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## Protocol Section
### Identification Module
**NCT ID:** NCT06445868
**Brief Title:** Construction and Preliminary Application of COM-B Based Sedentary Behavioural Booster Intervention Programme for Elderly Stroke Patients
**Official Title:** Construction and Preliminary Application of COM-B Based Sedentary Behavioural Booster Intervention Programme for Elderly Stroke Patients
#### Organization Study ID Info
**ID:** HMUDQ20231116221
#### Organization
**Class:** OTHER
**Full Name:** Harbin Medical University
### Status Module
#### Completion Date
**Date:** 2024-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-01
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-10
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-06-01
**Study First Submit QC Date:** 2024-06-01
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Harbin Medical University
#### Lead Sponsor
**Class:** OTHER
**Name:** Liu Shuxian
#### Responsible Party
**Investigator Affiliation:** Harbin Medical University
**Investigator Full Name:** Liu Shuxian
**Investigator Title:** researcher
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Explore the application effect of the sedentary behaviour intervention program for elderly stroke patients based on the COM-B model.
**Detailed Description:** The goal of this clinical trial is to text about in the application effect of the sedentary behaviour intervention program for elderly stroke patients based on the COM-B model. The main question it aims to answer are:
* Changes in sedentary behaviour in elderly stroke patients Participants will received a 12-week sedentary behaviour intervention programme.
Researchers will compare differences in sedentary behaviour between routine care control and intervention groups.
### Conditions Module
**Conditions:**
- Stroke
### 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:** 30
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Knowledge (information support, changing health attitudes); Motivation (motivation to change sedentary behaviour and improve exercise compliance); Capacity (development of exercise plans to improve sedentary behaviour change); Opportunities (increasing the timing of exercise and creating opportunities for sedentary behaviour change); Behaviour (monitoring and reinforcing sedentary behaviour change)
**Intervention Names:**
- Other: Sedentary behaviour intervention
**Label:** intervention group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Routine nursing education
**Label:** control group
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- intervention group
**Description:** COM-B-based development of specific sedentary behavioral interventions to reduce sedentary time, promote healthy activity, and improve quality of life in older stroke patients
**Name:** Sedentary behaviour intervention
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** International Physical Activity Questionnaire (IPAQ) Sedentary behavior and physical activity levels were assessed using the International Physical Activity Questionnaire (IPAQ), which was developed by the International Physical Activity Measurement Working Group (IPAMWG) in 2001, with the coefficients for sedentary behavior and validity scale correlation coefficients of 0.887 and 0.760 for sedentary behavior and 0.779 and 0.718 for physical activity, respectively. In this questionnaire, the metabolic equivalent of walking was 3.3, moderate activity intensity was 4.0, and high intensity activity was 8.0. The formula for calculating sedentary time was: sedentary time per day = (weekday sitting time x 5 + weekend sitting time x 2)/7
**Measure:** sedentary time
**Time Frame:** baseline (T0), 12-week post-intervention (T1), and 8-week follow-up (T2).
**Description:** Social Support Rating Scale (SSRS) This scale is mainly used for the evaluation of individual social support status, with 10 entries, including 3 dimensions of subjective support, objective support and utilization of support. The scoring method is the sum of the scores of each entry, and the higher the score, the higher the level of social support. The scale reliability coefficient was 0.896.
**Measure:** Social Support
**Time Frame:** baseline (T0), 12-week post-intervention (T1), and 8-week follow-up (T2).
**Description:** The Self-Rating Depression Scale (SDS) Self-Rating Depression Scale (SDS) is a 20-item self-rating scale, with scores of 1, 2, 3, and 4 for each item, and the sum of the scores of all items ranging from 53-62 indicating mild depression; 63-72 indicating moderate depression; and more than 72 indicating severe depression. The higher the total score, the more severe the depression. The Cronbach's alpha coefficient of the scale was 0.920.
**Measure:** Depression
**Time Frame:** baseline (T0), 12-week post-intervention (T1), and 8-week follow-up (T2).
**Description:** Functional Exercise Adherence Scale for Stroke Patients (Questionnaire of Exercise Adherence, EAQ) The EAQ was developed by Beilei Lin in 2013 to assess patients' adherence to rehabilitation exercises. It contains 14 entries divided into 3 dimensions (physical participation in exercise, exercise effect monitoring and active seeking of exercise advice adherence), with each entry scored on a scale of 1 to 4. The total score of the scale ranges from 14 to 56, and the adherence index is the percentage value of the patient's measured score to the maximum score of the scale (56). The level of patient adherence was judged according to the adherence index: ≤50% = low level, 50% to 75% = medium level, and ≥75% = high level. The scale had good content validity (0.95), structural validity and validity scale validity, and high retest reliability (ICC: 0.778-0.850) and internal consistency (Cronbach's alpha coefficient: 0.923).
**Measure:** Exercise Adherence
**Time Frame:** baseline (T0), 12-week post-intervention (T1), and 8-week follow-up (T2).
**Description:** Modified Barthel Index Scale (MBI) The MBI scale was made in 1989 by Canadian scholars Shah and Vanchay, who subdivided the BI scale into 5 levels.The MBI scale\[117\] contains 10 basic activities of daily living (ADLs) such as dressing, grooming, eating, bathing, walking, transferring from bed and chair to toilet, etc., and is divided into 5 levels according to the degree of independence from 1-5, with the lowest being 1 and the highest being 5, which is determined and scored out of 100 points according to the completion of the patient's performance. The higher the score, the better the ability to perform activities of daily living.
**Measure:** Ability to perform activities of daily living
**Time Frame:** baseline (T0), 12-week post-intervention (T1), and 8-week follow-up (T2).
**Description:** 10 meter maximum walking speed (10 mMWS) The 10m maximum walking speed can reflect the patient's walking speed and walking functional status. First, a 16-meter straight line is drawn on a smooth surface, with markings at 3 and 13 meters. Let the patient walk along this straight line, assistive devices can be used, the timing starts when they reach 3 meters and ends at 13 meters, the time needed is recorded and the step speed is calculated at the same time, in this study, the test was done 3 times and the average value was taken, the faster the speed represents the better the walking ability and the slower the worse.
**Measure:** 10 meter maximum walking speed
**Time Frame:** baseline (T0), 12-week post-intervention (T1), and 8-week follow-up (T2).
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Meet the diagnostic criteria for cerebral infarction and cerebral hemorrhage in the Diagnostic Points for Various Major Cerebrovascular Diseases in China 2019 issued by the Cerebrovascular Disease Group of the Neurology Branch of the Chinese Medical Association;
* Age ≥60 years;
* National Institute of Health stroke scale (NIHSS) score \<5 (i.e., mild stroke), stable vital signs, and able to cooperate with the survey;
* Total sedentary time ≥6 hours/day measured using the International Physical Activity Questionnaire;
* Resident for ≥6 months in the community residents;
* Patients or under the guidance of others can use WeChat.
Exclusion Criteria:
* Functional ambulation category scale (FAC) score \<2;
* serious myocardial infarction, cerebral hemorrhage and pulmonary embolism in the acute stage of the need to limit the activities of the situation;
* is participating in other physical activity or sedentary behavioral intervention programs;
* severe muscle weakness, fractures and other diseases resulting in limited physical activity;
* serious mental disorders such as schizophrenia or dementia resulting in severe cognitive impairment;
* speech and communication disorders.
**Minimum Age:** 60 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** shuxian Liu
**Phone:** 18238009052
**Role:** CONTACT
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000002561
- Term: Cerebrovascular Disorders
- ID: D000001927
- Term: Brain Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M22306
- Name: Stroke
- Relevance: HIGH
- As Found: Stroke
- ID: M5810
- Name: Cerebrovascular Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M5204
- Name: Brain Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000020521
- Term: Stroke
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06445855
**Brief Title:** The Effectiveness of Online Interpersonal Relationships-Based Pyschoeducation in Increasing Sexual Interest and Arousal in Women With Sexual Interest and Arousal Disorder
**Official Title:** The Effectiveness of Online Interpersonal Relationships-Based Pyschoeducation in Increasing Sexual Interest and Arousal in Women With Sexual Interest and Arousal Disorder
#### Organization Study ID Info
**ID:** Istanbul University-Cerrahpasa
#### Organization
**Class:** OTHER
**Full Name:** Marmara University
### Status Module
#### Completion Date
**Date:** 2025-06-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-31
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-01-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-09-30
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-31
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Marmara University
#### Responsible Party
**Investigator Affiliation:** Istanbul University - Cerrahpasa (IUC)
**Investigator Full Name:** Zeynep Dilşah Yılmaz
**Investigator Title:** 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:** This study will be conducted to examine the effectiveness of interpersonal relationships-based online psychoeducation developed for women with sexual interest and arousal disorders.
**Detailed Description:** Female sexual interest and arousal disorders are common among sexual dysfunctions. In addition to the physical and mental health of women with sexual interest and arousal disorder, interpersonal relationships are also negatively affected. Based on this relationship, it is predicted that interpersonal relationship-based psychoeducation will be effective in the treatment of sexual interest and arousal disorder.
Interpersonal Relationship Psychotherapy or counseling is a short-term, easy, accessible approach that focuses specifically on interpersonal problems and is based on attachment theory, aiming to reduce depressive symptoms and improve interpersonal functioning.
The number of internet users and the possibilities of access to the internet are increasing significantly all over the world, and online health services via the internet are becoming widespread. Online psychoeducation inevitably takes its place in internet-based applications with technological developments.
In this context, this study will be conducted to increase the sexual interest and arousal levels of women with sexual interest and arousal disorders through online psychoeducation.
### Conditions Module
**Conditions:**
- Sexual Arousal Disorder
- Sexual Desire Disorder
**Keywords:**
- Sexual Arousal Disorder
- Sexual Desire Disorder
- Online Intervention Program
- Sexual Interest/ Arousal Disorder
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** One waiting group and one experimental group
##### Masking Info
**Masking:** DOUBLE
**Masking Description:** Women to be included in the study will be divided into two groups after randomization. The first group will be the experimental group and the second group will be the waiting group. The experimental group will receive 8 weeks of interpersonal relationship-based online psychotherapy.
**Who Masked:**
- PARTICIPANT
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 70
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Women in the experimental group will receive an 8-week online intervention program based on interpersonal relationships. An internet-based intervention application will be developed for this intervention. All interventions will be implemented from this intervention.
**Intervention Names:**
- Behavioral: Interpersonal relationship-based intervention program
**Label:** Experimental group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** After the interventions in the experimental group are completed, the intervention program will be applied to the women in the waiting group.
**Intervention Names:**
- Behavioral: Interpersonal relationship-based intervention program
**Label:** Waiting group
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Experimental group
- Waiting group
**Description:** An interpersonal relations-based intervention program will be implemented with an online intervention platform.
**Name:** Interpersonal relationship-based intervention program
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** The inventory is a 13-item inventory developed to measure the level of sexual interest and arousal of women specifically in the last 4 weeks. A total score between 0 and 51 is obtained from the SIDI-F. The cut-off score of the inventory is 33 and 94.7% of the women below this score have a sexual interest and desire disorder.
**Measure:** Sexual Interest and Desire Inventory-Female (SIDI-F)
**Time Frame:** 12 weeks
#### Secondary Outcomes
**Description:** The 13-item scale, which was developed to evaluate the distress experienced by women with sexual dysfunction, has a 5-point Likert structure. The increase in the scale score indicates an increase in the level of sexual distress in women. The cut-off score of the scale is 11.
**Measure:** Female Sexual Distress Scale-Revised
**Time Frame:** 12 weeks
**Description:** The scale was developed to evaluate the sexual problems and sexual functions of individuals in general in the last 4 weeks and consists of 19 questions and 6 subcategories (sexual desire, sexual arousal, lubrication, orgasm, satisfaction and pain). The first 2 questions of the scale are related to "sexual desire", questions 3-6 to "sexual arousal", questions 7-10 to "lubrication", questions 11-13 to "orgasm", questions 14-16 to "satisfaction" and questions 17-19 to "pain" subcategories. Questions 1, 2, 15 and 16 are scored between 1 and 5, while the remaining items are scored between 0 and 5. The highest score that can be obtained from the scale is 36 and the lowest score is 2.
**Measure:** Female Sexual Function Index (FSFI)
**Time Frame:** 12 weeks
**Description:** the dimensions of interpersonal relationships. It has four sub-dimensions: dependency, empathy, trust in others and emotional awareness. The higher the score, the higher the related sub-dimension
**Measure:** Interpersonal Relationship Dimensions Scale
**Time Frame:** 12 weeks
**Description:** hardware, mobile devices, online web pages. It is a five-point Likert-type scale with 10 items. Items with odd numbers are scored from one to five, while items with even numbers are scored from five to one. In the scale score calculation, the score obtained from each participant is multiplied by 2.5 and a score between 0-100 is obtained. A high score on the scale indicates that the usability of the system is high.
**Measure:** System Usability Scale (SUS-TR)
**Time Frame:** 12 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* A person of female biological sex,
* Expressing difficulties in sexual interest and arousal (yes to at least three of the following criteria) (questions related to these criteria will be added to the interview form)
* Decrease/absence in frequency or intensity of sexual activity,
* Decrease/absence of sexual fantasies/erotic thoughts,
* Inability to initiate sexual intercourse with their partner,
* Lack of sexual excitement and pleasure in almost all sexual relationships (about 75%),
* Decreased/absence of sexual interest/arousal to internal or external sexual erotic stimuli (e.g. written, oral, visual),
* Decreased/absence of genital or nongenital sensations in almost all sexual relationships (approximately 75%).
* Low mean scores on the Female Sexual Function Index and Sexual Interest and Desire Inventory-Female scales (mean score on the Female Sexual Function Index below 26.55, mean score on the Sexual Interest and Desire Inventory-Female below 33)
* Have sufficient knowledge about the use of the Internet,
* Women who have had a sexual partner for at least 1 year are among the inclusion criteria for this study.
Exclusion Criteria:
* Becoming pregnant or planning pregnancy during the psychoeducation period,
* Receive treatment for any sexual dysfunction,
* Withdrew from the study at any stage of the study,
* Women who do not attend more than one session of the psychoeducation will not be included in the study (Women who miss the weekly program of the psychoeducation will be allowed a maximum of 2 make-up sessions).
**Healthy Volunteers:** True
**Maximum Age:** 47 Years
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### See Also Links
**Label:** website address
**URL:** https://cinselakademi.com/Login
## 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
### Condition Browse Module - Browse Leaves
- ID: M21873
- Name: Sexual Dysfunctions, Psychological
- Relevance: HIGH
- As Found: Sexual Arousal Disorder
- 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: D000020018
- Term: Sexual Dysfunctions, Psychological
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06445842
**Brief Title:** Short-term Circuit Training on Muscle Mass and Quality of Life in Sedentary Postmenopausal Women
**Official Title:** The Effects of Short-Term Circuit Strength Training Intervention on Muscle Mass, Metabolic Health, Balance, Quality of Life, and Inflammaging in Sedentary Postmenopausal Women
#### Organization Study ID Info
**ID:** 5230490
#### Organization
**Class:** OTHER
**Full Name:** Loma Linda University
### Status Module
#### Completion Date
**Date:** 2025-05-29
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-05
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-05-29
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-31
**Study First Submit QC Date:** 2024-06-05
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Loma Linda University
#### Responsible Party
**Investigator Affiliation:** Loma Linda University
**Investigator Full Name:** Everett Lohman
**Investigator Title:** Assistant Dean for Graduate Academic & Research Affairs 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 purpose of this graduate student research study is to provide healthcare professionals with evidence of the potential of circuit strength training in improving the physical and psychosocial well-being of postmenopausal women.
**Detailed Description:** A randomized controlled trial design will investigate the effects of circuit training on the following dependent variables: muscle mass, strength, inflammatory markers, balance, functional capacity, and quality of life.
Body composition measurements will utilize IN-BODY technology. The Motor Control Screen Lower Body (MCS) will determine balance. For assessing strength, we will use the Dynamometer, specifically for grip strength. Ultrasound will gauge muscle mass, while the BTE (Baltimore Therapeutic Equipment) will handle quadriceps isometric muscle tests. The Peak Expiratory Flow (PEF) will evaluate respiratory strength. Participants' aerobic capacity will be gauged via the 6-minute Walk Test. Heart Rate Variability (HRV) evaluations will rely on Polar devices, and the Fitbit Inspire3. We will also employ the Fitbit Inspire3for tracking sleep quality. Psychosocial factors will be examined through: Falls Efficacy Scale-International (FES-I), SF-36 QOL Questionnaire, PHQ-ADS, and the Pittsburgh Sleep Quality Index (PSQI). Activity levels will be determined through the IPAQ-SF questionnaire. The questionnaires will be completed on Qualtrics or in hardcopy format. Blood tests will monitor inflammatory markers such as IL-6, TNF-α, and hs-CRP. The study will be conducted over 10 weeks, starting from the initial and final data collection. During the first week, participants will need to visit the research laboratory to undergo basic tests. After completing all procedures, including informed consent and blood collection, participants will be randomly assigned (computerized generated) to the experimental (exercise) group (N=18) or control (non-exercise) group (N=18).
In the first week, the exercise group will participate for two additional days to introduce the exercise, evaluate their movements, and determine their maximum exercise capacity. The experimental group will participate in circuit strength training sessions lasting approximately 45 minutes three times a week for 8 weeks. The exercise protocol will consist of a 10-minute warm-up and cool-down, two sets of 12-minute high-intensity circuit training exercises, and a 3-minute break between sets. The intensity of the exercises will be gradually increased every two weeks for 8 weeks.
Meanwhile, the control group will need to maintain their sedentary lifestyle without changing their activity levels or diet.
After completing the 8-week exercise protocol, all participants will visit the lab for a second round of data collection. Additionally, the exercise protocol will be shown to the control group during the retest day of the study.
### Conditions Module
**Conditions:**
- Postmenopausal
**Keywords:**
- postmenopausal
- balance
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 46
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** This group will perform exercises three times a week for eight weeks, with each session lasting approximately 45 minutes.
**Intervention Names:**
- Other: Exercise
**Label:** Exercise Group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** This group will maintain their sedentary lifestyle and will not make any changes to their diet or activity levels during this period
**Intervention Names:**
- Other: No exercise
**Label:** Non-Exercise Group
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Exercise Group
**Description:** The protocol involves a 10-minute warm-up and cool-down session, followed by two sets of high-intensity circuit training exercises (bench press, squats, overhead press, calf raising, barbell row, deadlifts) that last 12 minutes each (6 stations×2sets). There will be a 3-minute break between the exercise sets. The heart rate required during the exercise will be between 70-90% of their maximum capacity and a pre-scale rate of 7.5. The intensity of the exercise will be progressive each two weeks, commencing at 50% of their one rep max and increasing to 80% in their last week. During the initial phase, participants will be required to complete eight reps for each exercise. We will encourage them to increase their intensity level every two weeks.
**Name:** Exercise
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Non-Exercise Group
**Description:** This group will need to maintain their sedentary lifestyle without changing their activity levels or diet
**Name:** No exercise
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The Pittsburgh Sleep Quality Index will be used to measure any trouble sleeping.
**Measure:** sleep quality
**Time Frame:** change between baseline and eight weeks
**Description:** Inflammatory biomarker IL-6 will be tested using a blood draw.
**Measure:** IL-6 Biomarker
**Time Frame:** change between baseline and eight weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Females aged between 50 and 75 years.
* Self-reported postmenopausal status (i.e., cessation of menstruation for a minimum of 12 months).
* Physically capable of participating in an exercise intervention.
* No engagement in structured resistance or aerobic training programs in the six months preceding the study.
Exclusion Criteria:
* Classification as moderate and highly active on the International Physical Activity Questionnaire (IPAQ) (600-3000 MET-minutes/week for "moderate" and higher than 3000 MET-minutes/week for "high" score)
* Diagnosis of any health condition that constitutes a contraindication to physical exercise (e.g., significant cardiovascular disease, orthopedic or neuromuscular restrictions impacting exercise performance or safety).
* Regular use of medication with the potential to affect study outcomes (e.g., corticosteroids, immunosuppressants).
**Gender Based:** True
**Gender Description:** Self-reported postmenopausal status
**Healthy Volunteers:** True
**Maximum Age:** 75 Years
**Minimum Age:** 50 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Everett Lohman, Dsc
**Phone:** (909) 558-1000
**Phone Ext:** 83171
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Loma Linda
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Everett Lohman, DSc
- **Phone:** 909-558-1000
- **Phone Ext:** 83171
- **Role:** CONTACT
**Country:** United States
**Facility:** Loma Linda University
**State:** California
**Status:** RECRUITING
**Zip:** 92354
#### Overall Officials
**Official 1:**
**Affiliation:** Loma Linda University
**Name:** Everett Lohman, DSc
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: T6034
- Name: Quality of Life
- Relevance: HIGH
- As Found: Quality of Life
### Intervention Browse Module - Browse Branches
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Ot
- Name: Other Dietary Supplements
### Intervention Browse Module - Browse Leaves
- ID: M4854
- Name: Benzocaine
- Relevance: LOW
- As Found: Unknown
- ID: T433
- Name: Tannic Acid
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06445829
**Brief Title:** Magnesium Sulfate Combined With Intraarticular Cocktail Injection for Analgesia After Simultaneous Bilateral Total Knee Arthroplasty
**Official Title:** Magnesium Sulfate Combined With Intraarticular Cocktail Injection for Analgesia After Simultaneous Bilateral Total Knee Arthroplasty
#### Organization Study ID Info
**ID:** 202400399A3
#### Organization
**Class:** OTHER
**Full Name:** Chang Gung Memorial Hospital
### Status Module
#### Completion Date
**Date:** 2026-04
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-02
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-04
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-06-02
**Study First Submit QC Date:** 2024-06-02
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Chang Gung Memorial Hospital
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Total knee arthroplasty is a safe procedure with excellent outcome. In recent years, simultaneous bilateral total knee arthroplasty has become more popular. In views of enhanced recovery after surgery, intraarticular cocktail injection for pain control has been developed. However, the safety accumulation dose for simultaneous bilateral knee injection is still an issue. Recently, adding magnesium sulfate to intraarticular cocktail injection in unilateral total knee arthroplasty has been proved effective for prolong pain control. We tempt to conduct a double blinded study to evaluate that whether adding magnesium sulfate intraarticular cocktail injection to one of the knees in simultaneous bilateral total knee arthroplasty patient could effectively decrease pain score with less analgesia dose or not.
### Conditions Module
**Conditions:**
- Osteoarthritis, Knee
**Keywords:**
- intraarticular injection
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** TRIPLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 80
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Cocktail injection with Marcaine, Dexamethasone, normal saline and Magnesium Sulfate
**Intervention Names:**
- Drug: Magnesium sulfate
**Label:** Cocktail injection with Magnesium Sulfate
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Cocktail injection with Marcaine, Dexamethasone, and normal saline
**Label:** Cocktail injection without Magnesium Sulfate
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Cocktail injection with Magnesium Sulfate
**Description:** adding 300mg magnesium sulfate into cocktail injection
**Name:** Magnesium sulfate
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Measure:** VAS score
**Time Frame:** day 0, day 1, day 2, day 3, day 7
**Measure:** muscle power
**Time Frame:** day 0, day 1, day 2, day 3
**Measure:** Straight leg raised test
**Time Frame:** day 0, day 1, day 2, day 3
**Measure:** active range of motion
**Time Frame:** day 0, day 1, day 2, day 3
#### Secondary Outcomes
**Measure:** Magnesium level in blood
**Time Frame:** day 0, day 1
**Measure:** Calcium level in blood
**Time Frame:** day 0, day 1
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* bilateral knee advanced osteoarthritis or osteonecrosis who tend to receive simultaneous bilateral total knee arthroplasty
Exclusion Criteria:
* hypersensitivity to magnesium sulfate
* hypermagnesemia
* severe cardiac, hepatic or renal compromised
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Shih Hui Peng
**Phone:** +886975360757
**Role:** CONTACT
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
### References Module
#### References
**Citation:** Zhao C, Wang L, Chen L, Wang Q, Kang P. Effects of magnesium sulfate on periarticular infiltration analgesia in total knee arthroplasty: a prospective, double-blind, randomized controlled trial. J Orthop Surg Res. 2023 Apr 14;18(1):301. doi: 10.1186/s13018-023-03790-w.
**PMID:** 37060089
**Citation:** Wang Q, Zhao C, Hu J, Ma T, Yang J, Kang P. Efficacy of a Modified Cocktail for Periarticular Local Infiltration Analgesia in Total Knee Arthroplasty: A Prospective, Double-Blinded, Randomized Controlled Trial. J Bone Joint Surg Am. 2023 Mar 1;105(5):354-362. doi: 10.2106/JBJS.22.00614. Epub 2023 Mar 1.
**PMID:** 36856693
## 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: 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: 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 - Ancestors
- ID: D000000700
- Term: Analgesics
- ID: D000018689
- Term: Sensory System Agents
- ID: D000018373
- Term: Peripheral Nervous System Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000000777
- Term: Anesthetics
- ID: D000002492
- Term: Central Nervous System Depressants
- ID: D000000889
- Term: Anti-Arrhythmia Agents
- ID: D000000927
- Term: Anticonvulsants
- ID: D000002121
- Term: Calcium Channel Blockers
- ID: D000049990
- Term: Membrane Transport Modulators
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000077264
- Term: Calcium-Regulating Hormones and Agents
- ID: D000015149
- Term: Tocolytic Agents
- ID: D000012102
- Term: Reproductive Control Agents
### Intervention Browse Module - Browse Branches
- Abbrev: AnArAg
- Name: Anti-Arrhythmia Agents
- Abbrev: ChanBlk
- Name: Channel Blockers
- Abbrev: Analg
- Name: Analgesics
- Abbrev: AntiConv
- Name: Anticonvulsants
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: Repr
- Name: Reproductive Control Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Infl
- Name: Anti-Inflammatory Agents
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: AnEm
- Name: Antiemetics
- Abbrev: Gast
- Name: Gastrointestinal Agents
- Abbrev: BDCA
- Name: Bone Density Conservation Agents
### Intervention Browse Module - Browse Leaves
- ID: M11270
- Name: Magnesium Sulfate
- Relevance: HIGH
- As Found: Increasing
- ID: M7102
- Name: Dexamethasone
- Relevance: LOW
- As Found: Unknown
- ID: M235549
- Name: Dexamethasone acetate
- Relevance: LOW
- As Found: Unknown
- ID: M5315
- Name: Bupivacaine
- Relevance: LOW
- As Found: Unknown
- ID: M4032
- Name: Analgesics
- Relevance: LOW
- As Found: Unknown
- ID: M4107
- Name: Anesthetics
- Relevance: LOW
- As Found: Unknown
- ID: M4213
- Name: Anti-Arrhythmia Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4246
- Name: Anticonvulsants
- Relevance: LOW
- As Found: Unknown
- ID: M5381
- Name: Calcium
- Relevance: LOW
- As Found: Unknown
- ID: M5384
- Name: Calcium Channel Blockers
- Relevance: LOW
- As Found: Unknown
- ID: M5398
- Name: Calcium, Dietary
- Relevance: LOW
- As Found: Unknown
- ID: M9789
- Name: Hormones
- Relevance: LOW
- As Found: Unknown
- ID: M17869
- Name: Tocolytic Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000008278
- Term: Magnesium Sulfate
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06445816
**Brief Title:** Does the Level of Pain in Pediatric Oncology Patients Affect the Level of Psychological Resilience in Parents?
**Official Title:** Does the Level of Pain in Pediatric Oncology Patients Affect the Level of Psychological Resilience in Parents?
#### Organization Study ID Info
**ID:** Istanbul Gelişim Üniversity
#### Organization
**Class:** OTHER
**Full Name:** Istanbul Gelisim University
### Status Module
#### Completion Date
**Date:** 2024-07-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-05
**Overall Status:** ACTIVE_NOT_RECRUITING
#### Primary Completion Date
**Date:** 2024-07-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-05-01
**Type:** ACTUAL
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-06-05
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Istanbul Gelisim University
#### Responsible Party
**Investigator Affiliation:** Istanbul Gelisim University
**Investigator Full Name:** Bahar Nur Kanbur
**Investigator Title:** Assistant Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Resilience is defined as generating coping strategies for the problems and situations that individuals face throughout their lives and developing these strategies in each new situation. While some individuals become helpless in the face of difficulties and give up the struggle, other individuals recover quickly in the face of difficulties and use coping methods well. Accordingly, these individuals have higher levels of crisis management and coping with stress.
**Detailed Description:** Psychological resilience is defined as the process of adaptation, the power of recovery or the ability to successfully overcome change/disasters against significant sources of stress such as a trauma, a threat, a tragedy or family and relational distress, serious health problems, workplace and financial problems. At the same time, psychological resilience, as a personality trait, is also used to mean the power to recover quickly, the power to overcome difficulties, resilience, flexibility and robustness. Individuals who are successful in repairing the psychological destruction that occurs as a result of negative emotional states are considered to be strong individuals in terms of psychological resilience.
Identification of protective factors Psychological resilience is a dynamic process resulting from the interaction of risk factors and protective factors. In the literature, the most frequently emphasized characteristics when defining psychological resilience are risk factors, protective factors that mitigate the impact of negative events and adaptation to risk factors.
Personal risk factors include anxious temperament, health problems, lack of self-confidence, inability to use effective coping mechanisms, inability to express oneself effectively, aggressive personality, pessimistic perspective.
Familial risk factors include lack of healthy family relationships, domestic violence, loss of parents, neglect and abuse in the family, and negative relationships.
Environmental risk factors include low socio-economic level, lack of positive role models, unemployment and migration.
Protective factors are situations that increase the individual\'s adaptation to all risk factors and improve the individual\'s competencies. In other words, they are factors that reduce or eliminate the negative effects of risk factors. In research, risk factors and protective factors are analyzed in three stages: individual, familial and environmental It is stated that individuals with high levels of psychological resilience have a higher level of control over their behaviors compared to other individuals, believe that they can achieve higher success as a result of their efforts, have better social competence and responsibilities, and are more successful in solving problems. When we look at other characteristics of individuals with high psychological resilience, it is stated that they have the power and resilience to influence the people around them and to take advantage of upsetting events and to achieve results. It has also been found that individuals with high levels of resilience have high levels of self-confidence and less anxiety. These individuals like to struggle and do not like to give up. Individuals with low levels of psychological resilience have poor self-control capacity, withdraw from the environment, do not participate in social life and show resistance to change. Individuals with good resilience prefer to struggle by questioning their lives.
### Conditions Module
**Conditions:**
- Pain
- Pediatric Oncology
- Psychological Resilience
### Design Module
#### Design Info
**Observational Model:** CASE_ONLY
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 50
**Type:** ESTIMATED
**Patient Registry:** True
**Study Type:** OBSERVATIONAL
**Target Duration:** 2 Days
### Arms Interventions Module
### Interventions
#### Intervention 1
**Description:** * Parents whose consent was obtained will be asked to fill out the Mother and Child Information Collection Form and Psychological Resilience Scale, respectively.
* Immediately after receiving chemotherapy, the pain levels of the children will be measured with the Facial Expressions Pain Scale - Faces Pain Scale-Revised (FPS-R).
* The psychological resilience scale will be applied to mothers.
**Name:** chemotherapy
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** The pain level of the child receiving chemotherapy will reduce the psychological resilience of the mother. In the schematic evaluation, the scoring method is free for measuring psychological resilience as high or low.
**Measure:** Psychological resilience scale
**Time Frame:** 2 day
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Children will be between 4-18 years old
* Communicable children and families
* The child will be hospitalized for inpatient treatment
Exclusion Criteria:
* Outpatients
* Terminal patients
* Children whose parents cannot be reached will be excluded from work
**Maximum Age:** 17 Years
**Minimum Age:** 4 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
**Study Population:** The study will consist of children between the ages of 4-18 and their parents who are being treated at the Oncology Clinic of Altınbaş University Medical Park Bahçelievler Hospital in Istanbul.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Istanbul
**Country:** Turkey
**Facility:** Istanbul Gelisim University
**State:** Avcılar
#### Overall Officials
**Official 1:**
**Affiliation:** Arel University
**Name:** Ebru Sevinç
**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: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000009369
- Term: Neoplasms
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06445803
**Brief Title:** CD19/CD22 CAR-T Cells in Adults With R/R ALL or NHL
**Official Title:** A Preliminary Study to Evaluate the Safety, Tolerability, Preliminary Efficacy and Pharmacokinetic Profile of KQ-2002 (CD19/CD22 CAR-T) in Adults With Recurrent or Refractory Acute Lymphoblastic Leukemia or Non-Hodgkin's Lymphoma
#### Organization Study ID Info
**ID:** KQ-2002-XC001
#### Organization
**Class:** OTHER
**Full Name:** Fudan University
### Status Module
#### Completion Date
**Date:** 2026-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-01
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2026-10
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-06-01
**Study First Submit QC Date:** 2024-06-01
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** Novatim Immune Therapeutics (Zhejiang) Co., Ltd.
#### Lead Sponsor
**Class:** OTHER
**Name:** Rong Tao
#### Responsible Party
**Investigator Affiliation:** Fudan University
**Investigator Full Name:** Rong Tao
**Investigator Title:** Chief physician
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** This study examines the safety, tolerability and preliminary efficacy of anti-CD19 /CD22 CAR T cells (KQ-2002)manufactured on-site in adults with relapsed or refractory CD19+ B cell acute lymphoblastic leukemia or CD19+ B cell non Hodgkin lymphoma.
**Detailed Description:** Patients will undergo screening, leukapheresis (cell collection), lymphodepleting chemotherapy with fludarabine and cyclophosphamide, followed by the anti-CD19 KQ-2002 CAR T cell infusion. The lymphodepleting chemotherapy is administered over 3 days IV to prepare the body for the CAR T cells. The CAR-T cells are infused between 2-7 days after the last dose of chemotherapy. Patients will be followed for two years after the cell infusion on the study and for up to 15 years to monitor for potential long term side effects of cell therapy.
### Conditions Module
**Conditions:**
- Acute Lymphoblastic Leukemia, in Relapse
- Acute Lymphoblastic Leukemia With Failed Remission
- B-cell Lymphoma Refractory
- B-cell Lymphoma Recurrent
**Keywords:**
- CAR-T therapy
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** SEQUENTIAL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 48
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** CD19/CD22-CAR-transduced T cells at escalating doses (0.5\~5.0 ×10\^6 cells/kg)
**Intervention Names:**
- Biological: KQ-2002 CAR-T cells （CD19/CD22 CAR T-Cells）
**Label:** Dose escalation
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** CD19/CD22-CAR-transduced T cells at MTD or highest dose administered
**Intervention Names:**
- Biological: KQ-2002 CAR-T cells （CD19/CD22 CAR T-Cells）
**Label:** Dose expansion
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Dose escalation
- Dose expansion
**Description:** CD19/CD22 cells will be infused on Day1 after induction chemotherapy regimen.
Lymphodepleting chemotherapy:3 days of IV chemotherapy with fludarabine and cyclophosphamide.
Fludarabine 30 mg/m2/day IV x 4 days (days -5 through -3) Cyclophosphamide 500 mg/m2/day IV x 2 days (days -5 and-3)
**Name:** KQ-2002 CAR-T cells （CD19/CD22 CAR T-Cells）
**Type:** BIOLOGICAL
### Outcomes Module
#### Primary Outcomes
**Description:** Will be recorded and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
**Measure:** Incidence of Dose-limiting toxicity
**Time Frame:** Up to 28 days
**Description:** Will be recorded and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
**Measure:** Incidence and severity of adverse events
**Time Frame:** Up to 15 years
#### Secondary Outcomes
**Description:** Proportion of patients achieving a response
**Measure:** Overall response rate
**Time Frame:** up to 15 years
**Description:** Preparative regimen until the documentation of disease progression or death due to any cause, whichever occurs first.
**Measure:** Progression free survival
**Time Frame:** up to 15 years
**Description:** Overall survival (OS) will be determined as the time from the start of the preparative regimen until death
**Measure:** Overall survival
**Time Frame:** up to 15 years
**Description:** MRD status post infusion，MRD will be performed utilizing flow cytometry or PCR.
**Measure:** MRD negative response rates（ Acute Lymphoblastic Leukemia ）
**Time Frame:** up to 15 years
**Description:** pk properties of CD19/CD22 CAR-T
**Measure:** Persistence of CD19/CD22 CAR-T cells blood, bone marrow
**Time Frame:** up to 15 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Male or female,≥18 years old;
* Histologically confirmed diagnosis of B-ALL or B-NHL(meeting one of the following conditions):
(B-NHL)
1. Second or greater relapse (CD20 regimens must be included) OR
2. Refractory to first-line chemotherapy or relapse within 1 year OR
3. Relapse within 1 year of auto-HSCT.
4. With measurable or evaluable lesions（Dose expansion cohort） (B-ALL)
a. Relapse within 12 months of complete remission on first treatment OR b. Relapse after second-line treatment OR c. Relapse after auto HST OR d. Failure to achieve CR/CRi at the end of induction therapy OR e. Ph+ ALL intolerance to TKI or refractory or relapse after treatment with at least two and more TKIs.
* ECOG 0\~2
* Estimated survival time ≥ 12 weeks;
* Main tissues and organs function well.
Exclusion Criteria:
* Subjects will be excluded related to the following prior therapy criteria:Prior treatment with bendamustine-containing or fludarabine;Anti-T-cell monoclonal antibody, donor lymphocyte infusion, and CNS radiotherapy within 8 weeks; Chemotherapy, lenalidomide, bortezomib within 2 weeks; vincristine within 1 week; glucocorticoids (prednisone ≥7.5 mg/d or equivalent) within 72 h
* Active or latent hepatitis B or active hepatitis C (test within 8 weeks of screening), or any uncontrolled infection at screening
* Uncontrolled, symptomatic, intercurrent illness including but not limited to angina pectoris, cerebrovascular accident or transient ischemia (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), New York Heart Association (NYHA) classification of ≥ Class III congestive heart failure, severe arrhythmia poorly controlled by medications, hepatic, renal, or metabolic disorders, and hypertension that is uncontrolled by standard therapy；
* active bleeding, or venous thromboembolic event
* Autoimmune diseases (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus, etc.) that result in end-organ damage or require systemic application of immunosuppressive drugs
* Central nervous system (CNS) disease or symptoms of CNS involvement
* Pregnant or nursing (lactating) women
* Presence of Grade 2 or above non-hematologic toxicity , alopecia and grade 2 neuropathy excluded
* Any Iinappropriate conditions in the opinion of the PI .
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Weijing Zhang
**Phone:** 021-64175590
**Phone Ext:** 88503
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Nanchang
**Contacts:**
***Contact 1:***
- **Email:** lifeigcp@[email protected]
- **Name:** Fei Li, MD
- **Phone:** 13970038386
- **Role:** CONTACT
***Contact 2:***
- **Name:** Fei Li, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** China
**Facility:** The First Affiliated Hospital of Nanchang University;
**State:** Jiangxi
**Status:** RECRUITING
**Zip:** 360000
**Location 2:**
**City:** Shanghai
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Rong Tao, MD
- **Phone:** 8621-64175590
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Wenhao Zhang, MD
- **Phone:** 8621-64175590
- **Role:** CONTACT
***Contact 3:***
- **Name:** Rong Tao, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** China
**Facility:** Fudan University Shanghai Cancer Center
**State:** Shanghai
**Status:** RECRUITING
**Zip:** 200032
#### Overall Officials
**Official 1:**
**Affiliation:** Fudan University
**Name:** Rong Tao, MD
**Role:** PRINCIPAL_INVESTIGATOR
### 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: D000008232
- Term: Lymphoproliferative Disorders
- ID: D000008206
- Term: Lymphatic Diseases
- ID: D000007160
- Term: Immunoproliferative Disorders
- ID: D000007154
- Term: Immune System Diseases
- ID: D000006402
- Term: Hematologic Diseases
- ID: D000008228
- Term: Lymphoma, Non-Hodgkin
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC15
- Name: Blood and Lymph Conditions
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M14850
- Name: Recurrence
- Relevance: LOW
- As Found: Unknown
- ID: M10945
- Name: Leukemia
- Relevance: HIGH
- As Found: Leukemia
- ID: M27585
- Name: Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Relevance: HIGH
- As Found: Acute Lymphoblastic Leukemia
- ID: M10951
- Name: Leukemia, Lymphoid
- Relevance: HIGH
- As Found: Lymphoblastic Leukemia
- ID: M11220
- Name: Lymphoma
- Relevance: HIGH
- As Found: Lymphoma
- ID: M18828
- Name: Lymphoma, B-Cell
- Relevance: HIGH
- As Found: B-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: M9490
- Name: Hematologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M11222
- Name: Lymphoma, Non-Hodgkin
- Relevance: LOW
- As Found: Unknown
- ID: T175
- Name: Acute Lymphoblastic Leukemia
- Relevance: HIGH
- As Found: Acute Lymphoblastic Leukemia
- ID: T3533
- Name: Lymphoblastic Lymphoma
- Relevance: HIGH
- As Found: Acute Lymphoblastic Leukemia
- ID: T3543
- Name: Lymphosarcoma
- Relevance: HIGH
- As Found: Lymphoma
- ID: T640
- Name: B-cell Lymphoma
- Relevance: HIGH
- As Found: B-cell Lymphoma
- ID: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000008223
- Term: Lymphoma
- ID: D000007938
- Term: Leukemia
- ID: D000054198
- Term: Precursor Cell Lymphoblastic Leukemia-Lymphoma
- ID: D000007945
- Term: Leukemia, Lymphoid
- ID: D000016393
- Term: Lymphoma, B-Cell
### 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:** NCT06445790
**Brief Title:** Efficacy of Cognitive Behavior Therapy in the Treatment of Chronic Pelvic Pain in Women
**Official Title:** Efficacy of Cognitive Behavior Therapy in the Treatment of Chronic Pelvic Pain in Women: A Randomized Controlled Trial
#### Organization Study ID Info
**ID:** IUB
#### Organization
**Class:** OTHER
**Full Name:** Islamia University of Bahawalpur
### Status Module
#### Completion Date
**Date:** 2024-10-20
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-05
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-10-20
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-20
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-03-29
**Study First Submit QC Date:** 2024-06-05
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Islamia University of Bahawalpur
#### Responsible Party
**Investigator Affiliation:** Islamia University of Bahawalpur
**Investigator Full Name:** Bushra Akram
**Investigator Title:** PhD Scholar
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** This will be the pilot study trial. The target population will be 30 individuals with Chronic Pelvic Pain (CCP). There will be 02 groups, Experimental Group and Control Group. The primary outcome measure will be Impact of Female Chronic Pelvic Pain Questionnaire (IF-CPPQ). The experimental group will receive CBT spread over 12 sessions.
### Conditions Module
**Conditions:**
- Chronic Pelvic Pain Syndrome
**Keywords:**
- Chronic Pelvic Pain, Pelvic Pain, Women
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** It will receive 12 sessions of Cognitive Behavior Therapy for Chronic Pelvic Pain.
**Intervention Names:**
- Behavioral: Cognitive Behavior Therapy for Chronic Pelvic Pain-CBT-cp
**Label:** Group A
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Group B will be control group.
**Label:** Group B
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Group A
**Description:** CBT-cp will be administered weekly sessions for 12 weeks.
**Name:** Cognitive Behavior Therapy for Chronic Pelvic Pain-CBT-cp
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** Impact of Female Chronic Pelvic Pain Questionnaire (IF-CPPQ)
**Measure:** Impact of Female Chronic Pelvic Pain Questionnaire (IF-CPPQ)
**Time Frame:** Up to 16 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Women of reproductive age.
2. Women with Chronic Pelvic Pain having no pathological or anatomical causes.
3. Women with Overactive Bladder Syndrome.
4. Women with Vulvodynia. -
Exclusion Criteria:
1. Women experiencing perimenopause or menopause.
2. Women with medical, or gynecological or hormonal abnormalities.
3. Women with mental disorders.
4. Women who use substances. -
**Gender Based:** True
**Maximum Age:** 45 Years
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
### IPD Sharing Statement Module
**Info Types:**
- STUDY_PROTOCOL
**IPD Sharing:** YES
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010146
- Term: Pain
- ID: D000009461
- Term: Neurologic Manifestations
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M19918
- Name: Pelvic Pain
- Relevance: HIGH
- As Found: Pelvic Pain
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: HIGH
- As Found: Chronic
### Condition Browse Module - Meshes
- ID: D000017699
- Term: Pelvic Pain
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06445777
**Brief Title:** Impact of Preventive Mental Health Programme on Social/Emotional Functioning and Resilience in Children in South Africa
**Official Title:** Impact of Preventive Mental Health Programme on Social/Emotional Functioning and Resilience in Children in South Africa
#### Organization Study ID Info
**ID:** LLRCT
#### Organization
**Class:** OTHER
**Full Name:** Little Lions Child Coaching
### Status Module
#### Completion Date
**Date:** 2024-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-31
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-12
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-31
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** University of Cape Town
**Class:** OTHER
**Name:** King's College London
#### Lead Sponsor
**Class:** OTHER
**Name:** Little Lions Child Coaching
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** The goal of this clinical trial is to test the effectiveness of a mental health prevention and promotion programme delivered to children (ages 8 to 13) living in under-resourced communities in South Africa.
The main question it aims to answer is:
Does the programme increase resilience and improve psychological well-being?
Participants will be asked to attend the programme twice a week after school for a period of six weeks and complete a series of questionnaires.
Researchers will compare children who attended the programme to those who did not to see if the programme resulted in better social/emotional functioning and resilience.
**Detailed Description:** Although the well-being of vulnerable South African children is a significant public health concern, few studies have evaluated the effectiveness of mental health prevention and promotion interventions in low- and middle- income countries. Little Lions Child Coaching is a South African youth-led, community-based non-governmental organisation (NGO) that aims to normalise mental health conversations and empower the next generation to tap into their emotional resilience by providing accessible mental health support to children in under-resourced communities surrounding Cape Town.
The aim of this effectiveness study is to measure how a mental health prevention and promotion programme, designed and implemented by Little Lions Child Coaching, impacts the resilience and social/emotional functioning of children (ages 8 to 13) living in townships surrounding Cape Town.
Participants in the intervention condition will receive the programme twice a week after school for a period of six weeks to boost their emotional awareness, confidence, coping skills and resilience. Resilience scores will be compared to a control group.
### Conditions Module
**Conditions:**
- Psychological Well-Being
**Keywords:**
- Emotional Resilience
- Mental Health Prevention
- South Africa
- Universal Mental Health Promotion
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
**Intervention Model Description:** Children will be randomly assigned to either the control or intervention group after the baseline assessment. Participants in the control group will receive the intervention at a later stage.
##### Masking Info
**Masking:** SINGLE
**Masking Description:** The researchers involved in data collection after the intervention will be masked.
**Who Masked:**
- INVESTIGATOR
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 150
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Behavioural/ psychosocial intervention (i.e., mental health prevention and promotion programme) to boost emotional awareness, confidence, coping skills, and resilience.
**Intervention Names:**
- Behavioral: Mental Health Prevention and Promotion
**Label:** Intervention Group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants in the control group will receive the intervention at a later stage.
**Label:** Control Group
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Intervention Group
**Description:** The Inner Lion Programme is made up of 12 interactive workshops which are based on four key pillars: building confidence by identifying strengths and personal qualities; improving emotional intelligence and self-awareness; establishing adaptive coping strategies and channels of support; and boosting resilience. Professionally created by Child Psychologist Stijn de Leeuw together with an advisory team of psychologists from the Netherlands and South Africa, the programme follows a carefully structured and curated prevention and promotion mental health curriculum with games, crafting activities, psycho-educational stories, dance, movement, and breathing exercises. Workshops are led by local role models (a male-female duo) with lived experience trained to be mental health coaches.
**Name:** Mental Health Prevention and Promotion
**Other Names:**
- Inner Lion Programme
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** A t-test will be used to determine whether the control versus intervention group had significantly different mean resilience scores after the intervention relative to the baseline assessment
**Measure:** Mean change from baseline in resilience scores using the Child and Youth Resilience Measure
**Time Frame:** At baseline and in 6 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Between 8 and 13 years old
* Fluent in Xhosa and/or English
* Lives in one of the following communities in Cape Town, South Africa: Khayelitsha, Langa, or Mfuleni
Exclusion Criteria:
* Younger than 8 years old or older than 13 years old
* Do not have a strong understanding of the language of instruction (i.e., Xhosa/English)
* Lives in an area outside of Khayelitsha, Langa, or Mfuleni
**Healthy Volunteers:** True
**Maximum Age:** 13 Years
**Minimum Age:** 8 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Impact Manager
**Phone:** 0791374527
**Phone Ext:** +27
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Stijn de Leeuw
**Phone:** 0610067521
**Phone Ext:** +27
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** University of Cape Town
**Name:** Susan Malcolm-Smith
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Access Criteria:** Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact [email protected]
**Description:** Data obtained through this study may be provided to qualified researchers with an academic interest in the effectiveness of universal mental health interventions for children and adolescents. To protect personal information, all data shared will be coded.
**Info Types:**
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
**IPD Sharing:** YES
**Time Frame:** Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06445764
**Acronym:** Trauma SimVR
**Brief Title:** Traumatic Cardiac Arrest and Trauma SimVR Training
**Official Title:** Enhancing Trauma Cardiopulmonary Resuscitation Simulation Training With the Use of Virtual Reality (Trauma SimVR): Protocol for a Randomized Controlled Trial
#### Organization Study ID Info
**ID:** 1388/2023
#### Organization
**Class:** OTHER
**Full Name:** Medical University of Vienna
### Status Module
#### Completion Date
**Date:** 2026-02-28
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-04
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2025-01-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-26
**Study First Submit QC Date:** 2024-06-04
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Medical University of Vienna
#### Responsible Party
**Investigator Affiliation:** Medical University of Vienna
**Investigator Full Name:** Josef Michael Lintschinger
**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 goal of this single-center, prospective, randomized, controlled trial is to evaluate the effectiveness of using virtual reality technology to provide learners with skills and knowledge in the management of traumatic cardiac arrest in first-year residents at the emergency department.
The main question it aims to answer is:
Does the use of virtual reality in the context of trauma cardiopulmonary resuscitation training result in shorter times to order/perform pre-defined critical actions?
Participants will learn management skills for in-hospital traumatic cardiac arrest using either newly developed virtual reality software or e-learning focused on the same content.
### Conditions Module
**Conditions:**
- Virtual Reality
- Heart Arrest
**Keywords:**
- in-hospital cardiac arrest
- Education, Medical
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 67
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Other: e-learning
**Label:** e-learning
**Type:** OTHER
#### Arm Group 2
**Intervention Names:**
- Other: Virtual reality training
**Label:** Virtual reality training
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- e-learning
**Description:** Participants will complete an e-learning course over a two-week period that focuses on skills and knowledge related to the management of in-hospital cardiac arrest. This course prepares participants for an in-person assessment.
**Name:** e-learning
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Virtual reality training
**Description:** Participants will complete a virtual reality training over a two-week period that focuses on skills and knowledge related to the management of in-hospital cardiac arrest. This training prepares participants for an in-person assessment.
**Name:** Virtual reality training
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Expert-based assessment of the difference in time (seconds) to the predefined primary critical action between randomized groups in video recordings of an in-person assessment simulation.
**Measure:** Time to critical action
**Time Frame:** evaluation within 4 weeks after study completion
#### Secondary Outcomes
**Description:** Expert-based assessment of the difference in time (seconds) to the predefined secondary critical action #1 between randomized groups in video recordings of an in-person assessment simulation.
**Measure:** Time to secondary critical action #1
**Time Frame:** evaluation within 4 weeks after study completion
**Description:** Expert-based assessment of the difference in time (seconds) to the predefined secondary critical action #2 between randomized groups in video recordings of an in-person assessment simulation.
**Measure:** Time to secondary critical action #2
**Time Frame:** evaluation within 4 weeks after study completion
**Description:** Expert-based assessment of the difference in unrecognized underlying causes of traumatic cardiac arrest between randomized groups in video recordings of an in-person assessment simulation.
**Measure:** Number of unrecognized causes of traumatic cardiac arrest
**Time Frame:** evaluation within 4 weeks after study completion
**Description:** Expert-based assessment of the difference in the number of patients declared dead prematurely between the randomized groups in video recordings of an in-person assessment simulation.
**Measure:** Number of patients declared dead prematurely
**Time Frame:** evaluation within 4 weeks after study completion
**Description:** Expert-based assessment of the difference in the frequency of protocol deviations between randomized groups in video recordings of an in-person assessment simulation. Protocol deviations are listed in the study protocol and reflect the recommendations of the guidelines on which the study is based.
**Measure:** Number of protocol deviations
**Time Frame:** evaluation within 4 weeks after study completion
**Description:** Expert-based assessment of the difference in time (seconds) to the predefined primary critical action between randomized groups in video recordings of an in-person assessment simulation based on gender.
**Measure:** Gender-differences in learning outcomes
**Time Frame:** evaluation within 4 weeks after study completion
**Description:** Assessment of the difference in global cognitive load between randomized groups immediately following the in-person assessment simulation using the National Aeronautics and Space Administration (NASA) global task load index, which ranges from 0 to 100. Higher scores indicate greater cognitive load.
**Measure:** Group difference in global cognitive load while performing the in-person assessment simulation
**Time Frame:** evaluation within 4 weeks after study completion
**Description:** Assessment of the difference in cognitive load (per objective) between randomized groups immediately following the in-person assessment simulation using the National Aeronautics and Space Administration (NASA) task load index, which ranges from 0 to 100.
Objectives are: (mental demand, physical demand, temporal demand, performance, effort, frustration). Higher scores indicate greater mental demand/higher physical demand/ higher temporal demand/worse performance/more effort/more frustration).
**Measure:** Group difference in cognitive load (per objective) while performing the in-person assessment simulation
**Time Frame:** evaluation within 4 weeks after study completion
**Description:** Assessment of differences (in seconds) in gaze behavior (dwell time in areas of interest) using Tobii Pro eye-tracking technology between randomized groups based on recordings of the in-person assessment simulation
The defined areas of interest for analysis are the manikin's head/airway, the manikin's thorax, the vital signs monitor, and the ventilator monitor.
**Measure:** Gaze behavior during the in-person assessment simulation: dwell-time in areas of interest
**Time Frame:** evaluation within 4 weeks after study completion
**Description:** Assessment of differences in gaze behavior (fixation count in areas of interest) using Tobii Pro eye-tracking technology between randomized groups based on recordings of the in-person assessment simulation.
The defined areas of interest for analysis are the manikin's head/airway, the manikin's thorax, the vital signs monitor, and the ventilator monitor.
**Measure:** Gaze behavior during the in-person assessment simulation: fixation count in areas of interest
**Time Frame:** evaluation within 4 weeks after study completion
**Description:** Assessment of differences (in seconds) in gaze behavior (average fixation duration in areas of interest) using Tobii Pro eye-tracking technology between randomized groups based on recordings of the in-person assessment simulation
The defined areas of interest for analysis are the manikin's head/airway, the manikin's thorax, the vital signs monitor, and the ventilator monitor.
**Measure:** Gaze behavior during the in-person assessment simulation: average fixation duration in areas of interest
**Time Frame:** evaluation within 4 weeks after study completion
**Description:** Assessment of differences (in seconds) in gaze behavior (time when no area of interest is illustrated) using Tobii Pro eye-tracking technology between randomized groups based on recordings of the in-person assessment simulation
The defined areas of interst for analysis are the manikin's head/airway, the manikin's thorax, the vital signs monitor, and the ventilator monitor.
**Measure:** Gaze behavior during the in-person assessment simulation: time when no area of interest is illustrated
**Time Frame:** evaluation within 4 weeks after study completion
**Description:** 5-point Likert scale
1 - not helpful at all; 2 - rather not helpful; 3 - neither helpful nor not helpful; 4 - rather helpful; 5 - very helpful
**Measure:** Participants' subjective impressions of their learning progress when using virtual reality/e-learning
**Time Frame:** evaluation within 4 weeks after study completion
**Description:** 5-point Likert scale
1 - not frustrated at all; 2 - rather not frustrated; 3 - neither frustrated nor not frustrated; 4 - rather frustrated; 5 - very frustrated
**Measure:** Participants' subjective impressions of their level of frustration when using virtual reality/e-learning
**Time Frame:** evaluation within 4 weeks after study completion
**Description:** 5-point Likert scale
1 - not enjoyed at all; 2 - rather not enjoyed; 3 - neither enjoyed nor not enjoyed; 4 - rather enjoyed; 5 - very enjoyed
**Measure:** Participants' subjective impression of their level of enjoyment when using virtual reality/e-learning
**Time Frame:** evaluation within 4 weeks after study completion
**Description:** 5-point Likert scale
1 - not confident at all; 2 - rather not confident; 3 - neither confident nor not confident; 4 - rather confident; 5 - very confident
**Measure:** Participants' subjective confidence in recognizing and providing initial care to polytraumatized patients in cardiac arrest in the in-person assessment simulation
**Time Frame:** evaluation within 4 weeks after study completion
**Description:** 5-point Likert scale
1 - not good at all; 2 - rather not good; 3 - neither good nor not good; 4 - rather good; 5 - very good
**Measure:** Participants' subjective overall performance in the simulation sessions
**Time Frame:** evaluation within 4 weeks after study completion
**Description:** 5-point Likert scale
1 - not good at all; 2 - rather not good; 3 - neither good nor not good; 4 - rather good; 5 - very good
**Measure:** Participants' overall performance in the simulation sessions from the expert's point of view
**Time Frame:** evaluation within 4 weeks after study completion
**Description:** Spearman correlation
Frequency of playing within the past 12 months: never; less than once a week; once per week; more than once per week; daily
**Measure:** The correlation between how often participants have played virtual reality video games in the past 12 months and the primary outcome
**Time Frame:** evaluation within 4 weeks after study completion
**Description:** Spearman correlation
Frequency of playing at the age of 6 to 18: never; less than once a week; once per week; more than once per week; daily
**Measure:** The correlation between how often participants have played virtual reality video games between the ages of 6 and 18 and the primary outcome
**Time Frame:** evaluation within 4 weeks after study completion
**Description:** Spearman correlation
Frequency of playing within the past 12 months: never; less than once a week; once per week; more than once per week; daily
**Measure:** The correlation between how often participants have played non-virtual-reality video games in the past 12 months and the primary outcome
**Time Frame:** evaluation within 4 weeks after study completion
**Description:** Spearman correlation
Frequency of playing at the age of 6 to 18: never; less than once a week; once per week; more than once per week; daily
**Measure:** The correlation between how often participants have played non-virtual-reality video games between the ages of 6 and 18 and the primary outcome
**Time Frame:** evaluation within 4 weeks after study completion
**Description:** Incidence of nausea, vomiting, dizziness, headache, overexertion/fatigue of the eyes (discomfort, blurred vision), stumbling, falling, bumping into real world objects while using virtual reality
**Measure:** Incidence rate of virtual reality related adverse events
**Time Frame:** evaluation within 4 weeks after study completion
**Description:** System Usability Scale score from 1 to 100 points
**Measure:** System usability score for use of VR simulations
**Time Frame:** evaluation within 4 weeks after study completion
**Description:** 7-point Likert scale
1 - the worst thing you can imagine; 2 - terrible; 3 - poor; 4 - okay; 5 - good; 6 - excellent; 7 - the best thing you can imagine
**Measure:** Adjective Rating Scale for the use of the virtual reality simulations
**Time Frame:** evaluation within 4 weeks after study completion
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* first-year residents at the emergency department
* only people who do not need eyeglasses for using VR
Exclusion Criteria:
- pre-disposition for cybersickness (motion sickness, pregnancy, pre-existing cybersickness)
**Gender Based:** True
**Healthy Volunteers:** True
**Maximum Age:** 110 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Josef Michael Lintschinger, MD
**Phone:** +4366493228562
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Christina Hafner, MD, PhD
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Vienna
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Josef Michael Lintschinger, MD
- **Phone:** +4366493228562
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Christina Hafner, MD, PhD
- **Role:** CONTACT
***Contact 3:***
- **Name:** Josef Michael Lintschinger, MD
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 4:***
- **Name:** Philipp Metelka, MD
- **Role:** SUB_INVESTIGATOR
***Contact 5:***
- **Name:** Lorenz Kapral, MSc
- **Role:** SUB_INVESTIGATOR
***Contact 6:***
- **Name:** Florian Kahlfuss, MD
- **Role:** SUB_INVESTIGATOR
***Contact 7:***
- **Name:** Lena Reischmann, MD
- **Role:** SUB_INVESTIGATOR
***Contact 8:***
- **Name:** Alexandra Kaider, Mag
- **Role:** SUB_INVESTIGATOR
***Contact 9:***
- **Name:** Caroline Holaubek, MD
- **Role:** SUB_INVESTIGATOR
***Contact 10:***
- **Name:** Georg Kaiser, MD
- **Role:** SUB_INVESTIGATOR
***Contact 11:***
- **Name:** Michael Wagner, MD
- **Role:** SUB_INVESTIGATOR
***Contact 12:***
- **Name:** Florian Ettl, MD
- **Role:** SUB_INVESTIGATOR
***Contact 13:***
- **Name:** Leonhard Sixt
- **Role:** SUB_INVESTIGATOR
***Contact 14:***
- **Name:** Eva Schaden, MD
- **Role:** SUB_INVESTIGATOR
***Contact 15:***
- **Name:** Christina Hafner, MD, PhD
- **Role:** SUB_INVESTIGATOR
**Country:** Austria
**Facility:** Medical University of Vienna
**Zip:** 1090
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000006331
- Term: Heart Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: All
- Name: All Conditions
- Abbrev: BC14
- Name: Heart and Blood Diseases
### Condition Browse Module - Browse Leaves
- ID: M17685
- Name: Wounds and Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M9411
- Name: Heart Arrest
- Relevance: HIGH
- As Found: Heart Arrest
- ID: M9419
- Name: Heart Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000006323
- Term: Heart Arrest
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06445751
**Brief Title:** Step Up for STEM and Health Careers
**Official Title:** Step up for STEM and Health Careers: An Interactive Digital Resource to Reduce STEM-related Biases and Improve High School STEM Learning Environments
#### Organization Study ID Info
**ID:** 2023B0273
#### Organization
**Class:** OTHER
**Full Name:** Ohio State University
### Status Module
#### Completion Date
**Date:** 2024-07-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-31
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-07-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** Resilient Games Studio
**Class:** OTHER
**Name:** University of Chicago
**Class:** NIH
**Name:** National Institutes of Health (NIH)
#### Lead Sponsor
**Class:** OTHER
**Name:** Ohio State University
#### Responsible Party
**Investigator Affiliation:** Ohio State University
**Investigator Full Name:** Nicole Thomas
**Investigator Title:** Research Scientist, CATALYST
**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 randomized controlled trial is to evaluate "Step Up for STEM and Health Careers". The "Step Up for STEM and Health Careers" ("Step Up") game is an interactive, digital resource that includes the key elements of a bystander intervention for high school students to understand the importance of diversity in STEM; it also addresses skills, attitudes, and awareness to attain positive STEM identities and mitigate bias and harassment in STEM and health learning environments.
Participants in the intervention arm will be asked to complete the Step Up interactive game; participants in the comparison group will be asked to view a PowerPoint presentation on bias and harassment in STEM/health fields as the control experience. The Step Up game intervention and study outcomes are theory-based (Theory of Planned Behavior, Social Cognitive Career Theory (SCCT)): we will assess the impact of Step Up on attitudes about STEM/health careers, STEM/health career self-efficacy, and bystander behavior.
**Detailed Description:** The goal of this randomized control trial is to evaluate the impact of the "Step Up for STEM and Health Careers" intervention game on STEM/health career and bystander attitudes, as well as self-efficacy. Participants will be randomly assigned to participate in either the Step Up intervention game or the educational PowerPoint presentation.
The "Step Up for STEM and Health Careers" intervention consists of students playing a "Step Up" game to help them understand the importance of diversity in STEM and health careers, attain STEM/health career self-efficacy, and create an inclusive learning environment for others. The control group consists of an educational PowerPoint presentation on the importance of diversity in STEM and health careers, STEM/health career self-efficacy, and creating an inclusive learning environment for others.
The Step Up intervention game (created by Resilient Games Studio (RGS)) consists of six digital episodes that focus on a specific topic: importance of diversity in STEM careers, heuristics and biases, structural biases and intersectionality, harassment, sexual harassment, and bystander behaviors. Each episode includes interactive mini-games to teach theory-based skills and lessons. Adult characters, who serve as "in-game" STEM/health role models, are integrated throughout the game. The game was built based on the Theory of Planned Behavior (TPB) and the Social Cognitive Career Theory (SCCT) to improve STEM/health career and bystander attitudes, as well as self-efficacy.
The educational PowerPoint presentation on bias and harassment in STEM/health fields was also created by RGS and will be used as a control experience for adolescent participants. The PowerPoint presentation will contain sections that correspond to each of the episode topics of the Step Up intervention game.
### Conditions Module
**Conditions:**
- Adolescent Behavior
**Keywords:**
- STEM
- Adolescents
- Diversity
- Digital Games
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 100
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Youth in the intervention group will play a six-episode, interactive game on the importance of diversity in STEM and health careers, STEM/health career self-efficacy, and creating an inclusive learning environment for others. This includes featuring diverse youth who model STEM/health self-efficacy; integrating STEM/health professional characters as "in-game" content experts and role models; and incorporating mini games to reinforce skills and behavior.
**Intervention Names:**
- Behavioral: Step Up for STEM and Health Careers ("Step Up") game
**Label:** Step Up for STEM Careers Game Intervention
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Youth in the comparator group will complete an educational PowerPoint presentation on the importance of diversity in STEM and health careers, STEM/health career self-efficacy, and creating an inclusive learning environment for others. This PowerPoint presentation will contain sections that correspond to each episode of the Step Up for STEM and Health Careers intervention.
**Intervention Names:**
- Behavioral: Educational PowerPoint Presentation on Diversity in STEM Careers
**Label:** Educational PowerPoint
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Step Up for STEM Careers Game Intervention
**Description:** Step Up for STEM and Health Careers ("Step Up") game is an interactive, digital resource to help high school students understand the importance of diversity in STEM and health careers, attain STEM/health career self-efficacy, and help them create an inclusive learning environment for others.
**Name:** Step Up for STEM and Health Careers ("Step Up") game
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- Educational PowerPoint
**Description:** An educational PowerPoint on Diversity in STEM careers to increase adolescents' STEM/health career self-efficacy, and help them create an inclusive learning environment for others.
**Name:** Educational PowerPoint Presentation on Diversity in STEM Careers
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** One's beliefs about outcomes associated with STEM/health careers
**Measure:** STEM/health career attitudes using modified Career Interest (Christensen, et al., 2014) and STEM Semantics (Knezek and Christensen, 2008) questionnaires
**Time Frame:** From baseline pre-test immediately preceding randomization to post-test up to 3 days post intervention/comparator
**Description:** The perception one has the requisite skills and capabilities for attaining a STEM/health career
**Measure:** STEM/health career self-efficacy using a modified Career Interest Questionnaire (Christensen, et al., 2014)
**Time Frame:** From baseline pre-test immediately preceding randomization to post-test up to 3 days post intervention/comparator
#### Secondary Outcomes
**Description:** One's intent to pursue a STEM/health career
**Measure:** Intent to pursue a STEM/health career using a modified Career Interest Questionnaire (Christensen, et al., 2014)
**Time Frame:** From baseline pre-test immediately preceding randomization to post-test up to 3 days post intervention/comparator
**Description:** One's knowledge of the value of diversity in STEM/health careers
**Measure:** Knowledge of the value of diversity in STEM/health careers using a questionnaire
**Time Frame:** From baseline pre-test immediately preceding randomization to post-test up to 3 days post intervention/comparator
**Description:** One's intent to intervene as a bystander when witnessing harassment on the basis of race, gender, disability status, etc.
**Measure:** Intent to intervene as a bystander when witnessing harassment on the basis of race, gender, disability status, etc., using a questionnaire derived from the Bystander Questionnaire (Garza et al., 2023; McMahon and Banyard, 2012)
**Time Frame:** From baseline pre-test immediately preceding randomization to post-test up to 3 days post intervention/comparator
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* English-speaking
* Access to a computer and internet connection
* Live in Chicago Metropolitan Area
* Current high school student (enrolled in grade 9-12); or in 12th grade in 2023-2024 school year
Exclusion Criteria:
-
**Healthy Volunteers:** True
**Maximum Age:** 19 Years
**Minimum Age:** 13 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Nikki Thomas, PhD
**Phone:** 614-247-6228
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Lindsey Sova, MPH
**Phone:** 614-366-8722
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Resilient Games Studio
**Name:** Tim Parsons
**Role:** STUDY_DIRECTOR
### 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:** NCT06445738
**Acronym:** PROSPECTIVE
**Brief Title:** Post-operative Radiotherapy Omission in Selected Patients With Early Breast Cancer Trial International Validation Experience
**Official Title:** A Two-arm, Non-randomised, Prospective, Multicentre Validation Study Using Magnetic Resonance Imaging (MRI) and Pathological Findings to Select Patients With Early Breast Cancer for Omission of Post-operative Radiotherapy
#### Organization Study ID Info
**ID:** BCT 2401
#### Organization
**Class:** OTHER
**Full Name:** Breast Cancer Trials, Australia and New Zealand
### Status Module
#### Completion Date
**Date:** 2039-01-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-04
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2032-01-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2025-01-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-06-04
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Breast Cancer Trials, Australia and New Zealand
#### 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 PROSPECTIVE trial aims to find out if using the results of Magnetic Resonance Imaging (MRI) for early breast cancer can select people to not have radiotherapy and still have a low chance of the cancer coming back after surgery.
The main question it aims to answer is:
\* Will cancer come back in the same breast as the original cancer in patients who have surgery for their breast cancer, but who don't have radiotherapy afterwards because the results of an MRI before surgery showed favourable characteristics for not having radiotherapy.
**Detailed Description:** Breast cancer is the most common serious malignancy in women and most patients are suitable for therapy involving surgery and adjuvant radiotherapy (RT). For most patients, there is a lack of evidence that breast conserving surgery without adjuvant RT is safe and therefore patients bear the costs, inconvenience and morbidity of RT. Prior attempts to identify large subsets of patients for whom RT can be safely omitted based on clinicopathological features of the index cancer have had limited success, and so RT is currently omitted only in some women over 65 or 70 with small low risk cancers. Identification of a much larger subset of patients in whom adjuvant RT could be safely omitted would be hugely significant, not only to the patients, but to the entire health system.
The ANZ 1002 PROSPECT study was a two-arm phase II study that used breast MRI findings and pathological features to identify a group of patients with low risk early breast cancer in whom RT may be safely omitted. The findings at the primary strongly support the hypothesis and suggest that the combination of preoperative MRI and pathological features can identify a substantial group of early breast cancer patients in whom adjuvant RT can be safely omitted.
A Health Economic analysis of PROSPECT found that the avoided costs of RT and its potential side effects is likely to substantially outweigh the extra cost of MRI scans and associated investigations. Parallel cross-sectional studies assessing Fear of Cancer Recurrence (FCR) and Health Related Quality of Life (HRQoL) in patients taking part in PROSPECT who either did or did not receive RT and a control group found a substantially lower FCR in PROSPECT patients who omitted RT as well as improved HRQoL.
The majority of screened and eligible patients (427/443 and 193/201, respectively) for PROSPECT were recruited from two Australian sites. Before the PROSPECT approach can be widely adopted, the findings need to be replicated in a multicentre, international study. In addition, patient reported outcomes and health economic assessments need to be performed prospectively and longitudinally.
PROSPECTIVE is the follow-up to PROSPECT which will address these issues, and also include translational research aspects to further study the natural history and outcomes of this group of lower risk early breast cancers.
### Conditions Module
**Conditions:**
- Breast Cancer
- Breast Cancer Female
**Keywords:**
- Omission of radiotherapy
- Magnetic Resonance Imaging (MRI)
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** A two-arm, non-randomised study using MRI and pathological findings to select patients for omission of post-operative radiotherapy.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 1400
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants with nil, minimal or mild parenchymal enhancement on pre-operative MRI whose pathology meets inclusion/exclusion requirements for omission of post-operative radiotherapy will be allocated to Arm A, unless the participant prefers to receive Standard Treatment (Arm B) or following clinical team recommendation.
Arm A participants will be divided into 2 groups:
* Arm A1: Grade 1 or 2/HER2 negative ("low risk")
* Arm A2: Grade 3 and/or HER2 positive ("high risk")
**Intervention Names:**
- Radiation: Arm A: Radiotherapy Omission
**Label:** Radiotherapy Omission
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants who are found to be ineligible for RT omission on study; includes management of MRI-detected lesions.
Participants with any of:
* Moderate or marked parenchymal enhancement on pre-operative MRI
* A malignant occult lesion identified on MRI; or
* Pathology that does not meet inclusion/exclusion criteria will receive standard multidisciplinary team recommendations to guide treatment. Participants may also be included in Arm B due to their own preference or following clinical team recommendation.
**Intervention Names:**
- Other: Arm B: Standard Treatment
**Label:** Standard Treatment
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Radiotherapy Omission
**Description:** Omission of radiotherapy based on pre-surgical MRI and pathology findings at surgery.
**Name:** Arm A: Radiotherapy Omission
**Other Names:**
- A1: Grade 1 or 2/HER2 negative; A2: Grade 3 and/or HER2 positive
**Type:** RADIATION
#### Intervention 2
**Arm Group Labels:**
- Standard Treatment
**Description:** Ineligible for RT omission on study; includes management of MRI-detected lesions.
**Name:** Arm B: Standard Treatment
**Type:** OTHER
### Outcomes Module
#### Other Outcomes
**Description:** To determine differences over time in perception of risk of recurrence between Arm A and Arm B in the breast and elsewhere in the body measured by 2 items adapted from Abbott et al.
**Measure:** PRO: Perception of risk of recurrence
**Time Frame:** From allocation, to 3-, 6-, 12-, 24- and 60 months median follow up post-surgery.
**Description:** To determine difference over time in QALYs between Arm A and Arm B measured by the EQ-5D-5L. A higher score means more problems with health.
**Measure:** PRO: difference over time in QALYs
**Time Frame:** From registration to allocation, 3-, 6-, 12-, 24- and 60 months median follow up post-surgery
**Description:** To determine difference in decision regret between Arm A and Arm B measured by the Decision Regret Scale (minimum score=1, maximum score=5; higher score indicates more regret).
**Measure:** PRO: Difference in decision regret
**Time Frame:** From registration to allocation, 3-, 6-, 12-, 24- and 60 months median follow up post-surgery
**Description:** To determine overall mental health and differences over time in depression between Arm A and Arm B measured by the Patient Health Questionnaire-2. A higher score indicates a greater symptom burden.
**Measure:** PRO: Overall mental health and differences over time in depression.
**Time Frame:** From allocation to 3-, 6-, 12-, 24- and 60 months median follow up post-surgery.
**Description:** To determine overall mental health and differences over time in anxiety between Arm A and Arm B measured by the Generalized Anxiety Disorder-2. A higher score indicates a greater symptom burden.
**Measure:** PRO: Overall mental health and differences over time in anxiety
**Time Frame:** From allocation to 3-, 6-, 12-, 24- and 60 months median follow up post-surgery.
**Description:** To analyse oncological outcomes in relation to the intensity of endocrine therapy (ET) (no ET, less than 2 years ET, 2-5 years ET, more than 5 years ET).
**Measure:** ET: Oncologic outcomes in relation to intensity of endocrine therapy (ET)
**Time Frame:** Median of 5 and 10 years follow up
**Description:** To number of occult lesions and malignant occult lesions detected on pre-operative MRI per institution
**Measure:** Radiology: Occult lesion and malignant occult lesion detection rate
**Time Frame:** At the time of the pre-operative MRI
**Description:** Outcomes of MRI in those patients who have MRI post-registration measured by BPR, occult lesion rate, biopsy approach, result of biopsy, malignant occult lesion rate.
**Measure:** Radiology: Outcomes of MRI
**Time Frame:** At the time of the pre-operative MRI
**Description:** Measured by the frequency of occult lesions on CEM in patients undergoing CEM in addition to MRI.
**Measure:** Radiology: Frequency and nature of occult lesions from Contrast Enhanced Mammography (CEM)
**Time Frame:** At the time of the pre-operative MRI
**Description:** Differences in treatment-related morbidity, as measured by QALYs (from the EQ-5D-5L).
**Measure:** Health Economics: The impact of the PROSPECTIVE model of care on QALYs
**Time Frame:** 60-months post-surgery
**Description:** By sequencing and analysis of index tumours.
**Measure:** Translational Research: Identify potential biomarkers of response and investigate tumour dynamics to identify patients in whom adjuvant therapy may be safely omitted.
**Time Frame:** At the time of diagnosis
**Description:** By sequencing and analysis of recurrent tumours.
**Measure:** Translational Research: Identify potential biomarkers of response and investigate tumour dynamics to identify patients in whom adjuvant therapy may be safely omitted.
**Time Frame:** At the time of surgery for recurrence
#### Primary Outcomes
**Description:** To determine the ipsilateral invasive recurrence rate (IIRR) in patients with favourable clinico-pathological features on MRI and unequivocally unifocal breast cancer treated with wide local excision but no adjuvant radiotherapy
**Measure:** Ipsilateral Invasive Recurrence Rate (IIRR) in low-risk patients omitting RT at a median of 5 years follow up
**Time Frame:** Median of 5 years follow up (when 300th low risk patient in Arm A reaches 5 years follow up)
**Description:** To determine the ipsilateral invasive recurrence rate (IIRR) in patients allocated to omit radiotherapy
**Measure:** Ipsilateral Invasive Recurrence Rate (IIRR) in all patients omitting RT at a median of 5 years follow up
**Time Frame:** Median of 5 years follow up
#### Secondary Outcomes
**Description:** To determine the ipsilateral invasive recurrence rate (IIRR) in patients allocated to omit radiotherapy
**Measure:** Ipsilateral Invasive Recurrence Rate (IIRR) in all patients omitting RT at a median of 10 years follow up
**Time Frame:** Median of 10 years follow up
**Description:** To determine the ipsilateral invasive recurrence rate (IIRR) in higher risk participants and the total cohort omitting RT.
**Measure:** IIRR in higher risk patients omitting RT and the total cohort omitting RT
**Time Frame:** Median of 5 years follow up
**Description:** To determine the ipsilateral invasive recurrence rate (IIRR) in the breast at 5 and 10 years in the entire cohort undergoing preoperative MRI and found to be ineligible for RT omission after BCS (Arm B).
**Measure:** IIRR in the breast at 5 and 10 years in the entire cohort undergoing pre-operative MRI and ineligible for RT omission
**Time Frame:** Median of 5 and 10 years follow up.
**Description:** To determine the ipsilateral invasive recurrence rate (IIRR) in the breast at 5 and 10 years in the entire cohort undergoing preoperative MRI (Arms A + B).
**Measure:** IIR in the breast at 5 and 10 years in the entire cohort undergoing pre-operative MRI
**Time Frame:** Median of 5 and 10 years follow up
**Description:** To determine the ipsilateral DCIS recurrence rate in the entire cohort undergoing pre-operative MRI (Arms A + B).
**Measure:** Ipsilateral DCIS recurrence rate in the entire cohort
**Time Frame:** Median of 5 and 10 years follow up.
**Description:** Ipsilateral DCIS and invasive recurrence rate in all cohorts separately and combined
**Measure:** Ipsilateral DCIS and invasive recurrence rate in all cohorts separately and combined
**Time Frame:** Median of 5 and 10 years follow up
**Description:** To determine the regional recurrence rate in the entire cohort undergoing preoperative MRI (Arms A + B).
**Measure:** Regional recurrence rate in all participants
**Time Frame:** Median of 5 and 10 years follow up
**Description:** To determine the distant recurrence rate in the entire cohort undergoing preoperative MRI (Arms A + B).
**Measure:** Distant recurrence rate in all participants
**Time Frame:** Median of 5 and 10 years follow up
**Description:** To determine the contralateral DCIS and invasive breast cancer in Arm A, Arm B, and the total cohort (Arms A + B)
**Measure:** Contralateral DCIS and invasive breast cancer in each arm separately, and combined
**Time Frame:** Median of 5 and 10 years follow up
**Description:** To determine the breast cancer specific survival rate in all groups separately and combined
**Measure:** Breast cancer specific survival rate in all groups separately and combined
**Time Frame:** Median of 5 and 10 years follow up
**Description:** To determine the overall survival rate in all groups separately and combined
**Measure:** Overall survival rate
**Time Frame:** Median of 5 and 10 years follow up
**Description:** To determine the difference in Fear of cancer recurrence (FCR) between Arm A and Arm B measured by the Fear of Cancer Recurrence Inventory Short Form (FCRI-SF). A higher score indicates a greater fear of recurrence.
**Measure:** PRO: Fear of Cancer Recurrence
**Time Frame:** Median 24 months post-surgery
**Description:** To determine the difference in HRQoL (functional and aesthetic outcomes) between Arm A and Arm B measured by the Breast Cancer Treatment Outcomes Scale (BCTOS). A higher score indicates greater morbidity.
**Measure:** PRO: HRQoL (functional and aesthetic outcomes)
**Time Frame:** 24 months post-surgery
**Description:** To determine the difference in HRQoL (fatigue, body image, financial toxicity) between Arm A and Arm B measured by the EORTC ILXX measure (custom measure for this protocol). A higher score indicates greater fatigue, poorer body image and greater financial toxicity.
**Measure:** PRO: HRQoL (fatigue, body image, financial toxicity)
**Time Frame:** 24 months post-surgery
**Description:** To determine the difference over time in FCR between Arm A and Arm B measured by the FCRI-SF. A higher score indicates a greater fear of recurrence.
**Measure:** PRO: Difference over time in FCR
**Time Frame:** From allocation to 3-, 6-, 12-, 24- and 60 months median follow up post-surgery
**Description:** To determine the difference over time in HRQoL (functional and aesthetic outcomes), between Arm A and Arm B measured by the BCTOS. A higher BCTOS score indicates greater morbidity.
**Measure:** PRO: Difference over time in HRQoL (functional and aesthetic outcomes)
**Time Frame:** From allocation to 6-, 12-, 24- and 60 months median follow up post-surgery
**Description:** To determine the difference over time in HRQoL (fatigue, body image, financial toxicity), between Arm A and Arm B measured by the EORTC ILXX measure (custom measure for this protocol). A higher score indicates greater fatigue, poorer body image and greater financial toxicity.
**Measure:** PRO: Difference over time in HRQoL (ffatigue, body image, financial toxicity)
**Time Frame:** From allocation to 6-, 12-, 24- and 60 months median follow up post-surgery
**Description:** Differences in QALYs between Arm A and Arm B measured by the EQ-5D-5L
**Measure:** PRO: Differences in Quality of Life Years (QALYs)
**Time Frame:** 24 months post-surgery
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
For inclusion in the study at Registration, participants must fulfil all of the following criteria:
1. Has provided written, informed consent to participate in the study.
2. Female participants ≥ 50 years old with histologically\* confirmed ER-positive and/or HER2-positive invasive breast cancer.
3. In good health and suitable for prolonged follow up with a life expectancy of at least 10 years; willing to be followed up for 10 years.
4. Breast imaging indicating unifocal\*\*, unilateral breast cancer must have been performed before pre-registration.
5. Willing/able to have surgery within 8 weeks of registration or pre-operative MRI, whichever occurs later.
6. Pathology material from index cancer must be available.
7. Have ECOG performance status 0-2.
8. Participants with Grade 3 cancer and/or HER2-positive cancer must agree to comply with systemic treatment recommendations.
* Oestrogen receptor and progesterone receptor status of invasive cancer will be assessed by immunohistochemistry on the diagnostic core biopsy specimen. The IHC results will be reported as percentage of nuclei stained and a score of intensity from negative, weak, intermediate or high staining
* HER2 neu status will be assessed by immunohistochemistry and will be scored as follows46:
* 0 or 1+ (HER2 negative): No staining or membrane staining that is incomplete and is faint/barely perceptible and in ≤ 10% of tumour cells (0); or incomplete membrane staining that is faint/barely perceptible and in \> 10% of tumour cells (1+).
* 2+ (equivocal): weak to moderate complete membrane staining observed in \> 10% of tumour cells. Must order reflex test (same specimen using ISH) or order a new test (new specimen if available using HIS or ISH).
* 3+ (HER2 positive): Circumferential membrane staining that is complete, intense and in \> 10% of tumour cells.
Exclusion Criteria:
Any one of the following at Registration is regarded as a criterion for exclusion from the study:
1) Triple negative breast cancer (ER-negative and PR-negative and HER2-negative) where ER and PR positivity is defined as Any one of the following at Registration is regarded as a criterion for exclusion from the study:
1. Triple negative breast cancer (ER-negative and PR-negative and HER2-negative) where ER and PR positivity is defined as ≥ 10% staining on IHC47.
2. Previous ipsilateral in-situ or invasive breast cancer.
3. Participants who have a mastectomy for the index cancer.
4. Lymphovascular invasion.
5. Multifocal/multicentric breast cancer.
6. Distant metastasis at diagnosis.
7. Bilateral breast cancer.
8. Known breast cancer predisposition gene mutation carriers (BRCA 1 or 2, PALB2, CHEK2, ATM, CDK1, p53).
9. Contraindication to MRI scanning.
10. Concurrent illness/conditions which limits life expectancy to 10 years.
11. Inability to give informed consent. 10% staining on IHC47.
2) Previous ipsilateral in-situ or invasive breast cancer. 3) Participants who have a mastectomy for the index cancer. 4) Lymphovascular invasion. 5) Multifocal/multicentric breast cancer. 6) Distant metastasis at diagnosis. 7) Bilateral breast cancer. 8) Known breast cancer predisposition gene mutation carriers (BRCA 1 or 2, PALB2, CHEK2, ATM, CDK1, p53).
9) Contraindication to MRI scanning. 10) Concurrent illness/conditions which limits life expectancy to 10 years. 11) Inability to give informed consent.
Allocation: Arm A - Radiotherapy Omission
In addition to the above criteria, for inclusion in the omission of radiation therapy arm of the study after surgery, participants must fulfil all the following criteria (see Section 9.5.2). Participants not fulfilling any one of the following criterial will be allocated to Arm B:
1. Female participants ≥ 50 years old with histologically\* confirmed ER-positive and/or HER2-positive, unifocal\*\*, unilateral invasive breast cancer.
2. Has nil/minimal or mild parenchymal enhancement on pre-operative MRI.
3. Breast conserving surgery with invasive primary tumour (including any surrounding DCIS) ≤ 20 mm.
4. Radial resection margins must be ≥ 2 mm clear of any invasive cancer and ≥ 2 mm clear of any DCIS. Superficial or deep margins of \< 2 mm for invasive cancer and DCIS are allowed if all breast tissue from the subcutaneous tissue or pectoralis fascia respectively was removed and radial margins are ≥ 2 mm for invasive cancer and DCIS.
5. pN0 (pN0 i+ is eligible for inclusion) by sentinel node biopsy and/or axillary dissection.
6. Absence of lymphovascular invasion and extensive intraductal component.
7. Have no additional BIRADS 3+ lesions not shown to be benign on pre-operative or surgical biopsy.
8. Participants must be allocated within 8 weeks after final breast surgery.
* Oestrogen receptor and progesterone receptor status of invasive cancer will be assessed by immunohistochemistry on the diagnostic core biopsy specimen. The IHC results will be reported as percentage of nuclei stained and a score of intensity from negative, weak, intermediate or high staining
* Where histopathology is unable to identify a 'bridge' of tumour tissue joining two or more apparent invasive cancer foci the following will be used to confirm unifocal disease:
* All foci must be of the same histology
* All foci must have the same hormone (ER and PR) and HER2 status. In relation to Allocation Criteria #3: the overall tumour size (including additional foci of DCIS) must remain ≤ 20 mm. The tumour size is defined as the longest distance between the outer most edges of all foci, the space between the two or more foci is included in the overall size: Size = ('Focus A + Focus B + 'the distance between A and B').
Allocation: Arm B - Standard Treatment
In addition to the above Inclusion Criteria, participants who fulfil one any of the following criteria will receive standard treatment:
1. Has moderate or marked parenchymal enhancement on pre-operative MRI.
2. Has a biopsy-proven malignant occult lesion (mOL) identified on MRI.
3. Suspicious lesion identified on CEM but not on MRI and confirmed on investigation to be a malignant lesion.
4. Surgical pathology does not meet the inclusion criteria.
5. Clinical team meeting determination that RT be recommended.
6. Participant chooses to have RT despite being eligible for RT omission.
**Minimum Age:** 50 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Heath Badger
**Phone:** +61 2 4925 5239
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Melbourne Health
**Name:** Bruce Mann, MD
**Role:** STUDY_CHAIR
**Official 2:**
**Affiliation:** Peter MacCallum Cancer Centre - Moorrabin
**Name:** Steven David, MD
**Role:** STUDY_CHAIR
**Official 3:**
**Affiliation:** Baylor College of Medicine
**Name:** Alastair Thompson, MD
**Role:** STUDY_CHAIR
### IPD Sharing Statement Module
**Access Criteria:** Researchers who submit a research proposal and BCT Data Request Application, which is assessed by BCT to have appropriate scientific value. Applications will be subject to approval by Breast Cancer Trials [email protected] (refer to BCT Data Sharing Guidelines).
**Description:** Anonymised Individual Patient Data (IPD) collected during the trial.
**Info Types:**
- STUDY_PROTOCOL
- ANALYTIC_CODE
**IPD Sharing:** YES
**Time Frame:** Data will be made available for request after publication of the main/final study results; no end date.
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000001941
- Term: Breast Diseases
- ID: D000012871
- Term: Skin Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M5220
- Name: Breast Neoplasms
- Relevance: HIGH
- As Found: Breast Cancer
- ID: M5218
- Name: Breast Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001943
- Term: Breast Neoplasms
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06445725
**Acronym:** ABaCo
**Brief Title:** Acceptance Based Coping Skills for Diabetes Delivered By Promotores
**Official Title:** Acceptance Based Coping (ABaCo) Skills Delivered By Promotores for Hispanic/Latino Patients With Type 2 Diabetes
#### Organization Study ID Info
**ID:** 7K23DK123398-04
**Link:** https://reporter.nih.gov/quickSearch/7K23DK123398-04
**Type:** NIH
#### Organization
**Class:** OTHER
**Full Name:** Baylor College of Medicine
### Status Module
#### Completion Date
**Date:** 2024-10-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-04
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-10-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-03-04
**Type:** ACTUAL
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-04-18
**Study First Submit QC Date:** 2024-06-04
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** The University of Texas Health Science Center at San Antonio
#### Lead Sponsor
**Class:** OTHER
**Name:** Baylor College of Medicine
#### Responsible Party
**Investigator Affiliation:** Baylor College of Medicine
**Investigator Full Name:** Kathryn E. Kanzler
**Investigator Title:** Associate Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The goal of this pilot clinical trial is to learn about the feasibility and acceptability of promotores (community health workers) delivering an educational intervention for Hispanic/Latino patients with type 2 diabetes.
The main questions it aims to answer are:
1. What is the impact of the ABaCo program on participants' blood sugar management and quality of life?
2. How well are we able to enroll participants and keep them in the ABaCo program?
3. Is this telephone-based, educational ABaCo program acceptable?
Participants will be asked to:
* Participate in four research visits: provide fingerstick blood samples before and after the program (at 6 months), and complete questionnaires at four times times during the program (before, twice during, and at 6 months).
* Participate in the ABaCo program: join seven (7) individual phone call visits with promotores to review educational information about caring for diabetes while keeping connected to life values. Each phone call lasts approximately 45 minutes once per week for six (6) weeks, then a refresher visit is a month later.
**Detailed Description:** This overall project aims to develop an acceptable and feasible Promotores-delivered intervention program for Hispanic/Latino patients with type 2 diabetes. Specifically, this study aims to conduct a mixed-methods, single arm pre-post intervention pilot trial (6 months) on the Acceptance Based Coping (ABaCo) program to
* Evaluate feasibility (recruitment and retention) and acceptability (satisfaction)
* Establish methods of assessing intervention fidelity
* Engage multi-level partners
* Estimate the magnitude of potential impact of ABaCo on selected mechanisms and outcomes.
Hypothesis: Participants receiving ABaCo will evidence clinically meaningful change from baseline to follow-up on glycemic management and quality of life (primary outcomes) and self-management skills and acceptance coping (secondary outcomes).
Procedures: Potential participants will be referred to study staff by the Promotores team at the University Health Robert B Green Campus Family Health Center. They will be contacted by study staff for a phone visit to conduct screening procedures. If eligible, they will be scheduled for an in-person visit at the Texas Diabetes Institute (TDI), where they will be consented, complete a fingerstick HbA1c test, and complete an initial assessment packet. Participants will then receive the intervention (telephone-delivered ABaCo skills program) delivered by one Promotor/a for 6 weeks and again at week 10 (booster visit). There will be phone-based assessments visit at week 6, and again at week 10. They will be invited to participate in an interview to provide feedback on their experiences in the program and study. A final in-person assessment at TDI will be conducted at 24 weeks (6 months) after baseline, including a fingerstick HbA1c test and a final assessment packet.
At the study conclusion, all engaged Promotores and clinical partners will also be invited to share their experiences via written and verbal feedback.
### Conditions Module
**Conditions:**
- Type 2 Diabetes
**Keywords:**
- community health worker
- acceptance and commitment therapy
- task shifting
- access to care
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** single arm, pre-post, mixed-methods pilot study
##### Masking Info
**Masking:** NONE
**Primary Purpose:** HEALTH_SERVICES_RESEARCH
#### Enrollment Info
**Count:** 20
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participant-patients will receive care as usual in the Nosotros Promotores program at University Health Robert B Green Campus Family Health Center, including standardized procedures (e.g., home visits, phone calls and in-clinic visits), along with this protocol - individual telephone-delivered ABaCo skills intervention delivered by one Promotor/a for 10 weeks (6 weeks plus booster at 10 weeks).
**Intervention Names:**
- Behavioral: Acceptance Based Coping (ABaCo)
**Label:** Acceptance Based Coping (ABaCo) Skills Training
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Acceptance Based Coping (ABaCo) Skills Training
**Description:** The educational ABaCo protocol consists of core Acceptance \& Commitment Therapy (ACT) interventions, culturally and contextually-tailored for this population, and in accordance with clinician-led versions of ACT for diabetes to include (a) identification of patient values, (b) teaching acceptance and brief mindfulness skills, and (c) techniques for engaging in valued activities while coping with difficult experiences (e.g., sugar cravings, distress). It is delivered by a community health worker (promotor/a) over 6 consecutive weeks over the phone, followed by a booster call at week 10.
**Name:** Acceptance Based Coping (ABaCo)
**Type:** BEHAVIORAL
### Outcomes Module
#### Other Outcomes
**Description:** Recruitment (goal: n = 20)
**Measure:** Feasibility: Recruitment
**Time Frame:** 24 weeks
**Description:** Participant retention (goal: no more than 25% drop-out)
**Measure:** Feasibility: Retention
**Time Frame:** 24 weeks
**Description:** Interviews will be conducted with participants to understand experiences and opinions on acceptability, satisfaction, feasibility, barriers and facilitators to participation, and seek suggestions for further cultural/contextual tailoring.
**Measure:** Acceptability: Interviews
**Time Frame:** 10 weeks
**Description:** Satisfaction (acceptability) will be assessed during semistructured interviews with 3 Likert-type scale items: ease of learning; overall satisfaction; likely to recommend (goal: at least 80% report acceptability at an average of 4 or more on 7-pt scale).
**Measure:** Acceptability: Ratings
**Time Frame:** 10 weeks
#### Primary Outcomes
**Description:** Glycated hemoglobin (HbA1c) is the average blood glucose levels in past 3 months (HbA1c); higher percentages reflect higher levels of blood glucose (worse blood glucose management).
**Measure:** Average blood glucose management (HbA1c)
**Time Frame:** 0, 24 weeks
**Description:** PROMIS-10 consists of 10 items that assess physical and mental health, functioning, emotional distress, interference, overall quality of life. There are two subscales - Global Physical Health and Global Mental Health. The raw score range for both subscales is 4 to 20, but raw scores are converted to T-scores with a range of 20-80. Higher scores indicate better health. Strong psychometrics.
**Measure:** Quality of life: Patient Reported Outcomes Measurement Information System Global-10
**Time Frame:** 0, 6, 10, 24 weeks
#### Secondary Outcomes
**Description:** 11 Likert-type items (1-7): acceptance of distressing diabetes thoughts/feelings and their interference. The range of possible scores is 11-77; higher scores indicate greater non-acceptance of diabetes. Good internal consistency, construct and discriminant validity.
**Measure:** Diabetes Acceptance: Acceptance & Action Diabetes Questionnaire (AADQ)
**Time Frame:** 0, 6, 10, 24 weeks
**Description:** DAS is a recently-developed 20-item measure with Likert scale items (1-3) that identifies patients struggling to accept diabetes. Items 11 - 20 are reversed scored. The lowest possible score is 0, and the highest possible score is 60. Higher scores indicate greater diabetes acceptance. It will be used with the AADQ in pilot testing to inform best measures for next trial.
**Measure:** Diabetes Acceptance: Diabetes Acceptance Scale (DAS)
**Time Frame:** 0, 6, 10, 24 weeks
**Description:** 11-item scale assesses five different self-care regimen areas: Diet, exercise, blood-glucose testing, foot care, and smoking. The items are measured by days of the week on a scale of 0-7. The total score range is 0 -77. Higher scores indicate better self-care.
For the general diet score, the mean is taken for items 1 and 2. For specific diet, the mean for items 3 and 4 is taken, with item 4 being scored reversed.
For exercise scoring the mean is taken for items 5 and 6. Blood glucose is scored by taking the mean for items 7 and 8. While foot care is measured by taking the mean of items 9 and 10. Smoking is measured by item 11 and the number of cigarettes smoked per day.
Established, standardized.
**Measure:** Self-management: Summary of Diabetes Self-Care Activities
**Time Frame:** 0, 6, 10, 24 weeks
**Description:** 17 Likert-type scale items (1-6) measure diabetes-related distress with subscales of Emotional Burden, Physician Distress, Regimen Distress, and Interpersonal Distress. Total scores range from 17 -102, but an average score is calculated to determine level of distress, with higher scores indicating greater distress. An average score of \< 2 reflects little to no distress, an average score between 2. and 2.9 reflects moderate distress, and an average score of \> 3 reflects high distress. Strong psychometrics.
**Measure:** Diabetes Distress: Diabetes Distress Scale
**Time Frame:** 0, 6, 10, 24 weeks
**Description:** 4-item Likert scale measure (0-3). It is an ultra-brief screener that assesses anxiety and depression. Scores are rated as normal (0-2), mild (3-5), moderate (6-8), and severe (9-12). A total score greater than or equal to 3 on the first two questions suggests anxiety, while a total score greater than or equal to 3 on the last two questions suggests depression. Good psychometric properties.
**Measure:** Emotional Distress: Patient Health Questionnaire-4
**Time Frame:** 0, 6, 10, 24 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age 18-70
* Diagnosis of Type 2 Diabetes (T2DM)
* HbA1c of 7.5% or greater (may be taking oral agents or injectables for T2DM management)
* Evidence of avoidance coping (prescreen of \<48.4 on English or a \<52 on the Spanish Acceptance and Action Diabetes Questionnaire) and/or poor self-management skills (prescreen below recommended frequencies in 2 or more sub-scales of the Summary of Diabetes Self-Care Activities)
* Self-identifies as Hispanic/Latino
* Receiving ongoing care at study site clinic
* Preferred language is English or Spanish
Exclusion Criteria:
* A medical condition or life circumstance that would contraindicate participation
* Inability to read/comprehend the informed consent process or study instructions
**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:** Olivia Morris
**Phone:** 713-440-0345
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Karen Morado
**Phone:** 210) 450 - 3856
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** San Antonio
**Country:** United States
**Facility:** University of Texas Health Science Center at San Antonio
**State:** Texas
**Status:** RECRUITING
**Zip:** 78229
#### Overall Officials
**Official 1:**
**Affiliation:** Baylor College of Medicine; UT Health San Antonio
**Name:** Kathryn Kanzler, PsyD ABPP
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Access Criteria:** Email request to PI (Dr. Kanzler, [email protected]) , who will share in accordance with institutional policies.
**Description:** Based on ethical considerations, the following data produced during the project will be preserved and shared: deidentified standardized survey data; clinical data (i.e., lab values); recruitment and retention counts; qualitative data (aggregated matrix of interview responses).
To facilitate the interpretation of the data, metadata, including protocols and public data collection instruments, will be available and associated with the relevant datasets.
**Info Types:**
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
**IPD Sharing:** YES
**Time Frame:** Data will be available after the publication of primary outcomes
### References Module
#### References
**Citation:** Gregg JA, Callaghan GM, Hayes SC, Glenn-Lawson JL. Improving diabetes self-management through acceptance, mindfulness, and values: a randomized controlled trial. J Consult Clin Psychol. 2007 Apr;75(2):336-43. doi: 10.1037/0022-006X.75.2.336.
**PMID:** 17469891
**Citation:** Schmitt A, Reimer A, Kulzer B, Icks A, Paust R, Roelver KM, Kaltheuner M, Ehrmann D, Krichbaum M, Haak T, Hermanns N. Measurement of psychological adjustment to diabetes with the diabetes acceptance scale. J Diabetes Complications. 2018 Apr;32(4):384-392. doi: 10.1016/j.jdiacomp.2018.01.005. Epub 2018 Jan 31.
**PMID:** 29439862
**Citation:** Barnett ML, Lau AS, Miranda J. Lay Health Worker Involvement in Evidence-Based Treatment Delivery: A Conceptual Model to Address Disparities in Care. Annu Rev Clin Psychol. 2018 May 7;14:185-208. doi: 10.1146/annurev-clinpsy-050817-084825. Epub 2018 Jan 31.
**PMID:** 29401043
**Citation:** Khan MAB, Hashim MJ, King JK, Govender RD, Mustafa H, Al Kaabi J. Epidemiology of Type 2 Diabetes - Global Burden of Disease and Forecasted Trends. J Epidemiol Glob Health. 2020 Mar;10(1):107-111. doi: 10.2991/jegh.k.191028.001.
**PMID:** 32175717
**Citation:** American Diabetes Association. Standards of Medical Care in Diabetes-2018 Abridged for Primary Care Providers. Clin Diabetes. 2018 Jan;36(1):14-37. doi: 10.2337/cd17-0119. No abstract available.
**PMID:** 29382975
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000044882
- Term: Glucose Metabolism Disorders
- ID: D000008659
- Term: Metabolic Diseases
- ID: D000004700
- Term: Endocrine System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M7115
- Name: Diabetes Mellitus
- Relevance: HIGH
- As Found: Diabetes
- ID: M7119
- Name: Diabetes Mellitus, Type 2
- Relevance: HIGH
- As Found: Type 2 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
### Condition Browse Module - Meshes
- ID: D000003920
- Term: Diabetes Mellitus
- ID: D000003924
- Term: Diabetes Mellitus, Type 2
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06445712
**Brief Title:** Examining the Role of Pain in the Link Between Early Childhood Adversity and Psychopathology
**Official Title:** Examining the Role of Pain in the Link Between Early Childhood Adversity and Psychopathology
#### Organization Study ID Info
**ID:** 202312107
#### Organization
**Class:** OTHER
**Full Name:** Washington University School of Medicine
#### Secondary ID Infos
**ID:** UL1TR002345
**Link:** https://reporter.nih.gov/quickSearch/UL1TR002345
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2025-04-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-31
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-04-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Collaborators
**Class:** NIH
**Name:** National Center for Advancing Translational Sciences (NCATS)
#### Lead Sponsor
**Class:** OTHER
**Name:** Washington University School of Medicine
#### Responsible Party
**Investigator Affiliation:** Washington University School of Medicine
**Investigator Full Name:** Susan Perlman
**Investigator Title:** Professor of Psychiatry
**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 study is to investigate the role of physical pain in the link between childhood adversity and later psychopathology. Children who are participating in a larger longitudinal study will be asked to submerge their hand in cold water and hold it in the cold water as long as possible. Participants will do this twice, once alone and once holding the hand of their parent, to examine the role of parental support in pain development. The study will examine self-report of pain and salivary cortisol response to pain. It is hypothesized that children who have been exposed to more adversity will experience increased pain response and increased psychopathology symptoms. It is expected that higher social support in the family will decrease this relationship.
**Detailed Description:** This study will initiate a program of prospective research, linking early life adversity to both pain and psychopathology symptoms in the pre-adolescent period. This study will examine these links using an existing longitudinal sample of 6.5-9.5 year-old children experiencing familial stress. The project will examine the relationship between dysregulation and pain sensitivity from the behavioral perspective, but also through HPA axis dysregulation. Finally, the project will probe parental support as a moderator on the relationship between dysregulation and pain and psychopathology symptoms. The project will use a novel adaptation of the cold pressor test to examine experimental pain sensitivity as a function of parental support by including a condition in which the child holds the hand of their parent during the task. The project will also examine the neural basis of social support through parent-child brain synchronization. Support for the proposed model may indicate that interventions that increase parental support might decrease both pain and psychopathology.
### Conditions Module
**Conditions:**
- Child Development
**Keywords:**
- Pain
- Early Life Adversity
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** BASIC_SCIENCE
#### Enrollment Info
**Count:** 40
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Children will submerge their hand in cold water and be asked to hold it in as long as possible. They will do this both alone and holding the hand of a parent (counterbalanced).
**Intervention Names:**
- Behavioral: Parental Support Cold Pressor Task
**Label:** Pain Assessment
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Pain Assessment
**Description:** Child will submerge their hand in cold water alone and holding the hand of a parent.
**Name:** Parental Support Cold Pressor Task
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** Time hand is held in cold water
**Measure:** Pain Tolerance
**Time Frame:** 0-120 seconds
**Description:** Self-reported score on the Visual Analogue Scale for Pain. Participants use a physical sliding scale to indicate how much pain they experienced \[ higher numbers are equal to more pain; (no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm)\]
**Measure:** Pain Sensitivity
**Time Frame:** 0-60 seconds after experiencing stimulus
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Subjects who have been enrolled in our ongoing CARE study
Exclusion Criteria:
* Subjects who have not participated in the CARE study
**Maximum Age:** 9 Years
**Minimum Age:** 6 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Susan Perlman, PHD
**Phone:** 3142738403
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Saint Louis
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Susan Perlman, PHD
- **Phone:** 314-273-8403
- **Role:** CONTACT
**Country:** United States
**Facility:** Laboratory for Child Brain Development
**State:** Missouri
**Status:** RECRUITING
**Zip:** 63108
### 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: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06445699
**Brief Title:** Photodynamic Therapy With Hydrogel Dressing for Chronic Wounds
**Official Title:** Investigation the Clinical Effectiveness of Combination Topical Aminolaevulinic Acid-Photodynamic Therapy With Hydrogel Dressing for Treatment Chronic Cutaneous Wounds
#### Organization Study ID Info
**ID:** RYin
#### Organization
**Class:** OTHER
**Full Name:** Army Medical University, China
### Status Module
#### Completion Date
**Date:** 2024-06
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-04
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-06
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-01-01
**Type:** ACTUAL
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-06-04
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Army Medical University, China
#### Responsible Party
**Investigator Affiliation:** Army Medical University, China
**Investigator Full Name:** Rui Yin
**Investigator Title:** MD, PhD
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** 63 patients with chronic infectious wounds were enrolled in the controlled study. They were randomly divided into three groups equally. Group 1 (Grp.1): The patients received hydrogel dressing change at three days intervals. Group 2 (Grp.2): The patients received ALA-PDT treatment at ten days intervals for 4 sessions. Groups 3 (Grp.3): The patients received ALA-PDT at ten days intervals for 4 sessions combined with hydrogel dressing change every three days intervals. The wound healing rate, total effective rate, patient satisfaction, adverse reaction, and recurrence were assessed in all groups.
**Detailed Description:** Randomly divide the enrolled patients into three groups for treatment by utilizing SAS software (SAS Institute, Cary, NC, U.S.A.). Initially, the wound pus and secretions were washed three times with a sterile saline solution. Subsequently, surgical instruments were employed to debride the wound, particularly the necrotic tissue, as well as any carrion and foreign bodies within the wound bed and cavity, with care being taken to avoid injury to nerves and blood vessels in the surrounding area. Grp.1 was covered with hydrogel dressing (PAUL HARTMANN AG, Germany) and replaced 2-3 times a week with topical mupirocin ointment three times a day. Grp.2 received photodynamic therapy only. Grp.3 accepted PDT, then coated with hydrogel dressing as mentioned above. The treatment protocol of PDT is described as follows: after thorough debridement, ALA (Shanghai Fudan-Zhang jiang Bio-Pharmaceutical Co. Ltd, China) in an oil-in-water emulsion was smeared on the wound. After covering with dark plastic film for 3h, the wounds were illuminated by a light-emitting diode (LED) red light (Shenzhen Lifotronic Technology Co., Ltd, China). After the operation, a cold ice compress can be used to relieve the swelling and pain. Then, the hydrogel was uniformly applied to the wound and its surroundings (Grp.3). Grp.2 and Grp.3 received PDT at an interval of ten days for 4 sessions. In all groups, treatment responses and adverse reactions were recorded. All patients received the treatment as mentioned above and then evaluated the clinical outcome. After the end of the treatment, all patients returned for follow up at weeks 2, 4, 8 and 12.
### Conditions Module
**Conditions:**
- Photodynamic Therapy
**Keywords:**
- Wound healing
- Aminolaevulinic acid
- Photodynamic therapy
- Hydrogel dressing
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 69
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The patients received hydrogel dressing change at three days intervals
**Intervention Names:**
- Other: Hydrogel dressing
**Label:** Group 1 (Grp.1)
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** The patients received ALA-PDT treatment at ten days intervals for 4 sessions.
**Intervention Names:**
- Other: Photodynamic therapy
**Label:** Group 2 (Grp.2)
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** The patients received ALA-PDT at ten days intervals for 4 sessions combined with hydrogel dressing change every three days intervals.
**Intervention Names:**
- Other: Photodynamic therapy
- Other: Hydrogel dressing
**Label:** Group 3 (Grp.3)
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Group 2 (Grp.2)
- Group 3 (Grp.3)
**Description:** A number of studies have reported that PDT can accelerate wound healing by inactivating local bacterial infection and colonization of bacterial biofilm, promoting wound re-epithelialization.
**Name:** Photodynamic therapy
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Group 1 (Grp.1)
- Group 3 (Grp.3)
**Description:** Hydrogel dressing is widely applied in clinical practice to improve the regeneration ability of wound granulation tissue, promote the division and migration of epithelial cells, speed up wound healing and relieve the pain.
**Name:** Hydrogel dressing
**Type:** OTHER
### Outcomes Module
#### Other Outcomes
**Description:** The severity (absent; mild; moderate; severe) and duration of adverse reactions such as pain, burning sensation, erythema, oedema and pigmentation, treatment measures and efficacy were meticulously documented at each treatment and follow-up.
**Measure:** Adverse effects
**Time Frame:** Up to 12 weeks after the end of the treatment.
**Description:** Patients were surveyed about the recurrence after 12 weeks following the final course of treatment.
**Measure:** Recurrence
**Time Frame:** Up to 12 weeks after the end of the treatment.
#### Primary Outcomes
**Description:** Panoramic photographs of the wounds were taken by the same observer at each treatment and return visit using a digital camera, and the wound area was recorded using Image-Pro Plus 6.0 software. Wound size on the first day of treatment was considered to be 100%. The change in wound area size was compared to the initial before treatment and calculated as a percentage reduction.
**Measure:** Wound healing rate
**Time Frame:** Up to 12 weeks after the end of the treatment.
**Description:** The evaluation criteria were as follows: 1) If the wound area is completely healed, treatment was considered "significantly effective" (SE); 2) if the wound area was at least 50% healed, treatment was considered "effective" (E); 3) If the wound area was healed 30 - 50%, the treatment is considered as "improved" (IMP); 4) If the wound area is healed less than 30%, it is considered as "ineffective" (INE). "The total effectiveness rate" (Et) was calculated from the equation as follows:
Et = (NSE+NE)/Nt × 100% NSE = the number of patients belonging to the SE groups NE = the number of patients belonging to the E groups Nt = the total number of patients
**Measure:** The total effectiveness rate
**Time Frame:** Up to 12 weeks after the end of the treatment.
**Description:** Patients were surveyed about their level of satisfaction with the results after 12 weeks following the final course of treatment with the results as "satisfied," "somewhat satisfied," "somewhat dissatisfied," or "dissatisfied."
**Measure:** Patient satisfaction
**Time Frame:** Up to 12 weeks after the end of the treatment.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* 1) patients with chronic wounds caused by trauma or surgery who failed to heal after traditional formal medical treatment at least over three months;
* 2) Patients with stable vital signs who had no systemic medical disease and did not take glucocorticoids, immunosuppressive agents, or anticoagulants during the entire treatment process;
* 3) Participants provided signed informed consent, were able to comply with the program, were willing to participate in follow-up, and were able to cooperate in the observation of adverse events and efficacy;
* 4) The diameter of the skin wound should not exceed 10 centimeters.
Exclusion Criteria:
* 1) Patients are allergic to ALA;
* 2) Women with recent fertility, pregnancy or lactation plans;
* 3) Patients with deepening wounds or worsening infections;
* 4) Poor compliance leading to an inability to complete the treatment in its entirety;
* 5) Cutaneous ulcer caused by vascular disease, autoimmune diseases, metabolic diseases, local or metastatic malignant tumors.
**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:** Rui Yin, MD, PhD
**Phone:** 13101201667
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Pan Chen, MS
**Phone:** 18502362884
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Chongqing
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Rui Yin, MD, PhD
- **Phone:** 13101201667
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Pan Chen, MS
- **Phone:** 18502362884
- **Role:** CONTACT
**Country:** China
**Facility:** Department of Dermatology, Southwest Hospital, Third Military Medical University (Army Medical University)
**State:** Chongqing
**Status:** RECRUITING
**Zip:** 400038
#### Overall Officials
**Official 1:**
**Affiliation:** Southwest Hospital, Third Military Medical University, Chongqing, 400038, China
**Name:** Rui Yin, MD, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Nesi-Reis V, Lera-Nonose DSSL, Oyama J, Silva-Lalucci MPP, Demarchi IG, Aristides SMA, Teixeira JJV, Silveira TGV, Lonardoni MVC. Contribution of photodynamic therapy in wound healing: A systematic review. Photodiagnosis Photodyn Ther. 2018 Mar;21:294-305. doi: 10.1016/j.pdpdt.2017.12.015. Epub 2017 Dec 28.
**PMID:** 29289704
**Citation:** Khorsandi K, Hosseinzadeh R, Esfahani H, Zandsalimi K, Shahidi FK, Abrahamse H. Accelerating skin regeneration and wound healing by controlled ROS from photodynamic treatment. Inflamm Regen. 2022 Oct 4;42(1):40. doi: 10.1186/s41232-022-00226-6.
**PMID:** 36192814
**Citation:** Sies H, Jones DP. Reactive oxygen species (ROS) as pleiotropic physiological signalling agents. Nat Rev Mol Cell Biol. 2020 Jul;21(7):363-383. doi: 10.1038/s41580-020-0230-3. Epub 2020 Mar 30.
**PMID:** 32231263
**Citation:** Morley S, Griffiths J, Philips G, Moseley H, O'Grady C, Mellish K, Lankester CL, Faris B, Young RJ, Brown SB, Rhodes LE. Phase IIa randomized, placebo-controlled study of antimicrobial photodynamic therapy in bacterially colonized, chronic leg ulcers and diabetic foot ulcers: a new approach to antimicrobial therapy. Br J Dermatol. 2013 Mar;168(3):617-24. doi: 10.1111/bjd.12098. Epub 2013 Jan 18.
**PMID:** 23066973
**Citation:** Xu Y, Chen H, Fang Y, Wu J. Hydrogel Combined with Phototherapy in Wound Healing. Adv Healthc Mater. 2022 Aug;11(16):e2200494. doi: 10.1002/adhm.202200494. Epub 2022 Jul 6.
**PMID:** 35751637
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M17685
- Name: Wounds and Injuries
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06445686
**Acronym:** REACT
**Brief Title:** Ongoing Monitoring of Vital Signs in Patients With Idiopathic Pulmonary Fibrosis Before and After Acute Exacerbation.
**Official Title:** Ongoing Monitoring of Vital Signs in Patients With Idiopathic Pulmonary Fibrosis Before and After Acute Exacerbation. (REACT)
#### Organization Study ID Info
**ID:** 2023-A02063-42
#### Organization
**Class:** INDUSTRY
**Full Name:** Biosency
### Status Module
#### Completion Date
**Date:** 2026-02
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-04
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2026-02
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-29
**Study First Submit QC Date:** 2024-06-04
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Rennes University Hospital
**Class:** UNKNOWN
**Name:** Air de Bretagne
**Class:** UNKNOWN
**Name:** Association Fibroses Pulmonaires France
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Biosency
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The aim of this study is to assess the feasibility of early detection of acute exacerbations of idiopathic pulmonary fibrosis by the remote monitoring of vital signs.
The main question the study aims to answer is: Could a remote monitoring device allow for earlier detection of exacerbations with individualized monitoring and continuous data collection? All patients will receive conventional clinical follow-up based on their health status and clinical recommendations. At the same time, they will benefit from the Bora Care® medical remote monitoring device.
**Detailed Description:** All patients will receive conventional clinical follow-up based on their health status and clinical recommendations. At the same time, they will benefit from the Bora Care® medical remote monitoring device.
To do this, they will be equipped with a Bora Band® connected wristband that measures vital signs at home, and the Bora Box® Gateway that ensures connectivity and allows automatic data uploading in real time to the Bora Connect® data visualization platform.
The home healthcare provider Air de Bretagne will be involved in the study to support each patient in the use of the connected wristband.
At the end of the follow-up period, the collected data will be retrospectively analysed to identify the most relevant metrics within the time series of vital signs for early detection of Idiopathic Pulmonary Fibrosis exacerbations, and to assess the feasibility of early detection of Idiopathic Pulmonary Fibrosis exacerbations using a score that could trigger an alert prior to the date the patient reports clinical signs or the date the pulmonologist is consulted for exacerbation of Idiopathic Pulmonary Fibrosis.
Procedure:
* Inclusion Visit : 6-minute walk test and prescription of oxygen therapy
* Home Installation Visit: installation of oxygen therapy by Air de Bretagne and setup of the Bora Connect® bracelet and Bora Box® Gateway
* Follow-up Visit with the Pulmonologist at 6 months (M6): routine examinations, satisfaction questionnaire, and quality of life questionnaire
* End of Study Visit with the Pulmonologist at 12 months (M12): routine examinations, satisfaction questionnaire, and quality of life questionnaire.
(In case of exacerbation, the follow-up will be extended by 3 months to collect post-exacerbation data.)
### Conditions Module
**Conditions:**
- Idiopathic Pulmonary Fibrosis
**Keywords:**
- Idiopathic pulmonary fibrosis
- Remote monitoring
- Exacerbation
- Prevention
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 30
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Outcomes Module
#### Primary Outcomes
**Description:** Correlation between changes in time series of vital signs (heart rate, respiratory rate) in patients in the days prior to diagnosis of exacerbation of Idiopathic Pulmonary Fibrosis and onset of exacerbation of Idiopathic Pulmonary Fibrosis.
**Measure:** Assess the feasibility of early detection of acute IPF exacerbations with the Bora Care® Vital Signs Remote Monitoring Solution.
**Time Frame:** 1 year
#### Secondary Outcomes
**Description:** Evolution of vital signs in patients on days prior to the date of other medical events during follow-up.
**Measure:** Identify relevant metrics in the signals collected by the Bora Care® solution for early detection of medical events.
**Time Frame:** 1 year
**Description:** Number of hours of wearing the Bora Band® bracelet normalised by the total number of hours of the remote monitoring session, information collected via the Bora Care® too.
**Measure:** Assess compliance with the use of the Bora Care® bracelet by patients.
**Time Frame:** 1 year
**Description:** Subjective assessment by the patient of the device of the reassurance provided by the device, of the help to resume physical activity provided by the device, obtained using satisfaction questionnaires at M6 and M12.
SF36 Quality of Life Questionnaire score collected at D0, M6 and M12.
**Measure:** Assess patient satisfaction and reassurance provided by the remote monitoring solution
**Time Frame:** 1 year
**Description:** Subjective assessment of health care professionals' satisfaction with and adherence to the Bora Care® remote monitoring solution, including an organizational impact assessment and an assessment of clinical relevance using a questionnaire at the end of the study.
**Measure:** Assess the satisfaction and adherence of healthcare professionals to the remote monitoring solution.
**Time Frame:** 1 year
**Description:** Number and nature of Bora Care® adverse events
**Measure:** Assess side effects related to the Bora Care® device.
**Time Frame:** 1 year
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patient over 18 years of age, ideally 50% male and 50% female
* Patient with IPF with a known level of respiratory function (EFR and blood gas less than 3 months)
* Stable patient, i.e. without hospitalisation or exacerbation in the last 3 months
* Patient desaturating at 6MW in ambient air (AA) and requiring ambulatory oxygen therapy (SpO2 AA ⩽ 88%)
* Patient not receiving walking or permanent oxygen therapy at baseline
* Informed patient who has signed consent
* Patient affiliated to a social security scheme
* Patient not monitored by a home healthcare provider other than Air de Bretagne.
Exclusion Criteria:
* Vulnerable patient
* Patient receiving ambulatory or permanent oxygen therapy at baseline
* Patient already seen with another healthcare provider (e.g. OSAS)
* Patient unable to use the Bora Band® tool and without access to a caregiver
* Presence of co-morbidity considered unstable or very severe by the investigator
* Patient protected, under guardianship or incapable of giving free and informed consent
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Patients with Idiopathic Pulmonary Fibrosis with indication for ambulatory oxygen therapy (Sp02 (peripheral oxygen saturation) ≤ 88% in ambient air during 6-minute walk test)
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Alexis TOULLEC
**Phone:** 02 21 65 70 01
**Phone Ext:** +33
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Rennes
**Contacts:**
***Contact 1:***
- **Name:** Stéphane Jouneau, MD
- **Phone:** 0299282478
- **Phone Ext:** +33
- **Role:** CONTACT
**Country:** France
**Facility:** Chru Pontchaillou
**Status:** RECRUITING
**Zip:** 35000
#### Overall Officials
**Official 1:**
**Affiliation:** CHRU PONTCHAILLOU Rennes
**Name:** Stéphane JOUNEAU, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** Not applicable. Data are not intended to be shared with other researchers.
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010335
- Term: Pathologic Processes
- ID: D000017563
- Term: Lung Diseases, Interstitial
- ID: D000008171
- Term: Lung Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M14512
- Name: Pulmonary Fibrosis
- Relevance: HIGH
- As Found: Pulmonary Fibrosis
- ID: M27989
- Name: Idiopathic Pulmonary Fibrosis
- Relevance: HIGH
- As Found: Idiopathic Pulmonary Fibrosis
- ID: M8485
- Name: Fibrosis
- Relevance: HIGH
- As Found: Fibrosis
- ID: M11168
- Name: Lung Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M19813
- Name: Lung Diseases, Interstitial
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T3003
- Name: Idiopathic Pulmonary Fibrosis
- Relevance: HIGH
- As Found: Idiopathic Pulmonary Fibrosis
- ID: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000011658
- Term: Pulmonary Fibrosis
- ID: D000054990
- Term: Idiopathic Pulmonary Fibrosis
- ID: D000005355
- Term: Fibrosis
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06445673
**Acronym:** TripleTRE-NIS
**Brief Title:** A Prospective Non-interventional Observational Study to Observe Long-term Treatment and Outcomes in Pulmonary Arterial Hypertension (PAH) Patients
**Official Title:** A Prospective, Multicenter, International Non-interventional, Observational Cohort Study to Observe Long-term Treatment Patterns and Real-word Outcomes in PAH Group I Patients Previously Participating in TripleTRE - TripleTRE-NIS
#### Organization Study ID Info
**ID:** TREV1-10P.NIS
#### Organization
**Class:** INDUSTRY
**Full Name:** AOP Orphan Pharmaceuticals AG
### Status Module
#### Completion Date
**Date:** 2030-06
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-04
**Overall Status:** ENROLLING_BY_INVITATION
#### Primary Completion Date
**Date:** 2030-06
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-29
**Study First Submit QC Date:** 2024-06-04
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** AOP Orphan Pharmaceuticals AG
#### 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 observational study is to learn about the long-term development and outcomes of different treatment patterns of patients who initially participated in the TripleTRE study.
The primary objective of this non-interventional follow-up study is to assess the long-term real-world clinical outcomes, including disease progression and survival rates, in patients who initially participated in and completed the randomized TripleTRE trial.
Planned observation duration per patient is a minimum of 3 years.
### Conditions Module
**Conditions:**
- Pulmonary Arterial Hypertension
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 110
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** all patients previously treated within the TripleTRE trial who are willing to participate in this NIS
**Label:** TripleTRE NIS patients
### Outcomes Module
#### Other Outcomes
**Description:** This includes:
* Adverse events (S)AEs
* Adverse drug reactions (S)ADRs related to any of PAH treatments
* Adverse events related to underlying diagnosis, PAH
**Measure:** Frequency and seriousness of adverse events (AE) and adverse drug reactions (ADR)
**Time Frame:** up to year 3
**Description:** The EQ-5D-5L questionnaire consists of 2 parts - the EQ-5D-5L descriptive system and the EQ Visual Analogue scale. The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking (or placing a cross) in the box against the most appropriate statement in each of the 5 dimensions. This decision results in a 1-digit number expressing the level selected for that dimension. The digits for 5 dimensions can be combined in a 5-digit number describing the respondent's health state. It should be noted that the numerals 1-5 have no arithmetic properties and should not be used as a cardinal score.
**Measure:** Long-term change in QoL using European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) questionnaire
**Time Frame:** up to year 3
**Description:** Emphasis meaning something of special importance or significance. Please translate using the most appropriate term. The PH in emPHasis represents the condition Pulmonary Hypertension. The number 10 refers to the number of items in the questionnaire.
This questionnaire is designed to determine how Pulmonary Hypertension (PH) affects patient's life. It refers to how PH affects or the impact that PH has on the patient's life.
**Measure:** Long-term change in QoL using PAH-specific emPHasis-10 questionnaire
**Time Frame:** up to year 3
#### Primary Outcomes
**Measure:** Time to death or lung transplantation
**Time Frame:** up to year 3
**Description:** clinical worsening is defined as fulfilling on of the following criteria:
* PAH related death (including all deaths where PAH cannot be excluded as cause)
* Lung transplantation due to PAH
* PAH-related hospitalization
* Post baseline decrease in 6MWD by 15%
* Post baseline worsening of WHO FC
**Measure:** Time to first clinical worsening
**Time Frame:** up to year 3
**Description:** clinical worsening is defined as fulfilling on of the following criteria:
* PAH related death (including all deaths where PAH cannot be excluded as cause)
* Lung transplantation due to PAH
* PH-related hospitalization
* Post baseline decrease in 6MWD by 15%
* Post baseline worsening of WHO FC
**Measure:** Total number of clinical worsenings
**Time Frame:** up to year 3
#### Secondary Outcomes
**Description:** 6-Minute Walking Distance (6MWD) will be measured in meters
**Measure:** Long-term change in 6MWD
**Time Frame:** up to year 3
**Description:** any change or addition of new PH medication including dosing in time
**Measure:** Long-term change in PAH treatment regimens
**Time Frame:** up to year 3
**Description:** Risk status measured by simplified four-strata risk-assessment tool
**Measure:** Long-term change in risk status
**Time Frame:** up to year 3
**Description:** World Health Organization Functional Class (WHO FC) is categorized from I (no symptoms) to IV (severe dyspnea and symptoms)
**Measure:** Long-term change in WHO FC
**Time Frame:** up to year 3
**Description:** BDS - Borg Dyspnea Score, ranging from 0 (no exertion) to 10 (maximum)
**Measure:** Long-term change in BDS
**Time Frame:** up to year 3
**Description:** NT-proBNP/BNP: N-terminal pro Brain Natriuretic Peptide
**Measure:** Long-term change in NT-proBNP/BNP
**Time Frame:** up to year 3
**Description:** PVR to be measured in WU Parameter will be collected according to clinical routine
**Measure:** Long-term change in Pulmonary Vascular Resistance (PVR)
**Time Frame:** up to year 3
**Description:** mPAP to be measured in mmHg Parameter will be collected according to clinical routine
**Measure:** Long-term change in mean Pulmonary Arterial Pressure (mPAP)
**Time Frame:** up to year 3
**Description:** RAP to be measured in mmHg Parameter will be collected according to clinical routine
**Measure:** Long-term change in Right Atrial Pressure (RAP)
**Time Frame:** up to year 3
**Description:** mean Right Atrial Pressure (mRAP) to be measured in mmHg Parameter will be collected according to clinical routine
**Measure:** Long-term change in mean Right Atrial Pressure (mRAP)
**Time Frame:** up to year 3
**Description:** Cardiac index (CI) measured in liters per minute per square meter Parameter will be collected according to clinical routine
**Measure:** Long-term change in Cardiac Index (CI)
**Time Frame:** up to year 3
**Description:** Cardiac output (CO) measured in liters per minute Parameter will be collected according to clinical routine
**Measure:** Long-term change in Cardiac Output (CO)
**Time Frame:** up to year 3
**Description:** Pulmonary capillary wedge pressure (PCWP) measured in mmHg Parameter will be collected according to clinical routine
**Measure:** Long-term change in Pulmonary capillary wedge pressure (PCWP)
**Time Frame:** up to year 3
**Description:** Parameter will be collected according to clinical routine
**Measure:** Long-term change in Stroke volume index (SVI)
**Time Frame:** up to year 3
**Description:** RV-PA coupling estimated by the ratio of tricuspid annular plane systolic excursion by pulmonary artery systolic pressure Parameter will be collected according to clinical routine
**Measure:** Long-term change in RV-PA coupling
**Time Frame:** up to year 3
**Description:** RV end-diastolic area (RVEDA) measured in square centimeters Parameter will be collected according to clinical routine
**Measure:** Long-term change in RV end-diastolic area (RVEDA)
**Time Frame:** up to year 3
**Description:** RV end-systolic area (RVESA) measured in square centimeters Parameter will be collected according to clinical routine
**Measure:** Long-term change in RV end-systolic area (RVESA)
**Time Frame:** up to year 3
**Description:** RV fractional area change (RVFAC) calculated in % Parameter will be collected according to clinical routine
**Measure:** Long-term change in RV fractional area change (RVFAC)
**Time Frame:** up to year 3
**Description:** Right Atrium (RA) area in square centimeters Parameter will be collected according to clinical routine
**Measure:** Long-term change in Right Atrium (RA) area
**Time Frame:** up to year 3
**Description:** Pericardial effusion assessment will be done and rated as yes/no Parameter will be collected according to clinical routine
**Measure:** Long-term change in Pericardial effusion
**Time Frame:** up to year 3
**Description:** Parameter will be collected according to clinical routine
**Measure:** Long-term change in Right ventricular ejection fraction (RVEF)
**Time Frame:** up to year 3
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Patients previously participating in the randomized TripleTRE trial who are able and willing to provide a signed informed consent for study participation in NIS
Exclusion Criteria:
1. Lost to follow-up patients of TripleTRE study
2. Patients who discontinued all medicinal PAH treatments (e.g. after successful lung transplantation)
3. Patients who withdrew from the initial TripleTRE trial due to significant non-compliance with trial requirements (not adhering to therapy, not coming to hospital visits)
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** The study population will consist of patients who participated in the TripleTRE study and who have not been lost to follow-up and have given a written informed consent for their participation in the NIS.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Linz
**Country:** Austria
**Facility:** Ordensklinikum Linz
**Location 2:**
**City:** Vienna
**Country:** Austria
**Facility:** Medical University Vienna
**Location 3:**
**City:** Olomouc
**Country:** Czechia
**Facility:** Fakultní Nemocnice Olomouc
**Location 4:**
**City:** Praha
**Country:** Czechia
**Facility:** Všeobecná fakultní nemocnice v Praze
**Location 5:**
**City:** Paris
**Country:** France
**Facility:** Hôpital Bicêtre-- Assistance Publique Hopitaux de Paris
**Location 6:**
**City:** Strasbourg
**Country:** France
**Facility:** Hôpitaux Universitaires de Strasbourg
**Location 7:**
**City:** Berlin
**Country:** Germany
**Facility:** DRK Kliniken Berlin Westend
**Location 8:**
**City:** Dresden
**Country:** Germany
**Facility:** University Hospital Carl Gustav Carus of Technical University Dresden
**Location 9:**
**City:** Greifswald
**Country:** Germany
**Facility:** Universitätsmedizin Greifswald
**Location 10:**
**City:** Budapest
**Country:** Hungary
**Facility:** Gottsegen National Cardiovascular lnstitute
**Location 11:**
**City:** Szeged
**Country:** Hungary
**Facility:** Medical University of Szeged
**Location 12:**
**City:** Rome
**Country:** Italy
**Facility:** Sapienza University of Rome
**Location 13:**
**City:** Kraków
**Country:** Poland
**Facility:** John Paul II Hospital Krakow
**Location 14:**
**City:** Otwock
**Country:** Poland
**Facility:** Fryderyk Chopin Hospital in European Health Centre Otwock
**Location 15:**
**City:** Bucharest
**Country:** Romania
**Facility:** Emergency Institute for Cardiovascular Diseases Prof. Dr. C.C.Iliescu
**Location 16:**
**City:** Târgu-Mureş
**Country:** Romania
**Facility:** Emergency Clinical County Hospital of Targu Mures
**Location 17:**
**City:** Barcelona
**Country:** Spain
**Facility:** Hospital Clinic of Barcelona
**Location 18:**
**City:** Madrid
**Country:** Spain
**Facility:** Hospital Ramon y Cajal
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000006976
- Term: Hypertension, Pulmonary
- ID: D000008171
- Term: Lung Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M10024
- Name: Hypertension
- Relevance: HIGH
- As Found: Arterial Hypertension
- ID: M2261
- Name: Pulmonary Arterial Hypertension
- Relevance: HIGH
- As Found: Pulmonary Arterial Hypertension
- ID: M30541
- Name: Familial Primary Pulmonary Hypertension
- Relevance: HIGH
- As Found: Pulmonary Arterial Hypertension
- ID: M10027
- Name: Hypertension, Pulmonary
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M11168
- Name: Lung Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T4807
- Name: Pulmonary Arterial Hypertension
- Relevance: HIGH
- As Found: Pulmonary Arterial Hypertension
### Condition Browse Module - Meshes
- ID: D000081029
- Term: Pulmonary Arterial Hypertension
- ID: D000065627
- Term: Familial Primary Pulmonary Hypertension
- ID: D000006973
- Term: Hypertension
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06445660
**Acronym:** AMESIradiol
**Brief Title:** The Feasibility of a Radiological Score Based on CT Signs for Recognizing Salvageable Bowel in Acute Mesenteric Ischemia
**Official Title:** The Feasibility of a Radiological Score Based on Quantified Analysis of Computed Tomography Signs for Recognizing Salvageable Bowel in Acute Mesenteric Ischemia: A Retrospective Analysis of Prospective Study
#### Organization Study ID Info
**ID:** 03.01.2024
#### Organization
**Class:** OTHER
**Full Name:** University of Tartu
### Status Module
#### Completion Date
**Date:** 2024-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-31
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2023-04-05
**Type:** ACTUAL
#### Start Date
**Date:** 2022-06-06
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Tartu
#### Responsible Party
**Investigator Affiliation:** University of Tartu
**Investigator Full Name:** Annika Reintam Blaser
**Investigator Title:** associate professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Computed tomography (CT) is the standard modality for scanning patients with critical acute abdominal conditions, including suspected acute mesenteric ischemia (AMI). CT imaging can potentially differentiate between reversible and irreversible ischaemic damage of the bowel. This moment is pivotal in selecting the treatment strategy for AMI - in the absence of irreversible damage; reperfusion therapy can preserve intestinal viability, thereby avoiding the need for bowel resection. The present study tests the hypothesis that combining several symptoms may enhance the diagnostic performance of CT scanning in detecting salvageable bowel in patients with AMI. This study is an ancillary component of the AMESI study (Clinical Trials: NCT05218863) - a prospective, multicentre observational study aimed at identifying the incidence and describing the outcomes of acute mesenteric ischemia (AMI) in adult hospitalized patients. The ultimate purpose of the present study is to create a computed tomography-based radiological score for the assessment of bowel viability in patients with AMI.
### Conditions Module
**Conditions:**
- Acute Mesenteric Ischemia
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 200
**Type:** ESTIMATED
**Patient Registry:** True
**Study Type:** OBSERVATIONAL
**Target Duration:** 1 Year
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients included in the AMESI study as suspected AMI
**Label:** Controls
#### Arm Group 2
**Description:** Patients included in the AMESI study with confirmed AMI, who did not undergo bowel resection
Patients with one of the following:
1. treated endovascularly and did not undergo bowel resection secondarily
2. received surgical revascularization without bowel resection (initial or secondary)
3. received explorative laparoscopy or laparotomy without the need for bowel resection (initially or secondarily)
4. received conservative treatment without the need for secondary bowel resection
**Label:** AMI patients with salvageable bowel
#### Arm Group 3
**Description:** Patients included in the AMESI study with confirmed AMI who (one of the following):
1. underwent bowel resection initially
2. underwent bowel resection secondarily
3. did not undergo bowel resection because non-salvageable bowel
4. were changed to palliation due to the progression of ischaemia after any initial treatment with curative intention (including endovascular and conservative)
**Label:** AMI patients with non-salvageable bowel
### Outcomes Module
#### Primary Outcomes
**Description:** Frequency rate of common radiological signs in AMI patients with and without salvageable bowel.
**Measure:** Frequency rate
**Time Frame:** up to one month
#### Secondary Outcomes
**Description:** Frequency rate of common radiological signs/findings among patients with confirmed and suspected but eventually not confirmed AMI.
**Measure:** Frequency rate
**Time Frame:** up to one month
**Description:** Performance of the radiological score in patients with different types of AMI.
**Measure:** Performance of the radiological score
**Time Frame:** up to one month
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Participant in AMESI study
* confirmed or suspected acute mesenteric ischaemia
* CT scan of the entire abdominal cavity / full body using intravenous contrast media is available
Exclusion Criteria:
* Scans without the use of an intravenous contrast media or those covering only a partial area of the abdomen will be excluded.
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** This is a substudy of the AMESI study - "Incidence, Diagnosis, Management, and Outcome of Acute Mesenteric Ischaemia: A Prospective, Multicentre Observational Study." (Clinical Trials: NCT05218863) As of the end of August 2023, a total of 705 patients from 32 study sites worldwide have been enrolled, with 418 of them having confirmed cases of AMI. For patients with confirmed AMI, comprehensive data collection concerning diagnostics, management, and long-term outcomes has been completed
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Joel Starkopf
**Phone:** 53318400
**Phone Ext:** 372
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Kätlin Eiche
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Tartu
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Martin Reim, Dr
- **Role:** CONTACT
**Country:** Estonia
**Facility:** Tartu University Hospital
**Status:** RECRUITING
**Zip:** 50408
#### Overall Officials
**Official 1:**
**Affiliation:** University of Tartu, Department of Anaesthesiology and Intensive Care
**Name:** Joel Starkopf
**Role:** STUDY_CHAIR
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Document Section
### Large Document Module
#### Large Docs
- Date: 2024-01-03
- Filename: Prot_000.pdf
- Has ICF: False
- Has Protocol: True
- Has SAP: False
- Label: Study Protocol
- Size: 573510
- Type Abbrev: Prot
- Upload Date: 2024-05-22T05:56
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010335
- Term: Pathologic Processes
- ID: D000007410
- Term: Intestinal Diseases
- ID: D000005767
- Term: Gastrointestinal Diseases
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000010532
- Term: Peritoneal 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: BC06
- Name: Digestive System Diseases
- 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: Ischemia
- ID: M30554
- Name: Mesenteric Ischemia
- Relevance: HIGH
- As Found: Mesenteric Ischemia
- 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
- ID: M13441
- Name: Peritoneal 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: D000065666
- Term: Mesenteric Ischemia
- ID: D000007511
- Term: Ischemia
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06445647
**Brief Title:** Effect of Core Exercise on ADL in Hemodialysis
**Official Title:** Effect of Core Stability Exercise Training on Activities of Daily Living, Fatigue Level and Balance in Hemodialysis
#### Organization Study ID Info
**ID:** core exercise
#### Organization
**Class:** OTHER
**Full Name:** Beni-Suef University
### Status Module
#### Completion Date
**Date:** 2025-11-15
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-04
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-02-15
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-15
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-30
**Study First Submit QC Date:** 2024-06-04
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Beni-Suef University
#### Responsible Party
**Investigator Affiliation:** Beni-Suef University
**Investigator Full Name:** Mohammed Youssef Elhamrawy
**Investigator Title:** Lecturer of Physical therapy
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Finding the effect of core stability exercises with breathing exercises on Activities of daily living (ADLs), fatigue level and balance in maintenance hemodialysis patients.
**Detailed Description:** Sixty patients will be randomly assigned into two equal groups, the experimental (EX) group and the control group (CON). The participants' age will be 50-65 years and undergo hemodialysis. The Ex-group will attend three sessions/week of core stability exercise training (CSE) combined with Deep Breathing (25:30-min) for 8 weeks, the CON will attend 3 sessions/week of Deep Breathing (15-min) for 8 weeks. All the patients received only routine hemodialysis department care.
### Conditions Module
**Conditions:**
- Hemodialysis
**Keywords:**
- Core Exercise
- ADL
- Balance
- Hemodialysis
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** 30 hemodialysis patient
**Intervention Names:**
- Other: core Stability exercise
- Other: Breathing exercises
**Label:** Study Group
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** 30 hemodialysis patient
**Intervention Names:**
- Other: Breathing exercises
**Label:** Control group
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Study Group
**Description:** core stability exercise training
**Name:** core Stability exercise
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Control group
- Study Group
**Description:** Deep breathing and diaphragmatic breathing exercises
**Name:** Breathing exercises
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** ADLs will be assessed by Barthel Index (BI)
**Measure:** Activities of Daily Livings (ADLs)
**Time Frame:** up to 8 weeks
**Description:** Fatigue will be assessed by fatigue assessment scale. The total score ranges from 10 to 50. A total score \< 22 indicates no fatigue, a score ≥ 22 indicates fatigue.
**Measure:** Fatigue
**Time Frame:** up to 8 weeks
**Description:** Balance will be assessed by berg balance scale, the balance score ranges from 0 to 56, with lower scores indicating increased risk of balance loss and higher scores indicating improved functional mobility. Time up and go test (TUG)n Score \< 10 seconds = normal \< 20 seconds = good mobility; can walk outside alone; does not require a walking aid \< 30 seconds = walking and balance problems; cannot walk outside alone; requires walking aid.
**Measure:** Balance
**Time Frame:** up to 8 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Adults ranging from 55- 70 years old of both genders.
* Diagnosed as maintenance hemodialysis for at least 6 months or more.
* Free from mental illness, neuromuscular disorders, and serious lung problems and able to implement the interventional exercise.
Exclusion Criteria:
* Obesity (BMI ≥ 30 kg/m2)
* Orthopeadics or neurological problems that interferes with training.
* History of pulmonary problems (COPD, pneumonia)
* History of Myocardial infarction and/or cardiothoracic surgery
* Unstable medical status
* Dementia that interferes with the ability to follow instructions.
* History Chronic Fatigue Syndrome (CFS).
**Maximum Age:** 70 Years
**Minimum Age:** 55 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Mohammed Yo Elhamrawy, Ph.D
**Phone:** +201282805567
**Role:** CONTACT
**Contact 2:**
**Name:** Mohammed S Saif, Ph.D
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** National institute for Gerontology
**Name:** Mohammed S Saif
**Role:** PRINCIPAL_INVESTIGATOR
## 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: M8364
- Name: Fatigue
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06445634
**Brief Title:** Outcome of GATT Combined With Goniosynechiolysis in Glaucoma Patients With Secondary Synechial Angle Closure.
**Official Title:** Outcome of Gonioscopy-Assisted Transluminal Trabeculotomy Combined With Goniosynechiolysis in Glaucoma Patients With Secondary Synechial Angle Closure: A Prospective Case Series
#### Organization Study ID Info
**ID:** _MD-393-2023_
#### Organization
**Class:** OTHER
**Full Name:** Kasr El Aini Hospital
### Status Module
#### Completion Date
**Date:** 2025-08-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-05
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-08-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-04-01
**Type:** ACTUAL
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-31
**Study First Submit QC Date:** 2024-06-05
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Kasr El Aini Hospital
#### Responsible Party
**Investigator Affiliation:** Kasr El Aini Hospital
**Investigator Full Name:** Rokaya Emad Radwan
**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:** To evaluate the intraocular pressure reduction effect of combined gonioscopy-assisted transluminal trabeculotomy (GATT) with goniosynechialysis in eyes with secondary synechial angle closure glaucoma.
**Detailed Description:** Glaucoma is a group of diseases that present with cupping of the optic nerve head and visual-field defects. It is the most common cause of irreversible blindness all over the world.Angle-closure glaucoma is a type of glaucoma characterized by narrowing or closure of the anterior chamber angle.
Two major types of angle closure glaucoma are defined by the mechanism of angle closure: in appositional contact, the iris is pushed by a pressure difference between the posterior and anterior chambers due to relative pupillary block, while in synechial contact, the peripheral iris adheres to the trabecular meshwork by peripheral anterior synechiae (PAS). PAS can develop in various ocular conditions, including: ocular inflammation, a post-traumatic condition, after cataract surgery, or with an iris bombe in a pupillary block glaucoma.
Grover et al. described a technique for ab-Interno circumferential trabeculotomy termed gonioscopy-assisted transluminal trabeculotomy (GATT). The procedure aims to create a 360° trabeculotomy from an ab-Interno approach.
GATT procedure is a MIGS technique in which trabecular meshwork is circumferentially bypassed by incising it using a suture or microcatheter.In this technique, aqueous humor passes through the collector channels and episcleral veins through the cleaved open diseased trabecular meshwork.
Elsayed et al previously demonstrated that combining phacoemulsification with GATT in PACG yielded more favorable outcomes in terms of IOP, glaucoma medications and surgical success compared to phacoemulsification alone.However, to date, no studies have looked at the outcomes of combining goniosynechialysis with GATT in secondary angle closure glaucoma. In fact, most studies looking at the outcomes of GATT in different types of glaucoma excluded eyes with synechial angle closure.
Goniosynechialysis (GSL) is the process of physically separating PAS, which can develop in the trabecular meshwork due to various conditions including primary and secondary cases of angle closure.
So, for those cases of synechial angle closure glaucoma combining GATT and GSL might aid in the IOP lowering effect required.
### Conditions Module
**Conditions:**
- Glaucoma, Angle-Closure
**Keywords:**
- secodary angle closure
- GATT
- intra ocular pressure
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** prospective cohort
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 23
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Outcome of Gonioscopy-Assisted Transluminal Trabeculotomy Combined with Goniosynechiolysis in Glaucoma Patients with Secondary Synechial Angle Closure
**Intervention Names:**
- Other: Gonioscopy-Assisted Transluminal Trabeculotomy Combined with Goniosynechiolysis
**Label:** Gatt combined with goinosynechiolysis in secondary synechial angle closure
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Gatt combined with goinosynechiolysis in secondary synechial angle closure
**Description:** Gonioscopy-Assisted Transluminal Trabeculotomy Combined with Goniosynechiolysis in Glaucoma Patients with Secondary Synechial Angle Closure
**Name:** Gonioscopy-Assisted Transluminal Trabeculotomy Combined with Goniosynechiolysis
**Other Names:**
- GATT
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** measurement of intra ocular pressure and documentation of number of anti glaucoma medications post operative
**Measure:** IOP and glaucoma medications.
**Time Frame:** 1day,1 week,1 months, 3 months, 6 months and 1 year
**Description:** Surgical success will be defined as: complete if IOP is less than or equal to 21mmHg without medications and qualified success if IOP is less than or equal to 21mmHg with medications. Failure will be the inability to achieve such a pressure, the need for another glaucoma operation or the development of a sight-threatening complication (e.g., retinal detachment, endophthalmitis)
**Measure:** Surgical success.
**Time Frame:** 1day,1 week,1 months, 3 months, 6 months and 1 year
#### Secondary Outcomes
**Description:** rate of complications will be recorded
**Measure:** Complications.
**Time Frame:** 1day,1 week,1 months, 3 months, 6 months and 1 year
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients with secondary synechial angle closure glaucoma
* Involving more than 180 degrees of the iridocorneal angle
* Requiring surgery for uncontrolled IOP despite maximum tolerated therapy.
Exclusion Criteria:
* Eyes with PACG.
* Eyes with neovascular glaucoma. (Some apparently stable NVG cases would have remnants of neo-vessels in the angle that are hidden behind the synechiae).
* Eyes with retinal pathology.
* Eyes requiring combined phacoemulsification and GATT.
* Eyes with corneal pathology that can preclude surgery and imaging.
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Rokaya Radwan
**Phone:** 01066471468
**Phone Ext:** +2
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Fayrouz Aboalazaym
**Phone:** 01007419500
**Phone Ext:** +2
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Giza
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Rokaya Radwan
- **Phone:** 01066471468
- **Phone Ext:** +2
- **Role:** CONTACT
**Country:** Egypt
**Facility:** Kasralainy Hospitals
**Status:** RECRUITING
**Zip:** 11555
### IPD Sharing Statement Module
**Access Criteria:** will be uploaded
**Description:** medical data including intraocular pressure and study outcomes will be shared but excluding any participant confidential data
**Info Types:**
- STUDY_PROTOCOL
- SAP
- ICF
**IPD Sharing:** YES
**Time Frame:** After publication within 18 months
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009798
- Term: Ocular Hypertension
- ID: D000005128
- Term: Eye Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC11
- Name: Eye Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BC14
- Name: Heart and Blood Diseases
### Condition Browse Module - Browse Leaves
- ID: M9013
- Name: Glaucoma
- Relevance: HIGH
- As Found: Glaucoma
- ID: M18366
- Name: Glaucoma, Angle-Closure
- Relevance: HIGH
- As Found: Glaucoma, Angle-Closure
- ID: M12307
- Name: Neoplasm Metastasis
- Relevance: LOW
- As Found: Unknown
- ID: M10024
- Name: Hypertension
- Relevance: LOW
- As Found: Unknown
- ID: M12731
- Name: Ocular Hypertension
- Relevance: LOW
- As Found: Unknown
- ID: M8271
- Name: Eye Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000005901
- Term: Glaucoma
- ID: D000015812
- Term: Glaucoma, Angle-Closure
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06445621
**Acronym:** FOLL-OV
**Brief Title:** Early Detection of Relapse in Ovarian Cancer Using Capillary Home-sampling and a Protein Biomarker Test
**Official Title:** Early Detection of Relapse in Ovarian Cancer Using Capillary Home-sampling and a Multiplex Protein Biomarker Test - a Pilot Study
#### Organization Study ID Info
**ID:** FOU2024-00132
#### Organization
**Class:** OTHER
**Full Name:** Uppsala University Hospital
### Status Module
#### Completion Date
**Date:** 2026-05
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-31
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-05
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** Norrlands Universitetssjukhus, Umea, Sweden
#### Lead Sponsor
**Class:** OTHER
**Name:** Uppsala University Hospital
#### Responsible Party
**Investigator Affiliation:** Uppsala University Hospital
**Investigator Full Name:** Karin Stålberg
**Investigator Title:** Associate Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** PURPOSE/AIMS There is no consensus on optimal follow-up after ovarian cancer. A recent study demonstrated eight months prolonged survival in patients with complete surgical resection. Hence, it is crucial to detect relapses early, when the tumor burden is limited.
The research group have previously identified a plasma protein panel with high accuracy in detecting ovarian cancer at diagnosis and follow-up. The aim with this feasibility study is to validate the panel for its' capacity to detect early relapse in symptom-free patients in a user-friendly non-invasive way i.e. a home-administered capillary sampling. The results will be the foundation for a forthcoming national prospective randomized trial.
METHODS The study is designed as a prospective cohort study including women in the control program after ovarian cancer in Uppsala and Umeå, Sweden. The study participants should have no evidence of disease after primary treatment or after relapse. In addition to standard follow-up, they will be asked to take a capillary home-sample (blood-test from finger) every second month during one year or until relapse. The result of the test will not affect treatment, but solely be used for research purposes.
IMPORTANCE The study aims to clarify following issues:
1. Calibration of the risk score in capillary blood samples.
2. Evaluation of the logistics in home-sampling.
3. Evaluation of the acceptability (reasons of drop-out etc.) of home-sampling by structured interviews of a sample of study participants.
CLINICAL SIGNIFICANCE The hypothesis behind the study is that more frequent analysis of a protein panel specific for ovarian cancer, will lead to earlier detection of relapse, earlier treatment and a better prognosis. Additionally, in the future the vision is that women may choose between different ways of follow-up depending on individual risk factors, personal preferences and logistic reasons. In the long-term the results of the applicability of home-administered blood sampling from this study can be useful in other patient groups as well.
**Detailed Description:** Early detection of relapse in ovarian cancer using capillary home-sampling and a multiplex protein biomarker test - a pilot study
PURPOSE AND AIMS Epithelial ovarian cancer (EOC) is the deadliest of all gynecologic cancers, with 700 incident cases per year in Sweden. Even though almost three out of four women with EOC relapse within 2-3 years, there is a striking lack of prospective trials on optimized follow-up after EOC treatment. The research group have previously identified a plasma marker protein panel with high accuracy for ovarian cancer diagnosis and follow-up. The aim with this pilot study is to validate the protein panel for its capacity to detect early relapse in symptom-free patients in a user-friendly, non-invasive way i.e., a home-administered capillary sampling. Further, the results will be the foundation for a forthcoming national prospective randomized trial (RCT) - the FOLL-OV trial.
SURVEY OF THE FIELD/PRELIMINARY RESULTS One of the main purposes with a follow-up program is to find cancer relapse at an early stage and thereby improve the patient's chance of successful treatment and prolonged survival. Yet, there is a striking lack of prospective studies in the field.
A recent RCT demonstrated eight months prolonged overall survival when treated with surgery at first relapse, compared to chemotherapy alone, however, the survival benefit was limited to women where complete surgical resection was achieved (3). Hence, it has become more important than ever to detect relapse as soon as realistically possible, when the tumor burden is limited.
As of present, the Swedish National Guidelines for EOC recommend follow-up 3-4 times/year during the first two years after completed treatment. The follow-up consists of physical (and gynecologic) examination, transvaginal ultrasound, and is many times complemented with the EOC biomarker CA125, but this is optional. CA125 is an unspecific marker, and not elevated in all types of EOC. In a Cochrane review evaluating follow-up strategies of women with EOC, only one RCT was included, and thus further RCTs are needed to evaluate different types of follow-up strategies, using outcomes such as survival, quality of life (QoL), cost and psychological effects. Importantly, in two recent retrospective studies, almost no relapses were detected exclusively on physical examination and the need for regular in-clinic visits were questioned in favor of virtual meetings with a review of symptoms and measurements of tumor marker.
Clearly, better biomarkers for EOC relapse are needed. The research group have recently developed a risk score for detection of EOC based on analysis of 11 plasma proteins. When validated in two independent clinical cohorts, this assay showed a sensitivity of 0.83/0.91 and specificity of 0.88/0.92 for separating EOC and histology benign conditions. Further, we have demonstrated the possibility to track changes in relation to treatment outcome and relapse using the same risk score. Using machine learning, four distinct risk score trajectories are defined, that indicate that it could be possible to detect relapse events up to 60 days prior to the first clinically recorded event. These results were conducted using wet plasma, but previous investigations show that dried blood spots work well for proteomics analyses with the intended assay (PEA), although a re-calibration of the risk-score is needed to accommodate differences between the dry and wet format.
This pilot study, as part of a larger clinical research project, aims to re-calibrate the risk-score and to assess it in a clinical setting using a home-based capillary blood sampling.
AIMS/ OUTCOME
The pilot study will be designed as a prospective cohort study with aim to clarify following questions before planning of a national RCT:
* Calibration/validation of the risk score in capillary blood samples
* Accuracy of monthly home-sampling and standard Ca125 for diagnosis of relapse
* Evaluate the logistics in home-sampling (patients' instructions, registration, communication etc.)
* Evaluate the acceptability of home-sampling by semi-structured interviews of a sample of study participants (reasons of drop-out, communication aspects, pros and cons with repeated sampling)
METHOD The pilot study will be designed as a prospective cohort study.
Study population;
Inclusion criteria:
* ≥18 years of age
* Included in the control program for ovarian/fallopian/primary peritoneal cancer at Uppsala University Hospital, or at Norrlands University Hospital, Sweden
* Within 3 years after completed primary treatment for stage III-IV EOC, or after treatment for relapse
* No evidence of disease (normal CA 125 and no tumor detected on radiology or clinical examination).
* Patients on maintenance therapy (PARP-inhibitor, bevazicumab) can be included.
Exlusion: Other cancer diagnosis within 2 years (except squamous skin cancer or basalioma). Non-Swedish speaking. Not able to understand instructions.
Intervention The participants will follow the standard follow-up program with scheduled visit 3-4 times/year. The follow-up consists of physical (and gynecologic) examination, transvaginal ultrasound, and sampling of s-CA125.
At inclusion the participants will receive written information and sign informed consent.
Capillary test
Study participants will be asked to take a capillary blood sample:
* at inclusion with assistance from study nurse
* at home monthly during one year or until relapse
* at suspicion of relapse The capillary sample and sent in to the laboratory in an envelope provided to the study participants. The result of the capillary test will be retrospectively analyzed and consequently not affect treatment, but solely be used for research purposes. The results will not be communicated to the study participants.
Uppsala biobank In patients already included with written consent in the Uppsala biobank (U-CAN), follow-up blood samples will be taken according to the biobank routine at inclusion and in case of follow-up (https://www.u-can.uu.se).
End of study Relapse or after one year of inclusion
Data management
The following data will be entered and stored in a pseudonymized database (REDCap):
At inclusion:
* patient data (age, BMI, smoking comorbidity, performance status)
* tumor data (CA125, other tumour markers, histology, differention grade, tumor stage, BRCA/HRD status, radiology findings)
* previous treatment data (surgical and oncological).
At clinical visits/relapse (planned follow-up or unplanned visits):
* CA125 values
* symtoms and signs of relapse, including radiology
* Date and results of capillary tests
The code for personal identification will be stored in a separate file with password. Hence data in the research database cannot be linked to individual patients.
Assessment of feasibility
To evaluate feasibility and acceptability of the study, a short-form questionnaire with 5-7 questions will be handled to study participants at following occasions:
* Declining participation
* Drop-off from study protocol
* End of study A semi-structured interviews will be offered to a strategic sample of participants (around 10) with various age, medical history after completion of the study in order to identify pitfalls and areas of improvement.
Statistics/ power With approximately 250 women fulfilling these inclusion criteria at Uppsala University Hospital and Norrlands University Hospital yearly, and an anticipated inclusion rate of 50%, we will reach a study population of 125 women in one year. With a drop-out of 25 persons, 100 will remain for analysis. Around 30% of these women will suffer from relapse during the study period. With approximately 10 samples/ participant, we consider 1000 samples sufficient for the pilot study.
Analyses The collected capillary dry-cards (Ahlström AutoCollect™) are punched in a semi-automated equipment for punches to be analyzed. The laboratory analyses for the plasma protein biomarkers will be carried out at the Affinity Proteomics Facility at SciLifeLab Uppsala, using a custom assay provided by Olink Proteomics based on absolute quantification. The accuracy (sensitivity and specificity) of the risk score to detect relapse and the correlation with s-CA125 will be calculated with aid from machine learning. An optimal cut-off value for the test score will be approximated in ROC-curves, either as an individual increase (for example a doubling of lowest risk score) or at a group level. Time difference between raise in the protein panel score and clinical detection of recurrence will be analyzed.
These results will be used for power calculation and decision of sampling intervals for the forthcoming RCT.
For patients already included in the Uppsala biobank with written consent, venous blood samples will be analysed at follow-up and relapse to be able to validate the results from capillary in venous blood.
Further challenges with inclusion, reasons for drop-out will be analyzed by short-form questionnaire. Qualitative interviews with a selected group of study participants will be carried out to explore patient experience and acceptability and lay the foundation for patient information and communication in the RCT.
Clinical significance The hypothesis is that more frequent analysis of a protein panel specific for EOC, will lead to earlier detection of relapse, earlier treatment and a better prognosis. Additionally, in the future, the vision is that women may choose between different ways of follow-up depending on individual risk factors, personal preferences and logistic reasons. In the long-term the results of the evaluation of the applicability of home-administered blood sampling from this study can be useful in other patient groups as well.
### Conditions Module
**Conditions:**
- Ovarian Cancer
- Fallopian Tube Cancer
- Peritoneal Cancer
**Keywords:**
- ovarian cancer
- follow-up
- biomarker
- protein
### Design Module
#### Bio Spec
**Description:** capillary blood sample, venous blood sample
**Retention:** SAMPLES_WITHOUT_DNA
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 125
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Study population;
Inclusion criteria:
* ≥18 years of age
* Included in the control program for ovarian/fallopian/primary peritoneal cancer at Uppsala University Hospital, or in Norrlands University Hospital, Sweden
* Within 3 years after completed primary treatment for stage III-IV EOC, or after treatment for relapse
* No evidence of disease (normal CA 125 and no tumor detected on radiology or clinical examination).
* Patients on maintenance therapy (PARP-inhibitor, bevazicumab) can be included.
Exlusion: Other cancer diagnosis within 2 years (except squamous skin cancer or basalioma). Non-Swedish speaking. Not able to understand instructions.
**Label:** Women in control program after ovarian/fallopian/primary peritoneal cancer
### Outcomes Module
#### Primary Outcomes
**Description:** Accuracy (sensitivity/specificity) of the protein panel to detect recurrence
**Measure:** Accuracy of capillary home-sampling to detect recurrence
**Time Frame:** From date of inclusion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
**Description:** Analyses of the optimal protein panel to detect recurrence. Calculation of risk score/cut-off value for recurrence (ROC-curve)
**Measure:** Calibration/validation of the risk score in capillary blood samples
**Time Frame:** Capillary blood samples collected monthly for one year or until relapse
#### Secondary Outcomes
**Description:** 1. Tree short questions, regarding difficulties in blood test, by email at every monthly home-sample.
2. After end of study a e-mail questionnaire including questions about sampling intervals, difficulties with sampling, reasons for drop-out and open question about the study.
**Measure:** Evaluate the logistics in home-sampling (patients' instructions, registration, communication.)
**Time Frame:** Monthly short questionnaire and longer questionnaire at end-of study, maximum one year.
**Description:** Evaluate the acceptability of home-sampling by semi-structured interviews of a sample of study participants (reasons of drop-out, communication aspects, pros and cons with repeated sampling)
**Measure:** Evaluation of acceptability
**Time Frame:** Interviews after end of study, (after first relapse, drop-out or end-of-study) maximum one year.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* ≥18 years of age
* Included in the control program for ovarian/fallopian/primary peritoneal cancer at at Uppsala University Hospital, Uppsala or in Norrlands University Hospital, Umeå,
* Within 3 years after completed primary treatment for stage III-IV epithelial ovarian cancer, or after treatment for relapse
* No evidence of disease (normal CA 125 and no tumor detected on radiology or clinical examination).
Exclusion Criteria:
* Other cancer diagnosis within 2 years (except squamous skin cancer or basalioma).
* Non-Swedish speaking.
* Not able to understand instructions.
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Study participants are women included in the control program for ovarian/fallopian/primary peritoneal cancer at Uppsala University Hospital, Uppsala or in Norrlands University Hospital, Umeå, Sweden, . They should have been treated within 3 years after primary stage III-IV epithelial ovarian cancer (or diagnoses above), or within 3 years after treatment for relapse. Study participants should have no evidence of disease (normal CA 125 and no tumor detected on radiology or clinical examination) at inclusion.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Karin Stålberg, A/ Professor
**Phone:** +46186111577
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Umeå
**Contacts:**
***Contact 1:***
- **Name:** Ulrika Ottander, A/Professor
- **Role:** CONTACT
***Contact 2:***
- **Name:** Ulrika Ottander, A/Professor
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Sweden
**Facility:** Norrlands University Hospital
**Status:** RECRUITING
#### Overall Officials
**Official 1:**
**Affiliation:** Uppsala University Hospital
**Name:** Karin Stålberg, A/ Professor
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
### References Module
#### References
**Citation:** Enroth S, Ivansson E, Lindberg JH, Lycke M, Bergman J, Reneland A, Stalberg K, Sundfeldt K, Gyllensten U. Data-driven analysis of a validated risk score for ovarian cancer identifies clinically distinct patterns during follow-up and treatment. Commun Med (Lond). 2022 Oct 1;2:124. doi: 10.1038/s43856-022-00193-6. eCollection 2022.
**PMID:** 36196264
**Citation:** Enroth S, Berggrund M, Lycke M, Broberg J, Lundberg M, Assarsson E, Olovsson M, Stalberg K, Sundfeldt K, Gyllensten U. High throughput proteomics identifies a high-accuracy 11 plasma protein biomarker signature for ovarian cancer. Commun Biol. 2019 Jun 20;2:221. doi: 10.1038/s42003-019-0464-9. eCollection 2019.
**PMID:** 31240259
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000004701
- Term: Endocrine Gland Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000010049
- Term: Ovarian Diseases
- ID: D000000291
- Term: Adnexal Diseases
- ID: D000005831
- Term: Genital Diseases, Female
- ID: D000052776
- Term: Female Urogenital Diseases
- ID: D000005261
- Term: Female Urogenital Diseases and Pregnancy Complications
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000005833
- Term: Genital Neoplasms, Female
- ID: D000014565
- Term: Urogenital Neoplasms
- ID: D000091662
- Term: Genital Diseases
- ID: D000004700
- Term: Endocrine System Diseases
- ID: D000006058
- Term: Gonadal Disorders
- ID: D000002277
- Term: Carcinoma
- ID: D000009375
- Term: Neoplasms, Glandular and Epithelial
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000005184
- Term: Fallopian Tube Diseases
### 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: HIGH
- As Found: Ovarian Cancer
- ID: M1704
- Name: Carcinoma, Ovarian Epithelial
- Relevance: HIGH
- As Found: Ovarian Cancer
- ID: M5534
- Name: Carcinoma
- Relevance: LOW
- As Found: Unknown
- ID: M8328
- Name: Fallopian Tube Neoplasms
- Relevance: HIGH
- As Found: Fallopian Tube Cancer
- ID: M7863
- Name: Endocrine Gland Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M12972
- Name: Ovarian Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M3643
- Name: Adnexal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8943
- Name: Genital Diseases, Female
- Relevance: LOW
- As Found: Unknown
- ID: M2876
- Name: Genital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27093
- Name: Female Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14127
- Name: Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M8399
- Name: Female Urogenital Diseases and Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M8945
- Name: Genital Neoplasms, Female
- Relevance: LOW
- As Found: Unknown
- ID: M17315
- Name: Urogenital Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M7862
- Name: Endocrine System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M9163
- Name: Gonadal Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M12320
- Name: Neoplasms, Glandular and Epithelial
- Relevance: LOW
- As Found: Unknown
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
- ID: M8327
- Name: Fallopian Tube Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T4352
- Name: Ovarian Cancer
- Relevance: HIGH
- As Found: Ovarian Cancer
- ID: T4354
- Name: Ovarian Epithelial Cancer
- Relevance: HIGH
- As Found: Ovarian Cancer
- ID: T2189
- Name: Fallopian Tube Cancer
- Relevance: HIGH
- As Found: Fallopian Tube Cancer
### Condition Browse Module - Meshes
- ID: D000010051
- Term: Ovarian Neoplasms
- ID: D000077216
- Term: Carcinoma, Ovarian Epithelial
- ID: D000005185
- Term: Fallopian Tube 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:** NCT06445608
**Brief Title:** PIvotal Trial of the KARDION Cory P4 MechANical Circulatory SupporT SystEm
**Official Title:** PICANTE: PIvotal Trial of the KARDION Cory P4 MechANical Circulatory SupporT SystEm
#### Organization Study ID Info
**ID:** 000001057
#### Organization
**Class:** INDUSTRY
**Full Name:** Kardion Inc
### Status Module
#### Completion Date
**Date:** 2025-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-31
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-05
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-31
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Kardion Inc
#### 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 purpose of this trial is to demonstrate 30 day safety and effectiveness outcomes of the KARDION CORY P4 System in subjects who require hemodynamic support during a high-risk PCI procedure.
### Conditions Module
**Conditions:**
- Coronary Artery Disease
**Keywords:**
- High-risk PCI
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 310
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Device: Percutaneous Mechanical Circulatory Support
**Label:** KARDION Cory P4 System
**Type:** EXPERIMENTAL
#### Arm Group 2
**Intervention Names:**
- Device: Percutaneous Mechanical Circulatory Support
**Label:** Commercial Control
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Commercial Control
- KARDION Cory P4 System
**Description:** Patients are randomized to receive one of two types of percutaneous mechanical circulatory support devices during a high-risk PCI procedure.
**Name:** Percutaneous Mechanical Circulatory Support
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** The primary effectiveness endpoint of the clinical investigation is a composite endpoint of major adverse cardiac and cerebrovascular events (MACCE) comprised of all-cause death, myocardial infarction, stroke/TIA, target lesion revascularization, vascular complications, major bleeding, and acute kidney injury.
**Measure:** MACCE
**Time Frame:** 30 days post-procedure
**Description:** The primary safety endpoint of the clinical investigation is a composite endpoint of device-related safety events (as adjudicated by the CEC) requiring intervention, including cardiac or vascular complication, limb ischemia, increase in aortic insufficiency, or CPR or ventricular arrhythmia requiring cardioversion.
**Measure:** Device-Related Safety
**Time Frame:** 30 days post-procedure
#### Secondary Outcomes
**Description:** Technical Success defined as the ability of the MCS System to be delivered, operated without device malfunction through the end of procedure, and successful retrieval.
**Measure:** Technical Success
**Time Frame:** Index procedure
**Description:** Procedural Success defined as Technical Success and the ability of the MCS System to provide hemodynamic support preventing severe hypotension and without the need for escalation of mechanical circulatory support (i.e., replacement of the MCS System with a higher output mechanical circulatory support device). Severe hypotension defined as requiring continuous infusion of inotropic/pressor medications to restore hemodynamics to mean arterial pressure greater than 60 mmHg.
**Measure:** Procedural Success
**Time Frame:** Index Procedure
**Description:** Safety Outcome defined as Serious Device-Related Adverse Events (defined as any Serious Adverse Event adjudicated as related to the device by the Clinical Events Committee (CEC)) through 30 days following the index procedure.
**Measure:** Serious Device-Related Adverse Events
**Time Frame:** Index procedure through 30-day follow-up
**Description:** Individual MACCE components: all-cause death, MI, stroke/TIA, target lesion revascularization, vascular complications, major bleeding, and acute kidney injury.
**Measure:** Individual MACCE components
**Time Frame:** Index procedure through 30-day follow-up
**Description:** Cardiovascular death and non-cardiovascular death.
**Measure:** Death
**Time Frame:** Index procedure through 30-day follow-up
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Subject age ≥ 18 and ≤ 90 years at the time of screening
2. The subject has an LV ejection fraction of \< 50% (within 90 days of index procedure) AND is at high-risk due to any of the following:
* Unprotected left main coronary artery stenosis disease
* Last remaining epicardial native coronary artery
* Significant three vessel coronary artery disease
* Significant two vessel coronary artery disease of complex lesions
* Significant single vessel coronary artery disease of complex lesions and non-treated CTO
* Target vessel is a CTO with planned retrograde approach
* Intended calcium modification (by atherectomy, lithotripsy or laser)
* In multiple vessels OR
* In the left main OR
* In a final patent conduit OR
* Where the anatomic SYNTAX score is ≥32
3. Local heart team (interventional cardiologist, cardiac surgeon) has determined that the subject is an appropriate candidate for a PCI supported with a Mechanical Circulatory Support (MCS) System
4. Confirmed access site vasculature greater than 5.5 mm as measured by CT or femoral duplex ultrasound
5. The subject is willing and able to comply with the protocol-specified treatment and follow-up evaluations
6. The subject has been informed of the nature of the trial, agrees to its provisions, and has provided written informed consent approved by the appropriate Institutional Review Board (IRB) or Ethics Committee (EC)
Exclusion Criteria:
1. Any prior coronary revascularization or revascularization attempt within 30 days prior to index procedure
2. STEMI within 7 days prior to index procedure - defined as new ST elevation at the J point in at least 2 contiguous leads of ≥ 2 mm (0.2 mV) in men or ≥ 1.5 mm (0.15 mV) in women in leads V2-V3 and/or of ≥ 1 mm (0.1 mV) in other contiguous chest leads or the limb leads
3. Non-STEMI within 7 days prior to index procedure with an elevated cardiac biomarker (CK-MB or Troponin \>1x ULN) without CK-MB or Troponin value down trending
4. Cardiac arrest within 7 days prior to index procedure requiring CPR or defibrillation
5. Subjects with sustained ventricular tachycardia or repetitive/ prolonged non-sustained ventricular tachycardia or complex ventricular ectopy
6. Current left ventricular thrombus
7. Significant right heart failure (right ventricular fractional area change \<35% on echocardiography)
8. Known severe pulmonary hypertension (right ventricular systolic pressure (RVSP) on echo or pulmonary artery systolic pressure (PASP) on right heart catheterization \> 70mmHg
9. Combined cardiorespiratory failure
10. Presence of an atrial or ventricular septal defect (including post-infarct VSD)
11. Hypertrophic obstructive cardiomyopathy (HOCM), restrictive cardiomyopathy, or constrictive pericarditis
12. Cardiogenic shock (Cardiac index \< 1.8 l/min/m2) or pre-procedure use of inotropic or pressor therapy within 72 hours of the planned index procedure
13. Any use of mechanical circulatory support or an extracorporeal membrane oxygenation device within 14 days prior to index procedure
14. Severe aortic valve insufficiency or stenosis or aortic valve replacement
15. Aortic vascular disease (i.e., aortic aneurysm, dissection, extreme tortuosity or calcification that creates additional risk to the placement of a MCS device)
16. Cerebrovascular Accident (CVA) within 180 days prior to index procedure
17. Transient Ischemic Attack (TIA) within 90 days prior to index procedure
18. Known or suspected coagulopathy or abnormal coagulation parameters (defined as platelet count ≤ 100,000 or spontaneous INR ≥ 1.5 or known fibrinogen ≤ 1.5 g/l)
19. Known hemoglobin diseases, such as sickle cell anemia, hemolytic anemia or thalassemia
20. Subject has evidence of an active infection on the day of the index procedure requiring oral or intravenous antibiotics
21. Active infection of the intended access site
22. Chronic renal dysfunction (eGFR \< 30 mL/min/1.73 m²) and/or patients requiring renal replacement therapy with dialysis
23. History of liver dysfunction with elevation of liver enzymes and bilirubin 3 times the upper limit of normal (ULN) within 90 days prior to index procedure
24. Known or suspected severe pulmonary disease (e.g., forced expiratory volume (FEV)1 \< 1.0 l/s)
25. Allergy, sensitivity or intolerance to anesthesia, heparin, aspirin, adenosine diphosphate (ADP) receptor blockers, or contrast media, including known heparin-induced thrombocytopenia (HIT)
26. Any non-cardiac condition with life expectancy \< 3 years (e.g., cirrhosis, oxygen or oral steroid dependent COPD, cancer, etc.)
27. Subject is presently or recently intubated for the current admission (NOTE: recently intubated patients must be extubated for \> 24 hours with full neurologic recovery)
28. Decompensated heart failure requiring IV diuretics, vasopressors, or inotropic support within 2 days of index procedure
29. Morbid obesity (BMI ≥ 40 kg/m²)
30. Patients with an organ transplant
31. Patients with implanted left ventricular assist device
32. Cardiac tamponade
33. Left ventricular rupture
34. Women who are lactating, pregnant, or plan to become pregnant during the course of the investigation
35. Active COVID-19 infection
36. Any anatomical restriction that would preclude an MCS device from being delivered through the femoral artery to the left ventricle
37. Subject has other medical, social or psychological problems that, in the opinion of the Investigator, compromises the subject's ability to give written informed consent and/or to comply with trial procedures
38. Current participation in another investigational drug or device trial
39. Anticipated need for continued MCS support after conclusion of the PCI procedure
**Maximum Age:** 90 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Darin R. Lerew
**Phone:** 651-707-3795
**Role:** CONTACT
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000003327
- Term: Coronary Disease
- ID: D000017202
- Term: Myocardial Ischemia
- ID: D000006331
- Term: Heart Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000001161
- Term: Arteriosclerosis
- ID: D000001157
- Term: Arterial Occlusive Diseases
- ID: D000014652
- Term: Vascular Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M6546
- Name: Coronary Artery Disease
- Relevance: HIGH
- As Found: Coronary Artery Disease
- ID: M19506
- Name: Myocardial Ischemia
- Relevance: LOW
- As Found: Unknown
- ID: M6549
- Name: Coronary Disease
- Relevance: LOW
- As Found: Unknown
- ID: M10543
- Name: Ischemia
- Relevance: LOW
- As Found: Unknown
- ID: M9419
- Name: Heart Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M4469
- Name: Arteriosclerosis
- Relevance: LOW
- As Found: Unknown
- ID: M4465
- Name: Arterial Occlusive Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003324
- Term: Coronary Artery Disease
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06445595
**Brief Title:** The Relationship Between Obesity and Chronic Headache
**Official Title:** Investigation of the Effectiveness of Obesity in the Development of Chronic Headache After Traumatic Brain Injury
#### Organization Study ID Info
**ID:** 05-2024/19
#### Organization
**Class:** OTHER
**Full Name:** Karaman Training and Research Hospital
### Status Module
#### Completion Date
**Date:** 2025-10-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-31
**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:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-31
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Karaman Training and Research Hospital
#### Responsible Party
**Investigator Affiliation:** Karaman Training and Research Hospital
**Investigator Full Name:** HATİCE TOPRAK
**Investigator Title:** asst. prof
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** The relationship between obesity and the development of chronic headache after traumatic brain injury will be investigated.
**Detailed Description:** Traumatic brain injury (TBI) can be defined as an injury caused by an external force, particularly a direct blow to the head or exposure to a shock wave. In addition to the well-known consequences of TBI, including cognitive changes, motor deficits and sensory abnormalities, available evidence suggests that acute and chronic pain is also common after TBI. Obesity and TBI can be considered as public health problems with their increasing prevalence in recent years. Chronic pain adds to the already enormous clinical, psychological, social and economic burden of obesity. Developing mechanisms to prevent the development of pain after TBI has attracted the attention of researchers. Obesity is a preventable and modifiable clinical condition. The extent to which obesity may create adverse conditions after TBI remains unclear.
### Conditions Module
**Conditions:**
- Traumatic Brain Injury
### Design Module
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 80
**Type:** ESTIMATED
**Patient Registry:** True
**Study Type:** OBSERVATIONAL
**Target Duration:** 3 Months
### Arms Interventions Module
### Interventions
#### Intervention 1
**Description:** Patients will be contacted by phone
**Name:** patients with traumatic brain injury
**Other Names:**
- Patients will be contacted by phone
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** BMI is calculated by dividing weight in kilograms by the square of height in metres.
**Measure:** The relationship between Bady Mass Index (BMI) and the development of chronic headache
**Time Frame:** Postoperative 3 month.
#### Secondary Outcomes
**Description:** Head traumas that occur due to different reasons will be examined
**Measure:** The relationship between the nature of trauma and the development of chronic headache
**Time Frame:** Postoperative 3 month.
**Description:** Education levels will be defined as primary school, secondary school and university graduate.
**Measure:** The relationship between patients' education levels and chronic headache
**Time Frame:** Postoperative 3 month
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Individuals over the age of 18 who suffered a head injury
Exclusion Criteria:
* People with severe head trauma
* Those who do not speak Turkish
* Those with a history of chronic opioid user
* Those with alcohol and drug addiction
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** individuals over the age of 18 who suffered a head injury
### IPD Sharing Statement Module
**Description:** Sharing will be evaluated in cases where the responsible researcher is contacted.
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001927
- Term: Brain Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000006259
- Term: Craniocerebral Trauma
- ID: D000020196
- Term: Trauma, Nervous System
- ID: D000014947
- Term: Wounds and Injuries
- ID: D000010146
- Term: Pain
- ID: D000009461
- Term: Neurologic Manifestations
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: All
- Name: All Conditions
- 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: M5207
- Name: Brain Injuries
- Relevance: HIGH
- As Found: Brain Injury
- ID: M628
- Name: Brain Injuries, Traumatic
- Relevance: HIGH
- As Found: Traumatic Brain Injury
- ID: M9351
- Name: Headache
- Relevance: HIGH
- As Found: Headache
- ID: M12701
- Name: Obesity
- Relevance: LOW
- As Found: Unknown
- ID: M22529
- Name: Headache Disorders
- Relevance: HIGH
- As Found: Chronic Headache
- ID: M5204
- Name: Brain Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17685
- Name: Wounds and Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M9349
- Name: Craniocerebral Trauma
- Relevance: LOW
- As Found: Unknown
- ID: M22023
- Name: Trauma, Nervous System
- Relevance: LOW
- As Found: Unknown
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001930
- Term: Brain Injuries
- ID: D000070642
- Term: Brain Injuries, Traumatic
- ID: D000020773
- Term: Headache Disorders
- ID: D000006261
- Term: Headache
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06445582
**Brief Title:** SV2A-PET/CT and PET/MRI Combined Clinical Criteria Score in the Diagnosis of Early Cognitive Alteration
**Official Title:** Synaptic Vesicle Glycoprotein 2A-PET/CT and PET/MRI Combined Clinical Criteria Score in the Diagnosis of Early Cognitive Alteration
#### Organization Study ID Info
**ID:** 2023_ky_390
#### Organization
**Class:** OTHER_GOV
**Full Name:** Anhui Provincial Hospital
### Status Module
#### Completion Date
**Date:** 2025-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-04
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-12
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-06-04
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER_GOV
**Name:** Anhui Provincial Hospital
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Using SV2A-PET to character a cohort of patients with early cognitive impairment using the novel synaptic probe 18F-labeled difluoro-analog of UCB-J（also known as 18F-SDM-8）
**Detailed Description:** A community-based population (Han Chinese) in Hefei, China, based on the CANDI cohort；Single-center prospective case-control study；The projected enrollment population is 80; 40 patients with Alzheimer's Disease（AD）, 30 patients with Mild Cognitive Impairment（MCI）; 10 healthy controls. Diagnostic experiments and predictive prognostic experiments with new probes.
### Conditions Module
**Conditions:**
- Alzheimer Disease
**Keywords:**
- Molecular Imaging；
- Positron Emission Tomography Computed Tomography；
- SV2A protein, human
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 80
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** China Aging and Neurodegenerative Initiative
**Intervention Names:**
- Diagnostic Test: [18F]SDM-8
**Label:** CANDI
### Interventions
#### Intervention 1
**Arm Group Labels:**
- CANDI
**Description:** synaptic vesicle glycoprotein 2 A（SV2A）PET tracer \[18F\]SDM-8
**Name:** [18F]SDM-8
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** Standardized semi-quantitative values of SUVR for each brain region of the cerebral cortex；Standardized Uptake Value ratio (SUVr) is a metric used to evaluate the results of PET scans of the brain. It is a measure of the extent of abnormal metabolism or abnormal deposits in a brain region by comparing the uptake value of a specific brain region to the uptake values of neighboring regions.
SUVr is calculated as follows:
1. first, a reference region is selected, usually an adjacent region of healthy tissue that is unaffected by disease.
2. then, the uptake value for the region of interest (e.g., the brain region), denoted as SUV, is calculated.
3. next, the average uptake value of the reference region, denoted as SUVref, is calculated.
4. finally, the SUVr is calculated, obtained by dividing the SUV of the region of interest by the SUVref of the reference region.
**Measure:** SUVR（Standardized Uptake Value Ratio）
**Time Frame:** 1year
#### Secondary Outcomes
**Description:** AUC is defined as the area under the ROC curve enclosed with the axes. ROC (receiver operating characteristic curve) receiver operating characteristic curve, is invented by electronic engineers and radar engineers in World War II used to detect enemy carriers (aircraft, ships) on the battlefield indicators, belongs to the signal detection theory.
The SV2A SUVR calculation was performed using the reference brain region method described above, and the AUC was used to measure the ability of the SUVR to classify the AD disease spectrum versus healthy controls, and its correlation with clinical scale scores was analyzed.
**Measure:** AUC（Area under the curve）of SUVR
**Time Frame:** 1year
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* AD Group
* All diagnostic criteria for AD patients met the National Institute of Neurological Speech-Language Disorders Stroke Institute and Alzheimer's Disease and Related Disorders Association criteria;
* Comply with the American Psychiatric Association Diagnostic and Statistical Workbook of Mental Disorders, 5th edition (DSMIV);
* All subjects were unconscious and could be accompanied by behavioral and psychiatric abnormalities. Subjects who meet the above criteria are eligible for enrollment.
* Those who understand the process of this clinical trial and sign the informed consent form (in addition, non-AD volunteers will be recruited through verbal dissemination and posting of paper advertisements to serve as the non-AD control group, and the final control group will be screened by the clinician and consist of healthy people of similar age and gender).
* MCI Group
* Concerns about cognitive changes, and concerns about finding changes in comparison with one's prior level may originate from the patient himself or herself, from an informed person, or from an experienced specialist;
* Impairment of one or more cognitive areas, primarily memory, executive function, attention, language, and visuospatial function;
* Maintaining independence in daily living, there can be minor impairment in complex instrumental daily abilities;
* Absence of dementia, mild disease, and no evidence of serious impairment of social or occupational abilities;
* Presence of one of the Aβ class biomarkers and/ neuronal damage class markers detected by imaging, cerebrospinal fluid;
* All subjects and their guardians give informed consent to the study and sign the informed consent form;
Exclusion Criteria:
* With confirmed cerebrovascular disease, the presence of multiple or extensive cerebral infarcts;
* Other types of dementia: Parkinson's disease dementia, vascular dementia, frontotemporal lobe dementia, dementia with Lewy bodies;
* Sudden onset or stroke-like episodes;
* Early onset of focal neurological symptoms, such as hemiparesis, computational deficits, ataxia, or sensory loss;
* Seizures or gait abnormalities early in the onset of the disease;
* Evidence of drug applications that cause significant effects on cognitive function;
* Those who are allergic to alcohol;
* Persons with alcohol allergy; (ix) Persons with left-handedness; (x) Persons with left-handedness;
* Those with claustrophobia or other reasons for not being able to cooperate with the examination;
* Those with serious heart, liver, lung, kidney and other organ diseases, meeting the above conditions were excluded from the group.
**Healthy Volunteers:** True
**Maximum Age:** 90 Years
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** This study is a single-center prospective exploratory clinical trial, and given this, it is proposed to initially enroll only 80 evaluable subjects (including 40 patients with ALZHEIMER'S DISEASE, 30 patients with MILD COGNITIVE DISABILITY, and 10 age-sex matched non-ALZHEIMER 'S DISEASE controls), each subject underwent 18F-SDM-8 PET/CT imaging, the ability of the tracer to bind to SV2A in the brain as well as non-specific binding, and correlation analysis with changes in relevant clinical indicators to assess the safety and diagnostic efficacy of the tracer.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Zehua Zhu, MD
**Phone:** 15243611341
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** University of Sience and Technology of China
**Name:** Qiang Xie, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
### References Module
#### References
**Citation:** Stockburger C, Miano D, Baeumlisberger M, Pallas T, Arrey TN, Karas M, Friedland K, Muller WE. A Mitochondrial Role of SV2a Protein in Aging and Alzheimer's Disease: Studies with Levetiracetam. J Alzheimers Dis. 2016;50(1):201-15. doi: 10.3233/JAD-150687.
**PMID:** 26639968
**Citation:** Bajjalieh SM, Frantz GD, Weimann JM, McConnell SK, Scheller RH. Differential expression of synaptic vesicle protein 2 (SV2) isoforms. J Neurosci. 1994 Sep;14(9):5223-35. doi: 10.1523/JNEUROSCI.14-09-05223.1994.
**PMID:** 8083732
**Citation:** Spurrier J, Nicholson L, Fang XT, Stoner AJ, Toyonaga T, Holden D, Siegert TR, Laird W, Allnutt MA, Chiasseu M, Brody AH, Takahashi H, Nies SH, Perez-Canamas A, Sadasivam P, Lee S, Li S, Zhang L, Huang YH, Carson RE, Cai Z, Strittmatter SM. Reversal of synapse loss in Alzheimer mouse models by targeting mGluR5 to prevent synaptic tagging by C1Q. Sci Transl Med. 2022 Jun;14(647):eabi8593. doi: 10.1126/scitranslmed.abi8593. Epub 2022 Jun 1.
**PMID:** 35648810
**Citation:** Nabulsi NB, Mercier J, Holden D, Carre S, Najafzadeh S, Vandergeten MC, Lin SF, Deo A, Price N, Wood M, Lara-Jaime T, Montel F, Laruelle M, Carson RE, Hannestad J, Huang Y. Synthesis and Preclinical Evaluation of 11C-UCB-J as a PET Tracer for Imaging the Synaptic Vesicle Glycoprotein 2A in the Brain. J Nucl Med. 2016 May;57(5):777-84. doi: 10.2967/jnumed.115.168179. Epub 2016 Feb 4.
**PMID:** 26848175
**Citation:** Naganawa M, Li S, Nabulsi N, Henry S, Zheng MQ, Pracitto R, Cai Z, Gao H, Kapinos M, Labaree D, Matuskey D, Huang Y, Carson RE. First-in-Human Evaluation of 18F-SynVesT-1, a Radioligand for PET Imaging of Synaptic Vesicle Glycoprotein 2A. J Nucl Med. 2021 Apr;62(4):561-567. doi: 10.2967/jnumed.120.249144. Epub 2020 Aug 28.
**PMID:** 32859701
**Citation:** Li S, Cai Z, Wu X, Holden D, Pracitto R, Kapinos M, Gao H, Labaree D, Nabulsi N, Carson RE, Huang Y. Synthesis and in Vivo Evaluation of a Novel PET Radiotracer for Imaging of Synaptic Vesicle Glycoprotein 2A (SV2A) in Nonhuman Primates. ACS Chem Neurosci. 2019 Mar 20;10(3):1544-1554. doi: 10.1021/acschemneuro.8b00526. Epub 2018 Nov 16.
**PMID:** 30396272
**Citation:** Chen MK, Mecca AP, Naganawa M, Finnema SJ, Toyonaga T, Lin SF, Najafzadeh S, Ropchan J, Lu Y, McDonald JW, Michalak HR, Nabulsi NB, Arnsten AFT, Huang Y, Carson RE, van Dyck CH. Assessing Synaptic Density in Alzheimer Disease With Synaptic Vesicle Glycoprotein 2A Positron Emission Tomographic Imaging. JAMA Neurol. 2018 Oct 1;75(10):1215-1224. doi: 10.1001/jamaneurol.2018.1836.
**PMID:** 30014145
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000003704
- Term: Dementia
- ID: D000001927
- Term: Brain Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000024801
- Term: Tauopathies
- ID: D000019636
- Term: Neurodegenerative Diseases
- ID: D000019965
- Term: Neurocognitive Disorders
- ID: D000001523
- Term: Mental Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M3885
- Name: Alzheimer Disease
- Relevance: HIGH
- As Found: Alzheimer's Disease
- ID: M6904
- Name: Dementia
- Relevance: LOW
- As Found: Unknown
- ID: M5204
- Name: Brain Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M23002
- Name: Tauopathies
- Relevance: LOW
- As Found: Unknown
- ID: M21558
- Name: Neurodegenerative Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M21836
- Name: Neurocognitive Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
- ID: T2192
- Name: Familial Alzheimer Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000000544
- Term: Alzheimer Disease
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M340819
- Name: polysaccharide-K
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06445569
**Brief Title:** Safety and Efficacy of KH-1 for Stimulating Autophagy in Non-diabetic Adults With Elevated Blood Glucose Concentration
**Official Title:** A Randomized, Double-blind, Placebo-controlled, Proof-of-concept Study to Evaluate the Safety and Efficacy of the Test Product KH-1 for Stimulating Autophagy in Non-diabetic Adults With Elevated Blood Glucose Concentration
#### Organization Study ID Info
**ID:** K02-21-01-T0012
#### Organization
**Class:** INDUSTRY
**Full Name:** Kalin Health, LLC
### Status Module
#### Completion Date
**Date:** 2023-06-08
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-31
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-06-08
**Type:** ACTUAL
#### Start Date
**Date:** 2021-12-20
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-31
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Collaborators
**Class:** NETWORK
**Name:** Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Kalin Health, LLC
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Aging significantly impacts overall health and is a risk factor for developing diabetes. An estimated 50% of U.S. adults aged ≥65 years were reported to have prediabetes (defined as having a fasting glucose concentration of 100-125 mg/dl) in 2005-2008. The Centers for Disease Control and Prevention (CDC) has stated that in the United States, 88 million people (one in every 3 Americans) are currently classified as prediabetic, emphasizing the importance of preventative measures and early intervention to manage and reduce the risk of progression to diabetes. Additionally, an estimated 430 million individuals worldwide are expected to have prediabetes by 2030. Dietary supplementation of polyamines, spermidine in particular, have been touted to have beneficial health effects such as increasing life span and mitigating impacts of aging. Spermidine and spermine are polyamines that are being increasingly investigated for their ability to slow the aging process by inducing autophagy. Nevertheless, literature on these topics is scarce and results from trials have been inconclusive; therefore further research is needed. The novel nutraceutical KH-1, comprised of spermidine, spermidine derivatives and probiotics, is examined in this trial of healthy volunteers aged 18 years or over. This study evaluates KH-1 for its safety and its effect on glucose homeostasis. This study measures the effects of KH-1 on biomarkers for inflammation, cardiovascular disease, insulin sensitivity, and those important for autophagy. A qualitative assessment of the effect of KH-1 on well-being is also examined.
**Detailed Description:** Prediabetes is the intermediate state and precursor that can lead to an eventual diagnosis of diabetes. The presence of an elevated hemoglobin A1c (HbA1c), as well as insulin resistance with concomitant β-cell dysfunction is a strong indicator of prediabetes. Dietary and lifestyle changes are the most effective methods to control and prevent prediabetes, but maintenance of these changes is often difficult. Pharmaceutical options are indicated for treatment of diabetes rather than prevention of prediabetes, however many are associated with side effects. Therefore, a safe and effective alternative to prevent disease in metabolically dysregulated individuals is necessary.
The novel nutraceutical KH-1 is comprised of spermidine, amino acids, and a probiotic. This nutraceutical may offer a promising strategy for managing prediabetes.
This study is a double-blinded randomized controlled trial with 48 healthy volunteers to test the efficacy and safety of the novel nutraceutical KH-1. A total of 48 participants will be randomized in a double-blinded fashion, with 24 participants in each study group (KH-1 vs. placebo). After screening and randomization, participants will consume their assigned study product for 3 months, after which all participants will be assigned to consume the KH-1 for the remaining 3 months in an open-label fashion. Upon arrival at the clinic at the screening visit, participants will review the informed consent form (ICF), and if they agree to participate in the study, will sign and date the ICF, complete a brief screening, provide demographic information, and take part in other study activities indicated to be done on the screening visit. Participants who complete the screening process and qualify to continue are randomized to receive either the KH-1 or placebo in a 1:1 ratio for the first 3 months and assigned a unique randomization code. After the first 3 months, all participants will take KH-1. Participants will be instructed on the use of the nutraceutical product/placebo, according to label instructions. Participants will self-administer the study product at home and compliance will be assessed and documented at each visit. Venous blood samples will be collected at Week 0, Week 12 and Week 24 and analysed for biomarkers of glucose regulation and metabolism, cardiovascular health, inflammatory and autophagy biomarkers. Haematology and biochemistry parameters will be measured at screening, week 0, week 12 and week 24. A qualitative health questionnaire will be completed at 3 in-clinic visits and physical measurements to assess safety of the nutraceutical.
### Conditions Module
**Conditions:**
- PreDiabetes
- Aging
**Keywords:**
- Elevated Blood Glucose
- Spermidine
- Autophagy
- Probiotic
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Participants will consume their assigned study product for 3 months, after which all participants will be assigned to consume the KH-1 for the remaining 3 months in an open-label fashion.
##### Masking Info
**Masking:** QUADRUPLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** BASIC_SCIENCE
#### Enrollment Info
**Count:** 42
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Three capsules containing spermidine and amino acids. One stick packet containing probiotics.
**Intervention Names:**
- Dietary Supplement: KH-1
**Label:** KH-1
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** Three capsules containing hypromellose, hypromellose acetate succinate, purified water, pigments and gellen gum.
One stick packet containing microcrystalline cellulose.
**Intervention Names:**
- Other: Placebo
**Label:** Placebo
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- KH-1
**Description:** 3 capsules and one stick packet consumed daily around the same time
**Name:** KH-1
**Type:** DIETARY_SUPPLEMENT
#### Intervention 2
**Arm Group Labels:**
- Placebo
**Description:** 3 capsules and one stick packet consumed daily around the same time
**Name:** Placebo
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Between placebo and test product, change from baseline to 3 months in fasting insulin
**Measure:** Insulin resistance
**Time Frame:** 3 months
**Description:** Between placebo and test product, change from baseline to 3 months in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
**Measure:** Insulin resistance
**Time Frame:** 3 months
**Description:** Between placebo and test product, change from baseline to 3 months Oral Glucose Tolerance Test (OGTT)- derived indices of insulin dynamics
**Measure:** Insulin Resistance
**Time Frame:** 3 months
#### Secondary Outcomes
**Description:** Within-group change from baseline to 3 months for fasting insulin
**Measure:** Long-term effect on Insulin Resistance
**Time Frame:** 3 months
**Description:** Within-group change from baseline to 6 months for fasting insulin
**Measure:** Long-term effect on Insulin Resistance
**Time Frame:** 6 months
**Description:** Within-group change from baseline to 3 months for HOMA-IR
**Measure:** Long-term effect on Insulin Resistance
**Time Frame:** 3 months
**Description:** Within-group change from baseline to 6 months for HOMA-IR
**Measure:** Long-term effect on Insulin Resistance
**Time Frame:** 6 months
**Description:** Within-group change from baseline to 3 months for OGTT-derived indices
**Measure:** Long-term effect on Insulin resistance
**Time Frame:** 3 months
**Description:** Within-group change from baseline to 6 months for OGTT-derived indices
**Measure:** Long-term effect on Insulin Resistance
**Time Frame:** 6 months
**Description:** Between placebo and test product, change from baseline to 3 months in area under the glucose concentration (AUC) post-OGTT
**Measure:** Post-prandial Glycemic Response
**Time Frame:** 3 months
**Description:** Within-group change from baseline to 3 months in area under the glucose concentration (AUC) post-OGTT
**Measure:** Post-prandial Glycemic Response
**Time Frame:** 3 months
**Description:** Within-group change from baseline to 6 months in area under the glucose concentration (AUC) post-OGTT
**Measure:** Post-prandial Glycemic Response
**Time Frame:** 6 months
**Description:** Between placebo and test product, change from baseline to 3 months in 2-hour post-prandial glucose
**Measure:** Post-prandial Glycemic Response
**Time Frame:** 3 months
**Description:** Within-group change from baseline to 3 months in 2-hour post-prandial glucose
**Measure:** Post-prandial Glycemic Response
**Time Frame:** 3 months
**Description:** Within-group change from baseline to 6 months in 2-hour post-prandial glucose
**Measure:** Post-prandial Glycemic Response
**Time Frame:** 6 months
**Description:** Between placebo and test product, change from baseline to 3 months in fasting glucose
**Measure:** Glycemic Control
**Time Frame:** 3 months
**Description:** Within-group change from baseline to 3 months in fasting glucose
**Measure:** Glycemic Control
**Time Frame:** 3 months
**Description:** Within-group change from baseline to 6 months in fasting glucose
**Measure:** Glycemic Control
**Time Frame:** 6 months
**Description:** Between placebo and test product, change from baseline to 3 months in HbA1c
**Measure:** Glycemic Control
**Time Frame:** 3 months
**Description:** Within-group change from baseline to 3 months in HbA1c
**Measure:** Glycemic Control
**Time Frame:** 3 months
**Description:** Within-group change from baseline to 6 months in HbA1c
**Measure:** Glycemic Control
**Time Frame:** 6 months
**Description:** Between placebo and test product, change from baseline to 3 months in oral disposition index (DI) calculated by the ratio of the insulinogenic index over fasting insulin
**Measure:** β-cell Function
**Time Frame:** 3 months
**Description:** Within-group change from baseline to 3 months in oral DI
**Measure:** β-cell Function
**Time Frame:** 3 months
**Description:** Within-group change from baseline to 6 months in oral DI
**Measure:** β-cell Function
**Time Frame:** 6 months
**Description:** Between placebo and test product, change from baseline to 3 months in fasting triglycerides (TG)
**Measure:** Cardiovascular Biomarkers
**Time Frame:** 3 months
**Description:** Within-group change from baseline to 3 months in fasting TG
**Measure:** Cardiovascular Biomarkers
**Time Frame:** 3 months
**Description:** Within-group change from baseline to 6 months in fasting TG
**Measure:** Cardiovascular Biomarkers
**Time Frame:** 6 months
**Description:** Between placebo and test product, change from baseline to 3 months in fasting total cholesterol
**Measure:** Cardiovascular Biomarkers
**Time Frame:** 3 months
**Description:** Within-group change from baseline to 3 months in fasting total cholesterol
**Measure:** Cardiovascular Biomarkers
**Time Frame:** 3 months
**Description:** Within-group change from baseline to 6 months in fasting total cholesterol
**Measure:** Cardiovascular Biomarkers
**Time Frame:** 6 months
**Description:** Between placebo and test product, change from baseline to 3 months in fasting low-density lipoprotein (LDL)
**Measure:** Cardiovascular Biomarkers
**Time Frame:** 3 months
**Description:** Within-group change from baseline to 3 months in fasting LDL
**Measure:** Cardiovascular Biomarkers
**Time Frame:** 3 months
**Description:** Within-group change from baseline to 6 months in fasting LDL
**Measure:** Cardiovascular Biomarkers
**Time Frame:** 6 months
**Description:** Between placebo and test product, change from baseline to 3 months in high-density lipoprotein (HDL)
**Measure:** Cardiovascular Biomarkers
**Time Frame:** 3 months
**Description:** Within-group change from baseline to 3 months in HDL
**Measure:** Cardiovascular Biomarkers
**Time Frame:** 3 months
**Description:** Within-group change from baseline to 6 months in HDL
**Measure:** Cardiovascular Biomarkers
**Time Frame:** 6 months
**Description:** Between placebo and test product, change from baseline to 3 months in high-sensitivity C-reactive protein (hs-CRP)
**Measure:** Inflammatory Biomarkers
**Time Frame:** 3 months
**Description:** Within-group change from baseline to 3 months in hs-CRP
**Measure:** Inflammatory Biomarkers
**Time Frame:** 3 months
**Description:** Within-group change from baseline to 6 months in hs-CRP
**Measure:** Inflammatory Biomarkers
**Time Frame:** 6 months
**Description:** Between placebo and test product, change from baseline to 3 months in tumor necrosis factor (TNF)-alpha
**Measure:** Inflammatory Biomarkers
**Time Frame:** 3 months
**Description:** Within-group change from baseline to 3 months in TNF-alpha
**Measure:** Inflammatory Biomarkers
**Time Frame:** 3 months
**Description:** Within-group change from baseline to 6 months in TNF-alpha
**Measure:** Inflammatory Biomarkers
**Time Frame:** 6 months
**Description:** Between placebo and test product, change from baseline to 3 months in interleukin-6 (IL-6)
**Measure:** Inflammatory Biomarkers
**Time Frame:** 3 months
**Description:** Within-group change from baseline to 3 months in IL-6
**Measure:** Inflammatory Biomarkers
**Time Frame:** 3 months
**Description:** Within-group change from baseline to 6 months in IL-6
**Measure:** Inflammatory Biomarkers
**Time Frame:** 6 months
**Description:** Between placebo and test product, change from baseline to 3 months in Beclin-1
**Measure:** Autophagy
**Time Frame:** 3 months
**Description:** Within-group change from baseline to 3 months in Beclin-1
**Measure:** Autophagy
**Time Frame:** 3 months
**Description:** Within-group change from baseline to 6 months in Beclin-1
**Measure:** Autophagy
**Time Frame:** 6 months
**Description:** Between placebo and test product, change from baseline to 3 months in Cluster of Differentiation (CD) 3
**Measure:** Immunity Biomarkers
**Time Frame:** 3 months
**Description:** Within-group change from baseline to 3 months in CD3
**Measure:** Immunity Biomarkers
**Time Frame:** 3 months
**Description:** Within-group change from baseline to 6 months in CD3
**Measure:** Immunity Biomarkers
**Time Frame:** 6 months
**Description:** Between placebo and test product, change from baseline to 3 months in CD4
**Measure:** Immunity Biomarkers
**Time Frame:** 3 months
**Description:** Within-group change from baseline to 3 months in CD4
**Measure:** Immunity Biomarkers
**Time Frame:** 3 months
**Description:** Within-group change from baseline to 6 months in CD4
**Measure:** Immunity Biomarkers
**Time Frame:** 6 months
**Description:** Between placebo and test product, change from baseline to 3 months in CD8
**Measure:** Immunity Biomarkers
**Time Frame:** 3 months
**Description:** Within-group change from baseline to 3 months in CD8
**Measure:** Immunity Biomarkers
**Time Frame:** 3 months
**Description:** Within-group change from baseline to 6 months in CD8
**Measure:** Immunity Biomarkers
**Time Frame:** 6 months
**Description:** Between placebo and test product, change from baseline to 3 months in CD25
**Measure:** Immunity Biomarkers
**Time Frame:** 3 months
**Description:** Within-group change from baseline to 3 months in CD25
**Measure:** Immunity Biomarkers
**Time Frame:** 3 months
**Description:** Within-group change from baseline to 6 months in CD25
**Measure:** Immunity Biomarkers
**Time Frame:** 6 months
**Description:** Between placebo and test product, change from baseline to 3 months in Patient Health Questionnaire scores
**Measure:** Overall Patient Health
**Time Frame:** 3 months
**Description:** Within-group change from baseline to 3 months in Patient Health Questionnaire scores
**Measure:** Overall Patient Health
**Time Frame:** 3 months
**Description:** Within-group change from baseline to 6 months in Patient Health Questionnaire scores
**Measure:** Overall Patient Health
**Time Frame:** 6 months
**Description:** Between placebo and test product, change from baseline to 3 months in RAND-36 questionnaire scores
**Measure:** Overall Quality of Life
**Time Frame:** 3 months
**Description:** Within-group change from baseline to 3 months in RAND-36 questionnaire scores
**Measure:** Overall Quality of Life
**Time Frame:** 3 months
**Description:** Within-group change from baseline to 6 months in RAND-36 questionnaire scores
**Measure:** Overall Quality of Life
**Time Frame:** 6 months
**Description:** Between placebo and test product, change from baseline to 3 months in Perceived Stress Scale (PSS) scores
**Measure:** Stress
**Time Frame:** 3 months
**Description:** Within-group change from baseline to 3 months in PSS scores
**Measure:** Stress
**Time Frame:** 3 months
**Description:** Within-group change from baseline to 6 months in PSS scores
**Measure:** Stress
**Time Frame:** 6 months
**Description:** Change from baseline to 6 months in SBP (mmHg)
**Measure:** Systolic Blood Pressure (SBP)
**Time Frame:** 6 months
**Description:** Change from baseline to 6 months in DBP (mmHg)
**Measure:** Diastolic Blood Pressure (DBP)
**Time Frame:** 6 months
**Description:** Change from baseline to 6 months in heart rate (beats per minute)
**Measure:** Heart Rate
**Time Frame:** 6 months
**Description:** Change from baseline to 6 months in weight (kg)
**Measure:** Weight
**Time Frame:** 6 months
**Description:** Change from baseline to 6 months in percent body fat (%)
**Measure:** Percent Body Fat
**Time Frame:** 6 months
**Description:** Change from baseline to 6 months in BMI (kg/m2)
**Measure:** Body Mass Index (BMI)
**Time Frame:** 6 months
**Description:** Change from baseline in fasting whole blood hemoglobin (g/dL)
**Measure:** Whole Blood Hemoglobin
**Time Frame:** 6 months
**Description:** Change from baseline in fasting whole blood hematocrit (%)
**Measure:** Whole Blood Hematocrit
**Time Frame:** 6 months
**Description:** Change from baseline in fasting whole blood red blood cell count (x10\^6/uL)
**Measure:** Whole Blood Red Blood Cell Count
**Time Frame:** 6 months
**Description:** Change from baseline in fasting whole blood red blood cell distribution width (%)
**Measure:** Whole Blood Red Blood Cell Distribution Width
**Time Frame:** 6 months
**Description:** Change from baseline in fasting whole blood mean corpuscular volume (fL)
**Measure:** Whole Blood Mean Corpuscular Volume
**Time Frame:** 6 months
**Description:** Change from baseline in fasting whole blood mean corpuscular hemoglobin (pg)
**Measure:** Whole Blood Mean Corpuscular Hemoglobin
**Time Frame:** 6 months
**Description:** Change from baseline in fasting whole blood mean corpuscular hemoglobin concentration (g/dL)
**Measure:** Whole Blood Mean Corpuscular Hemoglobin Concentration
**Time Frame:** 6 months
**Description:** Change from baseline in fasting whole blood white blood cells (x10\^3/uL)
**Measure:** Whole Blood White Blood Cells
**Time Frame:** 6 months
**Description:** Change from baseline in fasting whole blood neutrophils (cells/uL)
**Measure:** Whole Blood Neutrophils
**Time Frame:** 6 months
**Description:** Change from baseline in fasting whole blood basophils (cells/uL)
**Measure:** Whole Blood Basophils
**Time Frame:** 6 months
**Description:** Change from baseline in fasting whole blood eosinophils (cells/uL)
**Measure:** Whole Blood Eosinophils
**Time Frame:** 6 months
**Description:** Change from baseline in fasting whole blood lymphocytes (cells/uL)
**Measure:** Whole Blood Lymphocytes
**Time Frame:** 6 months
**Description:** Change from baseline in fasting whole blood monocytes (cells/uL)
**Measure:** Whole Blood Monocytes
**Time Frame:** 6 months
**Description:** Change from baseline in fasting whole blood mean platelet volume (fL)
**Measure:** Whole Blood Mean Platelet Volume
**Time Frame:** 6 months
**Description:** Change from baseline in fasting whole blood platelet count (x10\^9/L)
**Measure:** Whole Blood Platelet Count
**Time Frame:** 6 months
**Description:** Change from baseline in fasting serum creatinine (umol/L)
**Measure:** Serum Creatinine
**Time Frame:** 6 months
**Description:** Change from baseline in fasting serum blood urea nitrogen (mg/dL)
**Measure:** Serum Blood Urea Nitrogen
**Time Frame:** 6 months
**Description:** Change from baseline in fasting serum ALP (U/L)
**Measure:** Serum Alkaline Phosphatase (ALP)
**Time Frame:** 6 months
**Description:** Change from baseline in fasting serum AST (U/L)
**Measure:** Serum Asparatate Transaminase (AST)
**Time Frame:** 6 months
**Description:** Change from baseline in fasting serum ALT (U/L)
**Measure:** Serum Alanine Transaminase (ALT)
**Time Frame:** 6 months
**Description:** Change from baseline in fasting serum albumin (g/dL)
**Measure:** Serum Albumin
**Time Frame:** 6 months
**Description:** Change from baseline in fasting serum total protein (g/dL)
**Measure:** Serum Total Protein
**Time Frame:** 6 months
**Description:** Change from baseline in fasting serum chloride (mmol/L)
**Measure:** Serum Chloride
**Time Frame:** 6 months
**Description:** Change from baseline in fasting serum sodium (mmol/L)
**Measure:** Serum Sodium
**Time Frame:** 6 months
**Description:** Change from baseline in fasting serum potassium (mmol/L)
**Measure:** Serum Potassium
**Time Frame:** 6 months
**Description:** Change from baseline in fasting serum calcium (mg/dL)
**Measure:** Serum Calcium
**Time Frame:** 6 months
**Description:** Change from baseline in fasting serum urea (mg/dL)
**Measure:** Serum Urea
**Time Frame:** 6 months
**Description:** Number of participants with adverse events
**Measure:** Incidence of Adverse Events
**Time Frame:** 6 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Healthy adult participants who are at least 50 years of age (inclusive) at the time of signing the informed consent form.
2. Have a body mass index (BMI) between 25.0 to 45.0 kg/m2 (inclusive).
3. In good general health and good oral health (no active or uncontrolled diseases, infections or conditions).
4. Impaired glucose metabolism evidence by either fasting glucose of 100 to 125 mg/dL at screening or an HbA1c between 5.7 and 6.4%.
5. Female participants of childbearing potential (i.e., participants who are not surgically sterilized or not post-menopausal (defined as amenorrhea for greater than 1 year), or transgendered males with retained ovaries and uterus) must agree to use a medically approved method of birth control for at least one month prior (or three months prior in the case of oral or long-acting injective contraceptives) to the first dose of study product and throughout the study, or abstain from heterosexual intercourse throughout the duration of the study and have a negative urine pregnancy result at baseline. For males of reproductive potential: use of condoms, abstinence from heterosexual intercourse, or other methods to ensure that their partners (if able) do not become pregnant during the course of the study.
6. Willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary consent, be able to understand and read the questionnaires, and carry out all study-related procedures.
Exclusion criteria:
1. Participant has a medical history of uncontrolled hypertension (i.e., ≥160 mmHg systolic and/or ≥100 mmHg diastolic)
2. Participant has a medical history of heart disease and/or cardiovascular disease, kidney disease (dialysis or renal failure), hepatic impairment or disease, or Type 1 or Type 2 diabetes.
3. Participant has a medical history of unstable thyroid disease, previously diagnosed major affective disorder, psychiatric disorder that required hospitalization in the year prior to screening, immune disorder (i.e., HIV/AIDS), or a history of cancer (except localized skin cancer without metastases or in situ cervical cancer) within 5 years prior to screening visit.
4. Female participants who are lactating, pregnant, or planning to become pregnant during the study.
5. Have a known intolerance, sensitivity, or allergy to any of the study products or their ingredients, or any of the excipients used in the formulation.
6. Have a known intolerance, sensitivity, or allergy to milk.
7. Unable to be prescribed at least one of the antibiotics outlined in the study protocol.
8. Any condition or abnormality that, in the opinion of the Investigator, would compromise the safety of the participant or the quality of the study data.
9. Currently taking dietary supplements other than vitamins (a 14-day washout period prior to baseline/Visit 2 would be permitted).
10. Taking any prescription medication at the time of randomization that is known to impact blood sugar and or blood sugar metabolism, as per Principal Investigator's (PI) discretion.
11. Use of certain medications in timeframes defined in the study protocol (Ampicillin, Gentamicin, Kanamycin, Streptomycin, Erythromycin, Clindamycin, Tetracycline, Chloramphenicol, Potassium sparing diuretics, Nitroglycerin and other nitrates, antidiabetic/Blood sugar lowering medications, any blood thinning medications (i.e., anticoagulant/antiplatelet drugs), antidepressants (use is permitted if dosage is maintained throughout the study), anxiolytics, antipsychotics , anticholinergics/antispasmodics, calcium-channel blockers (use is permitted if dosage is maintained throughout the study), Opioids.
12. Use of supplements dietary supplements/food/drink within 2 weeks or 7 half-lives (whichever is longer) prior to baseline and for the duration of the study, including foods/drinks rich in probiotics or prebiotics (e.g., yogurt, sauerkraut, kombucha) or synbiotics, Any herbs and supplements with hypoglycemic potential, any herbs or supplements that induce weight loss, any blood sugar lowering herbs or supplements, any blood thinning herbs or supplements
13. History of alcohol or substance abuse in the 12 months prior to screening.
14. Receipt or use of an investigational product in another research study within 28 days prior to baseline/Visit 2.
**Healthy Volunteers:** True
**Minimum Age:** 50 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Memphis
**Country:** United States
**Facility:** LifeDOC Research, PLLC
**State:** Tennessee
**Zip:** 38119
#### Overall Officials
**Official 1:**
**Affiliation:** LifeDOC Research, PLLC
**Name:** Pedro Velasquez, MD
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000044882
- Term: Glucose Metabolism Disorders
- ID: D000008659
- Term: Metabolic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M14117
- Name: Prediabetic State
- Relevance: LOW
- As Found: Unknown
- ID: M9994
- Name: Hyperglycemia
- Relevance: HIGH
- As Found: Elevated Blood Glucose
- ID: M20295
- Name: Glucose Intolerance
- Relevance: LOW
- As Found: Unknown
- ID: M11639
- Name: Metabolic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M25403
- Name: Glucose Metabolism Disorders
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000006943
- Term: Hyperglycemia
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06445556
**Brief Title:** Uplifting Equitable Park Use &Amp; Promoting Physical Activity Among African American Families in Minnesota: A Culturally-Responsive, Community-Engaged Approach
**Official Title:** Uplifting Equitable Park Use &Amp; Promoting Physical Activity Among African American Families in Minnesota: A Culturally-Responsive, Community-Engaged Approach
#### Organization Study ID Info
**ID:** MED-2024-32932
#### Organization
**Class:** OTHER
**Full Name:** University of Minnesota
### Status Module
#### Completion Date
**Date:** 2024-12-14
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-31
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-12-14
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-14
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Minnesota
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Social injustices, such as the absence of racial representation and culturally tailored programs in parks, may further discourage African American families from accessing and using these spaces. 10 Studies are needed to investigate how exposure to more equitable greenspace environments may support physical activity (PA) among African American families. Justice-focused, park-based PA interventions hold high promise for reducing health disparities and future cardiovascular diseases (CVD) and related chronic conditions (RCC) risk, thus carrying significant implications for the fields of public health, family medicine, and urban planning.
This pilot study is a two-arm, parallel randomized controlled trial that will be conducted in partnership with community stakeholders from the Three River Park District (TRPD); TRPD parks are located in the Twin Cities region of Minnesota. This trial aims to evaluate the changes in PA, psychological health, sleep, and blood pressure among a cohort of African American parent-child dyads who will be randomized to two intervention conditions. The intervention conditions are: (1) a culturally tailored, nature-based program offered at the TRPD (hereafter, "NatureUplift"), and (2) NatureUplift plus a supplementary walking/hiking educational component (hereafter, "NatureUplift+Active"). Participant dyads will be randomized to NatureUplift or NatureUplift+Active.
### Conditions Module
**Conditions:**
- Healthy
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** This pilot study is a two-arm, parallel randomized controlled trial. 12-16 parent-child dyads will be recruited
##### Masking Info
**Masking:** NONE
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 32
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Parent-child dyads randomized to NatureUplift group
**Intervention Names:**
- Behavioral: NatureUplift
**Label:** NatureUplift
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** Parent-child dyads randomized to NatureUplift+Active group
**Intervention Names:**
- Behavioral: NatureUplift+Active
**Label:** NatureUplift+Active
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- NatureUplift
**Description:** a culturally tailored, nature-based program offered at the TRPD. treatment condition will have a duration of 12 weeks, with 60 min/week of nature-based, light-intensity activities (e.g., forest bathing). Following week 12, participant dyads who were randomized to the NatureUplift intervention (i.e., delayed intervention arm) will receive access to 4 additional weeks of the NatureUplift+Active intervention.
**Name:** NatureUplift
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- NatureUplift+Active
**Description:** NatureUplift plus a supplementary walking/hiking educational component. treatment condition will have a duration of 12 weeks, with 60 min/week of nature-based, light-intensity activities (e.g., forest bathing) prescribed during the NatureUplift condition and an additional 60 min/week of supplementary moderate- intensity activities (e.g., walking and hiking) prescribed during the NatureUplift+Active condition. Those who were randomized to the NatureUplift+Active intervention will continue to receive access to 4 additional weeks of the NatureUplift+Active intervention.
**Name:** NatureUplift+Active
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** ActiGraph GT9X will be used to measure primary outcomes (time spent in light- (LPA), moderate- (MPA), and vigorous-intensity (VPA)) Fitbits are also used, but mostly to monitor compliance and not necessarily to report on the outcome.
**Measure:** Pre-/post-intervention changes in physical activity (PA)
**Time Frame:** 12 weeks
#### Secondary Outcomes
**Description:** assessed among child and adult participants using self-report measures, including survey items assessing for (1) perceived stress, (2) mood and affect, (3) anxiety symptoms, and (4) depressive symptoms.
**Measure:** Pre-/post-intervention changes in psychological health
**Time Frame:** 12 weeks
**Description:** Pre/Post-intervention changes in blood pressure assessed among child and adult participants using a digital blood pressure monitor
**Measure:** Pre-/post-intervention changes in blood pressure
**Time Frame:** 12 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
Inclusion criteria for adult parents/caregivers are:
* Able and willing to provide informed consent for child
* Are the child's primary caregiver, i.e., they are the adult who spends the largest proportion of time caring for the child (e.g., cleaning, feeding, etc.) or they spent an exactly equal proportion to another caregiver (e.g., parents each with 50% of childcare responsibilities)
* Are able to read and speak English
* Self-reported Black/African American
* Live in the Twin Cities area
* Participating in less than 60 min/day and 150 min/week of PA, assessed via a modified a Godin-Shephard Leisure Time Physical Activity Questionnaire
* No contraindications to engaging in PA, assessed via the Physical Activity Readiness Questionnaire (PAR-Q+)
* Parents need to own a smartphone or a tablet to synchronize both their Fitbit and their children's Fitbit with the Fitbit application.
Inclusion criteria for youth are:
* Able and willing to provide informed assent and to comply with study requirements
* Child aged 8-12 years
* Live with the consenting parent/caregiver at least 50% of the time
* Are able to read and speak English
Exclusion Criteria:
Exclusion criteria for adult parents/caregivers are:
* Currently engaged in ≥150 min/week of PA.
* Individuals with contraindications to exercise participation as indicated by the PAR-Q+.
* A self-reported physical/mental disability that would prevent them from being able to adhere to the intervention.
* Currently pregnant or planning to become pregnant during the study period.
* Currently breastfeeding.
* Unwilling to be randomized to a study group.
Exclusion criteria for youth are:
* Currently engaged in \>60 min of MVPA per day
* Individuals with contraindications to exercise participation as indicated by the PAR-Q+.
* Evidence of significant cognitive deficits or a severe, persistent psychiatric disorder (self-reported by the caregiver) that may interfere with comprehension of survey and adhere to the intervention.
**Healthy Volunteers:** True
**Minimum Age:** 8 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Junia de Brito, PhD, MPH, MBA
**Phone:** (612) 626-7834
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Minneapolis
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Junia de Brito, PhD, MPH, MBA
- **Phone:** 6126267834
- **Role:** CONTACT
**Country:** United States
**Facility:** University of Minnesota
**State:** Minnesota
**Status:** RECRUITING
**Zip:** 55455
#### Overall Officials
**Official 1:**
**Affiliation:** University of Minnesota
**Name:** Junia de Brito, PhD, MPH, MBA
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06445543
**Acronym:** NOURISH-HDP
**Brief Title:** Nutrition Optimization and Community Upliftment for Postpartum Recovery: Intervention to Support Healing After Hypertensive Disorders of Pregnancy
**Official Title:** Nutrition Optimization and Community Upliftment for Postpartum Recovery: Interventions to Support Healing (NOURISH) - Hypertensive Disorders of Pregnancy (HDP) Randomized Controlled Trial
#### Organization Study ID Info
**ID:** IRB00445487
#### Organization
**Class:** OTHER
**Full Name:** Johns Hopkins University
### Status Module
#### Completion Date
**Date:** 2026-06
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-31
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-03
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-09
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-31
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Johns Hopkins University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The goal of this clinical trial is to better understand how different strategies, timing, and enhancements to medically tailored food delivery will address structural inequities in the food environment, empower communities to sustain behavior change, and ultimately improve postpartum weight control to prevent chronic hypertension-a potent contributor to disparate mortality among Black women.
* To conduct a pilot randomized control trial to test the feasibility, acceptability, and effectiveness of a multi-component Medically Tailored Food (MTF) intervention, MFeast ENHANCED (a hybrid MTF intervention with a patient-activated change from prepared meals to fresh food delivery, customized for postpartum people, culturally customized for engagement and adherence, and food provision for dependents) versus MFeast Usual Care (prepared medically tailored foods only).
* To test sustainability and scalability.
Participants will:
* Respond to online surveys (supported by study team members via scheduled phone calls) via REDCap links shared before each study visit at baseline, 3 and 6 months post-delivery after the baseline survey.
* Submit anthropometric data (e.g. weight and blood pressure)
**Detailed Description:** This study will evaluate the feasibility, acceptability, and preliminary effectiveness of a postpartum dietary intervention for Black women with obesity and a recent pregnancy complicated by hypertensive disorders of pregnancy (HDP). The investigators will recruit women through Medicaid insurance plans (Priority Partners), clinical obstetric practice (Johns Hopkins Outpatient Center, Women's Health Center), perinatal community-based organizations (MOM Cares and Bloom Collective), and home-visiting locations (The Family Tree of Maryland)-all of which can verify clinical outcomes for participants.
At 37 weeks gestation, participants are contacted by the study team for consent, baseline data collection (baseline visit 1), and randomization 1:1 to receive the intervention vs. usual care (which begins in the first postpartum week). 3-7 days after randomization, the remainder of baseline visit information (baseline visit 2) is collected including information for prepared MTF food supplier Moveable Feast Baltimore. The intervention group will initially receive 10 weekly prepared heart-healthy meals from MFeast; Lactation nutritional snack bundles to boost milk supply + structural support for breastfeeding/ pumping via lactation consultants and pumping supply subsidization; culturally-adapted seasoning bundles; and dependent meal boxes for children in the household (i.e., will include 10 developmentally appropriate snack and small meal bundles, for up to 24 weeks. At postpartum week 8 participants will be offered a transition from prepared medically tailored meals to Instacart fresh food delivery (medically tailored via study team-crafted virtual grocery store) for 16 more weeks. Those assigned to the "MFeast Usual Care" group will receive 10 weekly prepared heart-healthy meals from Moveable Feast (MFeast).
### Conditions Module
**Conditions:**
- Obesity, Maternal
- Pre-Eclampsia; Complicating Pregnancy
- Gestational Hypertension
- Eclampsia; Complicating Pregnancy
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** The study design is a two parallel-arm pilot randomized controlled trial. The investigators will be applying the principles of a hybrid type 1 implementation-effectiveness randomized controlled trial.
##### Masking Info
**Masking:** SINGLE
**Masking Description:** Due to the nature of the intervention, blinding of participants or MFeast staff is not possible, but data collectors will be blinded to arm.
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 40
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** MFeast ENHANCED (a hybrid MTF intervention with a patient-activated transition from prepared meal to fresh food delivery, adaptations for postpartum people, structural and nutritional lactation support, cultural adaptations for engagement and adherence, and food provision for dependents)
**Intervention Names:**
- Behavioral: MFeast ENHANCED
**Label:** MFeast ENHANCED
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** MFeast Usual Care (prepared medically tailored meals only).
**Intervention Names:**
- Behavioral: MFeast Usual Care
**Label:** MFeast Usual Care
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- MFeast ENHANCED
**Description:** The intervention group will initially receive 10 weekly prepared heart-healthy meals from MFeast; Lactation nutritional snack bundles to boost milk supply + structural support for breastfeeding/ pumping via lactation consultants and pumping supply subsidization; culturally-adapted seasoning bundles; and dependent meal boxes for children in the household (i.e., will include 10 developmentally appropriate snack and small meal bundles, for up to 24 weeks. At postpartum week 8 participants will be offered a transition from prepared medically tailored meals to Instacart fresh food delivery (medically tailored via study team-crafted virtual grocery store) for 16 more weeks.
**Name:** MFeast ENHANCED
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- MFeast Usual Care
**Description:** Those assigned to the "MFeast Usual Care" group will receive 10 weekly prepared heart-healthy meals from MFeast.
**Name:** MFeast Usual Care
**Type:** BEHAVIORAL
### Outcomes Module
#### Other Outcomes
**Description:** Will be assessed using systolic and diastolic pressures classified per hypertension guidelines
**Measure:** Blood Pressure as assessed by Bluetooth blood pressure cuff
**Time Frame:** Baseline, 3 and 6 months postpartum
#### Primary Outcomes
**Description:** Participant Enrollment Rate as assessed by the percentage of participants consented/enrolled compared to the total eligible participants.
**Measure:** Participant Enrollment Rate
**Time Frame:** 6-8 months postpartum
**Description:** Participant Retention as assessed by the percentage of participants completing all study follow-up visits among all enrolled participants.
**Measure:** Participant Retention
**Time Frame:** 6-8 months postpartum
**Description:** Adherence as assessed by self-reported food consumption scores and photographs sent to the study team via secure messaging app. Food Consumption scores range from 0%, 25%, 50%, 75%, or 100%, indicating the amount of food consumed the prior week (self and dependents scores reported).
**Measure:** Adherence as assessed by self-reported food consumption scores and photographs
**Time Frame:** 6-8 months postpartum
**Description:** Participants rate satisfaction with the intervention's meal quality, delivery service, and likelihood of recommending the service to others at study completion, to assess the extent to which the intervention met their needs and preferences. Scores range from 8 to 32, with higher values indicating higher satisfaction.
**Measure:** Satisfaction as assessed by focus groups and the 8 item Client Satisfaction Questionnaire- (CSQ-8)
**Time Frame:** 6-8 months postpartum
**Description:** Analyze the messaging app and Slack Channel to determine the frequency and quality of discussions about meals and recipes.
**Measure:** Participant Engagement assessed by frequency and quality of meal discussions
**Time Frame:** 1-6 months postpartum
#### Secondary Outcomes
**Description:** The HEI uses a scoring system to evaluate a set of foods. The scores range from 0 to 100. An ideal overall HEI score of 100 reflects that the set of foods aligns with key dietary recommendations and dietary patterns published in the Dietary Guidelines.
**Measure:** Dietary Quality as assessed by the Healthy Eating Index (HEI) 24-hour recall
**Time Frame:** Baseline, 3 and 6 months postpartum
**Description:** The 4-item Stress Scale consists of 4 questions. The lowest total score is 0 and the highest total score is 16. Higher scores are correlated to more stress.
**Measure:** Stress assessed by the 4-item Stress Scale
**Time Frame:** Baseline, 3 and 6 months postpartum
**Description:** The 6-item Food Insecurity scale uses a subset of the standard 18 item food security scale. The Scores on the scale range from 0-6 with 0-1 indicating high or marginal food security, 2-4 indicating low food security and 5-6 indicating very low food security
**Measure:** Food Insecurity measured using a 6-item Food Insecurity Scale
**Time Frame:** Baseline, 3 and 6 months postpartum
**Description:** Will be assessed by calculating the difference in self reported pre-pregnancy weight (with Electronic Health Record validation) and postpartum weights (study provided scales)
**Measure:** Postpartum Weight (pounds) Retention as assessed by the difference in self-reported pre-pregnancy weight and postpartum weights
**Time Frame:** Baseline, 3 and 6 months postpartum
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age ≥18 years
* Self-identify as Black or African American
* Low-income (defined as eligible for Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) benefits)
* Speak English as a primary language
* Identify as a primary meal planner/preparer
* Hypertensive disorder of pregnancy, defined as one of the following: Gestational Hypertension, Preeclampsia, Eclampsia
* Gestational Age \>37 weeks
* Have a BMI \> 30 (calculated based on chart review of height and weight measurement)
* Willing to take part in the intervention and data collection procedures through online surveys
Exclusion Criteria:
* Mothers who have social support i.e. have family members preparing meals for the mother
* Mothers who are unlikely to be at the primary residence in the postpartum period
* Mothers with very specific dietary needs, i.e, food allergies, picky eaters, vegetarian/vegan
* Mothers whose birth outcome is a stillborn
* Mothers who have serious mental illness
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Michelle S Ogunwole, MD PhD
**Phone:** 2143154936
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Baltimore
**Country:** United States
**Facility:** East Baltimore Medical Campus
**State:** Maryland
**Zip:** 21205
#### Overall Officials
**Official 1:**
**Affiliation:** Johns Hopkins School of Medicine
**Name:** Michelle Ogunwole, MD, PhD
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000005261
- Term: Female Urogenital Diseases and Pregnancy Complications
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000007239
- Term: Infections
- ID: D000009765
- Term: Obesity
- ID: D000050177
- Term: Overweight
- ID: D000044343
- Term: Overnutrition
- ID: D000009748
- Term: Nutrition Disorders
- ID: D000001835
- Term: Body Weight
### Condition Browse Module - Browse Branches
- Abbrev: BC01
- Name: Infections
- Abbrev: All
- Name: All Conditions
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy 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: M16869
- Name: Toxemia
- Relevance: HIGH
- As Found: Hypertensive Disorders of Pregnancy
- ID: M10024
- Name: Hypertension
- Relevance: HIGH
- As Found: Hypertensive Disorders
- ID: M7633
- Name: Eclampsia
- Relevance: HIGH
- As Found: Eclampsia
- ID: M14106
- Name: Pre-Eclampsia
- Relevance: HIGH
- As Found: Pre-Eclampsia
- ID: M25635
- Name: Hypertension, Pregnancy-Induced
- Relevance: HIGH
- As Found: Gestational Hypertension
- ID: M14127
- Name: Pregnancy Complications
- Relevance: HIGH
- As Found: Complicating Pregnancy
- ID: M2040
- Name: Obesity, Maternal
- Relevance: HIGH
- As Found: Obesity, Maternal
- ID: M12701
- Name: Obesity
- Relevance: LOW
- As Found: Unknown
- ID: M20864
- Name: Sepsis
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular 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: M8399
- Name: Female Urogenital Diseases and Pregnancy Complications
- 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: M26186
- Name: Overweight
- Relevance: LOW
- As Found: Unknown
- ID: M25307
- Name: Overnutrition
- Relevance: LOW
- As Found: Unknown
- ID: M12684
- Name: Nutrition Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M5114
- Name: Body Weight
- Relevance: LOW
- As Found: Unknown
- ID: T2019
- Name: Eclampsia
- Relevance: HIGH
- As Found: Eclampsia
### Condition Browse Module - Meshes
- ID: D000014115
- Term: Toxemia
- ID: D000004461
- Term: Eclampsia
- ID: D000011225
- Term: Pre-Eclampsia
- ID: D000046110
- Term: Hypertension, Pregnancy-Induced
- ID: D000011248
- Term: Pregnancy Complications
- ID: D000079262
- Term: Obesity, Maternal
- ID: D000006973
- Term: Hypertension
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06445530
**Acronym:** NOURISH-GDM
**Brief Title:** Nutrition Optimization and Community Upliftment for Postpartum Recovery
**Official Title:** Nutrition Optimization and Community Upliftment for Postpartum Recovery: Interventions to Support Healing After Gestational Diabetes
#### Organization Study ID Info
**ID:** IRB00424214
#### Organization
**Class:** OTHER
**Full Name:** Johns Hopkins University
### Status Module
#### Completion Date
**Date:** 2026-06
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-31
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-03
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-09
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-31
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Johns Hopkins University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The goal of this clinical trial is to better understand how different strategies, timing, and enhancements to medically tailored food delivery will address structural inequities in the food environment, empower communities to sustain behavior change, and ultimately improve postpartum weight control to prevent type 2 diabetes-a potent contributor to disparate mortality among Black women.
The main aims of the study are:
* To conduct a pilot randomized control trial to test the feasibility, acceptability, and effectiveness of a multi-component Medically Tailored Food (MTF) intervention, Moveable Feast ENHANCED (a hybrid MTF intervention with a patient-activated change from prepared meals to fresh food delivery, customized for postpartum people, culturally customized for engagement and adherence, and food provision for dependents) versus MFeast Usual Care (prepared medically tailored foods only)
* To test sustainability and scalability.
Participants will:
* Respond to online surveys (supported by study team members via scheduled phone calls) via REDCap links shared before each study visit at baseline, 3, 6 months post-delivery after the baseline survey.
* Submit anthropometric data (i.e, weight) and information about laboratory results ( e.g. HgbA1C)
**Detailed Description:** This study will evaluate the feasibility, acceptability, and preliminary effectiveness of a postpartum dietary intervention for Black women with obesity and a recent pregnancy complicated by gestational diabetes mellitus (GDM). The investigators will recruit women through Medicaid insurance plans (Priority Partners), clinical obstetric practice (Johns Hopkins Outpatient Center, Women's Health Center), perinatal community-based organizations (MOM Cares and Bloom Collective), and home-visiting locations (The Family Tree of Maryland)-all of which can verify clinical outcomes for participants.
At 37 weeks gestation, participants are contacted by the study team for consent, baseline data collection (baseline visit 1), and randomization 1:1 to receive the intervention vs. usual care (which begins in the first postpartum week). 3-7 days after randomization, the remainder of baseline visit information (baseline visit 2) is collected including information for the prepared MTF vendor (Moveable Feast Baltimore)
The intervention group will initially receive prepared MTF (low carbohydrate, and low-fat meals, which have been shown to improve glycemia in people with prediabetes) delivered by Moveable Feast (MFeast) (10 meals weekly; Tailored Medical Nutrition Therapy (MNT) delivered by dieticians from MFeast via monthly phone calls and focused on two high yield topics only: ↓sugar-sweetened beverages and ↑ fruit and vegetable consumption; Lactation nutritional snack bundles to boost milk supply + structural support for breastfeeding/ pumping via lactation consultants and pumping supply subsidization; culturally-adapted seasoning bundles; and dependent meal boxes for children in the household (i.e., will include 10 developmentally appropriate snack and small meal bundles, for up to 24 weeks. At postpartum week 8, participants will be offered a transition from prepared medically tailored meals to Instacart fresh food delivery (medically tailored via study team-crafted virtual grocery store) for 16 more weeks.
Those assigned to the "MFeast Usual Care" group will receive prepared MTF delivered by MFeast and as-needed MNT from 1 to 24 weeks postpartum.
### Conditions Module
**Conditions:**
- Obesity, Maternal
- Gestational Diabetes
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** The study design is a two parallel-arm pilot randomized controlled trial. The investigators will be applying the principles of a hybrid type 1 implementation-effectiveness randomized controlled trial.
##### Masking Info
**Masking:** SINGLE
**Masking Description:** Due to the nature of the intervention, blinding of participants or MFeast staff is not possible, but data collectors will be blinded to arm.
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 40
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** MFeast ENHANCED (a hybrid MTF intervention with a patient-activated transition from prepared meal to fresh food delivery, adaptations for postpartum people, structural and nutritional lactation support, cultural adaptations for engagement and adherence, and food provision for dependents)
**Intervention Names:**
- Behavioral: MFeast ENHANCED
**Label:** MFeast ENHANCED
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** MFeast Usual Care (prepared medically tailored meals only).
**Intervention Names:**
- Behavioral: MFeast Usual Care
**Label:** MFeast Usual Care
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- MFeast ENHANCED
**Description:** Intervention group will initially receive prepared MTF (low carbohydrate, low-fat meals, which have been shown to improve glycemia in people with prediabetes) delivered by MFeast (10 meals weekly); Tailored Medical Nutrition Therapy (MNT) delivered by dieticians from MFeast via monthly phone calls and focused on only: ↓sugar-sweetened beverages and ↑fruit and vegetable consumption; Lactation snack bundles to boost milk supply + structural support for breastfeeding/pumping via lactation consultants and pumping supply subsidization; culturally-adapted seasoning bundles; and dependent meal boxes for children in the household (i.e., will include 10 developmentally appropriate snack and small meal bundles, for up to 24 weeks. At postpartum week 8 participants will be offered a transition from prepared medically tailored meals to Instacart fresh food delivery (via study team-crafted virtual grocery store) for 16 more weeks.
**Name:** MFeast ENHANCED
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- MFeast Usual Care
**Description:** Those assigned to the "MFeast Usual Care" group will receive prepared MTF delivered by MFeast and as needed MNT from 1 to 24 weeks postpartum.
**Name:** MFeast Usual Care
**Type:** BEHAVIORAL
### Outcomes Module
#### Other Outcomes
**Description:** Test will be done using 75 g oral glucose load with measurement of 2-hour plasma glucose levels. Obtained by electronic health records (EHR) or lab request.
**Measure:** 2 hour plasma glucose levels assessed using Oral Glucose Tolerance Test (OGTT)
**Time Frame:** 4-12 weeks postpartum
**Description:** HbA1C assessed by EHR or lab request
**Measure:** HbA1C
**Time Frame:** 3 and 6 months postpartum
**Description:** Will be measured by % time in euglycemia (glucose 70-139)
**Measure:** Percent time spent in euglycemia as assessed by participant blinded Continuous Glucose Monitor (CGM) sensor
**Time Frame:** 3 and 6 months postpartum
**Description:** Will be measured by % time with hyperglycemia (glucose \>140)
**Measure:** Percent time spent in hyperglycemia assessed by participant blinded CGM sensor
**Time Frame:** 3 and 6 months postpartum
**Description:** Postprandial glucose is calculated using the incremental area under the curve (AUCi) of blood glucose (mg/dL) over a period of time. The AUCi will be calculated for 1 hour (AUCi 0-60) after a meal. The participants will have the sensors on for 10 days, and will be asked to document their meals to correlate with calculated AUCi's.
**Measure:** Postprandial glucose excursions assessed by participant blinded CGM sensor
**Time Frame:** 3 and 6 months postpartum
**Description:** Mean daily glucose for 10 days in months 3 and 6 postpartum
**Measure:** Mean daily glucose
**Time Frame:** 3 and 6 months postpartum
#### Primary Outcomes
**Description:** Participant Enrollment Rate as assessed by the percentage of participants consented/enrolled compared to the total eligible participants
**Measure:** Participant Enrollment Rate
**Time Frame:** 6-8 months postpartum
**Description:** Retention as assessed by the percentage of participants completing all study follow-up visits among all enrolled participants.
**Measure:** Participant Retention
**Time Frame:** 6-8 months postpartum
**Description:** Consumption scores range from 0%, 25%, 50%, 75%, or 100%, indicating the amount of food consumed the prior week (self and dependents scores reported).
**Measure:** Adherence as assessed by self-reported food consumption scores and photographs sent to the study team via secure messaging app
**Time Frame:** 6-8 months postpartum
**Description:** Participants rate satisfaction with the intervention's meal quality, delivery service, and likelihood of recommending the service to others at study completion, to assess the extent to which the intervention met their needs and preferences. Scores range from 8 to 32, with higher values indicating higher satisfaction.
**Measure:** Satisfaction as assessed by focus groups and the 8 item Client Satisfaction Questionnaire- (CSQ-8)
**Time Frame:** 6-8 months postpartum
**Description:** Analyze the messaging app and Slack Channel to determine the frequency and quality of discussions about meals and recipes.
**Measure:** Participant Engagement assessed by frequency and quality of meal discussions
**Time Frame:** 1-6 months postpartum
#### Secondary Outcomes
**Description:** The HEI uses a scoring system to evaluate a set of foods. The scores range from 0 to 100. An ideal overall HEI score of 100 reflects that the set of foods aligns with key dietary recommendations and dietary patterns published in the Dietary Guidelines.
**Measure:** Dietary Quality as assessed by the Healthy Eating Index (HEI) 24-hour recall
**Time Frame:** Baseline, 3 and 6 months postpartum
**Description:** The 4-item Stress Scale consists of 4 questions. The lowest total score is 0 and the highest total score on the scale is 16. Higher scores are correlated to more stress.
**Measure:** Stress assessed by the 4-item Stress Scale.
**Time Frame:** Baseline, 3 and 6 months postpartum
**Description:** The 6-item Food Insecurity scale uses a subset of the standard 18 item food security scale. The Scores on the scale range from 0-6 with 0-1 indicating high or marginal food security, 2-4 indicating low food security and 5-6 indicating very low food security
**Measure:** Food Insecurity measured using a 6-item Food Insecurity scale.
**Time Frame:** Baseline, 3 and 6 months postpartum
**Description:** Will be assessed by calculating the difference in self reported pre-pregnancy weight (with Electronic Health Record validation) and postpartum weights (study provided scales)
**Measure:** Postpartum Weight Retention in pounds as assessed by the difference in self-reported pre-pregnancy weight and postpartum weights
**Time Frame:** Baseline, 3 and 6 months postpartum
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age ≥18 years
* Self-identify as Black or African American
* Low-income (defined as eligible for Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) benefits)
* Speak English as a primary language
* Identify as a primary meal planner/preparer
* Gestational diabetes
* Gestational age \>37 weeks
* Have a BMI \> 30 (calculated based on chart review of height and weight measurement)
* Willing to take part in the intervention and data collection procedures through online surveys
Exclusion Criteria:
* Mothers who have social support i.e. have family members preparing meals for the mother
* Mothers who are unlikely to be at the primary residence in the postpartum period
* Mothers with very specific dietary needs, i.e, food allergies, picky eaters, vegetarian / vegan
* Mothers whose birth outcome is a stillborn
* Mothers who have serious mental illness
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Michelle S Ogunwole, MD PhD
**Phone:** 2143154936
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Baltimore
**Country:** United States
**Facility:** East Baltimore Medical Campus
**State:** Maryland
**Zip:** 21205
#### Overall Officials
**Official 1:**
**Affiliation:** Johns Hopkins School of Medicine
**Name:** Michelle S Ogunwole, MD, PhD
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000011248
- Term: Pregnancy Complications
- ID: D000005261
- Term: Female Urogenital Diseases and Pregnancy Complications
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000003920
- Term: Diabetes Mellitus
- ID: D000044882
- Term: Glucose Metabolism Disorders
- ID: D000008659
- Term: Metabolic Diseases
- ID: D000004700
- Term: Endocrine System Diseases
- ID: D000009765
- Term: Obesity
- ID: D000050177
- Term: Overweight
- ID: D000044343
- Term: Overnutrition
- ID: D000009748
- Term: Nutrition Disorders
- ID: D000001835
- Term: Body Weight
### Condition Browse Module - Browse Branches
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M19012
- Name: Diabetes, Gestational
- Relevance: HIGH
- As Found: Gestational Diabetes
- ID: M7115
- Name: Diabetes Mellitus
- Relevance: LOW
- As Found: Unknown
- ID: M2040
- Name: Obesity, Maternal
- Relevance: HIGH
- As Found: Obesity, Maternal
- ID: M12701
- Name: Obesity
- 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: 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: M26186
- Name: Overweight
- Relevance: LOW
- As Found: Unknown
- ID: M25307
- Name: Overnutrition
- Relevance: LOW
- As Found: Unknown
- ID: M12684
- Name: Nutrition Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M5114
- Name: Body Weight
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000016640
- Term: Diabetes, Gestational
- ID: D000079262
- Term: Obesity, Maternal
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06445517
**Brief Title:** Study Evaluating ISM8207 in Participants With Advanced Solid Tumors and Relapsed/Refractory B-Cell Lymphoma
**Official Title:** A Phase 1, Open-label, Multicenter, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ISM8207 Monotherapy in Patients With Advanced Solid Tumors or Relapsed/Refractory B-Lymphoid Malignancies
#### Organization Study ID Info
**ID:** ISM8207_101
#### Organization
**Class:** INDUSTRY
**Full Name:** InSilico Medicine Hong Kong Limited
### Status Module
#### Completion Date
**Date:** 2027-02-28
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-31
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2026-11-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-04-25
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-31
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** InSilico Medicine Hong Kong Limited
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** The goal of this clinical trial is to study ISM8207 in participants with advanced solid tumors and relapsed/refractory B-cell lymphoma. The primary objective is to evaluate the safety and tolerability of ISM8207 orally administered in participants with advanced solid tumors and relapsed/refractory B-cell lymphoma
### Conditions Module
**Conditions:**
- Advanced Solid Tumors and Relapsed/Refractory B-cell Lymphoma
**Keywords:**
- Advanced solid tumors
- Relapsed/refractory B-cell lymphoma
- Lymphoma, B-cell
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** SEQUENTIAL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants will receive ISM8207 orally once on day 1 during single dose period (3 days) then once daily in repeated 28-day cycles from Cycle 1 onwards.
**Intervention Names:**
- Drug: ISM8207
**Label:** Dose Escalation: ISM8207
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants will receive ISM8207 orally once daily in repeated 28-day cycles.
**Intervention Names:**
- Drug: ISM8207
**Label:** Dose Expansion: ISM8207
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Dose Escalation: ISM8207
- Dose Expansion: ISM8207
**Description:** Pharmaceutical formulation: Capsules Mode of Administration: Oral
**Name:** ISM8207
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Measure:** Incidence of dose-limiting toxicity (DLT) events
**Time Frame:** 31 days
**Measure:** Incidence and severity of adverse events (AEs)
**Time Frame:** Approximately 2 years
**Measure:** Recommended phase 2 dose (RP2D)
**Time Frame:** 31 days
#### Secondary Outcomes
**Measure:** objective response rate (ORR)
**Time Frame:** Approximately 2 years
**Measure:** best objective response (BOR)
**Time Frame:** Approximately 2 years
**Measure:** duration of response (DoR)
**Time Frame:** Approximately 2 years
**Measure:** disease control rate (DCR)
**Time Frame:** Approximately 2 years
**Measure:** progression-free survival (PFS)
**Time Frame:** Approximately 2 years
**Measure:** 6-month overall survival (OS) rates
**Time Frame:** Approximately 2 years
**Measure:** 1-year overall survival (OS) rates
**Time Frame:** Approximately 2 years
**Measure:** maximum observed concentration (Cmax)
**Time Frame:** Approximately 2 years
**Measure:** time of maximum observed concentration (Tmax)
**Time Frame:** Approximately 2 years
**Measure:** area under the concentration-time curve (AUC)
**Time Frame:** Approximately 2 years
**Measure:** terminal half-life (t1/2)
**Time Frame:** Approximately 2 years
**Measure:** apparent clearance (CL/F)
**Time Frame:** Approximately 2 years
**Measure:** apparent volume of distribution (Vz/F)
**Time Frame:** Approximately 2 years
**Measure:** maximum observed concentration at steady state (Css,max)
**Time Frame:** Approximately 2 years
**Measure:** minimum observed concentration at steady state (Css,min)
**Time Frame:** Approximately 2 years
**Measure:** average concentration at steady state (Css,av)
**Time Frame:** Approximately 2 years
**Measure:** time of Css,max (Tss,max)
**Time Frame:** Approximately 2 years
**Measure:** AUC from time 0 to time dosing interval (AUCss,0-tau)
**Time Frame:** Approximately 2 years
**Measure:** CLss/Fss
**Time Frame:** Approximately 2 years
**Measure:** Vz/Fss
**Time Frame:** Approximately 2 years
**Measure:** accumulation ratio of Cmax (RCmax) after multiple doses
**Time Frame:** Approximately 2 years
**Measure:** accumulation ratio of AUC (RAUC) after multiple doses
**Time Frame:** Approximately 2 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Male or female participants with age ≥18 years at the time of signing the informed consent.
2. Advanced solid tumors: Histologically confirmed advanced or metastatic solid tumors who have disease progression after standard therapy, intolerable to standard therapy, or for whom no standard therapy exists.
B-cell lymphoma: Histologically confirmed B-cell lymphoma who had received at least one prior line of standard therapy and were relapsed after or refractory to the standard therapy.
3. Have measurable or evaluable lesions in Part 1 and at least one measurable target lesion in Part 2 as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria or Lugano 2014.
4. ECOG PS (Eastern Cooperative Oncology Group Performance Status)≤1.
5. Life expectancy of ≥12 weeks as judged by the investigator.
6. Adequate organ function as determined by medical assessment.
7. Capable of providing signed ICF and complying with the requirements and restrictions listed in the ICF and in this study protocol.
8. Female subjects of childbearing potential and male subjects must agree to use an effective method of contraception during the treatment period and for 90 days after the last dose of ISM8207.
Exclusion Criteria:
1. Prior treated with other QPCTL, CD47 or SIRPα inhibitors.
2. Burkitt lymphoma/leukemia, plasma cell myeloma, plasmablastic lymphoma.
3. Participation in other therapeutic clinical studies within 28 days or 5 half- lives (whichever is shorter) prior to first dose of study treatment.
4. Anti-tumor therapy (chemotherapy, immunotherapy, targeted therapy, biologic therapy, or other anti-tumor therapy) within 28 days or 5 half-lives, whichever is shorter prior to first dose of study treatment.
5. Previous allogeneic stem cell transplantation or autologous stem cell. transplantation within 3 months prior to first receiving study treatment.
6. Unresolved toxicity of Grade \>1 attributed to any prior therapies (excluding alopecia).
7. Received antitumor steroid therapy within 7 days prior to the first study treatment administration.
8. A serious illness or medical condition(s)
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Yichen Liu
**Phone:** 021-50831718
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Juan Xu
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Beijing
**Country:** China
**Facility:** Beijing Cancer Hospital
**State:** Beijing
**Status:** RECRUITING
**Zip:** 100142
**Location 2:**
**City:** Shanghai
**Country:** China
**Facility:** Shanghai Jiao Tong University School of Medicine-Ruijin Hospital
**State:** Shanghai
**Status:** RECRUITING
**Zip:** 200025
### 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: 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: M18828
- Name: Lymphoma, B-Cell
- Relevance: HIGH
- As Found: B-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: T640
- Name: B-cell Lymphoma
- Relevance: HIGH
- As Found: B-cell Lymphoma
### Condition Browse Module - Meshes
- ID: D000008223
- Term: Lymphoma
- ID: D000016393
- Term: Lymphoma, B-Cell
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06445504
**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:** MDT21022
#### Organization
**Full Name:** [Redacted]
### Status Module
**Delayed Posting:** True
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-04
**Overall Status:** WITHHELD
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-04-01
**Study First Submit QC Date:** 2024-06-04
### 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:** NCT06445491
**Brief Title:** Effect of Sequencing on Outcome Measures
**Official Title:** Influence of Test Order of Isokinetic Torque, Y-Balance/Firefighter-Specific Functional-Balance, and Forward-Step-Down on Test Performance: Identifying Optimal Sequences
#### Organization Study ID Info
**ID:** STUDY00002716
#### Organization
**Class:** OTHER
**Full Name:** Louisiana State University Health Sciences Center Shreveport
### Status Module
#### Completion Date
**Date:** 2024-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-04
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-08
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-06-04
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Louisiana State University Health Sciences Center Shreveport
#### 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 pilot study will examine the effect of testing order on test outcomes for measures of strength, dynamic balance, and movement quality. Each participant will perform a baseline test, then will perform the 6 iterations of the testing sequence.
**Detailed Description:** This study employs a Repeated Measures Design, with each participant tested multiple times in combinations of 1) the Isokinetic Torque Test, 2) the Y-Balance Test/Firefighter-Specific Functional-Balance Test, and 3) the Forward-Step-Down Test. The investigators will conduct a total of seven testing sessions, including a control session (informed consent, familiarization with outcome measures, and control data collection) and the following six different patterns: 1-2-3, 1-3-2, 2-1-3, 2-3-1, 3-1-2, and 3-2-1. The order of the sessions will be randomized and counterbalanced to prevent bias effects. The control session will be performed in the following order: (1) Forward-Step-Down Test, (2a) Firefighter Specific Functional Balance Test, (2b) Y-balance test, (3) isokinetic tests (hip then knee).
Participants will be asked to avoid exercise or vigorous physical activity for the 24 hours prior to any testing session to minimize the effects of non-test-related fatigue on the study outcomes. Pre and post-test fatigue will be measured with the Rating of Fatigue (ROF) Scale. Pre-and post-test exertion will be measured with the Borg Rating of Perceived Exertion (RPE) Scale (attached). Heartrate will be measured and recorded at each scale rating point.
Upon arrival for the control session, participants will have their height measured using a stadiometer and their weight recorded. This will be followed by the performance of the initial 1-2-3 pattern. The time needed for the participant to perform each test will be recorded and subsequent performances of that test will be carried out in this time frame.
For visits two through seven, participants will be weighed again upon arrival and perform one of the six patterns. Sessions two to seven will be separated by at least one day to minimize the influence of fatigue. Each session will include isokinetic torque measurements of the hip abductors and adductors, knee flexors and extensors, the Y-Balance Test, the Firefighter-Specific Functional-Balance Test, and the Forward-Step-Down Test. The dominant leg will be used for unilateral tests, as determined by the leg used to kick a ball. The order of outcome measures will be randomized for each participant to minimize the effects of fatigue and recovery.
Five minutes of warm-up on a stationary bike or walking will be performed to start each exercise session. Five minutes of rest and instruction will be provided between each outcome measure. Five minutes of rest will be given between isokinetic tests (hip abduction to adduction) to allow for machine set-up and instructions. One minute of rest will be given between each isokinetic speed, with three speeds tested for the hip (30°, 60°, and 120° per second) and knee (60°, 180°, and 300° per second) muscles.
### Conditions Module
**Conditions:**
- Muscle Weakness
**Keywords:**
- strength
- dynamic balance
- movement quality
- injury prevention
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
**Intervention Model Description:** All participants will receive all 6 iterations of testing order, but the order of test sequences will be randomized.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 12
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Testing order: (1) forward step down test, (2) firefighter specific functional balance test \& y-balance test, (3) hip isokinetic strength \& knee isokinetic strength
**Intervention Names:**
- Other: Control order
**Label:** control trial
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** Participants will perform the following variations on testing order over 6 separate sessions: 1-2-3, 1-3-2, 2-1-3, 2-3-1, 3-1-2, and 3-2-1
**Intervention Names:**
- Other: Randomized sequence
**Label:** sequenced trials
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- control trial
**Description:** Participants will perform an initial baseline of tests, order of 1- 2- 3
**Name:** Control order
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- sequenced trials
**Description:** the testing order will be randomized for follow up testing.
**Name:** Randomized sequence
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** a step-down task that is performed off a 20 cm box. Five repetitions are performed to give one score (minimum score 0, maximum score 6). A higher score is worse.
**Measure:** Forward-Step-Down Test
**Time Frame:** This outcome will be assessed at each visit throughout the study, an average of 6 weeks.
**Description:** A dynamic balance test performed by stepping down from a 15cm box, walking across a low beam (4cm high), and stepping up onto a 10cm box, turning around, and returning to the original box. 8 Trials are performed. In 4 trials, a bar is placed at 75% of the participant's height for them to negotiate while on the beam. A faster time with fewer errors is better.
**Measure:** Firefighter Specific Functional Balance Test
**Time Frame:** This outcome will be assessed at each visit throughout the study, an average of 6 weeks.
**Description:** A dynamic balance test that is performed on the dominant leg, reaching in the anterior, posteromedial, and posterolateral directions. The length of reach is standardized to participants' leg length. A higher score is better.
**Measure:** Y-Balance Test
**Time Frame:** This outcome will be assessed at each visit throughout the study, an average of 6 weeks.
**Description:** Knee extensor isokinetic strength will be tested at 60°, 180°, and 300° per second from the seated position with 5, 10, and 10 concentric contractions for each speed. A higher reading of strength is better.
**Measure:** Knee Extensor Isokinetic Test
**Time Frame:** This outcome will be assessed at each visit throughout the study, an average of 6 weeks.
**Description:** Hip abductor strength will be tested at 30°, 60°, and 120° per second from the standing position. A higher reading of strength is better.
**Measure:** Hip Abductor Isokinetic Test
**Time Frame:** This outcome will be assessed at each visit throughout the study, an average of 6 weeks.
#### Secondary Outcomes
**Description:** A score from 0-10 will be provided before and after each test category (strength, balance, movement quality). A higher score indicated more fatigue.
**Measure:** Rating of Fatigue
**Time Frame:** This outcome will be assessed at each visit throughout the study, an average of 6 weeks.
**Description:** A score from 6-20 will be provided before and after each test category (strength, balance, movement quality). A higher score indicated more perceived exertion.
**Measure:** Rating of Perceived Exertion
**Time Frame:** This outcome will be assessed at each visit throughout the study, an average of 6 weeks.
**Description:** heartrate will be recorded as a measure of physiological effort and for participant safety.
**Measure:** Heartrate
**Time Frame:** This outcome will be assessed at each visit throughout the study, an average of 6 weeks.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* healthy adult by Physical Activity Readiness Questionnaire+ screening process
Exclusion Criteria:
* lower extremity or spine injury in past 6 months
* vestibular disorder
* known pregnancy
* inability to complete data collection
**Healthy Volunteers:** True
**Maximum Age:** 57 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Erin McCallister, DPT
**Phone:** 3188133502
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Cory Coehoorn, PhD
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Shreveport
**Country:** United States
**Facility:** LSUHSC-Shreveport
**State:** Louisiana
**Zip:** 71103
#### Overall Officials
**Official 1:**
**Affiliation:** LSUHSC-Shreveport
**Name:** Erin McCallister, DPT
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Gagge AP, Stolwijk JA, Hardy JD. Comfort and thermal sensations and associated physiological responses at various ambient temperatures. Environ Res. 1967 Jun;1(1):1-20. doi: 10.1016/0013-9351(67)90002-3. No abstract available.
**PMID:** 5614624
**Citation:** Games KE, Winkelmann ZK, McGinnis KD, McAdam JS, Pascoe DD, Sefton JM. Functional Performance of Firefighters After Exposure to Environmental Conditions and Exercise. J Athl Train. 2020 Jan;55(1):71-79. doi: 10.4085/1062-6050-75-18. Epub 2019 Dec 26.
**PMID:** 31876454
**Citation:** Hewett TE, Ford KR, Hoogenboom BJ, Myer GD. Understanding and preventing acl injuries: current biomechanical and epidemiologic considerations - update 2010. N Am J Sports Phys Ther. 2010 Dec;5(4):234-51.
**PMID:** 21655382
**Citation:** Lopes TJA, Simic M, Myer GD, Ford KR, Hewett TE, Pappas E. The Effects of Injury Prevention Programs on the Biomechanics of Landing Tasks: A Systematic Review With Meta-analysis. Am J Sports Med. 2018 May;46(6):1492-1499. doi: 10.1177/0363546517716930. Epub 2017 Jul 31.
**PMID:** 28759729
**Citation:** Nascimento LR, Teixeira-Salmela LF, Souza RB, Resende RA. Hip and Knee Strengthening Is More Effective Than Knee Strengthening Alone for Reducing Pain and Improving Activity in Individuals With Patellofemoral Pain: A Systematic Review With Meta-analysis. J Orthop Sports Phys Ther. 2018 Jan;48(1):19-31. doi: 10.2519/jospt.2018.7365. Epub 2017 Oct 15.
**PMID:** 29034800
**Citation:** Park KM, Cynn HS, Choung SD. Musculoskeletal predictors of movement quality for the forward step-down test in asymptomatic women. J Orthop Sports Phys Ther. 2013;43(7):504-10. doi: 10.2519/jospt.2013.4073. Epub 2013 Jun 11.
**PMID:** 23756380
**Citation:** McCallister, E., & Flowers, D. W. (2020). Can the Forward-Step-Down Test Be Used Reliably in the Clinical Setting to Assess Movement Changes Resulting from Maximal Exertion? A Pilot Study. Internet Journal of Allied Health Sciences and Practice, 18(4).
**Citation:** Powers CM. The influence of abnormal hip mechanics on knee injury: a biomechanical perspective. J Orthop Sports Phys Ther. 2010 Feb;40(2):42-51. doi: 10.2519/jospt.2010.3337.
**PMID:** 20118526
**Citation:** van Melick N, Meddeler BM, Hoogeboom TJ, Nijhuis-van der Sanden MWG, van Cingel REH. How to determine leg dominance: The agreement between self-reported and observed performance in healthy adults. PLoS One. 2017 Dec 29;12(12):e0189876. doi: 10.1371/journal.pone.0189876. eCollection 2017.
**PMID:** 29287067
**Citation:** Brent JL, Myer GD, Ford KR, Paterno MV, Hewett TE. The effect of sex and age on isokinetic hip-abduction torques. J Sport Rehabil. 2013 Feb;22(1):41-6. doi: 10.1123/jsr.22.1.41. Epub 2012 Jun 18.
**PMID:** 22715125
**Citation:** Claiborne TL, Timmons MK, Pincivero DM. Test-retest reliability of cardinal plane isokinetic hip torque and EMG. J Electromyogr Kinesiol. 2009 Oct;19(5):e345-52. doi: 10.1016/j.jelekin.2008.07.005. Epub 2008 Oct 8.
**PMID:** 18845450
**Citation:** Gokeler A, Welling W, Zaffagnini S, Seil R, Padua D. Development of a test battery to enhance safe return to sports after anterior cruciate ligament reconstruction. Knee Surg Sports Traumatol Arthrosc. 2017 Jan;25(1):192-199. doi: 10.1007/s00167-016-4246-3. Epub 2016 Jul 16.
**PMID:** 27423208
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009135
- Term: Muscular Diseases
- ID: D000009140
- Term: Musculoskeletal Diseases
- ID: D000020879
- Term: Neuromuscular Manifestations
- ID: D000009461
- Term: Neurologic Manifestations
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000010335
- Term: Pathologic Processes
### Condition Browse Module - Browse Branches
- Abbrev: BC05
- Name: Musculoskeletal 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: M20944
- Name: Muscle Weakness
- Relevance: HIGH
- As Found: Muscle Weakness
- ID: M4554
- Name: Asthenia
- Relevance: LOW
- As Found: Unknown
- ID: M13204
- Name: Paresis
- Relevance: LOW
- As Found: Unknown
- ID: M12092
- Name: Muscular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12097
- Name: Musculoskeletal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M22619
- Name: Neuromuscular Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000018908
- Term: Muscle Weakness
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06445478
**Brief Title:** Effectiveness of Blood Flow Restricting Exercises and Isokinetic Exercises in Female Football Players
**Official Title:** Comparison of Blood Flow Restrictive Exercises and Isokinetic Exercises in Female Football Players: Randomized Controlled Study
#### Organization Study ID Info
**ID:** İREMNURESMANURRABİA
#### Organization
**Class:** OTHER
**Full Name:** Istanbul Medipol University Hospital
### Status Module
#### Completion Date
**Date:** 2023-12-31
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-04
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-06-01
**Type:** ACTUAL
#### Start Date
**Date:** 2023-04-02
**Type:** ACTUAL
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-04-29
**Study First Submit QC Date:** 2024-06-04
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Istanbul Medipol University Hospital
#### Responsible Party
**Investigator Affiliation:** Istanbul Medipol University Hospital
**Investigator Full Name:** Ebru Sever
**Investigator Title:** Lecturer
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Our aim in the study is; Comparison of blood flow restrictive exercises and isokinetic exercises in female football players. 30 female football players between the ages of 18-30 who came to DOIT Health \& Sports clinic to receive rehabilitation will be included in the study. Participants will be randomized into 2 groups. Resistant exercise with blood flow restrictive exercise (BFR-RE) will be applied to one group, and resistant exercise with isokinetic device (ID-RE) will be applied to the other group. An 8-week exercise protocol will be created for both groups and exercise training will be given twice a week. Demographic data form, Kineo Intelligent Load Isokinetic Device to measure muscle strength, tape measure to measure circumference, universal goniometer for joint range of motion, Illinois Agility Test for agility and quality of life; World Health Organization Quality of Life Scale-Short Form Turkish Version will be administered before exercise, at the 4th week and at the 8th week. The effectiveness of the applications for female football players and their advantages over each other will be examined. The 4-week and 8-week effects of 2 types of exercise will be examined.
### Conditions Module
**Conditions:**
- Female Football Players
**Keywords:**
- Resistance exercise
- Isokinetic exercise
- Female football player
- Blood flow restrictive exercise
- Athlete rehabilitation
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 30
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Resistant exercise with blood flow restrictive exercise (BFR-RE) training will be given 2 days a week for 8 weeks. Each exercise session will consist of 4 sets. There will be 30 repetitions in the first set and 15 repetitions in the next 3 sets, for a total of 75 repetitions. There will be a minimum of 30 seconds and a maximum of 60 seconds of rest intervals between sets. Since the application will be performed for the lower extremity muscle groups, a cuff will be placed on the proximal part of the lower extremity. Exercise load will be determined as 20-40% of 1 RM.
**Intervention Names:**
- Other: Blood Flow Restrictive Exercise and Isokinetic Exercise
**Label:** Group 1 (Resistant exercise with blood flow restrictive exercise (BFR-RE Group ))
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Resistant exercise with isokinetic device (ID-RE) training will be given 2 days a week for 8 weeks. During the training, leg press, squat and knee extension movements will be improved by increasing the resistance or changing the position depending on the athlete's condition.
**Intervention Names:**
- Other: Blood Flow Restrictive Exercise and Isokinetic Exercise
**Label:** Group 2 (Resistant exercise with isokinetic device (ID-RE Group))
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Group 1 (Resistant exercise with blood flow restrictive exercise (BFR-RE Group ))
- Group 2 (Resistant exercise with isokinetic device (ID-RE Group))
**Description:** Before providing exercise training, the muscle strength, circumference measurement, joint range of motion, agility and quality of life of female football players will be determined. Muscle strength measurements will be evaluated with the Kineo Intelligent Load Isokinetic Device for the BFR-RE and ID-RE groups. Then, both groups will be given 4 weeks of resistance exercise training. After this training, all evaluations will be made again. After this evaluation, another 4 weeks of training will be given and the evaluations will be re-applied at the end of the 8th week.
The "Informed Volunteer Consent Form" will be read and signed by 30 selected participants.
**Name:** Blood Flow Restrictive Exercise and Isokinetic Exercise
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** With Kineo, evaluation of lower/upper extremity and trunk muscles can be made. The device can also be used to provide strength training. The isokinetic method is characterized by movement at a predetermined constant speed regardless of the applied force. The test (single or double-sided) includes 5 consecutive movements with different speed and maximum power connection. Analysis of the graph allows evaluation of the relationship between force, velocity and angle. It allows isokinetic exercise to be performed at all workstations, both in the open chain and in the closed chain. Additionally, with Kineo Biphasic Load, it is possible to distinguish the load between concentric and eccentric phases to reduce muscle effort and make the work safer. Detailed reports on strength, muscle imbalances and all data necessary for continuous monitoring of the rehabilitation process are instantly visible, can be printed or exported in Excel format.
**Measure:** Kineo Intelligent Load Isokinetic Device
**Time Frame:** 10 weeks
**Description:** A foldable, non-elastic 7 mm wide tape measure will be used for circumference measurements. The tape measure will not be affected by the tensions during the measurement and the "0" starting part will be in the left hand, the area to be measured with the other hand will be wrapped with the tape measure and the circumference will be measured by placing the "0" point and the measured number side by side rather than on top of each other.
**Measure:** Thigh and Leg Circumference Measurement
**Time Frame:** 10 weeks
**Description:** Flexion and extension range of motion (ROM) of the knee was measured in degrees (°) using the "Universal Goniometer". Knee ROM was assessed using a goniometer with the participant lying supine with the heel elevated on a foam roller. Knee extension was measured with participants maximally extending the knee joint and was defined as the difference from 0° extension. Knee flexion was measured with patients bending their knees and lifting their heels toward their hips as far as possible. The pivot point of the goniometer was placed on the lateral condyle of the femur, and the fixed arm was placed on the lateral side of the leg in the direction of the midline of the femur, and the measurement was made so that the movable arm followed the movement of the fibula.
**Measure:** Universal Goniometer
**Time Frame:** 10 weeks
**Description:** It is used to determine the agility of athletes by taking into account their direction changes. Before the test, necessary explanations are made and the track is introduced, then the subjects are allowed to make 3-4 attempts at a low tempo. It is performed on a test track consisting of three cones arranged in a straight line with a width of 5 m, a length of 10 m and 3.3 m intervals in the middle section. The test consists of a slalom run, with 180° turns every 10 m, 40 m on the flat and 20 m between cones. Athletes are asked to start at the starting line of the test track, lying face down and with their hands in contact with the ground at shoulder level. With complete rest, the test is repeated 2 times and the best value is recorded in seconds.
**Measure:** Illinois Agility Test
**Time Frame:** 10 weeks
**Description:** The health-related quality of life scale was developed by WHO, and its validity and reliability were tested by Eser et al. The scale has two versions: long (WHOQOL-100) and short (WHOQOL-27) form. The scale measures physical, spiritual, social and environmental well-being and consists of 26 questions. The scale can be applied to non-elderly adults. Since each domain expresses the quality of life in its own field independently of each other, domain scores are calculated between 4-20. As the score increases, the quality of life increases.
**Measure:** World Health Organization Quality of Life Scale - Short Form Turkish Version
**Time Frame:** 10 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Being between the ages of 18-30
* Becoming a female football player
* Volunteering to participate in the study
Exclusion Criteria:
* Deep vein thrombosis
* Pregnancy
* Hypertension
* Anti-inflammatory use
* Unexplained chest pain
* Congenital heart disease
* Participants with a history of contraindications to exercise
* There is another study conducted at the same time as the study.
**Healthy Volunteers:** True
**Maximum Age:** 30 Years
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Istanbul
**Country:** Turkey
**Facility:** DOIT Health & Sports Clinic
**State:** Ataşehir
**Zip:** 34758
### 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:** NCT06445465
**Brief Title:** Study to Evaluate a Potential PET Radioligand for Imaging Alpha-synuclein Deposits in the Brain
**Official Title:** Phase 1 Study to Evaluate [18F]MNI-1216 ([18F]ACI-12589) as a Potential PET Radioligand for Imaging Alpha-synuclein Deposits in the Brain of Patients With Suspected Alpha-synuclein Pathology Compared With Healthy Volunteers
#### Organization Study ID Info
**ID:** 9105
#### Organization
**Class:** OTHER
**Full Name:** Invicro
### Status Module
#### Completion Date
**Date:** 2024-08
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-04
**Overall Status:** ACTIVE_NOT_RECRUITING
#### Primary Completion Date
**Date:** 2024-07
**Type:** ESTIMATED
#### Start Date
**Date:** 2020-12-24
**Type:** ACTUAL
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-04-23
**Study First Submit QC Date:** 2024-06-04
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** AC Immune SA
#### Lead Sponsor
**Class:** OTHER
**Name:** Invicro
#### 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 overall goal of this protocol is to evaluate \[18F\]MNI-1216 (also known as \[18F\]ACI-12589) as an α-synuclein targeted radiopharmaceutical in 3 parts as follows:
* Part 1: first in human (FiH) imaging
* Optional Part 2: expansion of FiH imaging
* Optional Part 3: retest imaging
A total of up to 30 participants may be enrolled and participate in the study. Part 1 of the study will include up to 10 participants (target of up to 5 healthy volunteers and up to 5 participants with idiopathic Parkinson's Disease). There will be an ongoing review of study data in Part 1 to evaluate the characteristics of tracer binding and safety. If the study results are deemed adequate in Part 1, Part 2 and/or Part 3 may be initiated. The decision to initiate Part 3 may also include a review of data from Part 2, if Part 2 is performed and the data are available. If performed, Part 2 will include up to 20 participants, including health volunteers and participants with α-synucleinopathies to acquire additional tracer-related data. If performed, Part 3 will include up to 10 participants from in Part 1 and/or Part 2 (including health volunteers and participants with α-synucleinopathies) to evaluate the reliability of \[18F\]MNI-1216 (\[18F\]ACI-12589) Positron Emission Tomography (PET) imaging.
**Detailed Description:** The overall goal of this protocol is to evaluate \[18F\]MNI-1216 (also known as \[18F\]ACI-12589) as an α-synuclein targeted radiopharmaceutical in 3 parts.
The specific objective for Parts 1, 2, and 3 is:
• To characterize \[18F\]MNI-1216 (\[18F\]ACI-12589) as a PET radioligand for imaging α-synuclein pathology.
The additional specific objectives for Part 1 and Part 2 are:
* To visually and quantitatively assess brain uptake and pharmacokinetics of \[18F\]MNI-1216 (\[18F\]ACI-12589) as a PET imaging marker for α-synuclein pathology in individuals with α-synucleinopathies (including idiopathic PD) compared with corresponding data from healthy volunteer participants.
* To evaluate the safety of a single injection of \[18F\]MNI-1216 (\[18F\]ACI-12589).
The additional specific objectives for Part 3 are:
* To evaluate the reliability (test/retest) of \[18F\]MNI-1216 (\[18F\]ACI-12589) parameters in individuals with α-synucleinopathies and healthy volunteers.
* To evaluate the safety of up to 2 injections of \[18F\]MNI-1216 (\[18F\]ACI-12589).
For each subject participating in the study, the duration of study participation will be up to 78 days.
In Part 1 and Part 2 (if Part 2 is performed), screening assessments will occur within 30 days prior to the Baseline \[18F\]MNI-1216 (\[18F\]ACI-12589) Imaging Visit (Day 1). If determined to be necessary by the study team, subjects may participate in an \[18F\]Florbetapir Imaging Visit up to 6 weeks following Day 1 (will be completed between Day 2 and Day 42). A Safety Phone Call for adverse event assessment will occur 4 days (±2 days) following each imaging visit performed. In Part 3 (if performed), subjects will participate in a Retest \[18F\]MNI-1216 (\[18F\]ACI-12589) Imaging Visit between Day 4 and Day 29 (within 3 days to 4 weeks) following the Baseline \[18F\]MNI-1216 (\[18F\]ACI-12589) Imaging Visit (Day 1). A Safety Phone Call for adverse event assessment will occur 4 days (±2 days) following the retest imaging visit, if performed.
### Conditions Module
**Conditions:**
- Alpha-Synucleinopathy
- Parkinson's Disease
- Dementia With Lewy Bodies
- Multisystem Atrophy
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** The study population will be composed of up to 30 subjects, including healthy volunteers and participants with α-synucleinopathies.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** BASIC_SCIENCE
#### Enrollment Info
**Count:** 30
**Type:** ESTIMATED
**Phases:**
- EARLY_PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The study population will be composed of participants with α-synucleinopathies.
**Intervention Names:**
- Drug: [18F]MNI-1216
**Label:** Participants with α-synucleinopathies.
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The study population will be composed of health volunteers.
**Intervention Names:**
- Drug: [18F]MNI-1216
**Label:** Healthy volunteers
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Healthy volunteers
- Participants with α-synucleinopathies.
**Description:** \[18F\]MNI-1216 is an intravenously administered radioactive imaging agent being studied as a potential positron emitting radiopharmaceutical for in vivo imaging of α-synuclein deposits.
**Name:** [18F]MNI-1216
**Other Names:**
- [18F]ACI-12589
**Type:** DRUG
### Outcomes Module
#### Other Outcomes
**Description:** To evaluate the reliability (test/retest) of parameters in individuals with α-synucleinopathies and healthy volunteers, Investigators will calculate the average and standard deviation of variability across subjects based on imaging data ((test - retest) / average (test, retest)).
**Measure:** Average variability across subjects
**Time Frame:** up to 78 days
**Description:** To evaluate the reliability (test/retest) of parameters in individuals with α-synucleinopathies and healthy volunteers, Investigators will calculate the intraclass correlation of test and retest scans from imaging data. Intraclass correlation is a reliability index in test/retest analyses.
**Measure:** Intraclass correlation (ICC) of test and retest scans
**Time Frame:** up to 78 days
#### Primary Outcomes
**Description:** Volume of distribution (VT) across multiple brain regions will be measured and comparison between participants with α-synucleinopathies and healthy volunteers will be performed to visually and quantitatively assess brain uptake and pharmacokinetics of \[18F\]MNI-1216 (\[18F\]ACI-12589) as a PET imaging marker for α-synuclein pathology in individuals with α-synucleinopathies.
**Measure:** Volume of distribution (VT) of [18F]MNI-1216 across multiple brain regions
**Time Frame:** up to 78 days
**Description:** Participants will be monitored to evaluate the safety of a single injection of \[18F\]MNI-1216 (\[18F\]ACI-12589). The following assessments will be performed to monitor participants for adverse reactions:
* Clinical laboratory tests.
* Vital signs.
* Physical findings.
* Electrocardiograms
**Measure:** Number of participants with [18F]MNI-1216-related adverse events as assessed by CTCAE
**Time Frame:** up to 78 days
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Participants is able to provide written informed consent, which must be obtained before any assessment is performed.
* Female participants must not be of childbearing potential, or agree to use contraception and not donate eggs if of childbearing potential. At the discretion of the Investigator, participants without documentation of non-childbearing potential may receive pregnancy testing.
* A woman is considered to be of childbearing potential if postmenarchal, has not reached a postmenopausal state (12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (ie, removal of ovaries, fallopian tubes, and/or uterus) or another cause as determined by the PI (eg, Müllerian agenesis).
* Women of childbearing potential must commit to remain abstinent (refrain from heterosexual intercourse) or use 2 forms of birth control, 1 of which is a barrier contraception method, for the duration of the study and 30 days after study completion. Periodic abstinence (eg, calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception.
* Women of childbearing potential must commit to not donate ovum for the duration of the study and 30 days after study completion.
* Male participants and their partners of childbearing potential must commit to the use of 2 methods of contraception, 1 of which is a barrier method for male participants for the study duration and 90 days after study completion.
* Male participants must not donate sperm for the study duration and for 90 days after study completion.
* Willing and able to cooperate with study procedures.
* For participants receiving arterial cannulation, adequate circulation to the hand for safe placement of arterial line (as determined by Allen's test) and blood clotting (PT and PTT).
* If participant takes bupropion, participant must agree to hold this medication for at least 12 hours prior to DaTscan imaging (if performed).
Additional Inclusion Criteria for healthy volunteers:
* Males and females aged ≥ 21 years.
* Healthy with no clinically relevant finding on physical examination at Screening and upon reporting to the clinic for the \[18F\]MNI-1216 (\[18F\]ACI-12589) Imaging Visit.
* No family history of α-synucleinopathy, including PD, or other early-onset neurological disease associated with dementia.
* No personal history of clinically significant neurologic and/or psychiatric disorders.
* No evidence of dopamine transporter deficit on DaTscan performed either as part of Screening or on previously acquired DaTscan (within 6 months prior to signing consent).
* Have a Montreal Cognitive Assessment (MoCA) score ≥ 26.
* No cognitive impairment as judged by the PI.
Additional Inclusion Criteria for Participants with α-synucleinopathy:
* Males and females aged ≥ 40 years.
* Participants diagnosed with any of the following:
* Idiopathic Parkinson's Disease
* Parkinson's Disease with genetic risk factor (except leucine-rich repeat kinase 2 \[LRRK2\] mutation)
* Dementia with Lewy Bodies
* Multisystem Atrophy
* A brain MRI consistent with a diagnosis of α-synucleinopathy, with no evidence of focal disease to account for the participant's neurological symptoms or MRI exclusion criteria listed below under "Exclusion Criteria".
* Evidence of dopamine transporter deficit on DaTscan performed either as part of Screening or on previously acquired DaTscan.
* Medications taken for symptomatic treatment of α-synucleinopathy must be maintained on a stable dosage regimen for at least 30 days before Screening Visit.
* Ability to tolerate lying in the scanner for up to \~180 minutes without excessive head or jaw tremor or dyskinesia sufficient to cause significant motion artifact on the PET scans.
Exclusion Criteria:
* Current or prior history of any alcohol or drug abuse in the past 2 years.
* Laboratory tests with clinically significant abnormalities and/or clinically significant unstable medical illness.
* Known history of hypersensitivity, including hypersensitivity to the active substances used for DaTscan, \[18F\]MNI-1216 (\[18F\]ACI-12589) and \[18F\]florbetapir or derivatives, or to any of the associated excipients.
* Participant has received an investigational drug within 30 days or five half-lives prior to the baseline assessments, whichever is longer.
* Prior participation in other research protocols or clinical care during the past year that would result in radiation exposure to an effective radiation dose exceeding the acceptable annual limit established by the US Federal Guidelines (effective dose of 50 mSv, including the procedures in this clinical protocol).
* Pregnant, lactating or breastfeeding.
* Evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, alternative neurological, immunodeficiency, pulmonary, or other disorder or disease.
* Unsuitable veins for repeated venipuncture.
* MRI with clinically significant structural abnormalities.
* Implants such as implanted cardiac pacemakers or defibrillators, insulin pumps, cochlear implants, metallic ocular foreign body, implanted neural stimulators, central nervous system (CNS) aneurysm clips and other medical implants that have not been certified for MRI, or history of claustrophobia in MRI.
* Participant has received treatment with a drug, antibody or vaccine targeting α-synuclein.
* Ongoing treatment with methylphenidate, modafinil, metoclopramide, alpha methyldopa, reserpine, or amphetamine derivative is prohibited 24 hours or during a period corresponding to 5 half-lives of the compound, whichever longer, prior to DaTscan imaging.
* Treatment with any antihemostasis medication (eg, warfarin, heparin, thrombin inhibitors, Factor Xa inhibitors, streptokinase, urokinase, tissue plasminogen activators) within 2 weeks of the planned arterial cannula placement (if performed) for either the baseline or retest imaging.
Additional Exclusion Criteria for Participants with α-synucleinopathy:
* Evidence of early frequent falls or eye movement abnormalities consistent with PSP.
* Individuals with known LRRK2 mutation (based on previous source documentation).
**Healthy Volunteers:** True
**Minimum Age:** 21 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** New Haven
**Country:** United States
**Facility:** Invicro
**State:** Connecticut
**Zip:** 06510
#### Overall Officials
**Official 1:**
**Affiliation:** Invicro
**Name:** David Russell, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## 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: D000019636
- Term: Neurodegenerative Diseases
- ID: D000003704
- Term: Dementia
- ID: D000019965
- Term: Neurocognitive Disorders
- ID: D000001523
- Term: Mental Disorders
- ID: D000057165
- Term: Proteostasis Deficiencies
- ID: D000008659
- Term: Metabolic Diseases
- ID: D000054969
- Term: Primary Dysautonomias
- ID: D000001342
- Term: Autonomic Nervous System Diseases
- ID: D000007022
- Term: Hypotension
- 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: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M4589
- Name: Atrophy
- Relevance: LOW
- As Found: Unknown
- ID: M13213
- Name: Parkinson Disease
- Relevance: HIGH
- As Found: Parkinson's Disease
- ID: M6904
- Name: Dementia
- Relevance: LOW
- As Found: Unknown
- ID: M22693
- Name: Lewy Body Disease
- Relevance: HIGH
- As Found: Dementia With Lewy Bodies
- ID: M2217
- Name: Synucleinopathies
- Relevance: HIGH
- As Found: Synucleinopathies
- ID: M21514
- Name: Multiple System Atrophy
- Relevance: HIGH
- As Found: Multisystem Atrophy
- ID: M15597
- Name: Shy-Drager Syndrome
- Relevance: HIGH
- As Found: Multisystem Atrophy
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- 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: 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: M28747
- Name: Proteostasis Deficiencies
- Relevance: LOW
- As Found: Unknown
- ID: M11639
- Name: Metabolic Diseases
- 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: M10072
- Name: Hypotension
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T3956
- Name: Multiple System Atrophy
- Relevance: HIGH
- As Found: Multisystem Atrophy
### Condition Browse Module - Meshes
- ID: D000010300
- Term: Parkinson Disease
- ID: D000020961
- Term: Lewy Body Disease
- ID: D000080874
- Term: Synucleinopathies
- ID: D000019578
- Term: Multiple System Atrophy
- ID: D000012791
- Term: Shy-Drager Syndrome
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M21258
- Name: Radiopharmaceuticals
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06445452
**Brief Title:** The Impact of SNAP-Ed Among Bhutanese Adults Residing in New Hampshire
**Official Title:** The Impact of SNAP-Ed on Dietary Quality, Food Safety Handling Behaviors, and Insulin Resistance Among Bhutanese Adults Residing in New Hampshire
#### Organization Study ID Info
**ID:** UNH-13-FY2022_38-01
#### Organization
**Class:** OTHER
**Full Name:** University of New Hampshire
### Status Module
#### Completion Date
**Date:** 2023-09-30
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-31
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2020-02-20
**Type:** ACTUAL
#### Start Date
**Date:** 2019-10-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-31
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University of New Hampshire
#### Responsible Party
**Investigator Affiliation:** University of New Hampshire
**Investigator Full Name:** Sherman Bigornia
**Investigator Title:** Assistant Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The goal of this pilot randomized controlled trial is to test the potential efficacy of Supplemental Nutrition Assistance Program Education (SNAP-Ed) among Bhutanese refugee adults residing in New Hampshire. The main questions are whether direct SNAP-Ed delivered through 6 lessons affects dietary quality and biomarkers of metabolic risk. Participants in the SNAP-Ed arm will be asked to participate in weekly lessons delivered in their homes by a bicultural and bilingual nutrition educator. Individuals in the control group did not receive SNAP-ED. All participants will be asked to complete surveys and provide blood and fecal samples prior at baseline and at the end of the study period (7 to 8 weeks).
### Conditions Module
**Conditions:**
- Supplemental Nutrition Assistance Program Education
- Bhutanese Refugee Adults
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 54
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Behavioral: Direct SNAP-Ed
**Label:** SNAP-Ed
**Type:** EXPERIMENTAL
#### Arm Group 2
**Intervention Names:**
- Behavioral: Direct SNAP-Ed
**Label:** No SNAP-Ed
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- No SNAP-Ed
- SNAP-Ed
**Description:** Six in-home SNAP-Ed lessons are delivered to participants in the SNAP-Ed arm. Lessons are offered weekly and directed by a bilingual and bicultural community health worker.
**Name:** Direct SNAP-Ed
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** All participants will provide three 24-hr recalls at baseline and the exit visit. Dietary intake will be average across the three recalls. The HEI score rubric will be applied to the dietary intakes where a higher score indicates greater adherence to the US Dietary Guidelines.
**Measure:** Healthy Eating Index Score
**Time Frame:** 0 and 7-8 weeks
**Description:** Homeostasis Model Assessment for Insulin Resistance (HOMA-IR) is calculated using fasting insulin and glucose values, where a higher values indicates greater insulin resistance. HbA1c will also be measured.
**Measure:** Glucose Homeostasis Biomarkers
**Time Frame:** 0 and 7-8 weeks
**Description:** Total cholesterol, LDL-Cholesterol, HDL-Cholesterol and triglycerides will be measured as an indicators of CVD risk.
**Measure:** Lipid Panel
**Time Frame:** 0 and 7-8 weeks
**Description:** TNF-alpha, C-Reactive Protein, and IL-6 will be measured where higher values indicate greater inflammation.
**Measure:** Inflammatory Biomarkers
**Time Frame:** 0 and 7-8 weeks
**Description:** Outcomes include short-chain fatty acids (Akkermansia municiphilla, Ruminococcus bromii, Faecalibacterium prausnitzii, Eubacterium rectale, and Eubacterium hallii) and lower abundance of those that synthesize branched-chain amino acids (Bacillus-Lactobacillus-Streptococcus groups, and Proteobacteria). In addition, gut microbial diversity will be assessed.
**Measure:** Gut Microbiome Composition
**Time Frame:** 0 and 7-8 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion criteria are (1) identifies as a Bhutanese refugee (2) 18 years and older (3) does most of the cooking and shopping for his/her household. Exclusion Criteria are (1) has been told by her/his doctor that she/he has diabetes (2) history of use of glucose lowering medications (3) pregnant or trying to become pregnant (4) currently diets for weight loss or dietary restrictions.
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Manchester
**Country:** United States
**Facility:** Building Community in New Hampshire
**State:** New Hampshire
**Zip:** 03101-1824
### IPD Sharing Statement Module
**IPD Sharing:** NO
## 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: M10370
- Name: Insulin Resistance
- 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:** NCT06445439
**Acronym:** OPT-RATE AF
**Brief Title:** Optimal Pacing Rate for Cardiac Resynchronization Therapy
**Official Title:** Optimal Pacing Rate for Cardiac Resynchronization Therapy After Atrioventricular Node Ablation in Persistent Atrial Fibrillation and Heart Failure
#### Organization Study ID Info
**ID:** STUDY00006952
#### Organization
**Class:** OTHER
**Full Name:** Medstar Health Research Institute
### Status Module
#### Completion Date
**Date:** 2025-08
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-03
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-08
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-12-19
**Type:** ACTUAL
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-03-25
**Study First Submit QC Date:** 2024-06-03
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** Medtronic
#### Lead Sponsor
**Class:** OTHER
**Name:** Medstar Health Research Institute
#### 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 is a prospective, randomized crossover study. The objective of the study is to determine if a pacing rate of 80 beats per minute (bpm) improves quality of life (QoL) and patient function after 3 months of intervention compared to 3 months of the current standard 60 bpm. The investigators will randomly assign half of the participants to a starting rate of 60 bpm and then switch them to a rate of 80 bpm for 3 months, and vice versa.
**Detailed Description:** Cardiac resynchronization therapy (CRT) after atrioventricular node (AVN) ablation for permanent atrial fibrillation (AF) has led to better outcomes in heart failure (HF) patients with reduced ejection fraction (HFrEF) and with preserved ejection fraction (HFpEF) compared to pharmacotherapy. Emerging evidence has demonstrated patients with HFpEF may benefit from a higher heart rate compared to standard heart-lowering therapies. The optimal pacing rate for CRT after AVN ablation in persistent AF and HFpEF remains unknown.
This is a prospective, randomized crossover study. The objective of the study is to determine if a pacing rate of 80 beats per minute (bpm) improves quality of life (QoL) and patient function after 3 months of intervention compared to 3 months of the current standard 60 bpm.
The investigators will randomly assign half of the participants to a starting rate of 60 bpm and then switch them to a rate of 80 bpm for 3 months, and vice versa. Patient mortality and HF hospitalizations will be recorded at each phase. An electrocardiogram, echocardiogram, pacemaker interrogation, BNP and creatinine levels, KCCQ-12, six-minute walk test, and physical activity measure will be obtained at baseline, 3 months, and 6 months.
### Conditions Module
**Conditions:**
- Atrial Fibrillation, Persistent
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
**Intervention Model Description:** The investigators will randomly assign half of the participants to a starting rate of 60 bpm and then switch them to a rate of 80 bpm for 3 months, and vice versa.
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 200
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Pacing rate of 60 bpm for the first 3 months, then switch to 80 bpm for the next 3 months.
**Intervention Names:**
- Device: Pacing rate of 80 bpm
- Device: Pacing rate of 60 bpm
**Label:** 60 bpm, then 80 bpm
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Pacing rate of 80 bpm for the first 3 months, then switch to 60 bpm for the next 3 months.
**Intervention Names:**
- Device: Pacing rate of 80 bpm
- Device: Pacing rate of 60 bpm
**Label:** 80 bpm, then 60 bpm
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- 60 bpm, then 80 bpm
- 80 bpm, then 60 bpm
**Description:** Pacing rate of 80 bpm
**Name:** Pacing rate of 80 bpm
**Type:** DEVICE
#### Intervention 2
**Arm Group Labels:**
- 60 bpm, then 80 bpm
- 80 bpm, then 60 bpm
**Description:** Pacing rate of 60 bpm
**Name:** Pacing rate of 60 bpm
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Quality of life as measured by the Kansas City Cardiomyopathy Questionnaire
**Measure:** Quality of life as measured by the Kansas City Cardiomyopathy Questionnaire
**Time Frame:** 3 months
**Description:** Function as measured by the Kansas City Cardiomyopathy Questionnaire
**Measure:** Function as measured by the Kansas City Cardiomyopathy Questionnaire
**Time Frame:** 3 months
#### Secondary Outcomes
**Description:** Quality of life as measured by the Six-Minute Walk Test
**Measure:** Quality of life as measured by the Six-Minute Walk Test
**Time Frame:** 3 months
**Description:** Function as measured by the International Physical Activity Questionnaire
**Measure:** Function as measured by the International Physical Activity Questionnaire
**Time Frame:** 3 months
**Description:** Change in B-type natriuretic peptide (BNP)
**Measure:** Change in B-type natriuretic peptide (BNP)
**Time Frame:** 3 months
**Description:** Change in creatinine
**Measure:** Change in creatinine
**Time Frame:** 3 months
**Description:** Change in New York Heart Association Class
**Measure:** Change in New York Heart Association Class
**Time Frame:** 3 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Age 18 years or older
2. History of persistent or permanent atrial fibrillation
3. Implantation of CRT or conduction system pacing in prior 3 months to 5 years of study start
4. History of intrinsic AVN block or have undergone AVN ablation in prior 3 months to 5 years of study start
5. LVEF ≥ 50%
6. N-terminal pro-B-type natriuretic peptide (NT-proBNP) \>400 pg/mL in the last 24 months
7. Clinical HF diagnosis or NYHA class II or higher
8. Able to provide informed consent
Exclusion Criteria:
1. LVEF \<50%
2. Wide QRS (greater than 150ms)
3. Isolated RV pacing
4. Severe valvular disease
5. Severe coronary artery disease as defined by one of the following:
1. ACS or PCI within 1 year
2. Any angina (CCS class 1+)
3. Unrevascularizable severe CAD (\>70% stenosis in 1+ major vessels and/or based on functional assessment)
6. ESRD
7. Significant primary pulmonary disease on home oxygen
8. Major orthopedic issues, such as being wheelchair bound and/or unable to perform a six-minute walk test
9. Ventricular ectopy \>15% premature ventricular contractions (PVC)
10. End stage cancer diagnosis
11. Life expectancy less than one year
12. Palliative or hospice care
13. Hypertrophic cardiomyopathy (HCM)
14. Uncorrected ventricular septal defect
15. Infiltrative cardiomyopathy (CM)
16. Uncontrolled hypertension as defined by blood pressure \>160/100 mm Hg on two measurements ≥15 minutes apart
17. Hemoglobin \<7 g/dL
18. Age \>90 years old
19. Pregnant or intends to become pregnant
**Maximum Age:** 90 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Sarahfaye Dolman
**Phone:** 302-530-1873
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Washington
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Sarahfaye Dolman
- **Phone:** 302-530-1873
- **Role:** CONTACT
***Contact 2:***
- **Name:** Athanasios Thomaides, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** MedStar Georgetown University Hospital
**State:** District of Columbia
**Status:** RECRUITING
**Zip:** 20007
**Location 2:**
**City:** Washington
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Sarahfaye Dolman
- **Phone:** 302-530-1873
- **Role:** CONTACT
***Contact 2:***
- **Name:** Athanasios Thomaides, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** MedStar Washington Hospital Center
**State:** District of Columbia
**Status:** RECRUITING
**Zip:** 20010
**Location 3:**
**City:** Clinton
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Sarahfaye Dolman
- **Phone:** 302-530-1873
- **Role:** CONTACT
***Contact 2:***
- **Name:** Athanasios Thomaides, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** MedStar Southern Maryland Hospital
**State:** Maryland
**Status:** RECRUITING
**Zip:** 20735
**Location 4:**
**City:** Fairfax
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Sarahfaye Dolman
- **Phone:** 302-530-1873
- **Role:** CONTACT
***Contact 2:***
- **Name:** Athanasios Thomaides, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** MedStar Heart and Vascular Office at Fairfax
**State:** Virginia
**Status:** RECRUITING
**Zip:** 22031
### IPD Sharing Statement Module
**Description:** Study data available from PI upon request.
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001145
- Term: Arrhythmias, Cardiac
- ID: D000006331
- Term: Heart Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000010335
- Term: Pathologic Processes
### Condition Browse Module - Browse Branches
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M4586
- Name: Atrial Fibrillation
- Relevance: HIGH
- As Found: Atrial Fibrillation
- ID: M9421
- Name: Heart Failure
- Relevance: LOW
- As Found: Unknown
- ID: M4453
- Name: Arrhythmias, Cardiac
- Relevance: LOW
- As Found: Unknown
- ID: M9419
- Name: Heart Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001281
- Term: Atrial Fibrillation
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06445426
**Acronym:** PEPRE2
**Brief Title:** Cystometry Using a Novel Microsensor System in Patients With Neurogenic Bladder Dysfunction
**Official Title:** Cystometry Using a Novel Microsensor System in Patients With Neurogenic Bladder Dysfunction
#### Organization Study ID Info
**ID:** SUPRE
#### Organization
**Class:** OTHER
**Full Name:** Sunnaas Rehabilitation Hospital
### Status Module
#### Completion Date
**Date:** 2023-12-31
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-31
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-10-31
**Type:** ACTUAL
#### Start Date
**Date:** 2022-06-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2022-08-05
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** SINTEF MiNaLab
**Class:** OTHER
**Name:** University of Oslo
#### Lead Sponsor
**Class:** OTHER
**Name:** Sunnaas Rehabilitation Hospital
#### Responsible Party
**Investigator Affiliation:** Sunnaas Rehabilitation Hospital
**Investigator Full Name:** Thomas Glott
**Investigator Title:** Medical director
**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 study is to assess the feasibility and safety of a novel system for percutaneous measurement of bladder pressure. The system allows for a minimally invasive procedure and high-quality recordings with a higher than conventional sampling rate and synchronization, and with physiological filling. The pressure sensor system has potential for being developed into a low-cost method with mass production.The study will include a sample of convenience of up to 40 subjects. The pressure will be recorded simultaneously with conventional and novel pressure recording system in the bladder. The simultaneous recording with the novel and the conventional method will provide a direct comparison of simultaneous recording of pressure between the two methods. Subjects will be examined for subjective or objective adverse events.
**Detailed Description:** The aim of the study is to assess the feasibility and safety of a novel system for measurement of bladder pressure. The system allows for a minimally invasive procedure and high-quality recordings with a higher than conventional sampling rate and synchronization. The pressure sensor system has potential for being developed into a low-cost method with mass production. In persons with spinal cord injury and neurogenic bladder dysfunction, measurement of pressure in the bladder (cystometry) is mandatory to evaluate risk factors and assess treatment options. This novel system consists of a micro electro mechanical system (MEMS) integrated in a hollow flexible tube made out of biocompatible material. Recording from this sensor catheter is transmitted to specialized electronic and digital devices for processing. Due to a sensor catheter with a diameter less than 1.0 mm, it is possible to perform transurethral cystometry using a simple minimally invasive technique. The study goal is to compare the simultaneous measurement of the conventional water perfused system compared to a novel pressure sensor system during cystometry. produce high-quality recordings with a higher than conventional sampling rate. The study will include a sample of convenience of up to 40 subjects. The pressure will be recorded simultaneously with conventional and novel pressure recording system in the bladder. Subjects will be examined for any subjective or objective adverse events. The simultaneous recording with the novel and the conventional method will provide a direct comparison of simultaneous recording of pressure between the two methods. Subjects will be examined for subjective or objective adverse events. The sample size is too small for comparison of validity of the two methods in clinical practice. However, the study should be able to conclude on reliability. Thus, pressure measurements will be assessed with both methods during cystometry in up to 40 subjects. Based on the technical specifications, we expect these measurements to be almost identical and thus reliable. The study is not intended to give conclusive results on the comparison between conventional water perfused recording and the novel MEMS pressure system. However, results from this initial study will be the basis for further studies with sufficient power to validate conventional versus novel MEMS technique.
### Conditions Module
**Conditions:**
- Spinal Cord Injuries
- Urinary Bladder, Neurogenic
**Keywords:**
- Urodynamics
### Design Module
#### Design Info
**Observational Model:** CASE_ONLY
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 33
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The pressure will be recorded simultaneously with conventional and novel pressure recording system in the bladder. The procedure will be done according to International Continence Society´s (ICS) recommended indications for the procedure. Investigational device is hooked into a 12F single-use hydrophilic catheter. After correct positioning is verified by ultrasound and x-ray, the investigational device is released from the insertion catheter. The insertion catheter is then carefully removed securing correct positioning of investigational device inside the bladder. The investigational device is connected to a data logger. In conventional device, the intravesical pressure is recorded using a water perfused 3F catheter with a 3 ml/hour perfusion rate. The 3F catheter is hooked on an 8F catheter to facilitate introduction into the bladder. The catheter used for pressure transmission are connected to external transducers and a computer with software processing the recording.
**Label:** Simulataneous bladder pressure recording
### Outcomes Module
#### Other Outcomes
**Description:** Subjects will be examined for any subjective or objective adverse events. The transurethral technique is well-known, and the complication rates are very low. However, there are known complications such as urinary tract infection, hematuria, pain, retention, and autonomic dysreflexia in tetraplegics. Subjects will be routinely examined for all these conditions, and if any of them occur, adequate treatment will be initiated according to hospital guidelines. The small-sized sensor tube (Ø ≈ 1.2 mm) provides a minimally invasive clinical procedure. In case of perforation, the lesion will be small.
**Measure:** Advert effects monitoring and resolution
**Time Frame:** 72 hours
#### Primary Outcomes
**Description:** The bladder pressure recorded simultaneously by a conventional clinical system and the prototype will be used for a systemstic comparison analysis in the time-amplitude and the time-frequency domains.
**Measure:** Bladder pressure
**Time Frame:** 24 hours
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Documented traumatic or non-traumatic spinal cord injury
* Documented neurogenic bladder dysfunction by previous cystometry
* More than 3 months after injury
* Subject is able to communicate in Norwegian
* Subject is able and willing to sign informed consent
* Subject is able to complete all study requirements
Exclusion Criteria:
* History or evidence of previous urological or lower abdominal abnormalities from disease or surgery
* Use of anti-platelet or anti-coagulant other than low molecular weight heparin or acetylsalicylic acid which cannot be discontinued
* Symptomatic urinary tract infection
* Hemophilia or other clotting disorders that cause bleeding diathesis
* Any condition or situation, which, in the investigator's opinion, puts the subject at significant risk, could confound the study results, or may interfere significantly with the subject's participation in the study
**Maximum Age:** 80 Years
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Subjects will be recruited from patients with chronic spinal cord injury (SCI) admitted for cystometry at Sunnaas Hospital´s urodynamic laboratory. All subjects will have a clinical indication for cystometry.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Oslo
**Country:** Norway
**Facility:** Sunnaas Rehabilitation Hospital
**State:** Nesoddtangen
**Zip:** N-1450
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000013118
- Term: Spinal Cord Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000020196
- Term: Trauma, Nervous System
- ID: D000014947
- Term: Wounds and Injuries
- ID: D000009461
- Term: Neurologic Manifestations
- ID: D000001745
- Term: Urinary Bladder Diseases
- ID: D000014570
- Term: Urologic Diseases
- ID: D000052776
- Term: Female Urogenital Diseases
- ID: D000005261
- Term: Female Urogenital Diseases and Pregnancy Complications
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000052801
- Term: Male Urogenital Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: All
- Name: All Conditions
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M15916
- Name: Spinal Cord Injuries
- Relevance: HIGH
- As Found: Spinal Cord Injury
- ID: M5031
- Name: Urinary Bladder, Neurogenic
- Relevance: HIGH
- As Found: Urinary Bladder, Neurogenic
- ID: M15915
- Name: Spinal Cord Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17685
- Name: Wounds and Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M22023
- Name: Trauma, Nervous System
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- 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: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27093
- Name: Female Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14127
- Name: Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M8399
- Name: Female Urogenital Diseases and Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M27095
- Name: Male Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000013119
- Term: Spinal Cord Injuries
- ID: D000001750
- Term: Urinary Bladder, Neurogenic
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06445413
**Acronym:** ACHIEVE
**Brief Title:** Tai Chi as a Novel Strategy to Increase Physical Activity Among Adults Pursuing Metabolic and Bariatric Surgery
**Official Title:** Tai Chi as a Novel Strategy to Increase Physical Activity Among Adults Pursuing Metabolic and Bariatric Surgery: A Feasibility and Acceptability Study
#### Organization Study ID Info
**ID:** R-HHC-2023-0177
#### Organization
**Class:** OTHER
**Full Name:** Hartford Hospital
### Status Module
#### Completion Date
**Date:** 2025-06-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-04
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-04-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-01-22
**Type:** ACTUAL
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-02-26
**Study First Submit QC Date:** 2024-06-04
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Hartford 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:** The goal of this clinical trial is to evaluate the feasibility and acceptability of a 10-wk hybrid Tai Chi (TC) program with in-person classes and online TC videos among 24 physically inactive adults who are seeking metabolic and bariatric surgery (MBS) in a single-arm trial.
The aims are:
Aim 1: Feasibility: To evaluate whether TC is feasible, defined as a mean attendance rate of ≥70% in-person TC classes attended.
Aim 2: Acceptability: To evaluate whether TC is acceptable, defined as a mean rating of ≥4 across 4 acceptability questionnaire items measured on a 5-point Likert scale (e.g., rate "Tai Chi practice is appealing to me" on a scale from 1 \[completely disagree\] to 5 \[completely agree\]).
Participants will complete four individual in-person visits where they will complete study assessments and ten weekly group in-person Tai Chi classes where they will practice Tai Chi with up to 5 other study participants. Additionally, they will be asked to practice Tai Chi at home with the aid of instructional online videos and log their practice.
### Conditions Module
**Conditions:**
- Obesity
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 24
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participation in ten weekly group in-person Tai Chi classes
**Intervention Names:**
- Other: Tai Chi
**Label:** Tai Chi class
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Tai Chi class
**Description:** Ten weekly 60-minute Tai Chi classes
**Name:** Tai Chi
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Percentage of Tai Chi classes attended over 10 week program
**Measure:** Attendance
**Time Frame:** Attendance will be taken at each class (up to 10 weeks)
**Description:** Number of times the weekly Tai Chi video is viewed
**Measure:** Video view frequency
**Time Frame:** Measured once weekly for up to 10 weeks
**Description:** Number of minutes the weekly Tai Chi video was played
**Measure:** Video view duration
**Time Frame:** Measured once weekly (up to 10 weeks)
**Description:** Number of times participant practices Tai Chi at home
**Measure:** Home practice frequency
**Time Frame:** Measured once weekly (up to 10 weeks)
**Description:** Number of minutes spent practicing Tai Chi at home
**Measure:** Home practice duration
**Time Frame:** Measured once weekly (up to 10 weeks)
**Description:** This is a validated tool to assess the acceptability of interventions with four 5-point Likert scale questions that will be rated from completely disagree to completely agree. Acceptability is defined as a mean rating of ≥4 across 4 acceptability questionnaire items measured on a 5-point Likert scale (e.g., rate "Tai Chi practice is appealing to me" on a scale from 1 \[completely disagree\] to 5 \[completely agree\]).
**Measure:** Acceptability of Tai Chi
**Time Frame:** Measured once at the end of Tai Chi class or when participant drops out
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Seeking to undergo MBS at HHC.
2. Be able to give valid informed consent in English. Attending the live, in-person, group TC classes each week is the main component of the intervention. During the classes, the TC instructor will be giving instructions and communicating with the participants in English. It is not practical to having an interpreter during the live classes. Therefore, participation is limited to those who are English speakers.
3. Be 18-70 years of age.
4. Have BMI≥35 kg/m2
5. Absence of cognitive impairment since participants will need to learn and memorize the TC forms. Must score ≥24 Mini-Mental State Examination.
6. Be physically inactive defined as performing \<150 min/wk of moderate to vigorous intensity PA based on self-report.
7. Be able to ambulate independently without use of an assistive device.
8. Be able to complete questionnaires and view TC instructional videos via REDCap.
9. Be able to commute to one of the HH Medical and Surgical Weight Loss Center clinics to participate in testing sessions and in-person TC classes.
Exclusion Criteria:
1. Having severe psychological or physical conditions that may impair their ability to adhere to the study protocol such as uncontrolled mental health issues, and severe arthritis.
2. Pregnant women.
**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:** Yin Wu, PhD
**Phone:** 860-972-5750
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Hartford
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Dale Bond, PhD
- **Phone:** 860-972-4318
- **Role:** CONTACT
**Country:** United States
**Facility:** Hartford Hospital
**State:** Connecticut
**Status:** RECRUITING
**Zip:** 06102
## 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:** NCT06445400
**Brief Title:** A Study of BL-M07D1, BL-M07D1+Pertuzumab and BL-M07D1+Pertuzumab+Docetaxel in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer
**Official Title:** A Phase II Clinical Trial to Evaluate the Efficacy and Safety of BL-M07D1, BL-M07D1+Pertuzumab and BL-M07D1+Pertuzumab+Docetaxel as First-line Treatment in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer
#### Organization Study ID Info
**ID:** BL-M07D1-205
#### Organization
**Class:** INDUSTRY
**Full Name:** Sichuan Baili Pharmaceutical Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2026-06
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-31
**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:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-31
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Sichuan Baili Pharmaceutical Co., Ltd.
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This study is a phase II clinical trial to evaluate the safety and efficacy of BL-M07D1, BL-M07D1+Pertuzumab and BL-M07D1+Pertuzumab+Docetaxel as first-line treatment in patients with unresectable locally advanced or metastatic HER2-positive breast cancer.
### Conditions Module
**Conditions:**
- HER2-positive Breast Cancer
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 120
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants received BL-M07D1, BL-M07D1+Pertuzumab and BL-M07D1+ Pertuzumab+Docetaxel in the first cycle (3 weeks). Participants who had a clinical benefit could receive additional cycles of additional treatment. Administration will be discontinued because of disease progression or intolerable toxicity or for other reasons.
**Intervention Names:**
- Drug: BL-M07D1
- Drug: Pertuzumab
- Drug: Docetaxel
**Label:** Study treatment
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Study treatment
**Description:** Administration by intravenous infusion for a cycle of 3 weeks.
**Name:** BL-M07D1
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Study treatment
**Description:** Administration by intravenous infusion for a cycle of 3 weeks.
**Name:** Pertuzumab
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- Study treatment
**Description:** Administration by intravenous infusion for a cycle of 3 weeks.
**Name:** Docetaxel
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** ORR is defined as the percentage of participants, who has a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experiences a confirmed CR or PR is according to RECIST 1.1.
**Measure:** Objective Response Rate (ORR)
**Time Frame:** Up to approximately 24 months
**Description:** The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for phase II study, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation study of BL-M07D1.
**Measure:** Recommended Phase II Dose (RP2D)
**Time Frame:** Up to approximately 24 months
#### Secondary Outcomes
**Description:** The PFS is defined as the time from the participant's first dose of BL-M07D1 to the first date of either disease progression or death, whichever occurs first.
**Measure:** Progression-free Survival (PFS)
**Time Frame:** Up to approximately 24 months
**Description:** The DCR is defined as the percentage of participants who has a CR, PR, or Stable Disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease \[PD: at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD\]).
**Measure:** Disease Control Rate (DCR)
**Time Frame:** Up to approximately 24 months
**Description:** The DOR for a responder is defined as the time from the participant's initial objective response to the first date of either disease progression or death, whichever occurs first.
**Measure:** Duration of Response (DOR)
**Time Frame:** Up to approximately 24 months
**Description:** TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of BL-M07D1. The type, frequency and severity of TEAE will be evaluated during the treatment of BL-M07D1.
**Measure:** Treatment-Emergent Adverse Event (TEAE)
**Time Frame:** Up to approximately 24 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Sign the informed consent form voluntarily and follow the protocol requirements;
2. Gender is not limited;
3. Age ≥18 years old and ≤75 years old;
4. Expected survival time for 3 months or more;
5. Patients with histologically and/or cytologically confirmed unresectable locally advanced or metastatic HER2-positive breast cancer;
6. Consent to provide archived tumor tissue samples or fresh tissue samples from the primary or metastatic lesions;
7. At least one measurable lesion meeting the RECIST v1.1 definition was required;
8. Physical condition score ECOG 0 or 1 ;
9. The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0;
10. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
11. No blood transfusion, no colony-stimulating factor, and no albumin are allowed within 14 days before the first use of the study drug, and the organ function level must meet the requirements;
12. Blood coagulation function: international standardization ratio (INR) 1.5 or less, and the part activated clotting time (APTT) live enzymes acuities were 1.5 x ULN;
13. Urinary protein ≤2+ or ≤1000mg/24h;
14. Fertile female subjects, or male subjects with fertile partners, must use highly effective contraception from 7 days before the first dose until 7 months after the end of the dose. Female subjects of childbearing potential had to have a negative serum pregnancy test within 7 days before the first dose.
Exclusion Criteria:
1. Received chemotherapy with mitomycin C and nitrosourea within 6 weeks before the first dose, received surgery within 4 weeks before the first dose, and received endocrine therapy within 2 weeks before the first dose;
2. Patients with locally advanced or metastatic disease who have received previous systemic therapy;
3. Had received prior ADC drug therapy with camptothecin derivative as toxin;
4. Screening within the first half of the serious heart, cerebrovascular disease;
5. Complicated with pulmonary diseases leading to severe impairment of lung function;
6. A history of ILD/interstitial pneumonia requiring steroid therapy, current ILD/interstitial pneumonia, or suspected ILD;
7. QT prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;
8. Other primary malignancies diagnosed within 5 years before the first dose;
9. Poorly controlled hypertension;
10. Patients with active central nervous system metastases;
11. Need treatment intervention of unstable thrombotic events, except infusion related thrombosis;
12. Patients with a history of allergy to recombinant humanized antibodies or to any excipients of the trial drug;
13. Had received more than the following cumulative doses of anthracyclines;
14. Systemic corticosteroids or immunosuppressive agents were required within 2 weeks before study dosing;
15. Patients with massive or symptomatic effusions or poorly controlled effusions;
16. Severe systemic infection within 4 weeks before screening;
17. Active autoimmune and inflammatory diseases;
18. Human immunodeficiency virus antibody positive, active hepatitis B virus infection or hepatitis C virus infection;
19. Previous history of allogeneic stem cell, bone marrow or organ transplantation;
20. A history of severe neurological or psychiatric illness;
21. Pregnancy or lactation women;
22. Patients who were deemed by the investigator to be ineligible for participation in the study.
**Maximum Age:** 75 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Sa Xiao, PHD
**Phone:** 15013238943
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Guangzhou
**Contacts:**
***Contact 1:***
- **Name:** Herui Yao
- **Role:** CONTACT
***Contact 2:***
- **Name:** Herui Yao
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 3:***
- **Name:** Qiang Liu
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** China
**Facility:** Sun Yat-sen Memorial Hospital, Sun Yat-sen University
**State:** Guangdong
#### Overall Officials
**Official 1:**
**Affiliation:** Sun Yat-sen Memorial Hospital,Sun Yat-sen University
**Name:** Herui Yao
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** Sun Yat-sen Memorial Hospital,Sun Yat-sen University
**Name:** Qiang Liu
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000001941
- Term: Breast Diseases
- ID: D000012871
- Term: Skin Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M5220
- Name: Breast Neoplasms
- Relevance: HIGH
- As Found: Breast Cancer
- ID: M5218
- Name: Breast Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001943
- Term: Breast Neoplasms
### Intervention Browse Module - Ancestors
- 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: D000074322
- Term: Antineoplastic Agents, Immunological
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M1668
- Name: Docetaxel
- Relevance: HIGH
- As Found: Physical
- ID: M289243
- Name: Pertuzumab
- Relevance: HIGH
- As Found: Present
- ID: M26197
- Name: Tubulin Modulators
- Relevance: LOW
- As Found: Unknown
- ID: M26196
- Name: Antimitotic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M1346
- Name: Antineoplastic Agents, Immunological
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000077143
- Term: Docetaxel
- ID: C000485206
- Term: Pertuzumab
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06445387
**Brief Title:** Pain During Femoral Sheath Removal in Patients Undergoing Percutaneous Coronary Intervenion
**Official Title:** The Effect of Virtual Reality Glasses and Ice Applıcatıon on the Level of Pain During Femoral Sheath Removal in Patients Undergoing Percutaneous Coronary Intervenion
#### Organization Study ID Info
**ID:** AU-SBE-ASoylu-03
#### Organization
**Class:** OTHER
**Full Name:** Amasya University
### Status Module
#### Completion Date
**Date:** 2023-01-04
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-04
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2022-11-03
**Type:** ACTUAL
#### Start Date
**Date:** 2021-07-12
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-06-04
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Amasya 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:** It is to examine the effect of virtual reality and ice application on the pain level due to femoral sheath extraction.
**Detailed Description:** After obtaining the necessary permissions for the research, the patients who were followed up in the hemodialysis unit of X,Y, Z Hospitals were randomly divided into three groups (virtual reality glasses application, ice application and control group).
Randomization: Since the number of male and female patients was wanted to be kept equal, simple randomization would not be possible, so the stratified randomization method was used.
Patients were assigned to groups in equal numbers according to their femoral sheath sizes. In our clinic, size 6 and 7 femoral sheaths are applied to male patients, and number 6 femoral sheaths are applied to female patients. Male patients were assigned to equal groups according to femoral sheath size 6 and 7.
Since PCI is not performed in our clinic on weekends except for emergencies, data were collected during working hours during a five-day weekday period.
The pain level of the patients was evaluated using a numerical rating scale;
* before the femoral sheath extraction (PAS1),
* during the femoral sheathing (SDQ2),
* immediately after the femoral sheathing (SDQ3),
* 30 minutes after the femoral sheathing (SDQ4) and
* 1 hour after the femoral sheathing (SDQ4). SDÖ5) was evaluated and recorded.
### Conditions Module
**Conditions:**
- Percutaneous Coronary Intervention
- Virtual Reality
- Nursing Caries
- Cryotherapy
- Pain Management
**Keywords:**
- Percutaneous Coronary Intervention
- Virtual Reality
- Pain Management
- Nursing
- Ice Application
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** It is a randomized controlled, single-blind, experimental study. Participants were assigned to three groups: intervention (virtual reality group and ice group) and control group.
##### Masking Info
**Masking:** SINGLE
**Masking Description:** It is a randomized controlled, single-blind, experimental study.
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 108
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The procedure was tested for five minutes, one hour before application, to evaluate the patients' compliance and to detect any possible problems after wearing the glasses. In patients who did not experience any problems after the test, glasses were put on the patient just before the femoral sheath and remained on for 20 minutes.
**Intervention Names:**
- Other: Virtual Reality Glasses
**Label:** Virtual Reality Glasses Gruop
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Before taking the femoral sheath, the researcher applied cold to the area where the femoral sheath was located with an ice pack for 20 minutes. A femoral sheath was performed immediately after the ice bag was removed.
**Intervention Names:**
- Other: Ice Application Group
**Label:** Ice Application Group
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** The general procedure of the clinic was applied to the control group. Femoral sheath was removed without any invasive procedure.
**Intervention Names:**
- Other: Control Group
**Label:** Control Group
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Virtual Reality Glasses Gruop
**Description:** Preparation Stage of Virtual Glasses: A 20-minute video consisting of nature scenes shot with a 360-degree camera was selected by the researchers from YouTube. Permission was obtained from the person who created the video.
For the selection of music, both the music that is good for diseases were examined in the literature and an expert opinion was taken from a faculty member (Phd, assistant professor) working at the Faculty of Music and Fine Arts of a university. The music used in the video was created with works selected from the Hüseyni maqam.
**Name:** Virtual Reality Glasses
**Other Names:**
- Experimental
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Ice Application Group
**Description:** Features of the ice and ice bag used for patients in ice application; Ice cubes with dimensions of 9.5 x 26 x 3.5 cm were used. The ice bag is made of cotton and polyester coated fabric and is easily bendable. In this way, the ice bag was ensured to fit properly to the patient's femoral region. It is reusable and heat insulated. The procedure was carried out by following the cold application step protocol created by the researchers using the literature.
**Name:** Ice Application Group
**Other Names:**
- Experimental
**Type:** OTHER
#### Intervention 3
**Arm Group Labels:**
- Control Group
**Description:** They continued to receive their routine treatment and care. No changes were made in their routine treatment and care.
**Name:** Control Group
**Other Names:**
- Control
**Type:** OTHER
### Outcomes Module
#### Other Outcomes
**Description:** The patients' opinions regarding the application of ice and virtual reality glasses were evaluated.
**Measure:** Questionnaire
**Time Frame:** "through study completion, an average of 1 year".
#### Primary Outcomes
**Description:** The Numeric Rating Scale is a pain screening tool, commonly used to assess pain severity at that moment in time using a min:0-max:10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable" (10). This scale is a valid and reliable scale developed to determine the pain level of patients. The numerical rating scale simplifies the description of the pain level by the patient and makes it easier for the monitoring nurse to record the patient's pain rating. That the pain increases as the score increases, and then the patient verbally tells the numerical value of the pain intensity he/she feels. Pain score was measured before femoral sheath removal (time 1), and, during femoral sheath removal (2nd time),and, immediately after femoral sheath removal (3rd time), and 30 minutes after femoral sheath removal (4th time), and1 hour after femoral sheath removal (5th time).
**Measure:** Pain Scores: Numerical rating scale
**Time Frame:** "through study completion, an average of 1 year".
#### Secondary Outcomes
**Description:** Vital parameters (Pulse rate measured in minutes) of the patients were evaluated
Pulse rate was measured before femoral sheath removal (time 1) Pulse rate was measured during femoral sheath removal (2nd time) Pulse rate was measured immediately after femoral sheath removal (3rd time) Pulse rate was measured 30 minutes after femoral sheath removal (4th time) Pulse rate was measured 1 hour after femoral sheath removal (5th time
**Measure:** Physiological parameter
**Time Frame:** "through study completion, an average of 1 year".
**Description:** Vital parameters (respiration-rate measured in minutes) of the patients were evaluated.
Respiration rate was measured before femoral sheath removal (time 1) Respiration rate was measured during femoral sheath removal (2nd time) Respiration rate was measured immediately after femoral sheath removal (3rd time) Respiration rate was measured 30 minutes after femoral sheath removal (4th time) Respiration rate was measured 1 hour after femoral sheath removal (5th time)
**Measure:** Physiological parameter
**Time Frame:** "through study completion, an average of 1 year".
**Description:** Vital parameters (blood pressure-measured in mmHg) of the patients were evaluated
Blood pressure was measured before femoral sheath removal (time 1) Blood pressure was measured during femoral sheath removal (2nd time) Blood pressure was measured immediately after femoral sheath removal (3rd time) Blood pressure was measured 30 minutes after femoral sheath removal (4th time) Blood pressure was measured 1 hour after femoral sheath removal (5th time)
**Measure:** Physiological parameter
**Time Frame:** "through study completion, an average of 1 year".
**Description:** Vital parameters (body temperature measured in degrees Centigrant) of the patients were evaluated
Body temperature was measured before femoral sheath removal (time 1) Body temperature was measured during femoral sheath removal (2nd time) Body temperature was measured immediately after femoral sheath removal (3rd time) Body temperature was measured 30 minutes after femoral sheath removal (4th time) Body temperature was measured 1 hour after femoral sheath removal (5th time)
**Measure:** Physiological parameter
**Time Frame:** "through study completion, an average of 1 year".
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Intervention in the femoral region,
* Femoral sheath size is 6-7 fr,
* Presence of only one sheath in the femoral region,
* No analgesics were administered before femoral sheath removal,
* Absence of serious bleeding and major hematoma in the femoral region,
* Being over 18 years of age,
* No communication problems,
* Having a place and time orientation,
* No dizziness,
* Not having any psychiatric disease,
* No visual, auditory or mental problems,
* No previously identified cold allergy,
* Being willing and willing to participate in the study,
Exclusion Criteria:
* Serious bleeding and major hematoma development in the femoral region,
* Not applying intracoronary stent or coronary angioplasty after coronary angiography,
* Vital signs are abnormal enough to prevent intervention,
* Having visual, auditory and mental disabilities,
* Having a communication problem,
* Not being willing and able to participate in the study,
* It is defined as wanting to withdraw from the study at any stage of the study or being excluded from the study by the researcher.
**Gender Based:** True
**Gender Description:** There were equal numbers of men and women in all three groups
**Maximum Age:** 100 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Amasya
**Country:** Turkey
**Facility:** Amasya University İnstitute of Health Sciences
**State:** Merkez
**Zip:** 05100
#### Overall Officials
**Official 1:**
**Affiliation:** Amasya University Faculty of Health Science
**Name:** Eylem Topbaş, Phd
**Role:** STUDY_DIRECTOR
**Official 2:**
**Affiliation:** Amasya University Faculty of Medical Science
**Name:** Gökhan KESKİN, Phd
**Role:** STUDY_DIRECTOR
**Official 3:**
**Affiliation:** Amasya University Instutue of Health Science
**Name:** Aycan SOYLU, Msc
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** starting in December 2025
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR)
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Wang HL, Keck JF. Foot and hand massage as an intervention for postoperative pain. Pain Manag Nurs. 2004 Jun;5(2):59-65. doi: 10.1016/j.pmn.2004.01.002.
**PMID:** 15297952
**Citation:** Paice JA, Cohen FL. Validity of a verbally administered numeric rating scale to measure cancer pain intensity. Cancer Nurs. 1997 Apr;20(2):88-93. doi: 10.1097/00002820-199704000-00002.
**PMID:** 9145556
## 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: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06445374
**Brief Title:** Effects of Inhaled Epinephrine on Systemic Allergic Reactions During Allergy Testing Immunotherapy or Oral Challenges
**Official Title:** A Phase 1b Open-Label Exploratory Study Evaluating Inhaled Epinephrine in Individuals With Known or Suspected Metabisulfite Sensitivity Experiencing Systemic Allergic Reactions During Allergy Testing Immunotherapy or Oral Challenges
#### Organization Study ID Info
**ID:** GHL-101
#### Organization
**Class:** OTHER
**Full Name:** 1232176 BC Ltd.
### Status Module
#### Completion Date
**Date:** 2024-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-04
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-12-21
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-30
**Study First Submit QC Date:** 2024-06-04
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Dr. George Luciuk
#### Responsible Party
**Investigator Affiliation:** 1232176 BC Ltd.
**Investigator Full Name:** Dr. George Luciuk
**Investigator Title:** Founder, Chief Medical Officer
**Type:** SPONSOR_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:** The purpose of this exploratory study is to evaluate the effects of inhaled epinephrine in patients with known or suspected metabisulfite sensitivity who experience a systemic allergic reaction (SAR) while undergoing allergy testing, immunotherapy or oral challenges.
**Detailed Description:** This is a Phase 1b, single-center, open label exploratory study that will evaluate the effects of inhaled epinephrine in patients with known or suspected metabisulfite sensitivity and who are undergoing planned allergy testing, subcutaneous immunotherapy (SCIT), oral challenges (food and/or drug), or oral immunotherapy (OIT). This study will enroll and dose up to 60 patients.
The maximum duration of subject participation is approximately 1 week.
### Conditions Module
**Conditions:**
- Hypersensitivity
- Anaphylaxis
**Keywords:**
- Immunotherapy
- Epinephrine
- Upper airway laryngeal edema
- Upper airway pharyngeal edema
- Hypersensitivity
- Hypersensitivity, immediate
- Anaphylaxis
- Vasoconstrictor agents
- Adrenergic alpha-Agonists
- Adrenergic beta-Agonists
- Bronchodilator agents
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The first inhalation will be administered as soon as possible (i.e., within approximately 30 seconds) following identification of a Grade 2 or greater SAR and confirmation of enrollment by the Principal Investigator. The second inhalation will be administered approximately 10 seconds later, and the subject will be observed for approximately 2 minutes for signs of symptom resolution.
Inhalations will continue in this manner until either:
1. resolution of systemic symptoms (defined as a reduction in SAR Grade to ≤1), or
2. maximum number of inhalations (8 inhalations) is reached, or
3. administration of intra-muscular epinephrine, whichever occurs earlier
**Intervention Names:**
- Drug: Inhaled Epinephrine
**Label:** Inhaled Epinephrine
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Inhaled Epinephrine
**Description:** 0.125 mg per inhalation.
The maximum proposed dose to be administered is 1.0 mg (consisting of 8 inhalations of 0.125 mg over 6 minutes).
**Name:** Inhaled Epinephrine
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Defined as a reduction in systemic allergic reaction (SAR) Grade to ≤ 1.
**Measure:** Time to resolution of systemic symptoms.
**Time Frame:** From first dose administration to 60 minutes following first dose administration.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Males or females, aged ≥ 18 years with known or suspected metabisulfite sensitivity who can also have a clinical history of immunoglobulin E (IgE)-mediated allergy, including a documented sensitivity to allergens (i.e., positive skin prick test, or positive in vitro serum IgE).
2. Have undergone either a) allergy testing for suspected sensitivity/allergy, b) oral challenge (food and/or drug), c) oral immunotherapy (OIT) to treat existing allergies or d) subcutaneous immunotherapy (SCIT) following a prior allergic reaction AND experiences a systemic allergic reaction (SAR) rated as Grade ≥2, following allergy testing, SCIT, oral challenge (food and/or drug), or OIT, and deemed eligible for enrollment by the Principal Investigator.
3. For females of child-bearing potential, not pregnant or lactating, willing to use a highly effective method of birth control between Screening and End-of-Study Visits.
Exclusion Criteria:
1. Known reaction or sensitivity to epinephrine or any of the ingredients of inhaled epinephrine.
2. Known history or presence of clinically relevant cardiovascular, respiratory, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurological, psychological or other disease/condition that could confound the results of the study or place the subject at undue or additional risk per the judgment of the Investigator.
3. Uncontrolled asthma or chronic obstructive pulmonary disease (COPD).
4. Recent life-threatening asthma within the last 6 months which required admission to hospital prior to study start.
5. Use of any tobacco or of any inhaled products, including vaping and water pipes (Hookahs) within 12 months prior to screening and/or a 10 pack per year history of use.
6. Use of antihistamines within 5 days and/or bronchodilators within 24 hours of pre-challenge visit.
7. Surgical procedures within 90 days of screening that could result in confounding of results or additional risk to the subject, per the judgment of the Investigator.
8. Abnormal vital signs at screening (i.e., systolic blood pressure: \< 90 or \>140 mmHg, diastolic blood pressure: \< 40 or \> 90 mmHg or, Heart rate: \< 45 or \> 100 bpm), respiration rate \< 8 or \> 20 resp./min.
9. Females who are pregnant, plan to become pregnant or lactating.
10. Participation in another clinical study involving an investigational drug within 30 days prior to screening, an investigational biologic within 60 days prior to screening, or current/planned participation in another interventional study during this study.
11. Previous treatment in this study.
12. Any other reason that, in the opinion of the Investigator, is likely to unfavourably alter subject risk-benefit, confound results, or make it difficult for the subject to fully comply with study requirements.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** George H. Luciuk, MD
**Phone:** 1-604-270-7801
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Richmond
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** George H. Luciuk, MD
- **Phone:** 1-604-270-7801
- **Role:** CONTACT
***Contact 2:***
- **Name:** George H. Luciuk, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Canada
**Facility:** 1232176 Bc Ltd
**State:** British Columbia
**Status:** RECRUITING
**Zip:** V7C 5L9
#### Overall Officials
**Official 1:**
**Affiliation:** 1232176 BC Ltd.
**Name:** George H. Luciuk, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Access Criteria:** Any purpose. URL to be added.
**Description:** All individual participant data collected during the trial, after deidentification
**Info Types:**
- STUDY_PROTOCOL
- ICF
- CSR
**IPD Sharing:** YES
**Time Frame:** Immediately after publication, and for a period of 5 years.
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007154
- Term: Immune System Diseases
- ID: D000006969
- Term: Hypersensitivity, Immediate
### Condition Browse Module - Browse Branches
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BC09
- Name: Ear, Nose, and Throat Diseases
### Condition Browse Module - Browse Leaves
- ID: M10018
- Name: Hypersensitivity
- Relevance: HIGH
- As Found: Hypersensitivity
- ID: M4038
- Name: Anaphylaxis
- Relevance: HIGH
- As Found: Anaphylaxis
- ID: M27137
- Name: Respiratory Aspiration
- Relevance: LOW
- As Found: Unknown
- ID: M7657
- Name: Edema
- Relevance: LOW
- As Found: Unknown
- ID: M10020
- Name: Hypersensitivity, Immediate
- Relevance: LOW
- As Found: Unknown
- ID: M10836
- Name: Laryngeal Edema
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000006967
- Term: Hypersensitivity
- ID: D000000707
- Term: Anaphylaxis
### Intervention Browse Module - Ancestors
- ID: D000000316
- Term: Adrenergic alpha-Agonists
- ID: D000000322
- Term: Adrenergic Agonists
- ID: D000018663
- Term: Adrenergic Agents
- ID: D000018377
- Term: Neurotransmitter Agents
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000000318
- Term: Adrenergic beta-Agonists
- ID: D000001993
- Term: Bronchodilator Agents
- ID: D000001337
- Term: Autonomic Agents
- ID: D000018373
- Term: Peripheral Nervous System Agents
- ID: D000018927
- Term: Anti-Asthmatic Agents
- ID: D000019141
- Term: Respiratory System Agents
- ID: D000009184
- Term: Mydriatics
- ID: D000013566
- Term: Sympathomimetics
- ID: D000014662
- Term: Vasoconstrictor Agents
### Intervention Browse Module - Browse Branches
- Abbrev: VaCoAg
- Name: Vasoconstrictor Agents
- Abbrev: Resp
- Name: Respiratory System Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M7992
- Name: Epinephrine
- Relevance: HIGH
- As Found: Less
- ID: M2853
- Name: Immunomodulating Agents
- Relevance: LOW
- As Found: Unknown
- ID: M20746
- Name: Adrenergic Agents
- 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: M17409
- Name: Vasoconstrictor Agents
- Relevance: LOW
- As Found: Unknown
- ID: M5269
- Name: Bronchodilator Agents
- Relevance: LOW
- As Found: Unknown
- ID: M3668
- Name: Adrenergic alpha-Agonists
- Relevance: LOW
- As Found: Unknown
- ID: M3670
- Name: Adrenergic beta-Agonists
- Relevance: LOW
- As Found: Unknown
- ID: M3673
- Name: Adrenergic Agonists
- Relevance: LOW
- As Found: Unknown
- ID: M20504
- Name: Neurotransmitter Agents
- Relevance: LOW
- As Found: Unknown
- ID: M20963
- Name: Anti-Asthmatic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M21137
- Name: Respiratory System Agents
- Relevance: LOW
- As Found: Unknown
- ID: M12139
- Name: Mydriatics
- Relevance: LOW
- As Found: Unknown
- ID: M16345
- Name: Sympathomimetics
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000004837
- Term: Epinephrine
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06445361
**Acronym:** PAD1ZOL
**Brief Title:** Prevalence of NAFLD in T1DM Patients
**Official Title:** The Prevalence of Non-Alcoholic Fatty Liver Disease in Type 1 Diabetes Mellitus Patients Followed at Ziekenhuis Oost-Limburg, Genk, Belgium
#### Organization Study ID Info
**ID:** Z-2022007
#### Organization
**Class:** OTHER
**Full Name:** Ziekenhuis Oost-Limburg
### Status Module
#### Completion Date
**Date:** 2024-11-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-03
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-11-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-02-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-02-28
**Study First Submit QC Date:** 2024-06-03
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Ziekenhuis Oost-Limburg
#### 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 the prevalence of NAFLD in T1DM patients.
### Conditions Module
**Conditions:**
- NAFLD
- Type 1 Diabetes
- Fatty Liver, Nonalcoholic
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** DIAGNOSTIC
#### Enrollment Info
**Count:** 138
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** FibroScan measurement
**Intervention Names:**
- Diagnostic Test: FibroScan
**Label:** Study cohort
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Study cohort
**Description:** Performance of a FibroScan measurement to determine steatosis and fibrosis.
**Name:** FibroScan
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** To determine the prevalence of steatosis in a cohort of T1DM patients followed at the Departments of Endocrinology in ZOL by means of the FibroScan® device with controlled attenuation parameter (CAP) measurements.
**Measure:** Prevalence of NAFLD in T1DM
**Time Frame:** During the intervention
**Description:** To determine the prevalence of fibrosis in a cohort of T1DM patients followed at the Departments of Endocrinology in ZOL by means of the FibroScan® device with vibration controlled attenuation parameter (VCTE) measurements.
**Measure:** Prevalence of fibrosis in T1DM
**Time Frame:** During the intervention
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* T1DM
* ≥ 18 years of age
* Written informed consent obtained
Exclusion Criteria:
* Excessive alcohol use
* Exclusion of other causes of liver disease and secondary causes of liver steatosis
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Leen Heyens, MsC
**Phone:** 089 21 20 55
**Phone Ext:** +32
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Genk
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Leen Heyens, MsC
- **Phone:** 089 21 20 55
- **Phone Ext:** +32
- **Role:** CONTACT
**Country:** Belgium
**Facility:** Ziekenhuis Oost-Limburg
**State:** Limburg
**Status:** RECRUITING
**Zip:** 3600
### IPD Sharing Statement Module
**Description:** During the study period IPD will not be made available for other researchers. When the study is completed and results are reported, IPD can be shared.
**IPD Sharing:** NO
## 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
- ID: D000008107
- Term: Liver Diseases
- ID: D000004066
- Term: Digestive System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M11107
- Name: Liver Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8375
- Name: Fatty Liver
- Relevance: HIGH
- As Found: Fatty Liver
- ID: M7115
- Name: Diabetes Mellitus
- Relevance: LOW
- As Found: Unknown
- ID: M30540
- Name: Non-alcoholic Fatty Liver Disease
- Relevance: HIGH
- As Found: Fatty Liver, Nonalcoholic
- 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
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T5868
- Name: Visceral Steatosis
- Relevance: HIGH
- As Found: Fatty Liver
### Condition Browse Module - Meshes
- ID: D000005234
- Term: Fatty Liver
- ID: D000065626
- Term: Non-alcoholic Fatty Liver Disease
- ID: D000003922
- Term: Diabetes Mellitus, Type 1
### Intervention Browse Module - Browse Branches
- Abbrev: Hemat
- Name: Hematinics
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M11110
- Name: Liver Extracts
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06445348
**Brief Title:** Cervical Pedicle Screw Based on ct
**Official Title:** Morphometric Analysis of Sub Axial Cervical Spine Pedicle in Egyptian Population
#### Organization Study ID Info
**ID:** Cervical pedicle screw
#### Organization
**Class:** OTHER
**Full Name:** Assiut University
### Status Module
#### Completion Date
**Date:** 2026-06-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-31
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-05-21
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-31
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Assiut University
#### Responsible Party
**Investigator Affiliation:** Assiut University
**Investigator Full Name:** Michael Atef Mikhaeel
**Investigator Title:** Morphometric Analysis of sub axial cervical spine pedicle in Egyptian population
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** The aim of study to analyze morphometry of sub axial cervical spine pedicle in an Egyptian population based on computed tomography (CT) and thus asses the safety and feasibility of cervical pedicle screw in the sub axial cervical spine
**Detailed Description:** Cervical pedicle screw (CPS) fixation is found to be superior compared with lateral mass screws because it provides more axial, bending and torsional stability and has a low risk of loosening with cyclical loading \[1\] Despite biomechanical superiority, CPS fixation is not universally accepted among surgeon s because their accuracy and safety remain technically challenging because of the close proximity of vital structures as spinal cord and vertebral artery and inherent variability in pedicle s at each level.\[2\] In addition. limited space is available for screw placement because of complex of cervical spine vertebrae. Therefore, the risk of complication due to screw violation of the adjacent vascular and neural structures is expected to be high when performing the operation without a clear understanding of morphometric characteristics of the pedicles. \[3\] Morphometry of the cervical pedicles was studied before using cadavers but comparative computed tomography (CT) data from the age matched population shown significant differences. Recent advances in CT have made anatomic measurements more accurate.\[4\] The present study was undertaken to determine the 3-dimensional pedicle geometry by calculating variables like pedicle length (PL). Pedicle height (PH). Pedicle width (PW), Pedicle axis length (PAL), Pedicle transverse angulation (PTA), Pedicle sagittal angulation (PSA), Superior pedicle distance (SPD), and lateral pedicle distance (LPD). \[5\] Fortunately, computed tomography (CT) scanning become a routine preoperative examination in spinal surgery patients.\[6\]
### Conditions Module
**Conditions:**
- Cervical Pedicle Screw
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 80
**Type:** ESTIMATED
**Patient Registry:** True
**Study Type:** OBSERVATIONAL
**Target Duration:** 1 Day
### Arms Interventions Module
### Interventions
#### Intervention 1
**Description:** Servical medical screw
**Name:** Cervical pedicle screw
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Morphometric Analysis of sub axial cervical spine pedicle in Egyptian population
**Measure:** Assessment of feasibility of sub axial cervical spine pedicle
**Time Frame:** Baseline
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:Any patient from 16 to 60 years old admitted to Assiut university hospital and undergoes cervical Spine CT.
-
Exclusion Criteria:
* 1-individuals with a history of cervical spine abnormalities. 2- individuals with previous cervical spine injury 3-individuals with congenital or developmental malformations of cervical spine 4-patients with inflammatory. infectious, neoplastic condition
**Gender Based:** True
**Maximum Age:** 65 Years
**Minimum Age:** 16 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
**Study Population:** Sample size was calculated using Epi- Info7. According to results of previous study (put ref.) , the pullout strength failed by fracture of pedicle screw in 40% of patients undergoing cervical spine CT. Based on this percentage, confidence limits of 7% and a confidence level of 80%, the sample needed for the study was estimated to be about 80 patients.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Michael Atef Mikhaeel
**Phone:** 01283635331
**Role:** CONTACT
**Contact 2:**
**Name:** Mahmoud Fouad
**Role:** CONTACT
### References Module
#### References
**Citation:** Farooque K, Yadav R, Chowdhury B, Gamanagatti S, Kumar A, Meena PK. Computerized Tomography-Based Morphometric Analysis of Subaxial Cervical Spine Pedicle in Asymptomatic Indian Population. Int J Spine Surg. 2018 Aug 3;12(2):112-120. doi: 10.14444/5017. eCollection 2018 Apr.
**PMID:** 30276069
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06445335
**Acronym:** PAD2ZOL
**Brief Title:** Prevalence of NAFLD in T2DM Patients
**Official Title:** The Prevalence of Non-Alcoholic Fatty Liver Disease in Type 2 Diabetes Mellitus Patients Followed at Ziekenhuis Oost-Limburg, Genk, Belgium
#### Organization Study ID Info
**ID:** CTU2019009
#### Organization
**Class:** OTHER
**Full Name:** Ziekenhuis Oost-Limburg
### Status Module
#### Completion Date
**Date:** 2024-11-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-03
**Overall Status:** ACTIVE_NOT_RECRUITING
#### Primary Completion Date
**Date:** 2024-11-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2019-03-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-06-03
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Ziekenhuis Oost-Limburg
#### 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 the prevalence of non-alcoholic fatty liver disease (NAFLD) in patients with type 2 diabetes mellitus (T2DM).
### Conditions Module
**Conditions:**
- NAFLD
- T2D
- Type 2 Diabetes
- Fatty Liver, Nonalcoholic
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** DIAGNOSTIC
#### Enrollment Info
**Count:** 385
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Diagnostic Test: FibroScan
**Label:** FibroScan
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- FibroScan
**Description:** Performance of a FibroScan measurement.
**Name:** FibroScan
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** To determine the prevalence of non-alcoholic fatty liver disease (NAFLD) in type 2 diabetes mellitus (T2DM) patients followed at the department of Endocrinology in Ziekenhuis Oost-Limburg (ZOL), Genk, Belgium by means of FibroScan measurements.
**Measure:** Prevalence of non-alcoholic fatty liver disease (NAFLD) in type 2 diabetes mellitus (T2DM) patients
**Time Frame:** Baseline
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* ≥ 18 years of age
* Having type 2 diabetes mellitus (T2DM)
* Written informed consent obtained
Exclusion Criteria:
* Excessive alcohol use
* Exclusion of other causes of liver disease and secondary causes of steatosis
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Genk
**Country:** Belgium
**Facility:** Ziekenhuis Oost-Limburg
**State:** Limburg
**Zip:** 3600
#### Overall Officials
**Official 1:**
**Affiliation:** Ziekenhuis Oost-Limburg
**Name:** Mathieu Struyve, 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: D000008107
- Term: Liver Diseases
- ID: D000004066
- Term: Digestive System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M11107
- Name: Liver Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8375
- Name: Fatty Liver
- Relevance: HIGH
- As Found: Fatty Liver
- ID: M7115
- Name: Diabetes Mellitus
- Relevance: LOW
- As Found: Unknown
- ID: M7119
- Name: Diabetes Mellitus, Type 2
- Relevance: HIGH
- As Found: Type 2 Diabetes
- ID: M30540
- Name: Non-alcoholic Fatty Liver Disease
- Relevance: HIGH
- As Found: Fatty Liver, Nonalcoholic
- 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: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T5868
- Name: Visceral Steatosis
- Relevance: HIGH
- As Found: Fatty Liver
### Condition Browse Module - Meshes
- ID: D000005234
- Term: Fatty Liver
- ID: D000065626
- Term: Non-alcoholic Fatty Liver Disease
- ID: D000003924
- Term: Diabetes Mellitus, Type 2
### Intervention Browse Module - Browse Branches
- Abbrev: Hemat
- Name: Hematinics
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M11110
- Name: Liver Extracts
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06445322
**Brief Title:** Prescreening Study to Identify Potential Participants for ACDN-01 Clinical Trials
**Official Title:** Prescreening Study to Identify Potential Participants With ABCA4-related Retinopathy for ACDN-01 Clinical Trials
#### Organization Study ID Info
**ID:** ACDN-01-000
#### Organization
**Class:** INDUSTRY
**Full Name:** Ascidian Therapeutics, Inc
### Status Module
#### Completion Date
**Date:** 2030-08-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-31
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2027-08-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-30
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-31
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Ascidian Therapeutics, Inc
#### 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 an observational prescreening study. Individuals who are eligible for prescreening will undergo testing procedures that may be used to determine eligibility in ACDN-01 clinical trials.
**Detailed Description:** The prescreening process will be used to help determine the initial eligibility and interest of potential participants in ACDN-01 clinical trials by conducting assessments of key eligibility criteria before the clinical trial screening procedures are performed.
### Conditions Module
**Conditions:**
- Stargardt Disease
- Stargardt Disease 1
- Cone Rod Dystrophy
- Juvenile Macular Degeneration
**Keywords:**
- ABCA4
- ABCA4-related retinopathy
- Stargardt Disease
- Stargardt macular dystrophy
- Cone rod dystrophy
- Gene editing
- RNA
- Gene Therapy
- Exon editing
- IRD
- Inherited retinal disease
- Inherited retinal dystrophy
- Inherited retinal degeneration
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** CROSS_SECTIONAL
#### Enrollment Info
**Count:** 50
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The prescreening study consists of genetic and visual assessments and will require at least 1 onsite visit. All clinical assessments performed are for the purpose of determining research eligibility for ACDN-01 clinical trials.
**Intervention Names:**
- Diagnostic Test: Prescreening Assessments
**Label:** Prescreening Group
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Prescreening Group
**Description:** Various genetic and visual assessments.
**Name:** Prescreening Assessments
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** Using a Clinical Laboratory Improved Amendments (CLIA)-certified laboratory.
**Measure:** Confirm mutations in the ABCA4 gene
**Time Frame:** 12 months
**Description:** Using a Clinical Laboratory Improved Amendments (CLIA)-certified laboratory.
**Measure:** Confirm the absence of pathogenic mutations in genes known to cause retinal disease other than ABCA4-related retinopathy
**Time Frame:** 12 months
**Description:** Measure best corrected visual acuity and low luminance visual acuity
**Measure:** Measure BCVA and LLVA
**Time Frame:** 12 months
**Description:** Using FAF imaging
**Measure:** Measure the area of retinal atrophy
**Time Frame:** 12 months
**Description:** Using OCT (SD-OCT)
**Measure:** Measure baseline retinal structure
**Time Frame:** 12 months
**Description:** Confirm historical timepoint images
**Measure:** Historical FAF or OCT images
**Time Frame:** 4 years
**Description:** Collect past measurements
**Measure:** Historical BCVA/LLVA measurements
**Time Frame:** 4 years
### Eligibility Module
**Eligibility Criteria:** Key Inclusion Criteria:
* Presence of mutations in the ABCA4 gene
* ABCA4 retinopathy phenotype (Stargardt disease type 1 or cone-rod dystrophy)
Key Exclusion Criteria:
* The presence of pathogenic or likely pathogenic mutations in other genes known to cause cone-rod dystrophy or Stargardt maculopathy
* Retinal disease other than ABCA4-related retinopathy
* Presence of a medical condition (systemic or ophthalmic), psychiatric condition, including substance abuse disorder, or physical examination or laboratory finding that may in the opinion of the principal investigator and sponsor preclude adherence to the scheduled study visits, safe participation in the study, or affect the results of the study.
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Males and females with a diagnosis of ABCA4-related retinopathy will be invited to give informed consent prior to prescreening procedures. After appropriate informed consent/assent has been obtained, potential participants will then undergo the assessments to determine eligibility for ACDN-01 clinical trials.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Associate Director, Clinical Operations
**Phone:** 207-573-0412
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Gainesville
**Country:** United States
**Facility:** Vitreo Retinal Associates
**State:** Florida
**Status:** RECRUITING
**Zip:** 32607
**Location 2:**
**City:** Cincinnati
**Country:** United States
**Facility:** Cincinnati Eye Institute
**State:** Ohio
**Status:** RECRUITING
**Zip:** 45245
**Location 3:**
**City:** Dallas
**Country:** United States
**Facility:** Retina Foundation of Texas
**State:** Texas
**Status:** RECRUITING
**Zip:** 75382
**Location 4:**
**City:** Houston
**Country:** United States
**Facility:** Retina Consultants of Texas
**State:** Texas
**Status:** NOT_YET_RECRUITING
**Zip:** 77401
#### Overall Officials
**Official 1:**
**Affiliation:** Ascidian Therapeutics
**Name:** Alia Rashid
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012162
- Term: Retinal Degeneration
- ID: D000012164
- Term: Retinal Diseases
- ID: D000005128
- Term: Eye Diseases
- ID: D000015785
- Term: Eye Diseases, Hereditary
- ID: D000030342
- Term: Genetic Diseases, Inborn
- ID: D000058499
- Term: Retinal Dystrophies
### Condition Browse Module - Browse Branches
- Abbrev: BC11
- Name: Eye Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC16
- Name: Diseases and Abnormalities at or Before Birth
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M11260
- Name: Macular Degeneration
- Relevance: HIGH
- As Found: Stargardt Disease
- ID: M2147
- Name: Stargardt Disease
- Relevance: HIGH
- As Found: Stargardt Disease
- ID: M851
- Name: Cone-Rod Dystrophies
- Relevance: HIGH
- As Found: Cone-Rod Dystrophy
- ID: M14999
- Name: Retinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14997
- Name: Retinal Degeneration
- Relevance: LOW
- As Found: Unknown
- ID: M29107
- Name: Retinal Dystrophies
- Relevance: LOW
- As Found: Unknown
- ID: M8271
- Name: Eye Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M18339
- Name: Eye Diseases, Hereditary
- Relevance: LOW
- As Found: Unknown
- ID: M23686
- Name: Genetic Diseases, Inborn
- Relevance: LOW
- As Found: Unknown
- ID: T5470
- Name: Stargardt Disease
- Relevance: HIGH
- As Found: Stargardt Disease
- ID: T1446
- Name: Cone-rod Dystrophy
- Relevance: HIGH
- As Found: Cone-Rod Dystrophy
- ID: T1448
- Name: Cone-rod Dystrophy 2
- Relevance: HIGH
- As Found: Cone-Rod Dystrophy
### Condition Browse Module - Meshes
- ID: D000008268
- Term: Macular Degeneration
- ID: D000080362
- Term: Stargardt Disease
- ID: D000071700
- Term: Cone-Rod Dystrophies
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06445309
**Acronym:** IMMUGOLD
**Brief Title:** Design and Development of a Functional Plant-based Beverage Formulated According to the Main Nutritional Guides for Early Elderly Requirements to Improve Nutritional Status and Immunity for the Early Elderly People to Get Well-healthy Ageing
**Official Title:** Design and Development of a Functional Plant-based Beverage Formulated According to the Main Nutritional Guides for Early Elderly Requirements to Improve Nutritional Status and Immunity for the Early Elderly People to Get Well-healthy Ageing
#### Organization Study ID Info
**ID:** CEIPSA-2023-PR-0024
#### Organization
**Class:** OTHER
**Full Name:** University Rovira i Virgili
### Status Module
#### Completion Date
**Date:** 2025-02
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-03
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-12
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-09
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-06-03
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University Rovira i Virgili
#### Responsible Party
**Investigator Affiliation:** University Rovira i Virgili
**Investigator Full Name:** Rosa Sola
**Investigator Title:** Clinical professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Populations around the world are aging and this demographic transition will impact almost every aspect of society. Furthermore, the COVID-19 pandemic has highlighted the seriousness of gaps in policies, systems and services. According to the World Health Organization (WHO) plan for 2021-2030, a decade of concerted global action on healthy ageing is urgently needed to ensure that older people can realize their potential in dignity and equality in nutritional requirements. An effective way to address the inherent demographic change, which translates into the health status of older people, is through the maintenance of adequate nutritional status. Public health services require new funding to address this problem, but if we bring new strategies to health policies, by improving nutrition, we could impact the reduction of costs at the level of medical care in the ageing population. In older people, according to the latest guidelines on nutritional requirements in geriatrics from the Spanish Nutrition Foundation (FEN), the British Nutrition Foundation and The European Society for Clinical Nutrition and Metabolism (ESPEN), multinutrient strategies instead of mononutrient strategies, are gaining importance due to relevant scientific evidence based on controlled and randomized clinical trials. Therefore, following the nutritional requirements in healthy ageing, an important aspect is to strengthen immunity in this population.
Consequently, the food industry is booming in the development of new functional alternatives, such as plant-based beverages, which are well positioned in the market and can offer healthy functional beverage options to people of early elderly age (60 to 75 years) as a target population due to the ease with which they are ingested. Therefore, investments in small and medium-sized companies to encourage the incorporation of trained doctoral personnel and add innovation value to this type of product are essential for resilience.
Therefore, the present proposal hypothesizes that, following the nutritional needs for healthy ageing, a multinutrient-optimized beverage as a functional food can improve immunity and reduce inflammation and oxidation in women and men in the elderly population.
### Conditions Module
**Conditions:**
- Deglutition Disorders
### Design Module
#### Design Info
**Observational Model:** OTHER
**Time Perspective:** CROSS_SECTIONAL
#### Enrollment Info
**Count:** 80
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Between 80-100 healthy volunteers between 60-75 years old are needed to carry out this sensory tasting study in untrained tasters.
Additionally, the participant will be given a form to assess the Geriatric Oral Health Assessment Index (GOHAI) and a form for the assessment of dysphagia (EAT-10) to assess the participant's sensory perceptions, as well as any oral health problems. oral health that could interfere with the results of the sensory tasting.
**Intervention Names:**
- Other: Sensory test of functional plant-based drink
**Label:** Group 1
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Group 1
**Description:** Once the volunteers have been recruited, a telephone interview lasting less than 10 minutes will be carried out where what the study consists of will be explained as well as the information sheet for the participant will be read to them so that they understand what the study consists of. study. Once the necessary questions have been asked according to the inclusion criteria, if the participant enters the study, data such as name, surname, age, gender, smoker, consumer of vegetable drinks, pathologies and contact information will be collected. If the participant does not enter the study, their personal data will no longer be collected and they will be informed that according to the exclusion criteria they can no longer participate in the study. Once these data are obtained, it will be randomized using the EXCEL program.
**Name:** Sensory test of functional plant-based drink
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Sensory attributes will be assessed.
**Measure:** Sensory test of a functional plant-based drink
**Time Frame:** immediatly after intervention
#### Secondary Outcomes
**Description:** To test the oral health of the early elderly population. Geriatric Oral Health Assessment Index (GOHAI TEST). Consists in a little questionnaire of 12 questions items classified by Yes, always; F, frequently; AV, sometimes; RV, rarely; N, never.
**Measure:** Oral health
**Time Frame:** immediatly after intervention
**Description:** To test the dysphagia status of the early elderly population. Eating Assessment Tool EAT-10 TEST. Consists in a little questionnaire of 10 items classified punctued betwen 0-4 being 0 any problem and 4 severe problem.
**Measure:** Dysphagia
**Time Frame:** immediatly after intervention
### Eligibility Module
**Eligibility Criteria:** Inclusion criteria:
- Men or women ≥60 years old \<75 years old; Written informed consent provided prior to the sensory tasting study.
Exclusion Criteria:
* Type 2 diabetes
* Chronic alcoholism
* Early community-dwelling seniors
* Failure to comply with study guidelines.
Selection criteria
Volunteers will be recruited through several ways:
* general databases of participants from previous clinical trials of the NFOC-Salut group
* Leaflets with study information, as well as contact information, will be distributed in health centers, civic centers and social centers.
* The information will be disseminated through brochures with contact information among the people who are registered in the IMSERSO to select those who meet the inclusion criteria according to the study population in order to reach the largest number of subjects possible.
**Healthy Volunteers:** True
**Maximum Age:** 75 Years
**Minimum Age:** 60 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Between 80-100 healthy volunteers between 60-75 years old are needed to carry out this sensory tasting study in untrained tasters, the target population of this functional drink. According to Gacula and Rutenbeck, 2005, The sample size ranges from 20 to 200 to detect a difference ranging between 0.0 and 1.0 on a 9-point hedonic scale. For the simulated consumer data, the significant difference was first observed with a difference of 0.60 when n = 40. Factors such as the age of the participants and the number of sensory attributes it is recommended to increase the number of participants, concluding that Between 40-100 participants would be enough to observe a difference above 0.6. Furthermore, according to the European Sensory Network, 2011, for sensory tasting studies with hedonic attributes, between 80-100 participants are recommended.
All participants will try the same vegetable drink.
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000004935
- Term: Esophageal Diseases
- ID: D000005767
- Term: Gastrointestinal Diseases
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000010608
- Term: Pharyngeal Diseases
- ID: D000010038
- Term: Otorhinolaryngologic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: BC09
- Name: Ear, Nose, and Throat Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC07
- Name: Mouth and Tooth Diseases
### Condition Browse Module - Browse Leaves
- ID: M6882
- Name: Deglutition Disorders
- Relevance: HIGH
- As Found: Deglutition Disorders
- ID: M8085
- Name: Esophageal 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: M13515
- Name: Pharyngeal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12961
- Name: Otorhinolaryngologic Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003680
- Term: Deglutition Disorders
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Derm
- Name: Dermatologic Agents
### Intervention Browse Module - Browse Leaves
- ID: M5953
- Name: Chlorhexidine
- Relevance: LOW
- As Found: Unknown
- ID: M344731
- Name: Chlorhexidine gluconate
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06445296
**Brief Title:** Postprandial Effects of Animal Versus Plant-Based Protein
**Official Title:** Acute Effects of Animal Versus Plant-Based Protein Within a Realistic High-Fat Meal on Metabolic and Inflammatory Factors
#### Organization Study ID Info
**ID:** 2103201
#### Organization
**Class:** OTHER
**Full Name:** Ball State University
### Status Module
#### Completion Date
**Date:** 2024-12-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-31
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-08-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-11-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-04-26
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Ball State 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:** Shifting away from diets high in animal products towards more plant predominant diets is recommended by many health organizations to both reduce the negative environmental impacts of animal agriculture and to improve health outcomes. As a result, a number of plant-based meat alternatives such as Beyond Meat have been formulated to promote increased plant consumption. However, evidence is limited on the impact of newer plant-based meat alternatives on common cardiometabolic risk factors. The investigators aim to compare the acute metabolic, gastrointestinal, and inflammatory effects of a plant-based meat alternative (i.e., Beyond Meat) versus a comparable beef product within the context of high-fat, "Western-style" meal (i.e., eggs, meat, refined bread product). The investigators will also examine whether these responses differ based on whether individuals have a normal-weight or have overweight/obesity.
**Detailed Description:** The investigators will recruit individuals with a BMI in the normal (18.5-24.9 kg/m2) or overweight/ obesity (\>25.0 kg/m2) ranges from the Ball State University campus and surrounding communities. Each participant will complete two meal trials in a randomized crossover design. At each meal trial, a intravenous catheter will be inserted and baseline blood sample collected. Next, participants will consume a high-fat, Western style meal consisting of eggs cooked in butter, a croissant and either 4 oz of 80% ground beef or 4 oz of Beyond Meat ("Cookout Classic" variety). The Beyond Meat and beef products have nearly identical macronutrient profiles, allowing for examination of the unique properties of the two protein sources. Regardless of primary protein source (beef or Beyond Meat), each meal will contain 980 calories (60g fat). Following completion of each meal, blood samples will also be collected 1-, 2-, 3-, and 4-hours. The investigators will measure metabolic markers (i.e., triglycerides, glucose, HDL-C) immediately upon sample collection using the Piccolo Xpress clinical chemistry analyzer. Additional blood will be collected and stored as serum in order to measure indicators of inflammation (e.g., IL-6) and intestinal permeability (e.g., lipopolysaccharide binding protein) using commercially available ELISAs.
### Conditions Module
**Conditions:**
- Overweight or Obesity
**Keywords:**
- Plant-based meat alternatives
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
##### Masking Info
**Masking:** SINGLE
**Masking Description:** While complete blinding is not possible (participants will see/taste the food they eat), the investigators will not tell participants whether they are consuming beef or Beyond Meat.
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 30
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** During the Beyond Meat arm, participants will consume a high-fat meal containing Beyond Meat (rather than beef). Meals will be otherwise identical.
**Intervention Names:**
- Other: High-fat meal containing Beyond Meat
**Label:** Meal Consumption with Beyond Meat
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** During the Beef arm, participants will consume a high-fat meal containing beef (rather than Beyond Meat). Meals will be otherwise identical.
**Intervention Names:**
- Other: High-fat meal containing beef
**Label:** Meal Consumption with Beef
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Meal Consumption with Beef
**Description:** High-fat meal (eggs cooked in butter, croissant) with 80% ground beef.
**Name:** High-fat meal containing beef
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Meal Consumption with Beyond Meat
**Description:** High-fat meal (eggs cooked in butter, croissant) with Beyond Meat Cookout Classic.
**Name:** High-fat meal containing Beyond Meat
**Type:** OTHER
### Outcomes Module
#### Other Outcomes
**Description:** The investigators will measure body composition using bioelectrical impedance (InBody).
**Measure:** Body composition
**Time Frame:** Through study completion, up to 1 year.
**Description:** The investigators will measure blood pressure using an automated cuff (Omron).
**Measure:** Systolic and diastolic pressure
**Time Frame:** Through study completion, up to 1 year.
#### Primary Outcomes
**Description:** The investigators will measure serum IL-6 at baseline and 1-, 2-, 3-, and 4-hours after each meal containing either beef or Beyond Meat. Serum will be banked from each visit and this measurement will take place upon study completion.
**Measure:** Serum interleukin (IL)-6
**Time Frame:** Through study completion, up to 1 year.
**Description:** The investigators will measure serum LBP at baseline and 1-, 2-, 3-, and 4-hours after each meal containing either beef or Beyond Meat. Serum will be banked from each visit and this measurement will take place upon study completion.
**Measure:** Serum lipopolysaccharide binding protein (LBP)
**Time Frame:** Through study completion, up to 1 year.
**Description:** The investigators will measure serum sCD14 at baseline and 1-, 2-, 3-, and 4-hours after each meal containing either beef or Beyond Meat. Serum will be banked from each visit and this measurement will take place upon study completion.
**Measure:** Serum soluble CD14 (sCD14)
**Time Frame:** Through study completion, up to 1 year.
**Description:** The investigators will measure serum lipopolysaccharide at baseline and 1-, 2-, 3-, and 4-hours after each meal containing either beef or Beyond Meat. Serum will be banked from each visit and this measurement will take place upon study completion.
**Measure:** Serum lipopolysaccharide
**Time Frame:** Through study completion, up to 1 year.
**Description:** The investigators will measure serum (TNF)-alpha at baseline and 1-, 2-, 3-, and 4-hours after each meal containing either beef or Beyond Meat. Serum will be banked from each visit and this measurement will take place upon study completion.
**Measure:** Serum tumor necrosis factor (TNF)-alpha
**Time Frame:** Through study completion, up to 1 year.
#### Secondary Outcomes
**Description:** The investigators will measure triglycerides at baseline and 1-, 2-, 3-, and 4-hours after each meal containing either beef or Beyond Meat. These measurements will take place immediately and a complete dataset will be compiled upon study completion.
**Measure:** Triglycerides
**Time Frame:** Through study completion, up to 1 year.
**Description:** The investigators will measure HDL-C at baseline and 1-, 2-, 3-, and 4-hours after each meal containing either beef or Beyond Meat. These measurements will take place immediately and a complete dataset will be compiled upon study completion.
**Measure:** HDL-C
**Time Frame:** Through study completion, up to 1 year.
**Description:** The investigators will measure glucose at baseline and 1-, 2-, 3-, and 4-hours after each meal containing either beef or Beyond Meat. These measurements will take place immediately and a complete dataset will be compiled upon study completion.
**Measure:** Glucose
**Time Frame:** Through study completion, up to 1 year.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* 18 - 50 years.
* Body mass index \> 18.5 kg/m2
* Not pregnant (females only)
* Not postmenopausal (females only).
* Not been diagnosed with cardiovascular disease.
* Not been diagnosed with a cardiometabolic conditions (e.g., type 2 diabetes)
* Not been diagnosed with a chronic inflammatory condition (e.g., rheumatoid arthritis, inflammatory bowel disease).
* Does not regularly take anti-inflammatory drugs (more than 2x week).
* Does not use glucose-lowering drugs (e.g., metformin)
* Does not use lipid-lowering drugs (e.g., statins)
* Does not use tobacco products or any illicit drugs.
* Does not have a pacemaker.
* Can consume pea products (Beyond Meat is made from pea protein).
Exclusion Criteria:
* Not between the ages of 18-50
* Body mass index \< 18.5 kg/m2
* Pregnant (females only)
* Postmenopausal status (females only).
* Been diagnosed with cardiovascular disease.
* Been diagnosed with a cardiometabolic conditions (e.g., type 2 diabetes)
* Been diagnosed with a chronic inflammatory condition (e.g., rheumatoid arthritis, inflammatory bowel disease).
* Regularly take anti-inflammatory drugs (more than 2x week).
* Uses glucose-lowering drugs (e.g., metformin)
* Uses lipid-lowering drugs (e.g., statins)
* Uses tobacco products or any illicit drugs.
* Have a pacemaker.
* Allergic to pea products (Beyond Meat is made from pea protein).
**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:** Bryant Keirns, PhD
**Phone:** 765-285-8356
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Muncie
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Bryant Keirns, PhD
- **Phone:** 765-285-8356
- **Role:** CONTACT
**Country:** United States
**Facility:** Health Professions Building, Ball State University
**State:** Indiana
**Status:** RECRUITING
**Zip:** 47306
#### Overall Officials
**Official 1:**
**Affiliation:** Ball State University
**Name:** Bryant Keirns
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000044343
- Term: Overnutrition
- ID: D000009748
- Term: Nutrition Disorders
- ID: D000001835
- Term: Body Weight
### Condition Browse Module - Browse Branches
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M26186
- Name: Overweight
- Relevance: HIGH
- As Found: Overweight
- ID: M12701
- Name: Obesity
- Relevance: LOW
- As Found: Unknown
- ID: M25307
- Name: Overnutrition
- Relevance: LOW
- As Found: Unknown
- ID: M12684
- Name: Nutrition Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M5114
- Name: Body Weight
- Relevance: LOW
- As Found: Unknown
- ID: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000050177
- Term: Overweight
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06445283
**Brief Title:** Determination of Venous Thromboembolism Risk and Nursing Practices in Patients Hospitalized in Medical Services
**Official Title:** Determination of Venous Thromboembolism Risk and Nursing Practices in Patients Hospitalized in Medical Services in a Tertiary University Hospital: Point Prevalence Study
#### Organization Study ID Info
**ID:** HU-NS-VTERisk001
#### Organization
**Class:** OTHER
**Full Name:** Hacettepe University
### Status Module
#### Completion Date
**Date:** 2024-02-21
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-31
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2024-02-21
**Type:** ACTUAL
#### Start Date
**Date:** 2024-02-21
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-31
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Hacettepe University
#### Responsible Party
**Investigator Affiliation:** Hacettepe University
**Investigator Full Name:** Humeyra Zengin, RN,PhD
**Investigator Title:** Director of Nursing Services
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Together with individual predisposition to form vascular clots and clinical conditions that further increase this risk, venous thromboembolism (VTE) poses a significant additional morbidity and mortality risk for the majority of the world's population. Although VTE causes serious disability and death when undiagnosed, it is a medical condition that can be prevented when diagnosed early. Although all hospitalized patients are at risk of DVT, studies have shown that 75% of hospitalized patients are hospitalized in internal clinics.As a result of this observational study, it was aimed to determine the VTE risk levels of the patients from the time of hospitalization and to determine preventive nursing care for VTE.
**Detailed Description:** Venous Thromboembolism (VTE) refers to interrelated diagnoses such as Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE). 10-20% of venous thromboembolic events occur in medical patients and 10-80% in intensive care patients. Recognized as a major complication for medical and surgical patients, VTE has been described as the 'silent killer' of hospitalized patients. During the Covid-19 pandemic in recent years, high rates of thrombolytic events have been reported in hospitalized COVID-19 patients. Nurses have an important role in identifying risk factors for VTE, taking precautions and assessing patient compliance with these precautions. The nurse should identify risk factors in the preoperative period, long-term and intensive care hospitalizations by taking a comprehensive history and physical assessment of the patient before hospitalization. There are several risk assessment models developed to assess the risk of VTE for application to inpatient medical patients. There are various risk assessment models developed for application to inpatient medical patients. Padua and IMPROVE VTE risk assessment models are frequently used. In the literature, it is stated that the Padua model gives moderate results and the IMPROVE model gives moderate-good results in predicting risk (Skeik \& Westergard 2020). Therefore, risk levels were not determined with the IMPROVE risk assessment tool in this study.
### Conditions Module
**Conditions:**
- Venous Thromboembolism
**Keywords:**
- Venous Thromboembolism
- Nursing Practise
### Design Module
#### Design Info
**Observational Model:** CASE_ONLY
**Time Perspective:** OTHER
#### Enrollment Info
**Count:** 157
**Type:** ACTUAL
**Patient Registry:** True
**Study Type:** OBSERVATIONAL
**Target Duration:** 30 Days
### Arms Interventions Module
### Interventions
#### Intervention 1
**Description:** Determination of VTE risk levels of patients using IMPROVE risk assessment tool according to deep vein thrombosis and pulmonary embolism risk factors
**Name:** Determination of VTE risk levels
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** IMPROVE VTE Risk modeli,the seven risk factors evaluated in this model are history of VTE, thrombophilia, cancer in remission within the last 5 years, lower extremity paralysis or paresthesia (leg falling to the bed within 5 seconds), immobilization (complete immobility in bed or chair for ≥ 1 day), ICU (ICU)/Coronary ICU hospitalization, Age ≥ 60 years. In this model with a maximum of 12 points; 0-1 point range is defined as low VTE risk, 2-3 point range as moderate VTE risk and 4 points and above high VTE risk,
**Measure:** Determination of IMPROVE risk model risk levels according to deep vein thrombosis and pulmonary embolism risk factors
**Time Frame:** 21 February 2024
#### Secondary Outcomes
**Description:** Nursing Practise; Informing patients about VTE, To Mobilize the Patient Leg exercises in bed Compression Elastic Socks Intermittent Pneumatic Compression Evaluation of the lower extremities (calf pain, edema, discoloration, tenderness, temperature increase and pulse control, etc.) Daily monitoring of laboratory tests Evaluation of the Glasgow Coma Scale
**Measure:** Rate of implementation of nursing practices for VTE risk
**Time Frame:** 21 February 2024
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* To be conscious,
* Consent of the patient's relatives to participate in the study in unconscious patients
* 24 hours have passed since hospitalization
* The patient admitted to hospitalization has been pre-assessed by the nurse and the pre-assessment form and nurse observation form have been completed
Exclusion Criteria:
* Surgical patients
* Pregnant patients
* Refusing to participate in the study during the completion of the data collection forms.
* In unconscious patients, the patient's relatives did not give consent to participate in the study
* Unconscious patient whose relatives cannot be reached
* The patient admitted to hospitalization was not pre-assessed by the nurse and the pre-assessment form and nurse observation form were not filled out
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** The population of the study will consist of patients hospitalized in the medical clinics of an Adult Hospital of a University. The Adult Hospital serving adult patients has a capacity of 801 beds and the number of beds allocated for medical services is 211.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Altındağ
**Country:** Turkey
**Facility:** Hacettepe University
**State:** Ankara
**Location 2:**
**City:** Ankara
**Country:** Turkey
**Facility:** Hacettepe Uviversity
#### Overall Officials
**Official 1:**
**Affiliation:** Director of Nursing Services
**Name:** Humeyra Zengin
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000016769
- Term: Embolism and Thrombosis
- 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
### Condition Browse Module - Browse Leaves
- ID: M16682
- Name: Thromboembolism
- Relevance: HIGH
- As Found: Thromboembolism
- ID: M27780
- Name: Venous Thromboembolism
- Relevance: HIGH
- As Found: Venous Thromboembolism
- ID: M16686
- Name: Thrombosis
- Relevance: LOW
- As Found: Unknown
- ID: M7784
- Name: Embolism
- Relevance: LOW
- As Found: Unknown
- ID: M19128
- Name: Embolism and Thrombosis
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000013923
- Term: Thromboembolism
- ID: D000054556
- Term: Venous Thromboembolism
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06445270
**Brief Title:** Evidence-informed Trial of Lifestyle Interventions to Improve Glycemic Parameters and Reduce Gestational Diabetes in High-risk Pregnant Individuals
**Official Title:** Evidence-informed Trial of Lifestyle Interventions to Improve Glycemic Parameters and Reduce Gestational Diabetes in High-risk Pregnant Individuals
#### Organization Study ID Info
**ID:** PREVENT-GDM
#### Organization
**Class:** OTHER
**Full Name:** Indiana University
### Status Module
#### Completion Date
**Date:** 2030-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-31
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2029-04
**Type:** ESTIMATED
#### Start Date
**Date:** 2025-04
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-31
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Northeastern University
**Class:** OTHER
**Name:** University of Texas
#### Lead Sponsor
**Class:** OTHER
**Name:** Indiana University
#### Responsible Party
**Investigator Affiliation:** Indiana University
**Investigator Full Name:** David Haas
**Investigator Title:** Munsick Professor of Obstetrics and Gynecology
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** The goal of this study is assess the impact of a higher intensity dietary and activity counseling program to improve blood sugar control and reduce the chance of developing gestational diabetes (GDM) as compared to the current standard diet and activity counseling.
**Detailed Description:** GDM is associated with adverse maternal and newborn outcomes, as well as potential lifelong consequences. Currently, clinical guidelines recommend screening for pre-existing Type 2 diabetes mellitus at new obstetric visits for individuals at high risk of developing GDM. For those who do not screen positive, but still may be at risk for GDM, standard practice is for basic diet, exercise, and weight gain counseling.
In this study, eligible participants will be randomized into one of two groups: usual care with standard diet and exercise counseling or a GDM prevention program that consists of a more intensive exercise and monitoring program.
All participants will be asked to wear an activity tracker and continuous glucose monitors (CGMs) at specified time points throughout their pregnancy. Blood will be drawn at specified time points to measure hemoglobin A1c, lipids, and HOMA-IR measures.
### Conditions Module
**Conditions:**
- Gestational Diabetes
- Pregnancy Complications
**Keywords:**
- gestational diabetes
- prevention
- pregnancy
- continuous glucose monitor
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 100
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** This arm consists of standard of care counseling for diet and exercise.
**Label:** Control
**Type:** NO_INTERVENTION
#### Arm Group 2
**Description:** This arm consists of a more intensive exercise and monitoring program. .
**Intervention Names:**
- Behavioral: GDM Prevention Program
**Label:** GDM Prevention Program
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- GDM Prevention Program
**Description:** Participants will receive hybrid and group monthly contacts with registered dieticians and lifestyle coaches. Participants will attend monthly in-person physical activity sessions.
**Name:** GDM Prevention Program
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Measure:** Time spent in euglycemia
**Time Frame:** 7 days per month
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Gestational age less or equal to 16 + 6 weeks confirmed via ACOG dating guidelines AND one of the following
* 35 years of age or older
* Family history of first degree relative with diabetes mellitus
* Body Mass Index (BMI) greater than or equal to 30
* Hemoglobin A1c value between 5.9% to 6.4%
Exclusion Criteria:
* Multiple gestations
* Current diagnosis of Type 1 or 2 diabetes mellitus including a diagnosis during this pregnancy
* Pre-pregnancy chronic (\>2 weeks) usage of systemic steroids (inhaled and short term usage acceptable)
* Planned pregnancy termination
* Currently taking or took 3 months prior to conception Metformin
* Unable to provide informed consent in English or Spanish
* Major fetal anomalies listed below that are known prior to enrollment.
Major fetal anomalies:
* Congenital diaphragmatic hernia
* Congenital cystic adenomatoid malformation
* Pleural effustions
* Chylothorax
* Bronchogenic cyst
* Bronchopulmonary sequestration
* Anomalous pulmonary venous return
* Tricuspid atresia
* Mitral atresia
* Double right ventricle
* Ebstein's malformation
* Pulmonary atresia
* Hypoplastic left heart syndrome
* Aortic coarctation
* Fetal arrhythmias
* Transposition of the great vessels
* Tetrology of Fallot
* Double outlet right ventricle
* Aortic stenosis
* Holoprosencephaly
* Anencephaly
* Dandy-Walker malformation or variant
* Septo-optic dysplasia
* Neural tube defect
* Vein of Galen aneurysm
* Bilateral renal agenesis
* Cystic renal disease
* Obstructive uropathy
* Horseshoe kidney
* Megacystis microcolon
* Cloacal abnormality
* Achondrogenesis
* Thanatophoric dysplasia
* Thoracic dysplasia
* Osteogenesis imperfecta
* Short rib polydacyly
* Any skeletal defect with suspected small thorax
* Hypophosphatemia
* Any karyotypic abnormality
* Any suspected genetic syndrome
* Cleft lip/palate
* Micrognathia
* Hydrops
* Fetal anemia (\<35% on cordocentesis)
* Neck mass
* Gastroschsis
* Omphalocele
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** David M Haas, MD
**Phone:** 317-880-3960
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Indianapolis
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Kathleen Flannery
- **Phone:** 317-880-3961
- **Role:** CONTACT
***Contact 2:***
- **Name:** David M Haas, MD, MS
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Sidney and Lois Eskenazi Hospital
**State:** Indiana
**Zip:** 46202
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000044882
- Term: Glucose Metabolism Disorders
- ID: D000008659
- Term: Metabolic Diseases
- ID: D000004700
- Term: Endocrine System Diseases
- ID: D000005261
- Term: Female Urogenital Diseases and Pregnancy Complications
- ID: D000091642
- Term: Urogenital Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: 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: M19012
- Name: Diabetes, Gestational
- Relevance: HIGH
- As Found: Gestational Diabetes
- ID: M7115
- Name: Diabetes Mellitus
- Relevance: HIGH
- As Found: Diabetes
- ID: M14127
- Name: Pregnancy Complications
- Relevance: HIGH
- As Found: Pregnancy Complications
- 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: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27093
- Name: Female Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8399
- Name: Female Urogenital Diseases and Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000016640
- Term: Diabetes, Gestational
- ID: D000011248
- Term: Pregnancy Complications
- ID: D000003920
- Term: Diabetes Mellitus
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06445257
**Brief Title:** A Clinical Study Evaluating the Safety and Efficacy of ZRMT Regimen in the Treatment of PCNSL
**Official Title:** A Prospective, Multicenter, Open-label, Single-arm Clinical Study Evaluating the Safety and Efficacy of ZRMT Regimen in the Treatment of Primary Central Nervous System Lymphoma (PCNSL)
#### Organization Study ID Info
**ID:** KY-2023-044-02
#### Organization
**Class:** OTHER
**Full Name:** Huai'an First People's Hospital
### Status Module
#### Completion Date
**Date:** 2026-04-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-05
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2026-04-13
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-09-15
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-31
**Study First Submit QC Date:** 2024-06-05
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Affiliated Hospital of Nantong University
**Class:** OTHER
**Name:** The First People's Hospital of Changzhou
**Class:** OTHER
**Name:** The Affiliated Hospital of Xuzhou Medical University
**Class:** OTHER
**Name:** Northern Jiangsu People's Hospital
#### Lead Sponsor
**Class:** OTHER
**Name:** Huai'an First People's Hospital
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** This study is a prospective, multicenter, open-label, single-arm clinical trial evaluating the safety and efficacy of the ZRMT (Zanubrutinib-Rituximab-Methotrexate-Temozolomide) regimen in the treatment of primary central nervous system lymphoma (PCNSL) with diffuse large B-cell lymphoma.
This study includes an induction phase for PCNSL ± ASCT and a sequential maintenance phase.
**Detailed Description:** This study is a single-arm, open-label, multicenter, phase II clinical trial aimed at evaluating the safety, tolerability, and preliminary efficacy of ZRMT regimen ± ASCT followed by sequential zebutinib monotherapy as maintenance treatment for newly diagnosed PCNSL. A total of 30 subjects are planned to be enrolled.
Primary central nervous system lymphoma (PCNSL) accounts for only 1-2% of non-Hodgkin lymphoma (NHL) patients, with over 90% of PCNSL cases being diffuse large B-cell lymphoma. PCNSL is characterized by an aggressive clinical course and poor prognosis, with a 5-year overall survival (OS) rate of only 30.1% even with intensive chemotherapy and autologous stem cell transplantation as first-line consolidation. Additionally, the median age of onset for PCNSL is close to 70 years. Therefore, a low-toxicity and highly effective treatment regimen is crucial in the management of PCNSL. Currently, the standard treatment for PCNSL is combination chemotherapy based on high-dose methotrexate (HD-MTX), which has improved the survival of PCNSL patients compared to previous surgical resection or whole-brain radiation therapy. However, the efficacy of HD-MTX is not durable, with only 20% of patients achieving sustained remission after 2 years of HD-MTX monotherapy.
Young and healthy patients with PCNSL are recommended to undergo ASCT consolidation therapy in CR1 phase after intensified induction. However, approximately 25-35% of PCNSL patients are aged 70 or above, and these patients may not be suitable candidates for ASCT. Therefore, the treatment options for elderly and frail PCNSL patients still require further research.
Studies have shown that PCNSL is primarily of the ABC subtype of DLBCL. Whole exome sequencing has revealed that PCNSL patients typically have mutations in the MYD88 and CD79B genes, leading to the classification of PCNSL as the MCD subtype. Both of these genes are key molecules in the BCR signaling pathway. Mutations in MYD88 and CD79B ultimately lead to activation of NF-кB, promoting tumor cell proliferation and inhibiting apoptosis. The high frequency and functional activation of this pathway also provide new targets for treatment.The non-receptor tyrosine kinase Bruton tyrosine kinase (BTK) is a key molecule in the B-cell receptor (BCR) signaling pathway and is involved in the activation and survival of ABC subtype DLBCL cells. The BTK inhibitor Ibrutinib has shown promising anti-tumor activity in relapsed/refractory DLBCL, with higher response rates observed in ABC subtype patients compared to germinal center subtype patients (5% vs 37%, p=0.0106).
Zanbrutinib is a novel and potent covalent selective inhibitor of Bruton tyrosine kinase (BTK). Currently, the FDA has approved zanbrutinib for the treatment of relapsed/refractory chronic lymphocytic leukemia, mantle cell lymphoma, marginal zone lymphoma, and Waldenström macroglobulinemia, which are B-cell lymphomas. It is actively being studied and explored in other B-cell tumors, including diffuse large B-cell lymphoma, and promising efficacy and safety data are being reported gradually.In a multicenter, single-arm phase 2 study, 41 patients with relapsed/refractory DLBCL were treated with oral zanbrutinib at a dose of 160 mg twice daily until disease progression or intolerable toxicity. With a median follow-up of 6.8 months, the overall response rate (ORR) was 29.3%, with a complete response (CR) rate of 17.1%. The median duration of response (DOR), progression-free survival (PFS), and overall survival (OS) were 4.5, 2.8, and 8.4 months, respectively. This study preliminarily demonstrates the efficacy of zanbrutinib in central nervous system-involved DLBCL. Recent studies presented at ASH suggest that regimens containing BTK inhibitors show promising efficacy in first-line treatment of PCNSL, and the exploration of novel drug combinations with chemotherapy holds the potential to bring deeper and more durable remissions for PCNSL patients. However, further investigation is needed to determine the optimal drug combinations.
The main objective of this study is to evaluate the safety, tolerability, and preliminary efficacy of the ZRMT regimen in the treatment of newly diagnosed PCNSL. The secondary objective is to assess the preliminary efficacy of the ZRMT regimen ± ASCT followed by sequential maintenance therapy with zanubrutinib.After screening, eligible patients will receive zanubrutinib 160 mg BID orally, rituximab: 375 mg/m2 intravenously on day 7, methotrexate: 3-3.5 g/m2 intravenously on day 1, and temozolomide 100 mg on days 1-5. Treatment will be given for 6-8 cycles, and patients who achieve a partial response (PR) or better can choose to undergo ASCT if they meet the transplantation criteria. After transplantation or for patients who do not undergo transplantation, zanubrutinib monotherapy maintenance treatment will be administered at a dose of 160 mg BID orally for 2 years or until disease progression, death, or intolerable adverse reactions.
### Conditions Module
**Conditions:**
- Primary Central Nervous System Lymphoma
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 30
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** zanubrutinib 160 mg BID orally rituximab: 375 mg/m2 intravenously on day 7, methotrexate: 3-3.5 g/m2 intravenously on day 1, and temozolomide 100 mg on days 1-5.
Treatment will be given for 6-8 cycles, and patients who achieve a partial response (PR) or better can choose to undergo ASCT if they meet the transplantation criteria. After transplantation or for patients who do not undergo transplantation, zanubrutinib monotherapy maintenance treatment will be administered at a dose of 160 mg BID orally for 2 years or until disease progression, death, or intolerable adverse reactions.
**Intervention Names:**
- Drug: zanubrutinib 160 mg BID orally
**Label:** The ZRMT regimen is used to treat PCNSL
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- The ZRMT regimen is used to treat PCNSL
**Description:** The ZRMT induction and maintenance regimen
**Name:** zanubrutinib 160 mg BID orally
**Other Names:**
- rituximab: 375 mg/m2 intravenously on day 7
- methotrexate: 3-3.5 g/m2 intravenously on day 1
- temozolomide 100 mg on days 1-5
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Refers to the proportion of patients whose tumor volume has decreased to a predetermined value and can be maintained for a minimum duration requirement
**Measure:** Overall response rate，ORR
**Time Frame:** The period of 1 year from the start of treatment.
**Description:** refers to the time from the first assessment of CR or PR to the first assessment of PD or death for any reason
**Measure:** Complete response，CR
**Time Frame:** The period of 1 year from the start of treatment
**Description:** refers to the time from the first assessment of CR or PR to the first assessment of PD or death for any reason
**Measure:** Duration of response,DOR
**Time Frame:** The period of 1 year from the start of treatment
**Description:** refers to the proportion of patients who have not died within 1 year after the start of the first treatment.
**Measure:** 1 Year-Overall survival,1y-OS
**Time Frame:** The period of 1 year from the start of treatment
**Description:** refers to the proportion of patients who have not experienced disease progression or death within 1 year after the start of the first treatment
**Measure:** Progression-Free Survival,PFS
**Time Frame:** The period of 1 year from the start of treatment
**Description:** refers to the time from the start of the first treatment to death (for any reason)
**Measure:** Overall survival, OS
**Time Frame:** The period of 1 year from the start of treatment
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* According to the 2016 WHO classification of hematopoietic and lymphoid tissue tumors, the patient has been histopathologically diagnosed with primary central nervous system diffuse large B-cell lymphoma.
* Age ≥18 years and ≤75 years, any gender.
* Performance status score (ECOG): 0-1.
* Male participants and reproductive-age females must use contraception during the study and for 3 months after the last dose.
* Reproductive-age females must have a negative serum or urine pregnancy test at screening.
* Expected survival of more than 3 months.
* Laboratory tests must meet the following criteria:Hematology: Hemoglobin (Hb) ≥80 g/L, absolute neutrophil count (ANC) ≥1.5 × 109/L, platelet count (PLT) ≥75 × 109/L.Liver function: Serum total bilirubin (TBIL) ≤1.5 × upper limit of normal (ULN), aspartate aminotransferase (AST) ≤2.5 × ULN, alanine aminotransferase (ALT) ≤2.5 × ULN.Renal function: Creatinine clearance rate (Ccr) ≥50 mL/min.Coagulation function: International normalized ratio (INR) and prothrombin time (PT) ≤1.5 × ULN.Note: Patients who do not meet the above criteria may receive supportive treatment at the discretion of the investigator.
* The patient is aware of and voluntarily agrees to participate in the study and is able to comply with the scheduled visits and related procedures as specified in the protocol.
Exclusion Criteria:
* Patients who are determined by the investigator to be allergic, resistant, or intolerant to the drugs in the treatment regimen.
* Patients who have received any investigational drugs or radiation therapy within the past 4 weeks.
* Patients who have undergone major surgery within the past 4 weeks (excluding surgery related to the disease).
* Patients with severe infections within the past 4 weeks, as determined by the investigator, who are not suitable for treatment.
* Patients with a history of stroke or intracranial hemorrhage within the past 3 months, or active grade 3 or higher gastrointestinal bleeding.
* Patients who are pregnant or breastfeeding.
* Patients with impaired cardiac function or significant cardiac diseases, including but not limited to: a) myocardial infarction, congestive heart failure, or viral myocarditis within the past 6 months; b) symptomatic cardiac diseases requiring treatment intervention, such as unstable angina or arrhythmias; c) NYHA class II-IV heart function; d) echocardiographic ejection fraction (EF) below 50% or below the lower limit of the study center.
* Patients with a known history of human immunodeficiency virus (HIV) infection, primary immunodeficiency diseases, or active tuberculosis.
* Patients with poorly controlled hypertension or diabetes.
* Patients with active hepatitis B or hepatitis C infection (for HBsAg-positive or HBcAb-positive subjects, they can be included if HBV-DNA is not detected; for HCV antibody-positive subjects, they can be included if HCV-RNA is not detected).
* Patients with a history of malignant tumors that may affect the implementation of the trial protocol or result analysis (excluding cured basal cell carcinoma of the skin, cervical carcinoma in situ, ductal carcinoma in situ of the breast, localized gastric or intestinal mucosal carcinoma, and localized prostate cancer).
* Patients with active mental disorders, alcoholism, drug abuse, or substance abuse.
* Patients who are determined by the investigator to be unsuitable for participation in this study.
**Maximum Age:** 75 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Chunling Wang
**Phone:** 15189552696
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Huai'an
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Chunling Wang
- **Phone:** 15189552696
- **Role:** CONTACT
**Country:** China
**Facility:** The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University（Huai'an First People's Hospital）
**State:** Jiangsu
**Status:** RECRUITING
**Zip:** 210000
### 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: 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: 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: LOW
- As Found: Unknown
- ID: T4686
- Name: Primary Central Nervous System Lymphoma
- Relevance: HIGH
- As Found: Primary Central Nervous System Lymphoma
### Condition Browse Module - Meshes
- ID: D000008223
- Term: Lymphoma
### Intervention Browse Module - Ancestors
- ID: D000000970
- Term: Antineoplastic Agents
- ID: D000007155
- Term: Immunologic Factors
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000018501
- Term: Antirheumatic Agents
- ID: D000000020
- Term: Abortifacient Agents, Nonsteroidal
- ID: D000000019
- Term: Abortifacient Agents
- ID: D000012102
- Term: Reproductive Control Agents
- ID: D000000964
- Term: Antimetabolites, Antineoplastic
- ID: D000000963
- Term: Antimetabolites
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000003879
- Term: Dermatologic Agents
- ID: D000004791
- Term: Enzyme Inhibitors
- ID: D000005493
- Term: Folic Acid Antagonists
- ID: D000007166
- Term: Immunosuppressive Agents
- ID: D000019384
- Term: Nucleic Acid Synthesis Inhibitors
- ID: D000018906
- Term: Antineoplastic Agents, Alkylating
- ID: D000000477
- Term: Alkylating Agents
- ID: D000092004
- Term: Tyrosine Kinase Inhibitors
- ID: D000047428
- Term: Protein Kinase Inhibitors
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: ARhu
- Name: Antirheumatic Agents
- Abbrev: Derm
- Name: Dermatologic Agents
- Abbrev: Repr
- Name: Reproductive Control Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Micro
- Name: Micronutrients
- Abbrev: Hemat
- Name: Hematinics
- Abbrev: Vi
- Name: Vitamins
- Abbrev: AA
- Name: Amino Acids
### Intervention Browse Module - Browse Leaves
- ID: M11703
- Name: Methotrexate
- Relevance: HIGH
- As Found: Breast Cancer
- ID: M1692
- Name: Temozolomide
- Relevance: HIGH
- As Found: Skills
- ID: M42199
- Name: Zanubrutinib
- Relevance: HIGH
- As Found: Mobile Health
- ID: M373
- Name: Rituximab
- 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: M4281
- Name: Antimetabolites
- Relevance: LOW
- As Found: Unknown
- ID: M7074
- Name: Dermatologic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M7951
- Name: Enzyme Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M17546
- Name: Vitamin B Complex
- Relevance: LOW
- As Found: Unknown
- ID: M8618
- Name: Folic Acid
- Relevance: LOW
- As Found: Unknown
- ID: M8619
- Name: Folic Acid Antagonists
- Relevance: LOW
- As Found: Unknown
- ID: M10212
- Name: Immunosuppressive 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: M2889
- Name: Tyrosine Kinase Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M25820
- Name: Protein Kinase Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: T447
- Name: Folinic Acid
- Relevance: LOW
- As Found: Unknown
- ID: T446
- Name: Folic Acid
- Relevance: LOW
- As Found: Unknown
- ID: T448
- Name: Folate
- Relevance: LOW
- As Found: Unknown
- ID: T475
- Name: Vitamin B9
- Relevance: LOW
- As Found: Unknown
- ID: T22
- Name: Tyrosine
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000008727
- Term: Methotrexate
- ID: D000077204
- Term: Temozolomide
- ID: C000629551
- Term: Zanubrutinib
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06445244
**Acronym:** AKGHTN
**Brief Title:** α-ketoglutarate in Patients With Hypertension
**Official Title:** The Effects of α-ketoglutarate on Blood Pressure and Endothelial Function in Hypertensive Patients
#### Organization Study ID Info
**ID:** KY-IIT-2024-001
#### Organization
**Class:** OTHER
**Full Name:** First Affiliated Hospital, Sun Yat-Sen University
### Status Module
#### Completion Date
**Date:** 2024-08-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-31
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-07-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-30
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-31
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Jun Tao
#### Responsible Party
**Investigator Affiliation:** First Affiliated Hospital, Sun Yat-Sen University
**Investigator Full Name:** Jun Tao
**Investigator Title:** Guangxi Hospital Division of The First Affiliated Hospital, Sun Yat-Sen University
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Is US Export:** True
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Cardiovascular and cerebrovascular diseases are most terrible killers endangering the health of Chinese residents, and hypertension is the most important risk factor. Hypertension related microvascular rarefaction and endothelial dysfunction are the common pathological basis and initiation of cardiovascular and cerebrovascular disease. Therefore, reducing blood pressure and delaying or reversing endothelial dysfunction is an effective way to treat hypertension and prevent cardiovascular disease. Alpha-ketoglutarate (αKG) is a critical metabolic intermediate in the tricarboxylic acid (TCA) cycle, involves in diverse cellular biological activities, such as central metabolism, antioxidative defense, epigenetic regulation, and cell proliferation. The latest research found that with the growth of age, the level of αKG is decreasing, and increasing the content of αKG can prolong the life of multiple species including human. Recent clinical trials found that αKG supplementation can effectively improve the level of αKG in cells, delay aging, improve the metabolic process of cells without adverse reactions. However, the effect of αKG supplementation on reducing blood pressure and protecting vascular endothelial function has not been reported. Therefore, this study aims to focus on hypertension, a major chronic disease, and to observe the effects of αKG supplementation on endothelial function and blood pressure in patients with hypertension, so as to provide a new treatment strategy for hypertension and associated endothelial dysfunction.
### Conditions Module
**Conditions:**
- Hypertension
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 30
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** AKG Double Wood® + lifestyle modification
**Intervention Names:**
- Dietary Supplement: Alpha-ketoglutarate supplied as 1000mg capsule
- Behavioral: Behavioral: Lifestyle modification
**Label:** α-KG group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Lifestyle modification only
**Intervention Names:**
- Behavioral: Behavioral: Lifestyle modification
**Label:** Control group
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- α-KG group
**Description:** AKG Double Wood® + lifestyle modification AKG Double Wood®: 500mg, qd, for one months. Lifestyle modification: intake 1400-1600 kcal/day: 54% carbohydrates, 24% proteins, 22% lipids, 108 mg cholesterol, 35 g fiber; avoid smoking and alcohol consumption; performing aerobic activity 4 days per week such as 45 min on a stationary bicycle.
**Name:** Alpha-ketoglutarate supplied as 1000mg capsule
**Type:** DIETARY_SUPPLEMENT
#### Intervention 2
**Arm Group Labels:**
- Control group
- α-KG group
**Description:** Lifestyle modification: intake 1400-1600 kcal/day: 54% carbohydrates, 24% proteins, 22% lipids, 108 mg cholesterol, 35 g fiber; avoid smoking and alcohol consumption; performing aerobic activity 4 days per week such as 45 min on a stationary bicycle.
**Name:** Behavioral: Lifestyle modification
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** Change of FMD between αKG-treated participants and non-αKG-treated participants
**Measure:** Effect of αKG on flow mediated dilation （FMD）
**Time Frame:** Up to 1 month
**Description:** Change of baPWV between αKG-treated participants and non-αKG-treated participants
**Measure:** Effect of αKG on brachial-ankle pulse wave velocity （baPWV）
**Time Frame:** Up to 1 month
#### Secondary Outcomes
**Description:** Change of systolic blood pressure and diastolic blood pressure between αKG-treated participants and non-αKG-treated participants
**Measure:** Effect of αKG on blood pressure
**Time Frame:** Up to 1 month
**Description:** Change of serum αKG levels between αKG-treated participants and non-αKG-treated participants
**Measure:** Effect of αKG on serum αKG levels
**Time Frame:** Up to 1 month
**Description:** Change of retinal vascular density between αKG-treated participants and non-αKG-treated participants
**Measure:** Effect of αKG on retinal vascular density
**Time Frame:** Up to 1 month
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1、 Primary hypertension (office blood pressure: systolic blood pressure 130～159 mmHg and/or diastolic blood pressure 80～99 mmHg, which meets the diagnostic criteria of hypertension class 1 of 2018AHA hypertension guidelines) and accompanied by vascular dysfunction (FMD\<5%); 2、 Age between 18 and 65 years old; 3, Not using any drugs and dietary supplements that affect blood pressure and vascular endothelial function in the last 3 months, mainly including antihypertensive, lipid-lowering, hypoglycemic drugs and natural plant extract antioxidants; 4、 Voluntarily sign the informed consent form after fully understanding the purpose and process of the study, disease characteristics, drug effects, methods of relevant examinations, and potential risks/benefits of the study.
Exclusion Criteria:
1. Presence of secondary hypertension (those who have been diagnosed with secondary hypertension in the past and have not been definitively cured, and if secondary hypertension is suspected, a complete examination is required to exclude common secondary hypertension, including renal hypertension (renal parenchymal lesions, renal artery stenosis), primary aldosteronism, Cushing's syndrome, pheochromocytoma, aortic constriction, and severe obstructive sleep apnea);
2. Acute myocardial infarction within the past 6 months;
3. recent history of stroke (within 6 months); 4, Dilated heart disease, hypertrophic cardiomyopathy, rheumatic heart disease, congenital heart disease, severe heart valve disease (severe valve stenosis and or regurgitation);
5. patients with a combination of serious physical illnesses, such as cancer; 6, Severe hepatic or renal dysfunction (ALT and or AST) ≥ 3 times the upper limit of normal, or dialysis end-stage renal disease or eGFR \< 30 ml/min/1.73 m2, or serum creatinine \> 2.5 mg/dL \[\> 221 μmol/L\]); 7. Symptomatic heart failure or reduced left ventricular ejection fraction (\<40%) within the past 6 months; 8. History of hypersensitivity to the study drug or to its components after administration; 9. Participating in other clinical studies; 10. Patients with mental illness who are unable to cooperate; 11, Pregnant, lactating or expectant mothers;
**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:** Xia Wenhao, MD, PhD
**Phone:** +86 15818193120
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Liu Zhefu
**Phone:** +86 18774082778
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Guangxi
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Xia Wenhao, MD,PhD
- **Phone:** +8615818193120
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Liu Zhefu
- **Phone:** +8618774082778
- **Role:** CONTACT
**Country:** China
**Facility:** Wenhao Xia
**State:** Nanning
**Status:** RECRUITING
**Zip:** 530028
#### Overall Officials
**Official 1:**
**Affiliation:** Guangxi Hospital Division of The First Affiliated Hospital, Sun Yat-Sen University
**Name:** Xia Wenhao, MD, PhD
**Role:** STUDY_CHAIR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- 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
### Condition Browse Module - Browse Leaves
- ID: M10024
- Name: Hypertension
- Relevance: HIGH
- As Found: Hypertension
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000006973
- Term: Hypertension
### 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:** NCT06445231
**Acronym:** ECHOGER
**Brief Title:** Echocardiography in Nursing Home
**Official Title:** Implementation and Effectiveness of Screening Echocardiography Performed in Nursing Home: ECHOGER
#### Organization Study ID Info
**ID:** RC22_0449
#### Organization
**Class:** OTHER
**Full Name:** Nantes University Hospital
### Status Module
#### Completion Date
**Date:** 2029-09-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-31
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2027-09-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** Directorate of Health Care Supply
#### Lead Sponsor
**Class:** OTHER
**Name:** Nantes 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 study seeks to explore the implementation characteristics (acceptability, appropriateness, feasibility, adoption, fidelity, penetration, implementation cost and sustainability) of systematic echocardiography in nursing homes and its impact on rates of heart failure flare-up and unscheduled hospitalization at 12 months among included nursing homes.
**Detailed Description:** Open-label cluster randomized type 1 hybrid trial, with 2 parallel arms: nursing homes will be randomized in the interventional (echocardiography by sonographer) or non-interventional arms (usual care). In the interventional arm echocardiography will be proposed to all residents of the nursing home at baseline. Clinical management will be adapted to the result of echocardiography by the general practitioner, in accordance with the cardiologist. The main objective is to assess the impact at 12 months of the initial performance of a systematic simplified echocardiography on the rate of nursing home residents presenting with heart failure episode or cardiovascular pathology. The Primary endpoint is the number of nursing home residents presenting a heart failure episode or an unscheduled hospitalization for heart failure or other cardiovascular pathologies at 12 months.
Thirty nursing homes and 1050 residents will be included overall
### Conditions Module
**Conditions:**
- Heart Diseases
- Heart Failure
- Heart Valve Diseases
**Keywords:**
- Echocardiography
- Nursing Home
- Implementation
- Heart Failure
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Nursing home randomization in 1:1 ratio between echocardiography and no-echocardiography
##### Masking Info
**Masking:** NONE
**Masking Description:** Not relevant
**Primary Purpose:** SCREENING
#### Enrollment Info
**Count:** 1050
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants from nursing homes allocated to echocardiographic screening group will benefit of one echocardiography at inclusion.
**Intervention Names:**
- Diagnostic Test: Implementation of echocardiography in nursing homes
**Label:** Echocardiographic screening arm
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants from nursing homes allocated to no-screening group. Participants will be followed for medical management and care as usual.
**Label:** Usual care
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Echocardiographic screening arm
**Description:** An ultrasound will be carried out in the EHPAD, the result of which will be interpreted by a cardiologist then sent to the establishment and the attending physician with instructions to follow.
**Name:** Implementation of echocardiography in nursing homes
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** Number of residents with heart failure flare (worsening of at least 1 NYHA class) or unplanned hospitalization for heart failure
**Measure:** Count of resident presenting a heart failure decompensation
**Time Frame:** 12 months
#### Secondary Outcomes
**Description:** A binary outcome will be constructed, based on the following algorithm: clinically significative change set to "yes" if a change in ongoing drug prescription is observed, and/or a cardiologist visit is planned, and/or a geriatrist visit is planned, and/or an hospitalization for clinical work-up is set, and/or a resume of the ultrasound is sent to the GP. Otherwise (all components set to "absent"), this outcome will be set to "None".
**Measure:** Presence of a clinically significative change in medical management and care in the month following ultrasound
**Time Frame:** 12 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria :
Nursing homes residents with a life-expectancy estimated \> 1 year, and able to participate to the study, giving an oral consent
Exclusion Criteria :
* no accessible to echocardiography
* closed unit (severe Alzheimer disease...)
* recent contagious disease such Covid (\<15 days)
* no consent to participate
* no social security number
**Healthy Volunteers:** True
**Minimum Age:** 65 Years
**Sex:** ALL
**Standard Ages:**
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Thierry LE TOURNEAU, PU-PH
**Phone:** 33 2 40 16 54 98
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Anne-Sophie BOUREAU, PH
**Phone:** 33 2 40 16 85 35
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Nantes University Hospital
**Name:** Thierry LE TOURNEAU, PU-PH
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** YES
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000002318
- Term: Cardiovascular Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M9421
- Name: Heart Failure
- Relevance: HIGH
- As Found: Heart Failure
- ID: M9419
- Name: Heart Diseases
- Relevance: HIGH
- As Found: Heart Disease
- ID: M9437
- Name: Heart Valve Diseases
- Relevance: HIGH
- As Found: Heart Valve Diseases
### Condition Browse Module - Meshes
- ID: D000006333
- Term: Heart Failure
- ID: D000006331
- Term: Heart Diseases
- ID: D000006349
- Term: Heart Valve Diseases
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06445218
**Acronym:** SKUAD-P
**Brief Title:** Observational Study of Musculoskeletal Patients in an Emergency Department in France
**Official Title:** Observational Study of Musculoskeletal Patients in an Emergency Department in France : a Pilot Study
#### Organization Study ID Info
**ID:** CHRD0823
#### Organization
**Class:** OTHER
**Full Name:** Hôpital NOVO
### Status Module
#### Completion Date
**Date:** 2024-08
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-31
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-08
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-31
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** University of Brighton
#### Lead Sponsor
**Class:** OTHER
**Name:** Hôpital NOVO
#### 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 purpose of this study is to estimate the number of patients who come to the emergency department with a musculoskeletal referral, to describe the different types of diagnosis for these patients and their treatment and discharge.
**Detailed Description:** There is a crisis in the emergency department (ED) in France, as their number of consultations have constantly increased over the past ten years . Musculoskeletal disorders (MSK) are the most common cause of consultations in ED, as an example there is an average of 30% of ED consultations being for traumatic issues . Moreover, 90% of all patients coming in ED in France have a favourable prognosis of evolution (no risk of seriousness). In this situation, one of the propositions to help to reduce the ED burden is to allow a direct access to physiotherapists. They are the recommended profession to treat patients for musculoskeletal conditions and several studies showed physiotherapy assessment and treatment in an emergency service is safe and beneficial both for the patients and the hospital teams. They have reported to increase satisfaction, to reduce medications and requirement for expensive imaging on one hand, and to reduce the costs and to give more time to the medical team on the other hand This role does not exist yet in France, although more than 48 countries across the world have implemented it, and French physiotherapists are advocating for it. A recent text has been adopted by the French government allowing patients with recent ankle sprain or low back pain to self-refer to physiotherapists working in hospitals or in care home. . However, this access is very restricted, which will make the implementation difficult as it might not be sufficient to assist the ED. Moreover, there is a lack of information on the number and the type of diagnostic of patients with a MSK label coming to the ED, which makes it difficult to assess the impact this role could have on French ED.
In this context, a retrospective survey, describing how many patients with a musculoskeletal label are coming to the ED, and how they are managed, could help to estimate the worthiness of physiotherapist direct access in French ED.
Question : What is the proportion, the type of diagnostic and the management of musculoskeletal disorder in emergency department in one hospital in France?
### Conditions Module
**Conditions:**
- Musculoskeletal Pain
**Keywords:**
- Emergency department
- musculoskeletal disorder
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 168
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Collection of various data from patients' medical file, such as demographic data, diagnostic results, discharge, treatment....
**Intervention Names:**
- Other: Data collection
**Label:** Data collection
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Data collection
**Description:** Collection of various data from patients' medical file, such as demographic data, diagnostic results, discharge, treatment....
**Name:** Data collection
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The description of the patients, triaged by the emergency reception and referral nurse as having a potential musculoskeletal pathology, will be carried out by collecting the different types of diagnoses, based on the International Classification of Diseases - 10th revision (ICD10) and their severity, as well as their age and gender, and the treatments that have been prescribed (medication, imaging, physiotherapy, other...).
**Measure:** Description of the population considered to have a potential musculoskeletal disorder after nursing triage
**Time Frame:** At the end of the study, an average of 3 month
#### Secondary Outcomes
**Description:** Collection of the duration of care (from registration at the emergency department to the patient's discharge)
**Measure:** Description of the management of patients (duration) with a potential musculoskeletal disorder after nursing triage
**Time Frame:** At the end of the study, an average of 3 month
**Description:** Collection of the number of patients per day of the week (Monday to Sunday) and by time slots between 8am and 8pm during the day and between 8pm and 8am at night
**Measure:** Description of the management of patients (number of patients per day of the week) with a potential musculoskeletal disorder after nursing triage
**Time Frame:** At the end of the study, an average of 3 month
**Description:** Collection of different referrals (hospitalization, return home..) at the end of patient care
**Measure:** Description of the management of patients (referrals at the end of patient care) with a potential musculoskeletal disorder after nursing triage
**Time Frame:** At the end of the study, an average of 3 month
**Description:** Number of patients with a potential musculoskeletal disorder, after nursing triage, out of the total number of people consulting during the same period
**Measure:** Assessment of the prevalence of people with a potential musculoskeletal disorder after nursing triage
**Time Frame:** At the end of the study, an average of 3 month
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria :
* Patients aged between 18 and 68
* Patients admitted to emergency with a triage by the Reception and Referral Nurse of 0, 1 or 2
* Patients who consulted for one of the following reasons:
Lower limb pain (T13.9) Lower limb trauma (M79.61) Upper limb pain (T11.9) Upper limb trauma (M79.60) Spinal pain (M54.9) Lumbar or flank pain (R10.3) Diffuse/unspecific pain (R52.9) Loss of sensitivity/paraesthesia
- Patients informed of the study and who did not object
Exclusion Criteria :
* Patients with another reason for consultation associated with the first
* Patients under guardianship / curatorship and patients under safeguard of justice.
**Maximum Age:** 68 Years
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Patients suffering from musculoskeletal disorders in an emergency department
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Maryline DELATTRE
**Phone:** +3333130754131
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Véronique DA COSTA
**Phone:** +3333130755069
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Pontoise
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Benoit ANCEL
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Olivier FANCELLI
- **Phone:** +33 1 30 75 40 40
- **Phone Ext:** 73 84
- **Role:** CONTACT
**Country:** France
**Facility:** Emergency Service - Hôpital NOVO - Pontoise site
**Zip:** 95300
#### Overall Officials
**Official 1:**
**Affiliation:** Hôpital NOVO
**Name:** Benoit ANCEL
**Role:** PRINCIPAL_INVESTIGATOR
### References Module
#### References
**Citation:** Babatunde OO, Bishop A, Cottrell E, Jordan JL, Corp N, Humphries K, Hadley-Barrows T, Huntley AL, van der Windt DA. A systematic review and evidence synthesis of non-medical triage, self-referral and direct access services for patients with musculoskeletal pain. PLoS One. 2020 Jul 6;15(7):e0235364. doi: 10.1371/journal.pone.0235364. eCollection 2020.
**PMID:** 32628696
**Citation:** Demont A, Quentin J, Bourmaud A. [Impact of models of care integrating direct access to physiotherapy in primary care and emergency care contexts in patients with musculoskeletal disorders: A narrative review]. Rev Epidemiol Sante Publique. 2020 Sep;68(5):306-313. doi: 10.1016/j.respe.2020.08.001. Epub 2020 Sep 3. French.
**PMID:** 32893028
**Citation:** Demont A, Bourmaud A, Kechichian A, Desmeules F. The impact of direct access physiotherapy compared to primary care physician led usual care for patients with musculoskeletal disorders: a systematic review of the literature. Disabil Rehabil. 2021 Jun;43(12):1637-1648. doi: 10.1080/09638288.2019.1674388. Epub 2019 Oct 11.
**PMID:** 31603709
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000020969
- Term: Disease Attributes
- ID: D000010335
- Term: Pathologic Processes
- ID: D000009135
- Term: Muscular Diseases
- ID: D000009140
- Term: Musculoskeletal Diseases
- ID: D000010146
- Term: Pain
- ID: D000009461
- Term: Neurologic Manifestations
### Condition Browse Module - Browse Branches
- Abbrev: BC05
- Name: Musculoskeletal Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
### Condition Browse Module - Browse Leaves
- ID: M29444
- Name: Musculoskeletal Pain
- Relevance: HIGH
- As Found: Musculoskeletal Pain
- ID: M7796
- Name: Emergencies
- Relevance: HIGH
- As Found: Emergency
- ID: M12097
- Name: Musculoskeletal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
- ID: M12092
- Name: Muscular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000059352
- Term: Musculoskeletal Pain
- ID: D000004630
- Term: Emergencies
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06445205
**Brief Title:** Utilising Volumetric Absorptive Microsampling (VAMS) Technology to Monitor Tacrolimus and Creatinine
**Official Title:** Utilising Volumetric Absorptive Microsampling (VAMS®) Technology to Monitor Tacrolimus and Creatinine Concentrations in Adult Renal Transplant Patients
#### Organization Study ID Info
**ID:** 322562
#### Organization
**Class:** OTHER
**Full Name:** Lancashire Teaching Hospitals NHS Foundation Trust
#### Secondary ID Infos
**Domain:** Health research Authority
**ID:** 22/PR/1599
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2024-11-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-31
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-08-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-02-13
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-31
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Lancashire Teaching Hospitals NHS Foundation Trust
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Tacrolimus is a medicine given to try and stop rejection of a new kidney after transplant surgery. If too much taken the kidney may be damaged. If not enough taken, the risk of rejection is increased. Creatinine is a waste product made by the muscles and is normally removed from the body by the kidneys. If kidney function gets worse, the creatinine level in the blood goes up and means the new new kidney is not working properly. It is important to monitor levels of tacrolimus and creatinine regularly, to keep the kidney as healthy as possible. Regular monitoring also aids with balancing the amount of tacrolimus that patients need to take.
The COVID-19 pandemic led to changes in the delivery of transplant services. One such changes was a move to the use of point-of-care, and at home devices.
The study involves the set-up a new method in an NHS laboratory to test tacrolimus and creatinine levels in blood collected in the normal blood tubes and to compare the results with this new collection device, to see if the results are the same.
If the results match, patients will continue to collect a blood sample using the new devices and send it to the laboratory. This will save both patients and the NHS time and money as they will not have to travel to a hospital to have their bloods taken.
**Detailed Description:** A minimum of 50 adult renal transplant patients (\>18 years old) taking tacrolimus as an immunosuppressant will be recruited when attending their routine outpatient follow up appointment, or if selected as eligible by the Renal Consultants and transplant nurses. Written consent will be obtained from all participants.
Patients attending blood clinic to have their routine blood samples taken will also have a finger prick and a small amount of blood (10µl) will be collected by volumetric absorptive micro sampling (VAMS) using the Mitra® device (Neoteryx), according to manufacturer's instructions. Two venous blood samples will be collected from the patients by venepuncture by trained phlebotomists/nurses. A 4ml EDTA and a 4ml serum gel sample (to measure tacrolimus and renal function as part of routine care). Tacrolimus and creatinine are measured in venous blood samples as part of routine patient care therefore these will be processed as normal, and results reported. The paired capillary samples collected using the Mitra® device will be batched and run when appropriate by liquid chromatography-mass spectrometry (LC-MS/MS). Mitra® devices will be stored at -20 degree Celsius, prior to analysis.
Venous EDTA whole blood samples (collected by venepuncture) and capillary whole blood samples (collected by VAMS®) will be analysed for tacrolimus using a validated LC-MS/MS assay in routine clinical use in the lab using the Waters ACQUITY UPLC system and Xevo TQD MS. Capillary whole blood samples (collected by VAMS®) and serum samples will be analysed for creatinine using an LC-MS/MS method which will be developed in house. For the method comparison, serum samples (collected by venepuncture) will be analysed for creatinine using an enzymatic method on the Roche platform. All sample analysis will be performed in an ISO 15189 accredited laboratory.
### Conditions Module
**Conditions:**
- Kidney Transplant Rejection
- Kidney Replacement
### Design Module
#### Design Info
**Observational Model:** OTHER
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 50
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Sample collection via standard phlebotomy as well as point-or-care Mitra device.
**Intervention Names:**
- Diagnostic Test: Mitra® device with VAMS® (volumetric absorptive microsampling) technology
**Label:** Sample collection
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Sample collection
**Description:** Capillary blood sample
**Name:** Mitra® device with VAMS® (volumetric absorptive microsampling) technology
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** That Tacrolimus is within range: 10-20ng/ml
**Measure:** Tacrolimus in Capillary Blood Samples
**Time Frame:** 6 months
**Description:** That Creatinine is within range: 52.2 - 119.3 micromoles/L
**Measure:** Creatinine in Capillary Blood Samples
**Time Frame:** 6 months
#### Secondary Outcomes
**Description:** Results match standard venous results for Tacrolimus and is within range:10-20ng/ml then use of VAMS will be implemented into routine clinical practice for monitoring renal patients post transplant.
**Measure:** Tacrolimus is concordant with venous blood sample
**Time Frame:** 6 months
**Description:** Results match standard venous results for Creatinine and is within range: 52.2 - 119.3 micromoles/L.
**Measure:** Creatinine is concordant with venous blood sample
**Time Frame:** 6 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Post renal transplant patients taking tacrolimus
* having regular bloods taken for tacrolimus and renal function testing.
* Patients must be taking tacrolimus as part of their immunosuppressive regimen.
* They must be over 18 years of age
Exclusion Criteria:
* Patients under the age of 18 (the study is for adults only).
* Vulnerable adults who are deemed unable to give consent themselves - If applicable, this can be assessed using the Trust clinical tool 'Assessment of Mental Capacity'.
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Adult renal transplant patients (\>18 years old) taking tacrolimus as an immunosuppressant
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Kina Bennett, PhD
**Phone:** +44177252
**Phone Ext:** 2031
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Research Access
**Phone:** +44177252
**Phone Ext:** 2031
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Preston
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Research Access
- **Phone:** (+44) 1772 52
- **Phone Ext:** 2031
- **Role:** CONTACT
***Contact 2:***
- **Name:** Kina Bennett, PhD
- **Phone:** (+44) 1772 52
- **Phone Ext:** 2031
- **Role:** CONTACT
***Contact 3:***
- **Name:** Rosalyn Dunston
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United Kingdom
**Facility:** Lancashire Teaching Hospitals NHS Foundation Trust
**State:** Lancashire
**Status:** RECRUITING
**Zip:** PR2 9HT
#### Overall Officials
**Official 1:**
**Affiliation:** Lancashire Teaching Hospitals NHS Foundation Trust
**Name:** Kina Bennett, PhD
**Role:** STUDY_CHAIR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Document Section
### Large Document Module
#### Large Docs
- Date: 2023-01-27
- Filename: Prot_000.pdf
- Has ICF: False
- Has Protocol: True
- Has SAP: False
- Label: Study Protocol
- Size: 232372
- Type Abbrev: Prot
- Upload Date: 2024-05-31T07:51
## Derived Section
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M18950
- Name: Tacrolimus
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06445192
**Brief Title:** Evaluating the Impact of a Virtually Supervised Exercise Intervention and Group Counseling on Inflammation and the Microbiome of Smokers at High Risk for Lung Cancer, BE FIT Trial
**Official Title:** The BE FIT Study: Feasibility of an Exercise Intervention on Microbiome and Immune Function in a High-Risk Cohort for Lung Cancer
#### Organization Study ID Info
**ID:** OSU-22194
#### Organization
**Class:** OTHER
**Full Name:** Ohio State University Comprehensive Cancer Center
#### Secondary ID Infos
**Domain:** CTRP (Clinical Trial Reporting Program)
**ID:** NCI-2023-05556
**Type:** REGISTRY
### Status Module
#### Completion Date
**Date:** 2025-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-31
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-11-03
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2023-10-17
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Ohio State University Comprehensive Cancer Center
#### Responsible Party
**Investigator Affiliation:** Ohio State University Comprehensive Cancer Center
**Investigator Full Name:** Marisa Bittoni
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** This phase II trial evaluates how a virtually supervised exercise intervention in combination with group counseling affects inflammation and the bacterial composition (microbiome) of the gut in smokers who are at high risk for lung cancer. Physical exercise has been shown to reduce lung cancer development and to have beneficial effects on the gut microbiome and inflammation. Group counseling may promote adherence to the exercise intervention by empowering participants to exert greater control over their behavior and environment. This clinical trial may help researchers understand how exercise impacts inflammation and the microbiome in people at risk for lung cancer and whether or not exercise with counseling can improve health outcomes in high-risk individuals.
**Detailed Description:** PRIMARY OBJECTIVES:
I. To evaluate the feasibility and preliminary efficacy of establishing a multi-component virtually-delivered exercise intervention trial with longitudinal biomarker and microbiome collection in the Ohio State University Lung Cancer Screening Clinic (OSULCSC).
II. To determine the impact of the multi-component virtually-delivered exercise intervention on the microbiome and inflammatory biomarkers.
OUTLINE: Participants are randomized to 1 of 2 groups.
GROUP I: Participants receive the supervised aerobic and resistance exercise intervention over 1 hour via telehealth twice a week (BIW) in weeks 1-8 and once a week (QW) in weeks 9-12 and then continue with unsupervised exercise sessions BIW in weeks 13-52. Participants also attend group counseling sessions over 1 hour QW in weeks 1-8 and bi-weekly in weeks 9-12. Participants also wear a Fitbit throughout the trial and undergo collection of blood samples at baseline and follow up.
GROUP II: Participants receive usual care consisting of education on standard recommendations for physical activity, the benefits of exercise, and an example of a light walking program. Participants also wear a Fitbit throughout the trial and undergo collection of blood samples at baseline and follow up.
After completion of study intervention, participants are followed up at 12 weeks and 1 year.
### Conditions Module
**Conditions:**
- Lung Carcinoma
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Masking Description:** Outcome assessments will be obtained by research staff blinded to treatment group assignment.
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 40
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants receive the supervised aerobic and resistance exercise intervention over 1 hour via telehealth BIW in weeks 1-8 and QW in weeks 9-12 and then continue with unsupervised exercise sessions BIW in weeks 13-52. Participants also attend group counseling sessions over 1 hour QW in weeks 1-8 and bi-weekly in weeks 9-12. Participants also wear a Fitbit throughout the trial and undergo collection of blood samples at baseline and follow up.
**Intervention Names:**
- Procedure: Biospecimen Collection
- Other: Exercise Counseling
- Other: Exercise Intervention
- Other: Medical Device Usage and Evaluation
- Other: Physical Performance Testing
- Other: Questionnaire Administration
- Other: Telemedicine
**Label:** Group I (exercise intervention)
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants receive usual care consisting of education on standard recommendations for physical activity, the benefits of exercise, and an example of a light walking program. Participants also wear a Fitbit throughout the trial and undergo collection of blood samples at baseline and follow up.
**Intervention Names:**
- Other: Best Practice
- Procedure: Biospecimen Collection
- Other: Medical Device Usage and Evaluation
- Other: Physical Performance Testing
- Other: Questionnaire Administration
**Label:** Group II (usual care)
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Group II (usual care)
**Description:** Receive usual care
**Name:** Best Practice
**Other Names:**
- standard of care
- standard therapy
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Group I (exercise intervention)
- Group II (usual care)
**Description:** Undergo collection of blood samples
**Name:** Biospecimen Collection
**Other Names:**
- Biological Sample Collection
- Biospecimen Collected
- Specimen Collection
**Type:** PROCEDURE
#### Intervention 3
**Arm Group Labels:**
- Group I (exercise intervention)
**Description:** Attend group counseling
**Name:** Exercise Counseling
**Type:** OTHER
#### Intervention 4
**Arm Group Labels:**
- Group I (exercise intervention)
**Description:** Receive aerobic and resistance exercise intervention via telehealth
**Name:** Exercise Intervention
**Type:** OTHER
#### Intervention 5
**Arm Group Labels:**
- Group I (exercise intervention)
- Group II (usual care)
**Description:** Wear Fitbit
**Name:** Medical Device Usage and Evaluation
**Type:** OTHER
#### Intervention 6
**Arm Group Labels:**
- Group I (exercise intervention)
- Group II (usual care)
**Description:** Ancillary studies
**Name:** Physical Performance Testing
**Other Names:**
- Physical Fitness Testing
- Physical Function Testing
**Type:** OTHER
#### Intervention 7
**Arm Group Labels:**
- Group I (exercise intervention)
- Group II (usual care)
**Description:** Ancillary studies
**Name:** Questionnaire Administration
**Type:** OTHER
#### Intervention 8
**Arm Group Labels:**
- Group I (exercise intervention)
**Description:** Receive aerobic and resistance exercise intervention via telehealth
**Name:** Telemedicine
**Other Names:**
- Telehealth
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** To evaluate the feasibility and preliminary efficacy of establishing a multi-component virtually-delivered exercise intervention trial with longitudinal biomarker and microbiome collection in the Ohio State University Lung Cancer Screening Clinic (OSULCSC)
**Measure:** Number of patients recruited to virtually-delivered exercise intervention (feasibility)
**Time Frame:** Up to 1 year
**Description:** Study adherence is defined as a) the proportion of patients attending at least 20 out of 24 sessions for the 12-week program and b) the percentage of biospecimen samples collected at the post program period (12 weeks). This study will be considered feasible if the compliance rate for both of these combined is 75% or more. Descriptive statistics will be used to examine the distribution of all patient and treatment characteristics, including compliance.
**Measure:** Proportion of patients who achieve study adherence (feasibility) based on attendance to the exercise program sessions and biospecimens submitted.
**Time Frame:** During 12-week program
**Description:** Will assess the effect of the intervention on inflammatory markers of C-reactive protein and IL-6 separately using linear mixed models with the biomarker serving as the outcome variable. Will also assess the changes in the biomarkers across time in each intervention group.
**Measure:** Assess the number of participants with a change in inflammatory biomarkers
**Time Frame:** Baseline to post-intervention (12 weeks)
**Description:** Will assess the effect of the intervention on the diversity and relative abundances of individual microbes. Will compare everyone's post-intervention time point to baseline in control and the exercise interventions cohorts, applying linear or generalized mixed-effects models for the diversity or individual microbes.
**Measure:** Microbe relative abundances
**Time Frame:** Baseline to post-intervention (12 weeks)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* 50-77 years of age
* Current or former smoker with 20-pack year smoking history and within the last 15 years
* Fewer than 60 minutes of participation in moderate intensity physical activity each week
* All participants must be free of severe heart, respiratory (e.g. chronic obstructive pulmonary disease \[COPD\]), or systemic disease that would make moderate intensity exercise participation unsafe
* Willing to sign an informed consent
Exclusion Criteria:
* Person is on a regimen of the following medications: immunosuppressants, bisphosphonates, steroids, anticoagulants, warfarin, apixaban, probiotics
* Person undergoing treatment for cancer in any form
* Person plans to enter smoking cessation or change status
**Healthy Volunteers:** True
**Maximum Age:** 77 Years
**Minimum Age:** 55 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** The Ohio State Comprehensive Cancer Center
**Phone:** 800-293-5066
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Columbus
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Marisa Bittoni, PhD
- **Phone:** 614-206-3518
- **Role:** CONTACT
***Contact 2:***
- **Name:** Marisa Bittoni, PhD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Ohio State University Comprehensive Cancer Center
**State:** Ohio
**Status:** RECRUITING
**Zip:** 43210
#### Overall Officials
**Official 1:**
**Affiliation:** Ohio State University Comprehensive Cancer Center
**Name:** Marisa Bittoni, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### See Also Links
**Label:** The Jamesline
**URL:** http://cancer.osu.edu
## 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: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
### Condition Browse Module - Browse Leaves
- ID: M5534
- Name: Carcinoma
- Relevance: LOW
- As Found: Unknown
- ID: M10293
- Name: Inflammation
- Relevance: LOW
- As Found: Unknown
- ID: M11172
- Name: Lung Neoplasms
- Relevance: HIGH
- As Found: Lung Carcinoma
- ID: M14979
- Name: Respiratory Tract Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M16658
- Name: Thoracic Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M11168
- Name: Lung Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000008175
- Term: Lung Neoplasms
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06445179
**Acronym:** ENDO-RAS
**Brief Title:** ENDOmetriosis Robotic Assisted Surgery
**Official Title:** Robot-Assisted Versus Standard Laparoscopic Approach of Total Hysterectomy for Deep Infiltrating Endometriosis and Adenomyosis: A Multicenter, Open-label Randomized Controlled Trial
#### Organization Study ID Info
**ID:** 2024-A00350-47
#### Organization
**Class:** OTHER
**Full Name:** GCS Ramsay Santé pour l'Enseignement et la Recherche
### Status Module
#### Completion Date
**Date:** 2027-06
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-31
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2027-06
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-27
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** GCS Ramsay Santé pour l'Enseignement et la Recherche
#### 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 purpose of this study is to compare the robot-assisted approach with the laparoscopic approach in terms of reducing the rates of intraoperative and postoperative complications in patients undergoing total hysterectomy for DIE and adenomyosis without digestive tract involvement.
**Detailed Description:** The ENDO-RAS trial aims to evaluate the safety and effectiveness of robot-assisted laparoscopy compared to conventional laparoscopy for hysterectomy in patients with Deep infiltrating endometriosis and adenomyosis without digestive tract involvement, as verified by magnetic resonance imaging and classified using both the ENZIAN and Deep Pelvic Endometriosis Index classifications. These classifications are used to evaluate Deep infiltrating endometriosis and reproducibly predict the occurrence of postoperative complications.
Eligible patients will be recruited from the gynecological surgery department after meeting the inclusion and non-inclusion criteria and signed informed consent forms. Participants will then be randomly assigned to receive either robot-assisted total laparoscopic hysterectomy or total laparoscopic hysterectomy.
The ENDO-RAS Trial is a multicenter, randomized, controlled, and open-label study. Eligible patients will be randomized into two parallel groups.
### Conditions Module
**Conditions:**
- Endometriosis
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Eligible patients will be randomized into two parallel groups.
##### Masking Info
**Masking:** NONE
**Masking Description:** The ENDO-RAS Trial is a multicenter, randomized, controlled, and open-label study.
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 224
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** In the control group, all patients will undergo a Total Laparoscopic Hysterectomy. The number of ports needed for the laparoscope and assistants will be reported.
**Intervention Names:**
- Procedure: Total Laparoscopic Hysterectomy
- Device: Ureterolysis
**Label:** without Robotic-Assisted
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** All patients in the experimental group will undergo a Robotic-Assisted Total Laparoscopic Hysterectomy using either the HugoTM Robot-Assisted Surgery system (Medtronic©), the Da Vinci® Xi or X Surgical System, or CMR versus (if available). The number of ports required for the laparoscope, robotic arms, and assistants will be documented.
**Intervention Names:**
- Procedure: Total Laparoscopic Hysterectomy
- Device: Ureterolysis
**Label:** Robotic-Assisted
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Robotic-Assisted
- without Robotic-Assisted
**Description:** The standard procedure for performing total hysterectomy will also follow the Querleu and Morrow classification system, which divides the procedure into four types based on the extent of resection:
* Type A: minimum resection of paracervix.
* Type B: transection of the paracervix and the ureter.
* Type C: Transection of paracervix at the junction with the internal iliac vascular system
* Type D: Laterally extended resection. Furthermore, bilateral ureterolysis will be performed with the option of bilateral concomitant salpingo-oophorectomy.
**Name:** Total Laparoscopic Hysterectomy
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- Robotic-Assisted
- without Robotic-Assisted
**Description:** unilateral or bilateral ureterolysis with or without bilateral adnexectomy
**Name:** Ureterolysis
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Rate of intra- and post-operative complications (Clavien-Dindo grade 2 or higher) following surgery (Total Laparoscopic Hysterectomy).
**Measure:** Intra and post-operative complication rates
**Time Frame:** 3 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* ≥ 18 years of age.
* Diagnosed adenomyosis, either internal or external (magnetic resonance imaging) per the Enzian and dPEI classifications.
* Diagnosed deep infiltrating endometriosis per the Enzian and dPEI classifications, without the involvement of the digestive tract.
* Failure of first- and second-line medical treatment.
* Eligibility for total hysterectomy with complete removal of endometriosis lesions.
* Participants covered by entitled to social security.
* All participants must provide written informed consent before undergoing the surgical procedure.
Exclusion Criteria:
* Digestive tract involvement.
* Adenomyosis only.
* Contraindications to surgery.
* Participants who are under guardianship, curatorship, or deprivation of liberty.
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Pierre MD COLLINET
**Phone:** 677707402
**Phone Ext:** +33
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Lille
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Pierre MD COLLINET
- **Role:** CONTACT
**Country:** France
**Facility:** Hôpital Privé le Bois
**Zip:** 59000
## 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: Endometriosis
- ID: M30012
- Name: Adenomyosis
- Relevance: LOW
- As Found: Unknown
- ID: M8943
- Name: Genital Diseases, Female
- Relevance: LOW
- As Found: Unknown
- ID: M2876
- Name: Genital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27093
- Name: Female Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14127
- Name: Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M8399
- Name: Female Urogenital Diseases and Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000004715
- Term: Endometriosis
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06445166
**Brief Title:** Propranolol for the Treatment of Kaposi Sarcoma in Adults
**Official Title:** A Multicenter Phase II Study of Propranolol for the Treatment of Kaposi Sarcoma in Adults
#### Organization Study ID Info
**ID:** 24-x173
#### Organization
**Class:** OTHER
**Full Name:** Washington University School of Medicine
### Status Module
#### Completion Date
**Date:** 2027-09-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-31
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2027-03-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-09-30
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-31
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Washington University School of Medicine
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Is US Export:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Kaposi sarcoma (KS) lesions are initiated by endothelial cells infected with KS herpesvirus (KSHV), also known as human herpesvirus 8 (HHV-8). Lesion progression is driven by abnormal angiogenesis, chronic inflammation, and uncontrolled cell proliferation. KS remains one of the most commonly diagnosed cancers in many African countries where economic constraints prevent successful treatment in most patients. Treatment outcomes in developed countries are also often unsatisfactory in HIV positive patients despite good virological and immunological responses to antiretroviral therapy. Therefore, identification of new oral, safe treatment options for treatment of KS remains a research priority. Given the known anti-angiogenic properties and based on the treatment response with other benign vascular lesions such as infantile hemangioma, propranolol is a good candidate for the treatment of KS. The hypothesis of this study is that treating patients with Kaposi sarcoma with propranolol will result in an overall response rate (complete response rate plus partial response rate) of at least 45%, and that propranolol will be safe and well tolerated in this patient population.
### Conditions Module
**Conditions:**
- Kaposi Sarcoma
**Keywords:**
- Propranolol
- Kaposi
- Sarcoma
- Phase II
- HIV
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 25
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Begin at 1/2 the target dose for 2 days (4 doses), followed by a tolerability assessment. Patients who tolerate the 1/2 dose will begin the target dose on Day 3 for 2 days (4 doses), after which tolerability will be assessed. Patients who do not tolerate the target dose will decrease to a 1/2 dose for 2 days and then discontinue treatment; these patients will be withdrawn from the study and replaced. Those who continue will take the target dose for 12 weeks. At 12-week time point, one of the following paths will be taken:
* Complete response: continue taking propranolol at the target dose for another 6 weeks, followed by a reduced dose (1/2 the target) for 7 days, then discontinue treatment
* Partial response: continue taking propranolol at the target dose for another 12 weeks, followed by a reduced dose (1/2 the target) for 7 days, then discontinue treatment
* No response (stable disease/disease progression):reduced dose (1/2 the target) for 7 days, then discontinue treatment
**Intervention Names:**
- Drug: Propranolol Hydrochloride
**Label:** Propranolol
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Propranolol
**Description:** Dosing is as follows:
* Patients who weigh 40 to 59 kg:
* 40 mg BID (target)
* 20 mg BID (half the target)
* Patients who weigh ≥ 60 kg:
* 60 mg BID (target)
* 30 mg BID (half the target)
**Name:** Propranolol Hydrochloride
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** ORR is defined as the proportion of participants with complete response (CR) or partial response (PR) based on AMC KS Response Criteria.
**Measure:** Objective response rate (ORR)
**Time Frame:** Through completion of treatment (estimated to be 25 weeks)
#### Secondary Outcomes
**Measure:** Incidence of intolerable toxicities and treatment-emergent adverse events (TEAEs) based on CTCAE v 5.0.
**Time Frame:** From start of treatment through 30 days after completion of treatment (estimated to be 29 weeks)
**Measure:** Time to recurrence or progression among responders overall.
**Time Frame:** Through completion of follow-up (estimated to be 6 months and 25 weeks)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Biopsy proven Kaposi Sarcoma that is measurable with a millimeter ruler. Patients presenting for both front-line therapy and subsequent-line therapy will be considered.
* Must have two lesions greater or equal to 4 x 4 mm that are accessible for 3-mm punch biopsy.
* Must be KS stage T0 (confined to skin and/or lymph nodes and/or minimal oral lesions) or T1 (limited to tumor-associated edema of cutaneous lesions without functional impairment or flat oral lesions).
* At least 18 years of age.
* Weight \>40 kg
* ECOG performance status ≤ 2
* Meets the appropriate HIV-related criteria:
* If HIV positive, patient must be on antiretroviral therapy (ART) that conforms to local standards of care for at least 12 weeks. HIV positive patients will not be excluded based on CD4 count or HIV viral load.
* If on ART 12 to 24 weeks, must show evidence of KS progression requiring further systemic treatment.
* If on ART for \> 24 weeks, must show no evidence of regression in the last 8 weeks.
* If HIV negative, must not show evidence of improvement in the 12 weeks prior to enrollment.
* Propranolol is US FDA pregnancy category C. For this reason, women of childbearing potential must agree to use adequate contraception prior to study entry, for the duration of study participation, and for one month after completion of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, s/e must inform her treating physician immediately.
* Able to take an oral pill.
* Ability to understand and willingness to sign an IRB approved written informed consent document.
Exclusion Criteria:
* Visceral disease causing functional impairment.
* Urgently clinically indicated for immediate cytotoxic chemotherapy. Patients who have received cytotoxic chemotherapy \> 4 weeks prior to screening are eligible.
* Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial
* Currently taking beta-andrenergic antagonist(s) for other indications. Prior use is allowed.
* Currently receiving concurrent treatment with an anticancer therapy. Patients must not have received any anticancer therapies within 4 weeks prior to receiving the first dose of propranolol.
* Currently receiving any other investigational agents.
* A history of allergic reactions or hypersensitivity attributed to compounds of similar chemical or biologic composition to propranolol.
* History of asthma or current diagnosis of obstructive airway disease such as asthma, COPD, or bronchiolitis.
* History of diabetes mellitus, as defined by any of the following: A random blood glucose value of at least 200 mg/dL in the presence of hyperglycemia symptoms (weight loss, blurry vision, thirst, polyuria), fasting plasma glucose value of at least 126 mg/dL, A1c value of at least 6.5%, or two hour plasma glucose value of at least 200 mg/dL during a 75 g oral glucose tolerance test.
* History of uncompensated heart failure, severe sinus bradycardia, sick sinus syndrome, or heart block greater than first degree.
* History of hypotension (systolic blood pressure \<90 mmHg or mean arterial pressure \<65 mmHg) or orthostasis (\>20 mmHg fall in systolic pressure or \>10 mmHg fall in diastolic pressure with standing).
* Shortness of breath, hemoptysis, or moderate/severe cough not attributable to causes other than KS.
* Bleeding from the mouth or rectum not attributable to causes other than KS.
* Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
* Concern for KSHV inflammatory cytokine syndrome.
* Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 21 days of study entry.
* Evidence of chronic hepatitis B virus (HBV) that is detectable on suppressive therapy. Patients with evidence of chronic HBV infection with undetectable HBV viral load on suppressive therapy are eligible. HBV testing not required in the absence of known history of infection.
* History of hepatitis C virus (HCV) infection that has not been cured or that has a detectable viral load. Patients with a history of HCV that has been treated and cured are eligible. Patients with HCV infection who are currently on treatment and have an undetectable HCV viral load are eligible. HCV testing not required in the absence of known history of infection.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Lee Ratner, M.D., Ph.D.
**Phone:** 314-362-8836
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Minneapolis
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Shane McAllister, M.D., Ph.D.
- **Phone:** 612-626-5637
- **Role:** CONTACT
***Contact 2:***
- **Name:** Shane McAllister, M.D., Ph.D.
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** University of Minnesota
**State:** Minnesota
**Zip:** 55455
**Location 2:**
**City:** Saint Louis
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Lee Ratner, M.D., Ph.D.
- **Phone:** 314-362-8836
- **Role:** CONTACT
***Contact 2:***
- **Name:** Lee Ratner, M.D., Ph.D.
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 3:***
- **Name:** Thomas Odeny, M.D., MPH, Ph.D.
- **Role:** SUB_INVESTIGATOR
***Contact 4:***
- **Name:** Kandice Roberts, M.D.
- **Role:** SUB_INVESTIGATOR
***Contact 5:***
- **Name:** Feng Gao, M.D., Ph.D.
- **Role:** SUB_INVESTIGATOR
**Country:** United States
**Facility:** Washington University School of Medicine
**State:** Missouri
**Zip:** 63110
**Location 3:**
**City:** New York
**Contacts:**
***Contact 1:***
- **Name:** Ethel Cesarman, M.D., Ph.D.
- **Phone:** 212-746-8838
- **Role:** CONTACT
***Contact 2:***
- **Name:** Ethel Cesarman, M.D., Ph.D.
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** New York Presbyterian/Weill Cornell
**State:** New York
**Zip:** 10065
#### Overall Officials
**Official 1:**
**Affiliation:** Washington University School of Medicine
**Name:** Lee Ratner, M.D., Ph.D.
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Access Criteria:** Anyone who wishes to access the data for any purpose may be granted access to the data.
**Description:** The data shared will consist of 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.
### References Module
#### See Also Links
**Label:** Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
**URL:** http://www.siteman.wustl.edu
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000018204
- Term: Neoplasms, Connective and Soft Tissue
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000009369
- Term: Neoplasms
- ID: D000006566
- Term: Herpesviridae Infections
- ID: D000004266
- Term: DNA Virus Infections
- ID: D000014777
- Term: Virus Diseases
- ID: D000007239
- Term: Infections
- ID: D000009383
- Term: Neoplasms, Vascular Tissue
### Condition Browse Module - Browse Branches
- Abbrev: BC01
- Name: Infections
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: All
- Name: All Conditions
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M15332
- Name: Sarcoma, Kaposi
- Relevance: HIGH
- As Found: Kaposi's Sarcoma
- ID: M15327
- Name: Sarcoma
- Relevance: HIGH
- As Found: Sarcoma
- ID: M18250
- Name: HIV Infections
- Relevance: LOW
- As Found: Unknown
- ID: M3522
- Name: Acquired Immunodeficiency Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M20350
- Name: Neoplasms, Connective and Soft Tissue
- Relevance: LOW
- As Found: Unknown
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
- ID: M10283
- Name: Infections
- Relevance: LOW
- As Found: Unknown
- ID: M6368
- Name: Communicable Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M9643
- Name: Herpesviridae Infections
- Relevance: LOW
- As Found: Unknown
- ID: M17522
- Name: Virus Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7442
- Name: DNA Virus Infections
- Relevance: LOW
- As Found: Unknown
- ID: M12328
- Name: Neoplasms, Vascular Tissue
- Relevance: LOW
- As Found: Unknown
- ID: T5284
- Name: Soft Tissue Sarcoma
- Relevance: HIGH
- As Found: Sarcoma
- ID: T3199
- Name: Kaposi Sarcoma
- Relevance: HIGH
- As Found: Kaposi's Sarcoma
### Condition Browse Module - Meshes
- ID: D000012514
- Term: Sarcoma, Kaposi
- ID: D000012509
- Term: Sarcoma
### Intervention Browse Module - Ancestors
- ID: D000000319
- Term: Adrenergic beta-Antagonists
- ID: D000018674
- Term: Adrenergic Antagonists
- ID: D000018663
- Term: Adrenergic Agents
- ID: D000018377
- Term: Neurotransmitter Agents
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000000889
- Term: Anti-Arrhythmia Agents
- ID: D000000959
- Term: Antihypertensive Agents
- ID: D000014665
- Term: Vasodilator Agents
### Intervention Browse Module - Browse Branches
- Abbrev: AnArAg
- Name: Anti-Arrhythmia Agents
- Abbrev: AnAg
- Name: Antihypertensive Agents
- Abbrev: VaDiAg
- Name: Vasodilator Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M14298
- Name: Propranolol
- Relevance: HIGH
- As Found: Entinostat
- ID: M3671
- Name: Adrenergic beta-Antagonists
- Relevance: LOW
- As Found: Unknown
- ID: M20746
- Name: Adrenergic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M20755
- Name: Adrenergic Antagonists
- Relevance: LOW
- As Found: Unknown
- ID: M20504
- Name: Neurotransmitter Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4213
- Name: Anti-Arrhythmia Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4277
- Name: Antihypertensive Agents
- Relevance: LOW
- As Found: Unknown
- ID: M17412
- Name: Vasodilator Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000011433
- Term: Propranolol
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06445153
**Brief Title:** Digitalized Clinical Decision Support for the Prevention of Postoperative Delirium (POD)
**Official Title:** Digitalized Clinical Decision Support for the Prevention of Postoperative Delirium (POD)
#### Organization Study ID Info
**ID:** Digi-POD
#### Organization
**Class:** OTHER
**Full Name:** Charite University, Berlin, Germany
### Status Module
#### Completion Date
**Date:** 2025-10-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-05
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-10-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-03
**Type:** ACTUAL
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-06-05
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** BARMER
**Class:** OTHER
**Name:** Technische Universität Berlin
**Class:** OTHER
**Name:** Freie Universität Berlin
**Class:** UNKNOWN
**Name:** Universitätsklinik der Ruhr-Universität Bochum
#### Lead Sponsor
**Class:** OTHER
**Name:** Charite University, Berlin, Germany
#### Responsible Party
**Investigator Affiliation:** Charite University, Berlin, Germany
**Investigator Full Name:** Claudia Spies
**Investigator Title:** Head of the Department of Anesthesiology and Intensive Care Medicine (CCM/CVK)
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The project aims to improve patient safety, reduce barriers to the implementation of current guideline recommendations, reduce workload in clinics, increase efficiency in work processes and close gaps in care.
**Detailed Description:** Postoperative delirium (POD) is the most common post-operative complication in the 70+ age group, affecting approximately fifteen percent of elderly patients. POD is characterized by impaired attention, awareness, and cognitive function. Both patients and their families are severely affected by the effects of this condition. While symptoms of POD occur during hospitalization, they have a critical impact on post-hospitalization quality of life, dependency on long-term care, and life expectancy.
The overarching goal of the Digi-POD project consortium is to develop a digital decision support system that makes current evidence-based guideline recommendations for POD machine-readable and allows automated, real-time validation against clinical data.
### Conditions Module
**Conditions:**
- Postoperative Delirium
**Keywords:**
- Clinical decision support system, Delirium risk factors, recommendations, surgery
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** SEQUENTIAL
**Intervention Model Description:** Digi-POD is a multicenter, prospective, longitudinal intervention study in a before-and-after design with quantitative process analysis
##### Masking Info
**Masking:** NONE
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 800
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Control phase: in this phase, all study patients receive the standard therapy of the respective study center.
**Label:** Control phase
**Type:** NO_INTERVENTION
#### Arm Group 2
**Description:** In this phase, the intervention with Digi-POD is made available as Clinical Decision Support System. The intervention consists of providing patients, relatives and caregivers with Digi-POD decision support for the prevention of delirium and treatment decisions for delirium in accordance with the recommendations from the guidelines in addition to the standard therapy of the respective study center.
**Intervention Names:**
- Other: Intervention with clinical decision support system
**Label:** Intervention phase
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Intervention phase
**Description:** To this phase, patient data is automated and systematically analyzed in order to derive decision support based on current evidence and make it available to Digi-POD users (patients, relatives, nursing staff, doctors, other healthcare professionals).
**Name:** Intervention with clinical decision support system
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Guideline adherence: proportion of guideline recommendations fulfilled per patient in the first five postoperative days. The guideline adherence rate up to postoperative day 5 (or earlier if the patient has already been discharged) is calculated as a simple division: Number of recommendations fulfilled by number of all recommendations (N=6). A guideline adherence rate of at least 4 out of 6 points (67%) per patient is considered clinically sufficient.
**Measure:** Guideline adherence
**Time Frame:** Up to five days
**Description:** Number of postoperative delirium- free days within 5 days postoperatively per patient
**Measure:** Postperative delirium- free days
**Time Frame:** Up to five days
#### Secondary Outcomes
**Description:** Signals are measured by Electroencephalography Monitor.
**Measure:** Changes of Electroencephalography
**Time Frame:** Participants will be followed up until the end of the operation, an expected average of 60 minutes
**Description:** Blood pressure is measured in millimeters of mercury. Drop in blood pressure, Digi-POD cutoff RR systolic below 20% of baseline from start of surgery to discharge ICU.
**Measure:** Blood pressure
**Time Frame:** Participants will be followed up until the end of hospital stay, an expected average of 7 days
**Description:** Heart rate (or pulse rate) is the frequency of the heartbeat measured by the number of contractions of the heart per minute.
**Measure:** Pulse
**Time Frame:** Participants will be followed up until the end of hospital stay, an expected average of 7 days
**Description:** Heart rhythm is measured by an electrocardiogram used to evaluate heart frequencies.
**Measure:** Heart rhythm
**Time Frame:** Participants will be followed up until the end of hospital stay, an expected average of 7 days
**Description:** Heart rate is measured by an electrocardiogram used to evaluate the heart. Heart rate drop Digi-POD cutoff below 50 bpm from start of surgery to discharge ICU.
**Measure:** Heart rate
**Time Frame:** Participants will be followed up until the end of hospital stay, an expected average of 7 days
**Description:** Oxygen saturation is measured by pulse oximetry.
**Measure:** Oxygen saturation
**Time Frame:** Participants will be followed up until the end of hospital stay, an expected average of 7 days
**Description:** If dexmedetomidine is administered by the attending physician, the information from the patient's dexmedetomidine medication chart is recorded.
**Measure:** Amount of dexmedetomidine
**Time Frame:** Participants will be followed up until the end of intensive care unit stay, an expected average of 3 days.
**Description:** Multicomponent/multimodal preventive measures to avoid POD are recorded by a questionnaire.
**Measure:** Therapeutic measures against postoperative delirium (POD)
**Time Frame:** Participants will be followed up until the end of hospital stay, an expected average of 7 days
**Description:** Multicomponent team meetings to discuss preventive measures to avoid POD will be recorded by a questionnaire.
**Measure:** Team meetings on postoperative delirium (POD)
**Time Frame:** Participants will be followed up until the end of hospital stay, an expected average of 7 days
**Description:** Delirium incidence is measured with validated delirium scores.
**Measure:** Delirium incidence
**Time Frame:** Participants will be followed up until the end of hospital stay, an expected average of 7 days
**Description:** Delirium duration is measured in days
**Measure:** Delirium duration
**Time Frame:** Participants will be followed up until the end of hospital stay, an expected average of 7 days
**Description:** Proportion of patients with adequate (at least 4 out of 6 points) adherence to guidelines.
**Measure:** Proportion of patients with adequate adherence
**Time Frame:** Participants will be followed up until the end of hospital stay, an expected average of 7 days
**Description:** Proportion of patients with good (at least 5 out of 6 points) adherence to guidelines
**Measure:** Proportion of patients with good adherence
**Time Frame:** Up to 7 postoperative days
**Description:** Number of POD-free days in patients who achieved less than 80% adherence to the guidelines.
**Measure:** Number of POD-free days in patients who achieved less than 80% adherence to the guidelines.
**Time Frame:** Up to 7 postoperative days
**Description:** Percentage of guideline recommendations fulfilled per patient in the first 7 postoperative days.
**Measure:** Guideline adherence
**Time Frame:** Up to 7 postoperative days
**Description:** Number of POD-free days within 7 days is measured postoperatively per patient:in
**Measure:** Number of POD-free days within 7 days
**Time Frame:** Up to 7 postoperative days
**Description:** Delirium incidence in patients who received delirium screening with validated delirium scores twice a day in at least two shifts (per-protocol analysis)
**Measure:** Delirium incidence within 7 days
**Time Frame:** Up to 7 postoperative days
**Description:** Anxiety is measured by Faces Anxiety Scale
**Measure:** Anxiety
**Time Frame:** Up to 5 postoperative days
**Description:** Pain is measured with validated pain scores, scoring form 0 (no pain) to 10 (highest pain).
**Measure:** Pain
**Time Frame:** Up to 5 postoperative days
**Description:** Depth of sedation is measured with the Richmond Agitation-Sedation Scale (RASS)
**Measure:** Depth of sedation
**Time Frame:** Up to 5 postoperative days
**Description:** Functional performance is measured with the Glagow Coma Scale
**Measure:** Functional performance
**Time Frame:** Up to 5 postoperative days
**Description:** Concomitant medication is measured in dosis per day.
**Measure:** Concomitant medication
**Time Frame:** Up to 5 postoperative days
**Description:** Postoperative procedures/therapies and complications classified according to Clavien-Dindo
**Measure:** Complications
**Time Frame:** Up to 7 postoperative days
**Description:** Infection status is measured by chart review
**Measure:** Infection status
**Time Frame:** Up to 7 postoperative days
**Description:** The total score in the CCI is derived by summing the assigned weights of all comorbid conditions presented by the client. Higher scores indicate a more severe condition and consequently, a worse prognosis.
**Measure:** Charlson comorbidity index (CCI)
**Time Frame:** Participants will be followed up until the end of hospital stay, an expected average of 7 days
**Description:** Cognitive status is measured with validated scores.
**Measure:** Change in cognitive status
**Time Frame:** Up to 6 months
**Description:** Care level is measured by chart review.
**Measure:** Change in care level for BARMER patients
**Time Frame:** Up to 6 months
**Measure:** Change in utilization of inpatient care
**Time Frame:** Up to 6 months
**Description:** Patient-Reported Outcome Measures are recorded by PROM instruments.
**Measure:** Change in Patient-Reported Outcomes Measures (PROMs)
**Time Frame:** Up to 3 months
**Description:** Patient-Reported Experience Measures are recorded by PREM instruments.
**Measure:** Change in Patient-Reported Experience Measures (PREMs)
**Time Frame:** Participants will be followed up until the end of hospital stay, an expected average of 7 days
**Description:** Frailty is measured by a modified Fried score.
**Measure:** Change in the result from the detailed geriatric assessment and the frailty scoring
**Time Frame:** Up to 6 months
**Description:** Length of hospital stay is measured in days.
**Measure:** Length of hospital stay
**Time Frame:** Participants will be followed up until the end of hospital stay, an expected average of 7 days
**Description:** Length of intensive care unit stay is measured in days.
**Measure:** Length of intensive care unit stay
**Time Frame:** Participants will be followed up until the end of hospital stay, an expected average of 7 days
**Description:** Discharge type is taken from the medical record.
**Measure:** Discharge type
**Time Frame:** Participants will be followed up until the end of hospital stay, an expected average of 7 days
**Description:** Length of stay in the recovery room is measured in hours.
**Measure:** Length of stay in the recovery room
**Time Frame:** Participants will be followed up until the end of hospital stay, an expected average of 7 days
**Description:** Duration of surgery is measured in minutes.
**Measure:** Duration of surgery
**Time Frame:** Participants will be followed up until the end of operation, an expected average of 2 hours
**Description:** Duration of anesthesia is measured in minutes.
**Measure:** Duration of anesthesia
**Time Frame:** Participants will be followed up until the end of operation, an expected average of 2 hours
**Description:** Recommended therapies (physiotherapy, memory consultation, nutritional counseling) are measured by physical assessments.
**Measure:** Recommended therapies
**Time Frame:** Up to 6 months
**Description:** Incidence of Post Intensive Care Syndrome (PICS) is measured by a composite of psychological, cognitive and functional scores.
**Measure:** Incidence of Post Intensive Care Syndrome (PICS)
**Time Frame:** Up to 3 months
**Description:** Health economic data according to cost of patient care (The §21 dataset (diagnoses and operation-codes).
**Measure:** Social data/Paragraph 21 data
**Time Frame:** Up to 6 months
**Description:** Mortality is measured inhospital and during ths FU phase.
**Measure:** All-cause "mortality"
**Time Frame:** Up to 6 months
**Description:** Direct care costs during inpatient treatment from the perspective of SHI (statutory health insurance).
**Measure:** Direct cost data
**Time Frame:** Participants will be followed up until the end of hospital stay, an expected average of 7 days
**Description:** e.g. for outpatient/inpatient treatment, medication, remedies/aids and long-term care) from the perspective of statutory health insurance (SHI) and statutory long-term care insurance (LTCI)
**Measure:** Follow-up costs
**Time Frame:** Up to 6 months
**Description:** Utilization of benefits from (statutory health insurance) (SHI) and statutory long-term care insurance (GPV) (in particular need for long-term care, outpatient/inpatient treatment)
**Measure:** Utilization of benefits
**Time Frame:** Up to 6 months
**Description:** Personnel resources are measured by commitment time
**Measure:** Personnel resources during the hospital stay
**Time Frame:** Participants will be followed up until the end of hospital stay, an expected average of 7 days
**Description:** Costs are calculated with project data.
**Measure:** Investment costs
**Time Frame:** Participants will be followed up until the end of hospital stay, an expected average of 7 days
**Description:** Costs are calculated with project data.
**Measure:** Maintenance costs
**Time Frame:** Participants will be followed up until the end of hospital stay, an expected average of 7 days
### Eligibility Module
**Eligibility Criteria:** Study patients:
Inclusion Criteria:
* Age ≥ 70 years
* Male and female patients
* Patients who are insured through statutory health insurance
* Patients capable of giving consent for inclusion: by the patient, preoperatively
* Patients under guardianship for inclusion: written declaration of consent by guardian
* Operation (elective)
Exclusion Criteria:
* Insufficient language skills
* Moribund patients
Study relatives
Inclusion Criteria:
* Age ≥ 18 years
* Male and female relatives
* Relatives capable of giving consent for inclusion
Exclusion Criteria:
* Insufficient language skills
* No consent for data entry
Substudy of the Charité - University Berlin:
Inclusion criteria:
- All inpatients ≥ 18 years of age who have undergone delirium screening with a validated delirium screening instrument
**Minimum Age:** 70 Years
**Sex:** ALL
**Standard Ages:**
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Claudia Spies, MD, Prof.
**Phone:** +49 30 450 55 11 02
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Bad Oeynhausen
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Vera von Dossow, MD, Prof.
- **Phone:** 05731 97-1128
- **Role:** CONTACT
***Contact 2:***
- **Name:** Vera von Dossow, MD
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 3:***
- **Name:** Janis Fliegenschmidt
- **Role:** SUB_INVESTIGATOR
**Country:** Germany
**Facility:** Institut für Anästhesiologie und Schmerztherapie-Herz- und Diabeteszentrum NRW- Universitätsklinik der Ruhr-Universität Bochum
**State:** Bochum
**Status:** RECRUITING
**Zip:** 32545
**Location 2:**
**City:** Berlin
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Claudia Spies, MD, Prof.
- **Phone:** +49 30 450 55 11 02
- **Role:** CONTACT
***Contact 2:***
- **Name:** Claudia Spies, MD, Prof.
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 3:***
- **Name:** Fatima Halzl-Yürek, MD
- **Role:** SUB_INVESTIGATOR
**Country:** Germany
**Facility:** Department of Anaesthesiolgy and Intensive Care Medicine CCM/CVK, Charite- University Berlin
**Status:** RECRUITING
**Zip:** 13355
**Location 3:**
**City:** Berlin
**Contacts:**
***Contact 1:***
- **Name:** Thomas König, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Thomas König, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Germany
**Facility:** CARITAS Klinik Maria Heimsuchung
**Status:** RECRUITING
**Location 4:**
**City:** Berlin
**Contacts:**
***Contact 1:***
- **Name:** Christian von Heymann, MD, Prof.
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Germany
**Facility:** Klinikum im Friedrichshain - Vivantes - Netzwerk für Gesundheit GmbH
**Status:** RECRUITING
#### Overall Officials
**Official 1:**
**Affiliation:** Charite University, Berlin, Germany
**Name:** Claudia Spies, MD, Prof.
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000003221
- Term: Confusion
- ID: D000019954
- Term: Neurobehavioral Manifestations
- ID: D000009461
- Term: Neurologic Manifestations
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000019965
- Term: Neurocognitive Disorders
- ID: D000001523
- Term: Mental Disorders
- ID: D000011183
- Term: Postoperative Complications
- ID: D000010335
- Term: Pathologic Processes
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M6894
- Name: Delirium
- Relevance: HIGH
- As Found: Delirium
- ID: M772
- Name: Emergence Delirium
- Relevance: HIGH
- As Found: Postoperative Delirium
- ID: M6446
- Name: Confusion
- 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
- 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: M14065
- Name: Postoperative Complications
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003693
- Term: Delirium
- ID: D000071257
- Term: Emergence Delirium
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06445140
**Acronym:** MONAGE
**Brief Title:** Dynamics of Motivational Factors for Physical Activity and Nutrition in Oncogeriatrics
**Official Title:** Dynamics of Motivational Factors for Physical Activity and Nutrition in Oncogeriatrics
#### Organization Study ID Info
**ID:** PROICM 2024-01 MON
#### Organization
**Class:** OTHER
**Full Name:** Institut du Cancer de Montpellier - Val d'Aurelle
### Status Module
#### Completion Date
**Date:** 2026-09-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-31
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-09-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-28
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Institut du Cancer de Montpellier - Val d'Aurelle
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Oncogeriatric: a collaboration between oncologists and geriatricians which aims to ensure that all elderly cancer patients receive treatment adapted to their condition, thanks to a multidisciplinary and multi-professional approach.
This project aims to gain a better understanding of the motivational determinants of PA and nutrition in elderly cancer patients.
It has a dual objective:
1. to identify clusters/groups in patients on the basis of daily motivational factors focusing on PA and nutrition
2. on the basis of the results obtained in (1), to propose an interventional study based on the previously established clusters, in order to examine the effects of a behavioral intervention on patients' adherence to PA and nutrition, both agreed according to an individualized goal and defined in agreement with the patient and the multidisciplinary team, taking into account the recommendations.
**Detailed Description:** While cancer is the leading cause of death in people aged 75 to 85, and the second leading cause of death in people over 85 , there is little evidence in the elderly due to their under-representation in clinical trials. This under-representation increases the risk of under- or over-treatment in this population, making the elderly even more vulnerable to chemotherapy-related toxicities \[3\]. There is considerable heterogeneity in the population of patients over 70. Some advance in age with few comorbidities and maintained independence, while others combine several chronic pathologies and deficits . Treatments to combat these comorbidities are sometimes subject to drug interactions with anticancer therapies, which makes prescribing treatments all the more difficult in oncogeriatrics. The balance between quality of life and quantity of life is fundamental in drawing up a care plan \[5\]. Support for the elderly cancer patient must be comprehensive and individualized, incorporating the patient's opinion and a multidisciplinary approach to meet all identified needs .
Physical inactivity and undernutrition: risky behaviours leading to over-toxicity of treatments, worsening of co-morbidities and increased risk of mortality.
Ageing leads to physiological changes (hormonal, metabolic, etc.) and an increase in risk behaviours, including physical inactivity and undernutrition \[6,7\]. These are responsible for a loss of strength and muscle mass \[8\], exacerbated by cancer and its treatments \[9\], a phenomenon all the more marked in the elderly.
This progressive and generalized loss of muscle mass and strength is associated with a deterioration in physical capacity and high rates of hospitalization and mortality.Reduced muscle mass is associated with over-toxicity to chemotherapies, with a direct impact on survival.Reduced muscle strength is an important predictor of adverse events such as falls .Beyond muscle-related issues, these risk behaviors associated with aging also lead to the onset of other comorbidities and a higher risk of mortality .
In this context, nutritional monitoring and physical activity (PA) are two complementary and effective interventions for maintaining muscle status and preventing undernutrition during oncology treatment. More specifically, prevention and management of this loss of muscle mass and strength should be based on adequate energy and protein intake and multimodal PA (including muscle strengthening coupled with exercise conditioning) at moderate intensity.
These recommendations apply to both primary, age-related mass loss, and secondary, disease-related mass loss.
Although an intervention combining nutritional monitoring and regular PA practice is recognized as effective in maintaining muscle status and preventing undernutrition, it is difficult to achieve high adherence and lasting behavioural changes to move the elderly towards a more active lifestyle and to change their eating habits .
The theory of planned behavior: a theoretical approach that facilitates behavior change towards an active lifestyle associated with adapted nutritional behaviors.
Identifying the motivational factors associated with PA and nutrition in this population could help facilitate the adoption and sustainability of these behaviours.
The literature indicates that using a theoretical approach to identify motivational factors associated with PA and nutrition is important to facilitate behavior change and hope for higher adherence . A meta-analysis has showń that no theory is superior to another in terms of effectivenesś for modifying PA and that interventions are more effective when based on a single theory rather than a combination of theories . In this respect, the theory of planned behavior (TCP) is commonly used in the study of behavior change, particularly for an aging population (Figure 1). This theory assumes that the adoption of a behavior stems from the formation of intentions in the individual. These intentions are facilitated by attitudes, subjective norms (particularly in the caregiver) and self-perceived behavioral control:
* Attitudes represent the benefits perceived by the individual in performing the behavior, i.e. benefits related to the usefulness of the behavior and those related to the pleasure of performing it.
* Subjective norms correspond to the individual's social influence, represented by what those around him think of the behavior he wants to undertake.
* Perceived behavioral control refers to the perceived ease or difficulty of performing the behavior, and thus to the individual's belief that he or she possesses the necessary resources to perform the behavior. Moreover, this variable is assumed to be directly related to behavior.
However, TCP has been criticized for its variable prediction of behavioral intentions. Indeed, the designs used are based on a limited number of measures, failing to take into account the temporal fluctuation of perceptions and intra-individual variability. In response to these methodological limitations, Maher and colleagues investigated the use of repeated-measures methods to assess the relationship between intentions and behavior. In particular, the study revealed that intentions can vary according to the time of day, reflecting the dynamics of motivational variables. As a result, repeated-measures methods are effective for measuring TCP variables, as they identify the contexts most conducive to putting intentions into action.
In this respect, the Ecological Momentary Assessment (EMA) method enables repeated sampling of behaviors and psychological variables, in real time , which could take into account the temporal fluctuation of perceptions.
This data collection method is suitable for measuring TCP variables and could improve their predictive level. It is feasible with high compliance, above 80%, in the elderly.
Behavior change techniques: an effective, individualized intervention to optimize the adoption and sustainability of health behaviors
In oncology and geriatrics, intervention research indicates that an increase in TCP variables is accompanied by a significant increase in PA levels. Interventions based on behavior change techniques (BCT) , alone or in combination, have been shown to be effective in promoting PA and nutritionhave validated a taxonomy that lists 16 groups of CBTs: 1. goal and planning, 2. behavioral monitoring and feedback, 3. social support, 4. knowledge modification, 5. behavioral consequences, 6. behavioral comparison, 7. associations, 8. repetition and substitution, 9. comparison of outcomes, 10. behavior-related rewards and threats, 11. regulation, 12. antecedents, 13. identitý, 14. anticipating consequences, 15. self-conviction, 16. imagery/hidden learning.
In a context where the scientific literature does not allow for the reproducibility of protocols, which are often insufficiently described, this taxonomy standardizes the language used in intervention studies, and contributes to their readability and dissemination within the scientific community.
By improving the observability and feasibility of the components of an intervention, it becomes possible to develop effective, individualized interventions that take into account the singularity of the individual and his or her situation. With the aim of developing an optimal behavior-change intervention for elderly cancer patients, further research is needed into understanding the mechanisms of action and the effect of CBTs on PA and nutrition behaviors. To this end, N-of-1 designs facilitate the development of individualized interventions, taking into account intra-individual variability and the fluctuation of measured variables \[27\]. In particular, these N-of-1 designs have been recommended by the authors in recent research perspectives on CBT and PA behaviors and nutrition.
### Conditions Module
**Conditions:**
- Cancer
**Keywords:**
- oncogeriatry
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 55
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** This study is divided into two distinct parts (phase):
- A first observational part, already carried out, with the specific aim of assessing the relationship between motivation and behavior, for physical activity and nutrition.
The observational part enabled us to observe the relevant motivational levers for developing the second part of the study, the interventional part.
- The specific aim of the second, interventional part, in which we are inviting you to take part, is to improve physical activity and nutrition behaviours through the implementation of a behavioural intervention\*.
**Intervention Names:**
- Behavioral: Collecting the variables and Implementation of a behavioural intervention
**Label:** Observation phase and Intervention phase
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Observation phase and Intervention phase
**Description:** The observational phase (during 15 days)
* Two measurements per day for motivational variables and physical activity and nutrition
* Two measurements per day for nutrition
* Three measurements per day for fatigue
* Continuous PA measurement by accelerometer
The interventional phase :
Part A (during 7 days)
* measuring physical activity (PA)
* complete questionnaires and numerical scales :
* Motivational factors
* Self-evaluation of nutrition
* Self-assessment of fatigue
Part B: BEHAVIORAL INTERVENTION (10 weeks),the APA teacher will call a patient once a week for follow-up.
Answer questionnaires and scales on the digital platform will be done :
* Motivational factors
* Self-evaluation of nutrition
* Self-assessment of fatigue
Part C : End of interventional phase(during 7 days)
* measuring physical activity
* complete questionnaires and numerical scales :
* Motivational factors
* Self-evaluation of nutrition
* Self-assessment of fatigue
**Name:** Collecting the variables and Implementation of a behavioural intervention
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** Clusters (groups of patients) evaluated by the "silhouette coefficient" and seprated by behavior, on one hand concerning Physical Activity (PA) and on the other hand concerning nutrition.
**Measure:** For observationnal phase : Identify relevant motivational levers in order to build a personalized and adapted behavioral intervention to improve physical activity and nutrition behaviors, via cluster analysis.
**Time Frame:** from baseline at 15 days
**Description:** Quality of nutrition questionnaire (Ingestas)
**Measure:** For Interventionnal phase : Improving nutrition behaviors of elderly cancer patients
**Time Frame:** from baseline at 12 weeks
**Description:** Number of physical activities
**Measure:** For Interventionnal phase : Improving physical activity behaviors of elderly cancer patients
**Time Frame:** from baseline at 12 weeks
#### Secondary Outcomes
**Description:** The proportion of participants with a data collection rate
**Measure:** Measure the population's adherence to a methodology using digital tools and data collection via EMA.
**Time Frame:** at 15 days and at 12 weeks
**Description:** Percentage of patients included vs total number of patients offered study
**Measure:** Study acceptance of participation in the study and reasons for refusal
**Time Frame:** at 15 days and at 12 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Patient aged 70 or over
2. With cancer (solid tumors, all sites)
3. G8 ≤ 14
4. Inactive (patient not meeting recommended physical activity levels of 150 minutes per week at moderate intensity)
5. Patient has given informed, written and express consent
6. Patient affiliated to a French social security scheme.
Exclusion Criteria:
1. Known presence of brain metastases
2. Inability to participate in digital platform assessments or physical tests
3. Inability to eat orally
4. Contraindication or inability to engage in physical activity
5. Patient unable to follow up regularly for psychological, family, numerical, social or geographical reasons
6. Person deprived of liberty or under protective custody or guardianship.
**Minimum Age:** 70 Years
**Sex:** ALL
**Standard Ages:**
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** MOUSSION AURORE
**Phone:** 0467613102
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** GALLET SUCHET BLANDINE
**Phone:** +334 67 61 3055
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Montpellier
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** MOUSSION AURORE
- **Phone:** 0467613102
- **Role:** CONTACT
***Contact 2:***
- **Name:** GALLET SUCHET BLANDINE
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 3:***
- **Name:** BRUSSEAU MATHIS
- **Role:** SUB_INVESTIGATOR
**Country:** France
**Facility:** Institut Du Cancer de Montpellier
#### Overall Officials
**Official 1:**
**Affiliation:** Institut du Cancer de Montpellier
**Name:** GALLET SUCHET BLANDINE
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06445127
**Brief Title:** Evaluation of Patients With Lupus Nephritis Using Kidney MRI (Magnetic Resonance Imaging)
**Official Title:** Evaluation of Patients With Lupus Nephritis Using Kidney MRI (Magnetic Resonance Imaging)
#### Organization Study ID Info
**ID:** IRB00354110
#### Organization
**Class:** OTHER
**Full Name:** Johns Hopkins University
### Status Module
#### Completion Date
**Date:** 2026-05-17
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-31
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2026-05-17
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-07
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** Janssen Scientific Affairs, LLC
#### Lead Sponsor
**Class:** OTHER
**Name:** Johns Hopkins University
#### 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 is being done to find out if a non-invasive Magnetic Resonance Imaging (MRI) examination of the kidneys may be helpful for diagnosing lupus nephritis in patients with systemic lupus erythematosus (SLE).
Participation involves having a kidney MRI that will take between 30 to 60 minutes. Participants may have 1-4 kidney MRIs over a 6-month time period.
**Detailed Description:** The primary objective of this research is to evaluate the best techniques for magnetic resonance imaging (MRI) of the kidneys in patients with lupus nephritis. This research is being done to evaluate a minimally-invasive method for assessing kidney inflammation and kidney damage in patients with lupus nephritis. Both kidneys will be assessed.
### Conditions Module
**Conditions:**
- Lupus Nephritis
- Lupus Erythematosus, Systemic
- Lupus
- SLE
- SLE Nephritis
- SLE; Glomerulonephritis (Etiology)
- SLE (Systemic Lupus)
**Keywords:**
- Lupus
- Kidney disease in lupus
- Renal disease in lupus
- Lupus SLE
- Lupus and kidneys
- Lupus nephritis
- Protein in urine
- Inflammation in the kidney in patients with lupus
- Lupus and kidney impairment
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** Participants will undergo a MRI (1-4). This is a non-invasive test. No radiation. No contrast. No IV catheter.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** DIAGNOSTIC
#### Enrollment Info
**Count:** 15
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** A participant will undergo a MRI (1-4).
**Intervention Names:**
- Device: MRI
**Label:** MRI
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- MRI
**Description:** A non-invasive, non-contrast, renal MRI will be performed.
**Name:** MRI
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** The presence of inflammation within both kidneys will be measured using MRI.
**Measure:** Presence of inflammation
**Time Frame:** Six months
**Description:** The presence of fibrosis within both kidneys will be measured using MRI.
**Measure:** Presence of fibrosis
**Time Frame:** Six months
**Description:** The presence of atrophy within both kidneys will be measured using MRI.
**Measure:** Presence of atrophy
**Time Frame:** Six months
#### Secondary Outcomes
**Description:** MRI findings of inflammation will be correlated to UPCR above and below 0.5 grams.
**Measure:** Inflammation in the kidneys will be correlated to Urine Protein Creatinine Ratio (UPCR)
**Time Frame:** Six months
**Description:** MRI findings of fibrosis will be correlated to UPCR above and below 0.5 grams.
**Measure:** Fibrosis in the kidneys will be correlated to UPCR (Urine Protein Creatinine Ratio)
**Time Frame:** Six months
**Description:** MRI findings of atrophy will be correlated to UPCR above and below 0.5 grams.
**Measure:** Atrophy in the kidneys will be correlated to UPCR (Urine Protein Creatinine Ratio)
**Time Frame:** Six months
**Description:** Detection of inflammation within both kidneys will be correlated to class I-VI lupus nephritis confirmed by the kidney biopsy.
Class I: Minimal Mesangial Nephritis
Class II: Mesangial Proliferative Nephritis
Class III: Focal Nephritis
Class IV: Diffuse Nephritis
Class V: Membranous Nephritis
Class VI: Advanced Sclerosing Nephritis
**Measure:** Inflammation will be correlated with kidney biopsy classes
**Time Frame:** Six months
**Description:** Detection of atrophy within both kidneys will be correlated to class I-VI lupus nephritis confirmed by the kidney biopsy.
Class I: Minimal Mesangial Nephritis
Class II: Mesangial Proliferative Nephritis
Class III: Focal Nephritis
Class IV: Diffuse Nephritis
Class V: Membranous Nephritis
Class VI: Advanced Sclerosing Nephritis
**Measure:** Atrophy will be correlated with kidney biopsy classes
**Time Frame:** Six months
**Description:** Detection of fibrosis within both kidneys will be correlated to class I-VI lupus nephritis confirmed by the kidney biopsy.
Class I: Minimal Mesangial Nephritis
Class II: Mesangial Proliferative Nephritis
Class III: Focal Nephritis
Class IV: Diffuse Nephritis
Class V: Membranous Nephritis
Class VI: Advanced Sclerosing Nephritis
**Measure:** Fibrosis will be correlated with kidney biopsy classes
**Time Frame:** Six months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Male and female adults over the age of 18 who have been diagnosed with SLE and are able to undergo a kidney MRI.
Exclusion Criteria:
* The participant cannot take part in the study if they have any contraindications to MRI as specified by the current clinical MRI screening protocols including: metallic foreign objects within the body, programmable shunt/shunt, epidural or Swan Ganz catheter, ear or cochlear implant, eye implant, aneurysm clip, pacemaker/wires, internal defibrillator, tissue expander, recent stent placement, blood vessel coil, tracheostomy, stimulator/wires, infusion pump, penile prosthesis, intra-uterine device (IUD), surgical clips, bullets/pellets/bullet ball (BB), medication patch, tattoo, artificial limb, history of welding or metal fragments in eyes, pregnancy, claustrophobia, requirement of conscious sedation or anesthesia, colonoscopy procedure in the last 8 weeks.
* Any patient that is receiving renal dialysis.
* Any patient that has undergone a renal transplant.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Rebecca Krimins, DVM, MS
**Phone:** 410-955-9617
**Role:** CONTACT
**Contact 2:**
**Name:** Homa Timlin, MD, MSc, MRCP, CCST
**Phone:** 410-955-9617
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Baltimore
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Rebecca Krimins, DVM, MS
- **Phone:** 410-955-9617
- **Role:** CONTACT
***Contact 2:***
- **Name:** Homa Timlin, MD, MSc, MRCP, CCST
- **Phone:** 410-955-9617
- **Role:** CONTACT
**Country:** United States
**Facility:** Johns Hopkins University School of Medicine
**State:** Maryland
**Status:** RECRUITING
**Zip:** 21287
#### Overall Officials
**Official 1:**
**Affiliation:** Johns Hopkins School of Medicine
**Name:** Rebecca Krimins, DVM, MS
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** Johns Hopkins School of Medicine
**Name:** Homa Timlin, MD, MSc, MRCP, CCST
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007674
- Term: Kidney Diseases
- 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: D000003240
- Term: Connective Tissue Diseases
- ID: D000001327
- Term: Autoimmune Diseases
- ID: D000007154
- Term: Immune System Diseases
### 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: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M10698
- Name: Kidney Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10293
- Name: Inflammation
- Relevance: LOW
- As Found: Unknown
- ID: M12338
- Name: Nephritis
- Relevance: HIGH
- As Found: Nephritis
- ID: M11178
- Name: Lupus Nephritis
- Relevance: HIGH
- As Found: Lupus Nephritis
- ID: M9031
- Name: Glomerulonephritis
- Relevance: HIGH
- As Found: Glomerulonephritis
- ID: M11177
- Name: Lupus Erythematosus, Systemic
- Relevance: HIGH
- As Found: Lupus Erythematosus, Systemic
- ID: M26718
- Name: Renal Insufficiency
- Relevance: LOW
- As Found: Unknown
- ID: M14368
- Name: Proteinuria
- 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: 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
- ID: T3523
- Name: Lupus Nephritis
- Relevance: HIGH
- As Found: Lupus Nephritis
- ID: T2525
- Name: Glomerulonephritis
- Relevance: HIGH
- As Found: Glomerulonephritis
### Condition Browse Module - Meshes
- ID: D000009393
- Term: Nephritis
- ID: D000008181
- Term: Lupus Nephritis
- ID: D000005921
- Term: Glomerulonephritis
- ID: D000008180
- Term: Lupus Erythematosus, Systemic
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06445114
**Brief Title:** Using CircuLating Tumor DNA to Risk Adapt Post-Operative Therapy for HPV-associated Oropharyngeal Cancer
**Official Title:** ULTRA-HPV Using Circulating Tumor DNA to Risk Adapt Post-operative Therapy for HPV Associated Oropharyngeal Cancer
#### Organization Study ID Info
**ID:** IIT2023-14-ZUMSTEG-ULTRA-HPV
#### Organization
**Class:** OTHER
**Full Name:** Cedars-Sinai Medical Center
### Status Module
#### Completion Date
**Date:** 2031-07
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-31
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2031-07
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Zachary Zumsteg
#### Responsible Party
**Investigator Affiliation:** Cedars-Sinai Medical Center
**Investigator Full Name:** Zachary Zumsteg
**Investigator Title:** Sponsor-Investigator
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** This is a single institution phase II study that will enroll patients with T0-3N0-2 p16-positive oropharyngeal squamous cell carcinoma (OSCC) undergoing resection of all gross visible disease at the primary site and in the lymph nodes.
**Detailed Description:** All eligible patients will be treated with a de-intensified cisplatin-based chemoradiation regimen after undergoing transoral robotic surgery. Enrolled patients will be risk-assessed and assigned to specific regimens based on a combination of their post-operative cTTMV-HPV DNA, as determined by results from NavDx kits by Naveris, and pathologic features. All patients will receive a dose of 40 mg/m2 IV weekly concurrently with radiation therapy. Patients ineligible to receive cisplatin at this dose will undergo modified sydtemic therapy. Patients will recieve concurrent radiation in a dose of 30 Gy in 15 fractions to the primary tumor bed, ipsilateral neck +/- contralateral neck. Based on risk-stratification, some patients will receive a sequential boost of 10 Gy over 5 fractions or 20 Gy over 10 fractions.
### Conditions Module
**Conditions:**
- Oropharyngeal Cancer
- Carcinoma
**Keywords:**
- Transoral Robotic Surgery (TORS)
- pT0 tumors (unknown primary)
- p16
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** Prospective single arm multicenter clinical trial
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 50
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Low risk pathology with post-op HPV DNA (-): cisplatin-based chemoradiation with 30 Gy in 15 fractions and 3 cycles of weekly cisplatin 40mg/m2 IV on Days 1, 8, and 15 of radiation.
Low risk pathology with post-op HPV DNA (+): cisplatin-based chemoradiation with 40 Gy in 20 fractions and 4 cycles of weekly cisplatin 40mg/m2 IV on Days 1, 8, 15, and 22 of radiation.
High risk pathology with post-op HPV DNA (-), excluding patients with both 5 LN+ and ENE+ or pre-op HPV DNA≤12 copies/mL: cisplatin-based radiation with 40 Gy in 20 fractions and 4 cycles of weekly cisplatin 40mg/m2 IV on Days 1, 8, 15, and 22 of radiation.
High risk pathology with post-op HPV DNA (+) OR pre-op HPV DNA≤12 copies/mL OR both 5 or more LN+ and ENE+: cisplatin-based radiation with 50 Gy in 25 fractions with 5 cycles of weekly cisplatin 40mg/m2 IV on Days 1, 8, 15, 22, and 29 of radiation.
**Intervention Names:**
- Drug: Cisplatin
**Label:** Single Arm
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Single Arm
**Description:** Low risk pathology with post-op HPV DNA (-): cisplatin-based chemoradiation with 30 Gy in 15 fractions and 3 cycles of weekly cisplatin 40mg/m2 IV on Days 1, 8, and 15 of radiation.
Low risk pathology with post-op HPV DNA (+): cisplatin-based chemoradiation with 40 Gy in 20 fractions and 4 cycles of weekly cisplatin 40mg/m2 IV on Days 1, 8, 15, and 22 of radiation.
High risk pathology with post-op HPV DNA (-), excluding patients with both 5 LN+ and ENE+ or pre-op HPV DNA≤12 copies/mL: cisplatin-based radiation with 40 Gy in 20 fractions and 4 cycles of weekly cisplatin 40mg/m2 IV on Days 1, 8, 15, and 22 of radiation.
High risk pathology with post-op HPV DNA (+) OR pre-op HPV DNA≤12 copies/mL OR both 5 or more LN+ and ENE+: cisplatin-based radiation with 50 Gy in 25 fractions with 5 cycles of weekly cisplatin 40mg/m2 IV on Days 1, 8, 15, 22, and 29 of radiation.
**Name:** Cisplatin
**Other Names:**
- Chemoradiation
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** The primary objective of this study is to assess the 2-year progression-free survival (PFS) of de-intensified post-operative chemoradiation in patients with HPV-associated oropharyngeal cancer when basing treatment intensity on both standard pathologic features and post-operative Blood-based circulating tumor tissue modified viral (cTTMV-HPV DNA)
**Measure:** 2-year progression-free (PFS)
**Time Frame:** 2 Years
#### Secondary Outcomes
**Description:** Proportion of patients alive, based on time from enrollment to death from any cause.
**Measure:** Overall Survival (OS)
**Time Frame:** 2 Years
**Description:** Proportion of patients without local recurrence or regional recurrence, as defined above, based on the time from enrollment to the first evidence of either local or regional recurrence, irrespective of prior distant recurrence. Death from causes unrelated to cancer is a competing event.
**Measure:** Locoregional Control
**Time Frame:** 2 Years
**Description:** Proportion of patients without distant recurrence, based on time from enrollment to distant recurrence, irrespective of prior local or regional recurrence. Distant metastasis includes any recurrent disease outside of the head and neck, cervical lymph nodes, or retropharyngeal lymph nodes. Death from causes unrelated to cancer is a competing event.
**Measure:** Distant Control
**Time Frame:** 2 Years
**Description:** Proportion of patients without oropharyngeal cancer-related or treatment-related death, based on time from enrollment to death from oropharyngeal cancer or treatment. Death from other causes is a competing event.
**Measure:** Cause-Specific Survival
**Time Frame:** 2 Years
**Description:** To assess quality of life changes before, during and after treatment via Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
PRO-CTCAE responses are scored from 0 to 4 (or 0/1 for absent/present), with lower scoring indicating an absence of symptoms to higher scoring reflecting higher severity of symptoms.
**Measure:** Mean change in patient-reported outcomes using Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
**Time Frame:** 2 Years
**Description:** To assess quality of life changes before, during and after treatment via Hearing Handicap Inventory for Adults (HHIA-S). The scale ranges from 0 to 4 (0 - no, 2 - sometimes, 4- yes) for each question identifying problems with hearing loss, as self-reported by patients. The total number of points for the 25 questions range from 0 to 100, with 0 indicating no handicap to 100 indicating total handicap.
**Measure:** Mean change in patient-reported outcomes using Hearing Handicap Inventory for Adults (HHIA-S)
**Time Frame:** 2 Years
**Description:** To assess quality of life changes before, during and after treatment via EORTC QLQ-C30. The EORTC QLQ-C30 is composed of both multi-item scales and single-item measures. These include 5 functional scales, 3 symptom scales, a global health status / QoL, and 6 single items. All of the scales and single-item measures range in score from 0-100. A high scale score represents a higher response level and represents a high/healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale represents a high level of problems. Most questions are scored 1 to 4, with exception to global health questions scored from 1 to 7. The raw scores are then standardized by a linear transformation, so that scores range from 0 to 100; a higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms.
**Measure:** Mean change in patient-reported outcomes using European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30)
**Time Frame:** 2 Years
**Description:** To assess quality of life changes before, during and after treatment via the MD Anderson Dysphagia Index (MDADI). The MDADI is a patient-reported, 20-item scale that quantifies four domains: an individual's global (G), physical (P), emotional (E), and functional (F) perceptions of their swallowing ability. Two summary scores can be obtained from the MDADI: 1) global and 2) composite. The global scale is a single question, scored individually, to assess the overall impact that swallowing abilities have on quality of life. The composite MDADI score summarizes overall performance on remaining 19-items of the MDADI, as a weighted average of the physical, emotional, and functional subscale questions. Summary and subscale MDADI scores are normalized to range from 20 (extremely low functioning) to 100 (high functioning). Five possible responses to the items on the MDADI are: strongly agree, agree, no opinion, disagree, and strongly disagree, and scored on a scale of 1 to 5 respectively.
**Measure:** Mean change in patient-reported outcomes using the MD Anderson Dysphagia Inventory (MDADI)
**Time Frame:** 2 Years
**Description:** To assess quality of life changes before, during and after treatment via the University of Michigan Xerostomia-Related Quality of Life Scale (XeQoLS). XeQOLS is a patient-reported, 15-item scale that measures four domains: physical functioning, pain/discomfort, personal/psychologic functioning, and social functioning. Patient responses to all four domains are averaged, and the total scores range from 0 to 4; an increased xerostomia burden is indicated by a higher score.
**Measure:** Mean change in patient-reported outcomes using University of Michigan Xerostomia-Related Quality of Life Scale (XeQoLS)
**Time Frame:** 2 Years
**Description:** To assess quality of life changes before, during and after treatment via the 5-level version of the EuroQol five dimensional instrument EQ-5D-5L.The EQ-5D-5L descriptive system comprises of five dimensions: (MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN / DISCOMFORT and ANXIETY / DEPRESSION), with each dimension having five response levels: no problems, slight problems, moderate problems, severe problems, unable to /extreme problems - severity level of each dimension are coded from 1 to 5, respectively. The visual analog scale (EQ VAS) attached to this questionnaire records the respondent's overall self-rated perception of current health status on a vertical visual analogue scale, where the endpoints are scored from 0 to 100, 100 being the 'The best health you can imagine' and 0 indicating 'The worst health you can imagine'
**Measure:** Mean change in patient-reported outcomes using 5-level version of the EuroQol five dimensional instrument EQ-5D-5L
**Time Frame:** 2 Years
**Description:** To assess dysphagia before, during, and after treatment with the MD Anderson Dysphagia Inventory (MDADI) tool. The MDADI is a patient-reported, 20-item scale that quantifies four domains: an individual's global (G), physical (P), emotional (E), and functional (F) perceptions of their swallowing ability. Two summary scores can be obtained from the MDADI: 1) global and 2) composite. The global scale is a single question, scored individually, to assess the overall impact that swallowing abilities have on quality of life. The composite MDADI score summarizes overall performance on remaining 19-items of the MDADI, as a weighted average of the physical, emotional, and functional subscale questions. Summary and subscale MDADI scores are normalized to range from 20 (extremely low functioning) to 100 (high functioning). Five possible responses to the items on the MDADI are: strongly agree, agree, no opinion, disagree, and strongly disagree, and scored on a scale of 1 to 5 respectively.
**Measure:** Mean change in Dysphagia using MDADI
**Time Frame:** 2 Years
**Description:** To assess dysphagia before, during, and after treatment with the modified barium swallow. MBS is an analysis of swallowing through three phases: oral (mouth), pharyngeal (throat) and upper esophagus. A Modified Barium Swallow Study (MBSS) is a special x-ray that allows the Radiologist (who specializes in using x-rays) and Speech Language Pathologist (SLP) to identify why you are having trouble swallowing. The MBS provides quantitative evaluation of 17 physiologic components of swallowing distributed across three functional domains: oral, pharyngeal, and esophageal. MBS components are scored on an ordinal scale from 0 (indicating no impairment) to a maximum of 2, 3, or 4, depending on the specific component.
**Measure:** Mean change in Dysphagia using Modified Barium Swallow
**Time Frame:** 2 Years
**Description:** To assess the 2-year PFS (Progression-Free Survival) in the high-risk \[extranodal extension (ENE), positive margins, ≥5 positive lymph nodes (LNs)\] and intermediate-risk \[T3, close margins, LN size \> 3cm, 2 or more LN+, lymphovascular invasion (LVI), perineural invasion (PNI)\] subgroups separately. The difference between the proportion of patients alive and without evidence of local, regional, or distant recurrence at 2 years from study enrollment, in high-risk and intermediate subgroups.
**Measure:** 2-year Progression-Free Survival
**Time Frame:** 2 Years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* AJCC 8th edition T0-3N0-2 p16-positive oropharyngeal (tonsil, base of tongue, glossotonsillar sulcus, soft palate, oropharyngeal wall) squamous cell carcinoma or squamous cell carcinoma of unknown primary involving the cervical lymph nodes. Cytologic diagnosis from a cervical lymph node is sufficient for diagnosis in the presence of clinical evidence of a primary tumor in the oropharynx.
* For patients with pT0 tumors (unknown primary), there must be at least one metastatic lymph node present in cervical level II.
* p16 is strongly positive by immunohistochemistry or high-risk HPV is detected by in-situ hybridization.
* Have undergone or will undergo gross total resection of all known disease in the head and neck via transoral robotic surgery. For patients with clinical unknown primary tumors, a patient must undergo both ipsilateral tonsillectomy and base of tongue resection unless the primary is identified clinically or pathologically at the time of surgery. If the primary is identified, then only resection of the primary site is required. If the primary tumor is resected with negative margins with a non-robotic surgery, such as a diagnostic tonsillectomy, this is considered acceptable and further robotic surgery is not necessary.
* Have undergone or will undergo neck dissection.
* Have at least one of the following after surgery:
* Pathologic stage T3
* 2 or more positive lymph nodes
* At least one lymph node \>3cm
* Contralateral lymph node involvement
* Lymphovascular invasion
* Perineural invasion
* Extranodal extension
* Close/positive margins: Close margins are considered ≤3mm from the peripheral margins and ≤1mm from the deep margin on the en bloc specimen, unless the area of close margin is re-resected and without carcinoma.
* Patients consented preoperatively are required to have detectable cTTMV-HPV DNA based on pre-operative NavDx testing. For patients consented post-operatively, NavDx testing should be performed on the tumor tissue to ensure detectable HPV DNA and for HPV subtyping.
* Age ≥ 18 years old
* ECOG performance status 0 or 2 within 56 days of start of chemoradiation.
* Women of childbearing potential require a negative serum or urine pregnancy test within 28 days prior to start of chemoradiation.
* Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
* Adequate hematologic and renal function within 56 days of start of chemoradiation, defined as:
* Hemoglobin ≥ 9.0 g/dL
* Platelets ≥ 100, 000 cells/mm3
* ANC ≥ 1.5 X 109/L
* Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
* Aspartate aminotransferase/alanine aminotransferase ≤ 3.0 x upper limit of normal (ULN)
* Serum creatinine ≤1.5 x upper limit of normal (ULN) OR a calculated creatinine clearance ≥50 mL/min estimated using the following Cockcroft-Gault equation
Exclusion Criteria:
* AJCC 8th edition pT4 or cN3 disease.
* Radiologic or clinical evidence of distant metastasis.
* Recurrent disease.
* Inability to achieve gross total resection at time of surgery.
* Greater than 56 days (8 weeks) after surgical resection of the primary site.
* Prior radiation to the head and neck \> 30 Gy.
* Prior active invasive (not in situ) malignancy within the prior 2 years, excluding cutaneous basal cell or squamous cell carcinoma, low or intermediate risk prostate cancer, papillary thyroid cancer, stage T1aN0 kidney cancer, low-grade T1-2N0 salivary cancer, AJCC 8th edition stage I-II breast cancer, well-differentiated neuroendocrine tumors (e.g., carcinoid tumors), low grade non-Hodgkin lymphoma, or Stage 0, I, and III cutaneous melanomas. Patients with synchronous or multifocal oropharyngeal cancers are not excluded, as long as at least one of these tumors meet inclusion criteria for the trial.
* Severe, active co-morbidity, defined as follows:
* Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
* Transmural myocardial infarction within the last 6 months
* Acute bacterial or fungal infection requiring intravenous antibiotics at the time of enrollment
* Hepatic insufficiency resulting in clinical jaundice and/or known coagulation defects
* Moderate to severe hearing loss.
* Active connective tissue disease (e.g. systemic lupus erythematous, scleroderma) requiring immunosuppression.
* Pregnant or breast-feeding women.
* Prior allergic reaction to cisplatin.
* Live vaccines within 30 days prior to the first dose of chemoradiation. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, BCG, and typhoid (oral vaccine). Season influenza vaccines for injection are generally killed virus vaccines and are allowed; however intranasal influenza vaccines (e.g. Flu-Mist®) are live attenuated vaccines and are not allowed.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Clinical Trial Navigator
**Phone:** 3104232133
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Beverly Hills
**Contacts:**
***Contact 1:***
- **Name:** Clinical Trial Recruitment Navigator
- **Role:** CONTACT
***Contact 2:***
- **Name:** Kevin Scher, MD
- **Role:** SUB_INVESTIGATOR
***Contact 3:***
- **Name:** David Hoffman, MD
- **Role:** SUB_INVESTIGATOR
***Contact 4:***
- **Name:** Kamalesh Sankhala, MD
- **Role:** SUB_INVESTIGATOR
***Contact 5:***
- **Name:** Leland Green, MD
- **Role:** SUB_INVESTIGATOR
***Contact 6:***
- **Name:** Jeremy Lorber, MD
- **Role:** SUB_INVESTIGATOR
**Country:** United States
**Facility:** Cedars-Sinai Cancer at Beverly Hills (THO)
**State:** California
**Zip:** 90211
**Location 2:**
**City:** Los Angeles
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Zachary S Zumsteg, MD
- **Phone:** 310-248-8375
- **Role:** CONTACT
***Contact 2:***
- **Name:** Allen Ho, MD
- **Role:** SUB_INVESTIGATOR
***Contact 3:***
- **Name:** Jon Mallen-St. Clair, MD
- **Role:** SUB_INVESTIGATOR
***Contact 4:***
- **Name:** Evan Walgama, MD
- **Role:** SUB_INVESTIGATOR
***Contact 5:***
- **Name:** Alain Mita, MD
- **Role:** SUB_INVESTIGATOR
***Contact 6:***
- **Name:** Jun Gong, MD
- **Role:** SUB_INVESTIGATOR
***Contact 7:***
- **Name:** Ronald Natale, MD
- **Role:** SUB_INVESTIGATOR
***Contact 8:***
- **Name:** Stephen Shiao, MD
- **Role:** SUB_INVESTIGATOR
***Contact 9:***
- **Name:** Julie Jang, MD
- **Role:** SUB_INVESTIGATOR
***Contact 10:***
- **Name:** Zachary S Zumsteg, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Cedars Sinai Medical Center
**State:** California
**Zip:** 90048
**Location 3:**
**City:** Tarzana
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Vanessa Vasco
- **Role:** CONTACT
***Contact 2:***
- **Name:** Benjamin L King, MD
- **Role:** SUB_INVESTIGATOR
***Contact 3:***
- **Name:** Robert S Reznik, MD
- **Role:** SUB_INVESTIGATOR
***Contact 4:***
- **Name:** Natasha Banerjee, MD
- **Role:** SUB_INVESTIGATOR
***Contact 5:***
- **Name:** Johnny K Chang, MD
- **Role:** SUB_INVESTIGATOR
***Contact 6:***
- **Name:** Ryan Ponec, MD
- **Role:** SUB_INVESTIGATOR
***Contact 7:***
- **Name:** Anirban Balmanoukian, MD
- **Role:** SUB_INVESTIGATOR
**Country:** United States
**Facility:** CS Cancer at Valley Oncology Medical Group
**State:** California
**Zip:** 91356
**Location 4:**
**City:** Torrance
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Sarah Valdez
- **Phone:** 310-750-3300
- **Phone Ext:** 73422
- **Role:** CONTACT
***Contact 2:***
- **Name:** Hugo Hool, MD
- **Role:** SUB_INVESTIGATOR
***Contact 3:***
- **Name:** Vanessa Dickey, MD
- **Role:** SUB_INVESTIGATOR
***Contact 4:***
- **Name:** David Chan, MD
- **Role:** SUB_INVESTIGATOR
***Contact 5:***
- **Name:** Syed Jilani, MD
- **Role:** SUB_INVESTIGATOR
***Contact 6:***
- **Name:** Thomas Lowe, MD
- **Role:** SUB_INVESTIGATOR
***Contact 7:***
- **Name:** Swati Sikaria, MD
- **Role:** SUB_INVESTIGATOR
***Contact 8:***
- **Name:** Andrew Horodner, MD
- **Role:** SUB_INVESTIGATOR
***Contact 9:***
- **Name:** Bryan Chang, MD
- **Role:** SUB_INVESTIGATOR
***Contact 10:***
- **Name:** Thyra Endicott, MD
- **Role:** SUB_INVESTIGATOR
***Contact 11:***
- **Name:** Andrew Schumacher, MD
- **Role:** SUB_INVESTIGATOR
***Contact 12:***
- **Name:** Usama Mahmood, MD
- **Role:** SUB_INVESTIGATOR
***Contact 13:***
- **Name:** Rebecca Philipson, MD
- **Role:** SUB_INVESTIGATOR
**Country:** United States
**Facility:** CS Cancer at the Hunt Cancer Center
**State:** California
**Zip:** 90505
#### Overall Officials
**Official 1:**
**Affiliation:** Cedars-Sinai Medical Center
**Name:** Zachary S Zumsteg, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010610
- Term: Pharyngeal Neoplasms
- ID: D000010039
- Term: Otorhinolaryngologic Neoplasms
- ID: D000006258
- Term: Head and Neck Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000010608
- Term: Pharyngeal Diseases
- ID: D000009057
- Term: Stomatognathic Diseases
- ID: D000010038
- Term: Otorhinolaryngologic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: All
- Name: All Conditions
- Abbrev: BC07
- Name: Mouth and Tooth Diseases
- Abbrev: BC09
- Name: Ear, Nose, and Throat Diseases
### Condition Browse Module - Browse Leaves
- ID: M5534
- Name: Carcinoma
- Relevance: LOW
- As Found: Unknown
- ID: M12885
- Name: Oropharyngeal Neoplasms
- Relevance: HIGH
- As Found: Oropharyngeal Cancer
- ID: M13517
- Name: Pharyngeal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M12962
- Name: Otorhinolaryngologic Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M9348
- Name: Head and Neck Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M13515
- Name: Pharyngeal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12017
- Name: Stomatognathic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12961
- Name: Otorhinolaryngologic Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000009959
- Term: Oropharyngeal Neoplasms
### Intervention Browse Module - Ancestors
- ID: D000000970
- Term: Antineoplastic Agents
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M6182
- Name: Cisplatin
- Relevance: HIGH
- As Found: Adults
### Intervention Browse Module - Meshes
- ID: D000002945
- Term: Cisplatin
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06445101
**Brief Title:** Vital@Work: an Intervention for Prevention of Mental Health Complaints at Work
**Official Title:** Vital@Work: an Evidence-based Intervention Program for Prevention of Mental Health Complaints at Work, Tailored to Specific Organisational Needs and Contextual Factors
#### Organization Study ID Info
**ID:** LSHM22035-H025
#### Organization
**Class:** OTHER
**Full Name:** Amsterdam UMC, location VUmc
### Status Module
#### Completion Date
**Date:** 2026-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-31
**Overall Status:** ENROLLING_BY_INVITATION
#### Primary Completion Date
**Date:** 2025-09
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-04-17
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-31
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Health Holland
**Class:** OTHER
**Name:** Stichting Trimbos-Instituut
#### Lead Sponsor
**Class:** OTHER
**Name:** Amsterdam UMC, location VUmc
#### Responsible Party
**Investigator Affiliation:** Amsterdam UMC, location VUmc
**Investigator Full Name:** Luuk Bouwens
**Investigator Title:** MSc
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The objective of the current study, Vital@Work, is to keep employees in the Netherlands vital on the long term by preventing work-related mental health problems. Therefore, we test an evidence based Participatory Approach (PA) to compose a mental health program tailored to behavioral, organizational \& contextual (BOC) determinants of individuals and populations at risk. The PA is investigated in four different organizations, which differ in sector, size (small and large organizations), type of organization (private or public) and type of work. The varied organizations, each characterized by unique BOC-determinants, provide an opportunity for researching tailored intervention activities that aim to effectively prevent work-related mental health problems. By identifying common factors across these diverse organizations, we aim to grasp patterns of mechanisms for interventions to mental health at work. By doing this, we come closer to opening black box of how and why interventions work and thus closer to tailoring interventions to needs of both individuals and organizations
**Detailed Description:** This study evaluates the PA as a strategy to implement measures to prevent or reduce work-related mental health problems by a cluster randomized controlled trial, including an intervention and control group. Employees in departments allocated to the intervention group receive the PA intervention in addition to the existing range of preventive mental health measures within the organization. Departments assigned to the control group receive standard practice and therefore only the existing range of preventive interventions will be highlighted and further drawn to the attention of employees (without the PA intervention). Due to the PA intervention and associated activities, it is not possible to blind the researchers and department managers. However, employees in the departments randomized to the intervention or control group are not aware of the research design. Only department managers are informed about the research design and the outcome of randomization, and they are asked not to communicate the research design to the employees.
The PA consists of six steps: 1) preparation: create prerequisites and initiate the PA, 2) risk assessment: analysis of bottlenecks and risks 3) solutions: Analysis of potential solutions 4) action planning: jointly formulating a plan of action to realize solutions 5) implementation: implementing measures by means of the action plan and 6) evaluation: evaluation of the approach.
For each intervention group, a participatory working group will be established, comprising 5-7 employees, a department manager/supervisor, a health and safety coordinator, an HR representative, and a communication specialist. Each intervention group is coordinated by a process facilitator who is responsible for preparing the meetings with the working group and leading the discussions during these sessions. To prepare individuals for this role, the process facilitator receives training, provided by researchers experienced in the PA.
The participative working group will go through steps 2 to 4 of the PA during a day session, resulting in an action plan for the intervention activities to be implemented. Subsequently, this action plan will be implemented throughout the entire team comprising the intervention group. This implementation process will be led by the process facilitator, supported by change agents. Ideally, (some of) the working group members will act as change agents. Change agents have the task of implementing interventions as widely as possible within the department and ensuring a smooth implementation process so that employees actually make use of the innovations. In order to act as catalysts for the implementation process within the department, the change agents and the process facilitator are trained by researchers experienced in the PA. The duration of the entire implementation period is approximately 12 months, but depends on the selected intervention activities, with short-term implementations lasting \< 3 months, and long-term implementations lasting \> 3 months.
### Conditions Module
**Conditions:**
- Stress
**Keywords:**
- work-related emotional exhaustion
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** Cluster randomized controlled trial comparing intervention group with care as usual group.
Randomization is carried out at the cluster (team or department) level to prevent contamination between employees assigned to the intervention group and those in the control group.
##### Masking Info
**Masking:** SINGLE
**Masking Description:** Due to the PA intervention and associated activities, it is not possible to blind the researchers and department managers to the condition they are assigned to. However, employees in the departments randomized to the intervention or control group are not aware of the research design. Only department managers are informed about the research design and the outcome of randomization, and they are asked not to communicate the research design to the employees.
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 1668
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Employees in departments allocated to the intervention group receive the PA strategy in addition to the existing range of preventive mental health measures within the organization.
**Intervention Names:**
- Other: Participatory Approach
**Label:** Participatory Approach (intervention)
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Departments assigned to the control group receive usual strategies and therefore only have access to the existing range of preventive interventions within the organization (without the PA intervention).
**Label:** Care as usual
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Participatory Approach (intervention)
**Description:** The participatory approach is a stepwise, collaborative approach to the analysis and solvation of bottlenecks that cause stress in employees.
**Name:** Participatory Approach
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Stress will be assessed using the stress subscale of the short version of the Depression Anxiety and Stress Scale (DASS-21; Lovibond \& Lovibond, 1995), designed to measure the emotional states of depression, anxiety and stress. The stress subscale of DASS-21 comprises seven statements. Participants indicate the extent to which these statements applied to them during the past week, using a Likert scale ranging from 0 ('never') to 3 ('almost always').
**Measure:** Stress
**Time Frame:** Baseline - 6 months after baseline - 12 months after baseline
#### Secondary Outcomes
**Description:** At the individual level, we will assess work-related psychosocial risk factors, including job demands, autonomy, supervisor support and co-worker support. For measuring job demands, we will utilize four subscales from the validated Dutch version of The Copenhagen Psychosocial Questionnaire (COPSOQ-III; Burr et al., 2019; Kristensen et al., 2005) subscales quantitative demands, cognitive demands, emotional demands and work pace. The COPSOQ is a globally recognized and extensively employed tool for assessing a range of psychosocial factors in workplaces (Burr et al., 2019) and has demonstrated acceptable psychometric characteristics
**Measure:** Work related psychosocial risk factors
**Time Frame:** Baseline - 6 months after baseline - 12 months after baseline
**Description:** Sense of Community will be measured using three items form the validated Dutch version of COPSOQ-III (Burr et al., 2019; Kristensen et al., 2005)
**Measure:** Sense of community
**Time Frame:** Baseline - 6 months after baseline - 12 months after baseline
**Description:** At employee level, the Psychosocial Safety Climate (PSC) is assessed using the Dutch translation of the PSC-4, a shortened version of the PSC-12 (Dollard, 2019). The psychometrics and predictive validity of the PSC-4 are just as strong as those of the PSC-12, suggesting support for the use of the concise PSC-4 in both research and practice (Dollard, 2019)
**Measure:** Psychosocial safety climate
**Time Frame:** Baseline - 6 months after baseline - 12 months after baseline
**Description:** Presenteeism will be assessed by two items of the World Health Organization Health and Work Performance Questionnaire (HPQ) (Kessler et al., 2003) and an item obtained from Vänni et al. (2018). The absenteeism history of the employee in the twelve months prior to the survey will be assessed using a set of three questions. Additionally, two questions will be included regarding the most recent absenteeism incident experienced by employees. This most recent incident may potentially have occurred more than twelve months ago, allowing for responses from employees who have not been absent in the past twelve months but were absent before that period. They are asked about the type of complaints that led to their most recent absence and whether these complaints were work-related.
**Measure:** Presenteeism and absenteeism
**Time Frame:** Baseline - 6 months after baseline - 12 months after baseline
**Description:** To assess implementation outcomes, a series of questions (12 items) will be used concerning existing and recently introduced resources (interventions, measures, policies, and additional support) designed to foster mental health and prevent related issues. These items focus on the availability and utilization of existing and newly provided resources.
**Measure:** Implementation outcomes
**Time Frame:** Baseline - 6 months after baseline - 12 months after baseline
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Inclusion will be done on cluster level (e.g. team or department), after discussing this with participating organizations. The inclusion criteria for participation in the study comprise being at least 18 years of age, holding an employment contract with the participating organization.
Exclusion Criteria:
* The exclusion criteria include being under 18 years old, not being part of the participating teams/departments, or not having an employment contract with the participating organization.
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Amsterdam
**Country:** Netherlands
**Facility:** Amsterdam UMC
**Location 2:**
**City:** Amsterdam
**Country:** Netherlands
**Facility:** GGZ Ingeest
**Location 3:**
**City:** Amsterdam
**Country:** Netherlands
**Facility:** Transavia
**Location 4:**
**City:** Den Haag
**Country:** Netherlands
**Facility:** RSO
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06445088
**Brief Title:** Diagnostic Accuracy of EBV C Promoter Methylation Kit in Nasopharyngeal Carcinoma
**Official Title:** Evaluation of Diagnostic Performance of a Detection Kit for Epstein-Barr Virus C Promoter Methylation in Nasopharyngeal Carcinoma
#### Organization Study ID Info
**ID:** YKP2023-02-04
#### Organization
**Class:** OTHER
**Full Name:** Sun Yat-sen University
### Status Module
#### Completion Date
**Date:** 2026-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-30
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-28
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-27
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER_GOV
**Name:** Fujian Cancer Hospital
**Class:** OTHER
**Name:** Wuzhou Red Cross Hospital
**Class:** OTHER
**Name:** Zhongshan People's Hospital, Guangdong, China
**Class:** OTHER
**Name:** First Affiliated Hospital of Guangxi Medical University
#### Lead Sponsor
**Class:** OTHER
**Name:** Sun Yat-sen University
#### Responsible Party
**Investigator Affiliation:** Sun Yat-sen University
**Investigator Full Name:** Hai-Qiang Mai,MD,PhD
**Investigator Title:** Hai Qiang Mai, MD.PHD
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This clinical study aims to evaluate the diagnostic performance of a new Epstein-Barr virus (EBV) C promoter methylation detection kit. All participants will undergo a series of diagnostic tests including VCA-IgA, EBNA1-IgA, and EBV-DNA assays. Additionally, nasopharyngeal swabs will be analyzed for EBV C promoter methylation. Confirmatory biopsy will be performed on all patients to establish a definitive diagnosis. This comprehensive approach seeks to assess the effectiveness of the methylation detection kit in a clinical setting.
### Conditions Module
**Conditions:**
- Nasopharyngeal Carcinoma
**Keywords:**
- Nasopharyngeal Carcinoma
- Diagnosis
- Methylation Detection
- Epstein-Barr virus
### Design Module
#### Bio Spec
**Description:** Blood and nasopharyngeal swabs
**Retention:** SAMPLES_WITH_DNA
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 908
**Type:** ESTIMATED
**Patient Registry:** True
**Study Type:** OBSERVATIONAL
**Target Duration:** 6 Months
### Arms Interventions Module
#### Arm Group 1
**Description:** The participant has signs or symptoms suggestive of nasopharyngeal carcinoma, or has a condition that needs to be differentiated from nasopharyngeal carcinoma
**Intervention Names:**
- Diagnostic Test: VCA-IgA, EBNA1-IgA, and EBV-DNA
- Diagnostic Test: EBV C Promoter Methylation Detection in nasopharyngeal swab samples
**Label:** Diagnosis cohort
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Diagnosis cohort
**Description:** Detect VCA-IgA, EBNA1-IgA, and EBV-DNA for all participants.
**Name:** VCA-IgA, EBNA1-IgA, and EBV-DNA
**Type:** DIAGNOSTIC_TEST
#### Intervention 2
**Arm Group Labels:**
- Diagnosis cohort
**Description:** Detection of methylation status of Epstein-Barr virus C promoter in human nasopharyngeal swab samples
**Name:** EBV C Promoter Methylation Detection in nasopharyngeal swab samples
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Other Outcomes
**Description:** During follow-up consultations 1 to 6 months post-discharge, nasopharyngeal swabs will be collected to observe the dynamics of EBV C promoter methylation before and after treatment for nasopharyngeal carcinoma
**Measure:** Dynamics of EBV C Promoter Methylation Before and After Nasopharyngeal Carcinoma Treatment
**Time Frame:** From enrollment to the end of treatment at 6 months, up to 1 years
#### Primary Outcomes
**Description:** Measure the sensitivity of Epstein-Barr Virus (EBV) C Promoter Methylation as a diagnostic marker for Nasopharyngeal Carcinoma (NPC). Sensitivity will be calculated as the proportion of true positive cases (patients correctly identified with NPC) out of the total number of actual NPC cases.
**Measure:** Sensitivity of Epstein-Barr Virus C Promoter Methylation in Diagnosing Nasopharyngeal Carcinoma
**Time Frame:** From enrollment to final diagnosis, up to 4 weeks
**Description:** Measure the specificity of Epstein-Barr Virus (EBV) C Promoter Methylation as a diagnostic marker for Nasopharyngeal Carcinoma (NPC). Specificity will be calculated as the proportion of true negative cases (patients correctly identified without NPC) out of the total number of actual non-NPC cases.
**Measure:** Specificity of Epstein-Barr Virus C Promoter Methylation in Diagnosing Nasopharyngeal Carcinoma
**Time Frame:** From enrollment to final diagnosis, up to 4 weeks
**Description:** Evaluate the agreement between Epstein-Barr Virus (EBV) C Promoter Methylation and the gold standard diagnostic methods for Nasopharyngeal Carcinoma (NPC) using the Kappa statistic. The Kappa value will indicate the consistency and reliability of EBV C Promoter Methylation as a diagnostic tool compared to established diagnostic criteria.
**Measure:** Kappa Value of Epstein-Barr Virus C Promoter Methylation in Diagnosing Nasopharyngeal Carcinoma
**Time Frame:** From enrollment to final diagnosis, up to 4 weeks
**Description:** This measure evaluates the positive, negative, and total concordance rates, as well as the Kappa Value, between test reagents and two established sequencing techniques-Sanger sequencing and pyrosequencing-for detecting Epstein-Barr virus C promoter methylation. The accuracy of these detection methods is assessed by comparing their results to those obtained through the widely used and mature technologies of Sanger dideoxy chain termination and pyrosequencing, often considered the "gold standards" for gene sequence analysis. This study aims to evaluate the reliability and accuracy of the test reagents in identifying methylation of the EBV C promoter, using these established sequencing benchmarks.
**Measure:** Concordance Analysis of Test Reagents and Sequencing Methods in EBV C Promoter Methylation Detection
**Time Frame:** From enrollment to final diagnosis, up to 4 weeks
#### Secondary Outcomes
**Description:** This outcome measures the agreement rates between EBV C promoter methylation and EBV-related antibodies in the diagnosis of nasopharyngeal carcinoma without a gold standard for comparison. It includes an evaluation of the positive concordance rates, negative concordance rates, and Kappa value, which might reflect limited conclusiveness but offer insight into the relative alignment of these diagnostic tests. This will help ascertain their comparative reliability and diagnostic utility in a real-world setting.
**Measure:** Concordance Rates between EBV-Related Antibodies and EBV C Promoter Methylation
**Time Frame:** From enrollment to final diagnosis, up to 4 weeks
**Description:** This outcome measures the agreement rates between EBV C promoter methylation and EBV-DNA in the diagnosis of nasopharyngeal carcinoma without a gold standard for comparison. It includes an evaluation of the positive concordance rates, negative concordance rates, and Kappa value, which might reflect limited conclusiveness but offer insight into the relative alignment of these diagnostic tests. This will help ascertain their comparative reliability and diagnostic utility in a real-world setting.
**Measure:** Concordance Rates between EBV-DNA and EBV C Promoter Methylation
**Time Frame:** From enrollment to final diagnosis, up to 4 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
Participants who meet the following Article 1 and also meet one of Articles 2 to 6 can be enrolled:
* Understand, sign, and date the informed consent document to participate in the study
* Display one or more symptoms or signs indicative of nasopharyngeal carcinoma
* Test positive for EBV antibodies or EBV DNA
* Be diagnosed with other head and neck carcinomas
* Be diagnosed with malignancies associated with EBV infection
* Require differential diagnosis from nasopharyngeal carcinoma during endoscopic or other imaging examinations
* Fulfill any additional conditions deemed appropriate by the investigator for inclusion in this study
Exclusion Criteria:
* Have been diagnosed with nasopharyngeal carcinoma and have undergone treatment
* Experience relapse or metastasis of nasopharyngeal carcinoma following treatment
* Have unsuccessful nasopharyngeal swab collections
* Present any other conditions considered by the investigator as unsuitable for participation in this trial
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
**Study Population:** The study population includes individuals suspected of having nasopharyngeal carcinoma or who may be confused with nasopharyngeal carcinoma cases.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Hai-Qiang Mai
**Phone:** +86-020-87343380
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Fuzhou
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Zhen-Zhou Xiao
- **Phone:** +86-0591-62752500
- **Role:** CONTACT
***Contact 2:***
- **Name:** Zhen-Zhou Xiao
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** China
**Facility:** Fujian Cancer Hospital
**State:** Fujian
**Zip:** 350014
**Location 2:**
**City:** Guangzhou
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Hai-Qiang Mai
- **Phone:** +86-020-87343380
- **Role:** CONTACT
***Contact 2:***
- **Name:** Hai-Qiang Mai
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** China
**Facility:** Sun Yat-Sen University Cancer Center
**State:** Guangdong
**Zip:** 510060
**Location 3:**
**City:** Zhongshan
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Min-Yi Fu
- **Phone:** +86-0760-89880340
- **Role:** CONTACT
***Contact 2:***
- **Name:** Min-Yi Fu
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** China
**Facility:** ZhongShan City People's Hospital
**State:** Guangdong
**Zip:** 528400
**Location 4:**
**City:** Nanning
**Country:** China
**Facility:** The First Affiliated Hospital of Guangxi Medical University
**State:** Guangxi
**Zip:** 530021
**Location 5:**
**City:** Wuzhou
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Min-Zhong Tang
- **Phone:** +86-0774-3846519
- **Role:** CONTACT
***Contact 2:***
- **Name:** Min-Zhong Tang
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** China
**Facility:** Wuzhou Red Cross Hospital
**State:** Guangxi
**Zip:** 543002
#### Overall Officials
**Official 1:**
**Affiliation:** Sun Yat-sen University
**Name:** Hai-Qiang Mai
**Role:** STUDY_CHAIR
**Official 2:**
**Affiliation:** Fujian Cancer Hospital
**Name:** Zhen-Zhou Xiao
**Role:** PRINCIPAL_INVESTIGATOR
**Official 3:**
**Affiliation:** Wuzhou Red Cross Hospital
**Name:** Min-Zhong Tang
**Role:** PRINCIPAL_INVESTIGATOR
**Official 4:**
**Affiliation:** Zhongshan People's Hospital, Guangdong, China
**Name:** Min-Yi Fu
**Role:** PRINCIPAL_INVESTIGATOR
**Official 5:**
**Affiliation:** First Affiliated Hospital of Guangxi Medical University
**Name:** Zhe Zhang
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## 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: D000009303
- Term: Nasopharyngeal Neoplasms
- ID: D000010610
- Term: Pharyngeal Neoplasms
- ID: D000010039
- Term: Otorhinolaryngologic Neoplasms
- ID: D000006258
- Term: Head and Neck Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009302
- Term: Nasopharyngeal Diseases
- ID: D000010608
- Term: Pharyngeal Diseases
- ID: D000009057
- Term: Stomatognathic Diseases
- ID: D000010038
- Term: Otorhinolaryngologic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: All
- Name: All Conditions
- Abbrev: BC07
- Name: Mouth and Tooth Diseases
- Abbrev: BC09
- Name: Ear, Nose, and Throat Diseases
- Abbrev: BC01
- Name: Infections
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M5534
- Name: Carcinoma
- Relevance: HIGH
- As Found: Carcinoma
- ID: M1730
- Name: Nasopharyngeal Carcinoma
- Relevance: HIGH
- As Found: Nasopharyngeal Carcinoma
- ID: M17522
- Name: Virus Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M21881
- Name: Epstein-Barr Virus Infections
- 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: M12254
- Name: Nasopharyngeal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M13517
- Name: Pharyngeal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M12962
- Name: Otorhinolaryngologic Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M9348
- Name: Head and Neck Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M12253
- Name: Nasopharyngeal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M13515
- Name: Pharyngeal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12017
- Name: Stomatognathic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12961
- Name: Otorhinolaryngologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T4047
- Name: Nasopharyngeal Carcinoma
- Relevance: HIGH
- As Found: Nasopharyngeal Carcinoma
### Condition Browse Module - Meshes
- ID: D000002277
- Term: Carcinoma
- ID: D000077274
- Term: Nasopharyngeal Carcinoma
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M10118
- Name: Immunoglobulin A
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06445075
**Acronym:** EMBRAZE
**Brief Title:** Efficacy and Safety of Apitegromab for the Treatment of Adults Who Are Overweight or Obese
**Official Title:** A Phase 2 Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Apitegromab in Overweight and Obese Adult Subjects
#### Organization Study ID Info
**ID:** SRK-015-006
#### Organization
**Class:** INDUSTRY
**Full Name:** Scholar Rock, Inc.
### Status Module
#### Completion Date
**Date:** 2025-10-20
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-30
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-06-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Scholar Rock, Inc.
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** A phase 2 study to evaluate the effects of apitegromab as an adjunctive therapy to GLP-1 agonist therapy in subjects with overweight or obesity
**Detailed Description:** This phase 2 randomized, double-blind, placebo-controlled, multicenter study will assess the safety, efficacy, and pharmacokinetics (PK) of apitegromab when used as an adjunctive therapy to GLP-1 agonist therapy in subjects with overweight and obesity and without diabetes. Each subject will receive either semaglutide or tirzepatide, depending upon availability, and will maintain that course throughout the treatment period. In addition, all subjects will be randomized 1:1 to receive either apitegromab or placebo during the treatment period.
### Conditions Module
**Conditions:**
- Overweight and Obesity
**Keywords:**
- Overweight
- Obesity
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Parallel Assignment
##### Masking Info
**Masking:** QUADRUPLE
**Masking Description:** Active treatment, randomized, double-blind, placebo-controlled
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 100
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Apitegromab + incretin mimetic
**Intervention Names:**
- Drug: Apitegromab
- Drug: Semaglutide
- Drug: Tirzepatide
**Label:** Cohort 1
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Placebo + incretin mimetic
**Intervention Names:**
- Drug: Placebo
- Drug: Semaglutide
- Drug: Tirzepatide
**Label:** Cohort 2
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Cohort 1
**Description:** Apitegromab (SRK-015) is a fully human anti-proMyostatin monoclonal antibody (mAb) that specifically binds to human pro/latent myostatin, inhibiting myostatin activation. Apitegromab will be administered every 4 weeks by intravenous (IV) infusion.
**Name:** Apitegromab
**Other Names:**
- SRK-015
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Cohort 2
**Description:** Same appearance and composition as apitegromab drug product but does not contain the active ingredient. Placebo will be administered every 4 weeks by intravenous (IV) infusion.
**Name:** Placebo
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- Cohort 1
- Cohort 2
**Description:** Glucagon-like peptide-1 (GLP-1) receptor agonist. Semaglutide will be administered every week by subcutaneous injection.
**Name:** Semaglutide
**Other Names:**
- WEGOVY
**Type:** DRUG
#### Intervention 4
**Arm Group Labels:**
- Cohort 1
- Cohort 2
**Description:** Glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist. Tirzepatide will be administered every week by subcutaneous injection.
**Name:** Tirzepatide
**Other Names:**
- ZEPBOUND
**Type:** DRUG
### Outcomes Module
#### Other Outcomes
**Description:** Blood samples will be assessed for HbA1c (glycated hemoglobin)
**Measure:** Change from Baseline in HbA1c
**Time Frame:** Baseline up to 32 weeks
**Description:** Blood samples will be assessed for fasting serum triglycerides
**Measure:** Change from baseline in fasting serum triglycerides
**Time Frame:** Baseline up to 32 weeks
**Description:** Blood samples will be assessed for total cholesterol
**Measure:** Change from baseline in total cholesterol
**Time Frame:** Baseline up to 32 weeks
**Description:** Blood samples will be assessed low-density lipoprotein cholesterol (LDL-C)
**Measure:** Change from baseline in low-density lipoprotein cholesterol (LDL-C)
**Time Frame:** Baseline up to 32 weeks
#### Primary Outcomes
**Description:** Dual-energy X-ray absorptiometry will be used to evaluate body composition
**Measure:** Change from Baseline in total Lean Body Mass (kg) at 24 weeks
**Time Frame:** Baseline and 24 weeks
#### Secondary Outcomes
**Description:** Total body weight will be assessed via a calibrated scale
**Measure:** Change from Baseline in body weight
**Time Frame:** Baseline and 24 weeks
**Description:** Dual-energy X-ray absorptiometry will be used to evaluate body composition
**Measure:** Change from Baseline in percent lean body mass (%)
**Time Frame:** Baseline and 24 weeks
**Description:** Dual-energy X-ray absorptiometry will be used to evaluate body composition
**Measure:** Change from Baseline in fat body mass (kg and %)
**Time Frame:** Baseline and 24 weeks
**Description:** Dual-energy X-ray absorptiometry will be used to evaluate body composition
**Measure:** Change from Baseline in visceral adipose tissue (VAT), subcutaneous adipose tissue (SAT), and trunk fat body mass (kg and %)
**Time Frame:** Baseline and 24 weeks
**Description:** Dual-energy X-ray absorptiometry will be used to evaluate body composition
**Measure:** Percent (%) of weight loss from baseline due to fat body mass loss
**Time Frame:** Baseline and 24 weeks
**Description:** Dual-energy X-ray absorptiometry will be used to evaluate body composition
**Measure:** Percent (%) of weight loss from baseline due to lean body mass loss
**Time Frame:** Baseline and 24 weeks
**Description:** Blood samples will be assessed for circulating concentration of apitegromab
**Measure:** Concentration of apitegromab in circulation over time
**Time Frame:** Baseline up to 40 weeks
**Description:** Blood samples will be assessed for circulating concentration of latent myostatin
**Measure:** Concentration of latent myostatin in circulation over time
**Time Frame:** Baseline up to 24 weeks
**Description:** Incidence and severity of TEAEs and SAEs
**Measure:** Treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
**Time Frame:** Baseline up to 40 weeks
**Description:** Measured in serum blood samples
**Measure:** Presence of anti-drug antibodies (ADA) against apitegromab over time
**Time Frame:** Baseline up to 40 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria
* Able to comprehend the informed consent process and provide written informed consent prior to study enrollment and the conduct of any study-related assessments to study enrollment and the conduct of any study-related assessments
* Male or female, age ≥ 18 and ≤ 65 years at the time of informed consent
* Stable body weight (±5 kg) within 90 days of Screening
* At Screening, a BMI of:
1. ≥30.0 kg/m2 to ≤45.0 kg/m2 or
2. ≥27.0 kg/m2 to \<30.0 kg/m2 with the presence of 1 or more weight-related comorbid condition(s). Note: See exclusion criteria for specific organ class disease parameters
Exclusion Criteria:
* History of or active cardiovascular, neurovascular, peripheral vascular, pulmonary, hepatic, pancreatic, neuromuscular, and/or psychiatric disease
* Active malignancy, other than local subcutaneous squamous cell and basal cell carcinomas
* History of immunosuppressive, chemotherapeutic, or radiation treatment within 12 months prior to Screening
* History of Type 1 diabetes or active Type 2 diabetes (T2D). If there was a history of T2D and it resolved, then the resolution must have occurred \>12 months prior to Screening. Prediabetes managed with nonpharmacologic approaches (exercise and diet) is not an exclusion
**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:** Scholar Rock, Inc. Clinical Trials Administration
**Phone:** 857-259-3860
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Chula Vista
**Country:** United States
**Facility:** ProSciento CRU
**State:** California
**Status:** RECRUITING
**Zip:** 91911
**Location 2:**
**City:** Bellaire
**Country:** United States
**Facility:** Apex Mobile Clinical Research
**State:** Texas
**Status:** RECRUITING
**Zip:** 77401
**Location 3:**
**City:** San Antonio
**Country:** United States
**Facility:** Clinical Trials of Texas, LLC dba Flourish Research
**State:** Texas
**Status:** NOT_YET_RECRUITING
**Zip:** 78229
### IPD Sharing Statement Module
**IPD Sharing:** YES
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000044343
- Term: Overnutrition
- ID: D000009748
- Term: Nutrition Disorders
- ID: D000001835
- Term: Body Weight
### Condition Browse Module - Browse Branches
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M26186
- Name: Overweight
- Relevance: HIGH
- As Found: Overweight
- ID: M12701
- Name: Obesity
- Relevance: LOW
- As Found: Unknown
- ID: M25307
- Name: Overnutrition
- Relevance: LOW
- As Found: Unknown
- ID: M12684
- Name: Nutrition Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M5114
- Name: Body Weight
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000050177
- Term: Overweight
### Intervention Browse Module - Ancestors
- ID: D000097789
- Term: Glucagon-Like Peptide-1 Receptor Agonists
- ID: D000007004
- Term: Hypoglycemic Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000054795
- Term: Incretins
- ID: D000006728
- Term: Hormones
- ID: D000006730
- Term: Hormones, Hormone Substitutes, and Hormone Antagonists
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Hypo
- Name: Hypoglycemic Agents
- Abbrev: Gast
- Name: Gastrointestinal Agents
### Intervention Browse Module - Browse Leaves
- ID: M4230
- Name: Antibodies, Monoclonal
- Relevance: LOW
- As Found: Unknown
- ID: M353561
- Name: Semaglutide
- Relevance: HIGH
- As Found: Carbohydrate
- ID: M204206
- Name: Tirzepatide
- Relevance: HIGH
- As Found: 1600
- ID: M4225
- Name: Antibodies
- Relevance: LOW
- As Found: Unknown
- ID: M10184
- Name: Immunoglobulins
- Relevance: LOW
- As Found: Unknown
- ID: M9043
- Name: Glucagon
- Relevance: LOW
- As Found: Unknown
- ID: M3401
- Name: Glucagon-Like Peptide-1 Receptor Agonists
- Relevance: LOW
- As Found: Unknown
- ID: M26997
- Name: Glucagon-Like Peptide 1
- Relevance: LOW
- As Found: Unknown
- ID: M27905
- Name: Incretins
- Relevance: LOW
- As Found: Unknown
- ID: M8866
- Name: Gastric Inhibitory Polypeptide
- Relevance: LOW
- As Found: Unknown
- ID: M10054
- Name: Hypoglycemic 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
### Intervention Browse Module - Meshes
- ID: C000591245
- Term: Semaglutide
- ID: C000629749
- Term: Tirzepatide
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06445062
**Brief Title:** Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors
**Official Title:** A Platform Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors
#### Organization Study ID Info
**ID:** RMC-GI-102
#### Organization
**Class:** INDUSTRY
**Full Name:** Revolution Medicines, Inc.
### Status Module
#### Completion Date
**Date:** 2027-07-15
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-30
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2027-05-15
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Revolution Medicines, 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:** The purpose of this platform study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of novel RAS(ON) inhibitors combined with Standard(s) of Care (SOC) or with novel agents.
The first three subprotocols include the following:
Subprotocol A: RMC-6236 + 5-fluorouracil-based regimens
Subprotocol B: RMC-6236 + cetuximab with or without mFOLFOX6
Subprotocol C: RMC-6236 + gemcitabine + nab-paclitaxel
**Detailed Description:** The platform study design allows combinations of RAS(ON) inhibitors with other anticancer agents to be evaluated in patients with RAS-mutated solid tumors with a focus on GI cancers.
This is an open-label platform study to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of novel RAS(ON) inhibitors combined with Standard of Care (SOC) or with novel agents, and to define the Recommended Phase 2 Dose and Schedule (RP2DS). Enrollment of patients with RAS mutations will be specified in each subprotocol.
Subprotocol A is an open-label, multicenter study of RMC-6236 in combination with 5-fluorouracil-based regimens in patients with unresectable or metastatic colorectal cancer or metastatic pancreatic ductal adenocarcinoma. Subprotocol B is an open-label, multicenter study of RMC-6236 in combination with cetuximab with or without mFOLFOX6 in patients with unresectable or metastatic colorectal cancer or metastatic pancreatic ductal adenocarcinoma. Subprotocol C is an open-label, multicenter study of RMC-6236 in combination with gemcitabine and nab-paclitaxel in patients with metastatic pancreatic ductal adenocarcinoma. Each subprotocol consists of two parts: Part 1 - Dose Exploration and Part 2 - Dose Expansion.
### Conditions Module
**Conditions:**
- Colorectal Cancer
- CRC
- Pancreatic Ductal Adenocarcinoma
- PDAC
- Gastrointestinal Cancer
- Metastatic Pancreatic Ductal Adenocarcinoma
**Keywords:**
- CRC
- PDAC
- RAS Mutation
- KRAS G12X
- Colorectal Cancer
- Pancreatic Cancer
- Pancreatic Ductal Carcinoma
- KRAS Q61 Mutation
- KRAS G12 Mutation
- RAS Wild-type
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 406
**Type:** ESTIMATED
**Phases:**
- PHASE1
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** RMC-6236 (QD) and Bevacizumab with 5-fluorouracil-based regimens
**Intervention Names:**
- Drug: RMC-6236
- Drug: mFOLFOX6 regimen
- Drug: bevacizumab
- Drug: mFOLFIRINOX regimen
**Label:** Subprotocol A: RAS-mutated unresectable or metastatic CRC or metastatic PDAC
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** RMC-6236 (QD) and Cetuximab with or without mFOLFOX6
**Intervention Names:**
- Drug: RMC-6236
- Drug: mFOLFOX6 regimen
- Drug: cetuximab
**Label:** Subprotocol B: RAS-mutated unresectable or metastatic CRC or metastatic PDAC
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** RMC-6236 (QD) and Gemcitabine with Nab-paclitaxel
**Intervention Names:**
- Drug: RMC-6236
- Drug: gemcitabine
- Drug: nab-paclitaxel
**Label:** Subprotocol C: metastatic PDAC
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Subprotocol A: RAS-mutated unresectable or metastatic CRC or metastatic PDAC
- Subprotocol B: RAS-mutated unresectable or metastatic CRC or metastatic PDAC
- Subprotocol C: metastatic PDAC
**Description:** Oral tablet
**Name:** RMC-6236
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Subprotocol A: RAS-mutated unresectable or metastatic CRC or metastatic PDAC
- Subprotocol B: RAS-mutated unresectable or metastatic CRC or metastatic PDAC
**Description:** IV infusion
**Name:** mFOLFOX6 regimen
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- Subprotocol A: RAS-mutated unresectable or metastatic CRC or metastatic PDAC
**Description:** IV infusion
**Name:** bevacizumab
**Type:** DRUG
#### Intervention 4
**Arm Group Labels:**
- Subprotocol A: RAS-mutated unresectable or metastatic CRC or metastatic PDAC
**Description:** IV infusion
**Name:** mFOLFIRINOX regimen
**Type:** DRUG
#### Intervention 5
**Arm Group Labels:**
- Subprotocol B: RAS-mutated unresectable or metastatic CRC or metastatic PDAC
**Description:** IV infusion
**Name:** cetuximab
**Type:** DRUG
#### Intervention 6
**Arm Group Labels:**
- Subprotocol C: metastatic PDAC
**Description:** IV infusion
**Name:** gemcitabine
**Type:** DRUG
#### Intervention 7
**Arm Group Labels:**
- Subprotocol C: metastatic PDAC
**Description:** IV infusion
**Name:** nab-paclitaxel
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Evaluate the safety and tolerability in the study population characterized by incidence, abnormal laboratory assessments, severity, and seriousness of adverse events in relation to the study treatment.
**Measure:** Adverse events
**Time Frame:** Up to 3 years
**Description:** Number of participants with dose limiting toxicities
**Measure:** Dose limiting toxicities
**Time Frame:** 28 days
#### Secondary Outcomes
**Description:** Blood concentration of RMC-6236 over time
**Measure:** Pharmacokinetics of RMC-6236
**Time Frame:** 21 weeks
**Description:** Overall Response Rate per RECIST v1.1
**Measure:** ORR
**Time Frame:** Up to 3 years
**Description:** Duration of Response per RECIST v1.1
**Measure:** DOR
**Time Frame:** Up to 3 years
**Description:** Incidence of Response per RECIST v1.1
**Measure:** DCR
**Time Frame:** Up to 3 years
**Description:** Time to Response per RECIST v1.1
**Measure:** TTR
**Time Frame:** Up to 3 years
**Description:** Progression Free Survival per RECIST v1.1
**Measure:** PFS
**Time Frame:** Up to 3 years
**Description:** Overall Survival
**Measure:** OS
**Time Frame:** Up to 3 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
All Patients (unless otherwise noted):
* ≥ 18 years of age
* ECOG PS is 0 to 1
* Adequate organ function as outlined by the study
* Must have pathologically documented, pancreatic carcinoma with documented metastatic disease or RAS-mutated, histologically or cytologically confirmed colorectal adenocarcinoma with documented unresectable or metastatic disease (Subprotocol A and B)
* Must have pathologically documented, poorly differentiated pancreatic carcinoma with documented metastatic disease (Subprotocol C) -
Exclusion Criteria:
All Patients:
* Primary central nervous system (CNS) tumors
* Impaired gastrointestinal (GI) function that may significantly alter the absorption of RMC drugs
* Major surgery within 28 days of first dose
Other inclusion/exclusion criteria may apply.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Revolution Medicines
**Phone:** 650-779-2300
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Irving
**Country:** United States
**Facility:** NEXT Oncology Dallas
**State:** Texas
**Status:** RECRUITING
**Zip:** 75039
**Location 2:**
**City:** Fairfax
**Country:** United States
**Facility:** Virginia Cancer Specialists
**State:** Virginia
**Status:** RECRUITING
**Zip:** 22314
#### Overall Officials
**Official 1:**
**Affiliation:** Revolution Medicines
**Name:** Study Director
**Role:** STUDY_DIRECTOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007414
- Term: Intestinal Neoplasms
- ID: D000004067
- Term: Digestive System Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000005767
- Term: Gastrointestinal Diseases
- ID: D000003108
- Term: Colonic Diseases
- ID: D000007410
- Term: Intestinal Diseases
- ID: D000012002
- Term: Rectal Diseases
- ID: D000002277
- Term: Carcinoma
- ID: D000009375
- Term: Neoplasms, Glandular and Epithelial
- ID: D000009370
- Term: Neoplasms by Histologic Type
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: All
- Name: All Conditions
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M5534
- Name: Carcinoma
- Relevance: LOW
- As Found: Unknown
- ID: M3585
- Name: Adenocarcinoma
- Relevance: HIGH
- As Found: Adenocarcinoma
- ID: M13110
- Name: Pancreatic Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M25356
- Name: Carcinoma, Ductal
- Relevance: LOW
- As Found: Unknown
- ID: M22725
- Name: Carcinoma, Pancreatic Ductal
- Relevance: LOW
- As Found: Unknown
- ID: M17890
- Name: Colorectal Neoplasms
- Relevance: HIGH
- As Found: Colorectal Cancer
- ID: M8886
- Name: Gastrointestinal Neoplasms
- Relevance: HIGH
- As Found: Gastrointestinal Cancer
- ID: M7256
- Name: Digestive System Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M10448
- Name: Intestinal 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
- ID: M14844
- Name: Rectal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12320
- Name: Neoplasms, Glandular and Epithelial
- Relevance: LOW
- As Found: Unknown
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
- ID: T4387
- Name: Pancreatic Cancer
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000015179
- Term: Colorectal Neoplasms
- ID: D000000230
- Term: Adenocarcinoma
- ID: D000005770
- Term: Gastrointestinal 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: D000074322
- Term: Antineoplastic Agents, Immunological
- ID: D000020533
- Term: Angiogenesis Inhibitors
- ID: D000043924
- Term: Angiogenesis Modulating Agents
- ID: D000006133
- Term: Growth Substances
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000006131
- Term: Growth Inhibitors
- ID: D000000964
- Term: Antimetabolites, Antineoplastic
- ID: D000000963
- Term: Antimetabolites
### 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: M2985
- Name: Gemcitabine
- Relevance: HIGH
- As Found: Activity
- ID: M246
- Name: Bevacizumab
- Relevance: HIGH
- As Found: Non-
- ID: M315
- Name: Cetuximab
- Relevance: HIGH
- As Found: Side
- ID: M8600
- Name: Fluorouracil
- 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: M1346
- Name: Antineoplastic Agents, Immunological
- Relevance: LOW
- As Found: Unknown
- ID: M22318
- Name: Angiogenesis Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M9231
- Name: Growth Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M4281
- Name: Antimetabolites
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000017239
- Term: Paclitaxel
- ID: D000068258
- Term: Bevacizumab
- ID: D000093542
- Term: Gemcitabine
- ID: D000068818
- Term: Cetuximab
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06445049
**Acronym:** INTRINSIC
**Brief Title:** Intrinsic Respiratory Rate Assessment During Mechanical Ventilation to Accelerate Spontaneous Breathing and Extubation
**Official Title:** Assessing Intrinsic Respiratory Rate in Mechanically Ventilated Adult Patients With Reverse Triggering as an Incentive for Accelerating Transition to Spontaneous Breathing and Extubation: Pilot Randomized Clinical Trial - INTRINSIC
#### Organization Study ID Info
**ID:** 4902
#### Organization
**Class:** OTHER
**Full Name:** Unity Health Toronto
### Status Module
#### Completion Date
**Date:** 2027-06-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-05
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2027-06-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-30
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-30
**Study First Submit QC Date:** 2024-06-05
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Unity Health Toronto
#### 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 study is to identify patients with reverse triggering who's the potential to breath spontaneously is hidden because of the ventilator management strategy by performing a simple 30sec-test with includes reducing the support from the ventilator. The findings will provide clear advice to doctors on how to better care for these patients.
This will be a pilot randomized clinical trial including 70 adult patients (aimed at equal number of men and woman) sedated and under controlled ventilation having reverse triggering. The study will be conducted in two ICUs: 1) St. Michael's Hospital, Toronto Canada and 2) Toronto Western Hospital, Toronto, Canada.
**Detailed Description:** The objective of this study is to investigate the impact of assessing intrinsic respiratory rate in mechanically ventilated patients with reverse triggering on the facilitation of transition to spontaneous breathing and successful extubation.
Patients will be excluded if under current use of continuous neuromuscular blocking agent or severe metabolic acidosis (Ph\<7.25 at the time of study procedure.
Patients will be screened every morning from 8:00 am to 9:00 am all the patients under controlled ventilation to detect the presence of reverse triggering by looking at the screen on the ventilator (2-5 min observation). The research team (research MDs, physiotherapists and respiratory therapists) is very well trained at detecting reverse triggering. Patients will then be randomized to standard of care or intervention using a deferred consent model.
* Control group: standard care.
* Intervention group: The intervention is a simple brief test as follows: With the ventilator set with the patient clinical settings, it will be performed an up to 30sec-long or two inspiratory effort and expiratory occlusion maneuver on the ventilator and/or switch the patient to pressure support for up to 30sec-long to assess the presence of intrinsic respiratory rate.
If an intrinsic respiratory rate ≥8 breaths per minute is present and P/F ratio is ≥150 it will be performed a 5-minute "test" in pressure support ventilation with the pressure support level to match the clinical setting of the patient. If the patient tolerates well 5 minutes in pressure support (see criteria below) the clinical team will be informed:
- It will be indicated that the patient tolerated 5 min of pressure support ventilation and suggest to the clinicians and physician in charge to transition the patient to pressure support ventilation plus suggest reducing sedation.
### Conditions Module
**Conditions:**
- Reverse Triggering
- Patient Ventilator Dyssynchrony
**Keywords:**
- Mechanical Ventilation
- Dyssynchrony
- Reverse Triggering
- Intensive Care Unit
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Deferred consent model
##### Masking Info
**Masking:** NONE
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 70
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The participant will receive the current standard intensive care.
**Label:** Standard Care
**Type:** NO_INTERVENTION
#### Arm Group 2
**Description:** The intervention is a simple brief test as follows: With the ventilator set with the patient clinical settings, it will be performed an up to 30sec-long or two inspiratory effort and-expiratory occlusion maneuver on the ventilator and/or switch the patient to pressure support for up to 30sec-long to assess the presence of intrinsic respiratory rate.
If an intrinsic respiratory rate ≥8 breaths per minute is present and P/F ratio is ≥150 it will be performed a 5-minute "test" in pressure support ventilation with the pressure support level to match the clinical setting of the patient. If the patient tolerates well 5 minutes in pressure support (see criteria below) the clinical team will be informed:
- It will be indicated that the patient tolerated 5 min of PSV and suggest to the clinicians and physician in charge to transition the patient to pressure support ventilation plus suggest reducing sedation.
**Intervention Names:**
- Other: brief test
**Label:** brief test
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- brief test
**Description:** The intervention is a simple brief test as follows: With the ventilator set with the patient clinical settings, it will be performed an up to 30sec-long or two inspiratory effort and-expiratory occlusion maneuver on the ventilator and/or switch the patient to pressure support for up to 30sec-long to assess the presence of intrinsic respiratory rate.
If an intrinsic respiratory rate ≥8 breaths per minute is present and P/F ratio is ≥150 it will be performed a 5-minute "test" in pressure support ventilation with the pressure support level to match the clinical setting of the patient. If the patient tolerates well 5 minutes in pressure support (see criteria below) the clinical team will be informed:
- It will be indicated that the patient tolerated 5 min of PSV and suggest to the clinicians and physician in charge to transition the patient to pressure support ventilation plus suggest reducing sedation.
**Name:** brief test
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Number of patients tolerating the transition to assisted breathing (e.g., Pressure Support Ventilation, Neurally Adjusted Ventilatory Assist, Proportional assist ventilation with load-adjustable gain factors), or having an SBT, or being extubated within 48 hours
**Measure:** Number of patients tolerating the transition to assisted breathing, or having an SBT, or being extubated within 48 hours
**Time Frame:** 48 hours
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Adult patients (aimed at equal number of men and woman) sedated and under controlled ventilation having reverse triggering.
Exclusion Criteria:
* under current use of continuous neuromuscular blocking agent or severe metabolic acidosis (Ph\<7.25) at the time of study procedure.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Laurent Brochard, MD
**Phone:** 4168645686
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Antenor Rodrigues, Ph.D.
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Unity Health Toronto - St. Michael's Hospital
**Name:** Laurent Brochard
**Role:** PRINCIPAL_INVESTIGATOR
### References Module
#### References
**Citation:** Rodrigues A, Telias I, Damiani LF, Brochard L. Reverse Triggering during Controlled Ventilation: From Physiology to Clinical Management. Am J Respir Crit Care Med. 2023 Mar 1;207(5):533-543. doi: 10.1164/rccm.202208-1477CI.
**PMID:** 36470240
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012131
- Term: Respiratory Insufficiency
- ID: D000012120
- Term: Respiration Disorders
- ID: D000012140
- Term: Respiratory Tract Diseases
- ID: D000012818
- Term: Signs and Symptoms, Respiratory
### Condition Browse Module - Browse Branches
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M27137
- Name: Respiratory Aspiration
- Relevance: LOW
- As Found: Unknown
- ID: M3385
- Name: Patient-Ventilator Asynchrony
- Relevance: HIGH
- As Found: Patient-Ventilator Dyssynchrony
- ID: M14968
- Name: Respiratory Insufficiency
- Relevance: LOW
- As Found: Unknown
- ID: M14957
- Name: Respiration Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15623
- Name: Signs and Symptoms, Respiratory
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000097742
- Term: Patient-Ventilator Asynchrony
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06445036
**Acronym:** THYPARS
**Brief Title:** Tunisian Clinical Registry on Hypoparathyroidism and Pseudo-hypoparathyroidism.
**Official Title:** Tunisian Clinical Registry on Hypoparathyroidism and Pseudo-hypoparathyroidism.
#### Organization Study ID Info
**ID:** DAC-015-THYPARS
#### Organization
**Class:** OTHER
**Full Name:** Dacima Consulting
### Status Module
#### Completion Date
**Date:** 2025-02-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-31
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-02-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-09-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-31
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** Société Tunisienne D'endocrinologie De Diabétologie Et Des Maladies Métaboliques
#### Lead Sponsor
**Class:** OTHER
**Name:** Dacima Consulting
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Observational, multicenter, national, cross-sectional study aiming to describe the epidemiological clinical, biological and therapeutic profile of patients suffering from defect in secretion (hypoparathyroidism) or action (pseudo-hypoparathyroidism) of parathyroid hormone.
**Detailed Description:** Endocrinologists from both sectors (public and private) are participating in the study. Data will be captured electronically by DACIMA Clinical Suite, according to FDA 21 CFR part 11 (Food and Drug Administration 21 Code of Federal Regulations part 11), HIPAA (Health Insurance Portability and Accountability Act) \& ICH (International Conference on Harmonisation) requirements.
### Conditions Module
**Conditions:**
- Hypoparathyroidism
- Pseudo Hypoparathyroidism
**Keywords:**
- Hypoparathyroidism
- Pseudo Hypoparathyroidism
- Clinical Registry
- Endocrinology
- Parathyroid gland
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** CROSS_SECTIONAL
#### Enrollment Info
**Count:** 1000
**Type:** ESTIMATED
**Patient Registry:** True
**Study Type:** OBSERVATIONAL
**Target Duration:** 1 Day
### Outcomes Module
#### Primary Outcomes
**Description:** Number of subjects with primary hypoparathyroidism at enrollment
**Measure:** Incidence of primary hypoparathyroidism
**Time Frame:** At inclusion
**Description:** Number of subjects with congenital hypoparathyroidism at enrollment
**Measure:** Incidence of congenital hypoparathyroidism
**Time Frame:** At inclusion
**Description:** Number of subjects with acquired hypoparathyroidism at enrollment
**Measure:** Incidence of acquired hypoparathyroidism
**Time Frame:** At inclusion
**Description:** Number of subjects with secondary hypoparathyroidism at enrollment
**Measure:** Incidence of secondary hypoparathyroidism
**Time Frame:** At inclusion
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Hypoparathyroidism defined by low serum calcium \< 2.2 mmol/l (\< 88 mg/l) associated with inadequate PTH (low or normal) and normal creatinine
Exclusion Criteria:
* Cervical surgery \< 6 months.
* Transient (neonatal, etc.) or functional (dysmagnesemia, etc.) hypoparathyroidism.
* Other causes of hypocalcemia: vitamin D deficiency, chronic renal failure, etc.
* Familial hypocalcemia hypercalciuria.
* Pseudo-pseudo-hypoparathyroidism.
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Consecutive patients suffering from hypoparathyroidism and/or pseudo hypoparathyroidism
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Nabila Rekik Mejdoub, MD
**Phone:** +216 98 609 300
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Rabie Razgallah, MD
**Phone:** +216 20 509 729
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Sfax
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Nabila Rekik Mejdoub, MD
- **Phone:** +216 98 609 300
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Rabie Razgallah, MD
- **Phone:** +216 20 509 729
- **Role:** CONTACT
**Country:** Tunisia
**Facility:** Société Tunisienne D'endocrinologie De Diabétologie Et Des Maladies Métaboliques
**Zip:** 3000
#### Overall Officials
**Official 1:**
**Affiliation:** Société Tunisienne D'endocrinologie De Diabétologie Et Des Maladies Métaboliques
**Name:** Nabila Rekik Mejdoub, MD
**Role:** STUDY_CHAIR
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
### References Module
#### See Also Links
**Label:** Website of Société Tunisienne D'endocrinologie De Diabétologie Et Des Maladies Métaboliques
**URL:** https://endocrino-tunisie.com/
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010279
- Term: Parathyroid Diseases
- ID: D000004700
- Term: Endocrine System Diseases
- ID: D000001851
- Term: Bone Diseases, Metabolic
- ID: D000001847
- Term: Bone Diseases
- ID: D000009140
- Term: Musculoskeletal Diseases
- ID: D000008664
- Term: Metal Metabolism, Inborn Errors
- ID: D000008661
- Term: Metabolism, Inborn Errors
- ID: D000030342
- Term: Genetic Diseases, Inborn
- ID: D000008659
- Term: Metabolic Diseases
- ID: D000002128
- Term: Calcium Metabolism Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BC05
- Name: Musculoskeletal Diseases
- Abbrev: BC16
- Name: Diseases and Abnormalities at or Before Birth
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M14404
- Name: Pseudohypoparathyroidism
- Relevance: HIGH
- As Found: Pseudo Hypoparathyroidism
- ID: M14413
- Name: Pseudopseudohypoparathyroidism
- Relevance: HIGH
- As Found: Pseudo Hypoparathyroidism
- ID: M10061
- Name: Hypoparathyroidism
- Relevance: HIGH
- As Found: Hypoparathyroidism
- ID: M13192
- Name: Parathyroid Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7862
- Name: Endocrine System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5126
- Name: Bone Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5130
- Name: Bone Diseases, Metabolic
- Relevance: LOW
- As Found: Unknown
- ID: M12097
- Name: Musculoskeletal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M11641
- Name: Metabolism, Inborn Errors
- Relevance: LOW
- As Found: Unknown
- ID: M11644
- Name: Metal Metabolism, Inborn Errors
- Relevance: LOW
- As Found: Unknown
- ID: M23686
- Name: Genetic Diseases, Inborn
- Relevance: LOW
- As Found: Unknown
- ID: M11639
- Name: Metabolic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5391
- Name: Calcium Metabolism Disorders
- Relevance: LOW
- As Found: Unknown
- ID: T2949
- Name: Hypoparathyroidism
- Relevance: HIGH
- As Found: Hypoparathyroidism
- ID: T4783
- Name: Pseudohypoparathyroidism
- Relevance: HIGH
- As Found: Pseudo Hypoparathyroidism
- ID: T4796
- Name: Pseudopseudohypoparathyroidism
- Relevance: HIGH
- As Found: Pseudo Hypoparathyroidism
### Condition Browse Module - Meshes
- ID: D000011547
- Term: Pseudohypoparathyroidism
- ID: D000011556
- Term: Pseudopseudohypoparathyroidism
- ID: D000007011
- Term: Hypoparathyroidism
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M13194
- Name: Parathyroid Hormone
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06445023
**Acronym:** EMBARQ-CSU1
**Brief Title:** A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria (EMBARQ-CSU1)
**Official Title:** A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Barzolvolimab in Patients With Chronic Spontaneous Urticaria Who Remain Symptomatic Despite H1 Antihistamine Treatment (EMBARQ-CSU1)
#### Organization Study ID Info
**ID:** CDX0159-12
#### Organization
**Class:** INDUSTRY
**Full Name:** Celldex Therapeutics
#### Secondary ID Infos
**ID:** 2024-513208-32-00
**Type:** CTIS
### Status Module
#### Completion Date
**Date:** 2027-04
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-31
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-10
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-31
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Celldex Therapeutics
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The purpose of this study is to establish the efficacy, safety and tolerability of barzolvolimab in adult participants with Chronic Spontaneous Urticaria (CSU) inadequately controlled by non-sedating second generation H1-antihistamines in comparison to placebo.
**Detailed Description:** This is a global, multicenter, randomized, double-blind, parallel group, placebo-controlled phase 3 study investigating the efficacy, safety and tolerability of barzolvolimab in adult participants with Chronic Spontaneous Urticaria (CSU) who are symptomatic despite treatment with non-sedating second generation H1-antihistamines at 1-4 times the locally approved dose.
There is a screening period of up to 4 weeks, followed by a 24-week placebo-controlled treatment period, a 28-week active treatment period where all participants receive barzolvolimab followed by a 16-week treatment free period.
Approximately 915 adult participants (610 in the active arms and 305 in the placebo arm) will be randomly assigned to the treatment arms.
### Conditions Module
**Conditions:**
- Chronic Spontaneous Urticaria
**Keywords:**
- CDX-0159
- barzolvolimab
- chronic spontaneous urticaria
- CSU
- urticaria activity score
- itch severity score
- hives severity score
### 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:** 915
**Type:** ESTIMATED
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** barzolvolimab given once as a 300 mg subcutaneous injection followed by 150 mg administered every 4 weeks for 52 weeks
**Intervention Names:**
- Biological: barzolvolimab
**Label:** barzolvolimab 150 mg
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** barzolvolimab given once as a 450 mg subcutaneous injection followed by 300 mg administered every 8 weeks for 52 weeks
**Intervention Names:**
- Biological: barzolvolimab
**Label:** barzolvolimab 300 mg
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Placebo injection subcutaneous every 4 weeks for 24 weeks and then barzolvolimab 300 mg followed by 150 mg administered every 4 weeks for 28 weeks.
**Intervention Names:**
- Biological: barzolvolimab
- Biological: Matching placebo
**Label:** Placebo then barzolvolimab 150 mg
**Type:** EXPERIMENTAL
#### Arm Group 4
**Description:** Placebo injection subcutaneous every 4 weeks for 24 weeks and then barzolvolimab 450 mg followed by 300 mg administered every 8 weeks for 28 weeks.
**Intervention Names:**
- Biological: barzolvolimab
- Biological: Matching placebo
**Label:** Placebo then barzolvolimab 300 mg
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Placebo then barzolvolimab 150 mg
- Placebo then barzolvolimab 300 mg
- barzolvolimab 150 mg
- barzolvolimab 300 mg
**Description:** Subcutaneous Administration
**Name:** barzolvolimab
**Type:** BIOLOGICAL
#### Intervention 2
**Arm Group Labels:**
- Placebo then barzolvolimab 150 mg
- Placebo then barzolvolimab 300 mg
**Description:** Matching placebo Subcutaneous Administration
**Name:** Matching placebo
**Type:** BIOLOGICAL
### Outcomes Module
#### Primary Outcomes
**Description:** Evaluate efficacy of barzolvolimab on urticaria activity as measured by urticaria activity score (UAS).
The UAS7 is a simple scoring system to evaluate urticaria signs and symptoms. It is based on scoring wheals (hive severity score) and itch (itch severity score) separately on a scale of 0 (no signs/symptoms) to 3 (intense signs/symptoms) over 7 days. The final score is calculated by adding together the daily scores, which can range from 0 to 6, for 7 days. This results in a maximum total score of 42, and a minimum possible score of 0.
**Measure:** Mean change from baseline to Week 12 of UAS7 (Urticaria Activity Score)
**Time Frame:** From Day 1 (first dose) to Day 85 (Week 12)
#### Secondary Outcomes
**Description:** The ISS7 and HSS7 combined together make up the UAS7 scoring system to evaluate urticaria signs and symptoms. The ISS7 is the itch severity score for 7 days, the scores range from 0 to 21.
**Measure:** Mean change from baseline to Week 12 of ISS7 (Itch Severity Score)
**Time Frame:** From Day 1 (first dose) to Day 85 (Week 12)
**Description:** The ISS7 and HSS7 combined together make up the UAS7 scoring system to evaluate urticaria signs and symptoms. The HSS7 score is the wheal/hives severity score for 7 days, the scores range from 0 to 21.
**Measure:** Mean change from baseline to Week 12 of HSS7 (Hives Severity Score)
**Time Frame:** From Day 1 (first dose) to Day 85 (Week 12)
**Description:** Proportion of participants who achieve complete absence of hives and itch (UAS7 = 0) at Week 12.
**Measure:** Percentage of participants with UAS7 = 0 at Week 12
**Time Frame:** From Day 1 (first dose) to Day 85 (Week 12)
**Description:** Evaluate efficacy of barzolvolimab on urticaria activity as measured by urticaria activity score (UAS) in participants who did not respond to or did not tolerate omalizumab.
The UAS7 is a simple scoring system to evaluate urticaria signs and symptoms. It is based on scoring wheals (hive severity score) and itch (itch severity score) separately on a scale of 0 (no signs/symptoms) to 3 (intense signs/symptoms) over 7 days. The final score is calculated by adding together the daily scores, which can range from 0 to 6, for 7 days. This results in a maximum total score of 42, and a minimum possible score of 0.
**Measure:** Mean change from baseline in UAS7 in participants refractory to omalizumab treatment at Week 12
**Time Frame:** From Day 1 (first dose) to Day 85 (Week 12)
**Description:** Proportion of participants who achieve complete absence of hives and itch (UAS7 = 0) at Week 12 in participants who did not respond to or did not tolerate omalizumab.
**Measure:** Proportion of participants with UAS7 = 0 in participants refractory to omalizumab treatment at Week 12
**Time Frame:** From Day 1 (first dose) to Day 85 (Week 12)
**Description:** Proportion of participants who achieve control of their urticaria signs and symptoms (UAS7 \</=6) at Week 12.
**Measure:** Percentage of participants with UAS7 ≤ 6 at Week 12
**Time Frame:** From Day 1 (first dose) to Day 85 (Week 12)
**Description:** Evaluate efficacy of barzolvolimab on urticaria activity as measured by urticaria activity score (UAS).
The UAS7 is a simple scoring system to evaluate urticaria signs and symptoms. It is based on scoring wheals (hive severity score) and itch (itch severity score) separately on a scale of 0 (no signs/symptoms) to 3 (intense signs/symptoms) over 7 days. The final score is calculated by adding together the daily scores, which can range from 0 to 6, for 7 days. This results in a maximum total score of 42, and a minimum possible score of 0.
**Measure:** Mean change from baseline in UAS7 at Week 4
**Time Frame:** From Day 1 (first dose) to Day 29 (Week 4)
**Description:** Evaluate efficacy of barzolvolimab on urticaria activity as measured by urticaria activity score (UAS).
The UAS7 is a simple scoring system to evaluate urticaria signs and symptoms. It is based on scoring wheals (hive severity score) and itch (itch severity score) separately on a scale of 0 (no signs/symptoms) to 3 (intense signs/symptoms) over 7 days. The final score is calculated by adding together the daily scores, which can range from 0 to 6, for 7 days. This results in a maximum total score of 42, and a minimum possible score of 0.
**Measure:** Mean change from baseline in UAS7 at Week 24
**Time Frame:** From Day 1 (first dose) to Day 169 (Week 24)
**Description:** Proportion of participants who achieve complete absence of hives and itch (UAS7 = 0) at Week 24.
**Measure:** Percentage of participants with UAS7 = 0 at Week 24
**Time Frame:** From Day 1 (first dose) to Day 169 (Week 24)
**Description:** Occurrence of treatment emergent adverse events and serious adverse events during the study.
**Measure:** Incidence of Treatment-Emergent Adverse Events
**Time Frame:** From Day 1 (first dose) to Day 477 (Week 68)
### Eligibility Module
**Eligibility Criteria:** Key Inclusion Criteria:
1. Males and females, \>/= 18 years of age.
2. Diagnosis of chronic spontaneous urticaria (CSU) \>/= 6 months.
3. CSU despite the use of a stable regimen of second generation non-sedating H1-antihistamine as defined by:
1. The presence of hives for \>/= 6 weeks at any time prior to Visit 1 despite the use of non-sedating H1-antihistamines.
2. Must be on a stable regimen of second generation non-sedating H1-antihistamine for \>/= 4 weeks prior to study treatment.
3. UAS7 of \>/= 16 and ISS7 of \>/= 8 during the 7 days prior to treatment.
4. Normal blood counts and liver function tests.
5. Both males and females of child-bearing potential must agree to use highly effective contraceptives during the study and for 150 days after treatment.
6. Willing and able to complete a daily symptom electronic diary and comply with study visits.
7. Participants with and without prior biologic experience are eligible.
Key Exclusion Criteria:
1. Women who are pregnant or nursing.
2. Chronic inducible urticaria that would confound the study endpoints.
3. Other diseases associated with urticaria.
4. Active pruritic skin condition in addition to CSU.
5. Medical condition that would cause additional risk or interfere with study procedures.
6. Known HIV, hepatitis B or hepatitis C infection.
7. Vaccination of a live vaccine within 2 months prior to study treatment (subjects must agree to avoid live vaccinations during the study). Inactivated vaccines are allowed such as seasonal influenza injection or COVID-19 vaccine.
8. History of anaphylaxis
9. Prior treatment with barzolvolimab
There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Celldex Therapeutics
**Phone:** 844-723-9363
**Role:** CONTACT
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000017445
- Term: Skin Diseases, Vascular
- ID: D000012871
- Term: Skin Diseases
- ID: D000006969
- Term: Hypersensitivity, Immediate
- ID: D000006967
- Term: Hypersensitivity
- ID: D000007154
- Term: Immune System Diseases
- ID: D000002908
- Term: Chronic Disease
- ID: D000020969
- Term: Disease Attributes
- ID: D000010335
- Term: Pathologic Processes
### Condition Browse Module - Browse Branches
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M14396
- Name: Pruritus
- Relevance: LOW
- As Found: Unknown
- ID: M17330
- Name: Urticaria
- Relevance: HIGH
- As Found: Urticaria
- ID: M2129
- Name: Chronic Urticaria
- Relevance: HIGH
- As Found: Chronic Spontaneous Urticaria
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M19714
- Name: Skin Diseases, Vascular
- Relevance: LOW
- As Found: Unknown
- ID: M10018
- Name: Hypersensitivity
- Relevance: LOW
- As Found: Unknown
- ID: M10020
- Name: Hypersensitivity, Immediate
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: 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: D000014581
- Term: Urticaria
- ID: D000080223
- Term: Chronic Urticaria
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Infe
- Name: Anti-Infective Agents
### Intervention Browse Module - Browse Leaves
- ID: M9709
- Name: Histamine Antagonists
- Relevance: LOW
- As Found: Unknown
- ID: M9710
- Name: Histamine H1 Antagonists
- Relevance: LOW
- As Found: Unknown
- ID: M84065
- Name: Trichostatin A
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06445010
**Brief Title:** Musical Playlist of the Grief Journey
**Official Title:** Playlist of the Grief Journey: Humanizing Bereavement Through Music
#### Organization Study ID Info
**ID:** STUDY00000463
#### Organization
**Class:** OTHER
**Full Name:** Brown University
### Status Module
#### Completion Date
**Date:** 2025-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-31
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-08
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-31
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** The Miriam Hospital
#### Lead Sponsor
**Class:** OTHER
**Name:** Brown University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The goal of this clinical trial is to learn about the effectiveness of a music-based intervention as a bereavement strategy for individuals who are a part of the Loss of Spouse/Life Partner Grief Support Group at HopeHealth, a healthcare organization in Providence, Rhode Island that specializes in home care, hospice care, palliative care, and grief support. The main question it ams to answer is:
* Will the experience of creating a musical playlist help individuals in bereavement process their grief more effectively?
Participants will undergo the following main tasks:
* A baseline pre-assessment survey that asks about the role of music in the participant's and their partner's life, as well as how music has helped participants with their grief.
* A 75-minute Zoom session with the study investigator which includes a conversation about the participant's loved one and grief journey. This Zoom session serves to find themes and emotions in the participant's grief journey which will be as foundations for musical playlists.
* Participants will create their own musical playlist based on guidance from the study investigator.
* A post-assessment survey that asks participants to reflect on the experience of creating a playlist. This survey also examines if music plays a new role in the participant's life.
**Detailed Description:** The death of a loved one is a universal experience and one of life's greatest stressors. Although most bereaved individuals navigate through intense acute grief that lessens with time, approximately 10% develop prolonged grief disorder (PGD), characterized by persistent mental distress, maladaptive thoughts, avoidance behaviors, and impaired functionality. The COVID-19 pandemic has potentially increased PGD cases, and individuals on the grief spectrum face risks for various medical and psychological issues. Given that PGD was only recently recognized in the DSM-5 in 2022 and effective bereavement strategies are lacking, research in this area is crucial. Music-based interventions have shown promise in enhancing recovery in diverse settings, including cancer treatment and dementia care, by reducing anxiety and distress and engaging cognitive and social functions. However, studies on music's role in bereavement are limited. Recent research on expressive arts therapies suggests that music could be a valuable tool in supporting grieving individuals, highlighting the need to explore its potential in facilitating the grief journey.
The goals of this project are three-fold:
* Creating personalized music playlists with survivors after conversing with them about their grief journey to not only humanistically explore and reflect on their experience but also to create a long-lasting tool they can keep and be effectively utilized to help process their grief.
* This playlist will also be shared amongst participating individuals so that their story can be shared in this novel and creative way. Participants can also learn about other's stories and reflections through this shared medium.
* Integrating this project into the Warren Alpert Medical School curriculum as part of the new Medical Humanities Initiative, and having first through third year medical students pairing up with grieving individuals, having a conversation with them, and co-creating a personalized music playlist.
### Conditions Module
**Conditions:**
- Music Therapy
- Bereavement
**Keywords:**
- Grief Support, Creative Arts
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 30
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants created a musical playlist over 1 week based on themes and emotions from their grief journey.
**Intervention Names:**
- Other: Creating Musical Playlist
**Label:** Creating Musical Playlist
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Creating Musical Playlist
**Description:** Personal music playlist for therapeutic listening and sharing with other individuals in bereavement
**Name:** Creating Musical Playlist
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** A vetted question with study directors serves to measure if using music as a medium to express participants' grief has any impact on mental health and well-being before and after the music playlist creation experience.
**Measure:** Change from Baseline in Music's Impact on Mental Health and Well-Being
**Time Frame:** Baseline and Week 1
**Description:** Vetted questions with study directors serve to measure the importance of music in participants' life before and after the music playlist creation experience. These questions also examine the likelihood of participants to continue listening to their playlists after the project conclusion as a therapeutic resource.
**Measure:** Change from Baseline in the Importance of Music in Participant's Life
**Time Frame:** Baseline and Week 1
**Description:** Vetted questions with study directors ask participants to reflect on their overall experience on creating and listening to their musical playlist. The questions ask participants to elaborate on how the exercise has helped them process/navigate/provide a new perspective to their grief experience? The study investigator also asks participants to reflect on any pieces of music that particularly connected with them and why.
**Measure:** Qualitative Learning Moments After Music Playlist Creation
**Time Frame:** Baseline and Week 1
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Participant in HopeHealth's Spouse/Life Partner Grief Support group
* Sufficient hearing capacity to hear music
* Access to a computer, laptop, phone, iPad, or any other technological device that's able to support YouTube, Apple Music, Spotify, or another preferred streaming service
* Ability to complete pre- and post-assessments in English.
Exclusion Criteria:
* Participants who have participated in any music-based intervention for bereavement
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Diana A Wang, BA
**Phone:** 5094302922
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Brown University
**Name:** Diana A Wang, BA
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** HopeHealth
**Name:** Deanna Church
**Role:** STUDY_DIRECTOR
**Official 3:**
**Affiliation:** HopeHealth
**Name:** Sarah DeCosta, LMHC
**Role:** STUDY_DIRECTOR
**Official 4:**
**Affiliation:** Brown University
**Name:** Fred J Schiffman, MD
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**Description:** There is no plan to make IPD available to other researchers. All collected data will be kept internal to the investigator on the project.
**IPD Sharing:** NO
## Document Section
### Large Document Module
#### Large Docs
- Date: 2024-05-29
- Filename: Prot_000.pdf
- Has ICF: False
- Has Protocol: True
- Has SAP: False
- Label: Study Protocol
- Size: 208642
- Type Abbrev: Prot
- Upload Date: 2024-05-31T11:56
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06444997
**Brief Title:** Efficacy and Safety of Oxycodone Hydrochloride for Long-term Analgesia in ICU Patients
**Official Title:** Efficacy and Safety of Oxycodone Hydrochloride and Remifentanil for Long-term Analgesia During Invasive Mechanical Ventilation in Postoperative Patients: A Pilot Study
#### Organization Study ID Info
**ID:** B2024-161R
#### Organization
**Class:** OTHER
**Full Name:** Shanghai Zhongshan Hospital
### Status Module
#### Completion Date
**Date:** 2025-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-05
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-02-28
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-06-05
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Shanghai Zhongshan 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 goal of this clinical trial is to learn if oxycodone hydrochloride works to manage pain in patients requiring mechanical ventilation. It will also assess the safety of oxycodone hydrochloride. The main questions it aims to answer are:
1. Does oxycodone hydrochloride effectively lower the CPOT (Critical Care Pain Observation Tool) score in mechanically ventilated patients?
2. What medical problems do participants have when using oxycodone hydrochloride? Researchers will compare oxycodone hydrochloride to remifentanil to see if oxycodone works better to manage pain in these patients.
Participants will:
* Receive either oxycodone hydrochloride injection at a dose of 0.03-0.2 mg/kg/h or remifentanil injection at a dose of 2-9 μg/kg/h.
* Have their pain scores assessed every 15 minutes until the CPOT score is less than 3. After reaching the target pain score, assessments will be done every 4 hours.
* Have their vital signs and monitoring data recorded.
* Have analgesia and sedation scores recorded from days 1 to 7 after administration, with drug dosages adjusted based on pain scores.
* Have the incidence of adverse reactions and changes in gastrointestinal function observed and recorded from days 1 to 7 after administration.
* If extubated within 7 days, relevant data will be collected based on the time of extubation.
* Be followed up on day 28 through the electronic medical record system to gather data on the extubation success rate and incidence of complications within the 28-day period.
**Detailed Description:** This study is a single-center, single-blind, randomized controlled exploratory study involving subjects aged 18 to 80 who are expected to require mechanical ventilation for ≥24 hours and who were intubated and received mechanical ventilation for less than 3 days before enrollment. Subjects will be treated with either oxycodone hydrochloride injection or remifentanil injection and will be randomly assigned in a 1:1 ratio, giving each subject a 50% chance of being assigned to the control group.
Trial Group: Subjects will receive oxycodone hydrochloride injection at a dose of 0.03-0.2 mg/kg/h. Pain scores will be assessed every 15 minutes until the CPOT (Critical Care Pain Observation Tool) score is less than 3. After achieving the target pain score, pain scores will be assessed every 4 hours.
Control Group: Subjects will receive remifentanil hydrochloride injection at a dose of 2-9 μg/kg/h. Pain scores will be assessed every 15 minutes until the CPOT score is less than 3. After achieving the target pain score, pain scores will be assessed every 4 hours.
During this period, the vital signs and monitoring data of the subjects will be recorded. Analgesia and sedation scores will be recorded from days 1 to 7 after administration, and the analgesic and sedative drug dosages will be adjusted based on the subjects' pain scores. Additionally, the incidence of adverse reactions and changes in gastrointestinal function will be observed and recorded from days 1 to 7 after administration.
There are no biological detection indicators in this study; all evaluations are made by the researchers through scoring sheets and will not affect the subjects' normal treatment. If a subject is extubated and weaned off the ventilator within 7 days, relevant data will be collected based on the time of extubation. On the 28th day after administration, doctors will follow up via the electronic medical record system to gather data on the extubation success rate, incidence of complications, and other relevant indicators within the 28-day period.
### Conditions Module
**Conditions:**
- Oxycodone
- Analgesia
- Mechanical Ventilation
- Postoperative
- Remifentanil
**Keywords:**
- Oxycodone
- oxycodone hydrochloride
- long term analgesic
- Analgesia
- Mechanical Ventilation
- Remifentanil
- Pilot Study
- ICU
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Phases:**
- PHASE4
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Continuous infusion therapy
**Intervention Names:**
- Drug: Oxycodone Hydrochloride
**Label:** Oxycodone Hydrochloride
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Continuous infusion therapy
**Intervention Names:**
- Drug: Remifentanil
**Label:** Remifentanil
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Oxycodone Hydrochloride
**Description:** Oxycodone hydrochloride will be administered at a continuous infusion dose of 0.03-0.2 mg/kg/h.
**Name:** Oxycodone Hydrochloride
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Remifentanil
**Description:** Remifentanil will be administered at a continuous infusion dose of 2-9 μg/kg/h.
**Name:** Remifentanil
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** By CPOT Form.
**Measure:** Percentage of time with Critical care Pain Observation Tool (CPOT) < 3 without rescue analgesia within 7 days of mechanical ventilation.
**Time Frame:** Mechanical ventilation within 7 days after administration of analgesics.
#### Secondary Outcomes
**Description:** Collect relevant data by case form
**Measure:** Days without mechanical ventilation
**Time Frame:** Within 28 days after administration
**Description:** Defined as not using non-invasive or invasive mechanical ventilation within 48 hours after the first spontaneous breathing trial (SBT) in 28 days
**Measure:** Successful extubation rate
**Time Frame:** Within 28 days after administration
**Description:** Assessed according to diagnostic criteria
**Measure:** Ventilator-associated pneumonia
**Time Frame:** Within 28 days after administration
**Description:** Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). The CAM-ICU provides a binary outcome: the presence or absence of delirium. The assessment results in either a positive or negative diagnosis for delirium, where a positive result indicates the presence of delirium and a worse outcome for the patient.
**Measure:** Delirium
**Time Frame:** Within 28 days after administration
**Description:** Collect relevant data by case form
**Measure:** Length of Stay (LOS) in ICU
**Time Frame:** From ICU admission to ICU discharge (typically within 1 to 4 weeks)
**Description:** Gastrointestinal Failure (GIF) score. The score ranges from 0 to 4, a higher GIF score signifies a more severe gastrointestinal dysfunction and a worse outcome for the patient.
**Measure:** Change in gastrointestinal function within 7 days of dosing
**Time Frame:** Postdose 1, 2, 3, 4, 5, 6, 7 days
**Description:** Investigator assessment by observation
**Measure:** Adverse Event (AE) incidence rate
**Time Frame:** 7 days postdose
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* 18 ≤ Age ≤ 80
* Intubated and mechanically ventilated \< 3 days prior to enrollment
* Expected need for continuous mechanical ventilation ≥ 24 hours
Exclusion Criteria:
* Patients requiring deep sedation (e.g., mechanical ventilation patients with severe man-machine dyssynchrony, respiratory distress due to severe respiratory failure, application of neuromuscular blockers, status epilepticus, surgical procedures requiring strict immobilization, mild hypothermia treatment, etc.);
* Chronic kidney disease, severe liver dysfunction (Child-Pugh Class C)
* Severe shock requiring norepinephrine ≥ 0.5 µg/kg/min
* American Society of Anesthesiologists (ASA) Class 5 patients (near death)
* Nerve injury or organic pathological changes in the brain
* Need for designated sedatives or anesthetics other than study drug during treatment
* Patients with chronic pain, frequently taking strong opioids, such as morphine
* History of alcohol or drug abuse
* Participation in other opioid studies within 30 days
* Pregnant or lactating women
* Patients with study drug allergy and contraindications Patients who are not suitable for inclusion in the study as judged by the investigator
**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:** Yunhang Zhang
**Phone:** 19542814786
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Shanghai
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Yunhang Zhang
- **Phone:** 19542814786
- **Role:** CONTACT
**Country:** China
**Facility:** Zhongshan Hospital Fudan University
**State:** Shanghai
**Zip:** 200032
#### Overall Officials
**Official 1:**
**Affiliation:** Fudan University
**Name:** Ming Zhong
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010468
- Term: Perceptual 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: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M3727
- Name: Agnosia
- Relevance: HIGH
- As Found: Analgesia
- ID: M13379
- Name: Perceptual 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
- ID: T241
- Name: Agnosia
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000000377
- Term: Agnosia
### Intervention Browse Module - Ancestors
- ID: D000000701
- Term: Analgesics, Opioid
- ID: D000009294
- Term: Narcotics
- ID: D000002492
- Term: Central Nervous System Depressants
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000000700
- Term: Analgesics
- ID: D000018689
- Term: Sensory System Agents
- ID: D000018373
- Term: Peripheral Nervous System Agents
### 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: M1696
- Name: Remifentanil
- Relevance: HIGH
- As Found: 60 minutes
- ID: M13020
- Name: Oxycodone
- Relevance: HIGH
- As Found: Cell Function
- 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: D000077208
- Term: Remifentanil
- ID: D000010098
- Term: Oxycodone
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06444984
**Brief Title:** The Movie Theater Study
**Official Title:** The Movie Theater Study: Acute Cardiometabolic Effects of a Cinema-Style Meal
#### Organization Study ID Info
**ID:** 2141491-1
#### Organization
**Class:** OTHER
**Full Name:** Ball State University
### Status Module
#### Completion Date
**Date:** 2025-03
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-31
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-09
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-03-24
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-31
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Ball State University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Increasing attention has been paid to meals with unusual characteristics that are consumed on a semi-regular basis (e.g., "tailgating," pizza buffets). The purpose of this study is to describe the acute cardiometabolic effects of a cinema-style meal rich in refined sugar, total carbohydrate, and moderate in fat (i.e., soda, popcorn, candy).
**Detailed Description:** Participants will complete two study visits in random order. For one visit, participants will consume popcorn (6 cups popped microwave popcorn), soda (32 oz Coke-a-cola), and candy (2.17 oz of Skittles) in the morning while fasting (i.e., the "fasting trial"). For the other visit, participants will report fasting and then first consume a high-fat meal (two Jimmy Dean's breakfast sandwiches; the "fed trial"). After consuming the high-fat meal during the fed trial, participants will be allowed to leave for three hours. During this three-hour period, the investigators will ask participants to only consume water and remain sedentary. Upon return, participants will consume the same movie theater style meal (popcorn, soda, candy).
Regardless of fasting or fed trials, procedures for this study will be largely similar between the two visits. Participants will arrive having fasted for \~10 hours, avoided exercise and alcohol for \> 24 hours, and avoided anti-inflammatory medications for \> 72 hours. First, the investigators will perform a baseline vascular ultrasound using the flow-mediated dilation (FMD) technique on all participants. Upon completion of FMD, the investigators will perform a blood draw in one of two ways (depending on the trial). For the fasting trial, the investigators will insert an indwelling intravenous catheter (IV) to minimize needle sticks. After a baseline blood sample is collected, participants will consume the movie theater-style meal and remain in the lab for four hours. During this time, the investigators will collect blood samples at 0.5-, 1-, 2-, 3-, and 4-hours post meal to measure potential changes in metabolic and inflammatory markers and indicators of endotoxemia. The investigators will also measure FMD at 2- and 4-hours post movie theater-style meal. During the fed trial, the investigators will first perform a single venipuncture to obtain a blood sample in order to have a true baseline sample for the fed trial. When participants return from this three-hour break, the procedures for the fed trial will be identical to the fasting trial (IV inserted, moving theater meal consumed, serial blood draws and FMD completed at the same timepoints over a four-hour period).
### Conditions Module
**Conditions:**
- Hyperglycemia, Postprandial
- Hyperinsulinemia
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
##### 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:** During the fasting meal trial, participants will report fasted and consume a movie theater style meal.
**Intervention Names:**
- Other: Fasting Trial
**Label:** Fasting Meal Trial
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** During the fed meal trial, participants will report fasted and first consume a high-fat breakfast. Participants will then be asked to consume a movie theater style meal three hours later.
**Intervention Names:**
- Other: Fed Trial
**Label:** Fed Meal Trial
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Fasting Meal Trial
**Description:** Participants will report fasted and consume popcorn (6 cups popped microwave popcorn), soda (32 oz Coke-a-cola), and candy (2.17 oz of Skittles) in the morning.
**Name:** Fasting Trial
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Fed Meal Trial
**Description:** Participants will report fasted and first consume a high-fat meal (Jimmy Deans) in the morning. After a three-hour break, participants will consume popcorn (6 cups popped microwave popcorn), soda (32 oz Coke-a-cola), and candy (2.17 oz of Skittles).
**Name:** Fed Trial
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The investigators will measure glucose at baseline and 0.5-, 1-, 2-, 3-, and 4-hours after each meal trial.
**Measure:** Glucose
**Time Frame:** Through study completion, up to 1 year.
**Description:** The investigators will measure serum insulin at baseline and 0.5-, 1-, 2-, 3-, and 4-hours after each meal trial.
**Measure:** Insulin
**Time Frame:** Through study completion, up to 1 year.
**Description:** The investigators will measure triglycerides at baseline and 0.5-, 1-, 2-, 3-, and 4-hours after each meal trial.
**Measure:** Triglycerides
**Time Frame:** Through study completion, up to 1 year.
**Description:** The investigators will measure HDL-C at baseline and 0.5-, 1-, 2-, 3-, and 4-hours after each meal trial.
**Measure:** HDL-C
**Time Frame:** Through study completion, up to 1 year.
**Description:** The investigators will measure serum LBP at baseline and 0.5-, 1-, 2-, 3-, and 4-hours. after each meal trial.
**Measure:** Lipopolysaccharide binding protein (LBP)
**Time Frame:** Through study completion, up to 1 year.
**Description:** The investigators will measure serum sCD14 at baseline and 0.5-, 1-, 2-, 3-, and 4-hours after each meal trial.
**Measure:** soluble CD14 (sCD14)
**Time Frame:** Through study completion, up to 1 year.
**Description:** The investigators will measure serum IL-6 at baseline and 0.5-, 1-, 2-, 3-, and 4-hours after each meal trial.
**Measure:** Interleukin (IL)-6
**Time Frame:** Through study completion, up to 1 year.
**Description:** The investigators will measure FMD at baseline, 2-hours, and 4-hours after each meal trial.
**Measure:** Flow-mediated dilation
**Time Frame:** Through study completion, up to 1 year.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* 18-45 years old
* Not pregnant or expecting to become pregnant (females only)
* Not postmenopausal (females only).
* Not been diagnosed with a cardiometabolic conditions (e.g., heart disease, type 2 diabetes)
* Not been diagnosed with a chronic inflammatory condition (e.g., rheumatoid arthritis, inflammatory bowel disease).
* Does not regularly take anti-inflammatory drugs (more than 2x week) or able to temporarily suspend use of anti-inflammatory drugs.
* Does not use glucose-lowering drugs (e.g., metformin)
* Does not use lipid-lowering drugs (e.g., statins)
* Does not use tobacco products or any illicit drugs.
* Does not have a pacemaker.
Exclusion Criteria:
* Not 18-45 years old
* Pregnant or expecting to become pregnant (females only)
* Postmenopausal (females only).
* Been diagnosed with a cardiometabolic conditions (e.g., heart disease, type 2 diabetes)
* Been diagnosed with a chronic inflammatory condition (e.g., rheumatoid arthritis, inflammatory bowel disease).
* Regularly take anti-inflammatory drugs (more than 2x week) or unable to temporarily suspend use of anti-inflammatory drugs.
* Use glucose-lowering drugs (e.g., metformin)
* Use lipid-lowering drugs (e.g., statins)
* Use tobacco products or any illicit drugs.
* Has a pacemaker.
**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:** Bryant Keirns, PhD
**Phone:** 7652858356
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Muncie
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Bryant Keirns, PhD
- **Phone:** 765-285-8356
- **Role:** CONTACT
**Country:** United States
**Facility:** Health Professions Building, Ball State University
**State:** Indiana
**Status:** RECRUITING
**Zip:** 47306
#### Overall Officials
**Official 1:**
**Affiliation:** Ball State University
**Name:** Bryant Keirns
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000044882
- Term: Glucose Metabolism Disorders
- ID: D000008659
- Term: Metabolic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M9994
- Name: Hyperglycemia
- Relevance: HIGH
- As Found: Hyperglycemia, Postprandial
- ID: M9997
- Name: Hyperinsulinism
- Relevance: HIGH
- As Found: Hyperinsulinemia
- ID: M11639
- Name: Metabolic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M25403
- Name: Glucose Metabolism Disorders
- Relevance: LOW
- As Found: Unknown
- ID: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000006943
- Term: Hyperglycemia
- ID: D000006946
- Term: Hyperinsulinism
### Intervention Browse Module - Browse Branches
- Abbrev: VaCoAg
- Name: Vasoconstrictor Agents
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: HB
- Name: Herbal and Botanical
### Intervention Browse Module - Browse Leaves
- ID: M6271
- Name: Cocaine
- Relevance: LOW
- As Found: Unknown
- 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:** NCT06444971
**Brief Title:** Effects of Post-isometric Relaxation Technique on Chest Expansion and Pulmonary Function Tests in Smokers
**Official Title:** Effects of Post-isometric Relaxation Technique on Chest Expansion and Pulmonary Function Tests in Smokers
#### Organization Study ID Info
**ID:** FUI/CTR/2024/8
#### Organization
**Class:** OTHER
**Full Name:** Foundation University Islamabad
### Status Module
#### Completion Date
**Date:** 2024-06-27
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-05
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-06-25
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-03-07
**Type:** ACTUAL
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-27
**Study First Submit QC Date:** 2024-06-05
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Foundation University Islamabad
#### 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 primary objective of the study was to investigate the immediate effects of PIR technique on chest expansion and pulmonary functions in cigarette smokers.This quasi-experimental pre-test post-test study will be conducted. Participants of interest would be approached and explained about the research. Informed written consent will be taken. Recruited participants will receive PIR technique on assessory respiratory muscles and chest expansion and pulmonary function tests will be obtained before and after the treatment. Data collection tools for this study are spirometer and measuring tape.
**Detailed Description:** Tobacco use, particularly cigarette smoking, is a major cause of disease and death globally. In Pakistan, the prevalence of tobacco use has increased significantly, with men being more likely to smoke than women. Chronic smoking is strongly associated with cardiovascular and respiratory diseases, as well as various forms of cancer. Smoking negatively affects lung function, leading to reduced pulmonary capacity and chronic obstructive pulmonary disease. Additionally, long-term smoking may lead to the loss of respiratory capacity and systemic muscle mass, affecting the performance and work of breathing.
The primary objective of the study was to investigate the effects of PIR technique on chest expansion and pulmonary functions in cigarette smokers.
This quasi-experimental pre-test post-test study will be conducted over one year at FFH, FUSH and among the general public. A sample will be calculated through pilot study. Participants between the ages of 18-60 will be recruited using convenience sampling. Inclusion criteria included individuals with min of 2 pack-years of tobacco smoking, while exclusion criteria included patients with certain cardiopulmonary medical conditions and those who underwent surgery or physiotherapy within past few months. Data collection tools for this study are spirometer and measuring tape.
There is little to no literature on the effects of PIR technique on chest expansion and pulmonary functions in cigarette smokers. The immediate effects of PIR technique demonstrated in this study will provide physical therapists with valuable insight into its use as a treatment option for smokers to improve their pulmonary function. Moreover, this study adds to the existing literature on manual therapy and its effects on smokers. The findings of this study will provide a basis for future research in the field of musculoskeletal rehabilitation and will encourage future researchers to explore this area further.
### Conditions Module
**Conditions:**
- Tobacco Smoking
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** This study is a quasi pre test post test study with a single group. Participants will be recruited according to inclusion criteria .Each participant will receive same treatment .
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 40
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Post isometric relaxation technique will be applied to sternocleidomastoid and scalene muscles in all the participants with following parameters
* Participant will perform isometric contractions using 20 -30% of their strength
* HOLD TIME: 5-7 sec followed by 20 to 30 sec stretch
* REST TIME: 5 sec
* REPETITIONS: 3-5 repetitions
**Intervention Names:**
- Procedure: Post isometric Relaxation
**Label:** PIR Group
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- PIR Group
**Description:** Post isometric relaxation technique: It is defined as a manual procedure which involves the precisely controlled and specifically directed active contraction of a muscle at varying levels of intensity against a counterforce applied by the therapist.
PIR will be applied to following muscles
1. scalene (anterior, middle and posterior)
2. sternocleidomastoid
**Name:** Post isometric Relaxation
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** Measuring tape will be used to measure chest expansion at axillary level.
**Measure:** Chest expansion
**Time Frame:** Immediate after treatment
**Description:** the maximum amount of air you can forcibly exhale from your lungs after fully inhaling measured using hand held spirometer
**Measure:** Forced Vital Capacity(FVC)
**Time Frame:** Immediate after treatment
**Description:** The volume of air (in liters) exhaled in the first second during forced exhalation after maximal inspiration measured using hand held spirometer.
**Measure:** Forced Expiratory Volume in 1 second (FEV1)
**Time Frame:** Immediate after treatment
**Description:** the volume of air forcefully expelled from the lungs in one quick exhalation measured using hand held spirometer
**Measure:** Peak Expiratory Flow (PEF)
**Time Frame:** Immediate after treatment
**Description:** The ratio of the forced expiratory volume in the first one second to the forced vital capacity of the lung measured using hand held spirometer
**Measure:** FEV1/ FVC
**Time Frame:** Immediate after treatment
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Individuals between the ages of 18-60
* Only tobacco cigarette smokers
* Cigarette smokers (with min 2 pack years )
* Both males and females
Exclusion Criteria:
* Patients undergoing any surgery
* Symptomatic patients of cystic fibrosis, asthma, exercise induced asthma, unstable angina, bronchitis , bronchiectasis, chest deformities, congenital cardiopulmonary disorders , disc herniation, current rib or vertebral fracture
* Patients with a positive history of trauma, fracture or surgery of the cervical and thoracic spine in the last 12 months
**Healthy Volunteers:** True
**Maximum Age:** 60 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Huma Masood, MS-MSKPT*
**Phone:** 03485289948
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Rawalpindi
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Zara Khalid, DPT, MS-CPPT,PHD*
- **Phone:** 03335415822
- **Role:** CONTACT
**Country:** Pakistan
**Facility:** Foundation University College of Physical Therapy
**State:** Punjab
**Status:** RECRUITING
**Zip:** 46000
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06444958
**Brief Title:** Morbidity and Mortality Rates Among Children Aged 0-59 Months
**Official Title:** Morbidity and Mortality Rates Among Children Aged 0-59 Months: A Cross-sectional Study From Mogadishu, Somalia
#### Organization Study ID Info
**ID:** KHRC2024/050
#### Organization
**Class:** OTHER
**Full Name:** Kalkaal Hospital
### Status Module
#### Completion Date
**Date:** 2023-12-15
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-05
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-12-15
**Type:** ACTUAL
#### Start Date
**Date:** 2023-01-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-30
**Study First Submit QC Date:** 2024-06-05
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Kalkaal Hospital
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This retrospective observational study aimed to investigate the patterns of morbidity and mortality among children under 5 years of age in the population served by Kalkaal Hospital. Researchers analyzed 2023 data from the hospital's electronic medical records and administrative databases to identify the most common pediatric diagnoses and causes of illness and death in this community.
**Detailed Description:** This study investigated the patterns of morbidity and mortality among children under 5 years of age in the population served by Kalkaal Hospital. The specific objectives were to:
Identify the most common diagnoses and causes of illness and death in the under-5 population presenting to Kalkaal Hospital.
Analyze demographic factors (e.g. age, sex) associated with certain disease profiles and health outcomes.
Evaluate treatment practices, health service utilization, and mortality rates for the key pediatric health issues identified.
Provide a comprehensive epidemiological assessment of the burden of childhood illness and mortality in this local community.
Methods:
This was a retrospective, observational study that analyzed 2023 data from the electronic medical records and administrative databases of Kalkaal Hospital. The researchers extracted and analyzed the following data:
Outpatient department records: Diagnoses, treatments, patient demographics Inpatient admission records: Admission diagnoses, treatments, patient outcomes (discharged, transferred, died) Mortality records: Causes of death for pediatric patients The data was cleaned, coded, and analyzed using statistical software. Descriptive statistics were calculated to characterize the morbidity and mortality patterns. Regression analyses were conducted to identify demographic and clinical factors associated with key health outcomes.
### Conditions Module
**Conditions:**
- Morbidity;Infant
### Design Module
#### Design Info
**Observational Model:** CASE_ONLY
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 1675
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
### Interventions
#### Intervention 1
**Description:** extracting and analyzing the following data:
Outpatient department records: Diagnoses, treatments, patient demographics Inpatient admission records: Admission diagnoses, treatments, patient outcomes (discharged, transferred, died) Mortality records: Causes of death for pediatric patients
**Name:** observational study without any intervention component.
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** This outcome measure will calculate the incidence rates of various morbidities among children under 18 years of age who presented to the Kalkaal Hospital outpatient department or were admitted to the inpatient wards during the 5-year study period (2018-2022). The incidence rates will be reported for the top 10 most common morbidities observed in the study population.
**Measure:** Incidence Rate of Morbidities: Incidence rates of various morbidities among children presenting to the outpatient department and inpatient wards.
**Time Frame:** JANUARY-DECEMBER 2023
**Description:** This outcome measure will determine the mortality rates among children under 18 years of age treated at Kalkaal Hospital, stratified by the following age groups: under 28 days, 29-365 days, and 1-5 years. The analysis will also identify risk factors associated with mortality in each age group.
**Measure:** Mortality Rate by Age Group: Mortality rates and associated risk factors across different age groups of children under 18 (under 28 days, 29-365 days, 1-5 years).
**Time Frame:** JANUARY-DECEMBER 2023
**Description:** This outcome measure will calculate the median length of hospital stay for children under 18 years old who were admitted to the Kalkaal Hospital inpatient wards during the study period. The average length of stay will be reported overall, as well as by primary diagnosis categories.
**Measure:** Average Length of Hospital Stay: Median hospital stay duration for children under 18 years old.
**Time Frame:** JANUARY-DECEMBER 2023
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Children aged 0-59 months who were admitted to Kalkaal Hospital during the specified study period.
2. Medical records with complete and adequate information regarding age, gender, presenting symptoms, and diagnoses.
-
Exclusion Criteria:
1. Children outside the age range of 0-59 months.
2. Medical records with missing or incomplete information necessary for the analysis.
3. Children admitted to Kalkaal Hospital for reasons unrelated to the study objectives (adult patients, non-pediatric cases).
**Maximum Age:** 59 Months
**Minimum Age:** 0 Months
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
**Study Population:** Children under 5 years of age in the population served by Kalkaal Hospital
The target population was the pediatric patients under the age of 5 who accessed healthcare services at Kalkaal Hospital.
The researchers extracted data from the hospital's records on all children under 5 who presented as outpatients, were admitted as inpatients, or were recorded in the mortality database.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Mogadishu
**Country:** Somalia
**Facility:** Kalkaal Hospital
**State:** Banadir
**Zip:** +252
### IPD Sharing Statement Module
**Description:** Data Sharing Plan:
The de-identified individual patient data (IPD) collected and analyzed for this retrospective observational study on pediatric morbidity and mortality at Kalkaal Hospital will be made available to other researchers upon reasonable request.
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: Rare
- Name: Rare Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: T4202
- Name: Oculocerebral Syndrome With Hypopigmentation
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06444945
**Brief Title:** Effects of Mulligan Mobilization With Movement as Compared to Kaltenborn Joint Mobilization in the Management of Knee Osteoarthritis
**Official Title:** Effects of Mulligan Mobilization With Movement as Compared to Kaltenborn Joint Mobilization in the Management of Knee Osteoarthritis
#### Organization Study ID Info
**ID:** FUI/CTR/2024/13
#### Organization
**Class:** OTHER
**Full Name:** Foundation University Islamabad
### Status Module
#### Completion Date
**Date:** 2024-12-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-05
**Overall Status:** ENROLLING_BY_INVITATION
#### Primary Completion Date
**Date:** 2024-12-10
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-10
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-27
**Study First Submit QC Date:** 2024-06-05
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Foundation University Islamabad
#### 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 randomised controlled trial and the purpose of this study is to determine the Effects of Mulligan mobilization with movement as compared to Kaltenborn joint mobilization in the management of knee osteoarthritis." To determine the effects of Mulligan MWM as compared to Kaltenborn joint mobilization in terms of pain, function, range of motion and gait in persons with knee osteoarthritis.
### Conditions Module
**Conditions:**
- Knee Osteoarthritis
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Parallel designed randomized control trial
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- INVESTIGATOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 40
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Group A receiving Mulligan MWM joint mobilization
**Intervention Names:**
- Device: Heating pad
- Device: Transcutaneous electrical nerve stimulation(TENS)
- Procedure: Mulligan mobilization with movement (MWM)
- Procedure: Resistance Training exercise
**Label:** Mulligan MWM group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Group B receiving Kaltenborn Joint mobilization
**Intervention Names:**
- Device: Heating pad
- Device: Transcutaneous electrical nerve stimulation(TENS)
- Procedure: Kaltenborn joint mobilization
- Procedure: Resistance Training exercise
**Label:** Kaltenborn mobilization group
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Kaltenborn mobilization group
- Mulligan MWM group
**Description:** Heating pad will be used for heating purpose.
**Name:** Heating pad
**Type:** DEVICE
#### Intervention 2
**Arm Group Labels:**
- Kaltenborn mobilization group
- Mulligan MWM group
**Description:** TENS is used for symptomatic pain relief
**Name:** Transcutaneous electrical nerve stimulation(TENS)
**Type:** DEVICE
#### Intervention 3
**Arm Group Labels:**
- Mulligan MWM group
**Description:** It provides short term pain relief and to restore pain-free, functional movements by achieving full range at the joint
**Name:** Mulligan mobilization with movement (MWM)
**Type:** PROCEDURE
#### Intervention 4
**Arm Group Labels:**
- Kaltenborn mobilization group
**Description:** The purpose of joint mobilization is to restore normal, painless joint function. In restricted joints, this involves the restoration of joint play to normalize the roll-gliding that is essential to active movement.
**Name:** Kaltenborn joint mobilization
**Type:** PROCEDURE
#### Intervention 5
**Arm Group Labels:**
- Kaltenborn mobilization group
- Mulligan MWM group
**Description:** Resistance training increases muscle strength by making your muscles work against a weight or force.
**Name:** Resistance Training exercise
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** knee pain will be measured using visual analogue scale (VAS) from 0-100mm.A higher score on VAS indicated greater pain.
**Measure:** knee pain
**Time Frame:** 2 weeks
**Description:** knee functional disability will be assessed using Knee Osteoarthritis and Outcome Score(KOOS) with a score ranging from 0-100. A lower score on KOOS signifies greater functional disability
**Measure:** Functional disability
**Time Frame:** 2 weeks
**Description:** knee range of motion will be measured using a goniometer. A higher ROM signifies positive outcome.
**Measure:** Knee range of motion
**Time Frame:** 2 weeks
**Description:** Gait analysis will be done to analyze stride length. A greater stride length signifies positive outcome and prognosis.
**Measure:** Stride length
**Time Frame:** 2 weeks
**Description:** Gait analysis will be done to analyze gait velocity. A greater gait velocity signifies positive outcome and prognosis.
**Measure:** Gait velocity
**Time Frame:** 2 weeks
**Description:** Isometeric Muscle Strength will be quantified using dynamometer. A higher score on dynamometer signifies greater muscle strength and good prognosis.
**Measure:** Isometeric Muscle Strength
**Time Frame:** 2 weeks
**Description:** walking related performance fatigability will be measured using 6 minute walk test. Greater fatigibility indicates poorer outcome.
**Measure:** Walking related performance fatigability
**Time Frame:** 2 weeks
**Description:** 5 repetition sit to stand test will be used to determine knee related functional capacity which will be quantified in terms of time. A smaller time will denote greater functional capacity.
**Measure:** Functional Capacity
**Time Frame:** 2 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Individuals aged 40-70 years (Osama et al, 2022)
* Having KOA history of no less than 3 months
* Knee pain less than 8/10 on numeric pain rating scale (NPRS).
* Radiological evidence of grade III or less on Kellgren classification
* Patients referred from rehab department
Exclusion Criteria:
* Those with signs of serious pathology, such as malignancy, inflammatory disorder or infection.
* History of trauma or fractures in lower extremity.
* Signs of lumbar radiculopathy or myelopathy.
* History of knee surgery or replacement.
* Receiving intra-articular steroid therapy in the preceding two months.
**Maximum Age:** 70 Years
**Minimum Age:** 40 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Islamabad
**Country:** Pakistan
**Facility:** Foundation University Islamabad
#### Overall Officials
**Official 1:**
**Affiliation:** Foundation University Islamabad
**Name:** Shanza Fatima, DPT
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** Foundation University Islamabad
**Name:** Muhammad Osama, PHD*
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001168
- Term: Arthritis
- ID: D000007592
- Term: Joint Diseases
- ID: D000009140
- Term: Musculoskeletal Diseases
- ID: D000012216
- Term: Rheumatic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC05
- Name: Musculoskeletal Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
### Condition Browse Module - Browse Leaves
- ID: M22168
- Name: Osteoarthritis, Knee
- Relevance: HIGH
- As Found: Knee Osteoarthritis
- ID: M12926
- Name: Osteoarthritis
- Relevance: HIGH
- As Found: Osteoarthritis
- ID: M4476
- Name: Arthritis
- Relevance: LOW
- As Found: Unknown
- ID: M10621
- Name: Joint Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12097
- Name: Musculoskeletal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15045
- Name: Rheumatic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6323
- Name: Collagen Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000010003
- Term: Osteoarthritis
- ID: D000020370
- Term: Osteoarthritis, Knee
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06444932
**Brief Title:** SUPPLEMENTARY EFFECTS OF RESISTANCE TRAINING IN ADDITION TO JOINT MOBILIZATION IN PERSONS WITH KNEE OSTEOARTHRITIS
**Official Title:** SUPPLEMENTARY EFFECTS OF RESISTANCE TRAINING IN ADDITION TO JOINT MOBILIZATION IN PERSONS WITH KNEE OSTEOARTHRITIS
#### Organization Study ID Info
**ID:** FUI/CTR/2024/12
#### Organization
**Class:** OTHER
**Full Name:** Foundation University Islamabad
### Status Module
#### Completion Date
**Date:** 2024-12-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-05
**Overall Status:** ENROLLING_BY_INVITATION
#### Primary Completion Date
**Date:** 2024-12-10
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-10
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-27
**Study First Submit QC Date:** 2024-06-05
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Foundation University Islamabad
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Joint mobilization and resistance exercise training are effective conservative treatment options for the management of osteoarthritis. However, currently no study has highlighted the supplementary effects of resistance training in addition to joint mobilization in people suffering from knee osteoarthritis. The current study is aimed at bridging the gap in literature and providing evidence regarding the additive impact of resistance training to joint mobilization in knee osteoarthritis.
### Conditions Module
**Conditions:**
- Knee Osteoarthritis
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Double arm parallel design RCT
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- INVESTIGATOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 44
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Procedure: Joint Mobilization
- Device: Transcutaneous Electric Nerve Stimulation (TENS)
- Device: Heating Pad
**Label:** Active Comparator
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Intervention Names:**
- Procedure: Joint Mobilization
- Procedure: Resistance Exercise Training
- Device: Transcutaneous Electric Nerve Stimulation (TENS)
- Device: Heating Pad
**Label:** Experimental Group
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Active Comparator
- Experimental Group
**Description:** Patellofemoral and tibiofemoral joint mobilization
**Name:** Joint Mobilization
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- Experimental Group
**Description:** Lower limb resistance exercise training
**Name:** Resistance Exercise Training
**Type:** PROCEDURE
#### Intervention 3
**Arm Group Labels:**
- Active Comparator
- Experimental Group
**Description:** Transcutaneous Electric Nerve Stimulation (TENS)
**Name:** Transcutaneous Electric Nerve Stimulation (TENS)
**Type:** DEVICE
#### Intervention 4
**Arm Group Labels:**
- Active Comparator
- Experimental Group
**Description:** Heating pad for heat therapy
**Name:** Heating Pad
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Walking related performance fatigability will be measured using 6 minute walk test. Greater fatigability indicates poorer outcome.
**Measure:** Walking related performance fatigability
**Time Frame:** 4 weeks
**Description:** Gait analysis will be done to analyze stride length. A greater stride length signifies positive outcome and prognosis.
**Measure:** Stride Length
**Time Frame:** 4 weeks
**Description:** Gait analysis will be done to analyze gaot velocity. A greater gait velocity signifies positive outcome and prognosis.
**Measure:** Gait velocity
**Time Frame:** 4 weeks
**Description:** Knee Pain will be measured using visual analogue scale (VAS) from 0-100mm. A higher score on VAS indicated greater pain.
**Measure:** Knee Pain
**Time Frame:** 4 weeks
**Description:** Knee range of motion will be measured using a goniometer. A higher ROM signifies positive outcome.
**Measure:** Knee range of motion
**Time Frame:** 4 weeks
**Description:** Knee functional disability will be assessed using Knee Osteoarthritis and Outcome Score (KOOS) with a score ranging from 0-100. A lower score on KOOS signifies greater functional disability.
**Measure:** Functional Disability
**Time Frame:** 4 weeks
**Description:** Isometric Muscle Strength will be quantified using dynamometer. A higher score on dynamometer signifies greater muscle strength and good prognosis.
**Measure:** Isometric Muscle Strength
**Time Frame:** 4 weeks
**Description:** 5 repetition sit to stand test will be used to determine knee related functional capacity, which will be quantified in terms of time. A smaller time will denote greater functional capacity.
**Measure:** Functional capacity
**Time Frame:** 4 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Knee OA grade I-III
* Individuals of either gender aged 40-70 years
* Knee OA history of no less than 3 months
* Knee pain no more than 8/10 cm on the visual analogue scale (VAS)
* Radiological evidence of grade III or less on Kellgren classification.
Exclusion Criteria:
* Those with signs of serious pathology such as malignancy, inflammatory disorder or infection.
* History of trauma or fractures in lower extremity
* Signs of lumbar radiculopathy or myelopathy
* History of knee surgery or replacement and/or receiving intra-articular steroid therapy in the preceding two months
**Maximum Age:** 70 Years
**Minimum Age:** 40 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Islamabad
**Country:** Pakistan
**Facility:** Foundation Univeristy Islamabad
#### Overall Officials
**Official 1:**
**Affiliation:** Foundation University Islamabad
**Name:** Wania Maheen, DPT
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** Foundation University Islamabad
**Name:** Muhammad Osama, PhD*
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001168
- Term: Arthritis
- ID: D000007592
- Term: Joint Diseases
- ID: D000009140
- Term: Musculoskeletal Diseases
- ID: D000012216
- Term: Rheumatic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC05
- Name: Musculoskeletal Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
### Condition Browse Module - Browse Leaves
- ID: M22168
- Name: Osteoarthritis, Knee
- Relevance: HIGH
- As Found: Knee Osteoarthritis
- ID: M12926
- Name: Osteoarthritis
- Relevance: HIGH
- As Found: Osteoarthritis
- ID: M4476
- Name: Arthritis
- Relevance: LOW
- As Found: Unknown
- ID: M10621
- Name: Joint Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12097
- Name: Musculoskeletal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15045
- Name: Rheumatic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6323
- Name: Collagen Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000010003
- Term: Osteoarthritis
- ID: D000020370
- Term: Osteoarthritis, Knee
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06444919
**Acronym:** CADOR
**Brief Title:** Capsaicin in Digital Osteoarthritis Versus Control : a Randomized Study
**Official Title:** Capsaicin in Digital Osteoarthritis Versus Control : a Randomized Study
#### Organization Study ID Info
**ID:** PHRC IR 2022 MATHIEU
#### Organization
**Class:** OTHER
**Full Name:** University Hospital, Clermont-Ferrand
#### Secondary ID Infos
**ID:** 2024-511159-16-00
**Type:** CTIS
### Status Module
#### Completion Date
**Date:** 2028-01-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-31
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2028-01-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-09-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-31
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** Grünenthal GmbH
#### Lead Sponsor
**Class:** OTHER
**Name:** University Hospital, Clermont-Ferrand
#### 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 objective of this multicentric, randomized controlled double-blind clinical trial is to demonstrate the efficacy of transdermal application of capsaicin in patients with painful digital osteoarthritis with a neuropathic pain component.
Participants will receive either a transdermal patch of capsaicin 179 mg (8%) or the control treatment (capsaicin 0.04%).
Researchers will compare the intensity of pain in the fingers at day 60 in the capsaicin 8% group versus capsaicin 0.04% (control arm)
**Detailed Description:** Visit 0 : Screening visit (D0 - 30 days): Screen for eligibility
Visit 1 :Inclusion visit (D0): Randomization and blinded patch application of capsaicin 8% or 0.04%
Visit 2: Follow-up visit 1 (D60 + 7 days): Assessment +/- Patch renewal. Patients with finger pain still greater than 4/10 may receive an open application of a capsaicin 8%
Visit 3:Follow-up visit 2 (D120 +/- 7 days): Final assessment.
For the duration of the study, the patient will record in a notebook: analgesics, anti-inflammatories, corticoids and daily hand pain VAS.
Blood samples will be taken at V1 and V2 for subsequent measurement of pro-inflammatory cytokines (IL6, IL8, TNFa) and markers of cartilage degradation, in order to build up a serum library.
### Conditions Module
**Conditions:**
- Osteoarthritis Hand
- Neuropathic Pain
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 120
**Type:** ESTIMATED
**Phases:**
- PHASE4
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** patch 179 mg, 30 min
**Intervention Names:**
- Drug: Capsaicin 179 Mg Cutaneous Patch
**Label:** Capsaicin 8%
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** patch low dose, 30 min
**Intervention Names:**
- Drug: Capsaicine low dose 0.04 %
**Label:** Capsaicin 0.04%
**Type:** SHAM_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Capsaicin 8%
**Description:** patch application for 30 minutes on the painful fingers.
**Name:** Capsaicin 179 Mg Cutaneous Patch
**Other Names:**
- QUTENZA
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Capsaicin 0.04%
**Description:** patch application for 30 minutes on the painful fingers. the low-dose patch has a similar appearance to the active patch. It allows you to keep the blind, because it also causes reactions at the capsaicin application site (erythema, burning).
**Name:** Capsaicine low dose 0.04 %
**Other Names:**
- control treatment
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** measured on a visual analogic scale ranging from 0 to 100 mm
**Measure:** Intensity of pain in the fingers
**Time Frame:** Day 60
#### Secondary Outcomes
**Description:** Cochin Hand Functional Disability Scale score
**Measure:** Functional disability
**Time Frame:** Day 60
**Description:** Modified Functional Index for Hand OsteoArthritis score (FIHOA)
**Measure:** Functional index
**Time Frame:** Day 60
**Description:** Hospital Anxiety and Depression Scale score (HADs)
**Measure:** Anxiety and depression
**Time Frame:** Day 60
**Description:** Osteoarthritis Symptom Inventory Scale score (OASIS9)
**Measure:** Painful symptoms of osteoarthritis
**Time Frame:** Day 60
**Description:** side effect rate
**Measure:** Treatment safety
**Time Frame:** Day 60
**Description:** Patient Global Impression of Change " (PGIC) score
**Measure:** Patient impression of change
**Time Frame:** Day 60
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Diagnosis of digital osteoarthritis fulfilling the American College of Rheumatology criteria;
* Presence of finger pain of ≥ 40 mm on a visual analogue scale (VAS);
* Presence of finger pain with a neuropathic pain component (DN4 score ≥ 4/10)
* Inadequate response, adverse reactions, and/or contraindications to conventional analgesics and NSAIDs;
Exclusion Criteria:
* Patient with isolated rhizarthrosis;
* Patient with other joint disease affecting the fingers (gout, chondrocalcinosis, RA, spondyloarthritis, psoriatic arthritis);
* Patient with upper extremity pain syndrome that may interfere with the assessment of finger pain;
* Patient with another pathology responsible for neuropathic hand pain (carpal tunnel syndrome, diabetic neuropathy, Guyon's tunnel syndrome, cervicobrachial neuralgia, brachial plexitis);
* Patient with skin lesions on the fingers (psoriasis, wounds, chronic ulcers, eczema, shingles, dermatitis);
* Patient with poorly controlled high blood pressure;
* Patient with hypersensitivity to capsaicin;
* Patient who had 8% capsaicin patch use in the year prior to the study;
* Patient who has received intramuscular, intra-articular or intravenous corticosteroid therapy, another disease-modifying anti-rheumatic therapy (methotrexate, salazopyrine) or an intra-articular injection into the joints of the fingers within the previous 3 months;
* Patient wearing wrist or finger orthoses in the previous month;
* Patient with fibromyalgia;
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Lise Laclautre
**Phone:** 334.73.754.963
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Clermont-Ferrand
**Contacts:**
***Contact 1:***
- **Name:** Lise Laclautre
- **Role:** CONTACT
***Contact 2:***
- **Name:** Sylvain Mathieu
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** France
**Facility:** CHU de Clermont-Ferrand
#### Overall Officials
**Official 1:**
**Affiliation:** University Hospital, Clermont-Ferrand
**Name:** Sylvain Mathieu
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001168
- Term: Arthritis
- ID: D000007592
- Term: Joint Diseases
- ID: D000009140
- Term: Musculoskeletal Diseases
- ID: D000012216
- Term: Rheumatic Diseases
- 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: BC05
- Name: Musculoskeletal Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
### Condition Browse Module - Browse Leaves
- ID: M12926
- Name: Osteoarthritis
- Relevance: HIGH
- As Found: Osteoarthritis
- ID: M12381
- Name: Neuralgia
- Relevance: HIGH
- As Found: Neuropathic Pain
- 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
- 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: D000010003
- Term: Osteoarthritis
- ID: D000009437
- Term: Neuralgia
### Intervention Browse Module - Ancestors
- ID: D000000982
- Term: Antipruritics
- ID: D000003879
- Term: Dermatologic Agents
- ID: D000018689
- Term: Sensory System Agents
- ID: D000018373
- Term: Peripheral Nervous System Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
### Intervention Browse Module - Browse Branches
- Abbrev: Derm
- Name: Dermatologic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M5471
- Name: Capsaicin
- Relevance: HIGH
- As Found: Cerebral Palsy
- ID: M7074
- Name: Dermatologic Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000002211
- Term: Capsaicin
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06444906
**Brief Title:** A Two-Part, Randomized Study of Dermacyte® Amniotic Wound Care Matrix
**Official Title:** A Two-Part, Randomized Study of Dermacyte® Amniotic Wound Care Matrix for the Treatment of Diabetic Foot Ulcers (DFU)
#### Organization Study ID Info
**ID:** DM-DFU-201
#### Organization
**Class:** INDUSTRY
**Full Name:** Merakris Therapeutics
### Status Module
#### Completion Date
**Date:** 2025-05-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-30
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-05-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-09-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-30
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Merakris Therapeutics
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** True
**Is FDA Regulated Drug:** False
**Is Unapproved Device:** True
**Is US Export:** False
### Description Module
**Brief Summary:** This is a multi-center, prospective, two-part, controlled study to determine the percentage of participants with complete ulcer closure of a target DFU at Week 12 following treatment with Dermacyte Matrix or SOC.
**Detailed Description:** This is a multi-center, prospective, two-part, controlled study to determine the percentage of participants with complete ulcer closure of a target DFU at Week 12 following treatment with Dermacyte Matrix or standard of care (SOC).
Part 1 of the study will enroll 20 participants to determine the percentage of participants with a complete ulcer closure following treatment with Dermacyte Matrix at Week 12.
In Part 2 of the study approximately 65 participants will be randomized 1:1 to receive Dermacyte Matrix or SOC for 12 weeks. The final sample size for Part 2 may be adjusted based on the effect size observed in Part 1 of the study.
For the purposes of this study, SOC therapy will consist of debridement of nonviable tissue, saline-moistened non-occlusive dressing, weight off-loading to decrease pressure on extremity, aggressive treatment of infection and arterial revascularization if indicated.
### Conditions Module
**Conditions:**
- Diabetic Foot Ulcer
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 85
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Dermacyte Matrix will be applied topically in conjunction with SOC on a weekly frequency and dosed by square centimeters to match the ulcer surface area.
**Intervention Names:**
- Device: Dermacyte Matrix
**Label:** Dermacyte Matrix
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** SOC therapy will consist of weekly debridement of nonviable tissue as clinically indicated, saline-moistened non-occlusive dressing, weight off-loading to decrease pressure on extremity, aggressive treatment of infection and arterial revascularization if indicated.
**Intervention Names:**
- Other: Standard of Care (SOC)
**Label:** Standard of Care
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Dermacyte Matrix
**Description:** The appropriate square centimeters of Dermacyte Matrix is applied directly to the target DFU that is free of debris and necrotic tissue. The Dermacyte Matrix will be applied at weekly intervals or for up to 10 applications.
**Name:** Dermacyte Matrix
**Type:** DEVICE
#### Intervention 2
**Arm Group Labels:**
- Standard of Care
**Description:** SOC therapy will consist of debridement of nonviable tissue, saline-moistened non-occlusive dressing, weight off-loading to decrease pressure on extremity, aggressive treatment of infection and arterial revascularization if indicated at weekly intervals or for up to 10 applications.
**Name:** Standard of Care (SOC)
**Type:** OTHER
### Outcomes Module
#### Other Outcomes
**Description:** QoL will be assessed at Baseline and Week 12 via patient reported outcomes using the Neuro-QoL (Quality of Life in Neurological Disorders); a disease-specific instrument that has been validated for assessing the impact of peripheral neuropathy and foot ulceration and quality of life in patients with diabetes.
**Measure:** To measure change in quality of life (QoL)
**Time Frame:** 12 weeks
#### Primary Outcomes
**Description:** Wound healing will be assessed by observation of skin re-epithelialization without drainage or dressing requirements confirmed at two consecutive study visits at least 2 weeks apart.
**Measure:** To determine the efficacy of Dermacyte Matrix compared to SOC
**Time Frame:** 12 weeks
#### Secondary Outcomes
**Description:** Safety will be assessed throughout the study. Adverse events will be recorded using the NCI Common Terminology Criteria for Adverse Events Version 5 (CTCAE v5).
**Measure:** To determine the safety of Dermacyte Matrix compared to SOC
**Time Frame:** 12 weeks
**Description:** Healing rate will be assessed by percent area reduction of the target ulcer from Baseline to Week 12.
**Measure:** To determine the heal rate of DFU for Dermacyte Matrix and SOC
**Time Frame:** 12 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Participant 18 years old or older
2. Type I or Type II diabetes mellitus
3. Participant has well controlled glucose levels, with HbA1c \< 12% within 3 months of Dermacyte Matrix application
4. Participant has adequate lower extremity perfusion, with Ankle-Brachial Index \> 0.8 (note: this is an ABI-equivalent, based on biphasic or triphasic color duplex - PVR or MRA. Diabetics often have peripheral vascular calcification or poorly compressible vessels resulting in abnormally high Ankle-Brachial Indices.) or dorsum transcutaneous oxygen test (TcPO2) \> 30 mmHg. The presence of tibial and plantar pulses is preferred.
5. Willing and able to tolerate and maintain the required weight off-loading of the affected limb and perform necessary dressing changes
6. DFU is full thickness (Wagner Grade I or II)
7. Adults with a chronic non-healing DFU (at least 30 days but no longer than 52 weeks old) will be eligible for enrollment
8. Participant's ulcer size \>0.5cm2 and \< 20cm2 area post-debridement
9. Participant has plantar ulcers of greater than or equal to 4 weeks duration at presentation, unresponsive to standard wound care
10. Participant should have no evidence of unresolved gross soft-tissue infection or boney pathology (i.e. osteomyelitis)
11. Participant should have no evidence of underlying co-morbid conditions that would adversely affect wound healing such as: Cancer, Raynaud's syndrome, severe venous insufficiency or uncorrected arterial insufficiency, etc.
12. Participant should not be on medications that compromise healing: cytotoxic chemotherapeutics, etc
Exclusion Criteria:
1. Suspected or confirmed signs of infection of the study ulcer/limb including soft-tissue infection or osteomyelitis
2. Subjects who are currently receiving, or have received within 4 weeks prior to study entry agents known to impair or affect wound healing, including:
1. Adriamycin (doxorubicin), bleomycin, sirolimus (Rapamune, rapamycin) and anti-TNF cytotoxic/immunosuppressive agents;
2. Radiation therapy at the ulcer site;
3. Other immunosuppressive agents.
3. Subjects presenting with:
1. Charcot foot with a bony deformity
2. Chopart's amputation
3. Calcaneus ulcers
4. Subjects previously treated with amniotic membrane or any other advanced therapy at the target site for 1 month prior to enrollment
5. Subjects with evidence of skin cancer within or adjacent to the ulcer site.
6. History of bone cancer of the affected limb
7. Subjects who have significant arterial disease as determined by ABI, duplex Doppler sonography (PVR) or magnetic resonance angiography (MRA): Ankle-Brachial Index \< 0.8 (note: this is an ABI-equivalent, based on biphasic or triphasic color duplex - PVR or MRA. Diabetics often have peripheral vascular calcification or poorly compressible vessels resulting in abnormally high ABIs); dorsum transcutaneous oxygen test (TcPO2) \< 30 mmHg; absence of tibial or plantar pulses.
8. Subjects who have documented clinically significant medical conditions, which would impair wound healing. This includes:
1. Renal impairment (creatinine \>2.5 mg/dL);
2. Hepatic impairment (2XULN);
3. Hematological disorders (abnormities of formed elements);
4. Neurologic disorders resulting in significant impairment of sensory and motor functions as judged by the investigator;
5. Excessive lymphedema that could interfere with wound healing
6. Subjects with signs and symptoms of cellulitis;
7. Subjects with ulcers with sinus tracts associated with an ongoing infection;
8. Subjects with active deep vein thrombosis;
9. Subjects with uncontrolled diabetes, as demonstrated by increased HbA1C (\> 12%);
10. Immunocompromised subjects (e.g., lymphoma, AIDS, myelodysplastic disorders)
9. HBOT within 3 days of treatment visit
**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:** Travis C Jarrell, MS
**Phone:** 301-905-6702
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Consultant
**Name:** Sean O'Connell, PhD
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000003925
- Term: Diabetic Angiopathies
- ID: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000007871
- Term: Leg Ulcer
- ID: D000012883
- Term: Skin Ulcer
- ID: D000012871
- Term: Skin Diseases
- ID: D000048909
- Term: Diabetes Complications
- ID: D000003920
- Term: Diabetes Mellitus
- ID: D000004700
- Term: Endocrine System Diseases
- ID: D000003929
- Term: Diabetic Neuropathies
- ID: D000005534
- Term: Foot Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: All
- Name: All Conditions
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC05
- Name: Musculoskeletal Diseases
### Condition Browse Module - Browse Leaves
- ID: M17685
- Name: Wounds and Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M19933
- Name: Diabetic Foot
- Relevance: HIGH
- As Found: Diabetic Foot
- ID: M18919
- Name: Foot Ulcer
- Relevance: HIGH
- As Found: Foot Ulcer
- ID: M17206
- Name: Ulcer
- Relevance: LOW
- As Found: Unknown
- ID: M7120
- Name: Diabetic Angiopathies
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10883
- Name: Leg Ulcer
- Relevance: LOW
- As Found: Unknown
- ID: M15686
- Name: Skin Ulcer
- Relevance: LOW
- As Found: Unknown
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7115
- Name: Diabetes Mellitus
- Relevance: LOW
- As Found: Unknown
- ID: M26004
- Name: Diabetes Complications
- Relevance: LOW
- As Found: Unknown
- ID: M7862
- Name: Endocrine System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7124
- Name: Diabetic Neuropathies
- Relevance: LOW
- As Found: Unknown
- ID: M8658
- Name: Foot Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000017719
- Term: Diabetic Foot
- ID: D000016523
- Term: Foot Ulcer
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06444893
**Brief Title:** Morphofunctional Analysis and Gene Expression of Inflammation Molecules and Response Mechanisms to Oxidative Stress in Kidney Tissue of Deceased Patients With SARS-CoV-2 Virus Infection: "Ancestral Variant"
**Official Title:** Morphofunctional Analysis and Gene Expression of Inflammation Molecules and Response Mechanisms to Oxidative Stress in Kidney Tissue of Deceased Patients With SARS-CoV-2 Virus Infection: "Ancestral Variant"
#### Organization Study ID Info
**ID:** C-5920
#### Organization
**Class:** OTHER_GOV
**Full Name:** Instituto Nacional de Enfermedades Respiratorias
### Status Module
#### Completion Date
**Date:** 2023-10-08
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-03
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2020-12-31
**Type:** ACTUAL
#### Start Date
**Date:** 2020-03-30
**Type:** ACTUAL
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-06-03
**Study First Submit QC Date:** 2024-06-03
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER_GOV
**Name:** Instituto Nacional de Enfermedades Respiratorias
#### Responsible Party
**Investigator Affiliation:** Instituto Nacional de Enfermedades Respiratorias
**Investigator Full Name:** Jesus Rivero, MD
**Investigator Title:** MD
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The involvement of the kidneys in patients infected with the SARS-CoV-2 virus at the outset of the pandemic was associated with high mortality rates worldwide. This was in part due to the generation of an inflammatory process and exacerbated oxidative stress. The present study was initiated to investigate the relationship between morphofunctional changes and gene expression in the kidney tissue of deceased Mexican patients prior to the initiation of vaccination.
The investigator designed a single-center, prospective, cohort study, to analyze and relate the morphofunctional changes and gene expression of inflammatory and oxidative stress molecules in the kidney tissue of men who died from severe COVID-19. A total of 40 percutaneous renal biopsies from deceased patients with SARS-CoV-2 infection were included in the study and divided into two a groups. One group was preserved in trizol to obtain RNA and total protein, while the remaining sample was fixed in formalin to be examined by staining with hematoxylin and eosin. The histopathological analysis was conducted by an experienced nephropathologist. The expression of molecules was evaluated by real-time PCR (nphs2, slc9a1, cx3cl1, havcr1, slc22a17, sod2, egf, timp2, hmox1, fabp1, and so forth). The following biomarkers were analyzed: IL-6, Arg-1, DPP4, GSTT1, GGT1, OCL, CYP3A4, and CL-8. Additionally, Western blot analysis was conducted on claudins-5, occludin, HSP70, NRF-2, SOD2, NQO1, γ-GCL, and RAGE. The estimated glomerular filtration rate (eGFR) was calculated using the CKD-EPI (2021) equation, with the subjects divided into two groups based on their eGFR: \>60 or \<60 ml/min/1.73 m². The statistical analysis was conducted using the Stata program and GraphPad Prism software.
### Conditions Module
**Conditions:**
- COVID-19
- Kidney Injury
- Gene Amplification
- Oxidative Stress
- Inflammatory Response
### Design Module
#### Bio Spec
**Description:** kidney biopsies of deceased patients with COVID-19
**Retention:** SAMPLES_WITH_DNA
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 40
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Outcomes Module
#### Primary Outcomes
**Description:** Morphofunctional Changes
**Measure:** To analyze and relate the morphofunctional changes and gene expression of inflammatory molecules and response mechanisms to oxidative stress in the kidney tissue of patients who died from severe COVID-19.
**Time Frame:** At the time of death
#### Secondary Outcomes
**Description:** Content
**Measure:** Evaluate the content of proteins involved in the antioxidant response.
**Time Frame:** At the time of death
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Not having at least one creatinine measurement.
* Family members will not accept to participate.
Exclusion Criteria:
* Specimens with sub-optimal quality for analysis.
**Gender Based:** True
**Gender Description:** We chose only males for the study due to they presented a major deleterious effect in scientific literature.
**Maximum Age:** 80 Years
**Minimum Age:** 15 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** MALE
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
**Study Population:** Adults \>15 years old who died at the INER with a confirmed diagnosis of SARS-CoV-2 infection
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Mexico City
**Country:** Mexico
**Facility:** National Institute of Respiratory Diseases
**State:** Ciudad DE México
**Zip:** 14080
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007239
- Term: Infections
- ID: D000010335
- Term: Pathologic Processes
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC01
- Name: Infections
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
### Condition Browse Module - Browse Leaves
- ID: M10293
- Name: Inflammation
- Relevance: HIGH
- As Found: Inflammation
- ID: M17522
- Name: Virus Diseases
- Relevance: HIGH
- As Found: Virus Infection
- ID: M2561
- Name: COVID-19
- 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: M6845
- Name: Death
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000014777
- Term: Virus Diseases
- ID: D000007249
- Term: Inflammation
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06444880
**Brief Title:** Phase II Trial of Ubamatamab Alone or in Combination With Cemiplimab in MUC16-Expressing SMARCB1-Deficient Malignancies
**Official Title:** Phase II Trial of Ubamatamab Alone or in Combination With Cemiplimab in MUC16-Expressing SMARCB1-Deficient Malignancies
#### Organization Study ID Info
**ID:** 2023-1062
#### Organization
**Class:** OTHER
**Full Name:** M.D. Anderson Cancer Center
#### Secondary ID Infos
**Domain:** NCI-CTRP Clinical Registry
**ID:** NCI-2024-04755
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2028-07-31
**Type:** ESTIMATED
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-30
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-07-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-11-29
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-30
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** Regeneron Pharmaceuticals
#### Lead Sponsor
**Class:** OTHER
**Name:** M.D. Anderson Cancer Center
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** To find out if ubamatamab, given by itself or in combination with cemiplimab, can help to control the disease in participants with renal medullary carcinoma (RMC) and epithelioid sarcoma (ES).
**Detailed Description:** Primary Objectives • To determine the objective response rate (ORR) and disease control rate (DCR), per RECIST 1.1, of ubamatamab alone and in combination with cemiplimab in patients with locally advanced or metastatic MUC16-expressing SMARCB1-deficient malignancies, RMC or ES, who have progressed on at least one prior line of therapy.
Secondary Objectives
• To determine the efficacy and safety of ubamatamab alone or in combination with cemiplimab in participants with locally advanced or metastatic MUC16-expressing SMARCB1-deficient malignancies such as RMC or ES who have progressed on at least one prior line of therapy. Efficacy will be measured by overall survival (OS), progression-free survival (PFS), and duration of response (DOR).
Exploratory Objectives
* To determine the objective response rate (ORR) and disease control rate (DCR), per RECIST 1.1, of the overall strategy of ubamatamab alone followed by combination with cemiplimab in participants with locally advanced or metastatic MUC16-expressing SMARCB1-deficient malignancies, RMC or ES, who have progressed on at least one prior line of therapy.
* To evaluate potential biomarkers, such as serum CA-125 and tumor tissue MUC16 expression levels for participant stratification, and to determine via the molecular profiling of biopsy and blood specimens, the mechanisms of resistance to ubamatamab alone or in combination with cemiplimab.
### Conditions Module
**Conditions:**
- SMARCB1-Deficient Malignancies
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** SINGLE_GROUP
##### 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:** Stage 1 of study treatment involves being given ubamatamab by itself by vein. The first dose will be given over about 4 hours. Depending on how participants respond, later doses may be given over shorter periods of time (possibly down to 30 minutes per infusion). Participants dose of ubamatamab will be increased from a starting dose on Day 1 to a full dose on Day 15.
Participants will receive ubamatamab 1 time every week for the first 4 weeks, then every 3 weeks after that, unless the disease gets worse or intolerable side effects occur.
• If the disease gets worse after completing 6 weeks of treatment, participants will move to Stage 2 and receive combination therapy.
**Intervention Names:**
- Drug: Ubamatamab
**Label:** Stage I
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants in Stage 2 will begin receiving ubamatamab and cemiplimab.
* If participants are enrolled directly into Stage 2, but did not have therapy with ubamatamab alone, participants will receive ubamatamab 1 time each week for 4 weeks, before beginning combination therapy.
* If participants have already completed Stage 1 and are moving on to Stage 2, participants will begin with combination therapy.
During Stage 2, ubamatamab is given by vein over 30 minutes to 4 hours, as described above. Cemiplimab is given by vein over 30 minutes.
**Intervention Names:**
- Drug: Ubamatamab
- Drug: Cemiplimab
**Label:** Stage 2
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Stage 2
- Stage I
**Description:** Given by IV
**Name:** Ubamatamab
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Stage 2
**Description:** Given by IV
**Name:** Cemiplimab
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
**Measure:** Safety and adverse events (AEs)
**Time Frame:** Through study completion; an average of 1 year.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Participants with locally advanced or metastatic RMC (RMC cohort) or ES (ES cohort) histologically confirmed by expert pathology review and loss of SMARCB1 staining by IHC. Participants with advanced or metastatic unclassified renal cell carcinoma with medullary phenotype (a rare SMARCB1 negative RMC variant occurring in individuals without sickle hemoglobinopathies) are also eligible for the RMC cohort.
2. Eligible participants should either demonstrate serum CA-125 levels ≥ 70 units/ml during screening or positive H score of \>25 for MUC16 (CA-125) by IHC in tumor tissues collected within 12 months from screening as noted in participant EMR:
1. The H score is calculated using the standard formula commonly used in IHC: H score = \[(0 x % negative cells) + (1 x % weak positive cells) + (2 x % moderate positive cells) + (3 x % strong positive cells). For instance, if 50% of tumor cells show weak staining, 30% of tumor cells show moderate staining, and 20% of cells show strong staining, the H-score would be: (50×1)+(30×2)+(20×3)=50+60+60=170.
2. If serum CA-125 ≥ 70 units/ml then participants will be enrolled without delay. IHC for MUC16 will be used as a correlative biomarker but not for trial eligibility.
3. If serum CA-125 \< 70 units/ml then for trial eligibility, MUC16 expression should be checked by IHC in tumor tissues collected within 12 months from screening:
i. If H score is \< 25 then the patient will not be eligible for the trial ii. If H score ≥ 25 then the patient will be eligible for the trial
3. Participants will be eligible in the RMC cohort regardless of whether they have had prior nephrectomy or still have their primary tumor in-situ.
4. Participants must have at least one measurable site of disease, defined as a lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) and measures ≥ 15 mm with conventional techniques or ≥ 10 mm with more sensitive techniques such as MRI or CT scan. If the patient has had previous radiation to the marker lesion(s), there must be evidence of progression since the radiation.
5. Participants must have progressed on at least one line of prior therapy.
6. There must be evidence of progression on or after last treatment regimen received.
7. ECOG performance status 0-1
a. NOTE: If participant is unable to walk due to paralysis, but is mobile in a wheelchair, participant is considered to be ambulatory for the purpose of assessing their performance status.
8. Age (at the time of consent/assent): ≥ 18 years
a. RMC is the third most common renal cell carcinoma in children and young adults in the United States21 and while we will initially enroll participants aged ≥18 years old, we will in coordination with Regeneron consider allowing pediatric participants ≥12 years old if no trial limiting toxicities (TOX), as defined in Section 9.1.2., after the interim analysis of the first 10 participants enrolled and based on the accumulated pharmacokinetic / pharmacodynamic data of ubamatamab in this population at that time. If these criteria are fulfilled, then adolescent participants age 12 years and older will be allowed with signed assent and parental consent according to institutional guidelines and requirements, as long as their weight is \>40 kg given that this is the lower weight limit for which safety following ubamatamab with or without cemiplimab exposure has been ascertained.
9. Consent to MD Anderson companion laboratory protocol 2014-0938
10. Participants must have adequate organ and marrow function as defined below:
Hemoglobina ≥ 9 g/dl (treatment allowed) Absolute neutrophil countb ≥ 1,000/µL Platelets ≥ 75,000/µL Total bilirubin ≤ 1.5 mg/dl AST(SGOT) or ALT (SGPT) ≤ 2.5 X institutional ULN, except in known hepatic metastasis, wherein may be ≤ 5 x ULN Serum Creatininec ≤ 1.5 x ULN by gender (as long as patient does not require dialysis)
a May receive transfusion within the screening period b Without growth factor support (filgrastim or pegfilgrastim) for at least 14 days c If creatinine is not \<1.5×ULN, then calculate by Cockcroft-Gault methods or local institutional standard and CrCl must be \>30 mL/kg/1.73 m2
11. Participants with controlled brain metastases are allowed on protocol if the brain metastases were surgically resected or treated with radiosurgery or Gamma knife, without recurrence or edema for 1 month (4 weeks). Participants actively requiring glucocorticoids for uncontrolled brain or leptomeningeal metastases are not eligible.
12. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of the study drug.
13. Women must not be breastfeeding.
14. WOCBP must agree to follow instructions for method(s) of contraception from the time of registration for treatment for the duration of treatment with study drug (s) plus 5 half-lives of study drug (s) plus 30 days (duration of ovulatory cycle) for a total of 5 months post treatment completion. Men must agree to effective contraception from the time of registration for treatment to 7 months post last protocol treatment.
Investigators shall counsel WOCBP and male participants who are sexually active with WOCBP on the importance of pregnancy prevention and the implications of an unexpected pregnancy Investigators shall advise WOCBP and male participants who are sexually active with WOCBP on the use of highly effective methods of contraception. Highly effective methods of contraception have a failure rate of \< 1% per year when used consistently and correctly.
Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Patient/Partner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 7 months after completion of ubamatamab/cemiplimab administration.
The effects of ubamatamab/cemiplimab on the developing human fetus are unknown. For this reason and because immunotherapy agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female participants, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:
* Postmenopausal (no menses in greater than or equal to 12 consecutive months).
* History of hysterectomy or bilateral salpingo-oophorectomy.
* Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
* History of bilateral tubal ligation or another surgical sterilization procedure.
15. Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
1. Participants must not have any other malignancies within the past 2 years except for in situ carcinoma of any site, or adequately treated (without recurrence post-resection or post-radiotherapy) carcinoma of the cervix or basal or squamous cell carcinomas of the skin, ductal carcinoma in situ of the breast or low-risk early stage prostate adenocarcinoma with negligible risk of metastasis or death
2. Participants previously treated with T-cell-redirecting bispecific antibodies or MUC16-targeted therapies (including vaccines) are excluded. Participants who received CAR-T therapies within 30 days of first dose of study drug are also excluded. However, participants previously treated with immune checkpoint therapies such as anti-PD1, anti-PD-L1, anti-CTLA-4, or anti-LAG-3 immune checkpoint inhibitors are eligible, as long as they have been off these therapies for at least 60 days (\~3 half-lives) prior to initiation of study treatment with ubamatamab.
3. Participants currently receiving anticancer therapies or who have received anticancer therapies (including chemotherapy and targeted therapies such as tazemetostat) within 2 weeks (14 days) prior to study Day 1 are excluded. Participants who have completed palliative radiation therapy more than 14 days prior to the first dose of the combination immunotherapy are eligible.
4. Participants with persistent grade ≥2 adverse events from prior systemic therapies that would confound timely detection of immune-related adverse events due to ubamatamab and/or cemiplimab or otherwise hinder patient participation in the clinical trial.
5. Participants, who have had a major surgery or significant traumatic injury (injury requiring \> 4 weeks (28 days) to heal) within 4 weeks (28 days) of start of study drug, participants who have not recovered from the side effects of any major surgery (defined as requiring general anesthesia).
6. Participants who have organ allografts.
7. Known or suspected autoimmune disease. Participants with a history of inflammatory bowel disease (including Crohn's disease and ulcerative colitis) and autoimmune disorders such as rheumatoid arthritis, systemic progressive sclerosis \[scleroderma\], Systemic Lupus Erythematosus or autoimmune vasculitis \[e.g., Wegener's Granulomatosis\] are excluded from this study. Participants with a history of Hashimoto's thyroiditis only requiring hormone replacement, Type I diabetes, or psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are allowed to participate.
8. Uncontrolled infection with human immunodeficiency virus, hepatitis B or hepatitis C infection; or diagnosis of immunodeficiency.
1. Participants with HIV who have controlled infection (undetectable viral load with the exception of clinically insignificant blips and CD4 count above 350 either spontaneously or on a stable antiviral regimen) are permitted.
2. Participants with hepatitis B surface antigen positive (HepBsAg+) who have controlled infection (serum hepatitis B virus DNA PCR that is below the limit of detection AND receiving antiviral therapy for hepatitis B) are permitted.
3. Participants with HBsAg negative but total HBV core antibody positive (HBc Ab+) are permitted with the following requirements: Serum HBV DNA PCR should be tested and if it is above the limit of detection at screening then antiviral therapy for HBV must be initiated prior to study entry. If serum HBV DNA PCR is below the limit of detection periodic monitoring of HBsAg must be performed every 12 months +/- 3 months.
4. Participants who are Hepatitis C virus antibody positive (HCV Ab +) who have controlled infection (undetectable HCV RNA by PCR either spontaneously or in response to a successful prior course of anti-HCV therapy) are permitted.
9. Any underlying medical condition, which in the opinion of the Investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events, such as a condition associated with frequent diarrhea, uncontrolled nausea or vomiting. Patients with active COVID-19 disease as indicated by a positive polymerase reaction (PCR) test are excluded. Participants with previous COVID-19 disease are allowed if ≥30 days from last positive test, and COVID-19 symptoms have resolved and/or PCR test is now negative.
10. Participants must not be scheduled to receive another experimental drug while on this study.
11. Participants who are on high dose steroid (e.g., \> 10mg prednisone daily or equivalent) or other more potent immune suppression medications (e.g., infliximab). Topical, inhaled, intra-articular, ocular, or intranasal corticosteroids (with minimal systemic absorption) are allowed. A brief course (\<48 hours) of systemic corticosteroids for prophylaxis (eg, from contrast dye allergy) is permitted. Physiological corticosteroid replacement therapy for adrenal insufficiency (up to hydrocortisone 30 mg / daily or equivalent) is also permitted.
12. Left ventricular ejection fraction (LVEF) assessment with documented LVEF \< 50% by transthoracic echocardiogram (TTE) within 6 months prior to start of study treatment. In cases of LVEF 45-50% in absence of clinical symptoms, after review and clearance by cardiologist, the patient may be enrolled.
13. Active myocarditis, regardless of etiology.
14. Moderate to large pericardial effusion (eg, \> approximately 100 mL) as measured by echocardiogram at baseline. Multigated acquisition (MUGA) is not sufficient for evaluating pericardial effusion.
15. Has a history of any clinically significant arrhythmia including atrial fibrillation or implantation of a pacemaker or defibrillator.
16. Participants who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:
1. Symptomatic congestive heart failure of New York heart Association Class III or IV
2. Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months of start of study drug, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease
3. Systemic fungal, bacterial, viral, or other infection that is not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement) despite appropriate antibiotics or other treatment.
4. Participants with a history of major psychiatric illness judged unable to fully understand the investigational nature of the study and the risks associated with the therapy.
17. Participants must not have history of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of ubamatamab or cemiplimab or that might affect the interpretation of the results of the study or render the participant at high risk from treatment complications.
18. Participants should not receive immunization with attenuated live vaccines within 30 days of planned start of study medication.
a. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.
19. Female participants who are pregnant or breast feeding, or adults of reproductive potential who are not willing to use effective birth control methods as defined above.
20. Any participants who cannot be compliant with the appointments required in this protocol must not be enrolled in this study.
21. History of allergic reactions attributed to compounds of similar chemical or biologic composition to ubamatamab or cemiplimab.
22. Participants with psychiatric illness/social situations that would limit compliance with study requirements.
**Minimum Age:** 12 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Pavlos Msaouel, MD,PHD,PHD
**Phone:** (713) 563-4585
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Houston
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Pavlos Msaouel, MD,PHD,PHD
- **Phone:** 713-563-4585
- **Role:** CONTACT
***Contact 2:***
- **Name:** Pavlos Msaouel, MD,PHD,PHD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** MD Anderson Cancer Center
**State:** Texas
**Zip:** 77030
#### Overall Officials
**Official 1:**
**Affiliation:** M.D. Anderson Cancer Center
**Name:** Pavlos Msaouel, MD,PHD,PHD
**Role:** PRINCIPAL_INVESTIGATOR
### References Module
#### See Also Links
**Label:** MD Anderson Cancer Center
**URL:** http://www.mdanderson.org
## Derived Section
### Condition Browse Module - Meshes
- ID: D000009369
- Term: 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: M302522
- Name: Cemiplimab
- Relevance: HIGH
- As Found: Front
- ID: M1346
- Name: Antineoplastic Agents, Immunological
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: C000627974
- Term: Cemiplimab
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06444867
**Brief Title:** A Study to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of LEO 158968
**Official Title:** An Open-label, Phase 1b, Multi-site Trial to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Following a Single Dose of LEO 158968 in Subjects With Gout Flares
#### Organization Study ID Info
**ID:** LP0189-2318
#### Organization
**Class:** INDUSTRY
**Full Name:** LEO Pharma
#### Secondary ID Infos
**ID:** 2023-508793-29
**Type:** EUDRACT_NUMBER
### Status Module
#### Completion Date
**Date:** 2025-02
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-30
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-02
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-30
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** LEO Pharma
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** The main objective of the study is to evaluate the effect on pain of a single, subcutaneous (SC) dose of LEO 158968 in participants with gout flares.
### Conditions Module
**Conditions:**
- Joint Pain
- Gout Flares
- Joint Inflammation
**Keywords:**
- LEO 158968
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 15
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants with gout flares will receive a single SC dose of LEO 158968 on Day 1.
**Intervention Names:**
- Drug: LEO 158968
**Label:** LEO 158968
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- LEO 158968
**Description:** SC injection
**Name:** LEO 158968
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** The 5-point Likert scale for pain intensity assesses the degree of pain experienced by a participant. The scale is scored from 0 (no pain) to 4 (severe pain).
**Measure:** Number of Participants with a Patient-reported Pain Intensity Score of 0 or 1 as Assessed by the 5-point Likert Scale on Day 4
**Time Frame:** Day 4
#### Secondary Outcomes
**Description:** The 5-point Likert scale for pain intensity assesses the degree of pain experienced by a participant. The scale is scored from 0 (no pain) to 4 (severe pain).
**Measure:** Number of Participants with a Patient-reported Pain Intensity Score of 0 or 1 as Assessed by the 5-point Likert Scale on Day 8
**Time Frame:** Day 8
**Description:** The 5-point Likert scale for pain intensity assesses the degree of pain experienced by a participant. The scale is scored from 0 (no pain) to 4 (severe pain).
**Measure:** Number of Participants with a ≥2-point Reduction in Patient-reported Pain Intensity Score as Assessed by the 5-point Likert
**Time Frame:** Day 1 to Day 8
**Measure:** Number of Participants Experiencing a Change in Pain Intensity in Affected Joints as Assessed by the Visual Analog Scale (VAS) Pain Score
**Time Frame:** Baseline to Day 8
**Description:** A TEAE is defined as any event not present prior to administration of the trial drug or any event already present that worsens in either severity or frequency following exposure to the trial drug. A serious AE (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires participant to be hospitalized, results in disability, is a congenital anomaly, is a medical condition not immediately life-threatening but that requires intensive treatment in emergency room or at home. Any clinically significant changes in physical examination findings and abnormal objective test findings (eg, laboratory, x-ray, ECG) will be recorded as AEs.
**Measure:** Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
**Time Frame:** Baseline to Day 85
**Measure:** Number of Participants with LEO 158968 Anti Drug Antibodies (ADA) from Baseline to Day 85
**Time Frame:** Baseline to Day 85
**Measure:** Number of Participants with LEO 158968 ADA from Baseline to Day 29
**Time Frame:** Baseline to Day 29
**Measure:** Number of Participants Using Rescue Medications from Baseline to Day 8
**Time Frame:** Baseline to Day 8
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Signed and dated informed consent has been obtained prior to any protocol-related procedures.
* Participants meeting the American College of Rheumatology (ACR)/EULAR 201517 gout criteria with a score ≥8.
* Presence of a gout flare for no longer than 96 hours prior to the baseline visit.
* In case of naïve or newly diagnosed participants, the presence of monosodium urate (MSU) crystals in synovial fluid will be evaluated and confirmed.
* At least 1 joint affected by acute gout (eg, ankle, foot, knee, toe). Participants may have oligoarticular gout, defined as \>1 and \<5 affected joints. However, participants with polyarticular gout are not eligible. In case the participant has more than one affected joint, the investigator should select the most symptomatic joint (most painful/with more inflammatory signs) for the study assessments (primary endpoint), and it will be identified as the 'index joint'.
* At screening and baseline (Day 1), a participant-reported joint pain at rest of ≥50 mm on a 0 100 mm VAS with pain intensity ≥2 using a 5-point Likert scale and at least 2 of the following criteria in the target joint:
1. participant-reported flare.
2. participant-reported warm joint.
3. participant-reported swollen joint.
* Body mass index: ≤40 kg/m2, at screening.
* Participants on ULT (xanthine oxidase inhibitors, uricosuric agents) with no changes in therapy for at least 2 weeks before dosing.
* Male participants, if not surgically sterilized, must agree to use adequate contraception and not donate sperm from admission to the clinical research center until all follow-up procedures are complete. Adequate contraception for the male participant (and his female partner, if she is of childbearing potential) is defined as using hormonal contraceptives or an intrauterine device combined with at least 1 of the following forms of contraception: a diaphragm, a cervical cap, or a condom. Total abstinence from heterosexual intercourse, in accordance with the lifestyle of the participant, is also acceptable.
* Participants with hypertension, cardiovascular disease, diabetes, or renal disorder are required to be on a stable dose and schedule, with no changes in therapy for at least 4 weeks before screening and baseline, are expected to remain on a stable regimen during trial participation, and the diseases are biologically and clinically controlled.
Exclusion Criteria:
* Use of specified pain relief medications, including systemic glucocorticoids, within 4 weeks before the baseline visit, and weak and strong opioids, colchicine, and nonsteroidal anti inflammatory drugs within 7 days before the baseline visit.
* Presence of an acute gout flare in more than 4 joints at the baseline visit.
* Other causes of acute or chronic inflammatory arthritis (including rheumatoid arthritis, psoriatic arthritis, and calcium pyrophosphate deposition disease), tophaceous gout, or evidence/suspicion of infectious/septic arthritis.
* History of malignancy within the past 5 years, with the exception of basal cell skin cancer, carcinoma-in-situ of the cervix, or low-risk prostate cancer after curative therapy.
* Known hypersensitivity to any components of the product.
* Presence of active or recurrent bacterial, fungal, or viral infections within 15 days prior to the baseline visit, or presence of human immunodeficiency virus (HIV) infection, and hepatitis B and C infection.
* Presence of active or latent tuberculosis (to be determined by chest X-ray and a tuberculosis screening questionnaire).
* Uncontrolled clinically significant hematologic, pulmonary, endocrine, metabolic, gastrointestinal, central nervous system, or hepatic disease.
* Unstable cardiovascular disease, defined as a recent clinical deterioration (eg, unstable angina, myocardial infarction, cerebrovascular events, or rapid atrial fibrillation) in the last 3 months prior to screening, or a cardiac hospitalization within the 3 months prior to screening.
* Participants who have undergone major surgery within 2 weeks before the baseline visit or have an unhealed operation wound.
* The presence of any medical or psychological condition or laboratory results that, in the Investigator's opinion, might create a risk to the participants or the trial.
* History of alcohol or substance abuse within the 12 months prior to the baseline visit or any condition associated with poor compliance as judged by the Investigator.
* Clinically significant general pain or non-gout-related joint pain that would interfere with the participant's ability to accurately assess pain in the target joint, at the discretion of the Investigator.
* Current participation in any other interventional clinical trial.
**Gender Based:** True
**Maximum Age:** 80 Years
**Minimum Age:** 18 Years
**Sex:** MALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Clinical Disclosure
**Phone:** (+1) 877-557-1168
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** LEO Pharma
**Name:** Medical Expert
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**Access Criteria:** Data sharing is subject to approved scientifically sound research proposal and signed data agreement
**Info Types:**
- STUDY_PROTOCOL
- SAP
**IPD Sharing:** YES
**URL:** http://leopharmatrials.com/for-professionals
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010335
- Term: Pathologic Processes
- ID: D000007592
- Term: Joint Diseases
- ID: D000009140
- Term: Musculoskeletal Diseases
- ID: D000010146
- Term: Pain
- ID: D000009461
- Term: Neurologic Manifestations
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC05
- Name: Musculoskeletal Diseases
- Abbrev: BC16
- Name: Diseases and Abnormalities at or Before Birth
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC10
- Name: Nervous System Diseases
### Condition Browse Module - Browse Leaves
- ID: M10293
- Name: Inflammation
- Relevance: HIGH
- As Found: Inflammation
- ID: M20833
- Name: Arthralgia
- Relevance: HIGH
- As Found: Joint Pain
- ID: M4476
- Name: Arthritis
- Relevance: HIGH
- As Found: Joint Inflammation
- ID: M9177
- Name: Gout
- Relevance: LOW
- As Found: Unknown
- ID: M13066
- Name: Pain
- 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: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000018771
- Term: Arthralgia
- ID: D000001168
- Term: Arthritis
- ID: D000007249
- Term: Inflammation
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06444854
**Acronym:** PROTECTR
**Brief Title:** Patient Reported Outcomes Targeting Early Chest Tube Removal (PROTECTR) Study
**Official Title:** Patient Reported Outcomes Targeting Early Chest Tube Removal (PROTECTR) Study
#### Organization Study ID Info
**ID:** PROTECTR
#### Organization
**Class:** OTHER
**Full Name:** Lawson Health Research Institute
### Status Module
#### Completion Date
**Date:** 2026-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-05
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-07-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-30
**Study First Submit QC Date:** 2024-06-05
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Lawson Health Research Institute
#### Responsible Party
**Investigator Affiliation:** Lawson Health Research Institute
**Investigator Full Name:** Rahul Nayak
**Investigator Title:** Director of Research
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This study is a single centre, prospective clinical trial evaluating the safety and feasibility of implementing a same day chest tube removal protocol in patients undergoing Video Assisted Thoracic Surgery (VATS) anatomical pulmonary surgery.
**Detailed Description:** Pulmonary resections are performed for a multitude of diagnostic and therapeutic reasons. The last decade has seen a rapid advancement of minimally invasive surgical (MI) approaches which have resulted in improved patient outcomes. However, the post-operative care pathways have not evolved sufficiently to account for these changes. As such, many patients are still admitted after a minor lung resection for monitoring with a chest tube remaining in situ for a minimum of 24 hours. There have been a few retrospective cohort studies that demonstrate that patients do not experience significant complications during that 24-hour period that would warrant hospitalization. However, there have been no prospective controlled studies evaluating the safety and feasibility of early chest tube removal and discharge after a wedge resection. Furthermore, the maintenance of a large bore chest tube for an extended period is a cause for increased patient discomfort, increased narcotic use and may contribute to chronic pain secondary to intercostal nerve compression. As such, the prolonged chest tube maintenance and hospitalization may overall result in more patient harm than benefit.
Our group recently completed and presented a prospective safety and feasibility study demonstrating that chest tubes can be discontinued as early as 3 hours after minor MIS wedge resections of the lung with no adverse events. This study validated safety criteria that will be implemented moving forward. Furthermore, the maintenance of a large bore chest tube for an extended period is a cause for increased patient discomfort, increased narcotic use and may contribute to chronic pain secondary to intercostal nerve compression. As such, the prolonged chest tube maintenance and hospitalization may overall result in more patient harm than benefit. In the study mentioned previously, early chest tube removal led to 40% more patients being opioid free at post operative day 1 compared to those who underwent routine care.
Nevertheless, it is unclear if patients who undergo more extensive surgeries involving vascular dissection and longer operative times (i.e., pulmonary lobectomies and segmentectomies) will derive the same benefit. The incisions required to complete more complex operations are also larger compared to wedge resections. As such the pain associated with having a chest tube may or may not be as apparent in the setting of the larger incision. It is also unclear what the long-term impact of early chest tube removal has on quality of life in the perioperative period.
### Conditions Module
**Conditions:**
- Lung Surgery
- Chest Tube Removal
- ERAS
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** CROSSOVER
**Intervention Model Description:** This study is a single centre, prospective clinical trial evaluating the safety and feasibility.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 130
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** early chest tube removal at 3 hours
**Intervention Names:**
- Procedure: early chest tube removal
**Label:** Intervention
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Routine post operative chest tube care
**Label:** Control
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Intervention
**Description:** Chest tube removal
**Name:** early chest tube removal
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** These patients have chest tube removed if they meet study criteria
**Measure:** Rate of successful same day chest tube removal
**Time Frame:** 30 days post-op
**Description:** Difference in EQ5D5L scores between standard care and early chest tube removal on POD1 and POD30.
**Measure:** EQ5D5L score
**Time Frame:** 30 days post-op
**Description:** Mean Morphine Equivalents used on post operative day 1
**Measure:** MME POD1
**Time Frame:** 24 hours
**Description:** Rate of pleural reintervention (defined as requiring reinsertion of a chest tube or return to the operating room)
**Measure:** Pleural reintervention
**Time Frame:** 30 days post-op
#### Secondary Outcomes
**Description:** The rates of grade 1 to 5 complications as per the TSQIC will be recorded for up to 30 days after surgery in the divisional thoracic REDCap database.
**Measure:** Complications
**Time Frame:** 30 days post-op
**Description:** Duration the patient had chest tubes in situ will be measured by collecting the date and time of arrival to PACU and the date and time the chest tube was removed.
**Measure:** Chest Tube duration
**Time Frame:** 30 days post-op
**Description:** Unplanned returns to clinic or emergency room within the first 30 days after surgery
**Measure:** Unplanned return
**Time Frame:** 30 days post-op
**Description:** Duration of hospital length of stay
**Measure:** LOS
**Time Frame:** 30 days post-op
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* 18 yrs or older
* scheduled to undergo elective VATS segmental or lobar resection of the lung
Exclusion Criteria:
* Pulmonary function tests demonstrating forced expiratory volume in 1 second (FEV1) \<50% predicted, FEV1 \<1.5L and/or diffusion lung capacity of carbon monoxide (DLCO) \<50% predicted
* Patient receives an intraoperative pleurodesis
* Conversion to open thoracotomy or mini thoracotomy intraoperatively.
* Underlying cognitive disorder resulting in inability to complete activities of daily living.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Deb Lewis
**Phone:** 5196858500
**Phone Ext:** 75685
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** London
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Deb Lewis
- **Role:** CONTACT
***Contact 2:***
- **Name:** Rahul Nayak, MD MSc
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Canada
**Facility:** London Health Sciences Centre
**State:** Ontario
**Zip:** N6A 5W9
#### Overall Officials
**Official 1:**
**Affiliation:** Western University
**Name:** Rahul Nayak, MD 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:** NCT06444841
**Brief Title:** Paper-Based and Smartphone-Based Memory Supports
**Official Title:** Smartphone-Based Solutions for Prospective Memory in Mild Cognitive Impairment and Dementia
#### Organization Study ID Info
**ID:** STUDY00004527
#### Organization
**Class:** OTHER
**Full Name:** Baylor University
#### Secondary ID Infos
**ID:** 1R01AG082783-01
**Link:** https://reporter.nih.gov/quickSearch/1R01AG082783-01
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2028-09-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-28
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2028-09-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** University of Texas at Austin
**Class:** OTHER
**Name:** Baylor Scott and White Health
**Class:** NIH
**Name:** National Institute on Aging (NIA)
#### Lead Sponsor
**Class:** OTHER
**Name:** Baylor University
#### Responsible Party
**Investigator Affiliation:** Baylor University
**Investigator Full Name:** Michael Scullin
**Investigator Title:** Associate Professor of Psychology and Neuroscience
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Alzheimer's disease and related dementias lead to marked declines in daily functioning, independence, and quality of life. One of the earliest cognitive changes in these conditions is impairment in prospective memory, or the ability to remember future intentions such as taking medications at a given time. Prior intervention studies that targeted prospective memory used mnemonic strategies or cognitive training, but these approaches resulted in modest gains in clinical populations. By contrast, a Stage I pilot trial indicated that smartphone-based memory aids (reminder apps) can be accepted and used by persons with mild cognitive impairment and mild dementia to improve both subjective and objective prospective memory performance. The investigators will now test for efficacy, durability, and generalizability of benefits across diverse samples in a Stage II randomized controlled trial. Some 200 participants with mild cognitive impairment or mild dementia will be recruited, half of whom will be from digitally-disadvantaged backgrounds (low socioeconomic status, rural, or historically underrepresented groups). Participants will complete baseline assessments and then be randomly assigned to a smartphone reminder app intervention or an active control condition that uses a paper- based memory support system. Across a 4-week intervention period, participants will complete patient-selected and experimenter-assigned prospective memory assessments and receive booster training sessions to promote self-efficacy with the intervention/control system. Durability of effects will be assessed at 3-month and 6-month follow-up sessions. As a secondary aim, study partners will be simultaneously enrolled to collect informant ratings, track how much study partners assist the participants, and determine whether improving prospective memory in patients improves quality of life in study partners (e.g., by reducing the double to-do list burden of remembering for themselves and for care recipients). As a third aim, the investigators will identify barriers and facilitators to smartphone interventions in digitally-disadvantaged individuals who have historically been underrepresented in technology and dementia research.
### Conditions Module
**Conditions:**
- Alzheimer Disease
- Dementia, Mild
- Mild Cognitive Impairment
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 200
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants will use Google Calendar, an off-the-shelf app that is free and user-friendly, to provide reminders on their smartphone to perform prospective memory tasks at the appropriate time. In the current study, participants will offload their personal and experimentally assigned tasks into the digital calendar with reminders enabled.
**Intervention Names:**
- Behavioral: Digital - Google Calendar
**Label:** Smartphone-based app
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants will use a Memory Support System, which is an established paper-based calendar and note taking system that can fit into one's pocket. In the current study they will use the system to offload personal and experimentally assigned tasks and notes into the schedule, to-do list, and journal sections of the notebook.
**Intervention Names:**
- Behavioral: Paper-based - Memory Support System
**Label:** Paper-based notebook
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Smartphone-based app
**Description:** Digital calendar apps allow one to digitally "off-load" intentions either by typing them or by speaking them (speech-to-text voice-dictation capabilities). In addition, they deliver automated reminders to perform intended tasks, either at a single time (e.g., Monday at 9 am) or at recurring times (e.g., every night at 8 pm).
**Name:** Digital - Google Calendar
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- Paper-based notebook
**Description:** The Memory Support System is an established paper-based solution for prospective memory functioning. There is considerable evidence in the literature for its utility in mild cognitive impairment (MCI) and it has face validity to patients as supporting memory.
**Name:** Paper-based - Memory Support System
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** Participants will need to remember to call the study phone number at both 1) regular times each week (set at baseline for the entire study duration), and 2) irregular times each week (experimenter-assigned times that change).
**Measure:** Objective Prospective Memory Performance
**Time Frame:** Measured for 6 months
**Description:** Based on the goal attainment scaling framework; via a structured interview at baseline, the participant and study partner will identify 5-10 activities from the participant's daily routine that require frequent use of prospective memory. At follow-up sessions, participants rate the degree to which each of these personal activities improved or worsened.
**Measure:** Patient-Centered/Patient-Selected Prospective Memory Performance
**Time Frame:** Measured for 6 months
**Description:** Co-participants will complete the Direct Impact of Care (Scales Measuring the Impact of Dementia on Carers - Direct Impact) scale. This scale has 18 items to which the co-participant respond Agree or Disagree, with Agree responses indicating a greater impact of the care they provide on their own lives.
**Measure:** Caregiving-Related Quality of Life
**Time Frame:** Measured for 6 months
#### Secondary Outcomes
**Description:** The Cognitive Burden of Caregiving Scale (CBCS) is a 14 item scale assessing cognitive burden associated with caregiving, strategy use independence and assistance, and time preoccupation. Items are responded to on a 1-7 likert scale (max score of 98) with higher scores indicating greater cognitive burden.
**Measure:** Caregiving Cognitive Burden
**Time Frame:** Measured for 6 months
**Description:** Total number of entries for the digital or paper calendar
**Measure:** Calendar Use
**Time Frame:** Measured for 6 months
**Description:** Participants will complete the Montreal Cognitive Assessment (MoCA), a rapid screening assessment to help detect mild cognitive impairment in numerous cognitive domains (attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation). Scores range from 0 to 30, with lower scores indicating worse outcomes.
**Measure:** Montreal Cognitive Assessment
**Time Frame:** Measured during screening and at study completion
**Description:** Participants in the digital condition will provide their total minutes of screen time from their phone's settings.
**Measure:** Smartphone Use - Screen Time
**Time Frame:** Measured for 6 months
**Description:** Participants in the digital condition will provide the total number of notifications they received, found in their phone's settings.
**Measure:** Smartphone Use - Notifications
**Time Frame:** Measured for 6 months
**Description:** Participants in the digital condition will provide the total number of pickups/unlocks of their phone, found in their phone's settings.
**Measure:** Smartphone Use - Pickups
**Time Frame:** Measured for 6 months
**Description:** Participants in the digital condition will provide their most used apps, found in their phone's settings.
**Measure:** Smartphone Use - Apps
**Time Frame:** Measured for 6 months
**Description:** Participants in the digital condition will provide the total amount of time they spent using Google Calendar, found in their phone's settings.
**Measure:** Smartphone Use - Google Calendar
**Time Frame:** Measured for 6 months
**Description:** The 21-item Prospective and Retrospective Memory Questionnaire uses a 5-point scale ran to assess the frequency of retrospective and prospective memory failures, such as forgetting to take a pill.
**Measure:** Prospective and Retrospective Memory Questionnaire - Subjective Memory Functioning
**Time Frame:** Measured for 6 months
**Description:** Co-Participants will complete a modified instrumental activities of daily living scale to assess participants' ability to independently complete activities of daily living, such as preparing meals or making purchases with analog and digital approaches. The 6-point scale ranges from Normal to Dependent and includes Not Applicable/Unknown response options, with greater scores indicating a greater need of assistance.
**Measure:** Modified Functional Activities Questionnaire
**Time Frame:** Measured for 6 months
**Description:** Participants will complete the Quality of Life in Neurological Disorders (Neuro-QOL) subscale for depression. The subscale has 8 items that are rated from Never to Always. The subscale total score range from 8 (minimum) to 40 (maximum), with lower scores indicating better outcomes.
**Measure:** Neuro-QoL - Depression
**Time Frame:** Measured for 6 months
**Description:** The 7-item Insomnia Severity Index asks participants to rate the severity of both nighttime and daytime components of their insomnia, with higher scores indicating worse outcomes.
**Measure:** Insomnia Severity Index
**Time Frame:** Measured for 6 months
**Description:** The Everyday Cognition (ECOG-12) questionnaire uses a 5-point scale to assess the participant's ability to perform certain everyday tasks, such as remembering the current date, rated from "I perform the task much worse than 10 years ago" to "There has been no change in my ability compared to 10 years ago."
**Measure:** Everyday Cognition
**Time Frame:** Measured for 6 months
**Description:** The NIH Toolbox General Life Satisfaction questionnaire uses a 7-point scale to assess participants' sense of fulfillment with their lives.
**Measure:** General Life Satisfaction
**Time Frame:** Measured for 6 months
**Description:** The Coping Self-Efficacy questionnaire uses an 11-point scale - ranging from 0, cannot do at all, to 10, certain can do - assessing the participant's confidence in solving personal or emotional problems.
**Measure:** Coping Self-Efficacy
**Time Frame:** Measured for 6 months
**Description:** Study personnel will conduct semi-structured qualitative interviews with dyads to determine the most helpful, challenging, interesting, and important themes from their experience using their memory strategy.
**Measure:** Follow-Up Qualitative Interview
**Time Frame:** Measured at 6 months
**Description:** Number of minutes to complete smartphone/memory notebook training
**Measure:** Training/Booster Duration
**Time Frame:** Measured for 1 month (throughout intervention period)
**Description:** Self report scale of frequency of using different memory strategies ranging from Never to All the Time, with greater scores indicating more frequent calendar and journal use.
**Measure:** Self Reported Memory Strategy Use
**Time Frame:** Measured for 6 months
**Description:** Self report usage of pharmacological, cognitive, and group therapies.
**Measure:** Self Reported Current Treatments
**Time Frame:** Measured for 6 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Demonstrate capacity to consent via structured interview that involves reviewing core study features and probing for understanding of potential benefits/consequences of participating, and understanding that one can withdraw consent at any point, or availability to obtain surrogate consent.
* Clinical features consistent with a diagnosis of MCI or dementia. For clinic-referred participants, available records will be reviewed to ensure the clinical diagnosis meets published diagnostic guidelines. If there is not sufficient documentation for diagnostic purposes, then semi-structured clinical interview and cognitive screening (see below) will be reviewed by clinical staff.
* Cognitive status for inclusion will be assessed by Montreal Cognitive Assessment (MoCA) scores of 17-25 (or 12-18 for the telephone version if in-clinic assessment is not feasible). While some studies suggested that these ranges are appropriate across diverse groups, recent work indicates that adjustment of 1-2 points for different demographics improves instrument sensitivity in disadvantaged groups. The latter approach will be taken.
* Functional status will be assessed via semi-structured interview with the Global Deterioration Scale (GDS), with stage 3 or 4 indicating independence in basic self-maintenance activities.
* Adequate sensory and motor abilities to utilize a smartphone with accommodation.
* Availability of a co-participant who sees the participant at least once a month.
Co-Participant Inclusion Criteria:
* The co-participant will need to be over the age of 18, consent to participation, and see the participant at least once per month.
Exclusion Criteria:
* History of serious mental illness including schizophrenia or bipolar disorder that is judged by the clinician to be the primary cause of cognitive decline.
* Indication of moderate or severe dementia based on clinical documentation, MoCA score, and/or collateral/informant activities of daily living measure during the screening process (GDS score ≥5).
* Language difficulties significant enough to interfere with the screening procedures.
* Uncorrected hearing loss, vision loss, or motor dysfunction significant enough to interfere with training.
* No study partner.
* At the current time, individuals who do not identify as conversational in English will be excluded from participation.
Co-Participant Exclusion Criteria:
* Sees participant less than once per month.
* At the current time, individuals who do not identify as conversational in English will be excluded from participation.
**Minimum Age:** 50 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Michael Scullin, PhD
**Phone:** 254-710-2251
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Jared Benge, PhD
**Phone:** 512-495-5285
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Austin
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Jared Benge, PhD
- **Phone:** 512-495-5285
- **Role:** CONTACT
**Country:** United States
**Facility:** UT Health Austin Comprehensive Memory Center
**State:** Texas
**Zip:** 78712
**Location 2:**
**City:** Temple
**Contacts:**
***Contact 1:***
- **Name:** Michael Scullin
- **Role:** CONTACT
**Country:** United States
**Facility:** Baylor Scott & White Healthcare
**State:** Texas
**Zip:** 76508
**Location 3:**
**City:** Waco
**Contacts:**
***Contact 1:***
- **Name:** Michael Scullin
- **Role:** CONTACT
**Country:** United States
**Facility:** Baylor University
**State:** Texas
**Zip:** 76798
#### Overall Officials
**Official 1:**
**Affiliation:** Baylor University
**Name:** Michael Scullin, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Access Criteria:** Open sharing.
**Description:** The investigators will use the repository provided by the Global Alzheimer's Association Interactive Network (GAAIN), depositing data within 9 months of publication.
**Info Types:**
- STUDY_PROTOCOL
- SAP
- ICF
**IPD Sharing:** YES
**Time Frame:** Deposit data within 9 months of publication.
## 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
- ID: D000003072
- Term: Cognition 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: M29705
- Name: Cognitive Dysfunction
- Relevance: HIGH
- As Found: Mild Cognitive Impairment
- 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: M6301
- Name: Cognition 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
- ID: D000060825
- Term: Cognitive Dysfunction
### Intervention Browse Module - Browse Branches
- Abbrev: PhSol
- Name: Pharmaceutical Solutions
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M21860
- Name: Pharmaceutical Solutions
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06444828
**Brief Title:** Comparing Outcomes of Non-surgical Versus Surgical Treatment of Shoulder Fractures With Different Shoulder Replacements
**Official Title:** Outcome Following Reverse Shoulder Arthroplasty for Acute Proximal Humerus Fractures in Patients 60 Years of Age and Older With Different Inclination Implants Versus Non-surgical Treatment- Trial Protocol: a Prospective RCT, Single Blinded
#### Organization Study ID Info
**ID:** ISRCTN85422168
#### Organization
**Class:** OTHER
**Full Name:** University of Southern Denmark
### Status Module
#### Completion Date
**Date:** 2025-09-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-30
**Overall Status:** ACTIVE_NOT_RECRUITING
#### Primary Completion Date
**Date:** 2024-09-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2021-09-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2023-11-30
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Region of Southern Denmark
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Southern Denmark
#### Responsible Party
**Investigator Affiliation:** University of Southern Denmark
**Investigator Full Name:** Klaus Wilhelm Josef Hanisch
**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 optimal treatment of complex shoulder fracture is controversial. In general, non-surgical treatment is recommended for older patients, but results are often unsatisfying. Therefore different surgical approaches have been tried to improve outcomes for this group of patients. Reverse shoulder arthroplasty has shown promising results for these types of fractures and changes in the design of the implant might improve outcomes further. The aim of this study is to compare the outcomes of complex shoulder fractures after non-surgical versus surgical treatment and compare two different types of implants.
**Detailed Description:** The optimal treatment of proximal humeral fracture (PHF) Neer type III and IV AO B1.1,1.2 and C1.1,3.1 is controversial. National guidelines for Denmark have been published in 2015 and updated 2019. They recommend conservative treatment to all kinds of PHF for patients aged above 60 years. Exceptions are fracture-dislocations, headsplits or surgical conditions, where intervention is mandatory like open fractures and impaired nerve- and circulation.
Recently reverse shoulder arthroplasty (RSA) has gained expanding popularity in treating PHF . Compared with osteosynthesis (ORIF) or hemiarthroplasty (HA) outcomes were superior , . The importance of tuberosity healing for good functional outcomes has lead to development of different implants and fixation techniques. The original RSA design by Grammont with 155 degree inclination of the humeral stem was made for cuff-arthropathy. This design moves the center of rotation in a medial direction, and increase the tension on the tuberosities.
In contrast "anatomical" designed humeral implants with 135 degree enables more anatomical refixation of the tuberosities with less tension and might reduce the risk of resorption or displacement of the fragments. To implant a 155 degree RSA the surgeon has to remove parts of the rotator cuff, to enable the sliding rotation. On the other hand with a 135 degree inclination humeral component, a cuff sparing technique is possible.
The aim of this study is to compare outcomes of two different designed RSA stems versus conservative treatment of PHF Neer type III or IV / AO B\&C.
### Conditions Module
**Conditions:**
- Proximal Humeral Fracture
- Humeral Head Fracture
**Keywords:**
- proximal humerus fracture
- Reverse Shoulder Arthroplasty
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** RCT, single blinded
##### Masking Info
**Masking:** SINGLE
**Masking Description:** non information of the type of implant used is given to the patient
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 90
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Proximal humeral fractures (PHF) treated non-operative, Rehabilitation only
**Label:** non operative treatment
**Type:** NO_INTERVENTION
#### Arm Group 2
**Description:** RSA 135/ 155 inclination
**Intervention Names:**
- Procedure: Non-operative
**Label:** Reverse Shoulder Arthroplasty (RSA)
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Reverse Shoulder Arthroplasty (RSA)
**Description:** Non-operative treatment versus operative treatment (surgery)
**Name:** Non-operative
**Other Names:**
- Surgery Reverse Shoulder Arthroplasty
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** All participants are assessed with online questionnaire, Patient Related Outcome Measurement (PROM) 0-100% (100% best), validated
**Measure:** The primary outcome is Western Ontario Osteoarthritis of the Shoulder Index (WOOS)
**Time Frame:** one years follow up (FU)
#### Secondary Outcomes
**Description:** All participants are assessed with function scores. 0-100% (100% best) by physiotherapist
**Measure:** Constant Murley score
**Time Frame:** one and two years FU
**Description:** All participants are assessed with online questionnaire PROM 0-100% (100% best)
**Measure:** Subjective shoulder Volume (SSV)
**Time Frame:** one and two years FU
**Description:** stating healing, displacement, resorbtion of the tuberosities
**Measure:** x-rays
**Time Frame:** one and two years FU
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
Displaced Proximal Humeral Fractures (PHF) Neer type III or IV / AO B\&C. Radiological confirmed
Exclusion Criteria:
other types of PHF, Head splits, gleno-humeral dislocations, pathological fractures. Refuse to participate in the study. Non-compliant, drug/alcohol abuse or institutionalized, (Low-cooperative),
**Maximum Age:** 90 Years
**Minimum Age:** 60 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Esbjerg
**Country:** Denmark
**Facility:** University Hospital Southern Danmark
**State:** South
**Zip:** 6700
#### Overall Officials
**Official 1:**
**Affiliation:** University of Southern Denmark
**Name:** Klaus Hanisch
**Role:** STUDY_CHAIR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### See Also Links
**Label:** Related Info
**URL:** http://doi.org/10.1186/ISRCTN85422168
## Document Section
### Large Document Module
#### Large Docs
- Date: 2023-12-08
- Filename: Prot_SAP_000.pdf
- Has ICF: False
- Has Protocol: True
- Has SAP: True
- Label: Study Protocol and Statistical Analysis Plan
- Size: 949793
- Type Abbrev: Prot_SAP
- Upload Date: 2023-12-08T11:27
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000014947
- Term: Wounds and Injuries
- ID: D000001134
- Term: Arm Injuries
- ID: D000070599
- Term: Shoulder Injuries
### Condition Browse Module - Browse Branches
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M26370
- Name: Fractures, Bone
- Relevance: HIGH
- As Found: Fracture
- ID: M9869
- Name: Humeral Fractures
- Relevance: HIGH
- As Found: Humeral Fractures
- ID: M15592
- Name: Shoulder Fractures
- Relevance: HIGH
- As Found: Proximal Humeral Fracture
- ID: M17685
- Name: Wounds and Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M4444
- Name: Arm Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M602
- Name: Shoulder Injuries
- Relevance: LOW
- As Found: Unknown
- ID: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000050723
- Term: Fractures, Bone
- ID: D000006810
- Term: Humeral Fractures
- ID: D000012784
- Term: Shoulder Fractures
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06444815
**Acronym:** STEALTH-001
**Brief Title:** A Study of VET3-TGI in Patients With Solid Tumors
**Official Title:** A Phase 1/1b Study of VET3-TGI Administered Alone and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors
#### Organization Study ID Info
**ID:** STEALTH-001
#### Organization
**Class:** INDUSTRY
**Full Name:** KaliVir Immunotherapeutics
### Status Module
#### Completion Date
**Date:** 2027-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-30
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2027-09-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-08-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-30
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** KaliVir Immunotherapeutics
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** VET3-TGI is an oncolytic immunotherapy designed to treat advanced cancers. VET3-TGI has not been given to human patients yet, and the current study is designed to find a safe and effective dose of VET3-TGI when administered by direct injection into tumor(s) (called an intratumoral injection) or when given intravenously (into the vein) both alone and in combination with pembrolizumab in patients with solid tumors (STEALTH-001).
**Detailed Description:** VET3-TGI was changed in a laboratory to infect and kill cancer cells, leaving healthy cells alone. This is a Phase 1 dose escalation (and expansion) study with VET3-TGI administered by direct injection into tumor(s) or by intravenous infusion. The dose escalation has 4 groups: the first group (Group A) will determine the highest tolerated dose of VET3-TGI when injected into tumor(s); the second group (Group C) will determine the highest tolerated dose of VET3-TGI when infused into the vein. The third and fourth groups (Group B and D) will combine VET3-TGI with pembrolizumab. These groups will begin at the highest tolerated dose determined in Group B and Group D, respectively.
Once the highest tolerated dose is found for each of these groups, that dose may be expanded to up to 15 additional patients to better examine the efficacy of VET3-TGI.
### Conditions Module
**Conditions:**
- Solid Tumor, Adult
- Microsatellite Stable Colorectal Cancer
- Head and Neck Squamous Cell Carcinoma
- Cervical Cancer
- Kidney Cancer
- Renal Cell Carcinoma
- Melanoma Stage IV
- Merkel Cell Carcinoma of Skin
- Mesothelioma
- Non-small Cell Lung Cancer
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Dose escalation of VET3-TGI alone administered by direct injection into tumor(s) x 4. Booster injections of VET3-TGI are permitted for up to 2 years.
**Intervention Names:**
- Drug: VET3-TGI
**Label:** Group A: VET3-TGI alone intratumoral
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** VET3-TGI will be given in combination with pembrolizumab at the highest tolerated dose from Group A. Pembrolizumab will be administered via intravenous (IV) infusion for up to 2 years.
**Intervention Names:**
- Drug: VET3-TGI
- Drug: Pembrolizumab
**Label:** Group B: VET3-TGI intratumoral in combination with pembrolizumab
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Dose escalation of VET3-TGI alone administered by IV infusion x 6. Booster infusions of VET3-TGI are permitted for up to 2 years.
**Intervention Names:**
- Drug: VET3-TGI
**Label:** Group C: VET3-TGI alone intravenous
**Type:** EXPERIMENTAL
#### Arm Group 4
**Description:** VET3-TGI will be given in combination with pembrolizumab at the highest tolerated dose from Group C. Pembrolizumab will be administered via intravenous (IV) infusion for up to 2 years.
**Intervention Names:**
- Drug: VET3-TGI
- Drug: Pembrolizumab
**Label:** Group D: VET3-TGI intravenous in combination with pembrolizumab
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Group A: VET3-TGI alone intratumoral
- Group B: VET3-TGI intratumoral in combination with pembrolizumab
- Group C: VET3-TGI alone intravenous
- Group D: VET3-TGI intravenous in combination with pembrolizumab
**Description:** Oncolytic vaccinia virus engineered with immunomodulatory transgenes
**Name:** VET3-TGI
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Group B: VET3-TGI intratumoral in combination with pembrolizumab
- Group D: VET3-TGI intravenous in combination with pembrolizumab
**Description:** anti-pd1 antibody
**Name:** Pembrolizumab
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Percentage of patients with adverse events by grade as determined by NCI CTCAE v5.0
**Measure:** Incidence of adverse events with VET3-TGI alone or in combination with pembrolizumab
**Time Frame:** 108 months
**Description:** Number of dose limiting toxicities, as defined in the protocol, by dose group
**Measure:** Incidence of dose limiting toxicities reported with VET3-TGI alone or in combination with pembrolizumab
**Time Frame:** 4 weeks
**Description:** he highest dose of VET3-TGI in each group that can be administered where fewer than 2 patients have a dose-limiting safety event alone or when combined with pembrolizumab as assessed by NCI CTCAE v.5.0 during the Phase 1 dose escalation
**Measure:** Determine the recommended Phase 2 dose
**Time Frame:** 4 weeks
#### Secondary Outcomes
**Description:** The number and proportion of patients with a partial response (PR) or complete response (CR) on imaging by RECIST 1.1
**Measure:** Efficacy assessment: overall response rate (ORR)
**Time Frame:** 108 months
**Description:** Median duration of response in patients with a CR or PR
**Measure:** Efficacy assessment: Duration of response (DOR)
**Time Frame:** 108 months
**Description:** The number and proportion of patients with stable disease (SD), or a partial response (PR) or complete response (CR) on imaging by RECIST 1.1
**Measure:** Efficacy assessment: disease control rate (DCR)
**Time Frame:** 108 months
**Description:** Median time until patient disease progression (PD)
**Measure:** Efficacy assessment: Time to tumor progression (TTP)
**Time Frame:** 108 months
**Description:** Median duration of progression free survival of subjects
**Measure:** Efficacy assessment: Progression free survival (PFS)
**Time Frame:** 108 months
**Description:** median duration of survival across all subjects
**Measure:** Overall survival
**Time Frame:** 108 months
**Description:** number of subject tissue samples with immune cell infiltrates and heat map changes in the molecular signature of tissue samples
**Measure:** Immune changes in tissue and blood
**Time Frame:** 6 weeks
**Description:** Number of subject tissues with positive VET3-TGI gene signatures denoting delivery and complete replication of VET3-TGI
**Measure:** VET3-TGI delivery and replication kinetics
**Time Frame:** 6 weeks
### Eligibility Module
**Eligibility Criteria:** Key Inclusion Criteria:
* Have pathologically confirmed, advanced, unresectable, or metastatic solid tumors. Preferred indications include, but are not limited to, breast carcinoma, bladder carcinoma, cervical squamous carcinoma, colorectal carcinoma, esophageal carcinoma, head and neck squamous carcinoma, renal cell carcinoma, ovarian carcinoma, sarcoma, thymoma, and uterine carcinoma.
* Failed, intolerant to, or refused potentially curative treatment options, including but not limited to, standard of care molecularly targeted agents, immunotherapy (e.g., anti -pembrolizumab/PDL1 antibodies), and chemotherapy
* Measurable disease as per RECIST 1.1 criteria
* At least one tumor amenable to safe ITu injections and/or biopsies
* ECOG performance status 0 or 1
* Demonstrate adequate organ function
* Must be willing to comply with all protocol procedures and adhere to post-treatment care instructions
Additional Inclusion criteria exist
Key Exclusion Criteria:
* Prior systemic therapy washout (dependent upon the therapy)
* Requires use of anti-platelet or anti-coagulant therapy that cannot be safely suspended for per protocol biopsies or intra-tumoral injections.
* CNS metastases and/or carcinomatous meningitis that have not been completely resected or completely irradiated.
* Prior history of myocarditis
* Known HIV/AIDS, active HBV or HCV infection.
* Receiving high dose immunosuppressive medication or has a significant immunodeficiency (e.g. transplant recipient, etc).
Additional Exclusion criteria exist
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Adina Pelusio
**Phone:** +13057722084
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** James Burke, MD
**Role:** CONTACT
### IPD Sharing Statement Module
**Description:** Data is aggregated.
**IPD Sharing:** NO
## 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: D000018358
- Term: Neuroendocrine Tumors
- ID: D000017599
- Term: Neuroectodermal Tumors
- ID: D000009373
- Term: Neoplasms, Germ Cell and Embryonal
- ID: D000009380
- Term: Neoplasms, Nerve Tissue
- ID: D000002294
- Term: Carcinoma, Squamous Cell
- ID: D000014565
- Term: Urogenital Neoplasms
- ID: D000052776
- Term: Female Urogenital Diseases
- ID: D000005261
- Term: Female Urogenital Diseases and Pregnancy Complications
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000000230
- Term: Adenocarcinoma
- ID: D000014571
- Term: Urologic Neoplasms
- ID: D000007674
- Term: Kidney Diseases
- ID: D000014570
- Term: Urologic Diseases
- ID: D000052801
- Term: Male Urogenital Diseases
- ID: D000000236
- Term: Adenoma
- ID: D000018301
- Term: Neoplasms, Mesothelial
- ID: D000006258
- Term: Head and Neck Neoplasms
- ID: D000027601
- Term: Polyomavirus Infections
- ID: D000004266
- Term: DNA Virus Infections
- ID: D000014777
- Term: Virus Diseases
- ID: D000007239
- Term: Infections
- ID: D000014412
- Term: Tumor Virus Infections
- ID: D000018278
- Term: Carcinoma, Neuroendocrine
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: All
- Name: All Conditions
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: BC01
- Name: Infections
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M5534
- Name: Carcinoma
- Relevance: HIGH
- As Found: Carcinoma
- ID: M5548
- Name: Carcinoma, Renal Cell
- Relevance: HIGH
- As Found: Renal Cell Carcinoma
- ID: M5550
- Name: Carcinoma, Squamous Cell
- Relevance: LOW
- As Found: Unknown
- ID: M11172
- Name: Lung Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M5546
- Name: Carcinoma, Non-Small-Cell Lung
- Relevance: LOW
- As Found: Unknown
- ID: M17967
- Name: Carcinoma, Merkel Cell
- Relevance: HIGH
- As Found: Merkel Cell Carcinoma
- ID: M11634
- Name: Mesothelioma
- Relevance: HIGH
- As Found: Mesothelioma
- ID: M10703
- Name: Kidney Neoplasms
- Relevance: HIGH
- As Found: Kidney Cancer
- ID: M5830
- Name: Uterine Cervical Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M11528
- Name: Melanoma
- Relevance: LOW
- As Found: Unknown
- ID: M2537
- Name: Mesothelioma, Malignant
- 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: M20495
- Name: Neuroendocrine Tumors
- Relevance: LOW
- As Found: Unknown
- ID: M19845
- Name: Neuroectodermal Tumors
- Relevance: LOW
- As Found: Unknown
- ID: M20388
- Name: Neuroectodermal Tumors, Primitive
- Relevance: LOW
- As Found: Unknown
- ID: M12318
- Name: Neoplasms, Germ Cell and Embryonal
- Relevance: LOW
- As Found: Unknown
- ID: M12325
- Name: Neoplasms, Nerve Tissue
- Relevance: LOW
- As Found: Unknown
- ID: M17315
- Name: Urogenital Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27093
- Name: Female Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14127
- Name: Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M8399
- Name: Female Urogenital Diseases and Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M3585
- Name: Adenocarcinoma
- Relevance: LOW
- As Found: Unknown
- ID: M17320
- Name: Urologic Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M10698
- Name: Kidney 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: M3591
- Name: Adenoma
- Relevance: LOW
- As Found: Unknown
- ID: M20445
- Name: Neoplasms, Mesothelial
- Relevance: LOW
- As Found: Unknown
- ID: M9348
- Name: Head and Neck Neoplasms
- 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: M23236
- Name: Polyomavirus Infections
- Relevance: LOW
- As Found: Unknown
- ID: M17522
- Name: Virus Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7442
- Name: DNA Virus Infections
- Relevance: LOW
- As Found: Unknown
- ID: M17162
- Name: Tumor Virus Infections
- Relevance: LOW
- As Found: Unknown
- ID: M20423
- Name: Carcinoma, Neuroendocrine
- Relevance: LOW
- As Found: Unknown
- ID: T4906
- Name: Renal Cell Carcinoma
- Relevance: HIGH
- As Found: Renal Cell Carcinoma
- ID: T1341
- Name: Clear Cell Renal Cell Carcinoma
- Relevance: LOW
- As Found: Unknown
- ID: T3716
- Name: Merkel Cell Carcinoma
- Relevance: HIGH
- As Found: Merkel Cell Carcinoma
- ID: T3584
- Name: Malignant Mesothelioma
- Relevance: LOW
- As Found: Unknown
- ID: T4091
- Name: Neuroendocrine Tumor
- Relevance: LOW
- As Found: Unknown
- ID: T4092
- Name: Neuroepithelioma
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000015266
- Term: Carcinoma, Merkel Cell
- ID: D000002277
- Term: Carcinoma
- ID: D000002292
- Term: Carcinoma, Renal Cell
- ID: D000008654
- Term: Mesothelioma
- ID: D000077195
- Term: Squamous Cell Carcinoma of Head and Neck
- ID: D000007680
- Term: Kidney Neoplasms
### 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: M349416
- Name: Pembrolizumab
- Relevance: HIGH
- As Found: Mg/m2
- ID: M4225
- Name: Antibodies
- Relevance: LOW
- As Found: Unknown
- ID: M10184
- Name: Immunoglobulins
- 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:** NCT06444802
**Acronym:** LINEMAP
**Brief Title:** Model-informed Precision Dosing for Linezolid
**Official Title:** Model-informed Precision Dosing for Linezolid: a Pilot Randomized Clinical Trial
#### Organization Study ID Info
**ID:** TTU 08.922
#### Organization
**Class:** OTHER
**Full Name:** University of Hamburg-Eppendorf
### Status Module
#### Completion Date
**Date:** 2026-06-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-30
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-02-28
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-09-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Hamburg-Eppendorf
#### Responsible Party
**Investigator Affiliation:** University of Hamburg-Eppendorf
**Investigator Full Name:** Flaminia Olearo
**Investigator Title:** Principal Investigator
**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:** Study Rationale: Previous in vitro and retrospective in vivo studies suggest that optimal linezolid concentrations (between 2 and 7 mg/L) achieve clinical efficacy and microbiological eradication while minimizing side effects like thrombocytopenia and the emergence of resistance. No prospective or randomized clinical trial has confirmed these findings, and there is no consensus on how to adjust linezolid dosing to achieve optimal drug concentrations.
Objectives: The primary objective is to determine if model-informed precision dosing optimizes linezolid dosing to achieve therapeutic trough concentrations compared to a standard dose. Secondary objectives include assessing the PK/PD profile, investigating the prevalence of linezolid resistance among gram-positive bacteria, assessing microbiological resolution of infection, and evaluating the safety and tolerability of linezolid.
Methodology: This study is an open, monocentric pilot randomized controlled trial with two arms: standard dose therapy versus dose adjustment based on model-informed precision dosing using therapeutic drug monitoring and PK/PD targets developed in TMDx software.
Sample Size: 28 patients, 14 in each group. Assumptions are based on only 25% of patients in intensive care achieving the optimal therapeutic range with standard dosing, compared to an expected 80% achieving this with model-informed precision dosing.
Selection Criteria: Adult patients (18+ years) already starting linezolid treatment for gram-positive infections, expected to require treatment beyond the next calendar day. Exclusions include imminent death, expected or confirmed pregnancy, expected linezolid treatment of less than 4 days or more than 4 weeks.
Outcomes: The primary endpoint is defined as the difference in the proportion of patients in the intervention and in the control groups who maintained a trough linezolid concentration of 2 to 7 mg/L on Day 7 and Day 13.
### Conditions Module
**Conditions:**
- Gram-Positive Bacterial Infections
**Keywords:**
- Linezolid
- PK-PD Model
- TDM
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 28
**Type:** ESTIMATED
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Linezolid dosing based on a model-informed precision dosing (TDMx)
**Intervention Names:**
- Drug: Linezolid
**Label:** Linezolid Dosing based on TDMx
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Patient will receive Linezolid at standard dose
**Intervention Names:**
- Drug: Linezolid
**Label:** Standard Linezolid dosing
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Linezolid Dosing based on TDMx
- Standard Linezolid dosing
**Description:** Linezolid dosing will be adapted according to a model informed precision dosing (TDMx)
**Name:** Linezolid
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** The primary endpoint is defined as the likehood in achieving a trough linezolid concentration of 2 to 8 mg/L on Day 7
**Measure:** Through concentration in the target
**Time Frame:** Day 7 of linezolid treatment
#### Secondary Outcomes
**Description:** Percentage of the dosing interval while drug concentration remains above the MIC (f%T \> MIC)
**Measure:** Pharmacokinetic:
**Time Frame:** Day 7 and day 13 of linezolid treatment
**Description:** Median variation of platelets count after the start up to end of linezolid treatment
**Measure:** Thrombocytopenia
**Time Frame:** From the start of linezolid treatment and up to 14 days
**Description:** Frequency of lactic acidosis and peripheral neuropathy
**Measure:** lactic acidosis and peripheral neuropathy
**Time Frame:** From the start of linezolid treatment and up to 14 days
**Description:** Time to microbiologic eradication is calculated as the interval between the first isolation of a Gram-positive pathogen causing the infection and the first negative culture from the same type of biological material
**Measure:** Microbiology
**Time Frame:** From the start of linezolid treatment and up to 14 days
**Description:** Time to development of resistance to linezolid in Gram-positive bacteria is calculated as the interval in days between the first isolation of a specific bacteria species sensitive to linezolid and the first isolation of the same species showing resistance, in any type of biological material.
**Measure:** Microbiology
**Time Frame:** From the start of linezolid treatment and up to 14 days
**Description:** Rate of Relapse of gram-positive infection (growth of the same gram-positive organism in the blood culture or in another primarily site infected up to EOF).
**Measure:** Microbiology
**Time Frame:** At the end of treatment up to the end of 30 day follow-up
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. ≥ 18 years of age
2. Linezolid treatment is indicated or has been started due to pneumonia, skin or soft tissue infection; the patient has received no more than 2 infusions of 600 mg linezolid each
3. with written informed consent of the patient or
4. with written informed consent of his/her legal representative or
5. after using the option of inclusion via spouse according to § 1358 BGB or
6. after application of the independent consultant procedure
7. Patients of childbearing age: negative pregnancy test
Exclusion Criteria:
1. Patients receiving antibiotics active against Gram-positive bacteria at the same time of linezolid
2. Infection other than pneumonia, skin or soft tissue infection, especially tuberculosis, endocarditis and osteomyelitis
3. Death is deemed imminent and inevitable
4. Pregnancy
5. Lactation/breastfeeding
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Flaminia Olearo, MD
**Phone:** 00491738815647
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Dominic Wichmann, Prof
**Role:** CONTACT
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001423
- Term: Bacterial Infections and Mycoses
- ID: D000007239
- Term: Infections
### Condition Browse Module - Browse Branches
- Abbrev: BC01
- Name: Infections
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M4722
- Name: Bacterial Infections
- Relevance: HIGH
- As Found: Bacterial Infections
- ID: M19252
- Name: Gram-Positive Bacterial Infections
- Relevance: HIGH
- As Found: Gram-Positive Bacterial Infections
- 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
### Condition Browse Module - Meshes
- ID: D000001424
- Term: Bacterial Infections
- ID: D000016908
- Term: Gram-Positive Bacterial Infections
### Intervention Browse Module - Ancestors
- ID: D000000900
- Term: Anti-Bacterial Agents
- ID: D000000890
- Term: Anti-Infective 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
### Intervention Browse Module - Browse Leaves
- ID: M400
- Name: Linezolid
- Relevance: HIGH
- As Found: In vivo
- ID: M4222
- Name: Anti-Bacterial Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4214
- Name: Anti-Infective Agents
- Relevance: LOW
- As Found: Unknown
- ID: M7951
- Name: Enzyme Inhibitors
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000069349
- Term: Linezolid
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06444789
**Acronym:** dBM-DEV
**Brief Title:** AI-PROGNOSIS - Digital Biomarkers Development Study (dBM-DEV)
**Official Title:** AI-based Parkinson's Disease Risk Assessment and Prognosis - Digital Biomarkers Development, Validation and Verification Study (AI-PROGNOSIS dBM-DEV Study)
#### Organization Study ID Info
**ID:** RC31/23/0184 - RC31/24/0031
#### Organization
**Class:** OTHER
**Full Name:** University Hospital, Toulouse
### Status Module
#### Completion Date
**Date:** 2025-07-15
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-30
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-07-15
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-15
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** European Union
**Class:** OTHER
**Name:** University Hospital Carl Gustav Carus
**Class:** OTHER
**Name:** Aristotle University Of Thessaloniki
#### Lead Sponsor
**Class:** OTHER
**Name:** University Hospital, Toulouse
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** dBM-dev study is a multicentre low-intervention research study which concerns REM sleep behaviour disorder (RBD) who is the best predictor for neurodegenerative diseases including Parkinson's disease (PD). RBD can only be confirmed by polysomnography, which is a cumbersome procedure. The main objective of this study is to identify a novel, robust dBM for the detection of RBD using smartwatch-based recordings of passive data.The study is conducted step-wise on two subsequent cohorts referred to as the development cohort and the confirmation cohort.
**Detailed Description:** The development cohort comprises 30 patients with RBD and 30 matched controls on sex and age with patients RBD.
The confirmation cohort comprises 30 patients with PD. Following a baseline visit comprising standard clinical evaluation and Parkinson questionnaires, participants will undergo daily-life dBM tracking over a duration of 4 weeks for development cohort and 3 months for confirmation cohort. Additionally, PD patients enrolled in the confirmation cohort will receive a polysomnography which permits to verificate if they have a RBD. The investigation is conducted in four European sites.
### Conditions Module
**Conditions:**
- Parkinson Disease
**Keywords:**
- REM sleep behaviour disorder
### Design Module
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 90
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Detection of RBD signs by using the connected smartwach during 4 weeks
**Intervention Names:**
- Device: connected smartwatch
**Label:** Development cohort of patients with known RBD
#### Arm Group 2
**Description:** Detection of RBD signs by using the connected smartwach during 4 weeks
**Intervention Names:**
- Device: connected smartwatch
**Label:** Development cohort of matched controls = people who don't have RBD age and sex matched
#### Arm Group 3
**Description:** Detection of RBD signs by using the connected smartwach during 3 months
**Intervention Names:**
- Device: connected smartwatch
**Label:** Confirmation cohort of parkinson disease patients = people who are supposed to have RBD
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Confirmation cohort of parkinson disease patients = people who are supposed to have RBD
- Development cohort of matched controls = people who don't have RBD age and sex matched
- Development cohort of patients with known RBD
**Description:** The smartwatch is worn by the patient and data are sent automatically to a server that detects if there are signs of RBD.
**Name:** connected smartwatch
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** the digital biomarker will be identified from passive actigraphy and photoplethysmography data of a separate development cohort
**Measure:** Incidence of nights in a confirmation cohort in which RBD episodes are indicated by a score (digital biomarker) derived from passive actigraphy and photoplethysmography data captured by a smartwatch
**Time Frame:** 4 weeks
#### Secondary Outcomes
**Description:** the digital biomarker will be identified from passive actigraphy and photoplethysmography data of a separate development cohort
**Measure:** Correlation between the incidence of daytime somnolence episodes per week indicated by a score (digital biomarker) derived from passive actigraphy and photoplethysmography data captured by a smartwatch
**Time Frame:** 4 weeks
**Measure:** The score of the Epworth Sleepiness Scale at baseline, measured by the Spearman correlation coefficient, in a confirmation cohort;
**Time Frame:** 3 months
**Measure:** Number of camera-based movement assessments acquired by each participant relative to the number of scheduled camera-based movement assessments.
**Time Frame:** 4 weeks (for development cohort) and 3 months (for confirmation cohort)
**Measure:** Number of cognitive tasks completed by each participant relative to the number of scheduled cognitive tasks.
**Time Frame:** 4 weeks (for development cohort) and 3 months (for confirmation cohort)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria for development cohort:
Group of RBD patients
* Diagnosis of RBD (confirmed by polysomnography)
* Able to use a compatible smartphone with the study app
* Having a care partner with whom they share their bedroom at night
Group of Healthy matched controls:
* Healthy volunteers age and sex matched to the enrolled RBD patients.
* Able to use a compatible smartphone with the study app
* No history of RBD.
Inclusion Criteria for confirmation cohort
* Clinical confirmed diagnosis of PD
* RBD Screening Questionnaire score : 3 - 12 points
* Absence of dementia
* Able to use a compatible smartphone with the study app
* Having a care partner with whom they share their bedroom at night
Exclusion Criteria for all cohorts:
Inability to consent for study procedures as judged by the investigator. Lacking motivation to participate in study procedures as judged by the investigator.
Lack of social security.
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** 1 group of persons with RBD
1 group of persons without RBD
1 group of persons with Parkinson disease
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Nadege ALGANS
**Phone:** 33-561777204
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Anna RIBYCKA
**Phone:** 33-561778252
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Toulouse
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Amel DRIF
- **Role:** CONTACT
***Contact 2:***
- **Name:** Margherita FABBRI
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 3:***
- **Name:** Olivier RASCOL
- **Role:** SUB_INVESTIGATOR
**Country:** France
**Facility:** Neurology Toulouse Hospital
**Location 2:**
**City:** Dresden
**Contacts:**
***Contact 1:***
- **Name:** Björn FALKENBURGER
- **Role:** CONTACT
***Contact 2:***
- **Name:** Björn FALKENBURGER
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Germany
**Facility:** Klinik und Poliklinik für Neurologie of University Hospital (Regulatory autorization pending)
**Location 3:**
**City:** Madrid
**Contacts:**
***Contact 1:***
- **Name:** Monica KURTIS
- **Role:** CONTACT
***Contact 2:***
- **Name:** Monica KURTIS
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Spain
**Facility:** Hospital Ruber Internacional
**Location 4:**
**City:** London
**Contacts:**
***Contact 1:***
- **Name:** Dhaval TRIVEDI
- **Role:** CONTACT
***Contact 2:***
- **Name:** Dhaval TRIVEDI
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United Kingdom
**Facility:** King's college of London (Regulatory authorization pending)
#### Overall Officials
**Official 1:**
**Affiliation:** Toulouse Hospital
**Name:** Margherita FABBRI
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** University Hospital Carl Gustav Carus of Dresden
**Name:** Björn FALKENBURGER
**Role:** STUDY_CHAIR
### References Module
#### See Also Links
**Label:** Related Info
**URL:** https://www.ai-prognosis.eu
## 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: BXM
- Name: Behaviors and Mental Disorders
- 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: M22015
- Name: REM Sleep Behavior Disorder
- Relevance: LOW
- As Found: Unknown
- 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
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06444776
**Acronym:** TASTE
**Brief Title:** Therapy-Associated Saliva and Taste Change Evaluation (TASTE) in Head & Neck Cancer Patients Undergoing Radiotherapy
**Official Title:** Therapy-Associated Saliva and Taste Change Evaluation (TASTE) in Head & Neck Cancer
#### Organization Study ID Info
**ID:** 2022-00706
#### Organization
**Class:** OTHER
**Full Name:** Kantonsspital Aarau
### Status Module
#### Completion Date
**Date:** 2027-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-30
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-10
**Type:** ESTIMATED
#### Start Date
**Date:** 2022-12-19
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-30
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Kantonsspital Aarau
**Class:** OTHER
**Name:** University of Bern
**Class:** OTHER
**Name:** University of Zurich
#### Lead Sponsor
**Class:** OTHER
**Name:** Sonja Stieb, MD
#### Responsible Party
**Investigator Affiliation:** Kantonsspital Aarau
**Investigator Full Name:** Sonja Stieb, MD
**Investigator Title:** Dr. med. Sonja Stieb, MD
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** One of the main side effects of radiation therapy to the head and neck region is altered taste sensation. This causes significant morbidity and has profound effects on the quality of life (QoL) of patients. While radiation-associated toxicities like xerostomia and dysphagia are part of large investigations, data on taste impairment is sparse.
The TASTE study sets out to further our understanding of this common side effect with the goal to prevent radiation-associated taste impairment in future patients.
In this prospective, observational multicenter study 150 head and neck cancer patients undergoing radiation therapy will be recruited. Participants will undergo repetitive (semi-) objective and subjective assessment of their taste, smell and salivary function at specific time points before, during and after radiotherapy. Primary endpoint will be patient-reported taste impairment 12 months post radiation therapy using a standardized quality of life questionnaire (MDASI-HN). Secondary endpoints will include taste impairment measured using taste strips at 12 months and 2 years post radiation therapy. Differences between subgroups (radiation side, chemotherapy, etc.) and changes over time will be assessed while adjusting for confounding factors (e.g. age, sex, smoking history). Based on the aquired data, a normal tissue complication probability model for late radiation-associated taste impairment will be develeoped.
### Conditions Module
**Conditions:**
- Head and Neck Cancer
**Keywords:**
- Head and Neck Cancer
- Radiotherapy
- Taste impairment
- Dysgeusia
- Xerostomia
- Saliva
- Quality of life
### Design Module
#### Bio Spec
**Description:** Saliva
**Retention:** SAMPLES_WITHOUT_DNA
#### Design Info
**Observational Model:** OTHER
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 150
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Diagnostic Test: Repetitive (semi-)objective and subjective taste, smell, and saliva analysis
**Label:** Head and neck cancer patients referred for radiation therapy
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Head and neck cancer patients referred for radiation therapy
**Description:** Study participants will undergo repetitive assessments of their taste, smell and saliva, using quality of life questionnaires, taste strips, sniffin sticks, and analysis of salivary function and composition.
Assessments will be done before treatment, in the 4th week (+/- 1 week) and last week of radiation therapy (+/- 1 week), and at 6 months (+/- 1 months) and 1 and 2 years post-therapy (+/- 3 months).
At the minimum, participants are expected to complete the assessments at baseline and 1 year after the end of radiation therapy. Assessments at all other time points are strongly encouraged but will be optional.
**Name:** Repetitive (semi-)objective and subjective taste, smell, and saliva analysis
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** Patient-reported taste impairment assessed by the MDASI-HN (MD Anderson Symptom Inventory Head and Neck module) questionnaire
**Measure:** Taste impairment
**Time Frame:** 12 months post-treatment
#### Secondary Outcomes
**Description:** Patient-reported taste impairment assessed by the MDASI-HN (MD Anderson Symptom Inventory Head and Neck module) questionnaire
**Measure:** Taste impairment
**Time Frame:** 24 months post-treatment
**Description:** Taste impairment diagnosed using taste strips
**Measure:** Taste impairment
**Time Frame:** 12 and 24 months post-treatment
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Head and neck cancer patients
* Referred for radiation therapy with curative intent, both definitive and post-operative
* Age ≥18
* Karnofsky performance index of at least 50%
* Anticipated mean radiation dose to the taste bud bearing tongue mucosa or at least one of the major salivary glands (parotid, submandibular, and/or sublingual gland) of at the minimum 5 Gy
Exclusion Criteria:
* Pregnancy
* Pre-existing subjective complete loss of taste before start of radiation therapy
* Planning CT and radiation therapy with oral stent or spacer
* Partial or total glossectomy which impairs taste assessments of at least one side of the tongue or impairs contouring of the taste bud bearing tongue mucosa on the planning CT
* Inability to follow instructions related to study procedures or inability to fill in the questionnaires
* Inability to provide informed consent
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Adult head and neck cancer patients referred for radiation therapy with curative intent, both definitive and post-operative
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Sonja Stieb, MD
**Phone:** +41 62 838 4179
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Oliver Riesterer, Prof., MD
**Phone:** +41 62 838 4249
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Aarau
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Sonja Stieb, MD
- **Phone:** +41 62 838 4179
- **Role:** CONTACT
**Country:** Switzerland
**Facility:** Kantonsspital Aarau, Zentrum für Radio-Onkologie KSA-KSB
**State:** Aargau
**Status:** RECRUITING
**Zip:** 5001
**Location 2:**
**City:** Bern
**Country:** Switzerland
**Facility:** Universitätsspital Bern
**Status:** NOT_YET_RECRUITING
**Zip:** 3010
**Location 3:**
**City:** Zürich
**Country:** Switzerland
**Facility:** Universitätsspital Zürich
**Status:** NOT_YET_RECRUITING
**Zip:** 8091
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: All
- Name: All Conditions
- Abbrev: BC07
- Name: Mouth and Tooth Diseases
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
### Condition Browse Module - Browse Leaves
- ID: M9348
- Name: Head and Neck Neoplasms
- Relevance: HIGH
- As Found: Neck Cancer
- ID: M17724
- Name: Xerostomia
- Relevance: LOW
- As Found: Unknown
- ID: M7582
- Name: Dysgeusia
- Relevance: LOW
- As Found: Unknown
- ID: T6034
- Name: Quality of Life
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000006258
- Term: Head and Neck Neoplasms
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06444763
**Brief Title:** Effect of Maolactin™ FMR on Exercise Recovery, Inflammation and Muscle Comfort in an Otherwise Healthy Population
**Official Title:** Effect of Maolactin™ FMR Supplementation on Exercise Recovery, Inflammation, and Muscle Comfort in an Otherwise Healthy Population: A Double-blind Randomized Placebo-controlled Study
#### Organization Study ID Info
**ID:** MAOJOI(B)
#### Organization
**Class:** INDUSTRY
**Full Name:** RDC Clinical Pty Ltd
### Status Module
#### Completion Date
**Date:** 2025-07-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-05
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-04-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-31
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-06-05
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** RDC Clinical Pty Ltd
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** This is a double blind, randomised, placebo-controlled, parallel-group trial to evaluate the effect of Maolactin FMR supplementation on chronic inflammation, mobility and muscle and joint pain in an otherwise healthy population of adults 45-65 years old over 14 weeks with 12 weeks supplementation.
This is PART B of the study.
### Conditions Module
**Conditions:**
- Chronic Inflammation
- Mobility
- Muscle Pain
- Joint Pain
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 100
**Type:** ESTIMATED
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** 2 capsules containing a total of 500 mg/day active proteins taken once daily before the morning meal
**Intervention Names:**
- Drug: Maolactin
**Label:** Maolactin
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** 2 capsules containing maltodextrin (0mg/day active proteins) taken once daily before the morning meal
**Intervention Names:**
- Drug: Maltodextrin
**Label:** Maltodextrin
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Maolactin
**Description:** Once daily dose of 2 capsules containing a total of 500mg/day Maolactin
**Name:** Maolactin
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Maltodextrin
**Description:** Once daily dose of 2 capsules of Maltodextrin containing a total of 0mg/day Maolactin
**Name:** Maltodextrin
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Change in Inflammatory status as assessed by C-reactive protein (CRP) via blood test
**Measure:** Change in Inflammatory status
**Time Frame:** Baseline and Week 12
#### Secondary Outcomes
**Description:** Change in Weight as measured by digital scales
**Measure:** Change in Weight
**Time Frame:** Baseline and Week 12
**Description:** Change in BMI as assessed by digital scale for weight and stadiometer for height
**Measure:** Change in Body Mass Index (BMI)
**Time Frame:** Baseline and Week 12
**Description:** Change in MSK-HQ as self-reported by participants. Scored on a range of 0-56, with a higher score indicating health status.
**Measure:** Change in Musculoskeletal Health Questionnaire (MSK-HQ)
**Time Frame:** Baseline, Week 6 and Week 12
**Description:** Change in VAS Muscle Pain as self-reported by participants. Minimum score = 0, Maximum score = 10. Higher scores indicate a higher level of muscle pain.
**Measure:** Change in Visual Analogue Scale (VAS) Muscle Pain
**Time Frame:** Baseline, Week 6 and Week 12
**Description:** Change in VAS Pain as self-reported by participants. Minimum score = 0, Maximum score = 10. Higher scores indicate a higher level of pain
**Measure:** Change in Visual Analogue Scale (VAS) Pain
**Time Frame:** Baseline, Week 6 and Week 12
**Description:** Change in VAS Fatigue as self-reported by participants. Minimum score = 0, Maximum score = 10. Higher scores indicate a higher level of fatigue.
**Measure:** Change in Visual Analogue Scale (VAS) Fatigue
**Time Frame:** Baseline, Week 6 and Week 12
**Description:** Change in VAS Mobility as self-reported by participants. Minimum score = 0, Maximum score = 10. Higher scores indicate a higher level of mobility.
**Measure:** Change in Visual Analogue Scale (VAS) Mobility
**Time Frame:** Baseline, Week 6 and Week 12
**Description:** Change in VAS Stiffness as self-reported by participants. Minimum score = 0, Maximum score = 10. Higher scores indicate a higher level of stiffness.
**Measure:** Change in Visual Analogue Scale (VAS) Stiffness
**Time Frame:** Baseline, Week 6 and Week 12
**Description:** Change in MFI as self-reported by participants. Comprises 20 questions rated on a 5 point scale. with a higher score indicating a higher level of fatigue.
**Measure:** Change in Multidimensional Fatigue Inventory (MFI)
**Time Frame:** Baseline, Week 6 and Week 12
**Description:** Change in BP as assessed by digital blood pressure monitor
**Measure:** Change in Blood Pressure (BP)
**Time Frame:** Baseline and Week 12
**Description:** Change in HR as assessed by digital heart rate monitor
**Measure:** Change in Heart Rate (HR)
**Time Frame:** Baseline and Week 12
**Description:** Change in Oxygen Saturation as measured by pulse oximeter
**Measure:** Change in Oxygen Saturation
**Time Frame:** Baseline and Week 12
**Description:** Change in Cytokines as measured by blood test
**Measure:** Change in Cytokines
**Time Frame:** Baseline and Week 12
**Description:** Change in MCP-1 as measured by blood test
**Measure:** Change in Monocyte Chemotactic Protein-1 (MCP-1)
**Time Frame:** Baseline and Week 12
**Description:** Change in NF-kB as measured by blood test
**Measure:** Change in Nuclear Factor KappaB (NF-kB)
**Time Frame:** Baseline and Week 12
**Description:** Change in P-selectin as measured by blood test
**Measure:** Change in P-selectin
**Time Frame:** Baseline and Week 12
**Description:** Change in E-selectin as measured by blood test
**Measure:** Change in E-selectin
**Time Frame:** Baseline and Week 12
**Description:** Change in MMP3 as measured by blood test
**Measure:** Change in Matrix Metalloproteinase-3 (MMP3)
**Time Frame:** Baseline and Week 12
**Description:** Change in COMP as measured by blood test
**Measure:** Change in Cartilage Oligomeric Matrix Protein (COMP/thrombospondin-5)
**Time Frame:** Baseline and Week 12
**Description:** Change in CPII as measured by blood test
**Measure:** Change in Type II procollagen (CPII)
**Time Frame:** Baseline and Week 12
**Description:** Change in C2C as measured by blood test
**Measure:** Change in Type II collagen (C2C)
**Time Frame:** Baseline and Week 12
**Description:** Change in CK as measured by blood test
**Measure:** Change in Creatine Kinase (CK)
**Time Frame:** Baseline and Week 12
**Description:** Change in Myoglobin as measured by blood test
**Measure:** Change in Myoglobin
**Time Frame:** Baseline and Week 12
**Description:** Change in FBC as measured by blood test
**Measure:** Change in Full Blood Count (FBC)
**Time Frame:** Baseline and Week 12
**Description:** Change in Platelet agglomeration as measured by blood test
**Measure:** Change in Platelet agglomeration
**Time Frame:** Baseline and Week 12
**Description:** Change in Lp-PLA2 as measured by blood test
**Measure:** Change in Lipoprotein-associated phospholipase A2 (Lp-PLA2)
**Time Frame:** Baseline and Week 12
**Description:** Change in ICAM-1 as measured by blood test
**Measure:** Change in Intercellular Cell Adhesion Molecule-1 (ICAM-1)
**Time Frame:** Baseline and Week 12
**Description:** Change in ICAM-2 as measured by blood test
**Measure:** Change in Intercellular Cell Adhesion Molecule-2 (ICAM-2)
**Time Frame:** Baseline and Week 12
**Description:** Change in VCAM-1 as measured by blood test
**Measure:** Change in Vascular Cell Adhesion Molecule-1 (VCAM-1)
**Time Frame:** Baseline and Week 12
**Description:** Change in VCAM-2 as measured by blood test
**Measure:** Change in Vascular Cell Adhesion Molecule-2 (VCAM-2)
**Time Frame:** Baseline and Week 12
**Description:** Change in PECAM-1 as measured by blood test
**Measure:** Change in Platelet Endothelial Cell Adhesion Molecule-1 (PECAM-1)
**Time Frame:** Baseline and Week 12
**Description:** Change in ESR as measured by blood test
**Measure:** Change in Erythrocyte Sedimentation Rate (ESR)
**Time Frame:** Baseline and Week 12
**Description:** Change in LDH as measured by blood test
**Measure:** Change in Lactate Dehydrogenase (LDH)
**Time Frame:** Baseline and Week 12
**Description:** Change in P38 as measured by blood test
**Measure:** Change in P38 Mitogen-activated Protein Kinases (P38)
**Time Frame:** Baseline and Week 12
**Description:** Change in E/LFT as measured by blood test
**Measure:** Change in Electrolytes and Liver Function Tests (E/LFT)
**Time Frame:** Baseline and Week 12
**Description:** Change in 2 minute walk test as measured by exercise testing
**Measure:** Change in 2 minute walk test
**Time Frame:** Baseline and Week 12
**Description:** Change in sit-to-stand test as measured by exercise testing
**Measure:** Change in sit-to-stand test
**Time Frame:** Baseline and Week 12
**Description:** Change in Hand Grip Strength as measured by dynamometer
**Measure:** Change in Hand Grip Strength
**Time Frame:** Baseline and Week 12
**Description:** Change in Adverse Events self-reported by participants
**Measure:** Change in Adverse Events
**Time Frame:** 12 week period from enrolment to participant conclusion
**Description:** Change in Gastrointestinal Tolerance as measured by Gastrointestinal Tolerance (GIT) Questionnaire
**Measure:** Change in Gastrointestinal Tolerance
**Time Frame:** 1 week after starting product and Week 12
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Adults 45-65 years old
* Generally healthy
* BMI 25.0 - 35.0 kg/m2
* C-reactive protein (CRP) equal to or greater than 2.0 mg/L
* Feel pain or discomfort in joints/muscle for at least 3 months
* Able to provide informed consent
* Agree not to change current diet and/or exercise frequency or intensity during study period
* Agree to not participate in another clinical trial while enrolled in this trial
Exclusion Criteria:
* Serious illness(1) e.g., mood disorders such as depression, anxiety or bipolar disorder, neurological disorders such as MS, kidney disease, liver disease or heart conditions
* Unstable illness(2) e.g., diabetes and thyroid gland dysfunction
* Unstable intake of any medication or supplement(3)
* Acute injuries on reporting area
* Current malignancy (excluding Basal Cell Carcinoma) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years
* Currently taking Coumadin (Warfarin), Heparin, Dalteparin, Enoxaparin or other anticoagulation therapy including low dose aspirin
* Receiving medications known to affect inflammation such as steroids
* Active smokers, nicotine use or drug (prescription or illegal substances) abuse
* Chronic past and/or current alcohol use (\>21 alcoholic drinks per week)
* Pregnant or lactating women
* Allergic to any of the ingredients in active or placebo formula
* Participants who are currently participating in any other clinical trial or who have participated in any other clinical trial during the past 1 month
* Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion
1. A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments.
2. An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity.
3. An unstable intake is any dose that has changed by more than 10% of the previous dose in the past 4-weeks
**Healthy Volunteers:** True
**Maximum Age:** 65 Years
**Minimum Age:** 45 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Amanda Rao, PhD
**Phone:** +61 414 488 559
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** David Briskey, PhD
**Phone:** +61 421 784 077
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Brisbane
**Country:** Australia
**Facility:** RDC Clinical Pty Ltd
**State:** Queensland
**Zip:** 4006
#### Overall Officials
**Official 1:**
**Affiliation:** RDC Clinical Pty Ltd
**Name:** David Briskey, PhD
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010335
- Term: Pathologic Processes
- ID: D000007592
- Term: Joint Diseases
- ID: D000009140
- Term: Musculoskeletal Diseases
- ID: D000010146
- Term: Pain
- ID: D000009461
- Term: Neurologic Manifestations
- ID: D000009135
- Term: Muscular Diseases
- ID: D000009468
- Term: Neuromuscular Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000059352
- Term: Musculoskeletal Pain
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC05
- Name: Musculoskeletal Diseases
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M10293
- Name: Inflammation
- Relevance: HIGH
- As Found: Inflammation
- ID: M20833
- Name: Arthralgia
- Relevance: HIGH
- As Found: Joint Pain
- ID: M30156
- Name: Myalgia
- Relevance: HIGH
- As Found: Muscle Pain
- ID: M13066
- Name: Pain
- 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: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: M12092
- Name: Muscular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12411
- Name: Neuromuscular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M29444
- Name: Musculoskeletal Pain
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000018771
- Term: Arthralgia
- ID: D000063806
- Term: Myalgia
- ID: D000007249
- Term: Inflammation
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06444750
**Acronym:** CURIE
**Brief Title:** Comparison of the Proteome in ICU Patients in Search for TRALI Biomarkers
**Official Title:** Comparison of the Proteome in ICU Patients in Search for TRALI Biomarkers: A Case-control Study
#### Organization Study ID Info
**ID:** CURIE
#### Organization
**Class:** OTHER
**Full Name:** Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
### Status Module
#### Completion Date
**Date:** 2025-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-05
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-09
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-09
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-31
**Study First Submit QC Date:** 2024-06-05
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
#### Responsible Party
**Investigator Affiliation:** Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
**Investigator Full Name:** A.P.J. Vlaar
**Investigator Title:** Head of department of Intensive Care Medicine
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Transfusion-related acute lung injury (TRALI) is a severe complication of blood transfusions. After a transfusion, TRALI develops in 0.08-15% of cases. The incidence of TRALI is 50-100 times higher in critically ill patients compared to the general hospital population. No biomarkers are yet known to detect TRALI. This study will compare blood samples of TRALI patients with blood samples of intensive care patients in order to find possible biomarkers for TRALI.
**Detailed Description:** Background of the study:
Transfusion-related acute lung injury (TRALI) is a severe complication of blood transfusions. After a transfusion, TRALI develops in 0.08-15% of cases. Due to preventive measures the incidence has decreased. However, the incidence of TRALI is 50-100 times higher in critically ill patients compared to the general hospital population. Since the absolute incidence of respiratory transfusion complications is low and TRALI is under-diagnosed and -reported, to this date is has not been possible to elucidate the pathophysiology of TRALI. Consequently, no biomarkers are yet known to detect TRALI. This study aims to gain insight in cellular pathways underlying TRALI development which could enhance transfusion safety.
Objective of the study:
* To investigate the proteome in TRALI patients and thus gain knowledge on TRALI pathophysiology. This knowledge can be used to investigate preventive measures and therapy for TRALI.
* To identify biomarkers specific for TRALI, thus aiding in future diagnostics of TRALI.
Study design:
Case-control study. Samples available from known TRALI patients stored at Sanquin Blood Bank will be compared to samples from intensive care patients with acute respiratory distress syndrome (ARDS) or pneumonia.
We will screen ICU patients for eligibility for one of our groups and ask for informed consent. After obtaining informed consent, patients depending on whether they need a transfusion. After admission and informed consent we will collect remaining blood samples from the clinical laboratory within 24 hours of arrival.
Additionally, extra blood samples (40mL) will be drawn from patients within 24 hours of arrival.
For Group 1 (patients who receive a transfusion but do not have lung injury), Group 2 (patients who receive a transfusion and have ARDS), and Group 3 (patients who receive a transfusion with local lung injury) a second tube blood sample (30mL) will be drawn 12 hours after the first transfusion. We will collect two samples for this group to analyze the effect of transfusion on the proteome
Study population:
Adult intensive care patient who are admitted with:
- pneumonia, indirect lung injury or no pulmonary injury Healthy volunteers.
Primary study parameters/outcome of the study:
The main aim of this research is to use proteomics to study protein profiles and identify biomarkers that correlate with TRALI.
Secundary study parameters/outcome of the study (if applicable):
The secondary outcomes of this research will be CD34 cultured neutrophils and T cell subsets. Furthermore, we will study the effect of transfusion on the patient's proteome.
### Conditions Module
**Conditions:**
- Transfusion-Related Acute Lung Injury
- ARDS, Human
**Keywords:**
- Transfusion-Related Acute Lung Injury
- Proteomics
- Intensive Care Unit
- Critical Ill patients
### Design Module
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 210
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** ICU patients who receive a transfusion and without lung injury. This will give an overview of the proteome of critical ill patients who received a transfusion but without lung injury. This way specific proteome changes caused by transfusion can be identified
**Intervention Names:**
- Other: Blood sample collection
**Label:** ICU patients without lung injury with transfusion
#### Arm Group 2
**Description:** ICU patients who receive a transfusion and have ARDS caused by indirect lung injury (e.g. pancreatitis, trauma, non-pulmonary sepsis). This will give an overview of the proteome of critical ill patients who receive a transfusion and have lung injury not caused by TRALI.
**Intervention Names:**
- Other: Blood sample collection
**Label:** ICU patients with ARDS (indirect) with transfusion
#### Arm Group 3
**Description:** ICU patients who receive a transfusion and have infectious lung injury (locally). This will give an overview of the proteome of patients with local lung injury.
**Intervention Names:**
- Other: Blood sample collection
**Label:** ICU patients with pneumonia with transfusion
#### Arm Group 4
**Description:** ICU patients without transfusion and with ARDS caused by indirect lung injury. This will give an overview of the proteome of ICU patients with a systemic cause of lung injury. Proteins that are specifically involved in a systemic reaction can be identified.
**Intervention Names:**
- Other: Blood sample collection
**Label:** ICU patients with ARDS (indirect) without transfusion
#### Arm Group 5
**Description:** ICU patients without transfusion and with infectious pneumonia. This will give an overview of proteins involved in local lung injury.
**Intervention Names:**
- Other: Blood sample collection
**Label:** ICU patients with pneumonia without transfusion
#### Arm Group 6
**Description:** Healthy volunteers.
**Intervention Names:**
- Other: Blood sample collection
**Label:** Healthy volunteers
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Healthy volunteers
- ICU patients with ARDS (indirect) with transfusion
- ICU patients with ARDS (indirect) without transfusion
- ICU patients with pneumonia with transfusion
- ICU patients with pneumonia without transfusion
- ICU patients without lung injury with transfusion
**Description:** Blood sample collection of maximum 70 ml
**Name:** Blood sample collection
**Other Names:**
- Blood draw
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The main aim of this research is to use proteomics to study protein profiles and identify biomarkers that correlate with TRALI.
**Measure:** Biomarkers for TRALI
**Time Frame:** Within 24 hours of ICU admission
#### Secondary Outcomes
**Description:** The secondary outcomes of this research will be CD34 cultured neutrophils and T cell subsets. Furthermore, we will study the effect of transfusion on the patient's proteome.
**Measure:** CD34 cultured neutrophils and T cell subsets
**Time Frame:** Within 24 hours of ICU admission
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
Patients on the ICU:
* Without lung injury who received a red blood cell or platelet transfusion. We exclude plasma transfusion as 1) the incidence of TRALI after plasma transfusion has decreased after introduction of Omniplasma and 2) most reported TRALI cases are induced by red blood cell and platelet transfusion as these transfusions are most frequently administered (36, 37). We thus expect improved comparability with the samples already collected at Sanquin with:
* Non-lung infection induced ARDS with and without a blood transfusion;
* Pneumonia, without a blood transfusion.
Exclusion Criteria:
1. Patients with "objection to registration of data for scientific use" as noted in the patient file.
2. Patients in whom it is impossible to obtain blood samples.
3. Patients with massive haemorrhage.
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** ARDS patients, pneumonia patients, patients without lung injury admitted to the adult intensive care who do or do not receive a blood transfusion, and healthy volunteers.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Isabella Viegen, Bsc
**Phone:** +31 20 566 3311
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Anna-Linda Peters, MD/PhD
**Phone:** +31 20-566 9111
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Amsterdam UMC
**Name:** Alexander Vlaar, Professor
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000008171
- Term: Lung Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
- ID: D000013898
- Term: Thoracic Injuries
- ID: D000014947
- Term: Wounds and Injuries
- ID: D000012120
- Term: Respiration Disorders
- ID: D000065227
- Term: Transfusion Reaction
- ID: D000006402
- Term: Hematologic Diseases
- ID: D000007154
- Term: Immune System Diseases
### 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: BC15
- Name: Blood and Lymph Conditions
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: BC16
- Name: Diseases and Abnormalities at or Before Birth
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M28143
- Name: Lung Injury
- Relevance: HIGH
- As Found: Lung Injury
- ID: M28144
- Name: Acute Lung Injury
- Relevance: HIGH
- As Found: Acute Lung Injury
- ID: M1199
- Name: Transfusion-Related Acute Lung Injury
- Relevance: HIGH
- As Found: Transfusion-Related Acute Lung Injury
- ID: M14965
- Name: Respiratory Distress Syndrome
- Relevance: HIGH
- As Found: ARDS, Human
- ID: M14964
- Name: Respiratory Distress Syndrome, Newborn
- Relevance: LOW
- As Found: Unknown
- ID: M16355
- Name: Syndrome
- 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: M16657
- Name: Thoracic Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M17685
- Name: Wounds and Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M14957
- Name: Respiration Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M30490
- Name: Transfusion Reaction
- Relevance: LOW
- As Found: Unknown
- ID: M9490
- Name: Hematologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T192
- Name: Acute Respiratory Distress Syndrome
- Relevance: HIGH
- As Found: Acute Lung Injury
- ID: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
- ID: T4927
- Name: Respiratory Distress Syndrome, Infant
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000055370
- Term: Lung Injury
- ID: D000055371
- Term: Acute Lung Injury
- ID: D000012128
- Term: Respiratory Distress Syndrome
- ID: D000073617
- Term: Transfusion-Related Acute Lung Injury
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06444737
**Acronym:** OPDPH
**Brief Title:** Contribution of Ondansetron to Preventing Post-Dural Puncture Headaches Following Spinal Anesthesia
**Official Title:** Contribution of Ondansetron to Preventing Post-Dural Puncture Headaches Following Spinal Anesthesia for Cesarean Sections : A Randomized Controlled Trial
#### Organization Study ID Info
**ID:** ondansetron effect on PDPH
#### Organization
**Class:** OTHER
**Full Name:** Mongi Slim Hospital
### Status Module
#### Completion Date
**Date:** 2024-08-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-05
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-06-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-11-30
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-06-05
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Mongi Slim Hospital
#### Responsible Party
**Investigator Affiliation:** Mongi Slim Hospital
**Investigator Full Name:** Mhamed Sami Mebazaa
**Investigator Title:** Professor head of anesthesiology and ICU department
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** A prospective, bicentric, randomized, double-blind controlled study including parturients scheduled for elective caesarean delivery under spinal anaesthesia and randomized and assigned to one of the two groups:
Group O ondansetron : receiving Intravenous (IV) ondansetron 0.10 mg/ kg diluted in 5 ml normal saline, 5 min before spinal anesthesia Group C control : receiving IV normal saline 5 ml (control group) 5 min before spinal anesthesia
OBJECTIVE :
To evaluate the efficacy of ondansetron in preventing post-dural puncture headache after spinal anaesthesia for caesarean section.
**Detailed Description:** Spinal anesthesia is the most common anesthetic technique used for Caesarean sections. However, it is not denied from complications.
Post-dural puncture headache is a major complication of spinal anesthesia, with an incidence ranging from 1.5% to 36%.
OBJECTIVE :
To evaluate the efficacy of ondansetron in preventing post-dural puncture headache after spinal anaesthesia for caesarean section.
the investigators conducted a prospective, bicentric, randomized, double-blind controlled study over a period of 07 months from November 2023 to june 2024.
the investigators included in the study all parturients:
* Aged between 18-45 years
* ASA 2
* Between 37 and 41 weeks of gestation
* scheduled for elective caesarean delivery under spinal anaesthesia
* To be delivered by unscheduled caesarean section whose indication does not involve a vital maternal or fetal emergency, according to the Lucas' classification.
The eligible parturients were randomly assigned to two groups through block randomization using computerized random numbers.
were assigned to one of the two parallel groups to receive either :
* Intravenous (IV) ondansetron 0.10 mg/ kg diluted in 5 ml normal saline, 5 min before spinal anesthesia : Group O (Ondansetron)
* Or IV normal saline 5 ml (control group) 5 min before spinal anesthesia : Group C (control)
### Conditions Module
**Conditions:**
- Post-Dural Puncture Headache
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** TRIPLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- OUTCOMES_ASSESSOR
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 300
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Group ondansetron : parturients receiving intravenous (IV) ondansetron 0.10 mg/ kg diluted in 5 ml normal saline, 5 min before spinal anesthesia
**Intervention Names:**
- Drug: Intravenous ondansetron
**Label:** Group O
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Group control : receiving IV normal saline 5 ml (control group) 5 min before spinal anesthesia
**Intervention Names:**
- Drug: Intravenous normal saline
**Label:** Group C
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Group O
**Description:** Intravenous (IV) ondansetron 0.10 mg/ kg diluted in 5 ml normal saline, 5 min before spinal anesthesia
**Name:** Intravenous ondansetron
**Other Names:**
- ondansetron
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Group C
**Description:** Intravenous normal saline 5 ml (control group) 5 min before spinal anesthesia
**Name:** Intravenous normal saline
**Other Names:**
- Placebo
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** the occurrence of positional headaches at any time postoperatively
**Measure:** Incidence of post-dural punction headache (PDPH) during the first seven postoperative days.
**Time Frame:** 7 days
#### Secondary Outcomes
**Description:** on postoperatively
**Measure:** day of PDPH's occurence
**Time Frame:** 7 days
**Description:** on postoperatively
**Measure:** day of PDPH's resolution
**Time Frame:** 7 days
**Description:** assessed by the numerical pain scale from 0 to 10 (0 being no pain and 10 being the maximum unimaginable pain).
**Measure:** Headache severity
**Time Frame:** 7 days
**Description:** paracetamol or NSAIDs
**Measure:** Need for analgesic treatment due to headaches
**Time Frame:** 7 days
**Description:** need of treatement
**Measure:** Occurrence of post-operative nausea and/or vomiting
**Time Frame:** 7 days
**Description:** Mean arterial pressure during hospitalization
**Measure:** Mean arterial pressure in mmgh
**Time Frame:** 3 days
**Description:** Mean arterial pressure during hospitalization
**Measure:** heart rate
**Time Frame:** 3 days
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Aged between 18-45 years
* ASA 2
* Between 37 and 41 weeks of gestation
* scheduled for elective caesarean delivery under spinal anaesthesia
* To be delivered by unscheduled caesarean section whose indication does not involve a vital maternal or fetal emergency, according to the Lucas' classification
Exclusion Criteria:
* All patients who required :
* more than two attempts for spinal anaesthesia
* conversion to general anesthesia following failure of spinal anesthesia (defined as a sensory block level \<T6) or an intraoperative complication (such as hemorrhage or anaphylactic shock).
As well as patients who have subsequently withdrawn their consent for participating to our study.
**Gender Based:** True
**Gender Description:** parturients scheduled for elective caesarean delivery under spinal anaesthesia
**Maximum Age:** 45 Years
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Mhamed Sami Mebazaa, professor
**Phone:** 22252589
**Phone Ext:** 00216
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Amani Ben Haj Youssef, assistant
**Phone:** 96874336
**Phone Ext:** 00216
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Tunis
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Mhamed sami Mebazaa, professor
- **Phone:** 22252589
- **Phone Ext:** 00216
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Amani Ben haj Youssef, assistant
- **Phone:** 96874336
- **Phone Ext:** 00216
- **Role:** CONTACT
**Country:** Tunisia
**Facility:** Mongi slim hospital
**Status:** RECRUITING
**Zip:** 2085
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010146
- Term: Pain
- ID: D000009461
- Term: Neurologic Manifestations
- ID: D000051271
- Term: Headache Disorders, Secondary
- ID: D000020773
- Term: Headache Disorders
- ID: D000001927
- Term: Brain Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC04
- Name: Neoplasms
### Condition Browse Module - Browse Leaves
- ID: M9351
- Name: Headache
- Relevance: HIGH
- As Found: Headache
- ID: M26670
- Name: Post-Dural Puncture Headache
- Relevance: HIGH
- As Found: Post-Dural Puncture Headache
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: M22529
- Name: Headache Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M12307
- Name: Neoplasm Metastasis
- Relevance: LOW
- As Found: Unknown
- ID: M26658
- Name: Headache Disorders, Secondary
- Relevance: LOW
- As Found: Unknown
- ID: M5204
- Name: Brain Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000051299
- Term: Post-Dural Puncture Headache
- ID: D000006261
- Term: Headache
### Intervention Browse Module - Ancestors
- ID: D000000932
- Term: Antiemetics
- ID: D000001337
- Term: Autonomic Agents
- ID: D000018373
- Term: Peripheral Nervous System Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000005765
- Term: Gastrointestinal Agents
- ID: D000000982
- Term: Antipruritics
- ID: D000003879
- Term: Dermatologic Agents
- ID: D000058831
- Term: Serotonin 5-HT3 Receptor Antagonists
- ID: D000012702
- Term: Serotonin Antagonists
- ID: D000018490
- Term: Serotonin Agents
- ID: D000018377
- Term: Neurotransmitter Agents
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
### Intervention Browse Module - Browse Branches
- Abbrev: AnEm
- Name: Antiemetics
- Abbrev: Derm
- Name: Dermatologic Agents
- Abbrev: Gast
- Name: Gastrointestinal Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
### Intervention Browse Module - Browse Leaves
- ID: M19588
- Name: Ondansetron
- Relevance: HIGH
- As Found: Mental health
- ID: M4107
- Name: Anesthetics
- Relevance: LOW
- As Found: Unknown
- ID: M4251
- Name: Antiemetics
- Relevance: LOW
- As Found: Unknown
- ID: M8881
- Name: Gastrointestinal Agents
- Relevance: LOW
- As Found: Unknown
- ID: M7074
- Name: Dermatologic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M15512
- Name: Serotonin
- Relevance: LOW
- As Found: Unknown
- ID: M29246
- Name: Serotonin 5-HT3 Receptor Antagonists
- Relevance: LOW
- As Found: Unknown
- ID: M20504
- Name: Neurotransmitter Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000017294
- Term: Ondansetron
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06444711
**Acronym:** OPTIMISE
**Brief Title:** OPTIMISation of Cardio-renal-metabolic-pulmonary Disease Guideline Adherence in High Risk Community Dwelling Individuals
**Official Title:** A Randomised Clinical Trial for OPTIMISation of Cardio-renal-metabolic-pulmonary Disease Guideline Adherence in High Risk Community Dwelling Individuals and Evaluation of Outcomes
#### Organization Study ID Info
**ID:** 343919
#### Organization
**Class:** OTHER
**Full Name:** University of Leeds
### Status Module
#### Completion Date
**Date:** 2045-04
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-05
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-04
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-06-05
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Leeds
#### Responsible Party
**Investigator Affiliation:** University of Leeds
**Investigator Full Name:** Dr Christopher Gale
**Investigator Title:** Professor of Cardiovascular Medicine
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Cardiovascular disease (CVD) causes a quarter of all deaths in the United Kingdom (UK). This is the single biggest area where the National Health Service (NHS) can save lives by detecting and treating risk factors early.
Improvements in control of blood pressure, cholesterol, diabetes, kidney disease, as well as weight loss in individuals who are obese, have been shown to reduce the risk of CVD and death. The NHS has guidelines for investigations and treatments for risk factors recommended by the National Institute for Health and Care Excellence (NICE).
Though it is known that better control of risk factors will reduce the risk of CVD the investigators do not know whether having extra appointments in primary care with heart specialists can lead to better treatment and better control of risk factors.
The OPTIMISE trial (OPTIMISation of Cardio-renal-metabolic-pulmonary Disease Guideline Adherence in High Risk Community Dwelling Individuals) will compare patients who have consultations at a local General Practitioner (GP) practice by a cardiology professional to optimise the treatment of their risk factors (OPTIMISE) with those patients who receive standard care (Standard care). Standard care is patients being seen by their GP at routine care appointments.
Participants in the OPTIMISE arm will be reviewed by the cardiology professional and recommended treatment in line with current NICE guidance. They will be seen at 3 months to review their treatment and potentially adjusted to ensure it meets NICE guidelines.
Participants in the standard arm will have data related to their cardiovascular, renal, metabolic and pulmonary risk factors collected through their Electronic Health Record (EHR).
At 6 months, all participants will be seen to find out changes to their prescribed medication and the effect of this on their blood pressure, cholesterol, blood sugar level, and body mass index (BMI).
All participants will also complete a quality of life questionnaire prior to randomisation study and at 6 months to identify any differences between the arms and time points.
**Detailed Description:** Cardiovascular disease (CVD) causes a quarter of all deaths in the UK and is the largest cause of premature mortality in deprived areas. The National Health Service (NHS) Long Term Plan emphasises that this is the single biggest area where the NHS can save lives and that better detection and treatment of cardiovascular, renal, metabolic and pulmonary risk factors is a priority.
Treatment of blood pressure, cholesterol, diabetes, kidney disease, as well as weight loss in individuals who are obese, have been shown in randomised clinical trials (RCT) to reduce the risk of CVD and cardiovascular death.
Many risk factors for patients with CVD do not occur in isolation, but often co-exist in clusters and increase the risk of other risk factors such as obesity, high blood pressure and diabetes.
In the NHS CVD risk factors identification and improvement is through contact with a healthcare professional in primary care. It is from primary care that the prescription of medications and monitoring to control cardio-renal-metabolic-pulmonary risk factors is delivered.
Research has demonstrated that, especially during the Coronavirus disease 2019 (COVID-19) pandemic, the management of cardio-renal-metabolic-pulmonary risk factors, through monitoring of observations and blood tests and prescription of medications, deteriorated. That is, patients in the community may not be receiving the full extent of NICE guideline directed care and prescriptions of medications for cardiovascular, renal, metabolic and pulmonary risk factors to reduce their risk of future cardiovascular events like heart attack, stroke and death.
The investigator's research has demonstrated that individuals identified as at higher predicted risk of Atrial Fibrillation (AF) are also at increased risk of other conditions such as chronic kidney disease, heart failure, diabetes mellitus, stroke/transient ischaemic attack, myocardial infarction and peripheral vascular disease. The investigators have also shown in their study Future Innovations in Novel Detection of Atrial Fibrillation (FIND AF) that high FIND-AF predicted risk individuals are also at higher risk of death, the majority of which are of cardiovascular cause during 10 years of follow up. Accordingly, individuals at higher FIND-AF predicted risk may have comorbidities and cardiovascular risk factors that are undiagnosed or under-treated during routine practice that may be potential targets for guideline directed treatment to reduce the risk of future adverse events.
The study will take advantage of the FIND AF Primary Care network and processes by recruiting from the FIND AF participants who have already been identified as having a high FIND AF predicted risk score. OPTIMISE (OPTIMISation of Cardio-renal-metabolic-pulmonary Disease Guideline Adherence in High Risk Community Dwelling Individuals) will compare General Practitioner (GP) based clinic appointments with a cardiovascular healthcare professional compared to usual care on therapeutic interventions for cardio-renal-metabolic-pulmonary disease and risk factors. It will determine the effect of the differing approaches over a follow up of six months to find out if GP based clinic appointments with a cardiovascular healthcare provides better outcomes for patients than standard care.
OPTIMISE is a multicentre pragmatic prospective randomised open-label blinded-endpoint strategy trial (PROBE).
Eligible patients will have consented to take part in the FIND AF pilot study and be assessed as at high risk of developing Atrial Fibrillation in the next 6 months by the FIND AF algorithm.
For patients who have consented to the optional follow up visit for the FIND AF pilot study, prior to their visit they will be posted the OPTIMISE patient information sheet. At the visit the patient will have the opportunity to ask questions, provide consent and complete a questionnaire. They will then undergo randomisation into either the standard care arm or the Optimisation arm. The aim is to recruit 1:1 between the two arms. If the participant is randomised to the Optimisation arm, the patient will undergo the Optimise baseline appointment at the same time as the FIND AF pilot study optional visit. Combining the visits will reduce the overall time required by the participant as it will avoid duplication of any clinical observations.
For patients who have consented to further contact from the research team and have either already undergone the FIND AF pilot study optional visit or have declined to attend the visit, they will be sent the patient information sheet, consent, questionnaire and a reply paid envelope. They will be supplied with the study team's contact information so if they have any questions they can contact the team. Upon receipt of the consent and questionnaire, the study team will randomise the participant. The study team will then contact the participant with the results of the randomisation and if the patient has been randomised to the Optimisation arm, arrange the baseline appointment.
It will be clearly stated that the participant has the right to refuse participation without giving a reason and can withdraw from the study at any time without prejudicing their further treatment or their legal rights. The participant will be allowed as much time as wished to consider the information, and the opportunity to question the research team, their GP, or family and friends to decide whether they will participate in the study.
For the baseline assessment, the research team cardiology doctor will review the data stored in the participant's GP records with relation to previous cardiovascular disease, hypertension, dyslipidaemia, chronic kidney disease, diabetes, Body Mass Index (BMI), Chronic obstructive pulmonary disease (COPD) and smoking history. At the baseline appointment they will conduct observations and blood tests that are recommended in National Institute for Health and Care Excellence (NICE) guidance if the results are not already available in the GP medical records. They will also carry out an ambulatory lung test (to screen for risk of pulmonary diseases).
For patients in the Optimisation arm, the research team cardiology doctor will recommend changes to treatment if the treatment the patient is currently on does not adhere to NICE guidelines. The research team will not directly initiate treatment, but will provide a letter and verbal communication with the participant's GP of the recommendations.
Patients in the standard arm will have consented to their data being reviewed in their GP's record as per the Optimisation arm however they will not undergo an appointment with the research team cardiology doctor and no recommendations for changes to treatment will be identified.
For patients in the Optimisation arm, at three months following their baseline appointment, they will attend their second visit and undergo the same tests as at the baseline appointment and again, will recommend changes in line with NICE guidance.
At six months both participants in the Optimisation arm and the standard arm will have their observations (e.g. blood pressure, BMI) and an ambulatory lung test taken during an appointment by a research team suitably qualified health professional, as well as any blood tests that are indicated by the patient's known comorbidities (e.g. HBA1c if known to have diabetes), as well as completing a patient-reported outcome measure (EQ-5D-5L).
All visits will take place at the participant's primary care site.
An endpoint adjudication committee, blinded to allocation, will review observations, laboratory measures and GP medical records data for the participant to establish adherence of care to guidelines.
### Conditions Module
**Conditions:**
- Cardiovascular Diseases
- Renal Disease
- Metabolic Disease
- Pulmonary Disease
**Keywords:**
- Cardiology
- Atrial Fibrillation
- Renal disease
- Metabolic disease
- Pulmonary disease
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Multicentre pragmatic prospective randomised open-label blinded-endpoint strategy trial (PROBE).
##### Masking Info
**Masking:** SINGLE
**Masking Description:** An endpoint adjudication committee, blinded to allocation, will review observations, laboratory measures and GP medical records data for the participant to establish adherence of care to guidelines.
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 138
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The participant will complete a questionnaire (EQ-5D-5L) at both baseline and six months. Their baseline information will be collected from their electronic health records. They will be advised to see their GP as part of their routine care. At six months they will attend a visit where their clinical observations will be recorded.
**Label:** Standard care
**Type:** NO_INTERVENTION
#### Arm Group 2
**Description:** Participants in the intervention arm will attend a baseline visit and two further research appointments at three months and six months from time of randomisation, For baseline assessment, the research cardiology doctor will review the participant's GP records with relation to previous cardiovascular disease, hypertension, dyslipidaemia, chronic kidney disease, diabetes, BMI, COPD and smoking history. They will conduct observations and blood tests that are recommended in NICE guidance if the results are not already available. They will carry out an ambulatory lung test (to screen for risk of pulmonary diseases). They will recommend changes to treatment if the treatment the patient is currently on does not adhere to guidelines. The research team will provide a letter and verbal communication with the participant's GP of the recommendations. For the second visit at three months after randomisation, the research team doctor will conduct the same review as undertaken at the first visit.
**Intervention Names:**
- Other: NICE guidance
**Label:** Optimisation arm
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Optimisation arm
**Description:** Patients will be assessed to determine whether their current treatment is in line with NICE guidelines. Changes will be made to their treatment plan in order for them to comply with NICE guidelines with the aim of reducing the number of serious adverse events in the group. They will be followed up until 6 months to identify improvements in their conditions
**Name:** NICE guidance
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The proportion of patients with any of the following therapeutic intervention to optimise cardio-renal-metabolic-pulmonary risk factor management including initiation or increase in dose regimen of:
* Angiotensin converting enzyme inhibitor / angiotensin 2 receptor blocker
* Calcium channel blocker / thiazide-like diuretic / spironolactone / alpha blocker / beta blocker
* SGLT2 inhibitor
* Glucagon-like peptide (GLP) -1 receptor agonist
* Metformin / Dipeptidyl peptidase 4 (DPP4) inhibitor / pioglitazone / sulphonylurea / insulin
* Statin / ezetimibe / icosapent ethyl / bempedoic acid / PCSK9 inhibitor
* Orlistat
* Nicotine replacement therapy / bupropion
* Inhaler therapy
**Measure:** The proportion of patients with any of the following therapeutic intervention to optimise cardio-renal-metabolic-pulmonary risk factor management
**Time Frame:** 6 months
#### Secondary Outcomes
**Description:** The proportion of participants who have experienced any of the individual components of primary endpoint
**Measure:** Components of primary endpoint
**Time Frame:** 6 months
**Description:** The median time to primary endpoint from randomisation reported in days
**Measure:** Time to primary endpoint
**Time Frame:** 6 months
**Description:** Number of patients receiving a diagnosis of new cardio-renal-metabolic-pulmonary risk factor (hypertension, diabetes, chronic kidney disease, obesity, current smoking, COPD) between randomisation and six months.
**Measure:** Number of participants developing a new cardio-renal-metabolic-pulmonary risk factor
**Time Frame:** 6 months
**Description:** Time to diagnosis of a new cardio-renal-metabolic-pulmonary risk factor
**Measure:** Time to diagnosis of a new cardio-renal-metabolic-pulmonary risk factor
**Time Frame:** 6 months
**Description:** Number of participants with a new uptake of guideline directed risk factor management in those with recorded cardio-renal-metabolic-pulmonary risk factors (hypertension, lipid modification, diabetes, chronic kidney disease, obesity, current smoking, COPD), between randomisation and six months
**Measure:** Number of participants with a new uptake of guideline directed risk factor management
**Time Frame:** 6 months
**Description:** A comparison of the two arms of the change in EuroQol five dimensional descriptive system (EQ-5D-5L) questionnaire score between randomisation and six months follow-up with a large change indicating a better outcome. Analysis will be carried out as per the EuroQoL guidance and will incorporate both questions and scale participant responses.
**Measure:** Change in EuroQol five dimensional descriptive system (EQ-5D-5L) questionnaire score
**Time Frame:** 6 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Consented participants in the FIND-AF study
* Higher predicted FIND-AF risk according to the FIND-AF score
Exclusion Criteria:
* Unable to give written informed consent for participation in the study
* Unable to adhere to the study requirements
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Chris Gale
**Phone:** 07779413379
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Catherine Reynolds
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** University of Leeds
**Name:** Chris P. Gale
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** University of Leeds
**Name:** Ramesh Nadarajah
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
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**PMID:** 30165516
**Citation:** Marx N, Federici M, Schutt K, Muller-Wieland D, Ajjan RA, Antunes MJ, Christodorescu RM, Crawford C, Di Angelantonio E, Eliasson B, Espinola-Klein C, Fauchier L, Halle M, Herrington WG, Kautzky-Willer A, Lambrinou E, Lesiak M, Lettino M, McGuire DK, Mullens W, Rocca B, Sattar N; ESC Scientific Document Group. 2023 ESC Guidelines for the management of cardiovascular disease in patients with diabetes. Eur Heart J. 2023 Oct 14;44(39):4043-4140. doi: 10.1093/eurheartj/ehad192. No abstract available. Erratum In: Eur Heart J. 2023 Dec 21;44(48):5060. Eur Heart J. 2024 Feb 16;45(7):518.
**PMID:** 37622663
**Citation:** Visseren FLJ, Mach F, Smulders YM, Carballo D, Koskinas KC, Back M, Benetos A, Biffi A, Boavida JM, Capodanno D, Cosyns B, Crawford C, Davos CH, Desormais I, Di Angelantonio E, Franco OH, Halvorsen S, Hobbs FDR, Hollander M, Jankowska EA, Michal M, Sacco S, Sattar N, Tokgozoglu L, Tonstad S, Tsioufis KP, van Dis I, van Gelder IC, Wanner C, Williams B; ESC Scientific Document Group. 2021 ESC Guidelines on cardiovascular disease prevention in clinical practice. Eur J Prev Cardiol. 2022 Feb 19;29(1):5-115. doi: 10.1093/eurjpc/zwab154. No abstract available.
**PMID:** 34558602
**Citation:** Ortiz A, Wanner C, Gansevoort R; ERA Council. Chronic kidney disease as cardiovascular risk factor in routine clinical practice: a position statement by the Council of the European Renal Association. Eur J Prev Cardiol. 2022 Dec 7;29(17):2211-2215. doi: 10.1093/eurjpc/zwac186.
**PMID:** 35997796
**Citation:** Zelniker TA, Wiviott SD, Raz I, Im K, Goodrich EL, Bonaca MP, Mosenzon O, Kato ET, Cahn A, Furtado RHM, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Sabatine MS. SGLT2 inhibitors for primary and secondary prevention of cardiovascular and renal outcomes in type 2 diabetes: a systematic review and meta-analysis of cardiovascular outcome trials. Lancet. 2019 Jan 5;393(10166):31-39. doi: 10.1016/S0140-6736(18)32590-X. Epub 2018 Nov 10. Erratum In: Lancet. 2019 Jan 5;393(10166):30.
**PMID:** 30424892
**Citation:** Yumuk V, Tsigos C, Fried M, Schindler K, Busetto L, Micic D, Toplak H; Obesity Management Task Force of the European Association for the Study of Obesity. European Guidelines for Obesity Management in Adults. Obes Facts. 2015;8(6):402-24. doi: 10.1159/000442721. Epub 2015 Dec 5. Erratum In: Obes Facts. 2016;9(1):64.
**PMID:** 26641646
**Citation:** Dale CE, Takhar R, Carragher R, Katsoulis M, Torabi F, Duffield S, Kent S, Mueller T, Kurdi A, Le Anh TN, McTaggart S, Abbasizanjani H, Hollings S, Scourfield A, Lyons RA, Griffiths R, Lyons J, Davies G, Harris D, Handy A, Mizani MA, Tomlinson C, Thygesen JH, Ashworth M, Denaxas S, Banerjee A, Sterne JAC, Brown P, Bullard I, Priedon R, Mamas MA, Slee A, Lorgelly P, Pirmohamed M, Khunti K, Morris AD, Sudlow C, Akbari A, Bennie M, Sattar N, Sofat R; CVD-COVID-UK Consortium. The impact of the COVID-19 pandemic on cardiovascular disease prevention and management. Nat Med. 2023 Jan;29(1):219-225. doi: 10.1038/s41591-022-02158-7. Epub 2023 Jan 19.
**PMID:** 36658423
**Citation:** Herrett E, Gallagher AM, Bhaskaran K, Forbes H, Mathur R, van Staa T, Smeeth L. Data Resource Profile: Clinical Practice Research Datalink (CPRD). Int J Epidemiol. 2015 Jun;44(3):827-36. doi: 10.1093/ije/dyv098. Epub 2015 Jun 6.
**PMID:** 26050254
**Citation:** Nadarajah R, Wu J, Hogg D, Raveendra K, Nakao YM, Nakao K, Arbel R, Haim M, Zahger D, Parry J, Bates C, Cowan C, Gale CP. Prediction of short-term atrial fibrillation risk using primary care electronic health records. Heart. 2023 Jun 26;109(14):1072-1079. doi: 10.1136/heartjnl-2022-322076.
**PMID:** 36759177
**Citation:** Odutayo A, Wong CX, Hsiao AJ, Hopewell S, Altman DG, Emdin CA. Atrial fibrillation and risks of cardiovascular disease, renal disease, and death: systematic review and meta-analysis. BMJ. 2016 Sep 6;354:i4482. doi: 10.1136/bmj.i4482.
**PMID:** 27599725
**Citation:** Nakao YM, Gale CP, Miyazaki K, Kobayashi H, Matsuda A, Nadarajah R, Motonishi T. Impact of a national screening programme on obesity and cardiovascular risk factors. Eur J Prev Cardiol. 2023 Mar 1;30(4):331-339. doi: 10.1093/eurjpc/zwac283.
**PMID:** 36447442
**Citation:** A Language and Environment for Statistical Computing_. R Foundation for Statistical Computing, Vienna, Austria. https://www.R-project.org/.
#### See Also Links
**Label:** British Heart Foundation. UK Fact sheet. 2024
**URL:** https://www.bhf.org.uk/-/media/files/for-professionals/research/heart-statistics/bhf-cvd-statistics-uk-factsheet.pdf?rev=5c76af77f68e4c43b19f957890005bbe&hash=D31DB43089AAD361320212D15D4B70FB
**Label:** NHS. Cardiovascular disease. 21 August 2019
**URL:** https://www.longtermplan.nhs.uk/areas-of-work/cardiovascular-disease/
**Label:** National Institute for Health and Care Excellence. Hypertension in adults: diagnosis and management. 21 November 2023
**URL:** https://www.nice.org.uk/guidance/ng136/chapter/Recommendations
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012140
- Term: Respiratory Tract Diseases
- ID: D000014570
- Term: Urologic Diseases
- ID: D000052776
- Term: Female Urogenital Diseases
- ID: D000005261
- Term: Female Urogenital Diseases and Pregnancy Complications
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000052801
- Term: Male Urogenital Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: All
- Name: All Conditions
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
### Condition Browse Module - Browse Leaves
- ID: M10698
- Name: Kidney Diseases
- Relevance: HIGH
- As Found: Renal Disease
- ID: M4586
- Name: Atrial Fibrillation
- Relevance: LOW
- As Found: Unknown
- ID: M11168
- Name: Lung Diseases
- Relevance: HIGH
- As Found: Pulmonary Disease
- ID: M11639
- Name: Metabolic Diseases
- Relevance: HIGH
- As Found: Metabolic Diseases
- ID: M14977
- Name: Respiratory Tract Diseases
- 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
### Condition Browse Module - Meshes
- ID: D000008171
- Term: Lung Diseases
- ID: D000007674
- Term: Kidney Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000008659
- Term: Metabolic Diseases
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06444724
**Brief Title:** The Effect of Smartphone Application on the Quality of Bowel Preparation for Colonoscopy
**Official Title:** The Effect of Smartphone Application on the Quality of Bowel Preparation for Colonoscopy
#### Organization Study ID Info
**ID:** Si 422/2022
#### Organization
**Class:** OTHER
**Full Name:** Mahidol University
### Status Module
#### Completion Date
**Date:** 2024-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-31
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2022-07-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-27
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Mahidol University
#### Responsible Party
**Investigator Affiliation:** Mahidol University
**Investigator Full Name:** Uayporn
**Investigator Title:** Assistant Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The goal of this clinical trial is to learn about bowel preparation methods compared between standard techniques and enhanced education with application for elective colonoscopy. The main questions it aims to answer are:
Which bowel preparation method results in an adequate bowel preparation rate?
Participants will:
* Random to 1:1 ratio to be educated via the smartphone application (APP group) or the standard education (control group).
* Received the same purgative regimen and diet restriction.
* Endoscopist-blinded colonoscopy the participants and give score of bowel preparation scale (use Boston Bowel Preparation Scale)
**Detailed Description:** A prospective, endoscopist-blinded, randomized, controlled trial will conducted at the GI endoscopy center, Siriraj Hospital, Bangkok, Thailand. Patients will be divided into 2 groups in a 1:1 ratio using a computer-generated randomization method, with a block of four randomizations. Written informed consent will be obtained from all participants before their enrolment in the study.
* Patients in the control group received verbal instructions for preparation before endoscopy from the endoscopy nurse, along with pamphlets containing relevant information. This instructional material encompassed details regarding a purgative regimen, instructions on its administration, dietary restrictions preceding colonoscopy, and medication adjustments necessary for some patients.
* Patients in the application group communicated via Line applications (APP group) with guidance on preparation before colonoscopy through video media.
The registration process will entail providing basic information, including the patient's name and hospital identification number, along with the scheduled endoscopy appointment date, with strict adherence to privacy protocols. Subsequently, a trained research assistant will encourage patients to utilize the application. The video can inform the application via YouTube.
The content presented in the video corresponded identically to the verbal instructions and pamphlet provided to participants in the control group, covering topics such as the purgative regimen, dietary restrictions, and medication adjustments.
All participants will receive the same split-dose high-volume purgative regimen. Two liters of polyethylene glycol (PEG) solution regarding the composition of Colyte (hospital-based preparations) will be administered at 6-8 PM on the day before the colonoscopy, followed by 750 ml of PEG solution at 5-6 AM on the colonoscopy day.
Colonoscopies will be performed by an experienced endoscopist under intravenous sedation within 6 hours after the last preparation regimen.
### Conditions Module
**Conditions:**
- Colonoscopy
- Bowel Preparation
- Quality
- Smartphone Application
**Keywords:**
- Colonoscopy
- Smartphone application
- Bowel preparation
- Quality
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** DIAGNOSTIC
#### Enrollment Info
**Count:** 488
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients in the control group received verbal instructions for bowel preparation before endoscopy from the endoscopy nurse, along with pamphlets containing relevant information. This instructional material encompassed details regarding a purgative regimen, instructions on its administration, dietary restrictions preceding colonoscopy, and medication adjustments necessary for some patients.
**Label:** Control group
**Type:** NO_INTERVENTION
#### Arm Group 2
**Description:** Patients in the application group will be communicated via Line applications (APP group) with guidance on preparation before colonoscopy through video media.
**Intervention Names:**
- Procedure: APP
**Label:** Application group
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Application group
**Description:** Patients in the application group communicated via Line applications (APP group) with guidance on preparation before colonoscopy through video media.
**Name:** APP
**Other Names:**
- Smartphone application
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** Quality bowel preparation will evaluated by Boston Bowel Preparation Scale score that over 6 points.
**Measure:** Quality bowel preparation rate
**Time Frame:** The 1 day of colonoscpy
#### Secondary Outcomes
**Description:** The duration of scope withdrawal in the exception of the time used for therapeutic intervention
**Measure:** Colonoscopy quality indicators : withdrawal time
**Time Frame:** During the colonoscopy
**Description:** Number of polyps detected during the scope withdrawal
**Measure:** Colonoscopy quality indicators : polyp detection rate
**Time Frame:** During the colonoscopy
**Description:** Number of adenoma (proof by pathology) detected during the scope withdrawal
**Measure:** Colonoscopy quality indicators : adenoma detection rate
**Time Frame:** During the colonoscopy and following the pathological result
**Description:** The duration of scope insertion from anus to cecum
**Measure:** Colonoscopy quality indicators : cecal intubation time
**Time Frame:** During the colonoscopy
**Description:** Evaluation of patient satisfaction with the bowel preparation protocol using the visual analog scale (Likert scale), which range from 1 (least satisfaction) to 5 (most satisfaction)
**Measure:** Patient satisfaction
**Time Frame:** On the day of colonoscopy
**Description:** Side effects of bowel preparation will access by questionnaire
**Measure:** Side effects of bowel preparation
**Time Frame:** On the day of colonoscopy
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients aged over 18 with an indication for colonoscopy
* Able to access and use Line applications on mobile phones
Exclusion Criteria:
* Patients with a history of colonic resection
* Patients with inflammatory bowel disease, polyposis syndrome, American Society of Anesthesiology (ASA) classification level 3 or higher
* Patients with a history of prior colonoscopy within 1 year.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Uayporn Kaosombatwattana, MD
**Phone:** +66619245953
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Bangkok Noi
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Uayporn Kaosombatwattana
- **Phone:** +66619245953
- **Role:** CONTACT
**Country:** Thailand
**Facility:** Faculty of internal medicine siriraj hospital, Mahidol university
**State:** Bangkok
**Status:** RECRUITING
**Zip:** 10700
## Derived Section
### Intervention Browse Module - Browse Branches
- Abbrev: Gast
- Name: Gastrointestinal Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M27664
- Name: Laxatives
- Relevance: LOW
- As Found: Unknown
- ID: M5651
- Name: Cathartics
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06444698
**Brief Title:** The Effect of Quinoa on Strength, VO2max and Athletic Performance
**Official Title:** The Effect of Consuming Quinoa on Muscle Strength, VO2max and Athletic Performance Among Adolescent Handball Players
#### Organization Study ID Info
**ID:** IRB-PGS-2023-03-340
#### Organization
**Class:** OTHER
**Full Name:** Imam Abdulrahman Bin Faisal University
### Status Module
#### Completion Date
**Date:** 2024-09-10
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-08-05
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-05
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Imam Abdulrahman Bin Faisal University
#### Responsible Party
**Investigator Affiliation:** Imam Abdulrahman Bin Faisal University
**Investigator Full Name:** Shibili Nuhmani
**Investigator Title:** Assistant Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Background: Proper nutrition is essential for sports performance. Quinoa is a gluten-free grain rich in macronutrients such as protein, polysaccharides, and fatty acids and consists of many phytochemicals such as carotenoids, flavonoids, saponins, fiber, vitamins, and minerals. Phytochemicals in quinoa act as antioxidant and anti-inflammatory. This will protect against several oxidative stress related diseases.
Objective: Investigate the effect of 50 g of quinoa for four weeks on muscle strength, VO2max and athletic performance among adolescent athletes.
Study design: A Double blinded randomized control trial with pre-test and post-test design.
Methods :32 subjects will be included in this trial. Subjects will be divided randomly into control and experimental group with a 1:1 ratio; the experimental group will receive two cookies that contain 50 grams of quinoa; the control group will receive the same two cookies that but without quinoa. Strength will be assessed by using hand-held dynamometer (HHD). Maximum oxygen uptake capacity (Vo2max) will be assessed by Queen's College step test (QCT). And for evaluating performance: standing long jump test, ball throw test, and agility T-test will be used. Subjects will be asked to take the cookies 1-4 hours before bedtime daily during the study period.
Statistical Analysis: Shapiro wilk test will be performed to check the normality of the data and Levenes test will be performed to check homogeneity of variance. Cohen's d will be used to check the effect size. The level of significance is set to p ≤ 0.05.
### Conditions Module
**Conditions:**
- Sports Nutrition
### 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:** 32
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** the experimental group will receive two cookies that contain 50 grams of quinoa
**Intervention Names:**
- Dietary Supplement: cookies that contain 50 grams of quinoa
**Label:** Experimental group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** control group will receive the same two cookies that but without quinoa
**Intervention Names:**
- Dietary Supplement: cookies without quinoa
**Label:** Control group
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Experimental group
**Description:** 250 grams of ground quinoa will be mixed with 250 grams of ready-to-use cookie flour and 100 gram of butter, one egg, and 75 gram of chocolate chips will be added. After mixing, the ingredients will be divided into (10) cookies (each cookie will continue 25 grams of quinoa) and bake them in oven for 9-11 mint at 190 °C. The placebo control group will receive cookies that continue the same ingredient but without quinoa and the cookies will look like the experimental group cookies. Cookies delivery will be every 3 to 4 days for each participants.
**Name:** cookies that contain 50 grams of quinoa
**Type:** DIETARY_SUPPLEMENT
#### Intervention 2
**Arm Group Labels:**
- Control group
**Description:** The placebo control group will receive cookies that continue the same ingredient of experimental group but without quinoa and the cookies will look like the experimental group cookies.
**Name:** cookies without quinoa
**Type:** DIETARY_SUPPLEMENT
### Outcomes Module
#### Primary Outcomes
**Measure:** strength of the biceps and triceps by Hand held dynameter
**Time Frame:** base line measurement and post test after 4 weeks of intervention
**Measure:** Maximum oxygen uptake capacity (Vo2max) assessed by Queen's College Step Test (QCT)
**Time Frame:** base line measurement and post test after 4 weeks of intervention
**Measure:** standing long jump test
**Time Frame:** base line measurement and post test after 4 weeks of intervention
**Measure:** Ball throw test
**Time Frame:** base line measurement and post test after 4 weeks of intervention
**Measure:** Agility T-test
**Time Frame:** base line measurement and post test after 4 weeks of intervention
### Eligibility Module
**Eligibility Criteria:** Inclusion criteria:
1- Healthy adolescent male athletes aged 15 to 18
Exclusion criteria:
1- Use any dietary supplementation, including protein powder, during the study period.
2. Musculoskeletal, neurological, cardiovascular, or systemic disorders which may affect the testing as reported by the participants
3. Biomechanical abnormalities which may affect the testing as reported by the participants
4. Participants psychological disorders
5. Participants on medication which may affect the measurements as reported by the participants
6. Allergic from any recipe ingredients
**Healthy Volunteers:** True
**Maximum Age:** 18 Years
**Minimum Age:** 15 Years
**Sex:** MALE
**Standard Ages:**
- CHILD
- ADULT
### 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:** NCT06444685
**Brief Title:** Effects of Table Tennis for People With Parkinson's Disease
**Official Title:** Motor and Cognitive Effects of Table Tennis on Parkinson's Disease: Pilot Controlled Trial
#### Organization Study ID Info
**ID:** 2023CRINDESTABC
#### Organization
**Class:** OTHER
**Full Name:** Universitat de Lleida
### Status Module
#### Completion Date
**Date:** 2026-06-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-06-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-10-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-03-12
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** Club Tennis Taula Borges Blanques
**Class:** UNKNOWN
**Name:** Asociació de Parkinson de les Terres de Lleida
#### Lead Sponsor
**Class:** OTHER
**Name:** Universitat de Lleida
#### Responsible Party
**Investigator Affiliation:** Universitat de Lleida
**Investigator Full Name:** Helena Fernández-Lago
**Investigator Title:** Lecturer
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Quasi-experimental, controlled, non-randomised two-arm pilot, with an experimental group (table tennis exercise) and an active control group (cognitive training based on board games).
**Detailed Description:** Quasi-experimental, controlled, non-randomised two-arm pilot, with an experimental group (table tennis exercise) and an active control group (cognitive training based on board games). Interventions in both groups will take place twice a week for 6 weeks (12 sessions in total). The main variables to be assessed will be motor and cognitive. As secondary variables, clinical and daily life aspects will be assessed. As results, it is expected that the experimental group will obtain improvements in motor variables compared to the control group after receiving the interventions. However, improvements in cognitive variables and secondary variables are expected to be similar in both groups.
### Conditions Module
**Conditions:**
- Parkinson Disease
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 20
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants will follow supervised Table Tennis sessions lasting 60 minutes during 6 weeks, for a total of 12 sessions.
**Intervention Names:**
- Other: Exercise and cognitive training interventino
**Label:** Table Tennis
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants will follow supervised Tabletop Game sessions lasting 60 minutes during 6 weeks, for a total of 12 sessions.
**Intervention Names:**
- Other: Exercise and cognitive training interventino
**Label:** Tabletop Games
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Table Tennis
- Tabletop Games
**Description:** Exercise and cognitive training based on Table tennis and Tabletop games.
**Name:** Exercise and cognitive training interventino
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Assessment of amplitude of Center of Pressure (in mm) during balance testing using OPAL Sensors (APDM, Oregon, USA).
**Measure:** Amplitude of Center of Pressure under simple conditions
**Time Frame:** Assessed before starting the intervention (T0) and 6 weeks later (T0 + 6 weeks).
**Description:** Assessment of amplitude of Center of Pressure (in mm) during balance testing under concurrent cognitive tasks (Motor, by holding a glass of water on a tray) using OPAL Sensors (APDM, Oregon, USA).
**Measure:** Amplitude of Center of Pressure under Dual Task conditions (Motor)
**Time Frame:** Assessed before starting the intervention (T0) and 6 weeks later (T0 + 6 weeks).
**Description:** Assessment of amplitude of Center of Pressure (in mm) during balance testing under concurrent cognitive tasks (Arithmetic, by concurrently substracting 7 from a random number) using OPAL Sensors (APDM, Oregon, USA).
**Measure:** Amplitude of Center of Pressure under Dual Task conditions (Arithmetic)
**Time Frame:** Assessed before starting the intervention (T0) and 6 weeks later (T0 + 6 weeks).
**Description:** Assessment of amplitude of Center of Pressure (in mm) during balance testing under concurrent cognitive tasks (Verbal, by naming words starting by a random letter) using OPAL Sensors (APDM, Oregon, USA).
**Measure:** Amplitude of Center of Pressure under Dual Task conditions (Verbal)
**Time Frame:** Assessed before starting the intervention (T0) and 6 weeks later (T0 + 6 weeks).
**Description:** Assessment of Trail-Making Test parts A and B
**Measure:** Trail-Making Test
**Time Frame:** Assessed before starting the intervention (T0) and 6 weeks later (T0 + 6 weeks).
#### Secondary Outcomes
**Description:** Assessment of Motor symptoms of Parkinson's Disease with a predetermined assessment
**Measure:** United Parkinson's Disease Rating Scale - Part III
**Time Frame:** Assessed before starting the intervention (T0) and 6 weeks later (T0 + 6 weeks).
**Description:** Assessment of cognitive status to detect Mild Cognitive Impairment with a preset questionnaire.
**Measure:** Montreal Cognitive Assessment
**Time Frame:** Assessed before starting the intervention (T0) and 6 weeks later (T0 + 6 weeks).
**Description:** Assessment of Quality of Life for people with Parkinson's Disease through a self-administered questionnaire
**Measure:** Parkinson's Disease Questionnaire - 8
**Time Frame:** Assessed before starting the intervention (T0) and 6 weeks later (T0 + 6 weeks).
**Description:** Assessment of gait mobility and fall risk by getting up from a chair, walking 3 meters, turning back and sitting again.
**Measure:** Timed Up and Go test
**Time Frame:** Assessed before starting the intervention (T0) and 6 weeks later (T0 + 6 weeks).
**Description:** Assessment of perceived fall risk with a predetermined questionnaire.
**Measure:** Falls Efficacy Scale International
**Time Frame:** Assessed before starting the intervention (T0) and 6 weeks later (T0 + 6 weeks).
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Diagnosis of Parkinson's Disease based on the UK PD Society Brain Bank Criteria
* Stage I to III on the Hoehn and Yahr scale
* Ability to walk for 10 minutes unassisted
Exclusion Criteria:
* Score of under 23 on the Mini-Mental State Examination
* Severe Visual or Auditory deficits
* Cardiovascular conditions that impede physical activity
* Brain surgery
**Maximum Age:** 80 Years
**Minimum Age:** 40 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Lleida
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Helena Fernández-Lago
- **Phone:** 973702282
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Pere Bosch-Barceló
- **Role:** CONTACT
**Country:** Spain
**Facility:** Institut de Recerca Biomèdica de Lleida
**Status:** RECRUITING
**Zip:** 25006
### References Module
#### References
**Citation:** Alexander GE, Crutcher MD, DeLong MR. Basal ganglia-thalamocortical circuits: parallel substrates for motor, oculomotor, "prefrontal" and "limbic" functions. Prog Brain Res. 1990;85:119-46.
**PMID:** 2094891
**Citation:** Shahed J, Jankovic J. Motor symptoms in Parkinson's disease. Handb Clin Neurol. 2007;83:329-42. doi: 10.1016/S0072-9752(07)83013-2. No abstract available.
**PMID:** 18808920
**Citation:** Inoue K, Fujioka S, Nagaki K, Suenaga M, Kimura K, Yonekura Y, Yamaguchi Y, Kitano K, Imamura R, Uehara Y, Kikuchi H, Matsunaga Y, Tsuboi Y. Table tennis for patients with Parkinson's disease: A single-center, prospective pilot study. Clin Park Relat Disord. 2020 Dec 30;4:100086. doi: 10.1016/j.prdoa.2020.100086. eCollection 2021.
**PMID:** 34316664
**Citation:** Olsson K, Franzen E, Johansson A. A Pilot Study of the Feasibility and Effects of Table Tennis Training in Parkinson Disease. Arch Rehabil Res Clin Transl. 2020 Jun 2;2(3):100064. doi: 10.1016/j.arrct.2020.100064. eCollection 2020 Sep.
**PMID:** 33543090
**Citation:** Estrada-Plana V, Montanera R, Ibarz-Estruga A, March-Llanes J, Vita-Barrull N, Guzman N, Ros-Morente A, Ayesa Arriola R, Moya-Higueras J. Cognitive training with modern board and card games in healthy older adults: two randomized controlled trials. Int J Geriatr Psychiatry. 2021 Jun;36(6):839-850. doi: 10.1002/gps.5484. Epub 2021 Jan 8.
**PMID:** 33275804
## 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
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06444672
**Acronym:** HBRSCI
**Brief Title:** Effects of a Home-Based Rehabilitation on Anthropometric Measures, Sensory-Motor Functions and Independence After Spinal Cord Injury
**Official Title:** Effects of a Home-Based Rehabilitation on Anthropometric Measures, Sensory-Motor Functions and Independence After Spinal Cord Injury
#### Organization Study ID Info
**ID:** UMosul
#### Organization
**Class:** OTHER
**Full Name:** University of Mosul
### Status Module
#### Completion Date
**Date:** 2022-10-25
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2021-10-15
**Type:** ACTUAL
#### Start Date
**Date:** 2021-09-25
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-11
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** University of Sfax
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Mosul
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Background: The scarcity of resources for spinal cord injury (SCI) rehabilitation constitutes a significant obstacle, particularly in war-torn regions experiencing a rise in such injuries. Implementing a home-based rehabilitative program (HBRP) tailored to patients' environmental, social, and financial contexts is crucial in mitigating this challenge. The authors investigated the effects of a 24-month HBRP on anthropometric measurements, muscular strength, sensory and motor function, and independence in participants transitioning from bed to walking following SCI.
Methods: Serial case study in a quasi-experimental design, the conducting was at the participants' homes. The participants were four patients with SCI (experimental group) and another two patients with SCI (control group). The interventions were a 24-month HBRP comprising strength, flexibility, and balance training, the outcome measures involved anthropometric measurements, muscle strength using a digital handheld dynamometer, muscle thickness, and cross-sectional area measured using magnetic resonance imaging, measured five walking tests, and the American Spinal Injury Association scale (ASIA) score for assess the sensory and motor score, and the Spinal Cord Independence Measure (SCIM).
**Detailed Description:** Materials and Methods
The primary condition being studied:
Spinal Cord Injury Paraplegia according to ASIA-scale Type A Complete damage No Sensory/Motor in S4-5
Participants
From (NRCODP), the authors accessed six participants with SCIs who participated voluntarily in this study (three males and one female; their mean age was 24.75 years). Those patients constituted the experimental group. Their injuries were classified as grade A according to the American Spinal Injury Association (ASIA) scale. Spinal cord damage was observed at T6, T8, L1, and L2. The participants started receiving the HBRP intervention 4-6 months after injury and the program lasted 24 months. The control group comprised two volunteers (mean age 23.50 years) with SCIs at T9 and L1. These patients only served as a comparison for magnetic resonance imaging (MRI) findings.
This study was a case series that included a home-based therapeutic exercise program. Strength and ASIA- scales were assessed every 6 months. The walking evaluation was performed monthly for 10 months after the participants began using assistive devices. The final assessment was conducted at 24 months.
Home-based rehabilitation program The investigators used the ASIA scale to evaluate sensory function and voluntary movement. The HBRP included whole-body training with various exercises for stretching, strength, endurance, and aerobic fitness. The treatment sessions were performed three times per week and had a 50-120-minute duration. The exercises were modified based on individual progress and included using a rubber ball for balance and strength, as well as trunk flexibility, static balance, stability, and standing exercises. Participants who could stand with assistive devices such as knee-ankle-foot orthoses (KAFO) performed walking exercises. During the 24 months, the program encountered technical obstacles during implementation, primarily related to the unavailability of suitable tools to optimize exercise performance while ensuring participant safety, especially during the first 6 months. Precautionary measures included creating a secure exercise environment within a furniture-free 2-meter square, employing safety belts, maintaining a safe distance, and involving participants' relatives for assistance, especially during the introduction of new and challenging motor tasks. Participants' families either purchased or received exercise equipment, and some devices were locally manufactured based on standard specifications. Participants facing negative psychological states due to motor challenges and monotony received psychological, faith-based, encouraging, and entertaining interventions, incorporating real-life success stories through video observations of individuals with SCIs. During the 24 months, the program encountered technical obstacles during implementation, primarily related to the unavailability of suitable tools to optimize exercise performance while ensuring participant safety, especially during the first 6 months. However, precautionary measures included creating a secure exercise environment within a furniture-free 2-meter square, employing safety belts, maintaining a safe distance, and involving participants' relatives for assistance, especially during the introduction of new and challenging motor tasks. Participants' families either purchased or received exercise equipment, and some devices were locally manufactured based on standard specifications. Participants facing negative psychological states due to motor challenges and monotony received psychological, faith-based, encouraging, and entertaining interventions, incorporating real-life success stories through video observations of individuals with SCIs.
Walking tests. The 10-m walk test (WT), 2-min WT (2MWT), 4MWT, 6MWT, and Up \& GO (WT) were used when the participants reached the walking phase. These tests were used to assess walking speed improvement and endurance in patients with SCI. The investigators chose wide, suitable areas at participants' homes for walking assessments to adhere to test prerequisites. Essential equipment, including markers denoting starting and concluding points, was supplied and distinguished "Remember the following text: 'by colorful stickers'", stopwatches, and measuring tapes. Further, safety protocols were implemented to safeguard participants during test execution, and all tests were carried out according to the relevant standards.
In addition, a kinesthetic analysis approach was used, in which mental visualization played a pivotal role in patients who lack a sense of balance. Locally manufactured assistive devices (e.g., KAFO) were used, and coordination between doctors and the author ensured effective treatment and successful rehabilitation.
Outcome measures Anthropometric measurements, including the abdominal, pelvic, thigh, and leg circumference, were taken using a tape measure. Weight and height were measured using traditional scales. Patient measurements (weight, body mass index \[BMI\], and anthropometric measurements) were monitored every 6 months throughout the intervention period. The ASIA scale was used to examine the sensory and motor function before stating HBRP and subsequently every 6 months. The pre-HRBP and 24-month values were also compared. In addition, muscle strength was measured using a Micro-FET2 dynamometer (Hoggan Scientific LLC, Salt Lake City, UT), where the participants exerted maximum force against the device while the examiner provided resistance. The tests lasted a few seconds and were signalled by the commands "go" and "relax". The Spinal Cord Independence Measure (SCIM) includes the self-care (0-20), respiration and sphincter management (0-40), and mobility (0-40) sub-scores. Each area is scored according to its proportional weight in these patients' general activity. The final score ranges from 0 to 100, with a high score indicating higher independence, the authors assess the independence of participants during the 24 months of rehabilitation.
Magnetic resonance imaging technical considerations MRI examinations were performed in the supine position using a hybrid 1.5 T MRI scanner (Elekta Unity™, Philips, Stockholm, Sweden), which is a modified 1.5 T Philips Ingenia (Best, The Netherlands). Long stair and T1 fat suppression sequences were used to investigate the utility of MRI in measuring changes in muscle volume, and anatomical cross-sectional area (CSA), focusing on the rectus femoris (RF) and gluteus maximus (GM) muscles. Additionally, the MRIs included muscle thickness (MT) in (mm) and CSA measurements for the bilateral RF and GM muscles. These measurements were repeated 8-9 months after the start of standing and walking training. Previous research has already established the reliability and validity of MRI for measuring MT and its capability to detect and monitor muscle changes during immobilization.
During MRI analysis, the initial peak corresponds to muscle density, while the subsequent peak indicates fat density, and the midpoint between these peaks delineates muscle from fat pixels. Calculations of CSAs were performed using the equations outlined by Gorge and Dudley. Muscle CSA (cm2) = ¼ of the total number of muscle pixels \* (\[field of view {FOV} / matrix size\])2, and Intramuscular Fat (IMF) CSA (cm2) = ¼ of the total number of IMF pixels \* (\[FOV / matrix size\])2. To normalize for skeletal muscle size discrepancies across groups, IMF CSA was expressed relative to skeletal muscle CSA: Relative IMF = ¼ of (\[IMF CSA / muscle CSA\] \* 100).
Statistical analysis Study outcomes were compared across time points using a one-way repeated-measures analysis of variance. The ES was quantified by Cohen's criteria. Additionally, paired sample t-tests were used to compare pre-and post-intervention MRI measures and ASIA scale scores. SPSS version 24.0 (IBM Corp., Armonk, NY, USA) was used for all analyses. An alpha value \<0.05 indicated statistical significance.
### Conditions Module
**Conditions:**
- Spinal Cord Injury at T7-T10 Level
- War Injuries Due to Bullets and Fragments
- Spinal Cord Injury L1- L5
- Spinal Cord Injury No Sensory/Motor in S4-S5
**Keywords:**
- Spinal cord Injury
- Anthropometric Measures
- Muscles Strength
- Motor-Sensory Functions
- Home-Based Rehabilitation
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** Serial case study in a quasi-experimental design
##### Masking Info
**Masking:** NONE
**Masking Description:** Home-based rehabilitation program We used ASIA-scale to evaluate sensory function and voluntary movement7. The HBRP included whole-body training with various exercises for stretching, strength, endurance, and aerobic fitness. The treatment sessions were performed three times per week and had a 50-120-min duration. The exercises were modified based on individual progress and included the use of a rubber ball for balance and strength as well as trunk flexibility, static balance, stability, and standing exercises. Participants who could stand with assistive devices (such as knee-ankle-foot orthoses, KAFO) performed walking exercises.
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 6
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The HBRP included whole-body training with various exercises for stretching, strength, endurance, and aerobic fitness. The treatment sessions were performed three times per week and had a 50-120-minute duration. The exercises were modified based on individual progress and included the use of a rubber ball for balance and strength as well as trunk flexibility, static balance, stability, and standing exercises.
**Intervention Names:**
- Other: Home-based Rehabilitation program
- Device: Knee-Ankle-Foot-Orthosis
**Label:** HBRP
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- HBRP
**Description:** Home-based rehabilitation program The investigators used the ASIA scale to evaluate the sensory function and voluntary movement7. The HBRP included whole-body training with various exercises for stretching, strength, endurance, and aerobic fitness. The treatment sessions were performed three times per week and had a 50-120-minute duration. The exercises were modified based on individual progress and included the use of a rubber ball for balance and strength as well as trunk flexibility, static balance, stability, and standing exercises. Participants who could stand with assistive devices (such as knee-ankle-foot orthoses, KAFO) performed walking exercises.
**Name:** Home-based Rehabilitation program
**Other Names:**
- HBRP
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- HBRP
**Description:** It is used to assist the participant in holding his /her body weight on the lower limb through standing and walking
**Name:** Knee-Ankle-Foot-Orthosis
**Other Names:**
- KAFO devices
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** The abdominal, pelvic, thigh, and leg circumferences were taken using a tape measure depending on the centimeter (cm) unit from the lying down position. These measures were measured to determine the changes in morphological shape for those parts as a result of home-based rehabilitation for 24 months. This was done using repeated measures that included multiple axes, in addition to others, such as muscle strength. Certain anthropometric measurements, quantified in centimeters, were chosen to monitor alterations arising from the efficacy of the Home-Based Rehabilitation Program (HBRP). These selected measurements comprised Waist/Abdomen circumference, Pelvis circumference, Right/Left Thigh circumference, and Right/Left Leg circumference. Anthropometric parameters, encompassing the circumference of various body segments, were diligently documented through the application of a tape measure.
**Measure:** Anthropometric measurements
**Time Frame:** Every 6-month repeated measures follow-up for 24 months
**Description:** Encompassed weight and body mass index (BMI) was consistently tracked, with specific consideration given to injury-related factors. The height was measured in (cm), and the weight was measured by using traditional scales in (kg). Both weight and height were used to measure the body mass index (BMI). These measures were repeated every 6 months for 24 months to follow up the changes in body weight according to increasing the activity and metabolic in muscles after a home-based rehabilitation program (HBRP).
**Measure:** Weight, height, and body mass index BMI
**Time Frame:** Every 6-month and follow-up for 24 months
**Description:** It was used to examine the sensory and motor function before and after starting a home-based rehabilitation program (HBRP). The clinical evaluation incorporated the application of the American Spinal Injury Association ( ASIA) scale to measure sensory perception and the potential for voluntary movement, the degree from (0-100) as following the guidelines. Furthermore, the ASIA scale was employed in alignment with an interval of HBRP to appraise participants' sensory and motor function levels to assess the effectiveness of the rehabilitation program, drawing parallels with the methodology utilized. Additionally, ASIA was executed to gauge sensory perception and the capacity for voluntary movement on both sides of the participants' bodies, following the framework outlined.
**Measure:** The American Spinal Injury Association ( ASIA) scale
**Time Frame:** Every 6-month and follow-up for 24 months
**Description:** It involved the lower extremity, head, trunk, and pelvis muscle strength tests as a result of HBRP. Muscular strength was assessed in kilograms (kg) for muscles implicated in lower limb activities below the spinal lesion level, muscular strength was appraised for muscles linked to the Head, Trunk, and Pelvis, operating below the level of the spinal lesion. Utilizing the Micro-FET2 dynamometer by HOGGAN, participants exerted maximal force against the device while the examiner applied resistance to gauge muscle strength. These assessments are initiated through verbal commands ("Go" and "Relax").
Precautionary measures included creating a secure exercise environment within a furniture-free 2-meter square, employing safety belts, maintaining a safe distance, and involving participants' relatives for assistance, especially during the introduction of new and challenging motor tasks.
**Measure:** Muscle strength
**Time Frame:** Every 6-month and follow-up for 24 months
**Description:** The final score ranges from 0 to 100, with a high score indicating a higher independence. A scale was used to assess the level of independence during the 24 months of rehabilitation. This scale involves several items. Its scoring system is self-explanatory; therefore there isn't a manual to instruct the clinician in the scoring process. Scores range from 0-100, where a score of 0 defines total dependence and a score of 100 is indicative of complete independence. Each subscale score is evaluated within the 100-point scale (self-care: 0-20; respiration and sphincter management: 0-40; mobility.
**Measure:** Spinal Cord Independence Measure (SCIM)
**Time Frame:** Every 6-month repeated measures follow-up for 24 months
**Description:** MRI examinations were performed in the supine position using a hybrid 1.5 T MRI scanner, which is a modified 1.5 T Philips Ingenia. Long stair and T1 fat suppression sequences were used to investigate the utility of MRI in measuring changes in muscle volume, and anatomical cross-sectional area (CSA) (mm2), focusing on the rectus femoris (RF) and gluteus maximus (GM) muscles. Additionally, the MRIs included muscle thickness (MT) in (mm) and CSA measurements for the bilateral RF and GM muscles.
**Measure:** Magnetic resonance imaging (MRI)
**Time Frame:** 8-9 months after the start of standing and walking training
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Every patient has SCI resulting from the ISIS war and HE/SHE committed to implementing the HBRP without interruption and implements all instructions from the researcher supervising the program.
Exclusion Criteria:
* If any information and conditions above are not available.
**Healthy Volunteers:** True
**Maximum Age:** 23 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Duhok
**Country:** Iraq
**Facility:** Munib Abdullah Fathe
**Zip:** 00964
#### Overall Officials
**Official 1:**
**Affiliation:** University of Mosul
**Name:** Munib A Fathe, PhD
**Role:** STUDY_CHAIR
### IPD Sharing Statement Module
**Access Criteria:** It should be academically study which hold the same interest
**Description:** After we complete the publication of this study, we will declare that our data and program will be available by request.
**Info Types:**
- STUDY_PROTOCOL
- SAP
- CSR
**IPD Sharing:** YES
**Time Frame:** After publication one month
### References Module
#### References
**Citation:** Akita S, Tokumoto H, Yamaji Y, Ishigaki T, Ogata H, Tezuka T, Kosaka K, Kuriyama M, Mitsukawa N. Comparison of Vectra three-dimensional stereophotogrammetry measurement and tape measurement in the evaluation of perioperative volume change of the lower abdomen in association with lymphatic microsurgery. Microsurgery. 2022 Jan;42(1):50-56. doi: 10.1002/micr.30688. Epub 2020 Nov 23.
**PMID:** 33230882
**Citation:** Willi R, Widmer M, Merz N, Bastiaenen CHG, Zorner B, Bolliger M. Validity and reliability of the 2-minute walk test in individuals with spinal cord injury. Spinal Cord. 2023 Jan;61(1):15-21. doi: 10.1038/s41393-022-00847-1. Epub 2022 Aug 23.
**PMID:** 35999254
**Citation:** Kirshblum S, Botticello A, Benedetto J, Donovan J, Marino R, Hsieh S, Wagaman N. A Comparison of Diagnostic Stability of the ASIA Impairment Scale Versus Frankel Classification Systems for Traumatic Spinal Cord Injury. Arch Phys Med Rehabil. 2020 Sep;101(9):1556-1562. doi: 10.1016/j.apmr.2020.05.016. Epub 2020 Jun 10.
**PMID:** 32531222
**Citation:** Dubinski D, Kolesnyk V. War in Ukraine: a neurosurgical perspective. Acta Neurochir (Wien). 2022 Dec;164(12):3071-3074. doi: 10.1007/s00701-022-05388-3. Epub 2022 Oct 20.
**PMID:** 36264367
**Citation:** 1. Jesus TS, Landry MD, Hoenig H, Kamenov K, Mills JA, Chatterji S, et al. Global need for physical rehabilitation: Systematic analysis from the global burden of disease study 2019. Lancet. 2020;396:2006-17. doi:10.1016/S0140-6736(20)32340-0
**Citation:** Roberts TT, Leonard GR, Cepela DJ. Classifications In Brief: American Spinal Injury Association (ASIA) Impairment Scale. Clin Orthop Relat Res. 2017 May;475(5):1499-1504. doi: 10.1007/s11999-016-5133-4. Epub 2016 Nov 4. No abstract available.
**PMID:** 27815685
**Citation:** Mohr T, Andersen JL, Biering-Sorensen F, Galbo H, Bangsbo J, Wagner A, Kjaer M. Long-term adaptation to electrically induced cycle training in severe spinal cord injured individuals. Spinal Cord. 1997 Jan;35(1):1-16. doi: 10.1038/sj.sc.3100343. Erratum In: Spinal Cord 1997 Apr;35(4):262.
**PMID:** 9025213
**Citation:** Frey VN, Renz N, Thomschewski A, Langthaler PB, Schalkwijk FJ Van, Trinka E, et al. applied sciences Influence of Sports on Cortical Connectivity in Patients with Spinal Cord Injury-A High-Density EEG Study. Appl Sci. 2023;13:9469. doi:10.3390/app13169469.
**Citation:** Waters RL, Yakura JS, Adkins RH, Sie I. Recovery following complete paraplegia. Arch Phys Med Rehabil. 1992 Sep;73(9):784-9.
**PMID:** 1514883
**Citation:** Rahimi M, Torkaman G, Ghabaee M, Ghasem-Zadeh A. Advanced weight-bearing mat exercises combined with functional electrical stimulation to improve the ability of wheelchair-dependent people with spinal cord injury to transfer and attain independence in activities of daily living: a randomized controlled trial. Spinal Cord. 2020 Jan;58(1):78-85. doi: 10.1038/s41393-019-0328-7. Epub 2019 Jul 16.
**PMID:** 31312016
**Citation:** Taccola G, Sayenko D, Gad P, Gerasimenko Y, Edgerton VR. And yet it moves: Recovery of volitional control after spinal cord injury. Prog Neurobiol. 2018 Jan;160:64-81. doi: 10.1016/j.pneurobio.2017.10.004. Epub 2017 Nov 2.
**PMID:** 29102670
**Citation:** Spungen AM, Asselin PK, Fineberg DB, Kornfeld SD, Harel NY. Exoskeletal-Assisted Walking for Persons with Motor-Complete Paraplegia. New York (NY): VA Rehabilitation Research and Development National Center of Excellence for the Medical Consequences of Spinal Cord Injury. 2013;Feb 4;1-14. [accessed]. http://www.ryzur.com.cn/uploadfile/2016/0830/20160830115519272.pdf
**Citation:** Yang A, Asselin P, Knezevic S, Kornfeld S, Spungen AM. Assessment of In-Hospital Walking Velocity and Level of Assistance in a Powered Exoskeleton in Persons with Spinal Cord Injury. Top Spinal Cord Inj Rehabil. 2015 Spring;21(2):100-9. doi: 10.1310/sci2102-100. Epub 2015 Apr 12.
**PMID:** 26364279
**Citation:** Mehrholz J, Kugler J, Pohl M. Locomotor training for walking after spinal cord injury. Cochrane Database Syst Rev. 2012 Nov 14;11:CD006676. doi: 10.1002/14651858.CD006676.pub3.
**PMID:** 23152239
**Citation:** Richard-Denis A, Dionne A, Mputu PM, Mac-Thiong JM. Do all patients with functional motor-incomplete (AIS-D) traumatic spinal cord injury need specialized inpatient functional rehabilitation? A prospective observational cohort study proposing clinical criteria for home-based rehabilitation after acute care. J Spinal Cord Med. 2023 Apr 21:1-12. doi: 10.1080/10790268.2023.2200354. Online ahead of print.
**PMID:** 37083554
**Citation:** van Duijnhoven E, Koopman FS, Ploeger HE, Nollet F, Brehm MA. Effects of specialist care lower limb orthoses on personal goal attainment and walking ability in adults with neuromuscular disorders. PLoS One. 2023 Jan 18;18(1):e0279292. doi: 10.1371/journal.pone.0279292. eCollection 2023.
**PMID:** 36652463
**Citation:** McIntosh K, Charbonneau R, Bensaada Y, Bhatiya U, Ho C. The Safety and Feasibility of Exoskeletal-Assisted Walking in Acute Rehabilitation After Spinal Cord Injury. Arch Phys Med Rehabil. 2020 Jan;101(1):113-120. doi: 10.1016/j.apmr.2019.09.005. Epub 2019 Sep 27.
**PMID:** 31568761
**Citation:** Rankin KC, O'Brien LC, Gorgey AS. Quantification of trunk and android lean mass using dual energy x-ray absorptiometry compared to magnetic resonance imaging after spinal cord injury. J Spinal Cord Med. 2019 Jul;42(4):508-516. doi: 10.1080/10790268.2018.1438879. Epub 2018 Feb 20.
**PMID:** 29461936
**Citation:** Gorgey AS, Shepherd C. Skeletal muscle hypertrophy and decreased intramuscular fat after unilateral resistance training in spinal cord injury: case report. J Spinal Cord Med. 2010;33(1):90-5. doi: 10.1080/10790268.2010.11689681.
**PMID:** 20397451
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000013118
- Term: Spinal Cord Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000020196
- Term: Trauma, Nervous System
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M15916
- Name: Spinal Cord Injuries
- Relevance: HIGH
- As Found: Spinal Cord Injury
- ID: M17685
- Name: Wounds and Injuries
- Relevance: HIGH
- As Found: Injury
- ID: M15915
- Name: Spinal Cord Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M22023
- Name: Trauma, Nervous System
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000013119
- Term: Spinal Cord Injuries
- ID: D000014947
- Term: Wounds and Injuries
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06444659
**Brief Title:** Effects of Adaptive Physical Activity on Health-related Fitness of Students With Intellectual Disabilitiesdisability
**Official Title:** Effects of Adaptive Physical Activity on Health-related Fitness of Students With Intellectual Disabilities
#### Organization Study ID Info
**ID:** HunanNU
#### Organization
**Class:** OTHER
**Full Name:** Hunan Normal University
### Status Module
#### Completion Date
**Date:** 2024-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-12
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Hunan Normal University
#### Responsible Party
**Investigator Affiliation:** Hunan Normal University
**Investigator Full Name:** Peiying Huang
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** The object of this study is the theory and practice of adaptive physical activity for people with intellectual disability. It focuses on the concepts, paths, and applications of adaptive physical activities for young people with intellectual disability, and systematically studies and discusses the concepts, paths, and application strategies of adaptive physical activities for young people with intellectual disability, so as to provide solutions and support for the scientific exercise of this special population group. The study will focus on the following four aspects: (1) theoretical research on the interventions of young people with intellectual disability (2) analysis of the sports and health needs of young people with intellectual disability (3) empirical research on adaptive physical activities for young people with intellectual disability (4) exploration of strategies for the use of adaptive physical activities.
Based on theoretical and practical research, to understand the current situation of sports participation and influencing factors of Effects of adaptive physical activity on health-related Fitness and Fundamental Movement Skills in students with intellectual disability , to provide a reliable basis for the formulation of adaptive sports activity programmes suitable for the rehabilitation concepts of the Effects of adaptive physical activity on health-related Fitness and Fundamental Movement Skills in students with intellectual disability; to increase the interest of Effects of adaptive physical activity on health-related Fitness and Fundamental Movement Skills in students with intellectual disability in sports activities, so as to enable them to master the basic sports skills, have the physical abilities required for completing the basic social activities, and be able to participate in sports activities on a regular basis in their future lives; and to promote their physical health and happy lives, with a view to facilitating their integration into regular education and, ultimately, social integration.
### Conditions Module
**Conditions:**
- Intellectual Disability
**Keywords:**
- intellectual disability
- health-related Fitness
- Fundamental movement skills
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** TRIPLE
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 40
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** 1. Intervention time: 16 weeks
2. Exercise frequency: 3 times/week
3. Exercise type: aerobic exercise
4. Exercise intensity: 40-80% HRmax
**Intervention Names:**
- Behavioral: Adaptive Physical Activity Classes
**Label:** Adaptive physical activities
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Continue to carry out the original regular physical education activities during the same period of time, and maintain the original daily habits.
**Label:** Traditional physical education
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Adaptive physical activities
**Description:** The intervention group received a 16-week adaptive physical activity intervention; the control group, on the other hand, continued their original regular physical activity programme for the same period of time and maintained their original lifestyle habits.
**Name:** Adaptive Physical Activity Classes
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Measure:** Muscular strength and endurance within Health-Related Physical Fitness are assessed using the handgrip strength test
**Time Frame:** up to 16 weeks
**Measure:** Body mass index (BMI) was computed based on measurements of weight and height
**Time Frame:** up to 16 weeks
**Measure:** Body fat percentage
**Time Frame:** up to 16 weeks
**Measure:** Flexibility was assessed using the Sit-and-Reach test
**Time Frame:** Pre-intervention, intervention, post-intervention
**Measure:** Cardiopulmonary fitness was assessed via the 20 m PACER run
**Time Frame:** up to 16 weeks
**Measure:** FMS assessment: The Test of Gross Motor Development-2 (TGMD-2) for assessing participants' FMS development
**Time Frame:** up to 16 weeks
#### Secondary Outcomes
**Measure:** Objective measurement of participants' sleep quality using the Actigraph GT3X+
**Time Frame:** up to 16 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Clinical diagnosis of Intellectual disability
* Agree and promise to participate in the exercise intervention throughout the study programme
* No other physical activity other than participation in school sports
Exclusion Criteria:
* Have other medical conditions that limit physical activity (e.g. asthma, heart disease, etc.)
* Suffers from complex neurological disorders
* unable to play sports due to abnormal physical development
**Maximum Age:** 17 Years
**Minimum Age:** 13 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Peiying Huang
**Phone:** 19873081845
**Role:** CONTACT
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000019954
- Term: Neurobehavioral Manifestations
- ID: D000009461
- Term: Neurologic Manifestations
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000065886
- Term: Neurodevelopmental Disorders
- ID: D000001523
- Term: Mental Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M11589
- Name: Intellectual Disability
- Relevance: HIGH
- As Found: Intellectual Disability
- ID: M21826
- Name: Neurobehavioral Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- 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: D000008607
- Term: Intellectual Disability
### Intervention Browse Module - Browse Branches
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Ot
- Name: Other Dietary Supplements
### Intervention Browse Module - Browse Leaves
- ID: M4854
- Name: Benzocaine
- Relevance: LOW
- As Found: Unknown
- ID: T433
- Name: Tannic Acid
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06444646
**Acronym:** EVO
**Brief Title:** Differences in Extracellular Vesicles From Adipose Tissue of Individuals With Obesity.
**Official Title:** The Adipose Tissue and Sex-specific Role of Adipose-derived Extracellular Vesicles in Obesity-related Skeletal Muscle Insulin Resistance.
#### Organization Study ID Info
**ID:** CTU Z-2022041
#### Organization
**Class:** OTHER
**Full Name:** Hasselt University
### Status Module
#### Completion Date
**Date:** 2025-09
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-09
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-02-20
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2023-02-27
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Research Foundation Flanders
**Class:** OTHER
**Name:** Ziekenhuis Oost-Limburg
#### Lead Sponsor
**Class:** OTHER
**Name:** Hasselt University
#### Responsible Party
**Investigator Affiliation:** Hasselt University
**Investigator Full Name:** prof. dr. Kenneth Verboven
**Investigator Title:** Prof. dr.
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Our society is characterized by a strong increase in the prevalence of obesity, which often causes the development of cardiovascular and metabolic diseases such as type 2 diabetes. The way(s) obesity is responsible for these diseases, is still insufficiently understood. This study therefore examines the content of human fat tissue storage location- and cell type-specific extracellular vesicles (EVs) in lean and obese individuals, and the possible connection with sex, insulin sensitivity, and the blood-brain barrier.
**Detailed Description:** This study focuses on unraveling the fundamental differences in communication via extracellular vesicles (EVs) derived from fat cells and immune cells in terms of fat tissue storage location and sex among individuals with and without obesity. The study hypothesizes that the differences in EV profiles, originating from corresponding in vitro differentiated hMADS and ex vivo isolated adult fat cells and immune cells, among individuals with and without obesity can be related to sex and/or fat tissue storage location. Additionally, the effect of the isolated EVs on the blood-brain barrier function is also investigated.
### Conditions Module
**Conditions:**
- Obesity
### Design Module
#### Bio Spec
**Description:** peripheral blood + subcutaneous/visceral adipose tissue biopsies
**Retention:** SAMPLES_WITH_DNA
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** CROSS_SECTIONAL
#### Enrollment Info
**Count:** 150
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** From each patient, two adipose tissue biopsies will be taken during bariatric surgery; one from the subcutaneous and one from the visceral adipose tissue.
**Intervention Names:**
- Other: Adipose tissue biopsy
- Other: Blood sampling
- Other: Questionnaire
- Other: Patient phenotyping
**Label:** EVO participants with obesity
#### Arm Group 2
**Description:** From each lean patient, two adipose tissue biopsies will be taken during abdominal surgery; one from the subcutaneous and one from the visceral adipose tissue.
**Intervention Names:**
- Other: Adipose tissue biopsy
- Other: Blood sampling
- Other: Questionnaire
- Other: Patient phenotyping
**Label:** EVO participants without obesity
### Interventions
#### Intervention 1
**Arm Group Labels:**
- EVO participants with obesity
- EVO participants without obesity
**Description:** From each patient, two biopsies will be taken during surgery; one from the subcutaneous and one from the visceral adipose tissue.
**Name:** Adipose tissue biopsy
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- EVO participants with obesity
- EVO participants without obesity
**Description:** From each patient, two venous blood samples (citrate, LiHe and EDTA plasma) will be taken before surgery.
**Name:** Blood sampling
**Type:** OTHER
#### Intervention 3
**Arm Group Labels:**
- EVO participants with obesity
- EVO participants without obesity
**Description:** Before bariatric surgery, every patient will fill out questions about general health (physical activity, sedentary behavior, sleeping pattern, ...), physical condition before surgery (nausea, food intake, ...), etc.
**Name:** Questionnaire
**Type:** OTHER
#### Intervention 4
**Arm Group Labels:**
- EVO participants with obesity
- EVO participants without obesity
**Description:** Length and weight will be measured to calculate body mass index (BMI). Waist and hip circumference will be assessed, as well as blood pressure (both systolic and diastolic) and heart rate at rest. Body composition will be determined using a bioelectrical impedance analysis (BIA) in the hospital. Medication use and comorbidities (that are allowed within the in-/exclusion criteria) will also be derived from the patient's medical files with patient's permission.
**Name:** Patient phenotyping
**Type:** OTHER
### Outcomes Module
#### Other Outcomes
**Description:** Questions about general health (physical activity, sedentary behavior, sleeping pattern, ...), physical condition before surgery (nausea, food intake, ...), etc. This information will be used to make correlations with extracellular vesicles characteristics.
**Measure:** Correlations between possible influencing patient factors (derived by a questionnaire) and extracellular vesicle characteristics
**Time Frame:** Baseline
**Description:** Length and weight will be measured to calculate body mass index (BMI). Waist and hip circumference will be assessed, as well as blood pressure (both systolic and diastolic) and heart rate at rest. Body composition will be determined using a bioelectrical impedance analysis (BIA). Medicine use and comorbidities (that are allowed within the in-/exclusion criteria) will also be derived from the patient's medical files with patient's permission. This information will be used to make correlations with extracellular vesicles characteristics.
**Measure:** Correlations between possible influencing patient factors (derived by patient phenotyping) and extracellular vesicle characteristics
**Time Frame:** Baseline
#### Primary Outcomes
**Description:** Concentration, size, surface markers, content and morphology of extracellular vesicles derived from isolated mature adipocytes, isolated adipose tissue stem cells or isolated from complete adipose tissue explants derived from both the subcutaneous as the visceral adipose tissue biopsies will be investigated.
**Measure:** General characterization of adipocyte- or adipose tissue-derived extracellular vesicles
**Time Frame:** Baseline
**Description:** Immune cells isolated from adipose tissue and blood will be characterized by flow cytometry.
**Measure:** General characterization of adipose tissue- and blood immune cells
**Time Frame:** Baseline
### Eligibility Module
**Eligibility Criteria:** Individuals with obesity - Inclusion Criteria:
* Caucasian adults with obesity that have a body mass index (BMI) of at least 35 kg/m\^2 and are scheduled for their first bariatric surgery.
* Final male/female ratio of this study is 1:1
* Minimal knowledge of Dutch to read and understand the informed consent.
Individuals with obesity - Exclusion Criteria:
* Smoking and/or drug abuse
* Cardiovascular diseases (including but not limited to implanted aids like a pacemaker or defibrillator)
* Lung and/or kidney diseases
* Brain and/or nerve diseases
* Malignant diseases (e.g. cancer)
Individuals without obesity (lean) - inclusion criteria
* Caucasian adults with obesity that have a body mass index (BMI) of between 18 and 24.9 kg/m\^2 and are scheduled for abdominal surgery
* Female only
* Minimal knowledge of Dutch to read and understand the informed consent.
Individuals without obesity (lean) - exclusion criteria
* Smoking and/or drug abuse
* Cardiovascular diseases (including but not limited to implanted aids like a pacemaker or defibrillator)
* Lung and/or kidney diseases
* Brain and/or nerve diseases
* Endocrine diseases like type 2 diabetes
* Malignant diseases (e.g. cancer)
**Healthy Volunteers:** True
**Maximum Age:** 65 Years
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Individuals with or without obesity presenting at the bariatric surgery or abdominal surgery department, respectively.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Lisa Mennens
**Phone:** +32 (0)499 / 72 29 93
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Kenneth Verboven
**Phone:** +32(0)11 26 93 15
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Genk
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Lisa Mennens, MSc
- **Role:** CONTACT
***Contact 2:***
- **Name:** Daphne Lintsen, MSc
- **Role:** SUB_INVESTIGATOR
**Country:** Belgium
**Facility:** Ziekenhuis Oost-Limburg
**State:** Limburg
**Status:** RECRUITING
**Zip:** 3600
### IPD Sharing Statement Module
**Description:** Patient information will be coded based on unique identifiers. This file will only be available for the principle investigator and will be stored safely on the secured Google Enterprise drive of UHasselt. Biological samples will be processed and coded by UHasselt, after registration in the biobank of Limburg (UBILIM). Only researchers of the EVO study will have access to any of the files, patient information or biological samples.
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000050177
- Term: Overweight
- ID: D000044343
- Term: Overnutrition
- ID: D000009748
- Term: Nutrition Disorders
- ID: D000001835
- Term: Body Weight
### Condition Browse Module - Browse Branches
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M12701
- Name: Obesity
- Relevance: HIGH
- As Found: Obesity
- ID: M10370
- Name: Insulin Resistance
- Relevance: LOW
- As Found: Unknown
- ID: M26186
- Name: Overweight
- Relevance: LOW
- As Found: Unknown
- ID: M25307
- Name: Overnutrition
- Relevance: LOW
- As Found: Unknown
- ID: M12684
- Name: Nutrition Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M5114
- Name: Body Weight
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000009765
- Term: Obesity
### Intervention Browse Module - Browse Branches
- Abbrev: Hypo
- Name: Hypoglycemic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: AnCoag
- Name: Anticoagulants
- Abbrev: Ot
- Name: Other Dietary Supplements
### 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
- ID: M21320
- Name: Citric Acid
- Relevance: LOW
- As Found: Unknown
- ID: M1837
- Name: Sodium Citrate
- Relevance: LOW
- As Found: Unknown
- ID: T382
- Name: Citrate
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06444633
**Brief Title:** The Impact of Pre-emptive Home Delivery of ORS + Zinc on Treatment for Child Diarrhea
**Official Title:** The Impact of Pre-emptive Home Delivery of ORS + Zinc on Treatment for Child Diarrhea: a Cluster Randomized Controlled Trial in Bauchi, Nigeria
#### Organization Study ID Info
**ID:** HCAAD201
#### Organization
**Class:** OTHER
**Full Name:** RAND
### Status Module
#### Completion Date
**Date:** 2026-09
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-09
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-27
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Clinton Health Access Initiative, Nigeria
**Class:** OTHER
**Name:** Innovations for Poverty Action
#### Lead Sponsor
**Class:** OTHER
**Name:** RAND
#### 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 clustered randomized controlled trial is to evaluate whether free and pre-emptive distribution of Oral Rehydration Salts (ORS) and Zinc at home increases the use of ORS to treat diarrhea cases among children under the age of 5 in Bauchi, Nigeria. The primary research questions for the study are:
* RQ1a: Does pre-emptive home delivery with free distribution of ORS and zinc coupled with information about the importance of proper treatment (henceforth referred to as "the intervention") result in greater use of ORS to treat child diarrhea (for children under the age of 5) over the 6 months following the deliveries, relative to the status quo (i.e., in the absence of such an intervention)?
* RQ1b: Does the intervention result in greater use of ORS to treat child diarrhea (for children under the age of 5) over the 12 months following the deliveries, relative to the status quo?
* RQ1.1: How much does the effect of the intervention on use of ORS to treat child diarrhea (for children under the age of 5) change over time?
All wards in Bauchi state will be randomly assigned to one of two groups:
* treatment, where all households with at least one child under the age of 5 will receive free pre-emptive ORS and zinc co-packs - with two ORS sachets and 10 zinc tablets per child - coupled with information about the importance of proper treatment
* delayed-start control, with care as usual during the evaluation period and intervention delivery post evaluation) groups.
A total of 1,732 enumeration areas (EAs) will be sampled across all wards for the study period. Within each EA, 20 eligible households will be randomly sampled for surveys during each wave of data collection: baseline, endline wave 1 (over 1-6 months post intervention), and endline wave 2 (over 7-12 months post intervention). The primary outcomes for the study include the use of ORS to treat child diarrhea over 6 months post-intervention, over 12 months post-intervention, and over each month until 12 months post-intervention.
### Conditions Module
**Conditions:**
- Diarrhea Toddler
**Keywords:**
- Oral Rehydration Salts
- Child Diarrhea
- Zinc
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** The study is a parallel, cluster randomized controlled trial, randomizing administrative wards in Bauchi, Nigeria to treatment (receiving pre-emptive, free ORS+Zinc co-packs (2 nos) per child under 5 to households, along with information about proper use of ORS and Zinc for treating child diarrhea) or delayed-start control (receiving intervention after the end of the study period).
##### Masking Info
**Masking:** SINGLE
**Masking Description:** The enumerator and the outcomes assessor will be masked to the assignment of intervention.
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** HEALTH_SERVICES_RESEARCH
#### Enrollment Info
**Count:** 103920
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Wards randomly assigned to this arm will not receive any intervention until after endline data collection in completed. During the study period, the caregivers in this group will have standard access to ORS and zinc at local health facilities and pharmacies. Some community health workers in control villages could make household visits; however, any delivery of ORS or zinc in the control group is not expected as community health workers are generally not the source of diarrhea treatment.
**Label:** Delayed-start control
**Type:** NO_INTERVENTION
#### Arm Group 2
**Description:** Wards randomized to this arm will primarily receive four intervention components as described under the "Intervention" section
**Intervention Names:**
- Behavioral: Community Sensitization + Household visit + Information + Free pre-emptive distribution of ORS+Zinc
**Label:** Community Sensitization + Household visit + Information + Free pre-emptive distribution of ORS+Zinc
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Community Sensitization + Household visit + Information + Free pre-emptive distribution of ORS+Zinc
**Description:** The intervention will involve the following: 1) The communities will be sensitized on the importance of ORS and Zinc use for the treatment of child diarrhea, by the Clinton Health Access Initiative (CHAI). 2) Campaigners recruited by CHAI will visit each household in their catchment area that contain at child under 5 years old. 3) During the distribution visits, the campaigners will train caregivers on the dangers of diarrhea and the importance of ORS and zinc use, among other things (including how to prepare, use, and store ORS/zinc, benefits of the treatments, recommended health behaviors such as seeking care, and encouraging basic handwashing and hygiene practices). The caregivers will also receive a flyer describing the same information in their local language, for future reference. 4) Campaigners will then distribute two ORS and zinc co-packs (each co-pack contains two sachets of ORS and 10 tablets of zinc) for free for each child under the age of five in the household.
**Name:** Community Sensitization + Household visit + Information + Free pre-emptive distribution of ORS+Zinc
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** Self-reported ORS use for a case of child diarrhea that occurred within the last 4 weeks.
**Measure:** ORS Use (cases in last 4 weeks)
**Time Frame:** 1-6 months post intervention
**Description:** Self-reported ORS use for a case of child diarrhea that occurred within the last 4 weeks.
**Measure:** ORS Use (cases in last 4 weeks)
**Time Frame:** 1-12 months post intervention
**Description:** Self-reported ORS use for a case of child diarrhea that occurred within the last 4 weeks.
**Measure:** ORS Use (cases in last 4 weeks)
**Time Frame:** Each month from 1-12 months post intervention
#### Secondary Outcomes
**Description:** Self-reported Zinc + ORS use for a case of child diarrhea that occurred within the last 4 weeks.
**Measure:** Zinc + ORS use
**Time Frame:** 1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention
**Description:** Self-reported antibiotic use for a case of child diarrhea that occurred within the last 4 weeks.
**Measure:** Antibiotic use
**Time Frame:** 1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention
**Description:** Self-reported Zinc use for a case of child diarrhea that occurred within the last 4 weeks.
**Measure:** Zinc use alone
**Time Frame:** 1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention
**Description:** Binary and count variables; binary coded to 1 if caregiver started treatment on the same day the diarrhea began; count variable truncated to 7 days.
**Measure:** Time to ORS initiation
**Time Frame:** 1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention
**Description:** Self-reported use of untreated water to prepare ORS for treating diarrhea experienced by a child who is exclusively breastfed.
**Measure:** Exposure to unsafe drinking water
**Time Frame:** 1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention
**Description:** Self-reported use of ORS, seeking care, and purchase of ORS among households that experienced at least twice as many diarrhea cases as the number of children under 5.
**Measure:** Willingness to purchase new ORS packets
**Time Frame:** 1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention
**Description:** Self-reported mortality (all cause and diarrhea) of children under 5 since intervention
**Measure:** Child mortality; all cause and from diarrhea
**Time Frame:** 1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention
**Description:** Self-reported hospitalization (all cause and diarrhea) of children under 5 since intervention
**Measure:** Hospitalization from diarrhea
**Time Frame:** 1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention
**Description:** Count of episodes of diarrhea experienced by children who had at least one case of diarrhea since intervention.
**Measure:** Number of diarrhea episodes
**Time Frame:** 1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention
**Description:** Binary indicator, coded to 1 if caregiver sought care from each type of provider.
**Measure:** Care seeking outside the home
**Time Frame:** 1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention
**Description:** Binary indicator, coded to 1 for each type of wastage (co-packs being lost, co-packs being stolen, co-packs used for non-diarrhea reasons, co-packs given away)
**Measure:** Wastage of ORS and zinc packets
**Time Frame:** 1-6 months post intervention, 1-12 months post intervention, and each month from 1-12 months post intervention
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* At least 15 years old
* Has at least one child under 5 at baseline
* Proficiency in English or Hausa
Exclusion Criteria:
* Living in a temporary home (nomadic population)
* Does not speak English or Hausa
* Unable to give informed consent
**Healthy Volunteers:** True
**Minimum Age:** 15 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Nneka E Osadolor, Ph.D.
**Phone:** +234 7036838618
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** RAND
**Name:** Zachary Wagner, Ph.D.
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** RAND
**Name:** Stephanie Bonds, Ph.D.
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Access Criteria:** Re-identification of study participants will not be permitted. Other criteria as set by the repository.
**Description:** Deidentified data will be shared in a public repository at the end of the study.
**Info Types:**
- STUDY_PROTOCOL
**IPD Sharing:** YES
**Time Frame:** Indefinitely
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012817
- Term: Signs and Symptoms, Digestive
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M7159
- Name: Diarrhea
- Relevance: HIGH
- As Found: Diarrhea
- ID: M15622
- Name: Signs and Symptoms, Digestive
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003967
- Term: Diarrhea
### Intervention Browse Module - Browse Branches
- Abbrev: Micro
- Name: Micronutrients
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M17768
- Name: Zinc
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06444620
**Brief Title:** B/F/TAF to DTG/3TC Switch Study
**Official Title:** Efficacy, Safety and Tolerability of Switching to DTG/3TC Single Tablet Regimen From B/F/TAF in Older Persons Living With HIV in Kenya
#### Organization Study ID Info
**ID:** Sungura Study
#### Organization
**Class:** OTHER
**Full Name:** University of Nairobi
### Status Module
#### Completion Date
**Date:** 2026-06-15
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-06-15
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-15
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** ViiV Healthcare
**Class:** INDUSTRY
**Name:** Mylan Laboratories
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Nairobi
#### Responsible Party
**Investigator Affiliation:** University of Nairobi
**Investigator Full Name:** Loice Achieng Ombajo
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** OBJECTIVE:
To assess the efficacy and safety of switch to dolutegravir and lamivudine (DTG/3TC) single tablet regimen from bictegravir, emtricitabine and tenofovir alafenamide (B/F/TAF) in persons living with HIV aged 60 years old or more.
METHODS:
This is a phase 3b, multi-center, open-label, single-arm clinical trial over 96 weeks. The study will take place at two sites in Kenya: Kenyatta National Hospital (KNH) and Jaramogi Oginga Odinga Teaching and Referral Hospital (JOOTRH). Study visits will take place at screening, baseline, and weeks 4, 12, 24, 36, 48, 60, 72, 84, and 96 (with a 6-week extension as required for confirming HIV-1 RNA levels). A target of 240 participants from the ongoing B/F/TAF Elderly Switch Study will be enrolled. Eligible participants will be switched from B/F/TAF to DTG/3TC at enrollment and followed up for 96 weeks. The primary endpoint will be the proportion of participants with plasma HIV-1 RNA ≥ 50 copies/mL (Snapshot algorithm) at Week 48. Analysis of the primary endpoint will be performed for the intention to treat - exposed (ITT-E) population using the FDA snapshot method.
**Detailed Description:** BACKGROUND:
Three drug regimens for the treatment of HIV are widely used and successful in achieving viral suppression. However, they are associated with various adverse events including renal and bone disease, anaemia, mitochondrial toxicity, and possible association with increased cardiovascular events. Data from the ongoing B/F/TAF Elderly Switch Study has demonstrated high rates of renal insufficiency and osteoporosis in people living with HIV aged 60 years or more, hence the need for safe treatment options. Two drug regimens (2DR) have demonstrated non-inferiority to three drug regimens in patients who are treatment-naïve as well as in those who are virally suppressed on a first-line regimen and potentially have lower toxicity, fewer adverse drug events and a lower drug burden.
OVERALL STRATEGY:
This is a phase 3b, multi-centre, open-label, single-arm clinical trial over 96 weeks describing the efficacy of switching virally suppressed HIV-1 infected adults to DTG/3TC dual therapy from their current B/F/TAF regimen. The primary efficacy endpoint is the proportion of participants with viral load (VL) ≥ 50 copies/ml at week 48.
The study will take place at two sites in Kenya: Kenyatta National Hospital (KNH, the largest teaching and referral hospital in Kenya), and Jaramogi Oginga Odinga Teaching and Referral Hospital (JOOTRH, the largest teaching and referral hospital in the Nyanza region of Kenya). The outpatient HIV clinics at these sites currently provide antiretroviral therapy (ART) to over 15,000 persons living with HIV (PWH) combined. These two sites are currently participating in the B/F/TAF-elderly study.
Study visits will take place at screening, baseline, and weeks 4, 12, 24, 36, 48, and 96 (with a 6-week extension as required for confirming HIV-1 RNA levels within the FDA snapshot window). HIV-1 RNA viral load will be performed at screening and weeks 4, 12, 24, 48 and 96. If HIV-1 RNA is ≥ 50 copies/ml then a repeat test will be performed at least 2 weeks after the detectable result to confirm virological failure. If the repeat HIV-1 RNA result is ≥ 50 copies/ml this confirms protocol-defined virological failure (PDVF) and genotypic resistance testing will be performed for any repeat viral load ≥ 500 copies/ml. Other routine study investigations will include CD4 count, complete blood count, serum Cr, renal biomarkers, alanine transaminase (ALT), aspartate aminotransferase (AST), fasting lipids, fasting glucose and patient satisfaction questionnaires (HIVTSQ).
METHODS:
The anticipated sample size is 240 participants started on study treatment among patients on B/F/TAF therapy for at least 24 weeks and no prior virological failure (defined as two consecutive HIV-1 RNA viral loads ≥ 50 copies/ml separated by at least 2 weeks), with a viral load of \< 50 copies/ml for at least 12 weeks, and aged 60 years or above.
All participants will be recruited from the pool of patients who are exiting the B/F/TAF-elderly trial at the two study sites. Those who provide written informed consent will be assessed for eligibility through review of their medical records, history and physical examination.
Patients who provide informed consent and meet all eligibility criteria after screening investigations will be enrolled in the study within 28 days of the screening investigations and will complete baseline investigations (CD4 count, fasting lipid profile and fasting glucose). During the enrollment visit participants will be switched to DTG/3TC two drug regimen.
Participants will be engaged in the study for 96 weeks plus up to 28 days between screening and enrolment, and a follow-up visit up to 28 days beyond the week 96 visit if required to confirm HIV-1 RNA within the FDA snapshot window.
### Conditions Module
**Conditions:**
- HIV-1-infection
**Keywords:**
- HIV
- Bictegravir
- Tenofovir alafenamide
- Dolutegravir
- Dual therapy
- First-line
- Elderly
- Switch
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 240
**Type:** ESTIMATED
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants will be switched from B/F/TAF to a fixed-dose combined DTG/3TC pill each containing 50mg of dolutegravir and 300mg of lamivudine taken once daily for the duration of the study
**Intervention Names:**
- Drug: DTG/3TC
**Label:** Switch to DTG/3TC 2DR
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Switch to DTG/3TC 2DR
**Description:** This is a fixed-dose combined DTG/3TC pill each containing 50mg of dolutegravir and 300mg of lamivudine
**Name:** DTG/3TC
**Other Names:**
- Avridela
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Number and proportion of participants with plasma HIV-1 RNA ≥ 50 copies/mL as per the FDA Snapshot algorithm) at Week 48
**Measure:** Proportion of participants with virological failure at week 48
**Time Frame:** 48 weeks
#### Secondary Outcomes
**Description:** Number and proportion of participants with plasma HIV-1 RNA ≥ 50 copies/mL as per the FDA Snapshot algorithm at 24 weeks
**Measure:** Proportion of participants with virological failure at week 24
**Time Frame:** 24 weeks
**Description:** Number and proportion of participants with plasma HIV-1 RNA ≥ 50 copies/mL as per the FDA Snapshot algorithm at 96 weeks
**Measure:** Proportion of participants with virological failure at week 96
**Time Frame:** 96 weeks
**Description:** Number and proportion of participants with plasma HIV-1 RNA \<50 copies/mL as per the FDA Snapshot algorithm at 24, 48 and 96 weeks
**Measure:** Proportion of participants with treatment success
**Time Frame:** 24, 48 and 96 weeks
**Description:** Absolute values and changes from baseline in CD4+ cells count and CD4:CD8 ratio at 24, 48 and 96 weeks
**Measure:** Change in CD4
**Time Frame:** 24, 48 and 96 weeks
**Description:** Occurrence of disease progression (HIV associated conditions, AIDS, and death) through Weeks 24, 48 and 96
**Measure:** Number of participants with HIV disease progression
**Time Frame:** 24, 48 and 96 weeks
**Description:** Change in lipid parameters (total cholesterol, HDL and LDL cholesterol, triglyceride and TC/HDL ratio) from baseline to weeks 24, 48 and 96
**Measure:** Change in lipid parameters
**Time Frame:** 24, 48 and 96 weeks
**Description:** Change in fasting blood sugar from baseline to weeks 48 and 96
**Measure:** Change in fasting blood sugar
**Time Frame:** 48 and 96 weeks
**Description:** Change in blood pressure over 24, 48 and 96 weeks
**Measure:** Change in blood pressure
**Time Frame:** 24, 48 and 96 weeks
**Description:** Mean change in weight at week 24, 48 and 96
**Measure:** Change in weight
**Time Frame:** 24, 48 and 96 weeks
**Description:** Change from baseline in total and regional (trunk and limbs) fat and lean (fat-free) mass by dual energy x-ray absorptiometry (DXA) at 96 weeks in a subset of participants performing DXA scans
**Measure:** Change in fat and lean mass
**Time Frame:** 96 weeks
**Description:** Proportion of participants with ≥10% weight gain at weeks 48 and 96
**Measure:** Weight gain of 10% or more
**Time Frame:** 48 and 96 weeks
**Description:** Change from baseline in ASCVD score at weeks 48 and 96
**Measure:** Change in the Atherosclerotic Cardiovascular Disease (ASCVD) score which is a 10-year risk for ASCVD estimation with <5% being low risk and a higher percentage representing increased ASCVD risk
**Time Frame:** 48 and 96 weeks
**Description:** Patient satisfaction (HIVTSQs) at baseline, weeks 24 and 96
**Measure:** Patient satisfaction as measured using the HIV Treatment Satisfaction Questionnaire - Status version (HIVTSQs) which scores 10 variables on a 7-point likert score ranging from 0 to 6 with a higher score representing a better outcome
**Time Frame:** 24 and 96 weeks
**Description:** Patient satisfaction (HIVTSQc) at week 48
**Measure:** Change in patient satisfaction as measured using the HIV Treatment Satisfaction Questionnaire - Change version (HIVTSQc) which scores 10 variables on a 7-point likert score ranging from -3 to +3 with a higher score representing a better outcome
**Time Frame:** 48 weeks
**Description:** Health related quality of life (WHOQOL-HIV BREF) at baseline, week 48 and week 96 assessing 31 aspects on a 5-point likert scale ranging from 1 to 5 with a higher score representing a better outcome
**Measure:** Health related quality of life as measured using the World Health Organization Quality of Life brief questionnaire in HIV population (WHOQOL-HIV BREF) tool
**Time Frame:** 48 and 96 weeks
**Description:** Occurrence of viral resistance in participants meeting confirmed virologic withdrawal criterion (Plasma HIV-1 RNA ≥ 200 copies/mL preceded by a Plasma HIV-1 RNA ≥ 50 copies/mL) over time
**Measure:** HIV drug resistance
**Time Frame:** 24, 48 and 96 weeks
**Description:** Incidence and severity of adverse events and laboratory abnormalities over time through Week 96
**Measure:** Incidence of adverse events
**Time Frame:** 24, 48 and 96 weeks
**Description:** Occurrence of DTG/3TC-non-serious adverse drug-related reactions, all serious adverse events and proportion of participants who discontinue treatment due to adverse event
**Measure:** Treatment-related adverse events
**Time Frame:** 24, 48 and 96 weeks
**Description:** Change from Baseline (Day 1) in renal biomarkers at Weeks 48 and 96
**Measure:** Change in beta-2 microglobulin
**Time Frame:** 48 and 96 weeks
**Description:** Change from Baseline (Day 1) in renal biomarkers at Weeks 48 and 96
**Measure:** Change in retinol binding protein
**Time Frame:** 48 and 96 weeks
**Description:** Change from Baseline (Day 1) in renal biomarkers at Weeks 48 and 96
**Measure:** Change in cystatin C
**Time Frame:** 48 and 96 weeks
**Description:** Changes from baseline in estimated glomerular filtration rate (CKD-EPI creatinine) at 48 and 96 weeks
**Measure:** Change in the estimated glomerular filtration rate as measured using the 2021 CKD-EPI creatinine calculator
**Time Frame:** 48 and 96 weeks
**Description:** Changes from baseline in estimated glomerular filtration rate (CKD-EPI Creatinine-Cystatin C) at 48 and 96 weeks
**Measure:** Change in the estimated glomerular filtration rate as measured using the 2021 CKD-EPI creatinine-cystatin C calculator
**Time Frame:** 48 and 96 weeks
**Description:** Changes from baseline in the urinary protein/creatinine at 48 and 96 weeks
**Measure:** Change in urinary protein/creatinine ratio
**Time Frame:** 48 and 96 weeks
**Description:** Change from baseline in AST, ALT and GGT levels at week 48 and 96
**Measure:** Change in AST, ALT and gamma-glutamyltransferase (GGT)
**Time Frame:** 48 and 96 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Able and willing to understand and comply with the protocol requirements, instructions and restrictions
* Able and willing to give informed consent
* Have been randomised to the B/F/TAF arm and completed the B/F/TAF-elderly study. Participants should be on B/F/TAF until day 1 of entry into the current study
* HIV-1 RNA viral load \< 50 copies/ml at screening (within 28 days prior to enrollment)
Exclusion Criteria:
* Confirmed treatment failure as defined by two consecutive HIV-1 RNA viral loads ≥ 50 copies/ml separated by at least 2 weeks, after at least 6 months on ART or after a documented HIV-1 RNA viral load \< 50 copies/ml
* Using any protocol-defined prohibited medicine where the participant is unwilling or unable to switch to an alternative (see Section 5.2. under Prohibited medications and non-drug therapies)
* Evidence of hepatitis B virus (HBV) infection based on the results of testing at screening for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (anti-HBc), hepatitis B surface antibody (anti-HBs) and HBV DNA as follows:
1. Participants positive for HBsAg are excluded;
2. Participants negative for anti-HBs but positive for anti-HBc (negative HBsAg status), whether negative or positive for HBV DNA, are excluded;
3. Participants positive for anti-HBc (negative HBsAg status) and positive for anti-HBs (past and/or current evidence) are immune to HBV and are not excluded.
* Has AST and/or ALT at least 5-times greater than the upper limit of normal
* Severe hepatic impairment (Class C) as determined by Child-Pugh classification
* Has an estimated creatinine clearance (CrCl) below 30 ml/min (as estimated using the Cockcroft-Gault estimate for glomerular filtration rate)
* Documented opportunistic infection within 4 weeks prior to the study enrolment
* Any condition (including illicit drug use or alcohol abuse) or laboratory results which, in the investigator's opinion, interfere with assessments or completion of the study
* Untreated syphilis infection (positive rapid plasma reagin \[RPR\] at Screening without clear documentation of treatment). Participants who are at least 7 days post completed treatment are eligible.
* History or presence of allergy or intolerance to the study treatment or their components or drugs of their class or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.
* Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical, anal or penile intraepithelial neoplasia.
* Participants who in the investigator's judgment, poses a significant suicidality risk. Participant's history of suicidal behavior and/or suicidal ideation should be considered when evaluating for suicide risk
* Any evidence of any major 3TC resistance associated mutations (M184V/I and/or K65R and/or MDR) or presence of any major INSTI resistance associated mutation
**Minimum Age:** 60 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Joseph Nkuranga, MBChB, MSc
**Phone:** +254 737 223988
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Kisumu
**Country:** Kenya
**Facility:** Jaramogi Oginga Odinga Teaching and Referral Hospital
**Location 2:**
**City:** Nairobi
**Country:** Kenya
**Facility:** Kenyatta National Hospital
#### Overall Officials
**Official 1:**
**Affiliation:** University of Nairobi
**Name:** Loice A Ombajo, MD, MSc
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Access Criteria:** Access to IPD will be subject to the University of Nairobi data sharing requirements. Written requests should be submitted to the Principal Investigator providing a brief description of the individual or group making the request and detailing the reason for the same. Prior to sharing the data, the requestor will be required to sign a data access and sharing agreement.
**Description:** We will share the individual patient data (IPD) that underlie the results reported after de-identification (text, tables, figures and appendices)
**Info Types:**
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
**IPD Sharing:** YES
**Time Frame:** Beginning 6 months after publication of the final manuscript and for a period of 36 months
## Derived Section
### 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
### Condition Browse Module - Browse Leaves
- ID: M18250
- Name: HIV 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: M3522
- Name: Acquired Immunodeficiency Syndrome
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M21243
- Name: Lamivudine
- Relevance: LOW
- As Found: Unknown
- ID: M296
- Name: Tenofovir
- Relevance: LOW
- As Found: Unknown
- ID: M347662
- Name: Dolutegravir
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06444607
**Acronym:** HEPHESTOS
**Brief Title:** Hereditary Pheochromocytoma Assessment of Tumour Immunologies
**Official Title:** HEPHESTOS - Hereditary Pheochromocytoma Assessment of Tumour Immunologies
#### Organization Study ID Info
**ID:** 115703
#### Organization
**Class:** OTHER
**Full Name:** Radboud University Medical Center
### Status Module
#### Completion Date
**Date:** 2029-06-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2029-06-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Radboud University Medical Center
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** In this study, the investigators are examining the role of the immune system in pheochromocytoma and paraganglioma. The investigators aim to examine the differences in the immune system between people who have these tumors with and without a hereditary predisposition. The investigators also want to see how the immune system changes during the development of the tumor in people with a hereditary predisposition. Finally, the investigators will compare the data with a control group of people without these tumors. Ultimately, the investigators hope that the results will contribute to the discovery of new immune system-targeted medications for pheochromocytoma and paraganglioma.
**Detailed Description:** Rationale: Pheochromocytoma and Paraganglioma (PPGL) represent rare, catecholamine-secreting tumours (1). Genetic or sporadic mutations, accounting for approximately 70% of cases, significantly contribute to PPGL development, and are categorized into three clusters based on tumour formation mechanisms (2,3). Current treatment options, particularly for advanced or metastatic disease, are limited (4). Understanding the immune system's role and the impact of genetics on tumour immunology in PPGL could unveil crucial insights for therapeutic advancements. Earlier studies emphasized the immunogenic nature of PPGL, highlighting the tumour microenvironment (TME) and circulatory factors as key components (5-7). However, these studies lack specific examination of genotypes' effect on the immune system. This study aims to address this gap in two parts, particularly focusing on differences between genetic clusters.
Objective: To examine the differences in the immune system in PPGL regarding genetics. Part I will examine immune cell composition and response in circulation. Part II will examine immune cell composition in TME.
Study design: Part I will be a partly cross-sectional and partly prospective cohort study. Part II will be a histological study of retrospectively and prospectively collected PPGL samples.
Study population: Part I will include 80 patients with PPGL, 80 carriers of germline mutations predisposing for PPGL, and 40 sex and age matched healthy volunteers. Part II will include histological samples of 80 patients with hereditary disease and 80 patients with sporadic disease.
Main study parameters/endpoints: The main study outcomes are inflammatory molecules and proteins produced by stimulated and unstimulated immune cells from circulation, immune cell composition in histological PPGL samples and in circulation, and their genetic determinants. Secondary outcomes will comprise of transcriptional and epigenetic signature of circulating immune cells, circulating immunomodulating metabolites, trained immunity, and clinical outcomes such as tumour metastasis, survival.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: For patients and mutation carriers, there is no direct benefit in participating in this study. However, by participating, they can contribute to the acquisition of scientific knowledge and the development of new therapeutic targets and novel disease management strategies. Such strategies might benefit patients and mutation carriers in the future if they potentially develop advanced disease. There are no risks associated with the study. There are no interventions other than those related to the regular patient care (venipuncture). Thus, this study is considered to impose a low burden on patients.
### Conditions Module
**Conditions:**
- Pheochromocytoma
- Paraganglioma
**Keywords:**
- Pheochromocytoma
- Paraganglioma
- Tumor microenvironment
- Innate immunity
### Design Module
#### Bio Spec
**Description:** Serum, plasma, and white blood cells from participating patients, obtained from whole blood during routine care.
Histological samples from PPGL tissue after planned surgery.
**Retention:** SAMPLES_WITH_DNA
#### Design Info
**Observational Model:** OTHER
**Time Perspective:** OTHER
#### Enrollment Info
**Count:** 200
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Blood will be collected prior and after surgery for their pheochromocytoma/paraganglioma (as planned by their treating physician). Blood will also be collected prospectively during regular follow-up appointments after 1 year and after 2 years.
**Intervention Names:**
- Procedure: Venepuncture
**Label:** Patients with hereditary PPGL
#### Arm Group 2
**Description:** Blood will be collected prior and after surgery for their pheochromocytoma/paraganglioma (as planned by their treating physician). Blood will also be collected prospectively during regular follow-up appointments after 1 year and after 2 years.
**Intervention Names:**
- Procedure: Venepuncture
**Label:** Patients with sporadic PPGL
#### Arm Group 3
**Description:** Blood will be collected at inclusion, after 1 year and after 2 years.
**Intervention Names:**
- Procedure: Venepuncture
**Label:** Asymptomatic carriers of germline mutations predisposing for PPGL
#### Arm Group 4
**Description:** Blood material will be obtained from healthy anonymous donors according to the protocol "Donation of blood by healthy volunteers for experimental in-vitro research" (Human Subjects Review Board approval number: NL84281.091.23).
**Intervention Names:**
- Procedure: Venepuncture
**Label:** Sex and age matched healthy volunteers
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Asymptomatic carriers of germline mutations predisposing for PPGL
- Patients with hereditary PPGL
- Patients with sporadic PPGL
**Description:** Blood draw in the context of routine patient care, when a venipuncture is already scheduled.
**Name:** Venepuncture
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- Sex and age matched healthy volunteers
**Description:** Volunteering for blood draw.
**Name:** Venepuncture
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** e.g. cytokines
**Measure:** Immune cell response in circulation, both after stimulation and in an unstimulated state, measured as the concentration of inflammatory molecules and proteins.
**Time Frame:** Before surgery, 6 weeks after surgery, after 1 year, after 2 years.
**Measure:** Immune cell composition in histological PPGL specimens and in circulation.
**Time Frame:** Before surgery, 6 weeks after surgery, after 1 year, after 2 years. Histological specimens will only be obtained during surgery.
#### Secondary Outcomes
**Measure:** Transcriptional and epigenetic signature of circulating immune cells.
**Time Frame:** Before surgery, 6 weeks after surgery, after 1 year, after 2 years.
**Description:** e.g. catecholamines, succinate.
**Measure:** Concentration of immunomodulating metabolites in circulation.
**Time Frame:** Before surgery, 6 weeks after surgery, after 1 year, after 2 years.
**Measure:** Trained immunity assessment of circulating immune cells.
**Time Frame:** Before surgery, 6 weeks after surgery, after 1 year, after 2 years.
**Measure:** Tumour recurrence rate
**Time Frame:** After 1 year, after 2 years.
**Measure:** Metastasis rate
**Time Frame:** Before surgery, after 1 year, after 2 years.
**Measure:** Survival rate
**Time Frame:** After 1 year, after 2 years.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
Part I:
* Newly diagnosed patients with PPGL or newly diagnosed patients with (metastatic) PPGL recurrence.
* OR patients with mutations which predispose for the development of PPGL.
* Aged \> 18 years.
Part II:
* Confirmed PPGL on pathology.
* Aged \> 18 years.
Exclusion Criteria:
* Unable to provide informed consent.
* Active inflammatory or infectious comorbidities.
* Other malignancies which are under active treatment (except for basal cell carcinoma, other in situ carcinomas).
* Using medication interfering with the immune system
* Pregnancy or breastfeeding
* A self-reported alcohol consumption of \>21 units per week
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** For part I, the study population will consist of patients who are presenting or are currently under follow-up at the Radboudumc endocrinology department for their PPGL. We will include 80 patients with hereditary or sporadic cases of PPGL and an equivalent number of asymptomatic carriers. The healthy control group will consist of 40 age and sex matched healthy volunteers.
Part II will include histological samples of 160 patients with PPGL, of which 80 hereditary and 80 sporadic. A large part of the population will overlap between part I and part II, since almost all patients with PPGL undergo surgery for their tumour. These samples will partly be retrospectively collected from the Radboudumc Urology Biobank, where biomaterials from previously treated patients with PPGLs are kept and stored or future scientific research (Human Subjects Review Board approval number: CWOM-9803-0060). The remaining samples will be collected prospectively from patients undergoing surgery for their PPGL.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Kai Xu, M.D.
**Phone:** +316 42385270
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Marieke de Laat, M.D. PhD
**Phone:** +3124 361 4599
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Radboud University Medical Center
**Name:** Margo Dona, PhD
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** Radboud University Medical Center
**Name:** Henri Timmers, M.D. PhD
**Role:** PRINCIPAL_INVESTIGATOR
**Official 3:**
**Affiliation:** Radboud University Medical Center
**Name:** Romana Netea-Maier, M.D. PhD
**Role:** PRINCIPAL_INVESTIGATOR
**Official 4:**
**Affiliation:** Radboud University Medical Center
**Name:** Marieke de Laat, M.D. PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** Data will be made available by the corresponding author upon reasonable request.
**Info Types:**
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
- ANALYTIC_CODE
**IPD Sharing:** YES
**Time Frame:** One year after completion of the study.
### References Module
#### References
**Citation:** Lenders JW, Eisenhofer G, Mannelli M, Pacak K. Phaeochromocytoma. Lancet. 2005 Aug 20-26;366(9486):665-75. doi: 10.1016/S0140-6736(05)67139-5.
**PMID:** 16112304
**Citation:** Cascon A, Calsina B, Monteagudo M, Mellid S, Diaz-Talavera A, Curras-Freixes M, Robledo M. Genetic bases of pheochromocytoma and paraganglioma. J Mol Endocrinol. 2023 Jan 24;70(3):e220167. doi: 10.1530/JME-22-0167. Print 2023 Apr 1.
**PMID:** 36520714
**Citation:** Jhawar S, Arakawa Y, Kumar S, Varghese D, Kim YS, Roper N, Elloumi F, Pommier Y, Pacak K, Del Rivero J. New Insights on the Genetics of Pheochromocytoma and Paraganglioma and Its Clinical Implications. Cancers (Basel). 2022 Jan 25;14(3):594. doi: 10.3390/cancers14030594.
**PMID:** 35158861
**Citation:** Nolting S, Bechmann N, Taieb D, Beuschlein F, Fassnacht M, Kroiss M, Eisenhofer G, Grossman A, Pacak K. Personalized Management of Pheochromocytoma and Paraganglioma. Endocr Rev. 2022 Mar 9;43(2):199-239. doi: 10.1210/endrev/bnab019. Erratum In: Endocr Rev. 2021 Dec 14;: Endocr Rev. 2021 Dec 14;:
**PMID:** 34147030
**Citation:** Tufton N, Hearnden RJ, Berney DM, Drake WM, Parvanta L, Chapple JP, Akker SA. The immune cell infiltrate in the tumour microenvironment of phaeochromocytomas and paragangliomas. Endocr Relat Cancer. 2022 Sep 19;29(11):589-598. doi: 10.1530/ERC-22-0020. Print 2022 Nov 1.
**PMID:** 35975974
**Citation:** Gao X, Yamazaki Y, Pecori A, Tezuka Y, Ono Y, Omata K, Morimoto R, Nakamura Y, Satoh F, Sasano H. Histopathological Analysis of Tumor Microenvironment and Angiogenesis in Pheochromocytoma. Front Endocrinol (Lausanne). 2020 Nov 10;11:587779. doi: 10.3389/fendo.2020.587779. eCollection 2020.
**PMID:** 33244312
**Citation:** van der Heijden CDCC, Groh L, Keating ST, Kaffa C, Noz MP, Kersten S, van Herwaarden AE, Hoischen A, Joosten LAB, Timmers HJLM, Netea MG, Riksen NP. Catecholamines Induce Trained Immunity in Monocytes In Vitro and In Vivo. Circ Res. 2020 Jul 3;127(2):269-283. doi: 10.1161/CIRCRESAHA.119.315800. Epub 2020 Apr 3.
**PMID:** 32241223
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000018358
- Term: Neuroendocrine Tumors
- ID: D000017599
- Term: Neuroectodermal Tumors
- ID: D000009373
- Term: Neoplasms, Germ Cell and Embryonal
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000009369
- Term: Neoplasms
- ID: D000009380
- Term: Neoplasms, Nerve Tissue
### 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: M13578
- Name: Pheochromocytoma
- Relevance: HIGH
- As Found: Pheochromocytoma
- ID: M13149
- Name: Paraganglioma
- Relevance: HIGH
- As Found: Paraganglioma
- ID: M20495
- Name: Neuroendocrine Tumors
- Relevance: LOW
- As Found: Unknown
- ID: M19845
- Name: Neuroectodermal Tumors
- Relevance: LOW
- As Found: Unknown
- ID: M20388
- Name: Neuroectodermal Tumors, Primitive
- Relevance: LOW
- As Found: Unknown
- ID: M12318
- Name: Neoplasms, Germ Cell and Embryonal
- Relevance: LOW
- As Found: Unknown
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
- ID: M12325
- Name: Neoplasms, Nerve Tissue
- Relevance: LOW
- As Found: Unknown
- ID: T4530
- Name: Pheochromocytoma
- Relevance: HIGH
- As Found: Pheochromocytoma
- ID: T4409
- Name: Paragangliomas 1
- Relevance: HIGH
- As Found: Paraganglioma
- ID: T4091
- Name: Neuroendocrine Tumor
- Relevance: LOW
- As Found: Unknown
- ID: T4092
- Name: Neuroepithelioma
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000010673
- Term: Pheochromocytoma
- ID: D000010235
- Term: Paraganglioma
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06444594
**Acronym:** TRP
**Brief Title:** Transient Receptor Potential Channels
**Official Title:** Transient Receptor Potential Channels in Human Skin
#### Organization Study ID Info
**ID:** 24921
#### Organization
**Class:** OTHER
**Full Name:** Penn State University
### Status Module
#### Completion Date
**Date:** 2026-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-15
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Penn State University
#### Responsible Party
**Investigator Affiliation:** Penn State University
**Investigator Full Name:** Lacy Alexander
**Investigator Title:** Professor of Kinesiology
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Neurovascular signaling in the skin associated with stimulation of the transient receptor potential (TRP) channels. These channels are stimulated by both temperature and naturally occurring bioactive agents found in mint, chili peppers, garlic, etc. The aim of the study is to examine how topically applied TRP channel agonists including menthol, capsaicin and camphor impact neurovascular responses in the skin.
### Conditions Module
**Conditions:**
- Aging
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- INVESTIGATOR
**Primary Purpose:** BASIC_SCIENCE
#### Enrollment Info
**Count:** 45
**Type:** ESTIMATED
**Phases:**
- EARLY_PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Non-active topical gel
**Intervention Names:**
- Other: Vehicle gel
**Label:** Vehicle Gel
**Type:** PLACEBO_COMPARATOR
#### Arm Group 2
**Description:** Topical menthol gel applied once at 10%
**Intervention Names:**
- Drug: TRPM8 Agonist
**Label:** Transient Receptor Potential (M8) Agonist
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Topical capsaicin gel applied once at 0.05%
**Intervention Names:**
- Drug: TRPV4 Agonist
**Label:** Transient Receptor Potential (V4) Agonist
**Type:** EXPERIMENTAL
#### Arm Group 4
**Description:** Topical camphor gel applied once at 0.6%
**Intervention Names:**
- Drug: TRPV1 Agonist
**Label:** Transient Receptor Potential (V1) Agonist
**Type:** EXPERIMENTAL
#### Arm Group 5
**Description:** Topical menthol 10%, capsaicin 0.05%, camphor 0.6% applied once
**Intervention Names:**
- Drug: TRPM8, TRPV4, TRPV1 Agonists
**Label:** Transient Receptor Potential M8 V4 V1 Agonist
**Type:** EXPERIMENTAL
#### Arm Group 6
**Description:** no gel comparison
**Label:** no gel
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Transient Receptor Potential (M8) Agonist
**Description:** menthol gel 4-10%
**Name:** TRPM8 Agonist
**Other Names:**
- menthol
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Transient Receptor Potential (V1) Agonist
**Description:** camphor gel 5-20%
**Name:** TRPV1 Agonist
**Other Names:**
- camphor
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- Transient Receptor Potential (V4) Agonist
**Description:** capsaicin gel 0.05-1%%
**Name:** TRPV4 Agonist
**Other Names:**
- capsaicin
**Type:** DRUG
#### Intervention 4
**Arm Group Labels:**
- Transient Receptor Potential M8 V4 V1 Agonist
**Description:** menthol (4-10%), capsaicin (0.05-1%), camphor (5-20%)
**Name:** TRPM8, TRPV4, TRPV1 Agonists
**Other Names:**
- menthol, capsaicin, camphor
**Type:** DRUG
#### Intervention 5
**Arm Group Labels:**
- Vehicle Gel
**Description:** Inactive vehicle gel
**Name:** Vehicle gel
**Other Names:**
- Inactive vehicle gel
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Laser doppler flowmeter to measure skin blood flow during a slow local heating of the skin
**Measure:** Skin blood flow during slow local heating
**Time Frame:** 75 minutes
**Description:** heat and cold perception using a visual analog scale
**Measure:** Somatosensory perception
**Time Frame:** every 5 minutes for 120 minues
**Description:** pain pressure thresholds
**Measure:** algometer measurement
**Time Frame:** every 30 minutes for 120 minutes
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* 18-85 years old.
* Women will not be pregnant and/or breastfeeding.
Exclusion Criteria:
* Currently pregnant or breastfeeding
* Nicotine use (e.g., smoking, chewing tobacco etc.), quantified as more than 100 cigarettes or cigars in a lifetime)
* Known skin allergies or current rash, skin disease, disorders of pigmentation
* Diabetes
* Body mass index \>35kg\*m-2
* Using calcium channel blockers
* Raynaud's syndrome
* Allergy or hypersensitivity to menthol, camphor, capsaicin or adhesive
* Regular use (defined as greater than once a week) of topical analgesics that contain menthol, camphor or capsaicin
**Healthy Volunteers:** True
**Maximum Age:** 85 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Lacy Alexander, Ph.D.
**Phone:** 8148671781
**Role:** CONTACT
**Contact 2:**
**Name:** Sue K Slimak, R.N.
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** University Park
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Lacy Alexander, Ph.D.
- **Phone:** 814-867-1781
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Sue Slimak, R.N.
- **Role:** CONTACT
**Country:** United States
**Facility:** Noll Laboratory
**State:** Pennsylvania
**Zip:** 16802
#### Overall Officials
**Official 1:**
**Affiliation:** Penn State University
**Name:** Lacy Alexander, Ph.D.
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Intervention Browse Module - Ancestors
- ID: D000000982
- Term: Antipruritics
- ID: D000003879
- Term: Dermatologic Agents
- ID: D000018689
- Term: Sensory System Agents
- ID: D000018373
- Term: Peripheral Nervous System Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000000891
- Term: Anti-Infective Agents, Local
- ID: D000000890
- Term: Anti-Infective Agents
### Intervention Browse Module - Browse Branches
- Abbrev: Derm
- Name: Dermatologic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Infe
- Name: Anti-Infective Agents
### Intervention Browse Module - Browse Leaves
- ID: M5471
- Name: Capsaicin
- Relevance: HIGH
- As Found: Cerebral Palsy
- ID: M5424
- Name: Camphor
- Relevance: HIGH
- As Found: By 21
- ID: M11591
- Name: Menthol
- Relevance: HIGH
- As Found: Lactate
- ID: M7074
- Name: Dermatologic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4214
- Name: Anti-Infective Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4215
- Name: Anti-Infective Agents, Local
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000002164
- Term: Camphor
- ID: D000002211
- Term: Capsaicin
- ID: D000008610
- Term: Menthol
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06444581
**Brief Title:** Effectiveness of the Universal Prevention Program Super Skills for Life in Schools
**Official Title:** Prevention of Emotional Problems in Spanish School Children Aged 8 to 12 Years Old: Evaluation of the Super Skills for Life Program
#### Organization Study ID Info
**ID:** CIACIF/2021/269
#### Organization
**Class:** OTHER
**Full Name:** Universidad Miguel Hernandez de Elche
#### Secondary ID Infos
**Domain:** Generalitat Valenciana (España)
**ID:** CIACIF/2021/269
**Type:** OTHER_GRANT
### Status Module
#### Completion Date
**Date:** 2025-05
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-05
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-06
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-01-08
**Type:** ACTUAL
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Universidad Miguel Hernandez de Elche
#### Responsible Party
**Investigator Affiliation:** Universidad Miguel Hernandez de Elche
**Investigator Full Name:** Mireia Orgilés Amorós
**Investigator Title:** Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** This study aims to evaluate the effectiveness of a 12-session cognitive-behavioral transdiagnostic protocol for Spanish children aged 8 to 12 within an educational context, Super Skills for Life. The program, designed to enhance emotional management and social interaction skills, will be delivered in a group format and supplemented with multimedia materials. The study will compare outcomes between an intervention group and a wait-list control group.
**Detailed Description:** A 2 x 4 factorial design will be employed, with the intervention condition (intervention or waiting list) as the intergroup factor and the evaluation phase (pretest, posttest, 6-month follow-up, and 12-month follow-up) as the intragroup factor. Both parents and children will complete the same assessments at baseline, post-treatment, and follow-up stages. The researchers will analyze the changes in emotional and social variables from pre- to post-assessment in children who participate in the program.
### Conditions Module
**Conditions:**
- Social Skills
- Perfectionism
- Self Esteem
- Positive Affect
- Negative Affect
- Emotion Regulation
- Depressive Symptoms
- Anxiety Symptoms
- Mood Disorders
- Emotional Intelligence
**Keywords:**
- Social skills
- Emotional skills
- Prevention universal program
- Program evaluation
- Transdiagnostic protocol
- Cognitive-behavioral protocol
- Childhood
- Children
- School
- Educational context
- Group format
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
**Intervention Model Description:** Participants who meet the inclusion criteria and undergo the full baseline assessment will be assigned to the intervention group condition or to the wait-list control (WLC) group. Children assigned to the intervention condition will receive the twelve-week intervention. Participants in the WLC group will not receive any psychological intervention during the twelve-week program. Children and parents in all groups will complete the same set of measures at approximately the same time (pre-test and post-twelve weeks). Children in the WLC group will receive the intervention after the follow-up visit is completed.
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 600
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Super Skills intervention group: multimedia material version
The Super Skills program will be administered following the manual of the intervention by a trained therapist, as described in the section of intervention/ treatment and will be enriched with multimedia material that the implementer will project at various moments of the sessions.
Super Skills Structured and manualized intervention with a manual for the therapist and a workbook for the children. The intervention will be administered by Super Skills-trained clinical psychologists. Sessions will take place once a week for twelve weeks, with each session lasting approximately fifty minutes. The program includes emotional education and social skills training. These contents are learned through playful exercises, activities, readings and role-playing. The intervention modality will be face-to-face.
**Intervention Names:**
- Behavioral: Super Skills Schools
**Label:** Group experimental
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants in the wait-list group will receive no psychological intervention during the twelve-week duration of the Super Skills program. Families will be informed that children in this group will receive the intervention once the posttest is completed.
**Label:** Group without any intervention
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Group experimental
**Description:** Super Skills Structured and manualized intervention with a manual for the therapist and a workbook for the children. The intervention will be administered by Super Skills-trained clinical psychologists. Sessions will take place once a week for twelve weeks, with each session lasting approximately fifty minutes. The program includes emotional education and social skills training. These contents are learned through playful exercises, activities, readings and role-playing. The intervention modality will be face-to-face.
**Name:** Super Skills Schools
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** SSQ (Pupil Version) is a social skills assessment measure that focuses on a wide range of social behaviors in children aged 8-18. Scoring the Social Skills Questionnaire (Youth): Scores are rated from 0 (Not true), through 1 (Sometimes true), to 2 (Mostly true). The total score is computed by adding up the scores (0, 1, 2) for each item. Total scores range from 0 to 60. Higher scores on this scale indicate higher social skills in children.
**Measure:** Social Skills Questionnaire (SSQ) (Pupil Version)
**Time Frame:** Baseline
**Description:** SSQ (Pupil Version) is a social skills assessment measure that focuses on a wide range of social behaviors in children aged 8-18. Scoring the Social Skills Questionnaire (Youth): Scores are rated from 0 (Not true), through 1 (Sometimes true), to 2 (Mostly true). The total score is computed by adding up the scores (0, 1, 2) for each item. Total scores range from 0 to 60. Higher scores on this scale indicate higher social skills in children.
**Measure:** Social Skills Questionnaire (SSQ) (Pupil Version)
**Time Frame:** Immediately after the intervention
**Description:** SSQ (Pupil Version) is a social skills assessment measure that focuses on a wide range of social behaviors in children aged 8-18. Scoring the Social Skills Questionnaire (Youth): Scores are rated from 0 (Not true), through 1 (Sometimes true), to 2 (Mostly true). The total score is computed by adding up the scores (0, 1, 2) for each item. Total scores range from 0 to 60. Higher scores on this scale indicate higher social skills in children.
**Measure:** Social Skills Questionnaire (SSQ) (Pupil Version)
**Time Frame:** 6 months after the intervention
**Description:** SSQ (Pupil Version) is a social skills assessment measure that focuses on a wide range of social behaviors in children aged 8-18. Scoring the Social Skills Questionnaire (Youth): Scores are rated from 0 (Not true), through 1 (Sometimes true), to 2 (Mostly true). The total score is computed by adding up the scores (0, 1, 2) for each item. Total scores range from 0 to 60. Higher scores on this scale indicate higher social skills in children.
**Measure:** Social Skills Questionnaire (SSQ) (Pupil Version)
**Time Frame:** 12 months after the intervention
**Description:** PANAS-C-SF assesses two subscales in children aged 6 to 18 years: positive affect (joyful, lively, happy, energetic, and proud) and negative affect (angry, fearful/scared, afraid, and sad). Responses are rated on a 5-point Likert scale ranging from 1 (very slightly or never) to 5 (very much).
**Measure:** The Positive and Negative Affect Schedule for Children-Short Form (PANAS-C-SF)
**Time Frame:** Baseline
**Description:** PANAS-C-SF assesses two subscales in children aged 6 to 18 years: positive affect (joyful, lively, happy, energetic, and proud) and negative affect (angry, fearful/scared, afraid, and sad). Responses are rated on a 5-point Likert scale ranging from 1 (very slightly or never) to 5 (very much).
**Measure:** The Positive and Negative Affect Schedule for Children-Short Form (PANAS-C-SF)
**Time Frame:** Immediately after the intervention
**Description:** PANAS-C-SF assesses two subscales in children aged 6 to 18 years: positive affect (joyful, lively, happy, energetic, and proud) and negative affect (angry, fearful/scared, afraid, and sad). Responses are rated on a 5-point Likert scale ranging from 1 (very slightly or never) to 5 (very much).
**Measure:** The Positive and Negative Affect Schedule for Children-Short Form (PANAS-C-SF)
**Time Frame:** 6 months after the intervention
**Description:** PANAS-C-SF assesses two subscales in children aged 6 to 18 years: positive affect (joyful, lively, happy, energetic, and proud) and negative affect (angry, fearful/scared, afraid, and sad). Responses are rated on a 5-point Likert scale ranging from 1 (very slightly or never) to 5 (very much).
**Measure:** The Positive and Negative Affect Schedule for Children-Short Form (PANAS-C-SF)
**Time Frame:** 12 months after the intervention
**Description:** CERQ-k consists of 36 items that measure nine cognitive coping strategies. Each subscale represents one cognitive coping strategy: Self-blame, Other blame, Acceptance, Planning, Positive refocusing, Rumination or focus on thought, Positive reappraisal, Putting into perspective, and Catastrophizing. The response format of the items is a five-point scale from (almost) never to (almost) always. Each item is rated 1 to 5 points. Minimum value 36 and maximum value 180.
**Measure:** Measured by the Cognitive Emotion Regulation Questionnaire (CERQ-k)
**Time Frame:** Baseline
**Description:** CERQ-k consists of 36 items that measure nine cognitive coping strategies. Each subscale represents one cognitive coping strategy: Self-blame, Other blame, Acceptance, Planning, Positive refocusing, Rumination or focus on thought, Positive reappraisal, Putting into perspective, and Catastrophizing. The response format of the items is a five-point scale from (almost) never to (almost) always. Each item is rated 1 to 5 points. Minimum value 36 and maximum value 180.
**Measure:** Measured by the Cognitive Emotion Regulation Questionnaire (CERQ-k)
**Time Frame:** Immediately after the intervention
**Description:** CERQ-k consists of 36 items that measure nine cognitive coping strategies. Each subscale represents one cognitive coping strategy: Self-blame, Other blame, Acceptance, Planning, Positive refocusing, Rumination or focus on thought, Positive reappraisal, Putting into perspective, and Catastrophizing. The response format of the items is a five-point scale from (almost) never to (almost) always. Each item is rated 1 to 5 points. Minimum value 36 and maximum value 180.
**Measure:** Measured by the Cognitive Emotion Regulation Questionnaire (CERQ-k)
**Time Frame:** 6 months after the intervention
**Description:** CERQ-k consists of 36 items that measure nine cognitive coping strategies. Each subscale represents one cognitive coping strategy: Self-blame, Other blame, Acceptance, Planning, Positive refocusing, Rumination or focus on thought, Positive reappraisal, Putting into perspective, and Catastrophizing. The response format of the items is a five-point scale from (almost) never to (almost) always. Each item is rated 1 to 5 points. Minimum value 36 and maximum value 180.
**Measure:** Measured by the Cognitive Emotion Regulation Questionnaire (CERQ-k)
**Time Frame:** 12 months after the intervention
**Description:** SCAS-C-8 measures symptoms severity of the DSMIV anxiety disorders in children. Symptom frequency is recorded on a 3-point Likert scale from 0 (never) to 3 (always). This yields a minimum possible score of 0 and a maximum possible score of 24. Higher scores indicating greater severity of symptoms.
**Measure:** Baseline children's reported anxiety symptoms. Measured by Spence Children's Anxiety Scale Child Report Short (SCAS-C-8)
**Time Frame:** Baseline
**Description:** SCAS-C-8 measures symptoms severity of the DSMIV anxiety disorders in children. Symptom frequency is recorded on a 3-point Likert scale from 0 (never) to 3 (always). This yields a minimum possible score of 0 and a maximum possible score of 24. Higher scores indicating greater severity of symptoms.
**Measure:** Baseline children's reported anxiety symptoms. Measured by Spence Children's Anxiety Scale Child Report Short (SCAS-C-8)
**Time Frame:** Immediately after the intervention
**Description:** SCAS-C-8 measures symptoms severity of the DSMIV anxiety disorders in children. Symptom frequency is recorded on a 3-point Likert scale from 0 (never) to 3 (always). This yields a minimum possible score of 0 and a maximum possible score of 24. Higher scores indicating greater severity of symptoms.
**Measure:** Baseline children's reported anxiety symptoms. Measured by Spence Children's Anxiety Scale Child Report Short (SCAS-C-8)
**Time Frame:** 6 months after the intervention
**Description:** SCAS-C-8 measures symptoms severity of the DSMIV anxiety disorders in children. Symptom frequency is recorded on a 3-point Likert scale from 0 (never) to 3 (always). This yields a minimum possible score of 0 and a maximum possible score of 24. Higher scores indicating greater severity of symptoms.
**Measure:** Baseline children's reported anxiety symptoms. Measured by Spence Children's Anxiety Scale Child Report Short (SCAS-C-8)
**Time Frame:** 12 months after the intervention
**Description:** It assess depressive symptoms experienced in the past two weeks. The MFQS provides an overall score (minimum value 0, maximum value 26). Higher scores indicate more severe symptoms.
**Measure:** Measured by Mood and Feelings Questionnaire - Short Version (MFQS)
**Time Frame:** Baseline
**Description:** It assess depressive symptoms experienced in the past two weeks. The MFQS provides an overall score (minimum value 0, maximum value 26). Higher scores indicate more severe symptoms.
**Measure:** Measured by Mood and Feelings Questionnaire - Short Version (MFQS)
**Time Frame:** Immediately after the intervention
**Description:** It assess depressive symptoms experienced in the past two weeks. The MFQS provides an overall score (minimum value 0, maximum value 26). Higher scores indicate more severe symptoms.
**Measure:** Measured by Mood and Feelings Questionnaire - Short Version (MFQS)
**Time Frame:** 6 months after the intervention
**Description:** It assess depressive symptoms experienced in the past two weeks. The MFQS provides an overall score (minimum value 0, maximum value 26). Higher scores indicate more severe symptoms.
**Measure:** Measured by Mood and Feelings Questionnaire - Short Version (MFQS)
**Time Frame:** 12 months after the intervention
**Description:** The KidKINDL_children measures assess physical and emotional well-being of children aged 7 to 13 years across six dimensions: physical well-being, psychological well-being, self-esteem, family, social relationships, and school. Children rate each item on a 5-point Likert scale: never (1), almost never (2), sometimes (3), almost always (4), and always (5). The total score is calculated by adding the scores for each dimension (range for each dimension: 4 to 20 points). Higher scores on each subscale and on the total scale indicate lower symptoms in children.
**Measure:** Baseline level of physical and emotional well-being reported by children as measured by the KidKINDL_children questionnaire.
**Time Frame:** Baseline
**Description:** The KidKINDL_children measures assess physical and emotional well-being of children aged 7 to 13 years across six dimensions: physical well-being, psychological well-being, self-esteem, family, social relationships, and school. Children rate each item on a 5-point Likert scale: never (1), almost never (2), sometimes (3), almost always (4), and always (5). The total score is calculated by adding the scores for each dimension (range for each dimension: 4 to 20 points). Higher scores on each subscale and on the total scale indicate lower symptoms in children.
**Measure:** Level of physical and emotional well-being reported by children as measured by the KidKINDL_children questionnaire.
**Time Frame:** Immediately after the intervention
**Description:** The KidKINDL_children measures assess physical and emotional well-being of children aged 7 to 13 years across six dimensions: physical well-being, psychological well-being, self-esteem, family, social relationships, and school. Children rate each item on a 5-point Likert scale: never (1), almost never (2), sometimes (3), almost always (4), and always (5). The total score is calculated by adding the scores for each dimension (range for each dimension: 4 to 20 points). Higher scores on each subscale and on the total scale indicate lower symptoms in children.
**Measure:** Level of physical and emotional well-being reported by children as measured by the KidKINDL_children questionnaire.
**Time Frame:** 6 months after the intervention
**Description:** The KidKINDL_children measures assess physical and emotional well-being of children aged 7 to 13 years across six dimensions: physical well-being, psychological well-being, self-esteem, family, social relationships, and school. Children rate each item on a 5-point Likert scale: never (1), almost never (2), sometimes (3), almost always (4), and always (5). The total score is calculated by adding the scores for each dimension (range for each dimension: 4 to 20 points). Higher scores on each subscale and on the total scale indicate lower symptoms in children.
**Measure:** Level of physical and emotional well-being reported by children as measured by the KidKINDL_children questionnaire.
**Time Frame:** 12 months after the intervention
**Description:** It measures global satisfaction with self-concept (minimum value 0 and maximum value 120) and five dimensions (minimum value 0 and maximum value 24): Social (performance in social relationships); Academic/Professional (student/worker role); Emotional (perception of emotional state in general and in specific situations); Family (participation and integration into the family unit); and Physical self-concept (appearance and physical condition). Higher scores indicate greater satisfaction with self-image.
**Measure:** Self-Concept Form 5 (AF-5)
**Time Frame:** Baseline
**Description:** It measures global satisfaction with self-concept (minimum value 0 and maximum value 120) and five dimensions (minimum value 0 and maximum value 24): Social (performance in social relationships); Academic/Professional (student/worker role); Emotional (perception of emotional state in general and in specific situations); Family (participation and integration into the family unit); and Physical self-concept (appearance and physical condition). Higher scores indicate greater satisfaction with self-image.
**Measure:** Self-Concept Form 5 (AF-5)
**Time Frame:** Immediately after the intervention
**Description:** It measures global satisfaction with self-concept (minimum value 0 and maximum value 120) and five dimensions (minimum value 0 and maximum value 24): Social (performance in social relationships); Academic/Professional (student/worker role); Emotional (perception of emotional state in general and in specific situations); Family (participation and integration into the family unit); and Physical self-concept (appearance and physical condition). Higher scores indicate greater satisfaction with self-image.
**Measure:** Self-Concept Form 5 (AF-5)
**Time Frame:** 6 months after the intervention
**Description:** It measures global satisfaction with self-concept (minimum value 0 and maximum value 120) and five dimensions (minimum value 0 and maximum value 24): Social (performance in social relationships); Academic/Professional (student/worker role); Emotional (perception of emotional state in general and in specific situations); Family (participation and integration into the family unit); and Physical self-concept (appearance and physical condition). Higher scores indicate greater satisfaction with self-image.
**Measure:** Self-Concept Form 5 (AF-5)
**Time Frame:** 12 months after the intervention
#### Secondary Outcomes
**Description:** CAPS-S is an instrument designed to assess perfectionism in a Spanish child population aged between 8 and 11. It includes 13 items structured into 3 factors: Self-Oriented Perfectionism-Striving (SOP-Striving), Self-Oriented Perfectionism-Critical (SOP-Critical), and Socially Prescribed Perfectionism (SPP). Items are rated using a 5-point scale ranging from 1 (False - Not at all true of me) to 5 (Very True of me). Higher scores on this scale indicate higher levels of perfectionism in children.
**Measure:** The Child-Adolescent Perfectionism Scale (CAPS-S)
**Time Frame:** Baseline
**Description:** CAPS-S is an instrument designed to assess perfectionism in a Spanish child population aged between 8 and 11. It includes 13 items structured into 3 factors: Self-Oriented Perfectionism-Striving (SOP-Striving), Self-Oriented Perfectionism-Critical (SOP-Critical), and Socially Prescribed Perfectionism (SPP). Items are rated using a 5-point scale ranging from 1 (False - Not at all true of me) to 5 (Very True of me). Higher scores on this scale indicate higher levels of perfectionism in children.
**Measure:** The Child-Adolescent Perfectionism Scale (CAPS-S)
**Time Frame:** Immediately after the intervention
**Description:** CAPS-S is an instrument designed to assess perfectionism in a Spanish child population aged between 8 and 11. It includes 13 items structured into 3 factors: Self-Oriented Perfectionism-Striving (SOP-Striving), Self-Oriented Perfectionism-Critical (SOP-Critical), and Socially Prescribed Perfectionism (SPP). Items are rated using a 5-point scale ranging from 1 (False - Not at all true of me) to 5 (Very True of me). Higher scores on this scale indicate higher levels of perfectionism in children.
**Measure:** The Child-Adolescent Perfectionism Scale (CAPS-S)
**Time Frame:** 6 months after the intervention
**Description:** CAPS-S is an instrument designed to assess perfectionism in a Spanish child population aged between 8 and 11. It includes 13 items structured into 3 factors: Self-Oriented Perfectionism-Striving (SOP-Striving), Self-Oriented Perfectionism-Critical (SOP-Critical), and Socially Prescribed Perfectionism (SPP). Items are rated using a 5-point scale ranging from 1 (False - Not at all true of me) to 5 (Very True of me). Higher scores on this scale indicate higher levels of perfectionism in children.
**Measure:** The Child-Adolescent Perfectionism Scale (CAPS-S)
**Time Frame:** 12 months after the intervention
**Description:** The Kid_KiddoKINDL-R measures assess physical and emotional well-being of children aged 7 to 17 years across six dimensions: physical well-being, psychological well-being, self-esteem, family, social relationships, and school. Parents rate each item on a 5-point Likert scale: never (1), almost never (2), sometimes (3), almost always (4), and always (5). The total score is calculated by adding the scores for each dimension (range for each dimension: 4 to 20 points). Higher scores on each subscale and on the total scale indicate lower symptoms in children
**Measure:** Baseline level of physical and emotional well-being reported by parents as measured by the Kid_KiddoKINDL-R questionnaire
**Time Frame:** Baseline
**Description:** The Kid_KiddoKINDL-R measures assess physical and emotional well-being of children aged 7 to 17 years across six dimensions: physical well-being, psychological well-being, self-esteem, family, social relationships, and school. Parents rate each item on a 5-point Likert scale: never (1), almost never (2), sometimes (3), almost always (4), and always (5). The total score is calculated by adding the scores for each dimension (range for each dimension: 4 to 20 points). Higher scores on each subscale and on the total scale indicate lower symptoms in children
**Measure:** Level of physical and emotional well-being reported by parents immediately after the intervention measured by the Kid_KiddoKINDL-R questionnaire
**Time Frame:** Immediately after the intervention
**Description:** The Kid_KiddoKINDL-R measures assess physical and emotional well-being of children aged 7 to 17 years across six dimensions: physical well-being, psychological well-being, self-esteem, family, social relationships, and school. Parents rate each item on a 5-point Likert scale: never (1), almost never (2), sometimes (3), almost always (4), and always (5). The total score is calculated by adding the scores for each dimension (range for each dimension: 4 to 20 points). Higher scores on each subscale and on the total scale indicate lower symptoms in children
**Measure:** Level of physical and emotional well-being reported by parents 6 months after the intervention measured by the Kid_KiddoKINDL-R questionnaire
**Time Frame:** 6 months after the intervention
**Description:** The Kid_KiddoKINDL-R measures assess physical and emotional well-being of children aged 7 to 17 years across six dimensions: physical well-being, psychological well-being, self-esteem, family, social relationships, and school. Parents rate each item on a 5-point Likert scale: never (1), almost never (2), sometimes (3), almost always (4), and always (5). The total score is calculated by adding the scores for each dimension (range for each dimension: 4 to 20 points). Higher scores on each subscale and on the total scale indicate lower symptoms in children
**Measure:** . Level of physical and emotional well-being reported by parents at 12 months measured by the Kid_KiddoKINDL-R questionnaire
**Time Frame:** 12 months after the intervention
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Children aged 8 to 12 years.
* Be Spanish-speaking.
* Accepting informed consent to participate in the study.
Exclusion Criteria:
* Intellectual disability, behavioral symptoms or autistic spectrum symptoms whose severity prevented the continuation of treatment.
* Current psychological or pharmacological treatment for anxiety and/or depression.
* Not accepting or revoking informed consent to participate in the study.
**Maximum Age:** 12 Years
**Minimum Age:** 8 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Damián Hervás Begines, researcher
**Phone:** +34965222071
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Mireia Orgilés Amorós, professor
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Elche
**Country:** Spain
**Facility:** Department of Health Psychology. Miguel Hernandez University of Elche
**State:** Alicante
**Status:** RECRUITING
**Zip:** 03203
#### Overall Officials
**Official 1:**
**Affiliation:** Miguel Hernadez University of Elche
**Name:** Mireia Orgilés Amorós, professor
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**Access Criteria:** Upon request and verification by the principal investigator to consult the available data. The use of the data for distribution in any format is not permitted.
**Info Types:**
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
**IPD Sharing:** YES
**Time Frame:** Starting after finishing all analysis and publication.
### References Module
#### References
**Citation:** Orgiles M, Fernandez-Martinez I, Espada JP, Morales A. Spanish version of Super Skills for Life: short- and long-term impact of a transdiagnostic prevention protocol targeting childhood anxiety and depression. Anxiety Stress Coping. 2019 Nov;32(6):694-710. doi: 10.1080/10615806.2019.1645836. Epub 2019 Jul 23.
**PMID:** 31334667
**Citation:** Fernandez-Martinez I, Orgiles M, Morales A, Espada JP, Essau CA. One-Year follow-up effects of a cognitive behavior therapy-based transdiagnostic program for emotional problems in young children: A school-based cluster-randomized controlled trial. J Affect Disord. 2020 Feb 1;262:258-266. doi: 10.1016/j.jad.2019.11.002. Epub 2019 Nov 4.
**PMID:** 31733917
**Citation:** Melero S, Morales A, Espada JP, Mendez X, Orgiles M. Effectiveness of Group vs. Individual Therapy to Decrease Peer Problems and Increase Prosociality in Children. Int J Environ Res Public Health. 2021 Apr 9;18(8):3950. doi: 10.3390/ijerph18083950.
**PMID:** 33918640
**Citation:** Essau CA, Sasagawa S, Jones G, Fernandes B, Ollendick TH. Evaluating the real-world effectiveness of a cognitive behavior therapy-based transdiagnostic program for emotional problems in children in a regular school setting. J Affect Disord. 2019 Jun 15;253:357-365. doi: 10.1016/j.jad.2019.04.036. Epub 2019 Apr 16.
**PMID:** 31078836
**Citation:** Yoga Ratnam KK, Nik Farid ND, Yakub NA, Dahlui M. The Effectiveness of the Super Skills for Life (SSL) Programme in Promoting Mental Wellbeing among Institutionalised Adolescents in Malaysia: An Interventional Study. Int J Environ Res Public Health. 2022 Jul 30;19(15):9324. doi: 10.3390/ijerph19159324.
**PMID:** 35954681
#### See Also Links
**Label:** The Child Research Center is the Miguel Hernández University's center dedicated to child and adolescent mental health
**URL:** https://centroinvestigacioninfancia.umh.es/
**Label:** Super Skills for Life program website in Spain
**URL:** https://superskills.umh.es/
**Label:** Super Skills for Life program website in world
**URL:** https://www.superskillsforlife.com/
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001526
- Term: Behavioral Symptoms
- 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: M21835
- Name: Mood Disorders
- Relevance: HIGH
- As Found: Mood Disorders
- ID: M4324
- Name: Anxiety Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M7061
- Name: Depressive Disorder
- Relevance: LOW
- As Found: Unknown
- ID: M7058
- Name: Depression
- Relevance: HIGH
- As Found: Depressive Symptoms
- ID: M4818
- Name: Behavioral Symptoms
- Relevance: LOW
- As Found: Unknown
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003863
- Term: Depression
- ID: D000019964
- Term: Mood Disorders
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |