no neurological deficit; max 42)
**Measure:** National Institute of Health Stroke Scale score (NIHSS)
**Time Frame:** Days 7 and 90
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Patients with suspected acute stroke ischemic or hemorrhagic admitted in the emergency department within 24 hours from symptoms onset or from the last time seen normal.
2. Stroke mimics classified after neurologic examination and diagnostic procedures will be also included.
3. Age ≥18.
4. No significant pre-stroke functional dependence (mRS ≤ 2).
5. Baseline NIHSS score obtained prior to procedure must be equal or higher than 1 point. Patients with TIA and full recovery on admission must not be included.
6. Patients in whom BraiN20® monitoring can be performed without delay of acute stroke therapies.
7. Participation in other treatment or diagnostic test clinical trial is allowed if the patients fulfill the inclusion criteria of PROMISE-GLOBAL.
8. Informed consent obtained from patient or acceptable patient surrogate; or the deferred informed consent, to avoid the delay in the start of the stroke emergency therapies.
Exclusion Criteria:
- Clinical criteria
1. Patients with a well-documented history of neuromuscular diseases and other severe neurodegenerative disorders (Mild Cognitive Impairment is not exclusion criteria), prior stroke (TIA is not exclusion criteria) or nervous system tumors that could interfere with SEP assessment.
2. Serious, advanced, or terminal illness with an anticipated life expectancy of less than three months.
3. Women in the premenopausal period.
- Neuroimaging criteria
4. Acute infarct volume (ASPECTS) or ICH volume (AxBxC/2) on plane CT should be measured but they are not exclusion criteria and should not preclude any specific treatment according to local protocols (i.e., mechanical thrombectomy, hemicraniectomy or ICH evacuation).
5. Evidence of intracranial tumor (except small meningioma).
- BraiN20® medical device safety issues:
6. Subjects with a demand-type cardiac pacemaker, defibrillator, or other electrical implant or metal.
7. Patients with suspected or well-known cancerous skin lesions in the area where electrical stimulation is to be applied.
8. Patients who have a localized disorder in the wrist and forearm where electrical stimulation is to be applied (i.e., fractures or dislocations, vein puncture).
**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:** Alicia Martinez, MD, PhD
**Phone:** +34662121408
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Antoni Dávalos, MD, PhD
**Phone:** +34616968690
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Barcelona
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Pol Camps, MD, PhD
- **Phone:** +34935565986
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Rebeca Marin, RN
- **Phone:** +34935565986
- **Role:** CONTACT
***Contact 3:***
- **Name:** Garbiñe Ezcurra, MD
- **Role:** SUB_INVESTIGATOR
***Contact 4:***
- **Name:** Anna Ramos, MD, PhD
- **Role:** SUB_INVESTIGATOR
**Country:** Spain
**Facility:** Hospital Universitari de la Santa Creu i Sant Pau
**Status:** RECRUITING
**Zip:** 08025
**Location 2:**
**City:** Lleida
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Francisco Purroy, MD, PhD
- **Phone:** +34973702935
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Cristina Pereira, PhD
- **Phone:** +34973702935
- **Role:** CONTACT
**Country:** Spain
**Facility:** Hospital Universitari Arnau de Vilanova
**Status:** RECRUITING
**Zip:** 25198
**Location 3:**
**City:** Madrid
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Jose A Vivancos, MD, PhD
- **Phone:** +34915202416
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Mónica Sobrado, PhD
- **Phone:** +34915202416
- **Role:** CONTACT
***Contact 3:***
- **Name:** Alvaro Ximénez-Carrillo, MD
- **Role:** SUB_INVESTIGATOR
**Country:** Spain
**Facility:** Hospital Universitario La Princesa
**Status:** RECRUITING
**Zip:** 28006
#### Overall Officials
**Official 1:**
**Affiliation:** Fundació Institut d'Investigació en Ciències de la Salut Germans Trias iPujol
**Name:** Antoni Dávalos, MD, PhD
**Role:** STUDY_CHAIR
### IPD Sharing Statement Module
**Description:** Result will be presented at the European Stroke Organization Conference and published
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Alicia Martinez-Piñeiro MD, PhD [email protected] , Giuseppe Lucente MD, PhD , María Hernandez-Perez MD, PhD , Jordi Cortés PhD , Andrea Arbex MD , Natalia Pérez de la Ossa MD, PhD , Alba Ramos-Fransí MD, PhD , Miriam Almendrote MD , Mònica Millán MD, PhD , Meritxell Gomis MD, PhD , Laura Dorado MD, PhD , Carlos Castaño MD, PhD , Sebastián Remollo MD , Patricia Cuadras MD, PhD , Alicia Garrido MD , Nicolau Guanyabens MD , Joaquim Broto MD , Elena López-Cancio MD, PhD , Jaume Coll-Canti MD, PhD , Antoni Dávalos MD, PhD , and PROMISE (Somatosensory Evoked POtEntials MonItoring During Acute Ischemic StrokE) Study Group. Prognostic Accuracy of N20 Somatosensory Potential in Patients With Acute Ischemic Stroke and Endovascular Thrombectomy. Stroke: Vascular and Interventional Neurology. 2023 | Volume 3, Issue 5: e000735
**Citation:** Pittock SJ, Meldrum D, Hardiman O, Thornton J, Brennan P, Moroney JT. The Oxfordshire Community Stroke Project classification: correlation with imaging, associated complications, and prediction of outcome in acute ischemic stroke. J Stroke Cerebrovasc Dis. 2003 Jan;12(1):1-7. doi: 10.1053/jscd.2003.7.
**PMID:** 17903897
**Citation:** Sobrino Garcia P, Garcia Pastor A, Garcia Arratibel A, Vicente Peracho G, Rodriguez Cruz PM, Perez Sanchez JR, Diaz Otero F, Vazquez Alen P, Villanueva Osorio JA, Gil Nunez A. [Aetiological classification of ischaemic strokes: comparison of the new A-S-C-O classification and the classification by the Spanish Society of Neurology's Cerebrovascular Disease Study Group]. Neurologia. 2013 Sep;28(7):417-24. doi: 10.1016/j.nrl.2012.07.005. Epub 2012 Sep 19. Spanish.
**PMID:** 22998938
#### See Also Links
**Label:** Startup developing BraiN20(R)
**URL:** http://timeisbrain.com
## 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: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M10543
- Name: Ischemia
- Relevance: LOW
- As Found: Unknown
- ID: M22306
- Name: Stroke
- Relevance: HIGH
- As Found: Acute Stroke
- ID: M2400
- Name: Ischemic Stroke
- Relevance: LOW
- As Found: Unknown
- ID: M2404
- Name: Hemorrhagic Stroke
- Relevance: LOW
- As Found: Unknown
- ID: M5810
- Name: Cerebrovascular Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M5204
- Name: Brain Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000020521
- Term: Stroke
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06421324
**Acronym:** AIDA
**Brief Title:** Personalised Health Recommendations to the General Population Through an Integrated AI Guided
**Official Title:** Interventional Study Focused on Providing Personalised Health Recommendations to the General Population Through an Integrated AI Guided App as a Strategy for Gastric Cancer Prevention (AIDA)
#### Organization Study ID Info
**ID:** AIDA_HE
#### Organization
**Class:** OTHER
**Full Name:** Fundación para la Investigación del Hospital Clínico de Valencia
### Status Module
#### Completion Date
**Date:** 2026-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-17
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-07-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-08
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Tania Fleitas Kanonnikoff
#### Responsible Party
**Investigator Affiliation:** Fundación para la Investigación del Hospital Clínico de Valencia
**Investigator Full Name:** Tania Fleitas Kanonnikoff
**Investigator Title:** MD, PhD
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** This clinical study aims to be used to implement and validate the AIDA tool in two phases:
* Phase 1: Risk stratification and personalised recommendations \& Model development
* Phase 2: Mechanistic Model (Bioresource) development \& testing
**Detailed Description:** The AIDA objective (project) is to develop and validate a multidisciplinary AI-powered assistant that helps clinicians diagnose precancerous inflammation, suggests personalised therapeutic strategies for medical treatment and follow-up, and makes personalised recommendations for monitoring patient health status, thus contributing to gastric cancer prevention. This prospective clinical study aims to implement and validate such tool.
### Conditions Module
**Conditions:**
- Gastric Cancer
- Cancer Prevention
- Helicobacter Pylori Infection
- Artificial Intelligence
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** In practice, for rare diseases we chose a sample size that will allow estimation of sensitivity of the risk score to a pre-specified precision. We have chosen the sample size assuming that the resulting precancer detection model will have a sensitivity of at least 85%, and so that the lower 95% confidence interval will exceed 76%, with 80% power. The R package MKmisc estimates sample size for a proportion based on the Binomial distribution rather than a Normal approximation. In this case, we have estimated a sample size of 141 GIM + cancer and 141 GIM controls (282 in total). With 5% of samples assumed to be failing to be analysed due to a variety of technical reasons, we would need \~300 samples in total. In addition, to train the system 150 gastric cancer cases will be recruited which will provide pathology samples images and endoscopy images that will be taken as part of the clinical practice.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 450
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Subjects will be recruited prospectively from the Digestive Medicine/Endoscopy Departments of the centres involved. Patients will be treated according to the medical and patient decisions according to the clinical practice protocols of each site. Sample collection will be performed during a gastroscopy for pathological and molecular characterisation. This gastroscopy will be always indicated within usual clinical practice, so no additional risk is planned for the subjects included.
Inclusion criteria: Subjects ≥18 years old to whom an endoscopy is performed due to gastric symptoms, without previous history of gastric chronic inflammation or Helicobacter pylori infection
**Label:** Healthy controls
**Type:** NO_INTERVENTION
#### Arm Group 2
**Description:** Subjects will be recruited prospectively from the Digestive Medicine/Endoscopy Departments of the centres involved. Patients will be treated according to the medical and patient decisions according to the clinical practice protocols of each site. Sample collection will be performed during a gastroscopy for pathological and molecular characterisation. This gastroscopy will be always indicated within usual clinical practice, so no additional risk is planned for the subjects included.
Inclusion criteria: Subjects ≥18 years old with a diagnosis of Gastric Cancer, to whom a gastroscopy is indicated within clinical care naive for chemotherapy.
**Label:** Gastric cancer controls
**Type:** NO_INTERVENTION
#### Arm Group 3
**Description:** Subjects will be recruited prospectively from the Digestive Medicine/Endoscopy Departments of the centres involved. Patients will be treated according to the medical and patient decisions according to the clinical practice protocols of each site. Sample collection will be performed during a gastroscopy for pathological and molecular characterisation. This gastroscopy will be always indicated within usual clinical practice, so no additional risk is planned for the subjects included.
Inclusion criteria: Subjects ≥18 years old with a diagnosis of GIM or previous or current H. pylori infection, to whom a gastroscopy is indicated within clinical care
**Intervention Names:**
- Behavioral: Health reccommendations
**Label:** GIM cases
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- GIM cases
**Description:** Patients are given recommendations according to their risk group, based on the model which already predicted health indicators. This information will be sent to the patient's treating physician so that treatment and recommendations are aligned with the clinical care practice based on the European Code of Cancer guidelines, the H. pylori best practices guidelines and European GIM guidelines
**Name:** Health reccommendations
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** Scoring patients as low (\>30) / medium / high risk (\<6) according to:
* Degree of 'healthiness' of lifestyle (1 to 10, with 10 as very low and 10 as very high)
* Co-morbidities (Yes = 1 / No = 5)
* H. pylori infection history (Yes = 1 / No = 5)
* Previous gastric intestinal metaplasia (Yes = 1 / No = 5)
* Dysplasia or atrophy related to chronic gastritis (Yes = 1 / No = 5)
* Family history of cancer (Yes = 1 / No = 5)
**Measure:** Risk of developing Gastric Cancer based on medical records
**Time Frame:** At the recruitment stage
**Description:** AI driven H. pylori Eradication Therapy Recommendation
**Measure:** H. pylori Eradication Therapy Recommendation
**Time Frame:** From 30 days after the H.Pylori positive test result to one year after the first recommendation
**Description:** AI driven GIM risk score assessment of pre-cancerous lesions using imaging modalities based on: QLQ C30 and STO22 EORTC questionnaire, Healthy lifestyle questionnaire (adapted from EPICs), Baseline clinical data, If H. pylori positive: adherence to treatment: yes/no; eradication yes/no, If GIM: adherence to follow-up guidelines yes/no
**Measure:** GIM risk score assessment using imaging modalities
**Time Frame:** At the recruitment stage
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Subjects ≥ 18 years old with a diagnosis of GIM or previous or current H. pylori infection, to whom a gastroscopy is indicated within clinical care
* Availability of a signed informed consent form to participate in the study
Exclusion Criteria:
* Patients to whom an endoscopy is performed for the follow-up of another illness such as oesophageal varices and/or for therapy such as endoscopic dilation, feeding tube placement or endoscopic resection
* Subjects with a clinical diagnosis of gastric diseases other than GIM or GC
* Patients who have received antimicrobials during the four weeks prior to the endoscopy
* Patients who have received proton pump inhibitors and/or bismuth-based treatments at least two weeks prior to the endoscopy
* Subjects for whom clinical data are not available: H. pylori status, eradication treatment, sex, age, tobacco smoking, and first-degree family history of gastric cancer
* Subjects who lack the mental capacity to understand the nature and requirements of the study and who lack the ability to give 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:** Ana Miralles Marco, PhD
**Phone:** +34 689567412
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Valencia
**Country:** Spain
**Facility:** Hospital Clínico Universitario de Valencia
**Zip:** 46010
#### Overall Officials
**Official 1:**
**Affiliation:** Fundación para la Investigación del Hospital Clínico de Valencia
**Name:** Tania Fleitas, MD, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### See Also Links
**Label:** Website
**URL:** https://www.aidaeuproject.org/
## Document Section
### Large Document Module
#### Large Docs
- Date: 2023-02-07
- Filename: ICF_000.pdf
- Has ICF: True
- Has Protocol: False
- Has SAP: False
- Label: Informed Consent Form
- Size: 499898
- Type Abbrev: ICF
- Upload Date: 2024-05-07T10:27
## Derived Section
### Condition Browse Module - Ancestors
- 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: D000013272
- Term: Stomach Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC06
- Name: Digestive System 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: M16064
- Name: Stomach Neoplasms
- Relevance: HIGH
- As Found: Gastric Cancer
- ID: M10283
- Name: Infections
- Relevance: LOW
- As Found: Unknown
- ID: M6368
- Name: Communicable Diseases
- 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: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M16062
- Name: Stomach Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T5486
- Name: Stomach Cancer
- Relevance: HIGH
- As Found: Gastric Cancer
### Condition Browse Module - Meshes
- ID: D000013274
- Term: Stomach Neoplasms
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06421311
**Acronym:** URADJ
**Brief Title:** Observational Study of Muscle Invasive Urothelial Carcinoma Participants Treated With Adjuvant Nivolumab in France
**Official Title:** Ambispective Observational Study of Muscle Invasive Urothelial Carcinoma Patients Treated With Adjuvant Nivolumab in France
#### Organization Study ID Info
**ID:** CA209-1416
#### Organization
**Class:** INDUSTRY
**Full Name:** Bristol-Myers Squibb
### Status Module
#### Completion Date
**Date:** 2028-05-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-17
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2028-05-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-15
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-02
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Bristol-Myers Squibb
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
### Description Module
**Brief Summary:** This study will estimate the real-world effectiveness of adjuvant nivolumab therapy in adult participants with muscle invasive urothelial carcinoma (MIUC) in France.
### Conditions Module
**Conditions:**
- Urothelial Carcinoma
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** OTHER
#### Enrollment Info
**Count:** 300
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Drug: nivolumab
**Label:** Participants with muscle invasive urothelial carcinoma receiving nivolumab
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Participants with muscle invasive urothelial carcinoma receiving nivolumab
**Description:** According to approved product label (France)
**Name:** nivolumab
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Measure:** Disease-free survival (DFS) of participants
**Time Frame:** At months 3, 6, 9, 12, 18, 24, 30, 26, 48 and 60
#### Secondary Outcomes
**Measure:** Time to recurrence (TRR)
**Time Frame:** At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
**Measure:** Distance metastases-free survival (DMFS)
**Time Frame:** At months 3, 6, 9, 12, 18, 24, 30, 26, 48 and 60
**Measure:** Non-urothelial tract recurrence free survival (NUTRFS)
**Time Frame:** At months 3, 6, 9, 12, 18, 24, 30, 26, 48 and 60
**Measure:** Locoregional disease free survival (LRFDS)
**Time Frame:** At months 3, 6, 9, 12, 18, 24, 30, 26, 48 and 60
**Measure:** Overall survival (OS)
**Time Frame:** At months 3, 6, 9, 12, 18, 24, 30, 26, 48 and 60
**Measure:** Disease specific survival (DSS)
**Time Frame:** At months 3, 6, 9, 12, 18, 24, 30, 26, 48 and 60
**Measure:** Second progression-free survival (PFS2)
**Time Frame:** At months 3, 6, 9, 12, 18, 24, 30, 26, 48 and 60
**Measure:** Participant demographics
**Time Frame:** Baseline
**Measure:** Participant baseline clinical characteristics
**Time Frame:** Baseline
**Measure:** Participant history of other cancer(s
**Time Frame:** Baseline
**Measure:** Participant comorbidities pre-existing at the time of adjuvant therapy initiation
**Time Frame:** Index date
**Measure:** Participant renal function at treatment initiation
**Time Frame:** Day 1
**Measure:** Participant concomitant systemic treatment(s)
**Time Frame:** Day 1 and at months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
**Measure:** Diagnosis of muscle-invasive urothelial carcinoma diagnosis
**Time Frame:** Baseline
**Measure:** Systemic neoadjuvant treatment history
**Time Frame:** Baseline
**Measure:** Surgery for muscle-invasive urothelial carcinoma
**Time Frame:** Baseline
**Measure:** Participant history of previous urothelial carcinoma
**Time Frame:** Baseline
**Measure:** PD-L1 status testing results
**Time Frame:** Baseline
**Measure:** Participant muscle Invasive urothelial carcinoma disease characteristics
**Time Frame:** At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
**Measure:** Time from initial diagnosis of muscle invasive disease to adjuvant treatment initiation
**Time Frame:** At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
**Measure:** Delay in adjuvant nivolumab treatment initiation related to post-operative complications
**Time Frame:** Baseline
**Measure:** Time from radical surgery to adjuvant nivolumab treatment initiation
**Time Frame:** At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
**Measure:** Adjuvant nivolumab treatment duration
**Time Frame:** At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
**Measure:** Number of adjuvant nivolumab treatment cycles
**Time Frame:** At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
**Measure:** Dose adjuvant nivolumab per cycle
**Time Frame:** At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
**Measure:** Reason for adjuvant nivolumab treatment interruption
**Time Frame:** At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
**Measure:** Reason for adjuvant nivolumab treatment discontinuation
**Time Frame:** At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
**Measure:** Non-systemic treatments prescribed post adjuvant nivolumab discontinuation
**Time Frame:** At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
**Measure:** Systemic treatment prescribed post adjuvant nivolumab discontinuation
**Time Frame:** At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
**Measure:** Participant response to prescribed systemic treatment post adjuvant nivolumab discontinuation
**Time Frame:** At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
**Measure:** Participant adverse events
**Time Frame:** At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
**Description:** Prospective participants only
**Measure:** Participant reported outcomes as assessed by European Quality of Life-5 Dimensions (EQ-5D) Questionnaire
**Time Frame:** Baseline, and at months 3, 6, 9, 12, 18, 24, 30, and 36
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Participants with pathological evidence of muscle invasive urothelial carcinoma (originating in bladder, ureter, or renal pelvis) at high risk of recurrence after radical resection with programmed death-ligand 1 (PD-L1) tumour cell expression ≥ 1%:
* Who received neoadjuvant chemotherapy OR
* Who did not receive neoadjuvant chemotherapy and who are not eligible or refusing adjuvant cisplatin chemotherapy
* At least 18 years of age at the time of treatment decision
* Decision to treat with adjuvant nivolumab therapy has already been taken
* Participants who provide oral informed consent to participate in the study (or who express non-opposition to data collection during their lifetime for deceased patients enrolled retrospectively)
Exclusion Criteria:
* Participants with a current primary diagnosis of a cancer other than muscle invasive urothelial carcinoma within the past 5 years, ie, a cancer other than urothelial carcinoma that requires systemic or other treatment or has not been treated curatively (as per discretion of the investigator)
* Participants currently enrolled in an interventional clinical trial for their urothelial carcinoma. Patients who have completed their participation in an interventional trial or who are not receiving study drug anymore and who are only followed-up for overall survival (OS) can be enrolled. Patients enrolled in a clinical trial not evaluating an investigational drug can be enrolled (e.g. trial investigating novel imaging modalities).
* Pregnant women
* Participants under guardianship
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Adult participants in France with muscle invasive urothelial carcinoma (MIUC) that have been prescribed adjuvant nivolumab treatment.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** BMS Study Connect Contact Center www.BMSStudyConnect.com
**Phone:** 855-907-3286
**Role:** CONTACT
**Contact 2:**
**Name:** First line of the email MUST contain NCT # and Site #.
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Strasbourg
**Country:** France
**Facility:** ICANS Institut de Cancérologie Strasbourg Europe
**Zip:** 67200
#### Overall Officials
**Official 1:**
**Affiliation:** Bristol-Myers Squibb
**Name:** Bristol-Myers Squibb
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### 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:** https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009375
- Term: Neoplasms, Glandular and Epithelial
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000009369
- Term: Neoplasms
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M5534
- Name: Carcinoma
- Relevance: HIGH
- As Found: Carcinoma
- ID: M5551
- Name: Carcinoma, Transitional Cell
- Relevance: HIGH
- As Found: Urothelial Carcinoma
- ID: M12320
- Name: Neoplasms, Glandular and Epithelial
- Relevance: LOW
- As Found: Unknown
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
- ID: T5693
- Name: Transitional Cell Carcinoma
- Relevance: HIGH
- As Found: Urothelial Carcinoma
### Condition Browse Module - Meshes
- ID: D000002277
- Term: Carcinoma
- ID: D000002295
- Term: Carcinoma, Transitional Cell
### Intervention Browse Module - Ancestors
- ID: D000074322
- Term: Antineoplastic Agents, Immunological
- ID: D000000970
- Term: Antineoplastic Agents
- ID: D000082082
- Term: Immune Checkpoint 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
### Intervention Browse Module - Browse Leaves
- ID: M1854
- Name: Nivolumab
- Relevance: HIGH
- As Found: Prospective
- ID: M1346
- Name: Antineoplastic Agents, Immunological
- Relevance: LOW
- As Found: Unknown
- ID: M2342
- Name: Immune Checkpoint Inhibitors
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000077594
- Term: Nivolumab
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06421298
**Brief Title:** A Prospective, Single-arm, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Tafolecimab and Sintilimab Combined With Chemotherapy in Patients With Advanced or Metastatic Driver Gene-negative Non-small Cell Lung Cancer After Failure of First-line Immunotherapy.
**Official Title:** A Prospective, Single-arm, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Tafolecimab and Sintilimab Combined With Chemotherapy in Patients With Advanced or Metastatic Driver Gene-negative Non-small Cell Lung Cancer After Failure of First-line Immunotherapy.
#### Organization Study ID Info
**ID:** Immune rechallenge
#### Organization
**Class:** OTHER
**Full Name:** Beijing Chest Hospital, Capital Medical University
### Status Module
#### Completion Date
**Date:** 2027-05-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-17
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2027-05-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-17
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Jinghui Wang
#### Responsible Party
**Investigator Affiliation:** Beijing Chest Hospital, Capital Medical University
**Investigator Full Name:** Jinghui Wang
**Investigator Title:** chief physician
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The second-line treatment for patients who have progressed after first-line immune checkpoint inhibitor therapy, is chemotherapy based on docetaxel and other drugs. The treatment effect is limited. The median survival time of them are 6 months. So there is a huge unmet medical need.
This study is a Prospective, Single-arm, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Tafolecimab and Sintilimab Combined With Chemotherapy in Patients With Advanced or Metastatic Driver Gene-negative Non-small Cell Lung Cancer After Failure of First-line Immunotherapy. 30 patients will be enrolled.
The main endpoint is PFS，and the secondary endpoint are OS,DCR,DOR,ORR, and so on.
**Detailed Description:** This is a Prospective, Single-arm, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Tafolecimab and Sintilimab Combined With Chemotherapy in Patients With Advanced or Metastatic Driver Gene-negative Non-small Cell Lung Cancer After Failure of First-line Immunotherapy.
30 patients will be enrolled. These patients will be treated with chemotherapy combined with sintilimab and Tafolecimab.
The main endpoint is PFS，and the secondary endpoint are OS,DCR,DOR,ORR, and so on.
### Conditions Module
**Conditions:**
- Lung Cancer
**Keywords:**
- Immune rechallenge
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** Tafolecimab and Sintilimab Combined With Chemotherapy in Patients With Advanced or Metastatic Driver Gene-negative Non-small Cell Lung Cancer After Failure of First-line Immunotherapy.
##### 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:** tafolecimab sintilimab nab-paclitaxel docetaxel gemcitabine
**Intervention Names:**
- Drug: Tafolecimab
- Drug: Sintilimab
- Drug: Nab paclitaxel
- Drug: Docetaxel
- Drug: Gemcitabine
**Label:** Tafolecimab and Sintilimab Combined With Chemotherapy
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Tafolecimab and Sintilimab Combined With Chemotherapy
**Description:** 450mg Q4W ≤6cycle
**Name:** Tafolecimab
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Tafolecimab and Sintilimab Combined With Chemotherapy
**Description:** 200mg Q3W ≤2years
**Name:** Sintilimab
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- Tafolecimab and Sintilimab Combined With Chemotherapy
**Description:** 130mg/m² Q3W 4-6cycles
**Name:** Nab paclitaxel
**Type:** DRUG
#### Intervention 4
**Arm Group Labels:**
- Tafolecimab and Sintilimab Combined With Chemotherapy
**Description:** 75mg/m² Q3W 4-6cycles
**Name:** Docetaxel
**Type:** DRUG
#### Intervention 5
**Arm Group Labels:**
- Tafolecimab and Sintilimab Combined With Chemotherapy
**Description:** 1250mg/m² Q3W 4-6cycles
**Name:** Gemcitabine
**Type:** DRUG
### Outcomes Module
#### Other Outcomes
**Description:** To explore the use of iRECIST to evaluate the efficacy treatment of tolecizumab
**Measure:** To explore the use of iRECIST to evaluate the efficacy treatment of tolecizumab
**Time Frame:** up to 24 months
**Description:** Explore potential biomarkers that can predict efficacy, including but not limited to PD-L1 expression levels and TMB.
**Measure:** Explore potential biomarkers that can predict efficacy, including but not limited to PD-L1 expression levels and TMB.
**Time Frame:** up to 24 months
#### Primary Outcomes
**Description:** PFS defined as the time from first dose of study treatment until the first date of either objective disease progression or death due to any cause.
**Measure:** PFS
**Time Frame:** up to 24 months
#### Secondary Outcomes
**Description:** OS is defined as the time until death due to any cause. OS is defined as the time until death due to any cause.
OS is defined as the time until death due to any cause.
**Measure:** OS
**Time Frame:** up to 24 months
**Description:** Defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1.
**Measure:** DCR
**Time Frame:** up to 24 months
**Description:** defined as time since onset of CR or PR to relapse or death due to underlying cancer, whichever is earlier defined as time since onset of CR or PR to relapse or death due to underlying cancer, whichever is earlier defined as time since onset of CR or PR to relapse or death due to underlying cancer, whichever is earlier defined as time since onset of CR or PR to relapse or death due to underlying cancer, whichever is earlier defined as time since onset of CR or PR to relapse or death due to underlying cancer, whichever is earlier Defined as time since onset of CR or PR to relapse or death due to underlying cancer, whichever is earlier
**Measure:** DOR
**Time Frame:** up to 24 months
**Description:** ORR is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1.prior to progression or any further therapy.
**Measure:** ORR
**Time Frame:** up to 24 months
**Description:** Evaluation of adverse event rate according to CTCAE(Common terminology criteria for adverse events) v5.0
**Measure:** AE
**Time Frame:** up to 24 months
### Eligibility Module
**Eligibility Criteria:** inclusion criteria：
1. Sign a written informed consent before implementing any procedures related to the trial;
2. Age ≥18 years old and ≤75 years old;
3. Life expectancy ≥3 months;
4. Subjects with histologically or cytologically confirmed locally advanced (IIIB-IIIC), metastatic, or recurrent (Stage IV) NSCLC (International Association for the Study of Lung Cancer and Joint American Committee on Cancer Classification 8th Edition TNM Staging of Lung Cancer) relapse or disease progression following multimodal therapy (radiotherapy, surgical resection, or radical chemoradiotherapy for locally advanced disease);
5. Patients must have previously used PD-1 or PD-Ll inhibitors and have disease progression; 1) Participants receiving maintenance therapy (meaning maintenance therapy after an immune checkpoint inhibitor regimen) and who have progressed are eligible for inclusion.
2) Participants treated with adjuvant, neoadjuvant, or radical chemoradiotherapy containing PD-1 or PD-Ll inhibitors for locally advanced disease and who experienced tumor recurrence or metastasis within 6 months after completion of treatment were eligible for inclusion.
6. No EGFR, ALK and other mutations; 7. There was at least one radiographically measurable lesion according to the solid tumor efficacy evaluation criteria (RECIST v1.1 edition). Lesions located in the previous radiation field can be considered measurable lesions if progression is demonstrated; 8. Patients with stable brain metastases or whose brain metastases can be controlled were allowed to enroll; 9. ECOG score was 0-1; 10. With sufficient organ function, subjects must meet the following laboratory indicators:
1. Absolute neutrophil count (ANC) ≥1.5x10\^9/L without using granulocyte colony-stimulating factor in the past 14 days;
2. Without blood transfusion in the past 14 days, platelets ≥100×10\^9/L;
3. Hemoglobin \>9g/dL without blood transfusion or erythropoietin use in the past 14 days;
4. Total bilirubin ≤1.5×upper limit of normal (ULN);
5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) are ≤2.5×ULN (subjects with liver metastases are allowed ALT or AST ≤5×ULN);
6. Serum creatinine ≤1.5×ULN and creatinine clearance (calculated using Cockcroft-Gault formula) ≥60 ml/min;
7. Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN;
8. Euthyroid, defined as thyroid stimulating hormone (TSH) within the normal range. If baseline TSH is outside the normal range, subjects can also be enrolled if total T3 (or FT3) and FT4 are within the normal range;
9. Myocardial enzyme spectrum is within the normal range (if the researcher comprehensively judges that simple laboratory abnormalities without clinical significance are also allowed to be included); 11. Female subjects of childbearing potential should undergo a urine or serum pregnancy test with a negative result within 3 days before receiving the first dose of study drug (Day 1 of Cycle 1). If a urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Women of non-reproductive age were defined as at least 1 year postmenopausal, or had undergone surgical sterilization or hysterectomy; 12. If there is a risk of pregnancy, all subjects (regardless of male or female) need to use low annual failure rate during the entire treatment period until 120 days after the last dose of study drug (or 180 days after the last dose of study drug). Contraceptive measures at 1%; 13. Subjects determined by the researcher to meet the admission criteria;
Exclusion Criteria:
1. The pathology is small cell lung cancer (SCLC), including lung cancer that is a mixture of SCLC and NSCLC;
2. Have received the following treatments:
1) Received systemic anti-tumor treatment within 3 weeks before treatment, such as chemotherapy, targeted therapy, immunotherapy (including Chinese herbal treatment with anti-tumor indications), etc.; 2) Have received any investigational drug treatment within 4 weeks before treatment; 3) Received large doses of immunosuppressive drugs (systemic glucocorticoids exceeding 10 mg/day of prednisone or its equivalent) within 4 weeks before treatment; 4) Have received live attenuated vaccines within 4 weeks before treatment (or plan to receive live attenuated vaccines during the study); 5) Have undergone major surgery (such as open cavity, thoracotomy or Kaifu surgery) within 4 weeks before treatment, or have unhealed surgical wounds, ulcers or fractures.
3. There is clinically uncontrollable pleural effusion/abdominal effusion (subjects who do not need to drain the effusion or who stop drainage for 3 days without significant increase in effusion can be enrolled);
4. Subjects who have received chest radiation therapy greater than 30Gy within 6 months before treatment or palliative radiation therapy with a dose of 30Gy or less within 7 days before treatment (palliative treatment for bone lesions or intracranial lesions is allowed) Radiation Therapy);
5. Active autoimmune disease that requires systemic treatment (such as the use of disease-modifying drugs, glucocorticoids, or immunosuppressants) has occurred within 2 years before the first dose. Replacement therapies (such as thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency, etc.) are not considered systemic treatments;
6. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation;
7. Those who are known to be allergic to the active ingredients or excipients of tolesimab, the study drug;
8. Have not fully recovered from toxicity and/or complications caused by any intervention before initiating treatment (i.e., ≤Grade 1 or reaching baseline, excluding fatigue or alopecia);
9. Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive);
10. Untreated active hepatitis B (defined as HBsAg positivity and a detected HBV-DNA copy number greater than the upper limit of normal value in the laboratory of the research center);
Note: Hepatitis B subjects who meet the following criteria can also be enrolled:
1. If the HBV viral load is \<1000 copies/ml (200 IU/ml) before the first dose, the subject should receive anti-HBV treatment during the entire study chemotherapy drug treatment period to avoid viral reactivation.
2. Subjects with anti-HBc (+), HBsAg (-), anti-HBs (-) and HBV viral load (-) do not need to receive prophylactic anti-HBV treatment, but need to be closely monitored for viral reactivation
11. Subjects with active HCV infection (HCV antibody positive and HCV-RNA level higher than the lower limit of detection);
12. Get live vaccine within 30 days before the first dose (cycle 1, day 1); Note: Injectable inactivated virus vaccine against seasonal influenza is allowed within 30 days before the first dose; however, intranasal live attenuated influenza vaccine is not allowed.
13. Pregnant or lactating women;
**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:** Jinghui Wang
**Phone:** 13683128239
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Beijing
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Jinghui Wang
- **Phone:** 13683128239
- **Role:** CONTACT
**Country:** China
**Facility:** Beijing Chest Hospital, Capital Medical University
**State:** Beijing
**Status:** RECRUITING
#### Overall Officials
**Official 1:**
**Affiliation:** Employment relationship
**Name:** Beijing C Beijing Chest Hospital
**Role:** PRINCIPAL_INVESTIGATOR
## 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: M5546
- Name: Carcinoma, Non-Small-Cell Lung
- Relevance: LOW
- As Found: Unknown
- ID: M14979
- Name: Respiratory Tract Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M16658
- Name: Thoracic Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M11168
- Name: Lung Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000008175
- Term: Lung Neoplasms
### Intervention Browse Module - Ancestors
- ID: D000000972
- Term: Antineoplastic Agents, Phytogenic
- ID: D000000970
- Term: Antineoplastic Agents
- ID: D000050257
- Term: Tubulin Modulators
- ID: D000050256
- Term: Antimitotic Agents
- ID: D000050258
- Term: Mitosis Modulators
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000000964
- Term: Antimetabolites, Antineoplastic
- ID: D000000963
- Term: Antimetabolites
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M19537
- Name: Paclitaxel
- Relevance: HIGH
- As Found: Surgery
- ID: M231
- Name: Albumin-Bound Paclitaxel
- Relevance: LOW
- As Found: Unknown
- ID: M1668
- Name: Docetaxel
- Relevance: HIGH
- As Found: Physical
- ID: M2985
- Name: Gemcitabine
- Relevance: HIGH
- As Found: Activity
- ID: M2853
- Name: Immunomodulating Agents
- 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
- ID: M4281
- Name: Antimetabolites
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000017239
- Term: Paclitaxel
- ID: D000077143
- Term: Docetaxel
- ID: D000093542
- Term: Gemcitabine
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06421285
**Brief Title:** Effect of Preoperative Exercise on the Prevention of Secondary Lymphedema in Breast Cancer Patients
**Official Title:** Effect of Preoperative Exercise on the Prevention of Secondary Lymphedema in Breast Cancer Patients
#### Organization Study ID Info
**ID:** 2024-0255
#### Organization
**Class:** OTHER
**Full Name:** Asan Medical Center
### Status Module
#### Completion Date
**Date:** 2025-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-17
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-09-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-27
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Asan Medical Center
#### Responsible Party
**Investigator Affiliation:** Asan Medical Center
**Investigator Full Name:** Jae Yong Jeon, MD
**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:** Research purpose: Lymphedema is a very common complication in breast cancer patients. However, since there is currently no curable treatment, it is important to prevent and reduce the severity of lymphedema. The purpose of this study is to evaluate whether preoperative exercise is effective in preventing lymphedema after surgery. For secondary outcome, the preventive effects of exercise on other upper extremity dysfunctions (eg. pectoralis tightness, Axillary web syndrome, Adhesive capsulitis), which are common in breast cancer patients, were assessed.
**Detailed Description:** Study subjects:
* Patients aged 20 or older who were first diagnosed with breast cancer
* BMI over 23
* Patients scheduled to undergo neoadjuvant chemotherapy before surgery Study design: Prospective randomized controlled comparative clinical study
* Intervention is performed for at least 3 months during the neoadjuvant chemotherapy period before surgery.
* Treatment group: Individually tailored exercise consisting of aerobic, strength, and flexibility exercises is prescribed, self-exercise compliance monitoring through an application, and diet management education through nutritional counseling.
* Control group: One session of flexibility exercise training, diet management education through nutritional counseling
Result variable:
* Primary outcome variable:
1) Incidence and severity of postoperative lymphedema: bilateral upper limb volume, ICG lymphography
* Secondary outcome variables:
1. Clinical information: Demographic, disease and treatment-related data
2. Physical-related: height/weight/waist circumference measurement, body composition test, physical examination (axillary membrane evaluation)
3. Upper extremity function (shortening of the pectoralis major muscle, adhesive capsulitis): evaluation of shoulder range of motion, upper extremity muscle strength/grip strength
4. Quality of life assessment: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30(EORTC QLQ-C30), European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Breast cancer module 23(EORTC QLQ-BR23)
Assessment Schedule:
* Initial treatment and evaluation: Immediately after breast cancer diagnosis
* Follow-up evaluation: Immediately after completion of exercise intervention (preoperatively), and at 1, 3, and 6 months postoperatively.
Number of study subjects:
* This study will be conducted as a preliminary study for future research, and will be conducted on a total of 60 patients (30 in the experimental group and 30 in the control group) with an allocation ratio between groups of 1:1.
### Conditions Module
**Conditions:**
- Breast Neoplasms
**Keywords:**
- Preoperative Exercise
- Lymphedema
- Breast Cancer
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** * Intervention group
* Control group
##### Masking Info
**Masking:** SINGLE
**Masking Description:** * Patients aged 20 or older and younger than 80 years old who were first diagnosed with breast cancer
* BMI of 23 or higher
* Patients scheduled to undergo neoadjuvant chemotherapy before surgery
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Individually tailored exercise consisting of aerobic, strength, and flexibility exercises is prescribed, self-exercise compliance monitoring through an application, and diet management education through nutritional counseling.
**Intervention Names:**
- Behavioral: Aerobic exercise, Strength training, Flexibility exercise
**Label:** Intervention group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** One session of flexibility exercise education, diet management education through nutritional counseling
**Label:** Control group
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Intervention group
**Description:** Aerobic exercise: 30-40 minutes/time, 3-5 times a week, intensity of 4-6 points on the Rating of Perceived Exertion(RPE) 10-point scale(A simple conversation is possible during exercise, but the intensity is such that you feel out of breath) Strength training: 2-3 times a week, 3 sets of 10 repetitions per movement
* Upper extremities: Biceps brachii, triceps brachii, deltoid, pectoralis muscle exercise
* Lower extremities: gluteus maximus, hamstrings, quadriceps exercise Flexibility exercise: Stretching and mobility exercises reflecting post-surgery rehabilitation
**Name:** Aerobic exercise, Strength training, Flexibility exercise
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** Using a tape measure, measure the circumference from the wrist to the armpit every 4cm, then apply the ΣCircumference2/π formula to calculate the volume of the upper limb.
**Measure:** Bilateral upper limb volume
**Time Frame:** Immediately, Preoperatively, 1 month, 3 months, 6 months.
**Description:** Indocyanine green (ICG) contrast agent is injected subcutaneously in the distal area, and lymph fluid flowing to the proximal area through collateral lymphatic vessels is checked with an infrared camera.
**Measure:** ICG lymphography
**Time Frame:** Immediately, 6 months.
#### Secondary Outcomes
**Description:** After attaching electrodes to both hands and feet using the Inbody S10 equipment, quantitatively evaluate body composition by measuring human body impedance using multiple frequencies.
**Measure:** Body composition
**Time Frame:** Immediately, 6 months.
**Description:** Measurements are made according to a standardized protocol using a goniometer.
**Measure:** Shoulder range of motion
**Time Frame:** Immediately, Preoperatively, 1 month, 3 months, 6 months.
**Description:** Using a digital hand held dynamometer, the strength of elbow flexion and extension, shoulder abduction, and flexor extensor muscles was measured.
Measure grip strength using a digital hand held dynamometer
**Measure:** Upper limb strength, grip strength
**Time Frame:** Immediately, 6 months
**Description:** Evaluate the patient's quality of life through the corresponding questionnaire
**Measure:** EORTC QLQ-C30
**Time Frame:** Immediately, 6 months
**Description:** Evaluate the patient's quality of life through the corresponding questionnaire
**Measure:** EORTC QLQ-BR23
**Time Frame:** Immediately, 6 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients aged 20 or older and younger than 80 who were first diagnosed with breast cancer
* Patients scheduled for surgery and starting neoadjuvant chemotherapy before surgery
* Patients with body mass index (BMI) of 23 or more
Exclusion Criteria:
* Patients with medical contraindications to exercise intervention or pain or musculoskeletal conditions that may limit active exercise intervention
**Maximum Age:** 80 Years
**Minimum Age:** 20 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Jaeyong Jeon
**Phone:** +82-2-3010-3791
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Seungwoo Cha
**Phone:** +82-2-3010-3799
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Asan Medical Center
**Name:** Jaeyong Jeon
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** Asan Medical Center
**Name:** Heejeong Kim
**Role:** STUDY_CHAIR
**Official 3:**
**Affiliation:** Asan Medical Center
**Name:** Seungwoo Cha
**Role:** STUDY_CHAIR
**Official 4:**
**Affiliation:** Asan Medical Center
**Name:** Chul Jung
**Role:** STUDY_CHAIR
**Official 5:**
**Affiliation:** Asan Medical Center
**Name:** Hwayeong Cheon
**Role:** STUDY_CHAIR
**Official 6:**
**Affiliation:** Asan Medical Center
**Name:** Junghwa Do
**Role:** STUDY_CHAIR
**Official 7:**
**Affiliation:** Asan Medical Center
**Name:** Woojin Jeong
**Role:** STUDY_CHAIR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000001941
- Term: Breast Diseases
- ID: D000012871
- Term: Skin Diseases
- ID: D000008206
- Term: Lymphatic Diseases
### 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: BC15
- Name: Blood and Lymph Conditions
### Condition Browse Module - Browse Leaves
- ID: M5220
- Name: Breast Neoplasms
- Relevance: HIGH
- As Found: Breast Neoplasms
- ID: M12307
- Name: Neoplasm Metastasis
- Relevance: LOW
- As Found: Unknown
- ID: M11206
- Name: Lymphedema
- Relevance: HIGH
- As Found: Lymphedema
- ID: M5218
- Name: Breast Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M11203
- Name: Lymphatic Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001943
- Term: Breast Neoplasms
- ID: D000008209
- Term: Lymphedema
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06421272
**Brief Title:** APP-based Emotion Recognition Training Improve ASD Social Function
**Official Title:** APP-based Emotion Recognition Training Improve ASD Social Function
#### Organization Study ID Info
**ID:** UESTC-neuSCAN-94
#### Organization
**Class:** OTHER
**Full Name:** University of Electronic Science and Technology of China
### Status Module
#### Completion Date
**Date:** 2024-05-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-16
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-05-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-01-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-07
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Electronic Science and Technology of China
#### Responsible Party
**Investigator Affiliation:** University of Electronic Science and Technology of China
**Investigator Full Name:** Weihua Zhao
**Investigator Title:** Associate Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** The main aim of the study is to investigate whether APP-based emotional recognition training improve social function in autistic children.
**Detailed Description:** 50 ASD children age ranged from 4-10 years old will be randomly allocated to either app-based emotional recognition training or memory training groups for 2 months. Before and after training, some assessements were measured including Autism Diagnostic Observation Schedule-2, Childhood Autism Rating Scale, Wechsler Intelligence Scale and Psychoeducational Profile-3. Some other questionnaires are also collected including Social Responsibility Scale-2,Repetitive behavior scale-Revised,Caregiver Strains Questionnaire，Social Communication Questionnaire，Social Anxiety Scale for Children，Adaptive behavior assessment Schedule. Four eye-tracking tasks as follows: (1) Dynamic geometrical paired with dynamic child dancing; (2) Static neutral and emotional faces; (3) A dynamic gaze-following task; (4) social interaction behaviors paired with the toys alone; (5) spinning actions conducted via children paired with objects.
### Conditions Module
**Conditions:**
- Autism Spectrum Disorder High-Functioning
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Experimental group (emotion recognition); control group (memory training)
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 50
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Experimental group: ASD children were asked to do emotion recognition for eight weeks using iPAD. Two 15-minsute sessions each day was required.
**Intervention Names:**
- Behavioral: APP-based emotion recognition intervention
**Label:** APP-based emotion recognition trainning
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Control group: ASD children were asked to do memory training (i.e. 1 back) for eight weeks using iPAD. Two 15-minsute sessions each day was required.
**Intervention Names:**
- Behavioral: APP-based memory intervention
**Label:** APP-based memory training
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- APP-based emotion recognition trainning
**Description:** ASD children were asked to play emotion recognition-related games for eight weeks using iPAD. Two 15-minsute sessions each day was required.
**Name:** APP-based emotion recognition intervention
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- APP-based memory training
**Description:** ASD children were asked to play memory-related games for eight weeks using iPAD. Two 15-minsute sessions each day was required.
**Name:** APP-based memory intervention
**Type:** BEHAVIORAL
### Outcomes Module
#### Other Outcomes
**Description:** CARS
**Measure:** Other questionnaires and assessment
**Time Frame:** 1-2 hour
**Description:** PEP-3
**Measure:** Other questionnaires and assessment
**Time Frame:** 1-2 hour
**Description:** RBS-R
**Measure:** Other questionnaires and assessment
**Time Frame:** 1-2 hour
**Description:** SCQ
**Measure:** Other questionnaires and assessment
**Time Frame:** 1-2 hour
**Description:** CSQ
**Measure:** Other questionnaires and assessment
**Time Frame:** 1-2 hour
#### Primary Outcomes
**Description:** ADOS-2 assessment
**Measure:** ADOS-2 assessment
**Time Frame:** 1-2 hour
**Description:** SRS-2
**Measure:** SRS-2
**Time Frame:** half an hour
#### Secondary Outcomes
**Description:** Tasked based eye-tracking performance including fixation time, fixation counts
**Measure:** Visual performance across five tasks based on eye-tracking
**Time Frame:** half an hour
### Eligibility Module
**Eligibility Criteria:** Inclusion criteria: Clinical diagnosis of Autism Spectrum Disorder and follow these criteria: (1) Age range: 4-10 years old, gender not limited;(2) Ethnicity: Han nationality;(3) Autism Diagnostic Observation Schedule-Second Edition (ADOS-2) Comparison Score greater than or equal to 5 points (Le et al., 2022);(4) Considering that only high-functioning autism individuals can successfully complete the eye-tracking tasks, children with a Wechsler score greater than or equal to 60 points are selected; Exclusion criteria: (1) No neurological complications, such as epilepsy, cerebral palsy, fragile X syndrome, etc.;(2) No prior medical interventions, such as taking antipsychotic drugs, receiving transcranial magnetic stimulation, acupuncture, etc.;(3) No abnormal imaging diagnosis or any brain injury.
**Maximum Age:** 10 Years
**Minimum Age:** 4 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Chendu
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Weihua Zhao, Phd
- **Phone:** +86 18780247797
- **Role:** CONTACT
**Country:** China
**Facility:** University of Electronic Science and Technology
**State:** Sichuan
**Status:** RECRUITING
**Zip:** 611731
## 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: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06421259
**Brief Title:** Descriptive Analysis of Changes in Hepatitis B Markers in People Living With HIV on Injectable Therapy.
**Official Title:** To Switch or Not to Switch to CAB/RPV in PLWH With Past HBV Infection? Risk of HBV Reactivation? A Need for New HBV Markers?
#### Organization Study ID Info
**ID:** 24Infectio01
#### Organization
**Class:** OTHER
**Full Name:** Centre Hospitalier Universitaire de Nice
### Status Module
#### Completion Date
**Date:** 2026-05-20
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-15
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-05-20
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-20
**Type:** ESTIMATED
**Status Verified Date:** 2024-03
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Centre Hospitalier Universitaire de Nice
#### 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 order to assess the risk of hepatitis B reactivation in people living with HIV and undergoing injection therapy, we propose to carry out a descriptive analysis of the evolution of hepatitis B markers in this population.
### Conditions Module
**Conditions:**
- Hiv Infection
- Hepatitis B
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 15
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** HIV infected patients under injectable ART
**Label:** HIV infected patients under injectable ART
### Outcomes Module
#### Primary Outcomes
**Description:** HBV serology, DNA HBV levels
**Measure:** Risk of HBV reactivation under injectable HIV ART
**Time Frame:** From start of injectable HIV treatment to hepatitis B reactivation, assessed up to 24 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
-HIV infected patients under injectable ART
Exclusion Criteria:
-Active HBV infection
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** HIV infected patients attending care in the infectiious disease department of the Universitary Hospital of Nice
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Alissa NAQVI
**Phone:** 492035468
**Phone Ext:** +33
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Nice
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** [email protected] NAQVI
- **Phone:** 0492035468
- **Phone Ext:** +33
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Alissa NAQVI
- **Phone:** 0492035468
- **Phone Ext:** +33
- **Role:** CONTACT
**Country:** France
**Facility:** CHU NiICE
**State:** Alpes Maritimes
**Zip:** 0600
#### Overall Officials
**Official 1:**
**Affiliation:** Centre Hospitalier Universitaire de Nice
**Name:** Alissa NAQVI
**Role:** PRINCIPAL_INVESTIGATOR
## 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: 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: D000018347
- Term: Hepadnaviridae Infections
- ID: D000004266
- Term: DNA Virus Infections
### Condition Browse Module - Browse Branches
- Abbrev: BC01
- Name: Infections
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BC06
- Name: Digestive System Diseases
### Condition Browse Module - Browse Leaves
- ID: M18250
- Name: HIV Infections
- Relevance: LOW
- As Found: Unknown
- ID: M10283
- Name: Infections
- Relevance: HIGH
- As Found: Infection
- ID: M6368
- Name: Communicable Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M9592
- Name: Hepatitis A
- Relevance: HIGH
- As Found: Hepatitis
- ID: M9591
- Name: Hepatitis
- Relevance: HIGH
- As Found: Hepatitis
- ID: M9595
- Name: Hepatitis B
- Relevance: HIGH
- As Found: Hepatitis B
- ID: M3522
- Name: Acquired Immunodeficiency Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M11107
- Name: Liver Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M9610
- Name: Hepatitis, Viral, Human
- Relevance: LOW
- As Found: Unknown
- ID: M17522
- Name: Virus 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: M20487
- Name: Hepadnaviridae Infections
- Relevance: LOW
- As Found: Unknown
- ID: M7442
- Name: DNA Virus Infections
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000007239
- Term: Infections
- ID: D000006506
- Term: Hepatitis A
- ID: D000006509
- Term: Hepatitis B
- ID: D000006505
- Term: Hepatitis
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06421246
**Brief Title:** Activity in Geriatric Patients and Validation of the Danish Version of the Acute Care Mobility Assessment
**Official Title:** Activity in Geriatric Patients and Validation of the Danish Version of the Acute Care Mobility Assessment
#### Organization Study ID Info
**ID:** F-24023831
#### Organization
**Class:** OTHER
**Full Name:** Copenhagen University Hospital, Hvidovre
### Status Module
#### Completion Date
**Date:** 2024-07-15
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-07-15
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-15
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Copenhagen University Hospital, Hvidovre
#### Responsible Party
**Investigator Affiliation:** Copenhagen University Hospital, Hvidovre
**Investigator Full Name:** Mette Merete Pedersen
**Investigator Title:** Senior Researcher
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The study aim to assess 24-hour activity during hospitalization in older adults admitted to a geriatric ward and to validate the Danish version of the Acute Care Mobility Assessment.
**Detailed Description:** During two month, 24-hour activity will be assessed in all patients (65+) admitted to a geriatric ward in Denmark, who are able to walk and to provide informed consent (or vicarious consent. Activity will be measured for a maximum of 7 days. Demografic characteristics will be collected (sex, age, place of residence, comorbidities, admission diagnosis, civil status, frailty), and the patients will be asked about their: daily activities, walking ability, life space activity, present activity, use of walking aids, and falls. On inclusion, the patients will be assessed for their basic mobility, cognition, gait speed, and their level of mobility. The Acute Care Mobility Assessment will be validated on the initial 5-10 patients via cognitive debriefing interviews.
### Conditions Module
**Conditions:**
- Acute Disease
- Old Age
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
### Interventions
#### Intervention 1
**Description:** 24- hour activity will be assessed by SENS motion acitivity monitors, and the Acute Care mobility assessment will be validated by cognitive debriefing interviews in 5-10 patients
**Name:** Activity monitoring and validity of the Danish Version of the Acute Care Mobility Assessement
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** Number of daily steps taken assessed by a SENS motion accelerometer from inclusion and throughout hospitalization
**Measure:** Daily steps
**Time Frame:** 7 days
#### Secondary Outcomes
**Description:** Self-reported mobility by the Acute Care Mobility Assessment. A score of 0-12 can be obtained, with 0 reflecting poor mobility and 12 reflecting a high level of mobility.
**Measure:** Self-reported mobility
**Time Frame:** Days 2, 4 and 6 after inclusion
**Description:** By the Life Space Assessment-DK, which measure mobility and level of dependence in mobility. A score of 0-120 can be obtained, with 0 reflecting poor mobility and 120 reflecting high mobility.
**Measure:** Life Space mobility
**Time Frame:** At inclusion
**Description:** By the New Mobility Score, which assesses the ability to walk indoors and outdoors and the ability to go shopping. A score from 0-9 can be obtained, with 0 reflecting low mobility and 9 reflecting high mobility.
**Measure:** Self-reported pre-admission mobility
**Time Frame:** At inclusion
**Description:** By the Clinical Frailty Scale, which is a clinical evaluation of the degree of frailty of a person. It is scored by health care professionals on a scale from 1 (very fit) to 9 (terminally ill)
**Measure:** Frailty
**Time Frame:** At inclusion
**Description:** By the Orientation Memory Concentration Test, which is a screening of cognitive function. A score from 0 to 28 i obtained with lower scores reflecting poorer cognition (0-7: highly impaired; 8-17 points: moderately imparied; 18-24 points: mildly impaired; 25-28 points: no or insignificatn impairment).
**Measure:** Cognitive status
**Time Frame:** At inclusion
**Description:** By the Katz index, which assesses independence in 6 Activities of Daily Living on a scale from 0 to 6 with 0 reflecting dependence in all activities and 6 reflecting independence in all activities.
**Measure:** Activities of daily living
**Time Frame:** At inclusion
**Description:** By the The Cummulated Ambulation Score, which assessed the ability of a person to get in an out of bed, sit to stand from a chair and walk. It is scored from 0 to 6 with 0 reflecting inability to perform the 3 activities and a score of 6 refelcting independence in the three activities.
**Measure:** Basic mobility
**Time Frame:** Days 2, 4 and 6 after inclusion
**Description:** By the Johns Hopkins Higest Level of Mobility Scale which evaluates a patient's level of mobiltiy on a 1 (lying) to 8 (waling more than 250 feet) point scale
**Measure:** Highest level of mobility
**Time Frame:** At inclusion
**Description:** By the 4 meter habitual gait speed test. It assesses the patient's habitual gait speed on a 4-meter course. The test is scored in m/s.
**Measure:** Gait speed
**Time Frame:** At inclusion
**Description:** Daily time spent walking assessed by a SENS motion accelerometer from inclusion and throughout hospitalization
**Measure:** Daily walking
**Time Frame:** 7 days
**Description:** Daily time spent standing assessed by a SENS motion accelerometer from inclusion and throughout hospitalization
**Measure:** Daily standing
**Time Frame:** 7 days
**Description:** Daily time spent sitting/lying assessed by a SENS motion accelerometer from inclusion and throughout hospitalization
**Measure:** Daily lying/sitting
**Time Frame:** 7 days
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* 65 years
* no delirium
* ability to ambulate
Exclusion Criteria:
* in isolation
* teminally ill
**Minimum Age:** 65 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- OLDER_ADULT
**Study Population:** Older adults admitted to a geriatric ward at Copenhagen University Hospital, Hvidovre
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Mette M Pedersen, PhD
**Phone:** +4538623350
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Lea K Johansen, MHSc
**Phone:** +4538621590
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Hvidovre
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Mette M Pedersen, PhD
- **Phone:** +4538623350
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Lea K Johansen, MHSc
- **Phone:** +4538621590
- **Role:** CONTACT
***Contact 3:***
- **Name:** Mette M Pedersen, PhD
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 4:***
- **Name:** Lea K Johansen, MHSc
- **Role:** SUB_INVESTIGATOR
**Country:** Denmark
**Facility:** Copenhagen University Hospital, Hvidovre
**Status:** RECRUITING
**Zip:** 2650
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000020969
- Term: Disease Attributes
- ID: D000010335
- Term: Pathologic Processes
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M3564
- Name: Acute Disease
- Relevance: HIGH
- As Found: Acute Disease
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
- ID: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000000208
- Term: Acute Disease
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06421233
**Brief Title:** The Effect of Endorphin Massage Applied to Postpartum Women on Anxiety and Fatigue Levels
**Official Title:** The Effect of Endorphin Massage Applied to Postpartum Women on Anxiety and Fatigue Levels
#### Organization Study ID Info
**ID:** 2023/516
#### Organization
**Class:** OTHER
**Full Name:** TC Erciyes University
### Status Module
#### Completion Date
**Date:** 2023-11-30
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-15
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-11-30
**Type:** ACTUAL
#### Start Date
**Date:** 2023-09-04
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-08
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** TC Erciyes University
#### Responsible Party
**Investigator Affiliation:** TC Erciyes University
**Investigator Full Name:** Nurseli Soylu Erener
**Investigator Title:** Research Assistant
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The postpartum period, especially in the first few weeks, can be a difficult period for mothers to adapt to the new situation of having a baby. During this process, physiological, psychological and social changes occur in the mother's body. While many mothers adapt to these changes easily, some mothers may experience psychological disorders at different levels.Among these, anxiety and depression are the most common diseases. Anxiety can negatively affect mothers, especially during birth and the postpartum period.During the postpartum period, nurses have the opportunity to improve maternal and infant health by recognizing and treating anxiety.Physical symptoms associated with postpartum anxiety include fatigue, irritability, difficulty concentrating, and sleep disturbances. However, during the vaginal birth process, mothers may feel tired in the early postpartum period, as the pregnant woman spends a lot of energy by staying hungry for a long time. When the literature was examined, it was determined that endorphin massage reduces back pain in pregnant women, reduces anxiety level in pregnant women, accelerates the involution process in the postpartum period, and has positive effects on postpartum depression.Similar to endorphin massage, it has been determined that back massage reduces back pain in the postpartum period and provides the mother with both physiological and psychological relief. In addition, no study has been found examining the effect of endorphin massage applied to postpartum women on anxiety levels and fatigue in the postpartum period. Therefore, this study aimed to determine the effect of endorphin massage applied to postpartum women who gave birth vaginally on postpartum anxiety and fatigue levels.
**Detailed Description:** Birth is a very important experience in a woman's life. The postpartum period is a period of 6-8 weeks after birth. During this process, physiological, psychological and social changes occur in the puerperal woman's body. While many postpartum women easily adapt to these changes, some postpartum women may experience psychological disorders at different levels. Anxiety can negatively affect postpartum women, especially during birth and the postpartum period. Although it is generally desirable to experience anxiety at a normal and mild level, excessive anxiety can tire the individual emotionally.In addition, postpartum women may feel tired in the early postpartum period due to the pregnant woman fasting for a long time and spending too much energy during the vaginal birth process.This situation can be caused by many physical, psychological and situational factors. Postpartum fatigue can lead to deterioration in the general health of the mother and her baby, as well as other serious problems.Postpartum fatigue negatively affects women's physical and mental functions, wound healing, self-care skills and behaviors, energy, motivation and cognitive status, adaptation to motherhood, baby care behaviors, relationships with marriage and family members, including sexuality, work performance and quality of life. is a symptom.In this process, applications applied to postpartum women increase the quality of life by reducing fatigue.Endorphin massage is among the practices performed to improve the quality of life of women during the postpartum period. Endorphin is a natural painkiller known as the happiness hormone, which is similar to opioids secreted by the body, reduces pain, provides relaxation, protects the body against infections, accelerates metabolism. It is known that massage increases endorphin levels by having a relaxing effect on the muscles. Endorphin massage increases the release of endorphins, allowing the individual to relax, relaxing the muscles and reducing pain. Endorphin massage is a light massage technique that can increase the release of oxytocin and endorphin hormones and provide a feeling of calmness and comfort. When the literature was examined, it was determined that endorphin massage reduces back pain in pregnant women, reduces anxiety level in pregnant women, accelerates the involution process in the postpartum period, and has positive effects on postpartum depression.Similar to endorphin massage, it has been determined that back massage reduces back pain in the postpartum period and provides the mother with both physiological and psychological relief. In addition, no study has been found examining the effect of endorphin massage applied to postpartum women on anxiety levels and fatigue in the postpartum period. Therefore, this study aimed to determine the effect of endorphin massage applied to postpartum women who gave birth vaginally on postpartum anxiety and fatigue levels.
### Conditions Module
**Conditions:**
- Birth
- Anxiety
- Fatigue
**Keywords:**
- Birth
- Vaginal Birth
- Massage
- anxiety
- Endorphin
- Fatigue
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- OUTCOMES_ASSESSOR
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 50
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** * Personal introduction form, state and trait anxiety scale and visual similarity scale for fatigue were applied.
* Endorphin massage was applied twice by the researcher for 15 minutes every two hours.
* After the endorphin massage applied for the second time, the visual similarity scale and the state and trait anxiety scale were applied again for fatigue.
**Intervention Names:**
- Other: massage
**Label:** Intervention group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** * A personal introduction form, state and trait anxiety scale, and visual similarity scale for fatigue were applied.
* Two hours after the first evaluation, the visual similarity scale and the state and trait anxiety scale were applied again for fatigue.
**Label:** Control gruop
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Intervention group
**Description:** Endorphin massage will be given for 15 minutes every 2 hours.
**Name:** massage
**Other Names:**
- endorphin massage
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The state anxiety scale determines how the individual feels at a certain moment and under certain conditions. The scale consists of 20 questions and is asked to choose one of the options 'not at all', 'somewhat', 'a lot' and 'completely' depending on the severity of the thoughts or behaviors. The trait anxiety scale determines how the individual feels, regardless of the situation and conditions, and consists of 20 questions. In answering this scale, one is asked to choose one of the following options: 'almost never', 'sometimes', 'most of the time' and 'almost always', depending on the frequency of the thoughts or behaviors.
**Measure:** State and Trait Anxiety Scale
**Time Frame:** It was applied twice in total, two hours apart.
#### Secondary Outcomes
**Description:** The scale has sub-dimensions of fatigue and energy . It consists of a total of 18 items in two sub-dimensions.
The scale consists of 10 cm horizontal lines with positive expressions at one end and negative expressions at the other end of each item. While the items of the fatigue sub-dimension progress from positive to negative expressions, the items of the energy sub-dimension are in the opposite order. The lowest score obtained in the fatigue sub-dimension is zero and the highest score is 130. In the energy sub-dimension, scores are calculated between 0 and 50 points. A high score of the fatigue sub-dimension and a low score of the energy sub-dimension indicate that the severity of fatigue increases.
**Measure:** Visual Similarity Scale for Fatigue
**Time Frame:** It was applied twice in total, two hours apart.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Giving birth vaginally at term,
* Postpartum within 24 hours,
* Primiparous,
* Those who are healthy and have given birth to a single baby,
* Postpartum women who volunteered to participate in the study were included.
Exclusion Criteria:
* Those with psychiatric illness (Bipolar Disorder, Depression, Obsessive Compulsive Disorder),
* People with chronic diseases (Heart disease, Thyroid problems, Diabetes mellitus, Hypertension, asthma, COPD,
* Those who have been diagnosed with a risky pregnancy (Pre-eclampsia, Arthritis, Pregnancy-related hypertension, Gestational diabetes),
* Whose baby was admitted to neonatal intensive care,
* Postpartum women with postpartum bleeding were not included in the study.
**Healthy Volunteers:** True
**Maximum Age:** 40 Years
**Minimum Age:** 19 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Kocasinan
**Country:** Turkey
**Facility:** Kayseri City Hospital
**State:** Kayseri
#### Overall Officials
**Official 1:**
**Affiliation:** TC Erciyes University
**Name:** Nurseli SOYLU ERENER
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** Only the name of the research can be shared.
**IPD Sharing:** NO
### References Module
#### See Also Links
**Label:** Qian, J., Sun, S., Liu, L., \& Yu, X. (2021). Protocol: Effectiveness of non-pharmacological interventions for reducing postpartum fatigue: a systematic review protocol. BMJ Open, 11(10), 51136
**URL:** http://doi.org/10.1136/BMJOPEN-2021-051136
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001523
- Term: Mental Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M4324
- Name: Anxiety Disorders
- Relevance: HIGH
- As Found: Anxiety
- ID: M8364
- Name: Fatigue
- Relevance: HIGH
- As Found: Fatigue
- 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: D000005221
- Term: Fatigue
- ID: D000001008
- Term: Anxiety Disorders
### Intervention Browse Module - Ancestors
- ID: D000018377
- Term: Neurotransmitter Agents
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- 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: M7885
- Name: Endorphins
- Relevance: HIGH
- As Found: Trexeron
- ID: M20504
- Name: Neurotransmitter Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000004723
- Term: Endorphins
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06421220
**Brief Title:** Evaluation of the Efficacy and Safety of Indocyanine Green Tracing in 3D Fluorescent Laparoscopic Lymph Node Dissection for Gastric Cancer
**Official Title:** Clinical Efficacy and Safety Evaluation of Submucosal Injection of Indocyanine Green Tracer in 3D Fluorescent Laparoscopic Lymph Node Dissection for Gastric Cancer: a Prospective, a Multicenter, Randomized, Controlled Study Clinical Trial
#### Organization Study ID Info
**ID:** KYLL-202403-012-1
#### Organization
**Class:** OTHER
**Full Name:** Qilu Hospital of Shandong University
### Status Module
#### Completion Date
**Date:** 2028-04-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-16
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2028-04-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-20
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Qilu Hospital of Shandong University
#### Responsible Party
**Investigator Affiliation:** Qilu Hospital of Shandong University
**Investigator Full Name:** Wenbin Yu
**Investigator Title:** Professor， and Chief of Gastrointestinal Surgery Department
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Purpose of the study To evaluate whether the clinical efficacy of submucosal injection of indocyanine green tracer laparoscopic gastric cancer lymph node dissection is superior to that of laparoscopic gastric cancer lymph node dissection without indocyanine green tracer in 3D fluorescence laparoscopic mode in patients with gastric adenocarcinoma (cT1-4a, N-/+, M0). To observe the role of submucosal injection of ICG for tumor localization in fluorescence 3D fluorescence laparoscopic surgery and the application of lymph node dissection in laparoscopic radical surgery for gastric cancer.
Study design. Multicenter, randomized, open, parallel-controlled, superiority design. Subgroups Group A (experimental group): indocyanine green tracer 3D laparoscopic gastric cancer lymph node dissection group Group B (control group): no indocyanine green tracer 3D laparoscopic gastric cancer lymph node dissection group.
Study population Patients who met all the inclusion criteria and did not fall into any of the exclusion criteria were eligible to enter this study.
Randomization Patients were first evaluated preoperatively to determine that they could receive laparoscopic radical gastric cancer treatment and receive endoscopic indocyanine green labeling. Once the enrolled cases were determined to meet the admission criteria after laparoscopic exploration, they could be enrolled in this study for randomization. The central dynamic, stratified zone randomization method was used in this study, and the control factors considered were age, tumor site, and preoperative stage. Given the number of seeds and the length of the zones, SAS 9.2 programming was applied to generate the treatment allocation corresponding to the running number 484, which was deposited in the data center. A person at the participating research center was responsible for sending the enrolled case information (age, tumor site, and preoperative stage) to the randomization implementation department at the data center by email, phone, or SMS, and the contact person at each respective research center confirmed that the patient met the enrollment criteria, contacted the contact person for the assigned case in this study, and determined the enrollment of the case by further analyzing the case information, and at the same time, notified the contact person at the research center where the case was located The contact person of the research center where the case is located will be notified at the same time. Competitive enrollment was used in this study.
Blinding.
**Detailed Description:** Case enrollment period: complete enrollment of the required cases within 2 years.
Follow-up period: The 1st case enrollment is the starting point for follow-up, and the last case enrollment to the time of return of the postoperative pathology report (usually 2 weeks postoperatively) is the endpoint of follow-up for secondary study purposes except for the 2-year recurrence type. 2 years after the last 1 case enrollment is the follow-up endpoint for the primary study purpose.
Estimated time: 2024.5-2026.4 (completion of enrollment) - 2028.4 (completion of follow-up) Standardization of Surgical Procedures. Commonly followed principles of handling in both groups Anesthesia All surgeries were performed under general anesthesia with tracheal intubation; the use of epidural-assisted anesthesia depended on the anesthesiologist and was not prescribed in this study.
Obtaining cytologic specimens for abdominal lavage After entering the abdominal cavity, firstly, the cytology specimen of abdominal lavage was retained for postoperative examination (Specific method: ascites was taken directly when ascites was found to be present. If there is no ascites, 100 ml of saline is slowly injected into the abdominal cavity, and the washings are collected and sampled in the Douglas fossa for examination.) Intraoperative exploration After obtaining cytologic specimens from abdominal lavage, the abdominal cavity is explored to check for metastases to the liver, peritoneum, mesentery, and pelvis, and invasion of the gastric plasma membrane.
Provisions for lymph node dissection Gastric cancer D2 lymph node dissection is performed according to the Japanese Guidelines for the Treatment of Gastric Cancer (5th ed.) Lymph node dissection is performed in patients in group A. After lymph node dissection, the NIR mode is used to check for the presence of missing lymph nodes, and if there are any, remedial dissection is performed.
The rules about off-site lymph node dissection: when the tumor is located in the greater curvature of the stomach, or the splenic hilar lymph nodes are enlarged on preoperative imaging, or the lymph nodes in group 10 are visualized intraoperatively, selective splenic preservation and splenic hilar lymph node dissection will be performed for the lymph nodes in group 10; group 14 lymph nodes will also be selectively disseminated when they are visualized intraoperatively; and other off-site lymph nodes will be disseminated or not by decision of the surgeon if they are visualized intraoperatively. The cleared extrastriate lymph nodes should be sent for examination and recorded separately.
Provisions for gastrectomy According to the "Japanese Guidelines for the Treatment of Gastric Cancer" (5th edition), distal or total gastrectomy should be performed as long as the oncologic principle can be guaranteed. If the operator decides to perform total laparoscopic gastrointestinal reconstruction, a sterile marker pen is required to determine the surgical incision line based on the indocyanine green range or other methods before dissecting the gastric wall, and to preserve the photographic data.
Provision for resection of the greater omentum This study protocol requires total greater omentectomy for patients with progressive gastric cancer, and the remainder is not prescribed.
Provisions for digestive tract reconstruction The way of digestive tract reconstruction shall be decided by the surgeon according to his/her own experience and intraoperative conditions, if instrumental anastomosis is used, whether to manually reinforce the anastomosis with suture shall be decided by the surgeon, and it is not stipulated in this study protocol.
Provisions for Surgery-Related Devices and Instruments Energy devices, methods of vascular ligation, GI cutting and closing, and GI reconstruction instruments are determined by the surgeon responsible for the procedure based on experience and actual needs, and are not specified in this study protocol.
Provisions for gastric tube and abdominal drainage tube Whether to keep gastric tube or abdominal drainage tube after surgery is decided by the responsible surgeon based on experience and actual needs, and is not stipulated in this study protocol.
Provisions for other surgeries performed at the same time If intraoperative findings of comorbidities of other systems/organs are detected, and the surgeon in charge of the surgery and the consulting surgeon of the relevant department jointly decide that concurrent surgery is needed to deal with them, concurrent surgery can be performed, and the sequence is decided according to the clinical routine; however, cases are excluded from the PP set according to the exclusion criteria, and the cases are excluded from the PP set.
Provisions for the treatment of excluded cases found during surgery After the patient is judged to be a cull case by the surgeon responsible for the surgery during the operation, this study protocol is suspended, and the surgeon responsible for the surgery decides the follow-up treatment by himself/herself in accordance with the clinical practice routines of the participating centers (therapeutic decision-making on whether or not to carry out the resection of the primary gastric lesion, metastasis, etc., shall be decided by the surgeon responsible for the surgery) Provisions for laparoscopic surgery Provisions for pneumoperitoneum Carbon dioxide pneumoperitoneum is used with a maintenance pressure of 12-13 mmHg, which may be appropriately lowered in advanced age.
Provisions for poking holes and auxiliary incisions The location of puncture holes and auxiliary small incisions is not regulated, and the number of puncture holes should not exceed 5. Only 1 auxiliary small incision may be made, and it must usually be less than 10 cm. when an auxiliary small incision of more than 10 cm is required, the decision must be made at the discretion of the surgeon in charge of the procedure, and the rationale must be documented in detail in the CRF.
Definition of laparoscopic access Intra-abdominal operations must be performed using laparoscopic instruments supported by a camera system. Perigastric freeing, resection of the greater omentum, resection of the omental bursa, lymph node dissection, and management of the vasculature should be accomplished laparoscopically. Gastric resection, and digestive tract reconstruction, are permitted to be accomplished in the open state using auxiliary small incisions.
Provisions for intermediate open abdomen In the event of intraoperative intra-abdominal hemorrhage, organ injury, or other serious/life-threatening complications due to surgical manipulation, which are difficult to control laparoscopically, the abdomen must be actively staged and opened. If intraoperative complications due to carbon dioxide pneumoperitoneum occur, and the anesthesiologist and the surgeon in charge of the operation discuss that it may threaten the patient's life safety, the abdomen must be actively transferred and opened. Other technical, instrumental, and other factors that lead to an intermediate open abdomen are decided by the surgeon in charge of the operation, and the reasons are recorded. The length of the incision for a mid-rotation open abdomen was not regulated in this study. The reason for the mid-excision needs to be clearly documented in the CRF.
Follow-up of rejected cases in the laparoscopic group Whether to continue the surgery under laparoscopy or to intermediate open surgery is at the discretion of the surgeon in charge of the surgery based on clinical experience.
Technical approach to indocyanine green tracing in the study group Patients enrolled in group A (study group) were injected with 1 ml of indocyanine green (indocyanine green for injection, 25 mg/strike, indocyanine green for injection diluted to 0.625 mg/ml with sterilized water for injection) into the submucosal layer of the tumor at a total of four points in the four quadrants of the tumor before the operation, and the submucosal dark-green elevation could be observed after the injection of ICG. Intraoperative visualization of the SLN tracer was performed using ICG system products. (In cT1-2 patients, if the intraoperative position is difficult to determine, preoperative marking with a harmonized titanium clip is added).
### Conditions Module
**Conditions:**
- Gastric Cancer
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 484
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Procedure: Preoperative injection of indocyanine green
**Label:** Indocyanine green tracer 3D laparoscopic gastric cancer lymph node dissection group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Label:** Indocyanine green tracer-free 3D laparoscopic gastric cancer lymph node dissection group
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Indocyanine green tracer 3D laparoscopic gastric cancer lymph node dissection group
**Description:** Submucosal injection of indocyanine green into the gastric mucosa prior to surgery， indocyanine green，25mg，powder，once
**Name:** Preoperative injection of indocyanine green
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** Observation of the rate of disease-free survival of patients two years after surgery
**Measure:** 2-year disease free survival rate
**Time Frame:** 12 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
Age: 18-75 years old Gastric adenocarcinoma diagnosed histopathologically by endoscopic biopsy of the primary gastric lesion (pap, tub, muc, sig, por) The preoperative clinical stage was cT1-4a, N-/+, M0, according to the AJCC-8th TNM tumor stage.
Preoperative examination did not show distant metastasis, and the tumor did not directly invade the pancreas, spleen and other adjacent organs.
Preoperative ECOG physical status score 0/1 Preoperative ASA score I-III. Patient informed consent
Exclusion Criteria:
Pregnant or nursing women Serious mental illness History of upper abdominal surgery (except history of laparoscopic cholecystectomy) History of gastric surgery (including ESD/EMR for gastric cancer) Preoperative imaging suggestive of regional fusion of enlarged lymph nodes (maximum diameter ≥3cm) History of other malignant diseases within 5 years. Neoadjuvant therapy has been implemented History of unstable angina or myocardial infarction within 6 months History of cerebral infarction or cerebral hemorrhage within 6 months History of continuous systemic corticosteroid therapy within 1 month Require concomitant surgical treatment for other diseases. Gastric cancer complications (bleeding, perforation, obstruction) requiring emergency surgery.
Pulmonary function test FEV1 \<50% of the expected value Diffusely invasive gastric cancer Preoperatively confirmed tumor invading the dentate line or duodenum Previous history of iodine allergy Refusal of laparoscopic surgery
**Maximum Age:** 75 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Jinan
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Wenbin Yu, Phd
- **Phone:** +8618560082483
- **Role:** CONTACT
**Country:** China
**Facility:** Qilu hospital of Shandong University
**State:** Shandong
**Zip:** 250012
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Wei M, Liang Y, Wang L, Li Z, Chen Y, Yan Z, Sun D, Huang Y, Zhong X, Liu P, Yu W. Clinical Application of Indocyanine Green Fluorescence Technology in Laparoscopic Radical Gastrectomy. Front Oncol. 2022 Mar 4;12:847341. doi: 10.3389/fonc.2022.847341. eCollection 2022.
**PMID:** 35311067
**Citation:** Kwon IG, Son T, Kim HI, Hyung WJ. Fluorescent Lymphography-Guided Lymphadenectomy During Robotic Radical Gastrectomy for Gastric Cancer. JAMA Surg. 2019 Feb 1;154(2):150-158. doi: 10.1001/jamasurg.2018.4267.
**PMID:** 30427990
**Citation:** Kim TH, Kong SH, Park JH, Son YG, Huh YJ, Suh YS, Lee HJ, Yang HK. Assessment of the Completeness of Lymph Node Dissection Using Near-infrared Imaging with Indocyanine Green in Laparoscopic Gastrectomy for Gastric Cancer. J Gastric Cancer. 2018 Jun;18(2):161-171. doi: 10.5230/jgc.2018.18.e19. Epub 2018 Jun 28.
**PMID:** 29984066
**Citation:** Lan YT, Huang KH, Chen PH, Liu CA, Lo SS, Wu CW, Shyr YM, Fang WL. A pilot study of lymph node mapping with indocyanine green in robotic gastrectomy for gastric cancer. SAGE Open Med. 2017 Aug 21;5:2050312117727444. doi: 10.1177/2050312117727444. eCollection 2017.
**PMID:** 28856007
**Citation:** Huh YJ, Lee HJ, Kim TH, Choi YS, Park JH, Son YG, Suh YS, Kong SH, Yang HK. Efficacy of Assessing Intraoperative Bowel Perfusion with Near-Infrared Camera in Laparoscopic Gastric Cancer Surgery. J Laparoendosc Adv Surg Tech A. 2019 Apr;29(4):476-483. doi: 10.1089/lap.2018.0263. Epub 2018 Dec 27.
**PMID:** 30589374
**Citation:** Sherwinter DA, Boni L, Bouvet M, Ferri L, Hyung WJ, Ishizawa T, Kaleya RN, Kelly K, Kokudo N, Lanzarini E, Luyer MDP, Mitsumori N, Mueller C, Park DJ, Ribero D, Rosati R, Ruurda JP, Sosef M, Schneider-Koraith S, Spinoglio G, Strong V, Takahashi N, Takeuchi H, Wijnhoven BPL, Yang HK, Dip F, Lo Menzo E, White KP, Rosenthal RJ. Use of fluorescence imaging and indocyanine green for sentinel node mapping during gastric cancer surgery: Results of an intercontinental Delphi survey. Surgery. 2022 Dec;172(6S):S29-S37. doi: 10.1016/j.surg.2022.06.036.
**PMID:** 36427927
**Citation:** Chen QY, Xie JW, Zhong Q, Wang JB, Lin JX, Lu J, Cao LL, Lin M, Tu RH, Huang ZN, Lin JL, Zheng HL, Li P, Zheng CH, Huang CM. Safety and Efficacy of Indocyanine Green Tracer-Guided Lymph Node Dissection During Laparoscopic Radical Gastrectomy in Patients With Gastric Cancer: A Randomized Clinical Trial. JAMA Surg. 2020 Apr 1;155(4):300-311. doi: 10.1001/jamasurg.2019.6033.
**PMID:** 32101269
## Derived Section
### Condition Browse Module - Ancestors
- 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: D000013272
- Term: Stomach Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M16064
- Name: Stomach Neoplasms
- Relevance: HIGH
- As Found: Gastric Cancer
- ID: M8886
- Name: Gastrointestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M7256
- Name: Digestive System Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M16062
- Name: Stomach Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T5486
- Name: Stomach Cancer
- Relevance: HIGH
- As Found: Gastric Cancer
### Condition Browse Module - Meshes
- ID: D000013274
- Term: Stomach Neoplasms
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06421207
**Brief Title:** Open Label Study Exploring Tissue Histopathology After Ellacor® Procedure in an Abdominoplasty Model.
**Official Title:** Open Label Study to Explore Tissue Histopathology Following Reduction in Skin Surface Using the Ellacor® Micro-Coring™ Procedure in an Abdominoplasty Model.
#### Organization Study ID Info
**ID:** TP-00379
#### Organization
**Class:** INDUSTRY
**Full Name:** Cytrellis Biosystems, Inc.
### Status Module
#### Completion Date
**Date:** 2023-10-04
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-15
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-06-19
**Type:** ACTUAL
#### Start Date
**Date:** 2023-02-22
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-01-29
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Dallas Plastic Surgery Institute
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Cytrellis Biosystems, Inc.
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** True
**Is FDA Regulated Drug:** False
**Is US Export:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The goal of this study to better understand how the ellacor® Micro-Coring™ procedure works using an abdominoplasty, or tummy tuck surgery, model. The people participating in the study will have already decided that they want to have an abdominoplasty procedure.
The main questions this study aims to answer are:
1. how does the ellacor® procedure change skin tissue?
2. is the ellacor® device safe to use at specific treatment depths?
The ellacor® procedure will be performed on people who are going to have abdominoplasty surgery. The ellacor® treatment areas will be limited to the areas marked for removal of skin during the abdominoplasty. The treated tissue will be sent to a lab for microscopic study after the abdominoplasty procedure is complete. A minimum of 3 people will be treated in each of 2 groups for a total of 6 total participants.
3 participants in the first group will have the ellacor® procedure done 30 days before their abdominoplasty surgery. The ellacor® procedure will be done at different depths in designated locations: 4mm, 5mm and 7mm. The participants will be asked about any changes to their health or medications while on the study.
3 participants in the second group will have the ellacor® procedure done at 3 different timepoints, 30 days apart, all at the same depth of 4mm. They will also be asked about any changes to their health or medications while on the study.
Researchers will study the abdominoplasty tissue under a microscope after it has been removed from the participants. They will compare the areas treated by the ellacor® device to an area left untreated. This will reveal any changes in the skin tissue between treated and untreated areas, if they occur.
### Conditions Module
**Conditions:**
- Histopathology
- Wrinkle
- Rhytides
**Keywords:**
- Mechanism of Action
- Micro-Coring
- Abdominoplasty
- histopathology
- immunohistochemistry
- wrinkle treatment
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Abdominoplasty model
##### Masking Info
**Masking:** NONE
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 6
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Each subject will be treated a single time at 4mm, 5mm and 7 mm depths at a minimum of 3 treatment areas. A non-treated control area will also be designated. Histology evaluations for all treatment areas and the control area will occur 30 days after treatment (Day 30).
**Intervention Names:**
- Device: ellacor® Micro-Coring procedure
**Label:** Cohort 1 Safety Evaluation of Treatment Depths
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** Each subject will be treated at a specified depth (4mm). Treatment area 1 will have 3 treatments with the study device, each treatment 30 days apart starting on Day 0. Treatment area 2 will have 2 treatments with the study device 30 days apart starting on Day 30. Treatment area 3 will have a single treatment with the study device on Day 60. A non-treated control area will also be designated. Histology evaluations for all treatment areas and the control area will occur 30 days after the area 3 treatment (Day 90).
**Intervention Names:**
- Device: ellacor® Micro-Coring procedure
**Label:** Cohort 2 Multiple Treatment Histology
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Cohort 1 Safety Evaluation of Treatment Depths
- Cohort 2 Multiple Treatment Histology
**Description:** ellacor® Micro-Coring Technology is FDA approved for use by medical professionals for the treatment of moderate and severe wrinkles in the mid and lower face in adults aged 22 years or older with Fitzpatrick skin types I-IV.
**Name:** ellacor® Micro-Coring procedure
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** The incidence and severity of adverse events will be evaluated for both Study Cohorts.
**Measure:** Incidence and severity of adverse events
**Time Frame:** Adverse events will be collected from Day 0 (the initial ellacor treatment day) through the day of the scheduled abdominoplasty procedure (Day 30 for Cohort 1 or Day 90 for Cohort 2).
**Description:** Compare histopathology of stained tissue isolated after a single ellacor® treatment on abdominal tissue. Tissue being evaluated by staining will be isolated from excised abdominal tissue following abdominoplasty. Tissue will have an untreated control area compared to three treated areas wherein the depth of treatment will be 4mm, 5mm, and 7mm. The evaluation will include staining with: Hematoxylin and Eosin (H\&E), Herovici, and Movat stains. The use of these stains will provide a comparison of the structural tissue changes (H\&E stain), change in the presence of Type III (young) collagen and Type I (mature) collagen (Herovici stain) and change in the presence of collagen, fibrin and elastic fibers (Movat stain) of treated areas compared to untreated control area. Histopathology of the excised abdominal tissue will be performed at a central pathology laboratory by a designated pathologist who will provide detailed report of the findings.
**Measure:** The change in histopathology of abdominoplasty tissue samples after a single treatment with the ellacor® device at depths of 4mm, 5mm and 7mm as compared to an untreated control area.
**Time Frame:** Histopathological studies will be performed on excised abdominoplasty tissue approximately 30 days after a single ellacor® treatment.
**Description:** Evaluate the comparative histopathology of tissue isolated after multiple treatments on abdominal tissue. Tissue being evaluated by staining will be isolated from excised abdominal tissue after abdominoplasty. Tissue will have an untreated control area compared to three treated areas. Area 1 will have 3 treatments. Area 2 will have 2 treatments. Area 3 will have treatment. The evaluation will include staining with: Hematoxylin and Eosin, Herovici, and Movat stains. These stains will provide comparison of the structural tissue change (H\&E stain), change in the presence of Type III (young) and Type I (mature) collagen (Herovici stain) and change in the presence of collagen, fibrin and elastic fibers (Movat stain) of treated areas compared to the untreated control area. Histopathology of the excised abdominal tissue will be performed at a central pathology laboratory by a designated pathologist who will provide detailed report of the findings.
**Measure:** The change in histopathology of abdominoplasty tissue after 1, 2 and 3 ellacor® treatments (depth of 4mm) compared to untreated control area. Treatments are separated by 30 days with a final tissue comparison 90 days after the first treatment.
**Time Frame:** The histopathological studies will be performed on the excised abdominoplasty tissue approximately 90 days after the first ellacor® treatment, 60 days after the second treatment and 30 days after the final treatment is performed.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Undergoing planned abdominoplasty
* Are willing to donate their tissue for evaluation
* BMI ≤ 30
* Women 18 years or older
* Fitzpatrick scale I-VI
* Females of childbearing potential will have a negative urine pregnancy test prior to each procedure
* Are judged to be in good health based on the results of a medical history and physical examination (standard of care for abdominoplasty) at screening
* Has been informed of the nature of the study and agrees to its provisions and has provided written informed consent on a form, as approved by the IRB of the respective clinical site.
* Able and willing to comply with all visits, procedures and evaluation schedules and requirements
Exclusion Criteria:
* Having an active bleeding disorder or currently taking anticoagulants
* History of keloid formation or abnormal wound healing
* Inflammation or active infection and treatment area
* Compromised immune system (e.g., diabetes)
* Any surgery or treatments in the abdominal area 12 months prior to procedure
* Comorbid condition that could limit ability to participate in the study or to comply with follow up requirements
* Pregnant or breastfeeding
* Tattoo and/or mole located within the planned treatment area(s)
* Vulnerable populations include those defined 45 CFR 46 Subparts B, and those mentioned in 45 CFR 46.111(b): mentally disabled persons, or economically or educationally disadvantaged persons
* Any issue that at the discretion of the investigator would contraindicate the subject's participation
**Gender Based:** True
**Gender Description:** Self-representation.
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Dallas
**Country:** United States
**Facility:** Dallas Plastic Surgery Institute
**State:** Texas
**Zip:** 75231
#### Overall Officials
**Official 1:**
**Affiliation:** Dallas Plastic Surgery Institute
**Name:** Rod Rohrich, MD
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06421194
**Brief Title:** Functional and Nutritional Plant-based Mixed Protein Study (FuN Protein Study)
**Official Title:** Functional and Nutritional Plant-based Mixed Protein Study (FuN Protein Study)
#### Organization Study ID Info
**ID:** 2023/00944
#### Organization
**Class:** OTHER_GOV
**Full Name:** Clinical Nutrition Research Centre, Singapore
### Status Module
#### Completion Date
**Date:** 2025-01-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-15
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-01-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-02-23
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER_GOV
**Name:** Clinical Nutrition Research Centre, Singapore
#### Responsible Party
**Investigator Affiliation:** Clinical Nutrition Research Centre, Singapore
**Investigator Full Name:** Melvin Leow
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The study aims to investigate the effects of optimized plant protein mixtures versus their animal protein equivalents on satiety, protein metabolism, and overall metabolic health
**Detailed Description:** The research described in this application is crucial as it addresses a fundamental issue - the nutrition quality of plant-based diets. Plant-based diets are widely acknowledged for their health benefits as they are known to reduce disease risks and all-cause mortality. However, concerns about plant protein quality arise due to disparities in amino acid profiles, particularly their essential amino acid adequacy, which remains a challenge in adopting a plant-based protein diet as part of a healthy diet. Other challenges include low palatability, poor texture, flavor, and mouthfeel. To address this, the Singapore Institute of Food and Biotechnology Innovation (SIFBI) has developed Asian-centric plant-based food products by combining multiple plant-protein sources to emulate the amino acid profile of animal proteins. This approach aims to optimize plant-based diets by ensuring enhanced protein quantity and quality in a mixed meal, not only to encourage adaptation of plant based protein into daily meals for environmental sustainability but also with the long-term objectives to use diet as a means to improve metabolic health in the Asian demographics. This human study is designed to explore the effects of consuming optimized plant-protein-based products compared to conventional animal protein- based products on postprandial metabolism and overall metabolic health. The study is structured around several specific objectives:
1. Evaluate Nutritional Impact: The study aims to assess the nutritional efficacy of the investigational food products. This will involve measuring circulating amino acids and protein metabolism markers, such as blood urea and amino acid metabolites. Additionally, the study will examine the effects of these foods on overall metabolic health, including their impact on glycaemic response and inflammatory markers.
2. Investigate Postprandial Satiety: Another key aim is to explore the effects of investigational food items on postprandial appetite and satiety. This will help determine how these foods influence hunger and fullness sensations following consumption, which is crucial for understanding their potential role in weight management and metabolic regulation.
3. Investigate Consumer Acceptance: The study will also assess consumer acceptance of the investigational food products to identify the potential barriers. This includes evaluating the palatability of these products, as their taste, texture, and overall appeal are vital factors in determining their potential integration into regular diets.
4. Gain Mechanistic Insight: The study seeks to gain deeper mechanistic insights by systematically investigating changes in the postprandial circulating proteome. This analysis will enhance our understanding of the biological processes and pathways involved in the body's response to these food products post-consumption.
### Conditions Module
**Conditions:**
- Nutrition, Healthy
**Keywords:**
- plant-based protein
- Asian
- diet
- health outcomes
- animal-based protein
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
**Intervention Model Description:** A randomized controlled crossover trial, where participants will undergo four sessions, each followed by a six-day wash-out period.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 28
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Animal-based protein meal; Isoproteic at \~30g of total protein per meal. Siew mai (6 pieces) - steamed Ngoh Hiang (2 pieces) - oven baked
**Intervention Names:**
- Other: Investigational meal 1 - Commercial animal-based protein foods [Siew mai (6 pieces) and Ngoh hiang (2 pieces)]
**Label:** Treatment 1 Animal-based protein meal
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Animal-based protein meal; Isoproteic at \~30g of total protein per meal. Gyoza (11 pieces) - steamed Luncheon meat (5 pieces) - oven baked
**Intervention Names:**
- Other: Investigational meal 2- Commercial animal-based protein foods [Gyoza (11 pieces) and Luncheon meat (5 pieces)]
**Label:** Treatment 2 Animal-based protein meal
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Plant-based protein meal; Isoproteic at \~30g of total protein per meal. Siew mai (6 pieces) - steamed Ngoh Hiang (1 piece cut into 2) - oven baked
**Intervention Names:**
- Other: Investigational meal 3- Formulated plant-based protein foods [Siew mai (6 pieces) and Ngoh hiang (1 piece cut into 2)]
**Label:** Treatment 3 Plant-based protein meal
**Type:** EXPERIMENTAL
#### Arm Group 4
**Description:** Plant-based protein meal; Isoproteic at \~30g of total protein per meal. Gyoza (11 pieces) - steamed Luncheon meat (5 pieces) - oven baked
**Intervention Names:**
- Other: Investigational meal 4- Formulated plant-based protein foods [Gyoza (11 pieces) and Luncheon meat (5 pieces)]
**Label:** Treatment 4 Plant-based protein meal
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Treatment 1 Animal-based protein meal
**Description:** Participants consume a meal consisting of commercial animal-based protein foods (steamed Siew mai and oven-baked Ngoh hiang) in a fasted state.
**Name:** Investigational meal 1 - Commercial animal-based protein foods [Siew mai (6 pieces) and Ngoh hiang (2 pieces)]
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Treatment 2 Animal-based protein meal
**Description:** Participants consume a meal consisting of commercial animal-based protein foods (steamed Gyoza and oven-baked Luncheon meat) in a fasted state.
**Name:** Investigational meal 2- Commercial animal-based protein foods [Gyoza (11 pieces) and Luncheon meat (5 pieces)]
**Type:** OTHER
#### Intervention 3
**Arm Group Labels:**
- Treatment 3 Plant-based protein meal
**Description:** Participants consume a meal consisting of formulated plant-based protein foods (steamed Siew mai and oven-baked Ngoh hiang) in a fasted state.
**Name:** Investigational meal 3- Formulated plant-based protein foods [Siew mai (6 pieces) and Ngoh hiang (1 piece cut into 2)]
**Type:** OTHER
#### Intervention 4
**Arm Group Labels:**
- Treatment 4 Plant-based protein meal
**Description:** Participants consume a meal consisting of formulated plant-based protein foods (Gyoza and Luncheon meat) in a fasted state.
**Name:** Investigational meal 4- Formulated plant-based protein foods [Gyoza (11 pieces) and Luncheon meat (5 pieces)]
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Blood samples collected at 0, 15, 30, 45, 60, 90, 120, 150 and 180 minutes (plasma and serum)
**Measure:** Free amino acids
**Time Frame:** The initial baseline (before investigational meal) at 0 minute, and eight intervals post-meal at 15, 30, 45, 60, 90, 120, 150, and 180 minutes.
**Description:** Blood samples collected at 0, 15, 30, 45, 60, 90, 120, 150 and 180 minutes (plasma and serum)
**Measure:** Protein utilization
**Time Frame:** The initial baseline (before investigational meal) at 0 minute, and eight intervals post-meal at 15, 30, 45, 60, 90, 120, 150, and 180 minutes.
**Description:** Blood samples collected at 0, 15, 30, 45, 60, 90, 120, 150 and 180 minutes (serum)
**Measure:** Glucose homeostasis
**Time Frame:** The initial baseline (before investigational meal) at 0 minute, and eight intervals post-meal at 15, 30, 45, 60, 90, 120, 150, and 180 minutes.
**Description:** Blood samples collected at 0, 15, 30, 45, 60, 90, 120, 150 and 180 minutes (plasma and serum)
**Measure:** Gut hormones
**Time Frame:** The initial baseline (before investigational meal) at 0 minute, and eight intervals post-meal at 15, 30, 45, 60, 90, 120, 150, and 180 minutes.
**Description:** Blood samples collected at 0, 15, 30, 45, 60, 90, 120, 150 and 180 minutes (plasma and serum)
**Measure:** Markers related to general metabolic health
**Time Frame:** The initial baseline (before investigational meal) at 0 minute, and eight intervals post-meal at 15, 30, 45, 60, 90, 120, 150, and 180 minutes.
#### Secondary Outcomes
**Description:** To study molecular mechanism underlying the observed outcomes (plasma and serum).
**Measure:** Untargeted proteomics
**Time Frame:** The initial baseline (before investigational meal) at 0 minute, and eight intervals post-meal at 15, 30, 45, 60, 90, 120, 150, and 180 minutes.
**Description:** To assess participant's postprandial appetite and satiety, participants complete, C a Visual Analogue Scale (VAS) questionnaire pertaining to their appetite.
At baseline time 0 minute, one question will be asked and participants will mark on a scale to indicate how they feel at that moment.
A. Questions on appetite and desire for specific food type (how hungry you feel, how satisfied you feel, how full you feel, how much do you think you can eat)
Time 15 minute to time 180 minute (8 time points, post meal), following two questions will be asked and participants will mark on a scale to indicate how they feel at that moment.
A. Questions on appetite and desire for specific food type (how hungry you feel, how satisfied you feel, how full you feel, how much do you think you can eat) B. Questions on palatability of test meal (to complete immediately after meal intake) (visual appeal, smell, taste, aftertaste, palatibility)
**Measure:** Visual Analogue Scale Questionnaire
**Time Frame:** The initial baseline (before investigational meal) at 0 minute, and eight intervals post-meal at 15, 30, 45, 60, 90, 120, 150, and 180 minutes.
**Description:** Participants complete a questionnaire pertaining to their gastrointestinal (GI) symptoms before investigational meal (0 minute) and at the end of the session (180 minute). Gastrointestinal symptoms pertaining to flatulence, rumbling, bloating, abdominal pain, abdominal cramps, nausea.
**Measure:** Gastrointestinal Symptoms Questionnaire
**Time Frame:** The initial baseline (before investigational meal) at 0 minute, and eight intervals post-meal at 15, 30, 45, 60, 90, 120, 150, and 180 minutes.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Male
* Chinese ethnicity
* Age between 21 to 45 years
* Body Mass Index (BMI) between 18.5 to 27.5 kg/m2
* English-literate
Exclusion criteria:
* Smoking
* Having allergies or intolerances to any common food ingredients including eggs, fish, milk, peanuts, and tree nuts, shellfish, soya, wheat, pea, gluten, cereal, fruits, dairy products, meat, vegetable, sugar and sweetener, natural food colourings or flavourings, etc.
* Following special diets or having intentional dietary restrictions (e.g., vegetarians/vegans)
* Having a dislike towards plant-based or chicken-based foods
* Not willing to adhere to diet modification as in the study's instructions
* Not willing to stop any strenuous activity during or within 24 hours of test days
* Having glucose-6-phosphate dehydrogenase deficiency (G6PD deficiency)
* Having alcohol consumption on \> 4 days per week with ≥ 6 alcoholic drinks per week
* Having sustained elevation of blood pressure (\>160/95 mm Hg)
* HbA1c reading ≥ 6.5% (raised non-fasted/random HbA1c as defined by WHO/ IDF)
* Having previously undergone any gastrointestinal surgery or having history of gastrointestinal disorders
* Having a history of heart, liver, kidney, blood disorders (e.g., thalassemia) or thyroid dysfunctions
* Diabetic
* Having history of tuberculosis, HIV, Hepatitis B or Hepatitis C infections
* Having any prescription medication or any other alternative medicines or supplements (amino acids supplements, e.g. L-carnitine, glutamine and arginine) which may interfere with study measurements in the opinion of the study investigators
* Having antibiotics or suffering from diarrhoea within the last 4 weeks
* Having donated blood within 4 weeks of study participation
* Having poor veins or having history of severe vasovagal syncope (blackouts or fainting) from blood draws
* Employees of the SIFBI (Singapore Institute of Food and Biotechnology Innovation).
**Gender Based:** True
**Healthy Volunteers:** True
**Maximum Age:** 45 Years
**Minimum Age:** 21 Years
**Sex:** MALE
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Melvin Leow, Professor
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Wu Jia Yee, PhD
**Phone:** 6407 0778
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Singapore
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Melvin Leow, Professor
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Wu Jia Yee, PhD
- **Phone:** 6279-2730
- **Role:** CONTACT
**Country:** Singapore
**Facility:** Clinical Nutrition Research Centre
**Status:** RECRUITING
**Zip:** 117599
#### Overall Officials
**Official 1:**
**Affiliation:** Singapore Institute of Food and Biotechnology Innovation (SIFBI), A*STAR
**Name:** Melvin Leow, Professor
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06421181
**Acronym:** KEM-HEN
**Brief Title:** Hemodynamic Effects of Anesthesia Induction
**Official Title:** Hemodynamic Effects of Anesthesia Induction
#### Organization Study ID Info
**ID:** KEM-HEN
#### Organization
**Class:** OTHER
**Full Name:** Kliniken Essen-Mitte
### Status Module
#### Completion Date
**Date:** 2025-05-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-15
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-04-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-26
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Heinrich-Heine University, Duesseldorf
#### Lead Sponsor
**Class:** OTHER
**Name:** Kliniken Essen-Mitte
#### 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 idea of that project is to characterize the hemodynamic changes of a daily used clinical intervention (induction of anesthesia) in a highly controlled environment by two hemodynamic monitoring devices. The aim is an advanced hemodynamic profiling of this intervention and additionally screen for changes in flow patterns in an exploratory fashion.
Both devices complement one another in their hemodynamic profiling ability. One device is a continuous monitoring with instant traceable changes and the other an intermittent point-of-care ultrasound/echocardiography device with advanced possibilities for differential diagnostics.
A second purpose is to test the possibility to implement advanced echocardiography in a point-of-care approach during anaesthesia induction and evaluate the time and quality of a comprehensive analysis by a not-certified anaesthetists with an echocardiography device with features of artificial intelligence versus a certified expert.
**Detailed Description:** Mortality after surgery is still high and high-risk procedures are associated to high postoperative complication rates. For hemodynamic monitoring, a meta-analysis showed a reduction in mortality and especially for the esophageal Doppler a reduction in postoperative complications. However, the effects reducing mortality and morbidity have to be considered as low. Probably, this is the reason why daily clinical implementation rates of hemodynamic monitoring are low, too.
However, hemodynamic studies only focus on intraoperative optimization, but recent publications suggested that taking preoperative individual hemodynamic values for arterial blood pressure and cardiac index as targets for optimization provides advanced therapeutic options. Lastly, both studies do not provide data about the preoperative values and their changes during the induction of anesthesia.
Our own data confirm that the induction of anesthesia, the establishment of a working epidural and the surgical incision of the abdomen leads to decreased cardiac index and markers of inotropy in otherwise cardiovascular healthy patients. However, the intervention studies and our own data strongly suggest that starting hemodynamic monitoring after the induction of anesthesia or the surgical incision may foreclose that the clinician can guide the hemodynamic therapy towards individualized goals. Additionally, the corrective treatment in this scenario could be different from just vasopressors.
Nevertheless, in contrast to our own data a recent study showed that hypotension in the post-induction period is primarily associated with a decreased vascular tone due to anesthetic agents, suggesting that the appropriate treatment is vasopressors.
A detailed hemodynamic profiling of non-cardiac patients undergoing high-risk cancer surgery prior, during and after the induction of anaesthesia may provide new insights about the effects of anaesthetic drugs, positive pressure ventilation, and changes of sympathetic tone.
### Conditions Module
**Conditions:**
- Patients Undergoing Anaesthesia Induction
**Keywords:**
- Hemodynamic monitoring
- Point-of-care ultrasound
- Point-of-care echocardiography
- Anaesthesia induction
- Respiratory effects
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 30
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Outcomes Module
#### Other Outcomes
**Description:** The characteristics of an echocardiographic assessment will be analysed to examine the feasibility within clinical routine and the results will be compared to the results of a certified echocardiographic expert
**Measure:** Examination times of the echocardiographic assessment by a not-certified expert
**Time Frame:** Time from the start of anaesthesiological monitoring up to the start of anaesthesia induction, up to four hours
**Description:** The characteristics of an echocardiographic assessment will be analysed to examine the feasibility within clinical routine and the results will be compared to the results of a certified echocardiographic expert
**Measure:** Implementation rates in percentages of the echocardiographic assessment by a not-certified expert during clinical care
**Time Frame:** Time from the start of anaesthesiological monitoring up to the start of anaesthesia induction, up to four hours
**Description:** The characteristics of an echocardiographic assessment will be analysed to examine the feasibility within clinical routine and the results will be compared to the results of a certified echocardiographic expert
**Measure:** Number of missed diagnositics of the echocardiographic assessment by a not-certified expert vs. an assessment by a certified examiner
**Time Frame:** Time from the start of anaesthesiological monitoring up to the start of anaesthesia induction, up to four hours
**Description:** The complications will be graded according to the "Clavien-Dindo" classification from one to five with one being a minor complication and five being death
**Measure:** Incidence and description of postoperative complications
**Time Frame:** Time of hospital stay, i.d. from the time of surgery up to discharge from the hospital, up to 30 days after surgery
**Description:** The incidence of organ dysfunctions will be based on laboratory results and or pathophysiological features like delayed bowel opening after surgery
**Measure:** Incidence and description of postoperative organ dysfunctions
**Time Frame:** Time of hospital stay, i.d. from the time of surgery up to discharge from the hospital, up to 30 days after surgery
#### Primary Outcomes
**Description:** The heart rate will be monitored continuously to detect any change of it during the induction of anaesthesia. The change will be described in percentages.
**Measure:** Longitudinal change of heart rate assessed in percentages during the induction of anaesthesia
**Time Frame:** Time from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours
**Description:** The arterial blood pressures will be monitored continuously to detect any change of it during the induction of anaesthesia. The change will be described in percentages.
**Measure:** Longitudinal change of arterial blood pressure assessed in percentaqes during the induction of anaesthesia
**Time Frame:** Time from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours
**Description:** The stroke volume will be monitored continuously to detect any change of it during the induction of anaesthesia. The change will be described in percentages.
**Measure:** Longitudinal change of stroke volume assessed in percentaqes during the induction of anaesthesia
**Time Frame:** Time from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours
**Description:** The echocardiographic feature of strain imaging for the analysis of contractile performance of the myocardium will be monitored prior to induction and after induction of anaesthesia to detect any changes
**Measure:** Longitudinal change of myocardial strain imaging assessed by transthoracic echocardiography during the induction of anaesthesia
**Time Frame:** Time from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours
#### Secondary Outcomes
**Description:** The echocardiographic features will be monitored prior to induction and after induction of anaesthesia to detect any changes
**Measure:** Changes in percentages in a comprehensive echocardiographic assessment of the right ventricle and atrium
**Time Frame:** Time from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours
**Description:** The echocardiographic parameter will be monitored prior to induction and after induction of anaesthesia to detect any changes.
**Measure:** Changes of the left ventricular and atrial volume in percentages assessed by a transthoracic echocardiography
**Time Frame:** Time from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours
**Description:** The echocardiographic features will be monitored prior to induction and after induction of anaesthesia to detect any changes
**Measure:** Changes of the left ventricular systolic and diastolic function in percentages assessed by a transthoracic echocardiography
**Time Frame:** Time from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours
**Description:** The echocardiographic features will be monitored prior to induction and after induction of anaesthesia to detect any changes of the cardiac valve functions like increase of regurgitation
**Measure:** Changes of function of the cardiac valves assessed by a transthoracic echocardiography
**Time Frame:** Time from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours
**Description:** The haemodynamic features will be monitored prior to the start of induction up to the end of induction of anaesthesia to detect any changes
**Measure:** Changes in percentage of the cardiocirculatory flow in an advanced hemodynamic monitoring device based on a pulse-contour methodology in a continuous fashion during induction of anaesthesia
**Time Frame:** Time from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours
**Description:** The ultrasound features will be monitored prior to induction and after induction of anaesthesia to detect any changes
**Measure:** Changes of flow profiles of the splanchnic vessels as well as peripheral arteries determined by ultrasound
**Time Frame:** Time from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours
**Description:** The MSFP will be determined based on the stop-flow-methodology to determine additionally venous return characteristics
**Measure:** Mean systemic filling pressure (MSFP)
**Time Frame:** Time from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours
**Description:** BRS will be determined to analyse the impact of drugs of anaesthesia induction on the vegetative nervous system. The assessment is based on invasive measurement of the arterial blood pressure in combination with the electrocardiogram
**Measure:** Baroreceptor sensitivity (BRS)
**Time Frame:** Time from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients undergoing elective laparotomy in the hospital Evangelische Kliniken Essen-Mitte
* Due to the invasiveness of the planned surgery there is an indication for an arterial and central-venous line as well as an peridural catheter
Exclusion Criteria:
* Age \< 18 years
* Lack of written informed consent
* Insufficient language skills
* Unwillingness to have pseudonymized disease data stored at the study site and lack of consent to share anonymized data as part of the clinical trial
* American society of anaesthesiologists physical status higher as grade 3
* congestive heart failure with a grade of 2 or higher according to the New York heart association (NYHA)
* Ischemic cardiopathy with a grade of 2 or higher according to the Canadian cardiovascular society (CCS)
* Known severe valve pathologies of the heart
* Chronic kidney disease with dependency of hemodialysis
* Atrial fibrillation ora trail flutter
* Pulmonary hypertension
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Patients with the diagnosis of advanced primary ovarian cancer will be screened prior to cytoreductive surgery in cooperation with the colleagues of gynaecological oncology. If the patients are eligible they will be informed to give consent.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Aarne Feldheiser, M.D., PhD.
**Phone:** +49201174
**Phone Ext:** 31001
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Stefan Boland
**Phone:** +49201174
**Phone Ext:** 31001
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Essen
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Aarne Feldheiser, M.D., PhD.
- **Phone:** +49201174
- **Phone Ext:** 31001
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Stefan Boland, M.D.
- **Phone:** +49201174
- **Phone Ext:** 31001
- **Role:** CONTACT
**Country:** Germany
**Facility:** Evangelische Kliniken Essen-Mitte
**State:** NRW
**Zip:** 45136
#### Overall Officials
**Official 1:**
**Affiliation:** Evangelische Kliniken Essen-Mitte
**Name:** Aarne Feldheiser, M.D., PhD.
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Chong MA, Wang Y, Berbenetz NM, McConachie I. Does goal-directed haemodynamic and fluid therapy improve peri-operative outcomes?: A systematic review and meta-analysis. Eur J Anaesthesiol. 2018 Jul;35(7):469-483. doi: 10.1097/EJA.0000000000000778.
**PMID:** 29369117
**Citation:** Ripolles-Melchor J, Casans-Frances R, Espinosa A, Abad-Gurumeta A, Feldheiser A, Lopez-Timoneda F, Calvo-Vecino JM; EAR Group, Evidence Anesthesia Review Group. Goal directed hemodynamic therapy based in esophageal Doppler flow parameters: A systematic review, meta-analysis and trial sequential analysis. Rev Esp Anestesiol Reanim. 2016 Aug-Sep;63(7):384-405. doi: 10.1016/j.redar.2015.07.009. Epub 2016 Feb 10. English, Spanish.
**PMID:** 26873025
**Citation:** Sessler DI, Bloomstone JA, Aronson S, Berry C, Gan TJ, Kellum JA, Plumb J, Mythen MG, Grocott MPW, Edwards MR, Miller TE; Perioperative Quality Initiative-3 workgroup; POQI chairs; Miller TE, Mythen MG, Grocott MP, Edwards MR; Physiology group; Preoperative blood pressure group; Intraoperative blood pressure group; Postoperative blood pressure group. Perioperative Quality Initiative consensus statement on intraoperative blood pressure, risk and outcomes for elective surgery. Br J Anaesth. 2019 May;122(5):563-574. doi: 10.1016/j.bja.2019.01.013. Epub 2019 Feb 27.
**PMID:** 30916004
**Citation:** Kouz K, Wegge M, Flick M, Bergholz A, Moll-Khosrawi P, Nitzschke R, Trepte CJC, Krause L, Sessler DI, Zollner C, Saugel B. Continuous intra-arterial versus intermittent oscillometric arterial pressure monitoring and hypotension during induction of anaesthesia: the AWAKE randomised trial. Br J Anaesth. 2022 Oct;129(4):478-486. doi: 10.1016/j.bja.2022.06.027. Epub 2022 Aug 23.
**PMID:** 36008202
**Citation:** Futier E, Lefrant JY, Guinot PG, Godet T, Lorne E, Cuvillon P, Bertran S, Leone M, Pastene B, Piriou V, Molliex S, Albanese J, Julia JM, Tavernier B, Imhoff E, Bazin JE, Constantin JM, Pereira B, Jaber S; INPRESS Study Group. Effect of Individualized vs Standard Blood Pressure Management Strategies on Postoperative Organ Dysfunction Among High-Risk Patients Undergoing Major Surgery: A Randomized Clinical Trial. JAMA. 2017 Oct 10;318(14):1346-1357. doi: 10.1001/jama.2017.14172.
**PMID:** 28973220
**Citation:** Nicklas JY, Diener O, Leistenschneider M, Sellhorn C, Schon G, Winkler M, Daum G, Schwedhelm E, Schroder J, Fisch M, Schmalfeldt B, Izbicki JR, Bauer M, Coldewey SM, Reuter DA, Saugel B. Personalised haemodynamic management targeting baseline cardiac index in high-risk patients undergoing major abdominal surgery: a randomised single-centre clinical trial. Br J Anaesth. 2020 Aug;125(2):122-132. doi: 10.1016/j.bja.2020.04.094.
**PMID:** 32711724
**Citation:** Saugel B, Bebert EJ, Briesenick L, Hoppe P, Greiwe G, Yang D, Ma C, Mascha EJ, Sessler DI, Rogge DE. Mechanisms contributing to hypotension after anesthetic induction with sufentanil, propofol, and rocuronium: a prospective observational study. J Clin Monit Comput. 2022 Apr;36(2):341-347. doi: 10.1007/s10877-021-00653-9. Epub 2021 Feb 1.
**PMID:** 33523352
**Citation:** Middel C, Stetzuhn M, Sander N, Kalkbrenner B, Tigges T, Pielmus AG, Spies C, Pietzner K, Klum M, von Haefen C, Hunsicker O, Sehouli J, Konietschke F, Feldheiser A. Perioperative advanced haemodynamic monitoring of patients undergoing multivisceral debulking surgery: an observational pilot study. Intensive Care Med Exp. 2023 Sep 8;11(1):61. doi: 10.1186/s40635-023-00543-1.
**PMID:** 37682496
**Citation:** Feldheiser A, Juhl-Olsen P, Nordine M, Stetzuhn M, Wiegank L, Knebel F, Treskatsch S, Berger C. A comprehensive echocardiographic analysis during simulated hypovolaemia: An observational study. Eur J Anaesthesiol. 2023 Aug 1;40(8):578-586. doi: 10.1097/EJA.0000000000001863. Epub 2023 Jun 1.
**PMID:** 37265333
## 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: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06421168
**Brief Title:** Lung Function in Bariatric Surgery Candidates
**Official Title:** The Impact of Body Mass Index on Lung Function in Bariatric Surgery Candidates
#### Organization Study ID Info
**ID:** CJBariatric006
#### Organization
**Class:** OTHER
**Full Name:** China-Japan Friendship Hospital
### Status Module
#### Completion Date
**Date:** 2023-12-31
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-15
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-08-31
**Type:** ACTUAL
#### Start Date
**Date:** 2017-09-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** China-Japan Friendship Hospital
#### Responsible Party
**Investigator Affiliation:** China-Japan Friendship Hospital
**Investigator Full Name:** Yuntao Nie
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** This study aims to retrospectively investigate the impact of body mass index on lung function metrics, e.g. FEV1%, FVC%, FEV1/FVC%.
### Conditions Module
**Conditions:**
- Lung Function Decreased
- Obesity
### Design Module
#### Design Info
**Observational Model:** CASE_CROSSOVER
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 1834
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Outcomes Module
#### Primary Outcomes
**Description:** Class 1 obesity: 27.5 kg/m2 \< body mass index \< 32.5 kg/m2; Class 2 obesity: 32.5 kg/m2 \< body mass index \< 37.5 kg/m2; Class 2 obesity: body mass index \> 37.5 kg/m2.
**Measure:** FEV1, FVC, FEV1/FVC% in class 1, 2, and 3 obesity
**Time Frame:** At the time of pulmonary function testing
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Subjects with obesity (BMI ≥ 27.5 kg/m2 according to Chinese guidelines, guidelines from the American Society for Metabolic and Bariatric Surgery and International Federation for the Surgery of Obesity and Metabolic Disorders);
* Age \> 16 years;
* Complete preoperative pulmonary function tests
Exclusion Criteria:
* Patients with a history of lung surgery and/or respiratory diseases (e.g. asthma, pulmonary emphysema, and interstitial pulmonary fibrosis).
**Minimum Age:** 16 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
**Study Population:** Bariatric surgery candidates who completed lung function tests preoperatively were enrolled.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Beijing
**Country:** China
**Facility:** Yuntao Nie
**Zip:** 100029
#### Overall Officials
**Official 1:**
**Affiliation:** China-Japan Friendship Hospital
**Name:** Yuntao Nie, M.D.
**Role:** STUDY_CHAIR
### IPD Sharing Statement Module
**IPD Sharing:** YES
## 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: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06421155
**Brief Title:** Brain MRF in Children, Adolescents and Young Adults With Acute Leukemia
**Official Title:** A Pilot Study of Brain Magnetic Resonance Fingerprinting in Children, Adolescents and Young Adults With Acute Leukemia
#### Organization Study ID Info
**ID:** CASE3923
#### Organization
**Class:** OTHER
**Full Name:** Case Comprehensive Cancer Center
### Status Module
#### Completion Date
**Date:** 2028-11-14
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-15
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2027-11-14
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-30
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Case Comprehensive Cancer Center
#### 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 survival of children, adolescents and young adults (AYA) with acute leukemia has improved dramatically over the last two decades. This success is a result of using multiple chemotherapy drugs in combination, with the inclusion of drugs that enter the brain and prevent leukemia cells from growing there. Studies in these cancer survivors have shown that the exposure to these chemotherapy drugs can lead to risks for impaired brain function, also referred to as neurocognitive side effects of chemotherapy. There is an opportunity to identify participants at risk for these side effects and to prevent their development. The purpose of this study is to incorporate a brain imaging tool known as Magnetic Resonance Fingerprinting (MRF) to look for brain matter changes in acute leukemia participants receiving chemotherapy. The MRF scan will be performed at diagnosis and repeated at multiple times during the entire therapy duration as well as at defined intervals after therapy is complete. Investigators would also do an electronic test of memory and brain function (cognitive function), which would be administered in a gaming format on iPads or a similar device. The goal will be to correlate results of MRF imaging with the tests of cognitive function. The benefits of this imaging technique include that it can be done quickly (in minutes), it is non-invasive, it is resistant to motion-artifacts and it can be easily repeated for comparison purposes. The advantages of the cognitive test include its short duration of 20 minutes and its gaming format making it friendly for children to use.
**Detailed Description:** Acute leukemia (AL), including Acute Lymphoblastic Leukemia (ALL), Acute Myeloid Leukemia (AML) and myeloproliferative neoplasms (MPN) are among the most common childhood cancers, the 5-year overall survival of children with leukemia has significantly improved with the current treatment methods, and is now \~90 % for ALL participants and \~70 % for AML participants. There has been a remarkable shift in the treatment strategy for childhood acute leukemia to reduce the burden of therapy related complications. Most notably, the addition of central nervous system (CNS)-directed, intensified intravenous and intrathecal chemotherapy regimens for most standard risk participants has obviated the need for craniospinal radiation therapy (CRT), thus reserving CRT for high-risk participants. With the improved overall survival rates, there is an increasing focus on characterizing and mitigating the long-term effects of the disease and therapy that may affect the quality of life of these participants. The results of multiple studies have indicated that the long-term survivors of ALL and AML experience varying degrees of neurocognitive deficits including memory loss, poor concentration, deficits in executive functioning and personality changes5-9. Methotrexate which is an important chemotherapeutic agent in the treatment of acute leukemia is known to cause chemotherapy induced cognitive impairment (CICI), by causing complex glial dysfunction leading to disruption of activity-dependent myelination in the CNS.
Studies designed to characterize normal brain development in early childhood have not only contributed significantly to our understanding of healthy neurodevelopment, but have also helped to identify neurodevelopmental problems at an early stage, enabling the application of treatment interventions in a timely fashion. Although magnetic resonance imaging (MRI) has been used for this purpose, its application has been hampered by several limitations including the sensitivity to motion artifact, the length of time required to perform a scan, and the requirement for sedation for younger participants. These limitations can be overcome using a new technology known as magnetic resonance fingerprinting (MRF), which allows for rapid, efficient and simultaneous quantification of multiple tissue properties, and quantifies T1, T2 and Myelin Water Fraction (MWF) simultaneously. Sedation is not necessary since whole brain MRF imaging takes approximately 5 minutes to complete and is resistant to motion artifacts.
These properties position MRF for use to assess multiple tissue properties in both pediatric and AYA participants diagnosed with acute leukemia, before, during and after exposure to CNS directed chemotherapy. The investigator proposes to use MRF to monitor demyelination, which has been documented as an underlying mechanism contributing to the long-term neurocognitive deficits seen in participantsundergoing chemotherapy. The goal of using MRF in this context is that it might ultimately serve as a valuable imaging biomarker that would enable early detection of the participants that are at an increased risk of developing neurocognitive deficits due to exposure to anti-neoplastic chemotherapy, by detecting the myelin changes as defined by MRF quantification of myelin water fraction. The capacity for detection would facilitate development of early interventions for these high-risk participants, so that their quality of life can be preserved as much as possible.
The study will evaluate the feasibility of obtaining MRF imaging data along with assessments of neurocognitive function. Chanages/decline in neurocognitive function in pediatric participants undergoing treatment for acute leukemia have been tested, validated and reported by the Children's Oncology Group using a battery of assessment developed by Cogstate®. The computerized cognitive tests are rapid, reliable, and have demonstrated sensitivity to drug related changes in cognition. The tests have been designed and validated to withstand operational challenges during the conduction of clinical trials. The data system is HIPAA compliant U.S. FDA Class II Exempt Digital Medical Device.
### Conditions Module
**Conditions:**
- Acute Leukemia
- Acute Lymphoblastic Leukemia, Pediatric
- Acute Myeloid Leukemia in Children
- Myeloproliferative Neoplasm
**Keywords:**
- Acute Leukemia Children
- Acute Leukemia Adolescents
- Acute Leukemia Young Adults
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** DIAGNOSTIC
#### Enrollment Info
**Count:** 20
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Once the participants meeting the inclusion criteria are identified and formally consent to participate in the study, each participant will undergo a baseline MRF imaging exam along with the neurocognative testing, preferably prior to starting induction chemotherapy. The total treatment duration for an individual participant can vary anywhere between 6 months - 3 years depending on the type of acute leukemia, so investigator plans to obtain MRF scans every 6 months during the therapy as well as during the first year of the off -therapy period
**Intervention Names:**
- Other: MRF with neurocognative studies
**Label:** MRF +/-Neurocognitive Testing
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- MRF +/-Neurocognitive Testing
**Description:** Magnetic Resonance Imaging is used to assess the risk of neurocognitive side effects in pediatric and AYA patients with acute leukemia receiving chemotherapy and participants will also be asked to complete a neurocognitive battery designed by Cogstate and administered on iPad in a simple gaming format
**Name:** MRF with neurocognative studies
**Type:** OTHER
### Outcomes Module
#### Other Outcomes
**Description:** Cognitive assessment using Cogstate software
**Measure:** Incidence of brain tissue changes using neurocognitive testing
**Time Frame:** Baseline, every 6 months during the duration of therapy(up to 3.5 years), and every 6 months during the first year of the off-therapy period.
#### Primary Outcomes
**Description:** Mean myelin water fraction is measured by Student's T-test. The two-tailed means comparison will be considered statistically significant if a p-value of less than 0.5 is observed.
**Measure:** Incidence of alterations in brain structure as measured by mean myelin water fraction
**Time Frame:** Baseline and during chemotherapy(up to 3.5 years)
#### Secondary Outcomes
**Description:** Brain tissue property maps assessed using MRF scans
**Measure:** Incidence of change in tissue evaluation using brain property mapping
**Time Frame:** Baseline, every 6 months during the duration of therapy(up to 3.5 years), and every 6 months during the first year of the off-therapy period.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age range: 0 - 30 years
* Participants from University Hospitals Rainbow Babies \& Children's Hospital, UH Seidman Cancer Center, and participants referred from outside facilities diagnosed with acute leukemia.
* Meets diagnostic criteria for acute leukemia including acute lymphocytic leukemia (ALL), acute myeloid leukemia (AML) and myeloproliferative neoplasm/leukemia.
* Participants must have the ability to understand and the willingness to sign a written informed consent document. Participants who are 14 years and older must have the ability to understand and the willingness to sign a written informed consent document. Participants who are between the ages of 7 to 13 will be given an information sheet that explains the study to them. The information sheet may be used for study participants between the ages of 14-17 if it would better inform the child about the nature and procedures that will undergo as a participant in the study.
Exclusion Criteria:
* Individuals that are \>2 weeks into the induction chemotherapy for acute leukemia.
* Individuals with either a heart pacemaker, heart defibrillator, metal in the eye, some types of metal elsewhere within the body such as certain surgical clips for aneurysms in the head, heart valve prostheses, electrodes, some other implanted devices, or any other MRI contraindication
**Maximum Age:** 30 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Mari Dallas, MD
**Phone:** 216-844-6223
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Cleveland
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Mari Dallas, MD
- **Phone:** 216-844-6223
- **Role:** CONTACT
***Contact 2:***
- **Name:** Mari Dallas, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** University Hospitals Cleveland Medical Center, Rainbow Babies & Children's Hospital, Case Comprehensive Cancer Center
**State:** Ohio
**Zip:** 44106
#### Overall Officials
**Official 1:**
**Affiliation:** University Hospitals Cleveland Medical Center, Rainbow Babies & Children's Hospital, Case Comprehensive Cancer Center
**Name:** Mari Dallas, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Access Criteria:** Study team will only have access to submit data
**Description:** Clinical diagnosis, treatment, MRI/MRF and neurocognitive testing
**Info Types:**
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
**IPD Sharing:** YES
**Time Frame:** Data will be provided within 12 months from study completion and for at least 6 years after study closure.
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000009369
- Term: Neoplasms
- ID: D000006402
- Term: Hematologic Diseases
- ID: D000007945
- Term: Leukemia, Lymphoid
- ID: D000008232
- Term: Lymphoproliferative Disorders
- ID: D000008206
- Term: Lymphatic Diseases
- ID: D000007160
- Term: Immunoproliferative Disorders
- ID: D000007154
- Term: Immune System Diseases
- ID: D000020969
- Term: Disease Attributes
- ID: D000010335
- Term: Pathologic Processes
- ID: D000001855
- Term: Bone Marrow 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: 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: M10955
- Name: Leukemia, Myeloid
- Relevance: LOW
- As Found: Unknown
- ID: M18127
- Name: Leukemia, Myeloid, Acute
- Relevance: LOW
- As Found: Unknown
- ID: M27585
- Name: Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Relevance: HIGH
- As Found: Acute Lymphoblastic Leukemia
- ID: M10951
- Name: Leukemia, Lymphoid
- Relevance: LOW
- As Found: Unknown
- ID: M12149
- Name: Myeloproliferative Disorders
- Relevance: HIGH
- As Found: Myeloproliferative Neoplasms
- ID: M11220
- Name: Lymphoma
- Relevance: LOW
- As Found: Unknown
- ID: M3564
- Name: Acute Disease
- Relevance: HIGH
- As Found: Acute 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: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
- ID: M5134
- Name: Bone Marrow Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T3995
- Name: Myeloid Leukemia
- Relevance: LOW
- As Found: Unknown
- ID: T182
- Name: Acute Myeloid Leukemia
- Relevance: HIGH
- As Found: Acute Myeloid Leukemia
- ID: T188
- Name: Acute Non Lymphoblastic Leukemia
- Relevance: LOW
- As Found: Unknown
- ID: T175
- Name: Acute Lymphoblastic Leukemia
- Relevance: HIGH
- As Found: Acute Lymphoblastic Leukemia
- ID: T3533
- Name: Lymphoblastic Lymphoma
- Relevance: LOW
- As Found: Unknown
- ID: T170
- Name: Acute Graft Versus Host Disease
- Relevance: HIGH
- As Found: Acute
- ID: T1311
- Name: Chronic Myeloproliferative Disorders
- Relevance: HIGH
- As Found: Myeloproliferative Neoplasms
- ID: T1134
- Name: Childhood Acute Lymphoblastic Leukemia
- Relevance: HIGH
- As Found: Acute Lymphoblastic Leukemia, Pediatric
- 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: D000009196
- Term: Myeloproliferative Disorders
- ID: D000000208
- Term: Acute Disease
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |