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## Protocol Section ### Identification Module **NCT ID:** NCT06420232 **Acronym:** Food Anxiety **Brief Title:** Weighted Blanket to Treat Anxiety Related to Trying New Foods the Pediatric Population **Official Title:** Protocol for Using a Weighted Blanket to Treat Anxiety Related to Trying New Foods in the Pediatric Population #### Organization Study ID Info **ID:** 23-0342 #### Organization **Class:** OTHER **Full Name:** The University of Texas Medical Branch, Galveston ### Status Module #### Completion Date **Date:** 2026-04 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-16 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-03 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-20 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-10 **Study First Submit QC Date:** 2024-05-16 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** The University of Texas Medical Branch, Galveston #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Is Unapproved Device:** True **Is US Export:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This small experimental pilot study addresses the knowledge gap related to the use of weighted blankets for children with anxiety related to food and eating. **Detailed Description:** The purpose of the study is to research if weighted blankets might help children with anxiety related to food tolerate new foods better. The parent will be asked to complete a 10-question questionnaire and make a list of the foods the child eats on three occasions (before the study begins, after a control period and after the child uses the weighted blanket). The child will be asked to use a weighted blanket for 5 to 15 minutes prior to at least 3 meals a week for one month, and the child will be asked to complete a 20-question questionnaire taking about 5-12 minutes to complete asking about how they feel on days that they use the weighted blanket and one time a week during the month that they don't use the weighted blanket. The parent will be asked to report any new foods the child tries on the days that they do use the weighted blanket. The parent will be asked to keep the weighted blanket and supervise all use of the weighted blanket for safety. This study will take approximately 2 months total. ### Conditions Module **Conditions:** - Food Neophobia - Picky Eating - Avoidant Restrictive Food Intake Disorder - Anxiety State **Keywords:** - weighted blanket - food avoidance - picky eater - state anxiety - anxiety related to food - children ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** usual care waitlist control period followed by one month intervention ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 12 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Device: weighted blanket **Label:** Weighted Blanket **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Weighted Blanket **Description:** Blanket weighted with 10% or less of body weight applied to child prior to meals for duration no more than 15 minutes **Name:** weighted blanket **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** The FNSC questionnaire is composed of ten questions, being answered by parents in a scale from one to seven, in which number one means "not at all" and seven means "extremely distant to the reality of my child. **Measure:** Food Neophobia Scale for Children (FNSC) questionnaire **Time Frame:** Baseline, prior and post treatment, up to 2 months **Description:** The STAI-C Anxiety Scale asks for ratings of agreement on a 3-point scale using the stem "I feel..." for 20 items both indicative of the presence of anxiety (e.g., 1= not upset; 2= upset; 3= very upset) and reverse-worded (e.g., 1= very calm; 2= calm; 3= not calm) items. **Measure:** State-Trait Anxiety Inventory for Children (STAIC) **Time Frame:** Baseline, prior and post treatment, up to 2 months **Description:** Initial list of foods tolerated and subsequent foods added during the study **Measure:** Food Logs **Time Frame:** Baseline, prior and post treatment, up to 2 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Subject and guardian has provided informed consent in a manner approved by the IRB and is willing and able to comply with the trial procedures. 2. Subject has identified feeding challenges 3. Subject has anxiety related to food as reported by caregiver 4. Subject is between the ages of 8-12 5. Subject has good reading abilities 6. Subject weighs 30 pounds or more Exclusion Criteria: 1. Any medical condition that, in the opinion of the investigator, would place the subject at increased risk for participation due to the inability to remove the blanket safely. Examples of diagnoses that would exclude a participant include spinal cord injury, cerebral palsy, and muscular dystrophy. 2. Concurrent participation on another research study 3. Participants outside of the ages 8-12 4. Participants refuse to use the weighted blanket 5. If the use of a weighted blanket is contraindicated for any reason 6. Participants lacking the reading ability to complete a questionnaire 7. Participants who weigh under 30 pounds per parent report and cannot use a commercially available weighted blanket as the minimum weight of a weighted blanket is 3 pounds will be excluded but this exclusion is unlikely due to the inclusion age range **Healthy Volunteers:** True **Maximum Age:** 12 Years **Minimum Age:** 8 Years **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Claudia A Hilton, PhD **Phone:** 3143415161 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Heather D Celkis, BS **Phone:** 5129684297 **Role:** CONTACT #### Locations **Location 1:** **City:** Austin **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Heather D Celkis, BS - **Phone:** 512-968-4297 - **Role:** CONTACT **Country:** United States **Facility:** Capital Area Speech & Occupational Therapy **State:** Texas **Status:** RECRUITING **Zip:** 78759 ### IPD Sharing Statement Module **Access Criteria:** per request **Description:** upon request, deidentified data will be shared **Info Types:** - STUDY_PROTOCOL - SAP - ICF - CSR - ANALYTIC_CODE **IPD Sharing:** YES **Time Frame:** May 2025 for 5 years ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001523 - Term: Mental Disorders - ID: D000001068 - Term: Feeding and Eating Disorders ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M4324 - Name: Anxiety Disorders - Relevance: HIGH - As Found: Anxiety - ID: M5114 - Name: Body Weight - Relevance: HIGH - As Found: Weighted - ID: M2123 - Name: Avoidant Restrictive Food Intake Disorder - Relevance: HIGH - As Found: Avoidant Restrictive Food Intake Disorder - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: M4380 - Name: Feeding and Eating Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001835 - Term: Body Weight - ID: D000001008 - Term: Anxiety Disorders - ID: D000080146 - Term: Avoidant Restrictive Food Intake Disorder ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06420219 **Brief Title:** An Integrative Multi-Omic Characterization of Head and Neck Carcinogenesis, Progression and Recurrence **Official Title:** An Integrative Multi-Omic Characterization of Head and Neck Carcinogenesis, Progression and Recurrence #### Organization Study ID Info **ID:** 7H-23-4 #### Organization **Class:** OTHER **Full Name:** University of Southern California #### Secondary ID Infos **Domain:** CTRP (Clinical Trial Reporting Program) **ID:** NCI-2024-01559 **Type:** REGISTRY **Domain:** USC / Norris Comprehensive Cancer Center **ID:** 7H-23-4 **Type:** OTHER **ID:** P30CA014089 **Link:** https://reporter.nih.gov/quickSearch/P30CA014089 **Type:** NIH ### Status Module #### Completion Date **Date:** 2029-03-25 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2028-03-25 **Type:** ESTIMATED #### Start Date **Date:** 2024-03-25 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-03-25 **Study First Submit QC Date:** 2024-05-16 ### Sponsor Collaborators Module #### Collaborators **Class:** NIH **Name:** National Cancer Institute (NCI) #### Lead Sponsor **Class:** OTHER **Name:** University of Southern California #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** This study evaluates the cell and biomarkers associated with the aggressive behavior of cancer. **Detailed Description:** PRIMARY OBJECTIVE: I. High-resolution single-cell profiling of Cancer-associated fibroblasts (CAFs) in Human papillomavirus (HPV)+ Oropharyngeal Squamous Cell Carcinoma (OPSCC) and metastatic lymph nodes. OUTLINE: This is an observational study. Patients undergo photography, blood sample collection, tissue collection and have their medical records reviewed on study. ### Conditions Module **Conditions:** - Head and Neck Carcinoma ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 50 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients undergo photography, blood sample collection, tissue collection and have their medical records reviewed on study. **Intervention Names:** - Other: Non-Interventional Study **Label:** Observational ### Interventions #### Intervention 1 **Arm Group Labels:** - Observational **Description:** Non-interventional study **Name:** Non-Interventional Study **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Measure:** Overall survival **Time Frame:** Up to 5 years **Measure:** Disease free survival **Time Frame:** Up to 5 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Diagnosis/disease status: New diagnosis of head and neck cancer * Allowable type and amount of prior therapy: No prior treatment * Age ≥ 18 years. * Ability to understand and the willingness to sign a written informed consent. Exclusion Criteria: * Patients who have had treatment of head and neck cancer **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients with a new diagnosis of head and neck cancer ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Sandy Tran, MS **Phone:** 323-865-0451 **Role:** CONTACT #### Locations **Location 1:** **City:** Los Angeles **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Sandy Tran, MS - **Phone:** 323-865-0451 - **Role:** CONTACT ***Contact 2:*** - **Name:** Albert Y. Han, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** USC / Norris Comprehensive Cancer Center **State:** California **Status:** RECRUITING **Zip:** 90033 #### Overall Officials **Official 1:** **Affiliation:** University of Southern California **Name:** Albert Y Han, MD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes - ID: D000009385 - Term: Neoplastic Processes - ID: D000009369 - Term: Neoplasms ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M5534 - Name: Carcinoma - Relevance: LOW - As Found: Unknown - ID: M14850 - Name: Recurrence - Relevance: HIGH - As Found: Recurrence - ID: M30145 - Name: Carcinogenesis - Relevance: HIGH - As Found: Carcinogenesis - ID: M20559 - Name: Disease Progression - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: M12330 - Name: Neoplastic Processes - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000063646 - Term: Carcinogenesis - ID: D000012008 - Term: Recurrence ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06420206 **Brief Title:** Goals of Care Discussion for Patients With Advanced Lung and Gastrointestinal Cancer in the Emergency Department of a Comprehensive Cancer Center **Official Title:** Goals of Care Discussion for Patients With Advanced Lung and Gastrointestinal Cancer in the Emergency Department of a Comprehensive Cancer Center #### Organization Study ID Info **ID:** 2019-1024 #### Organization **Class:** OTHER **Full Name:** M.D. Anderson Cancer Center ### Status Module #### Completion Date **Date:** 2027-02-02 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2027-02-02 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-14 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** M.D. Anderson Cancer Center #### 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 improve quality of life for participants with advanced cancer, support their families, and lower overall cost of care. **Detailed Description:** Primary Objective: To compare overall percentage of days spent in an acute care setting over the 30-day period from time of the index emergency department (ED), referred to as Acute Cancer Care Center (ACCC), visit for patients who receive the emergency department-based GOC intervention and those who do not. Secondary Objective: To obtain data on rates of admission to the ICU, death in the hospital setting, symptom improvement for participants hospitalized, hospice referral, survival, and 30-day care costs for participants who receive the GOC intervention in the ACCC and those who do not. ### Conditions Module **Conditions:** - Lung Cancer - Gastrointestinal Cancer ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 200 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** In Group 1, participants will receive the usual standard of care, during your emergency room visit, provided by the Acute Cancer Care Center (ACCC) treating doctor who will address symptoms and other medical problems that brought the participant to the emergency room. **Intervention Names:** - Other: Standard of Care (Acute Cancer Care Center) **Label:** Acute Cancer Care Center **Type:** OTHER #### Arm Group 2 **Description:** In Group 2, participants will receive the above usual standard of care plus goals of care (GOC) intervention. **Intervention Names:** - Other: Standard of Care (Goals of Care) **Label:** Goals of Care **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Acute Cancer Care Center **Description:** In Group 1, participants will receive the usual standard of care by an emergency care physician not trained in palliative care. **Name:** Standard of Care (Acute Cancer Care Center) **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Goals of Care **Description:** In Group 2, participants will receive standard of care plus palliative care intervention by an emergency care physician trained in palliative care. **Name:** Standard of Care (Goals of Care) **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Measure:** Quality Of Life Questionnaire **Time Frame:** through study completion; an average of 1 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Participant is at least 18 years old presenting to the triage area of the MDACC ACCC for treatment 2. Participant has advanced lung or GI cancer. Advanced cancer patient defined as: locally recurrent or metastatic for which there is no curative treatment available. 3. Participant screens positive for at least 2 of 3 triple threat conditions (dyspnea, altered mental status, or poor performance status) 4. Participant has the ability to speak and write in English 5. Participant has the ability to provide consent OR is accompanied by a LAR able to provide consent Exclusion Criteria: 1. Participant is already enrolled in hospice 2. Participant is comatose 3. Participant has severe intellectual disability 4. Participant has a history of dementia documented in the medical records 5. Participant has baseline communication barriers such as aphasia or deafness 6. Participant is new to MDACC, without established oncology care at our institution at time of ACCC arrival 7. Participant is 18 years or older, currently cared for by pediatrics service 8. Pregnant women 9. Prisoners **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Ahmed Elsayem, MD,MPH **Phone:** (713) 745-9911 **Role:** CONTACT #### Locations **Location 1:** **City:** Houston **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Ahmed Elsayem, MD,MPH - **Phone:** 713-745-9911 - **Role:** CONTACT ***Contact 2:*** - **Name:** Ahmed Elsayem, MD,MPH - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** MD Anderson Cancer Center **State:** Texas **Status:** RECRUITING **Zip:** 77030 #### Overall Officials **Official 1:** **Affiliation:** M.D. Anderson Cancer Center **Name:** Ahmed Elsayem, MD,MPH **Role:** PRINCIPAL_INVESTIGATOR ### References Module #### See Also Links **Label:** MD Anderson Cancer Center **URL:** http://www.mdanderson.org ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020969 - Term: Disease Attributes - ID: D000010335 - Term: Pathologic Processes - 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 ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC06 - Name: Digestive System Diseases ### Condition Browse Module - Browse Leaves - ID: M7796 - Name: Emergencies - Relevance: HIGH - As Found: Emergency - ID: M11172 - Name: Lung Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8886 - Name: Gastrointestinal Neoplasms - Relevance: HIGH - As Found: Gastrointestinal Cancer - ID: M7256 - Name: Digestive System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000005770 - Term: Gastrointestinal Neoplasms - ID: D000004630 - Term: Emergencies ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06420193 **Acronym:** ASCENT **Brief Title:** Evaluating Procedures for a Study of the AYA Survivors Coping and Emotional Needs Toolkit **Official Title:** Evaluating the Feasibility and Acceptability of Study Procedures for a Full Factorial Trial of the AYA Survivors Coping and Emotional Needs Toolkit (ASCENT) #### Organization Study ID Info **ID:** 23-001795 #### Organization **Class:** OTHER **Full Name:** East Carolina University #### Secondary ID Infos **ID:** R00CA248701 **Link:** https://reporter.nih.gov/quickSearch/R00CA248701 **Type:** NIH ### Status Module #### Completion Date **Date:** 2024-09 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-30 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-09 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-03 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-07 **Study First Submit QC Date:** 2024-05-16 ### Sponsor Collaborators Module #### Collaborators **Class:** NIH **Name:** National Cancer Institute (NCI) #### Lead Sponsor **Class:** OTHER **Name:** East Carolina University #### Responsible Party **Investigator Affiliation:** East Carolina University **Investigator Full Name:** Karly M Murphy, PhD **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The investigators developed a digital intervention that aims to help adolescent and young adult cancer survivors (AYAs) manage symptoms of depression. This tool includes daily mood tracking, a psychoeducational module about cancer and depression, four components that are based on evidence-based interventions for depression. The goal of this study is to evaluate the acceptability of procedures for a future trial in which the investigators will test which component or combination of components meaningfully contribute to improvements in depressive symptoms among AYAs. Additionally, the investigators will evaluate study feasibility as well as intervention acceptability, satisfaction, usability, and engagement. ### Conditions Module **Conditions:** - Depression - Cancer - Adolescent - Young Adult - Adult ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** FACTORIAL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 16 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Feeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression). **Intervention Names:** - Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT) **Label:** Condition 1 **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Feeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Positivity component of ASCENT (an adaptation of a suite of evidence-based positive psychology interventions that aims to help AYAs savor the good things in life, use their strengths, and practice gratitude and kindness). **Intervention Names:** - Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT) **Label:** Condition 2 **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Feeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Being component of ASCENT (an adaptation of mindfulness training that aims to help AYAs maintain contact with the present moment with an attitude of acceptance). **Intervention Names:** - Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT) **Label:** Condition 3 **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** Feeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Being component of ASCENT (an adaptation of mindfulness training that aims to help AYAs maintain contact with the present moment with an attitude of acceptance); Positivity component of ASCENT (an adaptation of a suite of evidence-based positive psychology interventions that aims to help AYAs savor the good things in life, use their strengths, and practice gratitude and kindness). **Intervention Names:** - Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT) **Label:** Condition 4 **Type:** EXPERIMENTAL #### Arm Group 5 **Description:** Feeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Thinking component of ASCENT (an adaptation of cognitive restructuring that aims to help AYAs identify, evaluate, and restructure their negative automatic thoughts and core beliefs). **Intervention Names:** - Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT) **Label:** Condition 5 **Type:** EXPERIMENTAL #### Arm Group 6 **Description:** Feeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Thinking component of ASCENT (an adaptation of cognitive restructuring that aims to help AYAs identify, evaluate, and restructure their negative automatic thoughts and core beliefs); Positivity component of ASCENT (an adaptation of a suite of evidence-based positive psychology interventions that aims to help AYAs savor the good things in life, use their strengths, and practice gratitude and kindness). **Intervention Names:** - Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT) **Label:** Condition 6 **Type:** EXPERIMENTAL #### Arm Group 7 **Description:** Feeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Thinking component of ASCENT (an adaptation of cognitive restructuring that aims to help AYAs identify, evaluate, and restructure their negative automatic thoughts and core beliefs); Being component of ASCENT (an adaptation of mindfulness training that aims to help AYAs maintain contact with the present moment with an attitude of acceptance). **Intervention Names:** - Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT) **Label:** Condition 7 **Type:** EXPERIMENTAL #### Arm Group 8 **Description:** Feeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Thinking component of ASCENT (an adaptation of cognitive restructuring that aims to help AYAs identify, evaluate, and restructure their negative automatic thoughts and core beliefs); Being component of ASCENT (an adaptation of mindfulness training that aims to help AYAs maintain contact with the present moment with an attitude of acceptance); Positivity component of ASCENT (an adaptation of a suite of evidence-based positive psychology interventions that aims to help AYAs savor the good things in life, use their strengths, and practice gratitude and kindness) **Intervention Names:** - Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT) **Label:** Condition 8 **Type:** EXPERIMENTAL #### Arm Group 9 **Description:** Feeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Doing component of ASCENT (an adaptation of behavioral activation that aims to help AYAs engage in enjoyable activities, achieve their goals, and live in accordance with their values). **Intervention Names:** - Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT) **Label:** Condition 9 **Type:** EXPERIMENTAL #### Arm Group 10 **Description:** Feeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Doing component of ASCENT (an adaptation of behavioral activation that aims to help AYAs engage in enjoyable activities, achieve their goals, and live in accordance with their values); Positivity component of ASCENT (an adaptation of a suite of evidence-based positive psychology interventions that aims to help AYAs savor the good things in life, use their strengths, and practice gratitude and kindness). **Intervention Names:** - Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT) **Label:** Condition 10 **Type:** EXPERIMENTAL #### Arm Group 11 **Description:** Feeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Doing component of ASCENT (an adaptation of behavioral activation that aims to help AYAs engage in enjoyable activities, achieve their goals, and live in accordance with their values); Being component of ASCENT (an adaptation of mindfulness training that aims to help AYAs maintain contact with the present moment with an attitude of acceptance). **Intervention Names:** - Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT) **Label:** Condition 11 **Type:** EXPERIMENTAL #### Arm Group 12 **Description:** Feeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Doing component of ASCENT (an adaptation of behavioral activation that aims to help AYAs engage in enjoyable activities, achieve their goals, and live in accordance with their values); Being component of ASCENT (an adaptation of mindfulness training that aims to help AYAs maintain contact with the present moment with an attitude of acceptance); Positivity component of ASCENT (an adaptation of a suite of evidence-based positive psychology interventions that aims to help AYAs savor the good things in life, use their strengths, and practice gratitude and kindness). **Intervention Names:** - Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT) **Label:** Condition 12 **Type:** EXPERIMENTAL #### Arm Group 13 **Description:** Feeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Doing component of ASCENT (an adaptation of behavioral activation that aims to help AYAs engage in enjoyable activities, achieve their goals, and live in accordance with their values); Thinking component of ASCENT (an adaptation of cognitive restructuring that aims to help AYAs identify, evaluate, and restructure their negative automatic thoughts and core beliefs). **Intervention Names:** - Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT) **Label:** Condition 13 **Type:** EXPERIMENTAL #### Arm Group 14 **Description:** Feeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Doing component of ASCENT (an adaptation of behavioral activation that aims to help AYAs engage in enjoyable activities, achieve their goals, and live in accordance with their values); Thinking component of ASCENT (an adaptation of cognitive restructuring that aims to help AYAs identify, evaluate, and restructure their negative automatic thoughts and core beliefs); Positivity component of ASCENT (an adaptation of a suite of evidence-based positive psychology interventions that aims to help AYAs savor the good things in life, use their strengths, and practice gratitude and kindness). **Intervention Names:** - Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT) **Label:** Condition 14 **Type:** EXPERIMENTAL #### Arm Group 15 **Description:** Feeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Doing component of ASCENT (an adaptation of behavioral activation that aims to help AYAs engage in enjoyable activities, achieve their goals, and live in accordance with their values); Thinking component of ASCENT (an adaptation of cognitive restructuring that aims to help AYAs identify, evaluate, and restructure their negative automatic thoughts and core beliefs); Being component of ASCENT (an adaptation of mindfulness training that aims to help AYAs maintain contact with the present moment with an attitude of acceptance) **Intervention Names:** - Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT) **Label:** Condition 15 **Type:** EXPERIMENTAL #### Arm Group 16 **Description:** Feeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Doing component of ASCENT (an adaptation of behavioral activation that aims to help AYAs engage in enjoyable activities, achieve their goals, and live in accordance with their values); Thinking component of ASCENT (an adaptation of cognitive restructuring that aims to help AYAs identify, evaluate, and restructure their negative automatic thoughts and core beliefs); Being component of ASCENT (an adaptation of mindfulness training that aims to help AYAs maintain contact with the present moment with an attitude of acceptance); and Positivity component of ASCENT (an adaptation of a suite of evidence-based positive psychology interventions that aims to help AYAs savor the good things in life, use their strengths, and practice gratitude and kindness) **Intervention Names:** - Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT) **Label:** Condition 16 **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Condition 1 - Condition 10 - Condition 11 - Condition 12 - Condition 13 - Condition 14 - Condition 15 - Condition 16 - Condition 2 - Condition 3 - Condition 4 - Condition 5 - Condition 6 - Condition 7 - Condition 8 - Condition 9 **Description:** Participants will receive access to a digital depression self-management tool (ASCENT), which aims to help AYAs manage symptoms of depression post-treatment. All users will have access to the core tool which includes daily mood tracking and a psychoeducational module about cancer and depression. Depending on assigned condition, participants will also receive access to up to 4 intervention modules which have been adapted from existing evidence-based treatments for digital delivery to AYAs through a rigorous user-centered design process. Within each module there are 6 micro-lessons that include an educational video, a real story from an AYA that demonstrates the topic, multiple choice questions that ask the participant to apply the educational information to the AYA story, open-ended questions that ask the participant to apply the educational information to their own experience, and a practice activity in which they are asked to try out a relevant skill. **Name:** AYA Survivors Coping and Emotional Needs Toolkit (ASCENT) **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** An investigator-developed survey will be used to evaluate acceptability of study procedures. Mean scale scores range from 1 to 4, with higher scores indicating greater acceptability. Descriptive statistics and exact 95% confidence intervals (CIs) will be calculated. **Measure:** Acceptability of Study Procedures - Quantitative **Time Frame:** Week 6 **Description:** An investigator-developed semi-structured interview will be used to evaluate acceptability of study procedures. Transcriptions of semi-structured interviews will undergo rapid qualitative analysis to characterize the reasons for sub-optimal acceptability of study procedures. **Measure:** Acceptability of Study Procedures - Qualitative **Time Frame:** Weeks 6-8 #### Secondary Outcomes **Description:** Recruitment rate will be calculated as the number of participants enrolled in the study divided by the number of participants contacted. **Measure:** Study Feasibility - Recruitment Rate **Time Frame:** Upon enrollment of 16 participants **Description:** Retention will be defined as the proportion of patients who provide T1 (6 week) data. Patients who discontinue the intervention (refuse phone calls) but complete the outcome assessments will be counted in the numerator for calculating retention. **Measure:** Study Feasibility - Retention Rate **Time Frame:** Week 6 **Description:** An investigator-developed survey will be used to evaluate acceptability of the intervention. **Measure:** Intervention Acceptability - Quantitative **Time Frame:** Week 6 **Description:** An investigator-developed survey will be used to evaluate satisfaction with the intervention. Mean scale scores range from 1 to 4, with higher scores indicating greater satisfaction. Descriptive statistics and exact 95% confidence intervals (CIs) will be calculated. **Measure:** Intervention Satisfaction - Quantitative **Time Frame:** Week 6 **Description:** A semi-structured interview will be used to further characterize acceptability of and satisfaction with the intervention. Transcriptions of semi-structured interviews will undergo rapid qualitative analysis to characterize the reasons for sub-optimal acceptability of and satisfaction with the intervention. **Measure:** Intervention Acceptability & Satisfaction - Qualitative **Time Frame:** Weeks 6-8 **Description:** The System Usability Scale (SUS) will be administered to evaluate perceived usability of ASCENT. SUS scores range from 0 to 100, with higher scores indicating greater usability. Descriptive statistics and exact 95% confidence intervals (CIs) will be calculated. **Measure:** System Usability Scale **Time Frame:** Week 6 **Description:** Adherence will be calculated as the percentage of pages viewed by the participant within a module divided by the total number of pages in the module as indicated by metrics from the website. Mean adherence rate and exact 95% confidence intervals (CIs) for each intervention module will be calculated. **Measure:** Intervention Adherence **Time Frame:** Weeks 1-6 **Description:** The eHealth Engagement Scale will be administered to evaluate how engaging users found ASCENT engagement. Mean scale scores range from 1 to 4, with lower scores indicating greater engagement. Descriptive statistics and exact 95% confidence intervals (CIs) will be calculated. **Measure:** eHealth Engagement Scale **Time Frame:** Week 6 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age at enrollment (adolescents 15-17, emerging adults 18-25, young adults 26-39) * Age at diagnosis (adolescents 12-17, emerging adults 15-25, young adults 15-39) * Time since completion of treatment: 1 month to 5 years * Language: Fluent in English (spoken and written) * Technology: Own smart phone with data plan Exclusion Criteria: * Mental Health: Current diagnosis of severe or persistent mental illness * Suicidality: Severe suicidal ideation (including plan and intent) **Maximum Age:** 39 Years **Minimum Age:** 15 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** AnneMarie Coffey **Phone:** 252-328-6244 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Rachel Glock **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** East Carolina University **Name:** Karly M Murphy, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** All de-identified data collected from participants in this study will be preserved and shared in alignment with best practices for open science. Data will be submitted to Dataverse, a free NIH Generalist Repository Ecosystem Initiative (https://dataverse.org/researchers). **Info Types:** - STUDY_PROTOCOL - ICF **IPD Sharing:** YES ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001526 - Term: Behavioral Symptoms ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M7058 - Name: Depression - Relevance: HIGH - As Found: Depression - ID: M7061 - Name: Depressive Disorder - Relevance: LOW - As Found: Unknown - ID: M4818 - Name: Behavioral Symptoms - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003863 - Term: Depression ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Ot - Name: Other Dietary Supplements ### Intervention Browse Module - Browse Leaves - ID: M4854 - Name: Benzocaine - Relevance: LOW - As Found: Unknown - ID: T433 - Name: Tannic Acid - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06420180 **Brief Title:** Effect of Lower Limb Rotation on Clinical Outcomes After Arthroscopic Management in Patients With Symptomatic Femoroacetabular Impingement Syndrome **Official Title:** The Effect of Lower Limb Rotation on Clinical Outcomes After Arthroscopic Management in Patients With Symptomatic Femoroacetabular Impingement Syndrome #### Organization Study ID Info **ID:** lower limb rotation on FAI #### Organization **Class:** OTHER **Full Name:** Al-Azhar University ### Status Module #### Completion Date **Date:** 2027-11 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-07 **Type:** ESTIMATED #### Start Date **Date:** 2024-07 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-11 **Study First Submit QC Date:** 2024-05-16 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Al-Azhar University #### Responsible Party **Investigator Affiliation:** Al-Azhar University **Investigator Full Name:** mahmoud ahmed awad elmetwally **Investigator Title:** Assistant Lecturer of Orthopedic Surgery **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** To determine * The prevalence of abnormalities of femoral and acetabular versions and tibial torsion in symptomatic (FAI) Syndrome. * Analyse the subgroups of specific hip pathomorphologies associated with rotational abnormalities of lower limb (LL). * Which specific hip subtypes of (FAI) are associated with rotational abnormalities, * Outcomes of arthroscopic treatment of (FAI) syndrome in patients with rotational abnormalities compared with a control group of patients with normal rotation. **Detailed Description:** Femoroacetabular impingement (FAI) is characterised by an abnormal contact between the acetabulum and the femur, limiting range of motion and leading to hip pain and disability. (FAI) can be classified into three categories according to the specific pathomorphology involved. Cam type (FAI) represents asphericity of the femoral head due to abnormal morphology at the head neck junction. Pincer-type (FAI) on the other hand, occurs due to over-coverage of the femoral head by the acetabulum and premature contact between the acetabulum and femoral neck. Some patients may present with both of these abnormalities, known as mixed-typed (FAI). There is an interest in the role of acetabular and femoral versions and tibial torsion in (FAI). Lerch et al. found that 68% of 538 hips presenting with (FAI) or dysplasia showed abnormal femoral and/or acetabular versions. A more recent study by Lerch et al. also found abnormal tibial torsion in 42% of patients with (FAI) and dysplasia. It has been further speculated that excessive femoral anteversion or femoral retroversion may also play a role in the pathogenesis and treatment of (FAI). Excessive femoral retroversion has been considered by some to be a relative contraindication to corrective (FAI) surgery, as it has been found to be a risk factor for poor outcomes after hip arthroscopy for (FAI). Similarly, increased femoral version is a risk factor for inferior clinical outcomes after hip arthroscopy. Abnormalities of femoral version and tibial torsion were associated with anterior knee pain, knee osteoarthritis, and patellar instability. But the influence of combined abnormalities of femoral version and tibial torsion (combined torsional malalignment) for patients with hip pain is unknown. So, investigator hypothesized that patients with symptomatic (FAI) display significant rotation abnormalities of the acetabulum or femur and tibial and that the rotational abnormalities would portend an inferior prognosis when compared with a pair-matched control group of patients with normal range of lower limb rotation and patients with significant rotational abnormalities would have differing intraoperative hip pathology. ### Conditions Module **Conditions:** - Femoro Acetabular Impingement ### Design Module #### Design Info **Observational Model:** OTHER **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 50 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** CT rotational profile Will be used for measurement of LL rotational abnormality. MRI will be evaluated for the presence of labral tears, chondral lesions, ligamentum teres pathology, and other soft-tissue disorders. **Name:** hip arthroscopy **Other Names:** - MRI - CT **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** determine the prevalence of abnormalities of femoral and acetabular versions and tibial torsion in symptomatic FAI Syndrome. **Measure:** prevalence of lower limb rotation in FAI **Time Frame:** baseline **Description:** determine Outcomes of arthroscopic treatment of FAI syndrome in patients with rotational abnormalities compared with patients with normal rotation. normal rotation according to preoperative CT rotational profile: Acetabular version angle between 10⁰ to 25⁰. Femoral version angle between 10⁰ to 25⁰. Tibial torsion angle between 25⁰ to 40⁰. clinical outcome of arthroscopic treatment of patients with FAI syndrome using modified Harris Hip Score (mHHS) will be done preoperatively and postoperatively at 1.5 months, 3 months, 6 months, 1 year, and 2 years. The modified Harris hip score (mHHS) will be scored from 0 (worst functional outcome and maximum pain) to 100 points (best functional outcome and least pain) **Measure:** 2 years outcome of arthroscopic treatment of 50 patients with FAI syndrome using modified Harris Hip Score (mHHS). **Time Frame:** 2 years **Description:** determine Outcomes of arthroscopic treatment of FAI syndrome in patients with rotational abnormalities compared with patients with normal rotation. normal rotation according to preoperative CT rotational profile: Acetabular version angle between 10⁰ to 25⁰. Femoral version angle between 10⁰ to 25⁰. Tibial torsion angle between 25⁰ to 40⁰. clinical outcome of arthroscopic treatment of patients with FAI syndrome using Nonarthritic Hip Score (NAHS) will be done preoperatively and postoperatively at 1.5 months, 3 months, 6 months, 1 year, and 2 years. This score is divided into four domains: pain, mechanical symptoms, physical function, and level of activity. The maximum score is 100 indicating normal hip function. **Measure:** 2 years outcome of arthroscopic treatment of 50 patients with FAI syndrome using Nonarthritic Hip Score (NAHS). **Time Frame:** 2 years **Description:** determine Outcomes of arthroscopic treatment of FAI syndrome in patients with rotational abnormalities compared with patients with normal rotation. normal rotation according to preoperative CT rotational profile: Acetabular version angle between 10⁰ to 25⁰. Femoral version angle between 10⁰ to 25⁰. Tibial torsion angle between 25⁰ to 40⁰. clinical outcome of arthroscopic treatment of patients with FAI syndrome using Hip Outcome Score-Sports Specific Subscale (HOS-SSS) will be done preoperatively and postoperatively at 1.5 months, 3 months, 6 months, 1 year, and 2 years. The (HOS-SSS) is a patient-completed measure that consists of "(9 scored items) in which the response options are presented as 5-point Likert scales. Scores for each subscale range from 0% (least function) to 100% (most function). **Measure:** 2 years outcome of arthroscopic treatment of 50 patients with FAI syndrome using Hip Outcome Score-Sports Specific Subscale (HOS-SSS) **Time Frame:** 2 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * • Accepted to participate in the study (signing informed consent). * Skeletal maturity (Risser V score). * If their radiographic imaging, history, and physical examination demonstrated evidence of FAI or labral tears; if they experienced moderate to severe pain that was unresponsive to at least 3 months of nonsurgical treatment, including physical therapy, nonsteroidal anti-inflammatory drugs, and activity modification Exclusion Criteria: * • Incomplete radiographic documentation. * Previous surgery of the acetabulum, femur and/or tibia altering their version. * Skeletally immature hips (stage IV according to Risser). * Posttraumatic conditions. * If they were previously diagnosed with an ipsilateral hip condition, such as avascular necrosis, legg-calvé-perthes disease, or slipped capital femoral epiphysis. * If their tönnis grade of osteoarthritis is \>1. * Hip dysplasia will be defined as a lateral centre-edge angle (LCEA) less than 22°. * Patients with rheumatologic diseases. * Patients at risk of radiation exposure, such as pregnant women and patients after neoplastic diseases. **Maximum Age:** 45 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT **Study Population:** study will be conducted on patient aged between 18 to 45 years with radiographic imaging, history, and physical examination demonstrated evidence of FAI or labral tears; if they experienced moderate to severe pain that was unresponsive to at least 3 months of nonsurgical treatment, including physical therapy, nonsteroidal anti-inflammatory drugs, and activity modification ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** mahmoud A awad, M.Sc. of Orthopedic Surgery **Phone:** 01025118809 **Role:** CONTACT **Contact 2:** **Name:** maysara mohammed **Phone:** 01099003667 **Role:** CONTACT ### References Module #### References **Citation:** Arshad Z, Maughan HD, Sunil Kumar KH, Pettit M, Arora A, Khanduja V. Over one third of patients with symptomatic femoroacetabular impingement display femoral or acetabular version abnormalities. Knee Surg Sports Traumatol Arthrosc. 2021 Sep;29(9):2825-2836. doi: 10.1007/s00167-021-06643-3. Epub 2021 Jul 6. **PMID:** 34228156 **Citation:** Lerch TD, Todorski IAS, Steppacher SD, Schmaranzer F, Werlen SF, Siebenrock KA, Tannast M. Prevalence of Femoral and Acetabular Version Abnormalities in Patients With Symptomatic Hip Disease: A Controlled Study of 538 Hips. Am J Sports Med. 2018 Jan;46(1):122-134. doi: 10.1177/0363546517726983. Epub 2017 Sep 22. **PMID:** 28937786 **Citation:** Lerch TD, Liechti EF, Todorski IAS, Schmaranzer F, Steppacher SD, Siebenrock KA, Tannast M, Klenke FM. Prevalence of combined abnormalities of tibial and femoral torsion in patients with symptomatic hip dysplasia and femoroacetabular impingement. Bone Joint J. 2020 Dec;102-B(12):1636-1645. doi: 10.1302/0301-620X.102B12.BJJ-2020-0460.R1. **PMID:** 33249913 **Citation:** Imhoff FB, Funke V, Muench LN, Sauter A, Englmaier M, Woertler K, Imhoff AB, Feucht MJ. The complexity of bony malalignment in patellofemoral disorders: femoral and tibial torsion, trochlear dysplasia, TT-TG distance, and frontal mechanical axis correlate with each other. Knee Surg Sports Traumatol Arthrosc. 2020 Mar;28(3):897-904. doi: 10.1007/s00167-019-05542-y. Epub 2019 May 24. Erratum In: Knee Surg Sports Traumatol Arthrosc. 2019 Jun 21;: **PMID:** 31127313 **Citation:** Grunwald L, Histing T, Springer F, Keller G. MRI-based torsion measurement of the lower limb is a reliable and valid alternative for CT measurement: a prospective study. Knee Surg Sports Traumatol Arthrosc. 2023 Nov;31(11):4903-4909. doi: 10.1007/s00167-023-07533-6. Epub 2023 Aug 17. **PMID:** 37589766 **Citation:** Suarez-Ahedo C, Gui C, Rabe SM, Chandrasekaran S, Lodhia P, Domb BG. Acetabular Chondral Lesions in Hip Arthroscopy: Relationships Between Grade, Topography, and Demographics. Am J Sports Med. 2017 Sep;45(11):2501-2506. doi: 10.1177/0363546517708192. Epub 2017 Jun 7. **PMID:** 28590784 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000007592 - Term: Joint Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC05 - Name: Musculoskeletal Diseases ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M28927 - Name: Femoracetabular Impingement - Relevance: HIGH - As Found: Femoroacetabular Impingement Syndrome - ID: M10621 - Name: Joint Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000057925 - Term: Femoracetabular Impingement ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06420167 **Acronym:** FLORAL **Brief Title:** DapagliFLOzin in Renal AL Amyloidosis (FLORAL) **Official Title:** DapagliFLOzin in Renal AL Amyloidosis (FLORAL) #### Organization Study ID Info **ID:** 2023-074 #### Organization **Class:** OTHER **Full Name:** Barbara Ann Karmanos Cancer Institute ### Status Module #### Completion Date **Date:** 2027-04 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-04 **Type:** ESTIMATED #### Start Date **Date:** 2024-05 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Jeffrey Zonder #### Responsible Party **Investigator Affiliation:** Barbara Ann Karmanos Cancer Institute **Investigator Full Name:** Jeffrey Zonder **Investigator Title:** Principal Investigator, Multiple Myeloma Multidisciplinary team leader, M.D. **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Is US Export:** False ### Description Module **Brief Summary:** The goal of this clinical trial is to learn if an oral drug called dapagliflozin is safe and can reduce high protein levels in the urine of patients with renal amyloid light-chain (AL) amyloidosis using a decentralized study design. Participants will be: * screened for the trial via an online platform * contacted by study personal to obtain electronic consent * enrolled in the trial if eligible and consented * contacted by study personal for further instructions and directions * sent dapagliflozin oral medication (supplied by the site pharmacy) * followed up regularly with the study team via telemedicine or other online avenues * monitored using lab work, inquiries about side effects and assessment of protocol adherence at 1 month, 3 months and 6 months * continue treatment for 6 months **Detailed Description:** 1. Participants are recruited by one of the following methods: 1. Self-referral through the website 2. Receiving recruitment materials from their provider. 2. Participant visits the prescreening website. 1. High level prescreening questions are answered by the participant. 2. If appropriate based on answers to the questions, the participant may provide their contact information for follow up by the study team. 3. Study team contacts potential participants to review the study and explain next steps 4. Participant is provided with the link and password to view the video and sign the consent via Adobe Sign 5. An investigator will meet virtually with the participant to obtain medical history information, concomitant medications, and performance status (screening visit) 6. Once the participant passes screening in step 5, an order will be sent to the participant for the remaining screening labs to be done at a local laboratory that is covered by their insurance 7. The lab will fax results to the site 8. After review of eligibility and the study team will proceed with enrolling the participant if appropriate 9. The participant will proceed to the baseline visit (telehealth for any portion that can be done via phone/video and order for lab tests as previously described) if needed to comply with the protocol calendar/window. 10. The participant is approved to begin dosing by the investigator 11. The site will dispense via mail the following: 1. 4 month's supply of Dapagliflozin 2. A self-addressed envelope for return of the diary and pill bottles at the end of the dosing period 3. A weighing scale (if required) 12. Dosing compliance will be checked during initial study treatment via sharing of pill accountability data or screenshot of paper pill diary 13. If clinically indicated, labs will be ordered and run more frequently to assess for toxicity. 14. Visits 3, 4, and 5 will be conducted in the same manner as described above. 15. All pill bottles and diaries (if paper version is used) will be returned via the provided envelope ### Conditions Module **Conditions:** - Renal AL Amyloidosis ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 20 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Dapagliflozin 10mg orally, daily for 6 months **Intervention Names:** - Drug: Dapagliflozin **Label:** Dapagliflozin **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Dapagliflozin **Description:** 10mg orally once daily **Name:** Dapagliflozin **Other Names:** - BMS-512148 - Forxiga® / Farxiga® **Type:** DRUG ### Outcomes Module #### Other Outcomes **Description:** A patient's status will be recorded as 'yes' if any of the following three events occur at any time during the 6 months of study therapy: a sustained ≥50% decline in estimated glomerular filtration rate (eGFR); the onset of dialysis-requiring end- stage renal disease (ESRD); or death from a renal disease-related or cardiovascular cause. Otherwise, the status will be marked as 'no'. **Measure:** Proportion of patients experiencing any of the following: (1) sustained decline in eGFR, (2) onset of ESRD, or (3) death from a renal disease-related or cardiovascular cause. **Time Frame:** Up to Month 6 **Description:** The onset of ESRD in patients with Pavia Renal Stage II or III involvement will be recorded as binary (yes vs. no). **Measure:** Incidence rate of developing dialysis dependent ESRD in patients with Pavia Renal AL Stage II or III involvement. **Time Frame:** Up to Month 6 #### Primary Outcomes **Description:** A patient will be considered to have achieved the desired urine protein reduction if a 30% reduction in 24-hour albuminuria occurs at any point during the six-month period from the initiation of dapagliflozin therapy. The proportion of patients achieving this reduction will be calculated as the ratio of the total number of patients who experienced the reduction to the total number of evaluable patients. **Measure:** Proportion of patients achieving 30% reduction in daily proteinuria. **Time Frame:** Up to Month 6 #### Secondary Outcomes **Description:** The completion rate of tele-visits, including post-trial feedback, will be calculated as the ratio of completed tele-visits to scheduled tele-visits. **Measure:** Completion rate of tele-visits **Time Frame:** Up to Month 6 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Provision of signed and dated informed consent form. * Stated willingness to comply with study procedures, including remote telehealth consultations with the study team, confirming availability, and agreeing to use mobile/web applications for study purposes. * Age ≥18 years. * Histopathologic diagnosis of renal AL amyloidosis confirmed by biopsy of any tissue and evidence of \>1.0 g/day proteinuria without any other identifiable cause. * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2. * Plateau in any renal response (i.e., reduction in proteinuria) for at least 3 months prior to enrollment, as determined by the enrolling physician. * Residence in the state of Michigan. Exclusion Criteria: * Either ongoing first line induction with anti-plasma cell therapy or ongoing post- induction maintenance for \<6 months prior to enrollment. * Diagnosis of symptomatic multiple myeloma, including presence of lytic bone disease, plasmacytomas, ≥60% plasma cells in the bone marrow, or hypercalcemia, either currently or in the past. * Women of child-bearing potential (i.e., those who have not undergone chemical or surgical sterilization or are not postmenopausal) and who are unwilling to use a medically accepted and reliable form of contraception while participating in the study and for 2 weeks following the last dose of study medication, as determined by the investigator, or have a positive pregnancy test at the time of enrolment or are currently breastfeeding. * Known allergic reactions to components of the dapagliflozin. * Treatment requiring type 1 or type 2 diabetes mellitus. * Baseline eGFR \<25 mL/min/1.73m2. * Acute or chronic liver disease with severe impairment of liver function (e.g., ascites, esophageal varices or coagulopathy) * Current or previous use of any SGLT2i. * Initiation or dose modification of angiotensin converting enzyme inhibitors (ACE inhibitors) and angiotensin receptor blockers (ARBs) \<3 months prior to enrollment. * Active malignancy requiring treatment (other than AL amyloidosis and non-melanoma skin cancers). **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Christiane Houde **Phone:** 3135768673 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Jeffery Zonder, M.D. **Phone:** 3135768732 **Role:** CONTACT #### Locations **Location 1:** **City:** Detroit **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Christiane Houde - **Phone:** 313-576-8673 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Jeffery Zonder - **Phone:** 3135768732 - **Role:** CONTACT ***Contact 3:*** - **Name:** Jeffery Zonder, M.D. - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 4:*** - **Name:** Andrew Kin, M.D. - **Role:** SUB_INVESTIGATOR ***Contact 5:*** - **Name:** Aditi Sharma, M.D. - **Role:** SUB_INVESTIGATOR ***Contact 6:*** - **Name:** Joel Topf, M.D. - **Role:** SUB_INVESTIGATOR **Country:** United States **Facility:** Karmanos Cancer Institute **State:** Michigan **Zip:** 48201 #### Overall Officials **Official 1:** **Affiliation:** Barbara Ann Karmanos Cancer Institute **Name:** Jeffery Zonder, M.D. **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000057165 - Term: Proteostasis Deficiencies - ID: D000008659 - Term: Metabolic Diseases - ID: D000054219 - Term: Neoplasms, Plasma Cell - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000008232 - Term: Lymphoproliferative Disorders - ID: D000007160 - Term: Immunoproliferative Disorders - ID: D000007154 - Term: Immune System Diseases - ID: D000010265 - Term: Paraproteinemias ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M4021 - Name: Amyloidosis - Relevance: HIGH - As Found: Amyloidosis - ID: M1483 - Name: Immunoglobulin Light-chain Amyloidosis - Relevance: HIGH - As Found: AL Amyloidosis - ID: M28747 - Name: Proteostasis Deficiencies - Relevance: LOW - As Found: Unknown - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M27588 - Name: Neoplasms, Plasma Cell - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M11225 - Name: Lymphoproliferative Disorders - Relevance: LOW - As Found: Unknown - ID: M10206 - Name: Immunoproliferative Disorders - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: M13178 - Name: Paraproteinemias - Relevance: LOW - As Found: Unknown - ID: T254 - Name: AL Amyloidosis - Relevance: HIGH - As Found: AL Amyloidosis ### Condition Browse Module - Meshes - ID: D000075363 - Term: Immunoglobulin Light-chain Amyloidosis - ID: D000000686 - Term: Amyloidosis ### Intervention Browse Module - Ancestors - ID: D000077203 - Term: Sodium-Glucose Transporter 2 Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000007004 - Term: Hypoglycemic Agents - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: Hypo - Name: Hypoglycemic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M348449 - Name: Dapagliflozin - Relevance: HIGH - As Found: COPD - ID: M1691 - Name: Sodium-Glucose Transporter 2 Inhibitors - Relevance: LOW - As Found: Unknown - ID: M10054 - Name: Hypoglycemic Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000529054 - Term: Dapagliflozin ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06420154 **Brief Title:** The Safety and Efficacy of Anti-CD19 CAR-T Cells in Patients With Relapsed/Refractory Autoimmune Diseases **Official Title:** An Exploratory Clinical Study to Evaluating the Safety and Efficacy of Infusiing Anti-CD19-CAR-T Cells Injection (Anti-CD19-CAR-T Cells) in Patients With Relapsed/Refractory Autoimmune Diseases #### Organization Study ID Info **ID:** CD19-CN-A4 #### Organization **Class:** OTHER **Full Name:** First Affiliated Hospital of Wenzhou Medical University ### Status Module #### Completion Date **Date:** 2027-05-27 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-05-27 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-27 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** Shanghai First Song Therapeutics Co., Ltd #### Lead Sponsor **Class:** OTHER **Name:** First Affiliated Hospital of Wenzhou Medical University #### Responsible Party **Investigator Affiliation:** First Affiliated Hospital of Wenzhou Medical University **Investigator Full Name:** Li Sun **Investigator Title:** Professor and Chief Physician, Head of the Department of Rheumatology and Immunology, The First Affiliated Hospital of Wenzhou Medical University **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This is an investigator-initiated trial to evaluate the safety and efficacy of anti- CD19-CAR-T cells in the relapse or refractory autoimmune diseases. **Detailed Description:** This is an investigator-initiated trial to evaluate the safety and efficacy of anti- CD19-CAR-T cells in the relapse or refractory autoimmune diseases. Study intervention consists of a single infusion of CAR-transduced autologous T cells administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide. Interim analysis will be performed when the last participant finishes the visit of 12 weeks after CAR-T cells infusion. ### Conditions Module **Conditions:** - Systemic Lupus Erythematosus (SLE) - Sjogren's Syndrome - Systemic Sclerosis - Inflammatory Myopathy - ANCA Associated Vasculitis - Antiphospholipid Syndrome **Keywords:** - CAR T - CD19 - Autoimmune Diseases ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 9 **Type:** ESTIMATED **Phases:** - EARLY_PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Biological: anti-CD19-CAR-T cells **Label:** Treatment group **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Treatment group **Description:** The subjects received infusions of anti-CD19 CAR-T cells following completion of lymphodepleting preconditioning chemotherapy. Dosage：1×10\^5 cells/Kg; 3×10\^5 cells/Kg; 1×10\^6 cells/Kg frequency：single infusion **Name:** anti-CD19-CAR-T cells **Type:** BIOLOGICAL ### Outcomes Module #### Primary Outcomes **Description:** Percentage of patients receiving CAR-T cells who experience dose-limiting toxicities (DLTs). **Measure:** Incidence of dose-limiting toxicity **Time Frame:** Up to 28 days from CAR-T infusion **Description:** Safety assessments are conducted using the NCI-CTCAE version 5.0 standards (CRS and neurotoxicity will be graded according to ASTCT/ ASBMT grading criteria) **Measure:** Laboratory abnormalities and type, frequency and severity of adverse events **Time Frame:** Up to1 year from CAR-T infusion **Description:** Percentage of subjects for whom the desired dose of anti-CD19 -CAR-T cells can be successfully manufactured **Measure:** Proportion of patients for whom a CAR-T cell product could be prepared **Time Frame:** Up to 4 days from apheresis ### Eligibility Module **Eligibility Criteria:** Common Inclusion Criteria: 1. Voluntarily participate in clinical research. The person or legal guardian fully understands and informs the research and signs the informed consent form (ICF), and is willing to follow and complete all trial procedures; 2. Aged 18-65 years old; 3. ECOG score ≤ 2 points; 4. Expected survival period is at least 12 weeks; 5. Have good intravenous access (for apheresis) and have no other contraindications to blood cell separation; 6. When screening patients, laboratory tests must meet the following requirements and they must not have received cell growth factors within 7 days before screening hematology assessment (long-acting colony-stimulating factor (G-CSF/PEG-CSF) requires an interval of 2 weeks): <!-- --> 1. Absolute neutrophil count ≥1.0×10\^9/L; 2. Hemoglobin ≥60 g/L (without red blood cell transfusion within 14 days); 3. Platelets ≥50×10\^9/L; 4. Absolute lymphocytes (ALC) ≥ 0.5×10\^9/L; 5. Serum total bilirubin ≤1.5×upper limit of normal (ULN); 6. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN; 7. Creatinine \<1.5×ULN and endogenous creatinine clearance ≥60 mL/min. 7. The cardiac ejection fraction is ≥45%, echocardiography (ECHO) confirms that there is no pericardial effusion (except for a small amount or physiological), and the electrocardiogram results have no clinical significance; 8. Baseline oxygen saturation \>92% under non-oxygenation conditions; 9. Women of childbearing age must have a negative serum or urine pregnancy test report (women who have undergone surgical sterilization or women who are at least 2 years postmenopausal are not considered women of childbearing potential). Common Exclusion Criteria: 1. Have active central nervous system diseases, such as epilepsy, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease involving the central nervous system; 2. Fungal, bacterial, viral or other infections exist or are suspected and are not controlled or require intravenous antibiotic treatment; simple urinary tract infections and uncomplicated bacterial pharyngitis are allowed; 3. Suffering from hepatitis B (hepatitis B virus surface antigen and hepatitis B DNA \>1000 copies/ml) or hepatitis C (positive hepatitis C antibody test); syphilis infection (antibody positive); human immunodeficiency virus (HIV) infection; 4. Past medication: <!-- --> 1. CD19 targeted therapy; 2. Inject live vaccines within 4 weeks before enrollment; 3. Immunosuppressive antibodies (such as anti-CD20, anti-tumor necrosis factor, anti-interleukin 6 or anti-interleukin 6 receptor) used within 4 weeks before enrollment; 4. Use immunostimulatory or immune enhancer treatment (such as tacrolimus, cyclosporine, interferon-α, interferon-β, IL-2) within the 5 half-lives before apheresis; 5. Have used systemic cytotoxic drugs within 2 weeks before enrollment, including daily or weekly low-dose maintenance chemotherapy (cyclophosphamide, ifosfamide, bendamustine, clotrexate or Melphalan, vincristine, etc.); 6. Long-acting growth factors within 14 days before apheresis (such as pegfilgrastim) or short-acting growth factors within 5 days before apheresis or drugs used for cell mobilization (such as granulocyte colony-stimulating factor/non- Gestin, Plexafor); 7. The use of pharmacological doses of corticosteroids (\>10 mg/day of prednisone or equivalent doses of other corticosteroids) and other immunosuppressive drugs must be avoided within 4 days before enrollment. 5. Have a history of myocardial infarction, cardiac angioplasty or stent implantation, unstable angina or other clinically significant heart diseases within 12 months before enrollment; 6. History of genetic syndromes associated with bone marrow failure, such as Fanconi anemia, Kosterman syndrome, Swachmann-Diamond syndrome, etc.; 7. History of symptomatic deep vein thrombosis or pulmonary embolism requiring systemic anticoagulation within 6 months before enrollment. Subjects need to take prophylactic anticoagulant drugs; 8. Have suffered from other malignant tumors in the past or at the same time (except for basal cell carcinoma of the skin, carcinoma in situ of the breast/cervix and other malignant tumors that have been effectively controlled without treatment in the past five years); 9. Use of other investigational pharmaceutical products within 30 days before screening; 10.Women of childbearing age who are pregnant or breastfeeding (because chemotherapy has potentially dangerous effects on the fetus or baby); 11.Male and female subjects who are unwilling to undergo birth control within 6 months from the signing of the informed consent form to the completion of the last administration of the study drug; 12.Any medical activity that may interfere with the evaluation of the safety or efficacy of the study; 13.According to the investigator's judgment, the subject is unlikely to complete all study visits or procedures required by the protocol, including follow-up visits or comply with the requirements for participation in the study; 14.Those who have used any CAR-T cell products or other genetically modified T cell therapies in the past. Specific inclusion/exclusion criteria: Relapsed and refractory systemic lupus erythematosus： Inclusion criteria： 1. Comply with the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) SLE classification criteria; 2. In the moderate to severe active stage of the disease, SELENA-SLEDAI score \>6; 3. And have at least one British Island Lupus Assessment Group Index (BILAG-2004) Category A (severe performance) or two Category B (moderate performance) organ scores, or both; 4. Definition of relapse and refractory: Conventional treatment is ineffective or disease activity reappears after remission. The definition of routine treatment: the use of glucocorticoids (more than 1 mg/Kg/d) and cyclophosphamide, and any one or more of the following immunomodulatory drugs for more than 6 months: antimalarial drugs, azathioprine, mycophenolate mofetil , methotrexate, leflunomide,tacrolimus,cyclosporine, and biological agents including rituximab, belimumab, tatacept, etc. Exclusion criteria: 1. Combined with neuropsychiatric lupus; 2. Thrombotic thrombocytopenic purpura (TTP)/microthrombotic vasculopathy (TMA). Relapsed and Refractory Sjogren's Syndrome Inclusion criteria： 1. Meet the 2002 AECG criteria or the 2016 ACR/EULAR classification criteria for primary sjogren's syndrome; 2. Definition of relapse and refractory: Conventional treatment is ineffective or disease activity reappears after remission. The definition of routine treatment: the use of glucocorticoids (more than 1 mg/Kg/d) and cyclophosphamide, and any one or more of the following immunomodulatory drugs for more than 6 months: antimalarial drugs, azathioprine, mycophenolate mofetil , methotrexate, leflunomide, tacrolimus, cyclosporine, and biological agents including rituximab, belimumab, tatacept, etc. Exclusion criteria: 1. Combined with liver cirrhosis; 2. Combined with aplastic anemia (AA), myelodysplastic syndrome (MDS) or other myeloproliferative diseases (MPD); 3. Drug-induced thrombocytopenia; 4. Thrombotic thrombocytopenic purpura (TTP)/microthrombotic vasculopathy (TMA). Relapsed, Refractory/Progressive Diffuse Scleroderma Inclusion criteria： 1.Comply with the 2013 ACR classification criteria for scleroderma and comply with diffuse manifestations; 2.Combined with interstitial pneumonia: chest HRCT shows interstitial changes with ground glass exudation and the predicted value of FVC or DLCO in pulmonary function testing is \<70%; 3.Definition of relapse and refractory: Conventional treatment is ineffective or disease activity reappears after remission. The definition of routine treatment: the use of glucocorticoids (more than 1 mg/Kg/d) and cyclophosphamide, and any one or more of the following immunomodulatory drugs for more than 6 months: antimalarial drugs, azathioprine, mycophenolate mofetil , methotrexate, leflunomide, tacrolimus, cyclosporine and biological agents including rituximab, belimumab, tatacept, etc.; 4.Definition of progress: 1. Definition of skin progression: mRSS increase \>10%; 2. Definition of lung disease progression: FVC decreases by 10%, or FVC decreases by 5% and DLCO decreases by 15% (OMERACT progression). Exclusion criteria: 1. New York heart function class IV; 2. There is moderate to severe pulmonary hypertension (mean pulmonary artery pressure on echocardiography \>40 mmHg); 3. FVC \<45% predicted value; 4. DLCO \<40% predicted value; 5. Significant abnormalities on HRCT are not caused by SSc; 6. Persistent unexplained hematuria (5 red blood cells under high power) or creatinine clearance \<40ml/min; 7. Patients who have had autologous stem cell transplantation in the past; 8. There are signs of renal crisis; 9. Active antral vasodilation. Relapsed Refractory/Progressive Inflammatory Myopathy Inclusion criteria： 1.Comply with the 2017 EULAR/ACR classification criteria for inflammatory myopathies (including DM, PM, ASS and NM); 2.For those with muscle involvement, the MMT-8 score is lower than 142 and there are at least two abnormal findings in the following five core measurements (PhGA, PtGA or extramuscular disease activity score ≥ 2 points; HAQ total score ≥ 0.25; muscle enzymes level is 1.5 times the upper limit of the normal range); 3.Myositis antibody positive; 4.Definition of relapse and refractory: Conventional treatment is ineffective or disease activity reappears after remission. The definition of routine treatment: the use of glucocorticoids (more than 1 mg/Kg/d) and cyclophosphamide, and any one or more of the following immunomodulatory drugs for more than 6 months: antimalarial drugs, azathioprine, mycophenolate mofetil , methotrexate, leflunomide, tacrolimus, cyclosporine, and biological agents including rituximab, belimumab, tatacept, etc. 5.Definition of progressive: Rapidly progressive interstitial pneumonia occurring in a short period of time. Exclusion criteria: 1. Drug-induced myositis 2. Inclusion body myositis; 3. Tumor-related myositis (myositis occurring within 2 years after tumor diagnosis). Relapsed and Refractory ANCA-Associated Vasculitis Inclusion criteria： 1.Meet the 2022 ACR/EULAR diagnostic criteria for ANCA vasculitis, including microscopic polyangiitis, granulomatosis with polyangiitis, and eosinophilic granulomatosis with polyangiitis; 2.Positive ANCA-related antibodies (MPO-ANCA or PR3-ANCA positive); 3.Birmingham Vasculitis Activity Score (BVAS) ≥15 points (total score 63 points), indicating active vasculitis; 4.There must be at least one major item, at least 3 minor items, or at least two renal items in the BVAS assessment: hematuria and proteinuria; 5.Definition of relapse and refractory: Conventional treatment is ineffective or disease activity reappears after remission. The definition of routine treatment: the use of glucocorticoids (more than 1 mg/Kg/d) and cyclophosphamide, and any one or more of the following immunomodulatory drugs for more than 6 months: antimalarial drugs, azathioprine, mycophenolate mofetil , methotrexate, leflunomide, tacrolimus, cyclosporine and biological agents including rituximab, belimumab, tatacept, etc.; Exclusion criteria: 1.Estimated glomerular filtration rate (eGFR) \<15 mL/min/1.73 m2; 2.If the patient has alveolar hemorrhage, invasive pulmonary ventilation is required and the duration is expected to exceed the screening time; 3.Dialysis or plasma exchange is required during the screening period; 4.Have received a kidney transplant. Relapsed/Refractory/Catastrophic Antiphospholipid Syndrome Inclusion criteria： 1. Meet the diagnostic criteria for primary antiphospholipid syndrome revised in Sydney in 2006; 2. Positive medium-to-high titer phospholipid antibodies (LA, B2GP1 or acL IgG/IgM, more than two positive tests within 12 weeks); 3. Definition of relapse and refractory: use of warfarin anticoagulation or standard treatment instead of vitamin K antagonists (i.e., maintenance of the INR required for treatment) or use of standard therapeutic doses of low molecular weight heparin (LMWH), as well as use of hormones and cyclophosphamide treatment Recurrence of thrombosis; 4. Catastrophic antiphospholipid syndrome requires the following four criteria: <!-- --> 1. Involving three or more organs, systems and/or tissues; 2. Symptoms appear within 1 week; 3. Histology confirms small blood vessel obstruction in at least one organ or tissue; 4. aPL positive. Exclusion criteria: 1. Obstetric APS; 2. APS merged with other CTDs; 3. APS involves the nervous system. **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:** Jianxin Tu, Master's **Phone:** +86 18267726068 **Role:** CONTACT #### Locations **Location 1:** **City:** Wenzhou **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Jianxin Tu, Master's - **Phone:** +86 18267726068 - **Role:** CONTACT ***Contact 2:*** - **Name:** Li Sun, Master's - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 3:*** - **Name:** Songfu Jiang, Master's - **Role:** PRINCIPAL_INVESTIGATOR **Country:** China **Facility:** The First Affiliated Hospital of Wenzhou Medical University **State:** Zhejiang **Zip:** 325000 #### Overall Officials **Official 1:** **Affiliation:** First Affiliated Hospital of Wenzhou Medical University **Name:** LI Sun, Master's **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** Due to concerns regarding the security of patient personal information. **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004194 - Term: Disease - ID: D000010335 - Term: Pathologic Processes - ID: D000003240 - Term: Connective Tissue Diseases - ID: D000007154 - Term: Immune System Diseases - ID: D000012871 - Term: Skin Diseases - ID: D000001172 - Term: Arthritis, Rheumatoid - ID: D000001168 - Term: Arthritis - ID: D000007592 - Term: Joint Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000012216 - Term: Rheumatic Diseases - ID: D000014987 - Term: Xerostomia - ID: D000012466 - Term: Salivary Gland Diseases - ID: D000009059 - Term: Mouth Diseases - ID: D000009057 - Term: Stomatognathic Diseases - ID: D000015352 - Term: Dry Eye Syndromes - ID: D000007766 - Term: Lacrimal Apparatus Diseases - ID: D000005128 - Term: Eye Diseases - ID: D000009135 - Term: Muscular Diseases - ID: D000009468 - Term: Neuromuscular Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000056647 - Term: Systemic Vasculitis - ID: D000017445 - Term: Skin Diseases, Vascular ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC07 - Name: Mouth and Tooth Diseases - Abbrev: BC11 - Name: Eye Diseases - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: HIGH - As Found: Syndrome - ID: M15664 - Name: Sjogren's Syndrome - Relevance: HIGH - As Found: Sjogren's Syndrome - ID: M15415 - Name: Sclerosis - Relevance: LOW - As Found: Unknown - ID: M4629 - Name: Autoimmune Diseases - Relevance: HIGH - As Found: Autoimmune Diseases - ID: M15412 - Name: Scleroderma, Systemic - Relevance: HIGH - As Found: Systemic Sclerosis - ID: M25560 - Name: Scleroderma, Diffuse - Relevance: LOW - As Found: Unknown - ID: M11177 - Name: Lupus Erythematosus, Systemic - Relevance: HIGH - As Found: Systemic Lupus Erythematosus (SLE) - ID: M12172 - Name: Myositis - Relevance: HIGH - As Found: Inflammatory Myopathies - ID: M17405 - Name: Vasculitis - Relevance: HIGH - As Found: Vasculitis - ID: M28527 - Name: Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis - Relevance: HIGH - As Found: ANCA-associated Vasculitis - ID: M19097 - Name: Antiphospholipid Syndrome - Relevance: HIGH - As Found: Antiphospholipid Syndrome - ID: M12092 - Name: Muscular Diseases - Relevance: LOW - As Found: Unknown - ID: M6464 - Name: Connective Tissue Diseases - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: M4476 - Name: Arthritis - Relevance: LOW - As Found: Unknown - ID: M4480 - Name: Arthritis, Rheumatoid - 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: M17724 - Name: Xerostomia - Relevance: LOW - As Found: Unknown - ID: M15285 - Name: Salivary Gland Diseases - Relevance: LOW - As Found: Unknown - ID: M12019 - Name: Mouth Diseases - Relevance: LOW - As Found: Unknown - ID: M12017 - Name: Stomatognathic Diseases - Relevance: LOW - As Found: Unknown - ID: M18040 - Name: Dry Eye Syndromes - Relevance: LOW - As Found: Unknown - ID: M10664 - Name: Keratoconjunctivitis Sicca - Relevance: LOW - As Found: Unknown - ID: M10786 - Name: Lacrimal Apparatus Diseases - Relevance: LOW - As Found: Unknown - ID: M8271 - Name: Eye Diseases - Relevance: LOW - As Found: Unknown - ID: M12411 - Name: Neuromuscular Diseases - Relevance: LOW - As Found: Unknown - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M28526 - Name: Systemic Vasculitis - Relevance: LOW - As Found: Unknown - ID: M19714 - Name: Skin Diseases, Vascular - Relevance: LOW - As Found: Unknown - ID: T5565 - Name: Systemic Scleroderma - Relevance: LOW - As Found: Unknown - ID: T438 - Name: Antiphospholipid Syndrome - Relevance: HIGH - As Found: Antiphospholipid Syndrome - ID: T375 - Name: ANCA-associated Vasculitis - Relevance: HIGH - As Found: ANCA-associated Vasculitis - ID: T3040 - Name: Inclusion Body Myositis - Relevance: HIGH - As Found: Inflammatory Myopathies - ID: T3001 - Name: Idiopathic Inflammatory Myopathy - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000012859 - Term: Sjogren's Syndrome - ID: D000009220 - Term: Myositis - ID: D000014657 - Term: Vasculitis - ID: D000056648 - Term: Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis - ID: D000008180 - Term: Lupus Erythematosus, Systemic - ID: D000012595 - Term: Scleroderma, Systemic - ID: D000001327 - Term: Autoimmune Diseases - ID: D000016736 - Term: Antiphospholipid Syndrome - ID: D000013577 - Term: Syndrome ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06420141 **Brief Title:** The Prevalence of Neuropathic Pain Pathophysiology Associated With Ankle Fracture **Official Title:** The Prevalence of Neuropathic Pain Pathophysiology Associated With Ankle Fracture #### Organization Study ID Info **ID:** 19914 #### Organization **Class:** OTHER **Full Name:** Indiana University ### Status Module #### Completion Date **Date:** 2027-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-16 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2027-03-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-01-03 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-03-04 **Study First Submit QC Date:** 2024-05-16 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** Roman Natoli, MD, PhD **Class:** UNKNOWN **Name:** Kelly M. Naugle, PhD #### Lead Sponsor **Class:** OTHER **Name:** Indiana University #### Responsible Party **Investigator Affiliation:** Indiana University **Investigator Full Name:** Fletcher A White, MS, PhD **Investigator Title:** Professor of Anesthesia **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This application addresses the Peer Reviewed Medical Research Program Investigator-Initiated Research Award FY21 W81XWH-22-CPMRP-IIRA area of Chronic Pain Management Research Program- The investigators will utilize subjects who have sustained ankle fractures and may develop chronic pain following bone union. No attempt will be made to affect the experimental outcome in the subjects. This study will adhere to a core set of standards for rigorous study design and reporting to maximize the reproducibility and translational potential of research. **Detailed Description:** Persistent pain following bone fracture, such as neuropathic pain (NP), is a possible outcome of fracture repair following injury to the ankle and exhibits incidence rates at 1-year post-surgery of 18-42%. This pain state following bone healing (also known as bone union) will be referred to as bone fracture-associated NP (BFNP). Ankle fractures are among the most common surgically-treated fractures in adults, with the greatest incidence occurring in young males. Women are more commonly affected in other age groups. Distal radius fractures are the most common type of fracture for all age groups. Full healing from a fracture can take anywhere from several weeks to months. Pain that persists after fracture union has taken place is called chronic pain. Chronic or persistent NP is one of the worst, longest-lasting, and difficult symptom to manage after fracture repair in civilian and military populations. It is likely that some of the mechanisms leading to BFNP propagate early after injury, leading to opportunity for early interventions to prevent chronic pain. NP associated with bone fracture originates from an injury affecting the sensory aspects of the peripheral nervous system and may be associated with abnormal sensations called dysesthesia or from normally non-painful stimuli (allodynia). The condition may have continuous and/or episodic (paroxysmal) components, with the latter resembling stabbing pain or electric shocks. The condition of NP also tends to affect defined dermatomes, and there may be limits to the area of pain. The general working principle is that the injury leading to pain must directly involve the nociceptive pathways. An additional element which can contribute to NP includes sensitization of intact, uninjured pain neurons, which innervate the region adjacent to injured nerve fibers. These changes in the uninjured neurons may induce ongoing pain and may account for certain aspects of hyperalgesia (increased sensitivity to feeling pain). Conditions associated with bone fracture-associated NP (BFNP) include traction neuropathy, nerve compression from soft tissue edema, bone fragment, implants, and/or hematoma. In civilian adult populations, prevalence rates of NP are about 1 in every 10 adults over age 30, though the prevalence rate and people identified vary depending on the method of identification of NP. Though not distinctly defined as NP due to bone fracture, active-duty personnel and Veterans are at an increased risk of severe pain conditions compared with civilians. Given the numbers of active duty and Veterans who experience pain due to injury, the US military instituted a number of programs, guidelines and initiatives to better manage acute pain for combat-related injuries. These programs include pain control methods which can be readily administered and provide pain relief during immediate field hospital care, transport and subsequent care at military treatment facilities. Despite the instituted practices by the military, BFNP after fracture is a major problem and the literature that documents detailed outcomes of BFNP data are scarce. Bone fracture is known to induce a complex post-fracture healing process and involves an extensive inflammatory response by immune cells. These immune cells proliferate and permeate the fracture site and secrete a range of pro-inflammatory cytokines which aid in the healing process. However, some of these same proteins are known to contribute to a variety of pain conditions/diseases including migraine, fibromyalgia, complex regional pain syndrome and neuropathic pain. To better understand the manner in which immune cell production of factors contribute to chronic pain states, the investigaotrs have embarked on a series of clinical investigations of immune cells which may contribute to chronic post-traumatic headache following mild traumatic brain injury. Like previous work by other groups, the investigators have observed a unique response by immune cell subsets that may serve to discriminate between both subacute and chronic events following traumatic injury. These attributes may prove to be diagnostic and could be regarded as a hallmark of the development of BFNP by ultimately influencing pain modulation in the clinical patient. Additional mechanisms which may contribute to BFNP include a wind-up of mechanisms in the spinal cord (central sensitization), and maladaptive neuroplasticity with changes in endogenous pain modulation. Anti-nociceptive endogenous pain modulation involves intact engagement of descending pain inhibitory pathways, which serve to protect the injured individual from transforming acute pain to a chronic pain state. However, inefficient descending pain inhibition can be a pathogenic risk factor for developing chronic pain. The degree to which an individual can be assayed for an intact endogenous pain inhibition system can be assessed using a quantitative sensory test (QST) which serves to test condition pain modulation (CPM). The provoking factor for such a generalized sensitization of the pain system could be the continuous noxious input in earlier phases of the bone fracture healing process associated with the ongoing states of inflammation. Outcomes after trauma which contribute to chronic pain states are complex and are highlighted by a generalized failure in the clinical arena to improve patient conditions and quality of life once these conditions manifest themselves within the individual. However, recent studies have begun to yield novel insights into the injury-associated immune response which may be central to BFNP by using computational methods that account for temporal and spatial networks of mediators. Fundamental understanding of the immunologic responses associated with BFNP at distinct cross-sections in the recovery time frame and dynamically during progression of fracture healing process may yield better management and potentially mitigation of BFNP. Moreover, changing the standard of care treatment for BFNP by identifying at-risk patients early after injury could lead to decreased economic burden in treating BFNP and mitigation of the substantial decrease in quality of life these patients experience. Thus, evidenced-based and "precision" approaches to BFNP and management are greatly needed, in which mechanisms and other factors that contribute to BFNP are identified to guide treatment. The proposed project is significant because it is an essential step in understanding whether ankle fracture chronically alters biological pain risk factors. Such information is critical to 1) developing effective strategies to reduce the occurrence of BFNP, 2) providing prognostic information to individuals suffering with BFNP, and 3) designing evidenced-based and personalized treatments for BFNP. The proposed study is innovative because it will be the first prospective human study to evaluate the impact of bone fracture on innate immune function and endogenous pain modulatory function across time. This novel information will enhance our understanding of how ankle fracture elicits pathological risk factors for BFNP. Identification of salient risk factors for the initiation and maintenance of BFNP will allow a more personalized injury prognosis to predict those at greatest risk. ### Conditions Module **Conditions:** - Neuropathic Pain ### Design Module #### Bio Spec **Description:** blood **Retention:** SAMPLES_WITH_DNA #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 250 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** Chronic Pain Grading Scale (CPGS) will be used to determine if fracture patients have pain in the chronic phase of injury (6-9 month visit). The pain intensity subscale will be used to categorize participants into those with and without chronic pain. This score is the sum of three questions (current pain, worst pain, average pain over last month), each scored on an 11-point Likert scale with responses ranging from 0-10 for a maximum of 30 points. The participant will be asked to report only on pain related to the site of fracture. Participants scoring 1-30 on the characteristic pain intensity score in the last month at the site of fracture will be classified as having chronic pain related to the fracture. Patients reporting no pain (0) at the site of fracture in the last month will be classified as having no chronic pain. **Measure:** Chronic Pain Grading Scale **Time Frame:** 6-9 month **Description:** Douleur Neuropathique (Neuropathic Pain) 4 (DN4). The DN4 is a validated and reliable screening tool for neuropathic pain consisting of 10 items. The first 7 items relate to pain quality (i.e., sensory and pain descriptors) are based on interview with the patient. The last 3 items are based on clinical examination and assess hypoesthesia to touch, and hypoesthesia to prick and brushing. The items of the DN4 are scored based on a yes (1 point)/no (0 points) answer. This leads to a score range of 0-10. The cut-off value for the classification of neuropathic pain is a total score of 4 of 10.72 The DN4 has been used to identify NP in ankle fracture patients. **Measure:** Douleur Neuropathique (Neuropathic Pain) 4 **Time Frame:** 2 weeks to 1 year **Description:** Assessment of Chronic Regional Pain Syndrome (CRPS). Presence of CRPS will be assessed in study participants beginning at the 6-8 week follow-up visit and all subsequent visits. Assessment of CRPS at earlier timepoints cannot be done rigorously as pain, motor, temperature and other changes comprising in part the CRPS diagnostic criteria can be related to the recent trauma. In addition to the QST procedures, a validated CRPS sign and symptom checklist will be administered by the study coordinator containing items in the 4 symptom and 4 sign categories needed to establish a CRPS diagnosis. For this study the investigators will employ the more rigorous CRPS Research Criteria (all symptom categories positive and 2/4 sign categories). **Measure:** Assessment of Chronic Regional Pain Syndrome (CRPS) **Time Frame:** 2 weeks to 6-9 months **Description:** Central Sensitization measure: The most common quantitative sensory test used to measure central sensitization in human experimental studies is temporal summation of pain (TS).TS will be administered on the skin proximal to the level of injury and the contralateral uninjured side using a nylon monofilament (Touchtest Sensory Evaluator 6.65) calibrated to bend at 300g of pressure. As in previous studies, participants will rate the perceived pain intensity of a single contact of the monofilament using a 0 to 100 numeric rating scale. Then, participants will provide another pain rating following a series of 10 contacts administered at a rate of 1 contact per second, applied to the body site within an area of 1 cm2. The difference between pain ratings for the single versus multiple contacts reflects temporal summation of mechanical pain. Two trials will be administered. **Measure:** Central Sensitization measure **Time Frame:** 5-9 weeks to 6-9 months **Description:** Pain Inhibitory Test. Conditioned pain modulation (CPM) will be assessed by determining the ability of a cold pressor task to diminish pressure pain thresholds applied at a separate body site. For the conditioning stimulus, participants will immerse their non-affected hand up to the wrist in a cold water bath maintained at 10 degrees C for up to 1 minute or until they report intolerable pain.The test stimulus will be two trials of pressure pain thresholds (PPTs) administered on the left forearm. The experimenter will apply a slow constant rate of pressure and the participant will press a button when the sensation first becomes painful, at which time a device records the pressure. Three consecutive measurements with intervals of 20s will be obtained pre- and post- the conditioning stimulus. **Measure:** Pain Inhibitory Test **Time Frame:** 5-9 weeks to 6-9 months #### Secondary Outcomes **Description:** Mechanical detection thresholds will be examined using von Frey monofilaments, with each filament applied three times in ascending sequence until the threshold is detected in at least two of the three trials. Then, the next lower von Frey filament will be applied, and the lowest filament to be detected at least twice will be determined as the mechanical detection threshold. **Measure:** Mechanical Detection Thresholds **Time Frame:** 5-9 weeks to 6-9 months **Description:** A digital, handheld, clinical grade pressure algometer will be used for the mechanical procedures (AlgoMed, Medoc). The experimenter will apply a slow constant rate of pressure and record the pressure in kilograms when the subject responds. Pressure will be applied using a .5 cm2 probe. Subjects will be instructed to respond when they first feel pain and pressure at threshold will be recorded. Two consecutive measurements at each point with intervals of 20 s will be obtained. **Measure:** Pressure pain thresholds **Time Frame:** 5-9 weeks to 6-9 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 1) 18-85 years old * 2) an isolated rotational ankle (AO/OTA 44 types A-C) fracture that is treated operatively * 3) Abbreviated Injury Scale \< 3 for non-extremity body systems * 4) can speak, read, and understand English Exclusion Criteria: * 1) treated for a chronic pain condition prior to their qualifying injury * 2) on a pain contract * 3) multiple fractures * 4) pathologic fracture * 5) develops a complication in post-operative period or undergoes secondary procedures for the fracture **Healthy Volunteers:** True **Maximum Age:** 85 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** The investigators will enroll participants who have sustained rotational ankle (specifically AO/OTA 44 types AC) fractures that are treated operatively. Fracture patients will complete clinic assessment sessions at standard of care visits, including their first post-op appointment (2-3 weeks), at 6-8 weeks, at 3-4 months, and at 6-9 months post-operatively. These visits will allow assessments during the subacute and chronic stages of bone fracture associated neuropathic pain. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Fletcher A White, PhD **Phone:** 317-274-5264 **Role:** CONTACT #### Locations **Location 1:** **City:** Indianapolis **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Fletcher A White, PhD - **Phone:** 317-274-5164 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Roman Natoli, MD PhD - **Role:** CONTACT **Country:** United States **Facility:** Indiana University School of Medicine **State:** Indiana **Status:** RECRUITING **Zip:** 46202 ### References Module #### References **Citation:** Johansen A, Romundstad L, Nielsen CS, Schirmer H, Stubhaug A. Persistent postsurgical pain in a general population: prevalence and predictors in the Tromso study. Pain. 2012 Jul;153(7):1390-1396. doi: 10.1016/j.pain.2012.02.018. Epub 2012 Mar 24. **PMID:** 22445291 **Citation:** Scheer RC, Newman JM, Zhou JJ, Oommen AJ, Naziri Q, Shah NV, Pascal SC, Penny GS, McKean JM, Tsai J, Uribe JA. Ankle Fracture Epidemiology in the United States: Patient-Related Trends and Mechanisms of Injury. J Foot Ankle Surg. 2020 May-Jun;59(3):479-483. doi: 10.1053/j.jfas.2019.09.016. **PMID:** 32354504 **Citation:** Karl JW, Olson PR, Rosenwasser MP. The Epidemiology of Upper Extremity Fractures in the United States, 2009. J Orthop Trauma. 2015 Aug;29(8):e242-4. doi: 10.1097/BOT.0000000000000312. **PMID:** 25714441 **Citation:** Beetar JT, Guilmette TJ, Sparadeo FR. Sleep and pain complaints in symptomatic traumatic brain injury and neurologic populations. Arch Phys Med Rehabil. 1996 Dec;77(12):1298-302. doi: 10.1016/s0003-9993(96)90196-3. **PMID:** 8976315 **Citation:** Veljkovic A, Dwyer T, Lau JT, Abbas KZ, Salat P, Brull R. Neurological Complications Related to Elective Orthopedic Surgery: Part 3: Common Foot and Ankle Procedures. Reg Anesth Pain Med. 2015 Sep-Oct;40(5):455-66. doi: 10.1097/AAP.0000000000000199. **PMID:** 26192548 **Citation:** Rbia N, van der Vlies CH, Cleffken BI, Selles RW, Hovius SER, Nijhuis THJ. High Prevalence of Chronic Pain With Neuropathic Characteristics After Open Reduction and Internal Fixation of Ankle Fractures. Foot Ankle Int. 2017 Sep;38(9):987-996. doi: 10.1177/1071100717712432. Epub 2017 Jul 1. **PMID:** 28670914 **Citation:** Nahin RL. Severe Pain in Veterans: The Effect of Age and Sex, and Comparisons With the General Population. J Pain. 2017 Mar;18(3):247-254. doi: 10.1016/j.jpain.2016.10.021. Epub 2016 Nov 21. **PMID:** 27884688 **Citation:** Vallerand AH, Cosler P, Henningfield JE, Galassini P. Pain management strategies and lessons from the military: A narrative review. Pain Res Manag. 2015 Sep-Oct;20(5):261-8. doi: 10.1155/2015/196025. **PMID:** 26448972 **Citation:** Baca Q, Marti F, Poblete B, Gaudilliere B, Aghaeepour N, Angst MS. Predicting Acute Pain After Surgery: A Multivariate Analysis. Ann Surg. 2021 Feb 1;273(2):289-298. doi: 10.1097/SLA.0000000000003400. **PMID:** 31188202 **Citation:** Sun S, Diggins NH, Gunderson ZJ, Fehrenbacher JC, White FA, Kacena MA. No pain, no gain? The effects of pain-promoting neuropeptides and neurotrophins on fracture healing. Bone. 2020 Feb;131:115109. doi: 10.1016/j.bone.2019.115109. Epub 2019 Nov 9. **PMID:** 31715336 **Citation:** Lamparello AJ, Namas RA, Constantine G, McKinley TO, Elster E, Vodovotz Y, Billiar TR. A conceptual time window-based model for the early stratification of trauma patients. J Intern Med. 2019 Jul;286(1):2-15. doi: 10.1111/joim.12874. Epub 2019 Jan 9. **PMID:** 30623510 **Citation:** McKinley TO, Gaski GE, Zamora R, Shen L, Sun Q, Namas RA, Billiar TR, Vodovotz Y. Early dynamic orchestration of immunologic mediators identifies multiply injured patients who are tolerant or sensitive to hemorrhage. J Trauma Acute Care Surg. 2021 Mar 1;90(3):441-450. doi: 10.1097/TA.0000000000002998. **PMID:** 33093290 **Citation:** Almahmoud K, Abboud A, Namas RA, Zamora R, Sperry J, Peitzman AB, Truitt MS, Gaski GE, McKinley TO, Billiar TR, Vodovotz Y. Computational evidence for an early, amplified systemic inflammation program in polytrauma patients with severe extremity injuries. PLoS One. 2019 Jun 4;14(6):e0217577. doi: 10.1371/journal.pone.0217577. eCollection 2019. **PMID:** 31163056 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010523 - Term: Peripheral Nervous System Diseases - ID: D000009468 - Term: Neuromuscular Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations - ID: D000050723 - Term: Fractures, Bone - ID: D000014947 - Term: Wounds and Injuries - ID: D000016512 - Term: Ankle Injuries - ID: D000007869 - Term: Leg Injuries ### Condition Browse Module - Browse Branches - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M26370 - Name: Fractures, Bone - Relevance: LOW - As Found: Unknown - ID: M12381 - Name: Neuralgia - Relevance: HIGH - As Found: Neuropathic Pain - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M30291 - Name: Ankle Fractures - Relevance: HIGH - As Found: Ankle Fractures - 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 - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: M18909 - Name: Ankle Injuries - Relevance: LOW - As Found: Unknown - ID: M10881 - Name: Leg Injuries - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009437 - Term: Neuralgia - ID: D000064386 - Term: Ankle Fractures ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06420128 **Acronym:** SCOPE HPE **Brief Title:** Interprofessional Collaborative Practice in Primary Care: Potentially Avoidable Hospitalization **Official Title:** Collaborative Practice in Primary Care: a Comparison of the Global Rate of Potentially Avoidable Hospitalization, Depending on Whether Their General Practitioner is Part of a Primary Care Team. A Cohort Study With a 36-month Follow-up. #### Organization Study ID Info **ID:** RC21_0307 #### Organization **Class:** OTHER **Full Name:** Nantes University Hospital ### Status Module #### Completion Date **Date:** 2024-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-16 **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:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-03 **Study First Submit QC Date:** 2024-05-16 ### Sponsor Collaborators Module #### 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 World Health Organization supports collaborative practice in primary care, defining it as "when multiple health professionals from different professional backgrounds work together with patients, families, carers and communities to deliver the highest quality of care across settings" (1). Previous research have shown that collaborative practice in primary care improves care pathways, efficiency of care (2,3), job satisfaction among health professionals (4-6), and economic efficiency (3,7). Riverin et al. found a reduction in post-hospitalization mortality with collaborative practice (8). In France, the establishment of primary care teams following the American model of Centered Medical Homes is encouraged. In the Pays de la Loire region, two models exist: A national and a regional model. A major issue for patient care team is the care of seniors (9,10).Hospitalizations can have adverse health effects for this population (11,12). 45% of emergency admissions follow by a hospitalization concern them (13). The hypothesis of the study is that collaborative practice could reduce the global rate of potential avoidable hospitalizations among seniors. ### Conditions Module **Conditions:** - Hospitalization - Aged - Primary Health Care **Keywords:** - Collaborative practice - Seniors - Potentially avoidable hospitalization - Primary Care Team ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 500000 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients whose general practitioner is a member of a primary care team since at least 12 months **Intervention Names:** - Other: Primary care team **Label:** Primary care team #### Arm Group 2 **Description:** Patients whose general practitioner is not part of a primary care team **Label:** Traditional ### Interventions #### Intervention 1 **Arm Group Labels:** - Primary care team **Description:** Patients whose general practitioner is a member of a primary care team since at least 12 months **Name:** Primary care team **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Comparison of the global rate of potentially avoidable hospitalization of seniors, depending on whether their general practitioner is a member of a primary care team. Use of reimbursement data of Health Insurance System. **Measure:** Comparison of Global rate of potentially avoidable hospitalization **Time Frame:** 36 months #### Secondary Outcomes **Description:** Comparison of criterion of quality (rate of potentially avoidable hospitalization with emergency enter, rate of potentially avoidable hospitalization for patients with chronic disease(s), rate of rehospitalization at one month, mortality in post-hospitalization and rate of emergency admission), depending on whether their general practitioner is a member of a primary care team. Use of reimbursement data of Health Insurance System. **Measure:** Comparison of criterion of quality **Time Frame:** 36 months **Description:** Comparison of Global rate of potentially avoidable hospitalization depending the model of primary care team Description: comparison of global rate of potentially avoidable hospitalization depending general practitioner is a member of a national model of primary care team or a regional model of primary care team. Use of reimbursement data of Health Insurance System. **Measure:** Comparison of Global rate of potentially avoidable hospitalization depending the model of primary care team **Time Frame:** 36 months **Description:** To determine health expenditures per patient, annual and total. Use of reimbursement data of Health Insurance System. **Measure:** Medico-economic evaluation **Time Frame:** 36 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients over 75 years old and over 65 years old with chronic disease(s), with a general practitioner in Pays de la Loire, affiliated with the general health insurance system and have had at least one healthcare encounter, and residing in the Pays de la Loire region. Exclusion Criteria: * Patients whose general practitioner has ceased their practice or changed their affiliation, as well as patients who have switched to a new general practitioner. **Minimum Age:** 65 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - OLDER_ADULT **Study Population:** Seniors ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Cédric Rat, Doctor **Phone:** 02.40.41.28.28 **Role:** CONTACT #### Locations **Location 1:** **City:** Nantes **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Cédric RAT, Doctor - **Phone:** 02.40.41.28.28 - **Role:** CONTACT **Country:** France **Facility:** University Hospital **Zip:** 44093 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06420115 **Acronym:** TARGET **Brief Title:** Can Needle Size Improve Cancer Detection Rate of Transperineal MRI Target Prostate Biopsy Without Affecting Side Effects? **Official Title:** AOP2780 - Can Needle Size Improve Cancer Detection Rate of Transperineal MRI Target Prostate Biopsy Without Affecting Side Effects? #### Organization Study ID Info **ID:** AOP2780 #### Organization **Class:** OTHER **Full Name:** University Hospital Padova ### Status Module #### Completion Date **Date:** 2025-05-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-25 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-12-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-04-26 **Study First Submit QC Date:** 2024-05-16 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University Hospital Padova #### Responsible Party **Investigator Affiliation:** University Hospital Padova **Investigator Full Name:** FABIO ZATTONI **Investigator Title:** 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:** Differences in terms of diagnostic capability and side effects related to the needle caliber used for prostate biopsy sampling in patients with suspected prostate cancer **Detailed Description:** To assess whether a larger caliber (16G) prostate biopsy needle increases the diagnostic capability of prostate neoplasia compared to a smaller caliber (18G) needle, while keeping perioperative complications constant. ### Conditions Module **Conditions:** - Prostate Cancer Diagnosis **Keywords:** - pca - needle - 16 gauge - 18 gauge ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 580 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Device: different needle size for prostate biopsy **Label:** mpMRI target prostate biopsy with 16 gauge needle **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Device: different needle size for prostate biopsy **Label:** mpMRI target prostate biopsy with 18 gauge needle **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - mpMRI target prostate biopsy with 16 gauge needle - mpMRI target prostate biopsy with 18 gauge needle **Description:** MRI Fusion Transperineal Prostate Biopsy **Name:** different needle size for prostate biopsy **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** The primary outcome measure involves assessing the total number of biopsies, including both random and fusion-targeted approaches, that reveal the presence of prostate cancer. **Measure:** Total number of random and fusion-target biopsies with presence of prostate cancer **Time Frame:** When histological report available **Description:** The primary outcome measure focuses on the number and the detection rates of random and fusion-target biopsies revealing clinically significant prostate cancer aof clinically significant prostate cancer (defined as ISUP \>=2) between 16-gauge and 18-gauge biopsy needles. **Measure:** Number of random and fusion-target biopsies with clinically significant prostate cancer (defined as International Society of Urological Pathology >=2) **Time Frame:** When histological report available #### Secondary Outcomes **Description:** Neoplasia/core ratio, indicates the ratio of neoplastic tissue to healthy tissue within biopsy cores obtained through both 16 and 18 gauge biopsies for prostate cancer diagnosis. By analyzing this ratio, investivators seek to identify differences in diagnosis across the two different sizes **Measure:** Neoplasia/core ratio for each random and fusion-target biopsy **Time Frame:** When histological report available **Description:** The validated pain questionnaire employed in this study is designed to comprehensively assess the intra- and perioperative pain (following 7 days) experienced by patients undergoing prostate biopsy procedures with 18G and 16G needles. The visual analog scales "VAS" is a standardized validated questionnaire, a horizontal line, where one end represents "1 - no pain" and the other end represents "10 - worst possible pain." Patients are asked to mark on the line the point that best represents the intensity of their pain. **Measure:** Intra- and perioperative pain with 18G and 16G needles assessed using visual analog scale (VAS) **Time Frame:** 30 days **Description:** By tracking the number of hospitalizations occurring at both 30 and 60 days post-procedure among patients undergoing prostate biopsy within these specific time frames, researchers seek to assess the short-term post-procedural outcomes and potential complications associated with the biopsy procedure. These hospitalization data will provide information into the safety profile and healthcare utilization patterns following prostate biopsy, aiding in the optimization of patient care and risk management strategies. **Measure:** Number of hospitalizations at 30 and 60 days post-procedure **Time Frame:** 60 days from biopsy **Description:** Intraoperative complications refer to adverse events occurring during the biopsy procedure itself, while perioperative complications encompass those arising in the immediate post-procedural period. These complications may include but are not limited to bleeding, infection, urinary retention, and vasovagal reactions. By documenting these complications, investigators will evaluate the safety profile and potential risks associated with each needle gauge, thereby informing clinical decision-making and optimizing patient outcomes. **Measure:** Number of intra- and perioperative complications associated with 18G and 16G needles **Time Frame:** 30 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Clinical suspicion of prostate cancer (presence of elevated prostatic specific antigen and/or suspicious digital rectal examination); * Presence of at least one suspicious prostate lesion on MRI (Prostate Imaging-Reporting and Data System ≥ 3) according to the Prostate Imaging-Reporting and Data System v2.1 performed before Magnetic Resonance Imaging/transrectal ultrasound fusion biopsy. Exclusion Criteria: * Patients under active surveillance or with a previous diagnosis of prostate neoplasia prior to biopsy. * Previous radiotherapy to the prostate for neoplasia. **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Fabio F. Zattoni, MD, PhD **Phone:** 0498212730 **Role:** CONTACT #### Locations **Location 1:** **City:** Padua **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Fabio Zattoni, MD, PhD - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Filippo Carletti, MD - **Role:** CONTACT **Country:** Italy **Facility:** Urology Unit - Padua University Hospital **Status:** RECRUITING **Zip:** 35100 #### Overall Officials **Official 1:** **Affiliation:** Department of Surgery, Oncology and Gastroenterology, Urology Clinic, University of Padua, Padova, **Name:** Fabio Zattoni, MD, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** Only if requested **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000005834 - Term: Genital Neoplasms, Male - ID: D000014565 - Term: Urogenital Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000005832 - Term: Genital Diseases, Male - ID: D000091662 - Term: Genital Diseases - ID: D000091642 - Term: Urogenital Diseases - ID: D000011469 - Term: Prostatic Diseases - ID: D000052801 - Term: Male Urogenital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M14335 - Name: Prostatic Neoplasms - Relevance: HIGH - As Found: Prostate Cancer - ID: M8946 - Name: Genital Neoplasms, Male - Relevance: LOW - As Found: Unknown - ID: M17315 - Name: Urogenital Neoplasms - Relevance: LOW - As Found: Unknown - ID: M2876 - Name: Genital Diseases - Relevance: LOW - As Found: Unknown - ID: M8944 - Name: Genital Diseases, Male - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14333 - Name: Prostatic Diseases - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000011471 - Term: Prostatic Neoplasms ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06420102 **Brief Title:** Detecting Changes in Skin Status Over the Site of a Stage 1 Pressure Ulcer Using Biophysical Sensors and Biomarkers **Official Title:** Detecting Changes in Skin Status Over the Site of a Stage 1 Pressure Ulcer Using Biophysical Sensors and Biomarkers #### Organization Study ID Info **ID:** ERGO 66933 #### Organization **Class:** OTHER **Full Name:** University of Southampton ### Status Module #### Completion Date **Date:** 2023-07-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-16 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-03-10 **Type:** ACTUAL #### Start Date **Date:** 2021-11-16 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2023-08-23 **Study First Submit QC Date:** 2024-05-16 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** European Union **Class:** OTHER **Name:** University Hospital Southampton NHS Foundation Trust #### Lead Sponsor **Class:** OTHER **Name:** University of Southampton #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** During a patient's hospital stay the skin can be exposed to forces from sitting or lying and attachment to different medical devices. Skin health is maintained healthy through regular movements to remove pressure from the skin surface. However, sometimes if the skin is exposed to loads for prolonged periods, it can be compromised, and red marks can appear (stage one pressure ulcer). In most cases, these changes in the skin can be recovered, through regular movement and nursing care. However, in a small number of cases, the skin damage can progress further until a wound appears. It is important to find out why this may occur, so that preventive strategies can be implemented to protect skin health. Therefore, the project focuses on evaluating changes in skin health following the development of a minor pressure ulcer (stage one). This research proposal aims to better understand how the skin changes at the body sites compromised by stage 1 pressure ulcer, compared to healthy sites. This will be achieved via the use of measurements of skin health including physical sensors and sampling fluids and cells from the skin surface. The knowledge acquired from this study will help the understanding of how and why skin breaks down following early signs of damage. Some of the proposed sensing systems could then be used to support healthcare professionals to adopt the appropriate preventive strategies to avoid skin damage and subsequent wounds. A cohort of 50 patients will be recruited from a hospital setting, who present with a stage one pressure ulcer. Skin measurements will be taken three times to establish changes during their hospital stay. The investigators will establish if these measurements support the prediction of whether the stage one ulcer heals, remains the same, or progresses into a wound (stage two or higher pressure ulcer). **Detailed Description:** This is a case controlled longitudinal observational study on patients who have the early signs of pressure ulcers, termed stage 1. In this study, a series of non-invasive measurements will be performed to assess skin status in individuals presenting with stage 1 pressure ulcers (PU). Photographic images of the compromised skin site of participants will also be collected. Participants will be tested using a well-established protocol, which consist of visiting the patient on three different occasions during their hospital stay. The first two visits will be on consecutive days while the third skin assessment session will be carried out a day before the patient is discharged. The investigator team will ensure that the sessions, which will last approximately 15-20 minutes, avoiding any interference with patients personal or healthcare commitments. Different measurements on the participant skin surface will be taken using probes which are designed to monitor skin health (all probes are CE marked and have been employed previously in clinical trials). The measurements will include: 1. the pH (acidity) at the skin surface 2. the amount of water which is lost through the skin 3. skin hydration In addition, sebum (oily substance) and cells from the compromised and healthy areas of the skin using commercial tapes were collected. The aforementioned skin parameters will be taken at each visit using non-invasive, harmless wireless probes, which will be placed gently in contact with the skin for a 1-minute duration. Each probe was cleaned in-between assessments following the NHS infection control policies. Skin sebum will also be taken at each assessment from the areas of interest using sebutapes, which will be gently applied to the skin for 2 minutes before removal. These commercially available tapes have been used extensively in dermatological research. Corneocytes (outermost surface cells) will be taken only on the first visit from both the compromised and healthy sites of the skin. This will be achieved using a harmless tape stripping technique during which standard sellotapes will be applied to the skin surface and slightly pressed for 5 seconds prior to removal. ### Conditions Module **Conditions:** - Pressure Ulcer ### Design Module #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 50 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Individuals who are in hospital that present with a confirm grade 1 pressure ulcer. These include a range of sex, age and ethnicities. **Intervention Names:** - Diagnostic Test: Biophysical and biochemical skin assessment **Label:** Grade 1 pressure ulcer cohort ### Interventions #### Intervention 1 **Arm Group Labels:** - Grade 1 pressure ulcer cohort **Description:** Measurements are taken from the skin surface including transepidermal water loss, skin hydration and pH. In addition, non-invasive biofluid (sebum) is sampled from the skin to profile local inflammation. Skin surface cells were also stripped to assess corneocyte properties over the pressure ulcer and surrounding healthy skin. **Name:** Biophysical and biochemical skin assessment **Other Names:** - Corneocyte evaluation **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** Case controlled differences in transepidermal water loss between the site of a grade 1 pressure ulcer and health adjacent skin. A Tewameter (CK, Germany) was used to assess skin barrier function sampled over a 30 second period. This was measured over the site of the grade 1 pressure ulcer and one that was 10cm lateral (healthy site). This outcome was measured in g/m2/hr. **Measure:** Spatial and temporal differences in skin barrier function over a grade 1 pressure ulcer **Time Frame:** 3 weeks. #### Secondary Outcomes **Description:** Case controlled differences in the maturity of corneocyte cells over a grade 1 pressure ulcer. Cells were collected from a PU-compromised site and an adjacent control area and their topographical properties were analysed. Atomic force microscopy (AFM) imaging and nanoindentation experiments were performed to assess topography. **Measure:** Spatial differences in skin corneocyte topography over a grade 1 pressure ulcer **Time Frame:** 3 weeks. **Description:** Case controlled differences in the maturity of corneocyte cells over a grade 1 pressure ulcer. Cells were collected from a PU-compromised site and an adjacent control area and maturation properties were analysed. Maturity of corneodesmosomes was indirectly measured by immunostaining of desmoglein-1 (Dsg1). Parameters of measurement included surface roughness Sq (nm) and Youngs Modulus of cells (MPa). Qualitative analysis of immunostaining of desmoglein-1 (Dsg1) was also included. **Measure:** Spatial differences in skin corneocyte maturity over a grade 1 pressure ulcer **Time Frame:** 3 weeks. **Description:** Case controlled differences in skin inflammatory biomarkers between the site of a grade 1 pressure ulcer and health adjacent skin. Sebutapes were collected over three sessions to investigate the temporal changes in the inflammatory response. The panel of cytokines investigated included high-abundance cytokines, namely, IL-1α and IL-1RA, and low abundance cytokines; IL-6, IL-8, TNF-α, INF-γ, IL-33, IL-1β and G-CSF. Spatial and temporal differences between sites were assessed and thresholds were used to determine the sensitivity and specificity of each biomarker. Concentrations of protein biomarkers in the sebum will be presented in picograms per ml. **Measure:** Spatial and temporal differences in skin inflammation over a grade 1 pressure ulcer **Time Frame:** 3 weeks **Description:** Case controlled differences in skin hydration between the site of a grade 1 pressure ulcer and health adjacent skin. A Corneometer (CK, Germany) was used to assess skin hydration sampled 5 times over eac site. This was measured over the site of the grade 1 pressure ulcer and one that was 10cm lateral (healthy site). Stratum corneum hydration was measured in arbitrary units, according to the calibrated Corneometer. **Measure:** Spatial and temporal differences in skin hydration over a grade 1 pressure ulcer **Time Frame:** 3 weeks. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Aged over 18 years old * Individuals of all genders and ethnicities * Individuals presenting grade 1 PU (regardless of the anatomical location of the PU) * Individuals admitted to UHST * Have the capacity and English proficiency to provide informed consent Exclusion Criteria: * Individuals with broken skin * Patients at end of life * Patients who cannot be repositioned due to medical reasons * Patients in COVID-19 areas * Allergies or sensitivity to sebutape or Sellotape * Current active skin condition on the areas of measurement * Cognitive impairments which limit their ability to provide informed consent * Inability to understand English language **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Participants will be purposefully sampled from a number of departments/units at University Hospital Southampton (UHS) Foundation Trust. According to information from the Tissue Viability Department, an average number of 50 patients are referred monthly with presentations of early signs of PUs. The study is designed to recruit 50 participants over a 12-month period ### Contacts Locations Module #### Locations **Location 1:** **City:** Southampton **Country:** United Kingdom **Facility:** University Hospital Southampton (UHS) Foundation Trust **State:** Hampshire **Zip:** SO16 6YD ### IPD Sharing Statement Module **Description:** As per University of Southampton and EU guidelines anonymised from the study can be accessed through our ePrints provider. **IPD Sharing:** NO ### References Module #### References **Citation:** Jayabal H, Abiakam NS, Filingeri D, Bader DL, Worsley PR. Inflammatory biomarkers in sebum for identifying skin damage in patients with a Stage I pressure ulcer in the pelvic region: A single centre observational, longitudinal cohort study with elderly patients. Int Wound J. 2023 Sep;20(7):2594-2607. doi: 10.1111/iwj.14131. Epub 2023 Mar 5. **PMID:** 36872612 **Citation:** Abiakam NS, Jayabal H, Filingeri D, Bader DL, Worsley PR. Spatial and temporal changes in biophysical skin parameters over a category I pressure ulcer. Int Wound J. 2023 Oct;20(8):3164-3176. doi: 10.1111/iwj.14194. Epub 2023 Apr 14. **PMID:** 37060199 #### See Also Links **Label:** STINTS EU Marie Curie ITN funding home page **URL:** https://www.stints.eu/ ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000012883 - Term: Skin Ulcer - ID: D000012871 - Term: Skin Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M6870 - Name: Pressure Ulcer - Relevance: HIGH - As Found: Pressure Ulcer - ID: M17206 - Name: Ulcer - Relevance: HIGH - As Found: Ulcer - ID: M15686 - Name: Skin Ulcer - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003668 - Term: Pressure Ulcer - ID: D000014456 - Term: Ulcer ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06420089 **Acronym:** VIPER101 **Brief Title:** CD5-deleted Chimeric Antigen Receptor Cells (Senza5 CART5) for T Cell Non-Hodgkin Lymphoma (NHL) **Official Title:** CD5-deleted Chimeric Antigen Receptor Cells (Senza5 CART5) to Enhance Immunotherapy Against T Cell Non-Hodgkin Lymphoma (NHL): a First-in-human Phase I Clinical Trial #### Organization Study ID Info **ID:** VIPER 101 #### Organization **Class:** INDUSTRY **Full Name:** Vittoria Biotherapeutics ### Status Module #### Completion Date **Date:** 2027-06-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-16 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-30 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-04-30 **Study First Submit QC Date:** 2024-05-16 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** University of Pennsylvania #### Lead Sponsor **Class:** INDUSTRY **Name:** Vittoria Biotherapeutics #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** This is an open-label phase I study to determine the safety and recommended phase 2 dose (RP2D) of Senza5 CART5 cells in patients with relapsed or refractory CD5 positive nodal T cell NHL. RP2D will be based on the safety, tolerability, pharmacokinetics, and preliminary efficacy of Senza5 CART5 cells. This trial will evaluate up to 5 dose levels using the Bayesian Optimal Interval (BOIN) design enrolling 3 patients in each cohort to assess safety and achieve therapeutic levels so that the RP2D of Senza5 CART5 cells given as a single IV infusion can be determined. ### Conditions Module **Conditions:** - T Cell Non-Hodgkin Lymphoma ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** SEQUENTIAL **Intervention Model Description:** Open label ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Four treatment arms with Standard of Care Lymphodepletion: Fludarabine 25mg/m2 IV for 3 days Cyclophosphamide 250mg/m2 IV for 3 days **Intervention Names:** - Drug: Senza5 CART5 **Label:** Senza5 CART5 with standard of care lymphodepletion **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Four treatment arms in patients are lymphopenic into the corresponding dose level. **Intervention Names:** - Drug: Senza5 CART5 **Label:** Senza5 CART5 without standard of care lymphodepletion **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Senza5 CART5 with standard of care lymphodepletion - Senza5 CART5 without standard of care lymphodepletion **Description:** The Senza5 CART5 drug product consists of a dual population of engineered autologous T cells: CD5 knockout (KO)cells and CD5KO-CART5 cells **Name:** Senza5 CART5 **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Measure the occurrence of Dose Limiting Toxicity events of each dose level per arm **Measure:** Determine the recommended phase 2 dose (RP2D) of Senza5 CART5 cells **Time Frame:** 12 months #### Secondary Outcomes **Description:** Quantify quantifying the type and frequency of adverse events **Measure:** Determine the safety of Senza5 CART5 cells **Time Frame:** 12 months **Description:** Quantify the safety and tolerability of the highest dose **Measure:** Determine the maximum tolerated dose (MTD) **Time Frame:** 12 months **Description:** Quantify the number of product release failures and occurrence of dose failures (inability to meet targeted dose) **Measure:** Determine the manufacturing feasibility of Senza5 CART5 **Time Frame:** 12 months **Description:** Measure the objective response rate **Measure:** Determine efficacy of Senza5 CART5 **Time Frame:** 12 months **Description:** Measure the complete response rate **Measure:** Determine efficacy of Senza5 CART5 **Time Frame:** 12 months **Description:** Measure the best overall response **Measure:** Determine efficacy of Senza5 CART5 **Time Frame:** 12 months **Description:** Measure the duration of response **Measure:** Determine efficacy of Senza5 CART5 **Time Frame:** 12 months **Description:** Measure the overall survival **Measure:** Determine efficacy of Senza5 CART5 **Time Frame:** 12 months **Description:** Measure the progression free survival **Measure:** Determine efficacy of Senza5 CART5 **Time Frame:** 12 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Histologically or cytologically confirmed relapsed or refractory (r/r) CD5-positive nodal peripheral T-cell lymphoma (such as peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), nodal T-cell lymphomas with T-follicular helper (TFH) phenotype, including follicular T cell lymphoma, angioimmunoblastic lymphoma, or anaplastic large cell lymphoma) or other non-leukemic CD5+ aggressive mature T cell lymphomas (such as enteropathy-associated T cell lymphoma, monomorphic epitheliotropic intestinal T cell lymphoma, transformed mycosis fungoides, primary cutaneous aggressive epidermotropic CD8+ cytotoxic T-cell lymphoma, primary cutaneous insert gamma delta symbols lymphoma, or subcutaneous panniculitis like T cell lymphoma). 2. ≥50% expression of CD5 on flow cytometry or IHC on malignant cells on the most recent biopsy 3. Must have received at least one line of prior systemic therapy for their lymphoma; participants with anaplastic large cell lymphoma (ALCL) must have received prior brentuximab unless there was a contraindication to brentuximab. 4. Evaluable disease defined by at least one lesion that can be measured in least 1 dimension and measures at least 1.5 cm in its longest dimension by CT or PET scan, or bone/bone marrow involvement, or skin involvement. 5. No circulating CD5+ malignant cells identified by peripheral blood flow cytometry must be present. Exclusion Criteria: 1. Pregnant or lactating (nursing) women. 2. HIV infection. 3. Concurrent use of systemic steroids or immunosuppressant medications. 4. Any uncontrolled active medical disorder that would preclude participation as outlined. 5. History of immunodeficiency. 6. History of prior chimeric antigen receptor therapy (CAR T), autologous or syngeneic HCT \<100 days from transplant at the time of cell infusion or previous allo-HCT. 7. Active and/or systemic inflammatory or autoimmune diseases. 8. Signs or symptoms indicative of active CNS involvement. 9. Known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system, and unrelated to lymphoma or previous lymphoma treatment. 10. Clinically apparent arrhythmia, or arrhythmias that are not stable on medical management 11. Current participation in or prior participation in a study of an investigational agent or using an investigational device within 2 weeks of the first dose of treatment. 12. Prior monoclonal antibody therapy within 4 weeks prior to study Day 1 13. Prior use of alemtuzumab 14. Prior chemotherapy targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 15. Uncontrolled active infection requiring systemic therapy. 16. Circulating CD5+ malignant cells identified by peripheral blood flow cytometry present. 17. Active and/or systemic inflammatory or autoimmune diseases. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Vittoria Biotherapeutics, MD, PhD **Phone:** (215) 600-1380 **Role:** CONTACT #### Locations **Location 1:** **City:** Philadelphia **Country:** United States **Facility:** Vittoria Biotherapeutics **State:** Pennsylvania **Zip:** 19104 ### 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: M18829 - Name: Lymphoma, T-Cell - Relevance: HIGH - As Found: T-cell non-Hodgkin lymphoma - ID: M11222 - Name: Lymphoma, Non-Hodgkin - Relevance: HIGH - As Found: Non-Hodgkin Lymphoma - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M11225 - Name: Lymphoproliferative Disorders - Relevance: LOW - As Found: Unknown - ID: M11203 - Name: Lymphatic Diseases - Relevance: LOW - As Found: Unknown - ID: M10206 - Name: Immunoproliferative Disorders - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: T3543 - Name: Lymphosarcoma - Relevance: HIGH - As Found: Lymphoma ### Condition Browse Module - Meshes - ID: D000008223 - Term: Lymphoma - ID: D000008228 - Term: Lymphoma, Non-Hodgkin - ID: D000016399 - Term: Lymphoma, T-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 - ID: M2853 - Name: Immunomodulating Agents - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06420076 **Acronym:** BAH246 **Brief Title:** Sequential CAR-T Cells Therapy for CD5/CD7 Positive T-cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma Using CD5/CD7-Specific CAR-T Cells **Official Title:** This is an Open, Single-arm, Clinical Study to Evaluate the Efficacy and Safety of Anti-CD7/CD5 CAR-T Cells in the Treatment of Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia (T-ALL), ETP-ALL, and Lymphoblastic Lymphoma (TLBL). #### Organization Study ID Info **ID:** ESBI202496 #### Organization **Class:** OTHER **Full Name:** Essen Biotech ### Status Module #### Completion Date **Date:** 2026-12-28 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-12-10 **Type:** ESTIMATED #### Start Date **Date:** 2024-09-10 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Essen Biotech #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Chimeric antigen receptor (CAR)-modified T cells targeted against CD19 have demonstrated unprecedented successes in treating patients with hematopoietic and lymphoid malignancies. Besides CD19, many other molecules such as CD22, CD30,BCMA,CD123, etc. may be the potential to develop the corresponding CAR-T cells to treat patients whose tumors express those markers. In this study, investigators will evaluate the safety and efficacy of Sequential CAR-T Cells Targeting CD5/CD7 in patients with patients with relapsed or refractory T-ALL/LBL/ETP-ALL. The primary goal is safety assessment including cytokine storm response and any other adverse effects. In addition, disease status after treatment will also be evaluated. **Detailed Description:** Acute lymphoblast leukemia (T-ALL) is a neoplastic lymphoid leukemia characterized by the proliferation of immature precursor T cells. The combined chemotherapy has significantly improved the prognosis of T-acute lymphoblast leukemia/lymphoma. However, once the disease appears to be relapsed/refractory, there are limited treatment options, and the overall prognosis is extremely poor. Therefore, exploring safe and effective treatments is a critical unmet medical need. The patients will receive Sequential CAR-T Cells Targeting CD5/CD7 to examine the safety and, possibly the efficacy of CD5 CAR T-Cells in CD5+ CD7+ relapsed or refractory acute leukemia. ### Conditions Module **Conditions:** - T Cell Lymphoma - T Cell Leukemia - T-cell Acute Lymphoblastic Leukemia - T-Cell Lymphoma of CNS - T Cell Prolymphocytic Leukemia - T Cell Childhood ALL **Keywords:** - CAR-T - CD5 - CD7 - ETP-ALL ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** Patients enrolled in this clinical trial will receive a carefully designed treatment regimen. Prior to the infusion of CD5 and CD7 CAR-T cells, participants will undergo preconditioning chemotherapy. This chemotherapy serves to create an optimal environment for CAR-T cell therapy to effectively target and eliminate malignant B cells. Following chemotherapy, participants will receive the infusion of CD5 and CD7 CAR-T cells. ##### Masking Info **Masking:** NONE **Masking Description:** Open-label clinical trials are a category of clinical research where the masking is minimal or nonexistent. In such trials, both the participants and the researchers are fully aware of the treatment assignments, which means participants know the treatment they are receiving, and researchers are aware of each participant's treatment group. **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - PHASE1 - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients will be administered fludarabine phosphate intravenously (IV) over a 30-minute period on days -4 to -2. Additionally, cyclophosphamide will be administered intravenously (IV) over 60 minutes on day -2. Subsequently, patients will receive CD5/CD7 CAR T cells intravenously (IV) over a duration of 10-20 minutes on day 0. Patients who exhibit positive responses to the initial dose of CD5/CD7 CAR T cells, do not experience unacceptable side effects, and have a sufficient quantity of cells available may be eligible to receive 2 or 3 additional doses of CD5/CD7 CAR T cells. **Intervention Names:** - Biological: CD5/CD7 CAR-T **Label:** Sequential CAR-T Cells Targeting (CD5/CD7 CAR T cells, chemotherapy) **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Sequential CAR-T Cells Targeting (CD5/CD7 CAR T cells, chemotherapy) **Description:** The intervention in this clinical trial involves a novel approach using CD5/CD7 Chimeric Antigen Receptor T (CAR T) cells combined with chemotherapy. The goal is to assess safety and efficacy in patients with specific hematologic malignancies. Treatment Regimen: Patients in the trial will undergo the following regimen: Fludarabine Phosphate (Days -4 to -2): IV administration of fludarabine phosphate over 30 minutes on days -4 to -2. It's part of the preparatory regimen to enhance the body's response to CAR T-cell therapy. Cyclophosphamide (Day -2): IV cyclophosphamide over 60 minutes on day -2. CD5/CD7 Chimeric Antigen Receptor T Cells (Day 0): IV administration of investigational therapy, CD5/CD7 CAR T cells, over 10-20 minutes on day 0. Additional Doses: Eligible patients responding well to the initial CD5/CD7 CAR-T cell infusion without unacceptable side effects and sufficient CAR-T cell availability may receive 2 or 3 additional doses. **Name:** CD5/CD7 CAR-T **Other Names:** - EB-BH2026 **Type:** BIOLOGICAL ### Outcomes Module #### Primary Outcomes **Description:** Evaluation of all possible adverse reactions, including the number, incidence, and severity of symptoms such as cytokine release syndromes and neurotoxicity within 3 months after CAR-T infusion **Measure:** The number and incidence of adverse events after CD7/CD5 CAR infusion. **Time Frame:** 28 days **Description:** The disease response to CD7/CD5 CAR T cells is evaluated by bone marrow biopsy and aspirate within 1 year after CAR infusion. The proportion of subjects receiving CD7/CD5 CAR T infusion to 1) morphological remission (blasts \<5%): 2) flow cytometry analysis was blast negative, and 3) molecular biological remission (if applicable). **Measure:** Disease response to CD7/CD5 CAR T cells **Time Frame:** 1 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Signed written informed consent; Patients volunteer to participate in the clinical trial; * Diagnosis is mainly based on the World Health Organization (WHO) 2008; * Complete remission cannot be achieved after induction therapy; recurrence occurs after completion remission; the burden of leukemic blasts in the peripheral blood or bone marrow is greater than 5%; * Leukemic blast cells express CD7/CD5 (CD7 OR CD5 positive by flow cytometry or immunohistochemistry ≥70%); * The expected survival period is greater than 12 weeks; * ECOG score ≤2; * Age 2-60 years old; * HGB≥70g/L (can be transfused); * Total bilirubin does not exceed 3 times the upper limit of normal value, and AST and ALT do not exceed 5 times the upper limit of normal value. Exclusion Criteria: * Patients declining to consent for treatment * Prior solid organ transplantation * One of the following cardiac issues: atrial fibrillation; myocardial infarction within the past 12 months; prolonged QT syndrome or secondary QT prolongation; clinically significant pericardial effusion; cardiac insufficiency NYHA (New York Heart Association) III or IV; * History of severe pulmonary dysfunction diseases; * Severe infection or persistent infection cannot be effectively controlled; * Severe autoimmune disease or congenital immunodeficiency; * Active hepatitis; * Human immunodeficiency virus (HIV) infection; * Clinically significant viral infections, or uncontrollable viral reactivation, including EBV (Epstein-Barr virus). **Maximum Age:** 90 Years **Minimum Age:** 2 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** JAMAL ALKHAYER **Phone:** +97333799773 **Role:** CONTACT #### Locations **Location 1:** **City:** Shanghai **Country:** China **Facility:** District one hospital ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## 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: BC04 - Name: Neoplasms - Abbrev: BC15 - Name: Blood and Lymph Conditions - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M11220 - Name: Lymphoma - Relevance: HIGH - As Found: Lymphoma - ID: M18829 - Name: Lymphoma, T-Cell - Relevance: HIGH - As Found: T-cell Lymphoma - ID: M18833 - Name: Lymphoma, T-Cell, Peripheral - Relevance: HIGH - As Found: T-cell Lymphoma - ID: 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: M18119 - Name: Leukemia, T-Cell - Relevance: HIGH - As Found: T-cell leukemia - ID: M18122 - Name: Leukemia, Prolymphocytic - Relevance: HIGH - As Found: Prolymphocytic Leukemia - ID: M27587 - Name: Precursor T-Cell Lymphoblastic Leukemia-Lymphoma - Relevance: HIGH - As Found: T-cell Acute Lymphoblastic Leukemia - ID: M18121 - Name: Leukemia, Prolymphocytic, T-Cell - Relevance: HIGH - As Found: T-Cell Prolymphocytic Leukemia - ID: M18120 - Name: Leukemia-Lymphoma, Adult T-Cell - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M11225 - Name: Lymphoproliferative Disorders - Relevance: LOW - As Found: Unknown - ID: M11203 - Name: Lymphatic Diseases - Relevance: LOW - As Found: Unknown - ID: M10206 - Name: Immunoproliferative Disorders - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: M9490 - Name: Hematologic Diseases - Relevance: LOW - As Found: Unknown - ID: M11222 - Name: Lymphoma, Non-Hodgkin - Relevance: LOW - As Found: Unknown - ID: T3543 - Name: Lymphosarcoma - Relevance: HIGH - As Found: Lymphoma - ID: T4496 - Name: Peripheral T-cell Lymphoma - Relevance: HIGH - As Found: T-cell Lymphoma - ID: T175 - Name: Acute Lymphoblastic Leukemia - Relevance: HIGH - As Found: Acute Lymphoblastic Leukemia - ID: T3533 - Name: Lymphoblastic Lymphoma - Relevance: HIGH - As Found: Acute Lymphoblastic Leukemia - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown - ID: T1134 - Name: Childhood Acute Lymphoblastic Leukemia - Relevance: LOW - As Found: Unknown - ID: T5570 - Name: T-cell Prolymphocytic Leukemia - Relevance: HIGH - As Found: T-Cell Prolymphocytic Leukemia - ID: T224 - Name: Adult T-cell Leukemia/lymphoma - Relevance: LOW - As Found: Unknown - ID: T3393 - Name: Leukemia, T-cell, Chronic - 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: D000016399 - Term: Lymphoma, T-Cell - ID: D000016411 - Term: Lymphoma, T-Cell, Peripheral - ID: D000015458 - Term: Leukemia, T-Cell - ID: D000015463 - Term: Leukemia, Prolymphocytic - ID: D000054218 - Term: Precursor T-Cell Lymphoblastic Leukemia-Lymphoma - ID: D000015461 - Term: Leukemia, Prolymphocytic, T-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: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06420063 **Acronym:** BAH244 **Brief Title:** Sequential CAR-T Cells Targeting CD33/CD123 in Patients With Acute Myelocytic Leukemia AML **Official Title:** Sequential CAR-T Cell Infusion Targeting CD33 and CD123 for Refractory/Relapsed Acute Myeloid Leukaemia #### Organization Study ID Info **ID:** ESBI202495 #### Organization **Class:** OTHER **Full Name:** Essen Biotech ### Status Module #### Completion Date **Date:** 2026-12-28 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-12-10 **Type:** ESTIMATED #### Start Date **Date:** 2024-10-10 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Essen Biotech #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** This is an open, single-arm, clinical study to evaluate the efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) targeting CD33 or CD123 or both sequentially in the treatment of Acute Myelocytic Leukemia. **Detailed Description:** Chimeric antigen receptor (CAR)-modified T cells targeted against CD19 have demonstrated unprecedented successes in treating patients with hematopoietic and lymphoid malignancies. Besides CD19, many other molecules such as CD22, CD30,BCMA,CD123, etc. may have the potential to develop the corresponding CAR-T cells to treat patients whose tumors express those markers. In this study, investigators will evaluate the safety and efficacy of CAR-T targeting CD33/CD123 in patients with Acute Myelocytic Leukemia. The primary goal is safety assessment including cytokine storm response and any other adverse effects. In addition, disease status after treatment will also be evaluated. The purpose of this clinical trial is to assess the feasibility, safety, and efficacy of multiple CAR T-cell therapy which combines CAR T cells against AML Cells with CAR T cells targeting CD123 or CD33 in patients with relapsed and refractory AML. The study also aims to learn more about the function of CAR T cells and their persistence in AML patients. ### Conditions Module **Conditions:** - AML - Acute Myeloid Leukemia - AML, Adult Recurrent - AML, Adult **Keywords:** - aml - cd33 - cd123 - CAR-T ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** Patients enrolled in this clinical trial will receive a carefully designed treatment regimen. Before the infusion of CD33 and CD123 CAR-T cells, participants will undergo preconditioning chemotherapy. This chemotherapy serves to create an optimal environment for CAR-T cell therapy to effectively target and eliminate malignant B cells. Following chemotherapy, participants will receive the infusion of CD33 and CD123 CAR-T cells. ##### Masking Info **Masking:** NONE **Masking Description:** Open-label clinical trials are a category of clinical research where the masking is minimal or nonexistent. In such trials, both the participants and the researchers are fully aware of the treatment assignments, which means participants know the treatment they are receiving, and researchers are aware of each participant's treatment group. **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 85 **Type:** ESTIMATED **Phases:** - PHASE1 - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients will be administered fludarabine phosphate intravenously (IV) over a 30-minute period on days -4 to -2. Additionally, cyclophosphamide will be administered intravenously (IV) over 60 minutes on day -2. Subsequently, patients will receive CD33/123 CAR T cells intravenously (IV) over a duration of 10-20 minutes on day 0. Patients who exhibit positive responses to the initial dose of CD33/123 CAR T cells, do not experience unacceptable side effects, and have a sufficient quantity of cells available may be eligible to receive 2 or 3 additional doses of CD33/CD123 CAR T cells. **Intervention Names:** - Biological: CD123/CD33 CART **Label:** Treatment (CD33/CD123 CAR T cells, chemotherapy) **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Treatment (CD33/CD123 CAR T cells, chemotherapy) **Description:** The intervention in this clinical trial involves a novel approach using CD22/123-Chimeric Antigen Receptor T (CAR T) cells combined with chemotherapy. The goal is to assess safety and efficacy in patients with specific hematologic malignancies. Treatment Regimen: Patients in the trial will undergo the following regimen: Fludarabine Phosphate (Days -4 to -2): IV administration of fludarabine phosphate over 30 minutes on days -4 to -2. It's part of the preparatory regimen to enhance the body's response to CAR T-cell therapy. Cyclophosphamide (Day -2): IV cyclophosphamide over 60 minutes on day -2. CD33/123-Chimeric Antigen Receptor T Cells (Day 0): IV administration of investigational therapy, CD33/123-CAR T cells, over 10-20 minutes on day 0. Additional Doses: Eligible patients responding well to the initial CD33/123 CAR-T cell infusion without unacceptable side effects and sufficient CAR T cell availability may receive 2 or 3 additional doses. **Name:** CD123/CD33 CART **Other Names:** - EB-BH2025 **Type:** BIOLOGICAL ### Outcomes Module #### Primary Outcomes **Description:** Will be recorded and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 at three dose levels until the maximum tolerated dose (MTD) is determined. **Measure:** Incidence and severity of dose-limiting toxicities (DLTs) following chemotherapy preparative regimen and infusion of CD5/CD7 chimeric antigen receptor (CAR) T cells **Time Frame:** 28 days #### Secondary Outcomes **Description:** satisfy the targeted dose level and meet the required release specifications outlined in the Certificate of Analysis (COA) **Measure:** Rate of successful manufacture and expansion of the CD33/123 chimeric antigen receptor (CAR) T cells **Time Frame:** 10-14 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Subjects with acute myeloid leukemia who voluntarily signed informed consent and met the following criteria: * Age older than 6 months. * Confirmed expression of CLL-1, CD123 and/or CD33 in blast AML by immuno-histochemical staining or flow cytometry. * Karnofsky performance status (KPS) score is higher than 80 and life expectancy \> 3 months. * Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: cardiac ejection fraction ≥ 50%, oxygen saturation ≥ 90%, creatinine ≤ 2.5 × upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal, total bilirubin ≤ 2.0mg/dL. * Hgb≥80g/L. * No cell separation contraindications. * Abilities to understand and the willingness to provide written informed consent. Exclusion Criteria: * Severe illness or medical condition, which would not permit the patient to be managed according to the protocol, including active uncontrolled infection. * Active bacterial, fungal or viral infection not controlled by adequate treatment. * Known HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. * Pregnant or nursing women may not participate. * Use of glucocorticoid for systemic therapy within one week prior to entering the trial. * Patients, in the opinion of investigators, may not be able to comply with the study. **Maximum Age:** 90 Years **Minimum Age:** 6 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** JAMAL ALKHAYER **Phone:** +97333799773 **Role:** CONTACT #### Locations **Location 1:** **City:** Shanghai **Country:** China **Facility:** District one hospital ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000006402 - Term: Hematologic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC15 - Name: Blood and Lymph Conditions - 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: M10955 - Name: Leukemia, Myeloid - Relevance: HIGH - As Found: Myeloid Leukemia - ID: M18127 - Name: Leukemia, Myeloid, Acute - Relevance: HIGH - As Found: Acute Myeloid Leukemia - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M9490 - Name: Hematologic Diseases - Relevance: LOW - As Found: Unknown - ID: T3995 - Name: Myeloid Leukemia - Relevance: HIGH - As Found: Myeloid Leukemia - ID: T182 - Name: Acute Myeloid Leukemia - Relevance: HIGH - As Found: Acute Myeloid Leukemia - ID: T188 - Name: Acute Non Lymphoblastic Leukemia - Relevance: HIGH - As Found: Acute Myeloid Leukemia - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007938 - Term: Leukemia - ID: D000007951 - Term: Leukemia, Myeloid - ID: D000015470 - Term: Leukemia, Myeloid, Acute ### Intervention Browse Module - 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: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06420050 **Brief Title:** Testing a Novel Instagram Intervention for Heavy Alcohol Use **Official Title:** Testing a Novel Instagram Intervention for Heavy Alcohol Use: A Randomized Controlled #### Organization Study ID Info **ID:** IRB-23-11-6344 #### Organization **Class:** OTHER **Full Name:** Wayne State University ### Status Module #### Completion Date **Date:** 2024-09-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-09-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-20 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-04-10 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Emily Grekin #### Responsible Party **Investigator Affiliation:** Wayne State University **Investigator Full Name:** Emily Grekin **Investigator Title:** Associate Chair **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This project aims to test the efficacy of an Instagram-based intervention for reducing heavy alcohol use. More specifically, the investigators will use a randomized controlled design to analyze differences in alcohol use and alcohol-related outcomes (e.g., alcohol-related consequences, etc.) as well as differences in the use of protective behavioral strategies and mindfulness practices. Participants (80 Prolific users who report binge drinking) will be randomly assigned to 1 of 3 conditions: intervention or control. Those who are randomized to the intervention condition will be invited to follow study Instagram pages, and those who are randomized to the control condition will be invited to complete the assessments only. The investigators hypothesize that there will be greater reductions in alcohol use, frequency, and consequences and greater frequency of use of mindfulness exercises and protective behavioral strategies among those in the intervention condition as compared to those in the control condition. ### Conditions Module **Conditions:** - Heavy Drinking ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 80 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Behavioral: Instagram Intervention **Label:** Instagram Intervention **Type:** EXPERIMENTAL #### Arm Group 2 **Label:** Control **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Instagram Intervention **Description:** The intervention consists of a study Instagram page, which will post intervention content every day for 42 days. **Name:** Instagram Intervention **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** The investigators will analyze differences in the amount of days spent drinking. **Measure:** Change in Frequency of Past-month Alcohol Use Using the Computer-Administered Timeline Follow-Back **Time Frame:** Given pre-intervention and at 10-week follow-up **Description:** The investigators will analyze differences in amount of past-month alcohol use and the amount of past-month binge-drinking episodes. **Measure:** Change in Quantity of Past-month Alcohol Use Using the Computer-Administered Timeline Follow-Back **Time Frame:** Given pre-intervention and at 10-week follow-up #### Secondary Outcomes **Description:** The investigators will analyze the difference in frequency of recent protective behavioral strategy use using the Protective Drinking Practices Scale (minimum score = 20, maximum score = 120, and higher scores indicate a better outcome). **Measure:** Change in Frequency of Protective Behavioral Strategy Use Using the Protective Drinking Practices Scale **Time Frame:** Given pre-intervention and at 10-week follow-up **Description:** The investigators will analyze the difference in amount of consequences related to alcohol use using the Brief Young Adult Consequences Scale (minimum score = 0, maximum score = 24, and higher scores indicate a worse outcome). **Measure:** Change in the Amount of Recent Alcohol Consequences Using the Brief Young Adult Consequences Scale **Time Frame:** Given pre-intervention and at 10-week follow-up **Description:** The investigators will analyze the difference in frequency of use of mindfulness practices using the Mindfulness Awareness Scale (minimum score = 15, maximum score = 90, and higher scores indicate a better outcome). **Measure:** Change in Frequency of Mindfulness Practice Use Using the Mindfulness Awareness Scale **Time Frame:** Given pre-intervention and at 10-week follow-up **Description:** The investigators will analyze the difference in reported readiness to change drinking behavior using the Readiness to Change Questionnaire (minimum score = 12, maximum score = 84, and higher scores indicate a better outcome). **Measure:** Change in Readiness to Change Drinking Behavior Using the Readiness to Change Questionnaire **Time Frame:** Given pre-intervention and at 10-week follow-up **Description:** The investigators will ask participants to rate the intervention content on acceptability dimensions created specifically for this study (i.e., relevance, empathy, interest, helpfulness, respectfulness, personalization). On a given domain, minimum score = 1, maximum score = 5, and higher scores indicate better outcomes. **Measure:** Participant Subjective Reactions Using Likert Scales **Time Frame:** Given at 10-week follow-up **Description:** The investigators will ask participants to rate how the intervention has qualitatively impacted them using simple yes/no questions (i.e., if they remember seeing certain posts, if the posts made them think about their drinking, affected their sense of community, etc.). **Measure:** Participant Subjective Reactions Using Simple Yes/No Questions **Time Frame:** Given at 10-week follow-up ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Ages 18-30 * Report regular Instagram usage (i.e., at least a few times a week) * Report having met the NIAAA's criteria for a binge-drinking episode (4+ drinks in a sitting for cisgender women, 5+ drinks in a sitting for all other genders) at least twice a month for the past three month Exclusion Criteria: * No exclusion criteria **Healthy Volunteers:** True **Maximum Age:** 30 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Halle Thomas, M.A. **Phone:** 734-883-2669 **Role:** CONTACT #### Locations **Location 1:** **City:** Detroit **Country:** United States **Facility:** Wayne State University **State:** Michigan **Zip:** 48202 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Document Section ### Large Document Module #### Large Docs - Date: 2023-09-22 - Filename: Prot_SAP_000.pdf - Has ICF: False - Has Protocol: True - Has SAP: True - Label: Study Protocol and Statistical Analysis Plan - Size: 9347442 - Type Abbrev: Prot_SAP - Upload Date: 2024-04-18T11:10 - Date: 2024-02-12 - Filename: ICF_001.pdf - Has ICF: True - Has Protocol: False - Has SAP: False - Label: Informed Consent Form - Size: 213008 - Type Abbrev: ICF - Upload Date: 2024-04-04T10:14 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004327 - Term: Drinking Behavior ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M3774 - Name: Alcohol Drinking - Relevance: HIGH - As Found: Alcohol Use - ID: M7502 - Name: Drinking Behavior - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000000428 - Term: Alcohol Drinking ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M3777 - Name: Ethanol - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06420037 **Brief Title:** The Influence of the Individual Auditory-cognitive Need on the Aided Benefit Using Different Feature Settings **Official Title:** The Influence of the Individual Auditory-cognitive Need on the Aided Benefit Using Different Feature Settings #### Organization Study ID Info **ID:** ONZ-2023-0437 #### Organization **Class:** OTHER **Full Name:** University Ghent ### Status Module #### Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2023-11-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-04-16 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University Ghent #### 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 optimize hearing aid benefit based on the individual auditory-cognitive need using different hearing aid features in first-time hearing aid users between 45-80 years old with bilateral Phonak Audéo Paradise/Lumity 70 hearing aids. The main questions it aims to answer are: Does cognitive functioning affect hearing aid benefit? How can hearing aid fitting be optimized based on the individual auditory-cognitive profile? The hypothesis posits that cognitive abilities influence the effectiveness of hearing aids, alongside hearing status. Furthermore, if features of hearing aids improve speech understanding and listening effort, it is proposed that individuals with lower cognitive functioning will experience heightened benefits from hearing aids. The study will consist of three groups: one control group and two groups where one different feature will be modified. Participants will be tested at baseline measurement, including: * screening tests * audiological tests * questionnaires * cognitive tests * real-ear-measurement Following this, participants will be divided in one of the three groups, after which speech audiometry will be repeated. After a 4-week acclimatization period, the second measurement will take place, repeating speech audiometry and questionnaires. Subsequently, the hearing aid settings will be restored to their initial configuration. ### Conditions Module **Conditions:** - Speech Intelligibility - Hearing Loss, Sensorineural ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** SEQUENTIAL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** OTHER #### Enrollment Info **Count:** 40 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Within this control group, no changes will be made to the hearing aid settings. However, they undergo all other tests of the test protocol. **Intervention Names:** - Behavioral: Cognitive screening and vision screening - Behavioral: Audiological Assessment - Behavioral: Questionnaires - Behavioral: Cognition - Other: Real ear measurement **Label:** Individuals between 45-80 years with bilateral hearing aids (control group) **Type:** OTHER #### Arm Group 2 **Description:** Within this experimental group, a slight modification (which differs between groups) will be made to the basic hearing aid setting. **Intervention Names:** - Device: Hearing aid feature adjustment (frequency compression) of the following hearing aids: Phonak Audéo Paradise/Lumity 70 - Behavioral: Cognitive screening and vision screening - Behavioral: Audiological Assessment - Behavioral: Questionnaires - Behavioral: Cognition - Other: Real ear measurement **Label:** Individuals between 45-80 years with bilateral hearing aids (frequency compression) **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Within this experimental group, a slight modification (which differs between groups) will be made to the basic hearing aid setting. **Intervention Names:** - Device: Hearing aid feature adjustment (noise reduction) of the following hearing aids: Phonak Audéo Paradise/Lumity 70 - Behavioral: Cognitive screening and vision screening - Behavioral: Audiological Assessment - Behavioral: Questionnaires - Behavioral: Cognition - Other: Real ear measurement **Label:** Individuals between 45-80 years with bilateral hearing aids (noise reduction) **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Individuals between 45-80 years with bilateral hearing aids (frequency compression) **Description:** Upon enrollment, each participant will be allocated to one of three research groups and participants will remain unaware of their group assignment. This groups will undergo a slight modification, namely frequency compression turned off, to the basic setting. **Name:** Hearing aid feature adjustment (frequency compression) of the following hearing aids: Phonak Audéo Paradise/Lumity 70 **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - Individuals between 45-80 years with bilateral hearing aids (noise reduction) **Description:** Upon enrollment, each participant will be allocated to one of three research groups and participants will remain unaware of their group assignment. This groups will undergo a slight modification, namely noise reduction turned off, to the basic setting. **Name:** Hearing aid feature adjustment (noise reduction) of the following hearing aids: Phonak Audéo Paradise/Lumity 70 **Type:** DEVICE #### Intervention 3 **Arm Group Labels:** - Individuals between 45-80 years with bilateral hearing aids (control group) - Individuals between 45-80 years with bilateral hearing aids (frequency compression) - Individuals between 45-80 years with bilateral hearing aids (noise reduction) **Description:** The Dutch Montreal Cognitive Assessment will be assessed. The Snellen Eye Test will be used to screen for normal or corrected-to-normal vision. **Name:** Cognitive screening and vision screening **Type:** BEHAVIORAL #### Intervention 4 **Arm Group Labels:** - Individuals between 45-80 years with bilateral hearing aids (control group) - Individuals between 45-80 years with bilateral hearing aids (frequency compression) - Individuals between 45-80 years with bilateral hearing aids (noise reduction) **Description:** Three audiological tests are included: 1) Tympanometry to assess the middle ear status, 2) Pure-tone audiometry with headphone to evaluate the hearing thresholds, 3) Speech audiometry in free field to assess the ability to understand spoken sentences in quiet and in the presence of background noise. **Name:** Audiological Assessment **Type:** BEHAVIORAL #### Intervention 5 **Arm Group Labels:** - Individuals between 45-80 years with bilateral hearing aids (control group) - Individuals between 45-80 years with bilateral hearing aids (frequency compression) - Individuals between 45-80 years with bilateral hearing aids (noise reduction) **Description:** Three questionnaires are included: 1. The HAVICOP questionnaire to assess the hearing-related quality of life (Ceuleers, D., Baudonck, N., Keppler, H., Kestens, K., Dhooge, I., \& Degeest, S. (2023). Development of the hearing-related quality of life questionnaire for auditory-visual, cognitive and psychosocial functioning (hAVICOP). Journal of communication disorders, 101, 106291.) 2. the FAS (fatigue assessment scale) to assess how you usually feel 3. the EEAS (extended effort assessment scale) to assess how you experience listening in everyday life. **Name:** Questionnaires **Type:** BEHAVIORAL #### Intervention 6 **Arm Group Labels:** - Individuals between 45-80 years with bilateral hearing aids (control group) - Individuals between 45-80 years with bilateral hearing aids (frequency compression) - Individuals between 45-80 years with bilateral hearing aids (noise reduction) **Description:** Four cognitive functions, important for speech understanding, will be assessed both audibly and visually: divided attention, working memory, processing speed, and cognitive flexibility and inhibition. **Name:** Cognition **Type:** BEHAVIORAL #### Intervention 7 **Arm Group Labels:** - Individuals between 45-80 years with bilateral hearing aids (control group) - Individuals between 45-80 years with bilateral hearing aids (frequency compression) - Individuals between 45-80 years with bilateral hearing aids (noise reduction) **Description:** This test will give an objective assessment of the hearing aids' configuration. **Name:** Real ear measurement **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Based on the results of the speech understanding task, the speech reception threshold will give an indication of the ability to understand spoken sentences in quiet and noise. **Measure:** Speech reception threshold **Time Frame:** This outcome measure will be assessed twice during the initial measurement (both +/- 10 minutes) and once during the second measurement (+/- 10 minutes). #### Secondary Outcomes **Description:** Thirty-five sentences should be responded using a VAS (0-100). Mean scores will be calculated for each subdomain separately (auditory-visual, cognitive, and psychosocial functioning) as well as combined within a total score; the worse one's hearing-related quality of life, the lower the score. **Measure:** Hearing related quality of life **Time Frame:** This outcome parameter will be assessed twice: once during the initial measurement and once during the subsequent measurement (both +/- 10 minutes). **Description:** Ten sentences should be responded based on five categories, ranging from Never to Always: 1 = Never; 2 = Sometimes; 3 = Frequently; 4 = Often; and 5 = Always. **Measure:** Fatigue assessment **Time Frame:** This outcome parameter will be assessed twice: once during the initial measurement and once during the subsequent measurement (both +/- 5 minutes). **Description:** Ten sentences should be responded using a VAS (0-100). Mean scores will be calculated for each sentence. The lower the score, the lower the effort. **Measure:** Effort assessment **Time Frame:** This outcome parameter will be assessed twice: once during the initial measurement and once during the subsequent measurement (both +/- 5 minutes). **Description:** Cognitive functions such as 'divided attention', 'working memory', 'processing speed', and 'flexibility and inhibition' will be assessed both audibly and visually. Mean scores and average reaction times will be computed. **Measure:** Cognitive functioning (auditory and visual) **Time Frame:** These outcome measures will be assessed once during the first measurement (+/- 55 minutes). **Description:** Test to obtain an objective understanding of the current settings of the hearing aids. **Measure:** Real ear measurement **Time Frame:** This outcome measure will be assessed once during the first measurement (+/- 15-20 minutes). **Description:** The result (max 30) on the MoCA will be calculated. **Measure:** Screening of mild cognitive impairment (MoCA) and vision **Time Frame:** This outcome measure will be assessed once during the first measurement (+/- 5-10 minutes). ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Dutch-speaking individuals aged between 45-80 years old * individuals with normal vision (with glasses or lenses if needed) * individuals with age-related hearing loss * individuals with bilateral hearing aids (Phonak Audéo Paradise/Lumity 70) * individuals who are capable to give consent to participate in the study themselves Exclusion Criteria: * user of cochlear implants * use of influencing medication (for example: Rilatin and antidepressants) * learning disabilities (for example: dyslexia and dyscalculia) * (history of) neurological problems (brain tumor, epilepsy, history of stroke, ...) **Healthy Volunteers:** True **Maximum Age:** 80 Years **Minimum Age:** 45 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Louise Van Goylen, PhD **Phone:** +32484927235 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Hannah Keppler, Assoc. Prof. **Role:** CONTACT #### Locations **Location 1:** **City:** Ghent **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Hannah Keppler, Assoc. Prof. - **Role:** CONTACT **Country:** Belgium **Facility:** University Ghent **State:** East-Flanders **Status:** RECRUITING **Zip:** 9000 #### Overall Officials **Official 1:** **Affiliation:** University Ghent **Name:** Hannah Keppler, Assoc. Prof. **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006311 - Term: Hearing Disorders - ID: D000004427 - Term: Ear Diseases - ID: D000010038 - Term: Otorhinolaryngologic Diseases - ID: D000012678 - Term: Sensation Disorders - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC09 - Name: Ear, Nose, and Throat Diseases - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M24420 - Name: Hearing Loss - Relevance: HIGH - As Found: Hearing Loss - ID: M6840 - Name: Deafness - Relevance: LOW - As Found: Unknown - ID: M9407 - Name: Hearing Loss, Sensorineural - Relevance: HIGH - As Found: Hearing Loss, Sensorineural - ID: M9400 - Name: Hearing Disorders - Relevance: LOW - As Found: Unknown - ID: M7601 - Name: Ear Diseases - Relevance: LOW - As Found: Unknown - ID: M12961 - Name: Otorhinolaryngologic Diseases - Relevance: LOW - As Found: Unknown - ID: M15490 - Name: Sensation Disorders - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000034381 - Term: Hearing Loss - ID: D000006319 - Term: Hearing Loss, Sensorineural ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06420024 **Brief Title:** ACT for Older Adults Who Hear Voices (HSCED) **Official Title:** Acceptance and Commitment Therapy (ACT) for Older Adults Who Hear Voices: a Hermeneutic Single-case Efficacy Design (HSCED) Series #### Organization Study ID Info **ID:** 23007 #### Organization **Class:** OTHER **Full Name:** University of Nottingham ### Status Module #### Completion Date **Date:** 2024-08-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2024-05-31 **Type:** ESTIMATED #### Start Date **Date:** 2023-08-02 **Type:** ACTUAL **Status Verified Date:** 2023-08 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2023-03-23 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** Nottinghamshire Healthcare NHS Foundation Trust **Class:** UNKNOWN **Name:** Derbyshire Healthcare NHS Foundation Trust #### Lead Sponsor **Class:** OTHER **Name:** University of Nottingham #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Hearing voices (often referred to as "auditory hallucinations") is a common experience amongst the older adult population (those 65+ years of age) and can be associated with increased psychological distress. Acceptance and Commitment Therapy (ACT) is a psychological therapy that aims to reduce distress of hearing voices by altering the relationship someone has with voices, and has been shown to improve distress levels for working age adults who hear voices. ACT also appears to be a suitable intervention for older adults distressed by hearing voices, however, there is currently no research that has examined this. Therefore, research is now needed to evaluate whether ACT can support older adults who experience distress from hearing voices. This study will use a case study based research method, known as a Hermeneutic Single-Case Efficacy Design (HSCED) series. This method will involve 3 participants who will receive ACT for hearing voices. This will be delivered across approximately twelve 90-minute sessions. Participants will be asked to complete measures that assess areas such as distress levels and quality of life, which will be completed before, during and after therapy. A detailed report of each participant's level of progress will then be generated and evaluated by expert judges. This will determine whether progress has occurred as a direct result of the therapy, or due to other reasons, and allow conclusions to be drawn about the use of ACT for older adults distressed by hearing voices. Participants will be recruited from either Local Mental Health Teams at Nottinghamshire NHS Foundation Trust, or from the Hearing Voices Group in Beeston (Nottingham). Participants will be required to be age 65+ years and currently experience hearing voices that cause them distress. This study will be funded by the NHS and is estimated to last approximately 12-months with 5-months of participant involvement. **Detailed Description:** Chief Investigator: Dr Danielle De Boos Objectives: To investigate the efficacy of Acceptance and Commitment Therapy for older adults who hear voices in a Hermeneutic Single-Case Efficacy Design series. Trial Configuration: Case study series, recruited from multiple centres. Settings: Secondary care older adult mental health service and charity-based support groups. Sample size estimate: 3 Number of participants: Three participants. If a participant withdraws, a replacement participant will be sought. Eligibility criteria: Individuals who are 65+ years of age, experience moderate levels of distress (as defined by the Depression, Anxiety and Stress Scales-21), have capacity to provide informed consent, and express willingness to engage in the intervention are eligible to participate providing they do not have a diagnosis of dementia/cognitive impairment, are not currently receiving other psychological therapy and are able to independently communicate in English. Description of interventions: Acceptance and commitment therapy adapted to suit the needs of older adults. Twelve sessions are expected to take place, with a review at session six. Duration of study: Up to 20 months. Outcome measures: Personal Questionnaire (simplified) will be reviewed weekly. At baseline, pre-therapy, mid-therapy, post-therapy, and follow-up (4-6 weeks) participants will complete the following outcome measures: * Voices Acceptance and Action Scale-9, * Beliefs about voices questionnaire-revised, * Depression, Anxiety and Stress Scales-21, * Comprehensive assessment of Acceptance and Commitment Therapy processes (short-form), * Older People's Quality of Life questionnaire (brief version), * Psychotic Symptom Rating Scale (Auditory Hallucination sub-scale). Participants will also complete a change interview post-therapy with Trainee Clinical Psychologist (Jennifer Welch; University of Nottingham / University of Lincoln) who is independent to this study. Statistical methods: Reliable Change Index; adjudication panel; Framework Analysis; correlations; visual analysis ### Conditions Module **Conditions:** - Hearing Voices When No One is Talking ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** Hermeneutic Single Case Efficacy Design ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 3 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participant will receive ACT intervention **Intervention Names:** - Behavioral: Acceptance and Commitment Therapy **Label:** Intervention **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Intervention **Description:** See: https://link.springer.com/chapter/10.1007/0-306-48581-8_1 **Name:** Acceptance and Commitment Therapy **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Acceptance-based attitudes and actions in relation to voices **Measure:** Voices Acceptance and Action Scale-9 (Brockman et al., 2015) **Time Frame:** Approx. 0 weeks (baseline), 6 weeks (mid-therapy), 12-14 weeks (post therapy), 16-18 weeks (4-6 week follow-up) following enrolment to the study. **Description:** Beliefs, emotions, and behaviours relating to auditory hallucinations. **Measure:** Beliefs about voices questionnaire-revised (Chadwick et al., 2000) **Time Frame:** Approx. 0 weeks (baseline), 6 weeks (mid-therapy), 12-14 weeks (post therapy), 16-18 weeks (4-6 week follow-up) following enrolment to the study. **Description:** Depression, Anxiety and Stress **Measure:** Depression, Anxiety and Stress Scales-21 (Lovibond & Lovibond, 1995) **Time Frame:** Approx. 0 weeks (baseline), 6 weeks (mid-therapy), 12-14 weeks (post therapy), 16-18 weeks (4-6 week follow-up) following enrolment to the study. **Description:** Psychological flexibility **Measure:** Comprehensive assessment of Acceptance and Commitment Therapy processes, short-form (Morris et al., 2019) **Time Frame:** Approx. 0 weeks (baseline), 6 weeks (mid-therapy), 12-14 weeks (post therapy), 16-18 weeks (4-6 week follow-up) following enrolment to the study. **Description:** Quality of Life **Measure:** Older People's Quality of Life questionnaire, brief version (Bowling et al., 2013) **Time Frame:** Approx. 0 weeks (baseline), 6 weeks (mid-therapy), 12-14 weeks (post therapy), 16-18 weeks (4-6 week follow-up) following enrolment to the study. **Description:** Symptom severity of auditory hallucinations **Measure:** The Psychotic Symptom Rating Scales (Haddock et al., 1999) - Auditory Hallucination Sub-Scale **Time Frame:** Approx. 0 weeks, 6 weeks, 12-14 weeks, 16-18 weeks following enrolment to the study. #### Secondary Outcomes **Description:** Individualised client-generated goals **Measure:** Simplified Personal Questionnaire (Elliott et al., 1999) **Time Frame:** Weekly during the intervention (i.e., once per week during the intervention phase - this is anticipated to occur within the first 12-14 weeks of the participant's involvement with the study) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Currently experiences HV * 65+ years of age * Moderate levels of distress. This will be measured using recommended "Moderate" severity level cut-off scores on the Depression, Anxiety and Stress Scales-21 (Lovibond \& Lovibond, 1995) following the completion of Informed Consent Forms. * Having capacity to provide informed consent (in accordance with the Mental Capacity Act) * Willingness to engage in the intervention Exclusion Criteria: * Diagnosis of cognitive impairment or dementia (based on self-report), as this indicates a degree of cognitive impairment that would be difficult to accommodate for. * Current engagement with another psychological therapy * Unable to independently communicate in English without an interpreter (based on researcher's discretion at recruitment). **Minimum Age:** 65 Years **Sex:** ALL **Standard Ages:** - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Derby **Country:** United Kingdom **Facility:** Derbyshire Healthcare NHS Foundation Trust **State:** Derbyshire **Zip:** DE22 3LZ **Location 2:** **City:** Nottingham **Country:** United Kingdom **Facility:** Nottinghamshire Healthcare NHS Foundation Trust **State:** Nottinghamshire **Zip:** NG3 6AA #### Overall Officials **Official 1:** **Affiliation:** University of Nottingham **Name:** Danielle De Boos, DClinPsy **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06420011 **Acronym:** FAITH **Brief Title:** FAITH - Factor XA Inhibitor-Related InTracranial Haemorrhage **Official Title:** A Real-World, Observational, Multicentre Retrospective Analysis to Evaluate the Clinical Characteristics, Medical Management and Outcomes of Hospitalised Patients With Factor XA Inhibitor-Related InTracranial Haemorrhage (FAITH) #### Organization Study ID Info **ID:** D9603R00022 #### Organization **Class:** INDUSTRY **Full Name:** AstraZeneca ### Status Module #### Completion Date **Date:** 2024-09-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-16 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-09-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-15 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-03-04 **Study First Submit QC Date:** 2024-05-16 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** AstraZeneca #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** FAITH study is a multicentre retrospective analysis study that aims to understand the burden of ICH related to FXa inhibitors and the current treatment approaches in country/countries where specific reversal agents are not available yet. The results of this analysis will improve our understanding of FXa inhibitor-related ICH, its socioeconomic impact and factors associated with negative outcomes in real-world settings. The insights gained can inform clinical decision making and potentially lead to strategies to optimise the use of FXa inhibitors, increase the availability of specific reversal agents and improve patient safety and outcomes. **Detailed Description:** FAITH is a retrospective, non-interventional, multicentre cohort study that will retrieve the data from medical records of adult patients who were hospitalised with confirmed diagnosis of ICH while being treated with FXa inhibitors. The primary objectives of the study is to describe the characteristics and hospital outcomes of hospitalised patients with FXa inhibitors-related ICH in real-world settings. Data of consecutive patients admitted on or after 1 January 2021 and by 30 June 2023 will be retrieved. The index date is defined as the date of hospital admission.The identification of ICH will be based on the CT/MRI scan records and according to the ICD-10-CM diagnosis code. To establish the causal relation between FXa and ICH, the study will include only patients who were determined in the medical records to have taken oral FXa inhibitors.The historical data will be followed up from the index date (the date of hospital admission) until the earliest date of death, lost to follow-up or up to 6 months.The 6-month follow-up period will allow for the assessment of the disability rate and the need for supportive care among survivors. ### Conditions Module **Conditions:** - InTracranial Haemorrhage **Keywords:** - Factor XA Inhibitor-Related InTracranial Haemorrhage - FXa - ICH - FAITH ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 350 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** Age of the patients at the time of hospital admission (years) is recorded on Index day within 24 hours of hospitalization **Measure:** Patient characteristics **Time Frame:** Index day (Date of hospitalization) to 24hours **Description:** Race (Middle Eastern, Asian, other) of the eligible patients is collected **Measure:** Patient Characteristics **Time Frame:** Index day (Date of hospitalization) to 24hours **Description:** Sociodemographic characteristics like Sex (Male or Female) of the eligible patients is recorded on Index day **Measure:** Sociodemographic Characteristics of eligible patients **Time Frame:** Index day (Date of hospitalization) to 24hours **Description:** Sociodemographic characteristics like nationality of the eligible patients info is collected on Index day **Measure:** Sociodemographic Characteristics **Time Frame:** Index day (Date of hospitalization) to 24hours **Description:** Comorbidities info of the eligible patients is recorded on Index day **Measure:** Clinical characteristics **Time Frame:** Index day (Date of hospitalization) to 24hours **Description:** Clinical characteristics like BMI in Kg/m2 of the eligible patients is recorded on Index day **Measure:** Clinical Characteristics **Time Frame:** Index day (Date of hospitalization) to 24hours **Description:** At index date the following FXa inhibitor characteristics will be described : Indication ,type and dose pf FXa Inhibitor **Measure:** FXa inhibitor characteristics **Time Frame:** Time of last Fxa inhibitor dose to the time of hospital admission of maximum 24 hours **Description:** The primary ICH characteristics like type, site and presence of multicompartment haemorrhage during hospitalisation from Index date to 24hours **Measure:** ICH characteristics **Time Frame:** Index day to 1 week **Description:** The GCS is scored between 3 and 15. 3 being the worst and 15 the best. It is composed of three parameters: best eye response (E), best verbal response (V), and best motor response (M) **Measure:** GCS score **Time Frame:** Index day to 24hours **Description:** mRS score recorded within 24 hours on Index date The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or others causes of neurological disability. It is scored from: 0=No symptoms at all 1. No significant disability 2. Slight disability 3. Moderate disability 4. Moderately severe disability 5=Severe disability 6=death **Measure:** mRS score **Time Frame:** Index day to 24 hours **Description:** NIHSS score recorded within 24 hours on the Index date Scores range from 0 to 42, with higher scores indicating greater severity. Stroke severity may be stratified on the basis of NIHSS scores as follows: Very Severe: \>25 Severe: 15 - 24 Mild to Moderately Severe: 5 - 14 Mild: 1 - 5 **Measure:** NIHSS score **Time Frame:** Index date up to 24 hours **Description:** Haematoma volume based on baseline Imaging scans taken within 24 hours on the index date **Measure:** Haematoma volume **Time Frame:** Index day to 24 hours **Description:** BP at Index date during hospital admission and in 6, 24, and 72 hours **Measure:** BP (Systolic and Diastolic) **Time Frame:** Index day to 72 hours **Description:** Antihypertensive treatment patterns during hospitalisation from Index date to 1 week **Measure:** Antihypertensive treatment **Time Frame:** Index day to 1 Week **Description:** Number of patients died between index date (date of hospitalization) to Hospital discharge (maximum of 1 week) **Measure:** In-hospital mortality due to any cause **Time Frame:** Index date up to the death event during hospital stay (maximum 1 week) **Description:** Number of patients died between index date (date of hospitalization) up to 30 days **Measure:** Mortality at 30 days, post index event **Time Frame:** Index date up to 30 days **Description:** Number of patients died between index date (date of hospitalization) up to 3 months **Measure:** Mortality at 3 months post index event **Time Frame:** Index date up to 3 months **Description:** Number of patients died between index date (date of hospitalization) up to 6 months **Measure:** Mortality at 6 months post index event **Time Frame:** Index date up to 6 months **Description:** During the period from the hospital discharge date up to death event or 6 months, whichever occurs first, the following type of hospital discharge disposition will be described for survivors like Home, inpatient rehabilitation facility, nursing home, other hospitals/medical centres **Measure:** Type of discharge disposition **Time Frame:** Hospital discharge to Maximum of 6 months #### Secondary Outcomes **Description:** Time between the onset of the bleeding symptoms to admission of patient in hospital in hours. **Measure:** Time from symptoms onset to hospital admission **Time Frame:** Baseline (which is the date of hospitalization i.e. Index date) to a maximum of 24 hours **Description:** Time between patient hospital admission to the performing of Imaging scan in minutes, less than 1 hour **Measure:** Time from Hospital admission to time taken to do Imaging scan **Time Frame:** Index day (Date of hospitalization) to Maximum of one hour **Description:** Time between patient hospital admission to start of the any haemostatic therapy in minutes, in less than 1 hour **Measure:** Time from hospital admission to administration of any haemostatic therapy **Time Frame:** Index day (Date of hospitalization) to Maximum of one hour **Description:** The length of ICU stay of eligible patients in days from Index day to maximum of 1 week **Measure:** Healthcare resource utilization during hospitalisation **Time Frame:** Index day to maximum of 1 week **Description:** The length of hospitalisation of eligible patients in days from Index day to maximum of 1 week **Measure:** Length of hospitalisation in days **Time Frame:** Index day to maximum of 1 week **Description:** At hospital discharge (Maximum of 1 week from Index day) Modified Rankin Score (mRS) will be described Functional outcome assessed with the modified Rankin Scale (mRS) at hospital discharge .The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered of stroke or other causes of neurological disability. It is scored from: 0=No symptoms at all 1=No significant disability, 2=Slight disability 3=Moderate disability 4=Moderately severe disability 5=Severe disability 6=death **Measure:** Disability rate among survivors **Time Frame:** At hospital discharge (Maximum of 1 week from Index day) **Description:** At three months, after the index event (date of hospital admission) Modified Rankin Score (mRS) will be described. **Measure:** Disability rate among survivors **Time Frame:** Index day to 3 months **Description:** From the index date to 6 months the following HCRU will be described: Need for supportive medical care ,type of supportive care (including rehabilitation services), inpatient rehabilitation, outpatient rehabilitation, including occupational therapists, speech and language pathologists, dietician, nurse, adaptive equipment, everything else. **Measure:** Health care resource utilization after hospital admission up to 6 months **Time Frame:** Index date to 6 months **Description:** From the patient hospital discharge up to 6 months the following HCRU will be described: Number of inpatient readmissions after discharge and up to 6 months, Type of ward, Number of days of hospitalization Reason for readmission and Medications. **Measure:** Health care resource utilization within 6 months after hospital discharge. **Time Frame:** Hospital discharge up to 6 months **Description:** At six months after the index event (date of hospital admission) Modified Rankin Score (mRS) will be described. **Measure:** Disability rate among survivors **Time Frame:** Index day to Maximum of 6 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Men and women ≥ 18 years of age at the time of hospital admission. * Patients presented with a spontaneous or traumatic haemorrhage into any intracranial compartment. The diagnosis of ICH will be based on Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) scan and according to the ICD-10-CM diagnosis code. * Patients who were determined in the medical records to have taken a dose of oral FXa inhibitors within 24 hrs before hospital presentation that warranted reversal of anticoagulant activities. Exclusion Criteria: * Patients who were treated with andexanet alfa. * Patients who were enrolled in any clinical trials during the study period. **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** The study will recruit 350 adult patients (age ≥18 years at the time of hospital admission) hospitalised patients with FXa inhibitors-related ICH from a total of 20-25 sites from Asia-Pacific Region, Latin America, and the MEA, where FXa inhibitors specific reversal agent is not approved locally. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** AstraZeneca Clinical Study Information Center **Phone:** 1-877-240-9479 **Role:** CONTACT ### IPD Sharing Statement Module **Access Criteria:** When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. **Description:** Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared. **IPD Sharing:** YES **Time Frame:** AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. **URL:** https://astrazenecagroup-dt.pharmacm.com/DT/Home ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000002561 - Term: Cerebrovascular Disorders - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC14 - Name: Heart and Blood Diseases ### Condition Browse Module - Browse Leaves - ID: M9556 - Name: Hemorrhage - Relevance: HIGH - As Found: Hemorrhage - ID: M22113 - Name: Intracranial Hemorrhages - Relevance: HIGH - As Found: Intracranial Hemorrhage - 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: D000020300 - Term: Intracranial Hemorrhages - ID: D000006470 - Term: Hemorrhage ### Intervention Browse Module - Browse Branches - Abbrev: AnCoag - Name: Anticoagulants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M30513 - Name: Factor Xa Inhibitors - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419998 **Brief Title:** Transanal Versus Laparoscopic-assisted Transanal Through in the Management of Hirschsprung's Disease **Official Title:** One Stage Transanal Versus One Stage Laparoscopic-assisted Transanal Endorectal Pull-through in the Management of Hirschsprung's Disease in Pediatric Age Group; A Retrospective Study. #### Organization Study ID Info **ID:** 0306356 #### Organization **Class:** NETWORK **Full Name:** Egyptian Biomedical Research Network ### Status Module #### Completion Date **Date:** 2023-12-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-12-01 **Type:** ACTUAL #### Start Date **Date:** 2023-01-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** NETWORK **Name:** Egyptian Biomedical Research Network #### Responsible Party **Investigator Affiliation:** Egyptian Biomedical Research Network **Investigator Full Name:** Ahmed Elrouby **Investigator Title:** Associate Professor of pediatric Surgery **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The goal of this clinical trial is to compare the surgical and functional outcomes of pure transanal endorectal pull-through (TAERPT) and laparoscopic-assistance endorectal pull-through (LAERPT) in pediatric patients presented with Hirschsprung's Disease between 3 months and 18 years old. The main questions our study aims to answer are: * Does post-operative continence differs between the two groups? * Does post-operative constipation differs between the two groups? * Does post-operative soiling differs between the two groups * Does post-operative enterocolitis differs between the two groups? * Do post-operative complications differ between the two groups? If there is a comparison group: Researchers will compare between pure transanal endorectal pull-through (TAERPT) and laparoscopic-assistance endorectal pull-through (LAERPT) to see if there is a difference in post-operative continence, constipation, soiling, enterocolitis or complications. Participants will be divided into two groups; 40 patients will be treated by TAERPT and included in Group A and 30 patients will be treated by LAERPT and included in Group B. **Detailed Description:** Introduction: One-stage treatment of endorectal pull-through for Hirschsprung's disease could be approached through a complete transanal approach or with the assistance of laparoscopy. Our study aims to compare the surgical and functional outcomes of pure transanal endorectal pull-through (TAERPT) and laparoscopic-assistance endorectal pull-through (LAERPT). Material \& methods: This retrospective study included 70 pediatric patients presented with Hirschsprung's Disease to Elshatby University Hospital. 40 patients were treated by TAERPT and included in Group A and 30 patients were treated by LAERPT and included in Group B. The two groups were compared as regards the operative data as well as the post-operative outcomes including the time of passage of stools, time of tolerating oral feeding, the duration of hospital stay, and the development of any early postoperative complications. Also, the number of bowel habits, constipation, enterocolitis, abdominal distension, anastomotic stricture, and continence were assessed. ### Conditions Module **Conditions:** - Pediatric Disorder - Hirschprung's Disease ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 70 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Pediatric patients presented with Hirschsprung's disease treated by pure transanal endorectal pull-through (TAERPT) **Intervention Names:** - Procedure: Group A: Pure transanal endorectal pull-through (TAERPT) **Label:** Group A **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Pediatric patients presented with Hirschsprung's disease treated by laparoscopic-assistance endorectal pull-through (LAERPT) **Intervention Names:** - Procedure: Group B: Laparoscopic-assistance endorectal pull-through (LAERPT) **Label:** Group B **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Group A **Description:** Patients of Group A will be treated totally by pure transanal endorectal pull-through without the assistance of laparoscopy **Name:** Group A: Pure transanal endorectal pull-through (TAERPT) **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Group B **Description:** Patients of Group B will be treated transanal endorectal pull-through but with the assistance of laparoscopy **Name:** Group B: Laparoscopic-assistance endorectal pull-through (LAERPT) **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** The two groups will be compared according to post-operative continence whether continent or incontinent by using Abbreviated Baylor Social Continence Scale. the sore ranges from 0 to 24 with the minimum score revealing an excellent result and the highest score revealing the worst result. (Excellent = 0-5, Good = 7-12, Fair = 13-18, Poor = 19-24) **Measure:** Post-operative continence **Time Frame:** One post-operative year **Description:** The two groups will be compared according to post-operative constipation whether present or not **Measure:** Post-operative constipation **Time Frame:** One post-operative year **Description:** The two groups will be compared according to post-operative soiling whether present or not **Measure:** Post-operative soiling **Time Frame:** One post-operative year **Description:** The two groups will be compared according to post-operative enterocolitis whether present or not **Measure:** Post-operative enterocolitis **Time Frame:** One post-operative year **Description:** The two groups will be compared according to post-operative complications whether present or not **Measure:** Post-operative complications **Time Frame:** One post-operative year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria \* Pediatric patients with age range between 3 months and 18 years old presented with Hirschsprung's Disease who were confirmed to have this condition by contrast enema and/or rectal biopsy. Exclusion Criteria: * Patients with previous colostomy. **Maximum Age:** 18 Years **Minimum Age:** 3 Months **Sex:** ALL **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Alexandria **Country:** Egypt **Facility:** Ahmed El Rouby **Zip:** 12345 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004065 - Term: Digestive System Abnormalities - ID: D000004066 - Term: Digestive System Diseases - ID: D000008531 - Term: Megacolon - ID: D000003108 - Term: Colonic Diseases - ID: D000007410 - Term: Intestinal Diseases - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000000013 - Term: Congenital Abnormalities ### Condition Browse Module - Browse Branches - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M9703 - Name: Hirschsprung Disease - Relevance: HIGH - As Found: Hirschsprung Disease - ID: M12 - Name: Congenital Abnormalities - Relevance: LOW - As Found: Unknown - ID: M7254 - Name: Digestive System Abnormalities - 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: M11514 - Name: Megacolon - 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: T2802 - Name: Hirschsprung Disease - Relevance: HIGH - As Found: Hirschsprung Disease ### Condition Browse Module - Meshes - ID: D000006627 - Term: Hirschsprung Disease ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419985 **Brief Title:** Ketamine HCl Prolonged Release Oral Tablets for CRPS **Official Title:** A Phase 2 Single-arm, Open Label Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of Ketamine HCl Prolonged Release Tablets in Participants With Complex Regional Pain Syndrome #### Organization Study ID Info **ID:** 23015-0001 #### Organization **Class:** OTHER **Full Name:** University of Southern California ### Status Module #### Completion Date **Date:** 2026-07 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-06 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Southern California #### Responsible Party **Investigator Affiliation:** University of Southern California **Investigator Full Name:** Steven Richeimer **Investigator Title:** Professor of Clinical Anesthesiology **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetic profile of Ketamine HCl Prolonged Release (PR) tablets in participants with pain due to complex regional pain syndrome (CRPS). Additionally, this trial will explore the feasibility of the trial design through dosing compliance, clinical instruments, and efficacy signals. **Detailed Description:** This study will enroll patients with history of CRPS (greater than 6 months) at a single academic medical institution in the United States. All participants will be informed about the study and potential risks and will provided written informed consents prior to undergoing any study-related procedures. There are 3 cohorts of 3+3 participants each that are assigned escalating dose levels of oral Ketamine HCl PR (1 tablet=40mg). The daily dose of Ketamine PR for the 3 cohort is as follows: Cohort 1 is 80 mg/day (1 tablets of 40mg twice a day); Cohort 2 is 160 mg/day (2 tablets of 40mg twice a day); Cohort 3 is 240 mg/day (3 tablets of 40mg twice a day). Each cohort consists of 1 sentinel participant that must complete Visit 4 before the other 2 participants are enrolled. If participants withdraw from the study before completing Cycle 1 for reasons other than a dose-limiting toxicity, additional participants will be enrolled to replace them, until at least 3 successful participants have completed Cohort 1. At this time a safety review will be conducted. If there are 2 or more DLT events observed in Cohort 1, the study will stop. If there is 1 Dose Limiting Toxicity (DLT) event observed, an additional 3 participants will be enrolled in Cohort 1. If there are 2 or more DLT events observed in the additional set of participants, the study will stop. If there is ≤ 1 DLT event observed in the additional set, enrollment will open for Cohort 2. After at least 3 participants in Cohort 2 have completed Cycle 1, a safety review will be conducted to assess the safety and tolerability of the investigational product. If there are 2 or more DLT events observed in Cohort 2, the Maximum Tolerated Dose (MTD) will become 80mg ketamine HCl PR per day and the study will open for general enrollment. If there is 1 Dose Limiting Toxicity (DLT) event observed, an additional 3 participants will be enrolled in Cohort 2. If there are 2 or more DLT events observed in the additional set of participants, the MTD will become 80mg ketamine HCl PR per day and the study will open for general enrollment. If there is ≤ 1 DLT event observed in the additional set, enrollment will open for Cohort 3. After at least 3 participants in Cohort 3 have completed Cycle 1, a safety review will be conducted by the SRC to assess the safety and tolerability of the investigational product. If there are 2 or more DLT events observed in Cohort 3, the Maximum Tolerated Dose (MTD) will become 160mg ketamine HCl PR per day and the study will open for general enrollment. If there is 1 Dose Limiting Toxicity (DLT) event observed, an additional 3 participants will be enrolled in Cohort 3. If there are 2 or more DLT events observed in the additional set of participants, the MTD will become 160mg ketamine HCl PR per day and the study will open for general enrollment. If there is ≤ 1 DLT event observed in the additional set, the study will open for general enrollment where the MTD is 240mg ketamine HCl PR per day. If 0 DLT events are observed in Cohort 3, the study will open for general enrollment where the MTD is 240mg ketamine HCl PR per day. Health status assessments including physical exams, blood work, urinalysis, EKG and questionnaires to assess quality of life and pain scale measurement will be conducted at the clinic visits. The participants will also keep a daily diary to record pain levels and any additional pain medication needed. There will be a screening visit (day -28 to -7), clinic visits at day 1, week 2, week 4, week 8, and at the end of study (EOS) visit. There will be additional telemedicine visits at week 1, week 3 and at the safety followup visit approximately 4 weeks after the EOS visit. Definition of Dose Limiting Toxicities (DLT): Any of the following symptoms, if they interfere with the daily life of the participant, will be considered DLTs: * General - sedation, impaired consciousness * Head, Ear, Eyes, Nose, Throat - horizontal, vertical or rotary nystagmus, mydriasis, excessive salivation * Cardiovascular - hypertension, tachycardia, palpitations, arrhythmias, chest pain * Abdominal - abdominal pain, abdominal tenderness, nausea, vomiting * Neurological - altered mental status (disorientation), paranoia, dysphoria, anxiety, confusion, slurred speech, dizziness, ataxia, dysarthria, trismus, muscular rigidity, psychomotor, psychomimetic, or acute dystonic reactions * Genitourinary - lower urinary tract symptoms * Trauma - a thorough examination for evidence of trauma is needed as injuries secondary to ketamine intoxication can occur due to the diminished perception of pain. Any of the following symptoms will always be considered DLTs: * Respiratory - respiratory depression, apnea, laryngospasm * Cardiovascular - hypotension, bradycardia, myocardial infarction * Neurological - seizure, stupor, coma ### Conditions Module **Conditions:** - Complex Regional Pain Syndromes **Keywords:** - CRPS ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** SEQUENTIAL **Intervention Model Description:** 3 Cohorts of 3+3 ##### 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:** One 40mg tablet of Ketamine HCl PR twice a day **Intervention Names:** - Drug: 80mg Ketamine HCl Prolonged Release **Label:** 80mg Ketamine HCl PR **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Two 40mg tablets of Ketamine HCl PR twice a day **Intervention Names:** - Drug: 160mg Ketamine HCl Prolonged Release **Label:** 160mg Ketamine HCl PR **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Three 40mg tablets of Ketamine HCl PR twice a day **Intervention Names:** - Drug: Administration of Ketamine HCl Prolonged Release - 240mg **Label:** 240mg Ketamine HCl PR **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - 80mg Ketamine HCl PR **Description:** Administration of Ketamine HCl Prolonged Release - 80mg **Name:** 80mg Ketamine HCl Prolonged Release **Other Names:** - 80mg Ketamine PR **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - 160mg Ketamine HCl PR **Description:** Administration of Ketamine HCl Prolonged Release - 160mg **Name:** 160mg Ketamine HCl Prolonged Release **Other Names:** - 160mg Ketamine PR **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - 240mg Ketamine HCl PR **Description:** Administration of Ketamine HCl Prolonged Release - 240mg **Name:** Administration of Ketamine HCl Prolonged Release - 240mg **Other Names:** - 240mg Ketamine PR **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Number of participants with AEs, with abnormal vital signs, abnormal physical examination parameters; abnormal Electrocardiogram (EKG) parameters; abnormal laboratory parameters **Measure:** Safety of Ketamine HCl PR oral tablets **Time Frame:** Day 1 to 18 weeks **Description:** Maximum Plasma concentration \[Cmax\] is the maximum concentration of the drug, Ketamine, in the body, measured in grams/Liter. Blood samples are obtained at Day 2, 4, and 7. **Measure:** Maximum Plasma concentration [Cmax] of Ketamine **Time Frame:** Day 1 to Day 7 **Description:** Time to Maximum Plasma concentration \[Tmax\] is the time it takes for the drug Ketamine, to reach maximum concentration (Cmax), measured in minutes. Blood samples are obtained at Day 2, 4, and 7. **Measure:** Time to Maximum Plasma concentration [Tmax] of Ketamine **Time Frame:** Day 1 to Day 7 **Description:** MTD is determined by testing increasing doses from 80mg to 160mg to 240mg on dose escalation cohorts 1, 2, 3 with 3 to 6 participants each. MTD reflects the highest dose of drug that did not cause \>1 Dose Limiting Toxicity (DLT) event. **Measure:** Maximum Tolerated Dose (MTD) of Ketamine HCl PR oral tablets **Time Frame:** Up to 4 weeks for each dosing cohort #### Secondary Outcomes **Description:** Average Daily Pain Numerical Rating Scale is a validated, self-reported instrument used to assess average pain intensity level over the past 24 hours. It uses an 11-point (0-10) scale, with 0 being "no pain" and 10 being "worst pain imaginable." **Measure:** Average Daily Pain Numerical Rating Scale (ADP NRS) **Time Frame:** Day 1 to week 12 **Description:** The PROMIS-29 Profile v2.1 is a validated, self-reported instrument to measure functioning and well-being in 7 categories: physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities and pain interference. There are 4 questions in each of the 7 categories. Each question has five responses with a score from 1 to 5 (1 being best and 5 being worst). For each of these 7 categories, the lowest score is 4; the highest is 20. **Measure:** Patient-Reported Outcomes Measurement Information System-2 (PROMIS-29 Profile v2.1) **Time Frame:** Day 1 to week 12 **Description:** The CSS Questionnaire assesses changes in Complex Regional Pain Syndrome (CRPS) severity by asking for the presence or absence (score of 1 or 0) of 16 clinically assessed signs and symptoms of CRPS. A higher score is worse, indicate greater CRPS severity (range 0-16). **Measure:** Complex Regional Pain Syndrome Severity Scale (CSS) **Time Frame:** Day 1 to week 12 **Description:** Short-Form McGill Pain Questionnaire 2 (SF-MPQ-2) is a validated, self-reported tool used to measure the quality and the intensity of both neuropathic and non-neuropathic pain. It consists of 22 different descriptors of pain and each item is rated based on a 0-10 scale (with 0 being 'none' and 10 being 'worst possible'). The total score is calculated by summing the 22 individual scores. The higher the score, the greater the pain level. **Measure:** Short-Form McGill Pain Questionnaire 2 (SF-MPQ-2) **Time Frame:** Day 1 to week 12 **Description:** Patient Global Impression of Change is a validated, self-reported instrument consisting of a 7-point scale (1 through 7) depicting a patient's rating of overall improvement since a certain point in time. The higher PGIC scores, the greater improvement. We will compare the scores at the end of Cycle 1 (1-4 weeks), 2 (4-8 weeks), and 3 (8-12 weeks). **Measure:** Patient Global Impression of Change (PGIC) **Time Frame:** Day 1 to week 12 **Description:** Participants will record any change in the amount (expressed as MME) and frequency of opioid medications used for treating CRPS pain. **Measure:** Opioid sparing **Time Frame:** Day 1 to week 12 **Description:** Participants will record daily use of rescue medication (expressed in mg and number of tablets) for treating CRPS pain. Acetaminophen (up to 3000mg/day) will be offered as rescue medication for breakthrough pain. **Measure:** Medication sparing **Time Frame:** Day 1 to week 12 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Male and female participants between 18 and 70 years of age, inclusive, at Screening Visit. 2. Participants with a documented history of CRPS of at least 6 months at Visit 1. 3. Documented history of at least one sign in two of the categories of The Budapest Criteria for CRPS to support the diagnosis of CRPS. 4. Stable individual regular standard treatment regimen for CRPS pain, i.e., no change in drug and non-drug treatments for at least 4 weeks prior to Screening Visit and anticipated to remain stable throughout the study. 5. No surgery within one month, denervation procedures or neural blockade within 1 month of Screening Visit. 6. Participants on ketamine therapy at Screening Visit must agree to discontinue use for at least 14 days prior to the Baseline Observation Period. 7. Agree to discontinue any prohibited medications within 14 days of the Baseline Observation Period and for the duration of the study. 8. Average daily CRPS pain intensity score in the affected limb of ≥5 and ≤9 on an 11-point (0-10) NRS averaged over 7 days prior to Baseline Visit (Visit 1). This will be based on completion of at least 5 daily pain diary entries during the week prior to Visit 1, with no more than one 24-hour pain intensity score of zero or more than one 24-hour pain intensity score of 10. 9. Participants willing and able (e.g., mental and physical condition) to participate in all aspects of the trial, including use of medication, completion of subjective evaluations, attending scheduled clinic visits, completing telephone contacts, and compliance with protocol requirements as evidenced by providing signed written informed consent at Screening Visit. 10. For persons of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 6 weeks after the end of study intervention administration. 11. Previous enrollment in this trial or participation in any other clinical trial within the past 30 days prior to enrollment. Exclusion Criteria: 1. Known or suspected cardiovascular disease, arrythmias, and/or respiratory issues. 2. Abnormal EKG results, abnormal blood pressure and/or heart rates. 3. Known or suspected psychotic illness or neurologic disease. 4. Known or suspected elevated intraocular and/or intracranial pressure. 5. Known or suspected renal or urologic conditions or symptoms (i.e., bladder pain syndrome, interstitial cystitis), and/or abnormal baseline urinalysis results. 6. Known or suspected hyperthyroidism. 7. Allergy, hypersensitivity, or intolerance to ketamine or any of the investigational product excipients. 8. Participants receiving opioids ≥30 mg/day morphine milligram equivalents (MME), whether as part of their individual standard treatment regimen for CRPS pain or in context with any other indication, within the last two weeks prior to Visit 1. 9. Positive urine screen for any of the following: cocaine, amphetamine, methamphetamine, PCP, opioids, THC (other than medication used for individual standard treatment of pain) at Visit 1. 10. Known or suspected acute or chronic alcoholism, delirium tremens, or toxic psychosis. 11. Meet DSM-5 criteria for or current or past substance use disorder within the last 5 years for any psychoactive substances other than nicotine or caffeine. 12. Presence of aspartate aminotransferase (AST) levels ≥ 3 X upper limit of normal and/or alanine aminotransferase (ALT) levels ≥ 3 X upper limit of normal and/or total bilirubin ≥ 1.5 X upper limit of normal and/or creatinine ≥ 1.5 X upper limit of normal. 13. Evidence of moderate or severe renal impairment (CRCL \<60 ml/min) or participants with renal failure who are on any form of dialysis. 14. Any other condition of the patient that in the opinion of the investigator may compromise evaluation of the trial treatment or may jeopardize participant's safety, compliance or adherence to protocol requirements. 15. Previous enrollment in this trial or participation in any other clinical trial within the past 30 days prior to enrollment. **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:** Diane McIntee, MS **Phone:** 626-372-0075 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Faye Weinstein, PhD **Phone:** 323-442-6202 **Phone Ext:** 1 **Role:** CONTACT #### Locations **Location 1:** **City:** Los Angeles **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Steven Richeimer, MD - **Phone:** 323-442-6202 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Faye Weinstein, PhD - **Phone:** 323-442-6202 - **Phone Ext:** 1 - **Role:** CONTACT ***Contact 3:*** - **Name:** Steven Richeimer, MD - **Role:** PRINCIPAL_INVESTIGATOR ***Contact 4:*** - **Name:** Ashley Balentine, MD - **Role:** SUB_INVESTIGATOR **Country:** United States **Facility:** Pain Center, Keck Medical Center of University of Southern California **State:** California **Zip:** 90033 #### Overall Officials **Official 1:** **Affiliation:** Keck Medical Center of USC **Name:** Steven Richeimer, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004194 - Term: Disease - ID: D000010335 - Term: Pathologic Processes - ID: D000001342 - Term: Autonomic Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000010523 - Term: Peripheral Nervous System Diseases - ID: D000009468 - Term: Neuromuscular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: HIGH - As Found: Syndrome - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M22653 - Name: Complex Regional Pain Syndromes - Relevance: HIGH - As Found: Complex Regional Pain Syndrome - ID: M14861 - Name: Reflex Sympathetic Dystrophy - Relevance: HIGH - As Found: Complex Regional Pain Syndrome - ID: M4643 - Name: Autonomic Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M27979 - Name: Primary Dysautonomias - Relevance: LOW - As Found: Unknown - ID: M13432 - Name: Peripheral Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M12411 - Name: Neuromuscular Diseases - Relevance: LOW - As Found: Unknown - ID: T1440 - Name: Complex Regional Pain Syndrome - Relevance: HIGH - As Found: Complex Regional Pain Syndrome ### Condition Browse Module - Meshes - ID: D000020918 - Term: Complex Regional Pain Syndromes - ID: D000012019 - Term: Reflex Sympathetic Dystrophy - ID: D000013577 - Term: Syndrome ### 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: D000000778 - Term: Anesthetics, Dissociative - ID: D000018686 - Term: Anesthetics, Intravenous - ID: D000018681 - Term: Anesthetics, General - ID: D000000777 - Term: Anesthetics - ID: D000002492 - Term: Central Nervous System Depressants - ID: D000018691 - Term: Excitatory Amino Acid Antagonists - ID: D000018683 - Term: Excitatory Amino Acid Agents - ID: D000018377 - Term: Neurotransmitter Agents - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### 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: M10674 - Name: Ketamine - Relevance: HIGH - As Found: Provided - ID: M4032 - Name: Analgesics - Relevance: LOW - As Found: Unknown - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M4108 - Name: Anesthetics, Dissociative - Relevance: LOW - As Found: Unknown - ID: M20766 - Name: Anesthetics, Intravenous - Relevance: LOW - As Found: Unknown - ID: M20761 - Name: Anesthetics, General - Relevance: LOW - As Found: Unknown - ID: M20771 - Name: Excitatory Amino Acid Antagonists - Relevance: LOW - As Found: Unknown - ID: M20504 - Name: Neurotransmitter Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000007649 - Term: Ketamine ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419972 **Brief Title:** Multimodal Program for Climacteric Women **Official Title:** Effectiveness of a Combined Education and Exercise Program on the Physical, Functional and Psychological Status of Climacteric Women. #### Organization Study ID Info **ID:** UV_Menopause #### Organization **Class:** OTHER **Full Name:** University of Valencia ### Status Module #### Completion Date **Date:** 2025-02-28 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-12-25 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-30 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-07 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Valencia #### Responsible Party **Investigator Affiliation:** University of Valencia **Investigator Full Name:** Laura Fuentes Aparicio **Investigator Title:** Assistant Professor of Physiotherapy **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Your study seems to aim at emphasizing the significance of non-pharmacological and non-hormonal approaches in managing menopausal symptoms, particularly focusing on muscle training and education. This holistic approach acknowledges the importance of physical well-being, psychological support, and education to enhance women's quality of life during the menopausal transition. **Detailed Description:** Climacteric is a time of great transition for all women physically, mentally, and emotionally . This transition involves a host of physical, endocrine, and psychological changes that are influenced by ethnic, psychological, and sociocultural factors . Each woman's experience of the menopausal transition is unique; therefore, a one-size-fits-all approach to symptom management is not sufficient . Menopause is a retrospective diagnosis and is said to occur when menstrual activity has ceased for at least 12 consecutive months with no other physiologic or pathologic explanation for it . It marks the end of reproductive life and ovarian follicular activity by the onset of an estrogen deficiency that triggers various symptoms . The main symptoms aggregated according to the Menopause Rating Score MRS include somatic symptoms \[vasomotor symptoms (hot flashes and night sweats), sleeping difficulties, fatigue, palpitations, joint pain, worsening muscle ability and function, skin/eye dryness, and skin and hair changes\], psychological \[mental confusion, mood swings, increased anxiety, irritability\], and urogenital \[genitourinary syndrome symptoms (vaginal dryness, dyspareunia, irritation, itching, sexual dysfunction), bladder symptoms (altered frequency, level of urgency and incontinence). Focusing on the musculature and ligaments, we must also think about the tissues of the pelvic floor muscle (PFM), which are affected by the drop in estrogen levels, due to the existence of estrogen receptors in ligaments, musculature and pelvic support structures. The pelvic floor as a whole has an important role in supporting the organs of the pelvic cavity and is involved in the closing and opening mechanisms of the urethral, vaginal and anal tract . Taking this into account, what can be worked on voluntarily is the musculature. This estrogenic variation is also responsible for the onset of cardiovascular disease during the menopausal period, which is characterized by variations in the lipid profile and the predominant accumulation of abdominal fat. Treatments to treat menopausal symptoms include hormonal preparations, non-hormonal medications and non-pharmacological therapies. The latter two, non-pharmacological and non-hormonal therapies are generally the least studied. On genitourinary and urinary syndrome symptoms, the musculature has a fundamental role, and working on it will produce improvements in these factors. By training the pelvic floor muscle (PFM) there is a greater blood supply, which this will lead to a relaxation of the tissues and an increase in elasticity that will help in the genitourinary syndrome; and on the other hand, its training, increasing strength, will improve the control and efficacy of the closing and opening of the urethral, vaginal and anal tracts . On the other hand, physical activity will help in weight loss and improve body composition parameters . It should be noted that the information provided to women influences the understanding and how menopause and its symptoms are faced, being relevant to provide knowledge and education by the general practitioner or a qualified health personnel. Therefore, this study seeks to expand the information on non-pharmacological and non-hormonal therapies, such as active training of the pelvic floor muscle, generic muscle training and education, due to their potential efficacy. ### Conditions Module **Conditions:** - Climacteric Syndrome - Postmenopausal Symptoms - Menopause - Perimenopausal Disorder **Keywords:** - perimenopause - climacteric - Postmenopause - women's health ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 115 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** They will receive multimodal physiotherapy programme, which will combine therapeutic exercise based in general strength exercise combined with a pelvic floor education program. **Intervention Names:** - Other: multimodal physiotherapy programme **Label:** Experimental **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** They will not receive any type of intervention **Label:** Control **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Experimental **Description:** The intervention to which the climacteric women will be subjected will consist of a combined program of education and general strength and pelvic floor muscles exercises of 8 weeks duration, at a rate of 2 sessions/week. Each of the sessions will last 60 min, except for the first one, which will be 90 min. **Name:** multimodal physiotherapy programme **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** For performed the upper limb muscle strength (kg) evaluation will use different dynamometry test Dynamometry of Upper limb muscle: using the Hand grip strength (stable position - elbow 90º and arm in contact with the trunk , hold dynamometer with the hand and perform maximum grip force for 5seconds. **Measure:** Upper limb muscle strength **Time Frame:** 8 weeks (2 assessment times: T1(pre-intervention), T2 (Immediately post-intervention)and T3 (3-months follow-up) **Description:** The quadriceps dynamometry test (Lafayette Instrument) will be used to evaluate the muscular strength of the lower extremities, the unit of measure will be. The Lafayette measuring range is 0-300 lbs (136.1 kg/1335 N). **Measure:** Lower limb muscle strength **Time Frame:** 8 weeks (2 assessment times: T1(pre-intervention), T2 (Immediately post-intervention)and T3 (3-months follow-up) **Description:** For the isometric strength of the trunk flexors, the central dynamometry test (Lafayette Instrument) will be used: the patient will be in the supine position with the knees straight, the hips flexed at 30° and the trunk at 30°; placing the dynamometer on the sternum, below the suprasternal notch, the participants should place their hands on the opposite acromion processes.The Lafayette measuring range is 0-300 lbs (136.1 kg/1335 N). **Measure:** Trunk flexor isometric strength **Time Frame:** 8 weeks (2 assessment times: T1(pre-intervention), T2 (Immediately post-intervention)and T3 (3-months follow-up) **Description:** The Supine Bridge Test involves lying on a mat with knees and hips flexed, lifting the pelvis off the floor for alignment. The Prone Bridge requires lying face down on elbows, lifting the pelvis so only forearms and toes touch the floor. In the Side Bridge, one lies on their side, supporting the body with elbow, forearm, and feet while lifting the hips. Participants hold each position as long as possible to assess core strength and stability. **Measure:** Abdominopelvic muscle function **Time Frame:** 8 weeks (2 assesment times: T1(pre-intervention), T2 (Immediately post-intervention)and T3 (3-months follow-up) **Description:** Will be measure abdominal wall thickness at rest and during a draw-in maneuver for Transversus abdominis (TrA), obliquus internus (IO), and obliquus externus (EO) on the dominant side. Subjects will lie supine with hips and knees flexed. Using a 5.3-10 MegaHertz (MHz) linear probe, the transducer will be centered transversely just above the iliac crest at the umbilical level and aligned with the axillary midline. Three measurements will be taken at each point, averaged for analysis, with the M-line set to the midline for precise measurements. Changes in muscle thickness (cm) reflecting muscle activation will be observed. **Measure:** Abdominal ultrasound image **Time Frame:** 8 weeks (2 assesment times: T1(pre-intervention), T2 (Immediately post-intervention) and T3 (3-months follow-up) **Description:** Transabdominal ultrasound will be used, for this purpose convex probe will be place at suprapubic level in B-mode will be used (3.5-5MegaHertz (Mhz). Three measurements at each point and use the mean of the 3 for subsequent analyses. Changes in muscle thickness refected by muscle activation will be calculated as the thickness during contraction minus the resting thickness (cm) . **Measure:** Pelvic floor muscle ultrasound image **Time Frame:** 8 weeks (2 assesment times: T1(pre-intervention), T2 (Immediately post-intervention) and T3 (3-months follow-up) **Description:** Women will start from a seated position with feet flat on the floor and arms crossed, rise completely with hips and knees extended, then sit back down touching the seat, repeat for 30 seconds. Chair leaning against a wall, usual footwear. If unable to stand, hands can be placed on legs or mobility aids can be used, scored as adapted test. It is recommended to practice 2-3 slow repetitions for comprehension. Scoring: Count the total number of complete bipedestation (up and down) in a test. If at least one bipedestation is completed in 30 seconds, it is counted. If unable to stand, the score is zero. Record the adapted score if applicable. **Measure:** 30s chair-stand test **Time Frame:** 8 weeks (2 assesment times: T1(pre-intervention), T2 (Inmediately post-intervention) and T3 (3-months follow-up) **Description:** Vaginal palpation will be done using the Modified Oxford Scale, which comprises 6 levels. It demonstrates good interobserver reliability and serves as a subjective scale for clinical rather than research purposes. To gauge sensitivity to change, each point was supplemented with a +/-, expanding the scale to include 15 degrees. **Measure:** Pelvic floor muscles strength **Time Frame:** 8 weeks (2 assesment times: T1(pre-intervention), T2 (Immediately post-intervention) **Description:** A commercially available instrumented plastic dynamometric speculum (Pelvimeter, Phenix, Montpellier, France) was utilized to measure pelvic floor muscle (PFM) tone and maximum intravaginal pelvic floor muscle (PFM) strength generated through maximal voluntary contraction the measure will be reported in grams. All numerical values of pelvic floor muscle (PFM) dynamometry tone are presented as raw values, including the ambient pressure value (170 g). Latex or polyethylene protective covers were used, and the dynamometer was comfortably aligned in the participant's vaginal canal throughout the experiment. Pelvic floor muscle strength was calculated as the mean of three maximum voluntary contractions. **Measure:** Pelvic floor muscles Dynamometry **Time Frame:** 8 weeks (2 assesment times: T1(pre-intervention), T2 (Immediately post-intervention) and T3 (3-months follow-up) #### Secondary Outcomes **Description:** The Menopause Rating Scale (MRS) is a widely used tool for assessing symptoms related to menopause. The scoring scheme increases point by point with increasing subjectively perceived symptom severity for each of the 11 items (severity 0 \[no complaint\] to 4 score points \[very severe symptoms\]). The composite score for each of the dimensions (subscales) is based on the sum of the scores for each item of the respective dimensions. The composite score (total score) is the sum of the dimension scores. **Measure:** Menopause symptoms **Time Frame:** 8 weeks (2 assesment times: T1(pre-intervention), T2 (Immediately post-intervention) and T3 (3-months follow-up) **Description:** The Beck Depression Inventory (BDI) is a widely used self-report inventory for measuring the severity of depression symptoms. It consists of 21 multiple-choice questions, each assessing a different symptom of depression such as sadness, pessimism, guilt, and suicidal thoughts. Respondents rate the severity of each symptom over the past two weeks. Scores are summed to yield a total score, with higher scores indicating more severe depressive symptoms. The BDI is frequently used in clinical and research settings to assess depression severity and monitor treatment progress. **Measure:** Psychologic condition **Time Frame:** 8 weeks (2 assessent times: T1(pre-intervention), T2 (Immediately post-intervention) and T3 (3-months follow-up) **Description:** The Pelvic Floor Distress Inventory-20 (PFDI-20) is a recommended questionnaire for evaluating pelvic floor disorder (PFD) symptoms and measuring their impact on women's quality of life. This questionnaire is validated in Spanish. The PFDI-20 reflects different perspectives, thus including 20 questions divided into three symptom scales: pelvic organ prolapse symptoms (POP-DI) (questions 1 to 6); colorectal-anal symptoms (CRADI) (questions 7-14); and urinary symptoms (UDI) (questions 15-20). The questions in the CRADI scale are about fecal incontinence (FI), except for question 11, which addresses flatulence incontinence; whereas the UDI scale addresses urinary symptoms specifically. Question 16 pertains to urgency urinary incontinence (UUI), and question 17 pertains to stress urinary incontinence (SUI). Each question can be answered on four levels of dysfunction: none, mild, moderate, and severe. **Measure:** Urinary symptoms **Time Frame:** 8 weeks (2 assesment times: T1(pre-intervention), T2 (Immediately post-intervention) **Description:** Pelvic Floor Impact Questionnaire (PIKQ)It is a tool used to assess the impact of pelvic floor disorders, such as urinary incontinence, colorectal-anal symptoms, and genital prolapse, on various aspects of a person's life, including activities, relationships, and emotions. The questionnaire consists of seven questions for each symptom category (urine, colorectal-anal, and genital prolapse), with responses rated on a scale of none, mild, moderate, or severe. The total score is calculated by summing the scores from each category, with a maximum possible score of 300. **Measure:** Pelvic floor health knowledge **Time Frame:** 8 weeks (2 assesment times: T1(pre-intervention), T2 (Immediately post-intervention) and T3 (3-months follow-up) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Women aged ≥45 years * Women in climacteric period Exclusion Criteria: * Musculoskeletal, cognitive, infectious, neurological, or cardiorespiratory pathology impairing assessment or program completion. * Surgical intervention in lumbopelvic or gynecological region within the last 6 months. Undergoing oncological treatment. \* Also included women with stable hormone replacement therapy for at least the last 6 months. **Gender Based:** True **Healthy Volunteers:** True **Maximum Age:** 85 Years **Minimum Age:** 45 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Laura Fuentes-Aparicio, PhD **Phone:** 669682391 **Phone Ext:** 51227 **Role:** CONTACT #### Locations **Location 1:** **City:** Valencia **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Laura Fuentes-Aparicio, PT PhD - **Phone:** 669682391 - **Role:** CONTACT **Country:** Spain **Facility:** Laura Fuentes Aparicio **Zip:** 46010 ### 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: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: T6036 - Name: Menopause - Relevance: HIGH - As Found: Climacteric ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419959 **Brief Title:** NightWare and Cardiovascular Health in Veterans With PTSD **Official Title:** Improving Cardiovascular Health in Veterans With PTSD by Treating Trauma-Related Nightmares With NightWare #### Organization Study ID Info **ID:** CARB-005-23F #### Organization **Class:** FED **Full Name:** VA Office of Research and Development #### Secondary ID Infos **Domain:** Veterans Affairs **ID:** CX002762-01A1 **Type:** OTHER_GRANT **Domain:** COMIRB **ID:** 24-0284 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2026-09-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-09-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-10-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-03 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** FED **Name:** VA Office of Research and Development #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Is US Export:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** The purpose of this study is to learn more about the effectiveness of a prescription wrist-wearable device called NightWare (NW) on improving sleep in Veterans with nightmares related to posttraumatic stress disorder (PTSD). The investigators also want to learn whether it improves cardiovascular health among this population. **Detailed Description:** Posttraumatic stress disorder (PTSD) is associated with profound health consequences in Veterans, including cardiovascular disease (CVD), the leading cause of death in adults in the United States. Trauma-related nightmares, a hallmark of PTSD, are a debilitating symptom that can lead to poor sleep quality and other health issues that ultimately cause clinically significant impairments in daily functioning. Recently, nightmares were reported to be an independent predictor of CVD in Veterans, for reasons that are unclear. Poor sleep is associated with increased CVD risk, possibly by impairing vascular health and nervous system function. Nightmare-related sleep disturbances are often resistant to first-line treatment (e.g., psychotherapy, medications) and even with improvements, residual nightmares and sleep disturbances often persist that still meet clinical significance. Moreover, significant barriers often exist including access to care and lack of trained providers, that prevent reaching and engagement of individuals to treatments, and there is poor adherence to interventions overall. As such, there is a need to implement interventions and/or complementary approaches that may appeal to Veterans experiencing PTSD-related nightmares who are looking for alternatives. In this regard, NightWare (NW) digital therapeutic is a novel smart watch application that was recently granted Breakthrough Device designation by the FDA for the treatment of nightmares in adults with PTSD. It uses the wearer's biometric data (i.e., heart rate, body movement and position) to distinguish normal and distressed sleep and interrupt nightmares. Preliminary evidence demonstrated an improvement in subjective sleep quality in Veterans after 30-days of NW compared with a sham condition. However, it is unknown whether NW improves sleep quality in Veterans with PTSD with co-morbid medical conditions such as obstructive sleep apnea (OSA) or in those using medications (e.g., prazosin) to treat nightmares related to PTSD. It is also unknown if the effects of NW on sleep are similar in male and female Veterans, or whether improvements in sleep with NW result in improvements in objective sleep (i.e., sleep physiology) or cardiovascular health. In this context, this study will determine if 8 weeks of NW improves subjective sleep in Veterans with PTSD-related nightmares, including those with OSA and/or taking medications to treat PTSD related nightmares (e.g., prazosin). The change in Pittsburgh Sleep Quality Index (PSQI) scores from baseline to 8 weeks will be measured. Additional goals will evaluate changes in cardiovascular health outcomes with NW use and if there are potential sex differences in the response to NW. The proposed research is a high priority topic of the Veterans Affairs, as PTSD affects 11-23% of Veterans in a given year. The research is highly innovative and if successful will lead to significant advances in the healthcare of Veterans, particularly as it relates to the treatment of PTSD-related nightmares. ### Conditions Module **Conditions:** - Post-traumatic Stress Disorder (PTSD) - Cardiovascular Diseases - Autonomic Dysfunction - Vascular Stiffness - Nightmare - Endothelial Dysfunction - Veteran **Keywords:** - Sleep - Oxidative stress - aging, inflammation - sex/gender - Veteran - Trauma and Stressor Related Disorders - Mental Disorders - Nervous System Diseases - Autonomic Nervous System Diseases - Primary Dysautonomias - Cardiovascular Diseases - Stress Disorders, Post-Traumatic ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Randomized, double-blind, placebo (i.e., sham intervention) controlled parallel proof-of-concept study ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 125 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Intervention with NightWare Therapeutic System **Intervention Names:** - Device: NightWare **Label:** NightWare active **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** NightWare app disabled; device will not deliver an intervention **Intervention Names:** - Device: NightWare **Label:** NightWare Sham **Type:** SHAM_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - NightWare Sham - NightWare active **Description:** Nightware intervention app (enabled) will attempt to detect when an individual is having a nightmare based on a Nightware proprietary algorithm and attempt to disrupt the nightmare without awakening. In the sham comparator group the NightWare app will be disabled and not deliver an intervention. **Name:** NightWare **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Sleep questionnaire with a scale of 0 to 21 with a higher score indicating a significant sleep disturbance **Measure:** Change in Pittsburgh Sleep Quality Index **Time Frame:** Measured before and after 8 weeks of NightWare and sham conditions #### Secondary Outcomes **Description:** Total sleep duration (minutes) calculated through ambulatory electroencephalography. **Measure:** Change in physiological sleep - total sleep time **Time Frame:** Measured before and after 8 weeks of NightWare and sham conditions **Description:** Brachial artery flow mediated dilation (FMD) using ultrasound **Measure:** Change in endothelial function **Time Frame:** Measured before and after 8 weeks of NightWare and sham conditions **Description:** Cardiovagal baroreflex sensitivity (cBRS) measured using beat-to-beat time series of systolic blood pressures (finger photo-plethysmography) and R-R interval (three-lead electrocardiogram) will be recorded simultaneously at 1,000 Hz. **Measure:** Change in Autonomic function - spontaneous baroreflex sensitivity (BRS) **Time Frame:** Measured before and after 8 weeks of NightWare and sham conditions **Description:** Carotid-femoral pulse wave velocity (PWV) **Measure:** Change in large elastic artery stiffness **Time Frame:** Measured before and after 8 weeks of NightWare and sham conditions **Description:** Augmentation index and aortic blood pressure via pulse wave analysis **Measure:** Change in large elastic artery stiffness **Time Frame:** Measured before and after 8 weeks of NightWare and sham conditions **Description:** Heart rate variability **Measure:** Change in autonomic function - heart rate variability (HRV) **Time Frame:** Measured before and after 8 weeks of NightWare and sham conditions **Description:** Wake after sleep (minutes) calculated through ambulatory electroencephalography. **Measure:** Change in physiological sleep - wake after sleep onset **Time Frame:** Measured before and after 8 weeks of NightWare and sham conditions **Description:** Sleep efficiency (percentage) calculated through ambulatory electroencephalography. **Measure:** Change in physiological sleep - sleep efficiency **Time Frame:** Measured before and after 8 weeks of NightWare and sham conditions **Description:** REM sleep (minutes) calculated through ambulatory electroencephalography. **Measure:** Change in physiological sleep - REM sleep **Time Frame:** Measured before and after 8 weeks of NightWare and sham conditions **Description:** Deep sleep (minutes) calculated through ambulatory electroencephalography. **Measure:** Change in physiological sleep - Deep sleep **Time Frame:** Measured before and after 8 weeks of NightWare and sham conditions **Description:** Light sleep (minutes) calculated through ambulatory electroencephalography. **Measure:** Change in physiological sleep - Light sleep **Time Frame:** Measured before and after 8 weeks of NightWare and sham conditions ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Diagnosis of PTSD via American Psychiatric Association PTSD diagnostic criteria in the fifth edition of its Diagnostic and Statistical Manual of Mental Disorders (DSM-5). 2. Self-report having repetitive nightmares contributing to disrupted sleep; 3. Age 22 years (rationale is because the device has only been used in adults in 22 years and older); 4. Resting blood pressure (BP, \<160/100 mmHg); 5. Fasted glucose \<126 mg/dL; 6. Poor overall sleep quality as indicated by a Pittsburgh Sleep Quality Index (PSQI) score 6 or higher; 7. Epworth Sleepiness Scale (ESS): Question #8 score above "0" will prompt an additional question: Do you drive ("get behind the wheel") when you are drowsy? The answer must be "No" to be enrolled in the study due to safety concerns; 8. Wireless Internet and two power outlets in sleeping location; 9. Willingness not to use any other application which collects heart rate data on the phone and watch that is used for NightWare; Exclusion Criteria: 1. Unstable medical condition (e.g., uncontrolled hypertension or active CVD or cancer); 2. Active infection (note, anyone with an active infection would become eligible once the infection has ended); 3. Thyroid dysfunction, defined as an ultrasensitive TSH \<0.5 or \>5.0 mU/L; volunteers with abnormal TSH values will be re-considered for participation in the study after follow-up evaluation by the PCP with initiation or adjustment of thyroid hormone replacement; or other problems that would interfere with participation in the study; 4. Use of insulin or sulfonylureas 5. Pregnancy or currently breast feeding; 6. Current history (past 3 months) of substance (excluding marijuana) or alcohol abuse per the SCID-5. Adults with past substance or alcohol use disorders will be allowed to participate; 7. Participants will be excluded if they report elevated acute risk for suicidal self-directed violence warranting immediate hospitalization (e.g., suicidal ideation with intent, evaluated by the Columbia-Suicide Severity Rating Scale \[C-SSRS\]). 8. Shift workers (due to circadian rhythm disruption); 9. Diagnosis of active disorder of arousal from non-rapid eye movement sleep, rapid eye movement sleep behavior disorder, or narcolepsy; 10. Nocturia that causes awakening from sleep; 11. Known sleep walking or acting out dreams (contraindication to NW use); 12. Diagnosis or suspicion of dementia; 13. Seizure disorder 14. Participants experiencing severe cognitive impairment or current psychiatric symptoms of such severity that would preclude participation (e.g., active psychosis, imminently suicidal) **Gender Based:** True **Gender Description:** All genders **Healthy Volunteers:** True **Maximum Age:** 88 Years **Minimum Age:** 22 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Kerrie L Moreau, PhD **Phone:** (720) 885-1950 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Claire Cox, BS **Phone:** (303) 372-1396 **Role:** CONTACT #### Locations **Location 1:** **City:** Aurora **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Claire Cox, BS - **Phone:** 303-372-1396 - **Role:** CONTACT ***Contact 2:*** - **Name:** Kerrie L Moreau, PhD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Rocky Mountain Regional VA Medical Center, Aurora, CO **State:** Colorado **Zip:** 80045 #### Overall Officials **Official 1:** **Affiliation:** Rocky Mountain Regional VA Medical Center, Aurora, CO **Name:** Kerrie L Moreau, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000068099 - Term: Trauma and Stressor Related Disorders - ID: D000001523 - Term: Mental Disorders - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: M10293 - Name: Inflammation - Relevance: LOW - As Found: Unknown - ID: M24916 - Name: Stress Disorders, Traumatic - Relevance: HIGH - As Found: Traumatic Stress Disorder - ID: M16103 - Name: Stress Disorders, Post-Traumatic - Relevance: HIGH - As Found: Post Traumatic Stress Disorder (PTSD) - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M222 - Name: Trauma and Stressor Related Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: M4643 - Name: Autonomic Nervous System Diseases - Relevance: HIGH - As Found: Autonomic Dysfunction - ID: M27979 - Name: Primary Dysautonomias - Relevance: HIGH - As Found: Autonomic Dysfunction ### Condition Browse Module - Meshes - ID: D000001342 - Term: Autonomic Nervous System Diseases - ID: D000054969 - Term: Primary Dysautonomias - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000040921 - Term: Stress Disorders, Traumatic - ID: D000013313 - Term: Stress Disorders, Post-Traumatic ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419946 **Brief Title:** Lomustine in Addition to Standard of Care in Patients With MGMT Methylated Glioblastoma **Official Title:** Phase III Trial of Temozolomide/Lomustine (TMZ/LOM) Combination Therapy vs. Standard TMZ Therapy for Newly Diagnosed MGMT Promoter Methylated Glioblastoma (IDHwt) Patients +/- Tumor Treating Fields (Optune) #### Organization Study ID Info **ID:** 2023-506998-35-00 #### Organization **Class:** OTHER_GOV **Full Name:** Vastra Gotaland Region ### Status Module #### Completion Date **Date:** 2031-12-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2028-12-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-15 **Type:** ESTIMATED **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-04-29 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Skane University Hospital **Class:** OTHER **Name:** Gävle Hospital **Class:** OTHER **Name:** Karolinska Institutet **Class:** OTHER **Name:** Sahlgrenska University Hospital, Sweden **Class:** OTHER **Name:** Karlstad Central Hospital **Class:** OTHER **Name:** Ryhov County Hospital **Class:** OTHER **Name:** Kalmar County Hospital **Class:** OTHER **Name:** Oslo University Hospital **Class:** OTHER **Name:** St. Olavs Hospital **Class:** OTHER **Name:** Haukeland University Hospital **Class:** OTHER_GOV **Name:** Sorlandet Hospital HF **Class:** OTHER_GOV **Name:** Helse Stavanger HF **Class:** OTHER **Name:** Aarhus University Hospital **Class:** OTHER **Name:** University Hospital, Umeå **Class:** OTHER **Name:** Eskilstuna Lasarettet **Class:** OTHER **Name:** Region Örebro County #### Lead Sponsor **Class:** OTHER_GOV **Name:** Vastra Gotaland Region #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Background: Glioblastoma (GBM) is notoriously difficult to treat, with current therapies often extending life by only a few months. The standard treatment involves surgery followed by radiation and chemotherapy with Temozolomide (TMZ). The efficacy of TMZ, however, is significantly enhanced when the tumor's o6-methylguanine-DNA-methyltransferase (MGMT) gene is methylated. Recent studies, such as the NOA-09 trial, have suggested that adding Lomustine (LOM) to TMZ could improve outcomes for patients with this specific tumor profile. Hypothesis: The investigators hypothesize that the addition of LOM to the TMZ regimen will lead to significantly improved survival rates among patients with newly diagnosed glioblastoma who have a methylated MGMT promoter compared to those receiving only TMZ. Treatment Plans: The study will randomly assign participants to two groups: * Control Group: Standard treatment with TMZ during and after radiation therapy. * Experimental Group: TMZ combined with LOM, starting on the first day of radiation therapy. Outcome Measures: The primary outcome measure will be survival. Other outcomes will include progression-free survival (time from randomization until tumor progression or death), safety profiles (adverse effects of the treatments), and quality of life measures as well as neurocognitive outcomes. **Detailed Description:** Current evidence: In this section the investigators highlight the evidence behind the current standard fo care, and the emerging data supporting our approach. The RCT of Stupp showed that radiotherapy (RT) together with concomitant and adjuvant TMZ prolong survival. The NORDIC trial investigated the role of TMZ compared to RT for the subgroup of elderly patients, showing that survival was superior with TMZ, especially for those with mMGMT. LOM has been used for treatment of glioma for many decades, often used in combination with procarbazine and vincristine (PCV), but in recent years it is used in patients with glioblastoma as 2nd line therapy after failure of TMZ. A phase 3 trial with Tumor Treating Fields (TTF, alternating low intensity electromagnetic fields) showed prolonged survival in patients with glioblastoma, but it is not universally applied/approved. Despite full multimodal treatment with surgery, RT, TMZ and TTFields, the median survival is \<2 years. There is an unmet medical need to further improve treatments for these patients. One RCT (NOA-09) provided preliminary data to exploit the specific vulnerability of mMGMT in glioblastoma (although no use of TTF in this trial). The overall tolerability of TMZ-LOM in combination was acceptable, as most adverse events (AE) were moderate and transient. Furthermore, health-related quality of life (HRQoL) and neurocognition did not differ between groups. Estimated sample size and power: Sample size calculation is based upon the results from the CeTeG/NOA-09 trial. Accounting for attrition, a total of 200 mMGMT GBM patients have to be randomised. Patients that drop-out before start of any therapy will be replaced, which will lead to more than 200 patients being randomized. For overall survival (OS) all patients that started day 1 of radiochemotherapy will be analysed (modified ITT). For per protocol all patients that have completed week 6 of treatment arm will be analysed for outcome. Patients lost to follow-up after the start of chemotherapy will be evaluated as observations censored at the time of dropout. Approximately 45% of newly diagnosed patients have a mMGMT, thus for 200 randomised patients a minimum of 445 patients will be screened. Addition to the already described statistics: Randomizations are stratified for center and for TTFields. The primary confirmatory analysis will be based on the modified intention-to-treat (mITT) population. Survival parameters are measured in days starting from the day of randomization. Median time estimates as well as 95% confidence intervals will be reported. All additional analyses will be descriptive. The statistical analysis plan (SAP) and blinding of statisticians will ensure analytic transparency and robustness. Finally, similarly to avoid producing outdated results, the investigators plan to start TTF concomitant according to the Trident trial where results are expected soon. Nevertheless, if the Trident results are negative, the investigators will submit an amendment for using TTF according to the current standard of care. The reverse would not be possible in the middle of the trial as this has required extensive discussion, planning, and training with all sites. Balance with respect to TTF use is ensured with stratification in the randomization process. Further details of study design of this phase 3, open-label, multicenter randomised controlled trial with parallel group design is presented under respective subheadings. ### Conditions Module **Conditions:** - Glioblastoma, IDH-wildtype - MGMT-Methylated Glioblastoma **Keywords:** - precision medicine - temozolomide - lomustine - CCNU - survival ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Everyone: Radiotherapy (RT) consists of 60 Gy standard RT (RT 30x2Gy) Experimental treatment arm (TMZ/LOM): 6 cycles of LOM/TMZ Start day 1 of RT. Cycle length of 42 days. Duration 9 months. Standard treatment arm (TMZ): Oral TMZ 75 mg/m2 daily during RT and with start day 1 of RT. This is followed by 6 cycles of TMZ with start 4 weeks after the end of RT. Cycle length 28 days. Duration 8,5 months. Everyone: TTFields start with radiotherapy/chemotherapy - but only in Sweden where TTF is part of standard of care (SOC). Ongoing until 2nd progression or max 2 years. ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 200 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** arm with temozolomide (TMZ) plus lomustine (LOM) treatment. 6 cycles of LOM/TMZ Start day 1 of RT. Cycle length of 42 days. Duration 9 months. **Intervention Names:** - Drug: Temozolomide - Drug: Lomustine **Label:** treatment arm **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** arm with standard of care treatment with temozolomide only. Oral TMZ 75 mg/m2 daily during RT and with start day 1 of RT. This is followed by 6 cycles of TMZ with start 4 weeks after the end of RT. Cycle length 28 days. Duration 8,5 months. **Intervention Names:** - Drug: Temozolomide **Label:** standard arm **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - standard arm - treatment arm **Description:** In the experimental treatment arm: a combination of Temozolomide and Lomustine, taken together, two separate pills **Name:** Temozolomide **Other Names:** - TMZ **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - treatment arm **Description:** In the experimental treatment arm: a combination of Temozolomide and Lomustine, taken together, two separate pills **Name:** Lomustine **Other Names:** - LOM **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** visualized with Kaplan-Meier plot, tested with log-rank test **Measure:** overall survival **Time Frame:** assessed from day of randomization to death or 36 months follow-up (FU) #### Secondary Outcomes **Description:** radiological or clinical PFS according to the modified Response Assessment in Neuro-Oncology (mRANO) criteria (Kaplan-Meier plot, log-rank test) **Measure:** progression free survival (PFS) **Time Frame:** assessed from day of randomization to death or 36 months FU **Description:** According to the EORTC Quality of Life Questionnaire (EORTC QLQ-30) with brain cancer module 20; Evaluate minimal clinically important difference (MCID) (i.e. clinically relevant difference) according to guidelines. These questionnaires contain a total of 30 + 20 QoL-related questions which are scored on a nominal scale (0-5 points); the result of each question is recorded for computerized examination and the questions relating to the same dimension of QoL (e.g. emotional well-being) are taken together for an overall score of this dimension. The scores for the different dimensions will be compared between repeated assessments throughout the trial and between the two arms of the trial. Analysed at 8 different time points: 1. start of therapy = day 1 2. since first assessment 6 weeks later: middle of the first months (1.5) 3. from now on, every 6 months: month 7.5 4. month 13.5 5. month 19.5 6. month 25.5 7. month 31.5 8. month 37.5 (end of the follow-up after 4 years) **Measure:** quality of life (QoL) **Time Frame:** done at baseline after informed consent, before randomisation and start of treatment, week 6 from start of treatment= end of radiotherapy, and every 24 weeks from start of treatment and for max 36 months. **Description:** Verbal Memory Test: Participants are tasked with learning and recalling 15 words. They are asked to recognize the words among 15 distractors (other words). The test is repeated at the end of the test session (after approximately 30 minutes). This test measures how well the participant can learn and recall words. Low scores indicate verbal memory difficulties. Analysed at 8 different time points: 1. start of therapy (RT/chemotherapy/TTFields) = day 1 2. since first assessment 6 weeks later: middle of the first months (1.5) 3. from now on, every 6 months: month 7.5 4. month 13.5 5. month 19.5 6. month 25.5 7. month 31.5 8. month 37.5 (end of the follow-up after 4 years) Patients will be monitored with the "CNS Vital Signs", a validated computerized test battery with proven sensitivity to detect cognitive impairments in patients with brain tumors. The battery consists of 8 subtests. **Measure:** neurocognition - verbal memory **Time Frame:** done at baseline after informed consent, before randomisation and start of treatment, week 6 from start of treatment= end of radiotherapy, and every 24 weeks from start of treatment and for max 36 months. **Description:** Visual Memory Test: Participants are tasked with learning and recalling 15 geometric shapes. They are asked to recognize these among 15 distractors (other shapes). The test is repeated at the end of the test session (after approximately 30 minutes). This test measures how well the participant can learn and recall geometric shapes. Low scores indicate visual memory difficulties. Analysed at 8 different time points: 1. start of therapy (RT/chemotherapy/TTFields) = day 1 2. since first assessment 6 weeks later: middle of the first months (1.5) 3. from now on, every 6 months: month 7.5 4. month 13.5 5. month 19.5 6. month 25.5 7. month 31.5 8. month 37.5 (end of the follow-up after 4 years) Patients will be monitored with the "CNS Vital Signs" (CNS = central nervous system), a validated computerized test battery with proven sensitivity to detect cognitive impairments in patients with brain tumors. The battery consists of 8 subtests. **Measure:** neurocognition - visual memory **Time Frame:** done at baseline after informed consent, before randomisation and start of treatment, week 6 from start of treatment= end of radiotherapy, and every 24 weeks from start of treatment and for max 36 months. **Description:** Finger Tapping Test: The test measures motor speed and fine motor control. Participants are to perform three "tapping" sessions, lightly tapping the top of a key on the computer with each hand. This test measures how many "tappings" the participant performs with each hand. Motor speed varies according to hand dominance. Low scores indicate motor slowing. Analysed at 8 different time points: 1. start of therapy (RT/chemotherapy/TTFields) = day 1 2. since first assessment 6 weeks later: middle of the first months (1.5) 3. from now on, every 6 months: month 7.5 4. month 13.5 5. month 19.5 6. month 25.5 7. month 31.5 8. month 37.5 (end of the follow-up after 4 years) Patients will be monitored with the "CNS Vital Signs", a validated computerized test battery with proven sensitivity to detect cognitive impairments in patients with brain tumors. The battery consists of 8 subtests. **Measure:** neurocognition - motor speed and fine motor control **Time Frame:** done at baseline after informed consent, before randomisation and start of treatment, week 6 from start of treatment= end of radiotherapy, and every 24 weeks from start of treatment and for max 36 months. **Description:** Symbol Digit Coding: The test measures cognitive speed during simultaneous cognitive processes such as visual scanning, visual perception, visual memory, and motor skills. Low scores may indicate impulsivity, perception difficulties, or impaired processing speed. Analysed at 8 different time points: 1. start of therapy (RT/chemotherapy/TTFields) = day 1 2. since first assessment 6 weeks later: middle of the first months (1.5) 3. from now on, every 6 months: month 7.5 4. month 13.5 5. month 19.5 6. month 25.5 7. month 31.5 8. month 37.5 (end of the follow-up after 4 years) Patients will be monitored with the "CNS Vital Signs", a validated computerized test battery with proven sensitivity to detect cognitive impairments in patients with brain tumors. The battery consists of 8 subtests. **Measure:** neurocognition - cognitive speed **Time Frame:** done at baseline after informed consent, before randomisation and start of treatment, week 6 from start of treatment= end of radiotherapy, and every 24 weeks from start of treatment and for max 36 months. **Description:** Stroop Test: The test measures simple and complex reaction time, inhibition/disinhibition, mental flexibility, and focused attention. It also measures how well participants can adapt to changes and increasing complexity in the task. Long reaction times indicate mental slowing. A large number of errors indicate impulsivity, perception difficulties, or impaired processing speed. Analysed at 8 different time points: 1. start of therapy (RT/chemotherapy/TTFields) = day 1 2. since first assessment 6 weeks later: middle of the first months (1.5) 3. from now on, every 6 months: month 7.5 4. month 13.5 5. month 19.5 6. month 25.5 7. month 31.5 8. month 37.5 (end of the follow-up after 4 years) Patients will be monitored with the "CNS Vital Signs", a validated computerized test battery with proven sensitivity to detect cognitive impairments in patients with brain tumors. The battery consists of 8 subtests. **Measure:** neurocognition - simple and complex reaction time, inhibition/disinhibition, mental flexibility, and focused attention. **Time Frame:** done at baseline after informed consent, before randomisation and start of treatment, week 6 from start of treatment= end of radiotherapy, and every 24 weeks from start of treatment and for max 36 months. **Description:** Attention Shift Test: The test measures how well participants can shift attention and perform simultaneous tasks. Participants must adjust their responses to temporarily changed rules. Normal/good scores are achieved with a high proportion of correct answers and short reaction times. Analysed at 8 different time points: 1. start of therapy (RT/chemotherapy/TTFields) = day 1 2. since first assessment 6 weeks later: middle of the first months (1.5) 3. from now on, every 6 months: month 7.5 4. month 13.5 5. month 19.5 6. month 25.5 7. month 31.5 8. month 37.5 (end of the follow-up after 4 years) Patients will be monitored with the "CNS Vital Signs", a validated computerized test battery with proven sensitivity to detect cognitive impairments in patients with brain tumors. The battery consists of 8 subtests. **Measure:** neurocognition - attention **Time Frame:** done at baseline after informed consent, before randomisation and start of treatment, week 6 from start of treatment= end of radiotherapy, and every 24 weeks from start of treatment and for max 36 months. **Description:** Continuous Performance Test: The test measures attention, vigilance, and reaction time. Most normal participants achieve nearly perfect results on this test. Long response times indicate mental slowing or impaired attention. Analysed at 8 different time points: 1. start of therapy (RT/chemotherapy/TTFields) = day 1 2. since first assessment 6 weeks later: middle of the first months (1.5) 3. from now on, every 6 months: month 7.5 4. month 13.5 5. month 19.5 6. month 25.5 7. month 31.5 8. month 37.5 (end of the follow-up after 4 years) Patients will be monitored with the "CNS Vital Signs", a validated computerized test battery with proven sensitivity to detect cognitive impairments in patients with brain tumors. The battery consists of 8 subtests. **Measure:** neurocognition - attention, vigilance, and reaction time **Time Frame:** done at baseline after informed consent, before randomisation and start of treatment, week 6 from start of treatment= end of radiotherapy, and every 24 weeks from start of treatment and for max 36 months. **Description:** Emotional Perception Test: The test measures how well participants can perceive and identify specific emotions and their ability to perceive and understand social information. Low scores indicate difficulties with emotional perception. Analysed at 8 different time points: 1. start of therapy (RT/chemotherapy/TTFields) = day 1 2. since first assessment 6 weeks later: middle of the first months (1.5) 3. from now on, every 6 months: month 7.5 4. month 13.5 5. month 19.5 6. month 25.5 7. month 31.5 8. month 37.5 (end of the follow-up after 4 years) Patients will be monitored with the "CNS Vital Signs", a validated computerized test battery with proven sensitivity to detect cognitive impairments in patients with brain tumors. The battery consists of 8 subtests. **Measure:** neurocognition - Perception **Time Frame:** done at baseline after informed consent, before randomisation and start of treatment, week 6 from start of treatment= end of radiotherapy, and every 24 weeks from start of treatment and for max 36 months. **Description:** according to the Common Terminology Criteria for Adverse Events (CTCAE). (descriptive statistics between groups). A complementary analysis of AE by severity of event and by relationship to treatment will be performed (Chi2 test). Dose reductions, delay of therapy in subsequent courses and premature withdrawals will also be described. The Pharmacovigilance Sahlgrenska University Hospital will provide an unbiased evaluation of all serious adverse events. This ensures a qualified evaluation to support the sponsor to ensure patient safety. A Data Safety Monitoring Board (DSMB) is appointed to perform pre-planned interim analyses. Prompt ad-hoc meeting of the DSMB will be held in case of suspected unexpected serious adverse events. The committee can recommend a break or the stopping of the trial. **Measure:** Adverse events (AE) **Time Frame:** assessed from day of randomization to death or 36 months FU ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Newly diagnosed glioblastoma/gliosarcoma, IDH wild type * Methylated MGMT promoter * World Health Organization performance status 0-2 * Age 18-70 Exclusion Criteria: * Previous malignancy within 3 y or malignancy treated non-curatively * Previous chemotherapy or radiotherapy involving the head * Off-protocol tumor-specific treatment * Serious comorbidity **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:** Asgeir S Jakola, MD, PhD **Phone:** +46313429741 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Annika Malmström, MD. PhD **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** University Hospital, Linkoeping **Name:** Annika Malmström, MD, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** Since the proposed randomized controlled trial (RCT) will be running for many year and since the investigators want to avoid outdated results, there will be - independent of the results of this proposed RCT - a collaboration to pool this study's data with the very similar phase 3 trial, the NOA-09 study. Here, the investigators will set a meta-analysis in place to balance clinical benefit with time and costs in a good manner. Hence, data is used for new sub-projects to endorse findings. **IPD Sharing:** YES ### References Module #### References **Citation:** Stupp R, Mason WP, van den Bent MJ, Weller M, Fisher B, Taphoorn MJ, Belanger K, Brandes AA, Marosi C, Bogdahn U, Curschmann J, Janzer RC, Ludwin SK, Gorlia T, Allgeier A, Lacombe D, Cairncross JG, Eisenhauer E, Mirimanoff RO; European Organisation for Research and Treatment of Cancer Brain Tumor and Radiotherapy Groups; National Cancer Institute of Canada Clinical Trials Group. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med. 2005 Mar 10;352(10):987-96. doi: 10.1056/NEJMoa043330. **PMID:** 15758009 **Citation:** Malmstrom A, Gronberg BH, Marosi C, Stupp R, Frappaz D, Schultz H, Abacioglu U, Tavelin B, Lhermitte B, Hegi ME, Rosell J, Henriksson R; Nordic Clinical Brain Tumour Study Group (NCBTSG). Temozolomide versus standard 6-week radiotherapy versus hypofractionated radiotherapy in patients older than 60 years with glioblastoma: the Nordic randomised, phase 3 trial. Lancet Oncol. 2012 Sep;13(9):916-26. doi: 10.1016/S1470-2045(12)70265-6. Epub 2012 Aug 8. **PMID:** 22877848 **Citation:** Hegi ME, Diserens AC, Gorlia T, Hamou MF, de Tribolet N, Weller M, Kros JM, Hainfellner JA, Mason W, Mariani L, Bromberg JE, Hau P, Mirimanoff RO, Cairncross JG, Janzer RC, Stupp R. MGMT gene silencing and benefit from temozolomide in glioblastoma. N Engl J Med. 2005 Mar 10;352(10):997-1003. doi: 10.1056/NEJMoa043331. **PMID:** 15758010 **Citation:** Weller M, Le Rhun E. How did lomustine become standard of care in recurrent glioblastoma? Cancer Treat Rev. 2020 Jul;87:102029. doi: 10.1016/j.ctrv.2020.102029. Epub 2020 May 4. **PMID:** 32408220 **Citation:** Stupp R, Taillibert S, Kanner A, Read W, Steinberg D, Lhermitte B, Toms S, Idbaih A, Ahluwalia MS, Fink K, Di Meco F, Lieberman F, Zhu JJ, Stragliotto G, Tran D, Brem S, Hottinger A, Kirson ED, Lavy-Shahaf G, Weinberg U, Kim CY, Paek SH, Nicholas G, Bruna J, Hirte H, Weller M, Palti Y, Hegi ME, Ram Z. Effect of Tumor-Treating Fields Plus Maintenance Temozolomide vs Maintenance Temozolomide Alone on Survival in Patients With Glioblastoma: A Randomized Clinical Trial. JAMA. 2017 Dec 19;318(23):2306-2316. doi: 10.1001/jama.2017.18718. Erratum In: JAMA. 2018 May 1;319(17):1824. **PMID:** 29260225 **Citation:** Herrlinger U, Tzaridis T, Mack F, Steinbach JP, Schlegel U, Sabel M, Hau P, Kortmann RD, Krex D, Grauer O, Goldbrunner R, Schnell O, Bahr O, Uhl M, Seidel C, Tabatabai G, Kowalski T, Ringel F, Schmidt-Graf F, Suchorska B, Brehmer S, Weyerbrock A, Renovanz M, Bullinger L, Galldiks N, Vajkoczy P, Misch M, Vatter H, Stuplich M, Schafer N, Kebir S, Weller J, Schaub C, Stummer W, Tonn JC, Simon M, Keil VC, Nelles M, Urbach H, Coenen M, Wick W, Weller M, Fimmers R, Schmid M, Hattingen E, Pietsch T, Coch C, Glas M; Neurooncology Working Group of the German Cancer Society. Lomustine-temozolomide combination therapy versus standard temozolomide therapy in patients with newly diagnosed glioblastoma with methylated MGMT promoter (CeTeG/NOA-09): a randomised, open-label, phase 3 trial. Lancet. 2019 Feb 16;393(10172):678-688. doi: 10.1016/S0140-6736(18)31791-4. Epub 2019 Feb 14. **PMID:** 30782343 **Citation:** Weller J, Tzaridis T, Mack F, Steinbach JP, Schlegel U, Hau P, Krex D, Grauer O, Goldbrunner R, Bahr O, Uhl M, Seidel C, Tabatabai G, Brehmer S, Bullinger L, Galldiks N, Schaub C, Kebir S, Stummer W, Simon M, Fimmers R, Coch C, Glas M, Herrlinger U, Schafer N. Health-related quality of life and neurocognitive functioning with lomustine-temozolomide versus temozolomide in patients with newly diagnosed, MGMT-methylated glioblastoma (CeTeG/NOA-09): a randomised, multicentre, open-label, phase 3 trial. Lancet Oncol. 2019 Oct;20(10):1444-1453. doi: 10.1016/S1470-2045(19)30502-9. Epub 2019 Sep 2. **PMID:** 31488360 #### See Also Links **Label:** PubMed ID: 15758009 **URL:** https://pubmed.ncbi.nlm.nih.gov/15758009/ **Label:** PubMed ID: 22877848 **URL:** https://pubmed.ncbi.nlm.nih.gov/22877848/ **Label:** PubMed ID: 15758010 **URL:** https://pubmed.ncbi.nlm.nih.gov/15758010/ **Label:** PubMed ID: 32408220 **URL:** https://pubmed.ncbi.nlm.nih.gov/32408220/ **Label:** PubMed ID: 29260225 **URL:** https://pubmed.ncbi.nlm.nih.gov/29260225/ **Label:** PubMed ID: 30782343 **URL:** https://pubmed.ncbi.nlm.nih.gov/30782343/ **Label:** PubMed ID: 31488360 **URL:** https://pubmed.ncbi.nlm.nih.gov/31488360/ ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001254 - Term: Astrocytoma - ID: D000005910 - Term: Glioma - ID: D000018302 - Term: Neoplasms, Neuroepithelial - 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: D000009375 - Term: Neoplasms, Glandular and Epithelial - 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: M9019 - Name: Glioblastoma - Relevance: HIGH - As Found: Glioblastoma - ID: M4561 - Name: Astrocytoma - Relevance: LOW - As Found: Unknown - ID: M9020 - Name: Glioma - Relevance: LOW - As Found: Unknown - ID: M20446 - Name: Neoplasms, Neuroepithelial - 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: M12320 - Name: Neoplasms, Glandular and Epithelial - Relevance: LOW - As Found: Unknown - ID: M12325 - Name: Neoplasms, Nerve Tissue - Relevance: LOW - As Found: Unknown - ID: T2518 - Name: Glioblastoma - Relevance: HIGH - As Found: Glioblastoma - ID: T2519 - Name: Glioma - Relevance: LOW - As Found: Unknown - ID: T4092 - Name: Neuroepithelioma - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000005909 - Term: Glioblastoma ### Intervention Browse Module - Ancestors - ID: D000018906 - Term: Antineoplastic Agents, Alkylating - ID: D000000477 - Term: Alkylating Agents - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000000970 - Term: Antineoplastic Agents ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M1692 - Name: Temozolomide - Relevance: HIGH - As Found: Head - ID: M11130 - Name: Lomustine - Relevance: HIGH - As Found: Quantification - ID: M20942 - Name: Antineoplastic Agents, Alkylating - Relevance: LOW - As Found: Unknown - ID: M3820 - Name: Alkylating Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000077204 - Term: Temozolomide - ID: D000008130 - Term: Lomustine ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419933 **Brief Title:** Emotional Problems in Preschool Children: Evaluation of the SuperKids Program (PRE-KIDS) **Official Title:** Prevention of Emotional Problems in Preschool Children Aged to 4 to 6 Years Old: Evaluation of the SuperKids Program (PRE-KIDS) #### Organization Study ID Info **ID:** PID2021-126473NB-I00 #### Organization **Class:** OTHER **Full Name:** Universidad Miguel Hernandez de Elche ### Status Module #### Completion Date **Date:** 2025-08-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2023-11-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-08 **Study First Submit QC Date:** 2024-05-14 ### 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 **Oversight Has DMC:** True ### Description Module **Brief Summary:** Emotional problems are among the most frequent psychological problems in the school stage, having an early onset. When they are not detected and they do not receive adequate intervention, they persist and become chronic, being considered precursors of other problems in adolescence and adulthood. The early onset of emotional problems, and their precursor role for other disorders, justify the need for preventive interventions as soon as possible. Since there is evidence that anxiety and depression share common underlying mechanisms, preventive programs should address shared risk factors. For this reason, the objective of this study is to test the effectiveness of an 8-session cognitive-behavioral protocol developed for Spanish children aged 4 to 6 in the educational context in a controlled trial. The objective of the program is that children improve their skills to manage their own emotions and to improve their ability to interact with other. The program will be applied ina group format and will be enriched with multimedia material that the implementer will project at various moments of the sessions. **Detailed Description:** A 2 x 3 factorial design will be used, with the intervention variable as an intergroup factor (intervention or waiting list), and with the evaluation phase as an intragroup factor (pretest, posttest, 12 months follow-up). Parents and children will complete the same measures at baseline, post-treatment, and follow-up. The investigators will compare the results of pre- and post-assessments of children participating in the program on emotional and social variables. ### Conditions Module **Conditions:** - Emotional Problem **Keywords:** - Social skills - Emotional skills - Program evaluation - Preschool children ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER **Intervention Model Description:** Cross-assignment. Participants who meet the inclusion criteria and undergo the full baseline assessment will be assigned to the intervention group condition or to the WLC group. Children assigned to the intervention condition will receive the eight-week intervention. Participants in the WLC group will not receive any psychological intervention during the eight-week program. Children and parents in all groups will complete the same set of measures at approximately the same time (pre-test and post-eight 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:** TREATMENT #### Enrollment Info **Count:** 500 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Group without any intervention. Participants in the wait-list group will receive no psychological intervention during the eight-week duration of the SuperKids program. Families will be informed that children in this group will receive the intervention once the follow-up is completed. **Label:** Control group wait-list **Type:** NO_INTERVENTION #### Arm Group 2 **Description:** SuperKids Structured and manualized intervention with a manual for the therapist and a workbook for the children. The intervention will be administered by SuperKids-trained clinical psychologists. Sessions will take place once a week for eight weeks, with each session lasting approximately forty-five 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:** - Other: The SuperKids Program **Label:** Experimental group **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Experimental group **Description:** The SuperKids program will be administered following the manual of the intervention by a trained therapist, as described in the section of intervention/ treatment **Name:** The SuperKids Program **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Baseline level of physical and emotional well-being reported by parents as measured by the Kiddy-KINDL-R questionnaire. The Kiddy-KINDL-R measures assesses physical and emotional well-being of children aged 4 to 7 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 higher symptoms in children. **Measure:** The Kiddy-KINDL-R **Time Frame:** Before starting the study **Description:** Level of physical and emotional well-being reported by parents immediately after the intervention measured by the Kiddy-KINDL-R questionnaire. The Kiddy-KINDL-R measures assesses physical and emotional well-being of children aged 4 to 7 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 higher symptoms in children. **Measure:** The Kiddy-KINDL-R **Time Frame:** Immediately after the intervention. **Description:** Level of physical and emotional well-being reported by parents at 12 months Measured by the Kiddy-KINDL-R questionnaire. The Kiddy-KINDL-R measures assesses physical and emotional well-being of children aged 4 to 7 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 higher symptoms in children. **Measure:** The Kiddy-KINDL-R **Time Frame:** 12 months after the intervention. **Description:** Baseline child-reported anxiety symptoms as measured by the Preschool Spence Anxiety Scale (PAS). The PAS measures symptom severity of DSMIV anxiety disorders in children (subscales: total, panic and agoraphobia, generalized anxiety disorder, obsessive-compulsive disorder, social phobia, separation anxiety, and specific fears). The frequency of symptoms is recorded on a 3-point Likert scale from 0 (never) to 3 (always). A minimum possible score of 0 and a maximum possible score of 114 is obtained. Higher scores indicate greater symptom severity. Higher scores indicate greater symptom severity. **Measure:** Preschool Spence Anxiety Scale (PAS) **Time Frame:** Before starting the study **Description:** Anxiety symptoms reported by children immediately after the intervention measured using the Spence Preschool Anxiety Scale, (PAS). The PAS measures symptom severity of DSMIV anxiety disorders in children (subscales: total, panic and agoraphobia, generalized anxiety disorder, obsessive-compulsive disorder, social phobia, separation anxiety, and specific fears). The frequency of symptoms is recorded on a 3-point Likert scale from 0 (never) to 3 (always). A minimum possible score of 0 and a maximum possible score of 114 is obtained. Higher scores indicate greater symptom severity. Higher scores indicate greater symptom severity. **Measure:** Preschool Spence Anxiety Scale (PAS) **Time Frame:** Immediately after the intervention. **Description:** Child-reported anxiety symptoms at 12 months Measured using the Spence Preschool Anxiety Scale (PAS). The PAS measures symptom severity of DSMIV anxiety disorders in children (subscales: total, panic and agoraphobia, generalized anxiety disorder, obsessive-compulsive disorder, social phobia, separation anxiety, and specific fears). The frequency of symptoms is recorded on a 3-point Likert scale from 0 (never) to 3 (always). A minimum possible score of 0 and a maximum possible score of 114 is obtained. Higher scores indicate greater symptom severity. Higher scores indicate greater severity of symptoms. **Measure:** Preschool Spence Anxiety Scale (PAS) **Time Frame:** 12 months after the intervention. **Description:** Baseline Parent-reported depressive symptoms as measured by the Strengths and Difficulties Questionnaire, parent version (SDQ; Goodman, 1997). The SDQ measure examines emotional difficulties (5 items), conduct problems (5 items), hyperactivity (5 items), peer problems (5 items), and prosocial behavior (5 items) in children aged 3 to 16 years. Symptom frequency is recorded on a 3-point Likert scale from 0 (Not true) to 3 (Absolutely true). A minimum possible score of 0 and a maximum possible score of 114 is obtained. Higher scores indicate greater severity of symptoms. Higher scores indicate greater symptom severity. **Measure:** the Strengths and Difficulties Questionnaire **Time Frame:** Before starting the study **Description:** Depressive symptoms reported by parents inmediately after intervention measured by the Strengths and Difficulties Questionnaire, parent version (SDQ; Goodman, 1997). The SDQ measure examines emotional difficulties (5 items), conduct problems (5 items), hyperactivity (5 items), peer problems (5 items), and prosocial behavior (5 items) in children aged 3 to 16 years. Symptom frequency is recorded on a 3-point Likert scale from 0 (Not true) to 3 (Absolutely true). A minimum possible score of 0 and a maximum possible score of 114 is obtained. Higher scores indicate greater severity of symptoms. Higher scores indicate greater symptom severity. **Measure:** the Strengths and Difficulties Questionnaire **Time Frame:** Immediately after the intervention. **Description:** Depressive symptoms reported by parents at 12 months as measured by the Strengths and Difficulties Questionnaire, parent version (SDQ; Goodman, 1997). The SDQ measure examines emotional difficulties (5 items), conduct problems (5 items), hyperactivity (5 items), peer problems (5 items), and prosocial behavior (5 items) in children aged 3 to 16 years. Symptom frequency is recorded on a 3-point Likert scale from 0 (Not true) to 3 (Absolutely true). A minimum possible score of 0 and a maximum possible score of 114 is obtained. Higher scores indicate greater severity of symptoms. Higher scores indicate greater symptom severity. **Measure:** the Strengths and Difficulties Questionnaire **Time Frame:** 12 months after the intervention. **Description:** Baseline of children's behavioral inhibition measured using the Behavioral Inhibition Questionnaire (BIQ). The BIQ assesses the frequency of children's behavioral inhibition in six contexts across three domains: social novelty (unknown adults, peers, and performance in front of others), situational novelty (unfamiliar situations, preschool/separation), and novel physical activities with a possible risk of injury. This questionnaire has 30 items that are scored on a seven-point scale ranging from 1 (almost never) to 7 (almost always). Item scores are summed to create six scale scores: Unknown Peers, Unknown Adults, Performance Situations, Separation/Preschool, Unknown Situations, and Physically Challenging Situations. **Measure:** Behavioral Inhibition Questionnaire (BIQ **Time Frame:** Before starting the study **Description:** Children's behavioral inhibition was immediately measured after the intervention using the Behavioral Inhibition Questionnaire (BIQ). The BIQ assesses the frequency of children's behavioral inhibition in six contexts across three domains: social novelty (unknown adults, peers, and performance in front of others), situational novelty (unfamiliar situations, preschool/separation), and novel physical activities with a possible risk of injury. This questionnaire has 30 items that are scored on a seven-point scale ranging from 1 (almost never) to 7 (almost always). Item scores are summed to create six scale scores: Unknown Peers, Unknown Adults, Performance Situations, Separation/Preschool, Unknown Situations, and Physically Challenging Situations. **Measure:** Behavioral Inhibition Questionnaire (BIQ **Time Frame:** Immediately after the intervention. **Description:** Children's behavioral inhibition was measured at 12 months using the Behavioral Inhibition Questionnaire (BIQ). The BIQ assesses the frequency of children's behavioral inhibition in six contexts across three domains: social novelty (unknown adults, peers, and performance in front of others), situational novelty (unfamiliar situations, preschool/separation), and novel physical activities with a possible risk of injury. This questionnaire has 30 items that are scored on a seven-point scale ranging from 1 (almost never) to 7 (almost always). Item scores are summed to create six scale scores: Unknown Peers, Unknown Adults, Performance Situations, Separation/Preschool, Unknown Situations, and Physically Challenging Situations. **Measure:** Behavioral Inhibition Questionnaire (BIQ **Time Frame:** 12 months after the intervention. **Description:** Parental overprotective behavior is assessed with the Parental Overprotection Scale (OP, Edwards et al., 2008). POM evaluates, through 19 items, the overprotective behavior of parents towards their children, related in previous studies to anxiety in preschool children. Symptom frequency is recorded on a 3-point Likert scale, from 0 (not at all) to 4 (very much). **Measure:** Parental Overprotection Scale **Time Frame:** Baseline **Description:** Baseline parental depression, anxiety and stress symptoms Measured by the Depression Anxiety Stress Scales - short version (DASS-21). It contains a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress. Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content. The depression scale assesses dysphoria, hopelessness, devaluation of life, self-deprecation, lack of interest / involvement, anhedonia and inertia. The anxiety scale assesses autonomic arousal, skeletal muscle effects, situational anxiety, and subjective experience of anxious affect. The stress scale is sensitive to levels of chronic nonspecific arousal. It assesses difficulty relaxing, nervous arousal, and being easily upset / agitated, irritable / over-reactive and impatient. Scores for depression, anxiety and stress are calculated by summing the scores for the relevant items. **Measure:** Depression Anxiety Stress Scales - short version (DASS-21) **Time Frame:** Baseline ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Children aged 4 to 6 years. 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:** 6 Years **Minimum Age:** 4 Years **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Marina Serrano Ortiz **Phone:** +34965222071 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Mireia Orgilés Amorós **Phone:** +34 96 665 8348 **Role:** CONTACT #### Locations **Location 1:** **City:** Elche **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Marina Serrano Ortiz - **Phone:** +34965222071 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Mireia Orgilés Amorós - **Phone:** +34 96 665 8348 - **Role:** CONTACT **Country:** Spain **Facility:** Department of Health Psychology. Miguel Hernandez University of Elche Elche, Alicante, Spain, 03202 **State:** Alicante **Status:** RECRUITING **Zip:** 03202 #### Overall Officials **Official 1:** **Affiliation:** Universidad Miguel Hernandez de Elche **Name:** Mireia Orgilés Amorós **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Bishop G, Spence SH, McDonald C. Can parents and teachers provide a reliable and valid report of behavioral inhibition? Child Dev. 2003 Nov-Dec;74(6):1899-917. doi: 10.1046/j.1467-8624.2003.00645.x. **PMID:** 14669903 **Citation:** Orgiles M, Melero S, Penosa P, Espada JP, Morales A. [Parent-reported Health-Related Quality of Life in Spanish pre-schoolers: Psychometric properties of the Kiddy-KINDL-R]. An Pediatr (Engl Ed). 2019 May;90(5):263-271. doi: 10.1016/j.anpedi.2018.04.019. Epub 2018 Jul 6. Spanish. **PMID:** 31056090 **Citation:** Orgiles M, Penosa P, Fernandez-Martinez I, Marzo JC, Espada JP. Spanish validation of the Spence Preschool Anxiety Scale. Child Care Health Dev. 2018 Sep;44(5):753-758. doi: 10.1111/cch.12593. Epub 2018 Jul 22. **PMID:** 30033647 ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419920 **Acronym:** PROSPER **Brief Title:** Prosthetic Performance Enhancement Trial **Official Title:** Prosthetic Performance Enhancement Trial #### Organization Study ID Info **ID:** UNLV-2023-595 #### Organization **Class:** OTHER **Full Name:** University of Nevada, Las Vegas ### Status Module #### Completion Date **Date:** 2024-09-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-09-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-01 **Type:** ESTIMATED **Status Verified Date:** 2024-03 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-02 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Nevada, Las Vegas #### 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 research is to determine the feasibility of an uneven terrain walking program for lower limb prosthesis users. The training is designed to induce step-to-step variability during walking within a safe environment, with the aim of improving walking skill and confidence. **Detailed Description:** Despite advances in the technology for artificial limbs (prostheses), falling and the fear of falling continue to be barriers to mobility for many lower limb prosthesis users after their initial rehabilitation. The loss of ability and confidence in pursuing everyday tasks negatively impacts quality of life, and ongoing physical and mental health. This study will test and improve a rehabilitation training intervention involving walking on uneven ground to improve walking skill and confidence in lower limb prosthesis users. Lower limb prosthesis users will be recruited. Participants will be allocated randomly to receive either intervention A: training on a flat surface, or intervention B: training on an uneven surface. Depending on their ability and confidence, participants will complete the walking practice either on a treadmill or on a mat with an identical surface pattern. The walking practice will take place three times per week for four weeks. As each participant improves their ability, training tasks will be made more difficult by limiting handrail use, by increasing walking speed, and, for intervention B, also by making the walking surface more uneven. The objectives of this pilot study are to evaluate adherence and refine the training protocols in preparation for a definitive trial that will inform rehabilitation practices. ### Conditions Module **Conditions:** - Amputation - Lower Limb Amputation Below Knee (Injury) - Lower Limb Amputation Above Knee (Injury) - Lower Limb Amputation at Ankle (Injury) - Lower Limb Amputation Knee - Lower Limb Amputation at Hip (Injury) ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Feasibility study incorporating a single-blinded Phase I clinical trial with a parallel groups design, involving two treatment conditions: uneven terrain training (UT) and flat terrain (FT) training. Participants will be allocated randomly to UT and FT arms in a 3:1 ratio. ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** OTHER #### Enrollment Info **Count:** 35 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Walking on a standard, flat treadmill or mat. **Intervention Names:** - Other: Flat terrain locomotor training **Label:** Flat terrain training **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Walking on an uneven terrain treadmill or mat. **Intervention Names:** - Other: Uneven terrain locomotor training **Label:** Uneven terrain training **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Flat terrain training **Description:** The training will be comprised of up to 12 sets of 2-min continuous walking on a level treadmill or mat, interspersed with rest breaks of at least one minute. Training will be completed three times per week for four weeks. **Name:** Flat terrain locomotor training **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Uneven terrain training **Description:** The training will be comprised of up to 12 sets of 2-min continuous walking on an uneven terrain treadmill or mat, interspersed with rest breaks of at least one minute. Training will be completed three times per week for four weeks. **Name:** Uneven terrain locomotor training **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Percentage of planned sessions attended, per participant. **Measure:** Session adherence **Time Frame:** Through study completion, over 4 weeks #### Secondary Outcomes **Description:** Time to complete L-test, in s. Participant rises from a chair and guided by cones, walks 10m forward, turns 90 degrees, walks a further 10m, turns 180 degrees, then follows the same path back to the chair and sits. Result from a single test following one practice trial is recorded. **Measure:** L-test time **Time Frame:** Pre-intervention, within 5 days post intervention **Description:** 16-item self report measure recording confidence in performing activities during daily life that require balance, on numerical ratings scale, recorded as a percentage (out of 100). **Measure:** Activities-specific Balance Confidence Scale summary score **Time Frame:** Pre-intervention, within 5 days post intervention **Description:** Mean number of steps per day over 7 days, collected using ankle worn activity monitor. **Measure:** Average daily activity **Time Frame:** Pre-intervention, within 5 days post intervention **Description:** Time to complete forwards, lateral and backwards stepping pattern, in s. **Measure:** Four Square Step Test time **Time Frame:** Pre-intervention, within 5 days post intervention **Description:** Distance traveled along a narrow beam, in m. Participants traverse a 3.66 m narrow beam. The distance traveled until the participant places a foot on the ground is measured. The mean of the final three of five trials is recorded. **Measure:** Beam walking distance **Time Frame:** Pre-intervention, within 5 days post intervention **Description:** Walking distance traveled in two minutes, in m. **Measure:** Two-minute walk test distance **Time Frame:** Pre-intervention, within 5 days post intervention **Description:** Likert scale questions and short answer questions to determine acceptability of protocol to participants, assessed qualitatively. **Measure:** Protocol acceptability **Time Frame:** End of intervention week 4 **Description:** Number of participants recruited within one year **Measure:** Recruitment feasibility - recruitment rate **Time Frame:** From start of recruitment period, to 12 month time point. **Description:** Number of clinics from which at least one participant is recruited. **Measure:** Recruitment feasibility - participating clinics **Time Frame:** Through study completion, from start of recruitment period, to end of recruitment period or 30 month time point, whichever is sooner. **Description:** Sample characteristics of all participants enrolled in the study, regardless of completion. **Measure:** Recruitment feasibility - sample characteristics **Time Frame:** Through study completion, from start of recruitment period, to end of recruitment period or 30 month time point, whichever is sooner. **Description:** Completeness and quality of activity monitor data, measured as number of days with valid (non-erroneous) monitoring data. **Measure:** Activity data evaluation **Time Frame:** Throughout activity monitoring period, over 2 weeks **Description:** Medial-lateral trunk variability will be quantified during each bout of walking during each session. The maximum relative variability will be calculated as the difference in variability (standard deviation) of peak per-step lateral trunk velocity during UT walking sessions relative to that of overground walking, in m/s. **Measure:** Maximum relative variability of lateral trunk velocity during uneven terrain in comparison to overground walking **Time Frame:** Through study completion, over 4 weeks **Description:** Terrain contour depth at which the maximum relative variability was recorded, in m. **Measure:** Contour depth at maximum relative variability **Time Frame:** Through study completion, over 4 weeks **Description:** Step width variability will be quantified during each bout of walking during each session. The maximum relative variability will be calculated as the difference in variability (standard deviation) of step width during UT walking sessions relative to that of overground walking, in m. **Measure:** Maximum relative step width variability during uneven terrain in comparison to overground walking **Time Frame:** Through study completion, over 4 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * lower limb amputation at ankle (Symes) level and above * age 18+ years * fitted with a walking prosthesis and use it regularly for home and/or community ambulation * good socket fit, assessed by a score of 8-10 on the socket fit comfort scale * able to walk for three minutes at a time with or without an assistive device * willing to travel to the University of Nevada Las Vegas, Maryland Campus, for all training and assessment sessions Exclusion Criteria: * leg/foot ulcer or other conditions that cause pain during weight-bearing * poor skin integrity that could cause tissue breakdown by walking * cardiovascular, respiratory or other critical health conditions that preclude moderate physical activity * unilateral or bilateral upper limb absence or loss at the wrist and above that precludes use of handrails bilaterally, or would require asymmetrical adaptation to body posture for use. * pregnancy **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Jenny A Kent, PhD, CSci **Phone:** 7028955949 **Role:** CONTACT #### Locations **Location 1:** **City:** Las Vegas **Country:** United States **Facility:** University of Nevada Las Vegas **State:** Nevada **Zip:** 89154 #### Overall Officials **Official 1:** **Affiliation:** University of Nevada, Las Vegas **Name:** Jenny A Kent, PhD, CSci **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M17685 - Name: Wounds and Injuries - Relevance: HIGH - As Found: Injury ### Condition Browse Module - Meshes - ID: D000014947 - Term: Wounds and Injuries ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419907 **Acronym:** DIABETES-PRO **Brief Title:** Differing Completion Rates of DIABETES Education on Patient Reported Outcomes **Official Title:** A Feasibility Study Evaluating the Impact of Differing Completion Rates of a Face-to-face Diabetes Self-management Education Programme on Patient Reported Outcome Measures. #### Organization Study ID Info **ID:** UoL001848 #### Organization **Class:** OTHER **Full Name:** University of Liverpool #### Secondary ID Infos **Domain:** IRAS **ID:** 337691 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2026-05-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-11-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-15 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** St Helens & Knowsley Teaching Hospitals NHS Trust #### Lead Sponsor **Class:** OTHER **Name:** University of Liverpool #### 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 feasibility trial is to test the impact of differing completion rates of a face-to-face diabetes self-management education programme on patient-reported outcomes measuring self-care, diabetes distress and quality of life in people with type 2 diabetes. The main question it aims to answer is: 1. What is the impact of differing completion rates of DSME programmes on ability to self-care (primary outcome), diabetes distress and health related quality of life in type 2 diabetes. Researchers will compare participants across four study groups (Group 1 will receive a full DSME programme, Group 2 will receive 60%, Group 3 will receive 10% and Group 4 will have delayed education) to see if patients who attend minimal aspects (10%) of diabetes self-management education programmes gain clinically significant improvements in ability to self-care compared to those who do not attend and if the nationally accepted 60 % completion rate is as effective as 100% completion. Participants will: * complete three validated patient reported outcome measures testing self care activities, diabetes distress and health related quality of life. * Attend structured diabetes self-management education of differing completion rates dependent on the group they have been allocated to. * repeat the same three patient reported outcome measures 2-4 months after intervention. For participants in group 4 this will be 3-4 months from baseline. **Detailed Description:** Structured diabetes self-management education (DSME) is internationally recommended for all people with newly diagnosed type 2 diabetes and is designed to support patients in self-managing their condition and prevent associated long-term complications. DSME is proven to be as effective as pharmacotherapy in preventing diabetes associated morbidity and premature mortality but attendance at both a national and local level remains poor. Local records suggest that of those that start DSME (9%) only 12.6% complete the programme. Attendance at DSME is currently benchmarked as having completed a registration form and had at least one active engagement with a programmes content, with 'completion' measured against ≥60% completion despite landmark trials reporting outcomes based on the full completion of a programme. Little is known, of the effectiveness of DSME on the psychological and emotional health of people with diabetes who complete less than the full DSME programme. This feasibility study will test the impact of differing completion rates of a face-to-face DSME programme on patient reported outcomes measuring self-care, diabetes distress and quality of life in people with type 2 diabetes. Using a quantitative approach, a single centre, randomised feasibility study will be conducted, aiming to recruit 120 eligible people with type 2 diabetes due to attend a secondary care diabetes clinic in the Northwest UK for specialist support, education and advice. Participants will be randomised into one of four groups: Group 1 will receive a full DSME programme, Group 2 will receive 60%, Group 3 will receive 10% and Group 4 will have delayed education. Normal clinical care will continue. Preliminary outcomes (psychometric questionnaire scores measuring ability to self-care, diabetes distress and health related quality of life) will be evaluated at baseline and 3-4 months post-intervention. Measures of feasibility (eligibility, recruitment and retention rates) will be reported. Whilst the current literature evidences the clear benefits for people with type 2 diabetes attending DSME programmes, there is minimal understanding of the benefits of partial DSME completion on a person's ability to self-care despite national consensus accepting 60% attendance as 'completed'. The proposed research aims to test the feasibility of conducting a full randomised control trial to evaluate the effectiveness of DSME programmes on psychometric outcomes with differing completion rates ### Conditions Module **Conditions:** - Diabetes Mellitus, Type 2 - Patient Education as Topic **Keywords:** - health education - patient reported outcome measures - type 2 diabetes mellitus - patient education as topic ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 120 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** 100% of a face to face 6 hour structured diabetes self management education session **Intervention Names:** - Behavioral: Type 2 Live Well (structured diabetes self management education programme) **Label:** Group 1 **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** 60% of a face to face 6 hour structured diabetes self management education session. Total attendance will be 3 hours 36 minutes. **Intervention Names:** - Behavioral: Type 2 Live Well (structured diabetes self management education programme) **Label:** Group 2 **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** 10% of a face to face 6 hour structured diabetes self management education session. Total attendance will be 36 minutes. **Intervention Names:** - Behavioral: Type 2 Live Well (structured diabetes self management education programme) **Label:** Group 3 **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** Will not attend a face to face 6 hour structured diabetes self management education session **Intervention Names:** - Behavioral: Type 2 Live Well (structured diabetes self management education programme) **Label:** Group 4 **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Group 1 - Group 2 - Group 3 - Group 4 **Description:** Structured diabetes self management education programme designed to support those with type 2 diabetes self care and prevent long term associated complications. **Name:** Type 2 Live Well (structured diabetes self management education programme) **Type:** BEHAVIORAL ### Outcomes Module #### Other Outcomes **Description:** Other preliminary data will explore whether deprivation has any impact on PROMs across the four groups. **Measure:** Deprivation **Time Frame:** measured at baseline **Description:** Other preliminary data will explore whether diabetes duration has any impact on PROMs across the four groups. **Measure:** diabetes duration **Time Frame:** measured at baseline #### Primary Outcomes **Description:** Validated tool testing ability to self care in type 2 diabetes. Higher score indicates better self care (better outcome). **Measure:** Change in self-care activities outcome measure (pre and post intervention) using the Diabetes Self-Management Questionnaire - Revised (DSMQ-R) scale **Time Frame:** Measured at baseline and 3-4 months after intervention #### Secondary Outcomes **Description:** Validated tool measuring diabetes distress. Lower score indicates lower diabetes distress (better outcome). Score range 0-100. **Measure:** Change in diabetes distress (pre and post intervention) using the Problem Areas in Diabetes (PAID) tool **Time Frame:** Measured at baseline and 3-4 months after intervention **Description:** Validated tool measuring health related quality of life. The PROMIS Global-10 is a 10-item patient-reported questionnaire in which the response options are presented as 5-point (as well as a single 11-point) rating scales. The results of the questions are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health score. These scores are then standardized to the general population, using the "T-Score". The average "T-Score" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient. **Measure:** • Quality of life outcome measures (pre and post intervention) using the PROMIS-Global Health V1.2 scale **Time Frame:** Measured at baseline and 3-4 months after intervention ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * All patients with a diagnosis of type 2 diabetes aged ≥18 years of age referred to the Diabetes centre who are able to provide informed consent and are responsible for daily management of their diabetes will be screened for entry into the study Exclusion Criteria: The following patients will be excluded entry into the study: * Lack capacity to make an informed decision. * A diagnosis of type 1, type 3c, Maturity-onset diabetes of the young (MODY) or gestational diabetes. * Received structured education for their diabetes within the last 12 months either online or face to face. * Require 1:1 education support e.g., requires interpreter. * Patients unable to attend for structured classroom education e.g., housebound. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Gemma A Lewis **Phone:** 01744646668 **Role:** CONTACT #### Locations **Location 1:** **City:** St Helens **Contacts:** ***Contact 1:*** - **Name:** Gemma A Lewis - **Phone:** 01744646668 - **Role:** CONTACT ***Contact 2:*** - **Name:** Gemma A Lewis - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United Kingdom **Facility:** Diabetes Centre, St Helens Hospital **Zip:** WA93DA #### Overall Officials **Official 1:** **Affiliation:** University of Liverpool **Name:** Gemma A Lewis **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** All metadata records for the qualitative data will be uploaded onto the University research data repository. All records will be anonymised and identified by study number only in order to maintain confidentiality. **Info Types:** - STUDY_PROTOCOL - SAP **IPD Sharing:** YES **Time Frame:** Data will be available following the end of study and completion of associated publications and PhD thesis submission. ### References Module #### See Also Links **Label:** Secure online environment for University of Liverpool Researchers to deposit, share and promote data and information **URL:** https://datacat.liverpool.ac.uk/ ## 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 - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M7115 - Name: Diabetes Mellitus - Relevance: HIGH - As Found: Diabetes Mellitus - ID: M7119 - Name: Diabetes Mellitus, Type 2 - Relevance: HIGH - As Found: Diabetes Mellitus, Type 2 - ID: M21089 - Name: Facies - 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 ### Condition Browse Module - Meshes - ID: D000003920 - Term: Diabetes Mellitus - ID: D000003924 - Term: Diabetes Mellitus, Type 2 ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419894 **Acronym:** ADVOCATE-CMR **Brief Title:** Advanced Cardiac Magnetic Resonance Imaging for Assessment of Obstructive Coronary Artery Disease: ADVOCATE-CMR **Official Title:** Advanced Cardiac Magnetic Resonance Imaging for Assessment of Obstructive Coronary Artery Disease: ADVOCATE-CMR #### Organization Study ID Info **ID:** NL84828.015.23 #### Organization **Class:** OTHER **Full Name:** Amsterdam UMC, location VUmc ### Status Module #### Completion Date **Date:** 2033-06-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2033-06-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-03 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Amsterdam UMC, location VUmc #### Responsible Party **Investigator Affiliation:** Amsterdam UMC, location VUmc **Investigator Full Name:** Sonia Borodzicz-Jazdzyk **Investigator Title:** Project Leader **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Stress perfusion cardiovascular magnetic resonance (CMR) imaging is an established non-invasive imaging test for detection of obstructive coronary artery disease (CAD). Fully automated quantitative perfusion CMR (QP CMR) is a new technical advancement, which offers measurement of myocardial blood flow in CMR. Additionally, recent innovations have introduced various contrast-agent-free methods for CAD assessment, such as stress T1 mapping reactivity (∆T1) and oxygen-sensitive CMR (OS CMR). These methods might eliminate the necessity for contrast administration in clinical practice, simplifying, reducing time, invasiveness and costs in evaluating patients with suspected obstructive CAD. The ADVOCATE-CMR study aims to validate QP CMR, ∆T1 and OS CMR imaging against invasive fractional flow reserve (FFR) for detection of obstructive CAD. The study also aims to head-to-head compare the diagnostic accuracy of these CMR techniques with the conventional visual assessment of stress perfusion CMR and to correlate them to short- and long-term clinical outcomes. **Detailed Description:** Study design: Single-center, observational, prospective, cross-sectional cohort study performed at the Amsterdam University Medical Centers - Location VUmc. Study population: 182 symptomatic patients with suspected obstructive CAD (without a previous CAD history), scheduled for invasive coronary angiography (ICA) according to the decision of the treating clinician. Methods: 1. CMR image acquisition prior to clinically scheduled ICA, using the following pulse sequences: cine imaging, OS-CMR with breathing maneuvers, adenosine-stress and rest T1 mapping, adenosine-stress and rest QP-CMR, late gadolinium enhancement; 2. Fractional flow reserve (FFR), instantaneous wave-free ratio (iFR), ratio between proximal and distal coronary pressures over entire resting cycle period (Pd/Pa ratio), coronary flow reserve (CFR) and index of microcircular resistance (IMR) in all main coronary arteries during ICA; 3. Follow-up CMR according to the abovementioned protocol 3 months after ICA (or 3 months after revascularization, if performed separately more than 1 day following ICA); 4. Clinical follow-up - 3, 6 months, 1 and 3 years after ICA or revascularization (if performed separately more than 1 day following ICA) ### Conditions Module **Conditions:** - Coronary Artery Disease **Keywords:** - Stress perfusion cardiac magnetic resonance - Quantitative perfusion - Stress T1 mapping reactivity - Oxygen-sensitive cardiac magnetic resonance ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 182 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Outcomes Module #### Other Outcomes **Description:** Sensitivity, specificity, accuracy, AUC, PPV, NPV **Measure:** Diagnostic accuracies of QP CMR (stress MBF, stress rMBF, MPR and rMPR), ΔT1 and B-MORE to detect microvascular dysfunction (MVD), as defined by CFR **Time Frame:** ICA + hemodynamic measurements within 6 weeks of the initial CMR scan **Description:** Sensitivity, specificity, accuracy, AUC, PPV, NPV **Measure:** Diagnostic accuracy of QP CMR (stress MBF, stress rMBF, MPR and rMPR), ΔT1 and B-MORE to differentiate between MVD (as defined by CFR) and 3-vessel obstructive CAD **Time Frame:** ICA + hemodynamic measurements within 6 weeks of the initial CMR scan **Description:** Difference between stress MBF before revascularization (baseline) and after revascularization (in ml/g/min) **Measure:** Change in stress MBF after revascularization **Time Frame:** ICA + hemodynamic measurements within 6 weeks of the initial CMR scan **Description:** Difference between MPR before revascularization (baseline) and after revascularization **Measure:** Change in MPR after revascularization **Time Frame:** ICA + hemodynamic measurements within 6 weeks of the initial CMR scan **Description:** Difference between stress T1 mapping before revascularization (baseline) and after revascularization (in ms) **Measure:** Change in stress T1 mapping after revascularization **Time Frame:** ICA + hemodynamic measurements within 6 weeks of the initial CMR scan **Description:** Difference between ΔT1 before revascularization (baseline) and after revascularization **Measure:** Change in ΔT1 after revascularization **Time Frame:** ICA + hemodynamic measurements within 6 weeks of the initial CMR scan **Description:** Difference between B-MORE before revascularization (baseline) and after revascularization (in %) **Measure:** Change in B-MORE after revascularization **Time Frame:** ICA + hemodynamic measurements within 6 weeks of the initial CMR scan **Measure:** Costs of QP CMR, stress T1 mapping reactivity and OS CMR compared to ICA **Time Frame:** CMR and following ICA + hemodynamic measurements within 6 weeks of the initial CMR scan **Measure:** Procedural time of QP CMR, stress T1 mapping reactivity and OS CMR compared to ICA **Time Frame:** CMR and following ICA + hemodynamic measurements within 6 weeks of the initial CMR scan #### Primary Outcomes **Description:** Sensitivity, specificity, accuracy, area under the curve (AUC), positive predictive value (PPV), negative predictive value (NPV) **Measure:** Diagnostic accuracy of QP CMR (stress myocardial blood flow [MBF], stress relative MBF [rMBF], myocardial perfusion reserve [MPR] and relative MPR [rMPR]) to detect obstructive CAD, as defined by FFR **Time Frame:** ICA + hemodynamic measurements within 6 weeks of the initial CMR scan #### Secondary Outcomes **Description:** Sensitivity, specificity, accuracy, AUC, PPV, NPV **Measure:** Diagnostic accuracy of ΔT1 to detect obstructive CAD, as defined by FFR **Time Frame:** ICA + hemodynamic measurements within 6 weeks of the initial CMR scan **Description:** Sensitivity, specificity, accuracy, AUC, PPV, NPV **Measure:** Diagnostic accuracy of OS CMR (breathing-induced myocardial oxygenation reserve; B-MORE) to detect obstructive CAD, as defined by FFR **Time Frame:** ICA + hemodynamic measurements within 6 weeks of the initial CMR scan **Description:** Sensitivity, specificity, accuracy, AUC, PPV, NPV **Measure:** Head-to-head comparison of diagnostic accuracies of QP CMR (stress MBF, stress rMBF, MPR, rMPR), ΔT1, OS CMR (B-MORE) and conventional visual assessment of GBCA-based first pass perfusion imaging to detect obstructive CAD, as defined by FFR **Time Frame:** ICA + hemodynamic measurements within 6 weeks of the initial CMR scan **Description:** Sensitivity, specificity, accuracy, AUC, PPV, NPV **Measure:** Diagnostic accuracy of QP CMR (stress MBF, stress rMBF, MPR and rMPR) to detect obstructive CAD, as defined by iFR and resting Pd/Pa **Time Frame:** ICA + hemodynamic measurements within 6 weeks of the initial CMR scan **Description:** Sensitivity, specificity, accuracy, AUC, PPV, NPV **Measure:** Diagnostic accuracy of ΔT1 to detect obstructive CAD, as defined by iFR and resting Pd/Pa **Time Frame:** ICA + hemodynamic measurements within 6 weeks of the initial CMR scan **Description:** Sensitivity, specificity, accuracy, AUC, PPV, NPV **Measure:** Diagnostic accuracy of OS CMR (B-MORE) to detect obstructive CAD, as defined by iFR and resting Pd/Pa **Time Frame:** ICA + hemodynamic measurements within 6 weeks of the initial CMR scan **Description:** Sensitivity, specificity, accuracy, AUC, PPV, NPV **Measure:** Head-to-head comparison of diagnostic accuracies of QP CMR (stress MBF, stress rMBF, MPR, rMPR), ΔT1, OS CMR (B-MORE) and conventional visual assessment of first pass perfusion imaging to detect obstructive CAD, as defined by iFR and resting Pd/Pa **Time Frame:** ICA + hemodynamic measurements within 6 weeks of the initial CMR scan **Measure:** Relation of stress and rest MBF and rMBF, MPR and rMPR, ΔT1 and B-MORE to Seattle Angina Questionnaire (SAQ)-7 Summary score **Time Frame:** Before ICA and 3, 6 months, 1 and 3 years after the ICA (or revascularization if applicable) **Measure:** Relation of stress and rest MBF and rMBF, MPR and rMPR, ΔT1 and B-MORE to SAQ-7 Angina Frequency score **Time Frame:** Before ICA and 3, 6 months, 1 and 3 years after the ICA (or revascularization if applicable) **Measure:** Relation of stress and rest MBF and rMBF, MPR and rMPR, ΔT1 and B-MORE to SAQ-7 Physical Limitation score **Time Frame:** Before ICA and 3, 6 months, 1 and 3 years after the ICA (or revascularization if applicable) **Measure:** Relation of stress and rest MBF and rMBF, MPR and rMPR, ΔT1 and B-MORE to SAQ-7 Quality of Life score **Time Frame:** Before ICA and 3, 6 months, 1 and 3 years after the ICA (or revascularization if applicable) **Measure:** Relation of stress and rest MBF and rMBF, MPR and rMPR, ΔT1 and B-MORE to Rose Dyspnea Scale score **Time Frame:** Before ICA and 3, 6 months, 1 and 3 years after the ICA (or revascularization if applicable) **Description:** 1. Composite of cardiovascular (CV) death (death resulting from an acute myocardial infarction, sudden cardiac death, death due to heart failure, stroke, CV procedures, CV hemorrhage, other CV causes), myocardial infarction (according ESC/ACCF/AHA/WHF 4th Universal Definition of Myocardial Infarction), ischemia-driven coronary revascularization (all coronary revascularization performed in the context of myocardial infarction and those for worsening symptoms in combination with evidence of myocardial ischemia) or stroke (acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of hemorrhage or infarction); 2. Composite of myocardial infarction or ischemia-driven coronary revascularization; 3. Composite of cardiovascular death, stroke or myocardial infarction; 4. Myocardial infarction; 5. Ischemia-driven coronary revascularization; 6. Stroke; 7. Death from any cause; 8. CV death **Measure:** Prognostic value of QP CMR (stress MBF, stress rMBF, MPR and rMPR), stress T1 mapping reactivity and OS CMR (B-MORE) **Time Frame:** 3 months, 6 months, 1 year, 3 years ### Eligibility Module **Eligibility Criteria:** Inclusion criteria: * Suspected obstructive coronary artery disease * No documented prior history of coronary artery disease * Clinical referral for invasive coronary angiography according to the referring clinician's decision * Competent adult (age ≥18 years) * Signed informed consent Exclusion criteria: * Acute coronary syndrome * History of coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting surgery) * History of coronary artery disease or acute coronary syndrome (myocardial infarction, unstable angina) * Use of sildenafil or dipyridamole that cannot be terminated * Pregnancy or lactation * Allergic reaction to iodized contrast * Concurrent or prior (within last 30 days) participation in other research studies using interventional drugs * Extensive comorbidities (i.e. cancer, other severe chronic diseases) * Contraindication for cardiac magnetic resonance with gadolinium-based contrast agent (including severe claustrophobia, magnetic resonance unsafe implants/devices or MR conditional devices not suitable for 3T scanner, severe renal failure with estimated glomerular filtration rate\<30 mL/min/1,73 m2, known hypersensitivity for gadolinium-based contrast agent) * Contraindications for adenosine usage (including hypersensitivity to adenosine/dipyridamole/regadenoson, second or third degree atrio-ventricular block, sick sinus syndrome, sinus bradycardia (heart rate \<40 bpm), long QT syndrome, severe hypertension (\> 220/120 mmHg), systolic blood pressure \<90mmHg, concomitant use of dipyridamole, severe asthma or severe chronic obstructive pulmonary disease) **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** 182 symptomatic patients with suspected obstructive CAD (without a previous CAD history), scheduled for invasive coronary angiography according to the decision of the treating clinician. ## Derived Section ### Condition Browse Module - Ancestors - ID: D000006331 - Term: Heart Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000001161 - Term: Arteriosclerosis - ID: D000001157 - Term: Arterial Occlusive Diseases - ID: D000014652 - Term: Vascular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC20 - Name: Immune System Diseases - 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: HIGH - As Found: Coronary Artery Disease - ID: M6549 - Name: Coronary Disease - Relevance: HIGH - As Found: Coronary Artery Disease - ID: M10018 - Name: Hypersensitivity - 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 - ID: D000017202 - Term: Myocardial Ischemia - ID: D000003327 - Term: Coronary Disease ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419881 **Brief Title:** Tele-Drama Therapy for Community-Dwelling Older Adults With Constricted Life Space Mobility **Official Title:** Tele-Drama Therapy for Community-Dwelling Older Adults With Constricted Life Space Mobility: A Mixed Methods Randomized Control Study #### Organization Study ID Info **ID:** 217/22 #### Organization **Class:** OTHER **Full Name:** University of Haifa ### Status Module #### Completion Date **Date:** 2023-01-29 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2022-10-30 **Type:** ACTUAL #### Start Date **Date:** 2022-03-03 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** Uniper Care #### Lead Sponsor **Class:** OTHER **Name:** University of Haifa #### Responsible Party **Investigator Affiliation:** University of Haifa **Investigator Full Name:** Shoshi Keisari **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Older adults with constricted life-space mobility face increased risk of social isolation and poor mental health. Despite the benefits of therapeutic interventions, the literature indicates low use of mental health services in the older population, often due to mobility limitations and/or negative attitudes toward psychotherapy. Developing accessible interventions that address negative attitudes towards mental health services is crucial. Group drama therapy has shown to improve the mental health of older adults, and the creative process itself may help overcome stigmas associated with seeking mental health services. The aim of this study was to explore a 12-week tele-drama therapy group intervention tailored for older adults with constricted mobility. The intervention integrated playback theatre and life review therapy, and was delivered via Uniper Care, an accessible technology designed for older adults. The study will explore the contribution of the intervention and will examine the relationship between processes in drama therapy and their contribution on older adults mental health. This study will also explore the experience of participants, therapists and staff members. **Detailed Description:** Older adults suffering from constricted life space mobility experience higher rates of chronic disease, functional and cognitive impairments, depressive symptoms, limited access to medical care and minimal social encounters. Interventions that enhance social skills and increase opportunities for social interaction have showed promising results, but for older adults with constricted life space mobility, this is especially challenging since access to social encounters is limited. Tele-therapy offers a potential solution to these physical barriers and have been proven effective in treating common mental disorders, such as anxiety. However, a recent tele-therapy study that found that while participants appreciated the possibility of online therapy, many still refused to participate because they were not interested in focusing on sensitive subjects, such as their depression. These findings highlight the crucial need to develop accessible interventions that address these potential physical and emotional barriers that may prevent older adults with constricted mobility from consuming mental health services. Tele-drama therapy can offer a solution to these barriers, however the unexplored potential of online group drama therapy with older adults remains. The aim of this Randomized Control, mixed methods study was to explore a 12-week tele-drama therapy group intervention tailored for older adults with constricted mobility. The quantitative arm of this mixed-methods study aims to examine the impact of a tele-drama therapy intervention on the mental health of older adults with constricted life space mobility, and to pinpoint the associations between dramatic processes and outcome measures. The researchers hypothesize that Tele-drama therapy will (1) enhance social connectedness, self-acceptance, personal growth, and a sense of meaning in life, as compared to the control condition, (2) reduce depressive symptom and loneliness as compared to the control condition. In addition, the researchers hypothesize that in-session therapeutic change factors will predict better outcomes in the treatment group. The qualitative arm of this study will explore the experiences of participants and staff members. Participants: This study aimed to recruit 120 participants, factoring in a 15% dropout rate, based on an a-priori power analysis. The intervention was offered to 3,595 Uniper Care members residing throughout Israel. Participants were recruited over eight months and were randomly assigned to eight tele-drama therapy treatment groups or eight usual care groups who continued to receive the routine activities provided by Uniper Care. A total of 111 participants completed the study (88 % of those who started the intervention): 51 from the experimental groups and 60 from the control groups. A total of 15 participants (11.9%) dropped out throughout the study. The Online Platform: Uniper Care is a social club aimed to promote active aging using accessible technology designed with and for older adults. Uniper Care's service is delivered via the TV by connecting a remote and a camera to any TV that turns the TV from passive to interactive. Uniper Care is also accessible via other digital devices such as tablets, smart phone and desktop. Uniper Cares' service includes daily classes around physical, social, emotional and cognitive well-being, along with recorded programs and videos and gamification of various training. The Tele-drama Therapy Group Intervention: Eight groups of up to eight participants received a 12-week tele-drama therapy intervention, with each session lasting 75 minutes via the Uniper Care platform Sessions were delivered by four certified drama therapists who received training on the treatment protocol before the intervention. All sessions were recorded using OBS (Open Broadcast Software, v29.0.0) an external software program for screen recording and live streaming. All the recordings were secured on a computer with a password for further coding of the data. The 12-week intervention consisted of four stages: (1) Introduction (sessions 1-2): establishing participant acquaintance, a therapeutic alliance and a safe space for self-expression and exploration, (2) Life-review on stage (sessions 3-8): revisiting past positive life stories from new viewpoints, (3) Looking ahead (sessions 9-11): exploring future stories and goals to foster a sense of purpose and sense of self-development, and (4) Farewell: reflecting upon the group process and achievements, and closure. Measures: A demographic questionnaire administered at baseline. Outcome measures were assessed pre and post intervention for all participants. Process measures were assessed for participants in the experimental groups after session No. 10. Control variables (individual traits/differences) were assessed at baseline to examine their potential role as covariates. Semi-structured interviews were held with participants from three experimental groups, three drama therapists, and two Uniper Care community coordinators. The interviews were recorded and transcribed for further coding and analysis. Data Analysis: Quantitative Analysis: Statistical data will be collected and analyzed in SPSS, version 27, and R, version 3.5. The reliability of the study's scales will be assessed using Cronbach's alpha for internal consistency. Shapiro-Wilk test of normality will be conducted to determine whether the outcome variables are normally distributed. Chi square, t-tests or one-way ANOVA to examine differences between variables and groups, and some additional variables. Correlations will be calculated to analyze the relationships between sociodemographic, control, and outcome variables. To examine the effects of the intervention on outcome variables, the analysis will include repeated measures (pre/post) with mixed-models (random effects) by groups (Experiment/Control) including interaction between time X groups. Further follow-up exploratory analyses will attempt to find associations between outcome and process variables and individual traits. Qualitative Analysis: To explore the experiences of participants and staff members, qualitative analysis of the semi-structured interviews will apply reflexive thematic analysis of interviews (Braun \& Clarke, 2019). ### Conditions Module **Conditions:** - Constricted Life Space Mobility - Tele-drama Therapy **Keywords:** - Life Space Mobility - Tele-drama therapy intervention - Older Adults - Mental health - Social Connectedness ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Participants were randomly assigned to eight tele-drama therapy treatment groups or eight usual care groups. Participants in the experiment group received a 12-week tele-drama therapy intervention, with each session lasting 75 minutes via the Uniper Care platform. Participants in the usual care groups continued to receive the routine activities provided by Uniper Care. As a token of gratitude for their participation, participants in the control groups were offered a 3-session online playback theater workshop, in addition to a gift card. ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 111 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** This arm received a 12-week tele-drama therapy intervention, with each session lasting 75 minutes via the Uniper Care platform. **Intervention Names:** - Behavioral: Tele-drama therapy **Label:** Tele-drama therapy intervention **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** This usual care arm continued to receive routine activities provided by Uniper Care. **Intervention Names:** - Other: Usual Care **Label:** Usual Care **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Tele-drama therapy intervention **Description:** A 12-week tele-drama therapy group intervention integrating Playback Theater and Life Review Therapy **Name:** Tele-drama therapy **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Usual Care **Description:** This arm continued to receive the routine activities provided by Uniper Care **Name:** Usual Care **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Social connectedness was measured using a composite score of two measures: The 10-item satisfaction in social relationships subscale from the UCLA loneliness scale (Russell et al., 1980), and the 9-item positive relationships with others subscale of the psychological well-being scale (Ryff, 1991); both measures were rated on a 5-point scale. **Measure:** Social Connectedness **Time Frame:** (1) Baseline, (2) Post intervention **Description:** Psychological well-being was measured using two subscales from the Ryff scale (1991): self-acceptance and personal developement , which were rated from 1 (Strongly disagree) to 5 (Strongly agree). **Measure:** Psychological well-being **Time Frame:** (1) Baseline, (2) up to 1 week post intervention **Description:** Meaning in life was measured using an abridged 8-items version (Krause, 2007), adapted for older adults. Items were rated from 1 (Strongly disagree) to 5 (Strongly agree). **Measure:** Meaning in life **Time Frame:** (1) Baseline, (2) up to 1 week post intervention **Description:** Well-being was measured using the 5-item WHO-5 scale (Gosling et al., 2003; Keisari et al., 2022). Items were rated from 0 (Never) to 5 (All the time). **Measure:** Well-being **Time Frame:** (1) Baseline, (2) up to 1 week post intervention **Description:** Loneliness was measured using the 10-item dissatisfaction in social relationships subscale from the UCLA loneliness scale (Russell et al., 1980), with an additional item ("I feel lonely"). Items were rated from 1 (Never) to 5 (Always). **Measure:** Loneliness **Time Frame:** (1) Baseline, (2) up to 1 week post intervention **Description:** Depressive symptoms were measured using the Geriatric Depression Scale (Yesavage et al., 1982), a questionnaire composed of 15 yes/no questions that relate to how participants felt in the previous week. **Measure:** Depressive symptoms **Time Frame:** (1) Baseline, (2) up to 1 week post intervention #### Secondary Outcomes **Description:** Therapeutic alliance was measured using a 17-item alliance in art therapy questionnaire (Bat Or \& Zilcha-Mano, 2018), which was slightly adapted to the field of drama therapy by the research team. Items were rated from 1 (Does not describe my experience at all) to 5 (Completely describes my experience. **Measure:** Therapeutic alliance **Time Frame:** up to 1 week after session No. 10 **Description:** Meaningfulness in drama therapy was measured using a 15-item questionnaire (Baker et al., 2016), which was slightly adapted to measure the extent of meaning experienced by participants in the drama therapy process. Items were rated from 1 (Does not describe my experience at all) to 5 (Completely describes my experience. **Measure:** Meaningfulness in drama therapy **Time Frame:** up to 1 week after session No. 10 **Description:** Vitality was measured using a 5-item questionnaire that measured the subjective experience of feeling vital during the drama therapy session prior to the questionnaire (Ryan \& Frederick, 1997). Items were rated from 1 (Does not describe my experience at all) to 5 (Completely describes my experience. **Measure:** Vitality **Time Frame:** up to 1 week after session No. 10 **Description:** Subjective social support was measured using the 6 items from the abbreviated Duke social support index questionnaire (Koenig et al., 1993), with "family and friends" changed to "group members.". Items were rated from 1 (Hardly ever) to 3 (Most of the time **Measure:** Subjective social support **Time Frame:** up to 1 week after session No. 10 **Description:** Flow was measured using the 7-item state flow scale (Martin \& Jackson, 2008). Items were rated from (Does not describe my experience at all) to 5 (Completely describes my experience). **Measure:** Flow **Time Frame:** up to 1 week after session No. 10 **Description:** This measure of Client involvement in group drama therapy was assessed by drama therapists who rated a single-item question: "for each participant in the group, think about the way he/she behaved in the group and rate the extent of his/her active involvement in the dramatic process of treatment", from 1 ((Not at all) to 5 (Completely)). **Measure:** Client involvement in group drama therapy - Therapists assessment **Time Frame:** up to 1 week post intervention **Description:** This measure of Client involvement in group drama therapy was assessed by one of the research investigators using the 11-item Client Involvement and Interaction in Group DT (Tobon et al., 2011), an observational rating scale that was completed for each participant based on video recordings of three tele-DT sessions (2, 6, and 11). Items (were rated from 0 (never present) to 4 (always present **Measure:** Client involvement in group drama therapy - Investigators assessment **Time Frame:** up to 1 week post intervention ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. age 65 and over with constricted life space mobility 2. with normal cognitive functioning (assessed by the research coordinator and community coordinators at Uniper Care) 3. selected by the research coordinator and community coordinators as suitable to participate in a treatment group 4. with sufficient mastery of the Hebrew language 5. with an absence of a diagnosis of a mental disorder 6. who expressed interest in taking part in a drama therapy intervention and provided informed consent. Exclusion Criteria: 1. older adults who experienced the loss of a souse or child six months prior to the intervention 2. participants in the experimental group who missed four or more of the 12 sessions. **Minimum Age:** 65 Years **Sex:** ALL **Standard Ages:** - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Tel Aviv **Country:** Israel **Facility:** Uniper Care #### Overall Officials **Official 1:** **Affiliation:** University of Haifa **Name:** Shoshi Keisari, PhD **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** University of Haifa **Name:** Hod Orkibi, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** Upon Request **Description:** Upon Request **Info Types:** - STUDY_PROTOCOL - SAP - ICF - CSR - ANALYTIC_CODE **IPD Sharing:** YES **Time Frame:** One year after publication ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419868 **Acronym:** FDI2024 **Brief Title:** Acceptability and Feasibility of a Universal Preventive Intervention **Official Title:** Acceptability and Feasibility of a Universal Preventive Intervention for Depression and Anxiety in University Students #### Organization Study ID Info **ID:** FDI UAN23102 #### Organization **Class:** OTHER **Full Name:** Universidad de los Andes, Chile ### Status Module #### Completion Date **Date:** 2025-04-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-04-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-04-30 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Universidad de los Andes, Chile #### Responsible Party **Investigator Affiliation:** Universidad de los Andes, Chile **Investigator Full Name:** Jorge Gaete **Investigator Title:** Tenured Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Mental health in the university population has become a common and serious problem within university institutions worldwide in recent years. Various meta-analyses and systematic reviews have shown worrying figures in the last five years. In the USA, it has been described in medical students that between 6.0% and 66.5% have depression, between 7.7% and 65.5% anxiety disorders, and between 12.2% and 96.7% present stress. In China, on the other hand, a study reported in 2016 that the prevalence of depression was 23.8%. In Latin America, a Brazilian article conducted on medical students shows a prevalence of depression at 30.6%, anxiety disorders at 32.9%, and stress at 49.9%. In Chile, there are very few studies that address the prevalence of mental health disorders and associated risk factors in the university population. The article published in 2014 by Baader et al. is one of the first records was carried out on a population of 800 students in 2008 at the Austral University of Chile, reporting a prevalence of 27% of depression and 5.3% of students who present a moderate to severe risk of suicide. During April and May 2019, the results of the "First National University Mental Health Survey" project were presented, a project led by the Catholic University of Temuco and sponsored by the National Research and Development Agency (ANID), carried out to 600 students from the Catholic University of Temuco, the University of Concepción and the University of Tarapacá. This project showed that 46% of the students presented depressive symptoms, 46% anxiety symptoms, and 53.5% stress symptoms. Furthermore, 29.7% presented the three symptoms simultaneously, and 5.1% of the students had suicidal thoughts at the time of the study. In a review of published studies on mental health in higher education students in Chile, a wide variability in the prevalence of psychological symptoms among students was identified. The findings showed a range of prevalence of psychological distress between 22.9% and 40.7%, of depressive symptoms between 16.5% and 38.8%, of anxious symptoms between 16.5% and 23.7%, of cannabis consumption in the last 12 months between 19.7% and 29.7%, and alcohol consumption in the previous year between 84.0% and 92.6%. The data obtained from the Mental Health Surveys of the University of the Andes, applied in the years 2020 and 2022 to undergraduate students, indicate variations in the prevalence of different symptoms and psychological risks. Specifically, the prevalence of depressive symptoms decreased from 37.1% to 27.84%, and that of anxious symptoms decreased slightly from 37.9% to 36.13%. A notable decrease was observed in stress, going from 54.6% to 12.9%. On the other hand, the prevalence of suicide risk experienced a less pronounced decrease, from 20% to 18.4%, remaining at a considerably high rate. Taking into account the above, mental health problems in the university population continue to be a public health problem that must be addressed preventively through the implementation of evidence-based programs. Objective: This study aims to determine the acceptability and feasibility of an online universal mental health prevention program for university students. It is also expected to reduce depressive and anxious symptoms and improve quality of life. Outcomes: Primary response measures: Acceptability Assessment, Feasibility Assessment. Secondary response measures are depression, anxiety, and quality of life. The Outcomes section provides more details on anxiety and qu. Expected results: The data collected will allow us to determine the acceptability and satisfaction of the participants with the intervention using a quantitative measure of its credibility and to explore its effects on the participants, considering the change in depressive and anxiety symptoms and quality of life before and after the intervention. **Detailed Description:** STRATEGIES AND INTERVENTIONS ORIENTED ON THE PROMOTION AND PREVENTION OF MENTAL HEALTH PROBLEMS: Recent research highlights the effectiveness of preventive interventions on the mental health of university students, whether through digital media, in-person actions, or a combination of both. The contents of these interventions have allowed us to establish the mechanisms and main mediators that explain the effectiveness of these interventions. For example, recent studies have demonstrated the positive effects of mindfulness on individual health, decreasing the intensity of distress, accelerating emotional recovery, and increasing the ability to engage in goal-oriented behavior. In mindfulness training, people learn to self-regulate their attention. In this sense, in 2021, a pilot study with a control group was carried out at the Universidad de los Andes (ClinicalTrials.gov Identifier: NCT05114824) in which an intervention based on Mindfulness with cognitive-behavioral elements of 8 sessions was evaluated in undergraduate students. It showed a significant reduction in depressive and anxiety symptoms and an increase in quality of life in those students who participated in the intervention compared to the control group. This intervention was based on a program developed by Dr. Elizabeth English and evaluated by Dr. Julieta Galante at the University of Cambridge with excellent results. Another study in England evaluated a mindfulness intervention, which achieved notable reductions in perceived stress (d = -1.25), anxiety (d = -1.09), and depression (d = -1.06) in comparison with a control group, with sustained benefits during 3 and 6 month follow-ups. In Germany, a study evaluated an Internet-based intervention supported by a mobile application called "StudiCareStress." This intervention is based on cognitive-behavioral and third-wave techniques. It aligns with Lazarus' transactional model of stress by differentiating between problem-focused coping and coping focused on emotion regulation. Cognitive-behavioral problem-solving strategies are applied for problem-focused coping to reduce and eliminate modifiable stressors. Emotion regulation is how individuals monitor, evaluate, modify, and manage emotions to achieve relevant needs or goals. It has been shown to influence the reduction of various symptoms of emotional distress. The intervention comprised eight main modules. Completing 1 module took 30 to 90 minutes, and participants were recommended to complete at least one and a maximum of 2 modules per week. Therefore, the intervention was intended to be completed in approximately 5 to 7 weeks. This study revealed significant effects on stress relief (d = 0.69), anxiety (d = 0.76), depression (d = 0.63), and improvements in academic productivity (d = 0.33). ) and academic work performance (d = 0.34) after seven weeks. Another study in Australia evaluated the "moodgym" program, a program that is delivered over the Internet and is entirely self-administered. This program incorporates cognitive behavioral strategies such as "attentional bias modification" and "information processing." About the modification of attention bias, they are strategies that reduce the tendency of individuals with emotional disorders to pay too much attention to negative information. These strategies enable people to reduce attention to this negative information but, at the same time, actively use positive or neutral information. On the other hand, "information processing" strategies try to reduce the biases that can occur in individuals with emotional disorders such as depression, on the one hand, disconnect from negative content, improve the processes of information interpretation, and reduce memory biases. Participants completed the intervention for six weeks in the study that evaluated this program. Participants were asked to spend 40 minutes weekly on "moodgym", complete the sessions in one sitting, and only log into "moodgym" when prompted. Participants who completed the intervention had continued improvement in depressive symptoms. Furthermore, significantly fewer people in the intervention condition had diagnostic criteria for major depression at follow-up than in the control group. In a recent review, it was concluded that Internet-based interventions for the mental health of university students can have significant effects on depression, anxiety, and other mental health problems. When reviewing the components of the programs included in this review, it was also possible to conclude that the majority of these interventions, in addition to incorporating training in specific skills, either from cognitive behavioral theory or different aspects of emotional regulation, most of them also incorporate psychoeducational aspects and others related to the development of healthy behaviors such as the use of physical exercise and sleep hygiene. Unfortunately, in Chile and Latin America, no studies have evaluated preventive interventions using technology in the university population. All the results presented come from developed countries, but they are guidelines when designing an intervention that could be effective in our context. It is also important to mention that whatever the intervention, it must, on the one hand, incorporate the components that have been demonstrated as mediators in the prevention of depression and anxiety. On the other hand, they should be culturally relevant to promote involvement and adherence to this type of intervention in the university population. Whether through an internet platform or mobile applications, technology-based interventions are very promising in facilitating students' access to this content. In particular, the Universidad de los Andes has a CANVAS platform that favors students' work in their regular academic activities. Based on the experience shown in other interventions, such as the "moodgym" intervention, it can be expected that if these platforms are culturally attractive to students, they can generate better adherence. Finally, technology allows us to get closer to the common language in which university students are immersed. At the same time, if these interventions are effective, they have a high potential for scaling up to promote better well-being at the population level. These underscore the effectiveness of technology-based interventions, not only in improving mental health symptoms but also in the accessibility and appeal of these programs to students who might not otherwise seek help. Based on the above review, a successful universal mental health prevention program for university students should incorporate strategies that promote emotion regulation, a crucial component for well-being and social adaptation. Integrating mindfulness techniques and cognitive-behavioral therapy would make it easier for individuals to recognize and adequately manage their emotions. Likewise, the literature suggests the importance of developing skills for coping with academic stress through effectively assessing stressful situations and implementing strategies focused on problem-solving and emotional regulation skills. In addition, and according to the review, aspects of psychoeducation on stress, anxiety and depression, problem-solving, and development of healthy behaviors, such as physical activity and sleep care, should also be incorporated. In this study, the principal investigator propose to develop and evaluate a brief online intervention that incorporates the mediators of effectiveness demonstrated in other interventions, such as training in mindfulness skills, emotional regulation, coping with academic stress, problem-solving, and interpersonal effectiveness, which will prevent symptoms of depression and anxiety on undergraduate students. 2. Objectives: This study aims to determine the acceptability and feasibility of an online universal mental health prevention program for university students. It is also expected to reduce depressive and anxious symptoms and improve quality of life. 2.1. Primary objectives 1. Develop an online intervention aimed at preventing depression and anxiety, strengthening emotional regulation skills, mindfulness techniques, healthy coping with stress, problem-solving, psychoeducational skills, and healthy behaviors. 2. Determine the participant's acceptability and satisfaction with the intervention using the Client Satisfaction Questionnaire (CSQ-8). 3. Determine the feasibility of recruiting study subjects, retaining participants, attending sessions, and collecting quantitative data during the program. 2.2. Secondary objectives (1) Evaluate the effects of the intervention on the participants, their depressive and anxious symptoms, and their quality of life. 3. Design: This experimental study has a randomized controlled trial design and a control group. 4. Participants: The participants will be undergraduate students from the Universidad de los Andes with different majors. 5. Intervention: There are no proven interventions in university students that have evidence in Chile, but the literature review highlights interventions that have worked in countries such as England, Germany and Australia, which incorporate the following contents and mediators: emotion regulation, mindfulness techniques, coping skills, problem-solving, psychoeducation of anxiety and depression and development of healthy behaviors. In this project, the principal investigator will propose the design and creation of a self-applied online intervention that incorporates these components, and that should initially have six modules, which should be implemented in 4 to 8 weeks. Participants will receive access to the CANVAS platform, where they will find the sessions' content in video, audio, and text format. In addition, they will be asked to practice some techniques at home, with audiovisual material to guide them. Participants will be asked to complete the six sessions sequentially, completing each one before advancing to the next. Session attendance data will be collected and evaluated. 6. Outcomes: 6.1. Primary response measures 6.1.1. Acceptability Assessment Acceptability will be evaluated by determining how this intervention program is received by students and the extent to which this intervention relates to the needs of this target population. At the end of the program, the research team will develop an acceptability and satisfaction questionnaire for the intervention students. In addition, the Client Satisfaction Questionnaire (CSQ-8) instrument will be applied to evaluate satisfaction after implementation. 6.1.2. Feasibility Assessment To evaluate the feasibility, the principal investigator will consider the following variables: 1. Recruitment of participants and sample characteristics. 2. Evaluation of data collection and results. 3. Evaluation of the acceptability of the intervention and study procedures and response rates. 4. Evaluation of resources and the ability to manage and implement the study and intervention. 5. Preliminary evaluation of participants responses to the intervention. 6. Level of progress of the participants in the sessions. 6.2 Secondary response measures: Validated measures for depression, anxiety, quality of life, distress tolerance, insomnia, emotion regulation, mindfulness skills, cognitive behavior theory skills, and suicide ideation will used at baseline, after the intervention, and four months after the completion of the intervention. ### Conditions Module **Conditions:** - Depression/Anxiety **Keywords:** - Depression - Anxiety - Undergraduates - Universal prevention ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** This is an experimental study, with a randomized controlled trial design, with a control group. ##### Masking Info **Masking:** DOUBLE **Who Masked:** - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 272 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** This is a self-applied online intervention with six modules. It should be implemented over a period of 4 to 8 weeks. Participants will be guided through the program in a structured manner. They will start by accessing the CANVAS online platform, where they will find the content of the sessions in video, audio, and text formats. They will then be directed to practice exercises at home, with audiovisual material to guide them. It's crucial that participants complete the six sessions sequentially, as each session is designed to build upon the previous one, ensuring a comprehensive learning experience and effective learning. **Intervention Names:** - Behavioral: "Universal preventive intervention for depression and anxiety for university students" **Label:** Intervention group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Control group participants will be asked to respond to the baseline, after intervention, and four months after intervention. Once the study period is completed, and if the results show positive changes in the intervention group, they will be offered and asked to access the intervention. **Label:** Control group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Intervention group **Description:** This is a self-applied online intervention with six modules. It should be implemented over a period of 4 to 8 weeks. It includes emotion regulation, mindfulness exercises, coping strategies, problem-solving strategies, psychoeducation of anxiety and depression, and the development of healthy behaviors, explained through the following theoretical components: mindfulness and cognitive behavioral therapy. Participants will be guided through the program in a structured manner. They will start by accessing the CANVAS online platform, where they will find the content of the sessions in video, audio, and text formats. They will then be directed to practice exercises at home, with audiovisual material to guide them. It's crucial that participants complete the six sessions sequentially, as each session is designed to build upon the previous one, ensuring a comprehensive learning experience and effective learning. **Name:** "Universal preventive intervention for depression and anxiety for university students" **Other Names:** - Cuidate **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Acceptability will be evaluated by determining how this intervention program is received by students and the extent to which this intervention relates to the needs of this target population. The research team will develop an acceptability and satisfaction questionnaire and apply it to the intervention students. **Measure:** Acceptability Assessment **Time Frame:** through study completion, an average of 1 year **Description:** Initially, inclusion and exclusion criteria will be defined to ensure that participants are representatives of the target group. A tracking system will be implemented to monitor the number of people recruited. **Measure:** Feasibility Assessment: Number of participants recruited **Time Frame:** through study completion, an average of 1 year **Description:** A tracking system will be implemented to monitor the time needed to complete the recruitment process. **Measure:** Feasibility Assessment: Recruitment time for completion **Time Frame:** through study completion, an average of 1 year **Description:** Clear protocols will be established for data collection and analysis, ensuring accuracy and consistency. Statistical analyzes will be used to check the validity and reliability of the results. **Measure:** Feasibility Assessment: Evaluation of data collection and results. **Time Frame:** through study completion, an average of 1 year **Description:** Surveys will be used to collect opinions and perceptions of participants about the intervention and the methods used. **Measure:** Feasibility Assessment: Evaluation of the acceptability of the intervention **Time Frame:** through study completion, an average of 1 year **Description:** The completion and the time needed for completion of each module of the intervention will be registered. **Measure:** Feasibility Assessment: Level of progress of the participants in the sessions. **Time Frame:** through study completion, an average of 1 year **Description:** It is an 8-item instrument validated in English and translated and validated into Spanish that measures general satisfaction with health services received in various populations. The answers are Likert-type with four options each. In addition, there is space to write down comments and suggestions. This instrument will be slightly adapted to questions oriented to the study context. The Customer Satisfaction Questionnaire has an internal consistency ranging between α=0.83 and α=0.93. Each item on the CSQ-8 is rated on a 4-point scale, generally ranging from 1 (low satisfaction) to 4 (high satisfaction). Therefore, the minimum possible score on the CSQ-8 is 8 (1 point on each of the 8 items), and the maximum score is 32 (4 points on each item). A higher score on the CSQ-8 indicates greater client satisfaction with the services received, which is considered a better outcome. In this context, a higher score is better, as it reflects a better customer perception of the service. **Measure:** Client Satisfaction Questionnaire (CSQ-8) **Time Frame:** through study completion, an average of 1 year #### Secondary Outcomes **Description:** It is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which rates each of the 9 Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria from "0" (Never) to "3" (Almost Every Day). In Chile, it has been validated among people aged 20 years and over, with a sensitivity of 92% and a specificity of 89%, compared to the Hamilton Depression Scale. In addition, it has construct validity and concurrent predictive validity with the The International Classification of Diseases, 10th Revision (CIE-10) criteria for depression. The interpretation is made by adding the total of the first nine questions: 0-4 points, without depression; 5-9, mild depression; 10-14, moderate depression; 15-19, moderately severe depression; 20-27, severe depression. **Measure:** Patient Health Questionnaire-9 (PHQ-9) **Time Frame:** through study completion, an average of 1 year **Description:** GAD-7 was originally designed primarily as a screening and severity measure for generalized anxiety disorder, this instrument also has good performance characteristics for other common anxiety disorders: panic disorder, social anxiety disorder, and post-traumatic stress disorder. This consists of 7 questions. The score is calculated by assigning scores from 0 to 3 to response categories from "Never" to "Almost Every Day." It has been validated in Spanish, where a cut-off score of 10 showed adequate values of sensitivity (86.8%) and specificity (93.4%). The scale was significantly correlated with Hamilton Anxiety scal (HAM-A) (0.852, p \< 0.001), Hospital Anxiety and Depression Scale (HADS ) (anxiety domain, 0.903, p \< 0.001), and World Health Organization Disability Scale (WHO-DAS II) (0.696, p \< 0.001). The GAD-7 total score for the seven items ranges from 0 to 21 **Measure:** Generalized Anxiety Disorder (GAD-7) **Time Frame:** through study completion, an average of 1 year **Description:** It is an initiative of the National Institute of Health to develop measures that assess function and well-being in physical, mental, and social health domains. It has been translated into multiple languages and multiculturally validated. This instrument evaluates five areas: physical function, pain, fatigue, emotional stress, and social health. Four items are used to assess overall physical health, 3 of which use 5-category scales, and one item uses a 1-10 scale. Four items are used to determine global mental health, all using 5-category scales. Studies with the Spanish version of this instrument show good psychometric behavior. **Measure:** PROMIS Global Health v1.2.: Patient-Reported Outcomes Measurement Information System (PROMIS) **Time Frame:** through study completion, an average of 1 year **Description:** This instrument allows us to evaluate how people experience and endure distressing psychological states. The scale is constructed of 15 items, divided into four subscales that measure four factors: Tolerance (items 1, 3, and 5), understood as the perceived ability to handle strong emotions; Relief (items 2, 4, and 15), considered as "how relieved a person feels when they experience a strong emotion"; Evaluation (items 6, 7, 9, 10, 11 and 12), understood as the person's perceived ability to accept their strong emotions; and, Regulation (items 8, 13 and 14), understood as the effort that a person makes to manage their intense emotions openly. DTS is a scale designed to be self-administered that is answered using a type format. **Measure:** Distress Tolerance Scale (DTS) **Time Frame:** through study completion, an average of 1 year **Description:** It is a self-report instrument that measures the patient's perception of their insomnia. Its objective is subjective symptoms and consequences of insomnia. It was validated in English-speaking and Spanish-speaking populations. It is composed of 7 items, which gives a score that varies from 0 to 28, with clinical insomnia with 15 or more points. **Measure:** Insomnia Severity Index (ISI) **Time Frame:** through study completion, an average of 1 year **Description:** Is a 6-item self-report instrument of two common emotion regulation strategies: cognitive reappraisal (i.e., changing the way one thinks about a situation to change its emotional impact) and expressive suppression (i.e., inhibiting the expression behavior of emotion). It has a high level of reliability for each of the subscales: cognitive reappraisal subscale (α=0.87) and expressive suppression subscale (α=0.76). Each item on the ERQ-S is scored on a 7-point Likert scale, ranging from 1 (strongly disagree) to 7 (strongly agree). In the short version of 6 items (3 for each subscale), the minimum possible score would be 6 (1 point in each of the 6 items) and the maximum would be 42 (7 points in each of the 6 items). In terms of interpretation of the scores, a higher score on each subscale indicates more frequent use of that specific emotion regulation strategy. **Measure:** The Emotion Regulation Questionnaire-Short Form (ERQ-S) **Time Frame:** through study completion, an average of 1 year **Description:** It is a 12-item scale that measures mindfulness in everyday situations. The items are scored from one to four on a Likert-type scale where 1 refers to "rarely or never" and 4 means "almost always." Therefore, the minimum possible score on the CAMS-R is 12, and the maximum score is 48. A higher score on the CAMS-R indicates a greater disposition or ability in mindfulness or full attention. It measures four subscales: attention, attentional focus on the present, awareness, and acceptance without judgment regarding thoughts and feelings in daily life. Despite measuring them in four factors, it analyzes them generally without separating them, offering a global score. According to different studies, internal consistency ranges from α=0.74 to α=0.80, with a negative correlation between depression and anxiety and a positive correlation with cognitive flexibility and well-being. **Measure:** Cognitive and Affective Mindfulness Scale-Revised (CAMS-R) **Time Frame:** through study completion, an average of 1 year **Description:** Evaluates which components of Cognitive behavioral therapy (CBT) appear to be most active. This scale originally has 16 items that measures two skills: cognitive restructuring (CR) and behavioral activation (BA). Respondents rate each item on a 5-point Likert scale, from 1 (I don't do this) to 5 (I always do this). Both scales have good reliability (CR: α=0.88; BA: α=0.85). Two items refer to evaluating aspects related to a disease or treatment. Since cognitive-behavioral skills are evaluated in this study, these two items of the questionnaire are included, leaving an instrument of 14 items. In a study whose publication is under review with adolescents between 15 and 18 years old, using the 14-item instrument, it was found that the reliability was α=0.77 and ω=0.78 for BA and α=0, 80 and ω=0.81 for CR. The minimum score would be 14 and the maximum would be 70. A higher score on the CBTSQ indicates greater competence and use of cognitive behavioral therapy skills. **Measure:** The Cognitive-behavioral Therapy Skills Questionnaire (CBTSQ) **Time Frame:** through study completion, an average of 1 year **Description:** The first 5 items explore the presence of suicidal ideation, intention, and planning and are assessed over the past month. The sixth item explores suicidal behavior either as preparation, initiation of a suicide attempt, or a suicide attempt itself in the last three months. Each item is answered Yes or No. It has been validated in an English-speaking population (range of internal reliability goes from α=0.73 to α=0.93) and a Spanish-speaking population (α=0.53). The total score range is from 0 to 6 points. According to the answers provided To the different items, the categories of severity of suicidal ideation are established: If the answer is "Yes" to item 1 and/or item 2 and "No" to all the other items, a slight risk is indicated. If the answer is "Yes" to item 2 and answer "Yes" only to item 3, it suggests that the risk is moderate. If the answer si "Yes" to item 2 and the answer is "Yes" to any of items 4, 5, and 6, it indicates that the risk is severe. **Measure:** Columbia-Suicide Severity Rating Scale (C-SSRS) **Time Frame:** through study completion, an average of 1 year **Description:** Questions developed by the team will be used about history and previous mental health treatments and consultation with mental health services. Answers range from 0=No and 1=Yes. **Measure:** Mental Health History and Treatment: **Time Frame:** through study completion, an average of 1 year **Description:** Three questions developed by the team will be used to meseaure physical activity (e.g., How many minutes the students practice any physical activity during the week or weekends). **Measure:** Physical activity: **Time Frame:** through study completion, an average of 1 year ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Undergraduate students from the Universidad de los Andes, from different majors. * Over 18 years. * Able to read and speak Spanish. * Availability of time to participate. Exclusion Criteria: * PHQ-9 score ≥ 15 * Active suicidality, defined as suicidal ideation, planning or attempts, or self-harming behavior in the last 12 months. The Columbia Suicidality Scale will be used to exclude students with a score ≥ 3. * Who is undergoing psychiatric treatment for a serious condition, understood as psychotic pathology and/or substance abuse. * History of hospital admission for psychiatric pathology in the last two years. **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Jorge E Gaete, MD, PhD **Phone:** +56226181000 **Phone Ext:** 2277 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Valentina Romo **Phone:** +56984038329 **Role:** CONTACT ### IPD Sharing Statement Module **Access Criteria:** Any researchers who ask the principal investigator fot secondary analysis, data anonymized. **Description:** Data about primary and secondary outcomes without identifiable variables such as name, date of birth, or others. **Info Types:** - STUDY_PROTOCOL - SAP - CSR **IPD Sharing:** YES **Time Frame:** At the end of the study and until five years after the end of the study. **URL:** https://www.ismeuandes.cl/ ### References Module #### References **Citation:** Hope V, Henderson M. 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Two-item PROMIS(R) global physical and mental health scales. J Patient Rep Outcomes. 2017;1(1):2. doi: 10.1186/s41687-017-0003-8. Epub 2017 Sep 12. **PMID:** 29757325 **Citation:** Garcia-Campayo J, Zamorano E, Ruiz MA, Pardo A, Perez-Paramo M, Lopez-Gomez V, Freire O, Rejas J. Cultural adaptation into Spanish of the generalized anxiety disorder-7 (GAD-7) scale as a screening tool. Health Qual Life Outcomes. 2010 Jan 20;8:8. doi: 10.1186/1477-7525-8-8. **PMID:** 20089179 **Citation:** Blatch-Jones AJ, Pek W, Kirkpatrick E, Ashton-Key M. Role of feasibility and pilot studies in randomised controlled trials: a cross-sectional study. BMJ Open. 2018 Sep 25;8(9):e022233. doi: 10.1136/bmjopen-2018-022233. **PMID:** 30257847 **Citation:** Orsmond GI, Cohn ES. The Distinctive Features of a Feasibility Study: Objectives and Guiding Questions. OTJR (Thorofare N J). 2015 Jul;35(3):169-77. doi: 10.1177/1539449215578649. **PMID:** 26594739 **Citation:** Segal ZV, Dimidjian S, Beck A, Boggs JM, Vanderkruik R, Metcalf CA, Gallop R, Felder JN, Levy J. Outcomes of Online Mindfulness-Based Cognitive Therapy for Patients With Residual Depressive Symptoms: A Randomized Clinical Trial. JAMA Psychiatry. 2020 Jun 1;77(6):563-573. doi: 10.1001/jamapsychiatry.2019.4693. Erratum In: JAMA Psychiatry. 2020 May 1;77(5):545. **PMID:** 31995132 **Citation:** Garland A, Weinfurt K, Sugarman J. Incentives and payments in pragmatic clinical trials: Scientific, ethical, and policy considerations. Clin Trials. 2021 Dec;18(6):699-705. doi: 10.1177/17407745211048178. **PMID:** 34766524 **Citation:** Murphy MJ, Newby JM, Butow P, Loughnan SA, Joubert AE, Kirsten L, Allison K, Shaw J, Shepherd HL, Smith J, Andrews G. Randomised controlled trial of internet-delivered cognitive behaviour therapy for clinical depression and/or anxiety in cancer survivors (iCanADAPT Early). Psychooncology. 2020 Jan;29(1):76-85. doi: 10.1002/pon.5267. Epub 2019 Nov 12. **PMID:** 31659822 **Citation:** Gross JJ, John OP. Individual differences in two emotion regulation processes: implications for affect, relationships, and well-being. J Pers Soc Psychol. 2003 Aug;85(2):348-62. doi: 10.1037/0022-3514.85.2.348. **PMID:** 12916575 **Citation:** Harrer M, Adam SH, Baumeister H, Cuijpers P, Karyotaki E, Auerbach RP, Kessler RC, Bruffaerts R, Berking M, Ebert DD. Internet interventions for mental health in university students: A systematic review and meta-analysis. Int J Methods Psychiatr Res. 2019 Jun;28(2):e1759. doi: 10.1002/mpr.1759. Epub 2018 Dec 26. **PMID:** 30585363 **Citation:** Harrer M, Adam SH, Fleischmann RJ, Baumeister H, Auerbach R, Bruffaerts R, Cuijpers P, Kessler RC, Berking M, Lehr D, Ebert DD. Effectiveness of an Internet- and App-Based Intervention for College Students With Elevated Stress: Randomized Controlled Trial. J Med Internet Res. 2018 Apr 23;20(4):e136. doi: 10.2196/jmir.9293. **PMID:** 29685870 **Citation:** Galante J, Dufour G, Vainre M, Wagner AP, Stochl J, Benton A, Lathia N, Howarth E, Jones PB. A mindfulness-based intervention to increase resilience to stress in university students (the Mindful Student Study): a pragmatic randomised controlled trial. Lancet Public Health. 2018 Feb;3(2):e72-e81. doi: 10.1016/S2468-2667(17)30231-1. Epub 2017 Dec 19. **PMID:** 29422189 **Citation:** Bullis JR, Boe HJ, Asnaani A, Hofmann SG. The benefits of being mindful: trait mindfulness predicts less stress reactivity to suppression. J Behav Ther Exp Psychiatry. 2014 Mar;45(1):57-66. doi: 10.1016/j.jbtep.2013.07.006. Epub 2013 Jul 25. **PMID:** 23994223 **Citation:** Pacheco JP, Giacomin HT, Tam WW, Ribeiro TB, Arab C, Bezerra IM, Pinasco GC. Mental health problems among medical students in Brazil: a systematic review and meta-analysis. Braz J Psychiatry. 2017 Oct-Dec;39(4):369-378. doi: 10.1590/1516-4446-2017-2223. Epub 2017 Aug 31. **PMID:** 28876408 **Citation:** Lei XY, Xiao LM, Liu YN, Li YM. Prevalence of Depression among Chinese University Students: A Meta-Analysis. PLoS One. 2016 Apr 12;11(4):e0153454. doi: 10.1371/journal.pone.0153454. eCollection 2016. **PMID:** 27070790 **Citation:** Baader TM, Rojas CC, Molina JLF, Gotelli M V., Alamo CP, Fierro CF, et al. Diagnóstico de la prevalencia de trastornos de la salud mental en estudiantes universitarios y los factores de riesgo emocionales asociados. Rev Chil Neuropsiquiatr. 2014 Sep 1;52(3):167-76. **Citation:** Barrera-Herrera, A., & San Martín, Y. (2021). Prevalencia de Sintomatología de Salud Mental y Hábitos de Salud en una Muestra de Universitarios Chilenos. Psykhe, 30(1). https://doi.org/10.7764/psykhe.2019.21813 **Citation:** Martínez, P., Jiménez-Molina, Á., Mac-Ginty, S., Martínez, V., & Rojas, G. (2021). Salud mental en estudiantes de educación superior en Chile: una revisión de alcance con meta-análisis. Terapia PsicolóGica (Impresa), 39(3), 405-426. https://doi.org/10.4067/s0718-48082021000300405). **Citation:** MacDonald HZ, Baxter EE. Mediators of the relationship between dispositional mindfulness and psychological well-being in female college students. Mindfulness. 2017;8:398-407. **Citation:** Mandal SP, Arya YK, Pandey R. Mindfulness, Emotion Regulation, and Subjective Well-Being: Exploring the Link. SIS Journal of Projective Psychology & Mental Health. 2017;24(1). **Citation:** Roemer L, Williston SK, Rollins LG. Mindfulness and emotion regulation. Current Opinion in Psychology. 2015;3:52-7. **Citation:** McDermott, R., & Dozois, D. J. A. (2019). A randomized controlled trial of Internet-delivered CBT and attention bias modification for early intervention of depression. Journal of Experimental Psychopathology, 10(2), 204380871984250. https://doi.org/10.1177/2043808719842502 **Citation:** Santana VS, Gondim SMG. Regulação emocional, bem-estar psicológico e bem-estar subjetivo. Estudos de Psicologia (Natal). 2016;21:58-68. **Citation:** Giuliani NR, Berkman ET. Craving is an Affective State and Its Regulation Can Be Understood in Terms of the Extended Process Model of Emotion Regulation. Psychol Inq. 2015;26(1):48-53. doi: 10.1080/1047840X.2015.955072. No abstract available. **PMID:** 25780321 **Citation:** Küchler, A., Kählke, F., Vollbrecht, D., Peip, K., Ebert, D. D., & Baumeister, H. (2022). Effectiveness, Acceptability, and Mechanisms of Change of the Internet-Based Intervention StudiCare Mindfulness for College Students: a Randomized Controlled Trial. Mindfulness (New York. Print), 13(9), 2140-2154. https://doi.org/10.1007/s12671-022-01949-w **Citation:** Baader T, Molina JL, Venezian S, Rojas C, Farías R, Fierro-Freixenet C, et al. Validación y utilidad de la encuesta PHQ-9 (Patient Health Questionnaire) en el diagnóstico de depresión en pacientes usuarios de atención primaria en Chile. Revista chilena de neuro-psiquiatría. 2012;50(1):10-22. **Citation:** Simons JS, Gaher RM. The Distress Tolerance Scale: Development and Validation of a Self-Report Measure. Motivation and Emotion. 2005;29(2):83-102. **Citation:** Cardoso Ribeiro C, Gómez-Conesa A, Hidalgo Montesinos MD. Metodología para la adaptación de instrumentos de evaluación. Fisioterapia. 2010;32(6):264/70. **Citation:** Vázquez, F., Otero, P., López, L., Blanco, V., Torres, Á., & Dı́Az, O. (2018). La Prevención de la Depresión en Cuidadores a través de Multiconferencia Telefónica. Clínica Y Salud, 29(1), 14-20. https://doi.org/10.5093/clysa2018a2 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001526 - Term: Behavioral Symptoms - ID: D000019964 - Term: Mood Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M7058 - Name: Depression - Relevance: HIGH - As Found: Depression - ID: M4324 - Name: Anxiety Disorders - Relevance: HIGH - As Found: Anxiety - ID: M7061 - Name: Depressive Disorder - Relevance: HIGH - As Found: Depression - ID: M4818 - Name: Behavioral Symptoms - Relevance: LOW - As Found: Unknown - ID: M21835 - Name: Mood Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003863 - Term: Depression - ID: D000003866 - Term: Depressive Disorder - ID: D000001008 - Term: Anxiety Disorders ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419855 **Brief Title:** Study to Evaluate the Effectivity and Safety of BIOSCAFF®H Compared to DuraGen®, in Patients Undergoing Dural Repair **Official Title:** Post-approval, Multicenter Study to Evaluate the Efficacy and Safety of BIOSCAFF®H, a Human Collagen Graft, Compared to DuraGen®, a Bovine-derived Graft, in Patients Undergoing Dural Repair Following Cranial Surgery #### Organization Study ID Info **ID:** TOP-1122-IV #### Organization **Class:** INDUSTRY **Full Name:** Top Health S.A.P.I DE C.V. ### Status Module #### Completion Date **Date:** 2026-05 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-05 **Type:** ESTIMATED #### Start Date **Date:** 2024-07 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** CLINICAL RESEARCH PS MEXICO #### Lead Sponsor **Class:** INDUSTRY **Name:** Top Health S.A.P.I DE C.V. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Study in which the presence or absence of symptoms or any health condition is observed and recorded 30 days after a cranial surgery in which the physician places a material or graft, either BIOSCAFF®H or DuraGen®, into the skull; this material allows the regeneration of tissue that makes up one of the layers of the brain that was affected before or during surgery. The primary hypothesis of this study is that there will be no more than a 10% difference in outcomes between the BIOSCAFF®H device and the active comparator, DuraGen®, with respect to the incidence of cerebrospinal fluid leak or the presence of pseudomeningocele. **Detailed Description:** This study will help describe the safety profile and other aspects such as quality of life of the subjects who received it. The primary objective of the study is to evaluate the efficacy of the BIOSCAFF® H graft in patients undergoing dural surgery in the absence of cerebrospinal fluid leakage compared to the active comparator. This is a prospective, multicenter, cohort, post-approval study to evaluate the efficacy and safety of BIOSCAFF®H. It consists of a screening period and a follow-up period up to 52 weeks after surgery. Medical records of patients who underwent surgery less than 30 days post-operatively and were implanted with the BIOSCAFF®H human collagen dural substitute or the active bovine collagen-based comparator, DuraGen®, will be considered. It is estimated that approximately 86 dural surgery patients will be enrolled. ### Conditions Module **Conditions:** - Cerebrospinal Fluid Leakage **Keywords:** - Dural surgery - Sealing - Leakage - Cerebrospinal fluid - Collagen matrix graft - Dura ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 86 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Is a porous cross-linked human collagen Matrix or Sponge, used as a scaffold in the repair and restoration of dura mater defects, following craniotomy, laminectomy or in general when there is intentional (surgical procedure) or accidental damage to the dura mater. **Intervention Names:** - Device: Human collagen matrix graft **Label:** Human collagen matrix graft #### Arm Group 2 **Description:** Is a porous type 1 collagen matrix derived from bovine Achilles tendon, this matrix is absorbed after 8 weeks and is used for the repair and restoration of dura mater defects. **Intervention Names:** - Device: Bovine collagen matrix graft **Label:** Bovine collagen matrix graft ### Interventions #### Intervention 1 **Arm Group Labels:** - Human collagen matrix graft **Description:** Is a porous cross-linked human collagen Matrix or Sponge, used as a scaffold in the repair and restoration of dura mater defects, following craniotomy, laminectomy or in general when there is intentional (surgical procedure) or accidental damage to the dura mater. **Name:** Human collagen matrix graft **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - Bovine collagen matrix graft **Description:** Is a porous type 1 collagen matrix derived from bovine Achilles tendon, this matrix is absorbed after 8 weeks and is used for the repair and restoration of dura mater defects. **Name:** Bovine collagen matrix graft **Type:** DEVICE ### Outcomes Module #### Other Outcomes **Description:** The concentration of the immunoglobulins IgG, IgE, IgM, IgA in serum or plasma. **Measure:** To evaluate the serum/plasma concentration of immunoglobulins IgG, IgE, IgM, IgA as possible indicators of immunogenicity in BIOSCAFF®H compared to those implanted with DuraGen®. **Time Frame:** 180 days post-surgery **Description:** Change in Manchester Scale Score (MSS) during the first 6 months after surgery. It evaluates and rates 7 scar parameters: scar color (perfect, slight, obvious, or gross mismatch to surrounding skin), skin texture (matte or shiny), relationship to surrounding skin (range from flush to keloid), texture (range from normal to hard), margins (distinct or indistinct), size (\<1 cm, 1-5 cm, \>5 cm), and single or multiple. Results are converted to a scale of 5 (excellent scar) to 28 (worst scar). **Measure:** To evaluate wound healing 180 days after surgery **Time Frame:** 180 days post-surgery #### Primary Outcomes **Description:** To evaluate effectiveness of BIOSCAFF®️H graph in patients who underwent dural surgery on the incidence of cerebrospinal fluid leakage versus an active comparator **Measure:** Incidence of cerebrospinal fluid leakage **Time Frame:** 52 weeks post-surgery #### Secondary Outcomes **Description:** To evaluate the safety of BIOSCAFF®️H in relation to DuraGen®️ using the Modified Rankin Score (mRS-9Q), It consists of 9 questions to evaluate the degree of disability of the patient, with a minimum value of 0 indicating no symptoms and a maximum value of 5 indicating severe disability. **Measure:** To evaluate the safety of BIOSCAFF®️H in relation to DuraGen®️ at 60, 90 and 180 days post-surgery in patients who underwent dural surgery compared to day 30 post-surgery using the Modified Rankin Score (mRS-9Q). **Time Frame:** 180 days post-surgery **Description:** To evaluate the safety of BIOSCAFF®️H in relation to DuraGen®️ using the Barthel Index, which consists of 10 questions to assess the patient's level of disability, with a minimum score of 0 and a maximum score of 100 indicating severe disability. The closer a subject's score is to 0, the more dependent he/she is; the closer to 100, the more independent he/she is. **Measure:** To evaluate the safety of BIOSCAFF®️H in relation to DuraGen®️ at 60, 90 and 180 days post-surgery in patients who underwent dural surgery compared to day 30 post-surgery using the Barthel Index. **Time Frame:** 180 days post-surgery **Description:** To compare the results of the SF-36 and EQ-5D-5L quality of life scales in dural surgery patients implanted with BIOSCAFF®H or DuraGen® on days 60, 90, and 180 postoperatively compared to day 30 postoperatively. The SF-36 is a self-administered instrument consisting of 36 questions. For each scale, the responses to each question are coded and recoded (10 questions), and the results are converted to a scale from 0 (worst health) to 100 (best health). The EQ-5D-5L scale is a standardized measure of health status used to provide a simple, generic measure of health for clinical and economic evaluation with five dimensions. The maximum value is 100, which represents the best health you can imagine, and the minimum value of 0 represents the worst health you can imagine. It should be used in conjunction with the EuroQol website. After applying both scales to the patients, the results are compared. **Measure:** Compare the quality of life in patients who underwent dural surgery and were implanted **Time Frame:** 180 days post-surgery **Description:** Frequency of surgical site infections at 30, 60, 90, and 180 days after surgery. **Measure:** To evaluate the incidence of infection with BIOSCAFF®H at 30 days post-surgery compared to the active comparator and the safety of BIOSCAFF®H on the incidence of surgical site infections at 30, 60, 90 and 180 days post-surgery compared to DuraGen®. **Time Frame:** 180 days post-surgery **Description:** Adverse events and serious adverse events from day 0 through week 52 after surgery. **Measure:** To evaluate the incidence of adverse events and serious adverse events for BIOSCAFF®H compared to DuraGen® from day 0 to week 52 after surgery. **Time Frame:** 52 weeks post-surgery ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adults ≥18 years of age up to 70 years of age, of both sexes. * Patients who agree to participate and are able to provide written informed consent. * Patients who underwent dural surgery or duraplasty for pathological processes or who required dural grafting at the neurosurgeon's discretion with a maximum of 30 days postoperatively. * Patients in need of an incision of at least 2 cm in length. Exclusion Criteria: * Presence of empyema/subdural abscess or any type of systemic infection affecting/infiltrating the dura mater detected by the physician prior to surgery. * Diagnosis of malignant cranial tumor(NOTE: patients without a diagnosis of malignancy will still be allowed to enter the study). * The diagnosis of malignancy will be considered according to the classification of Tumors of the Central Nervous System, stipulated by the World Health Organization version 2021, considering the lowest taxonomic hierarchy (specific) of the tumor available in the diagnosis considering: Category, family or class, type and subtype. * The ICD-O morphological coding system will be used, to classify tumors as benign (Eligible) and malignant (Ineligible), considering: /0 for benign tumors; /1 nonspecific, borderline or of uncertain behavior as tumors that can be included in the study, while those coded as /2, /3 and /6 or metastatic tumors as ineligible. In APPENDIX 4 "Patient eligibility associated with the listing of tumors in the central nervous system" the classification of tumors according to the above-mentioned document is listed for clearer reference. * Drowsy or comatose patients at the time of screening. * Serum creatinine levels \>2.0 mg/dL. * Patient with a total bilirubin level \>2.5 mg/dL. * Previous surgery at the same site or patients with a previous craniotomy/craniectomy within 6 months prior to the study surgery. * Inability to read and understand protocol information by the participant. * History of symptomatic hydrocephalus. * Patients who have received chemotherapy or radiation therapy in the surgical region that was completed within 3 months prior to the planned surgery or are scheduled for the next 12 weeks. * Known history of hemophilia or other clinically significant coagulopathy. * Previous participation in any related device or investigational drug study within 30 days prior to screening. * Medical history report of status epilepticus in the patient. * Patients with uncontrolled diabetes according to ADA criteria: fasting glucose ≥200 mg/dL, HbA1C ≥8.5%. * Patients in whom radiological contrast medium is contraindicated. * Women who are breastfeeding or pregnant. * Patients with a body mass index (BMI) ≥ 35 kg/m2. **Maximum Age:** 70 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Adult patients of private and public clinical care, who have undergone dural surgery, residents of different states of Mexico ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Ana P. Villarruel Ornelas, BIB **Phone:** +52 33 2316 2042 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Yubitza I. Lara Vargas, BCSE **Phone:** +52 33 2316 2042 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Top Health S.A.P.I DE C.V. **Name:** Juan P. Aguilar Alemán, PhD **Role:** STUDY_DIRECTOR **Official 2:** **Affiliation:** Top Health S.A.P.I DE C.V. **Name:** Beni Camacho Perez, PhD **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Rosen CL, Steinberg GK, DeMonte F, Delashaw JB Jr, Lewis SB, Shaffrey ME, Aziz K, Hantel J, Marciano FF. Results of the prospective, randomized, multicenter clinical trial evaluating a biosynthesized cellulose graft for repair of dural defects. Neurosurgery. 2011 Nov;69(5):1093-103; discussion 1103-4. doi: 10.1227/NEU.0b013e3182284aca. **PMID:** 21670715 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009422 - Term: Nervous System Diseases - ID: D000006259 - Term: Craniocerebral Trauma - ID: D000020196 - Term: Trauma, Nervous System - ID: D000014947 - Term: Wounds and Injuries ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M30548 - Name: Cerebrospinal Fluid Leak - Relevance: HIGH - As Found: Cerebrospinal Fluid Leakage - ID: M12404 - Name: Neurologic Manifestations - 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: T1068 - Name: Cerebrospinal Fluid Leak - Relevance: HIGH - As Found: Cerebrospinal Fluid Leakage ### Condition Browse Module - Meshes - ID: D000065634 - Term: Cerebrospinal Fluid Leak ### Intervention Browse Module - Browse Branches - Abbrev: Repr - Name: Reproductive Control Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M266279 - Name: Estradiol 17 beta-cypionate - Relevance: LOW - As Found: Unknown - ID: M266280 - Name: Estradiol 3-benzoate - Relevance: LOW - As Found: Unknown - ID: M8108 - Name: Estradiol - Relevance: LOW - As Found: Unknown - ID: M234941 - Name: Polyestradiol phosphate - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419842 **Acronym:** HYPNINF **Brief Title:** Impact of Hypnosis for Performing Lumbar Infusion Tests **Official Title:** Evaluation of the Impact of Hypnosis for Performing Lumbar Infusion Tests. #### Organization Study ID Info **ID:** PI2023_843_0149 #### Organization **Class:** OTHER **Full Name:** Centre Hospitalier Universitaire, Amiens ### Status Module #### Completion Date **Date:** 2026-07 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-05 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-14 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Centre Hospitalier Universitaire, Amiens #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Infusion tests are now the gold standard for the diagnosis of chronic adult hydrocephalus (CAH), also known as normal pressure hydrocephalus. It is an invasive procedure using the same approach as a lumbar puncture. Once the intrathecal puncture is performed, the intracranial pressure is measured in lateral decubitus via a pressure head. Dynamic tests (injection of 0.9% NaCl at a constant flow rate) are performed after recording the basal pressure. This type of test lasts 30 to 45 minutes in lateral decubitus. Patients with CAH have cognitive-behavioral disorders that can alter the gesture and its interpretation in case of movements or contractures. Movement artefacts lead to a longer recording time. The longer the test, the more the patients' tolerance tends to decrease. Moreover, the patient's feeling towards this test is important because it may have to be repeated. Pain, anxiety and patient comfort are essential parameters to consider. Non-medicinal techniques (hypnosis, music therapy) have shown a tendency to reduce anxiety in pediatric and adult populations with an impact on instantaneous anxiety but also on personality-related anxiety. Most studies are focused on specific pathologies, primarily in palliative care, or on pediatric application. The use of these techniques in an elderly population with mild cognitive-behavioral disorders has not been explored. The objective is to evaluate the impact of hypnosis on anxiety, pain and comfort during the lumbar infusion test. ### Conditions Module **Conditions:** - Hypnosis - Hydrocephalus - Anxiety - Pain **Keywords:** - hypnosis - infusion study - Hydrocephalus - Anxiety - Pain ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** OTHER #### Enrollment Info **Count:** 90 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** In group 1, the patient benefits from a dedicated nurse consultation. During this consultation, the nurse will explain the highlights of the hospitalization, the procedure and anticipate the hypnosis technique to be used. The technique chosen during the consultation will be applied during the test. The nurse is positioned at the head of the patient and with physical contact. **Intervention Names:** - Other: hypnosis **Label:** hypnosis **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** In group 2, the patient benefits from a nurse consultation. Non-medicinal techniques are not offered. During the infusion test, the nurse will be positioned at the patient's head allowing proximity but without oral or physical intervention. **Intervention Names:** - Other: comfort **Label:** comfort **Type:** SHAM_COMPARATOR #### Arm Group 3 **Description:** In group 3, the IDE consultation is performed according to the same modalities as in group 2. During the procedure, the nurse will be out of the patient's field of vision and will assist the surgeon in the installation behind the patient. Only the surgeon will interact with the patient. **Label:** standard **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - hypnosis **Description:** the patient benefits from a dedicated nurse consultation. During this consultation, the nurse will explain the highlights of the hospitalization, the procedure and anticipate the hypnosis technique to be used. The technique chosen during the consultation will be applied during the test. The nurse is positioned at the head of the patient and with physical contact. **Name:** hypnosis **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - comfort **Description:** the patient benefits from a nurse consultation. Non-medicinal techniques are not offered. During the infusion test, the nurse will be positioned at the patient's head allowing proximity but without oral or physical intervention. **Name:** comfort **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Decrease in anxiety in group 1 compared to the other groups **Measure:** Decrease in anxiety in group 1compared to the other groups **Time Frame:** 2 years #### Secondary Outcomes **Description:** Decrease in pain on the numerical scale in group 1 versus other groups **Measure:** Decrease in pain in group 1 **Time Frame:** 2 years **Description:** Increase in comfort on the numerical scale in group 1 versus the other groups **Measure:** Increase in comfort in group 1 **Time Frame:** 2 years **Description:** Better overall patient impression (Likert scale) in group 1 versus other groups **Measure:** Better overall patient impression in group 1 versus other groups **Time Frame:** 2 years **Description:** Less heart rate variation in group 1 versus other groups **Measure:** Less heart rate variation in group 1 versus other groups **Time Frame:** 2 years **Description:** Decreased puncture time required in group 1 versus other groups **Measure:** Decreased puncture time required in group 1 versus other groups **Time Frame:** 2 years **Description:** fewer position changes required in group 1 versus other groups **Measure:** fewer position changes required in group 1 versus other groups **Time Frame:** 2 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patient over 65 years old undergoing assessment for suspected CAH in day hospitalization for a lumbar infusion test * No major cognitive impairment (MMSE\>20) Exclusion Criteria: * Patient less than 65 years old * Major cognitive impairment (MMSE\<20) * History of lumbar surgery * Contraindication to lumbar puncture or infusion test * Hearing impairment **Minimum Age:** 65 Years **Sex:** ALL **Standard Ages:** - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Laurence JANIAK, APRN **Phone:** 0322088943 **Role:** CONTACT #### Locations **Location 1:** **City:** Amiens **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Laurence JANIAK, APRN - **Phone:** 0322088943 - **Role:** CONTACT ***Contact 2:*** - **Name:** Cyril CAPEL, MD - **Role:** SUB_INVESTIGATOR **Country:** France **Facility:** CHU Amiens Picardie **State:** Picardie **Status:** RECRUITING **Zip:** 80054 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M4324 - Name: Anxiety Disorders - Relevance: LOW - As Found: Unknown - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M9907 - Name: Hydrocephalus - Relevance: HIGH - As Found: Hydrocephalus - 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: D000006849 - Term: Hydrocephalus ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419829 **Brief Title:** Physical Activity, Posture and Body Composition in Ontogeny **Official Title:** The Impact of Targeted Physical Activity on Body Composition, Posture and Physical Fitness of People of Different Ages #### Organization Study ID Info **ID:** AChwalWUHSS #### Organization **Class:** OTHER **Full Name:** Wroclaw University of Health and Sport Sciences ### Status Module #### Completion Date **Date:** 2029-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2028-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2023-01-15 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-08 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Wroclaw University of Health and Sport Sciences #### Responsible Party **Investigator Affiliation:** Wroclaw University of Health and Sport Sciences **Investigator Full Name:** Agnieszka Chwalczynska **Investigator Title:** PhD, 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 main aim of the research is to assess the impact of various forms of physical activity on body composition and posture. The basis of the research is the assessment of the current condition of people of different ages and the development of individualized physioprophylaxis programs for body posture and body weight abnormalities. In the senior group, the task of physioprophylactic programs is to prevent the loss of muscle mass, prevent falls and improve the quality of life. **Detailed Description:** The research is focused on three age groups: research in the progressive period of ontogenesis from 3 to 18 years of age, people in adulthood, and people in senior age, i.e. postmenopausal women and men over 65 years of age. The research is conducted in three stages - in the first stage: assessment of the current condition, i.e. body weight and composition, assessment of body posture, physical fitness (including age-appropriate tests), assessment of physical activity (IPAQ test, PAQ-C and PAQ-A test). ). In the second stage: development and implementation of physioprophylactic programs aimed at preventing overweight or obesity, body posture abnormalities, and reduced physical fitness. Physioprophylactic projects based on medical training are adapted to age and gender and the assessment of the current condition. The duration of the training project is 12 weeks, classes will be held twice a week for 60 minutes for adults, twice a week for 45 minutes for children over 7 years of age and twice a week for 30 minutes for preschool children. Physioprophylactic classes will complement school classes for the group under 18 years of age. The third part of the research project is the assessment of changes in body weight, body posture and physical fitness. The practical part will be complemented by meetings and lectures for the respondents and their parents (in the case of children) regarding the importance of physical activity, diet and physical fitness in the quality of life and its importance in various periods of ontogenetic development. The study of a given group will be completed with a follow-up study 6 months after the end of the research project The ongoing research project will allow the development of physioprophylactic programs with elements of medical training to counteract lifestyle diseases. ### Conditions Module **Conditions:** - Pediatric Obesity - Postural Balance - Physical Activity **Keywords:** - overweight and obesity - body posture - children's activity and physical fitness - activity and physical fitness of seniors - physioprophylaxis for falls ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** OTHER #### Enrollment Info **Count:** 1000 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Pediatric group - children aged 0-3 years old, participating in physiotherapeutic visits carried out as part of the assessment of the child's psychomotor development **Intervention Names:** - Other: psychoprophylactic program aimed at improving physical fitness - Diagnostic Test: assessment of body posture using the Kasperczyk method **Label:** Pediatric group #### Arm Group 2 **Description:** Pediatric older group - Children aged 3-6 years recruited as part of pre-school education **Intervention Names:** - Other: psychoprophylactic program aimed at normalizing body weight through medical training - Other: psychoprophylactic program aimed at improving body posture - Other: psychoprophylactic program aimed at improving physical fitness - Diagnostic Test: Body composition assessment - Diagnostic Test: assessment of body posture using the Kasperczyk method - Diagnostic Test: Assessment of physical fitness - Diagnostic Test: Balance assessment **Label:** Pediatric older group #### Arm Group 3 **Description:** School group - Children aged 7-15 recruited as part of compulsory schooling at primary school level **Intervention Names:** - Other: psychoprophylactic program aimed at normalizing body weight through medical training - Other: psychoprophylactic program aimed at improving body posture - Other: psychoprophylactic program aimed at improving physical fitness - Diagnostic Test: Body composition assessment - Diagnostic Test: assessment of body posture using the Kasperczyk method - Diagnostic Test: Assessment of physical fitness - Diagnostic Test: Balance assessment **Label:** School group #### Arm Group 4 **Description:** Respondents aged 15-25 recruited as part of secondary education, taking into account age (secondary school, university, graduate school) and gender division **Intervention Names:** - Other: psychoprophylactic program aimed at normalizing body weight through medical training - Other: psychoprophylactic program aimed at improving body posture - Other: psychoprophylactic program aimed at improving physical fitness - Diagnostic Test: Body composition assessment - Diagnostic Test: assessment of body posture using the Kasperczyk method - Diagnostic Test: Assessment of physical fitness - Diagnostic Test: Balance assessment **Label:** Youth group #### Arm Group 5 **Description:** Adult group - Respondents aged 25-55 **Intervention Names:** - Other: psychoprophylactic program aimed at normalizing body weight through medical training - Other: psychoprophylactic program aimed at improving physical fitness - Diagnostic Test: Body composition assessment - Diagnostic Test: Assessment of physical fitness - Diagnostic Test: Balance assessment **Label:** Adult group #### Arm Group 6 **Description:** Senior group - Tests at the age of over 55, in the case of women, the condition for inclusion in this group is the postmenopausal period **Intervention Names:** - Other: psychoprophylactic program aimed at normalizing body weight through medical training - Other: psychoprophylactic program aimed at improving body posture - Other: psychoprophylactic program aimed at improving physical fitness - Diagnostic Test: Body composition assessment - Diagnostic Test: assessment of body posture using the Kasperczyk method - Diagnostic Test: Assessment of physical fitness - Diagnostic Test: Balance assessment **Label:** Senior group ### Interventions #### Intervention 1 **Arm Group Labels:** - Adult group - Pediatric older group - School group - Senior group - Youth group **Description:** Based on the assessment of body weight and composition, a 12-week physiophylactic program will be carried out, adapted to the age and gender of the subjects. The program will be carried out twice a week for 30 to 60 minutes (depending on the group). The basis of the program will be the implementation of exercises that reduce fat mass, increase the flexibility and productivity of muscle mass. The classes will be conducted as part of medical training with a training load increasing to at least 85% of HR Max. The project will include theoretical classes for parents, children and seniors on eating habits, a proper age-appropriate diet, diet changes depending on the subject's health condition and physical activity, and the impact of diet on the process of puberty, adulthood and aging. **Name:** psychoprophylactic program aimed at normalizing body weight through medical training **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Pediatric older group - School group - Senior group - Youth group **Description:** Based on the body posture assessment, a 12-week physiotherapy program will be carried out, adapted to the age and gender of the subjects. The program will be carried out twice a week for 30 to 60 minutes (depending on the group). The basis of the program will be the implementation of exercises that strengthen the muscle corset, reducing asymmetrical positioning, habitual and during the implementation of professional tasks. The classes will be conducted using medical training and resistance exercises. The project will include theoretical classes for parents on sitting habits, the importance of physical activity in a child's development, the selection of footwear... **Name:** psychoprophylactic program aimed at improving body posture **Type:** OTHER #### Intervention 3 **Arm Group Labels:** - Adult group - Pediatric group - Pediatric older group - School group - Senior group - Youth group **Description:** Based on the assessment of physical fitness, a 12-week physiotherapy program will be carried out, adapted to the age and gender of the participants. The program will be carried out twice a week for 30 to 60 minutes (depending on the group). The basis of the program will be the implementation of exercises aimed at improving physical fitness, with particular emphasis on impaired motor skills. The classes will be conducted using functional training, resistance and stretching exercises, strengthening all muscle groups. In the case of children, special attention will be paid to the strength of the upper limbs, in the case of seniors, balance and coordination exercises will be introduced to improve time and space orientation. In all groups, the main goal is to improve functional fitness The project will include theoretical classes for parents, children and seniors on the importance of physical activity in the quality of life, in the process of maturation and aging. **Name:** psychoprophylactic program aimed at improving physical fitness **Type:** OTHER #### Intervention 4 **Arm Group Labels:** - Adult group - Pediatric older group - School group - Senior group - Youth group **Description:** Body composition assessment will be carried out using the BIA method on an eight-electrode body composition analyzer from TAnita. They will be marked: total mass, Total fat mass (FM) and segmental fat mass for five body segments: right leg (RL FM), Left leg (LL FM), right arm (RA FM), Left Arm (LA FM) trunk (TR FM). total fat-free mass (FFM) and segmental for five body segments: right leg (RL FFM), Left leg (LL FFM), right arm (RA FFM), Left Arm (LA FMM) trunk (TR FMM). Predicted total and segmental muscle mass (PMM) for five body segments: right leg (RL PMM), Left leg (LL PMM), right arm (RA PMM), Left Arm (LA PMM) trunk (TR PMM). Total water content (TBW) including intracellular water (ICW) and extracellular water (ECW) **Name:** Body composition assessment **Type:** DIAGNOSTIC_TEST #### Intervention 5 **Arm Group Labels:** - Pediatric group - Pediatric older group - School group - Senior group - Youth group **Description:** The Kasperczyk method was used to assess body posture, including physiotherapeutic assessment in both standing and sitting positions. The symmetry of the head, shoulders, spine curvatures, knee joints and foot positioning were assessed. The symmetry of the head position was examined in all three planes and in all movements, i.e. flexion - extension, right turn - left turn, rotation and combined movements. The lateral curvatures of the spine (scoliosis) and their physiological curvatures, their deepening or shallowing in all sections of the spine, as well as the mobility of the spine in all physiological planes of movement were assessed. The position of the shoulder and hip girdle was assessed, as well as the position of the upper limbs at the level of the knees and feet. The mobility of the lower and upper limbs was examined. **Name:** assessment of body posture using the Kasperczyk method **Type:** DIAGNOSTIC_TEST #### Intervention 6 **Arm Group Labels:** - Adult group - Pediatric older group - School group - Senior group - Youth group **Description:** It depends on the age of the person being examined. In the case of children, the EUROFIT physical fitness test is carried out with modifications for age and gender. For the senior group, the Rikli and Jones test is used **Name:** Assessment of physical fitness **Type:** DIAGNOSTIC_TEST #### Intervention 7 **Arm Group Labels:** - Adult group - Pediatric older group - School group - Senior group - Youth group **Description:** Balance assessment using the Zebris platform Static measurement - with eyes open and closed, assessing the load on the limbs during standing expressed in %, Balance analysis measurement - with eyes open and closed, test in a standing position, barefoot. The measurement duration is 30 seconds and the break between measurements is 30-60 seconds. Deflections of the center of gravity in the frontal and sagittal planes Length of the center of gravity swing path CoP - SPL \[cm\]. Inside the calculated ellipse lies 95% of the CoP location measurement data: amplitude, amplitude height, ellipse area (orientation of the direction of the ellipse's longitudinal axis relative to the platform's longitudinal axis, indicating clockwise rotation). **Name:** Balance assessment **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** The result of the project will be the development of physioprophylactic programs based on medical training aimed at normalizing body weight, improving and correcting body posture and improving physical fitness. The programs will be adapted to the problems diagnosed in control tests and the age and gender of the examined children and adolescents Their final effectiveness will be assessed during follow-up tests performed immediately after the end of the 12-week program and follow-up tests after 6 months. **Measure:** A physioprophylactic program for children aimed at normalizing body weight, improving physical fitness and correcting body posture **Time Frame:** 01.2027-12.2027 **Description:** The result of the preliminary tests will be an estimate of the scale of occurrence of body weight abnormalities and body posture abnormalities, which are not monitored during this period. An important cognitive element will also be the assessment of the physical fitness of adults, taking into account their age, gender, body weight, forms of work undertaken, and exposure to stress. Their final effectiveness will be assessed during follow-up tests performed immediately after the end of the 12-week program and follow-up tests after 6 months. **Measure:** Physiophylaxis in adulthood **Time Frame:** 01.2026-06.2027 **Description:** The result of the preliminary tests will be an estimate of the scale of occurrence of body weight abnormalities and body posture abnormalities, which are not monitored during this period. The physioprophylactic programs carried out will enable the development of standardized training programs aimed at improving the elderly's physical fitness, preventing falls, and maintaining the functionality and independence of older people. An important cognitive element will also be the assessment of the physical fitness of seniors, taking into account their age, gender, body weight, previously undertaken forms of work, exposure to stress, and quality of life. Their final effectiveness will be assessed during follow-up tests performed immediately after the end of the 12-week program and follow-up tests after 6 months. **Measure:** Physiophylaxis in seniors **Time Frame:** 01.2028-12.2028 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Informed written consent to participate in research and physical activity project of the examined person or his/her parent or legal guardian * There are no health contraindications to physical activity * no contraindications to the use of the bioelectrical impedance method (pacemaker, active cancer, pregnancy, metal elements in the body) Exclusion Criteria: * Remaining under the care of the Awad Postway correction clinic active therapeutic process of weight reduction * being under the care of a cardiology clinic due to heart and/or circulatory system diseases - high blood pressure * Condition after injuries to the spine, * Orthopedic equipment - orthoses, prostheses, splints, crutches, walking aids * lack of contact with the patient, impaired cognitive functions, inability to understand instructions when working in a group * Diseases of the central nervous system * Parkinson's disease, advanced senile dementia **Healthy Volunteers:** True **Maximum Age:** 90 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** The study group will be recruited from people living in the city of Wrocław and Lower Silesia from primary medical care centers, educational centers - kindergartens, and randomly selected primary schools. The Adult Group consists of people attending randomly selected secondary schools and various universities. The ej group will also include non-students recruited by invitation to participate in the research. The group of adults consists of people recruited on the basis of an open invitation carried out via social media, health facilities and large workplaces. The senior group will be recruited on the basis of an invitation addressed to senior activation centers ### Contacts Locations Module #### Locations **Location 1:** **City:** Wrocław **Country:** Poland **Facility:** Faculty of Physiotherapy, Department of Human Biology **State:** Dolnośląskie **Zip:** 51-612 #### Overall Officials **Official 1:** **Affiliation:** Wroclaw Uniwersity of Health and Sport Sciences **Name:** AGNIESZKA CHWAŁCZYŃSKA, PROF **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009765 - Term: Obesity - ID: D000050177 - Term: Overweight - ID: D000044343 - Term: Overnutrition - ID: D000009748 - Term: Nutrition Disorders - ID: D000001835 - Term: Body Weight ### Condition Browse Module - Browse Branches - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M12701 - Name: Obesity - Relevance: LOW - As Found: Unknown - ID: M26186 - Name: Overweight - Relevance: LOW - As Found: Unknown - ID: M30155 - Name: Pediatric Obesity - Relevance: HIGH - As Found: Pediatric Obesity - 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: D000063766 - Term: Pediatric Obesity ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419816 **Brief Title:** Effect of Linking Data Using Smartphone Application, 'Well Check', on Clinical Outcomes in Patients With Type 2 Diabetes Mellitus **Official Title:** A Primary Care-Based, Prospective, Multicenter, Cluster-Randomized, Pragmatic Clinical Trials to Determine the Effect of Linking Data With Investigators When Using the Electronic Health Record-Linked Smartphone Application, 'Well Check', on Clinical Outcomes in Patients With Type 2 Diabetes Mellitus #### Organization Study ID Info **ID:** DW_ODNENV_DB_01 #### Organization **Class:** INDUSTRY **Full Name:** Daewoong Pharmaceutical Co. LTD. ### Status Module #### Completion Date **Date:** 2026-06-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-30 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Daewoong 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 clinical study aims to evaluate the effects of using the "WellCheck" mobile application on blood glucose, blood pressure, and weight among Type 2 diabetes patients in real primary care settings. It is a prospective, multi-center, cluster-randomized, pragmatic clinical trial. Patients who can use the digital healthcare mobile application without difficulty are recruited based on the clinical judgment of the attending physician. **Detailed Description:** The study employs a 1:1 cluster-randomized allocation to differentiate between intervention (physician-managed "WellCheck" use) and control groups (self-managed "WellCheck" use) within primary care facilities where intervention and control groups are treated separately. Data collection includes demographic information, physical measurements, vital signs, laboratory tests, and safety evaluations for up to 24 weeks following the initiation of "WellCheck" use. While data collection aligns with routine clinical practice, additional follow-up visits are scheduled at 6, 12, 18, and 24 weeks post-baseline for efficacy and safety assessments. Researchers will collect necessary data based on routine clinical records and "WellCheck" data. ### Conditions Module **Conditions:** - Type 2 Diabetes ### Design Module #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 480 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** mobile application "WellCheck" use **Intervention Names:** - Other: Physician-managed "WellCheck" use - Other: self-managed "WellCheck" use **Label:** Patients with type 2 diabetes ### Interventions #### Intervention 1 **Arm Group Labels:** - Patients with type 2 diabetes **Description:** Physician-managed "WellCheck" use **Name:** Physician-managed "WellCheck" use **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Patients with type 2 diabetes **Description:** self-managed "WellCheck" use **Name:** self-managed "WellCheck" use **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** change in glycated hemoglobin (HbA1c) levels at 24 weeks from baseline **Measure:** change in glycated hemoglobin (HbA1c) levels **Time Frame:** 24 weeks #### Secondary Outcomes **Description:** change in glycated hemoglobin (HbA1c) levels at 12 weeks from baseline **Measure:** change in glycated hemoglobin (HbA1c) levels **Time Frame:** 12 weeks **Description:** change in FPG levels at 12 weeks from baseline **Measure:** change in FPG levels **Time Frame:** 12 weeks **Description:** change in FPG levels at 12 weeks from baseline **Measure:** change in FPG levels **Time Frame:** 24 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Adults aged 19 years and older. 2. Patients with Type 2 diabetes who are scheduled to receive initial treatment with Enavogliflozin or Enavogliflozin Extended-Release Tablets based on the attending physician's medical judgment, within the following insurance coverage ranges: * Enavogliflozin monotherapy * Combination therapy of Enavogliflozin with two agents (metformin) * Combination therapy of Enavogliflozin with three agents (metformin + DPP-4 inhibitor) 3. Individuals who have received detailed explanation and have understood the nature of the observational study and the investigational drug, and have provided written consent to participate voluntarily in the observational study and to comply with subject precautions during the study period. Exclusion Criteria: 1. Individuals with diabetes other than Type 2 diabetes (Type 1 diabetes, diabetic ketoacidosis, gestational diabetes, etc.). 2. Individuals who are contraindicated for Enavogliflozin or Enavogliflozin Extended-Release Tablets based on the approved indications: * Patients with a history of hypersensitivity reactions to the components of Enavogliflozin or Enavogliflozin Extended-Release Tablets * Patients with an eGFR (estimated Glomerular Filtration Rate) less than 30 mL/min/1.73m2, end-stage renal disease, or undergoing dialysis * Patients with moderate to severe hepatic impairment (AST or ALT \> 3 times the upper limit of normal, Total Bilirubin \> 2 times the upper limit of normal, hepatitis or hepatic failure) * Patients classified as NYHA (New York Heart Association) class III or IV 3. Patients initiating treatment with Enavogliflozin or Enavogliflozin Extended-Release Tablets at enrollment with an eGFR of less than 60ml/min/1.73m2. 4. Patients with unstable weight due to treatment with obesity drugs or weight loss medications within 3 months prior to enrollment or other treatments (surgery, dietary therapy, etc.). 5. Pregnant and lactating women. 6. Individuals currently participating in another clinical trial and receiving investigational drugs or investigational medical devices. 7. Other individuals deemed unsuitable for participation in the observational study based on the investigator's (attending physician's) judgment. **Maximum Age:** 80 Years **Minimum Age:** 19 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** According to the calculation using G\*Power 3.1.9.7, the required sample size for conducting this study is determined to be 11,698 individuals. Considering an approximate dropout rate of 30%, recruitment of around 15,000 participants is planned. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** NaRi Kim **Phone:** 82-10-6611-7051 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## 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 Mellitus - 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: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419803 **Acronym:** START2 **Brief Title:** Strict Versus Permissive Thresholds for Initiation of Pharmacotherapy in Gestational Diabetes (START 2) **Official Title:** Strict Versus Permissive Threshold for Initiation of Pharmacotherapy in Gestational Diabetes Mellitus (GDM) With Continuous Glucose Monitoring Use - A Randomized Control Trial (START 2 Trial) #### Organization Study ID Info **ID:** iRISID-2024-3181 #### Organization **Class:** OTHER **Full Name:** Thomas Jefferson University ### Status Module #### Completion Date **Date:** 2026-05 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-05 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-27 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** University of Rochester #### Lead Sponsor **Class:** OTHER **Name:** Thomas Jefferson 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 aim of our study is to compare neonatal and maternal outcomes using different thresholds for the initiation and titration of pharmacotherapy for gestational diabetes (GDM). Our goal is to compare a Strict and permissive threshold. The Strict study arm target range will be 65-120 mg/dL, with time in range goal of 70%. The permissive study arm target range will be 65-140 mg/dL, with target time in range goal of 70%. **Detailed Description:** Pregnancy is a state of insulin resistance to ensure that the growing fetus has ample nutrition. Gestational Diabetes (GDM) develops in pregnant patients with pancreatic dysfunction that leads to impairment of glucose tolerance. Various studies have examined the benefit of treatment for GDM, including the 2005 Australian Carbohydrate Intolerance Study in Pregnant Women (ACHOIS) and the 2009 Landon et al randomized controlled trials. These studies found that treatment was associated with a significant reduction in newborn complications of perinatal death, shoulder dystocia, large for gestational age infants, cesarean delivery, and birth trauma. The specific threshold value for initiation and up-titration of medical therapy is unknown. Lack of evidence leads to a wide variation in clinical practice of pharmacological initiation and titration for GDM. A systematic review and meta-analysis by Caissutti in 2019 analyzed criteria for initiating pharmacotherapy for GDM and noted the following: 12 of 15 trials initiated pharmacotherapy after 1-2 abnormal values over 1-2 weeks, 2 studies initiated pharmacotherapy after 50% of overall values were abnormal, and 1 study initiated pharmacotherapy after 30% of overall values were abnormal. However, there have been no randomized controlled trials of head-to-head comparison of different thresholds. The aim of our study is to compare neonatal and maternal outcomes using different thresholds for the initiation and titration of pharmacotherapy for GDM using continuous glucose monitor. Our goal is to compare a Strict and permissive threshold. The Strict study arm target range will be 65-120 mg/dL, with time in range goal of 70%. The permissive study arm target range will be 65-140 mg/dL, with target time in range goal of 70%. ### Conditions Module **Conditions:** - Gestational Diabetes - Pregnancy Related **Keywords:** - gestational diabetes - pregnancy - insulin - Initiation of medication ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 430 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The Strict study arm target range will be 65-120 mg/dL, with time in range goal of 70%. **Intervention Names:** - Drug: Insulin **Label:** Strict Arm **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** The permissive study arm target range will be 65-140 mg/dL, with target time in range goal of 70%. **Intervention Names:** - Drug: Insulin **Label:** Permissive **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Permissive - Strict Arm **Description:** Insulin will be used in gestational diabetics to control blood glucose levels **Name:** Insulin **Other Names:** - Lantus - Lispro - NPH - Levemir - Humalog **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Neonatal composite including the following measures: large for gestational age (LGA) of neonate defined as birth weight \>90th percentile for gestational age using the Fenton growth chart, hypoglycemia o defined as glucose \<40 mg/dL \<48 hours after birth or glucose, hyperbilirubinemia, stillbirth or neonatal death, birth trauma **Measure:** Neonatal Composite Outcome **Time Frame:** First 28 days of birth #### Secondary Outcomes **Description:** Gestational age at delivery in weeks and days **Measure:** Neonatal Outcome: Gestational Age of Birth **Time Frame:** Delivery Time **Description:** Scoring system provided a standardized assessment for infants after delivery from 0-10 **Measure:** Neonatal Outcome: APGAR Score **Time Frame:** At 1 minute of life and at 5 min of life **Description:** Birthweight in grams, Macrosomia (birthweight \>4000g, Small for gestational age (\<10th percentile based on Fenton Growth Charts) **Measure:** Neonatal Outcome: Birthweight **Time Frame:** Delivery Time **Description:** Breathing difficulties after birth requiring supplemental oxygen, mask, intubation, and/or surfactant **Measure:** Neonatal Outcome: Respiratory distress **Time Frame:** Within first 24 hours after delivery **Description:** Admission to neonatal intensive care unit (NICU) **Measure:** Neonatal Outcome: Admission to Neonatal intensive Care Unit **Time Frame:** From delivery to discharge from NICU **Description:** Maternal episode of hypoglycemia \< 60 mg/dL throughout the pregnancy **Measure:** Maternal Outcomes: Maternal hypoglycemia **Time Frame:** Initiation of insulin to delivery **Description:** An obstetric emergency where the anterior fetal shoulder becomes stuck on the maternal pubic symphysis, delaying the birth of the baby's body **Measure:** Maternal Outcomes: Shoulder Dystocia **Time Frame:** At Delivery **Description:** 3rd degree and 4th degree perineal injuries **Measure:** Maternal Outcomes: Obstetric anal sphincter injury (OASIS) **Time Frame:** At Delivery **Description:** Vacuum-assisted and Forcep-assisted vaginal Delivery **Measure:** Maternal Outcomes: Operative Delivery **Time Frame:** At Delivery **Description:** Cesarean birth **Measure:** Maternal Outcomes: Cesarean Delivery **Time Frame:** At Delivery **Description:** Defined as cumulative blood loss ≥1000 mL, or bleeding associated with signs/symptoms of hypovolemia within 24 hours of the birth process **Measure:** Maternal Outcomes: Postpartum hemorrhage **Time Frame:** Within 24 hours of delivery **Description:** Hypertensive disorders of pregnancy: gestational hypertension, Preeclampsia without severe features, Pre-eclampsia with severe features, severe range blood pressures defined as (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥110 mmHg), symptoms of central nervous dysfunction, thrombocytopenia with Platelet count \<100,000 platelets/microL, hepatic abnormalities, kidney impairment, and or pulmonary edema **Measure:** Maternal Outcomes: Hypertensive Disorders of Pregnancy **Time Frame:** From gestational age of 20 weeks during pregnancy to 6 weeks postpartum ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Live, non-anomalous fetus * Literacy in English, Spanish, Mandarin, or Arabic * Patients are also required to provide consent, demonstrate an understanding of the purpose of the study, and agree to the study protocol. Exclusion Criteria: * \<18 years at EDD * pre-existing diabetes or diagnosis of GDM prior to 24 weeks * multi-fetal gestation * known major fetal anomaly * known allergy to insulin * chronic maternal corticosteroid use * diagnosis of GDM based on finger sticks alone * patients who have contraindication to oral glucose tolerance test * a primary language other than English, Spanish, Mandarin, or Arabic **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:** Kavisha Khanuja, MD **Phone:** 2159555000 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Rodney McLaren Jr, MD **Phone:** 2159555000 **Role:** CONTACT #### Locations **Location 1:** **City:** Rochester **Contacts:** ***Contact 1:*** - **Name:** Sarah Crimmins, Do - **Role:** CONTACT **Country:** United States **Facility:** University of Rochester Medical Center **State:** New York **Zip:** 14642 **Location 2:** **City:** Philadelphia **Contacts:** ***Contact 1:*** - **Name:** Kavisha Khanuja, MD - **Role:** CONTACT ***Contact 2:*** - **Name:** Rodney McLaren, MD - **Role:** CONTACT **Country:** United States **Facility:** Thomas Jefferson University **State:** Pennsylvania **Zip:** 19107 ### References Module #### References **Citation:** Quintanilla Rodriguez BS, Mahdy H. Gestational Diabetes. 2023 Aug 8. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK545196/ **PMID:** 31424780 **Citation:** Catalano PM, Hauguel-De Mouzon S. Is it time to revisit the Pedersen hypothesis in the face of the obesity epidemic? Am J Obstet Gynecol. 2011 Jun;204(6):479-87. doi: 10.1016/j.ajog.2010.11.039. Epub 2011 Feb 2. **PMID:** 21288502 **Citation:** Gregory EC, Ely DM. Trends and Characteristics in Gestational Diabetes: United States, 2016-2020. Natl Vital Stat Rep. 2022 Jul;71(3):1-15. **PMID:** 35877134 **Citation:** Metzger BE, Persson B, Lowe LP, Dyer AR, Cruickshank JK, Deerochanawong C, Halliday HL, Hennis AJ, Liley H, Ng PC, Coustan DR, Hadden DR, Hod M, Oats JJ, Trimble ER; HAPO Study Cooperative Research Group. Hyperglycemia and adverse pregnancy outcome study: neonatal glycemia. Pediatrics. 2010 Dec;126(6):e1545-52. doi: 10.1542/peds.2009-2257. Epub 2010 Nov 15. **PMID:** 21078733 **Citation:** ACOG Practice Bulletin No. 190: Gestational Diabetes Mellitus. Obstet Gynecol. 2018 Feb;131(2):e49-e64. doi: 10.1097/AOG.0000000000002501. **PMID:** 29370047 **Citation:** Crowther CA, Hiller JE, Moss JR, McPhee AJ, Jeffries WS, Robinson JS; Australian Carbohydrate Intolerance Study in Pregnant Women (ACHOIS) Trial Group. Effect of treatment of gestational diabetes mellitus on pregnancy outcomes. N Engl J Med. 2005 Jun 16;352(24):2477-86. doi: 10.1056/NEJMoa042973. Epub 2005 Jun 12. **PMID:** 15951574 **Citation:** Landon MB, Spong CY, Thom E, Carpenter MW, Ramin SM, Casey B, Wapner RJ, Varner MW, Rouse DJ, Thorp JM Jr, Sciscione A, Catalano P, Harper M, Saade G, Lain KY, Sorokin Y, Peaceman AM, Tolosa JE, Anderson GB; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. A multicenter, randomized trial of treatment for mild gestational diabetes. N Engl J Med. 2009 Oct 1;361(14):1339-48. doi: 10.1056/NEJMoa0902430. **PMID:** 19797280 **Citation:** Hartling L, Dryden DM, Guthrie A, Muise M, Vandermeer B, Donovan L. Benefits and harms of treating gestational diabetes mellitus: a systematic review and meta-analysis for the U.S. Preventive Services Task Force and the National Institutes of Health Office of Medical Applications of Research. Ann Intern Med. 2013 Jul 16;159(2):123-9. doi: 10.7326/0003-4819-159-2-201307160-00661. **PMID:** 23712381 **Citation:** Davitt C, Flynn KE, Harrison RK, Pan A, Palatnik A. Current practices in gestational diabetes mellitus diagnosis and management in the United States: survey of maternal-fetal medicine specialists. Am J Obstet Gynecol. 2021 Aug;225(2):203-204. doi: 10.1016/j.ajog.2021.04.263. Epub 2021 May 14. No abstract available. **PMID:** 34000260 **Citation:** Caissutti C, Saccone G, Ciardulli A, Berghella V. Very tight vs. tight control: what should be the criteria for pharmacologic therapy dose adjustment in diabetes in pregnancy? Evidence from randomized controlled trials. Acta Obstet Gynecol Scand. 2018 Mar;97(3):235-247. doi: 10.1111/aogs.13257. Epub 2017 Dec 14. **PMID:** 29125636 **Citation:** Harrison RK, Cruz M, Wong A, Davitt C, Palatnik A. The timing of initiation of pharmacotherapy for women with gestational diabetes mellitus. BMC Pregnancy Childbirth. 2020 Dec 11;20(1):773. doi: 10.1186/s12884-020-03449-y. **PMID:** 33308193 **Citation:** Landy HJ, Gomez-Marin O, O'Sullivan MJ. Diagnosing gestational diabetes mellitus: use of a glucose screen without administering the glucose tolerance test. Obstet Gynecol. 1996 Mar;87(3):395-400. doi: 10.1016/0029-7844(95)00460-2. **PMID:** 8598962 **Citation:** Harper LM, Mele L, Landon MB, Carpenter MW, Ramin SM, Reddy UM, Casey B, Wapner RJ, Varner MW, Thorp JM Jr, Sciscione A, Catalano P, Harper M, Saade G, Caritis SN, Sorokin Y, Peaceman AM, Tolosa JE; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network. Carpenter-Coustan Compared With National Diabetes Data Group Criteria for Diagnosing Gestational Diabetes. Obstet Gynecol. 2016 May;127(5):893-898. doi: 10.1097/AOG.0000000000001383. **PMID:** 27054932 **Citation:** Blum AK. Insulin Use in Pregnancy: An Update. Diabetes Spectr. 2016 May;29(2):92-7. doi: 10.2337/diaspect.29.2.92. Erratum In: Diabetes Spectr. 2016 Aug;29(3):191. **PMID:** 27182178 **Citation:** Fenton TR, Kim JH. A systematic review and meta-analysis to revise the Fenton growth chart for preterm infants. BMC Pediatr. 2013 Apr 20;13:59. doi: 10.1186/1471-2431-13-59. **PMID:** 23601190 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000044882 - Term: Glucose Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases - ID: D000004700 - Term: Endocrine System Diseases - ID: D000011248 - Term: Pregnancy Complications - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: 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: 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: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000016640 - Term: Diabetes, Gestational - ID: D000003920 - Term: Diabetes Mellitus ### Intervention Browse Module - Ancestors - ID: D000007004 - Term: Hypoglycemic Agents - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: Hypo - Name: Hypoglycemic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M10365 - Name: Insulin - Relevance: HIGH - As Found: Day 1 - ID: M173166 - Name: Insulin, Globin Zinc - Relevance: LOW - As Found: Unknown - ID: M29802 - Name: Insulin Lispro - Relevance: HIGH - As Found: Spectroscopy - ID: M349 - Name: Insulin Detemir - Relevance: HIGH - As Found: Military - ID: M347 - Name: Insulin Glargine - Relevance: LOW - As Found: Unknown - ID: M10054 - Name: Hypoglycemic Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000007328 - Term: Insulin - ID: D000061268 - Term: Insulin Lispro - ID: D000069057 - Term: Insulin Detemir ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419790 **Brief Title:** Effect of Electrode Belt Used for Lung Monitoring With EIT on Tidal Volume **Official Title:** Effect of Electrode Belt Used for Lung Monitoring With Electrical Impedance Tomography on Tidal Volume of Healthy Volunteers #### Organization Study ID Info **ID:** C3/017 #### Organization **Class:** OTHER **Full Name:** Czech Technical University in Prague ### Status Module #### Completion Date **Date:** 2017-04-30 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2017-04-30 **Type:** ACTUAL #### Start Date **Date:** 2016-10-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Czech Technical University in Prague #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Tidal volumes of ten spontaneously breathing healthy volunteers were measured using spirometer in two situations: wearing EIT electrode belt and without electrode belt. The changes of the tidal volumes were analysed in order to conclude whether the electrode belt has any impact on the volumes. **Detailed Description:** Ten healthy, spontaneously breathing volunteers were in supine semi-sitting position and their tidal volume was measured for 15 min using spirometer Ergostick (Geratherm) twice: with electrode belt placed around the subjcest thorax in the level of 4th to 6th intercostal space in the parasternal line, and then without the electrode belt. The subjects were breathing for approx. 15 min sponatenously with deep, forced breathing in the last minute. The stiff silicone electrode belt used for lung monitoring with electrical impedance tomography system PulmoVista 500 (Dräger Medical) is being placed tightly around the subjects chest in order to monitor distribution of the ventilation. The aim of the study is to analyse the differences in tidal volumes of the spontaneously breathing subject with and without the electrode belt. Since the electrode belt is relatively stiff and the manufacturer recommends putting the belt on tightly, there is a possibility that it affects the breathing effort of the spontaneously breathing patients, which could possibly lead to lower tidal volumes. ### Conditions Module **Conditions:** - EIT Electrode Belt Stiffness - Tidal Volume Changes **Keywords:** - electrode belt - EIT - spirometry - tidal volume ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 10 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Data were obtained at two phases at supine semi-sitting position during 15 min sponatenous breathing and 1 min forced breathing. Subjects were breathing through spirometric probe first without electrode belt, and second with electrode belt placed tightly around the thorax as recommened by the manufacturer. **Intervention Names:** - Device: EIT electrode belt, spirometry **Label:** Healthy volunteers **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Healthy volunteers **Description:** Placing electrode belt for EIT monitoring and measuring tidal volume with spirometer **Name:** EIT electrode belt, spirometry **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Analysing the changes of tidal volumes caused by the presence of electrode belt **Measure:** Changes in tidal volumes **Time Frame:** 15 minutes ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * healthy volunteers Exclusion Criteria: * morbid obesity * Tiffeneau index lower than 80 % * wounded skin in the electrode belt location **Healthy Volunteers:** True **Maximum Age:** 50 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Kladno **Country:** Czechia **Facility:** Faculty of Biomedical Engineering, Czech Technical University in Prague **Zip:** 27201 #### Overall Officials **Official 1:** **Affiliation:** Faculty of Biomedical Engineering, Czech Technical University in Prague **Name:** Kristýna Koldová, Ph.D. **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419777 **Acronym:** START 1 **Brief Title:** Strict Versus Permissive Thresholds for Initiation of Pharmacotherapy in Gestational Diabetes **Official Title:** Strict Versus Permissive Threshold for Initiation of Pharmacotherapy in Gestational Diabetes Mellitus (GDM) With Glucometer Use - A Randomized Control Trial (START1) #### Organization Study ID Info **ID:** iRISID-2024-2999 #### Organization **Class:** OTHER **Full Name:** Thomas Jefferson University ### Status Module #### Completion Date **Date:** 2026-05 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-05 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-31 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** University of Rochester #### Lead Sponsor **Class:** OTHER **Name:** Thomas Jefferson 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 aim of our study is to compare neonatal and maternal outcomes using different thresholds for the initiation and titration of pharmacotherapy for gestational diabetes (GDM). Our goal is to compare a strict and permissive threshold. The strict threshold is defined as two abnormal values or more over a one-week period (two fasting values elevated, two of the same post prandial values elevated, or 1 fasting and 1 post prandial value elevated), whereas the permissive threshold is defined as 50% of values elevated over 1 week (50% of overall fasting values, 50% of postprandial values, or 50% of overall values). **Detailed Description:** Pregnancy is a state of insulin resistance to ensure that the growing fetus has ample nutrition. Gestational Diabetes (GDM) develops in pregnant patients with pancreatic dysfunction that leads to impairment of glucose tolerance. Various studies have examined the benefit of treatment for GDM, including the 2005 Australian Carbohydrate Intolerance Study in Pregnant Women (ACHOIS) and the 2009 Landon et al randomized controlled trials. These studies found that treatment was associated with a significant reduction in newborn complications of perinatal death, shoulder dystocia, large for gestational age infants, cesarean delivery, and birth trauma. The specific threshold value for initiation and up-titration of medical therapy is unknown. Lack of evidence leads to a wide variation in clinical practice of pharmacological initiation and titration for GDM. A systematic review and meta-analysis by Caissutti in 2019 analyzed criteria for initiating pharmacotherapy for GDM and noted the following: 12 of 15 trials initiated pharmacotherapy after 1-2 abnormal values over 1-2 weeks, 2 studies initiated pharmacotherapy after 50% of overall values were abnormal, and 1 study initiated pharmacotherapy after 30% of overall values were abnormal. However, there have been no randomized controlled trials of head-to-head comparison of different thresholds. The aim of our study is to compare neonatal and maternal outcomes using different thresholds for the initiation and titration of pharmacotherapy for gestational diabetes. Our goal is to compare a strict and relaxed threshold. The strict threshold is defined as two abnormal values or more over a one week period (two fasting values elevated, two of the same post prandial values elevated, or 1 fasting and 1 post prandial value elevated), whereas the relaxed threshold is defined as 50% of values elevated over 1 week (50% of overall fasting values, 50% of postprandial values, or 50% of overall values). ### Conditions Module **Conditions:** - Gestational Diabetes - Pregnancy Related **Keywords:** - gestational diabetes - pregnancy - insulin - Initiation of medication ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 430 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The strict threshold is defined as two abnormal values or more over a one-week period (two fasting values elevated, two of the same post prandial values elevated, or 1 fasting and 1 post prandial value elevated) **Intervention Names:** - Drug: Insulin **Label:** Strict Arm **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** The permissive threshold is defined as 50% of values elevated over 1 week (50% of overall fasting values, 50% of postprandial values, or 50% of overall values). **Intervention Names:** - Drug: Insulin **Label:** Permissive **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Permissive - Strict Arm **Description:** Insulin will be used in gestational diabetics to control blood glucose levels **Name:** Insulin **Other Names:** - Lantus - Lispro - NPH - Levemir - Humalog **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** neonatal composite including the following measures: large for gestational age (LGA) of neonate defined as birth weight \>90th percentile for gestational age using the Fenton growth chart, hypoglycemia o defined as glucose \<40 mg/dL \<48 hours after birth or glucose, hyperbilirubinemia, stillbirth or neonatal death, birth trauma **Measure:** Neonatal Composite Outcome **Time Frame:** First 28 days of birth #### Secondary Outcomes **Description:** Gestational age at delivery in weeks and days **Measure:** Neonatal Outcome: Gestational Age of Birth **Time Frame:** Delivery Time **Description:** Scoring system provided a standardized assessment for infants after delivery from 0-10 **Measure:** Neonatal Outcome: APGAR Score **Time Frame:** At 1 minute of life and at 5 min of life **Description:** Birthweight in grams, Macrosomia (birthweight \>4000g, Small for gestational age (\<10th percentile based on Fenton Growth Charts) **Measure:** Neonatal Outcome: Birthweight **Time Frame:** Delivery Time **Description:** Brachial plexus nerves in neonate are torn, stretched, or compressed at delivery **Measure:** Neonatal Outcome: Brachial Plexus Injury **Time Frame:** Delivery Time **Description:** Breathing difficulties after birth requiring supplemental oxygen, mask, intubation, and/or surfactant **Measure:** Neonatal Outcome: Respiratory distress **Time Frame:** Within first 24 hours after delivery **Description:** Admission to neonatal intensive care unit (NICU) **Measure:** Neonatal Outcome: Admission to Neonatal intensive Care Unit **Time Frame:** From delivery to discharge from NICU **Description:** Maternal episode of hypoglycemia \< 60 mg/dL throughout the pregnancy **Measure:** Maternal Outcomes: Maternal hypoglycemia **Time Frame:** Initiation of insulin to delivery **Description:** An obstetric emergency where the anterior fetal shoulder becomes stuck on the maternal pubic symphysis, delaying the birth of the baby's body. **Measure:** Maternal Outcomes: Shoulder Dystocia **Time Frame:** At Delivery **Description:** 3rd degree and 4th degree perineal injuries **Measure:** Maternal Outcomes: Obstetric anal sphincter injury (OASIS) **Time Frame:** At Delivery **Description:** Vacuum-assisted and Forcep-assisted vaginal Delivery **Measure:** Maternal Outcomes: Operative Delivery **Time Frame:** At Delivery **Description:** Cesarean birth **Measure:** Maternal Outcomes: Cesarean Delivery **Time Frame:** At Delivery **Description:** Defined as cumulative blood loss ≥1000 mL, or bleeding associated with signs/symptoms of hypovolemia within 24 hours of the birth process **Measure:** Maternal Outcomes: Postpartum hemorrhage **Time Frame:** Within 24 hours of delivery **Description:** Hypertensive disorders of pregnancy: gestational hypertension, Preeclampsia without severe features, Pre-eclampsia with severe features, severe range blood pressures defined as (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥110 mmHg), symptoms of central nervous dysfunction, thrombocytopenia with Platelet count \<100,000 platelets/microL, hepatic abnormalities, kidney impairment, and or pulmonary edema **Measure:** Maternal Outcomes: Hypertensive Disorders of Pregnancy **Time Frame:** From gestational age of 20 weeks during pregnancy to 6 weeks postpartum ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Live, non-anomalous fetus * Literacy in English, Spanish, Mandarin, or Arabic * Patients are also required to provide consent, demonstrate an understanding of the purpose of the study, and agree to the study protocol. Exclusion Criteria: * \<18 years at EDD * pre-existing diabetes or diagnosis of GDM before 24 weeks * multi-fetal gestation * known major fetal anomaly * known allergy to insulin * chronic maternal corticosteroid use * diagnosis of GDM based on finger sticks alone * patients who have contraindication to oral glucose tolerance test * a primary language other than English, Spanish, Mandarin, or Arabic **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:** Kavisha Khanuja, MD **Phone:** 215-955-5000 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Rodney McLaren Jr, MD **Phone:** 215-955-5000 **Role:** CONTACT #### Locations **Location 1:** **City:** Rochester **Country:** United States **Facility:** University of Rochester Medical Center **State:** New York **Zip:** 14642 **Location 2:** **City:** Philadelphia **Contacts:** ***Contact 1:*** - **Name:** Kavisha Khanuja, MD - **Role:** CONTACT ***Contact 2:*** - **Name:** Rodney McLaren, MD - **Role:** CONTACT **Country:** United States **Facility:** Thomas Jefferson University **State:** Pennsylvania **Zip:** 19107 ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Quintanilla Rodriguez BS, Mahdy H. Gestational Diabetes. 2023 Aug 8. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK545196/ **PMID:** 31424780 **Citation:** Catalano PM, Hauguel-De Mouzon S. Is it time to revisit the Pedersen hypothesis in the face of the obesity epidemic? Am J Obstet Gynecol. 2011 Jun;204(6):479-87. doi: 10.1016/j.ajog.2010.11.039. Epub 2011 Feb 2. **PMID:** 21288502 **Citation:** Gregory EC, Ely DM. Trends and Characteristics in Gestational Diabetes: United States, 2016-2020. Natl Vital Stat Rep. 2022 Jul;71(3):1-15. **PMID:** 35877134 **Citation:** Metzger BE, Persson B, Lowe LP, Dyer AR, Cruickshank JK, Deerochanawong C, Halliday HL, Hennis AJ, Liley H, Ng PC, Coustan DR, Hadden DR, Hod M, Oats JJ, Trimble ER; HAPO Study Cooperative Research Group. Hyperglycemia and adverse pregnancy outcome study: neonatal glycemia. Pediatrics. 2010 Dec;126(6):e1545-52. doi: 10.1542/peds.2009-2257. Epub 2010 Nov 15. **PMID:** 21078733 **Citation:** ACOG Practice Bulletin No. 190: Gestational Diabetes Mellitus. Obstet Gynecol. 2018 Feb;131(2):e49-e64. doi: 10.1097/AOG.0000000000002501. **PMID:** 29370047 **Citation:** Crowther CA, Hiller JE, Moss JR, McPhee AJ, Jeffries WS, Robinson JS; Australian Carbohydrate Intolerance Study in Pregnant Women (ACHOIS) Trial Group. Effect of treatment of gestational diabetes mellitus on pregnancy outcomes. N Engl J Med. 2005 Jun 16;352(24):2477-86. doi: 10.1056/NEJMoa042973. Epub 2005 Jun 12. **PMID:** 15951574 **Citation:** Landon MB, Spong CY, Thom E, Carpenter MW, Ramin SM, Casey B, Wapner RJ, Varner MW, Rouse DJ, Thorp JM Jr, Sciscione A, Catalano P, Harper M, Saade G, Lain KY, Sorokin Y, Peaceman AM, Tolosa JE, Anderson GB; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. A multicenter, randomized trial of treatment for mild gestational diabetes. N Engl J Med. 2009 Oct 1;361(14):1339-48. doi: 10.1056/NEJMoa0902430. **PMID:** 19797280 **Citation:** Hartling L, Dryden DM, Guthrie A, Muise M, Vandermeer B, Donovan L. Benefits and harms of treating gestational diabetes mellitus: a systematic review and meta-analysis for the U.S. Preventive Services Task Force and the National Institutes of Health Office of Medical Applications of Research. Ann Intern Med. 2013 Jul 16;159(2):123-9. doi: 10.7326/0003-4819-159-2-201307160-00661. **PMID:** 23712381 **Citation:** Davitt C, Flynn KE, Harrison RK, Pan A, Palatnik A. Current practices in gestational diabetes mellitus diagnosis and management in the United States: survey of maternal-fetal medicine specialists. Am J Obstet Gynecol. 2021 Aug;225(2):203-204. doi: 10.1016/j.ajog.2021.04.263. Epub 2021 May 14. No abstract available. **PMID:** 34000260 **Citation:** Caissutti C, Saccone G, Ciardulli A, Berghella V. Very tight vs. tight control: what should be the criteria for pharmacologic therapy dose adjustment in diabetes in pregnancy? Evidence from randomized controlled trials. Acta Obstet Gynecol Scand. 2018 Mar;97(3):235-247. doi: 10.1111/aogs.13257. Epub 2017 Dec 14. **PMID:** 29125636 **Citation:** Harrison RK, Cruz M, Wong A, Davitt C, Palatnik A. The timing of initiation of pharmacotherapy for women with gestational diabetes mellitus. BMC Pregnancy Childbirth. 2020 Dec 11;20(1):773. doi: 10.1186/s12884-020-03449-y. **PMID:** 33308193 **Citation:** Landy HJ, Gomez-Marin O, O'Sullivan MJ. Diagnosing gestational diabetes mellitus: use of a glucose screen without administering the glucose tolerance test. Obstet Gynecol. 1996 Mar;87(3):395-400. doi: 10.1016/0029-7844(95)00460-2. **PMID:** 8598962 **Citation:** Harper LM, Mele L, Landon MB, Carpenter MW, Ramin SM, Reddy UM, Casey B, Wapner RJ, Varner MW, Thorp JM Jr, Sciscione A, Catalano P, Harper M, Saade G, Caritis SN, Sorokin Y, Peaceman AM, Tolosa JE; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network. Carpenter-Coustan Compared With National Diabetes Data Group Criteria for Diagnosing Gestational Diabetes. Obstet Gynecol. 2016 May;127(5):893-898. doi: 10.1097/AOG.0000000000001383. **PMID:** 27054932 **Citation:** Blum AK. Insulin Use in Pregnancy: An Update. Diabetes Spectr. 2016 May;29(2):92-7. doi: 10.2337/diaspect.29.2.92. Erratum In: Diabetes Spectr. 2016 Aug;29(3):191. **PMID:** 27182178 **Citation:** Fenton TR, Kim JH. A systematic review and meta-analysis to revise the Fenton growth chart for preterm infants. BMC Pediatr. 2013 Apr 20;13:59. doi: 10.1186/1471-2431-13-59. **PMID:** 23601190 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000044882 - Term: Glucose Metabolism Disorders - ID: D000008659 - Term: Metabolic Diseases - ID: D000004700 - Term: Endocrine System Diseases - ID: D000011248 - Term: Pregnancy Complications - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: 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: 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: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000016640 - Term: Diabetes, Gestational - ID: D000003920 - Term: Diabetes Mellitus ### Intervention Browse Module - Ancestors - ID: D000007004 - Term: Hypoglycemic Agents - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: Hypo - Name: Hypoglycemic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M10365 - Name: Insulin - Relevance: HIGH - As Found: Day 1 - ID: M173166 - Name: Insulin, Globin Zinc - Relevance: LOW - As Found: Unknown - ID: M29802 - Name: Insulin Lispro - Relevance: HIGH - As Found: Spectroscopy - ID: M349 - Name: Insulin Detemir - Relevance: HIGH - As Found: Military - ID: M347 - Name: Insulin Glargine - Relevance: LOW - As Found: Unknown - ID: M10054 - Name: Hypoglycemic Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000007328 - Term: Insulin - ID: D000061268 - Term: Insulin Lispro - ID: D000069057 - Term: Insulin Detemir ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419764 **Brief Title:** Combining Chinese Medicine and Nutrition to Enhance Weight Loss After Bariatric Surgery **Official Title:** Combining Chinese Medicine and Nutrition to Enhance Weight Loss After Bariatric Surgery #### Organization Study ID Info **ID:** CCMNEWLABS #### Organization **Class:** OTHER **Full Name:** China-Japan Friendship Hospital ### Status Module #### Completion Date **Date:** 2025-07 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-07 **Type:** ESTIMATED #### Start Date **Date:** 2024-02-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** China-Japan Friendship Hospital #### Responsible Party **Investigator Affiliation:** China-Japan Friendship Hospital **Investigator Full Name:** Hua Meng **Investigator Title:** Director of the General Surgery Department & Obesity and Metabolic Disease Center of China-Japan Friendship Hospital **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This study aims to investigate the effects of Chinese herbal granule preparations on improving gastrointestinal symptoms in patients after bariatric surgery. It seeks to establish a novel treatment model that combines bariatric surgery with traditional Chinese medicine, providing clinical practice with additional evidence-based medical support. ### Conditions Module **Conditions:** - Traditional Chinese Medicine Treatment - Weight Change ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 120 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Postoperative patients are routinely provided with meal replacement recommendations and dietary plans. **Intervention Names:** - Other: Diet and meal replacements **Label:** nutrition intervention group **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Chinese herbal treatment is given on the basis of routine dietary intervention. **Intervention Names:** - Drug: Spleen Invigorating and Weight Reducing Decoction - Other: Diet and meal replacements **Label:** Traditional Chinese Medicine combined with nutritional intervention **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Traditional Chinese Medicine combined with nutritional intervention **Description:** Composition: Raw Astragalus (Huang Qi) 5g, Cang Zhu 5g, Fructus Aurantii Immaturus (Zhi Shi) 3g, Prepared Rhubarb (Shu Jun) 3g, Red Peony Root (Chi Shao Yao) 3g, Crataegus (Shan Zha) 3g, Tribulus (Bai Jie Li) 2g, Cimicifuga (Sheng Ma) 1g. Granule form, for oral administration. Take 1 dose daily (2 bags, once in the morning and once in the evening, dissolved in water), for a course of 1 month. **Name:** Spleen Invigorating and Weight Reducing Decoction **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Traditional Chinese Medicine combined with nutritional intervention - nutrition intervention group **Description:** The dietitian provides recommended meal plans based on body weight, and meal replacements are used postoperatively. **Name:** Diet and meal replacements **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Measure:** Percentage change in body weight **Time Frame:** Before bariatric surgery, 1 month after surgery, and 3 months after surgery. #### Secondary Outcomes **Measure:** Traditional Chinese Medicine syndrome score **Time Frame:** Before bariatric surgery, 1 month after surgery, and 3 months after surgery. **Description:** HbA1c, blood glucose, insulin levels **Measure:** blood glucose indicators **Time Frame:** Before bariatric surgery, 1 month after surgery, and 3 months after surgery. **Description:** total cholesterol, triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol **Measure:** blood lipid profile **Time Frame:** Before bariatric surgery, 1 month after surgery, and 3 months after surgery. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. BMI ≥ 27.5 kg/m²; 2. Undergoing metabolic bariatric surgery; 3. Traditional Chinese Medicine syndrome differentiation classified as Spleen Deficiency and Excess Dampness syndrome. Exclusion Criteria: 1. Contraindications for metabolic bariatric surgery; 2. Type 1 diabetes; 3. Complicated by other significant systemic diseases, such as severe liver and kidney diseases, malignant tumors, psychiatric disorders, etc; 4. Concurrent use of other medications or treatments that may affect body weight, such as metformin, semaglutide, endoscopic interventions, etc; 5. Pregnant or lactating women. **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:** Huang Yishan, doctor **Phone:** 18810621201 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Meng Hua, doctor **Phone:** 18611457779 **Role:** CONTACT #### Locations **Location 1:** **City:** Beijing **Country:** China **Facility:** China-Japan Friendship Hospital **Status:** RECRUITING ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001836 - Term: Body Weight Changes ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M18102 - Name: Weight Loss - Relevance: HIGH - As Found: Weight Loss - ID: M5114 - Name: Body Weight - Relevance: HIGH - As Found: Weight - ID: M5115 - Name: Body Weight Changes - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001835 - Term: Body Weight - ID: D000015431 - Term: Weight Loss ### Intervention Browse Module - Browse Branches - Abbrev: HB - Name: Herbal and Botanical - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: T317 - Name: Tribulus - Relevance: LOW - As Found: Unknown - ID: T63 - Name: Astragalus - Relevance: LOW - As Found: Unknown - ID: T181 - Name: Hawthorn - Relevance: LOW - As Found: Unknown - ID: T107 - Name: Chinese Rhubarb - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419751 **Brief Title:** the Effects of Different Exercise on Vascular Health **Official Title:** Research on the Effect of Lifestyle Intervention Combined With Wearable Devices Based on Different Exercise on Vascular Health #### Organization Study ID Info **ID:** 2023-ZX067 #### Organization **Class:** OTHER_GOV **Full Name:** China National Center for Cardiovascular Diseases ### Status Module #### Completion Date **Date:** 2025-06-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-30 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER_GOV **Name:** China National Center for Cardiovascular Diseases #### 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 explore the effect of smart app and wearable-based lifestyle intervention management on vascular health, comparing different exercise with the improvement of vascular arterial stiffness. The accuracy and consistency evaluation of smart wearable devices in screening for vascular health risks were also discussed. **Detailed Description:** This study intends to carry out a randomized controlled trial to dynamically monitor a variety of cardiovascular parameters in people with high risk of vascular health, using wearable devices and artificial intelligence-assisted health management platform, and provide intelligent lifestyle intervention programs with different exercise.By observing the improvement of vascular health in the study population, the management effect of intelligent lifestyle intervention on high-risk groups of vascular health was evaluated. It is expected that through comprehensive lifestyle intervention based on smart wearable devices, early prevention and control of arteriosclerosis can be achieved, the level of hospital health management will be improved, and more physical health and health economic benefits will be obtained. ### Conditions Module **Conditions:** - Mind-body Exercise - Vascular Health - M-health - Cardiac Rehabilitation **Keywords:** - m-health - mind-body exercise - cardiac rehabilitation - arterial stiffness ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 216 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Study participants were given training on dietary patterns, regular monitoring and follow-up through apps and wearable devices, and no forced exercise measures were performed. **Label:** Control **Type:** NO_INTERVENTION #### Arm Group 2 **Description:** Study participants were given training on dietary patterns, regular monitoring and follow-up through apps and wearable devices.Based on the status of the study participants and the results of the cardiopulmonary exercise test, the investigators prescribe moderate-intensity aerobic exercise combined with resistance exercise **Intervention Names:** - Behavioral: Regular exercise **Label:** Combined Exercise Group **Type:** ACTIVE_COMPARATOR #### Arm Group 3 **Description:** Study participants were given training on dietary patterns, regular monitoring and follow-up through apps and wearable devices.A standardized Baduanjin exercise program consists of eight postures, each training time is about 30 minutes (including 10 min warm-up, 2 times of Baduanjin, and 10 min of relaxation), 5 days/week, a total of 12 weeks. **Intervention Names:** - Behavioral: Baduanjin **Label:** Mind-body Exercise Group **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Combined Exercise Group **Description:** Based on the study participant's status and exercise assessment, the investigators prescribe moderate-intensity aerobic exercise combined with resistance exercise. Before each exercise, preparatory activities (10min), 20-30min moderate-intensity aerobic exercise, finishing activities (10min) at the end, 5 days/week, for 12 weeks, and at the same time, choose non-consecutive 3 days of resistance training in 5 aerobic training sessions to increase resistance training (choose 1\~2 muscle groups each time, 4\~5 movements, repeat each action 8\~12 times, repeat 2\~3 sets) **Name:** Regular exercise **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Mind-body Exercise Group **Description:** A professional therapist instructed the participants to learn and train Baduanjin before the intervention, and a standardized Baduanjin exercise program included eight postures, each training time was about 50 minutes (including 10 min of warm-up, 2 times of Baduanjin, and 10 min of relaxation), 5 days/week, a total of 12 weeks **Name:** Baduanjin **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** The cardio-cerebrovascular and aortic function detector (Campura, France, model: Complior Analyse) was used to measure cfPWV, and the study participants were in a supine position, lying flat on the pillow, with their palms up on their sides of the body, so that their whole body was relaxed and rested for about 3 minutes. PWV can reflect arterial stiffness, and the European Society of Cardiology recommends cfPWV \>10 m/s as the definitive threshold for assessing arterial functional changes in hypertension.We monitored cfPWV at baseline,3,6,9 months of the study. **Measure:** Cervical femoral pulse wave velocity（cfPWV） **Time Frame:** baseline,3months,6months,9 months #### Secondary Outcomes **Description:** The blood pressure of the limbs is measured with the Omron arteriosclerosis detector, and the pulse conduction velocity (baPWV) and ankle-brachial index (ABI) are calculated to automatically evaluate the degree of arteriosclerosis and blood vessel blockage. Positive criteria for baPWV: ≥1400 cm/s or baPWV% ≥ 19% is arteriosclerosis. Lower extremity vascular occlusion (ABI positive criteria): ≤0.9 for peripheral arterial stenosis and ≤0.5 for possible peripheral arterial occlusion.We monitored baPWV at baseline,3,6,9 months of the study. **Measure:** Brachi-ankle pulse wave velocity（baPWV） **Time Frame:** baseline,3months,6months,9 months **Description:** Blood pressure indicator: systolic blood pressure and diastolic blood pressure.We monitored blood pressure at baseline,3,6,9 months of the study. **Measure:** blood pressure **Time Frame:** baseline,3months,6months,9 months **Description:** Using bioelectrical impedance analysis to monitor body weight,weight and height will be combined to report BMI in kg/m\^2.We monitored body composition at baseline,3,6,9 months of the study. **Measure:** body weight **Time Frame:** baseline,3months,6months,9 months **Description:** Lipid metabolism indicators: total cholesterol , triglyceride , high density lipoprotein cholesterol, low density lipoprotein cholesterol.We monitored lipid metabolism parameters at baseline,3,6,9 months of the study. **Measure:** Lipid metabolism parameters: TC(mmol/L), TG(mmol/L), HDL-C(mmol/L), LDL-C(mmol/L) **Time Frame:** baseline,3months,6months,9 months **Description:** The measurement of muscle strength, balance and flexibility is completed by the rehabilitation therapist, mainly including: (1) upper limb muscle strength test (dumbbell arm curl test); (2) Lower limb muscle strength test (chair standing and sitting test); (3) balance ability test; (4) Lower limb flexibility assessment (chair sitting body forward bending test); (5) Upper limb flexibility assessment (two-hand dorsum extension test). Participants were observed for changes at baseline, 3,6,9 months. **Measure:** Physical fitness **Time Frame:** baseline,3months,6months,9 months **Description:** The PWV was analyzed by the smart watch through ECG (electrocardiogram) and PPG (photoplethysmography) sensors to evaluate the degree of vascular elasticity, and the vascular health index and evaluation were obtained, and the results were divided into low-risk, medium-risk, and high-risk. **Measure:** Vascular Health Index **Time Frame:** baseline,3months,6months,9 months **Description:** Study participants who received remote lifestyle interventions through the app, completed all exercise training content per week, or clocked in ≥ exercise 3 times were considered to have good compliance; Those who check in \< exercise 3 times a week are considered to have poor compliance. **Measure:** Application adherence **Time Frame:** baseline,3months,6months,9 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Age: ≥ 18 years old and \< 60 years old; 2. cfPWV\>10m/s; 3. Those who have 1 intelligent communication device and can use it proficiently (Android mobile phone is preferred); 4. People who have lived and/or worked relatively steadily in the past 6 months; 5. Signed informed consent. Exclusion Criteria: 1. Moderate to severe obesity (≥30kg/m\^2); 2. Acute myocardial infarction, acute tachyarrhythmia, pulmonary edema, severe aortic stenosis and other serious circulatory respiratory diseases and acute cardiovascular and cerebrovascular diseases; 3. severe essential hypertension (systolic blood pressure ≥180mmHg and/or diastolic blood pressure ≥110mmHg) or poorly controlled essential hypertension; 4. Patients with secondary hypertension, acute hypertension, subacute hypertension and hypertensive encephalopathy; 5. Significant arrhythmia (atrial fibrillation, etc.); 6. Patients with atherosclerotic cardiovascular diseases, such as coronary heart disease, severe peripheral atherosclerotic diseases, etc.; 7. Type 1 diabetes, uncontrolled type 2 diabetes or other diseases affecting carbohydrate metabolism; 8. Severe stenosis of the carotid and/or femoral arteries (resulting in significant abnormalities in the blood flow spectrum); Those who have anatomical abnormalities of the aorta and major branches and cannot complete PWV detection; 9. Cancer and other major comorbidities affecting arterial blood pressure; 10. Those who are unable to exercise due to fractures, joint instability and other physical diseases or diseases affecting the locomotor system; 11. Those who have involuntary physical movements due to mental illness, epilepsy or other diseases; 12. Those who have a pacemaker installed; 13. Pregnant/trying to conceive; 14. Patients with allergies, limb trauma or skin diseases who cannot cooperate with the completion of ABI and baPWV index examinations; 15. Those who have undergone or plan to have bariatric surgery in the next 12 months; 16. Those who have participated in other clinical studies in the past 3 months; 17. Refusal to sign informed consent. **Maximum Age:** 60 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Yifan Wu **Phone:** 01088398069 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Fuwai Hospital **Name:** Xue Feng **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419738 **Brief Title:** Efficacy of Combining Low Level Laser Therapy With Cognitive-behavioral Therapy on Myalgia in Temporomandibular Joint Disorders **Official Title:** Clinical, Psychosocial, Behavioral Characteristics and Treatment Effectiveness of Low Level Laser Therapy on Patients With Temporomandibular Joint Disorders #### Organization Study ID Info **ID:** NCS01050122107 #### Organization **Class:** OTHER **Full Name:** Hanoi Medical University ### Status Module #### Completion Date **Date:** 2025-01-04 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-24 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-01-04 **Type:** ESTIMATED #### Start Date **Date:** 2023-03-14 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Hanoi Medical University #### Responsible Party **Investigator Affiliation:** Hanoi Medical University **Investigator Full Name:** Nguyen Ngoc Hoa **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:** The purpose of this study is to evaluate the efficacy of combining low level laser therapy and cognitive behavioral treatment for patients with temporomandibular joint disorders using a randomized controlled design. **Detailed Description:** The purpose of this study is to evaluate the efficacy of combining low level laser therapy and cognitive behavioral treatment for patients with temporomandibular joint disorders using a randomized controlled design. 66 patients suffering from acute and subacute myalgia diagnosed using Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) at High-tech Center for Odonto-Stomatology, Institute of Odonto-Stomatology, Ha Noi Medical University, Viet Nam. Patients without treatment (because of economic or geographical conditions) were persuaded to join the control group. Group 3 includes 22 patients who will be counseled on changing habits, adjusting behavior, exercising and will be taken in order of examination. 44 patients will be randomized into the remaining 2 groups: * Group 1: wear stabilization splint at night for 2 months combined with counseling, behavior modification, and exercise. * Group 2: recieve low level laser treatment 3 times aweek, 20 seconds/ session, 10 sessions in total, combined with counseling, behavior modification, and exercise. Assessment takes place at baseline, after treatment approximately 2 weeks, 4 weeks, 12 weeks, 24 weeks later and 48 weeks follow up. The effects of the interventions are evaluated in terms of reduction in pain intensity (Visual Analogue Scale-VAS), number of masticatory muscle pain point with palpation, number of supplemental muscle pain with palpation, maximum mouth opening, right lateral movements, left lateral movements, protrusive movements, Jaw functional limitation scale (JFLS-8), psychological variables such as PHQ-9, PHQ-4, GAD-7. Data were entered and analyzed by SPSS 16.0 software. Use Mann-Whitney U test, Kruskal-Wallis test, and Wilcoxon test applied to non-normally distributed variables to compare VAS between groups at different follow-up times. Use paired t-test and independent t-test to compare the maximum opening, lateral movements, protrusive movements, JFLS-8, PHQ-9, PHQ-4, GAD-7 between groups before and after treatment. p value \< 0.05 is considered statistically significant. ### Conditions Module **Conditions:** - Temporomandibular Joint Disorders **Keywords:** - temporomandibular joint disorders, temporomandibular disorders, low-level laser therapy, temporomandibular disorders treatment ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** 66 patients were divided into 3 groups.Patients without treatment (because of economic or geographical conditions) were persuaded to join the control group. Group 3 includes 22 patients who will be counseled on changing habits, adjusting behavior, exercising and will be taken in order of examination. 44 patients will be randomized into the remaining 2 groups by using Excel software to create a random number table, patients will draw even numbers into group 2, odd numbers into group 1. * Group 1: wear stabilization splint at night for 2 months combined with counseling, behavior modification, and exercise. * Group 2: recieve low level laser treatment 3 times aweek, 20 seconds each time, 10 times in total, combined with counseling, behavior modification, and exercise. ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 66 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Cognitive behavioral treatment includes education about the disorder, proprioceptive awareness and reversing parafunctional habits, relaxation techniques, and stress management. Furthermore patients are also consulted on changing habits, adjusting behavior, exercising. Patients are instructed to adjust their behavior: quit harmful habits to limit pain in daily functional activities, maintain scientific sleep, maintain good head, neck and shoulder activities, soft diet and avoid hard foods, do exercises twice a day: open mouth wide combined with cool compresses and warm compresses. **Intervention Names:** - Behavioral: Cognitive behavioral treatment (CBT) **Label:** Cognitive behavioral treatment (CBT) **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** LLLT may facilitate the release of endogenous opioids, tissue repairment and cellular respiration, increase vasodilatation and pain threshold, and decrease inflammation. Diode low-energy laser machine (Sirolaser blue, Dentsply) are set the default mode according to the correct parameters before use: wavelength 660nm, energy level 2.5 J/cm2, power source 100mW. The projection head is placed perpendicular to the muscle being projected. The laser light is shined on the pain point at the beginning of the treatment, then it will shine on muscle points in turn: temporal muscle (anterior, middle, posterior), masseter muscle (upper, middle, lower), 5 points around the temporomandibular joint area (superior, anterior, lateral, posterior, posterior subcondylar). Each masticatory muscle area is treated for 20 seconds, 3 sessions /week (different days), 10 sessions total. In addition, patients are still instructed CBT as group 1. **Intervention Names:** - Radiation: Low level laser therapy combined with CBT (LLLT+CBT) **Label:** Low level laser therapy combined with CBT (LLLT+CBT) **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Maxillary occlusal splints are made of hard acrylic after taking impressions of the upper dental arches, recording of centric relation (Okeson). Splints are adjusted to provide even occlusal contact during jaw closing and chewing, and canine and incisor contact during protrusive movements of the jaw. Patients are instructed to use the splint each night at least 8 hours/day for a period of 8 weeks. In addition, patients are still instructed CBT as group 1. **Intervention Names:** - Device: Occlusal Splint combined with CBT (OS+CBT) **Label:** Occlusal Splint combined with CBT (OS+CBT) **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Cognitive behavioral treatment (CBT) **Description:** Cognitive behavioral treatment includes education about the disorder, proprioceptive awareness and reversing parafunctional habits, relaxation techniques, and stress management. Furthermore patients are also consulted on changing habits, adjusting behavior, exercising. Patients are instructed to adjust their behavior: quit harmful habits to limit pain in daily functional activities, maintain scientific sleep, maintain good head, neck and shoulder activities, soft diet and avoid hard foods, do exercises twice a day: open mouth wide combined with cool compresses and warm compresses. **Name:** Cognitive behavioral treatment (CBT) **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Low level laser therapy combined with CBT (LLLT+CBT) **Description:** LLLT may facilitate the release of endogenous opioids, tissue repairment and cellular respiration, increase vasodilatation and pain threshold, and decrease inflammation. Diode low-energy laser machine (Sirolaser blue, Dentsply) are set the default mode according to the correct parameters before use: wavelength 660nm, energy level 2.5 J/cm2, power source 100mW. The projection head is placed perpendicular to the muscle being projected. The laser light is shined on the pain point at the beginning of the treatment, then it will shine on muscle points in turn: temporal muscle (anterior, middle, posterior), masseter muscle (upper, middle, lower), 5 points around the temporomandibular joint area (superior, anterior, lateral, posterior, posterior subcondylar). Each masticatory muscle area is treated for 20 seconds, 3 sessions /week (different days), 10 sessions total. In addition, patients are still instructed CBT as group 1. **Name:** Low level laser therapy combined with CBT (LLLT+CBT) **Type:** RADIATION #### Intervention 3 **Arm Group Labels:** - Occlusal Splint combined with CBT (OS+CBT) **Description:** Maxillary occlusal splints are made of hard acrylic after taking impressions of the upper dental arches, recording of centric relation (Okeson). Splints are adjusted to provide even occlusal contact during jaw closing and chewing, and canine and incisor contact during protrusive movements of the jaw. Patients are instructed to use the splint each night at least 8 hours/day for a period of 8 weeks.In addition, patients are still instructed CBT as group 1. **Name:** Occlusal Splint combined with CBT (OS+CBT) **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** The VAS (Visual Analog Scale) pain scale consists of a 10 cm long straight line (without marks), with "no pain" written at the left end and "unbearable pain" written at the right end. Patients were instructed to mark a vertical line above the horizontal line indicating the intensity of their pain. The distance from the zero point to the marker is then measured in millimeters by a caliper. Add the total score of the answers to evaluate the severity according to the following scale: ≤3.4: mild; 3.5-7.4: average; ≥ 7.5: severe **Measure:** VAS **Time Frame:** Time Frame: Pre-Post-Design including 3 assessment points: pre-treatment, after 2 weeks, 4 weeks, 12 weeks, 24 weeks, 48 weeks follow up **Description:** Numbers of muscle pain points are determined by the examiner using a fingertip force of 1kg to palpate the masticatory muscles: temporal muscles (anterior, middle, posterior), masseter muscles (origin, body, attachment, surrounding muscles. Before palpating , the fingertip force needs to be calibrated 3 times with a micro scale, touching each side one by one. **Measure:** Numbers of masticatory muscle pain with palpation **Time Frame:** Time Frame: Pre-Post-Design including 3 assessment points: pre-treatment, after 2 weeks, 4 weeks, 12 weeks, 24 weeks, 48 weeks follow up **Description:** Maximum mouth opening (MMO) was defined asthe maximal interincisal distance on unassisted active mouth opening when the patient opens his mouth maximally without feeling pain. Use a ruler with mm value. **Measure:** Maximum mouth opening **Time Frame:** Time Frame: Pre-Post-Design including 3 assessment points: pre-treatment, after 2 weeks, 4 weeks, 12 weeks, 24 weeks, 48 weeks follow up **Description:** Numbers of supplemental muscle pain points are determined by the examiner using a fingertip force of 1kg to palpate the masticatory muscles: temporal muscles (anterior, middle, posterior), masseter muscles (origin, body, attachment, surrounding muscles. Before palpating , the fingertip force needs to be calibrated 3 times with a micro scale, touching each side one by one. **Measure:** Numbers of supplemental muscle pain with palpation **Time Frame:** Time Frame: Pre-Post-Design including 3 assessment points: pre-treatment, after 2 weeks, 4 weeks, 12 weeks, 24 weeks, 48 weeks follow up #### Secondary Outcomes **Description:** Ask the patient to open slightly, and to move his or her jaw as far as he/she can to the right, even if it is painful. Measure from the maxillary reference midline to the mandibular reference midline. **Measure:** Right lateral movements **Time Frame:** Time Frame: Pre-Post-Design including 3 assessment points: pre-treatment, after 2 weeks, 4 weeks, 12 weeks, 24 weeks, 48 weeks follow up **Description:** Ask the patient to open slightly, and to move his or her jaw as far as he/she can to the left, even if it is painful. Measure from the maxillary reference midline to the mandibular reference midline. **Measure:** Left lateral movements **Time Frame:** Time Frame: Pre-Post-Design including 3 assessment points: pre-treatment, after 2 weeks, 4 weeks, 12 weeks, 24 weeks, 48 weeks follow up **Description:** Ask the patient to open slightly, and to move his or her jaw as far as he/she can forward, even if it is painful. Measure the distance from the buccal surface of the mandibular tooth to the buccal surface of the maxillary tooth. **Measure:** Protrusive movements **Time Frame:** Time Frame: Pre-Post-Design including 3 assessment points: pre-treatment, after 2 weeks, 4 weeks, 12 weeks, 24 weeks, 48 weeks follow up **Description:** JFLS-8 (Jaw Functional Limitation Scale - 8) according to DC/TMD axis II to evaluate the level of mandibular function limitation in the past 30 days. The patient will be instructed to answer the questionnaire: in case the patient avoids the activity completely because it is too difficult to do, the patient will circle '10'. If the patient avoids an activity not for pain or difficulty, he/ she will leave this section blank. Activities include: chewing hard foods, chewing chicken, eating soft foods without chewing, opening mouth wide enough to drink from a cup, swallowing, yawning, speaking, laughing. **Measure:** JFLS-8 **Time Frame:** Time Frame: Pre-Post-Design including 3 assessment points: pre-treatment, after 2 weeks, 4 weeks, 12 weeks, 24 weeks, 48 weeks follow up **Description:** General anxiety symptoms were assessed using the 7-item scale from the Patient Health Questionnaire (GAD-7). The GAD-7 asks for anxiety symptoms during the past month on a 1 ('not at all') to 3 ('more than half of the days') rating scale (range 7-21). Higher scores indicate higher levels of anxiety. **Measure:** GAD-7 **Time Frame:** Time Frame: Pre-Post-Design including 3 assessment points: pre-treatment, after 2 weeks, 4 weeks, 12 weeks, 24 weeks, 48 weeks follow up **Description:** Patient Health Questionnaire-9 is a depression assessment form. Patients answer questions consisting of 9 items. Responses will be scored as follows: none: 0 points; several days: 1 point; more than half of the days of the week: 2 points; almost every day: 3 points. Add the total score of the answers to evaluate the severity according to the following scale: 0-4 points: normal; 5-9 points: mild; 10-14 points: average; 15-19 points: quite severe; 20-27 points: severe. **Measure:** PHQ-9 **Time Frame:** Time Frame: Pre-Post-Design including 3 assessment points: pre-treatment, after 2 weeks, 4 weeks, 12 weeks, 24 weeks, 48 weeks follow up **Description:** Oral behaviors checklist (OBC) is to determine the presence of parafunctional behaviors. The score is calculated by summing the validation scores of the corresponding items. Response options are scored 0-4 for each item. Based on a comparison of people with chronic TMDs to people without TMDs, scores of 0-16 are normal, while scores of 17-24 occur twice as often in people with TMDs, and scores of 25-62 occur 17 times more often. Acting as a risk factor for TMDs, a score between 25-62 contributes to the onset of TMDs **Measure:** OBC **Time Frame:** Time Frame: Pre-Post-Design including 3 assessment points: pre-treatment, after 2 weeks, 4 weeks, 12 weeks, 24 weeks, 48 weeks follow up ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients diagnosed with Temporomandibular joint Disorders (according to DC/TMD) with acute or subacute temporal muscle and/or masseter muscle pain (less than 3 months). * All patients aged 16 years or older, capable of comprehending the doctor's opinion and complying with the examination process. Exclusion Criteria: * Patients with chronic TMDs pain, swelling and pain in the mouth that prevent wearing a occlusal splint. * Patients with history of severe neurological disorders, autoimmune joint and muscle diseases, advanced malignant cancer, history of mental illness, history of alcoholism, drug and painkiller abuse, undergoing surgery and/or radiotherapy on the neck and face, other treatments on the neck and temporomandibular joint within 3 months, use of drugs that may affect the neuromuscular system. * Pregnant patients **Minimum Age:** 16 Years **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Hoa Nguyen Ngoc, Resident doctor **Phone:** +84 0906235460 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Binh Tran Thai, Doctor **Phone:** +84 0979066759 **Role:** CONTACT #### Locations **Location 1:** **City:** Ha Noi **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Yen Hoang, Ph.D - **Phone:** +84948851999 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Hoa Nguyen Ngoc, Resident doctor - **Phone:** +84 0906235460 - **Role:** CONTACT **Country:** Vietnam **Facility:** High-tech center for Ondonto-stomatology, Institute of Odonto-Stomatology, Ha Noi Medical University **Status:** RECRUITING **Zip:** 11300 ### IPD Sharing Statement Module **Description:** Investigators have no plans to publish data related to research participants because all patients included in the doctoral training project of Hanoi Medical University have signed a commitment not to disclose information about the patients in the Ethics Committee's Consent to Participate. **IPD Sharing:** UNDECIDED ### References Module #### References **Citation:** Ahrari F, Madani AS, Ghafouri ZS, Tuner J. The efficacy of low-level laser therapy for the treatment of myogenous temporomandibular joint disorder. Lasers Med Sci. 2014 Mar;29(2):551-7. doi: 10.1007/s10103-012-1253-6. Epub 2013 Jan 15. **PMID:** 23318917 **Citation:** Ahmad SA, Hasan S, Saeed S, Khan A, Khan M. Low-level laser therapy in temporomandibular joint disorders: a systematic review. J Med Life. 2021 Mar-Apr;14(2):148-164. doi: 10.25122/jml-2020-0169. **PMID:** 34104237 **Citation:** Xu GZ, Jia J, Jin L, Li JH, Wang ZY, Cao DY. Low-Level Laser Therapy for Temporomandibular Disorders: A Systematic Review with Meta-Analysis. Pain Res Manag. 2018 May 10;2018:4230583. doi: 10.1155/2018/4230583. eCollection 2018. **PMID:** 29861802 **Citation:** Ayyildiz S, Emir F, Sahin C. Evaluation of Low-Level Laser Therapy in TMD Patients. Case Rep Dent. 2015;2015:424213. doi: 10.1155/2015/424213. Epub 2015 Oct 26. **PMID:** 26587294 **Citation:** Desai AP, Roy SK, Semi RS, Balasundaram T. Efficacy of Low-Level Laser Therapy in Management of Temporomandibular Joint Pain: A Double Blind and Placebo Controlled Trial. J Maxillofac Oral Surg. 2022 Sep;21(3):948-956. doi: 10.1007/s12663-021-01591-4. Epub 2021 May 25. **PMID:** 36274894 **Citation:** Basili M, Barlattani A Jr, Venditti A, Bollero P. Low-level laser therapy in the treatment of muscle-skelet pain in patients affected by temporo-mandibular disorders. Oral Implantol (Rome). 2017 Jan 21;10(4):406-411. doi: 10.11138/orl/2017.10.4.406. eCollection 2017 Oct-Dec. **PMID:** 29682258 **Citation:** Farshidfar N, Farzinnia G, Samiraninezhad N, Assar S, Firoozi P, Rezazadeh F, Hakimiha N. The Effect of Photobiomodulation on Temporomandibular Pain and Functions in Patients With Temporomandibular Disorders: An Updated Systematic Review of the Current Randomized Controlled Trials. J Lasers Med Sci. 2023 Aug 5;14:e24. doi: 10.34172/jlms.2023.24. eCollection 2023. **PMID:** 37744015 **Citation:** Demirkol N, Sari F, Bulbul M, Demirkol M, Simsek I, Usumez A. Effectiveness of occlusal splints and low-level laser therapy on myofascial pain. Lasers Med Sci. 2015 Apr;30(3):1007-12. doi: 10.1007/s10103-014-1522-7. Epub 2014 Feb 7. **PMID:** 24504660 #### See Also Links **Label:** Efficacy of Low-Level Laser Therapy in Management of Temporomandibular Joint Pain: A Double Blind and Placebo Controlled Trial **URL:** https://link.springer.com/10.1007/s12663-021-01591-4 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000017271 - Term: Craniomandibular Disorders - ID: D000008336 - Term: Mandibular Diseases - ID: D000007571 - Term: Jaw Diseases - ID: D000009135 - Term: Muscular Diseases - ID: D000009057 - Term: Stomatognathic Diseases - ID: D000009209 - Term: Myofascial Pain Syndromes ### 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: BC07 - Name: Mouth and Tooth Diseases ### Condition Browse Module - Browse Leaves - ID: M10621 - Name: Joint Diseases - Relevance: HIGH - As Found: Joint Disorders - ID: M30156 - Name: Myalgia - Relevance: LOW - As Found: Unknown - ID: M16477 - Name: Temporomandibular Joint Disorders - Relevance: HIGH - As Found: Temporomandibular Joint Disorders - ID: M16478 - Name: Temporomandibular Joint Dysfunction Syndrome - Relevance: HIGH - As Found: Temporomandibular Joint Disorders - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M19566 - Name: Craniomandibular Disorders - Relevance: LOW - As Found: Unknown - ID: M11327 - Name: Mandibular Diseases - Relevance: LOW - As Found: Unknown - ID: M10601 - Name: Jaw Diseases - Relevance: LOW - As Found: Unknown - ID: M12092 - Name: Muscular Diseases - Relevance: LOW - As Found: Unknown - ID: M12017 - Name: Stomatognathic Diseases - Relevance: LOW - As Found: Unknown - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M8486 - Name: Fibromyalgia - Relevance: LOW - As Found: Unknown - ID: M12161 - Name: Myofascial Pain Syndromes - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007592 - Term: Joint Diseases - ID: D000013705 - Term: Temporomandibular Joint Disorders - ID: D000013706 - Term: Temporomandibular Joint Dysfunction Syndrome ### Intervention Browse Module - Ancestors - ID: D000000890 - Term: Anti-Infective Agents - ID: D000000935 - Term: Antifungal Agents - ID: D000007641 - Term: Keratolytic Agents - ID: D000003879 - Term: Dermatologic Agents ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: Derm - Name: Dermatologic Agents - Abbrev: Analg - Name: Analgesics - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: Ot - Name: Other Dietary Supplements ### Intervention Browse Module - Browse Leaves - ID: M7885 - Name: Endorphins - Relevance: LOW - As Found: Unknown - ID: M21989 - Name: Salicylic Acid - Relevance: HIGH - As Found: SOF - ID: M4033 - Name: Analgesics, Opioid - Relevance: LOW - As Found: Unknown - ID: M4854 - Name: Benzocaine - Relevance: LOW - As Found: Unknown - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown - ID: M6252 - Name: Clotrimazole - Relevance: LOW - As Found: Unknown - ID: M11796 - Name: Miconazole - Relevance: LOW - As Found: Unknown - ID: M4254 - Name: Antifungal Agents - Relevance: LOW - As Found: Unknown - ID: M10667 - Name: Keratolytic Agents - Relevance: LOW - As Found: Unknown - ID: M7074 - Name: Dermatologic Agents - Relevance: LOW - As Found: Unknown - ID: T433 - Name: Tannic Acid - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000020156 - Term: Salicylic Acid ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419725 **Brief Title:** Temporal Trends in Nonattendence Rate for Scheduled Outpatient Appointments. **Official Title:** Temporal Trends in Nonattendence Rate for Scheduled Outpatient Appointments. #### Organization Study ID Info **ID:** 6922 #### Organization **Class:** OTHER **Full Name:** Hospital Italiano de Buenos Aires ### Status Module #### Completion Date **Date:** 2023-12-31 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-12-31 **Type:** ACTUAL #### Start Date **Date:** 2016-01-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Hospital Italiano de Buenos Aires #### Responsible Party **Investigator Affiliation:** Hospital Italiano de Buenos Aires **Investigator Full Name:** LUCIA.PEREZ **Investigator Title:** Pediatrician. Non-sponsored research. Research Secretary of the University Italian Hospital of Buenos Aires. **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Ecological time-series study using secondary databases. **Detailed Description:** A time-series study will be conducted to evaluate nonattendance over time. The unit of analysis will be the appointment. ### Conditions Module **Conditions:** - Patient Non Attendance to Medical Care **Keywords:** - No Show Patients - Patient Non Attendance - Patient absenteeism - Patient compliance ### Design Module #### Design Info **Observational Model:** ECOLOGIC_OR_COMMUNITY **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 13823093 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Measure:** Describe the behavior over time of the nonattendance proportion in scheduled outpatient medical appointments for in-person medical care over an 8-year period (globally and by subgroups: gender, age, medical specialty, and medical coverage). **Time Frame:** 2016 to 2023 **Measure:** Evaluate temporal trends and changes (joinpoints) in the absenteeism proportion in scheduled outpatient medical appointments for in-person medical care over the same period. **Time Frame:** 2016 to 2023 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Appointments scheduled for outpatient medical care across all settings and specialties from January 1, 2016, to December 31, 2023 Exclusion Criteria: * Cancelled appointments, including cancellations made by the patient, medical team, and the appointment management system. * Appointments that do not correspond to scheduled in-person care (Teleconsultations, * Appointments for walk-in demand). * Scheduled appointments that are not for medical care (Health coverage or specialties that do not correspond to scheduled medical care, Appointments for procedures, * Appointments for complementary exams, Appointments for treatments such as speech therapy, physiotherapy, or other therapies). * Spontaneous overflow appointments where the patient spontaneously presents for care at that moment. These appointments cannot be absent as the present and the appointment are assigned simultaneously. * System errors that do not correspond to actual patient medical care appointments (Duplicate cancellations, Appointments where patient and physician coincide). **Maximum Age:** 110 Years **Minimum Age:** 0 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT - OLDER_ADULT **Study Population:** The study population comprises individuals who requested at least one appointment for scheduled outpatient medical care at Hospital Italiano de Buenos Aires during the study period in any of its settings. ### Contacts Locations Module #### Locations **Location 1:** **City:** Ciudad Autonoma de Buenos Aire **Country:** Argentina **Facility:** Hospital Italiano de Buenos Aires **Zip:** 1406 ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Giunta D, Briatore A, Baum A, Luna D, Waisman G, de Quiros FG. Factors associated with nonattendance at clinical medicine scheduled outpatient appointments in a university general hospital. Patient Prefer Adherence. 2013 Nov 8;7:1163-70. doi: 10.2147/PPA.S51841. eCollection 2013. **PMID:** 24235820 **Citation:** Giunta DH, Alonso Serena M, Luna D, Peroni ML, Sanchez Thomas D, Binder F, Blugerman GA, Fuentes N, Elizondo CM, Gonzalez Bernaldo de Quiros F. Association between non-attendance to outpatient clinics and emergency department consultations, hospitalizations and mortality in a Health Maintenance Organization. Int J Health Plann Manage. 2020 Sep;35(5):1140-1156. doi: 10.1002/hpm.3021. Epub 2020 Jul 9. **PMID:** 32648278 **Citation:** Carrillo GJS. Adhesión de los pacientes a las consultas de control ambulatorio. Investigación en Enfermería: Imagen y Desarrollo. 2011;9: 51-62. **Citation:** Kheirkhah P, Feng Q, Travis LM, Tavakoli-Tabasi S, Sharafkhaneh A. Prevalence, predictors and economic consequences of no-shows. BMC Health Serv Res. 2016 Jan 14;16:13. doi: 10.1186/s12913-015-1243-z. **PMID:** 26769153 **Citation:** Berg BP, Murr M, Chermak D, Woodall J, Pignone M, Sandler RS, Denton BT. Estimating the cost of no-shows and evaluating the effects of mitigation strategies. Med Decis Making. 2013 Nov;33(8):976-85. doi: 10.1177/0272989X13478194. Epub 2013 Mar 20. **PMID:** 23515215 **Citation:** Jabalera Mesa ML, Morales Asencio JM, Rivas Ruiz F, Porras Gonzalez MH. [Analysis of economic cost of missed outpatient appointments]. Rev Calid Asist. 2017 Jul-Aug;32(4):194-199. doi: 10.1016/j.cali.2017.01.004. Epub 2017 May 2. Spanish. **PMID:** 28476506 **Citation:** George A, Rubin G. Non-attendance in general practice: a systematic review and its implications for access to primary health care. Fam Pract. 2003 Apr;20(2):178-84. doi: 10.1093/fampra/20.2.178. **PMID:** 12651793 **Citation:** Wolff DL, Waldorff FB, von Plessen C, Mogensen CB, Sorensen TL, Houlind KC, Bogh SB, Rubin KH. Rate and predictors for non-attendance of patients undergoing hospital outpatient treatment for chronic diseases: a register-based cohort study. BMC Health Serv Res. 2019 Jun 14;19(1):386. doi: 10.1186/s12913-019-4208-9. **PMID:** 31200720 **Citation:** Karter AJ, Parker MM, Moffet HH, Ahmed AT, Ferrara A, Liu JY, Selby JV. Missed appointments and poor glycemic control: an opportunity to identify high-risk diabetic patients. Med Care. 2004 Feb;42(2):110-5. doi: 10.1097/01.mlr.0000109023.64650.73. **PMID:** 14734947 **Citation:** Lee RRS, Samsudin MI, Thirumoorthy T, Low LL, Kwan YH. Factors affecting follow-up non-attendance in patients with Type 2 diabetes mellitus and hypertension: a systematic review. Singapore Med J. 2019 May;60(5):216-223. doi: 10.11622/smedj.2019042. **PMID:** 31187148 **Citation:** Colubi MM, Perez-Elias MJ, Elias L, Pumares M, Muriel A, Zamora AM, Casado JL, Dronda F, Lopez D, Moreno S; SEAD Study Group. Missing scheduled visits in the outpatient clinic as a marker of short-term admissions and death. HIV Clin Trials. 2012 Sep-Oct;13(5):289-95. doi: 10.1310/hct1305-289. **PMID:** 23134630 **Citation:** Srisaenpang S, Pinitsoontorn S, Singhasivanon P, Kitayaporn D, Kaewkungwal J, Tatsanavivat P, Patjanasoontorn B, Reechaipichitkul W, Thiratakulpisan J, Srinakarin J, Srisaenpang P, Thinkamrop B, Apinyanurak C, Chindawong BO. Missed appointments at a tuberculosis clinic increased the risk of clinical treatment failure. Southeast Asian J Trop Med Public Health. 2006 Mar;37(2):345-50. **PMID:** 17124997 **Citation:** Ayten Turkcan & Lynn Nuti & Po-Ching DeLaurentis & Zhiyi Tian & Joanne Daggy & Lingsong Zhang & Mark Lawley & Laura Sands, 2013. **Citation:** Giunta DH, Alonso Serena M. Nonattendance rates of scheduled outpatient appointments in a university general hospital. Int J Health Plann Manage. 2019 Oct;34(4):1377-1385. doi: 10.1002/hpm.2797. Epub 2019 May 7. **PMID:** 31062463 **Citation:** Kim HJ, Fay MP, Feuer EJ, Midthune DN. Permutation tests for joinpoint regression with applications to cancer rates. Stat Med. 2000 Feb 15;19(3):335-51. doi: 10.1002/(sici)1097-0258(20000215)19:33.0.co;2-z. Erratum In: Stat Med 2001 Feb 28;20(4):655. **PMID:** 10649300 **Citation:** Daniel L, Paula O, Alejandro LO, Eduardo R, Federico P, Adrián G, et al. Implementación de una Historia Clínica Electrónica Ambulatoria: El Proyecto Itálica. 6to Simposio de Informática en Salud - 32 JAIIO 2003. 2003. **Citation:** Plazzotta F, Luna D, Gonzalez Bernaldo de Quiros F. [Health information systems: integrating clinical data in different scenarios and users]. Rev Peru Med Exp Salud Publica. 2015 Apr-Jun;32(2):343-51. Spanish. **PMID:** 26338397 **Citation:** Franco M, Giussi Bordoni MV, Otero C, Landoni MC, Benitez S, Borbolla D, Luna D. Problem Oriented Medical Record: Characterizing the Use of the Problem List at Hospital Italiano de Buenos Aires. Stud Health Technol Inform. 2015;216:877. **PMID:** 26262179 **Citation:** Luna D, Franco M, Plaza C, Otero C, Wassermann S, Gambarte ML, Giunta D, Gonzalez Bernaldo de Quiros F. Accuracy of an electronic problem list from primary care providers and specialists. Stud Health Technol Inform. 2013;192:417-21. **PMID:** 23920588 **Citation:** Plazzotta F, Otero C, Luna D, de Quiros FG. Natural language processing and inference rules as strategies for updating problem list in an electronic health record. Stud Health Technol Inform. 2013;192:1163. **PMID:** 23920937 **Citation:** Torre LA, Siegel RL, Ward EM, Jemal A. International variation in lung cancer mortality rates and trends among women. Cancer Epidemiol Biomarkers Prev. 2014 Jun;23(6):1025-36. doi: 10.1158/1055-9965.EPI-13-1220. Epub 2014 May 16. **PMID:** 24836468 #### See Also Links **Label:** National Cancer Institute. Division of Cancer Control and Population Science. Joinpoint Trend Analysis Software. **URL:** https://surveillance.cancer.gov/joinpoint/ **Label:** Medidas sanitarias por la pandemia de COVID-19 en Argentina. **URL:** https://es.wikipedia.org/wiki/Medidas_sanitarias_por_la_pandemia_de_COVID-19_en_Argentina#Del_20_al_31_de_marzo **Label:** COVID-19 pandemic in Argentina. **URL:** https://en.wikipedia.org/wiki/COVID-19_pandemic_in_Argentina ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419712 **Acronym:** VITDPOSTCOVID **Brief Title:** Effect of Vitamin D Supplementation on Glutathione Peroxidase (GPx) Activity, Interleukin-6 (IL-6) Levels and Clinical Outcomes in Post-COVID-19 Patients **Official Title:** Effect of Vitamin D Supplementation on Glutathione Peroxidase (GPx) Activity, Interleukin-6 (IL-6) Levels and Clinical Outcomes in Post-COVID-19 Patients #### Organization Study ID Info **ID:** C32-22 #### Organization **Class:** OTHER **Full Name:** Escuela Militar de Graduados de Sanidad, SEDENA ### Status Module #### Completion Date **Date:** 2023-05-25 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-04-20 **Type:** ACTUAL #### Start Date **Date:** 2022-11-25 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-15 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Escuela Militar de Graduados de Sanidad, SEDENA #### Responsible Party **Investigator Affiliation:** Escuela Militar de Graduados de Sanidad, SEDENA **Investigator Full Name:** IVÁN IGNACIO MEJÍA **Investigator Title:** DR. IVÁN IGNACIO MEJÍA **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 evaluate the effectiveness of vitamin D supplementation in treating neuropsychiatric symptoms and improving antioxidant levels in individuals diagnosed with post-COVID-19 condition, a state known as long-COVID. These individuals are primarily adults who have recovered from severe COVID-19 and exhibit persistent symptoms. The main questions it aims to answer are: Does vitamin D (cholecalciferol) supplementation decrease levels of anxiety and depression in patients with post-COVID-19 condition? Does vitamin D (cholecalciferol) supplementation increase glutathione peroxidase (GPx) activity in these patients? Researchers will compare the effects of daily versus bolus doses of vitamin D (cholecalciferol) to see if one method is more effective than the other in achieving sufficient vitamin D levels and improving clinical outcomes. Participants will: Be randomly assigned to receive either a daily dose or a bolus dose of vitamin D over an 8-week period. Undergo blood tests to measure biochemical markers such as interleukin-6 (IL-6) and GPx before and two months after starting supplementation. Have their lung function tested using spirometry and diffusing capacity for carbon monoxide. Complete the Hospital Anxiety and Depression Scale to assess changes in anxiety and depression levels. **Detailed Description:** This clinical trial investigates the potential therapeutic benefits of vitamin D supplementation in individuals experiencing persistent health issues following recovery from severe COVID-19, commonly referred to as post-COVID-19 condition or long-COVID. The study primarily focuses on the neuropsychiatric symptoms such as anxiety and depression and the antioxidant enzyme activity, specifically glutathione peroxidase (GPx), which plays a critical role in mitigating oxidative stress within the body. The trial is designed as a pilot, randomized controlled trial, where participants are divided into two groups to receive vitamin D in different dosing regimens: a daily dose and a bolus dose, administered weekly. This method allows for an examination of the efficacy of dosage frequency on achieving optimal serum vitamin D levels, which are hypothesized to influence the biochemical pathways involved in inflammatory and oxidative processes. During the study, participants\&#39; serum levels of 25-hydroxyvitamin D (25(OH)D), a marker for vitamin D status, are assessed to ensure they reach and maintain a target level that previous studies have associated with optimal immune function and reduced inflammation. The participants\&#39; initial vitamin D status is carefully evaluated to tailor the supplementation dose according to individual needs, following a formula that considers their weight and the desired increase in 25(OH)D levels. The antioxidant capacity of participants is measured through the activity of GPx in the blood. This enzyme is crucial for reducing oxidative stress, which is linked to various chronic diseases and has been suggested to play a significant role in the severity and progression of post-COVID-19 symptoms. By measuring GPx activity before and after vitamin D supplementation, the study aims to provide insights into the effectiveness of vitamin D in enhancing antioxidant defenses in post-COVID patients. Furthermore, the trial includes an evaluation of lung function using high-resolution computed tomography (HRCT) and standard pulmonary function tests, including spirometry and the diffusing capacity of the lung for carbon monoxide (DLCO). These assessments help to determine any improvements in respiratory health, which is often compromised in patients with long-term COVID-19 effects. The impact of vitamin D on neuropsychiatric symptoms is assessed using the Hospital Anxiety and Depression Scale (HADS), a validated tool that rates the severity of anxiety and depression symptoms. This aspect of the study highlights the potential of vitamin D not just as a physical health supplement but also as a modulator of mental health, particularly in the context of the ongoing recovery from a severe infectious disease. By conducting this trial, the researchers aim to shed light on the broader implications of vitamin D supplementation, not only as a means of improving vitamin D status but also as a potentially significant intervention for improving the quality of life and health outcomes in individuals suffering from long-term effects of COVID-19. ### Conditions Module **Conditions:** - Post-COVID19 Condition **Keywords:** - Post-COVID-19 condition - long-COVID-19 - vitamin D - cholecalciferol - interleukin-6 - glutathione peroxidase - cough - dyspnea - fatigue - anxiety - depression ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** TRIPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 54 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** This arm of the study involves daily administration of vitamin D to participants, with the dosage adjusted based on body weight and initial vitamin D levels, aiming to achieve and maintain optimal serum vitamin D levels **Intervention Names:** - Drug: vitamin D (cholecalciferol) supplementation **Label:** Daily Vitamin D Supplementation Group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** This arm of the study involves administering a weekly bolus dose of vitamin D, equivalent to the total daily dose accumulated over the week, to investigate the efficacy of this regimen in improving vitamin D levels and reducing post-COVID-19 symptoms. **Intervention Names:** - Drug: vitamin D (cholecalciferol) supplementation **Label:** Weekly Bolus Vitamin D Supplementation Group **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Daily Vitamin D Supplementation Group - Weekly Bolus Vitamin D Supplementation Group **Description:** This clinical pilot study administered and compared daily and bolus dosing regi-mens of vitamin D to achieve and maintain optimal serum levels of 25(OH)D in post-COVID patients. The daily dose group received constant and gradual supplementation of cholecalciferol, intended to achieve more stable 25(OH)D levels without peaks. Conversely, the bolus group received a weekly dose that could lead to rapid increases followed by gradual declines in 25(OH)D levels. The Daily dose of cholecalciferol was calculated using the following formula: Daily dose of cholecalciferol = \[Weight (kg) × desired increase in 25(OH)D (ng/ml) × 2.5\] - 10 . **Name:** vitamin D (cholecalciferol) supplementation **Type:** DRUG ### Outcomes Module #### Other Outcomes **Description:** Assessment of respiratory and general symptoms associated with long-COVID to determine any subjective improvement post-vitamin D supplementation **Measure:** Symptoms of Cough, Dyspnea, and Fatigue **Time Frame:** Baseline and two months post-supplementation. #### Primary Outcomes **Description:** This measure assesses the antioxidant enzyme activity level in the blood, indicating the body's capacity to reduce oxidative stress. Increased activity of GPx is expected as a result of vitamin D supplementation **Measure:** Glutathione Peroxidase (GPx) Activity **Time Frame:** Baseline and two months post-supplementation **Description:** The severity of anxiety and depression will be quantified using the Hospital Anxiety and Depression Scale (HADS). A decrease in HADS scores post-supplementation is anticipated. **Measure:** Neuropsychiatric Symptoms (Anxiety and Depression) **Time Frame:** Baseline and two months post-supplementation. #### Secondary Outcomes **Description:** IL-6 is a pro-inflammatory cytokine. The study aims to observe changes in IL-6 levels, which might not be significantly altered by vitamin D supplementation as per preliminary findings. **Measure:** Serum Levels of Interleukin-6 (IL-6) **Time Frame:** Baseline and two months post-supplementation. **Description:** Includes Forced Vital Capacity (FVC) and Forced Expiratory Volume in One Second (FEV1). Improvements in these parameters would suggest beneficial effects of vitamin D on lung health **Measure:** Lung Function Tests **Time Frame:** Baseline and two months post-supplementation. **Description:** This measure will confirm the efficacy of the vitamin D supplementation regimen in achieving and maintaining sufficient serum levels of vitamin D. **Measure:** Serum 25-Hydroxyvitamin D Levels **Time Frame:** Baseline and two months post-supplementation. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Diagnosis of Post-COVID-19 Condition: Patients must have been previously diagnosed with COVID-19 and continue to experience persistent symptoms after recovery. * Age: Participants must be adults aged 18 years or older. * Vitamin D Deficiency: Initial serum 25-hydroxyvitamin D levels below 40 ng/mL. * Completed Hospital Treatment for COVID-19: Patients must have been discharged from hospital treatment for COVID-19 at least 12 months prior to the study. * Ability to Give Informed Consent: Participants must be capable of understanding and willing to sign a consent form. * Ability to Perform Required Tests: Participants must be physically able to undergo spirometry and other functional tests as required by the study protocol. Exclusion Criteria: * Reading and Writing Difficulties: Patients who have difficulties in reading and/or writing that would impede their understanding of the study requirements or communication with study staff. * Inability to Perform Physical Tests: Patients unable to perform functional walk and spirometry tests. * Untreated Chronic Non-Respiratory Diseases: Individuals suffering from untreated chronic diseases such as diabetes mellitus, systemic arterial hypertension, hypothyroidism, or epilepsy that could interfere with the study outcomes. * Recent Use of Vitamin D Supplements: Patients who have taken vitamin D supplements within three months prior to the start of the study. * Participation in Other Clinical Trials: Patients currently participating in other clinical trials that might conflict with this study's protocol. * Pregnancy: Due to potential risks and lack of data on high-dose vitamin D supplementation during pregnancy, pregnant women will be excluded. **Maximum Age:** 70 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Mexico City **Country:** Mexico **Facility:** Instituto Nacional de Enfermedades Respiratorias **Zip:** 14080 ### IPD Sharing Statement Module **Description:** Upon completion of the study, and after publication of the primary findings, the following Individual Participant Data will be made available: Anonymized Participant Data: This includes all individual data collected during the trial, minus any personally identifiable information. Data types include: Demographic information (age, gender, etc.) Clinical data (symptoms, disease severity, etc.) Treatment data (dosage received, treatment duration, etc.) Outcome data (response to treatment, side effects, etc.) Laboratory results (vitamin D levels, IL-6 levels, GPx activity, etc.). **IPD Sharing:** YES ## Derived Section ### Condition Browse Module - Ancestors - ID: D000011024 - Term: Pneumonia, Viral - ID: D000011014 - Term: Pneumonia - ID: D000012141 - Term: Respiratory Tract Infections - ID: D000007239 - Term: Infections - ID: D000014777 - Term: Virus Diseases - ID: D000018352 - Term: Coronavirus Infections - ID: D000003333 - Term: Coronaviridae Infections - ID: D000030341 - Term: Nidovirales Infections - ID: D000012327 - Term: RNA Virus Infections - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: BC01 - Name: Infections - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M7058 - Name: Depression - Relevance: LOW - As Found: Unknown - ID: M4324 - Name: Anxiety Disorders - Relevance: LOW - As Found: Unknown - ID: M3013 - Name: Post-Acute COVID-19 Syndrome - Relevance: LOW - As Found: Unknown - ID: M2561 - Name: COVID-19 - Relevance: HIGH - As Found: COVID-19 - ID: M7591 - Name: Dyspnea - Relevance: LOW - As Found: Unknown - ID: M8364 - Name: Fatigue - Relevance: LOW - As Found: Unknown - ID: M7061 - Name: Depressive Disorder - Relevance: LOW - As Found: Unknown - ID: M6590 - Name: Cough - Relevance: LOW - As Found: Unknown - ID: M13904 - Name: Pneumonia - Relevance: LOW - As Found: Unknown - ID: M13914 - Name: Pneumonia, Viral - Relevance: LOW - As Found: Unknown - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M14978 - Name: Respiratory Tract Infections - Relevance: LOW - As Found: Unknown - ID: M17522 - Name: Virus Diseases - Relevance: LOW - As Found: Unknown - ID: M20490 - Name: Coronavirus Infections - Relevance: LOW - As Found: Unknown - ID: M6555 - Name: Coronaviridae Infections - Relevance: LOW - As Found: Unknown - ID: M23685 - Name: Nidovirales Infections - Relevance: LOW - As Found: Unknown - ID: M15149 - Name: RNA Virus Infections - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000086382 - Term: COVID-19 ### Intervention Browse Module - Ancestors - ID: D000014815 - Term: Vitamins - ID: D000018977 - Term: Micronutrients - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000050071 - Term: Bone Density Conservation Agents - ID: D000077264 - Term: Calcium-Regulating Hormones and Agents ### Intervention Browse Module - Browse Branches - Abbrev: BDCA - Name: Bone Density Conservation Agents - Abbrev: Micro - Name: Micronutrients - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: Vi - Name: Vitamins - Abbrev: Ot - Name: Other Dietary Supplements ### Intervention Browse Module - Browse Leaves - ID: M17550 - Name: Vitamin D - Relevance: HIGH - As Found: Protocol - ID: M6003 - Name: Cholecalciferol - Relevance: HIGH - As Found: 2.5 - ID: M17558 - Name: Vitamins - Relevance: LOW - As Found: Unknown - ID: M4854 - Name: Benzocaine - Relevance: LOW - As Found: Unknown - ID: M21009 - Name: Micronutrients - Relevance: LOW - As Found: Unknown - ID: M16885 - Name: Trace Elements - Relevance: LOW - As Found: Unknown - ID: M9789 - Name: Hormones - Relevance: LOW - As Found: Unknown - ID: M5381 - Name: Calcium - Relevance: LOW - As Found: Unknown - ID: M5398 - Name: Calcium, Dietary - Relevance: LOW - As Found: Unknown - ID: T442 - Name: Cholecalciferol - Relevance: HIGH - As Found: 2.5 - ID: T479 - Name: Vitamin D3 - Relevance: HIGH - As Found: Explanatory - ID: T440 - Name: Calciferol - Relevance: HIGH - As Found: Explanatory - ID: T433 - Name: Tannic Acid - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000014807 - Term: Vitamin D - ID: D000002762 - Term: Cholecalciferol ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419699 **Brief Title:** CPAx: Responsiveness and Minimal Clinically Important Difference **Official Title:** Responsiveness and the Minimal Clinically Important Difference of the Chelsea Critical Care Physical Assessment Tool (CPAx) in Critically Ill, Mechanically Ventilated Adults #### Organization Study ID Info **ID:** 5678 #### Organization **Class:** OTHER **Full Name:** Insel Gruppe AG, University Hospital Bern ### Status Module #### Completion Date **Date:** 2025-10 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-10 **Type:** ESTIMATED #### Start Date **Date:** 2024-05 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Monash University #### Lead Sponsor **Class:** OTHER **Name:** Insel Gruppe AG, University Hospital Bern #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Intensive care unit (ICU) acquired weakness is a common complication associated with long-term physical impairments in survivors of a critical illness. The Chelsea Critical Care Physical Assessment tool (CPAx) is a valid and reliable instrument for physical function and activity in critically ill patients at risk for muscle weakness. However, its ability to measure change over time (responsiveness) and the minimal clinically important difference (MCID) have not yet been rigorously investigated. This multi-centre, mixed-methods, longitudinal cohort study therefore aims to establish responsiveness and the MCID of the CPAx in the target population from ICU baseline to ICU and hospital discharge. The study uses routine data from standard physiotherapy sessions like mobility, function and activity with no additional burden for critically ill adults. The investigators expect the CPAx to be responsive allowing its use as a primary outcome in future effectiveness trials for the treatment of ICU-acquired weakness using the newly established MCID for sample size calculation. A high quality, rigorously tested measurement tool for physical function and activity in the ICU should benefit researchers, clinicians and patients. **Detailed Description:** The use of invasive life support in critically ill patients clearly saves lives but carries substantial risks, including intensive care unit (ICU) acquired weakness and long-term disability. The investigators urgently need a valid, reliable, and responsive measurement tool for this population to use in clinical practice and trials. The Chelsea Critical Care Physical Assessment tool (CPAx) is a promising measurement instrument to measure change in critically ill patients' physical function and activity. After several studies have confirmed its validity and excellent reliability, it is time to confirm responsiveness and to establish the MCID in a large, international sample of the target population. This multi-centre, mixed-methods, longitudinal cohort study will include critically ill, mechanically ventilated (\>72h) adults at risk for muscle weakness and collect their mobility, physical function and activity with the CPAx and other relevant measures at ICU baseline, to ICU and hospital discharge. Responsiveness will be determined by the ability of the CPAx to identify change according to a prespecified anchor (criterion validity) and by testing prospective hypotheses about the expected magnitude of change between the CPAx and other relevant measures (construct validity). The MCID will be established with anchor- and distribution-based methods, whereby a seven-point global rating of change scale obtained from treating ICU physiotherapists will serve as anchor to distinguish improved from unchanged patients. ### Conditions Module **Conditions:** - Muscle Weakness - Critical Illness Myopathy - Critical Illness Polyneuropathy - Critical Illness Polyneuromyopathy - Physical Inactivity **Keywords:** - Physiotherapy - Physical function and activity - Early rehabilitation - Measurement instrument - Critical illness - Critical care outcomes ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 120 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Outcomes Module #### Primary Outcomes **Description:** CPAx change score for ICU period (ICU baseline to ICU discharge); CPAx ranges from 0 (worst score) to 50 (best score) **Measure:** Chelsea Critical Care Physical Assessment tool (CPAx) change score **Time Frame:** Assessed at ICU discharge (within 24 hours before or after ICU discharge) #### Secondary Outcomes **Description:** CPAx change score for hospital period (ICU to hospital discharge); CPAx ranges from 0 (worst score) to 50 (best score) **Measure:** CPAx change score **Time Frame:** Assessed at hospital discharge (last value before discharge) **Description:** Seven-point global rating of change scale (GRC): (1) very much improved; (2) much improved; (3) little improved; (4) no change; (5) little deterioration; (6) much deterioration; (7) very much deterioration for 'physical function and activity' (rated by treating physiotherapist) **Measure:** Global rating of change scale **Time Frame:** ICU and hospital discharge (change for ICU and hospital period) **Description:** To evaluate mobility level, the score ranges from 0 (worst) to 10 (best) **Measure:** ICU Mobility Scale **Time Frame:** ICU baseline (within 72-144h after ICU admission), ICU and hospital discharge **Description:** To assess muscle strength, the minimal score is 0 (worst), the maximal score 60 (best), ICUAW is defined as \<48 points **Measure:** Medical Research Council Sum Score **Time Frame:** ICU baseline (within 72-144h after ICU admission), ICU and hospital discharge **Description:** To assess the level of sedation and/or cooperation, score ranges from -5 (unarousable) to +4 (combative) **Measure:** Richmond Agitation-Sedation Scale **Time Frame:** ICU baseline (within 72-144h after ICU admission), ICU and hospital discharge **Description:** To determine assistance in functional tasks, the score ranges from 0 (worst) to 36 (best) **Measure:** Modified Iowa Level of Assistance Scale **Time Frame:** ICU baseline (within 72-144h after ICU admission), ICU and hospital discharge **Description:** Categorical variable (death, external/internal hospital ward, external ICU/hospital, rehabilitation, home, other) to assess the predictive validity of the CPAx score **Measure:** ICU and discharge destinations **Time Frame:** ICU and hospital discharge ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age ≥ 18 years * Mechanical ventilation ≥ 72 hours * Expected to remain for ≥ 48 hours in the ICU * Physiotherapy referral Exclusion Criteria: * Not expected to survive to hospital discharge (imminent to death) * Second or subsequent ICU admission for this hospital stay * Transfer from external ICU (with an ICU stay of \>72 hours) * Primary neurological admission diagnosis (i.e., of the central nervous system including stroke, intracerebral haemorrhage, traumatic brain injury) * Known pregnancy * Living in a care facility pre-admission (severe pre-existing mental or physical disability) * Local regulations (i.e. Switzerland: refusal of general consent) **Minimum Age:** 18 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** The target population are critically ill adults who are mechanically ventilated for a prolonged period (≥ 72 hours) and who have an increased risk for ICUAW and long-term impairment. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Sabrina Eggmann, PhD **Phone:** +41 31 632 30 41 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Carol Hodgson, Prof **Phone:** +61 3 9903 0598 **Role:** CONTACT #### Locations **Location 1:** **City:** Bern **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Sabrina Eggmann, PhD - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Christa Villinger - **Role:** CONTACT **Country:** Switzerland **Facility:** Inselspital #### Overall Officials **Official 1:** **Affiliation:** Inselspital, Bern University Hospital, Switzerland; Monash University, Australia **Name:** Sabrina Eggmann, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** Solely anonymised main outcome data **IPD Sharing:** NO ### References Module #### References **Citation:** Corner EJ, Wood H, Englebretsen C, Thomas A, Grant RL, Nikoletou D, Soni N. The Chelsea critical care physical assessment tool (CPAx): validation of an innovative new tool to measure physical morbidity in the general adult critical care population; an observational proof-of-concept pilot study. Physiotherapy. 2013 Mar;99(1):33-41. doi: 10.1016/j.physio.2012.01.003. Epub 2012 Mar 30. **PMID:** 23219649 **Citation:** Eggmann S, Verra ML, Stefanicki V, Kindler A, Seyler D, Hilfiker R, Schefold JC, Bastiaenen CHG, Zante B. German version of the Chelsea Critical Care Physical Assessment Tool (CPAx-GE): translation, cross-cultural adaptation, validity, and reliability. Disabil Rehabil. 2022 Aug;44(16):4509-4518. doi: 10.1080/09638288.2021.1909152. Epub 2021 Apr 19. **PMID:** 33874842 **Citation:** Eggmann S, Verra ML, Stefanicki V, Kindler A, Schefold JC, Zante B, Bastiaenen CHG. Predictive validity of the Chelsea Critical Care Physical Assessment tool (CPAx) in critically ill, mechanically ventilated adults: a prospective clinimetric study. Disabil Rehabil. 2023 Jan;45(1):111-116. doi: 10.1080/09638288.2021.2022785. Epub 2022 Jan 7. **PMID:** 34994664 ## 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: D000009468 - Term: Neuromuscular Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000010523 - Term: Peripheral Nervous System Diseases - ID: D000020879 - Term: Neuromuscular Manifestations - 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: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M19010 - Name: Critical Illness - Relevance: HIGH - As Found: Critical Illness - ID: M20944 - Name: Muscle Weakness - Relevance: HIGH - As Found: Muscle Weakness - ID: M13204 - Name: Paresis - Relevance: LOW - As Found: Unknown - ID: M4554 - Name: Asthenia - Relevance: LOW - As Found: Unknown - ID: M13999 - Name: Polyneuropathies - Relevance: HIGH - As Found: Critical Illness Polyneuropathy - ID: M12092 - Name: Muscular Diseases - Relevance: LOW - As Found: Unknown - ID: M22700 - Name: Disease Attributes - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M12411 - Name: Neuromuscular Diseases - Relevance: LOW - As Found: Unknown - ID: M13432 - Name: Peripheral Nervous System 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 - ID: D000011115 - Term: Polyneuropathies - ID: D000016638 - Term: Critical Illness ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419686 **Acronym:** GIPALANIN **Brief Title:** The Glucagonotropic Effects of Glucose-dependent Insulinotropic Polypeptide and Alanine in Healthy Individuals **Official Title:** The Separate and Combined Glucagonotropic Effects of Glucose-dependent Insulinotropic Polypeptide and Alanine in Healthy Individuals #### Organization Study ID Info **ID:** H-21066812 #### Organization **Class:** OTHER **Full Name:** University Hospital, Gentofte, Copenhagen ### Status Module #### Completion Date **Date:** 2024-07 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-05 **Type:** ESTIMATED #### Start Date **Date:** 2024-01-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University Hospital, Gentofte, Copenhagen #### Responsible Party **Investigator Affiliation:** University Hospital, Gentofte, Copenhagen **Investigator Full Name:** Filip Krag Knop **Investigator Title:** MD PhD, 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 study is a randomised, double-blinded, placebo-controlled, crossover study enrolling 10 healthy male participants. Each participant will undergo four separate study days in randomised order. Each study day encompasses a continous 90-minute i.v. infusion with either placebo, glucose-dependent insulinotropic polypeptide (GIP), alanine or GIP + alanine. The primary objective of the study is to find out whether intravenous administration of the naturally occuring gut hormone GIP and the amino acid alanine, separately and combined, results in additive or synergistic glucagonotropic effects during euglycaemic conditions in healthy participants. Secondary objectives are to disclose the effect of the abovementioned interventions on insulin secretion and circulating levels of total and individual amino acids. ### Conditions Module **Conditions:** - Effect of iv Administration of GIP and Alanine ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** TRIPLE **Who Masked:** - PARTICIPANT - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 10 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Intravenous administration of saline for 90 minutes. **Intervention Names:** - Other: Placebo (saline) **Label:** Saline **Type:** PLACEBO_COMPARATOR #### Arm Group 2 **Description:** Intravenous administration of GIP for 90 minutes (priming dose 6 pmol/kg/min for 10 minutes and 4 pmol/kg for 80 minutes. **Intervention Names:** - Drug: GIP **Label:** GIP **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Intravenous administration of alanine for 90 minutes (28 umol/kg/min). **Intervention Names:** - Drug: Alanine **Label:** Alanine **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** Intravenous administration of GIP and alanine for 90 minutes. GIP is given at a priming dose of 6 pmol/kg/min for 10 minutes and then 4 pmol/kg for 80 minutes. Alanine is given at 28 umol/kg/min for 90 minutes. **Intervention Names:** - Drug: GIP + alanine **Label:** GIP + Alanine **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Saline **Description:** Intravenous saline during experimental days. **Name:** Placebo (saline) **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - GIP **Description:** Intravenous GIP administration during experimental days. **Name:** GIP **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Alanine **Description:** Intravenous alanine administration during experimental days. **Name:** Alanine **Type:** DRUG #### Intervention 4 **Arm Group Labels:** - GIP + Alanine **Description:** Intravenous administration of GIP and alanine during experimental days. **Name:** GIP + alanine **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Baseline **Measure:** Plasma concentrations of Glucagon **Time Frame:** Timepoint -30 to 90 minutes **Description:** Baseline-corrected area under the curve (bsAUC) **Measure:** Plasma concentrations of Glucagon **Time Frame:** Timepoint -30 to 90 minutes #### Secondary Outcomes **Description:** Baseline **Measure:** Serum concentration of Insulin **Time Frame:** Timepoint -30 to 90 minutes **Description:** Baseline-corrected area under the curve (bsAUC). **Measure:** Serum concentration of Insulin **Time Frame:** Timepoint -30 to 90 minutes **Description:** Baseline **Measure:** Serum concentration of C-peptid **Time Frame:** Timepoint -30 to 90 minutes **Description:** Baseline-corrected area under the curve (bsAUC). **Measure:** Serum concentration of C-peptid **Time Frame:** Timepoint -30 to 90 minutes **Description:** Baseline **Measure:** Plasma concentration of glucose **Time Frame:** Timepoint -30 to 90 minutes **Description:** Baseline-corrected area under the curve (bsAUC). **Measure:** Plasma concentration of glucose **Time Frame:** Timepoint -30 to 90 minutes **Description:** Peak value **Measure:** Plasma concentration of glucose **Time Frame:** Timepoint -30 to 90 minutes **Description:** Baseline **Measure:** Plasma concentration of GIP **Time Frame:** Timepoint -30 to 90 minutes **Description:** Baseline-corrected area under the curve (bsAUC). **Measure:** Plasma concentration of GIP **Time Frame:** Timepoint -30 to 90 minutes **Description:** Baseline **Measure:** Circulating levels of total amino acids **Time Frame:** Timepoint -30 to 90 minutes **Description:** Baseline-corrected area under the curve (bsAUC). **Measure:** Circulating levels of total amino acids **Time Frame:** Timepoint -30 to 90 minutes **Description:** Baseline **Measure:** Circulating levels of individual amino acids **Time Frame:** Timepoint -30 to 90 minutes **Description:** Baseline-corrected area under the curve (bsAUC). **Measure:** Circulating levels of individual amino acids **Time Frame:** Timepoint -30 to 90 minutes **Description:** Baseline **Measure:** Lipid profile **Time Frame:** Timepoint -30 to 90 minutes **Description:** Baseline-corrected area under the curve (bsAUC). **Measure:** Lipid profile **Time Frame:** Timepoint -30 to 90 minutes **Description:** Baseline **Measure:** Circulating levels of CTx **Time Frame:** Timepoint -30 to 90 minutes **Description:** Baseline-corrected area under the curve (bsAUC). **Measure:** Circulating levels of CTx **Time Frame:** Timepoint -30 to 90 minutes **Description:** Baseline **Measure:** Circulating levels of P1NP **Time Frame:** Timepoint -30 to 90 minutes **Description:** Baseline-corrected area under the curve (bsAUC). **Measure:** Circulating levels of P1NP **Time Frame:** Timepoint -30 to 90 minutes **Description:** Baseline **Measure:** Blood pressure **Time Frame:** Timepoint -30, 0, 30, 60, 90 **Description:** Baseline-corrected area under the curve (bsAUC). **Measure:** Blood pressure **Time Frame:** Timepoint -30, 0, 30, 60, 90 **Description:** Baseline **Measure:** Pulse **Time Frame:** Timepoint -30, 0, 30, 60, 90 **Description:** Baseline-corrected area under the curve (bsAUC). **Measure:** Pulse **Time Frame:** Timepoint -30, 0, 30, 60, 90 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Caucasian ethnicity * Body mass index (BMI) 20-27 kg/m\^2 * Glycated haemoglobin (HbA1c) ≤ 42 mmol/mol * Informed and written consent Exclusion Criteria: * Late microvascular complications except mild nonproliferative retinopathy * Liver disease (alanine aminotransferase (ALAT) and/or aspartate aminotransferase (ASAT) \> 2 times normal values) or history of hepatobiliary disorder * Treatment with any glucose-lowering drugs * Active or recent (within 5 years) malignant disease * Active tobacco smoking/use * Any condition considered incompatible with participation by the investigators. **Healthy Volunteers:** True **Maximum Age:** 70 Years **Minimum Age:** 18 Years **Sex:** MALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Julie V Warnøe, MD **Phone:** +4527282263 **Role:** CONTACT #### Locations **Location 1:** **City:** Hellerup **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Filip K. Knop, MD, PhD - **Phone:** +4526830161 - **Role:** CONTACT ***Contact 2:*** - **Name:** Julie V. Warnøe, MD - **Role:** SUB_INVESTIGATOR **Country:** Denmark **Facility:** Center for Clinical Metabolic Research, Gentofte Hospital **State:** Capital Region **Status:** RECRUITING **Zip:** 2900 #### Overall Officials **Official 1:** **Affiliation:** Center for Clinical Metabolic Research, Gentofte Hospital **Name:** Filip K Knop, MD, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Intervention Browse Module - Browse Branches - Abbrev: Gast - Name: Gastrointestinal Agents - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: AA - Name: Amino Acids ### Intervention Browse Module - Browse Leaves - ID: M8866 - Name: Gastric Inhibitory Polypeptide - Relevance: LOW - As Found: Unknown - ID: T0 - Name: Alanine - Relevance: HIGH - As Found: Transversus abdominis ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419673 **Brief Title:** Serplulimab Plus Chemoradiotherapy for Stage III-IVA Cervical Cancer **Official Title:** Induced and Concurrent Serplulimab Plus Chemoradiotherapy Followed by Toripalimab Maintenance Therapy for Stage III-IVA Cervical Cancer: a Prospective, Multicenter, Randomized, Open Controlled Clinical Trial #### Organization Study ID Info **ID:** HLX10IIT29 #### Organization **Class:** OTHER **Full Name:** Cancer Institute and Hospital, Chinese Academy of Medical Sciences ### Status Module #### Completion Date **Date:** 2028-05-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-16 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2025-05-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-16 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Cancer Institute and Hospital, Chinese Academy of Medical Sciences #### Responsible Party **Investigator Affiliation:** Cancer Institute and Hospital, Chinese Academy of Medical Sciences **Investigator Full Name:** LING YING WU **Investigator Title:** Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This study is a prospective, multicenter, randomized, open controlled clinical trial aimed at evaluating the effectiveness and safety of serplulimab plus chemoradiotherapy in FIGO 2018 stage III or IVA cervical squamous cell carcinoma, adenocarcinoma, and adenosquamous cell carcinoma patients who have not received prior treatment. **Detailed Description:** Cervical cancer is the most prevalent malignant tumor of the female reproductive system in China, with an estimated 150,700 new cases and 55,700 new deaths annually. Concurrent chemoradiotherapy (CRT) remains the standard treatment for locally advanced cervical cancer (LACC). However, for high-risk LACC (HR-LACC) patients, the 2-year progression-free survival (PFS) rate is only 57%-62%, and the 5-year overall survival (OS) rate is 52%-64%, which are the leading causes of patient mortality. The KEYNOTE-A18 study demonstrated that the combination of pembrolizumab and CRT reduced the progression risk and death risk by 30% and 27%, respectively, for HR-LACC patients. Following this, the FDA approved pembrolizumab in combination with CRT for the treatment of newly diagnosed stages III-IVA cervical cancer in January 2024. This prospective, multicenter, randomized, controlled clinical trial study aims to evaluate the effectiveness and safety of serplulimab induced and combined chemoradiotherapy in FIGO 2018 stage III or IVA cervical squamous cell carcinoma, adenocarcinoma, and adenosquamous cell carcinoma patients who have not received prior treatment. ### Conditions Module **Conditions:** - Cervical Cancer **Keywords:** - Serplulimab - Concurrent chemoradiotherapy - Cervical Cancer ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 240 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants receive serplulimab 300 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for 3 cycles followed by serplulimab 300 mg IV on Day 1 of each 6-week cycle (Q3W) for an additional 15 cycles. During the Q3W dosing period of serplulimab, participants receive concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m\^2 IV or carboplatin (AUC=2) once per week (QW) for 5 or 6 weeks plus external beam radiotherapy followed by brachytherapy not to exceed 8 weeks. **Intervention Names:** - Drug: Serplulimab - Drug: Cisplatin - Drug: Carboplatin - Radiation: Brachytherapy and External Beam Radiotherapy **Label:** Serplulimab + chemoradiotherapy , Serplulimab maintenance **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants receive concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m\^2 IV or carboplatin (AUC=2) once per week (QW) for 5 or 6 weeks plus external beam radiotherapy followed by brachytherapy not to exceed 8 weeks. **Intervention Names:** - Drug: Cisplatin - Drug: Carboplatin - Radiation: Brachytherapy and External Beam Radiotherapy **Label:** Concurrent chemoradiotherapy **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Serplulimab + chemoradiotherapy , Serplulimab maintenance **Description:** Serplulimab will be administered by intravenous infusion at a dose of 300mg on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. **Name:** Serplulimab **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Concurrent chemoradiotherapy - Serplulimab + chemoradiotherapy , Serplulimab maintenance **Description:** IV infusion **Name:** Cisplatin **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Concurrent chemoradiotherapy - Serplulimab + chemoradiotherapy , Serplulimab maintenance **Description:** IV infusion **Name:** Carboplatin **Type:** DRUG #### Intervention 4 **Arm Group Labels:** - Concurrent chemoradiotherapy - Serplulimab + chemoradiotherapy , Serplulimab maintenance **Description:** Brachytherapy and External Beam Radiotherapy **Name:** Brachytherapy and External Beam Radiotherapy **Type:** RADIATION ### Outcomes Module #### Primary Outcomes **Description:** PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, or by histopathologic confirmation of suspected disease progression, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. Unequivocal progression of non-target lesions is also considered PD. PFS data will be cumulated to a certain cut-off date and the analysis will be performed via Kaplan-Meier approach to estimate the PFS rate at Month 36 using the entire PFS data up to the cut-off date. **Measure:** Progression-Free Survival(PFS) at Month 36 **Time Frame:** Up to approximately 46 months. #### Secondary Outcomes **Description:** Overall Survival (OS) at Month 36 \[ Time Frame: Up to approximately 46 months \] OS, defined as the time from initiation of study treatment to death from any cause. OS data will be cumulated to a certain cut-off date and the analysis will be performed via Kaplan-Meier approach to estimate the OS rate at Month 36 using the entire OS data up to the cut-off date. The cut-off date is event-driven and estimated to be approximately 46 months. **Measure:** Overall Survival (OS) at Month 36 **Time Frame:** Up to approximately 46 months **Description:** ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target and non-target lesions and also includes reduction of all nodal lesions to \<10mm) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions and includes no unequivocal progression in non-target lesions) per RECIST 1.1. **Measure:** Objective Response Rate (ORR) **Time Frame:** Baseline up to approximately 36 months **Description:** The rate of CR (Disappearance of all target and non-target lesions and also includes reduction of all nodal lesions to \<10mm). **Measure:** Complete Response Rate（CRR） **Time Frame:** Baseline up to approximately 36 months **Description:** Ddefined as the interval between the date of the initial medication and the time of imaging progression. **Measure:** Time to the first disease progression （TTP） **Time Frame:** Up to approximately 24 months **Description:** Duration of response is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first. **Measure:** Duration of response (DOR) **Time Frame:** Up to approximately 24 months ### Eligibility Module **Eligibility Criteria:** Main Inclusion Criteria: 1. Age ≥ 18 years and ≤ 75 years at time of study entry. 2. Has histologically-confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix. 3. The International Federation of Gynecology and Obstetrics (FIGO) 2018 Stages III-IVA. 4. Diagnosed with PD-L1-positive (combined positive score ≥1). 5. Has not previously received any definitive surgical, radiation, or systemic therapy for cervical cancer. 6. WHO/ECOG performance status of 0 or 1. 7. Patient must have at least one measurable disease as defined by RECIST 1.1. Main Exclusion Criteria: 1. Has received prior therapy with an anti-programmed cell death receptor 1 (PD-1), anti-programmed cell death receptor ligand 1 (PD-L1), or anti-programmed cell death receptor ligand 2 (PD-L2) agent o.. 2. Ongoing participation in another clinical study, or planned initiation of treatment in this study less than 28 days from the end of treatment in the previous clinical study. 3. Known history of serious allergy to any active ingredie or any excipients list in monoclonal antibody. 4. The patient has other factors that, in the judgment of the investigator, may lead to forced early termination of the study. **Maximum Age:** 70 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Beijing **Country:** China **Facility:** Cancer Hospital, Chinese Academy of Medical Sciences **State:** Beijing **Zip:** 100021 #### Overall Officials **Official 1:** **Affiliation:** Cancer Institute and Hospital, Chinese Academy of Medical Sciences **Name:** LINGYING WU, MD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014594 - Term: Uterine Neoplasms - ID: D000005833 - Term: Genital Neoplasms, Female - ID: D000014565 - Term: Urogenital Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000002577 - Term: Uterine Cervical Diseases - ID: D000014591 - Term: Uterine Diseases - ID: D000005831 - Term: Genital Diseases, Female - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000091662 - Term: Genital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M5830 - Name: Uterine Cervical Neoplasms - Relevance: HIGH - As Found: Cervical Cancer - ID: M17342 - Name: Uterine Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8945 - Name: Genital Neoplasms, Female - Relevance: LOW - As Found: Unknown - ID: M17315 - Name: Urogenital Neoplasms - Relevance: LOW - As Found: Unknown - ID: M5825 - Name: Uterine Cervical Diseases - Relevance: LOW - As Found: Unknown - ID: M17339 - Name: Uterine Diseases - Relevance: LOW - As Found: Unknown - ID: M8943 - Name: Genital Diseases, Female - Relevance: LOW - As Found: Unknown - ID: M2876 - Name: Genital Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000002583 - Term: Uterine Cervical Neoplasms ### 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: M18650 - Name: Carboplatin - Relevance: HIGH - As Found: System - ID: M6182 - Name: Cisplatin - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000016190 - Term: Carboplatin ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419660 **Brief Title:** A Study in Healthy Men to Test Whether Esomeprazole Influences the Amount of BI 3000202 in the Blood **Official Title:** The Effect of Multiple Doses of Esomeprazole on the Pharmacokinetics of a Single Oral Dose BI 3000202 in Healthy Male Subjects (an Open-label, Randomized, Two-way Cross-over Study) #### Organization Study ID Info **ID:** 1509-0007 #### Organization **Class:** INDUSTRY **Full Name:** Boehringer Ingelheim #### Secondary ID Infos **Domain:** CTIS **ID:** 2023-509209-54-00 **Type:** REGISTRY **Domain:** WHO International Clinical Trials Registry Platform (ICTRP) **ID:** U1111-1298-9134 **Type:** REGISTRY ### Status Module #### Completion Date **Date:** 2024-07-02 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-28 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-07-02 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-21 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Boehringer Ingelheim #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The main objective of this trial is to investigate the effect of the proton pump inhibitor esomeprazole on the pharmacokinetics of BI 3000202 in plasma. ### Conditions Module **Conditions:** - Healthy ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** CROSSOVER ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 16 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** T=test R=reference **Intervention Names:** - Drug: BI 300202 - Drug: esomeprazole **Label:** Esomeprazole + BI 300202 (T) then BI 300202 (R) treatment **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Drug: BI 300202 - Drug: esomeprazole **Label:** BI 300202 (R) then esomeprazole + BI 300202 (T) treatment **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - BI 300202 (R) then esomeprazole + BI 300202 (T) treatment - Esomeprazole + BI 300202 (T) then BI 300202 (R) treatment **Description:** BI 300202 **Name:** BI 300202 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - BI 300202 (R) then esomeprazole + BI 300202 (T) treatment - Esomeprazole + BI 300202 (T) then BI 300202 (R) treatment **Description:** esomeprazole **Name:** esomeprazole **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) **Time Frame:** Up to 4 days **Measure:** Maximum measured concentration of the analyte in plasma (Cmax) **Time Frame:** Up to 4 days #### Secondary Outcomes **Measure:** Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) **Time Frame:** Up to 4 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests 2. Age of 18 to 55 years (inclusive) 3. Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive) 4. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial Exclusion Criteria: 1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator 2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm 3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance 4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator 5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders 6. Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair) 7. Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders 8. History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply. **Healthy Volunteers:** True **Maximum Age:** 55 Years **Minimum Age:** 18 Years **Sex:** MALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Boehringer Ingelheim **Phone:** 1-800-243-0127 **Role:** CONTACT #### Locations **Location 1:** **City:** Biberach **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Boehringer Ingelheim - **Phone:** 08007234742 - **Role:** CONTACT **Country:** Germany **Facility:** Humanpharmakologisches Zentrum Biberach **Status:** RECRUITING **Zip:** 88397 ### IPD Sharing Statement Module **Description:** Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency **IPD Sharing:** NO ### References Module #### See Also Links **Label:** Related Info **URL:** http://www.mystudywindow.com ## 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 ### Intervention Browse Module - Ancestors - ID: D000000897 - Term: Anti-Ulcer Agents - ID: D000005765 - Term: Gastrointestinal Agents - ID: D000054328 - Term: Proton Pump Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: Gast - Name: Gastrointestinal Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M30204 - Name: Esomeprazole - Relevance: HIGH - As Found: University - ID: M4188 - Name: Antacids - Relevance: LOW - As Found: Unknown - ID: M4219 - Name: Anti-Ulcer Agents - Relevance: LOW - As Found: Unknown - ID: M8881 - Name: Gastrointestinal Agents - Relevance: LOW - As Found: Unknown - ID: M27630 - Name: Proton Pump Inhibitors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000064098 - Term: Esomeprazole ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419647 **Brief Title:** Tracking Mood: The Effects of Daily Mood Tracking VAS on Alcohol Consumption in Adult Heavy Drinkers **Official Title:** Tracking Mood: The Effects of Daily Mood Tracking VAS on Alcohol Consumption in Adult Heavy Drinkers #### Organization Study ID Info **ID:** MOODSTUDYALCOHOL #### Organization **Class:** OTHER **Full Name:** University of Cambridge ### Status Module #### Completion Date **Date:** 2025-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-05 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** University of Cambridge #### Lead Sponsor **Class:** OTHER **Name:** Ilona Myllyniemi #### Responsible Party **Investigator Affiliation:** University of Cambridge **Investigator Full Name:** Ilona Myllyniemi **Investigator Title:** PhD Student **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The study aims to investigate the effects that mood tracking may have on the alcohol consumption of adults who consume more than 20 UK units of alcohol per week, classifying as high-risk drinkers. The intervention group will track their mood on a daily basis with a visual analogue scale, while the control group will report their daily time spent online. The hypothesis, based on a series of prior pilot studies on alcohol tracking methods, is that mood tracking can reduce alcohol consumption in high-risk drinkers and therefore be a suitable addition to interventions related to decreasing alcohol consumption in heavy drinkers. The study will be conducted online through the Prolific platform. **Detailed Description:** Participants will be recruited through Prolific. All participants will complete a series of demographic and psychometric questionnaires before beginning the study. Participants will also complete some of the psychometric questionnaires (RCQ, GAD-7, PHQ-9) at the end of the study to track any potential changes. Participants will be pre-screened for their motivation using a modified MTSS (Motivation to Stop Smoking) scale. Participants will also be asked to report their primary source of motivation regarding wanting to quit or reduce drinking, in addition to reporting their main goal regarding alcohol, where the options will be wanting to quit, wanting to reduce drinking, wanting to be more in control of their drinking, and not wanting to quit, reduce, or be more in control of drinking. All participants will also report their alcohol consumption using a timeline followback task with the ability to view both a calendar and a reference image of UK alcohol units. They'll report their alcohol consumption from the week before the study and complete two TLFBs during the study. Intervention group participants complete daily visual analogue scales of their mood. Control group participants complete daily reports of how many hours they spent online the previous day. ### Conditions Module **Conditions:** - Alcohol Abuse - Alcohol Drinking - Alcohol Use Disorder - Alcohol Dependence - Alcohol Intoxication **Keywords:** - Alcohol - AUD - Mood tracking - EMA - Emotional monitoring - Alcohol tracking ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 2000 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants complete daily mood tracking and weekly timeline followbacks of alcohol use **Intervention Names:** - Behavioral: Intervention **Label:** Intervention **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants complete daily logs of time spent online and weekly timeline followbacks of alcohol use **Label:** Control **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Intervention **Description:** Daily mood tracking tasks **Name:** Intervention **Other Names:** - Alcohol tracking - Mood tracking - Emotional monitoring - EMA **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Timeline followbacks completed of consumed alcohol units reflecting alcohol units (UK) of alcohol consumed before the study and throughout the study **Measure:** TLFB **Time Frame:** 3 weeks #### Secondary Outcomes **Description:** Comparison of potential changes in GAD-7 score before and after study **Measure:** GAD-7 **Time Frame:** 3 weeks **Description:** Comparison of potential changes in PHQ-9 score before and after study **Measure:** PHQ-9 **Time Frame:** 3 weeks **Description:** Comparison of potential changes in Readiness to Change score and Stage of Change destination before and after study **Measure:** RCQ **Time Frame:** 3 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Speaking fluent English * being over 18 years of age * High completion rates of previous studies on the Prolific platform * Being located in the United Kingdom * Consuming over 20 UK units of alcohol per week Exclusion Criteria: * Having an ongoing mental health condition **Gender Based:** True **Gender Description:** Gender options provided are as follows: Male, Female, Non-binary, Transgender man, Transgender woman, Other, Prefer not to say **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Valerie Voon, PhD, MD **Phone:** 01223768504 **Phone Ext:** +44 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Ilona S Myllyniemi, PhD Student **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** University of Cambridge **Name:** Valerie Voon, PhD, MD **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **Description:** Study protocol, statistical analysis plan, informed consent form will be shared **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004327 - Term: Drinking Behavior - ID: D000019973 - Term: Alcohol-Related Disorders - ID: D000019966 - Term: Substance-Related Disorders - ID: D000064419 - Term: Chemically-Induced Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BC25 - Name: Substance Related Disorders - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M3783 - Name: Alcoholism - Relevance: HIGH - As Found: Alcohol Use Disorder - ID: M3774 - Name: Alcohol Drinking - Relevance: HIGH - As Found: Alcohol Drinking - ID: M3781 - Name: Alcoholic Intoxication - Relevance: HIGH - As Found: Alcohol Intoxication - ID: M7502 - Name: Drinking Behavior - Relevance: LOW - As Found: Unknown - ID: M21842 - Name: Alcohol-Related Disorders - Relevance: LOW - As Found: Unknown - ID: M21837 - Name: Substance-Related Disorders - Relevance: LOW - As Found: Unknown - ID: M30302 - Name: Chemically-Induced Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000000437 - Term: Alcoholism - ID: D000000435 - Term: Alcoholic Intoxication - ID: D000000428 - Term: Alcohol Drinking ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M3777 - Name: Ethanol - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419634 **Brief Title:** Study of BMS-986497 (ORM-6151) in Participants With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome **Official Title:** Phase I Multicenter, Open-Label, First-in-Human Study of BMS-986497 (ORM-6151) in Subjects With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome #### Organization Study ID Info **ID:** CA235-0001 #### Organization **Class:** INDUSTRY **Full Name:** Bristol-Myers Squibb ### Status Module #### Completion Date **Date:** 2030-09-16 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-02-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-30 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Bristol-Myers Squibb #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this study is to assess the safety, tolerability, drug levels, drug efficacy and determine the recommended dose of BMS-986497 in participants with relapsed or refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). ### Conditions Module **Conditions:** - Acute Myeloid Leukemia - Myelodysplastic Syndrome **Keywords:** - BMS-986497 - First-in-Human - ORM-6151 - Acute myeloid leukemia (AML) - Myelodysplastic syndrome (MDS) - Cluster of differentiation 33 (CD33) - G1 to S phase transition 1 (GSPT1) - Open label study ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** SEQUENTIAL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 35 **Type:** ESTIMATED **Phases:** - PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: BMS-986497 **Label:** Part 1: Dose Escalation BMS-986497 **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Drug: BMS-986497 **Label:** Part 2: Dose Expansion BMS-986497 **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Part 1: Dose Escalation BMS-986497 - Part 2: Dose Expansion BMS-986497 **Description:** Specified dose on specified days **Name:** BMS-986497 **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Measure:** Incidence of dose-limiting toxicities (DLTs) **Time Frame:** Up to 21 days **Measure:** Incidence of treatment-emergent adverse events (TEAEs) **Time Frame:** Up to 2 years **Measure:** Determine the Recommended Phase 2 Dose (RP2D) **Time Frame:** Up to 2 years #### Secondary Outcomes **Measure:** Maximum concentration (Cmax) **Time Frame:** Up to 2 years **Measure:** Time to reach Cmax (Tmax) **Time Frame:** Up to 2 years **Measure:** Area under the curve from time 0 to last quantifiable concentration (AUC0-last) **Time Frame:** Up to 2 years **Measure:** Overall response rate (ORR) **Time Frame:** Up to 4 years **Measure:** Duration of response (DoR) **Time Frame:** Up to 4 years **Measure:** Best overall response (BOR) **Time Frame:** Up to 4 years **Measure:** Complete remission (CR) **Time Frame:** Up to 4 years **Measure:** Complete remission with incomplete hematologic recovery (Cri) **Time Frame:** Up to 4 years **Measure:** Complete remission with partial hematologic recovery (CRh) rate **Time Frame:** Up to 4 years **Measure:** Event-free survival (EFS) **Time Frame:** Up to 4 years **Measure:** Transition rate to allogeneic hematopoietic stem cell transplantation (HSCT) **Time Frame:** Up to 4 years **Measure:** Incidence of Anti-drug antibody (ADA) against BMS-986497 **Time Frame:** Up to 2 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Adults with primary or secondary relapsed and/or refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). * Detectable levels of cluster of differentiation 33 (CD33) expression. * Failed alternative therapies with established benefit. * Eastern Cooperative Oncology Group (ECOG) performance status ≤2 and adequate organ function. Exclusion Criteria: * Acute Promyelocytic Leukemia. * Clinically active central nervous system leukemia. * Active malignant solid tumor. * Pregnant or breastfeeding. * Other protocol-defined inclusion/exclusion criteria apply. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** BMS Study Connect Contact Center www.BMSStudyConnect.com **Phone:** 855-907-3286 **Role:** CONTACT **Contact 2:** **Name:** First line of the email MUST contain NCT # and Site #. **Role:** CONTACT #### Locations **Location 1:** **City:** New Haven **Contacts:** ***Contact 1:*** - **Name:** Site 0011 - **Role:** CONTACT **Country:** United States **Facility:** Local Institution - 0011 **State:** Connecticut **Zip:** 06510 **Location 2:** **City:** Chicago **Contacts:** ***Contact 1:*** - **Name:** Site 0010 - **Role:** CONTACT **Country:** United States **Facility:** Local Institution - 0010 **State:** Illinois **Zip:** 60611 **Location 3:** **City:** Boston **Country:** United States **Facility:** Local Institution - 0007 **State:** Massachusetts **Zip:** 02114 **Location 4:** **City:** Boston **Contacts:** ***Contact 1:*** - **Name:** Site 0014 - **Role:** CONTACT **Country:** United States **Facility:** Local Institution - 0014 **State:** Massachusetts **Zip:** 02114 **Location 5:** **City:** Saint Louis **Country:** United States **Facility:** Local Institution - 0013 **State:** Missouri **Zip:** 63110 **Location 6:** **City:** Hackensack **Contacts:** ***Contact 1:*** - **Name:** Site 0008 - **Role:** CONTACT **Country:** United States **Facility:** Local Institution - 0008 **State:** New Jersey **Zip:** 07601 **Location 7:** **City:** New York **Country:** United States **Facility:** Columbia University Irving Medical Center **State:** New York **Zip:** 10032 **Location 8:** **City:** Houston **Contacts:** ***Contact 1:*** - **Name:** Site 0006 - **Role:** CONTACT **Country:** United States **Facility:** Local Institution - 0006 **State:** Texas **Zip:** 77030 **Location 9:** **City:** Fairfax **Country:** United States **Facility:** Local Institution - 0009 **State:** Virginia **Zip:** 22031 **Location 10:** **City:** Toronto **Contacts:** ***Contact 1:*** - **Name:** Site 0002 - **Role:** CONTACT **Country:** Canada **Facility:** Local Institution - 0002 **State:** Ontario **Zip:** M5G 2M9 **Location 11:** **City:** Montreal **Contacts:** ***Contact 1:*** - **Name:** Site 0003 - **Role:** CONTACT **Country:** Canada **Facility:** Local Institution - 0003 **State:** Quebec **Zip:** H3T 1E2 #### Overall Officials **Official 1:** **Affiliation:** Bristol-Myers Squibb **Name:** Bristol-Myers Squibb **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **Description:** BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and research/disclosurecommitment.html **IPD Sharing:** NO ### References Module #### See Also Links **Label:** BMS Clinical Trial Information **URL:** https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html **Label:** BMS Clinical Trial Patient Recruiting **URL:** https://www.bmsstudyconnect.com/s/US/English/USenHome ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004194 - Term: Disease - ID: D000010335 - Term: Pathologic Processes - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms - ID: D000006402 - Term: Hematologic Diseases - ID: D000001855 - Term: Bone Marrow Diseases - ID: D000011230 - Term: Precancerous Conditions ### 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: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M16355 - Name: Syndrome - Relevance: HIGH - As Found: Syndrome - ID: M10945 - Name: Leukemia - Relevance: HIGH - As Found: Leukemia - ID: M10955 - Name: Leukemia, Myeloid - Relevance: HIGH - As Found: Myeloid Leukemia - ID: M18127 - Name: Leukemia, Myeloid, Acute - Relevance: HIGH - As Found: Acute Myeloid Leukemia - ID: M14164 - Name: Preleukemia - Relevance: HIGH - As Found: Myelodysplastic Syndrome - ID: M12145 - Name: Myelodysplastic Syndromes - Relevance: HIGH - As Found: Myelodysplastic Syndrome - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: M9490 - Name: Hematologic Diseases - Relevance: LOW - As Found: Unknown - ID: M5134 - Name: Bone Marrow Diseases - Relevance: LOW - As Found: Unknown - ID: M14111 - Name: Precancerous Conditions - Relevance: LOW - As Found: Unknown - ID: T3995 - Name: Myeloid Leukemia - Relevance: HIGH - As Found: Myeloid Leukemia - ID: T182 - Name: Acute Myeloid Leukemia - Relevance: HIGH - As Found: Acute Myeloid Leukemia - ID: T188 - Name: Acute Non Lymphoblastic Leukemia - Relevance: HIGH - As Found: Acute Myeloid Leukemia - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown - ID: T3993 - Name: Myelodysplastic Syndromes - Relevance: HIGH - As Found: Myelodysplastic Syndrome ### Condition Browse Module - Meshes - ID: D000007938 - Term: Leukemia - ID: D000007951 - Term: Leukemia, Myeloid - ID: D000015470 - Term: Leukemia, Myeloid, Acute - ID: D000011289 - Term: Preleukemia - ID: D000009190 - Term: Myelodysplastic Syndromes - ID: D000013577 - Term: Syndrome ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419621 **Brief Title:** PM8002 or Placebo Plus Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/Metastatic Triple-negative Breast Cancer **Official Title:** A Multicenter, Randomized, Double-blind Phase III Study of PM8002 or Placebo in Combination With Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/Metastatic Triple-negative Breast Cancer(TNBC) #### Organization Study ID Info **ID:** PM8002-C013C-TNBC-R #### Organization **Class:** INDUSTRY **Full Name:** Biotheus Inc. ### Status Module #### Completion Date **Date:** 2028-07 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-28 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-24 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-07 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Biotheus Inc. #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Is US Export:** False ### Description Module **Brief Summary:** This multicenter, randomized, double-blind study will evaluate the safety and efficacy of PM8002 in combination with Nab-Paclitaxel compared with placebo combined with Nab-Paclitaxel as first-line treatment in inoperable locally advanced/metastatic triple-negative breast cancer(TNBC) ### Conditions Module **Conditions:** - Triple Negative Breast Cancer(TNBC) ### 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:** 360 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients will receive both PM8002 and Nab-Paclitaxel. **Intervention Names:** - Drug: PM8002 - Drug: Nab-Paclitaxel **Label:** PM8002 Plus Nab-Paclitaxel **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Patients will receive both Placebo and Nab-Paclitaxel. **Intervention Names:** - Drug: Nab-Paclitaxel - Drug: Placebo **Label:** Placebo Plus Nab-Paclitaxel **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - PM8002 Plus Nab-Paclitaxel **Description:** PM8002 20 mg/kg via intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle **Name:** PM8002 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - PM8002 Plus Nab-Paclitaxel - Placebo Plus Nab-Paclitaxel **Description:** Nab-Paclitaxel 100mg/m2 via IV infusion on Days 1, 8, and 15 of each 28-day cycle **Name:** Nab-Paclitaxel **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Placebo Plus Nab-Paclitaxel **Description:** Placebo 20 mg/kg via IV infusion on Days 1 and 15 of each 28-day cycle **Name:** Placebo **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Progression-free survival is defined as the time from randomization to the first documented progressive disease (PD) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) based on assessments by Blinded Independent Review Committee (BIRC) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. **Measure:** Progression-Free Survival (PFS) assessed by Blinded Independent Review Committee (BIRC) **Time Frame:** Up to approximately 37 months from first patient in **Description:** Overall survival is defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis are censored at the date of the last follow-up. **Measure:** Overall Survival (OS) **Time Frame:** Up to approximately 37 months from first patient in #### Secondary Outcomes **Description:** Progression-free survival is defined as the time from randomization to the first documented PD per RECIST 1.1 based on assessments by investigator or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. **Measure:** PFS assessed by investigator **Time Frame:** Up to approximately 37 months from first patient in **Description:** ORR is defined as the percentage of participants in the analysis population who have a complete response (CR: disappearance of all lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experienced a CR or PR as assessed by BIRC or investigators based on RECIST 1.1 is presented. **Measure:** Objective response rate (ORR) assessed by BIRC or investigators **Time Frame:** Up to approximately 37 months from first patient in **Description:** DCR is defined as the sum rate of CR, PR and Stable Disease (SD), as determined by BIRC or investigators using RECIST v1.1 **Measure:** Disease control rate (DCR) assessed by BIRC or investigators **Time Frame:** Up to approximately 37 months from first patient in **Description:** DoR is defined as the time period from the date of initial CR or PR until the date of PD or death due to any cause, whichever occurs first. **Measure:** Duration of response (DoR) assessed by BIRC or investigators **Time Frame:** Up to approximately 37 months from first patient in **Description:** An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. **Measure:** Incidence and severity of Adverse Event (AE) according to CTCAE 5.0 **Time Frame:** Up to 30 days after last treatment **Description:** The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" (Item 29) and "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores were standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score are presented. **Measure:** Differences in the scores of health-related quality of life (HRQol) evaluated by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) **Time Frame:** Up to 30 days after last treatment **Description:** Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score denotes worse symptoms for the systemic therapy side effects symptom scale. **Measure:** Differences in the scores of health-related quality of life (HRQol) evaluated by EORTC Quality of Life Questionnaire - Breast Cancer (QLQ-BR42) **Time Frame:** Up to 30 days after last treatment ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Ability to understand and willing to provide written informed consent and to comply with scheduled visits and study procedures; * Female, aged 18 to 70 years (inclusive); * Histologically confirmed unresectable locally advanced or metastatic breast cancer with negative status for ER, PR, and HER-2. Testing results for all three markers conducted within 24 months prior to the initiation of the study by a local facility accredited by clinical research center are acceptable. If deemed necessary by the investigator during screening, subjects may provide additional biopsy to confirm the latest pathological; * Subjects who have not received prior systemic treatment（except endocrine therapy） for advanced breast cancer are eligible for the study. Subjects who have received Taxane-based chemotherapy during the neoadjuvant and/or adjuvant treatment phase are eligible, as long as the occurrence of relapse or metastasis is at least 12 months after the end of treatment; * Performance status as assessed by the Eastern Cooperative Oncology Group (ECOG) is 0-1; * Life expectancy of 12 weeks or more; * According to RECIST 1.1, the subject has at least 1 measurable lesion as the targeted lesion (the only bone metastasis or the only central nervous system metastasis should not be considered as a measurable lesion. A measurable lesion located at the previously irradiated radiation field or other local treatment area should not be selected as targeted lesion, unless the lesion shows unequivocal radiographic progression). Exclusion Criteria: * Previous treatment with immune checkpoint agonists (such as CD137 agonists) or immune checkpoint inhibitors (such as CTLA-4, PD-1, PD-L1, LAG3 monoclonal antibody, etc.) or anti-vascular endothelial growth factor (VEGF) target drugs; * Has uncontrolled or symptomatic brain or spine cord metastases; * Those who have had other active malignant tumors within 5 years prior to the study treatment, except for those that can be treated locally and have been cured ; * Poorly controlled hypertension (systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg); * With a history of hypertensive crisis or hypertensive encephalopathy; * With a history of abdominal fistula, tracheoesophageal fistula, gastrointestinal perforation, or intra-abdominal abscess within the last 6 months prior to the start of the study treatment; * Adverse events resulting from prior anti-tumor therapies should be assessed and graded according to the CTCAE 5.0 criteria, subjects whose AEs have not returned to Grade 1 or below; * Has uncontrollable pleural, pericardial, or abdominal effusions; * Has received allogeneic hematopoietic stem cell transplantation or organ transplantation. **Maximum Age:** 70 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Yanqing Cao **Phone:** +86 13810452270 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Linlin Fan **Phone:** +86 18612186005 **Role:** CONTACT #### Locations **Location 1:** **City:** Shanghai **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Jian Zhang, professor - **Role:** CONTACT **Country:** China **Facility:** Fudan University Shanghai Cancer Center #### Overall Officials **Official 1:** **Affiliation:** Fudan University **Name:** Jiong Wu, professor **Role:** STUDY_CHAIR **Official 2:** **Affiliation:** Fudan University **Name:** Jian Zhang, professor **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **Access Criteria:** NCI is committed to sharing data in accordance with NIH policy **Description:** The data will be published or presented for publications (poster, abstract,articles or papers) or any presentations. **IPD Sharing:** YES **Time Frame:** After the trial completed ## 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: M30373 - Name: Triple Negative Breast Neoplasms - Relevance: HIGH - As Found: Triple Negative 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 - ID: D000064726 - Term: Triple Negative Breast 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 ### 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: M26197 - Name: Tubulin Modulators - Relevance: LOW - As Found: Unknown - ID: M26196 - Name: Antimitotic Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000017239 - Term: Paclitaxel ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419608 **Brief Title:** Efficacy and Safety Study of BHV-7000 Monotherapy in Major Depression **Official Title:** A Phase 2 Multicenter, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of BHV-7000 Monotherapy in Major Depressive Disorder #### Organization Study ID Info **ID:** BHV7000-305 #### Organization **Class:** INDUSTRY **Full Name:** Biohaven Pharmaceuticals, Inc. ### Status Module #### Completion Date **Date:** 2025-07 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-30 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-05 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-28 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Biohaven Therapeutics Ltd. #### 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 determine the efficacy and safety of BHV-7000 in participants with Major Depressive Disorder (MDD) ### Conditions Module **Conditions:** - Major Depressive Disorder **Keywords:** - depression - depressed - depressive disorder - major depression - major depressive episode - antidepressant ### 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:** 300 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: BHV-7000 **Label:** BHV-7000 **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Drug: Placebo **Label:** Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - BHV-7000 **Description:** BHV-7000 75 mg taken once daily for 6 weeks **Name:** BHV-7000 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Placebo **Description:** Matching placebo taken once daily for 6 weeks **Name:** Placebo **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** The MADRS is a clinician- rated scale to assess depressive symptoms which consists of 10 items. Each item is scored on 7-point scale (0 \[absence of symptoms\] to 6 \[severe\]). A higher score represents a higher severity of the level of depression (total scores range from 0 to 60). **Measure:** Change in Montgomery- Åsberg Depression Rating Scale (MADRS) total score from baseline to week 6 **Time Frame:** Baseline to Week 6 #### Secondary Outcomes **Description:** The CGI-S is a clinician-rated scale to assess disease severity. The scale is scored on 8-point scale (0 \[not assessed\] to 7 \[severe\]). A higher score represents a higher severity illness. **Measure:** Change in Clinical Global Clinical Impression - Severity Scale (CGI-S) total score **Time Frame:** Baseline to Week 6 **Description:** The SHAPS is a subject self- administered scale to measure hedonic capacity which consists of 14 items (total scores range from 0 to 14). Each item has a set of 4 possible responses (Strongly or Definitely Agree, Agree, Disagree and Strongly Disagree). A total score is derived by summing the responses to each item. A higher score represents a higher level of anhedonia. **Measure:** Change in Snaith-Hamilton Pleasure Scale (SHAPS) total score from baseline to week 6 **Time Frame:** Baseline to Week 6 **Description:** The MADRS is a clinician- rated scale to assess depressive symptoms which consists of 10 items. Each item is scored on 7-point scale (0 \[absence of symptoms\] to 6 \[severe\]). A higher score represents a higher severity of the level of depression (total scores range from 0 to 60). **Measure:** Change in Montgomery- Åsberg Depression Rating Scale (MADRS) total score from baseline to week 1 **Time Frame:** Baseline to Week 1 **Description:** The SHAPS is a subject self- administered scale to measure hedonic capacity which consists of 14 items (total scores range from 0 to 14). Each item has a set of 4 possible responses (Strongly or Definitely Agree, Agree, Disagree and Strongly Disagree). A total score is derived by summing the responses to each item. A higher score represents a higher level of anhedonia. **Measure:** Change in Snaith-Hamilton Pleasure Scale (SHAPS) total score from baseline to week 1 **Time Frame:** Baseline to Week 1 **Description:** The Q-LES-Q-SF is a participant self-administered scale to assess the degree of enjoyment and satisfaction experienced in various areas of daily functioning. The form consists of 16 items. Each item is scored on 5-point scale. A higher score represents a higher level of satisfaction and enjoyment (total scores range from 14 to 70). **Measure:** Change in Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q- LES-Q-SF) total score **Time Frame:** Baseline to Week 6 **Description:** Safety and tolerability of BHV-7000 as assessed by frequency of unique subjects with SAEs; AEs leading to discontinuation; AEs judged to be related to study medication **Measure:** Number of Participants With Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and AEs judged to be related to study medication **Time Frame:** Screening through Week 8 **Description:** To assess the safety and tolerability of BHV-7000. This objective will be measured by assessing the number of unique subjects with grade 3 and 4 laboratory abnormalities. **Measure:** Number of Participants With Clinically Significant Laboratory Abnormalities **Time Frame:** Screening through Week 8 ### Eligibility Module **Eligibility Criteria:** Key Inclusion Criteria: 1. Subjects experiencing a moderate to severe episode of depression. 2. Subjects experiencing a current episode of depression for at least 2 months. 3. Subjects must be willing to discontinue all psychotropic medications (other medications to treat depression) before entering the study. 4. Male and Female participants 18 to 75 years of age at the time of consent. 5. Body Mass Index (BMI) must be ≥ 18 kg/m2 and ≤ 35 kg/m2. Key Exclusion Criteria: 1. Subjects taking more than 2 medications (other than benzodiazepines and medications targeting insomnia) to treat depression at the screening visit. 2. Subjects with a history of bipolar disorder, schizophrenia, or other neuropsychiatric conditions that may interfere with the conduct of the study. 3. Subjects with a history of medical conditions that may interfere with the conduct of the study. 4. Females who are pregnant, breastfeeding or planning to become pregnant. **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:** Chief Medical Officer **Phone:** 203-404-0410 **Role:** CONTACT #### Locations **Location 1:** **City:** Chandler **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** PRG Recruitment - **Phone:** 800-774-1534 - **Role:** CONTACT **Country:** United States **Facility:** Reverie Mind, LLC **State:** Arizona **Status:** NOT_YET_RECRUITING **Zip:** 85226 **Location 2:** **City:** Phoenix **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Angel Goewey - **Phone:** 602-562-7000 - **Role:** CONTACT **Country:** United States **Facility:** IMA Clinical Research **State:** Arizona **Status:** NOT_YET_RECRUITING **Zip:** 85012 **Location 3:** **City:** Little Rock **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Ashley Poole - **Phone:** 501-221-8681 - **Role:** CONTACT **Country:** United States **Facility:** WIRG **State:** Arkansas **Status:** NOT_YET_RECRUITING **Zip:** 72211 **Location 4:** **City:** Rogers **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Ashley Poole - **Phone:** 479-927-3000 - **Role:** CONTACT **Country:** United States **Facility:** WRN **State:** Arkansas **Status:** NOT_YET_RECRUITING **Zip:** 72758 **Location 5:** **City:** Anaheim **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Austina Cho - **Phone:** 714-999-6688 - **Role:** CONTACT **Country:** United States **Facility:** Advanced Research Center, Inc. **State:** California **Status:** NOT_YET_RECRUITING **Zip:** 92805 **Location 6:** **City:** Bellflower **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Paige Mansfield - **Phone:** 562-748-4999 - **Role:** CONTACT **Country:** United States **Facility:** CIT LA **State:** California **Status:** NOT_YET_RECRUITING **Zip:** 90706 **Location 7:** **City:** Encino **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Maha Kazim - **Phone:** 818-705-7450 - **Role:** CONTACT **Country:** United States **Facility:** WR-PRI Encino **State:** California **Status:** NOT_YET_RECRUITING **Zip:** 91316 **Location 8:** **City:** Garden Grove **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** David Walling - **Phone:** 714-799-7799 - **Role:** CONTACT **Country:** United States **Facility:** Collaborative Neuroscience Research, LLC (CenExel - CNS) **State:** California **Status:** RECRUITING **Zip:** 92845 **Location 9:** **City:** Los Angeles **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Navy Kaiser - **Phone:** 310-208-7144 - **Role:** CONTACT **Country:** United States **Facility:** CalNeuro Research Group **State:** California **Status:** NOT_YET_RECRUITING **Zip:** 90025 **Location 10:** **City:** Oceanside **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Hannah James - **Phone:** 760-758-2222 - **Role:** CONTACT **Country:** United States **Facility:** Excell Research, Inc. **State:** California **Status:** NOT_YET_RECRUITING **Zip:** 92056 **Location 11:** **City:** Redlands **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Alyson Long - **Phone:** 909-792-9007 - **Role:** CONTACT **Country:** United States **Facility:** Anderson Clinical Research **State:** California **Status:** NOT_YET_RECRUITING **Zip:** 92374 **Location 12:** **City:** Riverside **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Paige Mansfield - **Phone:** 951-300-4924 - **Role:** CONTACT **Country:** United States **Facility:** CIT IE **State:** California **Status:** NOT_YET_RECRUITING **Zip:** 92506 **Location 13:** **City:** Torrance **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Dakota Gainers - **Phone:** 714-799-7799 - **Role:** CONTACT **Country:** United States **Facility:** Cenexel CNS **State:** California **Status:** NOT_YET_RECRUITING **Zip:** 90504 **Location 14:** **City:** Upland **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Casey Rosas - **Phone:** 909-920-3000 - **Role:** CONTACT **Country:** United States **Facility:** Pacific Clinical Research Management Group **State:** California **Status:** NOT_YET_RECRUITING **Zip:** 91786 **Location 15:** **City:** Colorado Springs **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Terra Klaib - **Phone:** 719-634-6576 - **Role:** CONTACT **Country:** United States **Facility:** MCB Clinical Research Centers **State:** Colorado **Status:** NOT_YET_RECRUITING **Zip:** 80910 **Location 16:** **City:** Farmington **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Ellen Ciesielski - **Phone:** 860-679-6004 - **Role:** CONTACT **Country:** United States **Facility:** UConn Health **State:** Connecticut **Status:** NOT_YET_RECRUITING **Zip:** 06030 **Location 17:** **City:** Jacksonville **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Ashley Rich - **Phone:** 904-281-5757 - **Role:** CONTACT **Country:** United States **Facility:** Clinical Neuroscience Solutions, Inc **State:** Florida **Status:** NOT_YET_RECRUITING **Zip:** 32256 **Location 18:** **City:** Miami Lakes **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Wilmer Mejia - **Phone:** 305-330-9977 - **Role:** CONTACT **Country:** United States **Facility:** Floridian Neuroscience Institute **State:** Florida **Status:** NOT_YET_RECRUITING **Zip:** 33016 **Location 19:** **City:** Orlando **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Karen Assifuah - **Phone:** 407-425-5100 - **Role:** CONTACT **Country:** United States **Facility:** Clinical Neuroscience Solutions, Inc. **State:** Florida **Status:** NOT_YET_RECRUITING **Zip:** 32801 **Location 20:** **City:** Tampa **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Beth Williams - **Phone:** 813-800-5252 - **Role:** CONTACT **Country:** United States **Facility:** K2 Medical Research **State:** Florida **Status:** NOT_YET_RECRUITING **Zip:** 33607 **Location 21:** **City:** Decatur **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Katie Prowse - **Phone:** 404-537-1281 - **Role:** CONTACT **Country:** United States **Facility:** CenExel iResearch, LLC **State:** Georgia **Status:** NOT_YET_RECRUITING **Zip:** 30030 **Location 22:** **City:** Savannah **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Katherine Prowse - **Phone:** 912-744-0800 - **Role:** CONTACT **Country:** United States **Facility:** CenExel iResearch, LLC **State:** Georgia **Status:** NOT_YET_RECRUITING **Zip:** 31405 **Location 23:** **City:** Chicago **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Stephen Schneider - **Phone:** 773-989-8313 - **Phone Ext:** 116 - **Role:** CONTACT **Country:** United States **Facility:** Uptown Research Institute **State:** Illinois **Status:** RECRUITING **Zip:** 60640 **Location 24:** **City:** Elgin **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Mehwish Owais - **Phone:** 847-497-0421 - **Role:** CONTACT **Country:** United States **Facility:** Revive Research Institute, Inc. **State:** Illinois **Status:** NOT_YET_RECRUITING **Zip:** 60123 **Location 25:** **City:** Overland Park **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Rebecca Thomas - **Phone:** 913-381-7180 - **Role:** CONTACT **Country:** United States **Facility:** Collective Medical Research **State:** Kansas **Status:** NOT_YET_RECRUITING **Zip:** 66210 **Location 26:** **City:** Gaithersburg **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Evan Covington - **Phone:** 301-251-4702 - **Role:** CONTACT **Country:** United States **Facility:** CBH Health **State:** Maryland **Status:** NOT_YET_RECRUITING **Zip:** 20877 **Location 27:** **City:** Watertown **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Daniel Rutrick - **Phone:** 617-744-8542 - **Role:** CONTACT **Country:** United States **Facility:** Adams Clinical **State:** Massachusetts **Status:** RECRUITING **Zip:** 02472 **Location 28:** **City:** Flowood **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Sara Hall - **Phone:** 601-420-5812 - **Role:** CONTACT **Country:** United States **Facility:** Precise Clinical Research **State:** Mississippi **Status:** NOT_YET_RECRUITING **Zip:** 39232 **Location 29:** **City:** Las Vegas **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Mustafa Rawaf - **Phone:** 702-527-7401 - **Role:** CONTACT **Country:** United States **Facility:** IMA Clinical Research **State:** Nevada **Status:** NOT_YET_RECRUITING **Zip:** 89102 **Location 30:** **City:** Cherry Hill **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Hayon Choe - **Phone:** 856-857-9500 - **Role:** CONTACT **Country:** United States **Facility:** Center for Emotional Fitness **State:** New Jersey **Status:** RECRUITING **Zip:** 08002 **Location 31:** **City:** Toms River **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Jessica Sutton - **Phone:** 732-244-2299 - **Role:** CONTACT **Country:** United States **Facility:** Bio Behavioral Health **State:** New Jersey **Status:** NOT_YET_RECRUITING **Zip:** 08755 **Location 32:** **City:** Brooklyn **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Stanislav Rybchynskyi - **Phone:** 718-616-2072 - **Role:** CONTACT **Country:** United States **Facility:** SPRI Clinical Trials, LLC **State:** New York **Status:** NOT_YET_RECRUITING **Zip:** 11235 **Location 33:** **City:** Cedarhurst **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Yvette Vega - **Phone:** 516-295-7230 - **Role:** CONTACT **Country:** United States **Facility:** Neurobehavioral Research, Inc **State:** New York **Status:** NOT_YET_RECRUITING **Zip:** 11516 **Location 34:** **City:** Mount Kisco **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Gary Hyman - **Role:** CONTACT **Country:** United States **Facility:** Bioscience Research LLC **State:** New York **Status:** NOT_YET_RECRUITING **Zip:** 10549 **Location 35:** **City:** New York **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Matt Turzilli - **Phone:** 212-595-5012 - **Role:** CONTACT **Country:** United States **Facility:** The Medical Research Network, LLC **State:** New York **Status:** NOT_YET_RECRUITING **Zip:** 10128 **Location 36:** **City:** Rochester **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Barry Clark - **Phone:** 585-241-9670 - **Role:** CONTACT **Country:** United States **Facility:** Finger Lakes Clinical Research **State:** New York **Status:** NOT_YET_RECRUITING **Zip:** 14618 **Location 37:** **City:** Staten Island **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Daniel Gruener - **Phone:** 718-317-5522 - **Role:** CONTACT **Country:** United States **Facility:** RBA **State:** New York **Status:** NOT_YET_RECRUITING **Zip:** 10329 **Location 38:** **City:** Dayton **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Louis Wagner - **Phone:** 937-424-1050 - **Role:** CONTACT **Country:** United States **Facility:** Midwest Clinical Research Center **State:** Ohio **Status:** NOT_YET_RECRUITING **Zip:** 45417 **Location 39:** **City:** Allentown **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Trevor Stauffer - **Phone:** 610-820-0342 - **Role:** CONTACT **Country:** United States **Facility:** Lehigh Center for Clinical Research **State:** Pennsylvania **Status:** NOT_YET_RECRUITING **Zip:** 18104 **Location 40:** **City:** Media **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Ashley Ross - **Phone:** 610-891-9024 - **Phone Ext:** 1107 - **Role:** CONTACT **Country:** United States **Facility:** Suburban Research Associates **State:** Pennsylvania **Status:** NOT_YET_RECRUITING **Zip:** 19063 **Location 41:** **City:** Moosic **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Stephanie Terranella - **Phone:** 570-346-3686 - **Phone Ext:** 172 - **Role:** CONTACT **Country:** United States **Facility:** Scranton Medical Institute **State:** Pennsylvania **Status:** NOT_YET_RECRUITING **Zip:** 18509 **Location 42:** **City:** North Charleston **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Nikki Shebelskie - **Phone:** 843-856-3784 - **Role:** CONTACT **Country:** United States **Facility:** Coastal Carolina Research Center **State:** South Carolina **Status:** NOT_YET_RECRUITING **Zip:** 29405 **Location 43:** **City:** Austin **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Donald Garcia - **Role:** CONTACT **Country:** United States **Facility:** Donald J. Garcia, MD, PA dba Austin Clinical Trial Partners **State:** Texas **Status:** NOT_YET_RECRUITING **Zip:** 78737 **Location 44:** **City:** Dallas **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Erin Ashmore - **Phone:** 214-369-2603 - **Role:** CONTACT **Country:** United States **Facility:** FutureSearch Trials of Dallas **State:** Texas **Status:** NOT_YET_RECRUITING **Zip:** 75234 **Location 45:** **City:** DeSoto **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Brian Green - **Phone:** 972-283-6286 - **Role:** CONTACT **Country:** United States **Facility:** InSite Clinical Research, LLC **State:** Texas **Status:** RECRUITING **Zip:** 75115 **Location 46:** **City:** Houston **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Talia Mergi - **Phone:** 281-893-4117 - **Role:** CONTACT **Country:** United States **Facility:** Red Oak Psychiatry Associates, PA **State:** Texas **Status:** NOT_YET_RECRUITING **Zip:** 77373 **Location 47:** **City:** Plano **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Sonia Prashar - **Phone:** 972-267-1988 - **Role:** CONTACT **Country:** United States **Facility:** Aim Trials **State:** Texas **Status:** NOT_YET_RECRUITING **Zip:** 75093 **Location 48:** **City:** Wichita Falls **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Tonya Crosson - **Phone:** 940-322-1142 - **Role:** CONTACT **Country:** United States **Facility:** Grayline Research Center **State:** Texas **Status:** NOT_YET_RECRUITING **Zip:** 76309 **Location 49:** **City:** Clinton **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Amy Kenley - **Phone:** 801-928-3300 - **Role:** CONTACT **Country:** United States **Facility:** Alpine Reseach Organization **State:** Utah **Status:** NOT_YET_RECRUITING **Zip:** 84015 **Location 50:** **City:** Bellevue **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Kimberlee Wheeler - **Phone:** 425-453-0404 - **Role:** CONTACT **Country:** United States **Facility:** Northwest Clinical Research Center **State:** Washington **Status:** NOT_YET_RECRUITING **Zip:** 98007 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001526 - Term: Behavioral Symptoms - ID: D000019964 - Term: Mood Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M7058 - Name: Depression - Relevance: HIGH - As Found: Depressive Disorder - ID: M7061 - Name: Depressive Disorder - Relevance: HIGH - As Found: Depressive Disorder - ID: M7060 - Name: Depressive Disorder, Major - Relevance: HIGH - As Found: Major Depressive Disorder - ID: M4818 - Name: Behavioral Symptoms - Relevance: LOW - As Found: Unknown - ID: M21835 - Name: Mood Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003863 - Term: Depression - ID: D000003866 - Term: Depressive Disorder - ID: D000003865 - Term: Depressive Disorder, Major ### Intervention Browse Module - Browse Branches - Abbrev: PsychDr - Name: Psychotropic Drugs - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4247 - Name: Antidepressive Agents - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419595 **Acronym:** SASY **Brief Title:** Screening and Support for Youth (SASY) Intervention to Reduce Mental Health Disparities **Official Title:** SASY Intervention to Reduce Mental Health Disparities #### Organization Study ID Info **ID:** Exploratory 1 #### Organization **Class:** OTHER **Full Name:** Cambridge Health Alliance #### Secondary ID Infos **Domain:** NIMH **ID:** PAR-24-210 **Type:** OTHER_GRANT ### Status Module #### Completion Date **Date:** 2027-03-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-03-31 **Type:** ESTIMATED #### Start Date **Date:** 2025-11-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Cambridge Health Alliance #### 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 adapt the Screening and Support for Youth (SASY) intervention and approach to recruitment for racial, ethnic and linguistic diverse youth aged 12-17 in the Denver Health catchment area **Detailed Description:** To adapt the Screening and Support for Youth (SASY) intervention and approach to recruitment for racial, ethnic and linguistic diverse youth aged 12-17 in the Denver Health catchment area. Includes the recruitment of 220 youth (170 from schools/community and 50 hard-to-reach). 170 participants will be recruited by QR codes available on flyers that will be distributed in schools and community settings. This group will then be randomized to either follow up with the Engaging Youth Expertise for Prevention (EYE) or one of the study team's Research Coordinators (RC) and either EYE or the RC will carry out the assent/consent process with youth and their parents/guardians. For the subsequent (non-randomized) group of 50 hard-to-reach participants, the EYE team will utilize various methods for recruitment, and coordinate the assent/consent process with youth and their parents/guardians. All 200 participants will be offered a SASY screening which will include the K-CAT, Weiss Functional Impairment Scale (WFIRS-S), CAT-MH social determinants of health (SDOH), and assessment of current mental health treatment. All survey instruments will be delivered via REDCap. Each participant will be assigned a record identification (ID) and an acrostic, so their data can not be identifiable during analysis. All data will stay within the Cambridge Health Alliance (CHA) firewall and only the study team will have access to the results. These products are available in English and Spanish. A clinical risk score is generated by an algorithm combining symptoms and functional impairment based on national norms. Tier 1 is within normal, Tier 2 is at clinical risk, and Tier 3 is clinically ill. All participants will receive a motivational feedback session to discuss the results of the screening. The discussion will focus on the participant's reflections on how they feel, their perception of their symptoms and functioning, what changes they wish to make in their life, and what might support that change. The feedback will be given to the teens using non-clinical and non-research terms based upon the students' responses on the screening measures. Tier 1 participants will be offered screening and feedback on the screening results. Tier 2 participants will be offered screening, feedback on the screening results and a single session intervention (SSI). Tier 3 participants will be offered screening, feedback on the screening results, a single session intervention and information on community resources. The SSI will be accessed by a unique link provided to the participants, and includes several modules to choose from that participants can complete on their own and at their own pace. All participants will be invited for a follow-up survey at 1 month following initial screening. The follow-up survey will re-assess the KCAT and WFIRS, therapeutic alliance, and engagement in mental health treatment or behavioral interventions. All participants will be offered a $20 incentive for the initial screening and $20 for completing the follow-up survey. ### Conditions Module **Conditions:** - Adolescent Health - Minority Health - Mental Health - Community Health Services ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 220 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Study participants will be randomized for recruitment follow up by research team RC. **Intervention Names:** - Behavioral: Behavioral: Screening and Support for Youth (SASY) Multi-component Platform: includes screening, feedback, single session intervention, and resource information **Label:** Recruitment by Research Coordinator (RC) **Type:** OTHER #### Arm Group 2 **Description:** Study participants will be randomized for recruitment follow up by the EYE peer group (community youth research group) **Intervention Names:** - Behavioral: Behavioral: Screening and Support for Youth (SASY) Multi-component Platform: includes screening, feedback, single session intervention, and resource information **Label:** Recruitment by EYE **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Recruitment by EYE **Description:** Description: Description: Participants who interact with a QR code and express interest in participating will be randomized to receive either: 1) recruitment from a Research Coordinator (standard research staff approach) or 2) recruitment from an EYE for Prevention Youth Researcher. The process of consent, screening, providing feedback, and offering access to a Single Session Intervention and information on additional resources (per scoring on the screening into Tier 1 (low risk/normal), 2 (moderate/at risk), or 3 (high/clinical risk): Tier 1 = screening+feedback; Tier 2=screening+feedback+SSI; Tier 3=screening+feedback+SSI+resource information) will be the same in each group. The randomization is simply changing who provides the process and platform to the participant. **Name:** Behavioral: Screening and Support for Youth (SASY) Multi-component Platform: includes screening, feedback, single session intervention, and resource information **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Recruitment by Research Coordinator (RC) **Description:** Description: Description: Participants who interact with a QR code and express interest in participating will be randomized to receive either: 1) recruitment from a Research Coordinator (standard research staff approach) or 2) recruitment from an EYE for Prevention Youth Researcher. The process of consent, screening, providing feedback, and offering access to a Single Session Intervention and information on additional resources (per scoring on the screening into Tier 1 (low risk/normal), 2 (moderate/at risk), or 3 (high/clinical risk): Tier 1 = screening+feedback; Tier 2=screening+feedback+SSI; Tier 3=screening+feedback+SSI+resource information) will be the same in each group. The randomization is simply changing who provides the process and platform to the participant. **Name:** Behavioral: Screening and Support for Youth (SASY) Multi-component Platform: includes screening, feedback, single session intervention, and resource information **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Number and proportion of participants in Tiers 2 and 3 that start and/or complete the single session intervention. This will be a measure of engagement in services. **Measure:** Completion of Single session intervention **Time Frame:** 1 month following initial screening **Description:** Total number and proportion of 12-17 year olds recruited by the Research Coordinator vs. EYE Youth Researchers; also will examine this by proportion racial, ethnic and linguistic (REL) minoritized youth who participate (comparing Research Coordinator vs. EYE) **Measure:** Participation **Time Frame:** Immediate at time of enrollment #### Secondary Outcomes **Description:** Change on the K-CAT/WFIRS scores between time of screening (pre-) and post-intervention (SSI as the intervention) for Tiers 2 and 3 **Measure:** K-CAT/WFIRS scores - preliminary effectiveness **Time Frame:** 1 month following initial screening **Description:** Measure of therapeutic alliance with a) recruitment, screening, feedback and b) SSI. **Measure:** Therapeutic Alliance **Time Frame:** 1 month following initial screening **Description:** Self-reported measure of engagement for youth who scored in Tier 3 (and were provided SSI + resources). **Measure:** Engagement in Mental Health Treatment/Behavioral Change Activities **Time Frame:** 1 month following initial screening ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 12 to 17 year old teens Exclusion Criteria: * younger than 12 or older than 17 **Maximum Age:** 17 Years **Minimum Age:** 12 Years **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Laura Podewils, PhD **Phone:** 303-436-6000 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Taylor Witkowski, MA **Phone:** 617-806-8751 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Denver Health and Hospital Authority **Name:** Laura Podewils **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** Information will contain health insurance portability and accountability act (HIPAA) identifiers **IPD Sharing:** NO ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419582 **Brief Title:** BHV-7000 Acute Treatment of Bipolar Mania **Official Title:** A Phase 2/3, Multicenter, Inpatient, Placebo-Controlled, Double-blind Trial of BHV-7000 for the Acute Treatment of Manic Episodes, With or Without Mixed Features, Associated With Bipolar I Disorder #### Organization Study ID Info **ID:** BHV7000-204 #### Organization **Class:** INDUSTRY **Full Name:** Biohaven Pharmaceuticals, Inc. ### Status Module #### Completion Date **Date:** 2025-04 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-31 **Type:** ESTIMATED **Last Update Submit Date:** 2024-05-30 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-03 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-28 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Biohaven Therapeutics Ltd. #### 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 determine whether BHV-7000 is a safe and effective acute treatment for manic episodes in bipolar disorder I. ### Conditions Module **Conditions:** - Bipolar Disorder **Keywords:** - bipolar - mania - manic episode - manic state - bipolar disorder type 1 - manic depressive - manic bipolar - mixed features - mixed episode - mixed mania - bipolar episode ### 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:** 256 **Type:** ESTIMATED **Phases:** - PHASE2 - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: BHV-7000 **Label:** BHV-7000 **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Drug: Placebo **Label:** Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - BHV-7000 **Description:** BHV-7000 75 mg taken once daily for 21 days **Name:** BHV-7000 **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Placebo **Description:** Matching placebo taken once daily for 21 days **Name:** Placebo **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** The YMRS is a clinician administered scale that consists of 11 items used to assess the subject's symptoms of mania (total scores range from 0 to 60). The higher the YMRS score, the more severe the subject's symptoms of mania. **Measure:** Change in Young Mania Rating Scale (YMRS) total score from baseline to day 21 **Time Frame:** Baseline (day 1) to day 21 #### Secondary Outcomes **Description:** This objective will be measured by the change in Clinical Global Impression of Severity (CGI-S) score from baseline (day 1) to day 21). The CGI-S is a global index of patient disease severity as rated by the clinician on a scale from 0 to 7, with 0 meaning not assessed and 7 reflecting the most severe patients. **Measure:** Change in Clinical Global Clinical Impression - Severity Scale (CGI-S) total score **Time Frame:** Baseline (day 1) to day 21 **Description:** This objective will be measured by the change in YMRS total score from baseline (day 1) to day 7. The YMRS is a clinician administered scale that consists of 11 items used to assess the subject's symptoms of mania (total scores range from 0 to 60). The higher the YMRS score, the more severe the subject's symptoms of mania. **Measure:** Change in Young Mania Rating Scale (YMRS) total score from baseline to day 7 **Time Frame:** Baseline (day 1) to day 7 **Description:** To assess the safety and tolerability of BHV-7000. This objective will be measured by assessing the number of unique subjects with SAEs, AEs leading to discontinuation, AEs judged to be related to study medication that are observed during the Double-blind Treatment Phase (21 days). **Measure:** Number of Participants With Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and AEs judged to be related to study medication **Time Frame:** Baseline (day 1) to day 21 **Description:** To assess the safety and tolerability of BHV-7000. This objective will be measured by assessing the number of unique subjects with grade 3 and 4 laboratory abnormalities. **Measure:** Number of Participants With Clinically Significant Laboratory Abnormalities **Time Frame:** Baseline (day 1) to day 21 ### Eligibility Module **Eligibility Criteria:** Key Inclusion Criteria: 1. Participant must be voluntarily hospitalized for a current manic episode. 2. Male and female participants 18 years to 75 years of age at the time of the screening visit. 3. Body Mass Index (BMI) must be ≥ 18 kg/m2 and ≤ 35 kg/m2. 4. Meets DSM-5 criteria for bipolar disorder type I, with or without mixed features, as confirmed by MINI interview with at least one well- defined prior mood episode (in addition to the current episode). The most recent prior manic episode must have occurred in the last 2 years. 5. Episode of mania must not exceed 12 weeks in duration. 6. Participants must be able and willing to discontinue all other psychotropic medications during the Screening Phase (e.g., antidepressant, antimanic, antipsychotic medications). Key Exclusion Criteria: 1. Rapid cycling is excluded as defined herein by subjects who have experienced ≥ 6 distinct mood episodes in a year. Consecutive mood episodes must be demarcated either by a partial or full remission of at least 2 months' duration or by a switch to an episode of opposite polarity. Each manic or mixed episode must have lasted at least 1 week, and each hypomanic episode must have lasted at least 4 days. 2. Participants with a confirmed lifetime history of schizophrenia, psychotic disorders, dementia, delirium, amnesia, neurodegenerative disease, traumatic brain injury with clinically significant sequalae, seizure disorder, or other neurocognitive disorder. Previous diagnosis of psychotic spectrum disorders are allowable if the Investigator deems the diagnosis to be describing symptoms related to bipolar disorder. 3. Any medical condition, based on the judgement of the Investigator, that would confound the ability to adequately assess safety and efficacy outcome measures. **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:** Chief Medical Officer **Phone:** 203-404-0410 **Role:** CONTACT #### Locations **Location 1:** **City:** Bentonville **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Claudia Powell - **Phone:** 479-367-2688 - **Role:** CONTACT **Country:** United States **Facility:** Pillar Clinical Research, LLC **State:** Arkansas **Status:** NOT_YET_RECRUITING **Zip:** 72712 **Location 2:** **City:** Little Rock **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Ashley Poole - **Phone:** 501-221-8681 - **Role:** CONTACT **Country:** United States **Facility:** WIRG **State:** Arkansas **Status:** NOT_YET_RECRUITING **Zip:** 72211 **Location 3:** **City:** Rogers **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Ashley Poole - **Phone:** 479-927-3000 - **Role:** CONTACT **Country:** United States **Facility:** WRN **State:** Arkansas **Status:** NOT_YET_RECRUITING **Zip:** 72758 **Location 4:** **City:** Anaheim **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Austina Cho - **Phone:** 714-999-8866 - **Role:** CONTACT **Country:** United States **Facility:** Advanced Research Center, Inc. **State:** California **Status:** NOT_YET_RECRUITING **Zip:** 92805 **Location 5:** **City:** Bellflower **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Nikita Vera - **Phone:** 562-748-4999 - **Role:** CONTACT **Country:** United States **Facility:** CIT LA **State:** California **Status:** NOT_YET_RECRUITING **Zip:** 90706 **Location 6:** **City:** Culver City **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Victoria Garin - **Phone:** 424-227-8127 - **Role:** CONTACT **Country:** United States **Facility:** ProScience Research Group **State:** California **Status:** NOT_YET_RECRUITING **Zip:** 90230 **Location 7:** **City:** Garden Grove **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Andrew Lawlor - **Phone:** 714-799-7799 - **Role:** CONTACT **Country:** United States **Facility:** Cenexel CNS **State:** California **Status:** RECRUITING **Zip:** 92845 **Location 8:** **City:** Lemon Grove **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Corey Weise - **Phone:** 619-303-6130 - **Role:** CONTACT **Country:** United States **Facility:** Synergy San Diego **State:** California **Status:** NOT_YET_RECRUITING **Zip:** 91945 **Location 9:** **City:** Orange **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Abigail Parera - **Phone:** 714-289-1100 - **Role:** CONTACT **Country:** United States **Facility:** NRC Research Institute **State:** California **Status:** NOT_YET_RECRUITING **Zip:** 92868 **Location 10:** **City:** Riverside **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Paige Mansfield - **Phone:** 951-300-4924 - **Role:** CONTACT **Country:** United States **Facility:** CIT IE **State:** California **Status:** NOT_YET_RECRUITING **Zip:** 92506 **Location 11:** **City:** Torrance **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Dakota Gainers - **Phone:** 714-799-7799 - **Role:** CONTACT **Country:** United States **Facility:** Cenexel CNS **State:** California **Status:** NOT_YET_RECRUITING **Zip:** 90504 **Location 12:** **City:** Hollywood **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Jessmin Richani - **Phone:** 954-375-7795 - **Role:** CONTACT **Country:** United States **Facility:** Segal Trials - Larkin Behavioral Health Services-Inpatient & Early Phase Site **State:** Florida **Status:** NOT_YET_RECRUITING **Zip:** 33021 **Location 13:** **City:** Hollywood **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Edwin Gomez - **Phone:** 954-990-7649 - **Phone Ext:** 5303 - **Role:** CONTACT **Country:** United States **Facility:** Cenexel - RCA **State:** Florida **Status:** NOT_YET_RECRUITING **Zip:** 33024 **Location 14:** **City:** Miami Lakes **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Wilmer Mejia - **Phone:** 305-330-9977 - **Role:** CONTACT **Country:** United States **Facility:** Floridian Neuroscience Institute **State:** Florida **Status:** NOT_YET_RECRUITING **Zip:** 33016 **Location 15:** **City:** Miami Lakes **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Genesis Guzman - **Phone:** 786-570-1971 - **Role:** CONTACT **Country:** United States **Facility:** Segal Trials - Miami Lakes Medical Research-Inpatient & Early Phase Site **State:** Florida **Status:** NOT_YET_RECRUITING **Zip:** 33016 **Location 16:** **City:** Miami **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Vivian Salinas - **Phone:** 305-400-0814 - **Role:** CONTACT **Country:** United States **Facility:** LCC Medical Research Inst **State:** Florida **Status:** NOT_YET_RECRUITING **Zip:** 33126 **Location 17:** **City:** West Palm Beach **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Jahan Mahjabin - **Phone:** 561-578-8573 - **Role:** CONTACT **Country:** United States **Facility:** Neuroscience Research Institute **State:** Florida **Status:** NOT_YET_RECRUITING **Zip:** 33407 **Location 18:** **City:** Atlanta **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Leslie Gibbs - **Phone:** 404-881-5800 - **Role:** CONTACT **Country:** United States **Facility:** Atlanta Center for Medical Research **State:** Georgia **Status:** NOT_YET_RECRUITING **Zip:** 30331 **Location 19:** **City:** Decatur **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Katherine Prowse - **Phone:** 404-537-1281 - **Role:** CONTACT **Country:** United States **Facility:** CenExel iResearch, LLC **State:** Georgia **Status:** NOT_YET_RECRUITING **Zip:** 30030 **Location 20:** **City:** Savannah **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Katherine Prowse - **Phone:** 912-744-0800 - **Role:** CONTACT **Country:** United States **Facility:** CenExel iResearch, LLC **State:** Georgia **Status:** NOT_YET_RECRUITING **Zip:** 31405 **Location 21:** **City:** Chicago **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Stephen Schneider - **Phone:** 773-989-8313 - **Phone Ext:** 116 - **Role:** CONTACT **Country:** United States **Facility:** Uptown Research Institute **State:** Illinois **Status:** NOT_YET_RECRUITING **Zip:** 60640 **Location 22:** **City:** Chicago **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Brian Craig - **Phone:** 214-396-4844 - **Role:** CONTACT **Country:** United States **Facility:** Pillar Clinical Research **State:** Illinois **Status:** NOT_YET_RECRUITING **Zip:** 60641 **Location 23:** **City:** Gaithersburg **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Evan Covington - **Phone:** 301-251-4702 - **Role:** CONTACT **Country:** United States **Facility:** CBH Health **State:** Maryland **Status:** NOT_YET_RECRUITING **Zip:** 20877 **Location 24:** **City:** Flowood **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Sara Hall - **Phone:** 601-420-5812 - **Role:** CONTACT **Country:** United States **Facility:** Precise Clinical Research **State:** Mississippi **Status:** NOT_YET_RECRUITING **Zip:** 39232 **Location 25:** **City:** Saint Louis **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Israa Diab - **Phone:** 314-266-1243 - **Role:** CONTACT **Country:** United States **Facility:** Arch Clinical Trials **State:** Missouri **Status:** NOT_YET_RECRUITING **Zip:** 63141 **Location 26:** **City:** Marlton **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Lauren White - **Phone:** 856-452-9901 - **Phone Ext:** 727 - **Role:** CONTACT **Country:** United States **Facility:** Hassman Research Institute **State:** New Jersey **Status:** RECRUITING **Zip:** 08053 **Location 27:** **City:** Staten Island **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Daniel Gruener - **Phone:** 718-317-5522 - **Role:** CONTACT **Country:** United States **Facility:** RBA **State:** New York **Status:** NOT_YET_RECRUITING **Zip:** 10329 **Location 28:** **City:** Dayton **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Louis Wagner - **Phone:** 937-424-1050 - **Role:** CONTACT **Country:** United States **Facility:** Midwest Clinical Research Center **State:** Ohio **Status:** NOT_YET_RECRUITING **Zip:** 45417 **Location 29:** **City:** North Canton **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Aparna Pabbisetty - **Phone:** 330-493-1118 - **Role:** CONTACT **Country:** United States **Facility:** NBCR **State:** Ohio **Status:** NOT_YET_RECRUITING **Zip:** 44720 **Location 30:** **City:** Austin **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Missy Ward - **Phone:** 512-597-6704 - **Role:** CONTACT **Country:** United States **Facility:** Community Clinical Research, Inc. **State:** Texas **Status:** NOT_YET_RECRUITING **Zip:** 78754 **Location 31:** **City:** DeSoto **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Brian Green - **Phone:** 972-283-6286 - **Role:** CONTACT **Country:** United States **Facility:** InSite Clinical Research, LLC **State:** Texas **Status:** RECRUITING **Zip:** 75115 **Location 32:** **City:** Richardson **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Brian Craig - **Phone:** 214-396-4844 - **Role:** CONTACT **Country:** United States **Facility:** Pillar Clinical Research, LLC **State:** Texas **Status:** NOT_YET_RECRUITING **Zip:** 75080 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000068105 - Term: Bipolar and Related Disorders - ID: D000019964 - Term: Mood Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M4996 - Name: Bipolar Disorder - Relevance: HIGH - As Found: Bipolar Disorder - ID: M2598 - Name: Mania - Relevance: LOW - As Found: Unknown - ID: M226 - Name: Bipolar and Related Disorders - Relevance: LOW - As Found: Unknown - ID: M21835 - Name: Mood Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001714 - Term: Bipolar Disorder ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419569 **Acronym:** OA **Brief Title:** Efficacy of High Power Laser Versus Low Level Laser in Ultrasonographic and Functional Outcomes in Patients With Knee Osteoarthritis **Official Title:** Efficacy of High Power Laser Versus Low Level Laser in Ultrasonographic and Functional Outcomes in Patients With Knee Osteoarthritis #### Organization Study ID Info **ID:** P.T.REC/012/003450 #### Organization **Class:** OTHER **Full Name:** Cairo University ### Status Module #### Completion Date **Date:** 2024-12-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-12-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-30 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Cairo University #### Responsible Party **Investigator Affiliation:** Cairo University **Investigator Full Name:** Nabil Mahmoud Ismail Abdel-Aal **Investigator Title:** principle investigator nabil mahmoud ismail abdel-aal **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** this study will be conducted to compare between high power laser and low-intensity laser on ultrasonographic and functional outcomes in patients with knee osteoarthritis **Detailed Description:** Osteoarthritis (OA) is a major source of pain, disability, and socioeconomic cost worldwide. The epidemiology of the disorder is complex and multifactorial, with genetic, biological, and biomechanical components. It is estimated that 63 to 85 percent of Americans over age 65 have radiographic signs of OA and that 35 to 50 percent have symptoms of pain, stiffness or limitation of motion. Between 9 and 12 percent of elderly Americans (approximately 3 million people) have enough impairment from OA that they cannot perform their major activities, and half of these individuals are totally disabled (confined to bed or a wheelchair). High power laser therapy (HPL) that involves higher-intensity laser radiation is a new, painless, and powerful modality that showed significant results in pain reduction. One of the modalities commonly used by clinicians was Low Level Laser Therapy introduced as an alternative, safe and non-invasive treatment for OA about 30 years ago.A more recent systemic review investigated the effects of low-level and high-intensity laser therapy as adjunctive to rehabilitation exercise on pain, stiffness and function in knee osteoarthritis and concluded that Both LLLT and HPL are beneficial as adjuncts to rehabilitation exercise in the management of knee OA. Based on an indirect comparison, the HPL and exercise seems to have higher efficacy in reducing knee pain and stiffness, and in increasing function. To confirm this finding, a direct comparative investigation of the two types of laser therapy may be necessary. ninety patients with knee osteoarthritis will be assigned randomly to three groups; the first experimental will receive high power laser plus conventional physical therapy, second one will receive low-intensity laser and traditional physical therapy, finally, the third group will receive traditionally therapy only ### Conditions Module **Conditions:** - Knee Osteoarthritis **Keywords:** - High Power Laser - Low Level Laser - Ultrasonographic changes - Knee Osteoarthritis ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** high power laser and low level laser ##### Masking Info **Masking:** DOUBLE **Masking Description:** opaque sealed envelop **Who Masked:** - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 90 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** thirty patients will receive high-power laser and conventional physical therapy three times a week for eight weeks **Intervention Names:** - Other: high power laser - Other: conventional physical therapy **Label:** high power laser **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** thirty patients will receive low level laser and conventional physical therapy three times a week for eight weeks **Intervention Names:** - Other: low level laser - Other: conventional physical therapy **Label:** low level laser **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** thirty patients will receive conventional physical therapy three times a week for eight weeks **Intervention Names:** - Other: conventional physical therapy **Label:** conventional physical therapy **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - high power laser **Description:** Sessions will performed with scanning in longitudinal and perpendicular direction on the medial and lateral sides of the knee with Laser scanner machine. handpiece was positioned in contact and perpendicularly while the patient in a supine lying position with the knee flexed at 30° to open the joint surfaces to the laser beam (optical windows). The scanning was performed transversely and longitudinally in the anterior, medial, and lateral aspects of the knee joint with emphasis on the application on the joint line between the tibial and femoral epicondyles. The total energy delivered to the patient during one session was 1,250 J through three phases of treatment. The initial phase is performed with fast manual scanning with a total of 500 J. In the initial phase, the laser fluency is set to two successive subphases of 710 and 810 mJ/cm2 for a total of 500 J. **Name:** high power laser **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - low level laser **Description:** patients will receive laser with 0.5 W to gain energy density of 6 J/cm2, and total energy of 240 J during one session. LASER apparatus that will be used is Chattanoga Intelect Laser with 850nm wavelength and 200mW power Lasers. Same three phases like HPL with different energy dose. First phase: Fast manual scan 100 J. Second 10 point joint line phase with evey point 14 seconds and 4J to deliver a total of 40 J in this phase. Third phase: Slow manual scan 100 J. **Name:** low level laser **Type:** OTHER #### Intervention 3 **Arm Group Labels:** - conventional physical therapy - high power laser - low level laser **Description:** the patients will receive conventiobal physical therapy in the form of Exercise therapy program (1) Warm-up exercises: Walking at the usual speed on a flat surface for 10 min with hamstring and calf gentle stretches.(2) Major exercises for knee OA: Straight leg raise, quadriceps setting, heel raise, one leg balance, step ups, and quadriceps strengthening exercises. The US protocol consists of continuous ultrasonic waves of 1 MHz frequency and 1 W/cm2 intensity applied with a 5-cm diameter applicator. The patients will be placed in a supine position, and the US applied to the medial and lateral parts (5 min on each side) of the knee in circular movements with the probe at right angles to ensure maximum absorption of the energy. **Name:** conventional physical therapy **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** ultrasonographe device will be used to assess the osteophyte diameter **Measure:** osteophyte diameter **Time Frame:** up to eight weeks **Description:** utrasonographe device will be used to assess hyaline cartilage thickness **Measure:** hyaline cartilage thickness assessment **Time Frame:** up to eight weeks #### Secondary Outcomes **Description:** Knee Injury and Osteoarthritis Outcome Score questionnaire will be used to assess knee function.five patient-relevant subscales of KOOS are scored separately: Pain (nine items); Symptoms (seven items); ADL Function (17 items); Sport and Recreation Function (five items); Quality of Life (four items). A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic assessment scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved. **Measure:** knee function **Time Frame:** up to eight weeks **Description:** Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. The following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm) **Measure:** pain intensity **Time Frame:** up to eight weeks **Description:** digital goniometer will be used to assess knee range of motion **Measure:** knee range of motion **Time Frame:** up to eight weeks **Description:** algometer will be used to assess pressure pain threshold **Measure:** pressure pain threshold **Time Frame:** up to eight weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * X-ray stages II and III osteoarthritis * Age between 45 and 75 years. * BMI equal to or less than 35. Exclusion Criteria: * Unwillingness to participate in the study. * Uncompleted evaluation/treatment programs. * Any damage to the knee joint during the study. * Using any treatment other than prescribed therapeutic protocols. **Maximum Age:** 75 Years **Minimum Age:** 45 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** mohamed H abdo, doctoral **Phone:** 01007433819 **Role:** CONTACT ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001168 - Term: Arthritis - ID: D000007592 - Term: Joint Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000012216 - Term: Rheumatic Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases ### Condition Browse Module - Browse Leaves - ID: M12926 - Name: Osteoarthritis - Relevance: HIGH - As Found: Osteoarthritis - ID: M22168 - Name: Osteoarthritis, Knee - Relevance: HIGH - As Found: Knee Osteoarthritis - ID: M4476 - Name: Arthritis - Relevance: LOW - As Found: Unknown - ID: M10621 - Name: Joint Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M15045 - Name: Rheumatic Diseases - Relevance: LOW - As Found: Unknown - ID: M6323 - Name: Collagen Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010003 - Term: Osteoarthritis - ID: D000020370 - Term: Osteoarthritis, Knee ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419556 **Brief Title:** Analgesic Efficacy of an Intermediate CPB in Neck Surgeries. **Official Title:** Analgesic Efficacy of an Intermediate Cervical Plexus Block in Patients Undergoing Neck Surgeries. A Comparison Between Two Bupivacaine Concentrations. #### Organization Study ID Info **ID:** MS-425-2023 #### Organization **Class:** OTHER **Full Name:** Cairo University ### Status Module #### Completion Date **Date:** 2024-06-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-06-01 **Type:** ESTIMATED #### Start Date **Date:** 2023-03-05 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Cairo University #### Responsible Party **Investigator Affiliation:** Cairo University **Investigator Full Name:** Nagy Malak , MD **Investigator Title:** Lecturer of anesthesia ,SICU and pain **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study aims to investigate the analgesic efficacy of Intermediate Cervical Plexus Block combined with GA using two bupivacaine concentrations in patients undergoing neck surgeries (total thyroidectomy or total laryngectomy) **Detailed Description:** This randomized comparative study was conducted in Cairo University hospitals after the approval of the institutional research and ethics committee. Informed consent was obtained from all participants. The Consolidated Standards of Reporting Trials (CONSORT) Guidelines were followed. The patients were randomly allocated into two groups (H \& L) using computer generated random numbers that were concealed in opaque envelopes. Group H received 20 ml 0.25 % bupivacaine and Group L received 20 ml 0.125% bupivacaine bilaterally. * On arrival to the operating room, an 18G cannula was inserted with the infusion of 500 ml Ringer solution. Controloc 40 mg, ondansetron 8 mg, and dexamethasone 8 mg were administered as premedication. The diaphragmatic motion was assessed by a 3.5 MHz curvilinear transducer, siemens ACUSON X300 ultrasound. Each hemidiaphragm was first visualized by B-mode then M-mode was used to evaluate diaphragmatic excursion. For the right hemidiaphragm, the transducer was placed perpendicularly over the right subcostal margin in the anterior axillary line, the prob was then directed cephalad and dorsally to reach the posterior one-third of the diaphragm. Diaphragmatic excursions were measured and recorded in millimeters using the liver as an acoustic window during quiet breathing. The left hemidiaphragm was assessed in the same way using the spleen as an acoustic window. * All patients connected to an electrocardiograph (ECG), pulse oximeter, and non-invasive blood pressure (NIBP), and baseline values of HR and MAP were measured and recorded. Additional monitoring in the form of a capnogram, invasive blood pressure (IBP) through a radial artery cannula, peripheral nerve stimulator (PNS), Bispectral index (BIS), and urine output were connected after induction of GA. Anesthesia was induced by intravenous fentanyl 2µg/kg, propofol 1.5-2 mg/kg, and atracurium 0.5 mg. When the TOF count showed the disappearance of T1 (0/4), an appropriate-size endotracheal tube was inserted and secured. Under complete aseptic conditions, ultrasound guided bilateral ICPB was performed by a single staff anesthetist who is skilled in carrying out regional anesthesia. * ICPB technique: The patient's head was rested on a pillow and turned to the opposite side. A linear probe with higher frequencies was placed transversely over the midpoint of the SCM muscle. The carotid artery was identified and traced upwards to its bifurcation. the probe was then moved laterally to identify the tapering posterolateral end of the SCM muscle. Via an in-plane technique, a 22-gauge, 50 mm needle was advanced underneath the investing fascia of SCM muscle and above the interscalene groove until the "pop" on piercing the investing fascia was felt. The patient was then randomly allocated into two groups (H \& L) using computer generated random numbers that were concealed in opaque envelopes. Group H received 20 ml 0.25 % bupivacaine and Group L received 20 ml 0.125% bupivacaine. The technique was repeated on the opposite side. * During the intraoperative period, anesthesia was maintained with isoflurane 1.2-1.5 vol% to keep BIS value at 40-60 and atracurium 0.1mg/kg guided by PNS. Additional doses of fentanyl 0.05 µg/kg were administered when HR or MAP increased \> 20% of the baseline values. MAP and HR were measured after the skin incision, and then every 30 minutes till the end of surgery. The failed block was considered when ≥ four additional doses of fentanyl were required to manage the increased MAP or HR after skin incision. At the end of the surgery, one gram of paracetamol plus 30 mg of ketorolac were administered. * During the postoperative period, regular analgesia in the form of intravenous paracetamol one gram/8hr was prescribed. Pain severity was assessed by using the visual analog scale (VAS) (0= no pain and 100mm= worst pain) at 2, 4, 6, 8, 12, 18, and 24 hr postoperatively. Rescue analgesia in the form of intravenous morphine 0.05 mg/kg was given on the patient's complaint or when VAS ≥ 40 mm and repeated every 15-20 minutes until VAS \< 40 mm with a maximum morphine dose of 40 mg per 24 hours. The duration of analgesia was calculated as the time elapsed from the end of the ICPB block procedure till VAS ≥ 40mm. The total postoperative morphine consumption over 24 hours was calculated. The measurement of diaphragmatic excursions was repeated as mentioned above, hemi-diaphragmatic paresis was divided into three grades, depending on the percentage of diaphragm movement compared with baseline to be: none (\> 75%), partial paresis (25-75%), and complete paresis (\< 25%) ### Conditions Module **Conditions:** - Anesthesia - Thyroid - Neck - Bupivacaine **Keywords:** - Neck surgeries - Cervical Plexus Block - Bupivacaine ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 54 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The patient's head was rested on a pillow and turned to the opposite side. A linear probe with higher frequencies was placed transversely over the midpoint of the SCM muscle. The carotid artery was identified and traced upwards to its bifurcation. Probe was then moved laterally to identify the tapering posterolateral end of the SCM muscle. Via an in-plane technique, a 22-gauge, 50 mm needle was advanced underneath the investing fascia of SCM muscle and above the interscalene groove until the "pop" on piercing the investing fascia was felt. Group H received 20 ml 0.25 % bupivacaine **Intervention Names:** - Procedure: Cervical Plexus Block **Label:** Group H **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The patient's head was rested on a pillow and turned to the opposite side. A linear probe with higher frequencies was placed transversely over the midpoint of the SCM muscle. The carotid artery was identified and traced upwards to its bifurcation. Probe was then moved laterally to identify the tapering posterolateral end of the SCM muscle. Via an in-plane technique, a 22-gauge, 50 mm needle was advanced underneath the investing fascia of SCM muscle and above the interscalene groove until the "pop" on piercing the investing fascia was felt. Group L received 20 ml 0.125% bupivacaine. **Intervention Names:** - Procedure: Cervical Plexus Block **Label:** Group L received 20 ml 0.125% bupivacaine **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Group H - Group L received 20 ml 0.125% bupivacaine **Description:** The patient's head was rested on a pillow and turned to the opposite side. A linear probe with higher frequencies was placed transversely over the midpoint of the SCM muscle. The carotid artery was identified and traced upwards to its bifurcation. the probe was then moved laterally to identify the tapering posterolateral end of the SCM muscle. Via an in-plane technique, a 22-gauge, 50 mm needle was advanced underneath the investing fascia of SCM muscle and above the interscalene groove until the "pop" on piercing the investing fascia was felt. **Name:** Cervical Plexus Block **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** duration of anesthesia and Block-skin incision time differ between two groups (two concentrations of bupivacaine) **Measure:** Duration of analgesia **Time Frame:** duration of operation up to 6 hours #### Secondary Outcomes **Description:** Measured at two-time points: before anesthesia (baseline) and on arrival to PACU, with the calculation of the hemi-diaphragmatic paresis depending on the percentage of diaphragm movement compared with baseline as follows: none (\> 75%), partial paresis (25-75%), and complete paresis (\< 25%). **Measure:** The diaphragmatic motions measured by M-mode ultrasonography **Time Frame:** duration of operation up to 6 hours **Description:** Total postoperative Morphine consumption. **Measure:** Total postoperative Morphine consumption. **Time Frame:** 24 hours **Description:** scale (0= no pain and 100 mm= worst pain) and measured at 2, 4, 6, 8, 12, 18, and 24 hr postoperatively. Rescue analgesia in the form of intravenous morphine 0.05 mg/kg given on the patient's complaint or when VAS ≥ 40 mm and repeated every 15-20 minutes until VAS \< 40 mm with a maximum morphine dose of 40 mg per 24 hours. **Measure:** The postoperative VAS score **Time Frame:** 24 hours **Description:** Intraoperative MAP and HR were measured after the skin incision, and then every 30 minutes until the end of surgery. **Measure:** Hemodynamics **Time Frame:** duration of operation up to 6 hours **Description:** Intraoperative opioid (fentanyl) consumption.The failed block was considered when ≥ four additional doses of fentanyl were required to manage the increased MAP or HR after skin incision. **Measure:** opioid consumption. **Time Frame:** duration of operation up to 6 hours ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Any patient aged ≥ 40 years * ASA physical status I-III scheduled for total thyroidectomy or total laryngectomy under GA. Exclusion Criteria: * Patients with heart failure * history of arrhythmias * treatment with antiarrhythmic drugs * impaired pulmonary * Liver or kidney functions * Neck infection or rash **Maximum Age:** 70 Years **Minimum Age:** 40 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Nagy malak **Phone:** 01552480258 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Nagy malak **Phone:** 01552480258 **Role:** CONTACT #### Locations **Location 1:** **City:** Cairo **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Nagy malak - **Phone:** 01552480258 - **Role:** CONTACT **Country:** Egypt **Facility:** Cairo university Hospitals. kasralainy **State:** Governorate **Status:** RECRUITING **Zip:** 002 ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M16718 - Name: Thyroid Diseases - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Analg - Name: Analgesics ### Intervention Browse Module - Browse Leaves - ID: M5315 - Name: Bupivacaine - Relevance: LOW - As Found: Unknown - ID: M4032 - Name: Analgesics - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419543 **Brief Title:** Paradoxical Reactions of Remimazolam in Pediatric Painless Gastrointestinal Endoscopy **Official Title:** Paradoxical Reactions of Remimazolam in Pediatric Painless Gastrointestinal Endoscopy: a Prospective Observation Study #### Organization Study ID Info **ID:** PRPG #### Organization **Class:** OTHER **Full Name:** Tongji Hospital ### Status Module #### Completion Date **Date:** 2024-10-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-10-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-20 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Tongji Hospital #### Responsible Party **Investigator Affiliation:** Tongji Hospital **Investigator Full Name:** aijun xu **Investigator Title:** Doctor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Exploring the effect of remimazolam dose on paradoxical reactions in pediatric painless gastrointestinal endoscopy. **Detailed Description:** Exploring the effect of remimazolam dose on paradoxical reactions and sedation in pediatric painless gastrointestinal endoscopy, observing the performance and duration of paradoxical reactions, and analyze the factors. ### Conditions Module **Conditions:** - Endoscopy, Gastrointestinal ### Design Module #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 120 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The first induction dose of remimazolam is 0.1mg/kg. **Intervention Names:** - Drug: Remimazolam **Label:** 0.1mg/kg of remimazolam #### Arm Group 2 **Description:** The first induction dose of remimazolam is 0.2mg/kg. **Intervention Names:** - Drug: Remimazolam **Label:** 0.2mg/kg of remimazolam #### Arm Group 3 **Description:** The first induction dose of remimazolam is 0.3mg/kg. **Intervention Names:** - Drug: Remimazolam **Label:** 0.3mg/kg of remimazolam ### Interventions #### Intervention 1 **Arm Group Labels:** - 0.1mg/kg of remimazolam - 0.2mg/kg of remimazolam - 0.3mg/kg of remimazolam **Description:** Observe the incidence of paradoxical reactions after the first induction. **Name:** Remimazolam **Other Names:** - remimazolam besylate **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** observe the incidence of paradoxical reaction within 2 minutes **Measure:** incidence of paradoxical reaction **Time Frame:** 2 minutes after first infusion of remimazolam #### Secondary Outcomes **Description:** observe the performance and duration of paradoxical reaction within 2 minutes **Measure:** performance and duration of paradoxical reaction **Time Frame:** 2 minutes after first infusion of remimazolam **Description:** Total dose of the first administered plus supplemental doses of sedative drugs. **Measure:** dosage of sedative drugs **Time Frame:** First infusion until end of remimazolam administration **Description:** anesthesia time, induction time, surgical time, awakening time, and recovery time **Measure:** time records **Time Frame:** 1 day **Description:** respiratory suppression incidence;intraoperative blood pressure and heart rate changes: record the patient's intraoperative blood pressure, heart rate, and the use of related vasoactive drugs; postoperative adverse reactions: such as hypertension, hypotension, tachycardia, gastrointestinal symptoms, postoperative restlessness, etc. **Measure:** Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] **Time Frame:** 1 day ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age 1-18 years old, ASA I-II level; Sign an informed consent form. Exclusion Criteria: * Developmental delay or neurological and psychiatric disorders; Severe malnutrition or severe obesity; High risk of stomach fullness and reflux aspiration; Allergic to benzodiazepines and opioids; Those who have taken sedative, analgesic, or antidepressant drugs within 24 hours; Severe sleep apnea; Abnormal liver and kidney function; Recently participated in other clinical studies. **Maximum Age:** 18 Years **Minimum Age:** 1 Year **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT **Study Population:** We select children who choose to have a painless gastrointestinal endoscopy at Tongji Hospital. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** mujun Chang, doctor **Phone:** +862783663625 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** aihua Du, doctor **Phone:** +862783663625 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Tongji Hospita **Name:** aihua Du, doctor **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419530 **Brief Title:** A Study on Probiotic Formula in Autistic Children **Official Title:** A Double-blind Randomized Clinical Trail Study on the Effectiveness and Safety of Probiotic Formula in Autistic Children With Gastrointestinal Symptoms #### Organization Study ID Info **ID:** TMMU-DP-ASD-PMT-20240510 #### Organization **Class:** OTHER **Full Name:** Third Military Medical University ### Status Module #### Completion Date **Date:** 2028-06 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **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:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Third Military Medical University #### Responsible Party **Investigator Affiliation:** Third Military Medical University **Investigator Full Name:** Yanling Wei **Investigator Title:** Associate director / Associate professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** A Randomized controlled double-blind clinical study on the effectiveness and safety of probiotic formula in Autistic children with gastrointestinal symptoms. **Detailed Description:** Autism spectrum disorder (ASD) is a neurodevelopmental disorder of children with estimated prevalence of near 1% by WHO in 2022. To date, the cause and etiology of ASD is still unknown, and there is no proven effective pharmacological treatment for ASD. The gut microbiota has been proved to have great impact on neurological development, in this study, we aim to explore the effectiveness of safety of probiotic formula on ASD children, by comparing with placebo and fecal microbiota transplantation (FMT). This study will be a randomized, double-blind, placebo-controlled trial. Totally, 156 Autistic children with gastrointestinal symptoms will be enrolled and randomly allocated into three groups: probiotic formula group, fecal microbiota transplantation (FMT) group and placebo group. participants are treated with 4 probiotic formula/FMT/placebo capsules each day, for 84 days. Participants would be followed up at the 4th, 8th, 12th and 24th week after enrollment by simple physical examination, relevant scale questionaire (including Autism Behavior Checklist(ABC),Childhood Autism Rating Scale(CARS),Gastrointestinal Symptom Rating Scale(GSRS),Social Responsiveness Scale(SRS),Self-Rating Anxiety Scale(SAS) and Autism Diagnostic Observation Schedule(ADOS)), and blood and fecal samples collection. ### Conditions Module **Conditions:** - Autism Spectrum Disorder **Keywords:** - Autism Spectrum Disorder - Gut microbiota ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 156 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** In this arm, 4 placebo capsules would be oral administered by participants everyday for 84 days. **Intervention Names:** - Other: placebo capsule **Label:** Placebo group **Type:** PLACEBO_COMPARATOR #### Arm Group 2 **Description:** In this arm, 4 FMT capsules would be oral administered by participants everyday for 84 days. **Intervention Names:** - Other: FMT capsule **Label:** Fecal microbiota transplantation (FMT) group **Type:** ACTIVE_COMPARATOR #### Arm Group 3 **Description:** In this arm, 4 Probiotic formula capsules would be oral administered by participants everyday for 84 days. **Intervention Names:** - Other: Probiotic formula capsule **Label:** Probiotic formula group **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Probiotic formula group **Description:** The subjects take 4 capsules a day for 84 days. **Name:** Probiotic formula capsule **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Placebo group **Description:** The subjects take 4 capsules a day for 84 days. **Name:** placebo capsule **Type:** OTHER #### Intervention 3 **Arm Group Labels:** - Fecal microbiota transplantation (FMT) group **Description:** The subjects take 4 capsules a day for 84 days. **Name:** FMT capsule **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** This scale lists 57 items of abnormal performance in sensation, behavior, emotion and language, and makes the judgment of "yes" and "no" in each item. (the informant refers to the parents of the child or those who have lived with the child for more than two weeks.) when scoring, make "yes" and "no" to each item, "yes" is the symbol"√", and "no" is not marked. The total score of "yes" items is 158, and the screening limit is 53-67 points. 53 points were used as the diagnostic threshold of autism, and the diagnosis score was 67 points. **Measure:** Changes in Behavioral Rating Scale (ABC) scores of children with autism in 12th week and baseline **Time Frame:** week 12 #### Secondary Outcomes **Description:** The scale consists of 15 items, which are used by the examiners. Each item of the scale was scored according to 1-4 grades. The total score was greater than or equal to 30 points for diagnosis of autism, less than 36 points for mild-moderate autism, and for severe autism when the total score reached or greater than 36 points. **Measure:** Changes in Childhood Autism Rating Scale(CARS) before and after treatment **Time Frame:** week 0,4,8,12,24 **Description:** The scale is composed of 65 items in 5 subscales. The content of the scale mainly involves children's daily social situations, including social perception, cognition, communication, motivation, autistic behavior and other aspects. The scale adopts a 4-point rating, and each item has four options: never, sometimes, often, and always, and is completed by parents or long-term caregivers. The higher the score, the more severe the social impairment and autistic behavior. **Measure:** Changes in Social Responsiveness Scale(SRS) before and after treatment **Time Frame:** week 0,4,8,12 **Description:** The scale consists of 20 items. Each item is scored on a scale of 1 to 4, and the final score is the sum of the scores for the 20 items. The final score is multiplied by 1.25 to obtain the integer part, and the standard score is obtained. An anxiety total score below 50 is considered normal; 50-60 is mild, 61-70 is moderate, and above 70 is severe anxiety. **Measure:** Changes in Self-Rating Anxiety Scale(SAS) before and after treatment **Time Frame:** week 0,4,8,12 **Description:** The scale is a semi-structured, standardized assessment that includes communication, social interaction, play, and restrictive and repetitive behaviors. **Measure:** Changes in Autism Diagnostic Observation Schedule(ADOS) before and after treatment **Time Frame:** week 0,4,8,12 **Description:** The scale is a tool commonly used to measure gastrointestinal symptoms. It contains multiple dimensions and items to evaluate the patient's gastrointestinal health status through scoring. **Measure:** Changes in Gastrointestinal Symptom Rating Scale(GSRS) before and after treatment **Time Frame:** week 0,4,8,12, 24 **Description:** There are abnormal changes in erum neurotransmitters (including 5-HT, GABA, and dopamine) in autistic children.In order to explore whether "Precision Microbiota Transplantation" can improve serum neurotransmitters (including 5-HT, GABA, and dopamine) levels. **Measure:** Changes in Serum neurotransmitters (5-HT、GABA、Dopamine) of children with autism before and after treatment **Time Frame:** week 0,12 **Description:** There are abnormal changes in intestinal flora in autistic children.In order to explore whether "Precision Microbiota Transplantation" can improve the level of intestinal flora. **Measure:** Changes in gut microbiota of children with autism before and after treatment **Time Frame:** week 0,12 **Description:** This scale lists 57 items of abnormal performance in sensation, behavior, emotion and language, and makes the judgment of "yes" and "no" in each item. (the informant refers to the parents of the child or those who have lived with the child for more than two weeks.) when scoring, make "yes" and "no" to each item, "yes" is the symbol"√", and "no" is not marked. The total score of "yes" items is 158, and the screening limit is 53-67 points. 53 points were used as the diagnostic threshold of autism, and the diagnosis score was 67 points. **Measure:** Changes in Behavioral Rating Scale (ABC) scores of children with autism before and after treatment **Time Frame:** week 0,4,8, 24 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Children and adolescents aged 3-11 years old * Clinical diagnosis of ASD, based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) * Associated with gastrointestinal symptoms for at least 14 days (diarrhea, constipation, abdominal pain, bloating and/or food allergies/intolerances) * With guardians who can fully understand the informed consent and voluntarily sign the written informed consent Exclusion Criteria: * Antibiotics or probiotics used within 1 mont * Serious gastrointestinal problems that require immediate treatment (such as life-threatening intestinal obstruction, intestinal perforation, intestinal bleeding * Medications related to mental disorders or depression * Relying on tube feeding * Swallowing dysfunction that unable to take capsules * History of severe allergies * Paticipation in other clinical studies within 4 weeks * Poor compliance and have difficulty in completing follow-up. **Maximum Age:** 14 Years **Minimum Age:** 3 Years **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Yanling Wei, MD **Phone:** 15310354666 **Role:** CONTACT #### Locations **Location 1:** **City:** Chongqing **Country:** China **Facility:** Department of Gastroenterology, Daping Hospital, The Third Military Medical University **State:** Chongqing **Zip:** 400042 #### Overall Officials **Official 1:** **Affiliation:** Daping Hospital,Army medical university **Name:** Yanling Wei, MD **Role:** PRINCIPAL_INVESTIGATOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002659 - Term: Child Development Disorders, Pervasive - ID: D000065886 - Term: Neurodevelopmental Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M4623 - Name: Autistic Disorder - Relevance: LOW - As Found: Unknown - ID: M206 - Name: Autism Spectrum Disorder - Relevance: HIGH - As Found: Autism Spectrum Disorder - ID: M5903 - Name: Child Development Disorders, Pervasive - Relevance: LOW - As Found: Unknown - ID: M5902 - Name: Developmental Disabilities - Relevance: LOW - As Found: Unknown - ID: M30644 - Name: Neurodevelopmental Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000067877 - Term: Autism Spectrum Disorder ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419517 **Brief Title:** Pelvic Muscle Training and Electrostimulation to Treat Weak Pelvic Floor **Official Title:** Efficacy of PFMT and sEMG-triggered Electrostimulation in Treating the Very Weak Pelvic Floor: a Randomized Clinical Trial #### Organization Study ID Info **ID:** 23-0000035 #### Organization **Class:** OTHER **Full Name:** Azienda Unità Sanitaria Locale di Piacenza ### Status Module #### Completion Date **Date:** 2026-06-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-05-11 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-17 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-16 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** BEACMED s.r.l. #### Lead Sponsor **Class:** OTHER **Name:** Azienda Unità Sanitaria Locale di Piacenza #### Responsible Party **Investigator Affiliation:** Azienda Unità Sanitaria Locale di Piacenza **Investigator Full Name:** DR. GIANFRANCO LAMBERTI **Investigator Title:** Director, Rehabilitative Medicine Department **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This research will determine 1) whether the very weak pelvic floor can be improved with surface electromyography (s-EMG)-triggered electrostimulation added to pelvic floor muscle training and 2) whether sEMG-triggered electrostimulation added to pelvic floor muscle training can reduce leakage in Stress Urinary Incontinence (SUI) **Detailed Description:** Among women with pelvic floor dysfunction, it has long been known that PFM training is the first-line therapy for stress incontinence. One of the difficulties that clinicians often find upon examination is that many women present a very weak pelvic floor and are unable to contract their PFM. There is overwhelming evidence to show that conservative treatment in the form of pelvic muscle exercises (and to a lesser degree, electrotherapy, and vaginal weight therapy) is effective in the treatment of stress urinary incontinence. To date, there is some evidence to support the use of electrical stimulation for stress urinary incontinence in women, but we are still very uncertain about the full potential of this treatment because of the low quality of the existing evidence. ### Conditions Module **Conditions:** - Pelvic Floor Muscle Weakness - Incontinence Stress - Electricity; Effects - Muscle Weakness Condition **Keywords:** - Pelvic Floor Muscle Weakness - Electrical Stimulation - Pelvic Floor Muscle Training ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** Multicentric Prospective Clinical Trial with two parallel arms ##### Masking Info **Masking:** DOUBLE **Masking Description:** Double (participants, principal investigator). To improve the effect of blindness, participants were informed that the trial intended to compare the effects of two Electrical Stimulation (ES) methods for Stress Urinary Incontinence (SUI) **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 50 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Group A (supervised PFMT + EMG-triggered ES) Supervised Pelvic Floor Muscle Training Twenty sessions will be applied, 2 per week for ten weeks Stimulation parameters: Duration: 15 min Electrode placement: vaginal probe Frequency: 50 Hz. - Pulse width 250 microseconds Intensity: to motor response (activation of PFM) Number of sessions: 20 Ramp up/down: 1 sec. **Intervention Names:** - Device: EMG-triggered ES - Other: Pelvic Floor Muscle Training **Label:** Supervised Pelvic Floor Muscle Training + EMG-triggered ES **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Group B: Supervised PFMT + sham EMG-triggered ES) Supervised Pelvic Floor Muscle Training Twenty sessions will be applied, 2 per week for ten weeks Stimulation parameters: Duration: 15 min Electrode placement: vaginal probe model xx Frequency: 2 Hz. - Pulse width 10 microseconds Intensity: to sensory response Number of sessions: 20 Ramp up/down: 1 sec. **Intervention Names:** - Other: Pelvic Floor Muscle Training **Label:** Supervised PFMT + sham EMG-triggered ES) **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Supervised Pelvic Floor Muscle Training + EMG-triggered ES **Description:** The ES treatment protocol consisted of daily endovaginal electrostimulation sessions for four weeks. We used a portable unit EVOSTIM ®, which allowed us to use different frequencies and length of impulse and a probe Perisphera ® The average current intensity was adjusted according to the sensation of discomfort in each patient. **Name:** EMG-triggered ES **Other Names:** - Pelvic Floor Muscle Training **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - Supervised PFMT + sham EMG-triggered ES) - Supervised Pelvic Floor Muscle Training + EMG-triggered ES **Description:** Standardization of the supervised PFMT To achieve standardization of supervised PFMT treatments, a written protocol for the physiotherapeutic examinations and PFMT program will be provided to the physiotherapists (or nurse or midwife) delivering the treatments (See Additional file). **Name:** Pelvic Floor Muscle Training **Other Names:** - EMG-triggered ES **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** PFM strength by digital palpation done in the lithotomy position **Measure:** Pelvic Floor Muscles (PFM) Strength **Time Frame:** Baseline, four weeks, 6 and 12 months follow-up #### Secondary Outcomes **Description:** The change incontinence frequency (n.of episodes) deducted by frequency/volume chart **Measure:** Frequency/volume chart **Time Frame:** Baseline, four weeks, 6 and 12 months follow-up **Description:** Change of "International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF" scores, which varie from 0 (no impact of incontinence) to 19 (worst impact of incontinence in everyday life) **Measure:** International Consultation on Incontinence Questionnaire-Short Form(ICIQ-SF) **Time Frame:** Baseline, four weeks, 6 and 12 months follow-up ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * • Adult women (18 years old - 50 years old), with a Modified Oxford Score, determined by digital palpation, of 0 - 1, complaining leakage episode occurring more than once a week. * Between six and eighteen months after childbirth * Willing and able to be compliant with pelvic floor muscle exercise intervention (standard of care) for 12 weeks and to log compliance * Willing and able to undergo an extensive physical function evaluation Exclusion Criteria: * • pregnancy * severe neurological disease (Multiple Sclerosis, Parkinson's disease, spinal cord injury, major stroke or neuromuscular junction diseases) * previous operation for cancer or radiotherapy in the lower abdomen * Prior surgical intervention for urinary incontinence within the past 12 months * Hysterectomy within 12 months * voiding dysfunction * pelvic pain * severe prolapse (≥ grade 3) * recurrent urinary tract infection * pelvic or disseminated malignancies * women who were virgo intacta * women who declined vaginal examinations for any reasons * before four months of pregnancy * Having significant cognitive impairment or dementia * Unsafe to exercise (severe cardiopulmonary disease) * Unable/unwilling to provide informed consent * Patient has on physical examination, neurological and/or vaginal examination results which, in the opinion of the investigator, should exclude the subject. **Gender Based:** True **Gender Description:** Person's sense of self **Maximum Age:** 50 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Gianfranco Lamberti, MD **Phone:** +390523404657 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Gianluca Ciardi, MD **Phone:** +390523404657 **Role:** CONTACT #### Locations **Location 1:** **City:** Fiorenzuola d'Arda **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Gianfranco Lamberti, MD - **Phone:** +390523404657 - **Role:** CONTACT **Country:** Italy **Facility:** OSPEDALE FIORENZUOLA d'ARDA **State:** PC **Status:** RECRUITING **Zip:** 29017 #### Overall Officials **Official 1:** **Affiliation:** Azienda USL Piacenza **Name:** Gianfranco Lamberti, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** Individual participant data after deidentification **IPD Sharing:** NO ### References Module #### References **Citation:** Dumoulin C, Cacciari LP, Hay-Smith EJC. Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women. Cochrane Database Syst Rev. 2018 Oct 4;10(10):CD005654. doi: 10.1002/14651858.CD005654.pub4. **PMID:** 30288727 **Citation:** Bo K. Pelvic floor muscle training is effective in treatment of female stress urinary incontinence, but how does it work? Int Urogynecol J Pelvic Floor Dysfunct. 2004 Mar-Apr;15(2):76-84. doi: 10.1007/s00192-004-1125-0. Epub 2004 Jan 24. **PMID:** 15014933 ## 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 - ID: D000014549 - Term: Urinary Incontinence - ID: D000014555 - Term: Urination Disorders - ID: D000014570 - Term: Urologic Diseases - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000091642 - Term: Urogenital Diseases - ID: D000052801 - Term: Male Urogenital Diseases - ID: D000059411 - Term: Lower Urinary Tract Symptoms - ID: D000020924 - Term: Urological Manifestations ### 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 - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M20944 - Name: Muscle Weakness - Relevance: HIGH - As Found: Muscle Weakness - ID: M13204 - Name: Paresis - Relevance: HIGH - As Found: Muscle Weakness - ID: M4554 - Name: Asthenia - Relevance: HIGH - As Found: Weakness - ID: M17300 - Name: Urinary Incontinence, Stress - Relevance: HIGH - As Found: Incontinence Stress - ID: M17299 - Name: Urinary Incontinence - Relevance: LOW - As Found: Unknown - ID: M7936 - Name: Enuresis - 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 - ID: M17305 - Name: Urination Disorders - Relevance: LOW - As Found: Unknown - ID: M17319 - Name: Urologic Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M27093 - Name: Female Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14127 - Name: Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M8399 - Name: Female Urogenital Diseases and Pregnancy Complications - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M29464 - Name: Lower Urinary Tract Symptoms - Relevance: LOW - As Found: Unknown - ID: M22659 - Name: Urological Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000018908 - Term: Muscle Weakness - ID: D000010291 - Term: Paresis - ID: D000014550 - Term: Urinary Incontinence, Stress - ID: D000001247 - Term: Asthenia ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419504 **Brief Title:** The Effect of Ultrasonography-guided Fascial Plane Blocks in Breast Cancer Surgery Patients **Official Title:** The Effect of Ultrasonography-guided Pectoserratus Plane Block, Erector Spina Plane Block and Serratus Anterior Plane Block on Postoperative Opioid Consumption, Recovery Quality and Chronic Pain in Breast Cancer Surgery Patients #### Organization Study ID Info **ID:** 6/11 #### Organization **Class:** OTHER_GOV **Full Name:** Antalya Training and Research Hospital ### Status Module #### Completion Date **Date:** 2024-11-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-10-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-17 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-17 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER_GOV **Name:** Antalya Training and Research 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 aim of this study was to evaluate the efficacy of serratus anterior plane (SAP) block, pectoserratus plane (PECS II) block, and erector spinae plane (ESP) block on postoperative acute pain, quality of recovery and chronic pain in breast cancer surgery patients. **Detailed Description:** Breast cancer is the most common type of cancer in women. Although surgical treatment is effective and curative, it is associated with many complications in the postoperative period. Acute pain after surgery is one of them. Approximately half of women undergoing breast surgery describe significant post-operative pain (\>5 on the Visual Analogue Scale; VAS) score that is not always effectively controlled by standard post-operative treatments. Poorly controlled postoperative pain has been associated with impaired functional recovery, delayed discharge from the post-anesthetic care unit, and prolonged hospital stay. In addition, poorly managed acute pain becomes chronic and is described as 'post-mastectomy pain syndrome'. Regional techniques can reduce acute and chronic postoperative pain. The development of ultrasonography (US)-guided regional anesthesia has led to the development of fascial plane blocks. Serratus anterior plan (SAP) block, pectoserratus plan (PECS II) block, and erector spina plan (ESP) block are frequently used for postoperative analgesia in patients undergoing breast surgery. he aim of this study was to evaluate the efficacy of serratus anterior plane (SAP) block, pectoserratus plane (PECS II) block, and erector spinae plane (ESP) block on postoperative acute pain, quality of recovery and chronic pain in breast cancer surgery patients. ### Conditions Module **Conditions:** - Breast Cancer **Keywords:** - regional anesthesia - postoperative pain - recovery quality - chronic pain - breast cancer ### Design Module #### Design Info **Observational Model:** CASE_ONLY **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 96 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Before the surgery, US-guided SAP block will be performed **Intervention Names:** - Other: SAP block group **Label:** SAP block group #### Arm Group 2 **Description:** Before the surgery, US-guided PECS II block will be performed **Intervention Names:** - Other: PECS II block group **Label:** PECS II block group #### Arm Group 3 **Description:** Before the surgery, US-guided ESP blockwill be performed **Intervention Names:** - Other: ESP block group **Label:** ESP block group #### Arm Group 4 **Description:** No intervention **Intervention Names:** - Other: Control group **Label:** Control group ### Interventions #### Intervention 1 **Arm Group Labels:** - SAP block group **Description:** US-guided SAP block is performed approximately 30 minutes before the surgery in patients undergoing breast cancer surgery in a separate regional anesthesia room with standard anesthesia monitoring. **Name:** SAP block group **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - PECS II block group **Description:** US-guided PECS II block is performed approximately 30 minutes before the surgery in patients undergoing breast cancer surgery in a separate regional anesthesia room with standard anesthesia monitoring. **Name:** PECS II block group **Type:** OTHER #### Intervention 3 **Arm Group Labels:** - ESP block group **Description:** US-guided ESP block is performed approximately 30 minutes before the surgery in patients undergoing breast cancer surgery in a separate regional anesthesia room with standard anesthesia monitoring. **Name:** ESP block group **Type:** OTHER #### Intervention 4 **Arm Group Labels:** - Control group **Description:** No intervention **Name:** Control group **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** All patients will receive a standard patient controlled analgesia (PCA) protocol. The postoperative opioid consumption will only be recorded. **Measure:** postoperative opioid consumption **Time Frame:** 24 hours #### Secondary Outcomes **Description:** The Quality of Recovery-15 (QoR-15) is a 15-question questionnaire validated to assess poetoperative recovery. This questionnaire assesses patients' pain, physical comfort, physical independence, psychological support, and emotional status in the erly postoperative period. The patient is asked to express their status scoring from 0 to 10; therefore, the total score ranges from 0 to 150 points. **Measure:** recovery quality **Time Frame:** 5 minutes **Description:** Patients will be telephoned 3 months after the operation and the presence, localization, and intensity of the pain, its character, and its relation with rest and/or activity will be recorded by asking only verbally. **Measure:** chronic pain **Time Frame:** 3 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * elective breast surgery (modified radical mastectomy, breast conserving surgery, simple mastectomy, axillary lymph node dissection, etc.), * 18 to 65 years old, * American Society of Anaesthesiology (ASA) score I-III * body mass index (BMI) \<32 kg/m2 Exclusion Criteria: * contraindications to the block applications * history of mental or neurological disorders * history of chronic opioid use * chronic alcoholism * substance use * treatment of chronic pain * severe liver and kidney disease * uncooperative patients * patients scheduled for bilateral mastectomy **Gender Based:** True **Gender Description:** The patients scheduled for elective breast surgery (modified radical mastectomy, breast conserving surgery, simple mastectomy, axillary lymph node dissection, etc.) **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** It is planned to include ASA I-III patients between the ages of 18-65 who are planned to undergo breast cancer surgery ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Arzu Karaveli, M.D. **Phone:** +905325611300 **Role:** CONTACT #### Locations **Location 1:** **City:** Antalya **Contacts:** ***Contact 1:*** - **Name:** Antalya Training and Research Hospital - **Role:** CONTACT **Country:** Turkey **Facility:** University of Health Sciences, Antalya Training and Researh Hospital **State:** Muratpaşa **Status:** RECRUITING #### Overall Officials **Official 1:** **Affiliation:** University of Health Sciences, Antalya Training and Researh Hospital **Name:** Hafizenur O Atalay, M.D. **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** University of Health Sciences, Antalya Training and Researh Hospital **Name:** Arzu O Karaveli, M.D. **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Wang S, Shi J, Dai Y, Zhang J, Liu Q, Yang P, Zhu N. The effect of different nerve block strategies on the quality of post-operative recovery in breast cancer patients: A randomized controlled study. Eur J Pain. 2024 Jan;28(1):166-173. doi: 10.1002/ejp.2178. Epub 2023 Sep 1. **PMID:** 37655864 **Citation:** Fujii T, Shibata Y, Akane A, Aoki W, Sekiguchi A, Takahashi K, Matsui S, Nishiwaki K. A randomised controlled trial of pectoral nerve-2 (PECS 2) block vs. serratus plane block for chronic pain after mastectomy. Anaesthesia. 2019 Dec;74(12):1558-1562. doi: 10.1111/anae.14856. Epub 2019 Sep 19. **PMID:** 31535722 ## 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: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC17 - Name: Skin and Connective Tissue Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M13069 - Name: Pain, Postoperative - Relevance: LOW - As Found: Unknown - ID: M5220 - Name: Breast Neoplasms - Relevance: HIGH - As Found: Breast Cancer - ID: M29442 - Name: Chronic Pain - Relevance: LOW - As Found: Unknown - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M29453 - Name: Mastodynia - Relevance: LOW - As Found: Unknown - ID: M5218 - Name: Breast Diseases - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001943 - Term: Breast Neoplasms ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Analg - Name: Analgesics ### Intervention Browse Module - Browse Leaves - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M4033 - Name: Analgesics, Opioid - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419491 **Acronym:** NotiVIH **Brief Title:** Assisted Notification of Partners of Men Having Sex With Men Discovering Their Seropositivity **Official Title:** Assisted Notification of Partners of Men Having Sex With Men Discovering Their Seropositivity #### Organization Study ID Info **ID:** ANRS95048 #### Organization **Class:** OTHER_GOV **Full Name:** ANRS, Emerging Infectious Diseases ### Status Module #### Completion Date **Date:** 2026-05-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-22 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-05-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER_GOV **Name:** ANRS, Emerging Infectious Diseases #### 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 context of HIV has changed dramatically this last two decades with the availability of highly active and well tolerated antiretroviral therapies, and the extension of prevention methods to include treatment as prevention of onward transmissions. It is time to test and treat as many HIV infected people as possible. HIV testing that target people known to have been exposed to HIV is an interesting option to explore to curb the spread of the epidemic. Notifying HIV exposed sexual partner for them to get an HIV test and treatment contribute to reduce HIV transmissions. The partner notification (PN) gives the opportunity to HIV positive partners to access to care and negative partners, access to prevention services. Several tools have been developed worldwide, in particular in the United Kingdom and the US, to help HIV or index patients to notify their sexual partner or needle-sharing people. This approach is new in France and PN intervention has to be assessed. The present study aimed to assess the effectiveness of a digital PN tool or a counselling interview to help men having sex with men (MSM) newly diagnosed for HIV to notify their exposed partners. The study also aimed to evaluate the acceptability of these PN intervention in index patients and their notified partners in the French context. To meet the objectives, an interventional study was developed in index patients (described above) coupled with : * an observational study in notified partners to assess their PN acceptability and their HIV testing uptake after being notified * a qualitative study in a sample of index patients and notified partner to assess more in depth their PN acceptability. Expected results and perspectives Feasible and effective, assisted PN services may complete HIV testing offer (and by extension sexually transmitted infections screening) as well as the prevention offer Pre-Exposure Prophylaxis (PrEP) for MSM. The study will provide information enabling the best practice guides. In a next step, PN interventions adapted to other key populations will be studied. **Detailed Description:** Interventional study (supplementary information) This is a cluster-randomised interventional study that will compare two interventional arms: * The provision of a partner notification (PN) digital tool allowing the sending of anonymous or personalised standardised text messages to partners (Tool arm). * In addition to the provision of the PN digital tool, a PN approach assisted by a counsellor during a specific counselling interview and the option for the index patient to entrust the notification of some of their partners to the counsellor (Tool + Counselling arm). Notification of partners by the counsellor should be anonymous and reserved for partners for whom the risk of re-identification of the index case is very low. Randomisation of the centres 1:1. The PN intervention will be offered to index patients at the time of HIV diagnosis or antiretroviral treatment initiation. They will have the option to use the available tools and to notify all or some of their partners. Data on participant profile, PN assessment, acceptability, and consequences are collected by online self-administered questionnaires on a secure website. The one on participants' profile is available at enrollment and the another that collect the PN experience, one month later. The participant is invited by email to connect on the website and fill in the questionnaires. The calculation of the number of index patients was based on the main outcome: increase the number of notified partners. Considering a difference between the two arms of 34%, statistical power of 80%, risk of 5% and intra-cluster coefficient correlation of 0,03 with one-way test, 1104 exposed partners have to be stated in each arm. In median, MSM had 7 sexual partners within the 6 months before HIV diagnosis, ie. 157 index patients per arm. This number was rounded to 200 index patients per arm to take into account uncertainty about de the correlation coefficient and enable analysis adjusted for 6 confusion factors. Observational study in notified partners The PN message, delivered either through the digital tool or paper cards, informs the partners about their HIV/sexually transmitted infection (STI) exposure and invites them to get tested. It also contains a link to a website with information on PN, HIV testing and an invitation to participate in this study as a notified partner. The objectives of this part are to: * assess the HIV testing uptake after notification * estimate the HIV positivity rate among notified partners * describe the PN experience * evaluate the acceptability of notified partners, whatever they get or not HIV testing Notified partner register themselves on the study website. Like index patients, data on participant profile, PN acceptability, HIV testing and according to the test result, the linkage to care or to Pre-Exposure Prophylaxis (PrEP) are collected by online self-administered questionnaires on a secure website. The one on participants' profile is available at enrollment and the another that collect the PN experience and HIV testing, one month later. The participant is invited by email to connect on the website and fill in the questionnaires. Qualitative study A qualitative study based on individual interviews will be conducted with a sample of participants (index patients and notified partners) to assess more in depth the acceptability of HIV PN, identify the barriers and levers of PN, as well as the components of intervention in the PN process that need to be adapt. Around 30 interviews will be conducted according to the principle of data saturation. ### Conditions Module **Conditions:** - HIV Infections **Keywords:** - HIV - Partner notification tools ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 400 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** A partner notification digital tool allowing the sending of anonymous or personalised standardised text messages to partners and an information leaflet are provided to index patients **Label:** Digital notification tool **Type:** NO_INTERVENTION #### Arm Group 2 **Description:** In addition to the provision of the partner notification digital tool and the leaflet, a partner notification approach assisted by a trained counsellor during a specific counselling interview is offered to index patient. **Intervention Names:** - Other: Partner notification by a trained counsellor **Label:** Digital notification tool and counseling **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Digital notification tool and counseling **Description:** One (or more if needed) interview with a partner notification trained counsellor is offered to index patients. During the interview, the counsellor gives information on partner notification, helps the index patients to remember their partners, to assess their HIV/sexually transmitted infection exposure and explains options to notify them. During the interview, the index patient can choose to entrust the notification of some of their partners to the counsellor. However, according to French law, provider referral is permitted only when it is anonymous. Therefore, this option is reserved to partners with a lot of partners in order to limit the risk of identifying the index patient **Name:** Partner notification by a trained counsellor **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** An emailed invitation to complete an online self-administered questionnaire will be send to index patients to carry out an assessment of the notification process (number of partners exposed, contacted, notified, etc). Up to 3 reminders will be sent if no response. **Measure:** The percentage of partners notified one month after the intervention, among the number of exposed partners stated by index patients **Time Frame:** One month after the intervention #### Secondary Outcomes **Description:** Percentage of index patients who notified at least one exposed partner **Measure:** Percentage of acceptability of partner notification by index patients **Time Frame:** One month after the intervention **Description:** Percentage of index patients who reported violence, social harm, feeling left out from sexual partners. **Measure:** Percentage of adverse events of partner notification reported by index patients **Time Frame:** One month after the intervention ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * men * aged ≥18 * having sex with ≥2 men in the last 12 months * diagnosed for HIV since ≤3 months at the time of inclusion Exclusion criteria: * Persons who do not provide an email address, needed to receive the study questionnaires * Persons who do not speak or read French * Persons subject to a legal protection measure (guardianship, safeguard of justice) **Minimum Age:** 18 Years **Sex:** MALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** 01 40 25 78 03 Ghosn, MD PhD **Phone:** 01 40 25 78 03 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Karen Champenois, PhD **Phone:** 01 40 25 78 03 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** AP-HP Hôpital Bichat Claude-Bernard, Paris, France **Name:** Jade Ghosn, MD PhD **Role:** STUDY_DIRECTOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000086982 - Term: Blood-Borne Infections - ID: D000003141 - Term: Communicable Diseases - ID: D000007239 - Term: Infections - ID: D000015229 - Term: Sexually Transmitted Diseases, Viral - ID: D000012749 - Term: Sexually Transmitted Diseases - ID: D000016180 - Term: Lentivirus Infections - ID: D000012192 - Term: Retroviridae Infections - ID: D000012327 - Term: RNA Virus Infections - ID: D000014777 - Term: Virus Diseases - ID: D000091662 - Term: Genital Diseases - ID: D000091642 - Term: Urogenital Diseases - ID: D000007153 - Term: Immunologic Deficiency Syndromes - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: BC20 - Name: Immune System Diseases ### Condition Browse Module - Browse Leaves - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M3522 - Name: Acquired Immunodeficiency Syndrome - Relevance: LOW - As Found: Unknown - ID: M18250 - Name: HIV Infections - Relevance: HIGH - As Found: HIV Infections - ID: M2593 - Name: Blood-Borne Infections - Relevance: LOW - As Found: Unknown - ID: M15558 - Name: Sexually Transmitted Diseases - Relevance: LOW - As Found: Unknown - ID: M17933 - Name: Sexually Transmitted Diseases, Viral - Relevance: LOW - As Found: Unknown - ID: M18640 - Name: Lentivirus Infections - Relevance: LOW - As Found: Unknown - ID: M15026 - Name: Retroviridae Infections - Relevance: LOW - As Found: Unknown - ID: M17522 - Name: Virus Diseases - Relevance: LOW - As Found: Unknown - ID: M15149 - Name: RNA Virus Infections - Relevance: LOW - As Found: Unknown - ID: M2876 - Name: Genital Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M10199 - Name: Immunologic Deficiency Syndromes - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000015658 - Term: HIV Infections ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419478 **Acronym:** PSC-LCNA **Brief Title:** Postoperative Symptoms in Chinese Liver Cancer Patients: Network Analysis **Official Title:** Exploring Early Postoperative Core Symptoms in Chinese Patients With Primary Liver Cancer: a Cross-sectional and Longitudinal Network Analysis #### Organization Study ID Info **ID:** 83242306 #### Organization **Class:** OTHER **Full Name:** Anhui Medical University #### Secondary ID Infos **Domain:** the Natural Science Foundation of Anhui Provincial **ID:** 2023AH050604 **Type:** OTHER_GRANT ### Status Module #### Completion Date **Date:** 2022-09-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** TERMINATED #### Primary Completion Date **Date:** 2022-08-31 **Type:** ACTUAL #### Start Date **Date:** 2021-03-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-14 **Why Stopped:** The study stopped because recruitment goals were met ahead of schedule. ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Anhui Medical University #### Lead Sponsor **Class:** OTHER **Name:** Mengmeng Yuan #### Responsible Party **Investigator Affiliation:** Anhui Medical University **Investigator Full Name:** Mengmeng Yuan **Investigator Title:** Research Assistant **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Patients with primary liver cancer (PLC) experience a range of symptoms in the early postoperative period. Symptoms include cancer-related symptoms and adverse effects of treatment. Exploring the core symptoms and their dynamics in the early post-hepatectomy patients may help provide better symptom management programs. The purpose of this study was to identify the core symptoms in early post-hepatectomy patients and to explore the trajectory of their dynamics. During the period from March 2021 to September 2022, a total of 281 patients diagnosed with PLC and undergoing radical curative surgery were recruited from the hepatobiliary surgery departments of two hospitals in Eastern China, among whom 249 individuals (88.60%) agreed to participate in the study. A comprehensive symptom assessment was administered to the patients 1-2 days after surgery (T1) and 1-2 days before discharge (T2). Network analysis was used to identify core symptoms in early post-hepatectomy patients based on symptom severity. ### Conditions Module **Conditions:** - Patients With Primary Liver Cancer (PLC) Undergoing Curative Surgical Procedures - Importance of Identifying Core Symptoms for Improving Symptom Management in PLC Patients - Application of Network Analysis as a Crucial Component of Cancer Care **Keywords:** - Cancer Liver - Hepatectomy - Network analysis - Symptom burden ### Design Module #### Design Info **Observational Model:** OTHER **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 249 **Type:** ACTUAL **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Investigation of postoperative symptoms in eligible patients undergoing liver resection at two time points **Intervention Names:** - Other: postoperative symptoms **Label:** postoperative symptoms ### Interventions #### Intervention 1 **Arm Group Labels:** - postoperative symptoms **Description:** Observational study, focusing solely on symptom surveys of patients. **Name:** postoperative symptoms **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The MD Anderson Symptom Inventory (MDASI) is one of the most widely used symptom assessment tools for cancer patients in clinical and research settings and is used to evaluate the severity of symptoms and their impact on daily life. It consists of 13 core symptom items and 6 symptom interference items. The severity of each symptom is rated on an 11-point Likert scale (0 = "not at all" and 10 = "as bad as you can imagine"). The MDASI-C, a Chinese version translated in 2004 by Wang et al., has good reliability, with a Cronbach's alpha of 0.82-0.94. **Measure:** MD Anderson Symptom Inventory **Time Frame:** 1-2 days after surgery (T1) and 1-2 days before discharge (T2). #### Secondary Outcomes **Description:** The Symptom Module Specific for Primary Liver Cancer (TSM-PLC) can serve as an important supplement to the MDASI, providing instrumental security for the systematic assessment of symptoms in patients PLC. It consists of six symptom items: abdominal distension, diarrhea, loss of weight, jaundice, pruritus, and fever. The six items were rated in the same format as the first part of the MDASI. The TSM-PLC has good reliability (Cronbach's alpha of 0.835 for internal consistency and content validity of 0.91). **Measure:** Symptom Module Specific for Primary Liver Cancer **Time Frame:** 1-2 days after surgery (T1) and 1-2 days before discharge (T2). ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Eligible patients were ≥18 years of age; had a diagnosis of primary liver cancer based on pathologic examination; were receiving the first hepatectomy; were conscious, spoke Chinese, and had basic communication skills. Exclusion Criteria: * Exclusion criteria include concurrent malignant tumors, mental disorders, or consciousness impairments, as well as participation in other clinical interventions. **Maximum Age:** 90 Years **Minimum Age:** 40 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Participants with PLC who underwent curative surgical procedures between March 2021 and September 2022 at the Hepatobiliary Surgery Departments of two Eastern Chinese hospitals. ### Contacts Locations Module #### Locations **Location 1:** **City:** Hefei **Country:** China **Facility:** Anhui Medical University **State:** Anhui **Zip:** 234000 #### Overall Officials **Official 1:** **Affiliation:** Anhui Medical University **Name:** shuwen M Li, PhD **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **Description:** We do not plan to share individual participant data (Share IPD) to protect participant privacy. However, individuals who support the findings of this study may contact the study's principal investigator directly to request data. **IPD Sharing:** NO ### References Module #### References **Citation:** Zhu Z, Hu Y, Xing W, Guo M, Zhao R, Han S, Wu B. Identifying Symptom Clusters Among People Living With HIV on Antiretroviral Therapy in China: A Network Analysis. J Pain Symptom Manage. 2019 Mar;57(3):617-626. doi: 10.1016/j.jpainsymman.2018.11.011. Epub 2018 Nov 20. **PMID:** 30465875 **Citation:** Wang XS, Wang Y, Guo H, Mendoza TR, Hao XS, Cleeland CS. Chinese version of the M. D. Anderson Symptom Inventory: validation and application of symptom measurement in cancer patients. Cancer. 2004 Oct 15;101(8):1890-901. doi: 10.1002/cncr.20448. **PMID:** 15386315 **Citation:** Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. **PMID:** 33538338 **Citation:** Devarbhavi H, Asrani SK, Arab JP, Nartey YA, Pose E, Kamath PS. Global burden of liver disease: 2023 update. J Hepatol. 2023 Aug;79(2):516-537. doi: 10.1016/j.jhep.2023.03.017. Epub 2023 Mar 27. **PMID:** 36990226 **Citation:** Zou H, Li M, Lei Q, Luo Z, Xue Y, Yao D, Lai Y, Ung COL, Hu H. Economic Burden and Quality of Life of Hepatocellular Carcinoma in Greater China: A Systematic Review. Front Public Health. 2022 Apr 21;10:801981. doi: 10.3389/fpubh.2022.801981. eCollection 2022. **PMID:** 35530735 **Citation:** Liu D, Song T. Changes in and challenges regarding the surgical treatment of hepatocellular carcinoma in China. Biosci Trends. 2021 Jul 6;15(3):142-147. doi: 10.5582/bst.2021.01083. Epub 2021 Mar 14. **PMID:** 33716267 **Citation:** Drott J, Bjornsson B, Sandstrom P, Bertero C. Experiences of Symptoms and Impact on Daily Life and Health in Hepatocellular Carcinoma Patients: A Meta-synthesis of Qualitative Research. Cancer Nurs. 2022 Nov-Dec 01;45(6):430-437. doi: 10.1097/NCC.0000000000001044. Epub 2022 Jan 13. **PMID:** 35025775 **Citation:** Ellis J, Brearley SG, Craven O, Molassiotis A. Understanding the symptom experience of patients with gastrointestinal cancers in the first year following diagnosis: findings from a qualitative longitudinal study. J Gastrointest Cancer. 2013 Mar;44(1):60-7. doi: 10.1007/s12029-012-9443-9. **PMID:** 23054580 **Citation:** Ryu E, Kim K, Cho MS, Kwon IG, Kim HS, Fu MR. Symptom clusters and quality of life in Korean patients with hepatocellular carcinoma. Cancer Nurs. 2010 Jan-Feb;33(1):3-10. doi: 10.1097/NCC.0b013e3181b4367e. **PMID:** 19926981 **Citation:** Patel N, Maher J, Lie X, Gwaltney C, Barzi A, Karwal M, Macarulla T, Sun HC, Trojan J, Meyers O, Workman C, Morgan S, Negro A, Cohen G. Understanding the patient experience in hepatocellular carcinoma: a qualitative patient interview study. Qual Life Res. 2022 Feb;31(2):473-485. doi: 10.1007/s11136-021-02903-4. Epub 2021 Jun 11. **PMID:** 34115280 **Citation:** Zhu Z, Sun Y, Kuang Y, Yuan X, Gu H, Zhu J, Xing W. Contemporaneous symptom networks of multidimensional symptom experiences in cancer survivors: A network analysis. Cancer Med. 2023 Jan;12(1):663-673. doi: 10.1002/cam4.4904. Epub 2022 Jun 1. **PMID:** 35651298 **Citation:** Cha EJ, Hong S, Park DH, Ryu SH, Ha JH, Jeon HJ. A network analysis of panic symptoms in relation to depression and anxiety sensitivity in patients with panic disorder. J Affect Disord. 2022 Jul 1;308:134-140. doi: 10.1016/j.jad.2022.04.062. Epub 2022 Apr 13. **PMID:** 35429524 **Citation:** Zeng L, Huang H, Liu Y, Ruan C, Fan S, Xia Y, Zhou J. The core symptom in multiple myeloma patients undergoing chemotherapy: a network analysis. Support Care Cancer. 2023 Apr 25;31(5):297. doi: 10.1007/s00520-023-07759-7. **PMID:** 37097532 **Citation:** Bai W, Cai H, Wu S, Zhang L, Feng KX, Li YC, Liu HZ, Du X, Zeng ZT, Lu CM, Mi WF, Zhang L, Ding YH, Yang JJ, Jackson T, Cheung T, An FR, Xiang YT. Internet addiction and its association with quality of life in patients with major depressive disorder: a network perspective. Transl Psychiatry. 2022 Apr 4;12(1):138. doi: 10.1038/s41398-022-01893-2. **PMID:** 35379778 **Citation:** Cleeland CS, Mendoza TR, Wang XS, Chou C, Harle MT, Morrissey M, Engstrom MC. Assessing symptom distress in cancer patients: the M.D. Anderson Symptom Inventory. Cancer. 2000 Oct 1;89(7):1634-46. doi: 10.1002/1097-0142(20001001)89:73.0.co;2-v. **PMID:** 11013380 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000004066 - Term: Digestive System Diseases - ID: D000008107 - Term: Liver Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M11113 - Name: Liver Neoplasms - Relevance: HIGH - As Found: Liver Cancer - ID: M8886 - Name: Gastrointestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7256 - Name: Digestive System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M11107 - Name: Liver Diseases - Relevance: LOW - As Found: Unknown - ID: T4700 - Name: Primary Liver Cancer - Relevance: HIGH - As Found: Primary liver cancer - ID: T4202 - Name: Oculocerebral Syndrome With Hypopigmentation - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000008113 - Term: Liver Neoplasms ### Intervention Browse Module - Browse Branches - Abbrev: Hemat - Name: Hematinics - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M11110 - Name: Liver Extracts - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419465 **Brief Title:** The Effect of Health Protection and Promotion Training Programs on the Health Behavior of Older People **Official Title:** Comparison of the Effects of Peer and Nurse Led Health Protection and Promotion Training Programs Based on Social Cognitive Theory on the Health Behaviors of Older People #### Organization Study ID Info **ID:** 0286 #### Organization **Class:** OTHER **Full Name:** Akdeniz University ### Status Module #### Completion Date **Date:** 2025-08-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-01-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-11-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Akdeniz University #### Responsible Party **Investigator Affiliation:** Akdeniz University **Investigator Full Name:** Merve SIKLAROGLU **Investigator Title:** Research Assistant Merve SIKLAROGLU **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Protecting and improving health is an important intervention in preventing diseases, controlling chronic diseases and delaying their progression. Therefore, appropriate health promotion programs specific to elderly individuals need to be developed. Educational intervention is known to be effective in achieving behavioral change. This study differs from previous studies in that both peer (Intervention-1) and nurse-led (Intervention-2)-led education programs are planned as interventions. This research was designed as a mixed method study to compare the effects of Peer and Nurse Led Health Protection and Promotion Training Programs Based on Social Cognitive Theory (SCT) on the health behaviors of older people. The research will be carried out in two stages. The first phase was planned as a parallel two-arm non-randomized experimental study. This phase is planned to be carried out between November 2024 and January 2025 in two separate elderly homes in Muratpasa district of Antalya province, where older people are concentrated. The sample size was calculated as 108 older people (Intervention-1: 54, Intervention-2: 54). Intervention will be implemented for 12 weeks with the Health Protection and Promotion Training Program Based on SCT under peer leadership in the Intervention-1 group, and the same interventions will be carried out in the Intervention-2 group under the leadership of a nurse. Primary results of the research; health protection and promotion behavior practice, health promotion behavior practice level, self-efficacy belief and health seeking behavior. Secondary measurement results are; It is an assessment of blood pressure, blood sugar, body mass index and cardiovascular disease risk. Results will be measured before and 12 weeks after the intervention with the Health Protection and Promotion Behavior Checklist, Elderly Health Promotion Scale, General Self-Efficacy Scale, and Health Seeking Behavior Scale. In the second stage, it was planned to conduct two qualitative phenomenological design studies. In the first qualitative study, the investigators aimed to deeply understand the views of older people who received peer leader intervention and nurse intervention; In the second qualitative study, it was aimed to understand in depth the experiences of the older people as peer leaders in the health protection and promotion training program based on SCT. In the qualitative phase, the data will be based on the maximum diversity sampling method and will be collected through face-to-face in-depth individual interviews in the workshops of both elderly homes with Semi-Structured Interview Forms in February 2025. ### Conditions Module **Conditions:** - Older People - Health Promotion **Keywords:** - social cognitive theory - peer education - public health nursing - education - older people ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 108 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Behavioral: Peer-Led Health Protection and Promotion Training Program **Label:** Peer-Led Health Protection and Promotion Training Program **Type:** EXPERIMENTAL #### Arm Group 2 **Intervention Names:** - Behavioral: Health Protection and Promotion Training Program under the Leadership of a Public Health Nurse **Label:** Health Protection and Promotion Training Program under the Leadership of a Public Health Nurse **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Peer-Led Health Protection and Promotion Training Program **Description:** Multiple teaching methods will be used throughout 12 weeks; interactive group trainings on health protection and promotion issues and health seeking behavior methods, demonstration and demonstration using Google Fit and E-Nabiz mobile applications and downloading the applications to their phones, establishing WhatsApp groups to interact with peers, encouraging physical activity using the Google Fit mobile application. In order to provide social interaction, walking with peer leaders, health protection and development issues, receiving questions and opinions and giving guidance by individual phone calls regarding E-Nabiz and Google Fit mobile applications, holding peer group meetings and any of the Health Protection and Development Training Program targets. It consists of interventions such as giving a success badge for the relevant behavior if it reaches someone. Individual phone calls are also included in the intervention program. **Name:** Peer-Led Health Protection and Promotion Training Program **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Health Protection and Promotion Training Program under the Leadership of a Public Health Nurse **Description:** Multiple teaching methods will be used throughout 12 weeks; interactive group trainings on health protection and promotion issues and health seeking behavior methods, demonstration and demonstration using Google Fit and E-Nabiz mobile applications and downloading the applications to their phones, establishing WhatsApp groups to interact with nurses, encouraging physical activity using the Google Fit mobile application. To achieve any of the Health Protection and Development Training Program targets by walking with the nurse, taking individual phone calls regarding health protection and promotion issues, E-Nabiz and Google Fit mobile applications, receiving questions and opinions and giving guidance, holding group meetings in order to provide social interaction and social interaction. It consists of interventions such as giving a success badge for the relevant behavior. Individual phone calls are also included in the intervention program. **Name:** Health Protection and Promotion Training Program under the Leadership of a Public Health Nurse **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** This form was prepared by researchers in line with the relevant literature in order to evaluate the health protection and promotion behaviors of individuals aged 65 and over and their use of E-Nabiz and Google Fit mobile applications. Health Protection and Promotion Behavior Checklist consists of three parts. The answers to this form will be evaluated as "Yes: 1 point", "No: 0 points". This form consists of low (for women: 0-14 points; for men: 0-13 points), medium (for women: 15-28 points; for men: 14-26 points) and high (for women: 29-42 points; For men: 27-40 points). **Measure:** Health Protection and Promotion Behavior Checklist **Time Frame:** Change in performing health protection and promotion behaviors and using E-Nabiz and Google Fit mobile applications at the twelfth week from baseline **Description:** It was developed to evaluate health-promoting behaviors in elderly individuals aged 65 and over and consists of 22 items and 6 subscales. On a four-point Likert-type scale, the elderly individual's responses to health promotion behavior implementation behaviors are; never (1 point), sometimes (2 points), often (3 points), always (4 points). Scores between 22 and 88 are obtained from the scale. Evaluation of the scale is done by summing the scores obtained from the questions belonging to each sub-dimension. A high score is interpreted as an increase in the frequency of the individual applying health-promoting behaviors belonging to the relevant sub-dimension. **Measure:** Elderly Health Promotion Scale **Time Frame:** Change in the assessment of health promotion behaviors at the twelfth week from baseline **Description:** It was developed as 20 items to measure general self-efficacy and was revised by the same researchers in 1981, reducing the number of items to 10. The scale was prepared as a four-point Likert type, limited by completely false and completely true points. All items in the scale are scored positively, with a total score between 10 and 40. A high score means that general self-efficacy is high. **Measure:** General Self-Efficacy Scale **Time Frame:** Change in general self-efficacy level at the twelfth week from baseline **Description:** It consists of 12 items and 3 factors indicating health-seeking behavior. Health Search Behavior Scale covers online search behavior, professional search behavior and traditional search behavior factors. On a five-point Likert-type scale; The options are "1=I strongly disagree", "2=I disagree", "3=I am undecided", "4=I agree", "5=I strongly agree". The closer the averages obtained from the scale are to 5, the higher the health-seeking behavior, and the closer they are to 1, the lower the health-seeking behavior. **Measure:** Health Seeking Behavior Scale **Time Frame:** Change in health-seeking behavior at the twelfth week from baseline #### Secondary Outcomes **Description:** Health Evaluation Form; It consists of 27 questions that question blood pressure, blood sugar, body mass index (BMI) measurements and cardiovascular disease risk (CVD) assessment. The reason for making these measurements and evaluations in the Health Evaluation Form is the high incidence of hypertension, diabetes, obesity and CVD in the world and in Turkey, and these screenings are recommended for individuals aged 65 and over in the Guide to Periodic Examinations and Screening Tests Recommended in Family Medicine Practice. and active health screenings in the Disease Management Platform used in primary healthcare services. **Measure:** Health Assessment Form **Time Frame:** Change in the assessment of health at the twelfth week from baseline ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Low (for women: 0-4 points; for men: 0-3 points) or moderate (for women: 5-8 points; for men: 4-6 points) from the first part of the Health Protection and Promotion Behavior Checklist. Individuals aged 65 and over who score, * Those who come to the elderly home where the research will be conducted at least once a week, * Those residing in Antalya province, * Those who have and can use a smartphone, * Those who can speak and understand Turkish, * Those who do not have dementia according to the Mini Mental State Assessment Test Short Form (those who score 9 points and above), * Those who are independent according to the Katz Activities of Daily Living Scale (those who score 3 points and above), * Those who agreed to participate in the study voluntarily, * One elderly person from the same household will be included in this study. Exclusion Criteria: • Those who have previously received training on health protection will not be included in the research. **Healthy Volunteers:** True **Minimum Age:** 65 Years **Sex:** ALL **Standard Ages:** - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Merve SIKLAROGLU, Research Assistant **Phone:** +90-532-176-1440 **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419452 **Brief Title:** Effects of Unilateral, Bilateral and Combined Resistance Training on the Speed and Accuracy of the Serve in Youth Tennis Players **Official Title:** Effects of Unilateral, Bilateral and Combined Resistance Training on the Speed and Accuracy of the Serve in Youth Tennis Players #### Organization Study ID Info **ID:** MXudong #### Organization **Class:** OTHER **Full Name:** Universiti Putra Malaysia ### Status Module #### Completion Date **Date:** 2024-07-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** ENROLLING_BY_INVITATION #### Primary Completion Date **Date:** 2024-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-10 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-09 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Universiti Putra Malaysia #### Responsible Party **Investigator Affiliation:** Universiti Putra Malaysia **Investigator Full Name:** Ma Xudong **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study is to explore the effects of unilateral, bilateral and combined resistance training on the serve speed and accuracy of amateur youth tennis players in China. The subjects were young male tennis players aged 16-20 years from four universities in Gansu Province. The experiment was divided into control group (CG), experiment group 1 (EG1-unilateral group), experiment group 2 (EG2-bilateral group) and experiment group 3 (EG3-combined group). Used to compare the effects of different forms of resistance training on serve speed and accuracy. Previous studies have shown that unilateral and bilateral resistance training can effectively improve strength, power, and speed in athletes (Speirs, et al., 2016; Davo, Jimenez, \& Solana,. , 2018), there is still controversy when comparing the advantages and disadvantages of two forms of resistance training (Ramirez-Campillo et al., 2015; Donab and Wall. The results of this study will be expected to be updated in 2022. Unilateral resistance training, bilateral resistance training, and combined unilateral and bilateral resistance training were used as intervention models in this study. Based on the literature review, the training frequency of this experiment was arranged as 2 times/week, and the total training time was 6 weeks, with a fixed duration of each training session. Each training session lasted a maximum of 60 minutes. In this experiment, the interval between the two weekly training sessions was at least 24 h to prevent subjects from being in a fatigued state in the relevant muscle groups of the body and affecting the experimental level. **Detailed Description:** backgrounds Originally known as lawn tennis, tennis originated in France and became official in England. There is evidence that people participating in tennis can provide numerous health benefits. Secondly, tennis is a sport with anaerobic metabolism, supplemented by high-intensity aerobic metabolism, which means that tennis has a great demand for speed, strength and other physical qualities. However, in recent years, China's athletes have been in debt for a long time, resulting in weak basic qualities and lack of special ability, which restricts the development of China's athletes. In order to achieve good sports performance, the training method is very important. In the case of adolescents, where strength is gradually declining, evidence suggests that the implementation of scientific resistance training under perfect supervision can help the development of physical fitness and athletic performance. Secondly, resistance training is mostly focused bilaterally, and the advantage of unilateral resistance training is that it is superior to the BLD effect to improve strength than bilateral training. Evidence suggests that isometric strength gains after unilateral resistance training are almost twice as high as those after bilateral resistance training. Problem statement Strength levels in today's youth are declining, and evidence suggests that traditional training in youth focuses on bilateral and ignores movement patterns and focuses on single joints, resulting in low stroke power and poor speed in youth tennis players. Existing tennis training has focused on bilateral resistance training or tennis-specific technique training, but the results have not been significant. Tennis serve is very important, and it is the key to win in tennis matches. Evidence shows that muscle strength and explosive power are significantly related to tennis serve. Therefore, it is important to focus on the effects of different resistance training on tennis serve. Secondly, unilateral training is in line with the sport-specific characteristics and compound resistance training is significant for strength as well as explosive power, so these two training modalities are crucial for tennis. To summarize the problem statement of this study, there are three main problem statements, firstly, the importance of serve technique in tennis program, secondly, unilateral training is in line with the specific characteristics of unilateral movement of tennis serve, and thirdly, the importance of combined resistance training in tennis. Proposed solution Different forms of resistance training will provide different benefits to the athlete, and the sport of tennis is consistent with unilateral movement, in order to achieve better athletic performance as well as skill performance. The researcher will perform the following manipulation. Provide different forms of resistance training (unilateral, bilateral, and combined) and observe the changes in the athletic performance of tennis players in terms of strength, explosiveness, flexibility, and coordination. Provide different forms of resistance training (unilateral, bilateral, and combined) and observe the changes in the tennis players' serve speed and serve accuracy Literature review This chapter provides detailed information on the relevant literature and contributes to a comprehensive understanding of the following areas: (1) tennis serve characteristics, (2) youth resistance training safety, (3) resistance training programmes and guidelines, (4) youth resistance training and sports performance, (5 ) physical demands of the tennis serve, (6) the importance of unilateral resistance training, (7) the BLD effect of bilateral resistance training, and (8) the validity of combined resistance training. The literature review is concluded with a summary of the literature review. The work of this study and the outlook In the available studies, gains from unilateral resistance training and bilateral resistance training appear to produce relatively contradictory results.According to the principle of specificity of training, the structure pattern of training should imitate motor technique structure as much as possible. For example, tennis serving, soccer shooting, badminton spiking and other sports that are presented in the form of unilateral should be intervened by unilateral resistance training.However, bilateral resistance training programmes are widely used in existing studies.Therefore, the aim of this study was to investigate the effect of unilateral and bilateral resistance training on tennis serve performance of a unilateral nature.In addition, the benefits of unilateral and bilateral resistance training in exercise performance such as strength, speed, and explosive power are also different. Studies have shown that unilateral resistance training is more beneficial for exercise performance in the unilateral exercise mode, and bilateral resistance training is more beneficial for exercise performance in the bilateral exercise mode.Some studies, however, have yielded conflicting results. Gonzalo studied 22 male basketball players who completed unilateral and bilateral resistance training on Saturday and found that the unilateral group performed better in the bilateral CMJ than the bilateral group (UL: 37.4 ± 4.2 VS 39.8 ± 5.1, ES=0.47, %∆=6.5; BL: 38.9 ± 5.3 VS 40.6 ± 5.5 ES=0.27, %∆=4.5)In addition, another study showed that unilateral and bilateral resistance training were equally effective in improving lower limb strength in athletes, but there was no significant difference between the two groups (BL:75 ± 4.5 VS 81 ± 4.3; UL:76 ± 6.1 VS 83 ± 5.1, p\<0.05).In summary, this study will further confirm the improvement of unilateral and bilateral resistance training in strength, explosive power, coordination and other sports performance.In addition, as unilateral resistance training or reduced stability in unilateral testing has the potential to sacrifice strength development, this study will also focus on the effects of unilateral and bilateral resistance training on bilaterally dominant motor performance such as strength and explosiveness, as well as unilateral pattern tennis serve performance.This will address the occurrence of bilateral sets that are unfamiliar with unilateral training leading to the phenomenon of sacrificing strength to maintain stability. The phenomenon of migration of athletic performance such as strength and explosiveness in both uni- and multi-joint muscles has been confirmed by numerous studies,but there is little research on the phenomenon of complex skill transfer.This study will determine the effects of unilateral and bilateral resistance training on serving performance, thereby determining if there is also cross-education in complex motor skill performance.In addition, many studies have focused on the effects of unilateral and bilateral resistance training on the lower limbs, so this study will use the upper limb test as one of the indicators.Tennis serve is a complex movement involving multiple joint muscles, which is a process of transforming potential energy stored in the lower limbs into kinetic energy generated in the upper limbs, so the testing of upper and lower limb strength and explosive force indexes is particularly important. ### Conditions Module **Conditions:** - Exercise Training **Keywords:** - Resistance training ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 56 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Unilateral resistance training uses ipsilateral limb restricted contractions, in which each limb works independently, moving or opposing a given loading task **Intervention Names:** - Other: Unilateral resistance training programme **Label:** Unilateral resistance training **Type:** OTHER #### Arm Group 2 **Description:** Bilateral resistance training is the contraction of the same muscle in both limbs, that is, both limbs work together in a coordinated manner to cope with a given loading task **Intervention Names:** - Other: Bilateral resistance training programme **Label:** Bilateral resistance training **Type:** OTHER #### Arm Group 3 **Description:** Combined unilateral and bilateral forms of resistance training **Intervention Names:** - Other: Combined（UL+BL） resistance training programme **Label:** combined resistance training **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Unilateral resistance training **Description:** A method of training that increases muscle strength and endurance by using external resistance to a unilateral limb or movement. **Name:** Unilateral resistance training programme **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - Bilateral resistance training **Description:** A training method that increases muscle strength and endurance by using external resistance on both limbs or movements, **Name:** Bilateral resistance training programme **Type:** OTHER #### Intervention 3 **Arm Group Labels:** - combined resistance training **Description:** A method of training that uses limbs or movements to increase muscle strength and endurance by external resistance using unilateral and bilateral combined forms, **Name:** Combined（UL+BL） resistance training programme **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Muscle strength is the force produced by a muscle or muscle fibre against resistance **Measure:** Strength **Time Frame:** 6 weeks **Description:** Power is the capacity to produce maximum force in a brief time frame **Measure:** Power **Time Frame:** 6 weeks **Description:** Flexibility refers to muscle flexibility and joint mobility, such as the ability of a joint or muscle to move within an unrestricted, non-painful range of motion and to contract **Measure:** Flexibility **Time Frame:** 6 weeks **Description:** Coordination is the ability of the body to control muscle groups at the right time, in the right direction and at the right speed, and to mobilise muscles effectively to achieve precise movements **Measure:** Coordination **Time Frame:** 6 weeks **Description:** Speed is a form of physical quality, which refers to the ability of the human body to move under the specified conditions **Measure:** Serve speed **Time Frame:** 6 weeks **Description:** The degree of agreement between the test result and the accepted reference value, understood in the context of tennis as the amount of times the ball moves into the effective target range **Measure:** Serve accuracy **Time Frame:** 6 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Between 16 and 20 years of age. 2. National second-level athletes or above, or have participated in provincial or municipal competitions, or students majoring in tennis. 3. At least 2 years of tennis training experience. Exclusion Criteria: 1. Have performed systematic resistance training within the past three months. 2. Medical problems that may affect the study results, including athletes with recent history of surgery or injury. 3. Athletes at high risk for sports injuries. **Healthy Volunteers:** True **Maximum Age:** 20 Years **Minimum Age:** 16 Years **Sex:** MALE **Standard Ages:** - CHILD - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Lanzhou **Country:** China **Facility:** Northwest Normal University **State:** Gansu **Zip:** 730301 ## Document Section ### Large Document Module #### Large Docs - Date: 2024-05-16 - Filename: Prot_SAP_000.pdf - Has ICF: False - Has Protocol: True - Has SAP: True - Label: Study Protocol and Statistical Analysis Plan - Size: 7672715 - Type Abbrev: Prot_SAP - Upload Date: 2024-05-15T12:19 - Date: 2024-05-16 - Filename: ICF_001.pdf - Has ICF: True - Has Protocol: False - Has SAP: False - Label: Informed Consent Form - Size: 191023 - Type Abbrev: ICF - Upload Date: 2024-05-15T12:12 ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419439 **Brief Title:** Ketamine-assisted Integrative Treatment for Veterans With Chronic Low Back Pain and Comorbid Depression **Official Title:** Ketamine-assisted Integrative Treatment for Veterans With Chronic Low Back Pain and Comorbid Depression #### Organization Study ID Info **ID:** NURP-001-23F #### Organization **Class:** FED **Full Name:** VA Office of Research and Development #### Secondary ID Infos **Domain:** CSRD **ID:** IK2CX002646-01A2 **Type:** OTHER_GRANT ### Status Module #### Completion Date **Date:** 2029-06-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2028-12-01 **Type:** ESTIMATED #### Start Date **Date:** 2025-12-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-04-23 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** FED **Name:** VA Office of Research and Development #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Is US Export:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** This is a pilot study to evaluate the feasibility, acceptability, and safety of ketamine infusions followed by a brief behavioral intervention in Veterans with chronic low back pain and depression. **Detailed Description:** Chronic low back pain (CLBP) and depression are top causes of disability in the United States. Veterans are more likely to have both; prevalence is increasing. When CLBP and depression occur together, patients report more functional limitations, unemployment, and higher healthcare spending, and treatment is less successful. Novel approaches simultaneously addressing pain interference and depression symptoms are needed. This study will involve initial pilot feasibility testing of an intervention designed to help participants with chronic low back pain and depression both reduce pain interference and improve mood. This study will occur in two phases. The initial phase is a open-label single-arm pilot of the combined intervention (ketamine infusions followed by the brief behavioral intervention) in a small sample of Veterans (n=5). The objective is to develop and assess initial feasibility of study procedures and obtain participant feedback through semi-structured exit interviews. The second phase consists of a single-blind, two-arm, pilot feasibility randomized controlled trial (RCT) (n=44, 22 per arm) which will (a) assess feasibility benchmarks and (b) collect outcome data that will be used to calculate sample size to power a larger RCT. ### Conditions Module **Conditions:** - Chronic Low Back Pain - Depression **Keywords:** - Feasibility Studies - Pilot Projects - Randomized Controlled Trials - Clinical trials - Psychosocial Intervention - Narrative Medicine - Narrative Therapy - Ketamine - Ketamine, therapeutic use - Veterans - Veterans, Research Subjects - Low Back Pain, Recurrent/Chronic - Depression - Hallucinogens, Therapeutic Use ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** SEQUENTIAL **Intervention Model Description:** This study will occur in two phases which will occur sequentially and have different designs. The initial phase is a single-arm open-label, nonrandomized, non-blinded pilot study (n=5). The objective is to develop and assess initial feasibility of study procedures and obtain participant feedback through semi-structured exit interviews. The subsequent phase, informed by these findings, will consist of a single-blind, two-arm, pilot feasibility randomized controlled trial (RCT) (n=44, 22 per arm) which will (a) assess feasibility benchmarks and (b) collect outcome data that will be used to calculate sample size to power a larger RCT. ##### Masking Info **Masking:** SINGLE **Masking Description:** Participants in the second phase only will be blinded to the arm (intervention+minimally enhanced usual care vs minimally enhanced usual care alone). **Who Masked:** - PARTICIPANT **Primary Purpose:** OTHER #### Enrollment Info **Count:** 44 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Initial phase: A small open-label, single arm pilot study (n=5) will be conducted to develop and assess initial feasibility of study procedures and obtain participant feedback through semi-structured exit interviews. All participants in this open-label single arm pilot will receive the intervention (ketamine infusions followed by the brief behavioral intervention). There will be no control condition, randomization, or blinding. **Intervention Names:** - Drug: Ketamine hydrochloride - Behavioral: Brief narrative intervention **Label:** Open label, single arm pilot **Type:** OTHER #### Arm Group 2 **Description:** Second phase: Intervention arm of a single-blind, two-arm, pilot feasibility randomized controlled trial (RCT) (n=44, 22 per arm) which will (a) assess feasibility benchmarks and (b) collect outcome data that will be used to calculate sample size to power a larger RCT. Minimally Enhanced Usual Care will consist of educational reading materials regarding chronic back pain and depression. **Intervention Names:** - Drug: Ketamine hydrochloride - Behavioral: Minimally Enhanced Usual Care - Behavioral: Brief narrative intervention **Label:** Intervention + Minimally Enhanced Usual Care **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Second phase: Control arm of a single-blind, two-arm, pilot feasibility randomized controlled trial (RCT) (n=44, 22 per arm) which will (a) assess feasibility benchmarks and (b) collect outcome data that will be used to calculate sample size to power a larger RCT. Minimally Enhanced Usual Care will consist of educational reading materials regarding chronic back pain and depression. **Intervention Names:** - Drug: Ketamine hydrochloride - Behavioral: Minimally Enhanced Usual Care **Label:** Minimally Enhanced Usual Care Only **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Intervention + Minimally Enhanced Usual Care - Minimally Enhanced Usual Care Only - Open label, single arm pilot **Description:** Participants in Arms 1, 2, and 3 will receive four twice-weekly ketamine hydrochloride intravenous infusions dosed at 0.5mg/kg. **Name:** Ketamine hydrochloride **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Intervention + Minimally Enhanced Usual Care - Minimally Enhanced Usual Care Only **Description:** Minimally Enhanced Usual Care will consist of educational reading materials regarding chronic back pain and depression and will be provided to participants in arms 2 and 3 (pilot RCT). **Name:** Minimally Enhanced Usual Care **Other Names:** - Control **Type:** BEHAVIORAL #### Intervention 3 **Arm Group Labels:** - Intervention + Minimally Enhanced Usual Care - Open label, single arm pilot **Description:** Participants in Arm 1 (open label pilot) will receive the brief narrative intervention after four ketamine infusions. Participants in Arm 2 (those randomized after ketamine infusions are complete to the active arm of the pilot RCT) will receive the brief narrative intervention. **Name:** Brief narrative intervention **Other Names:** - Active/intervention **Type:** BEHAVIORAL ### Outcomes Module #### Other Outcomes **Description:** Enrollment benchmarks involve aiming to enroll 2-4 participants/month. **Measure:** Feasibility - Enrollment **Time Frame:** 18 months from start of study **Description:** Safety will be assessed via Adverse event (AE) assessment which will be obtained by means of a standard form assessing the presence of AEs. **Measure:** Presence of adverse events (AE)s **Time Frame:** Visits 1-7 or weekly (whichever is more frequent); Visit 8 (1 month follow up), Visit 9 (3 month follow up) **Description:** Pain interference will also be measured at these additional time points. Participants rate each item regarding experiences over the past 7 days on a Likert scale from 1 (not at all) to 5 (Very much). Raw scores (range 6 - 30, higher scores indicating more interference) are normed to mean of general population (T-score 50; SD 10); higher T-scores indicate higher pain interference. Minimum clinically important change is 3.0 - 3.5 point reduction in the T-score. **Measure:** Pain Interference (PROMIS Short Form v1.1 Pain Interference 6b) **Time Frame:** Visit 1 (Baseline), Visit 5 (post ketamine pre randomization), Visit 8 (1 month follow up), Visit 9 (3 month follow up) **Description:** Pain intensity will also be measured at these additional time points. Pain intensity will be measured using the NRS, a single-item measure where participants rate their pain intensity on a scale of 0 (no pain) to 10 (worst pain imaginable). In chronic pain, a reduction of 2 points or 30% is considered a meaningful improvement. **Measure:** Pain Intensity (Numeric Rating Scale) **Time Frame:** Visit 1 (Baseline), Visit 5 (post ketamine pre randomization), Visit 8 (1 month follow up), Visit 9 (3 month follow up) **Description:** Depression will also be measured at these additional time points. **Measure:** Depression (Quick Inventory of Depressive Symptoms - Self Report (QIDS-SR) ) **Time Frame:** Visit 1 (Baseline), Visit 5 (post ketamine pre randomization), Visit 8 (1 month follow up), Visit 9 (3 month follow up) **Description:** Participants will rate acceptability in multiple domains (helpfulness; convenience and comfort; satisfaction) on a 1-4 scale (1=very dissatisfied, 2=somewhat dissatisfied, 3=somewhat satisfied, 4=very satisfied). Benchmarks for acceptability include \>70% "somewhat" or "very satisfied" in all domains. **Measure:** Acceptability **Time Frame:** Visit 7 (8-10 days post randomization) **Description:** Participants rate their change overall on a 7-point Likert scale ranging from 1 (very much improved) to 7 (very much worse). **Measure:** Global Impression of Change (Patient Global Impression of Change (PGIC)) **Time Frame:** Visit 7 (8-10 days post randomization), Visit 8 (1 month follow up), Visit 9 (3 month follow up) **Description:** Cognitive flexibility refers to individuals' awareness of alternatives to a given situation, willingness to consider them, and belief that they can adapt. Individuals rate 12-items of the Cognitive Flexibility Scale (CFS) on a 6 point Likert scale ranging from 1 (strongly disagree) to 6 (strongly agree), total score range 12 - 72. Higher scores indicate more cognitive flexibility. **Measure:** Cognitive Flexibility (Cognitive Flexibility Scale (CFS)) **Time Frame:** Visit 1 (Baseline) , Visit 5 (post ketamine infusions pre randomization), Visit 7 (8-10 days post randomization), Visit 8 (1 month follow up), Visit 9 (3 month follow up) **Description:** Psychological flexibility refers to individuals' ability to both recognize and accept emotions and choose their subsequent action based on core beliefs and values (rather than a reflexive emotional response). It will be assessed via the 9-item Emotion Regulation Questionnaire (ERQ-9). **Measure:** Psychological Flexibility (Emotion Regulation Questionnaire (ERQ-9)) **Time Frame:** Visit 1 (Baseline) , Visit 5 (post ketamine infusions pre randomization), Visit 7 (8-10 days post randomization), Visit 8 (1 month follow up), Visit 9 (3 month follow up) **Description:** Psychological inflexibility will be assessed by the 7-item Acceptance and Action Questionnaire-II (AAQII). **Measure:** Psychological Inflexibility (Acceptance and Action Questionnaire-II (AAQII)) **Time Frame:** Visit 1 (Baseline) , Visit 5 (post ketamine infusions pre randomization), Visit 7 (8-10 days post randomization), Visit 8 (1 month follow up), Visit 9 (3 month follow up) **Description:** The Psychological Insight Questionnaire (PIQ) is a 23-item questionnaire developed to assess acute discoveries or realizations occasioned by a psychedelic experience, such as those regarding one's personality, relationships, behavioral patterns, or emotions. We will use the PIQ to assess changes in response to ketamine. **Measure:** Psychologically insightful experiences occurring in response to ketamine administration (Psychological Insight Questionnaire (PIQ)) **Time Frame:** Visit 5 (post ketamine infusions pre randomization) **Description:** The Mystical Experience Questionnaire (MEQ) is a 30-item validated measure assessing 4 factors of a mystical or psychedelic experience occasioned by ketamine. These include a mystical experience (e.g., "freedom from the limitations of your personal self and feeling a unity or bond with what was felt to be greater than your personal self"), positive mood (e.g., "sense of awe or awesomeness"), transcendence of time and space, and ineffability (feeling that the experience cannot be conveyed in words). **Measure:** Mystical Experiences Occasioned by Ketamine (Mystical Experience Questionnaire (MEQ)) **Time Frame:** Visit 5 (post ketamine infusions pre randomization) **Description:** Catastrophizing (the tendency to think of the future as irrationally negative) associates with poor outcomes in the setting of chronic pain, including poorer functional status. It will be measured via the 6-item Catastrophizing Subscale from the Coping Strategies Questionnaire (CSQ-CAT). **Measure:** Catastrophizing (Catastrophizing Subscale from the Coping Strategies Questionnaire (CSQ-CAT)) **Time Frame:** Visit 1 (Baseline) , Visit 5 (post ketamine infusions pre randomization), Visit 7 (8-10 days post randomization), Visit 8 (1 month follow up), Visit 9 (3 month follow up) **Description:** Self-efficacy is a cognitive tendency to perceive oneself as capable of managing life's problems. It will be measured via the 4-item PROMIS Self-Efficacy for Chronic Conditions - Managing Daily Activities -Short Form 4a. **Measure:** Self-Efficacy (PROMIS Self-Efficacy for Chronic Conditions - Managing Daily Activities -Short Form 4a) **Time Frame:** Visit 1 (Baseline) , Visit 5 (post ketamine infusions pre randomization), Visit 7 (8-10 days post randomization), Visit 8 (1 month follow up), Visit 9 (3 month follow up) **Description:** Fear-avoidance beliefs refers to the cognitive appraisal that certain kinds of activities may cause additional damage or pain; more fear-avoidance beliefs for physical activity (also called kinesiophobia) predict development of chronic pain and disability in those with acute low back pain. Fear-avoidance beliefs will be measured using the 4-item Fear-Avoidance Beliefs Questionnaire-Physical Activity Subscale (FABQ-PA). **Measure:** Fear-Avoidance Beliefs/Kinesiophobia (Fear-Avoidance Beliefs Questionnaire-Physical Activity Subscale (FABQ-PA)) **Time Frame:** Visit 1 (Baseline) , Visit 5 (post ketamine infusions pre randomization), Visit 7 (8-10 days post randomization), Visit 8 (1 month follow up), Visit 9 (3 month follow up) **Description:** The Fibromyalgia Survey Questionnaire (FSQ), adapted from the American College of Rheumatology Fibromyalgia Survey score, will be used to measure pain widespreadness and accompanying symptoms, also known as nociplastic features. It consists of two scales, the Widespread Pain Index (WPI) and the Symptom Severity score (SSS). The WPI instructs participants to indicate location(s) of pain (range 0 - 19, higher scores indicate more areas of pain). The SS score assesses additional symptoms including fatigue, unrefreshing sleep, and cognitive disruption (range 0 -12, higher scores indicate more symptoms). Total score range is 0 - 31, with higher scores indicating more nociplastic features of pain. Fibromyalgia screening positive cut points are WPI \>=7 and SSS \>=5 OR WPI of 4-6 and SSS \>= 9. **Measure:** Nociplastic Pain Characteristics (Fibromyalgia Survey Questionnaire (FSQ)) **Time Frame:** Visit 1 (Baseline) **Description:** PainDETECT will be used to evaluate presence of neuropathic features of back pain. PainDETECT instructs individuals to rate pain at different time points (range 0 - 10, with higher scores indicating more severe pain), and to select/rate agreement with items on a Likert scale from never to very strongly. Total score range is 0 - 38, with those scoring \>18 having likely neuropathic components of back pain. **Measure:** Neuropathic Pain Characteristics (painDETECT) **Time Frame:** Visit 1 (Baseline) **Description:** Target \>70% of participants who complete baseline measures will complete all four ketamine infusion sessions, the behavioral intervention (if assigned) and the initial post-intervention assessment battery. **Measure:** Feasibility - retention/attendance **Time Frame:** Visit 7 (8-10 days post randomization) **Description:** Target \>80% of participants complete follow-up assessments. **Measure:** Feasibility - measurement completion **Time Frame:** Visit 9 (3 month follow up) #### Primary Outcomes **Description:** Pain interference, defined as the extent to which pain impedes enjoyment of and participation in life activities (including cognitive, social, recreational, and self-care activities), will be the primary outcome. Raw scores (range 6 - 30, higher scores indicating more interference) are normed to mean of general population (T-score 50; SD 10); higher T-scores indicate higher pain interference. Minimum clinically important change is 3.0 - 3.5 point reduction in the T-score. **Measure:** Pain Interference (PROMIS Short Form v1.1 Pain Interference 6b) **Time Frame:** Visit 7 (8-10 days post randomization) #### Secondary Outcomes **Description:** Pain intensity will be measured using the NRS, a single-item measure where participants rate their pain intensity on a scale of 0 (no pain) to 10 (worst pain imaginable). In chronic pain, a reduction of 2 points or 30% is considered a meaningful improvement. **Measure:** Pain intensity (Numeric Rating Scale) **Time Frame:** Visit 7 (8-10 days post randomization) **Description:** The Quick Inventory of Depressive Symptoms - Self Report (QIDS-SR) is a 16-item rating scale assessing self-report of depressive symptoms. Scores range from 0 - 27, with higher scores indicating more severe depressive symptoms. Reductions of approximately 30% are considered clinically meaningful improvements in depressive symptoms. **Measure:** Depression (Quick Inventory of Depressive Symptoms - Self Report (QIDS-SR) ) **Time Frame:** Visit 7 (8-10 days post randomization) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Veterans with self-report of moderate to severe, high impact chronic low back pain (defined as 4/10 in severity via NRS, present 3 months on most days) and associated pain interference (defined as T-score 60 on the PROMIS Pain Interference measure), and current significant depressive symptoms (defined as a score 11 on the Quick Inventory of Depressive Symptoms - Self Report (QIDS-SR). * Medically stable (no hospitalizations in the past month lasting 3 days). * No changes in pain or depression medication regimen in 4 weeks. * No planned surgery, injections, hospitalizations, or other new interventions for back pain (except for physical therapy or exercise) or depression during the next four months (study duration). * Participants must have an adult who can drive them home after the ketamine treatments. Exclusion Criteria: * Inability to speak English due to the narrative intervention being conducted in English. * Inability or unwillingness to provide written informed consent (e.g. current delirium). * Current psychotic symptoms, or history of schizophrenia, schizoaffective disorder, and other psychotic disorder. * Currently participating in another clinical trial for pain or depression. * Current uncontrolled hypertension (defined as systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>100 mmHg). * Known elevated intracranial pressure, cerebral arterial aneurysm, or elevated intraocular pressure. * History of cirrhosis or unstable cardiac condition (e.g., decompensated congestive heart failure). * Any of the following lab values \>2x upper limit of normal: alanine transaminase (ALT), aspartate transferase (AST), direct bilirubin, alkaline phosphatase, creatinine; thyroid stimulating hormone (TSH) \<2x lower limit of normal or \>2x upper limit of normal. * Positive urine pregnancy test or lack of birth control method in Veterans of childbearing potential. * Known hypersensitivity to any excipient in the ketamine injection formulation. * Previously experienced serious adverse effects with ketamine. * On day of ketamine infusions, a urine drug screen positive for non-prescribed substances(s) (except cannabis) will exclude a participant from receiving ketamine * Current or previous abuse of ketamine. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Victoria D Powell, MD **Phone:** (734) 845-3072 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Sarah L Krein, PhD RN **Phone:** (734) 845-3621 **Role:** CONTACT #### Locations **Location 1:** **City:** Ann Arbor **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Victoria D Powell, MD - **Phone:** 734-845-3072 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Sarah L Krein, PhD RN - **Phone:** (734) 845-3621 - **Role:** CONTACT ***Contact 3:*** - **Name:** Victoria D Powell, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** VA Ann Arbor Healthcare System, Ann Arbor, MI **State:** Michigan **Zip:** 48105-2303 #### Overall Officials **Official 1:** **Affiliation:** VA Ann Arbor Healthcare System, Ann Arbor, MI **Name:** Victoria D Powell, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001526 - Term: Behavioral Symptoms - ID: D000019964 - Term: Mood Disorders - ID: D000001523 - Term: Mental Disorders - ID: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M7058 - Name: Depression - Relevance: HIGH - As Found: Depression - ID: M4714 - Name: Back Pain - Relevance: HIGH - As Found: Back Pain - ID: M19433 - Name: Low Back Pain - Relevance: HIGH - As Found: Low Back Pain - ID: M14850 - Name: Recurrence - Relevance: LOW - As Found: Unknown - ID: M7061 - Name: Depressive Disorder - Relevance: HIGH - As Found: Depression - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M4818 - Name: Behavioral Symptoms - Relevance: LOW - As Found: Unknown - ID: M21835 - Name: Mood Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - 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: D000001416 - Term: Back Pain - ID: D000017116 - Term: Low Back Pain - ID: D000003863 - Term: Depression - ID: D000003866 - Term: Depressive Disorder ### 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: D000000778 - Term: Anesthetics, Dissociative - ID: D000018686 - Term: Anesthetics, Intravenous - ID: D000018681 - Term: Anesthetics, General - ID: D000000777 - Term: Anesthetics - ID: D000002492 - Term: Central Nervous System Depressants - ID: D000018691 - Term: Excitatory Amino Acid Antagonists - ID: D000018683 - Term: Excitatory Amino Acid Agents - ID: D000018377 - Term: Neurotransmitter Agents - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: Analg - Name: Analgesics - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: PsychDr - Name: Psychotropic Drugs ### Intervention Browse Module - Browse Leaves - ID: M10674 - Name: Ketamine - Relevance: HIGH - As Found: Read - ID: M9305 - Name: Hallucinogens - Relevance: LOW - As Found: Unknown - ID: M4032 - Name: Analgesics - Relevance: LOW - As Found: Unknown - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M4108 - Name: Anesthetics, Dissociative - Relevance: LOW - As Found: Unknown - ID: M20766 - Name: Anesthetics, Intravenous - Relevance: LOW - As Found: Unknown - ID: M20761 - Name: Anesthetics, General - Relevance: LOW - As Found: Unknown - ID: M20771 - Name: Excitatory Amino Acid Antagonists - Relevance: LOW - As Found: Unknown - ID: M20504 - Name: Neurotransmitter Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000007649 - Term: Ketamine ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419426 **Acronym:** SuBiTo **Brief Title:** Prospective Study on Febrile Batteries in Pediatric Oncohaematological Patients (SuBiTo) **Official Title:** Studio Prospettico Sulle Batteriemie Febbrili Nei Pazienti Oncoematologici Pediatrici #### Organization Study ID Info **ID:** SuBiTO #### Organization **Class:** OTHER **Full Name:** Associazione Italiana Ematologia Oncologia Pediatrica ### Status Module #### Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-16 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2023-12-31 **Type:** ACTUAL #### Start Date **Date:** 2020-04-22 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2021-03-08 **Study First Submit QC Date:** 2024-05-16 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Associazione Italiana Ematologia Oncologia Pediatrica #### 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 define prospectively the incidence of multi-resistant germ batteries in paediatric oncoematological patients, to assess associated mortality, antibiotic resistance profile and the type of implemented therapy. **Detailed Description:** Bacterial infections are the most frequent cause of infectious morbidity and mortality in the patient undergoing chemotherapy or hemopoietic stem cell transplantation (TCSE). The main predisposing factor is the impairment of innate immunity as a result of the alteration of mucous barriers (mucositis/enteritis from chemotherapy or radiotherapy), skin (CVC) and neutropenia (non-specific haematological toxicity due to chemotherapy or radiotherapy on bones with hemopoietic marrow). The most frequent form of infection is represented by fever whose cause remains indeterminate in 60-80% of cases. In about 10-15% of cases fever is accompanied by the positivization of hemoculture and is configured as a microbiologically determined infection (IMD). In the remaining cases, infectious episodes may be clinically documented such as pneumonia or bronchitis confirmed for radiological examination or CT scans, without the identification of the causative agent; these are defined as clinically determined infections (ICDs). The knowledge, through hemoculture, of the germs responsible for febrile batteries over a given period of time, allows the definition of the predominant typology of germs responsible for systemic infection. On this basis, it is used to define the empirical antibiotic treatment that is given to the patient within a few hours of the onset of fever. Empirical antibiotic therapy must be effective with regard to the germs most represented in the department or in the area in question. Once the result of hemoculture has been received, usually within 48-72 hours, empirical antibiotic therapy can be maintained or modified in relation to the type of isolated germ and its susceptibility to antibiotics included in the empirical scheme. In fact, there is ample evidence that ready-to-treat with broad-spectrum antibiotics reduces mortality from bacterial infection in the immunocompromised patient, so this procedure is now a recommended approach by the guidelines. In addition to the knowledge of prevalent bacterial epidemiology for a certain type of immunocompromised patients in a given geographical area, a second tool capable of allowing appropriate empirical antibiotic therapy is the choice of therapy based on the presence or not of asymptomatic bacterial colonization of the patient. In fact, it is estimated that in 20-30% of cases the colonizing germ can become the cause of a batteriemia, facilitated by favoring factors such as the rupture of skin-mucous reefs or the appearance of neutropenia. The need to start empirical antibiotic therapy with effective molecules against causal germ (appropriate empirical therapy) has been shown to reduce bacterial infectious mortality at a time when antibiotic resistance is gradually increasing. It has been shown that inappropriate empirical antibiotic therapy, based on antibiotics to which the germ is not sensitive, is associated with increased infectious mortality from sepsis and septic shock. Among the adjuvant therapies used in immunosuppressed patients, in addition to antibiotic therapy, especially in patients with septic shock, there is the administration of opsonizing immunoglobulins and able to activate the complement such as, for example, immunoglobulins enriched in IgM. This practice is generally more established in immunocompetent patients while there are no prospective data in immunocompromised patients. Primary objective Incidence of febrile batteries from antibiotic-resistant gram negative germs (MDR) Secondary objectives Incidence of batteries from negative Gram germs; Incidence of batteries from gram positive germs; Incidence of fungemie; Incidence of septic shock; Incidence of batteries from colonising germs; Incidence of resistance to the main classes of antibiotics used empirically: cephalosporins of 3 and 4 generation (ceftazidime, cefipime), semisitical penicillins (piperacillin/tazobactam), carbapenemas (meropenem, imipenem), aminoglycosides (aminoglycosides (aikacin), second generation fluorquinolones; Response to empirical antibiotic therapy within 72 hours, without modification of empirical antibiotic therapy and without the use of Pentablobin; Response to empirical antibiotic therapy within 72 hours with the use of Pentaglobin within 72 hours of the onset of fever; Response to empirical antibiotic therapy with modification of the antibiotic (without the addition of antifungal), without the use of Pentaglobin; Response to empirical antibiotic therapy with modification of the antibiotic (without the addition of antifungal), with the use of Pentaglobin; Response of antibiotic therapy with empirical addition of antifungal with or without the use of Pentaglobin; Mortality at 30 days; Mortality at 90 days Design of the study Prospective, observational, non-interventional study to determine the incidence of febrile batteries from MDR germs in febrile oncohaematological patients. The study is aimed at the centers belonging to the Italian Society of Pediatric Oncology Hematology (IAEOP). Patients will be enrolled prospectively from the date of activation of the center. Eligible patients will include patients who develop fever after chemotherapy (either after first diagnosis or relapse) or after hemopoietic stem cell transplantation (TCSE) autologhe or allogenic, managed in ordinary hospitalization, subjected to endovenous antibiotic therapy for at least 72 hours for the treatment of the febrile episode. These patients will be the denominator of the study population. Patients who turn out to have positive hemoculture will represent the cases of the study population. A patient may be enrolled several times in the study both as "denominator/control" (hospitalization and example for several febrile episodes) and as a "case" (second episode of febrile batteriemia). In the latter case, the interval between the conclusion of a febrile episode (stable slibration, negative hemoculture) and the subsequent febrile episode must be at least 7 days. The febrile episodes considered will be only those in ordinary hospitalization (minimum 2 nights of hospitalization) while febrile episodes managed exclusively in day-care (Day-Hospital) or with home, oral or endovenous antibiotic therapy are excluded. Each participating centre must declare at the opening the standard procedure relating to: 1. Study of colonization: yes, no, method of investigation; 2. Standard antibiotic prophylaxis in acute myeloid leukemia (LLA), acute myeloid leukemia (LMA), non-Hodgkin lymphoma (LNH), allogenic TCSE, autologous TCSE; 3. Standard empirical therapy in non-colonized patient (first 48-72 hours); 4. Use of Pentaglobin (yes/no, criteria for use, dose). In the study patients, hospitalized by febrile episode in endovenous antibiotic therapy, the following information will be collected: sex, age at the time of the febrile episode, age at diagnosis of the basic disease, type of tumor, stage of treatment in hospitalization, type of transplant, presence or not of transplant disease against the host (only for allogenic transplantation), colonization or not, CVC or not, type of CVC, presence or not of urinary catheter, clinical characteristics of the febrile episode, date onset fever-date end fever, date start-date end of antibiotic therapy, date start-date end antifungal therapy, date start-date end therapy with Pentaglobin, result of haemoculture and antibiogram, number of neutrophils, number of lymphocytes, hypotension (in relation to normal values for age, saturation O2, need or not of hospitalization in intensive care , whether or not fluids are used, ventilatory support, renal replacement therapy, , maximum PCR-value (in the first 72 hours), PCT-value (maximum in the first 72 hours), Galactomanane (maximum value during the episode), β-D glucan (maximum value during the episode), survival at 30 and 90 days, final definition of the infectious episode (FUO, ICD, IMD), and possible toxicity related to antibiotic therapy. ### Conditions Module **Conditions:** - Bacterial Infections ### Design Module #### Design Info **Observational Model:** OTHER **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 2000 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** Incidence of batteries from negative Gram germs; Incidence of batteries from gram positive germs; Incidence of fungemie; Incidence of septic shock; Incidence of batteries from colonising germs; Incidence of resistance to the main classes of antibiotics **Name:** Battery incidence **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The evaluation of the incidence of febrile bacteremia due to MDR Gram-negative germs, i.e. bacteria that present resistance to at least 3 of the 5 classes of main antibiotics (3rd and 4th generation cephalosporins, beta-lactams, aminoglycosides, carbapenems and quinolones). **Measure:** Incidence of febrile bacteremia due to Gram-negative germs multi-resistant to antibiotics (MDR) **Time Frame:** 2020-2023 #### Secondary Outcomes **Description:** Incidence of various types of febrile episodes: fever of unknown origin (FUO), microbiologically determined infection (MDI) with positive blood culture and without positive blood culture, clinically determined infection (CDI). The incidence of the various types of febrile episodes was obtained as the ratio of cases of FUO, IMD with and without bacteremia, fungemia and CDI to total febrile episodes **Measure:** Incidence of various types of febrile episodes **Time Frame:** 2020-2023 **Description:** Incidence of bacteremia due to Gram-negative germs and bacteremia due to Gram-positive germs. The incidence of Gram-negative bacteremia and Gram-positive bacteremia was calculated by the ratio of different events to total IMDs with positive blood culture and total bacteremia. **Measure:** Bacteremia **Time Frame:** 2020-2023 **Description:** The incidence of fungemia was calculated as the ratio of fungemia cases to total microbiologically determined infection with positive blood culture. **Measure:** Fungaemia **Time Frame:** 2020-2023 **Description:** Risk factor analysis for incidence for bacteremia and IMD was performed by logistic regression models **Measure:** Risk factors for bacteremia and microbiologically documented infection (MDI) **Time Frame:** 2020-2023 **Description:** Evaluate clinical responce and mortality at 30 days. Mortality was derived from the ratio of the number of deaths to the total number of eligible patients. **Measure:** Mortality at 30 days **Time Frame:** 30 days **Description:** Evaluate clinical response and mortality at 90 days. Mortality was derived from the ratio of the number of deaths to the total number of eligible patients. **Measure:** Mortality at 90 days **Time Frame:** 90 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * written informed consent,- onset of fever after chemotherapy or after hemopoietic stem cell transplantation (TCSE), * endovenous antibiotic therapy for at least 72 hours for the treatment of the febrile episode. * ordinary hospitalization scheme * age \< 18 **Maximum Age:** 18 Years **Minimum Age:** 1 Month **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - CHILD - ADULT **Study Population:** Patients with febrile episodes managed during day-care (Day-Hospital) or with home oral or endovenous antibiotic therapy will be excluded. ### Contacts Locations Module #### Locations **Location 1:** **City:** Verona **Country:** Italy **Facility:** Azienda Ospedaliera Universitaria Integrata **State:** Italia **Zip:** 37126 **Location 2:** **City:** Ancona **Country:** Italy **Facility:** Azienda Ospedali Riuniti Presidio "G. Salesi" **Location 3:** **City:** Bari **Country:** Italy **Facility:** AOU Policlinico **Location 4:** **City:** Bologna **Country:** Italy **Facility:** Policlinico Sant'Orsola Malpighi Clinica **Location 5:** **City:** Bolzano **Country:** Italy **Facility:** Ospedale Regionale **Location 6:** **City:** Brescia **Country:** Italy **Facility:** Spedali Civili, Presidio Ospedale Dei Bambini **Location 7:** **City:** Cagliari **Country:** Italy **Facility:** Ospedale Pediatrico Microcitemico "Antonio Cao", Azienda Ospedaliera Brotzu **Location 8:** **City:** Catania **Country:** Italy **Facility:** AOU Policlinico Vittorio Emanuele **Location 9:** **City:** Ferrara **Country:** Italy **Facility:** Azienda Ospedaliero Universitaria Sant'Anna **Location 10:** **City:** Firenze **Country:** Italy **Facility:** Azienda Ospedaliero-Universitaria "Anna Meyer" **Location 11:** **City:** Genova **Country:** Italy **Facility:** Istituto G.Gaslini **Location 12:** **City:** Milano **Country:** Italy **Facility:** Fondazione IRCCS Istituto Nazionale Tumori **Location 13:** **City:** Modena **Country:** Italy **Facility:** Azienda Policlinico Di Modena **Location 14:** **City:** Monza **Country:** Italy **Facility:** Fondazione MBBM / AO San Gerardo Clinica **Location 15:** **City:** Napoli **Country:** Italy **Facility:** A.O.R.N. Santobono - Pausilipon **Location 16:** **City:** Padova **Country:** Italy **Facility:** Oncoematologia Pediatrica AOU di Padova **Location 17:** **City:** Palermo **Country:** Italy **Facility:** ARNAS Civico Di Cristina E Benfratelli **Location 18:** **City:** Parma **Country:** Italy **Facility:** Azienda Ospedaliero Universitaria Di Parma **Location 19:** **City:** Pavia **Country:** Italy **Facility:** Fondazione IRCCS, Policlinico San Matteo **Location 20:** **City:** Perugia **Country:** Italy **Facility:** A.O.U. "S.M. Della Misericordia" **Location 21:** **City:** Pescara **Country:** Italy **Facility:** Ospedale Civile Dello Spirito Santo Dipartimento Di Ematologia, Medicina Trasfusionale E Biotecnologie **Location 22:** **City:** Roma **Country:** Italy **Facility:** IRCCS Ospedale Pediatrico Bambino Gesù Dip.to di Oncoematologia e Terapia cellulare e Genica **Location 23:** **City:** San Giovanni Rotondo **Country:** Italy **Facility:** IRCCS Ospedale "Casa Sollievo Della Sofferenza" **Location 24:** **City:** Torino **Country:** Italy **Facility:** AOU Citta' Della Salute E Della Scienza Di Torino **Location 25:** **City:** Trieste **Country:** Italy **Facility:** IRCCS Materno Infantile "Burlo Garofolo" ### 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 - Abbrev: BC26 - Name: Wounds and Injuries ### Condition Browse Module - Browse Leaves - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M2454 - Name: Hyperthermia - Relevance: LOW - As Found: Unknown - ID: M4722 - Name: Bacterial Infections - Relevance: HIGH - As Found: Bacterial Infections - ID: M8464 - Name: Fever - 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 ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4222 - Name: Anti-Bacterial Agents - Relevance: LOW - As Found: Unknown - ID: M4224 - Name: Antibiotics, Antitubercular - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419413 **Brief Title:** A Translational Study to Describe Clinical Characteristics, Biomarkers and to Identify Phenotypes and Endotypes Associated With Differential Outcomes in Chinese Population **Official Title:** A Transnational Study to Describe Asthma Patient Clinical Characteristics, Treatment Patterns, Biomarkers and to Identify Phenotypes and Endotypes Associated With Differential Outcomes That May Support Future Development of Personalized Treatment Strategies in Chinese Population #### Organization Study ID Info **ID:** D2287R00186 #### Organization **Class:** INDUSTRY **Full Name:** AstraZeneca ### Status Module #### Completion Date **Date:** 2026-10-20 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-16 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-10-20 **Type:** ESTIMATED #### Start Date **Date:** 2024-01-18 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-04-25 **Study First Submit QC Date:** 2024-05-16 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** AstraZeneca #### Responsible Party **Type:** SPONSOR ### Description Module **Brief Summary:** A Translational Study to Describe Asthma Patient Clinical Characteristics, Treatment Patterns, Biomarkers and to Identify Phenotypes and Endotypes associated with Differential Outcomes that may Support Future Development of Personalised Treatment Strategies in Chinese Population ### Conditions Module **Conditions:** - Asthma ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 1000 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** up to 100 healthy participants, non-smokers, non-asthmatic with pre-bronchodilator Forced expiratory volume in 1 second (FEV1) ≥80% predicted. **Label:** Cohort A #### Arm Group 2 **Description:** up to 300 mild asthmatics on as-needed low dose inhaled corticosteroids (ICS)-formoterol, or low dose ICS plus as-needed short-acting β2 agonists (SABA), without the need for other controller medication. **Label:** Cohort B #### Arm Group 3 **Description:** up to 600 moderate to severe asthmatics on low or medium dose ICS-long acting β2 agonists (LABA), high dose alone or in combination with LABA with pre-bronchodilator FEV1 \< 80% predicted. **Label:** Cohort C ### Outcomes Module #### Primary Outcomes **Description:** Descriptive summary of demographic and subject characteristic, clinical characteristics and functional deliverables at baseline by study cohorts. **Measure:** Descriptive summary of demographic and subject characteristic, clinical characteristics and functional deliverables. **Time Frame:** At baseline **Description:** Descriptive summary of biomarker level at baseline by study cohorts. **Measure:** Descriptive summary of biomarker level. **Time Frame:** At baseline **Description:** Statistical clustering of key biomarkers in moderate to severe asthma cohort. **Measure:** Statistical clustering of key biomarkers. **Time Frame:** At baseline #### Secondary Outcomes **Description:** Mean difference in the biomarker level between study cohorts **Measure:** Mean difference in the biomarker level. **Time Frame:** At baseline **Description:** Statistical association between the biomarker and clinical disease outcomes in each asthma cohort. **Measure:** Statistical association between the biomarker and clinical disease outcomes. **Time Frame:** From 2023-2025 **Description:** Mean difference in the biomarker level between different tissues in each asthma cohort. **Measure:** Mean difference in the biomarker level between different tissues **Time Frame:** From 2023-2025 ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age 18 to 75 years of age * acceptable FEV1 (according to ATS and ERS) * compliance with study procedures All Asthma Cohorts * physician diagnosed Asthma greater or equal to 3 months prior to screening visit Exclusion Criteria: * history of alcohol or drug abuse within the past year * pregnant at time of an assessment * has an altered mental status at the time of informed consent * receipt marketed or investigational biologic(s) within 3 months or 5 half-lives prior to visit 1, whichever is longer * history or current upper or lower respiratory infection or symptoms within 2 weeks of baseline assessments * terminal diseases and/or organ failure or participants otherwise considered not appropriate for the study participation **Healthy Volunteers:** True **Maximum Age:** 75 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** A total of up to 1000 participants will be recruited and enrolled into Cohort A (healthy participants), Cohort B (mild asthmatics), and Cohort C (moderate to severe asthmatics). Enrollment will be monitored to, 1) ensure that no less than 30% of the study population in both Cohort B and Cohort C will be asthmatics with asthma onset before the age of 25 years (include 25 years); 2) ensure that at most 25% of participants who in both Cohort B and Cohort are current smokers or ex-smokers with a total smoking history of ≥10 pack years (not applicable for e-cigarettes); 3) ensure that at least 60% of participants in Cohort C have ACQ-5 ≥1.5; 4) ensure that no less than 30% of participants in Cohort C have severe asthma ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** AstraZeneca Clinical Study Information Center **Phone:** 1-877-240-9479 **Role:** CONTACT #### Locations **Location 1:** **City:** Chengdu **Country:** China **Facility:** Research Site **State:** Sichuan **Status:** RECRUITING **Location 2:** **City:** Beijing **Country:** China **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Location 3:** **City:** Changsha **Country:** China **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Location 4:** **City:** Dongguan **Country:** China **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Location 5:** **City:** Foshan **Country:** China **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Location 6:** **City:** Guangzhou **Country:** China **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Location 7:** **City:** Hainan **Country:** China **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Location 8:** **City:** Hohhot **Country:** China **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Location 9:** **City:** Huizhou **Country:** China **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Location 10:** **City:** Kunmin **Country:** China **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Location 11:** **City:** Nanjing **Country:** China **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Location 12:** **City:** Nanning **Country:** China **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Location 13:** **City:** Shanghai **Country:** China **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Location 14:** **City:** Shenyang **Country:** China **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Location 15:** **City:** Taiyuan **Country:** China **Facility:** Research Site **Status:** RECRUITING **Location 16:** **City:** Wenzhou **Country:** China **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Location 17:** **City:** Wuhan **Country:** China **Facility:** Research Site **Status:** RECRUITING **Location 18:** **City:** Xi'an **Country:** China **Facility:** Research Site **Status:** RECRUITING **Location 19:** **City:** Xuzhou **Country:** China **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Location 20:** **City:** Zhanjiang **Country:** China **Facility:** Research Site **Status:** NOT_YET_RECRUITING **Location 21:** **City:** Zhaoqing **Country:** China **Facility:** Research Site **Status:** NOT_YET_RECRUITING ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001982 - Term: Bronchial Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000008173 - Term: Lung Diseases, Obstructive - ID: D000008171 - Term: Lung Diseases - ID: D000012130 - Term: Respiratory Hypersensitivity - ID: D000006969 - Term: Hypersensitivity, Immediate - ID: D000006967 - Term: Hypersensitivity - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M4556 - Name: Asthma - Relevance: HIGH - As Found: Asthma - ID: M5258 - Name: Bronchial Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M11170 - Name: Lung Diseases, Obstructive - Relevance: LOW - As Found: Unknown - ID: M10018 - Name: Hypersensitivity - Relevance: LOW - As Found: Unknown - ID: M14967 - Name: Respiratory Hypersensitivity - Relevance: LOW - As Found: Unknown - ID: M10020 - Name: Hypersensitivity, Immediate - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001249 - Term: Asthma ### Intervention Browse Module - Browse Branches - Abbrev: Resp - Name: Respiratory System Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M304 - Name: Formoterol Fumarate - Relevance: LOW - As Found: Unknown - ID: M5269 - Name: Bronchodilator Agents - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419400 **Brief Title:** A Research Study to Explore the Impact of GP Support Via Text Messages to Patients With Asthma and/or COPD **Official Title:** A Randomised Controlled Trial to Evaluate the Impact of Supportive Text Messages From GP Practices on Self-reported Symptoms and Inhaler Adherence in Patients With Asthma and/or Chronic Obstructive Pulmonary Disease (COPD) Who Have Been Prescribed a Preventer (Daily) Inhaler (Inhaler Trial) #### Organization Study ID Info **ID:** Accurx-001 #### Organization **Class:** INDUSTRY **Full Name:** Accurx ### Status Module #### Completion Date **Date:** 2023-11-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-09-15 **Type:** ACTUAL #### Start Date **Date:** 2022-04-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Lindus Health #### Lead Sponsor **Class:** INDUSTRY **Name:** Accurx #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** A 6-month randomised controlled trial to evaluate the impact of text message support on symptom control and inhaler adherence for patients with asthma and/or COPD **Detailed Description:** This trial will be a 6-month prospective, randomised controlled trial in which the study population is randomly allocated (1:1) to an intervention or control group. The trial is multicentre and is non-blind. All patients in both groups will continue to receive their usual care for the duration of the study. Randomisation will be at the individual level. Participants will be randomly allocated as per a computer-generated randomisation list using a random number generator as part of the Microsoft .NET framework. This is a behavioural intervention. The intervention will consist of a series of supportive text messages to patients from their GP practice over a 6 month period. The messages will vary in frequency from 2 or 3 in the first weeks of the trial to only 1 or 2 a month in the final months of the trial. The content of the messages will vary; some will contain information about how to use a preventer inhaler, some will emphasise the importance of using it, and some will provide simple reminders to patients to take their inhaler. All participants will continue to receive their usual care throughout the duration of the study; the text message intervention with be in addition to their usual care. ### Conditions Module **Conditions:** - Asthma - COPD ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 6053 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The intervention group will receive a series of supportive text messages over the 6 month trial period, varying in content and frequency. They will also be asked to provide self reported data on their symptoms and their adherence at 3 points in time (start, mid-point, and end of trial). **Intervention Names:** - Behavioral: Supportive text messages **Label:** Supportive Text Messagses **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** The control group will receive no supportive text messages over the period of the trial. They will be asked to only provide self reported data on their symptoms and their adherence at 3 points in time (start, mid-point, and end of trial). **Label:** Control Group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Supportive Text Messagses **Description:** The intervention group will receive a series of supportive text messages over the 6 month trial period, varying in content and frequency. **Name:** Supportive text messages **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Changes in the MARS-5 Questionnaire **Measure:** Improved self-reported medication taking as measured by the The Medication Adherence Report Scale (MARS-5) Questionnaire **Time Frame:** Baseline to 13 and 26 weeks #### Secondary Outcomes **Description:** Changes in the Asthma Control Test **Measure:** Improved control of asthma symptoms as measured by the Asthma Control Test **Time Frame:** Baseline to 13 and 26 weeks (for asthma patients) **Description:** Reduction in days between consecutive preventer inhaler prescription requests **Measure:** A reduction in the interval between patients requesting preventer inhaler prescriptions **Time Frame:** Baseline to 13 and 26 weeks **Description:** Differences in the number of emergency admissions between the intervention and control group **Measure:** Difference in emergency admissions **Time Frame:** Over 26 weeks **Description:** Differences in the utilisation of NHS resources between the intervention and control group **Measure:** Differences in NHS utilisation **Time Frame:** Over 26 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Willing and able to provide informed consent and to comply with the study instructions 2. Male and females age 18 or older 3. Confirmed diagnosis of asthma and/or COPD as recorded in the patient's GP medical record 4. Currently prescribed a preventer inhaler 5. Access to a mobile phone 6. Ability to check text messages on phone 7. Ability to read Exclusion Criteria: 1. Inability to understand the study procedures 2. Inability or reluctance to provide responses to the study questionnaires 3. Inability to receive and respond to text messages **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Canterbury **Country:** United Kingdom **Facility:** University Medical Centre **State:** Kent **Zip:** CT2 7PB **Location 2:** **City:** Gravesend **Country:** United Kingdom **Facility:** Gravesend Medical Centre **State:** Kent **Zip:** DA12 2EN **Location 3:** **City:** Longfield **Country:** United Kingdom **Facility:** Jubilee Medical Centre **State:** Kent **Zip:** DA3 7QD **Location 4:** **City:** Rochester **Country:** United Kingdom **Facility:** Marlowe Park Medical Centre **State:** Kent **Zip:** ME2 2PW **Location 5:** **City:** Dudley **Country:** United Kingdom **Facility:** High Oak Surgery **State:** West Midlands **Location 6:** **City:** Stourbridge **Country:** United Kingdom **Facility:** Lion Health **State:** West Midlands **Zip:** DY8 3SS **Location 7:** **City:** Worsley **Country:** United Kingdom **Facility:** Wordsley Green Health Centre **State:** West Midlands **Zip:** DY8 5PD #### Overall Officials **Official 1:** **Affiliation:** Lindus Health **Name:** Luke Twelves **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001982 - Term: Bronchial Diseases - ID: D000012140 - Term: Respiratory Tract Diseases - ID: D000008173 - Term: Lung Diseases, Obstructive - ID: D000008171 - Term: Lung Diseases - ID: D000012130 - Term: Respiratory Hypersensitivity - ID: D000006969 - Term: Hypersensitivity, Immediate - ID: D000006967 - Term: Hypersensitivity - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M4556 - Name: Asthma - Relevance: HIGH - As Found: Asthma - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M11170 - Name: Lung Diseases, Obstructive - Relevance: LOW - As Found: Unknown - ID: M23449 - Name: Pulmonary Disease, Chronic Obstructive - Relevance: LOW - As Found: Unknown - ID: M5258 - Name: Bronchial Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: M10018 - Name: Hypersensitivity - Relevance: LOW - As Found: Unknown - ID: M14967 - Name: Respiratory Hypersensitivity - Relevance: LOW - As Found: Unknown - ID: M10020 - Name: Hypersensitivity, Immediate - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000001249 - Term: Asthma ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419387 **Brief Title:** The Effect of Flash Technique Via Self-Therapy App on Depression, Anxiety, and Traumatic Symptoms **Official Title:** The Effect of Flash Technique Via Self-Therapy App on Depression, Anxiety, and Traumatic Symptoms in Individuals Who Have Experienced a Traffic Accident: A Randomized-Controlled Design #### Organization Study ID Info **ID:** TBA2024 #### Organization **Class:** OTHER **Full Name:** Academy of Therapeutic Sciences, Turkey ### Status Module #### Completion Date **Date:** 2024-07-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** ACTIVE_NOT_RECRUITING #### Primary Completion Date **Date:** 2024-07-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-02-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Academy of Therapeutic Sciences, Turkey #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** EMDR is a psychotherapy method utilized for treating psychological traumas, with the Flash technique being one of its quickest and most effective methods. The "Self-Therapy" mobile application, accessible via Apple Store and Google Play, enables users to self-administer the Flash technique, following specific guidelines to help reduce symptoms like depression, anxiety, and stress linked to traumatic memories. Designed for adults over 18, particularly those diagnosed with mental health disorders, it is advised to be used under a psychiatrist's guidance. The application features a virtual guide, an avatar named Therapist Yağmur, who assists users through the process, including relaxation exercises and progress tracking. This allows users to pause and resume therapy as needed. Such applications represent a significant advancement in remote psychological support, potentially increasing access to psychotherapy and fostering societal acceptance of psychological health services. **Detailed Description:** EMDR is a psychotherapy method used in the treatment of psychological traumas. The Flash technique is considered one of the fastest and most effective techniques of EMDR. The self-therapy application allows users to apply the Flash technique by themselves by following guidelines, aiming to reduce depression, anxiety, and stress levels associated with traumatic memories. Applications like "Self-Therapy" could serve as an important model for the development and widespread adoption of remote psychological support services. With this project, individuals experiencing stressful life events could support their own healing process through a mobile application. This could lay the foundation for the development and expansion of similar mobile applications, thereby inspiring new projects and studies aimed at enhancing and increasing the accessibility of post-traumatic support services. The ease of access to psychotherapy through a mobile application could help increase societal awareness and acceptance of psychological health services.The "Self-Therapy" project is specifically designed for adults aged 18 and older who have experienced a traumatic or stressful event and perceive a decline in their quality of life due to its effects. The mobile application, available for download on both the Apple Store and Google Play, is primarily intended for individuals diagnosed with a mental health disorder, and it is recommended that they use the application under the guidance and recommendation of their psychiatrist. The application employs a virtual guide, an avatar named Therapist Yağmur, who leads users through the program. Through the avatar's instructions, users engage in the Flash technique to actively address and work through their traumatic memories. Additionally, the application includes relaxation exercises that can be utilized as needed. Users are able to track their progress within the app, enabling them to pause and resume their therapeutic journey as required, thereby facilitating a self-directed approach to managing and potentially mitigating the impacts of their traumatic experiences. ### Conditions Module **Conditions:** - Traumatic Stress Disorder **Keywords:** - EMDR - Mobile App - Traumatic Stress ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** EMDR Mobile App (Intervention) Group vs. Psycho-educational (Video) Control Group ##### Masking Info **Masking:** SINGLE **Masking Description:** Single **Who Masked:** - PARTICIPANT **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** EMDR Flash Technique protocol will be administered via Self-Therapy App. **Intervention Names:** - Device: Self-Therapy Mobile App **Label:** Self-Therapy App **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Psycho-Education will be administered via videos of a psychology professor. **Intervention Names:** - Other: Psycho-education Videos **Label:** Psycho-Education **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Self-Therapy App **Description:** Self-Therapy Mobile App includes videos and guidelines for applying EMDR Flash Technique **Name:** Self-Therapy Mobile App **Type:** DEVICE #### Intervention 2 **Arm Group Labels:** - Psycho-Education **Description:** Psycho-education Videos include guidelines for increasing emotion regulation skills. **Name:** Psycho-education Videos **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Depression, stress and anxiety scores will significantly change. Scores for depression, anxiety and stress are calculated by summing the scores. The scores are between 0-3, and more scores mean worse results. for the relevant items **Measure:** The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) **Time Frame:** 1-week and 1-month follow-up **Description:** Intrusion and hyperarousal scores will significantly change. The maximum mean score on each of the three subscales is '4', therefore the maximum 'total mean' IES- R score is 12. Lower scores are better. **Measure:** Impact of Events Scale Revised (IES-R) **Time Frame:** 1-week and 1-month follow-up ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Being over the age of 18 * Having access to the internet Exclusion Criteria: * A diagnosis of psychotic illness * Presence of mental retardation * Moderate or severe depression * Active suicidal thoughts **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Istanbul **Country:** Turkey **Facility:** Academy of Therapeutic Sciences ## Derived Section ### Condition Browse Module - Ancestors - ID: D000068099 - Term: Trauma and Stressor Related Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: BC26 - Name: Wounds and Injuries ### Condition Browse Module - Browse Leaves - ID: M7058 - Name: Depression - Relevance: LOW - As Found: Unknown - ID: M4324 - Name: Anxiety Disorders - Relevance: LOW - As Found: Unknown - ID: M24916 - Name: Stress Disorders, Traumatic - Relevance: HIGH - As Found: Traumatic Stress Disorder - ID: M7061 - Name: Depressive Disorder - Relevance: LOW - As Found: Unknown - ID: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: M222 - Name: Trauma and Stressor Related Disorders - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000040921 - Term: Stress Disorders, Traumatic ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419374 **Brief Title:** Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH **Official Title:** A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Compensated Cirrhosis Due to Metabolic Dysfunction-Associated Steatohepatitis (MASH) (ENLIGHTEN-Cirrhosis) #### Organization Study ID Info **ID:** BIO89-100-132 #### Organization **Class:** INDUSTRY **Full Name:** 89bio, Inc. ### Status Module #### Completion Date **Date:** 2031-08 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-29 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-24 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2028-06 **Type:** ESTIMATED #### Start Date **Date:** 2024-05 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** 89bio, 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 study will assess the efficacy and safety of pegozafermin administered in participants with compensated cirrhosis due to MASH (biopsy-confirmed fibrosis stage F4 MASH \[previously known as nonalcoholic steatohepatitis, NASH\]). ### Conditions Module **Conditions:** - Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis **Keywords:** - Liver disease - Fatty Liver - Digestive System Diseases - Metabolic diseases - Metabolic Dysfunction-Associated Steatohepatitis - MASH - Nonalcoholic steatohepatitis - NASH - Metabolic dysfunction-associated steatotic liver disease - MASLD - Nonalcoholic fatty liver disease - NAFLD - Fibrosis - Cirrhosis ### 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:** 762 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Biological: Pegozafermin **Label:** Pegozafermin **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Matched placebo **Intervention Names:** - Drug: Placebo **Label:** Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Pegozafermin **Description:** Subcutaneous injection **Name:** Pegozafermin **Other Names:** - BIO89-100 **Type:** BIOLOGICAL #### Intervention 2 **Arm Group Labels:** - Placebo **Description:** Subcutaneous injection **Name:** Placebo **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Fibrosis regression is defined as improvement in fibrosis by ≥1 stage, at Month 24 biopsy relative to baseline biopsy. **Measure:** Proportion of Participants Achieving Fibrosis Regression **Time Frame:** Baseline through Month 24 **Measure:** Time to First Occurrence of Disease Progression as Measured by Composite of Protocol -Specified Clinical Events **Time Frame:** Baseline through Month 60 #### Secondary Outcomes **Measure:** Change from Baseline in Enhanced Liver Fibrosis (ELF) Score **Time Frame:** Baseline, Month 24 and Month 60 **Measure:** Change from Baseline in Alanine Aminotransferase (ALT) Level **Time Frame:** Baseline, Month 24 and Month 60 **Measure:** Change from Baseline in FibroScan Vibration-controlled Transient Elastography (VCTE) **Time Frame:** Baseline, Month 24 and Month 60 **Measure:** Proportion of Participants who Develop Clinically Significant Portal Hypertension (CSPH) **Time Frame:** Baseline through Month 60 ### Eligibility Module **Eligibility Criteria:** Key Inclusion Criteria: * Males or non-pregnant females aged between 18 and 75 years (inclusive) at time of signing the informed consent form (ICF). * At least 1 metabolic risk factor. * Biopsy-confirmed fibrosis stage F4 MASH (per non-alcoholic steatohepatitis \[NASH\] Clinical Research Network (CRN) system) with compensated cirrhosis. * Body mass index (BMI) at screening ≥25.0 (≥23.0 for Asian participants) and \<50.0 kilograms (kg)/meters squared (m\^2). Key Exclusion Criteria: * Liver disorder other than MASH. * History or evidence of hepatic decompensation. * History or evidence of hepatocellular carcinoma. * Have type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus. * ALT or aspartate aminotransferase (AST) ≥250 units per liter (U/L). * Participants taking vitamin E (\>400 international units \[IU\]/day) must be on stable dose for at least 6 months prior to screening. Other inclusion and exclusion criteria may apply. **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:** ENLIGHTEN clinical trial **Phone:** 1-415-432-9270 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** 89bio, Inc. **Name:** Maya Margalit, MD **Role:** STUDY_DIRECTOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010335 - Term: Pathologic Processes - ID: D000008107 - Term: Liver Diseases - ID: D000004066 - Term: Digestive System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M11103 - Name: Liver Cirrhosis - Relevance: HIGH - As Found: Cirrhosis - ID: M11639 - Name: Metabolic Diseases - Relevance: LOW - As Found: Unknown - ID: M11107 - Name: Liver Diseases - Relevance: LOW - As Found: Unknown - ID: M8375 - Name: Fatty Liver - Relevance: HIGH - As Found: Steatohepatitis - ID: M8485 - Name: Fibrosis - Relevance: HIGH - As Found: Cirrhosis - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M30540 - Name: Non-alcoholic Fatty Liver Disease - Relevance: HIGH - As Found: Nonalcoholic Steatohepatitis - ID: T5868 - Name: Visceral Steatosis - Relevance: HIGH - As Found: Steatohepatitis ### Condition Browse Module - Meshes - ID: D000008103 - Term: Liver Cirrhosis - ID: D000005234 - Term: Fatty Liver - ID: D000065626 - Term: Non-alcoholic Fatty Liver Disease - ID: D000005355 - Term: Fibrosis ### Intervention Browse Module - Browse Branches - Abbrev: Hemat - Name: Hematinics - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M11110 - Name: Liver Extracts - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419361 **Brief Title:** [68Ga]Ga-Sa-DABI-4 PET Imaging of Stimulator of Interferon Gene Expression in Cancer Patients **Official Title:** [68Ga]Ga-Sa-DABI-4 PET Imaging of Stimulator of Interferon Gene Expression in Cancer Patients #### Organization Study ID Info **ID:** CYYY-KY-2024-049-01 #### Organization **Class:** OTHER **Full Name:** First Affiliated Hospital of Chongqing Medical University ### Status Module #### Completion Date **Date:** 2026-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-21 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** First Affiliated Hospital of Chongqing Medical University #### Responsible Party **Investigator Affiliation:** First Affiliated Hospital of Chongqing Medical University **Investigator Full Name:** Xiaoyang Zhang **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Stimulator of interferon gene (STING) protein plays a vital role in the immune surveillance of tumor microenvironment. Monitoring STING expression in tumors benefits the relevant STING therapy. This study will investigate the safety, biodistribution and potential usefulness of a novel 68Ga-labeled agonist (\[68Ga\]Ga-Sa-DABI-4) for noninvasive positron emission tomography (PET) imaging of STING expression in the tumor microenvironment. ### Conditions Module **Conditions:** - Stimulator of Interferon Gene - Cancer - Positron Emission Tomography ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Phases:** - EARLY_PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients will receive a single administration of \[68Ga\]Ga-Sa-DABI-4. **Intervention Names:** - Drug: [68Ga]Ga-Sa-DABI-4 **Label:** [68Ga]Ga-Sa-DABI-4 **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - [68Ga]Ga-Sa-DABI-4 **Description:** Each subject receives a single intravenous injection of \[68Ga\]Ga-Sa-DABI-4. **Name:** [68Ga]Ga-Sa-DABI-4 **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** The sensitivity, specificity, and accuracy of \[68Ga\]Ga-Sa-DABI-4 PET **Measure:** Diagnostic efficacy **Time Frame:** 15 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. At least 18 years of age. 2. Signed informed consent. 3. Patients with suspected or newly diagnosed or previously malignant disease. Exclusion Criteria: 1. Patients with non-malignant disease. 2. Patients with pregnancy. 3. The inability or unwillingness of the research participant, parent or legal representative to provide written informed consent. 4. Known or expected hypersensitivity to \[68Ga\]Ga-Sa-DABI-4 or any of its components. 5. Any serious medical condition or extenuating circumstance which the investigator feels may interfere with the procedures or evaluations of the study. **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Xiaoyang Zhang, PhD **Phone:** 023-89011755 **Role:** CONTACT #### Locations **Location 1:** **City:** Chongqing **Country:** China **Facility:** The First Affiliated Hospital of Chongqing Medical University **State:** Chongqing **Zip:** 400016 ## Derived Section ### 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: M10407 - Name: Interferons - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419348 **Brief Title:** 99mTc-QULIC-5-P1 SPECT Imaging in Patients With Prostate Cancer **Official Title:** 99mTc-QULIC-5-P1 SPECT Imaging in Patients With Prostate Cancer and Compared With 68Ga-PSMA-11 PET #### Organization Study ID Info **ID:** CYYY-KY-2023-268 #### Organization **Class:** OTHER **Full Name:** First Affiliated Hospital of Chongqing Medical University ### Status Module #### Completion Date **Date:** 2026-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-06-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-20 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** First Affiliated Hospital of Chongqing Medical University #### Responsible Party **Investigator Affiliation:** First Affiliated Hospital of Chongqing Medical University **Investigator Full Name:** Xiaoyang Zhang **Investigator Title:** Principal Investigator **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** 99mTc-QULIC-5-P1 is a new radiotracer targeting PSMA, which is promising as an excellent imaging agent applicable to PSMA positive prostate cancer. This study will investigate the safety, biodistribution and potential usefulness of 99mTc-QULIC-5-P1 SPECT imaging for the diagnosis of lesions in PSMA positive prostate cancer. ### Conditions Module **Conditions:** - Prostate Cancer Stage - PSMA - SPECT ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** DIAGNOSTIC #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Phases:** - EARLY_PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients will receive a single administration of 99mTc-QULIC-5-P1 **Intervention Names:** - Drug: 99mTc-QULIC-5-P1 **Label:** 99mTc-QULIC-5-P1 **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - 99mTc-QULIC-5-P1 **Description:** Each subject receives a single intravenous injection of 99mTc-QULIC-5-P1. **Name:** 99mTc-QULIC-5-P1 **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** The sensitivity, specificity, and accuracy of 99mTc-QULIC-5-P1 SPECT **Measure:** Diagnostic efficacy **Time Frame:** 15 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. At least 18 years of age. 2. Signed informed consent. 3. Patients with suspected or newly diagnosed or previously prostate cancer, with PSMA positive expression (supporting evidence may include MRI, CT, and pathology report, etc). Exclusion Criteria: 1. Patients with PSMA negative expression. 2. Patients with pregnancy. 3. The inability or unwillingness of the research participant, parent or legal representative to provide written informed consent. 4. Known or expected hypersensitivity to 99mTc-QULIC-5-P1 or any of its components. 5. Any serious medical condition or extenuating circumstance which the investigator feels may interfere with the procedures or evaluations of the study. **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** MALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Xiaoyang Zhang, PhD **Phone:** 023-89011755 **Role:** CONTACT #### Locations **Location 1:** **City:** Chongqing **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Xiaoyang Zhang, PhD - **Phone:** 023-89011755 - **Role:** CONTACT **Country:** China **Facility:** The First Affiliated Hospital of Chongqing Medical University **State:** Chongqing **Status:** RECRUITING **Zip:** 400016 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000005834 - Term: Genital Neoplasms, Male - ID: D000014565 - Term: Urogenital Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000005832 - Term: Genital Diseases, Male - ID: D000091662 - Term: Genital Diseases - ID: D000091642 - Term: Urogenital Diseases - ID: D000011469 - Term: Prostatic Diseases - ID: D000052801 - Term: Male Urogenital Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M14335 - Name: Prostatic Neoplasms - Relevance: HIGH - As Found: Prostate Cancer - ID: M8946 - Name: Genital Neoplasms, Male - Relevance: LOW - As Found: Unknown - ID: M17315 - Name: Urogenital Neoplasms - Relevance: LOW - As Found: Unknown - ID: M2876 - Name: Genital Diseases - Relevance: LOW - As Found: Unknown - ID: M8944 - Name: Genital Diseases, Male - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M14333 - Name: Prostatic Diseases - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000011471 - Term: Prostatic Neoplasms ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M352637 - Name: Gallium 68 PSMA-11 - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419335 **Brief Title:** Reducing Fatigue With CoQ10 Supplementation in Patients With Crohn's Disease Study **Official Title:** Reducing Fatigue With CoQ10 Supplementation in Patients With Crohn's Disease Study #### Organization Study ID Info **ID:** 855592 #### Organization **Class:** OTHER **Full Name:** University of Pennsylvania ### Status Module #### Completion Date **Date:** 2025-12-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-06-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-07 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Pennsylvania #### 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 includes an open label clinical trial comparing two doses of CoQ10 for 8 weeks to improve fatigue among patients with Crohn's disease and a prospective cohort study of healthy controls taking CoQ10 for 2 weeks. Additionally, among 15 participants who do not meet the fatigue threshold for the open label trial, the investigators will measure CoQ10 levels in blood and fasting urine, as well as complete the same data collection. Hypotheses 1. Fatigue will improve with CoQ10 and there will be a dose response with greater improvement with higher dose as measured by the Patient Reported Outcomes Measurement Information Systems Fatigue PROMIS Fatigue 7a instrument. 2. Fatigue will improve when measured with other fatigue scales in a similar dose dependent manner and that general and physical fatigue will improve more than mental fatigue. 3. CoQ10 will improve quality of life as measured with the short Inflammatory Bowel Disease Questionnaire (sIBDQ). ### Conditions Module **Conditions:** - Crohn Disease - Healthy ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 60 **Type:** ESTIMATED **Phases:** - EARLY_PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Drug: CoQ10 **Label:** Cohort 1 Crohn's Disease Patients with Fatigue **Type:** EXPERIMENTAL #### Arm Group 2 **Label:** Cohort 2 Crohn's Disease without Fatigue **Type:** NO_INTERVENTION #### Arm Group 3 **Intervention Names:** - Drug: CoQ10 **Label:** Cohort 3 Healthy Volunteers **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Cohort 1 Crohn's Disease Patients with Fatigue - Cohort 3 Healthy Volunteers **Description:** The core component of this pilot study will be a single center open label randomized trial comparing low dose and high dose CoQ10 among 30 patients with Crohn's disease and fatigue (Cohort 1) and 15 healthy volunteers (Cohort 3). **Name:** CoQ10 **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** The primary objective of this study is to assess whether there is sufficient evidence of a change (greater than 7 points) in fatigue among patients with Crohn's disease taking CoQ10 to warrant conduct of a larger, placebo-controlled clinical trial. The primary outcome will be measured with the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue 7a, a unidimensional scale that has been well validated and tested among the general population and patients with IBD and many other chronic disorders. The scale ranges from 33.7 to 75.8. Higher scores indicate more greater fatigue. **Measure:** Assess improved fatigue among patients with Crohn's Disease **Time Frame:** 8 weeks #### Secondary Outcomes **Description:** Secondary outcome measures will include improvement in domain specific fatigue, overall fatigue assessed with a different unidimensional scale using the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) for changes in Inflammatory Bowel Disease(IBD)-related quality of life. The scale ranges from 0 to 52. Higher scores indicate better quality of life. **Measure:** Change in domain specific fatigue **Time Frame:** 8 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria for all study participants To be eligible for this study all study participants must meet the following: 1. Provide informed consent 2. Male or female, age 18-70 3. Ability to take an oral medication 4. Willingness and ability to do electronic surveys Additional inclusion criteria for Cohort 1 and Cohort 2 participants: 1. Must have Crohn's disease for at least 3 months 2. Must be on stable medication regimen for Crohn's disease for at least 4 weeks 3. Clinically quiescent Crohn's disease based on the Patient Reported Outcome -Crohn's Disease (PRO2) average score for up to 7 days - daily liquid or very soft stool frequency of ≤1.5 and abdominal pain ≤1.0 5.3 Additional inclusion criteria for Cohort 1 1. Prescreening PROMIS Fatigue 7a T score \>60 5.4 Additional inclusion criteria for Cohort 2 and 3 1. Prescreening PROMIS Fatigue 7a T score \<55 Exclusion Criteria - for all study participants 1. Pregnant or lactating - a blood pregnancy test will be administered - fatigue is common with pregnancy and the post-partum period and is more likely to be unrelated to Crohn's 2. Chronic fatigue syndrome - noted in the medical record or self-reported 3. Depression as measured with PROMIS Depression scale 7a with T score \>=60 4. New York Heart Association (NYHA) class 3 or greater heart failure - if noted in the medical record 5. Untreated sleep apnea 6. Abnormal Thyroid Stimulating Hormone (TSH) - \<0.45 μlU/mL or \>5.33 μlU/mL 7. Iron deficiency or anemia - ferritin \< 20 without anemia or \<100 with anemia (hemoglobin \< 12g/dL in females or 13.5 g/dL in males) on the screening laboratory tests 8. B12 deficiency - \<180 pg/mL on the screening laboratory tests 9. Stage 3B or higher Chronic Kidney Disease (CKD) - based on an estimated glomerular filtration rate (eGFR) \< 45 ml/min on the screening laboratory tests 10. Diagnosis of cirrhosis - if noted in the medical record or self-reported 11. Diagnosis of primary sclerosing cholangitis 12. Diagnosis with hepatitis C without evidence of successful eradication 13. Cancer and receiving chemotherapy - if noted in the medical record or self-reported 14. Multiple Sclerosis - self-reported on in chart. 15. Taking systemic corticosteroids (e.g. prednisone or budesonide), not including single doses given to prevent adverse reactions to a medication or contrast agent 16. Taking warfarin - if noted in the medical record or self-reported 17. Diabetes requiring medication - if noted in the medical record or self-reported 18. Symptoms of an infection in the last 2 weeks - self-reported 19. Any other comorbidity or condition that the PI thinks is a contraindication to participation in this study Exclusion Criteria for Cohorts 1 and 3 1. Previous intolerance to CoQ10 **Healthy Volunteers:** True **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:** Brittaney Bonhomme **Phone:** 2158982625 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Lisa Nessel **Phone:** 2155736003 **Role:** CONTACT ### IPD Sharing Statement Module **Description:** Publication of the results of this study are planned. All publications emanating from this study will meet the authorship standards of the International Committee of Medical Journal Editors (ICMJE) standards. No data or samples obtained via this study will be shared with public repositories and there is no requirement to do so under the current funding mechanism for this study. If data or samples are shared with other investigators, they will be deidentified and the principal investigator will ensure that proper regulatory requirements are met before sharing the data. No data or samples will be provided outside of the University of Pennsylvania without an executed Material Transfer Agreement between the University of Pennsylvania and the institution receiving the data and or/samples. **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000015212 - Term: Inflammatory Bowel Diseases - ID: D000005759 - Term: Gastroenteritis - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000004066 - Term: Digestive System Diseases - ID: D000007410 - Term: Intestinal Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC06 - Name: Digestive System Diseases ### Condition Browse Module - Browse Leaves - ID: M8364 - Name: Fatigue - Relevance: LOW - As Found: Unknown - ID: M6638 - Name: Crohn Disease - Relevance: HIGH - As Found: Crohn's Disease - ID: M17917 - Name: Inflammatory Bowel Diseases - Relevance: LOW - As Found: Unknown - ID: M10444 - Name: Intestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M8875 - Name: Gastroenteritis - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003424 - Term: Crohn Disease ### Intervention Browse Module - Ancestors - ID: D000014815 - Term: Vitamins - ID: D000018977 - Term: Micronutrients - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: Micro - Name: Micronutrients - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Ot - Name: Other Dietary Supplements ### Intervention Browse Module - Browse Leaves - ID: M17201 - Name: Ubiquinone - Relevance: LOW - As Found: Unknown - ID: M271049 - Name: Coenzyme Q10 - Relevance: HIGH - As Found: Thoracic epidural - ID: M17558 - Name: Vitamins - Relevance: LOW - As Found: Unknown - ID: M21009 - Name: Micronutrients - Relevance: LOW - As Found: Unknown - ID: M16885 - Name: Trace Elements - Relevance: LOW - As Found: Unknown - ID: T383 - Name: Coenzyme Q10 - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000024989 - Term: Coenzyme Q10 ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419322 **Acronym:** ACE SMA **Brief Title:** Acceptability, Feasibility, Safety and Efficacy of a Optimized Rehabilitation Program for Treated Patients With Spinal Muscular Atrophy (SMA) (ACE SMA) **Official Title:** A Monocentric, Prospective and Longitudinal Study Investigating the Acceptability, Feasibility, Safety and Efficacy of an Optimized Rehabilitation Program for Treated Patients With SMA Compared to the Current Rehabilitation Program in United Kingdom: ACE SMA #### Organization Study ID Info **ID:** ACE SMA #### Organization **Class:** OTHER **Full Name:** University of Oxford #### Secondary ID Infos **Domain:** University Oxford Hospitals NHS Foundation Trust **ID:** PID17165 **Type:** OTHER ### Status Module #### Completion Date **Date:** 2026-06 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-16 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-06 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-02 **Study First Submit QC Date:** 2024-05-16 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Oxford Brookes University **Class:** OTHER **Name:** Oxford University Hospitals NHS Trust **Class:** UNKNOWN **Name:** ACE SMA Charity **Class:** UNKNOWN **Name:** Roche Products Limited **Class:** INDUSTRY **Name:** Scholar Rock, Inc. **Class:** INDUSTRY **Name:** Biohaven Therapeutics Ltd. #### Lead Sponsor **Class:** OTHER **Name:** University of Oxford #### 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 investigate the acceptability, feasibility, safety and efficacy of an optimized rehabilitation program for treated patients with spinal muscular atrophy (SMA) compared to the current rehabilitation program in the United Kingdom. The aim is to provide patients with more hands on physiotherapy and access to rehabilitation devices at home to support parents currently providing rehabilitation on their own. **Detailed Description:** The main study objective is to investigate whether an optimized rehabilitation program would be accepted and is feasible within the SMA patient community. The optimized program will comprise of goal orientated rehabilitation with more frequent hands on physiotherapy (every 2 weeks) as well as a SMA approved rehabilitation device used at home on a weekly basis, to provide the most appropriate therapy for each individual patient. All study participants will receive the optimized rehabilitation program over 12 months. An external control group will be used to determine the potential efficacy. Research study visits will take place at baseline, month 6 and month 12. At these visits a general physical exam will be undertaken alongside collecting the participant and carer perception, satisfaction and compliancy of the rehabilitation program. Motor function assessments according to age and ambulatory status will be assessed to help evaluate potential therapeutic benefits. ### Conditions Module **Conditions:** - Spinal Muscular Atrophy **Keywords:** - physiotherapy - rehabilitation - SMA - acceptability - feasibility - United Kingdom - physical therapy - prospective - Spinal Muscular Atrophy ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** All participants will receive the optimized rehabilitation program (intervention). An external control group will be used to determine the potential efficacy. ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 14 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Other: Optimized rehabilitation program **Label:** Treated cohort **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Treated cohort **Description:** Consisting of: goal-oriented rehabilitation, hands on physiotherapy sessions and home use of SMA approved rehabilitation device. **Name:** Optimized rehabilitation program **Type:** OTHER ### Outcomes Module #### Other Outcomes **Description:** Evaluation potential therapeutic benefits through assessment of motor functional scales. **Measure:** The Children's Hospital of Philadelphia Infant Test of Neuromuscular Disorders (CHOP INTEND): maximum score is 64 points. Measuring a change in functional total score between the treated study cohort and a control dataset. **Time Frame:** Baseline, Month 6, Month 12 (end of study). **Description:** Evaluation potential therapeutic benefits through assessment of motor functional scales. **Measure:** The Hammersmith Infant Neurological Examination section 2 (HINE-2): maximum score is 26 points. Measuring a change in functional total score between the treated study cohort and a control dataset. **Time Frame:** Baseline, Month 6, Month 12 (end of study). **Description:** Evaluation potential therapeutic benefits through assessment of motor functional scales. **Measure:** Revised Hammersmith Scale (RHS). The maximum score for RHS is 69 points. Measuring a change in functional total score between the treated study cohort and a control dataset. **Time Frame:** Baseline, Month 6, Month 12 (end of study). **Description:** Evaluation potential therapeutic benefits through assessment of motor functional scales. **Measure:** Hammersmith Functional Motor Scale Expanded (HFMSE) combined assessment. The maximum score is 66 points. Measuring a change in functional total score between the treated study cohort and a control dataset. **Time Frame:** Baseline, Month 6, Month 12 (end of study). **Description:** Evaluation potential therapeutic benefits through assessment of motor functional scales. **Measure:** World Health organization (WHO) developmental milestones: the final result is the highest achievable motor milestone. Measuring a change in functional total score between the treated study cohort and a control dataset. **Time Frame:** Baseline, Month 6, Month 12 (end of study). **Description:** Evaluation potential therapeutic benefits through assessment of motor functional scales. **Measure:** Revised upper limb module (RULM): from 30 months of age: maximum score is 37 points. Measuring a change in functional total score between the treated study cohort and a control dataset. **Time Frame:** Baseline, Month 6, Month 12 (end of study). **Description:** Evaluation potential therapeutic benefits through assessment of motor functional scales. **Measure:** 6 Minute Walk test (6MWT): from 4 years of age. Measuring a change in functional total score between the treated study cohort and a control dataset. **Time Frame:** Baseline, Month 6, Month 12 (end of study). #### Primary Outcomes **Description:** Number of eligible patients who accepted to participate in the study compared to the number of eligible patients who have refused to participate. **Measure:** Acceptability of an optimized rehabilitation program. Measured as number of eligible patients who accepted to participate in the study compared to the number of eligible patients who have refused to participate. Endpoint: 70% of acceptability. **Time Frame:** Baseline visit **Description:** Number of patients who complete the study compared to the number of included patients. **Measure:** Feasibility of an optimized rehabilitation program. Measured as the number of patients who complete the study compared to the number of included patients. Endpoint: 60% of feasibility. **Time Frame:** Month 12 (end of study) #### Secondary Outcomes **Description:** Number of Serious Adverse Events (SAEs). **Measure:** Safety of an optimized rehabilitation program. Measured as the number of serious adverse events (SAE) compared to the year before the baseline. **Time Frame:** From baseline to month 12 (end of study) **Description:** Potential effects of the optimized rehabilitation program on patients experience. **Measure:** Carer perception and satification measured through the Clinical Global Impression scale - Improvement (CGI I). Comparison of CGI-S score with CGI-I score of the treated group. **Time Frame:** Month 6 and Month 12 (end of study). **Description:** Potential effects of the optimized rehabilitation program on patients experience. **Measure:** Carer perception and satification measured through the Clinical Global Impression scale - Severity (CGI-S). Comparison of CGI-S score with CGI-I score of the treated group. **Time Frame:** Baseline visit: CGI-S. ### Eligibility Module **Eligibility Criteria:** Patient participant Eligibility Criteria: Inclusion Criteria: * Genetically confirmed SMA considered as a non-sitter, sitter or walker * Post-symptomatically treated and on stable dose for 12 months with any disease-modifying market-approved drug * Patients from 1-10 years of age at baseline * Parent(s)/legal guardian(s) of patients less than 16 years of age must provide written informed consent prior to the patient's participation in the study * Willing and able to comply with all protocol requirements and procedures. Exclusion Criteria: The participant may not enter the trial if ANY of the following apply: * Any acute or chronic condition which, as assessed by the investigator, significantly interferes with the rehabilitation of the patient * Need of diurnal and/or invasive ventilation, naps excluded * Currently enrolled in a treatment study; or treatment with an experimental therapy * Any surgical and/or medical intervention, according to the investigator, 3 months before baseline and/or during the study participation. Carer (considered as participant) Eligibility Criteria: Inclusion Criteria: * Willing and able to comply with all protocol requirements and procedures * Carer's child has been included in study. Exclusion Criteria: • No exclusion criteria. **Maximum Age:** 10 Years **Minimum Age:** 1 Year **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Serena Hill **Phone:** 01865618799 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Charlotte Lilien **Phone:** 01865618799 **Role:** CONTACT #### Locations **Location 1:** **City:** Oxford **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Serena Hill - **Phone:** 01865618799 - **Role:** CONTACT ***Contact 2:*** - **Name:** Charlotte Lilien - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United Kingdom **Facility:** Oxford Brookes University **State:** Oxfordshire **Zip:** OX3 0BP #### Overall Officials **Official 1:** **Affiliation:** University of Oxford, Department of Paediatrics **Name:** Charlotte Lilien **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020763 - Term: Pathological Conditions, Anatomical - ID: D000020879 - Term: Neuromuscular Manifestations - ID: D000009461 - Term: Neurologic Manifestations - ID: D000009422 - Term: Nervous System Diseases - ID: D000013118 - Term: Spinal Cord Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000016472 - Term: Motor Neuron Disease - ID: D000019636 - Term: Neurodegenerative Diseases - ID: D000009468 - Term: Neuromuscular Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC18 - Name: Nutritional and Metabolic Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M4589 - Name: Atrophy - Relevance: HIGH - As Found: Atrophy - ID: M12090 - Name: Muscular Atrophy - Relevance: HIGH - As Found: Muscular Atrophy - ID: M12091 - Name: Muscular Atrophy, Spinal - Relevance: HIGH - As Found: Spinal Muscular Atrophy - ID: M22519 - Name: Pathological Conditions, Anatomical - Relevance: LOW - As Found: Unknown - ID: M22619 - Name: Neuromuscular Manifestations - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown - ID: M15915 - Name: Spinal Cord Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M18879 - Name: Motor Neuron Disease - Relevance: LOW - As Found: Unknown - ID: M4024 - Name: Amyotrophic Lateral Sclerosis - Relevance: LOW - As Found: Unknown - ID: M21558 - Name: Neurodegenerative Diseases - Relevance: LOW - As Found: Unknown - ID: M12411 - Name: Neuromuscular Diseases - Relevance: LOW - As Found: Unknown - ID: T5342 - Name: Spinal Muscular Atrophy - Relevance: HIGH - As Found: Spinal Muscular Atrophy - ID: T349 - Name: Amyotrophic Lateral Sclerosis - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009133 - Term: Muscular Atrophy - ID: D000009134 - Term: Muscular Atrophy, Spinal - ID: D000001284 - Term: Atrophy ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419309 **Brief Title:** Comparison of the Effect of Gluten-Free-Lactose-Free / Aronia Melanocarpa Supplemented Diet in Patients With Hashimoto's Thyroiditis **Official Title:** Comparison of the Effect of Gluten-Free-Lactose-Free / Aronia Melanocarpa Supplemented Diet on Leptin, Ghrelin Levels and Inflammatory Status in Patients With Hashimoto Thyroiditis #### Organization Study ID Info **ID:** HUSBFBVDBE001 #### Organization **Class:** OTHER **Full Name:** Halic University ### Status Module #### Completion Date **Date:** 2025-08-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-21 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-05-15 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-15 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Halic 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:** Hashimoto's thyroiditis (HT) is the most common cause of chronic hypothyroidism in areas with sufficient iodine, stemming from an autoimmune response against thyroid peroxidase and/or thyroglobulin. It is the most prevalent autoimmune thyroid disease and a leading cause of overall hypothyroidism. Even when they reach euthyroidism, 82% of treated women with HT still have excess body weight, and 35% of them are obese. Thyroid dysfunction can affect the function of adipose tissue and lead to metabolic disturbances. Leptin can stimulate thyroid-stimulating hormone secretion, while thyroid-stimulating hormone can influence leptin release from adipose tissue. Additionally, HT patients often exhibit high levels of C-reactive protein and interleukin-6, suggesting an association between increased thyroid-stimulating hormone levels and the inflammatory process, which may contribute to comorbid disease risk in individuals with HT. Nutrition can serve as a complementary treatment for HT by affecting thyroid functions and having anti-inflammatory properties. Dietary interventions may involve eliminating gluten, lactose, or certain food components, or focusing on an anti-inflammatory dietary pattern while preventing nutritional deficiencies. Therefore, this study is a randomized controlled, single-blind trial designed to evaluate the effects of a gluten-free, lactose-free diet and a diet enriched with Aronia Melanocarpa, both individually and in combination, as well as healthy dietary protocols, on autoantibody levels, leptin, ghrelin, oxidative response, and weight loss in patients with Hashimoto's thyroiditis. The study aims to recruit a minimum of 80 participants aged 18-65 years, diagnosed with Hashimoto's thyroiditis at Istanbul Medical Faculty Hospital. In the initial face-to-face interview, participants will provide sociodemographic information, dietary habits, anthropometric measurements, and dietary intake records through a questionnaire. The study involves the inclusion of Aronia Melanocarpa in the diet (high anthocyanin content, 69.24 mg/100 ml), a gluten-free and lactose-free diet, both interventions being applied together, and the application of only healthy nutrition protocols to patients over an 8-week period, with serum assessments of thyroid-stimulating hormon, free T4, free T3, anti-thyroid peroxidase, anti-Tg, interleukin-6,anti tumor necrosis factor alpha, C-reactive protein and leptin-ghrelin levels at the beginning and end of the study. The goal is to create recommendations for patients, improve their quality of life, and establish sustainable nutritional interventions. ### Conditions Module **Conditions:** - Hashimoto Thyroiditis ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 80 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** People will be given a healthy diet by eliminating gluten-free lactose-containing foods from their diet. It will continue for 8 weeks. **Intervention Names:** - Other: Dietary intervention **Label:** Gluten- lactose free diet **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** In addition to a healthy diet, people will be given aronia melanocarpa fruit juice daily (high in anthocyanins, 69.24 mg/100 mL cyanidin-3-glucoside) and a gluten-free-lactose-free diet.It will continue for 8 weeks. **Intervention Names:** - Other: Dietary intervention **Label:** Aronia Melanocarpa added and Gluten- lactose free diet **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** People will be given aronia melanocarpa fruit juice daily (high in anthocyanins, 69.24 mg/100 mL cyanidin-3-glucoside).It will continue for 8 weeks. **Intervention Names:** - Other: Dietary intervention **Label:** Aronia Melanocarpa added diet **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** Healthy diet patterns with an average macronutrient content of 10-20% protein, 20-35% fat and 45-60% carbohydrate will be followed for 8 weeks. **Intervention Names:** - Other: Dietary intervention **Label:** Healthy eating group **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Aronia Melanocarpa added and Gluten- lactose free diet - Aronia Melanocarpa added diet - Gluten- lactose free diet - Healthy eating group **Description:** Four different dietary interventions are planned. * Gluten-free, lactose-free diet, * Diet enriched with Aronia Melanocarpa, * Gluten-free, lactose-free and enriched with Aronia Melanocarpa diet, * Healthy diet **Name:** Dietary intervention **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** The effect of diets on weight loss will be evaluated. Body composition analyzes of individuals (body weight (kg), body fat ratio (%), body water ratio (%), visceral fat ratio) will be performed using handheld device. **Measure:** Effect of diet on weight loss **Time Frame:** Start and end of study (8 weeks) **Description:** The effects of diets on leptin and ghrelin levels will be examined with venous blood samples. **Measure:** Effect of diet on hormone level **Time Frame:** Start and end of study (8 weeks) **Description:** To evaluate oxidative stress parameters, two 5 mL venous blood samples will be taken from each patient in yellow tubes after an overnight fast of at least eight hours between 08:00 and 09:00 in the morning. The blood sample will be kept at room temperature for 10-20 minutes and after being centrifuged at 2000-3000 rpm for 20 minutes, it will be transferred to Eppendorf tubes with the help of a sterile pipette and will be stored in 2 separate refrigerators at -20 °C. IL-6, TNF-alpha, CRP levels will be measured with commercial kits, following the company protocol. **Measure:** Effect of diet on inflammatory parameters **Time Frame:** Start and end of study (8 weeks) #### Secondary Outcomes **Description:** Thyroid Stimulating Hormone, free thyroxine, free triiodothyronine, thyroid peroxidase antibodies and anti-thyroglobulin biochemical parameters of the participants will be requested by the doctor with institutional permission and patient approval. **Measure:** Effect of diet on routine hashimoto thyroid parameters **Time Frame:** Start and end of study (8 weeks) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Being diagnosed with Hashimoto's thyroiditis by a doctor, * Being a female individual between the ages of 18-65, * Not being diagnosed with any chronic disease that would negatively affect functioning other than Hashimoto's thyroid, * Not having used selenium and iodine supplements in the last month, * Individuals should not lose more than 4 kg of weight in the last month, * Not having been on a strict elimination diet for more than 4 months in the last year, * Not having applied any nutritional intervention during the last three months before the study. Exclusion Criteria: * Pregnant or breastfeeding mother, * Individuals with chronic diseases, * Individuals allergic to red fruits **Gender Based:** True **Gender Description:** Since the prevalence of the disease is high in female individuals, it will be conducted with female individuals. **Healthy Volunteers:** True **Maximum Age:** 65 Years **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Berrak Basturk, Lecturer **Phone:** 05465088090 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Ayse Kubat Uzum, Profesor **Role:** CONTACT #### Locations **Location 1:** **City:** İstanbul **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Berrak Basturk, Lecturer - **Phone:** +905465088090 - **Role:** CONTACT **Country:** Turkey **Facility:** Halic University #### Overall Officials **Official 1:** **Affiliation:** Halic University **Name:** Berrak Basturk, Lecturer **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Halic University **Name:** Zeynep Ozerson, Assoc. prof. **Role:** STUDY_DIRECTOR **Official 3:** **Affiliation:** Istanbul University **Name:** Ayse Kubat Uzum, Profesor **Role:** STUDY_DIRECTOR **Official 4:** **Affiliation:** Istanbul University **Name:** Melike Cevikdizici, Nurse **Role:** STUDY_DIRECTOR **Official 5:** **Affiliation:** Biruni University **Name:** Yusuf Celik, Profesor **Role:** STUDY_DIRECTOR ## Derived Section ### Condition Browse Module - Ancestors - ID: D000013959 - Term: Thyroid Diseases - ID: D000004700 - Term: Endocrine System Diseases - ID: D000013967 - Term: Thyroiditis, Autoimmune - ID: D000001327 - Term: Autoimmune Diseases - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M26156 - Name: Hashimoto Disease - Relevance: HIGH - As Found: Hashimoto Thyroiditis - ID: M16725 - Name: Thyroiditis - Relevance: HIGH - As Found: Thyroiditis - ID: M16718 - Name: Thyroid Diseases - Relevance: LOW - As Found: Unknown - ID: M7862 - Name: Endocrine System Diseases - Relevance: LOW - As Found: Unknown - ID: M16726 - Name: Thyroiditis, Autoimmune - 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: T3542 - Name: Lymphomatous Thyroiditis - Relevance: HIGH - As Found: Hashimoto Thyroiditis ### Condition Browse Module - Meshes - ID: D000013966 - Term: Thyroiditis - ID: D000050031 - Term: Hashimoto Disease ### Intervention Browse Module - Browse Branches - Abbrev: Fl - Name: Flavonoid - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: T24 - Name: Anthocyanidin - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419296 **Brief Title:** Mortality of MBL-producing Enterobacteriaceae Bacteremias With the Combined Use of Ceftazidime-avibactam and Aztreonam vs. Other Active Antibiotics. A Multicenter Target Trial Emulation. **Official Title:** Mortality of MBL-producing Enterobacteriaceae Bacteremias With the Combined Use of Ceftazidime-avibactam and Aztreonam vs. Other Active Antibiotics. A Multicenter Target Trial Emulation. #### Organization Study ID Info **ID:** 6915 #### Organization **Class:** OTHER **Full Name:** Hospital Italiano de Buenos Aires ### Status Module #### Completion Date **Date:** 2024-07-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-07-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-15 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Hospital Italiano de Buenos Aires #### Responsible Party **Investigator Affiliation:** Hospital Italiano de Buenos Aires **Investigator Full Name:** Mariana Vaena **Investigator Title:** MD **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Ceftazidime-avibactam and aztreonam combination (CAZAVI + ATM) presents a potential alternative for the treatment of metallo-beta-lactamase (MBL)-type carbapenemase-producing Enterobacteriaceae (CPE) bacteremia, particularly where Cefiderocol is not readily available. This study proposes a Target Trial Emulation (TTE) to assess the efficacy and safety of CAZAVI + ATM compared to other active antibiotics (OAAs) in patients with MBL-type CPE bacteremia, and also to evaluate all-cause 30-day mortality, resistance profiles of isolated microorganisms, clinical failure rates, leukocyte count normalization, adverse events, occurrence of Clostridium difficile infection, and emergence of new multidrug-resistant microorganisms. The study expects to enroll at least 662 patients from 22 hospitals in Argentina. Data will be collected through the REDCap database, with rigorous verification for completeness and accuracy. The outcomes of this project will contribute vital insights into the efficacy and safety of CAZAVI + ATM, informing clinical practice guidelines for the management of MBL-type bacteremia across diverse settings. **Detailed Description:** Patients will be categorized into two treatment groups for analysis: CAZAVI + ATM treatment group and Other Active Antibiotics treatment group. As this study is retrospective, treatment group assignment will not be a randomized procedure. Allocation data will be collected from medical records as a dichotomous variable. In the present study, allocation to CAZAVI + ATM or OAAs will depend on various factors such as drug availability, hospital costs, and medical criteria. Therefore, to ensure comparability among participant characteristics, baseline factors will be adjusted to mitigate indication bias. To simulate randomization at baseline (identification of MBL-type CPE in blood samples), ensuring comparability between treatment groups, several covariates will be balanced: age, sex, comorbidities (Charlson score), Pitt score, immunosuppression with neutropenia, immunosuppression without neutropenia, days of hospitalization prior to culture, Sequential Organ Failure Assessment (SOFA) score, days of effective antibiotic treatment between blood culture and positivization \[25\]. Also, as this is a multicenter study, it will be adjusted for the characteristics of the center (public-private), including a total of 10 variables to be adjusted for. The start of the follow-up period (Time Zero or T0) will be defined by the identification of MBL-type CPE in at least one clinical blood sample (blood culture or PCR). From this point on, all patients will be followed up. A 24-hour grace period will be considered from the identification of MBL-type CPE until the patient initiates either of the two treatment groups. To mitigate immortality bias, the initiation of both treatment strategies will synchronize with the eligibility criteria at Time Zero of follow-up. Thus, every patient must remain alive from blood culture collection until MBL detection to be eligible for inclusion in the study, and antibiotic treatment must be initiated within 24 hours of detection. All enrolled patients will be followed until 30 days after inclusion in the study, death, or hospital discharge, whichever occurs first. A sample calculation was performed to test the null hypothesis of equality in the proportion of deaths among patients who received CAZAVI + ATM vs. OAAs. Falcone et al. reported a 19% mortality rate 30 days after inclusion in the CAZAVI + ATM arm and a 44% mortality rate in patients with OAAs. However, for the present study we consider an 80% power is necessary to detect a clinically relevant difference of 15%, therefore we expect a mortality of 34% in the OAAs arm and 19% in the CAZAVI + ATM arm. With an alpha of 5%, two-tailed test, expected ratio CAZAVI + ATM/OAAs of 1:1, a sample size of 270 patients (135 for each branch) is calculated. Finally, to address indication bias, an adjustment will be made with Propensity Score (PS) matching. Considering 10 confounders entered into the model, at least 10 to 20 events will be required for each variable. Therefore, as the outcome of the PS will be the CAZAVI + ATM exposure variable, at least 150 patients in the CAZAVI + ATM branch will be required. Thus,we consider the calculation of 300 patients, 150 per branch. A meticulous data collection plan will be carried out to ensure accuracy and confidentiality of the information collected. The following procedures will be implemented: Data source: Data will be obtained from paper or electronic medical records from each participating center. Patient tracking will be done through the bacteriology records of each hospital center. Data recording: Variables for each patient will be uploaded to a centralized REDCap database. The principal investigator and associated investigators of each participating center will be responsible for data upload. To maintain privacy and confidentiality, each patient will receive a randomly generated registration number to anonymize their identity in the database. Data access: Access to center-specific data will be restricted to the principal investigators. Researchers will access REDCap using personal credentials, limiting data access to authorized personnel only. Confidentiality and anonymization: Adherence to legal provisions, such as the Argentinian National Personal Data Protection (number 25.326) and the Habeas Data, will be strictly complied with in order to protect the confidentiality and privacy of the patients involved in the study. All collected data will be anonymized, devoid of patient identifiers. Data storage: Once the data upload is completed, the entire database will be stored under password and will only be available to the principal investigators of the study. All necessary precautions will be taken to ensure that the data are maintained in a secure and reliable environment. The research team is dedicated to upholding data privacy, complying with legal regulations, and conducting the study ethically and responsibly. ### Conditions Module **Conditions:** - Bacteremia **Keywords:** - multicenter - target trial emulation - bacteremia - metallo-beta-lactamase - carbapenemase-producing Enterobacteriaceae - ceftazidime-avibactam aztreonam ### Design Module #### Design Info **Observational Model:** OTHER **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 300 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** patients who received antibiotic therapy with a standard bacteremia treatment dose of Ceftazidima-Avibactam + Aztreonam (2.5 grams every 8 hours of ceftazidime-avibactam + 2 grams every 8 hours of aztreonam). Dosage adjustments for prolonged infusion or according to renal function will be considered. **Label:** CAZAVI + ATM #### Arm Group 2 **Description:** Patients who received a combination of at least two of the following antibiotics, with doses adjusted according to renal function: Colistin: 300 mg loading and 150 mg maintenance every 12 hours. Meropenem: 1000 or 2000 mg every 8 hours via infusion in 30 minutes or 3 hours. Fosfomycin: 12 to 24 grams per day, divided every 6 to 8 hours. Aminoglycoside (amikacin: 15 mg/kg/24 hours or gentamicin: 7 mg/kg/24 hours). Tigecycline: 100 or 200 mg loading and 50 or 100 mg maintenance every 12 hours. **Label:** Other Active Antibiotics treatment group ### Outcomes Module #### Primary Outcomes **Description:** death from any cause **Measure:** All-cause mortality **Time Frame:** within 30 days from the initiation of treatment (follow-up period) #### Secondary Outcomes **Description:** including the associated enzymatic mechanisms **Measure:** Describe the resistance profile of the isolated microorganisms **Time Frame:** 30-day follow-up period **Description:** presence of 1) Relapse: recurrent bacteremia due to the same bacteria; 2) Restart of antibiotic therapy targeting the same germs; 3) Local suppurative complication that was not present at the beginning of the infection; 4) Distant complications of the initial infection (defined by the growth of the same bacteria causing the initial bacteremia in distant sites) **Measure:** Compare clinical failure **Time Frame:** 30-day follow-up period **Description:** (leukocyte count less than 12x109/L). (leukocyte co(leukocyte count less than 12x109/L).unt less than 12x109/L) **Measure:** Compare the number of days to normalization of the leukocyte count in the laboratory **Time Frame:** 30-day follow-up period **Description:** including: neutropenia, thrombocytopenia, renal failure, hepatotoxicity, skin reactions and ion-losing tubulopathy **Measure:** Compare the proportion of adverse events **Time Frame:** 30-day follow-up period **Description:** Appearance of positive C. difficile toxin or positive C. difficile PCR **Measure:** compare the occurrence of Clostridium difficile infection **Time Frame:** 30-day follow-up period **Description:** such as KPC, NDM, VIM, IMP, OXA or EVR-producing CLD, detected in both clinical and surveillance samples **Measure:** compare the occurrence of new multidrug-resistant microorganisms **Time Frame:** 30-day follow-up period ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients aged 18 years or older * Confirmed bacteremia by MBL-type Carbapenemase-Producing Enterobacteriaceae (CPE) * Initiation of effective antibiotic therapy within 24 hours of identification of MBL-type CPE and within 96 hours of blood sample. Exclusion Criteria: * Bacteremia due to the following complicated infections: * Endocarditis or other endovascular infection without extractable focus. * Necrotizing fasciitis * Osteomyelitis or septic arthritis * Confirmed prostatitis * Non-drainable abscess or other unresolved infection requiring surgical intervention (e.g., cholecystitis) * Central nervous system infections * Empyema * Successive episodes of bacteremia by the same pathogen (with the same resistance profile) within the previous 60 days. * Polymicrobial bacteremias, not classified as contaminants. * Patients with documented allergy to beta-lactams. **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** The study will include a cohort of hospitalized patients from Argentine hospitals. Hospital centers will be invited to participate through the network of the Argentine Society of Medicine (SAM), the Argentine Society of Intensive Care (SATI) and the Argentine Society Of Infectious Diseases (SADI). ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Mariana Vaena, MD **Phone:** 5493624628553 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Hospital Italiano de Buenos Aires **Name:** Ivan Huespe, MD, MPh **Role:** STUDY_DIRECTOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** van Duin D, Doi Y. The global epidemiology of carbapenemase-producing Enterobacteriaceae. Virulence. 2017 May 19;8(4):460-469. doi: 10.1080/21505594.2016.1222343. Epub 2016 Aug 11. **PMID:** 27593176 **Citation:** Zhou R, Fang X, Zhang J, Zheng X, Shangguan S, Chen S, Shen Y, Liu Z, Li J, Zhang R, Shen J, Walsh TR, Wang Y. Impact of carbapenem resistance on mortality in patients infected with Enterobacteriaceae: a systematic review and meta-analysis. BMJ Open. 2021 Dec 14;11(12):e054971. doi: 10.1136/bmjopen-2021-054971. **PMID:** 34907071 **Citation:** Lee YL, Ko WC, Hsueh PR. Geographic patterns of global isolates of carbapenem-resistant Klebsiella pneumoniae and the activity of ceftazidime/avibactam, meropenem/vaborbactam, and comparators against these isolates: Results from the Antimicrobial Testing Leadership and Surveillance (ATLAS) program, 2020. Int J Antimicrob Agents. 2022 Nov-Dec;60(5-6):106679. doi: 10.1016/j.ijantimicag.2022.106679. Epub 2022 Oct 12. **PMID:** 36241011 **Citation:** Tsolaki V, Mantzarlis K, Mpakalis A, Malli E, Tsimpoukas F, Tsirogianni A, Papagiannitsis C, Zygoulis P, Papadonta ME, Petinaki E, Makris D, Zakynthinos E. Ceftazidime-Avibactam To Treat Life-Threatening Infections by Carbapenem-Resistant Pathogens in Critically Ill Mechanically Ventilated Patients. Antimicrob Agents Chemother. 2020 Feb 21;64(3):e02320-19. doi: 10.1128/AAC.02320-19. Print 2020 Feb 21. **PMID:** 31818820 **Citation:** El Nekidy WS, Al Ali M, Abidi E, Ghazi IM, Attallah N, El Lababidi R, Mooty M, Ghosn M, Mallat J. Microbiologic outcomes of ceftazidime-avibactam dosing in patients with sepsis utilizing renal replacement therapies. Hemodial Int. 2023 Jul;27(3):289-295. doi: 10.1111/hdi.13090. Epub 2023 May 5. **PMID:** 37144742 **Citation:** Caston JJ, Cano A, Perez-Camacho I, Aguado JM, Carratala J, Ramasco F, Soriano A, Pintado V, Castelo-Corral L, Sousa A, Farinas MC, Munoz P, Abril Lopez De Medrano V, Sanz-Pelaez O, Los-Arcos I, Gracia-Ahufinger I, Perez-Nadales E, Vidal E, Doblas A, Natera C, Martinez-Martinez L, Torre-Cisneros J. Impact of ceftazidime/avibactam versus best available therapy on mortality from infections caused by carbapenemase-producing Enterobacterales (CAVICOR study). J Antimicrob Chemother. 2022 Apr 27;77(5):1452-1460. doi: 10.1093/jac/dkac049. **PMID:** 35187577 **Citation:** Zheng G, Cai J, Zhang L, Chen D, Wang L, Qiu Y, Deng H, Bai H, Bian X, He J. Ceftazidime/Avibactam-Based Versus Polymyxin B-Based Therapeutic Regimens for the Treatment of Carbapenem-Resistant Klebsiella pneumoniae Infection in Critically Ill Patients: A Retrospective Cohort Study. Infect Dis Ther. 2022 Oct;11(5):1917-1934. doi: 10.1007/s40121-022-00682-0. Epub 2022 Aug 17. **PMID:** 35976531 **Citation:** Qu J, Xu J, Liu Y, Hu C, Zhong C, Lv X. Real-world effectiveness of ceftazidime/avibactam versus polymyxin B in treating patients with carbapenem-resistant Gram-negative bacterial infections. Int J Antimicrob Agents. 2023 Aug;62(2):106872. doi: 10.1016/j.ijantimicag.2023.106872. Epub 2023 May 27. **PMID:** 37247645 **Citation:** Yang P, Li Y, Wang X, Chen N, Lu X. Efficacy and safety of ceftazidime-avibactam versus polymyxins in the treatment of carbapenem-resistant Enterobacteriaceae infection: a systematic review and meta-analysis. BMJ Open. 2023 May 3;13(5):e070491. doi: 10.1136/bmjopen-2022-070491. **PMID:** 37137556 **Citation:** Nagvekar V, Shah A, Unadkat VP, Chavan A, Kohli R, Hodgar S, Ashpalia A, Patil N, Kamble R. Clinical Outcome of Patients on Ceftazidime-Avibactam and Combination Therapy in Carbapenem-resistant Enterobacteriaceae. Indian J Crit Care Med. 2021 Jul;25(7):780-784. doi: 10.5005/jp-journals-10071-23863. **PMID:** 34316172 **Citation:** Marshall S, Hujer AM, Rojas LJ, Papp-Wallace KM, Humphries RM, Spellberg B, Hujer KM, Marshall EK, Rudin SD, Perez F, Wilson BM, Wasserman RB, Chikowski L, Paterson DL, Vila AJ, van Duin D, Kreiswirth BN, Chambers HF, Fowler VG Jr, Jacobs MR, Pulse ME, Weiss WJ, Bonomo RA. Can Ceftazidime-Avibactam and Aztreonam Overcome beta-Lactam Resistance Conferred by Metallo-beta-Lactamases in Enterobacteriaceae? Antimicrob Agents Chemother. 2017 Mar 24;61(4):e02243-16. doi: 10.1128/AAC.02243-16. Print 2017 Apr. **PMID:** 28167541 **Citation:** Falcone M, Daikos GL, Tiseo G, Bassoulis D, Giordano C, Galfo V, Leonildi A, Tagliaferri E, Barnini S, Sani S, Farcomeni A, Ghiadoni L, Menichetti F. Efficacy of Ceftazidime-avibactam Plus Aztreonam in Patients With Bloodstream Infections Caused by Metallo-beta-lactamase-Producing Enterobacterales. Clin Infect Dis. 2021 Jun 1;72(11):1871-1878. doi: 10.1093/cid/ciaa586. **PMID:** 32427286 **Citation:** Hoffman KL, Schenck EJ, Satlin MJ, Whalen W, Pan D, Williams N, Diaz I. Comparison of a Target Trial Emulation Framework vs Cox Regression to Estimate the Association of Corticosteroids With COVID-19 Mortality. JAMA Netw Open. 2022 Oct 3;5(10):e2234425. doi: 10.1001/jamanetworkopen.2022.34425. **PMID:** 36190729 **Citation:** Huttner A, Albrich WC, Bochud PY, Gayet-Ageron A, Rossel A, Dach EV, Harbarth S, Kaiser L. PIRATE project: point-of-care, informatics-based randomised controlled trial for decreasing overuse of antibiotic therapy in Gram-negative bacteraemia. BMJ Open. 2017 Jul 13;7(7):e017996. doi: 10.1136/bmjopen-2017-017996. **PMID:** 28710229 **Citation:** Tingsgard S, Bastrup Israelsen S, Ostergaard C, Benfield T. Emulating a Target Trial of Shorter Compared to Longer Course of Antibiotic Therapy for Gram-Negative Bacteremia. Clin Infect Dis. 2024 Feb 17;78(2):292-300. doi: 10.1093/cid/ciad670. **PMID:** 37949816 #### See Also Links **Label:** Global antimicrobial resistance and use surveillance system (GLASS) report: 2022. World Health Organization; 9 Dec 2022 \[cited 3 Oct 2023\]. **URL:** https://www.who.int/publications/i/item/9789240062702 **Label:** Surveillance of antimicrobial resistance in Europe 2017. In: European Centre for Disease Prevention and Control **URL:** https://www.ecdc.europa.eu/en/publications-data/surveillance-antimicrobial-resistance-europe-2017 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001424 - Term: Bacterial Infections - ID: D000001423 - Term: Bacterial Infections and Mycoses - ID: D000007239 - Term: Infections - ID: D000018805 - Term: Sepsis - ID: D000018746 - Term: Systemic Inflammatory Response Syndrome - ID: D000007249 - Term: Inflammation - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC01 - Name: Infections - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M18877 - Name: Bacteremia - Relevance: HIGH - As Found: Bacteremia - ID: M10283 - Name: Infections - Relevance: LOW - As Found: Unknown - ID: M6368 - Name: Communicable Diseases - Relevance: LOW - As Found: Unknown - ID: M4722 - Name: Bacterial Infections - Relevance: LOW - As Found: Unknown - ID: M12136 - Name: Mycoses - Relevance: LOW - As Found: Unknown - ID: M4721 - Name: Bacterial Infections and Mycoses - Relevance: LOW - As Found: Unknown - ID: M20864 - Name: Sepsis - Relevance: LOW - As Found: Unknown - ID: M16869 - Name: Toxemia - Relevance: LOW - As Found: Unknown - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M20818 - Name: Systemic Inflammatory Response Syndrome - Relevance: LOW - As Found: Unknown - ID: M10293 - Name: Inflammation - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000016470 - Term: Bacteremia ### Intervention Browse Module - Browse Branches - Abbrev: Infe - Name: Anti-Infective Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4222 - Name: Anti-Bacterial Agents - Relevance: LOW - As Found: Unknown - ID: M1889 - Name: Meropenem - Relevance: LOW - As Found: Unknown - ID: M3924 - Name: Amikacin - Relevance: LOW - As Found: Unknown - ID: M5692 - Name: Ceftazidime - Relevance: LOW - As Found: Unknown - ID: M4224 - Name: Antibiotics, Antitubercular - Relevance: LOW - As Found: Unknown - ID: M8951 - Name: Gentamicins - Relevance: LOW - As Found: Unknown - ID: M6319 - Name: Colistin - Relevance: LOW - As Found: Unknown - ID: M99884 - Name: Avibactam, ceftazidime drug combination - Relevance: LOW - As Found: Unknown - ID: M233142 - Name: Avibactam - Relevance: LOW - As Found: Unknown - ID: M8700 - Name: Fosfomycin - Relevance: LOW - As Found: Unknown - ID: M1948 - Name: Tigecycline - Relevance: LOW - As Found: Unknown - ID: M4696 - Name: Aztreonam - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419283 **Brief Title:** Prospective Study on Safety and Efficacy of Stenting for Chronic Middle Cerebral Artery Occlusion With Limb Dysfunction **Official Title:** Evaluation of the Safety and Efficacy of Stenting for Chronic Middle Cerebral Artery Occlusion With Limb Dysfunction: a Prospective Study #### Organization Study ID Info **ID:** LLBA201952A #### Organization **Class:** OTHER **Full Name:** Huizhou Municipal Central Hospital ### Status Module #### Completion Date **Date:** 2024-03-01 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-15 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2022-12-01 **Type:** ACTUAL #### Start Date **Date:** 2019-08-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-07 **Study First Submit QC Date:** 2024-05-15 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Huizhou Municipal Central 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 study is to evaluate the safety and efficacy of stenting for revascularization treatment of chronic middle cerebral artery (MCA) occlusion in patients with chronic MCA occlusion. The main questions it aims to answer are: 1. Whether stenting treatment can improve blood flow restoration in chronic MCA occlusion. 2. If stenting can reduce the rates of reocclusion. 3. How stenting affects the recovery of neurological functions in these patients. Researchers will compare the stenting group, which received stenting revascularization in addition to aspirin treatment, to the control group, which received only aspirin treatment to see if stenting treatment provides superior outcomes in terms of neurological function improvement and safety profile. Participants will: 1. Undergo full cerebral angiography to identify the occlusion site. 2. All participants will be monitored for post-procedure complications and neurological function using the Modified Rankin Scale (mRS) and National Institutes of Health Stroke Scale (NIHSS) before and after treatment. 3. Participants will be followed up for three months post-treatment to assess the long-term efficacy and safety of the stenting procedure. ### Conditions Module **Conditions:** - Chronic Middle Cerebral Artery Occlusion - Stenting Treatment - Modified Rankin Scale - National Institutes of Health Stroke Scale ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 59 **Type:** ACTUAL **Phases:** - EARLY_PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Middle Cerebral Artery Stent Implantation **Intervention Names:** - Procedure: Middle Cerebral Artery Stent Implantation - Drug: standard treatment with aspirin. **Label:** stenting group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** standard treatment with aspirin. **Intervention Names:** - Drug: standard treatment with aspirin. **Label:** control group **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - stenting group **Description:** Middle Cerebral Artery Stent Implantation **Name:** Middle Cerebral Artery Stent Implantation **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - control group - stenting group **Description:** standard treatment with aspirin. **Name:** standard treatment with aspirin. **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** The Modified Rankin Scale (mRS) scores serve as a critical outcome measure to assess the effectiveness of stenting treatment for patients with chronic middle cerebral artery (MCA) occlusion. The mRS is a standardized instrument that evaluates the degree of disability or dependence in daily activities following a stroke. It ranges from 0 (no symptoms) to 6 (death), with a higher mRS score indicates a greater level of disability or dependence. **Measure:** the Modified Rankin Scale (mRS) scores **Time Frame:** 3 months **Description:** The National Institutes of Health Stroke Scale (NIHSS) scores：By quantifying the degree of neurological deficits in stroke patients before and three months after surgery, the efficacy and safety of stent implantation can be assessed. The NIHSS score includes multiple items, with higher scores indicating more severe functional impairments, ranging from a total score of 0 (no stroke) to 42 (severe stroke). **Measure:** the National Institutes of Health Stroke Scale (NIHSS) scores **Time Frame:** 3 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Age and gender: individuals aged 18 and above, regardless of gender. * Diagnosis: chronic MCA occlusion confirmed by imaging studies (such as Magnetic Resonance Imaging (MRI) or Computed Tomography (CT)) for more than 3 months. * Symptoms: neurological deficits caused by MCA occlusion, such as hemiplegia, speech disorders, etc. * Treatment History: no stenting revascularization for MCA occlusion within the past three months. Exclusion Criteria: * Acute stroke: occurrence of an acute cerebrovascular event within the past three months. * Other significant diseases: such as severe heart disease, liver or kidney dysfunction, cerebral hemorrhage, active bleeding, or coagulation disorders. * Allergy to contrast agents. * Severe mental illness or inability to comply with study requirements. * Pregnant or breastfeeding women. * Discovery of MCA occlusion without any symptoms. * Participation in other clinical trials within the past six months. **Maximum Age:** 99 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Huizhou **Country:** China **Facility:** Huihong Huang **State:** Guangdong **Zip:** 516001 ### IPD Sharing Statement Module **IPD Sharing:** NO ## Document Section ### Large Document Module #### Large Docs - Date: 2021-03-01 - Filename: Prot_SAP_000.pdf - Has ICF: False - Has Protocol: True - Has SAP: True - Label: Study Protocol and Statistical Analysis Plan - Size: 275770 - Type Abbrev: Prot_SAP - Upload Date: 2024-05-15T21:58 - Date: 2021-02-25 - Filename: ICF_001.pdf - Has ICF: True - Has Protocol: False - Has SAP: False - Label: Informed Consent Form - Size: 338243 - Type Abbrev: ICF - Upload Date: 2024-05-15T21:59 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000014652 - Term: Vascular Diseases - ID: D000002318 - Term: Cardiovascular Diseases - ID: D000002544 - Term: Cerebral Infarction - ID: D000020520 - Term: Brain Infarction - ID: D000002545 - Term: Brain Ischemia - ID: D000002561 - Term: Cerebrovascular Disorders - ID: D000001927 - Term: Brain Diseases - ID: D000002493 - Term: Central Nervous System Diseases - ID: D000009422 - Term: Nervous System Diseases - ID: D000002539 - Term: Cerebral Arterial Diseases - ID: D000020765 - Term: Intracranial Arterial Diseases - ID: D000020521 - Term: Stroke - ID: D000007238 - Term: Infarction - ID: D000007511 - Term: Ischemia - ID: D000010335 - Term: Pathologic Processes - ID: D000009336 - Term: Necrosis ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC14 - Name: Heart and Blood Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M22306 - Name: Stroke - Relevance: LOW - As Found: Unknown - ID: M10282 - Name: Infarction - Relevance: LOW - As Found: Unknown - ID: M22069 - Name: Infarction, Middle Cerebral Artery - Relevance: HIGH - As Found: Middle Cerebral Artery Occlusion - ID: M4465 - Name: Arterial Occlusive Diseases - Relevance: HIGH - As Found: Artery Occlusion - ID: M17400 - Name: Vascular Diseases - Relevance: LOW - As Found: Unknown - ID: M5793 - Name: Cerebral Infarction - Relevance: LOW - As Found: Unknown - ID: M22305 - Name: Brain Infarction - Relevance: LOW - As Found: Unknown - ID: M10543 - Name: Ischemia - Relevance: LOW - As Found: Unknown - ID: M5794 - Name: Brain Ischemia - Relevance: LOW - As Found: Unknown - ID: M5810 - Name: Cerebrovascular Disorders - Relevance: LOW - As Found: Unknown - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System Diseases - Relevance: LOW - As Found: Unknown - ID: M5788 - Name: Cerebral Arterial Diseases - Relevance: LOW - As Found: Unknown - ID: M22521 - Name: Intracranial Arterial Diseases - Relevance: LOW - As Found: Unknown - ID: M12284 - Name: Necrosis - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000020244 - Term: Infarction, Middle Cerebral Artery - ID: D000001157 - Term: Arterial Occlusive Diseases ### Intervention Browse Module - Ancestors - ID: D000000894 - Term: Anti-Inflammatory Agents, Non-Steroidal - ID: D000018712 - Term: Analgesics, Non-Narcotic - ID: D000000700 - Term: Analgesics - ID: D000018689 - Term: Sensory System Agents - ID: D000018373 - Term: Peripheral Nervous System Agents - ID: D000045505 - Term: Physiological Effects of Drugs - ID: D000000893 - Term: Anti-Inflammatory Agents - ID: D000018501 - Term: Antirheumatic Agents - ID: D000005343 - Term: Fibrinolytic Agents - ID: D000050299 - Term: Fibrin Modulating Agents - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000010975 - Term: Platelet Aggregation Inhibitors - ID: D000016861 - Term: Cyclooxygenase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000058633 - Term: Antipyretics ### Intervention Browse Module - Browse Branches - Abbrev: Antipy - Name: Antipyretics - Abbrev: Infl - Name: Anti-Inflammatory Agents - Abbrev: ARhu - Name: Antirheumatic Agents - Abbrev: FiAg - Name: Fibrinolytic Agents - Abbrev: Analg - Name: Analgesics - Abbrev: PlAggInh - Name: Platelet Aggregation Inhibitors - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M4548 - Name: Aspirin - Relevance: HIGH - As Found: Progression - ID: M4217 - Name: Anti-Inflammatory Agents - Relevance: LOW - As Found: Unknown - ID: M4218 - Name: Anti-Inflammatory Agents, Non-Steroidal - Relevance: LOW - As Found: Unknown - ID: M4032 - Name: Analgesics - Relevance: LOW - As Found: Unknown - ID: M20786 - Name: Analgesics, Non-Narcotic - Relevance: LOW - As Found: Unknown - ID: M20604 - Name: Antirheumatic Agents - Relevance: LOW - As Found: Unknown - ID: M8473 - Name: Fibrinolytic Agents - Relevance: LOW - As Found: Unknown - ID: M13865 - Name: Platelet Aggregation Inhibitors - Relevance: LOW - As Found: Unknown - ID: M19209 - Name: Cyclooxygenase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown - ID: M29176 - Name: Antipyretics - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000001241 - Term: Aspirin ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419270 **Acronym:** CAREHYPO **Brief Title:** Cardiovascular, Renal, and Skeletal Complications in Patients With Post-Surgical Hypoparathyroidism **Official Title:** Cardiovascular, Renal, and Skeletal Complications in Patients With Post-Surgical Hypoparathyroidism #### Organization Study ID Info **ID:** VK-1-10-72-169-23 #### Organization **Class:** OTHER **Full Name:** University of Aarhus ### Status Module #### Completion Date **Date:** 2028-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-23 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-05 **Type:** ESTIMATED #### Start Date **Date:** 2024-05 **Type:** ESTIMATED **Status Verified Date:** 2024-04 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-07 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Gødstrup Hospital #### Lead Sponsor **Class:** OTHER **Name:** University of Aarhus #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** The aim of this observational study is to learn about long term effects to post surgical hypoparathyroidism. The main questions are: 1. Patients with hypoparathyroidism do not have an increased arterial stiffness compared to healthy controls. 2. Patients with hypoparathyroidism do not have an increased coronary artery plaque burden assessed by cardiac CT compared to healthy controls. 3. Patients with hypoparathyroidism do not have an increased prevalence of vertebral fractures compared to healthy controls. Results will be compared with gender and age matched controls from the general population. Participants will have a CT scan, DXA scan, tonometry, blood samples and questionaries performed and collect a 24-hour urine sample. **Detailed Description:** Hypoparathyroidism is a rare endocrine disorder characterized by hypocalcemia with low or undetectable levels of parathyroid hormone. The most common cause of hypoparathyroidism is following neck surgery, whereas approximately 25% of hypoparathyroidism patients are suffering from non-surgical hypoparathyroidism due to e.g., genetic or autoimmune causes. According to updated international guidelines, the condition is considered chronic if treatment with calcium and activated vitamin D is still needed a year after surgery. A large retrospective cohort study of patients with chronic hypoparathyroidism shows that patients with chronic hypoparathyroidism have a significantly higher risk of cardiovascular disease, compared to patients without hypoparathyroidism. Additionally, it is well known that patients with hypoparathyroidism are at increased risk of renal and extra-skeleton calcifications, although cardiovascular calcifications are only sparsely investigated. Furthermore, both higher arterial stiffness assessed by pulse wave velocity and an increased heart rate have previously been shown in patients with non-surgical hypoparathyroidism. It is largely unknown whether this also applies to patients with post-surgical hypoparathyroidism. The overall aim of the project is to investigate cardiovascular, renal, and skeletal indices in patients diagnosed with Post Surgical hypoparathyroidism and test the following (null-)hypotheses: 1. H0: Patients with post-surgical hypoparathyroidism do not have an increased arterial stiffness compared to healthy controls. 2. H0: Patients with post-surgical hypoparathyroidism do not have an increased coronary artery plaque burden assessed by cardiac CT compared to healthy controls. 3. H0: Patients with post-surgical hypoparathyroidism do not have an increased prevalence of vertebral fractures compared to healthy controls. Patients and controls who accept participation will undergo a detailed examination in terms of: Medical history, physical examination, questionnaires, blood and 24-hour urine samples, DXA scan, HRpQCT, tonometry, 12-lead electrocardiogram, 24-hour blood pressure and a CT scan Data are analyzed according to their distribution using parametric or non-parametric statistics. To address the hypotheses, statistical power calculations have been performed. 50 patients with post-surgical hypoparathyroidism will be matched on sex and age (± 2 years) with 50 randomly selected otherwise healthy controls from the general population. ### Conditions Module **Conditions:** - Hypoparathyroidism - Cardiovascular Complication - Fractures, Bone - Renal Disease ### Design Module #### Design Info **Observational Model:** CASE_CONTROL **Time Perspective:** CROSS_SECTIONAL #### Enrollment Info **Count:** 100 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients with post-surgical hypoparathyroidism **Label:** Patients #### Arm Group 2 **Description:** Gender and age matched controls from the general population **Label:** Controls ### Outcomes Module #### Primary Outcomes **Description:** aortic pulse wave velocity in m/s **Measure:** Arterial stiffness **Time Frame:** 24 months **Description:** VFA assessing fractures in numbers **Measure:** Vertebral fractures **Time Frame:** 24 months **Description:** Heart CT scan assessing coronary artery calcium score **Measure:** coronary artery plaque burden **Time Frame:** 24 months #### Secondary Outcomes **Description:** Description of calcifications **Measure:** Renal indices **Time Frame:** 24 months **Description:** Description of bone status **Measure:** bone indices **Time Frame:** 24 months **Description:** Description of calcifications **Measure:** Cardiovascular indices **Time Frame:** 24 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: Patients only: * Chronic post surgical hypoparathyroidism diagnosed \> 5 years ago. (In case recruitment is too challenging, we will accept duration of disease of minimum one year. Including patients with longest duration of disease first.) * Require treatment with active vitamin D ≥ 1 µg/day Controls only: * No history of neck surgery * No history of parathyroid disease All participants: * Age ≥ 18 years * 25(OH)D vitamin ≥ 50 nmol/L * Serum magnesium ≥ 0,50 mmol/L * Able to read and understand Danish * Willing and able to sign the informed consent form Exclusion Criteria: * Estimated glomerular filtration rate (eGFR) \< 30 ml/min/1.73 m3 * Active cancer or former (except thyroid and basal cell skin) cancer treatment \< 5 year ago * Pregnancy, or breastfeeding \< 1 year ago * Untreated thyroid or liver diseases during the last year * Treatment with lithium within the last 4 weeks * Known allergy or sensitivity to iodine * Any reason that in the opinion of the investigator, that would prevent the patient from completing the study. **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** Patients will be recruited from endocrine clinics Controls will be recruited from the general population ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Sarah Thornhoj **Phone:** 40491821 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Aarhus University Hospital **Name:** Lars Rejnmark **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000010279 - Term: Parathyroid Diseases - ID: D000004700 - Term: Endocrine System Diseases - ID: D000014947 - Term: Wounds and Injuries ### Condition Browse Module - Browse Branches - Abbrev: BXS - Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions - Abbrev: All - Name: All Conditions - Abbrev: BC26 - Name: Wounds and Injuries - Abbrev: BC19 - Name: Gland and Hormone Related Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M10698 - Name: Kidney Diseases - Relevance: LOW - As Found: Unknown - ID: M26370 - Name: Fractures, Bone - Relevance: HIGH - As Found: Fractures, Bone - 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: M17685 - Name: Wounds and Injuries - Relevance: LOW - As Found: Unknown - ID: T2949 - Name: Hypoparathyroidism - Relevance: HIGH - As Found: Hypoparathyroidism ### Condition Browse Module - Meshes - ID: D000007011 - Term: Hypoparathyroidism - ID: D000050723 - Term: Fractures, Bone ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419257 **Brief Title:** Investigating the Efficacy of an Augmented Virtual Reality Driving Simulator on Institutionalized Dementia Patients **Official Title:** Investigating the Efficacy of an Augmented Virtual Reality Driving Simulator (VRDS) on Institutionalized Dementia Patients #### Organization Study ID Info **ID:** HS23059 (B2023:059) #### Organization **Class:** OTHER **Full Name:** University of Manitoba ### Status Module #### Completion Date **Date:** 2025-06-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-16 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-01-02 **Type:** ACTUAL **Status Verified Date:** 2023-07 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2023-08-01 **Study First Submit QC Date:** 2024-05-16 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Manitoba #### 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 improvement in health and welfare in modern society has led to an increase in life expectancy. Alternatively, the longer one lives, the more likely to experience deterioration in memory, cognitive ability, and executive function skills in our brains. While some cognitive impairments can be typical results of normal aging, a decline in spatial cognition can be a sign of dementia, especially Alzheimer's disease (AD). Based on the neuroplasticity of the brain even at old ages, there are some hopes to combat dementia by repeated use of cognitive exercises in the form of a serious game designed for older adults. A popular new technology to be used to design serious games is virtual reality (VR) designs. Aside from the gaming applications, the focus of VR experiments in medicine and neuroscience is to simulate a naturalistic environment to investigate brain function and/or use it for cognitive training. A virtual reality driving simulator (VRDS) has been developed by our team that is proposed to be installed in an existing car model at Riverview Health Center (RHC) dementia units. The VRDS has different levels of difficulty so that it can be utilized by people with different levels of cognitive impairments. However, in this study, the users will probably use only its level 1. The aim is to investigate the efficacy of the VRDS amongst institutionalized Alzheimer's/dementia patients, who are not capable of performing standard assessments. The goal is mainly to improve their mood and quality of life as many of these patients miss driving. Thus, their plausible mood change are assessed by asking the dementia unit nurses to share their observations of the patients in relation to VRDS usage; it will be a free-format anecdotal observation. In addition, while these patients are not expected to show any significant learning, playing this VRDS may improve patients' implicit memory; which can be observed by how well or poor they drive the simulated car; for example, how many times they crash to the curb or how many times they hit an animal, or how many times they ignore the red traffic light, etc.; these are reflected in the game's score. It is anticipated that this VRDS will have an overall positive effect on users' moods, and also it may result in an implicit memory improvement. **Detailed Description:** The only research instrument is the designed VRDS. Virtual Reality Driving Simulator (VRDS) Experiment The VRDS is a serious game that features three levels of difficulty and routes through a naturalistic country road. As the game progresses in each level, the route will contain various intersections. One intersection is located on the first level, while two and three intersections are located on the second and third levels. A number of traffic elements are placed along the road. Every intersection has a traffic light. There are stop signs at a few points throughout each level (one stop sign for each of the first two levels and two stop signs for the final level). In addition, an upcoming vehicle is occasionally placed in the opposite lane and during the initial stages of each level, the sudden appearance of a rural animal is simulated. In this study, our target users are advanced stage 3 and 4 dementia (in particular Alzheimer's disease) patients who are institutionalized. Therefore, the VRDS has been designed in a way that when a participant starts using it, the game will begin from level 1. In case they successfully complete the level, then they will automatically proceed to level 2. If the game remains idle, then it will be reset to level 1. There will be no written instructions but an audio messages is played as the warning (e.g. passing a red light without stopping) and encouraging messages when they reach a target on the road. User-specific log files are created for each training trial the user plays; they are created using an interactive input field before the training begins. Our analysis of the logged file lets us know for example whether the users have stopped at traffic signals and stop signs in a timely manner, or they have crashed to the curb, or haven't stopped when an animal jumps to the road, etc. The VRDS will be installed in the existing car model in A-B dementia units of the RHC. The steering wheel and accelerating pedal of the car will be replaced with the steering wheel and pedals that are used as input controllers of the VRDS game. The VRDS screen on the laptop will be projected to the actual front window of the car. In our experience, patients with advanced-stage dementia do not feel motion sickness; however, it is still possible for a participant to feel motion sickness, in that case, the research assistant next to the participant will stop the program and help the participant to get out of the car and back to their room. ### Conditions Module **Conditions:** - Advance Dementia ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 20 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Individuals who would use the VRDS **Intervention Names:** - Device: VRDS **Label:** VRDS users **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - VRDS users **Description:** VRDS is an augmented virtual reality driving simulator. **Name:** VRDS **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** a custom made questionnaire for interview of the nurses of the participants **Measure:** Nurses overall observations of the study participants on a scale of -1, 0 and 1 for worse, no change and improved, respectively. **Time Frame:** every week for a maximum of 52 weeks #### Secondary Outcomes **Description:** The VRDS logs all the information on how the game is played. Those information is used to give an overall score representing the performance of the user. **Measure:** The Game's score through the period of the study on a value between 0 to 100 for the minimum and maximum score in the game. **Time Frame:** every week for a maximum of 52 weeks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Living in a dementia care unit of Riverview Health Center * Being mobile and able to see. Exclusion Criteria: * Residents with significant mobility issues (wheelchair users) and those with significant visual impairment will be excluded. **Minimum Age:** 50 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Zahra Moussavi, Ph.D. **Phone:** 2044747023 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Saber Mirmiran, M.Sc. **Role:** CONTACT #### Locations **Location 1:** **City:** Winnipeg **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Zahra Moussavi, Ph.D. - **Phone:** 204-478-6163 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Saber Mirmiran, M.Sc. - **Role:** CONTACT ***Contact 3:*** - **Name:** Zahra Kazem-Moussavi, Ph.D. - **Role:** PRINCIPAL_INVESTIGATOR **Country:** Canada **Facility:** Riverview Health Center **State:** Manitoba **Status:** RECRUITING **Zip:** R3L 2P4 #### Overall Officials **Official 1:** **Affiliation:** University of Manitoba **Name:** Zahra Moussavi **Role:** PRINCIPAL_INVESTIGATOR ## 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: 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 ### Condition Browse Module - Browse Leaves - ID: M6904 - Name: Dementia - Relevance: HIGH - As Found: Dementia - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System 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 ### Condition Browse Module - Meshes - ID: D000003704 - Term: Dementia ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419244 **Brief Title:** Myosteatosis in Oeso-gastric Cancer: Clinical Impacts **Official Title:** Myosteatosis in Oeso-gastric Cancer: Clinical Impacts #### Organization Study ID Info **ID:** TuMECA #### Organization **Class:** OTHER **Full Name:** Cliniques universitaires Saint-Luc- Université Catholique de Louvain ### Status Module #### Completion Date **Date:** 2026-05-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-05-01 **Type:** ACTUAL #### Start Date **Date:** 2024-05-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-03-20 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Cliniques universitaires Saint-Luc- Université Catholique de Louvain #### 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 project is to study the presence of cancer-associated adipocytes in oesogastric cancers and their possible links with myosteatosis. This research project has a retrospective component, the aim of which is to analyse the body component based on imaging in patients with oesogastric neoplasia in order to determine the incidence of myosteatosis and to study the relationship with oncological and prognostic data. The second part of the project is prospective and will collect biological material (skeletal muscle, adipose tissue, tumour, blood) for histological, molecular and genomic analyses and will analyse muscle function in patients with oesogastric cancer. It will address the role of adipocytes in the tumour microenvironment of oesogastric cancer, focusing on their interactions with the observed muscle myosteatosis and prognosis. In the future, it will help to identify signalling pathways, targets and patients who could benefit from appropriate treatment. **Detailed Description:** Oesophageal and gastric cancer pose a significant challenge to caregivers, both in terms of the complexity of its presentation and its treatment. At diagnosis, patients often present with malnutrition associated with sarcopenia, which has a significant impact on morbidity and mortality. Although loss of muscle mass has received much attention in cancer, muscle quality, particularly the accumulation of fat in muscle named "myosteatosis", may be considered as a better predictor of a patient's physical condition and ability to recover from cancer treatments. Studying the tumor microenvironment is essential to understanding the mechanisms underlying disease progression. Cancer-associated adipocytes (CAA), a major component of this tumor microenvironment, provide an interface for dialogue with the tumor through the secretion of pro-inflammatory cytokines, metalloproteases and the release of free fatty acids. They have been described as capable of stimulating tumor progression, particularly in breast cancer. However, their presence in oesogastric cancer and possible links with myosteatosis have not been described. ### Conditions Module **Conditions:** - Esophageal Cancer - Gastric Cancer - Myopenia - Adipose Tissue Tumor ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** BASIC_SCIENCE #### Enrollment Info **Count:** 50 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients undergoing surgery **Intervention Names:** - Diagnostic Test: Myosteatosis **Label:** Surgical patients **Type:** OTHER #### Arm Group 2 **Description:** Patients not undergoing surgery **Intervention Names:** - Diagnostic Test: Myosteatosis **Label:** Non surgical patients **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Non surgical patients - Surgical patients **Description:** Determination of myosteatosis by imaging **Name:** Myosteatosis **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** Muscle fat infiltration measured by analysis of tissue density based on a CT scan in L3 with the help of body component analysis software **Measure:** Myosteatosis **Time Frame:** Through study completion, an average of 2 years #### Secondary Outcomes **Description:** Hand grip test **Measure:** Physical functional status 1 **Time Frame:** Through study completion, an average of 2 years **Description:** 6 minutes walking test **Measure:** Physical functional status 2 **Time Frame:** Through study completion, an average of 2 years **Description:** Chair lift test **Measure:** Physical functional status 3 **Time Frame:** Through study completion, an average of 2 years **Description:** Determining the presence and impact of tumor-associated adipocytes **Measure:** Cancer-associated adipocytes **Time Frame:** Through study completion, an average of 2 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Patients with cancer of the oesophagus, oeso-gastric junction or stomach * Treatment and estimated survival of more than 3 months * Signed informed consent * \> 18 years of age Exclusion Criteria: * Neuromuscular or orthopedic pathology * Cognitive disorders * Psychiatric disorders * Inability to communicate in French or English **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Yannick Deswysen, MD **Phone:** 00327642213 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Nicolas Lanthier, PhD **Phone:** 00327642822 **Role:** CONTACT #### Locations **Location 1:** **City:** Bruxelles **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Yannick Deswysen, MD - **Phone:** 00327642213 - **Role:** CONTACT **Country:** Belgium **Facility:** Cliniques universitaires Saint-Luc **Status:** RECRUITING **Zip:** 1200 #### Overall Officials **Official 1:** **Affiliation:** Cliniques universitaires Saint-Luc **Name:** Yannick Deswysen, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000005770 - Term: Gastrointestinal Neoplasms - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000004066 - Term: Digestive System Diseases - ID: D000005767 - Term: Gastrointestinal Diseases - ID: D000013272 - Term: Stomach Diseases - ID: D000018204 - Term: Neoplasms, Connective and Soft Tissue - ID: D000009370 - Term: Neoplasms by Histologic Type ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M16064 - Name: Stomach Neoplasms - Relevance: HIGH - As Found: Gastric Cancer - ID: M8088 - Name: Esophageal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M20351 - Name: Neoplasms, Adipose Tissue - Relevance: HIGH - As Found: Adipose Tissue Tumor - ID: M8886 - Name: Gastrointestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7256 - Name: Digestive System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M16062 - Name: Stomach Diseases - Relevance: LOW - As Found: Unknown - ID: 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: T5486 - Name: Stomach Cancer - Relevance: HIGH - As Found: Gastric Cancer - ID: T2141 - Name: Esophageal Cancer - Relevance: HIGH - As Found: Esophageal Cancer ### Condition Browse Module - Meshes - ID: D000013274 - Term: Stomach Neoplasms - ID: D000018205 - Term: Neoplasms, Adipose Tissue ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419231 **Brief Title:** Effectiveness of a Butyrate Formulation and Butyrate + Polyphenol Formulation on Gut Health, Permeability and Associated Symptoms **Official Title:** A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Effects of a Butyrate Formulation and a Butyrate + Polyphenol Formulation on Gut Health, Permeability and Associated Symptoms #### Organization Study ID Info **ID:** CL115 #### Organization **Class:** INDUSTRY **Full Name:** Supplement Formulators, Inc. ### Status Module #### Completion Date **Date:** 2025-02-21 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-01-24 **Type:** ESTIMATED #### Start Date **Date:** 2023-10-31 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** Compound Solutions Inc. #### Lead Sponsor **Class:** INDUSTRY **Name:** Supplement Formulators, 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:** The purpose of this study is the assess the effectiveness and safety of a Butyrate formulation and a Butyrate + Polyphenol formulation on gut health, permeability and associated symptoms **Detailed Description:** This is a double-blind, randomized, placebo-controlled, remote design study to evaluate the effects of a Butyrate formulation and Butyrate + Polyphenol formulation on gut health, intestinal permeability and associated symptoms. Participants will be asked to complete laboratory assessments and questionnaires. A total of up to 105 subjects (35 subjects per arm) will be enrolled in a randomly assigned sequence for the 28-day period. There will be three scheduled remote videoconferencing visits with two scheduled telephone contacts. The study subjects will complete assessment tools that include the Gastrointestinal Symptoms Rating Scale for IBS (GSRS-IBS), Digestion-Associated Quality of Life Questionnaire (DQLQ), Visual Abdominal Scale of Abdominal Pain, Bristol Stool Form (BSFS), Gastrointestinal-Global Assessment of Improvement (Gastrointestinal-GAI) and the Short Form-36 Health Survey (SF-36). Laboratory testing will include Gut Microbiome, Short Chain Fatty Acid Analysis, Gut Barrier Panel and Intestinal Permeability. ### Conditions Module **Conditions:** - Gut Health **Keywords:** - Gastrointestinal discomfort, abdominal pain, gas, bloating, diarrhea, constipation, heartburn, abdominal discomfort ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 105 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Butyrate Formulation: Take three (3) capsules daily in the morning with 8 oz. (240ml) of water **Intervention Names:** - Dietary Supplement: Butyrate Formulation **Label:** Butyrate Formulation **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Butyrate + Polyphenol Formulation: Take three (3) capsules daily in the morning with 8 oz. (240ml) of water **Intervention Names:** - Dietary Supplement: Butyrate + Polyphenol Formulation **Label:** Butyrate + Polyphenol Formulation **Type:** ACTIVE_COMPARATOR #### Arm Group 3 **Description:** Placebo: Take three (3) capsules daily in the morning with 8 oz. (240ml) of water **Intervention Names:** - Dietary Supplement: Placebo **Label:** Placebo **Type:** PLACEBO_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - Butyrate Formulation **Description:** Butyrate Formulation capsule:3 capsules daily **Name:** Butyrate Formulation **Type:** DIETARY_SUPPLEMENT #### Intervention 2 **Arm Group Labels:** - Butyrate + Polyphenol Formulation **Description:** Butyrate + Polyphenol Formulation capsule: 3 capsules daily **Name:** Butyrate + Polyphenol Formulation **Type:** DIETARY_SUPPLEMENT #### Intervention 3 **Arm Group Labels:** - Placebo **Description:** Placebo: 3 capsules daily **Name:** Placebo **Type:** DIETARY_SUPPLEMENT ### Outcomes Module #### Primary Outcomes **Description:** Assessment of the median change in the Gut Microbiome from baseline. **Measure:** Gut Microbiome **Time Frame:** 28 days **Description:** Assessment of the median change in the Gastrointestinal Symptom Rating Scale-IBS from baseline. **Measure:** Gastrointestinal Symptom Rating Scale- IBS (GSRS-IBS) **Time Frame:** 28 days #### Secondary Outcomes **Description:** Assessment of the median change in the Gut Barrier Panel Finger Stick Test from baseline. **Measure:** Gut Barrier Panel Finger Stick Test **Time Frame:** 28 days **Description:** Assessment of the median change in the Short Chain Fatty Acid Analysis from baseline. **Measure:** Short Chain Fatty Acid Analysis (SCFA) **Time Frame:** 28 days **Description:** Assessment of the median change in the Intestinal Permeability Test from baseline. **Measure:** Intestinal Permeability Test (IP) **Time Frame:** 28 days **Description:** Assessment of the median change in the Digestive Quality of Life Questionnaire from baseline. **Measure:** Digestive Quality of Life Questionnaire (DQLQ) **Time Frame:** 28 days **Description:** Assessment of the median change in the Visual Analogue Scale Questionnaire of abdominal pain from baseline. **Measure:** Visual Analogue Scale questionnaire of abdominal pain **Time Frame:** 28 days **Description:** Assessment of the median change in the Bristol Stool Form from baseline. **Measure:** Bristol Stool Form (BSFS) **Time Frame:** 28 days **Description:** Assessment of the median change in the Gastrointestinal- global assessment of improvement scale from baseline. **Measure:** Gastrointestinal- global assessment of improvement scales (Gastrointestinal- GAI) **Time Frame:** 28 days **Description:** Assessment of the median change in the SF-36 Health Survey from baseline **Measure:** Short Form-36 Health Survey (SF-36 Health Survey) **Time Frame:** 28 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Ambulatory, male or female, 21-70 years of age 2. A BMI of 18.5-34.9 3. Experiences at least three of the following conditions on a weekly basis (gastrointestinal discomfort, abdominal pain, gas, bloating, diarrhea or constipation) 4. Are comfortable fasting overnight 5. Are able to complete study procedures for up to approximately 6 hours on 2 separate days 6. Considered to be generally healthy on the basis of medical history 7. Willing to follow study instructions, including compliance with the study procedures and requirements Exclusion Criteria: 1. Unable to provide a urine specimen, stool specimen or blood sample from a finger stick 2. Currently on a galactose/lactose restricted diet 3. Having taken proton pump inhibitors (e.g. omeprazole, pantoprazole) within the past 3 months 4. History of oral antibiotic use within the past 3 months 5. Current or previous history of gastrointestinal disease including gallbladder problems, gallstones, biliary obstruction, irritable bowel disease (IBD) or that may interfere with the outcome parameters 6. Current or previous history of gastrointestinal cancer 7. Currently experience or have had a gastrointestinal infection (virus or bacterial) or food poisoning within the past month 8. Currently experience or have had a parasitic infection within the past 3 months 9. Currently experience or have a history of Crohn's disease, colitis, or celiac disease 10. Currently experience or have a history of severe endometriosis 11. History of gastrointestinal surgery which might influence gastrointestinal function except appendectomy or cholecystectomy 12. .History of thyroid disease (except on a stable dose of medication for ≥ 3 months before screening and unlikely to change medication or dose during the study) 13. History of hypertension (except on a stable dose of medication for ≥ 3 months before screening and unlikely to change medication or dose during the study) 14. A medical or surgical event requiring hospitalization, outpatient visits or emergency room visits within the past 5 years or in the judgment of the Study Investigator /Sub-I would preclude participation in the study 15. Current or previous history of diabetes 16. History of a major change in dietary habits with the past 1 month 17. History of cancer (including skin cancer) within the past 5 years 18. Known intolerance or allergy to sugar alcohols including mannitol, sorbitol, xylitol, lactulose or lactose 19. Women who are lactating, pregnant or planning pregnancy within the next two months 20. Women who are currently taking or have taken estrogen and/or progesterone as a method of birth control \< 3 months prior to screening or anticipates a change for the duration of the study period 21. Having donated blood or received a blood transfusion within 30 days before screening 22. Currently participating in another clinical research study or participated in another clinical research study within 30 days prior to screening **Healthy Volunteers:** True **Maximum Age:** 70 Years **Minimum Age:** 21 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Steven Hirsh, RPh, DPM **Phone:** 954-202-7679 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Giovanna Fernandez, BSN, RN **Phone:** 954-202-7678 **Role:** CONTACT #### Locations **Location 1:** **City:** Fort Lauderdale **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Steven Hirsh, RPh,DPM - **Phone:** 954-202-7679 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Giovanna Fernandez, BSN, RN - **Phone:** 954-202-7678 - **Role:** CONTACT ***Contact 3:*** - **Name:** Andrew Swick, PhD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Life Extension Clinical Research, Inc. **State:** Florida **Status:** RECRUITING **Zip:** 33304 #### Overall Officials **Official 1:** **Affiliation:** Life Extension **Name:** Andrew Swick, Ph.D **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Asbaghi O, Nazarian B, Reiner Z, Amirani E, Kolahdooz F, Chamani M, Asemi Z. The effects of grape seed extract on glycemic control, serum lipoproteins, inflammation, and body weight: A systematic review and meta-analysis of randomized controlled trials. Phytother Res. 2020 Feb;34(2):239-253. doi: 10.1002/ptr.6518. Epub 2019 Dec 26. Erratum In: Phytother Res. 2022 Mar;36(3):1413. **PMID:** 31880030 **Citation:** Banasiewicz T, Krokowicz L, Stojcev Z, Kaczmarek BF, Kaczmarek E, Maik J, Marciniak R, Krokowicz P, Walkowiak J, Drews M. Microencapsulated sodium butyrate reduces the frequency of abdominal pain in patients with irritable bowel syndrome. Colorectal Dis. 2013 Feb;15(2):204-9. doi: 10.1111/j.1463-1318.2012.03152.x. **PMID:** 22738315 **Citation:** Brooker S, Martin S, Pearson A, Bagchi D, Earl J, Gothard L, Hall E, Porter L, Yarnold J. Double-blind, placebo-controlled, randomised phase II trial of IH636 grape seed proanthocyanidin extract (GSPE) in patients with radiation-induced breast induration. Radiother Oncol. 2006 Apr;79(1):45-51. doi: 10.1016/j.radonc.2006.02.008. Epub 2006 Mar 20. **PMID:** 16546280 **Citation:** Canani RB, Costanzo MD, Leone L, Pedata M, Meli R, Calignano A. Potential beneficial effects of butyrate in intestinal and extraintestinal diseases. World J Gastroenterol. 2011 Mar 28;17(12):1519-28. doi: 10.3748/wjg.v17.i12.1519. **PMID:** 21472114 **Citation:** Cleophas MCP, Ratter JM, Bekkering S, Quintin J, Schraa K, Stroes ES, Netea MG, Joosten LAB. Effects of oral butyrate supplementation on inflammatory potential of circulating peripheral blood mononuclear cells in healthy and obese males. Sci Rep. 2019 Jan 28;9(1):775. doi: 10.1038/s41598-018-37246-7. **PMID:** 30692581 **Citation:** Conley BA, Egorin MJ, Tait N, Rosen DM, Sausville EA, Dover G, Fram RJ, Van Echo DA. Phase I study of the orally administered butyrate prodrug, tributyrin, in patients with solid tumors. Clin Cancer Res. 1998 Mar;4(3):629-34. **PMID:** 9533530 **Citation:** Cory H, Passarelli S, Szeto J, Tamez M, Mattei J. The Role of Polyphenols in Human Health and Food Systems: A Mini-Review. Front Nutr. 2018 Sep 21;5:87. doi: 10.3389/fnut.2018.00087. eCollection 2018. **PMID:** 30298133 **Citation:** Costa C, Tsatsakis A, Mamoulakis C, Teodoro M, Briguglio G, Caruso E, Tsoukalas D, Margina D, Dardiotis E, Kouretas D, Fenga C. Current evidence on the effect of dietary polyphenols intake on chronic diseases. Food Chem Toxicol. 2017 Dec;110:286-299. doi: 10.1016/j.fct.2017.10.023. Epub 2017 Oct 14. **PMID:** 29042289 **Citation:** Dallal, G. (2021). www.Randomization.com. http://www.randomization.com **Citation:** Drugs, O. o. N. (2005). Guidance for Industry Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers. Office of the Federal Register National Archives and Record Administration **Citation:** Edelman MJ, Bauer K, Khanwani S, Tait N, Trepel J, Karp J, Nemieboka N, Chung EJ, Van Echo D. Clinical and pharmacologic study of tributyrin: an oral butyrate prodrug. Cancer Chemother Pharmacol. 2003 May;51(5):439-44. doi: 10.1007/s00280-003-0580-5. Epub 2003 Mar 12. **PMID:** 12736763 **Citation:** Grosicki, G. (2021). Effects of 3-week Tributyrin Supplementation on the Gut Microbiome: A Pilot Study. Journal of the Academy of Nutrition and Dietetics, 121(9, Supplement), A23. https://doi.org/https://doi.org/10.1016/j.jand.2021.06.051 **Citation:** Hodges, J., Zeng, M., Cao, S., Pokala, A., Rezaei, S., Sasaki, G., Vodovotz, Y., & Bruno, R. (2022). Catechin-Rich Green Tea Extract Reduced Intestinal Inflammation and Fasting Glucose in Metabolic Syndrome and Healthy Adults: A Randomized, Controlled, Crossover Trial. Current Developments in Nutrition, 6(Supplement_1), 981-981. https://doi.org/10.1093/cdn/nzac068.010 **Citation:** Hodgkinson K, El Abbar F, Dobranowski P, Manoogian J, Butcher J, Figeys D, Mack D, Stintzi A. Butyrate's role in human health and the current progress towards its clinical application to treat gastrointestinal disease. Clin Nutr. 2023 Feb;42(2):61-75. doi: 10.1016/j.clnu.2022.10.024. Epub 2022 Nov 2. **PMID:** 36502573 **Citation:** Istas G, Wood E, Le Sayec M, Rawlings C, Yoon J, Dandavate V, Cera D, Rampelli S, Costabile A, Fromentin E, Rodriguez-Mateos A. Effects of aronia berry (poly)phenols on vascular function and gut microbiota: a double-blind randomized controlled trial in adult men. Am J Clin Nutr. 2019 Aug 1;110(2):316-329. doi: 10.1093/ajcn/nqz075. **PMID:** 31152545 **Citation:** Kapolou, A., Karantonis, H. C., Rigopoulos, N., & Koutelidakis, A. E. (2021). Association of Mean Daily Polyphenols Intake with Mediterranean Diet Adherence and Anthropometric Indices in Healthy Greek Adults: A Retrospective Study. Applied Sciences, 11(10), 4664. https://www.mdpi.com/2076-3417/11/10/4664 **Citation:** Le Sayec M, Xu Y, Laiola M, Gallego FA, Katsikioti D, Durbidge C, Kivisild U, Armes S, Lecomte M, Fanca-Berthon P, Fromentin E, Plaza Onate F, Cruickshank JK, Rodriguez-Mateos A. The effects of Aronia berry (poly)phenol supplementation on arterial function and the gut microbiome in middle aged men and women: Results from a randomized controlled trial. Clin Nutr. 2022 Nov;41(11):2549-2561. doi: 10.1016/j.clnu.2022.08.024. Epub 2022 Sep 6. **PMID:** 36228567 **Citation:** Ljotsson B, Jones M, Talley NJ, Kjellstrom L, Agreus L, Andreasson A. Discriminant and convergent validity of the GSRS-IBS symptom severity measure for irritable bowel syndrome: A population study. United European Gastroenterol J. 2020 Apr;8(3):284-292. doi: 10.1177/2050640619900577. Epub 2020 Jan 14. **PMID:** 32213021 **Citation:** Ma, G., & Chen, Y. (2020). Polyphenol supplementation benefits human health via gut microbiota: A systematic review via meta-analysis. Journal of Functional Foods, 66, 103829. https://doi.org/https://doi.org/10.1016/j.jff.2020.103829 **Citation:** Park SY, Kim YD, Kim MS, Kim KT, Kim JY. Cinnamon (Cinnamomum cassia) water extract improves diarrhea symptoms by changing the gut environment: a randomized controlled trial. Food Funct. 2023 Feb 6;14(3):1520-1529. doi: 10.1039/d2fo01835g. **PMID:** 36655542 **Citation:** Pietrzak A, Banasiuk M, Szczepanik M, Borys-Iwanicka A, Pytrus T, Walkowiak J, Banaszkiewicz A. Sodium Butyrate Effectiveness in Children and Adolescents with Newly Diagnosed Inflammatory Bowel Diseases-Randomized Placebo-Controlled Multicenter Trial. Nutrients. 2022 Aug 11;14(16):3283. doi: 10.3390/nu14163283. **PMID:** 36014789 **Citation:** Recharla N, Geesala R, Shi XZ. Gut Microbial Metabolite Butyrate and Its Therapeutic Role in Inflammatory Bowel Disease: A Literature Review. Nutrients. 2023 May 11;15(10):2275. doi: 10.3390/nu15102275. **PMID:** 37242159 **Citation:** Rosner, B. (2006). Hypothesis Testing Two-Sample Inference. In Fundamentals of Biostatistics (6th ed., pp. 331-334). Duxbury Press. **Citation:** Wang X, Qi Y, Zheng H. Dietary Polyphenol, Gut Microbiota, and Health Benefits. Antioxidants (Basel). 2022 Jun 20;11(6):1212. doi: 10.3390/antiox11061212. **PMID:** 35740109 **Citation:** Zhang H, Liu S, Li L, Liu S, Liu S, Mi J, Tian G. The impact of grape seed extract treatment on blood pressure changes: A meta-analysis of 16 randomized controlled trials. Medicine (Baltimore). 2016 Aug;95(33):e4247. doi: 10.1097/MD.0000000000004247. **PMID:** 27537554 ## 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: M6472 - Name: Constipation - Relevance: LOW - As Found: Unknown - ID: M7159 - Name: Diarrhea - Relevance: LOW - As Found: Unknown - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M18311 - Name: Abdominal Pain - Relevance: LOW - As Found: Unknown - ID: M9444 - Name: Heartburn - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419218 **Brief Title:** Increasing School Meal Participation **Official Title:** Evaluating a Marketing Campaign to Increase Participation in School Meals #### Organization Study ID Info **ID:** 75335 #### Organization **Class:** OTHER **Full Name:** Stanford University ### Status Module #### Completion Date **Date:** 2025-02 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-16 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-02 **Type:** ESTIMATED #### Start Date **Date:** 2024-09 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-16 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** Robert Wood Johnson Foundation #### Lead Sponsor **Class:** OTHER **Name:** Stanford University #### Responsible Party **Investigator Affiliation:** Stanford University **Investigator Full Name:** Anna Grummon **Investigator Title:** Assistant Professor **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This study aims to determine whether an online marketing campaign increases children's school meal participation. Parents whose children do not currently eat school meals frequently will be exposed to messages designed to encourage their children's increased participation in school meals. **Detailed Description:** In this 6-week-long online randomized controlled trial, participants will be randomized to one of two arms: 1) Control (neutral) messages or 2) Messages designed to increase school meal participation. In each arm, participants will join private Facebook groups corresponding to their study arm. The study team will post campaign messages to these groups. Participants will answer online survey questions before and after the study on their attitudes about school meals and their child's participation in school meals. ### Conditions Module **Conditions:** - Nutrition, Healthy **Keywords:** - health - nutrition - children - parent perceptions - school lunch - school breakfast - food access ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Masking Description:** The investigator and data analyst will not be aware of participants' assignments. **Who Masked:** - INVESTIGATOR **Primary Purpose:** OTHER #### Enrollment Info **Count:** 800 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants will view messages focused on the benefits of children eating school meals, using text and images developed based on parent interviews. Participants will view a total of 12 messages. **Intervention Names:** - Behavioral: School meal messages **Label:** School meal messages **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Participants will view messages focused on the benefits of children reading. Messages will be matched in length to the experimental messages. Participants will view a total of 12 messages. **Intervention Names:** - Behavioral: Control (neutral) messages **Label:** Control (neutral) messages **Type:** ACTIVE_COMPARATOR ### Interventions #### Intervention 1 **Arm Group Labels:** - School meal messages **Description:** Messages focused on the benefits of children consuming school lunch and breakfast, using text and images developed based on parent interviews. Participants will view a total of 12 messages. **Name:** School meal messages **Type:** BEHAVIORAL #### Intervention 2 **Arm Group Labels:** - Control (neutral) messages **Description:** Control messages approximately matched to the intervention messages on length and design, but discussing a neutral topic unrelated to school meals (reading). Participants will view a total of 12 messages. **Name:** Control (neutral) messages **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** Assessed with 1 item: "During the past 30 days, how often did your child usually eat breakfast he, she, or they got at school from the cafeteria?" This item will be scored on a 6-point scale from "0 days per week" (0) to "5 days per week" (5). **Measure:** Participation in school breakfast **Time Frame:** Collected in a ~10 minute survey at baseline and again at 6 weeks. **Description:** Assessed with 1 tem: "During the past 30 days, how often did your child usually eat lunch he, she, or they got at school from the cafeteria?" This item will be scored on a 6-point scale from "0 days per week" (0) to "5 days per week" (5). **Measure:** Participation in school lunch **Time Frame:** Collected in a ~10 minute survey at baseline and again at 6 weeks. #### Secondary Outcomes **Description:** Assessed with 6 items: First, participants will be asked to indicate how often in the past month: "The food that we bought just didn't last, and we didn't have money to get more" and "We couldn't afford to eat balanced meals" with response options of "Never true" (0), "Sometimes true" (1), or "Often true" (2). Next, participants will be asked, "In the last month, did you ever eat less than you felt you should because there wasn't enough money for food?"; "In the last month, were you ever hungry but didn't eat because there wasn't enough money for food?"; and "In the last month, did you or other adults in your household ever cut the size of your meals or skip meals because there wasn't enough money for food?" Responses: "No" (0), "Yes" (1). If "Yes" to any of these items, they will be asked: "How often did this happen?" with response options: "Only 1 or 2 days" (1), "Some days but not every day" (2), "Almost every day" (3). **Measure:** Household food insecurity **Time Frame:** Collected in a ~10 minute survey at baseline and again at 6 weeks. **Description:** Assessed with 7 items: participants will indicate how often in the past month: "I relied on only a few kinds of low-cost food to feed my child because I was running out of money to buy food"; "I couldn't feed my child a balanced meal, because I couldn't afford that."; "My child was not eating enough because I just couldn't afford enough food." "Was that often, sometimes, or never true for you in the last month?" with responses: "Never true" (0); "Sometimes true" (1); "Often true" (2). Participants will be asked whether in the last month... "did you ever cut the size of your child's meals because there wasn't enough money for food?"; "was your child ever hungry but you just couldn't afford more food?" and "did your child ever skip meals because there wasn't enough money for food?" with responses: "No" (0); "Yes" (1). If "Yes", they will be asked: "How often did this happen?" with responses: "Only 1 or 2 days" (1), "Some days but not every day" (2), "Almost every day" (3). **Measure:** Child food insecurity **Time Frame:** Collected in a ~10 minute survey at baseline and again at 6 weeks. **Description:** Assessed with 8 items: "Getting breakfast from school improves children's performance in school."; "Getting breakfast from school improves children's performance in sports."; "Getting breakfast from school improves children's energy."; "Getting breakfast from school makes children less likely to miss school."; "Getting breakfast from school makes children less likely to be late for school."; "Getting breakfast from school gives children enough food to eat."; "Getting breakfast from school gives children a variety of foods to eat."; "Getting breakfast from school gives children the chance to make their own choices." All items will use a 5-point Likert-type response scale: "Strongly disagree" (1); "Somewhat disagree" (2); "Neither agree nor disagree" (3); Somewhat agree (4); "Strongly agree" (5). **Measure:** Perceived benefits **Time Frame:** Collected in a ~10 minute survey at baseline and again at 6 weeks. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 18 years or older * Parent of a child attending a public school in grades 1-5 * Resides in one of the following states: California, Colorado, Maine, Minnesota, Michigan, * Massachusetts, New Mexico, Vermont * Has internet access * Has a Facebook account. Exclusion Criteria: * Younger than 18 years old * Does not have a child attending a public school in grades 1-5 * Resides out of one of the following states: California, Colorado, Maine, Minnesota, Michigan, Massachusetts, New Mexico, Vermont * Does not have internet access * Does not have a Facebook account **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Anna Grummon, PhD **Phone:** 6506447366 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Study Team **Phone:** 6503089140 **Role:** CONTACT #### Locations **Location 1:** **City:** Palo Alto **Country:** United States **Facility:** Stanford School of Medicine **State:** California **Zip:** 94304 #### Overall Officials **Official 1:** **Affiliation:** Assistant Professor **Name:** Anna Grummon, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** These materials will be posted publicly; researchers will be free to download them. **Description:** We plan to post de-identified raw data from the surveys to a public repository. **Info Types:** - STUDY_PROTOCOL - SAP - ANALYTIC_CODE **IPD Sharing:** YES **Time Frame:** We plan to post de-identified raw data from the surveys to a public repository upon publication of papers arising from the study. ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419205 **Brief Title:** A Phase 2 Study to Evaluate the Safety, PD, PK, and Clinical Activity of ADX-097 in Participants With IgAN, LN or C3G **Official Title:** A Phase 2 Study to Evaluate the Safety, Pharmacodynamics, Pharmacokinetics, and Clinical Activity of ADX-097 Administered Subcutaneously in Male and Female Participants Aged 18 Years or Older With IgAN, LN, or C3G #### Organization Study ID Info **ID:** ADX-097-201 #### Organization **Class:** INDUSTRY **Full Name:** Q32 Bio Inc. ### Status Module #### Completion Date **Date:** 2025-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-12 **Type:** ESTIMATED #### Start Date **Date:** 2024-06 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-08 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Q32 Bio 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:** A Phase 2 Study to Evaluate the Safety, Pharmacodynamics, Pharmacokinetics, and Clinical Activity of ADX-097 Administered Subcutaneously in Male and Female Participants Aged 18 Years or Older With Immunoglobulin A Nephropathy (IgAN), Lupus Nephritis (LN), or Complement Component 3 Glomerulopathy (C3G) ### Conditions Module **Conditions:** - IgA Nephropathy - Lupus Nephritis (LN) - C3 (Complement Component 3) Glomerulopathy ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Subcutaneous Placebo Injection **Intervention Names:** - Drug: ADX-097 **Label:** Open Label **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Open Label **Description:** Open Label **Name:** ADX-097 **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Incidence of adverse events (AEs) to evaluate the safety of ADX-097 when administered to participants with IgAN, LN, or C3G **Measure:** Incidence of adverse events (AEs) to evaluate the safety of ADX-097 **Time Frame:** 42 weeks #### Secondary Outcomes **Description:** To evaluate clinical activity of ADX-097 in participants with IgAN, LN, or C3G **Measure:** Change from baseline in urine protein-to-creatinine ratio (uPCR) **Time Frame:** 26 weeks **Description:** To evaluate clinical activity of ADX-097 in participants with IgAN, LN, or C3G **Measure:** Change from baseline in estimated glomerular filtration rate (eGFR) **Time Frame:** 26 weeks ### Eligibility Module **Eligibility Criteria:** Key Inclusion Criteria: 1. Male or female participants aged ≥18 years. 2. Urine protein \>0.75 g/24 hours or uPCR \>0.75 g/g. 3. Screening eGFR ≥30 mL/min/1.73m2 calculated by the Chronic Kidney Disease Epidemiology Collaboration creatinine equation (CKD-EPI GFR). 4. Participants receiving a RAAS inhibitor must have been on a stable dose (at the maximum recommended dose according to local guidelines or maximum tolerated dose) for at least 12 weeks prior to Study Day 1 that is projected to remain stable during the study. 5. Participants receiving a sodium-glucose cotransporter-2 (SGLT2) inhibitor or sparsentan must have been on a stable dose for at least 12 weeks prior to Study Day 1 that is projected to remain stable during the study. 6. Kidney biopsy-proven diagnosis of IgAN, LN or C3G obtained within 26 weeks of Day 1. Key Exclusion Criteria 1. A ≥50% decline in eGFR within 3 months before screening. 2. Concomitant significant renal disease other than IgAN, C3G, or LN. 3. Uncontrolled hypertension, defined as systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥90 mmHg, despite antihypertensive treatment. 4. Kidney, other solid organs, or bone marrow transplantation prior to or expected to occur during the study. **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Bhavya Haria **Phone:** 6173096647 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Kristin Orr **Phone:** 919.395.0132 **Role:** CONTACT ## 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: D000005921 - Term: Glomerulonephritis - ID: D000008180 - Term: Lupus Erythematosus, Systemic - 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: 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: M12338 - Name: Nephritis - Relevance: HIGH - As Found: Nephritis - ID: M11178 - Name: Lupus Nephritis - Relevance: HIGH - As Found: Lupus Nephritis - ID: M9032 - Name: Glomerulonephritis, IGA - Relevance: HIGH - As Found: IgA Nephropathy - ID: M9031 - Name: Glomerulonephritis - 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: M11177 - Name: Lupus Erythematosus, Systemic - 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: T3008 - Name: IgA Nephropathy - Relevance: HIGH - As Found: IgA Nephropathy - ID: T2525 - Name: Glomerulonephritis - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000009393 - Term: Nephritis - ID: D000008181 - Term: Lupus Nephritis - ID: D000005922 - Term: Glomerulonephritis, IGA ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419192 **Acronym:** MAMAN **Brief Title:** Modifying Nutrition to Modify Delivery in Nulliparous Women **Official Title:** Evaluation of the Feasibility and Acceptability of Dietary Advice to Encourage Spontaneous Work: Randomised Pilot Study #### Organization Study ID Info **ID:** DR230083 #### Organization **Class:** OTHER **Full Name:** University Hospital, Tours ### Status Module #### Completion Date **Date:** 2025-09 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-16 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-07 **Type:** ESTIMATED #### Start Date **Date:** 2024-07 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-10 **Study First Submit QC Date:** 2024-05-16 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University Hospital, Tours #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** In France, around 20% of women exceed the term of 41 weeks' amenorrhoea (SA). Maternal and foetal morbidity and mortality are increased when the term is exceeded, which justifies inducing labour. However, induction also increases maternal and foetal morbidity. According to several studies, regular consumption of dates during the last month of pregnancy may increase the rate of spontaneous labour and natural childbirth. Single-centre, randomised, open-label, 3-arm study : Experimental group n°1: 'dietary advice + food provided'. Advice to eat 7 dates a day from 37 weeks' gestation until delivery. The quantity of dates required will be provided to the women. Experimental group 2: 'dietary advice alone'. Advice to eat 7 dates a day from 37 weeks' gestation until delivery. The food will not be provided. Control group: no specific dietary advice. Routine care group. ### Conditions Module **Conditions:** - Pregnant Woman ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 150 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Eat 7 dates a day from 37 weeks' gestation (SA) until delivery. Women will be provided with the quantity of dates they need. **Intervention Names:** - Other: dietary advice - Other: food supplied **Label:** dietary advice + food supplied **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Advise to eat 7 dates a day from 37 weeks' gestation (SA) until delivery. The food will not be provided. **Intervention Names:** - Other: dietary advice alone **Label:** dietary advice alone **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** No specific dietary advice **Label:** usual care **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - dietary advice + food supplied **Description:** Eat 7 dates a day from 37 weeks' gestation until delivery. Women will be provided with the quantity of dates they need. **Name:** dietary advice **Type:** OTHER #### Intervention 2 **Arm Group Labels:** - dietary advice alone **Description:** Advise to eat 7 dates a day from 37SA until delivery. The food will not be provided. **Name:** dietary advice alone **Type:** OTHER #### Intervention 3 **Arm Group Labels:** - dietary advice + food supplied **Description:** Eat 7 dates a day from 37 weeks' gestation until delivery. Women will be provided with the quantity of dates they need. **Name:** food supplied **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Measure:** Rate of compliance with dietary advice to eat 7 dates a day at the end of pregnancy in nulliparous women. **Time Frame:** From 37 weeks'amenorrhoea to delivery (up to 41 weeks) #### Secondary Outcomes **Measure:** Evaluation of women's experience of the intervention using a post-partum questionnaire **Time Frame:** Following childbirth, during the stay in the maternity ward ; assessed up to 5 days ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Pregnant women * Age ≥ 18 years * Nulliparous * Single pregnancy with fetus in cephalic presentation * Pregnancy with physiological course * Gestational age ≥ 34 and ⩽ 37 SA * Membership of a social security scheme (CMU accepted) * Signed informed consent Exclusion Criteria: * Any contraindication to vaginal delivery * Presence of a foetal malformation * Diabetes of any type (1, 2 or gestational) * Food allergy contraindicating participation in the study * Illiterate or non-French-speaking women * Women under guardianship or trusteeship **Gender Based:** True **Minimum Age:** 18 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Adeline DE WITT, MD **Phone:** 02 47 47 47 36 **Role:** CONTACT #### Locations **Location 1:** **City:** Tours **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Caroline DIGUISTO, MD - **Role:** CONTACT ***Contact 2:*** - **Name:** Caroline DIGUISTO, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** France **Facility:** Gynaecology-obstetrics, University Hospital, Tours **Zip:** 37044 #### Overall Officials **Official 1:** **Affiliation:** University Hospital, Orléans **Name:** Adeline DE WITT, MD **Role:** STUDY_DIRECTOR ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419179 **Acronym:** GUIDANCE **Brief Title:** Maintenance Durvalumab (MEDI4736) and Olaparib (AZD2281) After Standard 1st Line Treatment (Carboplatin/Cisplatin, Etoposide, Durvalumab) in HRD Positive Extensive Disease (ED) Small-cell Lung Cancer (SCLC) **Official Title:** A Multicenter Phase II Trial of Maintenance Durvalumab (MEDI4736) and Olaparib (AZD2281) After Standard 1st Line Treatment (Carboplatin/Cisplatin, Etoposide, Durvalumab) in Homologous Recombination Deficiency (HRD) Positive Extensive Disease (ED) Small-cell Lung Cancer (SCLC) #### Organization Study ID Info **ID:** Uni-Koeln-5159 #### Organization **Class:** OTHER **Full Name:** University of Cologne #### Secondary ID Infos **ID:** 2024-512373-27-00 **Type:** CTIS ### Status Module #### Completion Date **Date:** 2026-12 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-16 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-09 **Type:** ESTIMATED #### Start Date **Date:** 2024-09 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-03 **Study First Submit QC Date:** 2024-05-16 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** AstraZeneca #### Lead Sponsor **Class:** OTHER **Name:** University of Cologne #### Responsible Party **Investigator Affiliation:** University of Cologne **Investigator Full Name:** Prof. Dr. Juergen Wolf **Investigator Title:** Clinical Prof. Dr. Jürgen Wolf **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Is US Export:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** Maintenance durvalumab (MEDI4736) and olaparib (AZD2281) after standard 1st line treatment (carboplatin/ cisplatin, etoposide, durvalumab) in HRD positive extensive disease (ED) small-cell lung cancer (SCLC) ### Conditions Module **Conditions:** - Small Cell Lung Carcinoma ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 29 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Study treatment (olaparib and durvalumab) starts with the initiation of maintenance therapy and is administered at a 28-day cycle until progression, unacceptable toxicity, or discontinuation for other reasons. Induction therapy (four cycles of carboplatin/cisplatin, etoposide, durvalumab) is administered as part of standard of care. **Intervention Names:** - Drug: Durvalumab - Drug: Olaparib **Label:** Combination of olaparib and durvalumab after four cycles of standard 1st line treatment **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Combination of olaparib and durvalumab after four cycles of standard 1st line treatment **Description:** 1500 mg i.v. Q4W **Name:** Durvalumab **Other Names:** - MEDI4736 - IMFINZI **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Combination of olaparib and durvalumab after four cycles of standard 1st line treatment **Description:** 300 mg BID orally **Name:** Olaparib **Other Names:** - AZD2281 - LYNPARZA **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** PFS according to investigator-assessed RECIST 1.1 from start of maintenance therapy **Measure:** Progression-free survival (PFS) **Time Frame:** Approximately two years (from First patient in (FSI) to Last patient last visit (LSLV)) #### Secondary Outcomes **Description:** Grading is based on CTCAE Version 5 **Measure:** Incidence, severity and grading of adverse events (AE) and seriouse adverse events (SAE). **Time Frame:** Approximately two years (from FSI to LSLV) **Description:** Grading is based on RECIST 1.1 **Measure:** ORR of maintenance. **Time Frame:** Approximately two years (from FSI to LSLV) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria Pre-Screening: * Newly diagnosed, histologically documented advanced or metastatic small-cell lung cancer (UICC stage III which is not amenable to curative radiochemotherapy or stage IV). \[...\] * Either de novo biopsies collected as part of routine clinical practice or archival tumor samples (taken ≤6 months prior to screening) are acceptable. * Planned or ongoing treatment with carboplatin/cisplatin, etoposide, durvalumab as 1st-line SoC. Pre-screening must begin no later than the start of the 3rd cycle to allow sufficient time for molecular analyses. \[...\] * Available radiographic chest and abdominal CT or MRI scans performed up to 42 days before initial first line treatment with carboplatin/cisplatin, etoposide and durvalumab. * At least one measurable site of disease as defined by RECIST v1.1 criteria. * \[...\] Inclusion Criteria Screening: * Completed pre-screening with fulfillment of all inclusion and exclusion criteria of pre-screening. Pre-screening must have tested positive for homologous recombination deficiency as defined in this protocol at central testing. \[...\] * Patients must not have radiographic or clinic disease progression while on induction therapy and/or prior to start of study treatment. * Patients must have received 4 cycles (21-day cycles) of chemoimmunotherapy with carboplatin or cisplatin, etoposide and durvalumab completed within 1 to 14 days prior to initiation of study treatment on C5D1. * Adequate organ and marrow function Exclusion Criteria Pre-Screening: * Induction therapy other than carboplatin/cisplatin, etoposide and durvalumab. * Radiographic or clinical evidence of progressive disease. * Negative HRD result in a previous pre-screening in this trial. * \[...\] Exclusion Criteria Screening: * Patients with symptomatic uncontrolled central nervous system (CNS) metastases. * Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days. * History of leptomeningeal carcinomatosis. * Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy. Exceptions are: 1. Alopecia (any Grade) 2. Vitiligo (any Grade) 3. Hypothyroidism stable on hormone replacement (Grade ≤2) 4. Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician 5. Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab or olaparib may be included only after consultation with the Sponsor. 6. ... **Maximum Age:** 120 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Jürgen Wolf, MD **Phone:** +49 221 478 **Phone Ext:** 89050 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Felix John, MD **Role:** CONTACT ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002283 - Term: Carcinoma, Bronchogenic - ID: D000001984 - Term: Bronchial Neoplasms - ID: D000008175 - Term: Lung Neoplasms - 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: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M5534 - Name: Carcinoma - Relevance: LOW - As Found: Unknown - ID: M11172 - Name: Lung Neoplasms - Relevance: LOW - As Found: Unknown - ID: M28323 - Name: Small Cell Lung Carcinoma - Relevance: HIGH - As Found: Small Cell Lung Carcinoma - ID: M5540 - Name: Carcinoma, Bronchogenic - Relevance: LOW - As Found: Unknown - ID: M5260 - Name: Bronchial Neoplasms - Relevance: LOW - As Found: Unknown - ID: M14979 - Name: Respiratory Tract Neoplasms - Relevance: LOW - As Found: Unknown - ID: M16658 - Name: Thoracic Neoplasms - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown - ID: T5271 - Name: Small Cell Lung Cancer - Relevance: HIGH - As Found: Small Cell Lung Cancer ### Condition Browse Module - Meshes - ID: D000055752 - Term: Small Cell Lung Carcinoma ### Intervention Browse Module - Ancestors - ID: D000074322 - Term: Antineoplastic Agents, Immunological - ID: D000000970 - Term: Antineoplastic Agents - ID: D000067856 - Term: Poly(ADP-ribose) Polymerase Inhibitors - ID: D000004791 - Term: Enzyme Inhibitors - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action ### Intervention Browse Module - Browse Branches - Abbrev: ANeo - Name: Antineoplastic Agents - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M18650 - Name: Carboplatin - Relevance: LOW - As Found: Unknown - ID: M8191 - Name: Etoposide - Relevance: LOW - As Found: Unknown - ID: M6182 - Name: Cisplatin - Relevance: LOW - As Found: Unknown - ID: M272500 - Name: Durvalumab - Relevance: HIGH - As Found: Electrical - ID: M233003 - Name: Olaparib - Relevance: HIGH - As Found: Prescription - ID: M341643 - Name: Etoposide phosphate - Relevance: LOW - As Found: Unknown - ID: M1346 - Name: Antineoplastic Agents, Immunological - Relevance: LOW - As Found: Unknown - ID: M205 - Name: Poly(ADP-ribose) Polymerase Inhibitors - Relevance: LOW - As Found: Unknown - ID: M7951 - Name: Enzyme Inhibitors - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: C000613593 - Term: Durvalumab - ID: C000531550 - Term: Olaparib ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419166 **Brief Title:** An Exploratory Clinical Study of GC012F Injection for the Treatment of Refractory Generalized Myasthenia Gravis **Official Title:** An Exploratory Clinical Study of GC012F Injection for the Treatment of Refractory Generalized Myasthenia Gravis #### Organization Study ID Info **ID:** TXB2024002 #### Organization **Class:** OTHER **Full Name:** Zhejiang University ### Status Module #### Completion Date **Date:** 2026-10-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2026-06-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-04-25 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Collaborators **Class:** INDUSTRY **Name:** Gracell Biotechnology Shanghai Co., Ltd. #### Lead Sponsor **Class:** OTHER **Name:** Zhejiang University #### Responsible Party **Investigator Affiliation:** Zhejiang University **Investigator Full Name:** He Huang **Investigator Title:** Director **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** This study is a single-arm, open-label early exploratory clinical trial designed to evaluate the safety, tolerability, and preliminary efficacy of GC012F injection in subjects with refractory GMG. Additionally, the study aims to assess the pharmacokinetic (PK), pharmacodynamic (PD) characteristics, and immunogenicity of GC012F injection in subjects. **Detailed Description:** This study is a single-arm, open-label early exploratory clinical trial designed to evaluate the safety, tolerability, and preliminary efficacy of GC012F injection in subjects with refractory GMG. Additionally, the study aims to assess the pharmacokinetic (PK), pharmacodynamic (PD) characteristics, and immunogenicity of GC012F injection in subjects. The trial consists of several phases: screening period, apheresis day, baseline period, lymphodepletion period, pre-infusion assessment period, GC012F infusion period, safety and efficacy follow-up period, long-term follow-up period, and study discontinuation visit (if applicable). Qualified subjects will undergo apheresis and receive the infusion after the production of CAR-T products. Subjects will undergo lymphodepletion before CAR-T cell infusion and assessment before infusion. Subjects meeting the cell infusion criteria will receive CAR-T cell infusion according to the dose specified in the protocol. Dose adjustments may occur based on safety and clinical efficacy for subjects in the same group or subsequent trial groups. ### Conditions Module **Conditions:** - Refractory Generalized Myasthenia Gravis ### Design Module #### Design Info **Allocation:** NA **Intervention Model:** SINGLE_GROUP ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 18 **Type:** ESTIMATED **Phases:** - EARLY_PHASE1 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Refractory Generalized Myasthenia Gravis **Intervention Names:** - Drug: GC012F injection **Label:** Refractory gMG subjects **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Refractory gMG subjects **Description:** Each subject will receive GC012F injection (CD19-BCMA CAR-T cells) once by intravenous infusion on Day 0. Other Name: CD19-BCMA CAR-T cells **Name:** GC012F injection **Type:** DRUG ### Outcomes Module #### Other Outcomes **Description:** Safety of GC012F **Measure:** • Detection rate of CAR-T cell antibodies in peripheral blood within 24 weeks post-GC012F infusion; **Time Frame:** within 24 weeks post-GC012F infusion; **Description:** Safety of GC012F **Measure:** • Changes in serum immunoglobulin levels (including IgG, IgM, IgA, and IgE) in patients within 24 weeks post-GC012F infusion; **Time Frame:** within 24 weeks post-GC012F infusion **Description:** Safety of GC012F **Measure:** • Detection rate of replication-competent lentivirus (RCL). **Time Frame:** Within 15 years after GC012F injection infusion #### Primary Outcomes **Description:** DLT **Measure:** Incidence of DLT **Time Frame:** Within 28 days after GC012F injection infusion **Description:** The electrocardiography shall be measured after 5 minutes of rest, and assessments included as follows: Heart rate, RR interval, PR interval, QT interval, QRS wave, QT interval and other indexes. **Measure:** Frequency and severity of abnormal findings in electrocardiograms **Time Frame:** Within 96 weeks after GC012F injection infusion **Description:** Any untoward medical event that occurs after a subject has administered an investigational product, which may be manifested as a symptom, sign, disease or laboratory abnormality but does not necessarily have a causal relationship with the investigational product. **Measure:** Frequency and severity of abnormal findings of adverse events. **Time Frame:** Within 96 weeks after GC012F injection infusion **Description:** The full physical examination at least includes assessments of skin, mucosa, lymph nodes, head, neck, chest, abdomen, spine/limbs, and nervous system. A full physical examination needs to be completed only during the screening period, and the physical examination can be performed in subsequent visit as per changes in signs and symptoms. **Measure:** Frequency and severity of abnormal findings in physical examinations **Time Frame:** Within 96 weeks after GC012F injection infusion **Description:** Laboratory tests include blood test，Coagulation function ，Infectious disease detection and tests recommended by the Investigator **Measure:** Frequency and severity of abnormal findings in laboratory tests **Time Frame:** Within 96 weeks after GC012F injection infusion **Description:** Vital signs shall be measured after 5 minutes of rest, and assessments included as follows: Temperature, oxygen saturation, heart rate, respiratory rate, resting systolic and diastolic blood pressure. **Measure:** Frequency and severity of abnormal findings in vital signs **Time Frame:** Within 96 weeks after GC012F injection infusion **Description:** Recommended phase I dose **Measure:** RP1D **Time Frame:** 2 years after GC012F injection infusion **Description:** maximum tolerated dose **Measure:** MTD **Time Frame:** 2 years after GC012F injection infusion #### Secondary Outcomes **Description:** PK results of GC012F **Measure:** PK parameters of CAR-T cells in peripheral blood after GC012F infusion (Cmax); **Time Frame:** Within 96 weeks after GC012F injection infusion **Description:** PK results of GC012F **Measure:** PK parameters of CAR-T cells in peripheral blood after GC012F infusion (Tmax); **Time Frame:** Within 96 weeks after GC012F injection infusion **Description:** PK results of GC012F **Measure:** PK parameters of CAR-T cells in peripheral blood after GC012F infusion ( AUC); **Time Frame:** Within 96 weeks after GC012F injection infusion **Description:** PK results of GC012F **Measure:** Levels of cytokines [IL-6、IL-10、IFN-γ、TNF-α、MCP-1(as applicable)], lymphocyte subsets, and soluble BCMA in peripheral blood after GC012F infusion; **Time Frame:** Within 28 days after GC012F injection infusion **Description:** Efficacy results of GC012F **Measure:** Disease activity indices:MG-ADL **Time Frame:** Within 96 weeks after GC012F injection infusion **Description:** Efficacy results of GC012F **Measure:** Disease activity indices:MGC **Time Frame:** Within 96 weeks after GC012F injection infusion **Description:** Efficacy results of GC012F **Measure:** Disease activity indices:QMG **Time Frame:** Within 96 weeks after GC012F injection infusion **Description:** Efficacy results of GC012F **Measure:** Disease activity indices: MG-QoL 15r **Time Frame:** Within 96 weeks after GC012F injection infusion **Description:** Efficacy results of GC012F **Measure:** Disease activity indices: post-intervention status according to the Myasthenia Gravis Foundation of America (MGFA) classification **Time Frame:** Within 96 weeks after GC012F injection infusion ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Subjects or his/her legal proxy/guardian voluntary signing the ICF, and willing and able to follow the procedure in this study. 2. Aged ≥18 years old, no gender limitation; 3. Patients with confirmed refractory GMG, and the clinical classification is IIa-IVb (including IIa, IIb, IIIa, IIIb, IVa and IVb) in screening; 4. Patients whose MG-ADL score is 5 or more, and the proportion of ocular symptoms is less than 50% in the total score; 5. Patients with poor efficacy of conventional treatment and/or no effective treatment means relapse or exacerbation despite conventional hormone, immunosuppressant (e.g., azathioprine, mycophenolate mofetil, tacrolimus, cyclosporin A, cyclophosphamide, etc.), or rituximab treatment; 6. Patients who are on corticosteroids, the dose of prednisone should not exceed 20 mg/d (or no more than an equivalent dose of another corticosteroid) during the 3 weeks prior to apheresis, and the dose isn't escalated during 3weeksk prior to apheresis, the dose isn't changed within 4 weeks prior to infusion; 7. Patients with positive MG-specific autoantibodies in the screening period: acetylcholine receptor autoantibody (anti-AChR) titer or muscle-specific tyrosine kinase autoantibody (anti-MuSK) or low-density lipoprotein receptor-associated protein 4 autoantibody (anti-LRP4) or anti-acetylcholine receptor cluster antibody must be higher than the upper limit of the laboratory reference normal value; 8. Life expectancy ≥3 months; 9. The results of laboratory test during screening period shall meet all following criteria: 1. Neu ≥1.0 × 109/L; Hb ≥8.0 g/dL; PLT ≥50 × 109/L; 2. ALT ≤3 × ULN; AST ≤3 × ULN; TBIL \<2 × ULN (DBIL ≤1.5 × ULN for subjects with Gilbert's syndrome) 3. Creatinine clearance (19.3 Appendix 3) ≥30 mL/min; 4. APTT ≤1.5 × ULN, PT ≤1.5 × ULN; 5. LVEF ≥50% based on echocardiography, no findings of pericardial effusion. 10. Women of child-bearing age should: 1. Have a negative serum β human chorionic gonadotropin (β-hCG) pregnancy test confirmed by investigators during the screening period; 2. Agree to avoid breastfeeding during the study period until at least 1 year after the infusion of GC012F Injection or until two consecutive flow cytometry tests show the absence of CAR-T cells (whichever occurs later). 11. Any male subjects who have sexual partners and female subjects with childbearing potential shall agree to take effective contraceptive methods (e.g. oral contraceptive pills, intrauterine device or condoms) from the screening starting until at least 1 year post GC012F Injection infusion or until two consecutive flow cytometry tests show the absence of CAR-T cells (whichever occurs later. Male subjects must agree to use condoms during sexual contact with pregnant females or females with fertility for at least 1 year after the infusion of GC012F Injection, even if a successful vasectomy has been performed; 12. Venous access available for blood collection, and no contraindications for leukapheresis. exclusion criteria: 1. Subjects have a history of severe hypersensitivity or allergy; 2. Any contraindication for fludarabine, cyclophosphamide and any component of the investigational product; 3. Subjects with any of the following heart diseases: 1. Congestive heart failure (New York Heart Association (NYHA) Class III or IV); 2. Experienced myocardial infarction or underwent coronary artery bypass grafting (CABG) within 6 months prior to screening period; 3. Clinically significant ventricular arrhythmias or a history of unexplained syncope not due to vasovagal reaction or dehydration; or a QTc interval \>480 ms during screening; 4. History of severe non-ischemic cardiomyopathy. 4. Accompanied by other uncontrolled malignancies. Subjects with the following conditions should be excluded: early-stage tumors that have received radical treatment (carcinoma in situ or grade 1 tumors, or non-ulcerated primary melanoma with a depth \<1 mm and no involvement of lymph nodes), basal cell skin cancer, skin squamous cell carcinoma, cervical carcinoma in situ, or breast cancer in situ that has received potential radical treatment; 5. Severe underlying medical conditions, such as: 1. Fungal, bacterial, viral or other infections or suspected fungal, bacterial, viral or other infections that cannot be controlled or require general intravenous administration; 2. Significant clinical evidence of dementia or mental status changes; 3. History of any central nervous system (CNS) or neurodegenerative diseases, (e.g., epilepsy, seizures, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, psychiatric disorders). 6. Positive results in any of the following tests: 1. HIV antibody positive; 2. HBsAg positive; or HBcAb positive and HBV-DNA above the lower limit of detection of the analytical method; 3. HCV antibody positive with HCV RNA above the lower limit of detection of the analysis method; or known history of hepatitis C without completion of antiviral therapy for ≥24 weeks; 4. Syphilis antibody positive. 7. Received therapy of non-hormonal immunosuppressants within 3 weeks prior to apheresis; 8. Major surgery within 2 weeks prior to leukapheresis or surgery plan during the study (except for local anesthesia surgery, but not performed within 2 weeks after infusion); 9. Receipt of a live-attenuated vaccine within 4 weeks prior to leukapheresis; 10. Intravenous injection of immunoglobulins or therapy of plasma exchange (PE); 11. Receipt of other biologics for MG within 3 weeks prior to apheresis or within 8 weeks prior to infusion; 12. Participation in any other clinical trial within 4 weeks prior to signing ICF, or the date of signing the ICF still within 5 half-lives of the drug from the last dose in the last clinical trial (whichever is longer); 13. Thymectomy within 12 months prior to ICF signing; 14. Pregnant women or lactating women who do not agree to abstain from breastfeeding, men and women who have a fertility plan during participation in this study or within 1 year after receiving study treatment; 15. Any situation that may hinder subjects' participation in the entire trial or confuse the results, or any situation in which investigators believe that participation in this study is not in the subject's best interests. **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:** He Huang, PhD **Phone:** 86-13605714822 **Role:** CONTACT #### Locations **Location 1:** **City:** Hanzhou **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** He Huang, PhD - **Phone:** 86-13605714822 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Yongxian Hu, PhD - **Phone:** 86-15957162012 - **Role:** CONTACT **Country:** China **Facility:** The First Affiliated Hospital,College of Medicine, Zhejiang University **State:** Zhejiang **Status:** RECRUITING **Zip:** 310003 ## 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 - ID: D000020361 - Term: Paraneoplastic Syndromes, Nervous System - ID: D000009423 - Term: Nervous System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000010257 - Term: Paraneoplastic Syndromes - ID: D000020274 - Term: Autoimmune Diseases of the Nervous System - ID: D000019636 - Term: Neurodegenerative Diseases - ID: D000020511 - Term: Neuromuscular Junction Diseases - ID: D000009468 - Term: Neuromuscular Diseases - ID: D000001327 - Term: Autoimmune Diseases - ID: D000007154 - Term: Immune System Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC20 - Name: Immune System Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M12112 - Name: Myasthenia Gravis - Relevance: HIGH - As Found: Myasthenia Gravis - ID: M20944 - Name: Muscle Weakness - Relevance: HIGH - As Found: Myasthenia - ID: M13204 - Name: Paresis - Relevance: LOW - As Found: Unknown - ID: M4554 - Name: Asthenia - 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 - ID: M16355 - Name: Syndrome - Relevance: LOW - As Found: Unknown - ID: M13170 - Name: Paraneoplastic Syndromes - Relevance: LOW - As Found: Unknown - ID: M22160 - Name: Paraneoplastic Syndromes, Nervous System - Relevance: LOW - As Found: Unknown - ID: M12367 - Name: Nervous System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M4629 - Name: Autoimmune Diseases - Relevance: LOW - As Found: Unknown - ID: M22094 - Name: Autoimmune Diseases of the Nervous System - Relevance: LOW - As Found: Unknown - ID: M21558 - Name: Neurodegenerative Diseases - Relevance: LOW - As Found: Unknown - ID: M22297 - Name: Neuromuscular Junction Diseases - Relevance: LOW - As Found: Unknown - ID: M12411 - Name: Neuromuscular Diseases - Relevance: LOW - As Found: Unknown - ID: M10200 - Name: Immune System Diseases - Relevance: LOW - As Found: Unknown - ID: T3973 - Name: Myasthenia Gravis - Relevance: HIGH - As Found: Myasthenia Gravis ### Condition Browse Module - Meshes - ID: D000009157 - Term: Myasthenia Gravis - ID: D000018908 - Term: Muscle Weakness ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419153 **Brief Title:** Evaluating the Efficacy of the Sub-psoas Fascial Plane Block for Post-operative Analgesia Following Hemiarthroplasty **Official Title:** Evaluating the Efficacy of the Sub-psoas Fascial Plane Block for Post-operative Analgesia Following Hemiarthroplasty #### Organization Study ID Info **ID:** C.A. 3190 #### Organization **Class:** OTHER **Full Name:** University College Hospital Galway ### Status Module #### Completion Date **Date:** 2024-11-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-16 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2024-09-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-13 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-04 **Study First Submit QC Date:** 2024-05-16 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** Prof John McDonnell **Class:** UNKNOWN **Name:** Prof John Laffey #### Lead Sponsor **Class:** OTHER **Name:** University College Hospital Galway #### Responsible Party **Investigator Affiliation:** University College Hospital Galway **Investigator Full Name:** Orla Murphy **Investigator Title:** Dr Orla Murphy, Specialist Registrar Anaesthesia **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** The study aims to examine the efficacy and safety of an ultrasound-guided regional anaesthetic technique intended to provide pain relief following hip surgery. It involves targeting a layer of tissue known as the psoas fascia, where the nerves of the lumbar plexus, supplying the lower limb, are located. There are many well-established ultrasound-guided techniques that target similar anatomical planes and structures, such as the psoas compartment block and quadratus lumborum plane block, which are widely used in clinical practice. This is not a new technique but rather a new approach to a well-established and utilized technique (the psoas compartment block). Early remobilisation plays a key role in the recovery of post-operative patients, helping to reduce the incidence of pneumonia, deep vein thrombosis, and delirium. By reducing motor weakness while still providing adequate pain relief and minimizing the use of strong painkillers such as morphine, it will help to reduce the risk of falls and length of hospital stay. An initial case series in GUH has previously followed a small cohort of patients who, following informed consent, underwent the subpsoas fascia plane (SPF) block vs. suprainguinal fascia iliaca block as part of their multimodal pain relief following surgery. It was found that in this group there was a reduction in postoperative pain scores, decreased use of strong painkillers, and earlier time to remobilisation. **Detailed Description:** Background: Hip fracture surgery is one of the commonest orthopaedic operations performed in the Republic of Ireland, and is associated with significant patient morbidity, mortality and health care costs. The National Irish Hip Fracture Report recorded 1,950 hip fractures in 2013, 71% were female and the highest proportions were in the 80-89 age group. It has been estimated that the overall prevalence of hip fractures is projected to increase in line with increasing elderly population and projected demographic changes. Early remobilization has become a key integral component of the optimal post-surgical management of hip fractures. Based on the National Institute for Health and Care Excellence (NICE) guidance, the National Hip Fracture UK Database has adopted patient remobilisation on the day of or day after surgery as a key performance indicator. Early mobilisation has been shown to reduce the risk of in-hospital mortality following hip fracture and to increase the likelihood of discharge from hospital. In 2018, 20% of patients failed to achieve the early remobilisation target, due to pain and/or hypotension, factors which might have been anticipated by clear perioperative protocols and closer working between surgery and anaesthetic colleagues. Current AAGBI guidelines describe core principles of the peri-operative management of people with hip fracture, with one of their aims recommending a peripheral nerve block immediately prior to operative fixation of a hip fracture (in the Emergency Department and at the time of surgery, provided six hours have passed between blocks). There are two peripheral nerve blocks commonly used in the perioperative setting of hip fracture repair, namely femoral or fascia iliaca block. Both techniques have been proven to be safe and efficacious, however, these peripheral nerve blocks have been associated with some residual muscle weakness and increased falls risk which further hampens the ability of a patient to remobilize post-operatively. There is a clinical need to establish a safe, reliable regional anaesthetic technique that will still offer long-acting opioid sparing analgesia, yet minimise the associated motor blockade in order to improve and facilitate remobilization. By also potentially interrupting the sympathetically mediated pain in the lower limb following hip surgery through the blockade of this lumbar sympathetic plexus, it may provide an avenue to produce significant analgesia without causing somatic sensory deficits (e.g. residual motor weakness), thereby facilitating early remobilisation and enhanced recovery. This is not a new technique, rather it is a new approach to a very well established and utilized technique (the psoas compartment block) which has been shown to be very effective, this approach is expected to be as efficacious and potentially safer than previous approaches as it avoids the nerve roots. In terms of the side effect profile of this novel approach to the PCB - there are no new expected side effects above the standard previously explained effects that can occur with any regional technique (for example, haematoma/ LAST / Neuropraxia). This approach would theoretically be associated with a lower side effect profile than previous landmark or current ultrasound-guided PCB technique as it avoids the risk profile of traversing the psoas muscle body and near the exit of the lumbar plexus nerve roots. This study aims to follow up on the inital case series discussed above to evaluate the efficacy of the SPF block for post op analgesia in patients undergoing hemiarthroplasty surgery. Aims and Objectives: This will be a randomised control trial. The primary aim of this study is to further evaluate the efficacy of a sub-psoas muscle fascial plane regional block for providing adequate opioid-sparing/reducing post-operative analgesia, in comparrisson to patients who do not receive a regional anaesthesia block and standard analgesic regieme. The secondary aim of this study is to explore patients' experience post-operatively in terms of their pain, time to remobilisation, total analgesic requirements, and quality of recovery. Study End Points/Primary Objectives: * To evaluate the post-operative analgesia provided by the proposed regional anaesthesia block, utilising: * Quality of Recovery 15 (QoR15) Score * Pain scores (Numerical rating scales, Pain Map, VAS, NRS) * Intraoperative and Postoperative Opioid Requirements Quantification * Time to remobilisation post-operatively * (see supplementary material) Study Design: This trial will take place in the Anaesthetic and Orthopaedic Departments, University Hospital Galway. All participants will be treated with either the sub-psoas fascial plane block pre or post-operatively, or no regional anaesethesia with a standard analgesic regieme. written consent will be obtained from each participant. Where informed consent is attained, a clinical note review will take place in addition to the psoas muscle sympathetic chain block pre-operatively. Patients will be closely monitored throughout the procedure and surgery. They will be followed up in the post-anaesthetic care recovery unit to assess their pain, in addition to on day one and two on the ward where a full assessment of their recovery, pain, opioid requirements and overall post-operative course will be carried out by the anaesthetic team member involved in this study. Study Methodology: In this RCT, all patients enrolled will be undergoing either emergency hip surgery under the orthopaedic team in the theatre complex in University Hospital Galway. Ethical approval from the Galway Clinical Research Ethics Committee will be sought. Once approved, the procedure will be explained at length by the primary research or co-investigators to the patient and all questions will be addressed. The aim would be to provide a timeframe for the patient to consider the procedure before providing consent (i.e. during pre-operative assessment on the ward the night before or morning of their surgery and undergoing the consent process when in the theatre complex). If the patient is agreeable, verbal informed consent will be obtained. a clinical note review will take place to attain basic demographic and clinical data including diagnosis, indication for surgery, type of surgery, type of anaesthetic technique, comorbidities, preadmission opioid requirements. The procedure will be explained at length to the patient and if agreeable to proceed, the patient will be monitored closely as normally would occur in the theatre setting, they will be positioned in theatre briefly onto their lateral side. Under ultrasound-guidance the regional nerve block will be performed by the experienced consultant anaesthesiologist, whereby 30ml of 0.75% Ropivicaine will be slowly injected into the subpsoas fascial plane, whilst at all times throughout and following the procedures the patient will be closely haemodynamically monitored. The patient will be followed up in the recovery post-anaesthetic care unit up to four hours following their surgery. They will then be reviewed by the one of the co-investigators at a timeframe of 0-24 hours and 24-48 hours post-operatively to further establish their analgesic efficacy, their pain scores (see supplementary appendix), quality of recovery, time to remobilization and opioids requirements, ensuring the patient is comfortable and aiming to maximize their recovery period. This is not a new technique, rather it is a new approach to a very well established and utilized technique - the psoas compartment block (PCB). The PCB utilizes a posterior approach whereby it traverses through the body of the psoas muscle thereby carrying the small risk profile of being near the plane of where the lumbar plexus roots exit the body of the muscle. ### Conditions Module **Conditions:** - Hemiarthroplasty **Keywords:** - anaesthesia, regional - SPF block - hemiarthroplasty - subpsoas fascia block ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 80 **Type:** ESTIMATED **Patient Registry:** True **Study Type:** OBSERVATIONAL **Target Duration:** 2 Days ### Arms Interventions Module #### Arm Group 1 **Description:** In this RCT, all patients enrolled will be undergoing Emergency HemiArthroplasty in the theatre complex in University Hospital Galway. Under ultrasound-guidance the SPF will be performed by the experienced consultant anaesthesiologist, whereby 30ml of 0.75% Ropivicaine will be slowly injected into the subpsoas fascial plane, whilst at all times throughout and following the procedures the patient will be closely haemodynamically monitored. The patient will be followed up in the recovery post-anaesthetic care unit up to four hours following their surgery. They will then be reviewed by the one of the co-investigators at a timeframe of 0-24 hours and 24-48 hours post-operatively to further establish their analgesic efficacy, their pain scores (see supplementary appendix), quality of recovery, time to remobilization and opioids requirements, ensuring the patient is comfortable and aiming to maximize their recovery period. **Label:** SPF Block Group #### Arm Group 2 **Description:** In this RCT, all patients enrolled will be undergoing Emergency HemiArthroplasty in the theatre complex in University Hospital Galway Participants randomized to 'standard care' will receive the standard care required as determined by the treating team in the form of intravenous analgesia. **Label:** No SPF Block Group ### Outcomes Module #### Primary Outcomes **Description:** Quality of Recovery 15 (QoR15) Score a patient-reported outcome measurement measuring QoR after surgery and anesthesia. minimum score of 0 (very poor recovery) and a maximum score of 150 (excellent recovery). **Measure:** Evaluation of Efficacy of SPF Block - Quality of Recovery **Time Frame:** 48 hours **Description:** Intraoperative and Postoperative Opioid Requirements Quantification **Measure:** Opioid Consumption **Time Frame:** 48 hours **Description:** Pain score - NRS - Numerical Rating Score requires the patient to rate their pain on a defined scale. 0-10 where 0 is no pain and 10 is the worst pain imaginable **Measure:** Pain Score **Time Frame:** 48 hours #### Secondary Outcomes **Description:** Time to remobilisation post-operatively **Measure:** Time to remobilisation post-operatively **Time Frame:** 48hrs ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Individuals undergoing orthopaedic surgery at the hip joint in University College Hospital, Galway. * Individuals over 18 years of age. * Individuals treated with psoas muscle sympathetic nerve blocks as part of multi-modal analgesic management. * Individuals with the capacity to make an informed decision regarding study participation. * Patients that provide written and verbal informed consent. * Patients whom have not received a fascia iliacus block in the emergency department prior to their surgery. Exclusion Criteria: * To be eligible, a patient must have none of these exclusion criteria * Individuals unable to provide informed consent. * Individuals \< 18 years of age. * Individuals with an intellectual disability (IQ \< 70), cognitive impairment, delirium or with dementia. * Allergy to the local anaesthesia block components. * Patients with absolute or relative contraindication to peripheral nerve blocks. * Coagulopathy (Prothrombin time/International Normalized Ratio of more than 1.50, Activated Partial Thromboplastin Time of more than 60 seconds). * Cases judged to be inappropriate by the chief investigator. * Patients whom have received a fascia iliacus block in the emergency department prior to their surgery **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** all patients enrolled will be undergoing Emergency HemiArthroplasty in the theatre complex in University Hospital Galway. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Orla Murphy, MB BCh BAO FCAI **Phone:** + 353 91 524 222 **Role:** CONTACT ## Derived Section ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Analg - Name: Analgesics ### Intervention Browse Module - Browse Leaves - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M4032 - Name: Analgesics - Relevance: LOW - As Found: Unknown - ID: M4033 - Name: Analgesics, Opioid - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419140 **Brief Title:** Multimodal Rehabilitation on Gastric Adenocarcinoma Patients Following Radical D2 Gastrectomy **Official Title:** The Impact of Multimodal Rehabilitation on the Outcomes of Gastric Adenocarcinoma Patients Following Radical D2 Gastrectomy: A Phase II, Multicenter, Open Label, and Randomized Clinical Study #### Organization Study ID Info **ID:** IRB-2024-349 #### Organization **Class:** OTHER **Full Name:** Zhejiang Cancer Hospital ### Status Module #### Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-05-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-04-16 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Zhejiang Cancer Hospital #### Responsible Party **Investigator Affiliation:** Zhejiang Cancer Hospital **Investigator Full Name:** Ying Jieer **Investigator Title:** Chief physician **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** This study has established a multidisciplinary rehabilitation team to recruit patients who underwent radical D2 gastrectomy in multiple centers and divided them into a rehabilitation group and a control group. Intervention will be carried out every time the patients come to the hospital for adjuvant chemotherapy and review. The control group uses traditional intervention model, and the rehabilitation group uses combined exercise/nutrition/psychology rehabilitation intervention. This study is expected to promote early recovery after gastric cancer surgery through multidisciplinary rehabilitation intervention, reduce the occurrence of complications, improve patients' tolerance to adjuvant chemotherapy, and improve patients' quality of life, and hope to improve the short-term and long-term outcomes of gastric cancer patients. ### Conditions Module **Conditions:** - Gastric Cancer ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 138 **Type:** ESTIMATED **Phases:** - PHASE2 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Standard SOX/XELOX adjuvant chemotherapy plus multimodal rehabilitation care **Intervention Names:** - Drug: Standard SOX/XELOX adjuvant chemotherapy plus multimodal rehabilitation **Label:** The rehabilitation group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Standard SOX/XELOX adjuvant chemotherapy without multimodal rehabilitation care **Label:** The control group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - The rehabilitation group **Description:** Motivational counseling to perform nutritional, psychological, and exercise inventions **Name:** Standard SOX/XELOX adjuvant chemotherapy plus multimodal rehabilitation **Type:** DRUG ### Outcomes Module #### Primary Outcomes **Description:** Completion rate of 8 cycles of adjuvant chemotherapy **Measure:** Adjuvant chemotherapy completion rate **Time Frame:** At the end of Cycle 8 (each cycle is 21 days) #### Secondary Outcomes **Description:** Proportion of subjects who have been free of disease recurrence within 3 years from randomization. **Measure:** 3-year disease-free survival (DFS) **Time Frame:** 3 year **Description:** Time from randomization to death **Measure:** Overall survival **Time Frame:** 3 year **Description:** Measured by GAD-7 questionnaire **Measure:** Emotional state **Time Frame:** 2 year **Description:** Weight **Measure:** Weight **Time Frame:** through study completion, an average of 2 year **Description:** Adverse event were evaluated through CTCAE **Measure:** Adverse event **Time Frame:** At the end of Cycle 8 (each cycle is 21 days) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Clinical diagnosis of Alzheimer's Disease * Must be able to swallow tablets * Age 18 to 75 years old * Patients with gastric adenocarcinoma (including gastroesophageal junction adenocarcinoma) confirmed by histopathology to be in pathological stage II/III (based on the eighth edition of the AJCC Cancer Staging Manual) * The patient underwent D2 radical resection within 3-6 weeks before randomization; and met the R0 resection criteria * The patient can undergo postoperative adjuvant chemotherapy after being selected into the randomization group, and the regimen is SOX/XELOX * Have not received previous anti-tumor treatment (including systemic chemotherapy and local radiotherapy), except for initial gastrectomy of the primary lesion * ECOG status score 0 or 1, with physical conditions to participate in sports training、Have sufficient bone marrow reserve function, ANC ≥1.5×109/L, platelet count ≥75×109/L, Hb ≥90 g/L before enrollment, and no bleeding tendency * Liver function test: alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) are all ≤ 2.5×ULN; serum bilirubin ≤ 1.5×ULN. For patients known to have Gilbert's disease: Serum bilirubin level ≤ 3ｘULN * Renal function test: Serum creatinine (Cr) ≤ 1.5 x ULN or creatinine clearance \> 50 ml/min (calculated according to Cockroft-Gault) * No mental illness, speech disorder or consciousness disorder, have certain understanding, communication and reading abilities, and be able to complete the questionnaire independently or with the assistance of the researcher * During the study, at least one source of social support (family member or friend) can monitor the safety and compliance of the intervention program * Can understand the situation of this study, and the patient and/or legal representative voluntarily agree to participate in this trial and sign the informed consent form. Exclusion Criteria: * Receive neoadjuvant chemotherapy or radiotherapy before surgery; * Participate in other clinical trials related to health behavior within 3 months before the trial; * Treated with any other study drugs or participated in another clinical trial with therapeutic intent within 28 days before enrollment; * Uncontrolled serious medical illness that the investigator believes will affect the subject's acceptance of the rehabilitation program, such as combined serious medical illness, including severe heart disease (such as New York Heart Association (NYHA) Class II or worse congestion heart failure), cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection, etc.; * Lack of ability to participate in sports training (such as: disability, paralysis of lower limbs, etc.); not suitable for participating in sports training, such as those suffering from skeletal muscle diseases, fractures within 6 months; suffering from exercise contraindications (angina pectoris, within 6 months) Myocardial infarction, congestive heart failure, chronic obstructive pulmonary disease, planned hip or knee replacement, use of a walker or wheelchair, recent stroke with hemiplegia, etc.); * Those who are receiving other forms of nutritional intervention; those who refuse to use oral nutritional preparations; * There is uncontrolled mental illness; * Known active HIV, HBV and HCV infection; * Patients with malignant tumors other than gastric cancer (except current gastric cancer) within the past 5 years; are eligible if they meet all the following criteria: treatment of malignant tumors with the purpose of cure, such as fully treated cervical cancer in situ, non-melanoma skin Cancer, localized prostate cancer after radical resection (PSA ≤ 10ng/ml); at the same time, no signs of recurrence or metastasis were found based on imaging follow-up results and any disease-specific tumor markers; * Those with difficulty swallowing, complete or incomplete gastrointestinal obstruction, active gastrointestinal bleeding, or perforation; * Pregnant or lactating female patients, or subjects of childbearing age who refuse to take contraceptive measures; * Patients judged by the researcher to be unfit to participate 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:** Jieer Jieer, Dr **Phone:** 0571-88122062 **Role:** CONTACT #### Locations **Location 1:** **City:** Hangzhou **Country:** China **Facility:** Zhejiang Cancer Hospital **State:** Zhejiang **Zip:** 310022 #### Overall Officials **Official 1:** **Affiliation:** Zhejiang Cancer Hospital **Name:** Jieer Jieer, Dr **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000002277 - Term: Carcinoma - ID: D000009375 - Term: Neoplasms, Glandular and Epithelial - ID: D000009370 - Term: Neoplasms by Histologic Type - ID: D000009369 - Term: Neoplasms ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M16064 - Name: Stomach Neoplasms - Relevance: LOW - As Found: Unknown - ID: M3585 - Name: Adenocarcinoma - Relevance: HIGH - As Found: Adenocarcinoma - ID: M5534 - Name: Carcinoma - Relevance: LOW - As Found: Unknown - ID: M12320 - Name: Neoplasms, Glandular and Epithelial - Relevance: LOW - As Found: Unknown - ID: M12315 - Name: Neoplasms by Histologic Type - Relevance: LOW - As Found: Unknown - ID: T5486 - Name: Stomach Cancer - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000000230 - Term: Adenocarcinoma ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419127 **Brief Title:** Embryo Assessment Utilizing Timelapse Imaging in Conjunction With Preimplantation Genetic Testing for Aneuploidy With Next Generation Sequencing **Official Title:** Embryo Assessment Utilizing Timelapse Imaging in Conjunction With Preimplantation Genetic Testing for Aneuploidy With Next Generation Sequencing #### Organization Study ID Info **ID:** GG1001 #### Organization **Class:** INDUSTRY **Full Name:** Gattaca Genomics ### Status Module #### Completion Date **Date:** 2029-06 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** 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:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** INDUSTRY **Name:** Gattaca Genomics #### 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 discern if there is a relationship between timelapse imagery of human oocytes/embryos and PGT results. Embryos of patients that are undergoing PGT will be placed into a timelapse incubator. The data obtained by the timelapse incubator will be used in conjunction with the PGT data to determine any relationships. **Detailed Description:** Timelapse imagery (TLI) is a multifaceted technology being utilized within the in vitro fertilization (IVF) space. With this technology it is possible to have a live, continuous video of embryo development from fertilization to implantation. During this live evaluation multiple datapoints can be extrapolated and used to determine embryo viability. Another technology used in the IVF space is preimplantation genetic testing for aneuploidy (PGT-A). With this technology, individual cells from the embryo are removed, amplified, and the chromosomal content of the cells is analyzed by next generation sequencing (NGS)-based technology, allowing the chromosomal content of the embryos to be determined prior to embryo transfer. To date, no one has combined the data from both tools to try to advance the IVF field. Gattaca Genomics is proposing utilizing the data obtained from TLI, in conjunction with the data obtained from PGT-A, to create a computer model that can accurately predict which embryos will lead to a successful outcome during IVF. ### Conditions Module **Conditions:** - Infertility, Female - Infertility, Male - Infertility - IVF - Aneuploidy **Keywords:** - ivf - infertility - pgt - embryo ### Design Module #### Bio Spec **Description:** The piece of the embryo that is utilized for PGT will be amplified, analyzed, and maintained according to standard operating procedures. **Retention:** SAMPLES_WITH_DNA #### Design Info **Observational Model:** COHORT **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 2000 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Infertile patients undergoing IVF with PGT. **Intervention Names:** - Diagnostic Test: Timelapse incubation and PGT **Label:** Infertile patients ### Interventions #### Intervention 1 **Arm Group Labels:** - Infertile patients **Description:** Patients will have their embryos cultured in a timelapse incubator and their PGT results will be compared to the data collected during timelapse incubation. **Name:** Timelapse incubation and PGT **Type:** DIAGNOSTIC_TEST ### Outcomes Module #### Primary Outcomes **Description:** time of embryo to undergo first cleavage **Measure:** Time to first cleavage **Time Frame:** 24 hours **Description:** time of embryo to form a blastocoel **Measure:** Time to blastulation **Time Frame:** 5-7 days **Description:** the morphological appearance of the pronuclei **Measure:** Fertilization morphology **Time Frame:** 24 hours **Description:** the morphological appearance of the embryos **Measure:** Embryo morphology **Time Frame:** 2-7 days **Description:** Patient age **Measure:** Patient age **Time Frame:** 0 days **Description:** Partner age **Measure:** Partner age **Time Frame:** 0 days **Description:** Patient diagnosis **Measure:** Patient diagnosis **Time Frame:** 0 days **Description:** Partner diagnosis **Measure:** Partner diagnosis **Time Frame:** 0 days **Description:** measurement of the spent culture media for amino acids, enzymes, and metabolites **Measure:** Metabolomics of culture media **Time Frame:** 7 days **Description:** antimullerian hormone level in female's blood **Measure:** AMH **Time Frame:** 0 days **Description:** the number of days the patient underwent stimulation for IVF **Measure:** Days of stimulation **Time Frame:** 0-15 days **Description:** the amount of stimulation meds the patient took during IVF treatment **Measure:** Dosage of stimulation meds **Time Frame:** 0-15 days **Description:** initial bhCG levels **Measure:** Pregnancy **Time Frame:** 2 weeks after transfer **Description:** development of a sac within the uterus post transfer **Measure:** implantation **Time Frame:** 4 weeks post transfer **Description:** development of fetal cardiac heartbeat after transfer **Measure:** fetal cardiac heartbeat **Time Frame:** 6 weeks **Description:** the livebirth of an infant after IVF **Measure:** livebirth **Time Frame:** approximately 9 months after transfer ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * all patients undergoing IVF with PGT Exclusion Criteria: * patients undergoing IVF and not electing for PGT **Maximum Age:** 50 Years **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT **Study Population:** All infertile patients undergoing IVF with PGT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Tyl H taylor **Phone:** 9806130105 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Tyl H taylor **Phone:** 9806130105 **Role:** CONTACT #### Locations **Location 1:** **City:** Fort Lauderdale **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Tyl H taylor - **Phone:** 980-613-0105 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Phone Ext:** taylor - **Role:** CONTACT ***Contact 3:*** - **Name:** Tyl H taylor, PhD, HCLD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** Gattaca Genomics **State:** Florida **Status:** RECRUITING **Zip:** 33308 ### IPD Sharing Statement Module **Description:** Data will not be shared with other researchers **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000091662 - Term: Genital Diseases - ID: D000091642 - Term: Urogenital Diseases - ID: D000005831 - Term: Genital Diseases, Female - ID: D000052776 - Term: Female Urogenital Diseases - ID: D000005261 - Term: Female Urogenital Diseases and Pregnancy Complications - ID: D000002869 - Term: Chromosome Aberrations - ID: D000010335 - Term: Pathologic Processes - ID: D000005832 - Term: Genital Diseases, Male - 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: BC23 - Name: Symptoms and General Pathology ### Condition Browse Module - Browse Leaves - ID: M10290 - Name: Infertility - Relevance: HIGH - As Found: Infertility - ID: M10291 - Name: Infertility, Female - Relevance: HIGH - As Found: Infertility, Female - ID: M10292 - Name: Infertility, Male - Relevance: HIGH - As Found: Infertility, Male - ID: M4112 - Name: Aneuploidy - Relevance: HIGH - As Found: Aneuploidy - ID: M2876 - Name: Genital Diseases - Relevance: LOW - As Found: Unknown - ID: M2875 - Name: Urogenital Diseases - Relevance: LOW - As Found: Unknown - ID: M8943 - Name: Genital Diseases, Female - 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: M6109 - Name: Chromosome Aberrations - Relevance: LOW - As Found: Unknown - ID: M8944 - Name: Genital Diseases, Male - Relevance: LOW - As Found: Unknown - ID: M27095 - Name: Male Urogenital Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000007246 - Term: Infertility - ID: D000007247 - Term: Infertility, Female - ID: D000007248 - Term: Infertility, Male - ID: D000000782 - Term: Aneuploidy ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419114 **Acronym:** OCTGTBIPPL **Brief Title:** Exploration of Optical Coherence Tomography-Guided Transbronchial Biopsy in Peripheral Pulmonary Lesions **Official Title:** Exploration of Optical Coherence Tomography-Guided Transbronchial Biopsy in Peripheral Pulmonary Lesions #### Organization Study ID Info **ID:** SichuanPPHGZ01 #### Organization **Class:** OTHER **Full Name:** Sichuan Provincial People's Hospital ### Status Module #### Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-16 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-03-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-10 **Study First Submit QC Date:** 2024-05-16 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Sichuan Provincial People's Hospital #### Responsible Party **Investigator Affiliation:** Sichuan Provincial People's Hospital **Investigator Full Name:** Guanghong Zhou **Investigator Title:** Attending physician **Type:** PRINCIPAL_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** In this prospective analysis, investigators collected and evaluated data from patients who underwent TBB at the Respiratory Endoscopy Center of Sichuan Provincial People's Hospital. The procedures utilized a novel approach combining OCT with R-EBUS for guidance. Eligibility for participation was determined based on established guidelines for the application of diagnostic flexible bronchoscopy in adults. The admission criteria of this study were as followed: (1) voluntary participation and written informed consent signed, (2) age ≥ 18 years old, (3) the platelets count and PT, APTT tests were normal, (4) normal ECG, (5) found PPL's by chest computed tomography (CT) within 2 weeks and (6) could not detect the lesions through routine diagnostic bronchoscopy. The exclusion criteria of this study were as followed: (1) patients with contraindication of bronchoscopy (such as respiratory failure and acute cardio-cerebrovascular events), (2) patients who refuse biopsy because of physical reasons or personal wishes, (3) patients with the objective reasons (such as abundant blood supply around the lesion) who could not complete the biopsy, (4) patients who are participating in other clinical studies, (5) patients with poor compliance who are believed by the researchers to be unable to cooperate for the completion of the examination and follow-up, and (6) women who were pregnant. R-EBUS and OCT In this study, all procedures were conducted using a standardized flexible bronchoscopy (Olympus, Japan) featuring an outer diameter of 4.2mm. R-EBUS system (Olympus, Japan) incorporated an ultra-thin radial ultrasonic probe (Olympus UM-S20-17S), which measures merely 1.4mm in diameter. The OCT (Yongshida Medical Technology, Guangdong, China) probe is a cylindrical catheter, 1.7mm in diameter and 150cm in length. Placing the probe through the working channel of bronchoscope for real time dynamic scanning of lesions. Research Process In this study, the entirety of the procedures was performed by the same respiratory physician with 5 years of experience in respiratory endoscopic diagnosis and treatment, including preoperative evaluation, preparation, lesion localization and biopsy. The respiratory physician had examined the bilateral airways with flexible bronchoscopy after the completion of preoperative anesthesia and found no lesions. The subsequent step involved the precise placement of the OCT probe, guided by prior CT scan results. This stage was critical for marking the lesion, determining its nature (benign or malignant), and, in cases of malignancy, identifying its pathological classification. In instances where the OCT failed to identify any lesion, the R-EBUS was employed to facilitate lesion localization and biopsy. Conversely, when PPLs was detected via OCT, R-EBUS was additionally utilized to corroborate the PPLs localization and to assist in completing the biopsy procedure. For cases where OCT localization failed, R-EBUS would be used. After successful confirmation with R-EBUS, an attempt was made again to insert the OCT probe and completed biopsy. Rapid On-Site Evaluation (ROSE) was employed for the assessment of biopsy specimens. A total of five specimens were collected from each lesion and subjected to ROSE. In scenarios where ROSE provided a definitive diagnosis, no additional biopsies were deemed necessary. Conversely, in instances where ROSE yielded non-definitive results, further biopsy samples were obtained. All biopsy specimens were preserved in 10% formalin, preparing them for detailed histopathological analysis. The ultimate pathological diagnoses were determined based on the reports issued by the pathology department. In this study, the demographics of all patients were documented, including age, gender, and smoking history. Additionally, detailed clinical parameters, such as the location and size of the lesions, airway grades (ranging from 0 to 24) that the PPLs located, location time of OCT and the number of specimens, were systematically recorded. investigators also conducted extensive follow-up to track histopathological outcomes, whether from surgical biopsies, CT-guided percutaneous transthoracic needle biopsies, or other diagnostic avenues, including chest CT performed two months post-procedure. All the patients were followed up by telephone or outpatient service on the 1st and 3rd day after the procedure, and adverse events were recorded. All individuals underwent general anesthesia and were fitted with a laryngeal mask. **Detailed Description:** See details in"Brief summary" ### Conditions Module **Conditions:** - Lung Neoplasm **Keywords:** - Peripheral Pulmonary Lesions ### Design Module #### Bio Spec **Description:** The biopsy specimen does not need to be extracted for DNA, and it is sent directly to the pathology department for examination. **Retention:** SAMPLES_WITHOUT_DNA #### Design Info **Observational Model:** OTHER **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 150 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module ### Interventions #### Intervention 1 **Description:** Comparing the localization ability of OCT and R-EBUS in Peripheral Pulmonary Lesions and the predictive ability of lung cancer pathological classification **Name:** Optical Coherence Tomography **Other Names:** - radial probe endobronchial ultrasound **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Ability to locate PPLs **Measure:** The diagnostic yield of OCT or R-EBUS-guided TBB in PPLs **Time Frame:** baseline #### Secondary Outcomes **Description:** The ability to distinguish between benign and malignant lesions and pathological classification of malignant lesions by using OCT and R-EBUS **Measure:** The pathological diagnostic value of OCT and R-EBUS **Time Frame:** baseline **Description:** age(year), gender(male, female), and smoking history(yes or no)，the location and size of the lesions, airway grades (ranging from 0 to 24) that the PPLs located, location time(seconds) of OCT and the number of specimens(number=1,2,3...)，surgical biopsies, CT-guided percutaneous transthoracic needle biopsies, or other diagnostic avenues, including chest CT performed two months post-procedure **Measure:** The demographics of all patients **Time Frame:** baseline and 2 months ### Eligibility Module **Eligibility Criteria:** The inclusion criteria of this study were as followed: (1)Clinical diagnosis of PPL's by chest computed tomography (CT) within 2 weeks, (2)voluntary participation and written informed consent signed, (3) age ≥ 18 years old, (4) the platelets count and PT, APTT tests were normal, (5) normal ECG and (6) could not detect the lesions through routine diagnostic bronchoscopy. The exclusion criteria of this study were as followed: (1) patients with contraindication of bronchoscopy (such as respiratory failure and acute cardio-cerebrovascular events), (2) patients who refuse biopsy because of physical reasons or personal wishes, (3) patients with the objective reasons (such as abundant blood supply around the lesion) who could not complete the biopsy, (4) patients who are participating in other clinical studies, (5) patients with poor compliance who are believed by the researchers to be unable to cooperate for the completion of the examination and follow-up, and (6) women who were pregnant. **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** (1) voluntary participation and written informed consent signed, (2) age ≥ 18 years old, (3) the platelets count and PT, APTT tests were normal, (4) normal ECG, (5) found PPL's by chest computed tomography (CT) within 2 weeks and (6) could not detect the lesions through routine diagnostic bronchoscopy. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Guanghong Zhou, master **Phone:** 8618302880040 **Role:** CONTACT #### Locations **Location 1:** **City:** Chengdu **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Guanghong Zhou, master - **Phone:** 18302880040 - **Role:** CONTACT **Country:** China **Facility:** Sichuan Provincial People's Hospital **State:** Sichuan **Status:** RECRUITING **Zip:** 610072 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000012142 - Term: Respiratory Tract Neoplasms - ID: D000013899 - Term: Thoracic Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000008171 - Term: Lung Diseases - ID: D000012140 - Term: Respiratory Tract Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M11172 - Name: Lung Neoplasms - Relevance: HIGH - As Found: Lung Neoplasms - ID: M14979 - Name: Respiratory Tract Neoplasms - Relevance: LOW - As Found: Unknown - ID: M16658 - Name: Thoracic Neoplasms - Relevance: LOW - As Found: Unknown - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M14977 - Name: Respiratory Tract Diseases - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000008175 - Term: Lung Neoplasms ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419101 **Brief Title:** Exploring the Diagnostic Biomarkers of Cognitive Disorders in China **Official Title:** Cohort Study on Biomarkers of Cognitive Disorders in China #### Organization Study ID Info **ID:** KS2024051 #### Organization **Class:** OTHER **Full Name:** Xuanwu Hospital, Beijing ### Status Module #### Completion Date **Date:** 2035-05-10 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-21 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2034-05-10 **Type:** ESTIMATED #### Start Date **Date:** 2024-05-30 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-07 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** First Hospital of Shijiazhuang City **Class:** OTHER **Name:** Chongqing Medical University **Class:** OTHER **Name:** Tianjin Huanhu Hospital **Class:** UNKNOWN **Name:** Central hospital Affiliated to Shandong First Medical University #### Lead Sponsor **Class:** OTHER **Name:** Cuibai Wei，Clinical Professor #### Responsible Party **Investigator Affiliation:** Xuanwu Hospital, Beijing **Investigator Full Name:** Cuibai Wei，Clinical Professor **Investigator Title:** Xuanwu Hospital, Capital Medical University **Type:** SPONSOR_INVESTIGATOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False ### Description Module **Brief Summary:** Dementia is a syndrome characterized by progressive global cognitive impairment that impairs occupational, family, or social functioning. It detrimentally affects personal health and quality of life, imposing significant medical economy, social and psychological burden on the countries and the patients' family. The internationally renowned dementia cohort includes the DIAN that focused on genetics studies, the ADNI cohort featuring imaging and the FINGERS cohort focused on risk factor intervention, etc. Establishing standardized and shared longitudinal follow-up dementia cohorts and clinical database is an essential challenge for constructing dementia cohort in China. Moreover, there is a lack of large-scale prospective longitudinal follow-up cohorts within the Chinese population that cover subjective cognitive decline (SCD) to explore biomarkers with diagnostic and early warning value for different kinds of dementia and pre-dementia stages. The study will rely on the dementia cohort based on Chinese population to explore the biological phenotype characteristics of the pre-dementia stage and different dementia subtypes, and observe the dynamic change rules of the dementia cohort vertically, so as to foster early intervention and improve prognosis for individuals with dementia. **Detailed Description:** The 3000 patients with pre-dementia stage and different dementia subtypes will be enrolled in this study, and data will be collected in the baseline including demographics, clinical symptoms, assessment of neuropsychology, neuroimaging, neuroelectrophysiology, blood samples, cerebrospinal fluid, etc. The changes of these data were dynamically observed through an annual follow-up. According to the neuropsychological evaluation results of follow-up, the subjects were divided into dementia progression (dementia-P) and dementia stabilization (dementia-S). Difference in clinical phenotype, neuropsychology, electrophysiology, neuroimaging, and body fluid multi-omics indicators between the two subtypes were compared and analyzed. The neuropsychological testes in patients with dementia included some neuropsychological scales such as, Clinical Dementia Rating (CDR), Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), etc. Multi-model neuroimaging evaluation screen the candidate neuroimaging markers, including structure and functional brain magnetic resonance imaging (MRI), Diffusion tensor image (DTI), 18 F-2-fluro-D-deoxy-glucose-positron emission tomography (18F-FDG-PET)，Amyloid-PET and tau-PET. To exploring neuroelectrophysiology biomarkers collect the data on polysomnography, resting state electroencephalogram, and evoked potentials (P1, N1, P2, N2, etc.). ELISA, SIMOA and other analytical methods were used to detect the contents related to dementia progression in the blood, cerebrospinal fluid, urine, saliva and feces. Multi-dimensional screening and identifying biomarkers of disease diagnosis and progression in all stages, from subjective cognitive impairment to mild cognitive impairment to dementia, in line with the characteristics of the Chinese population. ### Conditions Module **Conditions:** - Biomarkers - Dementia **Keywords:** - dementia - diagnostic biomarkers ### Design Module #### Bio Spec **Description:** blood samples, CSF, urine, faeces, saliva **Retention:** SAMPLES_WITH_DNA #### Design Info **Observational Model:** COHORT **Time Perspective:** PROSPECTIVE #### Enrollment Info **Count:** 3000 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** dementia-P (Compared with the baseline, MMSE score declined ≥ 4 points per year) **Label:** dementia progression #### Arm Group 2 **Description:** dementia-S (Compared with the baseline, MMSE score decreased \< 4 points per year） **Label:** dementia stabilization ### Outcomes Module #### Primary Outcomes **Description:** Assess statistically significant difference in score between dementia-P and dementia-S using the neuropsychological scales CDR. CDR, a multidimensional scale for dementia severity, which scored 0-3, with higher scores indicating worse functioning. **Measure:** Rate of change in global cognition as measured by Clinical Dementia Rating (CDR). **Time Frame:** 10 years #### Secondary Outcomes **Description:** Assess statistically significant difference in score between dementia-P and dementia-S using the neuropsychological scales MMSE. MMSE scores range from 0-30, with higher scores representing better cognitive function. **Measure:** Rate of change in global cognition as measured by Mini-Mental State Examination (MMSE) **Time Frame:** 10 years **Description:** Assess statistically significant difference in score between dementia-P and dementia-S using the neuropsychological scales MoCA. MoCA scores range from 0-30, with higher scores representing better cognitive function. **Measure:** Rate of change in global cognition as measured by Montreal Cognitive Assessment (MoCA) **Time Frame:** 10 years **Description:** Assess statistically significant difference in score between dementia-P and dementia-S using the neuropsychological scales ADAS-cog. ADAS-cog scores range from 0-70, with higher scores indicating better global cognitive function. **Measure:** Rate of change in the severity of cognitive impairment as assessed by Alzheimer's Disease Assessment Scale-Cognitive section (ADAS-cog). **Time Frame:** 10 years **Description:** Assess statistically significant difference in score between dementia-P and dementia-S using the neuropsychological scales like WHO-UCLA AVLT. WHO-UCLA AVLT scores depend on the number of correct words, which ranges from 0-15, with higher scores representing better memory function. **Measure:** Rate of change in memory function as assessed by World Health Organization-University of California, Los Angeles, auditory verbal learning test (WHO-UCLA AVLT). **Time Frame:** 10 years **Description:** Assess statistically significant difference in score between dementia-P and dementia-S using the neuropsychological scales like BNT. BNT scores range from 0-30, with higher scores representing better language function. **Measure:** Rate of change in language function as assessed by Boston Naming Test (BNT). **Time Frame:** 10 years **Description:** Assess statistically significant difference in score between dementia-P and dementia-S using the neuropsychological scales like NPI. Patient assessment grading scores range from 0-144 in NPI, and caregivers distress grading scores range from 0-60, with 0 representing the best. **Measure:** Rate of change in psychobehavioral symptoms as assessed by Neuropsychiatric Inventory (NPI). **Time Frame:** 10 years **Description:** Assess statistically significant difference between in score dementia-P and dementia-S using the neuropsychological scales like ADCS-ADL. ADCS-ADL scores range from 0-54, with higher scores indicating better completion ability. **Measure:** Rate of change in activities of daily living as assessed by Alzheimer's Disease Cooperative Study-Activity of Daily Living (ADCS-ADL). **Time Frame:** 10 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Male or female patients aged ≥40 and ≤90years; * Chief complaint or others describe a cognitive decline; * Ability to communicate in Chinese; * The patients and their families were informed and signed the informed consent. Exclusion Criteria: * MMSE\<10; * There are other neurological diseases that can cause brain dysfunction (such as depression, brain tumors, Parkinson's disease, metabolic encephalopathy, encephalitis, multiple sclerosis, epilepsy, traumatic brain injury, normal intracranial pressure hydrocephalus, etc.); * There are other systemic diseases that can cause cognitive impairment (such as hepatic insufficiency, renal insufficiency, Thyroid dysfunction, severe anemia, folic acid or vitamin B12 deficiency, syphilis, HIV infection, alcohol and drug abuse, etc.); * Suffering from a disease that cannot cooperate with the completion of cognitive examination; * There are contraindications to nuclear magnetic resonance; * There is mental and neurodevelopmental delay; * Refuse to draw blood; * Refuse to sign the informed consent. **Healthy Volunteers:** True **Maximum Age:** 90 Years **Minimum Age:** 40 Years **Sampling Method:** PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** This project will enroll about 3000 patients with dementia, who meet the inclusion and exclusion criteria, including subjective cognitive decline (SCD), MCI, AD, frontotemporal dementia (FTD), dementia with Lewy bodies (DLB), etc. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Cuibai Wei **Phone:** 83198319 **Role:** CONTACT #### Overall Officials **Official 1:** **Affiliation:** Xuan Wu Hospital of Capital Medical University, Beijing, China, 100053 **Name:** Cuibai Wei **Role:** PRINCIPAL_INVESTIGATOR ## 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: D000019965 - Term: Neurocognitive Disorders - ID: D000001523 - Term: Mental Disorders ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M6301 - Name: Cognition Disorders - Relevance: HIGH - As Found: Cognitive Disorders - ID: M6904 - Name: Dementia - Relevance: HIGH - As Found: Dementia - ID: M29705 - Name: Cognitive Dysfunction - Relevance: HIGH - As Found: Cognitive Disorders - ID: M5204 - Name: Brain Diseases - Relevance: LOW - As Found: Unknown - ID: M5742 - Name: Central Nervous System 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 ### Condition Browse Module - Meshes - ID: D000003704 - Term: Dementia - ID: D000060825 - Term: Cognitive Dysfunction - ID: D000003072 - Term: Cognition Disorders ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419088 **Brief Title:** Effect of Preoperative Individualized Education on Anxiety and Recovery. **Official Title:** Effect of Preoperative Individualized Education on Anxiety and Recovery in Patients Undergoing Minimally Invasive Lung Surgery #### Organization Study ID Info **ID:** EPIEAR #### Organization **Class:** OTHER **Full Name:** Fujian Medical University Union Hospital ### Status Module #### Completion Date **Date:** 2025-12-30 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-14 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2024-12-30 **Type:** ESTIMATED #### Start Date **Date:** 2024-03-12 **Type:** ACTUAL **Status Verified Date:** 2024-03 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-14 **Study First Submit QC Date:** 2024-05-14 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Fujian Medical University Union 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:** Researchers aim to investigate whether individualized preoperative education for patients is beneficial in reducing perioperative anxiety, promoting postoperative recovery, and enhancing postoperative quality of life. The educational content will cover aspects such as the surgery procedure, anesthesia, postoperative pain and anxiety management, recovery time, and any potential required treatments. All participants will be administered a questionnaire before the surgery to evaluate their specific concerns and fears. The intervention group will receive preoperative education through audio-visual materials followed by targeted preoperative counseling, while the control group will receive routine preoperative education. **Detailed Description:** Patients who met the research criteria were consulted prior to surgery, during which the research objectives were explained, and written consent was obtained. Following baseline assessment, patients were randomly allocated to either the individualized education group or the routine education group. Sociodemographic information was collected through face-to-face interviews conducted in the ward. Additionally, levels of anxiety and adverse events (sleep, pain, nausea, vomiting) were measured using the Visual Analog Scale (VAS) and Hospital Anxiety and Depression Scale (HADS). Patient anxieties regarding different aspects were assessed using specific concerns and fears scales. The intervention group received individualized educational interventions utilizing audiovisual materials. Based on identified personalized educational needs, researchers administered individualized preoperative education to the intervention group in the ward. Patients in the control group received only routine preoperative education from clinical nurses. The second assessment was conducted before patients were transferred to the operating room. Anxiety levels and adverse events (preoperative sleep, pain, nausea, and vomiting) were assessed using HADS and VAS. Postoperatively, pain, nausea, vomiting, and coughing were evaluated three times daily for the first three days (every 8 hours) using the Visual Analog Scale (VAS), and sleep was assessed daily using the Athens Insomnia Scale (AIS). Chronic symptoms and quality of life were assessed at postoperative weeks 1, 2, 4, 12, 26, and 52. Chronic cough was evaluated using the Leicester Cough Questionnaire, and chronic pain was evaluated using the Brief Pain Inventory. The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) and HADS were used for continuous assessment of quality of life, anxiety, and depression status. ### Conditions Module **Conditions:** - Education **Keywords:** - Preoperative education ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - OUTCOMES_ASSESSOR **Primary Purpose:** PREVENTION #### Enrollment Info **Count:** 156 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** received individualized educational interventions utilizing audiovisual materials **Intervention Names:** - Other: Preoperative individualized education **Label:** individualized education group **Type:** OTHER #### Arm Group 2 **Description:** only routine preoperative education **Label:** standard education group **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - individualized education group **Description:** Based on the identified individual education needs, the researcher implemented audio-visual education to the intervention group in the ward. **Name:** Preoperative individualized education **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Change in anxiety intensity scores **Measure:** Anxiety status **Time Frame:** Before and after education, 12 months after surgery **Description:** The Visual Analog Scale (VAS) was used to evaluate the intensity of pain, where 0 meant no pain, and 10 - the most severe pain. **Measure:** Postoperative pain **Time Frame:** Baseline, postoperative days 1,2,3 **Description:** The Visual Analog Scale (VAS) was used to evaluate the intensity of nausea and vomiting **Measure:** Postoperative nausea and vomiting **Time Frame:** Baseline, postoperative days 1,2,3 **Description:** Change in Athens Insomnia Scale **Measure:** Sleep disorders **Time Frame:** Baseline, postoperative days 1,2,3 #### Secondary Outcomes **Description:** The incidence of common postoperative complications **Measure:** Postoperative Complications **Time Frame:** 12 months after surgery **Description:** Change from baseline in quality of life scores on the European Organisation for Research and Treatment of Cancer 30 item Quality of Life Questionnaire at postoperative weeks 1, 2, 4, 12, 26, and 52. **Measure:** Quality of life after surgery **Time Frame:** Baseline, 12 months after surgery ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Aged 18 or above; 2. Received single-port thoracoscopic surgery; 3. Volunteered to participate in the study and signed an informed consent form. Exclusion Criteria: 1. Presence of a mental disorder 2. Preoperative pain 3. Pregnancy 4. Presence of other tumours requiring treatment. **Healthy Volunteers:** True **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:** Maohui Chen, Prof **Phone:** 18659181171 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Yizhou Huang **Phone:** 13959568242 **Role:** CONTACT #### Locations **Location 1:** **City:** Fuzhou **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Maohui Chen, Prof - **Phone:** 18659181171 - **Role:** CONTACT ***Contact 2:*** - **Email:** [email protected] - **Name:** Yizhou Huang - **Phone:** 13959568242 - **Role:** CONTACT **Country:** China **Facility:** Fujian Medical University Union Hospital **State:** Fujian **Status:** RECRUITING **Zip:** 350001 #### Overall Officials **Official 1:** **Affiliation:** Key Laboratory of Cardio-Thoracic Surgery, Fujian Medical University, Fujian Province University, Fu **Name:** Chun Chen, Prof **Role:** STUDY_CHAIR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M4324 - Name: Anxiety Disorders - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419075 **Acronym:** TEXAS **Brief Title:** Tranexamic Acid in Vaginal Reconstructive Surgery **Official Title:** Local Infiltration of TranExamic Acid in Surgical Management of Pelvic Organ Prolapse: a Pilot Randomized Clinical Trial #### Organization Study ID Info **ID:** 23-0273 #### Organization **Class:** OTHER **Full Name:** The University of Texas Medical Branch, Galveston ### Status Module #### Completion Date **Date:** 2026-03-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-07-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-08 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Collaborators **Class:** OTHER **Name:** MOUNT SINAI HOSPITAL **Class:** OTHER **Name:** The University of Texas Health Science Center, Houston #### Lead Sponsor **Class:** OTHER **Name:** The University of Texas Medical Branch, Galveston #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** True **Is US Export:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Tranexamic acid (TXA) has been demonstrated to reduce blood loss in trauma, orthopedic, cardiac, and plastic surgeries in numerous well-designed and adequately powered studies. As a result of this evidence for benefit, TXA is routinely used to reduce blood loss during these surgeries. There are no studies regarding the use of TXA in urogynecology. The investigators seek to explore the effect and safety of local infiltration of TXA in vaginal reconstructive surgery. **Detailed Description:** This is a multicenter, double blinded, pilot randomized clinical trial that will be conducted at UTMB Health, and other participating sites. Each participating site will obtain IRB approval. Women with symptomatic, stage II to IV Pelvic organ prolapse (POP) who plan colpocleisis will be approached to participate. Using the study protocol inclusion and exclusion criteria, patient's eligibility will be determined. All eligible subjects will provide the written informed consent before any research data is collected. All screening assessment will be completed at a preoperative, in-person, clinic visit, and within 60 days of surgery. The subject will then undergo randomization to the local TXA, or Vasopressin, or NS group with the total sample size of 36 female subjects (12 per group). Concomitant procedures for POP or urinary incontinence are permitted and will be based upon the operating surgeons' standard clinical practice and best clinical judgement. The anesthesia team is responsible for preparing the study agents, monitoring intraoperative cardiovascular parameters (blood pressure and heart rate) as well as adverse events, and determining the blood transfusion if needed. Subsequently, the subject will have postoperative follow up at 2 weeks and 6 weeks ### Conditions Module **Conditions:** - Pelvic Organ Prolapse **Keywords:** - Tranexamic Acid - Colpocleisis ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** The enrolled subjects will be randomized into one of the 3 arms including tranexamic acid (2 mg/dL), vasopressin (0.1 U/dL), and normal saline. ##### Masking Info **Masking:** QUADRUPLE **Masking Description:** The attending anesthesiologist will receive the randomized assignment from the lead research team at UTMB and prepare the diluted study agents. The OR staff, attending surgeon, and learners including fellows and residents are blinded. **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 36 **Type:** ESTIMATED **Phases:** - PHASE4 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Local infiltration of 50 cc NaCl 0.9% into the vaginal submucosa during colpocleisis dissection **Intervention Names:** - Other: NaCl 0.9% **Label:** Normal Saline (NaCl 0.9%) **Type:** PLACEBO_COMPARATOR #### Arm Group 2 **Description:** Local infiltration of 50 cc Tranexamic Acid (2 mg/dL) into the vaginal submucosa during colpocleisis dissection **Intervention Names:** - Drug: Tranexamic acid **Label:** Tranexamic Acid (2 mg/dL) **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** Local infiltration of 50 cc Vasopressin (0.1 U/dL) into the vaginal submucosa during colpocleisis dissection **Intervention Names:** - Drug: Vasopressin **Label:** Vasopressin (0.1 U/dL) **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Tranexamic Acid (2 mg/dL) **Description:** The intervention of 50 cc TXA (2 mg/mL) local infiltration is determined after carefully reviewing the literature. Scarafoni et al. recommends that the local TXA should not exceed at a concentration of 5-10 mg/mL to avoid cytotoxicity that may affect the wound re-epithelialization (22). In a prospective study on facelift bleeding, Kochuba et al. demonstrates that local TXA (1-2 mg/mL) with total 100 mg and 200 mg TXA safely and effectively decreased bleeding, operating room time, and drain output compared with traditional local anesthetic technique (14). Fathimani et all reports the local use of modified tumescent anesthesia solution with low TXA concentration (2 mg/dL) and total average dosage of TXA ranging 120-1000 mg is safe and promising in achieving less ecchymosis, edema, and seroma in common facial cosmetic surgical procedures (31). With a total dosage of 100 mg TXA and a volume of 50 cc injection, the concentration is calculated to be 2 mg/dL. **Name:** Tranexamic acid **Other Names:** - Tranexamic acid (CYKLOKAPRON) (Pfizer, New York, NY). **Type:** DRUG #### Intervention 2 **Arm Group Labels:** - Vasopressin (0.1 U/dL) **Description:** The intervention of 50 cc Vasopressin (0.1U/mL) local infiltration is determined from several systematic reviews. Hafidh et al. shows that injection of diluted Vasopressin (3.6 to 10 units) with various concentration during hysterectomy significantly reduces the intraoperative blood loss when compared to placebo, and without increasing the hazard of cardiovascular toxicities. Cui et al. reports similar results, but including other vaginal surgeries. The common preparation for dilute Vasopressin is 0.1 U/mL or 1.0 U/mL from a 1cc vial of 20 U/mL Vasopressin. The advantage of 0.1 U/mL concentration is to avoid a relatively large bolus of concentrated 1.0 U/mL Vasopressin injected intravascularly by accident. A cumulative total dose of 4 to 6 units of Vasopressin administered in a dilute solution is proposed to be an upper limit. Therefore, the cumulative total dose of 5 units Vasopressin from 50 cc (0.1U/mL) is in the safe therapeutic range. **Name:** Vasopressin **Other Names:** - Vasopressin (Vasostrict) (Par Pharmaceutical, Chestnut Ridge, NY). **Type:** DRUG #### Intervention 3 **Arm Group Labels:** - Normal Saline (NaCl 0.9%) **Description:** The intervention of 50 cc NaCl 0.9% local infiltration serves a placebo control. **Name:** NaCl 0.9% **Type:** OTHER ### Outcomes Module #### Primary Outcomes **Description:** Compare intraoperative QBL during colpocleisis with the local infiltration of Tranexamic acid to the current standard of care, vasopressin or normal saline. **Measure:** Intraoperative quantitative blood loss QBL (mL) **Time Frame:** Intraoperatively #### Secondary Outcomes **Description:** Compare the colpocleisis operative time between Tranexamic acid, vasopressin or normal saline groups **Measure:** Colpocleisis operative time (min) **Time Frame:** Intraoperatively **Description:** Evaluate the effect blood pressures at 1, 5, and 10 mins after the local infiltration of Tranexamic acid, vasopressin and NS into the vaginal mucosa. **Measure:** Intraoperative blood pressure (mmHg) **Time Frame:** Intraoperatively **Description:** Evaluate the effect on heart rate at 1, 5, and 10 mins after the local infiltration of Tranexamic acid, vasopressin and NS into the vaginal mucosa. **Measure:** Intraoperative hear rate (beats/min) **Time Frame:** Intraoperatively **Description:** Assess postoperative complications following colpocleisis using the Clavien-Dindo Classification (CDC) categories **Measure:** Postoperative complications **Time Frame:** 2 weeks and 6 weeks postoperatively **Description:** Quantify the need for blood-product transfusion and the volume administered as a direct result of colpocleisis, either intraoperative or postoperative **Measure:** Rate of transfusion **Time Frame:** Intraoperatively and 2 weeks postoperatively ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Females who are menopausal at the time of consent 2. Able to understand and read English 3. Able and willing to provide written informed consent 4. Able to comply with the follow-up study protocol, per clinician judgment 5. Symptomatic POP (bulge or pressure) evidenced with vaginal prolapse with POP-Q measurement consistent with Stage II-IV 6. LeFort or complete colpocleisis as desired surgical approach to correct POP with and without other concomitant procedures 7. History of abdominal or vaginal surgery for POP 8. American Society of Anesthesiologists (ASA) physical status I or II Exclusion Criteria: 1. Texas Department of Criminal Justice prisoners 2. Refusal of blood products (e.g, Jehovah's witnesses) 3. ASA physical status III or IV 4. Known allergy or hypersensitivity to TXA or any of the ingredients 5. Subarachnoid hemorrhage 6. Active intravascular clotting, thromboembolic disease (cerebral thrombosis, deep vein thrombosis, or pulmonary embolism) 7. Epilepsy, seizure disorders requiring anti-epileptic medication(s) 8. Acquired impaired color vision (color blindness, retinal involvement) 9. Intrinsic risk of thrombosis or thromboembolism (hypercoagulopathy, thrombogenic cardiac rhythm disease, thrombogenic valvular disease) 10. History of severe liver disease 11. Known allergy or hypersensitivity to 8-L-arginine vasopressin or chlorobutanol 12. History of cardiac diseases (decompensated congestive heart failure CHF, recent coronary artery disease CAD within 30 days, recent myocardial infarction MI within 30 days) 13. History of reversible nephrogenic diabetes insipidus 14. History of primary pelvic organ cancer (uterine, ovarian, endometrial, cervical, bladder) or any cancer that is metastatic to the pelvis 15. Prior or current pelvic radiation, or chemotherapy. 16. Females who desires to have vaginal sexual intercourse after the surgery **Healthy Volunteers:** True **Maximum Age:** 100 Years **Minimum Age:** 50 Years **Sex:** FEMALE **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Trieu H Do, MD **Phone:** 8326327964 **Role:** CONTACT #### Locations **Location 1:** **City:** Galveston **Country:** United States **Facility:** University of Texas Medical Branch Galveston **State:** Texas **Zip:** 77554 #### Overall Officials **Official 1:** **Affiliation:** University of Texas Medical Branch Galveston **Name:** Gokhan Kilic, MD **Role:** PRINCIPAL_INVESTIGATOR **Official 2:** **Affiliation:** Mount Sinai Hospital & Medical Center **Name:** Ann Tran, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Description:** We are not planning to make individual participant data (IPD) available to other researchers. **IPD Sharing:** NO ### References Module #### References **Citation:** Smith FJ, Holman CD, Moorin RE, Tsokos N. Lifetime risk of undergoing surgery for pelvic organ prolapse. Obstet Gynecol. 2010 Nov;116(5):1096-100. doi: 10.1097/AOG.0b013e3181f73729. **PMID:** 20966694 **Citation:** Cheng W, Bu C, Hong F, Zhong X, Jin C, Yang X, Sun X, Wang J. Perioperative hemorrhagic complications in pelvic floor reconstructive surgery. Int Urogynecol J. 2019 Jul;30(7):1141-1146. doi: 10.1007/s00192-018-3667-6. Epub 2018 May 21. **PMID:** 29785542 **Citation:** Lambrou NC, Buller JL, Thompson JR, Cundiff GW, Chou B, Montz FJ. Prevalence of perioperative complications among women undergoing reconstructive pelvic surgery. Am J Obstet Gynecol. 2000 Dec;183(6):1355-8; discussion 1359-60. doi: 10.1067/mob.2000.110911. **PMID:** 11120496 **Citation:** Johnson DJ, Scott AV, Barodka VM, Park S, Wasey JO, Ness PM, Gniadek T, Frank SM. Morbidity and Mortality after High-dose Transfusion. Anesthesiology. 2016 Feb;124(2):387-95. doi: 10.1097/ALN.0000000000000945. **PMID:** 26569167 **Citation:** Ghadimi K, Levy JH, Welsby IJ. Perioperative management of the bleeding patient. Br J Anaesth. 2016 Dec;117(suppl 3):iii18-iii30. doi: 10.1093/bja/aew358. **PMID:** 27940453 **Citation:** Cui Y, Chen I, Chernoff A, Clancy A. Effectiveness of prophylactic pharmacological hemostatic agents for reduction of blood loss at vaginal surgery: a systematic review and meta-analysis. Int Urogynecol J. 2023 Dec;34(12):2945-2957. doi: 10.1007/s00192-023-05614-1. Epub 2023 Aug 16. **PMID:** 37584705 **Citation:** Hafidh B, Latifah HM, Gari A, Alshahrani MS, AlSghan R, Alkhamis WH, Allam HS, AlRasheed MA, Bakhsh H, Abu-Zaid A, Baradwan S. Vasopressin to Control Blood Loss during Hysterectomy: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Minim Invasive Gynecol. 2022 Mar;29(3):355-364.e2. doi: 10.1016/j.jmig.2021.10.003. Epub 2021 Oct 12. **PMID:** 34648933 **Citation:** Willis-Gray MG, Husk KE, Brueseke TJ, Connolly A, Geller EJ. Lidocaine Use in Vaginal Surgery and Risk of Toxicity. Female Pelvic Med Reconstr Surg. 2020 Sep;26(9):546-549. doi: 10.1097/SPV.0000000000000622. **PMID:** 30346319 **Citation:** Zakhari A, Sanders AP, Solnik MJ. Tranexamic acid in gynecologic surgery. Curr Med Res Opin. 2020 Mar;36(3):513-520. doi: 10.1080/03007995.2019.1708533. Epub 2020 Jan 6. **PMID:** 31865770 **Citation:** Luetzenberg FS, Lyford-Pike S. Modern use of tranexamic acid in facial plastic surgery. Curr Opin Otolaryngol Head Neck Surg. 2023 Aug 1;31(4):219-223. doi: 10.1097/MOO.0000000000000886. Epub 2023 Apr 13. **PMID:** 37052603 **Citation:** Breau RH, Kokolo MB, Punjani N, Cagiannos I, Beck A, Niznick N, Buenaventura C, Cowan J, Knoll G, Momoli F, Morash C, Ruzicka M, Schachkina S, Tinmouth A, Xie HY, Fergusson DA. The effects of lysine analogs during pelvic surgery: a systematic review and meta-analysis. Transfus Med Rev. 2014 Jul;28(3):145-55. doi: 10.1016/j.tmrv.2014.05.002. Epub 2014 May 18. **PMID:** 24958068 **Citation:** El Minawi HM, Kadry HM, El-Essawy NM, El Saadany ZA, Nouh OM. The effect of tranexamic acid on blood loss in liposuction: a randomized controlled study. Eur J Plast Surg. 2023;46(2):227-237. doi: 10.1007/s00238-022-01995-6. Epub 2022 Oct 22. **PMID:** 36311870 **Citation:** Couto RA, Charafeddine A, Sinclair NR, Nayak LM, Zins JE. Local Infiltration of Tranexamic Acid With Local Anesthetic Reduces Intraoperative Facelift Bleeding: A Preliminary Report. Aesthet Surg J. 2020 May 16;40(6):587-593. doi: 10.1093/asj/sjz232. **PMID:** 31504134 **Citation:** Kochuba AL, Coombs DM, Kwiecien GJ, Sinclair NR, Zins JE. Prospective Study Assessing the Effect of Local Infiltration of Tranexamic Acid on Facelift Bleeding. Aesthet Surg J. 2021 Mar 12;41(4):391-397. doi: 10.1093/asj/sjaa198. **PMID:** 32644111 **Citation:** Coombs DM, Kwiecien GJ, Sinclair NR, Jin A, Zins JE. Local Infiltration of Tranexamic Acid During Facelift Improves Operating Room Efficiency: A Matched Patient Study. Aesthet Surg J. 2022 Aug 24;42(9):971-977. doi: 10.1093/asj/sjac067. **PMID:** 35350068 **Citation:** Ausen K, Fossmark R, Spigset O, Pleym H. Safety and Efficacy of Local Tranexamic Acid for the Prevention of Surgical Bleeding in Soft-Tissue Surgery: A Review of the Literature and Recommendations for Plastic Surgery. Plast Reconstr Surg. 2022 Mar 1;149(3):774-787. doi: 10.1097/PRS.0000000000008884. **PMID:** 35196701 **Citation:** Rohrich RJ, Cho MJ. The Role of Tranexamic Acid in Plastic Surgery: Review and Technical Considerations. Plast Reconstr Surg. 2018 Feb;141(2):507-515. doi: 10.1097/PRS.0000000000003926. **PMID:** 28938364 **Citation:** Buchsbaum GM, Lee TG. Vaginal Obliterative Procedures for Pelvic Organ Prolapse: A Systematic Review. Obstet Gynecol Surv. 2017 Mar;72(3):175-183. doi: 10.1097/OGX.0000000000000406. **PMID:** 28304415 **Citation:** Grzybowska ME, Futyma K, Kusiak A, Wydra DG. Colpocleisis as an obliterative surgery for pelvic organ prolapse: is it still a viable option in the twenty-first century? Narrative review. Int Urogynecol J. 2022 Jan;33(1):31-46. doi: 10.1007/s00192-021-04907-7. Epub 2021 Aug 18. **PMID:** 34406418 **Citation:** von Pechmann WS, Mutone M, Fyffe J, Hale DS. Total colpocleisis with high levator plication for the treatment of advanced pelvic organ prolapse. Am J Obstet Gynecol. 2003 Jul;189(1):121-6. doi: 10.1067/mob.2003.546. **PMID:** 12861149 **Citation:** Hill AJ, Walters MD, Unger CA. Perioperative adverse events associated with colpocleisis for uterovaginal and posthysterectomy vaginal vault prolapse. Am J Obstet Gynecol. 2016 Apr;214(4):501.e1-501.e6. doi: 10.1016/j.ajog.2015.10.921. Epub 2015 Oct 31. **PMID:** 26529371 **Citation:** Elena Scarafoni E. A Systematic Review of Tranexamic Acid in Plastic Surgery: What's New? Plast Reconstr Surg Glob Open. 2021 Mar 23;9(3):e3172. doi: 10.1097/GOX.0000000000003172. eCollection 2021 Mar. **PMID:** 33907653 **Citation:** Frishman G. Vasopressin: if some is good, is more better? Obstet Gynecol. 2009 Feb;113(2 Pt 2):476-477. doi: 10.1097/AOG.0b013e31819698bb. No abstract available. **PMID:** 19155925 **Citation:** Quantitative Blood Loss in Obstetric Hemorrhage: ACOG COMMITTEE OPINION, Number 794. Obstet Gynecol. 2019 Dec;134(6):e150-e156. doi: 10.1097/AOG.0000000000003564. **PMID:** 31764759 **Citation:** Ker K, Beecher D, Roberts I. Topical application of tranexamic acid for the reduction of bleeding. Cochrane Database Syst Rev. 2013 Jul 23;(7):CD010562. doi: 10.1002/14651858.CD010562.pub2. **PMID:** 23881695 **Citation:** DILLON TF, MARBURY BE, BONSNES RW, DOUGLAS RG, DU VIGNEAUD V. Vasopressin as a hemostatic in gynecologic surgery; a preliminary report. Obstet Gynecol. 1958 Apr;11(4):363-71. No abstract available. **PMID:** 13517741 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000020763 - Term: Pathological Conditions, Anatomical ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M14261 - Name: Prolapse - Relevance: HIGH - As Found: Prolapse - ID: M28618 - Name: Pelvic Organ Prolapse - Relevance: HIGH - As Found: Pelvic Organ Prolapse - ID: M22519 - Name: Pathological Conditions, Anatomical - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000011391 - Term: Prolapse - ID: D000056887 - Term: Pelvic Organ Prolapse ### Intervention Browse Module - Ancestors - ID: D000000933 - Term: Antifibrinolytic Agents - ID: D000050299 - Term: Fibrin Modulating Agents - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000006490 - Term: Hemostatics - ID: D000003029 - Term: Coagulants - ID: D000014662 - Term: Vasoconstrictor Agents - ID: D000050034 - Term: Antidiuretic Agents - ID: D000045283 - Term: Natriuretic Agents - ID: D000045505 - Term: Physiological Effects of Drugs ### Intervention Browse Module - Browse Branches - Abbrev: Coag - Name: Coagulants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: PhSol - Name: Pharmaceutical Solutions - Abbrev: NaAg - Name: Natriuretic Agents - Abbrev: VaCoAg - Name: Vasoconstrictor Agents - Abbrev: AA - Name: Amino Acids ### Intervention Browse Module - Browse Leaves - ID: M16902 - Name: Tranexamic Acid - Relevance: HIGH - As Found: Stage IV - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M21860 - Name: Pharmaceutical Solutions - Relevance: LOW - As Found: Unknown - ID: M17414 - Name: Vasopressins - Relevance: HIGH - As Found: Contained - ID: M4437 - Name: Arginine Vasopressin - Relevance: HIGH - As Found: Contained - ID: M4109 - Name: Anesthetics, Local - Relevance: LOW - As Found: Unknown - ID: M251802 - Name: Imidacloprid - Relevance: LOW - As Found: Unknown - ID: M4252 - Name: Antifibrinolytic Agents - Relevance: LOW - As Found: Unknown - ID: M9576 - Name: Hemostatics - Relevance: LOW - As Found: Unknown - ID: M6259 - Name: Coagulants - Relevance: LOW - As Found: Unknown - ID: M17409 - Name: Vasoconstrictor Agents - Relevance: LOW - As Found: Unknown - ID: T1 - Name: Arginine - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000014667 - Term: Vasopressins - ID: D000001127 - Term: Arginine Vasopressin - ID: D000014148 - Term: Tranexamic Acid ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419062 **Acronym:** BREATH-TRACHER **Brief Title:** The Use of Medical Devices to Monitor Chronic Obstructive Pulmonary Disease Patients Study BREATH-TRACHER 2 **Official Title:** The Use of Medical Devices to Monitor COPD Patients Study - An Observational Feasibility Study #### Organization Study ID Info **ID:** UEC23/71 #### Organization **Class:** OTHER **Full Name:** University of Strathclyde ### Status Module #### Completion Date **Date:** 2025-09-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-04-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2023-08-28 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** Fourth Frontier Technologies Ltd #### Lead Sponsor **Class:** OTHER **Name:** University of Strathclyde #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The proposed study will explore whether remote monitoring of a COPD patient can be undertaken using a wearable medical device. **Detailed Description:** This study will assess the sensitivity of a wearable device to measure the physiological signals in COPD patients, who have previously experienced hospitalization due to exacerbation of their COPD. The monitoring device will also assess the effectiveness of medication prescribed before, during, and after the COPD exacerbation to see if it has a role in directing day-to-day therapy. ### Conditions Module **Conditions:** - COPD Exacerbation Acute **Keywords:** - medical device - remote monitoring technologies - respiratory signal - heart rate - ECG ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The study population for this research consists of individuals diagnosed with COPD (Chronic Obstructive Pulmonary Disease) who have a history of exacerbation-induced hospitalization within the one-year period preceding recruitment. **Intervention Names:** - Device: Frontier X2 **Label:** People with COPD ### Interventions #### Intervention 1 **Arm Group Labels:** - People with COPD **Description:** Frontier X2 device will be used to measuring for physiological changes (breathing rate, heart rate, ECG, and heart rate variabilities) in people with COPD. **Name:** Frontier X2 **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Participants' breath rates, heart rate and ECG levels will be measured in their daily lives, and clinical changes will be examined when the clinical health of a COPD sufferer is starting to deteriorate. **Measure:** Clinical changes before COPD exacerbations **Time Frame:** 18 months #### Secondary Outcomes **Description:** To assess the usability and comfort of the wearable technology, assessed by qualitative interviews and field notes during fortnightly follow-up appointments from the perspective of the volunteer **Measure:** Device usage **Time Frame:** 18 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Any person aged 18 years or over. * Current diagnosis of COPD. * Be willing and able to comply with study procedures and be available for study visits. • Be able to use a 'smartphone or computer'. * Be able to give written consent. * Able to understand written and spoken English. Exclusion Criteria: * Inability to give written informed consent. * Known respiratory disorders are other than COPD which, in the opinion of the investigator, is the main contributor to the patient's symptoms (e.g. asthma, lung cancer, sarcoidosis, and other interstitial lung diseases (ILDs), tuberculosis, lung fibrosis, cystic fibrosis, and non-COPD related bronchiectasis). * Known history of significant systemic and other organ-related diseases, other than COPD, which in the opinion of the investigator, is likely to interfere with the study or impact on subject safety (e.g. severe rheumatoid arthritis and Lupus, kidney, liver, endocrine, psychological disorders). * Known to be severely alpha-1-antitrypsin deficient (PI, SZ or ZZ). * Based on their medical record if there is any social violence/substance misuse. * Having undergone lung surgery (e.g. lung volume reduction, lobectomy) within the last 6 months. * Have cancer or other terminal condition which, in the opinion of the investigator, has a mortality of 12 months or less. • Have, in the opinion of the investigator, evidence of alcohol, drug or solvent abuse. * Taking high-dose oral corticosteroid medication (equivalent to daily dose of ≥10 mg of prednisolone) for more than 3 consecutive months. * Pregnancy * Patients already involved in an ongoing research study. * Participation in an interventional clinical study within 3 months of Visit 1 or participation in a study using an investigational medicinal product (IMP) either in the previous 3 months or in the interval from last using the IMP to 5 times its half-life. * Patients with other significant lung disease, unable to consent, unable to use the technology (e.g. inability to use the data device, or complete the questionnaires), or at the clinician's discretion for other more significant medical/social reasons. * Known allergy to strap. * On long-term oxygen therapy. * Acute exacerbation of COPD within 6 weeks prior to inclusion. **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** The study population for this research consists of individuals diagnosed with COPD (Chronic Obstructive Pulmonary Disease) who have a history of exacerbation-induced hospitalization within the one-year period preceding recruitment. The target number of participants in this study is 30. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Alex Mullen, PhD **Phone:** 441415484409 **Role:** CONTACT #### Locations **Location 1:** **City:** Glasgow **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Alexander Mullen - **Phone:** +44 (0) 1415484409 - **Role:** CONTACT **Country:** United Kingdom **Facility:** Oakview Medical Practice in Alexandria **Zip:** G83 0UE ### IPD Sharing Statement Module **Description:** All data collected during the study will be immediately anonymized and will not be shared with third parties. **IPD Sharing:** NO ### References Module #### References **Citation:** Hawthorne G, Richardson M, Greening NJ, Esliger D, Briggs-Price S, Chaplin EJ, Clinch L, Steiner MC, Singh SJ, Orme MW. A proof of concept for continuous, non-invasive, free-living vital signs monitoring to predict readmission following an acute exacerbation of COPD: a prospective cohort study. Respir Res. 2022 Apr 26;23(1):102. doi: 10.1186/s12931-022-02018-5. **PMID:** 35473718 **Citation:** Seemungal TA, Hurst JR, Wedzicha JA. Exacerbation rate, health status and mortality in COPD--a review of potential interventions. Int J Chron Obstruct Pulmon Dis. 2009;4:203-23. doi: 10.2147/copd.s3385. Epub 2009 Jun 11. **PMID:** 19554195 **Citation:** Donaldson GC, Law M, Kowlessar B, Singh R, Brill SE, Allinson JP, Wedzicha JA. Impact of Prolonged Exacerbation Recovery in Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2015 Oct 15;192(8):943-50. doi: 10.1164/rccm.201412-2269OC. **PMID:** 26151174 ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M11170 - Name: Lung Diseases, Obstructive - Relevance: LOW - As Found: Unknown - ID: M23449 - Name: Pulmonary Disease, Chronic Obstructive - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419049 **Brief Title:** Impact of Standing Programs in Children With Spina Bifida: A Single Subject Design **Official Title:** Impact of Standing Programs in Children With Spina Bifida: A Single Subject Design #### Organization Study ID Info **ID:** 0819-275 #### Organization **Class:** OTHER **Full Name:** University of St. Augustine for Health Sciences ### Status Module #### Completion Date **Date:** 2025-08 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-02 **Type:** ESTIMATED #### Start Date **Date:** 2023-02-23 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of St. Augustine for Health Sciences #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Is US Export:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The purpose of this single-subject study is to investigate children with spinal bifida who have significant knee limitations in lower extremity passive range of motion to answer the following research questions: 1. Is a home standing program effective in reducing lower extremity passive range of motion limitations in children with Spina Bifida? 2. Does a home standing program change the quality of functional movement in children with spina bifida? 3. Does a home standing program change a child's performance in daily activities, mobility, and social/cognitive domains? 4. Does a home standing program change a child's health-related quality of life in children with spinal bifida? 5. Does a home standing program result in a change in gait velocity in children with Spina Bifida? **Detailed Description:** Stage 1: Reliability Stage Each child will be assessed by two study investigators in two different sessions on the same day, with a washout period of 3 hours between sessions. Intrarater reliability will be determined by comparing rater's scores for each child. These sessions will include goniometric measurements of lower extremity PROM and the 10-Meter Walk Test. Children will have the opportunity to rest or resume normal activities with a minimum of 3 hours between sessions. Interrater reliability will be determined based on the measurements in the same session by 2 different raters. Stage 2: Intervention Stage A single-subject study ABABA design will be used with dependent variables of passive range of motion, functional movement, functional skills performance, engagement, health-related quality of life and gait velocity will be recorded repeatedly for the individual participants across time and with systematic manipulation of the independent variable, which is the standing home program intervention. The study will span 28 weeks for the intervention Stage 2, consisting of three baseline phases (A) of four weeks each and two home program intervention phases (B) of eight weeks each that alternate in an ABABA design. Regardless of the phase, the following primary measures will be assessed at baseline and every two weeks from the beginning until the conclusion of the study: Goniometric passive range of motion for all phases and hip and knee angle measures while standing in the stander during intervention phases and 10 meter walk test at preferred walking speed. The following secondary measures will be assessed at baseline and every two weeks in phase A and every four weeks in phase B until the study's conclusion: Pediatric Neuromuscular Recovery Scale, Pediatric Evaluation of Disability Computer Adapted Test and Pediatric Quality of Life Inventory. Nonintervention phase (A): The study investigator will meet face to face with the participant biweekly for 28 weeks to perform primary and secondary outcome measures. The Pediatric Neuromuscular Recovery Scale will be administered by the study investigator in person and scored by another investigator, who is an expert with the Pediatric Neuromuscular Recovery Scale, via video conference (not recorded). Intervention phase (B): The study investigator will meet face to face with the participant biweekly for 28 weeks to perform outcome measures. The Pediatric Neuromuscular Recovery Scale will be administered by the study investigator in person and scored by another investigator via video conference. During the B phase, the study investigator will also provide parent instruction on the standing home program to ensure the parent and child can follow the home program. EasyStand will be providing the participants with the sit to stand stander for the duration of the intervention phases. A photo of the child in the stander will be taken by the investigator during each of these sessions and may be used in the dissemination of the project. The parent will keep a daily log of stander use and usual physical therapy-related activities. All of the measures will be analyzed to determine if there is a functional effect and if so, quantitative analysis methods will be used to determine the magnitude of the effect, and then the effect sizes will be combined to average intervention effects. ### Conditions Module **Conditions:** - Spina Bifida **Keywords:** - Spina Bifida - Standing Device ### Design Module #### Design Info **Allocation:** NON_RANDOMIZED **Intervention Model:** SINGLE_GROUP **Intervention Model Description:** Single subject design ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 12 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** A single-subject study ABABA design will be used with dependent variables of passive range of motion, functional movement, functional skills performance, engagement, health related quality of life and gait velocity will be recorded repeatedly for the individual participants across time and with systematic manipulation of the independent variable, which is the standing home program intervention. The study will span 28 weeks for the intervention Stage 2, consisting of three baseline phases (A) of four weeks each and two home program intervention phases (B) of eight weeks each that alternate in an ABABA design. **Intervention Names:** - Device: Altimate Medical EasyStand Bantam **Label:** Standing Program Intervention **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Children will be assessed by two study investigators in two different sessions on the same day, with a washout period of 3 hours between sessions. Intrarater reliability will be determined by comparing rater's scores for each child. These sessions will include goniometric measurements of lower extremity passive range of motion and the 10-Meter Walk Test. Children will have the opportunity to rest or resume normal activities with a minimum of 3 hours between sessions. Interrater reliability will be determined based on the measurements in the same session by 2 different raters. **Label:** Reliability **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Standing Program Intervention **Description:** Child will stand in stander 5 days per week for 60 min during each 8 wks intervention **Name:** Altimate Medical EasyStand Bantam **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** A universal goniometer will be used to measure the child's hip and knee joint passive range of motion. **Measure:** Goniometric Measurements **Time Frame:** Assessed at baseline and every two weeks from the beginning until the conclusion of the study at 28 wks. **Description:** The 10MWTpref measures gait velocity in youth with neurological diagnoses while using an assistive device and wearing orthoses **Measure:** 10 Meter Walk Test **Time Frame:** Assessed at baseline and every two weeks from the beginning until the conclusion of the study at 28 wks. #### Secondary Outcomes **Description:** Assesses the quality of functional movement in children with spina bifida ages 1-12yrs. The Peds NRS examines the quality of sitting, upper extremity function, standing and walking **Measure:** Pediatric Neuromuscular Recovery Scale (Peds NRS) **Time Frame:** Assessed at baseline and every two weeks in the nonintervention phase and every four weeks in intervention phase until the study's conclusion at 28 wks. **Description:** Clinical assessment in children with spinal impairments that measures four domains: 1) Daily Activities, 2) Mobility, 3) Social/Cognitive, and 4) Responsibility to construct a description of a child's functional status in everyday life **Measure:** Pediatric Evaluation of Disability Computer Adapted Test (PEDI-CAT) **Time Frame:** Assessed at baseline and every two weeks in the nonintervention phase and every four weeks in intervention phase until the study's conclusion at 28 wks **Description:** Measure of the HRQOL in children with chronic health conditions **Measure:** Pediatric Quality of Life Inventory (PedsQL™) **Time Frame:** Assessed at baseline and every two weeks in the nonintervention phase and every four weeks in intervention phase until the study's conclusion at 28 wks ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1) 5 to 12 years old, and 2) able to lay in a supine position on a plinth for testing and walk 10 meters. Participants will be excluded from the study if they have medical restrictions that contraindicate moving bilateral lower extremities through full passive range of motion (PROM), including but not limited to joint motion bony blocks, fractures before bone healing is complete, acute inflammatory or infectious process, disruption of soft tissue healing is likely, sharp, acute pain with joint movement or muscle elongation, hematoma or other soft tissue trauma, hypermobility and walking 10 meters. Exclusion Criteria: Participants will be excluded from the study if they have: 1) a diagnosis unrelated to MMC form of SB that limits standing, 2) a Modified Hoffer Scale level of 5, indicating an inability to ambulate. 3) medical restrictions that contraindicate standing, including but not limited to fractures and severe osteoporosis that precludes weight-bearing, and compromised cardiovascular or respiratory systems. **Maximum Age:** 12 Years **Minimum Age:** 5 Years **Sex:** ALL **Standard Ages:** - CHILD ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Marianne Hanover, DPT **Phone:** 7604105338 **Role:** CONTACT #### Locations **Location 1:** **City:** San Diego **Contacts:** ***Contact 1:*** - **Name:** Marianne Hanover, DPT - **Phone:** 760-410-5338 - **Role:** CONTACT **Country:** United States **Facility:** University of St. Augustine **State:** California **Status:** RECRUITING **Zip:** 92069 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000009436 - Term: Neural Tube Defects - ID: D000009421 - Term: Nervous System Malformations - ID: D000009422 - Term: Nervous System Diseases - ID: D000000013 - Term: Congenital Abnormalities ### Condition Browse Module - Browse Branches - Abbrev: BC10 - Name: Nervous System Diseases - Abbrev: BC16 - Name: Diseases and Abnormalities at or Before Birth - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M18607 - Name: Spinal Dysraphism - Relevance: HIGH - As Found: Spina Bifida - ID: M12380 - Name: Neural Tube Defects - Relevance: LOW - As Found: Unknown - ID: M12 - Name: Congenital Abnormalities - Relevance: LOW - As Found: Unknown - ID: M12365 - Name: Nervous System Malformations - Relevance: LOW - As Found: Unknown - ID: T5337 - Name: Spina Bifida - Relevance: HIGH - As Found: Spina Bifida ### Condition Browse Module - Meshes - ID: D000016135 - Term: Spinal Dysraphism ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419036 **Acronym:** BREATH-TRACHER **Brief Title:** The Use of Medical Devices to Monitor Chronic Obstructive Pulmonary Disease Patients Study BREATH-TRACHER 1 **Official Title:** The Use of Medical Devices to Monitor COPD Patients Study - An Observational Feasibility Study #### Organization Study ID Info **ID:** UEC23/51 #### Organization **Class:** OTHER **Full Name:** University of Strathclyde ### Status Module #### Completion Date **Date:** 2025-09-01 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-04-01 **Type:** ESTIMATED #### Start Date **Date:** 2024-06-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2023-08-28 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Collaborators **Class:** UNKNOWN **Name:** Pneumowave Ltd #### Lead Sponsor **Class:** OTHER **Name:** University of Strathclyde #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** The proposed study will explore whether remote monitoring of a COPD patient can be undertaken using a wearable medical device. **Detailed Description:** The proposed study will assess the sensitivity of a wearable device to measure the respiratory signals in COPD patients, who have previously experienced hospitalisation due to exacerbation of their COPD. Participation in the study involves wearing a small sensor. The monitoring device will also assess the effectiveness of medication prescribed before, during, and after the COPD exacerbation to see if it has a role in directing day-to-day therapy. ### Conditions Module **Conditions:** - COPD Exacerbation Acute **Keywords:** - medical device - remote monitoring technologies - respiratory signal ### Design Module #### Design Info **Observational Model:** COHORT **Time Perspective:** RETROSPECTIVE #### Enrollment Info **Count:** 30 **Type:** ESTIMATED **Study Type:** OBSERVATIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The study population for this research consists of individuals diagnosed with COPD (Chronic Obstructive Pulmonary Disease) who have a history of exacerbation-induced hospitalization within the one-year period preceding recruitment. **Intervention Names:** - Device: Pneumowave DC **Label:** Patients with COPD ### Interventions #### Intervention 1 **Arm Group Labels:** - Patients with COPD **Description:** Pneumowave biosensor(s) will be used to collect data from chest +/- movement. **Name:** Pneumowave DC **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Participants' breath rates will be measured through chest movement in their daily lives, and clinical changes in their breath rates will be examined. **Measure:** Clinical changes before COPD exacerbations **Time Frame:** 18 months #### Secondary Outcomes **Description:** • To assess the usability and comfort of the wearable technology, assessed by qualitative interviews and field notes during fortnightly follow-up appointments from the perspective of the volunteer **Measure:** Device usage **Time Frame:** 18 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Any person aged 18 years or over. * Current diagnosis of COPD. * Be willing and able to comply with study procedures and be available for study visits. • Be able to use a 'smartphone or computer'. * Be able to give written consent. * Able to understand written and spoken English. Exclusion Criteria: * Inability to give written informed consent. * Known respiratory disorders are other than COPD which, in the opinion of the investigator, is the main contributor to the patient's symptoms (e.g. asthma, lung cancer, sarcoidosis, and other interstitial lung diseases (ILDs), tuberculosis, lung fibrosis, cystic fibrosis, and non-COPD related bronchiectasis). * Known history of significant systemic and other organ-related diseases, other than COPD, which in the opinion of the investigator, is likely to interfere with the study or impact on subject safety (e.g. severe rheumatoid arthritis and Lupus, kidney, liver, endocrine, psychological disorders). * Known to be severely alpha-1-antitrypsin deficient (PI, SZ or ZZ). * Based on their medical record if there is any social violence/substance misuse. * Having undergone lung surgery (e.g. lung volume reduction, lobectomy) within the last 6 months. * Have cancer or other terminal condition which, in the opinion of the investigator, has a mortality of 12 months or less. • Have, in the opinion of the investigator, evidence of alcohol, drug or solvent abuse. * Taking high-dose oral corticosteroid medication (equivalent to daily dose of ≥10 mg of prednisolone) for more than 3 consecutive months. * Pregnancy * Patients already involved in an ongoing research study. * Participation in an interventional clinical study within 3 months of Visit 1 or participation in a study using an investigational medicinal product (IMP) either in the previous 3 months or in the interval from last using the IMP to 5 times its half-life. * Patients with other significant lung disease, unable to consent, unable to use the technology (e.g. inability to use the data device, or complete the questionnaires), or at the clinician's discretion for other more significant medical/social reasons. * Known allergy to surgical adhesive tape. * On long-term oxygen therapy. * Acute exacerbation of COPD within 6 weeks prior to inclusion. **Minimum Age:** 18 Years **Sampling Method:** NON_PROBABILITY_SAMPLE **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT **Study Population:** The study population for this research consists of individuals diagnosed with COPD (Chronic Obstructive Pulmonary Disease) who have a history of exacerbation-induced hospitalization within the one-year period preceding recruitment. The target number of participants in this study is 30. ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Alex Mullen, PhD **Phone:** 441415484409 **Role:** CONTACT #### Locations **Location 1:** **City:** Glasgow **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Alexander Mullen - **Phone:** +44 (0) 1415484409 - **Role:** CONTACT **Country:** United Kingdom **Facility:** Oakview Medical Practice in Alexandria **Zip:** G83 0UE ### IPD Sharing Statement Module **Description:** All data collected during the study will be immediately anonymized and will not be shared with third parties. **IPD Sharing:** NO ### References Module #### References **Citation:** Hawthorne G, Richardson M, Greening NJ, Esliger D, Briggs-Price S, Chaplin EJ, Clinch L, Steiner MC, Singh SJ, Orme MW. A proof of concept for continuous, non-invasive, free-living vital signs monitoring to predict readmission following an acute exacerbation of COPD: a prospective cohort study. Respir Res. 2022 Apr 26;23(1):102. doi: 10.1186/s12931-022-02018-5. **PMID:** 35473718 **Citation:** Seemungal TA, Hurst JR, Wedzicha JA. Exacerbation rate, health status and mortality in COPD--a review of potential interventions. Int J Chron Obstruct Pulmon Dis. 2009;4:203-23. doi: 10.2147/copd.s3385. Epub 2009 Jun 11. **PMID:** 19554195 **Citation:** Donaldson GC, Law M, Kowlessar B, Singh R, Brill SE, Allinson JP, Wedzicha JA. Impact of Prolonged Exacerbation Recovery in Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2015 Oct 15;192(8):943-50. doi: 10.1164/rccm.201412-2269OC. **PMID:** 26151174 ## Derived Section ### Condition Browse Module - Browse Branches - Abbrev: BC08 - Name: Respiratory Tract (Lung and Bronchial) Diseases - Abbrev: All - Name: All Conditions - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M11168 - Name: Lung Diseases - Relevance: LOW - As Found: Unknown - ID: M11170 - Name: Lung Diseases, Obstructive - Relevance: LOW - As Found: Unknown - ID: M23449 - Name: Pulmonary Disease, Chronic Obstructive - Relevance: LOW - As Found: Unknown - ID: T1303 - Name: Chronic Graft Versus Host Disease - Relevance: LOW - As Found: Unknown - ID: T170 - Name: Acute Graft Versus Host Disease - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419023 **Brief Title:** Impact of Pilates Method on Myofascial Stiffness, Cardiorespiratory Fitness and Quality of Life in Breast Cancer Women **Official Title:** Influence of Pilates Method Intervention on Changes in Myofascial Stiffness, Cardiorespiratory Fitness and Quality of Life in Women With Breast Cancer #### Organization Study ID Info **ID:** MTarnas_PhD #### Organization **Class:** OTHER **Full Name:** Poznan University of Physical Education ### Status Module #### Completion Date **Date:** 2023-12-15 **Type:** ACTUAL #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-22 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-20 **Overall Status:** COMPLETED #### Primary Completion Date **Date:** 2023-01-15 **Type:** ACTUAL #### Start Date **Date:** 2022-02-01 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-06 **Study First Submit QC Date:** 2024-05-16 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** Poznan University of Physical Education #### 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 effectiveness of breast cancer treatment is quite well documented. Still, side effects can underpin other treatment-induced diseases such as osteopenia, diabetes, and especially cardiovascular dysfunction. Therefore, finding a method that could partly counteract these side effects and at the same time be implemented throughout treatment is a challenge for researchers. The main purpose of this experimental, randomized control trial was to analyze the effect of the Pilates Method (PM) intervention on changing the myofascial stiffness along the thoracic and lumbar spine, cardiorespiratory fitness and quality of life in women with breast cancer receiving aromatase inhibitor therapy. The apllied procedure of 12 -week PM training included the training intervention based on hypothesis: * PM reduces myofascial stiffness along the thoracic and lumbar spine of women with breast cancer receiving aromatase inhibitor therapy * PM improves the cardiorespiratory fitness of women with breast cancer receiving aromatase inhibitor therapy * PM improves the quality of life of women with breast cancer receiving aromatase inhibitor therapy. Possible practical applications include the domains of exercise medicine, physical activity in cancer and public health. **Detailed Description:** The trial was conducted by Poznan University of Physical Education in cooperation with UMP (Poland). This design of trial assumed the parallel two-arm group, prospective, randomized controlled trial (RCT) comparing an exercises-based intervention (experimental group) to usual care and physical activity recommendation (control group) in women with breast cancer with perioperative hormonal treatment AI.Randomization were performed as a simple randomization with a 1:1 allocation (coin toss). All patients were assessed and recruited by two oncologists regarding eligibility to participate in the study. Before enrollment, all participants were given detailed information about experiment, procedures, risks, and benefits of the study and gave their written consent to participation. The patients were informed at any stage of the project may resign from participation without having to give a reason.The study was conducted in two stages. Patient recruitment and data collection started in February 2022. The baseline assessment of patients is carried out two weeks before the start of PT intervention. PT intervention lasted 12 weeks. Post-intervention assessment is performed during two weeks after PT intervention. Finally data (reports) collection and data preparation for analysis were completed in December 2023. Potential patients matching primary criteria underwent clinical, laboratory, EKG and echocardiographic follow-up assessment by cardiologist. Clinical specialists eligible for the study provided information about the study and presented informed consent to patients. The patients were referred for further study diagnostics after clinical qualification and signed written informed consent to the planned research. Together with oncologists the research group also included sports physiologists, cardiologist, certified Pilates teacher. All participants were evaluated by same qualified personnel according to standardized test protocols and in the same conditions at baseline and after 12-week intervention. Objective physical measurements were performed by trained and blinded assessors unaware of the assignment information. At the baseline and post training period were performed following assessments: * anthropometrics using digital stadiometer * body composition tested by the dual X-ray absorptiometry method * bone mineral density tested by the dual X-ray absorptiometry method * questionnaire assessment of: (i) quality of life using EORTC QLQ-C30 Questionnaire version 3.0, EORTC QLQ-BR23 Questionnaire Breast cancer module), (ii) pain using Brief Pain Inventory Short Form Questionnaire), (iii) level of physical activity using IPAQ Questionnaire * myofascial stiffness using myotonometr and a non-invasive shear-wave elastography examination * respiratory function measured with spirometric tests * cardiorespiratory fitness measured with: (i) cardiopulmonary exercise test CPET on the treadmil, (ii) metabolic response assessment with blood lactic acid concentration, (iii) subjective rating of perceived exertion with the Borg 6-20 scale * vascular circulation indicators measured with the use of the Flow Mediated Skin Fluorescence * inflammatory hematological ratios were calculated based on hematological medical patients indicators. Patients characteristics has been completed by medical records and socio-demographic questionnaires. The supervised physical activity intervention using the Pilates Method (60min each session, 2 sessions each week over 12 weeks) was used in this study. In the study took part two groups - Exercise Group (experimental group performing PM intervention) and Usual-Care Group (control group). The training program involved exercise performed on mats. The subjects took part in a model training session, during which all exercises were explained, performance was discussed, common mistakes were pointed out, and efforts were made to maintain proper exercise intensity and muscle activation and relaxation.The model PM training sessions was consisted of: 1. warm-up and respiratory exercises (5-10 min); 2. mat Pilates exercises with the traditional Pilates repertoire (basic, beginner) adapted for breast cancer patients needs and restrictions (40 min); 3. cool down and endings exercises (5 min); 4. session summary (2-3min). The training program was supervised by the same specialist of PM. ### Conditions Module **Conditions:** - Breast Cancer Female **Keywords:** - Pilates Method - quality of life - myofascial stiffness - pain - cardiorespiratory fitness - inflammation - breast cancer - aromatase inhibitor ### 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:** 44 **Type:** ACTUAL **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The exercise group (EG) participated in supervised physical activity intervention using the Pilates Method (exercises on the mat, 60min each session, 2 sessions each week over 12 weeks) were administered by certified Pilates teacher. **Intervention Names:** - Behavioral: supervised physical activity intervention using the Pilates Method (exercises on the mat) **Label:** Exercises group (EG) **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Patients in the U-CG were instructed to continue with their usual activities: a) to avoid changing their diet habits during intervention; b) being physically active as usual. **Label:** Usual-Care Group (U-CG) **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Exercises group (EG) **Description:** Each Pilates session was consisted of: a) introduction to the goal of training, familiarizing new skills (2-3 min); b) Pre-Pilates warm-up and respiratory exercises (5-10 min); c) mat Pilates exercises with the traditional Pilates repertoire: basic, beginner (40 min); d) cool down and endings exercises (5 min); e) session summary (2-3min). When required, exercises were adapted for breast cancer body needs and restrictions. Depending on the purpose of the exercise, different equipment was used (Pilates small ball 22 cm, Swiss ball, small massage balls, resistance band, towels, rollers, boxes, "Magic Circle"). **Name:** supervised physical activity intervention using the Pilates Method (exercises on the mat) **Type:** BEHAVIORAL ### Outcomes Module #### Other Outcomes **Description:** Patients clinical history are collected with study-specific questionnaires and medical records. **Measure:** Clinical history **Time Frame:** before and after 12-week intervention **Description:** Socio-demographic characteristics are collected with study-specific questionnaires. **Measure:** Socio-demographic characteristics **Time Frame:** before 12-week intervention #### Primary Outcomes **Description:** Quality of life - Global Health Status (GHS) assessment with EORTC QLQ-C30 Questionnaire version 3.0. On the scale minimum value is 1, maximum value is 7. A high score represents a high QoL (better outcome). **Measure:** Quality of life - Global Health Status **Time Frame:** before and after 12-week intervention **Description:** Quality of life - Functional scores assessment with EORTC QLQ-C30 Questionnaire version 3.0. On the scale minimum value is 1, maximum value is 4. A high score represents a high /healthy level of functioning (better outcome). **Measure:** Quality of life - Functional scores **Time Frame:** before and after 12-week intervention **Description:** Quality of life - Functional scores assessment with EORTC QLQ-C30 Questionnaire version 3.0. On the scale minimum value is 1, maximum value is 4. A high score for a symptom scale represents a high level of symptomatology /problems (worse outcome). **Measure:** Quality of life - Symptom scores **Time Frame:** before and after 12-week intervention **Description:** Quality of life - Functional scores (body image, sexual functioning, sexual enjoyment, future perspective) assessment with EORTC QLQ-BR23 Questionnaire (Breast cancer module). On the scale minimum value is 1, maximum value is 4. A high score represents a high /healthy level of functioning (better outcome). **Measure:** Quality of life - Functional scores (body image, sexual functioning, sexual enjoyment, future perspective) **Time Frame:** before and after 12-week intervention **Description:** Quality of life - Symptom scores (systemic therapy side effects, breast symptoms, arm symptoms, upset by hair loss) assessment with EORTC QLQ-BR23 Questionnaire (Breast cancer module).On the scale minimum value is 1, maximum value is 4. A high score for a symptom scale represents a high level of symptomatology / problems (worse outcome). **Measure:** Quality of life - Symptom scores (systemic therapy side effects, breast symptoms, arm symptoms, upset by hair loss) **Time Frame:** before and after 12-week intervention **Description:** Pain Severity Total Score assessment with Brief Pain Inventory (short form) Questionnaire. Pain severity is measured by four items: worst pain, least pain, average pain in the last 24 h, and pain now. On the scale minimum value is 0 (no pain), maximum value is 10 (pain as as you can imagine). **Measure:** Subjective pain assessment - Pain Severity Total Score **Time Frame:** before and after 12-week intervention **Description:** Pain Interference Total Score, Physical Interference, Affective Interference assessment with Brief Pain Inventory (short form) Questionnaire. The seven interference items (sleep disturbance, general activity, mood, work, relations with others, walking, and enjoyment of life) are assessed on a 0 to 10 scale, with 0 being "did not interfere" and 10 being "interfered completely". **Measure:** Subjective pain assessment - Pain Interference Total Score, Physical Interference, Affective Interference **Time Frame:** before and after 12-week intervention **Description:** The extent of pain complaints assessment with Brief Pain Inventory (short form) Questionnaire. Pointing out on the body diagram the places where the subject feels pain. **Measure:** Subjective pain assessment - the extent of pain complaints **Time Frame:** before and after 12-week intervention **Description:** Myofascial stiffness (N/m) assessment using myotonometer, MyotonPro® . **Measure:** Myofascial stiffness **Time Frame:** before and after 12-week intervention, before and after unit Pilates session **Description:** Assessment of myofascial stiffness (kPa) and (m/s) using a non-invasive shear-wave elastography examination AIXPLORER SuperSonic Imagine. **Measure:** Myofascial stiffness **Time Frame:** before and after 12-week intervention **Description:** Level of Resting Vital Capacity (l). Respiratory function assessment using MetaMax 3B-R2, MetaSoft Studio software 5.1.0, Cortex Biophysics Gmhb, Leipzig, Germany. **Measure:** Resting Vital Capacity **Time Frame:** before and after 12-week intervention **Description:** Level of Forced Vital Capacity (l). Respiratory function assessment using MetaMax 3B-R2, MetaSoft Studio software 5.1.0, Cortex Biophysics Gmhb, Leipzig, Germany. **Measure:** Forced Vital Capacity **Time Frame:** before and after 12-week intervention **Description:** Maximal Voluntary Ventilation (l/min). Respiratory function assessment using MetaMax 3B-R2, MetaSoft Studio software 5.1.0, Cortex Biophysics Gmhb, Leipzig, Germany. **Measure:** Maximal Voluntary Ventilation **Time Frame:** before and after 12-week intervention **Description:** Forced Expiratory Volume in the first second of expiration in %. Respiratory function assessment using MetaMax 3B-R2, MetaSoft Studio software 5.1.0, Cortex Biophysics Gmhb, Leipzig, Germany. **Measure:** Forced Expiratory Volume in the first second of expiration **Time Frame:** before and after 12-week intervention **Description:** Peak Expiratory Flow (l/s). Respiratory function assessment using MetaMax 3B-R2, MetaSoft Studio software 5.1.0, Cortex Biophysics Gmhb, Leipzig, Germany **Measure:** Peak Expiratory Flow **Time Frame:** before and after 12-week intervention **Description:** The modified Tiffeneau-Pinelli index is Forced Expiratory Volume in 1 second/ Vital Capacity ratio (%). A ratio below 70% is typically indicative of obstructive lung disease. Respiratory function assessment using MetaMax 3B-R2, MetaSoft Studio software 5.1.0, Cortex Biophysics Gmhb, Leipzig, Germany. **Measure:** The modified Tiffeneau-Pinelli index **Time Frame:** before and after 12-week intervention **Description:** Absolute Oxygen Uptake (l/min) at rest, at anaerobic threshold (AT), at respiratory compensation point (RCP). Indicators of aerobic capacity assessment with cardiopulmonary exercise test (CPET) is conducted while a test on the treadmill (H/P Cosmos Pulsar, Sports \& Medical, Nussdorf-Traunstein, Germany) using a breath-by-breath ergospirometer (Metamax 3B R2ergospirometer and Metasoft Studio v. 5.1.0 software package Cortex Biophysik, Leipzig, Germany). **Measure:** absolute Oxygen Uptake **Time Frame:** before and after 12-week intervention **Description:** Relative Oxygen Uptake (l/min/kg) at rest, at anaerobic threshold (AT), at respiratory compensation point (RCP). Indicators of aerobic capacity assessment with cardiopulmonary exercise test (CPET) is conducted while a test on the treadmill (H/P Cosmos Pulsar, Sports \& Medical, Nussdorf-Traunstein, Germany) using a breath-by-breath ergospirometer (Metamax 3B R2ergospirometer and Metasoft Studio v. 5.1.0 software package Cortex Biophysik, Leipzig, Germany). **Measure:** relative Oxygen Uptake **Time Frame:** before and after 12-week intervention **Description:** Volume of carbon dioxide (l/min) at rest, at anaerobic threshold (AT), at respiratory compensation point (RCP). Indicators of aerobic capacity assessment with cardiopulmonary exercise test (CPET) is conducted while a test on the treadmill (H/P Cosmos Pulsar, Sports \& Medical, Nussdorf-Traunstein, Germany) using a breath-by-breath ergospirometer (Metamax 3B R2ergospirometer and Metasoft Studio v. 5.1.0 software package Cortex Biophysik, Leipzig, Germany). **Measure:** Volume of carbon dioxide **Time Frame:** before and after 12-week intervention **Description:** Absolute Power Output (Watts) at rest, at anaerobic threshold (AT), at respiratory compensation point (RCP), at maximal/peak oxygen uptake. Indicators of aerobic capacity assessment with cardiopulmonary exercise test (CPET) is conducted while a test on the treadmill (H/P Cosmos Pulsar, Sports \& Medical, Nussdorf-Traunstein, Germany) using a breath-by-breath ergospirometer (Metamax 3B R2ergospirometer and Metasoft Studio v. 5.1.0 software package Cortex Biophysik, Leipzig, Germany). **Measure:** absolute Power Output **Time Frame:** before and after 12-week intervention **Description:** Relative Power Output (W/kg) at rest, at anaerobic threshold (AT), at respiratory compensation point (RCP), at maximal/peak oxygen uptake. Indicators of aerobic capacity assessment with cardiopulmonary exercise test (CPET) is conducted while a test on the treadmill (H/P Cosmos Pulsar, Sports \& Medical, Nussdorf-Traunstein, Germany) using a breath-by-breath ergospirometer (Metamax 3B R2ergospirometer and Metasoft Studio v. 5.1.0 software package Cortex Biophysik, Leipzig, Germany). **Measure:** relative Power Output **Time Frame:** before and after 12-week intervention **Description:** Indicators of aerobic capacity assessment with cardiopulmonary exercise test (CPET) is conducted while a test on the treadmill (H/P Cosmos Pulsar, Sports \& Medical, Nussdorf-Traunstein, Germany) using a breath-by-breath ergospirometer (Metamax 3B R2ergospirometer and Metasoft Studio v. 5.1.0 software package Cortex Biophysik, Leipzig, Germany). **Measure:** Power Output when respiratory ratio (RQ) equal 1 **Time Frame:** before and after 12-week intervention **Description:** Ventilatory equivalent for carbon dioxide (l/min) Indicators of aerobic capacity assessment with cardiopulmonary exercise test (CPET) is conducted while a test on the treadmill (H/P Cosmos Pulsar, Sports \& Medical, Nussdorf-Traunstein, Germany) using a breath-by-breath ergospirometer (Metamax 3B R2ergospirometer and Metasoft Studio v. 5.1.0 software package Cortex Biophysik, Leipzig, Germany). **Measure:** Ventilatory equivalent for carbon dioxide **Time Frame:** before and after 12-week intervention **Description:** Indicators of aerobic capacity assessment with cardiopulmonary exercise test (CPET) is conducted while a test on the treadmill (H/P Cosmos Pulsar, Sports \& Medical, Nussdorf-Traunstein, Germany) using a breath-by-breath ergospirometer (Metamax 3B R2ergospirometer and Metasoft Studio v. 5.1.0 software package Cortex Biophysik, Leipzig, Germany). **Measure:** Minute ventilation per carbon dioxide production VE/VCO2 slope **Time Frame:** before and after 12-week intervention **Description:** Resting and maximal Heart Rate (beats/min). Indicators of aerobic capacity assessment with cardiopulmonary exercise test (CPET) is conducted while an walking test on the treadmill using a heart rate monitor. **Measure:** Heart Rate **Time Frame:** before and after 12-week intervention **Description:** Metabolic response assessment with blood lactic acid concentration (mmol/l) are tasted before and after a cardiopulmonary exercise test (CPET) (Biosen C-line, EKF Diagnostics) **Measure:** Blood Lactic Acid Concentration **Time Frame:** before and after 12-week intervention **Description:** Borg 6-20 scale was applied to indicate the level of exertion by participant at maximal oxygen uptake /peak oxygen uptake workload during CPET. On the scale minimum value is 6 (no exertion at all), maximum value is 20 (maximal exertion). **Measure:** Subjective rating of perceived exertion **Time Frame:** before and after 12-week intervention #### Secondary Outcomes **Description:** Body Height (m) is measured using Digital stadiometer (Seca 285, SECA, Hamburg, Germany). **Measure:** Body Height **Time Frame:** before and after 12-week intervention **Description:** Body Mass (kg) is measured using Digital stadiometer (Seca 285, SECA, Hamburg, Germany). **Measure:** Body Mass **Time Frame:** before and after 12-week intervention **Description:** Total Body Mass (kg). Indicators of body composition are tested by the dual X-ray absorptiometry method (DXA, Lunar Prodigy; General Electric Lunar Healthcare Technologies, Madison, USA and enCORE v. 16 SP1 software). **Measure:** Total Body Mass **Time Frame:** before and after 12-week intervention, test conducted while fasting **Description:** Bone Mass (kg). Indicators of body composition are tested by the dual X-ray absorptiometry method (DXA, Lunar Prodigy; General Electric Lunar Healthcare Technologies, Madison, USA and enCORE v. 16 SP1 software). **Measure:** Bone Mass **Time Frame:** before and after 12-week intervention, test conducted while fasting **Description:** Muscle Mass (kg). Indicators of body composition are tested by the dual X-ray absorptiometry method (DXA, Lunar Prodigy; General Electric Lunar Healthcare Technologies, Madison, USA and enCORE v. 16 SP1 software). **Measure:** Muscle Mass **Time Frame:** before and after 12-week intervention, test conducted while fasting **Description:** Skeletal Muscle Mass (kg). Indicators of body composition are tested by the dual X-ray absorptiometry method (DXA, Lunar Prodigy; General Electric Lunar Healthcare Technologies, Madison, USA and enCORE v. 16 SP1 software). **Measure:** Skeletal Muscle Mass **Time Frame:** before and after 12-week intervention, test conducted while fasting **Description:** Lean Body Mass (kg). Indicators of body composition are tested by the dual X-ray absorptiometry method (DXA, Lunar Prodigy; General Electric Lunar Healthcare Technologies, Madison, USA and enCORE v. 16 SP1 software). **Measure:** Lean Body Mass **Time Frame:** before and after 12-week intervention, test conducted while fasting **Description:** Fat Mass (kg). Indicators of body composition are tested by the dual X-ray absorptiometry method (DXA, Lunar Prodigy; General Electric Lunar Healthcare Technologies, Madison, USA and enCORE v. 16 SP1 software). **Measure:** Fat Mass **Time Frame:** before and after 12-week intervention, test conducted while fasting **Description:** Fat-Free Mass (kg). Indicators of body composition are tested by the dual X-ray absorptiometry method (DXA, Lunar Prodigy; General Electric Lunar Healthcare Technologies, Madison, USA and enCORE v. 16 SP1 software). **Measure:** Fat-Free Mass **Time Frame:** before and after 12-week intervention, test conducted while fasting **Description:** Visceral Adipose Tissue (cm\^3). Indicators of body composition are tested by the dual X-ray absorptiometry method (DXA, Lunar Prodigy; General Electric Lunar Healthcare Technologies, Madison, USA and enCORE v. 16 SP1 software). **Measure:** Visceral Adipose Tissue 1 **Time Frame:** before and after 12-week intervention, test conducted while fasting **Description:** Visceral Adipose Tissue (g). Indicators of body composition are tested by the dual X-ray absorptiometry method (DXA, Lunar Prodigy; General Electric Lunar Healthcare Technologies, Madison, USA and enCORE v. 16 SP1 software). **Measure:** Visceral Adipose Tissue 2 **Time Frame:** before and after 12-week intervention, test conducted while fasting **Description:** Body Mass Index (BMI) (kg/m\^2). Indicators of body composition are tested by the dual X-ray absorptiometry method (DXA, Lunar Prodigy; General Electric Lunar Healthcare Technologies, Madison, USA and enCORE v. 16 SP1 software). **Measure:** Body Mass Index **Time Frame:** before and after 12-week intervention, test conducted while fasting **Description:** Relative Skeletal Muscle Mass Index (RSMI) (kg/m\^2). Indicators of body composition are tested by the dual X-ray absorptiometry method (DXA, Lunar Prodigy; General Electric Lunar Healthcare Technologies, Madison, USA and enCORE v. 16 SP1 software). **Measure:** Relative Skeletal Muscle Mass Index **Time Frame:** before and after 12-week intervention, test conducted while fasting **Description:** Intra-Cellular Water (kg). Body water component measured using TANITA MC-98OMA plus device. **Measure:** Intra-Cellular Water **Time Frame:** before and after 12-week intervention, test conducted while fasting **Description:** Extra-Cellular Water (kg). Body water component measured using TANITA MC-98OMA plus device. **Measure:** Extra-Cellular Water **Time Frame:** before and after 12-week intervention, test conducted while fasting **Description:** Total Body Water (kg). Body water component measured using TANITA MC-98OMA plus device.using TANITA MC-98OMA plus device. **Measure:** Total Body Water **Time Frame:** before and after 12-week intervention, test conducted while fasting **Description:** Bone Mineral Density (g/cm\^2). Indicators of bone mineral density are tested by the dual X-ray absorptiometry method (DXA, Lunar Prodigy; General Electric Lunar Healthcare Technologies, Madison, USA and enCORE v. 16 SP1 software). **Measure:** Bone Mineral Density **Time Frame:** before and after 12-week intervention, test conducted while fasting **Description:** Bone Mass Component (kg). Indicator is tested by the dual X-ray absorptiometry method (DXA, Lunar Prodigy; General Electric Lunar Healthcare Technologies, Madison, USA and enCORE v. 16 SP1 software). **Measure:** Bone Mass Component **Time Frame:** before and after 12-week intervention, test conducted while fasting **Description:** T-Score Index. Indicators of bone mineral density are tested and calculated by the dual X-ray absorptiometry method (DXA, Lunar Prodigy; General Electric Lunar Healthcare Technologies, Madison, USA and enCORE v. 16 SP1 software). **Measure:** T-Score **Time Frame:** before and after 12-week intervention, test conducted while fasting **Description:** Z-Score Index. Indicators of bone mineral density are tested and calculated by the dual X-ray absorptiometry method (DXA, Lunar Prodigy; General Electric Lunar Healthcare Technologies, Madison, USA and enCORE v. 16 SP1 software). **Measure:** Z-Score **Time Frame:** before and after 12-week intervention, test conducted while fasting **Description:** Indicators of inflammation (Neutrophil to Lymphocyte ratio, Monocyte to Lymphocyte ratio, Platelet to Lymphocyte ratio) are calculated made based on hematological medical records. **Measure:** Inflammatory hematological ratios **Time Frame:** before and after 12-week intervention **Description:** A self-report scale that measures physical activity. The IPAQ comprises 27 items that assess time spent engaging in various levels of physical activity and includes sitting time. Participants are asked to report their responses in terms of minutes, hours, or days. The units of measurement are METs min/week. The amount of physical activity is assessed based on intensity (moderate, intense, walking), and the amount of total physical activity is calculated by summing up the records across each dimension by intensity. A category of low physical activity is considered a result in the total physical activity below 600 METs min/week, moderate between 600 and 3000 METs min/week and high above 3000 METs min/week. Scores can be computed continuously or categorically. **Measure:** Level of Physical activity **Time Frame:** before and after 12-week intervention **Description:** Oxygen Pulse (ml). Indicators of aerobic capacity assessment with cardiopulmonary exercise test (CPET) is conducted while a test on the treadmill (H/P Cosmos Pulsar, Sports \& Medical, Nussdorf-Traunstein, Germany) using a breath-by-breath ergospirometer (Metamax 3B R2ergospirometer and Metasoft Studio v. 5.1.0 software package Cortex Biophysik, Leipzig, Germany). **Measure:** Oxygen Pulse **Time Frame:** before and after 12-week intervention **Description:** Breathing Frequency (breaths/min). Indicators of aerobic capacity assessment with cardiopulmonary exercise test (CPET) is conducted while a test on the treadmill (H/P Cosmos Pulsar, Sports \& Medical, Nussdorf-Traunstein, Germany) using a breath-by-breath ergospirometer (Metamax 3B R2ergospirometer and Metasoft Studio v. 5.1.0 software package Cortex Biophysik, Leipzig, Germany). **Measure:** Breathing Frequency **Time Frame:** before and after 12-week intervention **Description:** Indicators of aerobic capacity assessment with cardiopulmonary exercise test (CPET) is conducted while a test on the treadmill (H/P Cosmos Pulsar, Sports \& Medical, Nussdorf-Traunstein, Germany) using a breath-by-breath ergospirometer (Metamax 3B R2ergospirometer and Metasoft Studio v. 5.1.0 software package Cortex Biophysik, Leipzig, Germany). **Measure:** Respiratory Exchange Ratio **Time Frame:** before and after 12-week intervention **Description:** Ventilatory Efficiency (l/min) Indicators of aerobic capacity assessment with cardiopulmonary exercise test (CPET) is conducted while a test on the treadmill (H/P Cosmos Pulsar, Sports \& Medical, Nussdorf-Traunstein, Germany) using a breath-by-breath ergospirometer (Metamax 3B R2ergospirometer and Metasoft Studio v. 5.1.0 software package Cortex Biophysik, Leipzig, Germany). **Measure:** Ventilatory Efficiency **Time Frame:** before and after 12-week intervention **Description:** Tidal Volume (l) Indicators of aerobic capacity assessment with cardiopulmonary exercise test (CPET) is conducted while a test on the treadmill (H/P Cosmos Pulsar, Sports \& Medical, Nussdorf-Traunstein, Germany) using a breath-by-breath ergospirometer (Metamax 3B R2ergospirometer and Metasoft Studio v. 5.1.0 software package Cortex Biophysik, Leipzig, Germany). **Measure:** Tidal Volume **Time Frame:** before and after 12-week intervention **Description:** Speed (km/h). Indicators of aerobic capacity assessment with cardiopulmonary exercise test (CPET) is conducted while a test on the treadmill (H/P Cosmos Pulsar, Sports \& Medical, Nussdorf-Traunstein, Germany) using a breath-by-breath ergospirometer (Metamax 3B R2ergospirometer and Metasoft Studio v. 5.1.0 software package Cortex Biophysik, Leipzig, Germany). **Measure:** Speed **Time Frame:** before and after 12-week intervention **Description:** Distance (m) Indicators of aerobic capacity assessment with cardiopulmonary exercise test (CPET) is conducted while a test on the treadmill (H/P Cosmos Pulsar, Sports \& Medical, Nussdorf-Traunstein, Germany) using a breath-by-breath ergospirometer (Metamax 3B R2ergospirometer and Metasoft Studio v. 5.1.0 software package Cortex Biophysik, Leipzig, Germany). **Measure:** Distance **Time Frame:** before and after 12-week intervention **Description:** Vascular circulation indicators (Reactive Hyperemia Response, Hypoxia Sensitivity, Normoxia Oscillatory Index, the rate of Nicotinamide Adenine Dinucleotide fluorescence growth) are measured with the use of the Flow Mediated Skin Fluorescence (FMSF) using The AngioExpert device (AngioExpert, Poland). **Measure:** Indicators of vascular circulation **Time Frame:** baseline (before and immediately after CPET) and after 12-week intervention (before and immediately after CPET) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. women with invasive breast cancer 2. stage of disease according to TNM classification I-III 3. cancer with estrogen receptor expression in at least 10% of cell nuclei 4. supplemental hormone therapy with an aromatase inhibitor used for at least 6 months 5. performance status according to ECOG classification 0-1 6. BMI of 18.5-30 7. without chronic diseases affecting the limitation of the use of oncological treatment 8. without contraindications to participation in group supervised Pilates classes 9. participation in at least 17 of 24 classes according to the proposed schedule Exclusion Criteria: 1. invasive breast cancer stage IV according to TNM classification 2. performance status according to ECOG classification 2-4 3. unregulated hypertension 4. unstable ischemic heart disease 5. arrhythmia 6. rheumatic diseases 7. osteoporosis 8. advanced osteoarthritis 9. disease of rheumatic origin (AS, RA, fibromyalgia) 10. pregnancy 11. BMI \< 18.5 or above 30 12. unregulated hypothyroidism/hyperthyroidism Criteria for drop out The criteria for discontinuing allocated interventions are as follows: 1) participant's voluntary withdrawal from the study; 2) worsening of oncological prognosis that prevents the continuation; 3) absence of training sessions due to unjustified reasons in the case of the PG (compliance below 70%). **Healthy Volunteers:** True **Maximum Age:** 55 Years **Minimum Age:** 30 Years **Sex:** FEMALE **Standard Ages:** - ADULT ### Contacts Locations Module #### Locations **Location 1:** **City:** Poznan **Country:** Poland **Facility:** Poznan University of Physical Education **State:** Wielkopolskie **Zip:** 60-871 #### Overall Officials **Official 1:** **Affiliation:** Department of Athletics, Strength and Conditioning, Poznan Univ of Physical Ed, Poland **Name:** Maria Tarnas, Master **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 - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: BXM - Name: Behaviors and Mental Disorders ### Condition Browse Module - Browse Leaves - ID: M5220 - Name: Breast Neoplasms - Relevance: HIGH - As Found: Breast Cancer - ID: M10293 - Name: Inflammation - Relevance: LOW - As Found: Unknown - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M5218 - Name: Breast Diseases - Relevance: LOW - As Found: Unknown - ID: M15674 - Name: Skin Diseases - Relevance: LOW - As Found: Unknown - ID: T6034 - Name: Quality of Life - Relevance: HIGH - As Found: Quality of Life ### Condition Browse Module - Meshes - ID: D000001943 - Term: Breast Neoplasms ### Intervention Browse Module - Browse Branches - Abbrev: All - Name: All Drugs and Chemicals ### Intervention Browse Module - Browse Leaves - ID: M25769 - Name: Aromatase Inhibitors - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06419010 **Acronym:** PeRFOrMand **Brief Title:** Leukocyte- and Platelet-Rich Fibrin in the Surgical Treatment of Medication-related Osteonecrosis of the Jaw **Official Title:** Use of Leukocyte- and Platelet-Rich Fibrin in the Surgical Treatment of Medication-related Osteonecrosis of the Jaw: a Randomized Controlled Trial #### Organization Study ID Info **ID:** RC31/21/0165 #### Organization **Class:** OTHER **Full Name:** University Hospital, Toulouse ### Status Module #### Completion Date **Date:** 2027-05 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-16 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2027-05 **Type:** ESTIMATED #### Start Date **Date:** 2024-05 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-04-29 **Study First Submit QC Date:** 2024-05-16 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University Hospital, Toulouse #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Medication-related osteonecrosis of the jaw (MRONJ) is a rare but serious side-effect of antiresorptive therapies used in the management of bone diseases, such as osteoporosis or bone metastases. A surgical management can lead to a resolution of the disease, but with perfectible results. For this purpose, the use of autologous platelet concentrates (APC) can be useful. With this study, researchers aim to demonstrate the efficacy of L-PRF (Leukocyte- and Platelet-Rich Fibrin) as an adjunct to the surgical treatment of MRONJ in terms of wound healing. **Detailed Description:** Resulting in bone loss, infection, pain or discomfort, the presence of MRONJ decreases the quality of life of patients. There isn't any consensus about the treatment modalities for MRONJ, nor about its main goals. Traditionally, therapeutics only aimed to control and prevent the progression of the disease, but recent studies suggest that a whole resolution can currently be expected, especially from surgical therapies. These, when indicated, are not only intended for the removal of the pathological tissue, but above all for an hermetic mucosal healing, preventing secondary infection of the underlying bone. The L-PRF (Leukocyte- and Platelet-Rich Fibrin) is a second-generation APC, produced in a strictly autologous way, by extemporaneous centrifugation of the patient's own blood. A fibrin clot, containing leukocytes and thrombocytes, is thereby isolated and transformed into membranes by compression. Their appliance to the surgical site allows a slow release of growth factors and cytokines with a positive effect on the revascularization of the wound. Unfortunately, scientific evidence of their efficiencies is lacking. Therefore, a protocol of randomized clinical trial is proposed, aimed at evaluating the effect of the adjunction of APC to surgical procedures on the complete mucosal healing and thus the resolution of the MRONJ. The control treatment strategy consists of the complete removal of the necrotic bone, in bleeding margins, followed by a tension-free and hermetic closure. In the test group, suturing will be preceded by the application of L-PRF membranes under the wound. Patients will be followed for 6 months, during which the maintain of wound closure will be monitored. An evaluation of pain, health-related quality of life and oral health-related quality of life, will also be reported, such as the occurrence of adverse events. ### Conditions Module **Conditions:** - Osteonecrosis of the Jaw **Keywords:** - therapeutics - surgical - autologous platelet concentrates - Platelet-Rich Fibrin - PRF ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - INVESTIGATOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 150 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Patients will benefit from surgery with the use of L-PRF. **Intervention Names:** - Procedure: Surgery with the use of L-PRF **Label:** Experimental group **Type:** EXPERIMENTAL #### Arm Group 2 **Description:** Patients will benefit from standard surgical treatment. **Intervention Names:** - Procedure: Standard surgery **Label:** Control group **Type:** OTHER ### Interventions #### Intervention 1 **Arm Group Labels:** - Experimental group **Description:** The study protocol is the same as the standard surgery one but with additional use of L-PRF membranes **Name:** Surgery with the use of L-PRF **Type:** PROCEDURE #### Intervention 2 **Arm Group Labels:** - Control group **Description:** The standard surgical treatment, taking place in the operating room under general anesthesia **Name:** Standard surgery **Type:** PROCEDURE ### Outcomes Module #### Primary Outcomes **Description:** Proportion of subjects presenting complete mucosal healing, i.e. a return to stage 0 or the "at risk" stage of the AAOMS classification. **Measure:** Evaluation of the efficacy of the use of L-PRF during the surgical treatment of MRONJ, compared to surgical treatment alone, on complete mucosal healing. **Time Frame:** 6 months postoperatively #### Secondary Outcomes **Description:** Evaluation and comparison between the 2 groups of the evolution of the MRONJ stage - (improvement, stability, worsening). **Measure:** MRONJ stage - Month 1 **Time Frame:** 1 month postoperatively **Description:** Evaluation and comparison between the 2 groups of the evolution of the MRONJ stage - (improvement, stability, worsening). **Measure:** MRONJ stage - Month 3 **Time Frame:** 3 months postoperatively **Description:** Evaluation and comparison between the 2 groups of the evolution of the MRONJ stage - (improvement, stability, worsening). **Measure:** MRONJ stage - Month 6 **Time Frame:** 6 months postoperatively **Description:** Pain will be subjectively evaluated by the patients using a Numerical Scale, according to a score from 0 (absence of pain) to 10 (maximum pain imaginable). **Measure:** the postoperative pain - Month 1 **Time Frame:** 1 month postoperatively **Description:** Pain will be subjectively evaluated by the patients using a Numerical Scale, according to a score from 0 (absence of pain) to 10 (maximum pain imaginable). **Measure:** the postoperative pain - Month 3 **Time Frame:** 3 months postoperatively **Description:** Pain will be subjectively evaluated by the patients using a Numerical Scale, according to a score from 0 (absence of pain) to 10 (maximum pain imaginable). **Measure:** the postoperative pain - Month 6 **Time Frame:** 6 months postoperatively **Description:** Overall quality of life will be assessed by the WHOQOL-BREF questionnaire **Measure:** health-related quality of life - Month 1 - World Health Organization Quality of Life WHOQOL-BREF **Time Frame:** 1 month postoperatively **Description:** oral health-related quality of life will be assessed via the OHIP-14 questionnaire. **Measure:** health-related quality of life - Month 1 - OHIP-14 **Time Frame:** 1 month postoperatively **Description:** Overall quality of life will be assessed by the WHOQOL-BREF questionnaire and oral health-related quality of life will be assessed via the OHIP-14 questionnaire. **Measure:** health-related quality of life - Month 3 WHOQOL-BREF **Time Frame:** 3 months postoperatively **Description:** Oral Health Impact Profile of life will be assessed via the Oral Health Impact Profile OHIP-14 questionnaire. **Measure:** health-related quality of life - Month 3 Oral health-related quality OHIP-14 **Time Frame:** 3 months postoperatively **Description:** Overall quality of life will be assessed by the WHOQOL-BREF questionnaire **Measure:** health-related quality of life - Month 6 WHOQOL-BREF **Time Frame:** 6 months postoperatively **Description:** Oral health-related quality of life will be assessed via the OHIP-14 questionnaire. **Measure:** health-related quality of life - Month 6 - OHIP-14 **Time Frame:** 6 months postoperatively ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * MRONJ requiring surgical treatment according to AAOMS criteria (stage 2 or 3; failure of first-line treatments; sequestration of a necrotic bone block), the resection of which needs general anesthesia; * Affiliates or beneficiaries of a social security scheme. * Having given free and informed written consent. Exclusion Criteria: * Presence of a maxillo-mandibular neoplastic lesion; * Presence of several MRONJ lesions; * History of cervico-facial radiotherapy; * Contraindication to general anesthesia; * Reduced life expectancy (estimated at less than 6 months). **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Franck DELANOË, MD **Phone:** +33 5 61 77 74 76 **Role:** CONTACT #### Locations **Location 1:** **City:** Bordeaux **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Mathieu BONDAZ, MD - **Phone:** 05 56 79 56 79 - **Phone Ext:** +33 - **Role:** CONTACT ***Contact 2:*** - **Name:** Mathieu BONDAZ, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** France **Facility:** University Hospital - Centre François-Xavier Michelet **Location 2:** **City:** Bordeaux **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Jean-Christophe FRICAIN, MD - **Phone:** 05 56 79 56 79 - **Phone Ext:** +33 - **Role:** CONTACT ***Contact 2:*** - **Name:** Jean-Christophe FRICAIN, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** France **Facility:** University Hospital - Groupe hospitalier Pellegrin **Location 3:** **City:** Limoges **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Julie USSEGLIO, MD - **Phone:** 05 55 05 61 20 - **Phone Ext:** +33 - **Role:** CONTACT ***Contact 2:*** - **Name:** Julie USSEGLIO, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** France **Facility:** University Hospital **Location 4:** **City:** Montpellier **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Marie DE BOUTRAY, MD - **Phone:** 04 67 33 68 03 - **Phone Ext:** +33 - **Role:** CONTACT ***Contact 2:*** - **Name:** Marie DE BOUTRAY, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** France **Facility:** University Hospital Gui de CHAULIAC **Location 5:** **City:** Paris **Contacts:** ***Contact 1:*** - **Name:** Géraldine LESCAILLE, MD - **Phone:** 01 42 17 84 16 - **Phone Ext:** +33 - **Role:** CONTACT ***Contact 2:*** - **Name:** Géraldine LESCAILLE, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** France **Facility:** University Hospital Pitié-Salpêtrière **Zip:** 75013 **Location 6:** **City:** Toulouse **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Franck DELANOE, MD - **Phone:** 05 61 77 74 76 - **Phone Ext:** +33 - **Role:** CONTACT ***Contact 2:*** - **Name:** Franck DELANOE, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** France **Facility:** University Hospital **Zip:** 31000 **Location 7:** **City:** Toulouse **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Clément CAMBRONNE, MD - **Phone:** 06 78 18 54 78 - **Phone Ext:** +33 - **Role:** CONTACT ***Contact 2:*** - **Name:** Clément CAMBRONNE, MD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** France **Facility:** University Hospital #### Overall Officials **Official 1:** **Affiliation:** University Hospital, Toulouse **Name:** Claire VILLEPINTE, MD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001847 - Term: Bone Diseases - ID: D000009140 - Term: Musculoskeletal Diseases - ID: D000009336 - Term: Necrosis - ID: D000010335 - Term: Pathologic Processes ### Condition Browse Module - Browse Branches - Abbrev: BC05 - Name: Musculoskeletal Diseases - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M12943 - Name: Osteonecrosis - Relevance: HIGH - As Found: Osteonecrosis - ID: M5126 - Name: Bone Diseases - Relevance: LOW - As Found: Unknown - ID: M12097 - Name: Musculoskeletal Diseases - Relevance: LOW - As Found: Unknown - ID: M12284 - Name: Necrosis - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010020 - Term: Osteonecrosis ### Intervention Browse Module - Browse Branches - Abbrev: CNSDep - Name: Central Nervous System Depressants - Abbrev: All - Name: All Drugs and Chemicals - Abbrev: Derm - Name: Dermatologic Agents ### Intervention Browse Module - Browse Leaves - ID: M4107 - Name: Anesthetics - Relevance: LOW - As Found: Unknown - ID: M6263 - Name: Coal Tar - Relevance: LOW - As Found: Unknown ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06418997 **Brief Title:** Cognitive Behavioral Immersion: A Randomized Control Trial of Peer-Based Coaching in the Metaverse **Official Title:** Cognitive Behavioral Immersion: A Randomized Control Trial of Peer-Based Coaching in the Metaverse #### Organization Study ID Info **ID:** UP-23-00491 #### Organization **Class:** OTHER **Full Name:** University of Southern California #### Secondary ID Infos **ID:** R44MH132202 **Link:** https://reporter.nih.gov/quickSearch/R44MH132202 **Type:** NIH ### Status Module #### Completion Date **Date:** 2025-09 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** RECRUITING #### Primary Completion Date **Date:** 2025-06 **Type:** ESTIMATED #### Start Date **Date:** 2024-02-26 **Type:** ACTUAL **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Collaborators **Class:** NIH **Name:** National Institute of Mental Health (NIMH) #### Lead Sponsor **Class:** OTHER **Name:** University of Southern California #### Responsible Party **Investigator Affiliation:** University of Southern California **Investigator Full Name:** Iony Ezawa **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:** This study will test a new cognitive-behavioral skills training program (CBI) delivered in the metaverse. Although initial evidence suggested CBI was feasible for individuals experiencing depression or anxiety, CBI's effectiveness compared to no intervention has yet to be determined. The intervention may be delivered through virtual reality as well as flat-screen devices, such as a computer, which may also affect CBI's effectiveness. The study will enroll up to 306 participants with depression. One third of the participants will access CBI through virtual reality, one third of the participants will access CBI through a flat-screen device, and one third of the participants will be asked not to attend CBI sessions for the first 8 weeks of participation of the trial. For both CBI conditions, treatment will be provided over 8 weeks, with a 6-month follow-up period. Enrollment will be ongoing and groups will occur simultaneously. Potential participants are asked to complete an initial screening and an intake evaluation to determine eligibility. They will then receive 8-weeks of treatment. Participants will complete brief weekly self-report questionnaires throughout their time in the study. **Detailed Description:** Cognitive behavioral therapy (CBT) is one of the most effective tools for the treatment of depression and anxiety. Despite its many strengths, CBT-based clinical care is often very expensive and difficult to access. To address problems of accessibility, the field is increasingly utilizing lay therapists (also commonly referred to as coaches or peers) to provide cognitive behavioral coaching. There is also accumulating evidence indicating that technology can be used to deliver affordable and accessible treatments with outcomes comparable to traditional face-to-face psychotherapy treatments (Karyotaki et al., 2021). In particular, the metaverse (Internet-connected 3-D virtual environments have also that allow end-users to interact as avatars) may be a distinctively powerful medium through which to deliver engaging, affordable, accessible, and scalable mental health interventions. In addition, the use of social virtual reality (VR) mental health interventions is relatively unexplored, yet the sense of presence ("being there") it provides may be useful to increase immersiveness in a digital intervention or facilitate social interaction in a digital space. Therefore, the investigators plan to conduct a randomized controlled trial on CBI in order to investigate its effectiveness among different groups of people and investigate the role immersive VR, as opposed to a flat screen, may play in predicting outcome measures. Upon joining the study, participants are asked to complete surveys once a week for 8 weeks and brief monthly follow-up surveys for 6 months. If you are randomized to either of the CBI conditions, you will also be asked to attend 8 weekly 1-hour sessions through a virtual application (from a VR headset or flat-screen, depending on your condition). This study seeks to address the main following research questions: (1) Is CBI efficacious? (and for whom is it more or less efficacious?) And (2) Does immersive VR confer any advantage over and above accessing CBI via less immersive flat screen devices? ### Conditions Module **Conditions:** - Depression, Anxiety **Keywords:** - Metaverse - virtual reality - cognitive-behavioral - depression - depressive Disorders - mental disorders - skills group ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** OTHER #### Enrollment Info **Count:** 306 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Over 8 weekly 1-hour sessions, participants will learn about the cognitive-behavioral model from trained peer coaches, develop cognitive-behavioral skills that they can utilize in their daily lives (such as cognitive restructuring), and engage with a receptive community of peers. Participants randomized to this arm will access these sessions using a virtual reality headset. **Intervention Names:** - Behavioral: CBI **Label:** CBI-Virtual Reality **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Description:** Over 8 weekly 1-hour sessions, participants will learn about the cognitive-behavioral model from trained peer coaches, develop cognitive-behavioral skills and habits that they can utilize in their daily lives (such as cognitive restructuring), and engage with a receptive community of peers. Participants randomized to this arm will access these sessions using a flat-screen device, such as a computer. **Intervention Names:** - Behavioral: CBI **Label:** CBI-Flat Screen **Type:** ACTIVE_COMPARATOR #### Arm Group 3 **Description:** Participants randomized to this arm will be asked not to attend CBI sessions. **Label:** Delayed-Access Control **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - CBI-Flat Screen - CBI-Virtual Reality **Description:** CBI sessions follow a detailed manual to teach a group of peers cognitive and behavioral strategies that they may utilize in their daily lives, often based around the cognitive-behavioral model as a teaching tool. CBI aims to develop cognitive-behaviorally-based skills and habits in participants, such as behavioral activation, mood tracking, the identification and reframing of automatic thoughts, and assertion training. **Name:** CBI **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** The PHQ-9 (Kroenke et al., 2001) is a 9-item self-report measure with strong psychometric properties that mirrors the nine criteria for evaluating whether someone meets criteria for major depressive disorder (MDD) in the Diagnostic and Statistical Manual Fourth Edition (DSM-IV; American Psychiatric Association, 1994). Scores range from 0 to 27, with higher scores indicating great symptom severity. **Measure:** Patient Health Questionnaire (PHQ-9) **Time Frame:** Post-treatment (8-weeks) and follow-up (6-months) #### Secondary Outcomes **Description:** The GAD-7 (Spitzer et al., 2006) is a 7-item self-report measure with strong psychometric properties based on the diagnostic criteria for Generalized Anxiety Disorder (GAD-7) from the DSM-IV (American Psychiatric Association, 1994). Scores range from 0 to 21, with higher scores indicating great symptom severity. **Measure:** Generalized Anxiety Disorder Questionnaire (GAD-7) **Time Frame:** Post-treatment (8-weeks) and follow-up (6-months) **Description:** The WHO QOL (Whoqol Group, 1998) is a 26-item self-report cross-cultural measure of quality of life within the domains of physical health, psychological health, social relationships, and environment. During the follow-up period, we will transition to using only the first item of the measure assessing overall quality of life. Scores are transformed on a scale from 0 to 100, with higher scores indicating a higher quality of life. **Measure:** WHO Quality of Life-Brief (QOL) **Time Frame:** Post-treatment (8-weeks) and 1-item version at follow-up (6-months) ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * 18 years of age or older * Proficient in reading and speaking English * Have a computer with a stable internet connection * Score at or above the clinical threshold on the Patient Health Questionnaire (PHQ-9; Kroenke et al. 2001) Exclusion Criteria: * Sufficiently elevated levels of negative thoughts such that the individual is considered at high risk of harm, according to the Columbia Suicide Severity Rating Scale (CSSRS) **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Iony D Ezawa, PhD **Phone:** (213) 262-9992 **Role:** CONTACT #### Locations **Location 1:** **City:** Los Angeles **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Iony D Ezawa, PhD - **Phone:** 213-262-9992 - **Role:** CONTACT **Country:** United States **Facility:** University of Southern California **State:** California **Status:** RECRUITING **Zip:** 90089 #### Overall Officials **Official 1:** **Affiliation:** University of Southern California **Name:** Iony D Ezawa, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **IPD Sharing:** NO ### References Module #### References **Citation:** Karyotaki E, Efthimiou O, Miguel C, Bermpohl FMG, Furukawa TA, Cuijpers P; Individual Patient Data Meta-Analyses for Depression (IPDMA-DE) Collaboration; Riper H, Patel V, Mira A, Gemmil AW, Yeung AS, Lange A, Williams AD, Mackinnon A, Geraedts A, van Straten A, Meyer B, Bjorkelund C, Knaevelsrud C, Beevers CG, Botella C, Strunk DR, Mohr DC, Ebert DD, Kessler D, Richards D, Littlewood E, Forsell E, Feng F, Wang F, Andersson G, Hadjistavropoulos H, Christensen H, Ezawa ID, Choi I, Rosso IM, Klein JP, Shumake J, Garcia-Campayo J, Milgrom J, Smith J, Montero-Marin J, Newby JM, Breton-Lopez J, Schneider J, Vernmark K, Bucker L, Sheeber LB, Warmerdam L, Farrer L, Heinrich M, Huibers MJH, Kivi M, Kraepelien M, Forand NR, Pugh N, Lindefors N, Lintvedt O, Zagorscak P, Carlbring P, Phillips R, Johansson R, Kessler RC, Brabyn S, Perini S, Rauch SL, Gilbody S, Moritz S, Berger T, Pop V, Kaldo V, Spek V, Forsell Y. Internet-Based Cognitive Behavioral Therapy for Depression: A Systematic Review and Individual Patient Data Network Meta-analysis. JAMA Psychiatry. 2021 Apr 1;78(4):361-371. doi: 10.1001/jamapsychiatry.2020.4364. Erratum In: JAMA Psychiatry. 2024 Mar 1;81(3):320. **PMID:** 33471111 **Citation:** Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x. **PMID:** 11556941 **Citation:** Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092. **PMID:** 16717171 ## Derived Section ### Condition Browse Module - Ancestors - ID: D000001526 - Term: Behavioral Symptoms ### Condition Browse Module - Browse Branches - Abbrev: BXM - Name: Behaviors and Mental Disorders - Abbrev: All - Name: All Conditions ### Condition Browse Module - Browse Leaves - ID: M7058 - Name: Depression - Relevance: HIGH - As Found: Depression - ID: M4324 - Name: Anxiety Disorders - Relevance: LOW - As Found: Unknown - ID: M7061 - Name: Depressive Disorder - Relevance: LOW - As Found: Unknown - ID: M4815 - Name: Mental Disorders - Relevance: LOW - As Found: Unknown - ID: M14473 - Name: Psychotic Disorders - Relevance: LOW - As Found: Unknown - ID: M4818 - Name: Behavioral Symptoms - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003863 - Term: Depression ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06418984 **Brief Title:** Clinical Trial to Compare Clear Aligners' Auxiliaries on Rotational Accuracy **Official Title:** A Randomized Clinical Trial to Compare the Influence of Optimized Attachments, IPR and a Combination of Both Techniques on the Rotational Accuracy of Canines With Clear Aligners #### Organization Study ID Info **ID:** IRB202400491 #### Organization **Class:** OTHER **Full Name:** University of Florida ### Status Module #### Completion Date **Date:** 2025-02-15 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-20 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-17 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2025-01-28 **Type:** ESTIMATED #### Start Date **Date:** 2024-08-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-08 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Florida #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Is US Export:** True **Oversight Has DMC:** True ### Description Module **Brief Summary:** This randomized clinical trial aims to assess the effectiveness of optimized attachments, IPR and a combination of the two techniques on the rotational accuracy of canines with clear aligners **Detailed Description:** Study Visit 1 (V1): Upon fitting the inclusion criteria, the patient will be randomized to one of the four interventional groups. A member of the study team will collect the initial orthodontics records. These records include two radiographs (a panoramic radiograph and a lateral cephalogram), intraoral and extraoral photographs, and an iTero intraoral digital scan. The scan will be sent directly to the Align Technology Invisalign doctor platform to begin the process of fabricating the desired aligners according to the clinical instructions for the simulated treatment plan by the study team and the randomly assigned group for the patient. Study Visit 2 (V2): 5 weeks following visit 1, Invisalign aligners will be delivered to the included and randomized subjects, and associated treatment rendered. Subjects will be instructed to wear their aligners full-time except while eating, drinking, and brushing and change their aligners as recommended by Invisalign® every week. Study Visit 3 (V3): The trial will end after the patient has completed wearing the first stage of aligners. Final records will be collected: these include iTero intraoral digital scans to construct the 3D digital models, intraoral and extraoral photographs, and radiographs. To assess the accuracy of the achieved outcomes and compare the outcomes of the four treatment groups, the collected digital models (predicted simulated models and achieved final scanned models) will be superimposed and compared to assess the accuracy and predictability of rotational tooth movement in the included subjects, and treatment outcomes will be evaluated. The differences between the positions of each tooth in the two digital models (predicted from Clincheck and achieved from the final scan) will quantified for rotation: differences of 2° or more rotation will be considered clinically relevant. These values were chosen from the American Board of Orthodontics (ABO) model grading system for case evaluation and other clinical studies.5 Additionally, data related to treatment duration, number of aligners, and number of visits needed to complete the treatment will be gathered and analyzed in a de-identified form. ### Conditions Module **Conditions:** - Rotation of Tooth ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL **Intervention Model Description:** one control group and 3 experimental groups ##### Masking Info **Masking:** DOUBLE **Who Masked:** - PARTICIPANT - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 80 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** No Interproximal reduction or attachments will be used to help correct the rotation **Label:** Control **Type:** NO_INTERVENTION #### Arm Group 2 **Description:** Interproximal reduction will be performed in this arm **Intervention Names:** - Device: auxiliary **Label:** Inter proximal reduction **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** optimized composite attachments will be added to this arm **Intervention Names:** - Device: auxiliary **Label:** Optimized attachments **Type:** EXPERIMENTAL #### Arm Group 4 **Description:** Both Interproximal reduction will be implemented and optimized attachments will be added to this arm **Intervention Names:** - Device: auxiliary **Label:** IPR and optimized attachments **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - IPR and optimized attachments - Inter proximal reduction - Optimized attachments **Description:** the interventions are related to the adjuncts associated with clear aligners to improve the predictability and accuracy of tooth movement **Name:** auxiliary **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** 3D model superimposition will be used to assess the accuracy of tooth movement **Measure:** Accuracy of Canine rotation **Time Frame:** 6-9 months ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria * Physically healthy with no relevant allergies or medical problems * Male or female above 18 years old * Full permanent dentition except for the third molars * Any type of malocclusion with rotated canines that require derotation * Good oral hygiene and absence of periodontal disease * Malocclusion to be treated with Invisalign aligners (SmartTrack) * Any ethnic group Exclusion Criteria * Orthognathic surgical cases * An extraction treatment plan * Poor oral hygiene * Patients with syndromes or craniofacial anomalies. * The use of any other orthodontic appliance than clear aligners' (Invisalign) * Malocclusion that requires auxiliaries in the simulated plan ( buttons and elastics on the canines) **Healthy Volunteers:** True **Maximum Age:** 45 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT ## Derived Section ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06418971 **Acronym:** CRR **Brief Title:** The Caregiver Resource Room (CRR): Using Technology to Enhance Support for Dementia Family Caregivers **Official Title:** The Caregiver Resource Room: Using Technology to Enhance Support for Caregivers of Alzheimer's Disease and Related Dementias #### Organization Study ID Info **ID:** UP-23-00768 #### Organization **Class:** OTHER **Full Name:** University of Southern California #### Secondary ID Infos **ID:** R00AG073509 **Link:** https://reporter.nih.gov/quickSearch/R00AG073509 **Type:** NIH ### Status Module #### Completion Date **Date:** 2026-08-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-16 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-08-31 **Type:** ESTIMATED #### Start Date **Date:** 2025-03-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-02-27 **Study First Submit QC Date:** 2024-05-16 ### Sponsor Collaborators Module #### Collaborators **Class:** NIH **Name:** National Institute on Aging (NIA) #### Lead Sponsor **Class:** OTHER **Name:** University of Southern California #### Responsible Party **Investigator Affiliation:** University of Southern California **Investigator Full Name:** Francesca B Falzarano **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 purpose of this study is to develop and test CarePair, a web-based needs assessment and service referral platform for family caregivers of persons with dementia designed to alleviate stress and promote psychosocial well being. The main aims of this study are: * To evaluate the feasibility and acceptability of the CarePair web application. * To explore the potential for the CarePair web-application to reduce feelings of depression and burden, and improve caregivers' feelings of self-efficacy. Caregiver participants will be asked to log in and test the CarePair web application and complete study activities for a three-month duration. Researchers will compare the intervention group to an attention control comparator to see if application use is associated with improved psychosocial outcomes at follow-up. **Detailed Description:** In 2023, approximately 6.7 million diagnosed cases of Alzheimer's disease and related dementias (ADRD) were reported in the United States, with 83% of the caregiving burden shouldered by unpaid family members or friends. The duration of ADRD varies between 4-20 years, during which individuals often transition into a state of complete dependency. Without family caregivers, the long-term services and support system would be unsustainable. The dearth of accessible support for ADRD caregivers constitutes a significant public health emergency. Caregivers are frequently uncertain of which services are needed, available, and how to gain access - often leaving those most vulnerable without essential support. When queried about service underuse, study respondents who participated in the K99 phase of this project highlighted an information deficit tailored to specific cultures, demographics, and dementia types. They described the excess of online information as overwhelming, often irrelevant, impractical, or unaffordable. Existing technology-based solutions targeted toward enhancing personalized caregiver support are limited. Leveraging continued innovations in technology to inform the training and testing of machine learning algorithms, which can match and update resources while accounting for individual needs, preferences (in-person, virtual), and barriers (e.g., employment, lack of respite care), holds great potential to enhance the precision of service linkage for ADRD caregivers. This R00 project aims to develop, refine, and pilot test CarePair (formerly the Caregiver Resource Room), a web-based assessment and service referral platform for dementia caregivers. CarePair will leverage innovative machine learning algorithms to holistically evaluate caregivers' evolving needs, their barriers, and preferences to generate personalized service referrals relevant to their areas of identified need. Thus, the specific aims of the R00 are to 1) Use mixed-method and focus group data from the K99 phase to inform the iterative development of the CarePair, which includes a digital self-assessment tool employing machine learning to identify needs, categorize them, and generate targeted service recommendations; 2) Evaluate front- and back-end usability (e.g., via task analysis, heuristic evaluation) of the tool's content, design, features, functionality, and accuracy of service output. Feedback will inform modifications and iterative refinement of the CarePair Version 2.0; 3) Conduct a pilot randomized controlled trial to assess the feasibility, acceptability, and preliminary efficacy of CarePair in enhancing service awareness, addressing unmet needs, and improving mental health. The proposed research aligns with the NIA's strategic initiative to foster research scientists in aging and to develop promising interventions to better engage and support the well-being of ADRD family caregivers. ### Conditions Module **Conditions:** - Caregiver Burden - Caregiver Burnout - Dementia **Keywords:** - Dementia family caregivers ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** SINGLE **Who Masked:** - PARTICIPANT **Primary Purpose:** SUPPORTIVE_CARE #### Enrollment Info **Count:** 80 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** Participants randomized to the control arm will receive an American Association of Retired Persons (AARP) caregiver handbook and will receive biweekly check-in calls asking about their caregiving situation, service use, and strategies they are using to address needs. **Label:** Control Arm **Type:** NO_INTERVENTION #### Arm Group 2 **Description:** After completing baseline interviews, caregivers will be introduced to and trained in the use of the CarePair through video tutorials and virtual training sessions via video-conferencing software. They will have access to an email, text, and telephone contact should they experience technical difficulties. They will be instructed to login to CarePair twice per month and complete short questionnaires assessing their use of services and satisfaction with services (if used). If they have not used services, they will be asked to indicate any perceived barriers with use. At the RCT's conclusion, participants will complete a follow-up survey to obtain quantitative and qualitative feedback about their experience. Outcomes will include pilot data on satisfaction with output of service recommendations, interaction and usability of CarePair (primary outcomes), and caregiver self-efficacy, depression and caregiver burden (secondary outcomes). **Intervention Names:** - Behavioral: CarePair **Label:** CarePair Intervention Arm **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - CarePair Intervention Arm **Description:** This study will pilot test the feasibility and acceptability of a digital self-assessment and referral tool using machine learning models to enhance service use and address unmet needs in ADRD caregivers. **Name:** CarePair **Type:** BEHAVIORAL ### Outcomes Module #### Primary Outcomes **Description:** The platform's built-in analytics will measure engagement via number of application logins per participant to assess participant engagement as an assessment of feasibility. **Measure:** Participant Engagement, as Measured By Number of Application Logins Per Participant **Time Frame:** 3 Month Follow-Up **Description:** Five items will be administered to measure satisfaction with the intervention and web application across the following domains: 1) Overall Satisfaction; 2) Ease of Use; 3) Content Quality; 4) Design and Aesthetics; 5) Purpose Fulfillment. Responses are reported on a Likert scale ranging from 1 (not at all satisfied) to 5 (very satisfied). Total scores range from 5-25, with higher scores reflecting greater levels of participant satisfaction. Satisfaction will be evaluated based on a) the percentage of participants who report being "satisfied" or "very satisfied" with the intervention and web application, as well as b) open-ended feedback regarding the components of the application and intervention perceived to be of the most value/benefit; and c) likelihood and/or willingness to use the application in the future. **Measure:** Rates of Participant Satisfaction with Intervention and Web Application, as Measured by Post-Intervention Feedback **Time Frame:** 3 Month Follow-Up **Description:** Usability and accessibility of the web application design will be measured using the validated System Usability Scale (SUS). Total scores for the SUS range from 0-100, with higher scores indicative of greater usability. A threshold score of 68 is used to indicate adequate usability. **Measure:** Web Application Usability, as measured using the validated System Usability Scale (SUS). **Time Frame:** 3 Month Follow-Up #### Secondary Outcomes **Description:** Caregiving Self-Efficacy will be measured using the Revised Scale for Caregiving Self-Efficacy. Total scores range from 0-100, with higher scores indicative of greater feelings of perceived self-efficacy. **Measure:** Change from Baseline Caregiving Self-Efficacy scores on the 15-item Revised Scale for Caregiving Self-Efficacy at 4 Weeks. **Time Frame:** Baseline; 3-Month Follow-Up **Description:** The Zarit Burden Inventory (ZBI-12) will be used to measure family caregiver burden. Total scores range from 0-48, with higher scores indicative of greater burden. **Measure:** Change from Baseline Caregiver Burden scores as measured by the validated 12-item Zarit Burden Inventory (ZBI-12). **Time Frame:** Baseline; 3-Month Follow-Up **Description:** The PHQ-9 will be used to measure family caregiver depressive symptoms. Total scores range from 0-27, with higher scores indicative of greater caregiver depressive symptoms. **Measure:** Change from Baseline Caregiver Depressive Symptoms as measured by the validated Patient Health Questionnaire-9 (PHQ-9). **Time Frame:** Baseline; 3-Month Follow-Up ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * Primary caregiver of a community-dwelling person with dementia (PwD) * Greater or equal to 18 years of age * Able to use the internet and has internet access * English-speaking * Does not exhibit cognitive impairment (e.g., scoring below 3 on the Short Portable Mental Status Questionnaire, SPMSQ) Exclusion Criteria: * Not a primary caregiver to a community-dwelling person with dementia (PwD) * Under 18-years-old, * Does not speak English * Evidence of cognitive impairment **Healthy Volunteers:** True **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### Contacts Locations Module #### Central Contacts **Contact 1:** **Email:** [email protected] **Name:** Francesca B Falzarano, PhD **Phone:** 6464812858 **Role:** CONTACT **Contact 2:** **Email:** [email protected] **Name:** Annabelle V Greenfield, BS **Phone:** 6467809506 **Role:** CONTACT #### Locations **Location 1:** **City:** Los Angeles **Contacts:** ***Contact 1:*** - **Email:** [email protected] - **Name:** Annabelle Greenfield, BS - **Role:** CONTACT ***Contact 2:*** - **Name:** Francesca Falzarano, PhD - **Role:** PRINCIPAL_INVESTIGATOR **Country:** United States **Facility:** University of Southern California **State:** California **Zip:** 90089 #### Overall Officials **Official 1:** **Affiliation:** University of Southern California **Name:** Francesca Falzarano, PhD **Role:** PRINCIPAL_INVESTIGATOR ### IPD Sharing Statement Module **Access Criteria:** Individuals who wish to access the data are required to: 1) Use the data for research purposes only; 2) Not identify any individual participant; 3) Secure the data using appropriate computer technology such as password-protected servers and files; and 4) Return and/or destroy data after analyses are complete. **Description:** Data collected for the Caregiver Resource Room study will only be shared after the investigators have published the data addressing the study's specific aims. Intellectual property and data generated under this project will be administered in accordance with both University of Southern California (USC) and NIH policies, including the NIH Data Sharing Policy and Implementation Guidance. After publication of the investigator's main findings, access to databases and associated software tools generated and the code to create these tools under the project will be available for educational, research and non-profit purposes. **Info Types:** - STUDY_PROTOCOL - SAP - ICF - ANALYTIC_CODE **IPD Sharing:** YES **Time Frame:** These data will be shared after the investigators have published the specific aims of this study. Requests for the code used to create the Caregiver Resource Room will be reviewed by the investigative team and shared once feasibility, acceptability, and preliminary efficacy has been examined and the findings have been published. ## 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: D000019965 - Term: Neurocognitive Disorders - ID: D000001523 - Term: Mental Disorders - ID: D000013315 - Term: Stress, Psychological - ID: D000001526 - Term: Behavioral Symptoms ### 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: M2480 - Name: Caregiver Burden - Relevance: HIGH - As Found: Caregiver Burden - ID: M3885 - Name: Alzheimer Disease - Relevance: LOW - As Found: Unknown - ID: M1658 - Name: Burnout, Psychological - 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: 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: M16105 - Name: Stress, Psychological - Relevance: LOW - As Found: Unknown - ID: M4818 - Name: Behavioral Symptoms - Relevance: LOW - As Found: Unknown - ID: T2192 - Name: Familial Alzheimer Disease - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000003704 - Term: Dementia - ID: D000084802 - Term: Caregiver Burden ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06418958 **Brief Title:** Temperature Rise Caused by Short or Long-wavelengths **Official Title:** In Vivo Temperature Changes Caused by Exposure to Short- and Long-wavelengths #### Organization Study ID Info **ID:** IRB202300690 #### Organization **Class:** OTHER **Full Name:** University of Florida ### Status Module #### Completion Date **Date:** 2027-01-13 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-01-13 **Type:** ESTIMATED #### Start Date **Date:** 2025-01-13 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-02 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** University of Florida #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** True **Is FDA Regulated Drug:** False **Is Unapproved Device:** True **Is US Export:** False **Oversight Has DMC:** False ### Description Module **Brief Summary:** Red light has been shown to be less harmful than blue light in vitro and in vivo. Although red light has been already introduced in the market and is currently being used in patients for several reasons, no data exist on the use of red light applied to restorative procedures. This study aims to specifically measure the in vivo temperature rise in simulated restorative procedures using blue light (standard) and red light and its post-operative sensitivity rates. ### Conditions Module **Conditions:** - Post-operative Pain ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** QUADRUPLE **Who Masked:** - PARTICIPANT - CARE_PROVIDER - INVESTIGATOR - OUTCOMES_ASSESSOR **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 50 **Type:** ESTIMATED **Phases:** - NA **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Intervention Names:** - Device: Light-curing **Label:** Blue Light **Type:** ACTIVE_COMPARATOR #### Arm Group 2 **Intervention Names:** - Device: Light-curing **Label:** Red Light **Type:** EXPERIMENTAL ### Interventions #### Intervention 1 **Arm Group Labels:** - Blue Light - Red Light **Description:** Light Curing **Name:** Light-curing **Type:** DEVICE ### Outcomes Module #### Primary Outcomes **Description:** Temperature changes in degrees Celsius will be live-recorded by means of temperature probes for surface temperature acquisition. **Measure:** Temperature Change **Time Frame:** During restorative procedure. #### Secondary Outcomes **Description:** All patients will be called after the restoration(s) were placed to follow-up on any possible post-operative sensitivity or other questions or concerns. Post-operative sensitivity will be recorded as present or absent. If present, the post-operative sensitivity will be classified as mild, moderate, or severe according to the visual analog scale (VAS). **Measure:** Post-Operative Sensitivity **Time Frame:** One week (±2 days) after intervention. ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: * ASA I classification * Fully erupted pre-molar(s); * Absence of caries; * Absence of restoration. Exclusion Criteria: * Radiographic constriction of the pulp chamber; * Absence of apical closure; * Formation of pulp stones or diffuse calcification at the pulp chamber; * Presence of active carious lesions; * Diagnosed reversible or irreversible pulpitis; * Existing periapical lesion; * Existing or planned root canal treatment. **Healthy Volunteers:** True **Maximum Age:** 35 Years **Minimum Age:** 21 Years **Sex:** ALL **Standard Ages:** - ADULT ### IPD Sharing Statement Module **IPD Sharing:** UNDECIDED ## Derived Section ### Condition Browse Module - Ancestors - ID: D000011183 - Term: Postoperative Complications - ID: D000010335 - Term: Pathologic Processes - ID: D000010146 - Term: Pain - ID: D000009461 - Term: Neurologic Manifestations ### Condition Browse Module - Browse Branches - Abbrev: BC23 - Name: Symptoms and General Pathology - Abbrev: All - Name: All Conditions - Abbrev: BC10 - Name: Nervous System Diseases ### Condition Browse Module - Browse Leaves - ID: M13069 - Name: Pain, Postoperative - Relevance: HIGH - As Found: Post Operative Pain - ID: M13066 - Name: Pain - Relevance: LOW - As Found: Unknown - ID: M14065 - Name: Postoperative Complications - Relevance: LOW - As Found: Unknown - ID: M12404 - Name: Neurologic Manifestations - Relevance: LOW - As Found: Unknown ### Condition Browse Module - Meshes - ID: D000010149 - Term: Pain, Postoperative ### Misc Info Module - Version Holder: 2024-05-31
## Protocol Section ### Identification Module **NCT ID:** NCT06418945 **Brief Title:** Clinical Study on the Effect of Removal of Porphyromonas Gingivalis on Prognosis of Esophageal Cancer After Radical Surgery **Official Title:** Porphyromonas Gingivalis Elimination From Oral Improves Esophageal Cancer Patients Survival After Radical Operation #### Organization Study ID Info **ID:** PGESCC001 #### Organization **Class:** OTHER **Full Name:** The First Affiliated Hospital of Henan University of Science and Technology ### Status Module #### Completion Date **Date:** 2027-12-31 **Type:** ESTIMATED #### Expanded Access Info #### Last Update Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Last Update Submit Date:** 2024-05-13 **Overall Status:** NOT_YET_RECRUITING #### Primary Completion Date **Date:** 2026-12-31 **Type:** ESTIMATED #### Start Date **Date:** 2024-08-01 **Type:** ESTIMATED **Status Verified Date:** 2024-05 #### Study First Post Date **Date:** 2024-05-17 **Type:** ACTUAL **Study First Submit Date:** 2024-05-13 **Study First Submit QC Date:** 2024-05-13 ### Sponsor Collaborators Module #### Lead Sponsor **Class:** OTHER **Name:** The First Affiliated Hospital of Henan University of Science and Technology #### Responsible Party **Type:** SPONSOR ### Oversight Module **Is FDA Regulated Device:** False **Is FDA Regulated Drug:** False **Oversight Has DMC:** True ### Description Module **Brief Summary:** Esophagectomy is an important means of radical treatment of esophageal cancer, but due to local recurrence and metastasis, the 5-year survival rate of patients with esophageal cancer is only 20-30%. Studies have reported that about 50% of patients relapse within 1 year after surgery, and the short-term recurrence rate is high. Therefore, reducing the recurrence rate of esophageal cancer after operation is an important way to improve its prognosis. Porphyromonas gingivalis infection in ESCC tissues was significantly higher than that in paracancer tissues, and was significantly positively correlated with cancer cell differentiation, lymph node metastasis, TNM stage, and shortened survival of ESCC patients. In summary, porphyromonas gingivalis plays an important role in postoperative recurrence of esophageal cancer. Elimination of porphyromonas gingivalis can significantly reduce the recurrence rate of esophageal cancer after operation. Tinidazole is a class of nitroimidazole drugs. It has been pointed out that the pharmacological mechanism of Tinidazole is to inhibit the DNA synthesis of pathogenic bacteria, so as to eliminate bacteria in periodontal tissues and inhibit local inflammation. Based on this, we designed and fabricated a novel oral microneedle patch loaded with tinidazole. Tinidazole oral microneedle patch can effectively remove porphyromonas gingivalis and promote the repair of gingival tissue. In this study, based on the combination of mechanical removal and antibacterial treatment, a combination of ultrasonic dental cleaning and tinidazole oral composite microneedle patch was designed to completely remove porphyromonas gingivalis in oral cavity, and to evaluate the effect of removal of porphyromonas gingivalis in oral cavity on the prognosis of esophageal cancer after radical surgery. ### Conditions Module **Conditions:** - Evaluate the DFS of Patients With Esophageal Cancer Who Underwent Radical Operation After Regular Removal of Porphyromonas Gingivalis ### Design Module #### Design Info **Allocation:** RANDOMIZED **Intervention Model:** PARALLEL ##### Masking Info **Masking:** NONE **Primary Purpose:** TREATMENT #### Enrollment Info **Count:** 500 **Type:** ESTIMATED **Phases:** - PHASE3 **Study Type:** INTERVENTIONAL ### Arms Interventions Module #### Arm Group 1 **Description:** The routine follow-up review after radical resection of esophageal cancer was performed according to the schedule requirements **Label:** Arm 1:pg（-） **Type:** NO_INTERVENTION #### Arm Group 2 **Description:** Dental cleaning combined with gum tape treatment every three months until disease progression/recurrence/death or intolerable adverse reactions occur. **Intervention Names:** - Combination Product: Tinidazole oral microneedle patch **Label:** Arm 2:pg（+） **Type:** EXPERIMENTAL #### Arm Group 3 **Description:** The routine follow-up review after radical resection of esophageal cancer was performed according to the schedule requirements **Label:** Arm 3:pg（+） **Type:** NO_INTERVENTION ### Interventions #### Intervention 1 **Arm Group Labels:** - Arm 2:pg（+） **Description:** Ultrasonic teeth cleaning: After gargling with compound chlorhexidine gargle or 3% hydrogen peroxide gargle for 1 minute, the teeth were cleaned by ultrasonic wave. After the teeth were cleaned, the wound was rinsed with 3% hydrogen peroxide to stop bleeding. Immediately after the ultrasonic cleaning, two pieces of tinidazole oral composite microneedle patch were applied to the upper and lower gums close to the inside of the first molar, especially on the tooth loss or damage, and the mouth was kept closed for 15 minutes. After the microneedle was fully degraded, the room could be left. **Name:** Tinidazole oral microneedle patch **Other Names:** - Ultrasonic tooth cleaning **Type:** COMBINATION_PRODUCT ### Outcomes Module #### Primary Outcomes **Description:** Disease-free survival **Measure:** DFS **Time Frame:** 5 years ### Eligibility Module **Eligibility Criteria:** Inclusion Criteria: 1. Age 18-85 years old 2. Histologically confirmed esophageal cancer 3. Patients undergoing radical resection for esophageal cancer who do not require or are not eligible for radiotherapy，T1-T4N0-3M0 4. ECOG：0～1 5. Expected survival ≥12 weeks 6. Radical surgery was performed within 28 days and met R0 criteria 7. The patient did not receive neoadjuvant radiotherapy/neoadjuvant concurrent chemoradiotherapy before surgery and no longer received adjuvant radiotherapy/adjuvant chemoradiotherapy 8. If the major organs function normally, the following criteria are met: HB≥90g/L；b.ANC≥1.5×109/L；c.PLT ≥80×109/L；ALB≥30g/L；b.ALT和AST≤2.5ULN 9. Women of reproductive age should agree to use contraceptives (such as Iuds, contraceptives, or condoms) during the study period and for 6 months after the study ends; Have a negative serum or urine pregnancy test within 7 days prior to study enrollment and must be a non-lactating patient; Men should consent to patients who must use contraception during the study period and for 6 months after the end of the study period 10. The subjects voluntarily joined the study, signed informed consent, had good compliance, and cooperated with follow-up Exclusion Criteria: 1. Does not meet the above inclusion criteria 2. Patients with distant visceral metastases 3. Patients requiring adjuvant radiotherapy after neoadjuvant radiotherapy or radical surgery 4. Allergic to tinidazole or metabolic disorder 5. Patients in need of warfarin anticoagulation and those unable to abstain from alcohol 6. Patients who do not tolerate ultrasonic dental cleaning 7. Pregnant or lactating women 8. Patients with other malignancies within 5 years (except cured basal cell carcinoma of the skin and cervical carcinoma in situ) 9. Patients with a history of psychotropic substance abuse who are unable to abstain or have mental disorders 10. Patients who have participated in clinical trials of other drugs within four weeks 11. Patients with concomitant diseases that, in the investigator's judgment, seriously endanger patient safety or interfere with the patient's completion of the study 12. Patients with recurrent mouth ulcers or other oral diseases that affect the oral flora 13. Patients with chronic infectious diseases or autoimmune diseases requiring prolonged or repeated use of antimicrobials or glucocorticoids 14. The researchers did not consider it suitable for inclusion **Maximum Age:** 85 Years **Minimum Age:** 18 Years **Sex:** ALL **Standard Ages:** - ADULT - OLDER_ADULT ### IPD Sharing Statement Module **Info Types:** - STUDY_PROTOCOL **IPD Sharing:** YES ## Derived Section ### Condition Browse Module - Ancestors - ID: D000005770 - Term: Gastrointestinal Neoplasms - ID: D000004067 - Term: Digestive System Neoplasms - ID: D000009371 - Term: Neoplasms by Site - ID: D000009369 - Term: Neoplasms - ID: D000006258 - Term: Head and Neck Neoplasms - ID: D000004066 - Term: Digestive System Diseases - ID: D000004935 - Term: Esophageal Diseases - ID: D000005767 - Term: Gastrointestinal Diseases ### Condition Browse Module - Browse Branches - Abbrev: BC04 - Name: Neoplasms - Abbrev: BC06 - Name: Digestive System Diseases - Abbrev: All - Name: All Conditions - Abbrev: Rare - Name: Rare Diseases ### Condition Browse Module - Browse Leaves - ID: M8088 - Name: Esophageal Neoplasms - Relevance: HIGH - As Found: Esophageal Cancer - ID: M8886 - Name: Gastrointestinal Neoplasms - Relevance: LOW - As Found: Unknown - ID: M7256 - Name: Digestive System Neoplasms - Relevance: LOW - As Found: Unknown - ID: M9348 - Name: Head and Neck Neoplasms - Relevance: LOW - As Found: Unknown - ID: M8883 - Name: Gastrointestinal Diseases - Relevance: LOW - As Found: Unknown - ID: M7255 - Name: Digestive System Diseases - Relevance: LOW - As Found: Unknown - ID: M8085 - Name: Esophageal Diseases - Relevance: LOW - As Found: Unknown - ID: T2141 - Name: Esophageal Cancer - Relevance: HIGH - As Found: Esophageal Cancer ### Condition Browse Module - Meshes - ID: D000004938 - Term: Esophageal Neoplasms ### Intervention Browse Module - Ancestors - ID: D000000477 - Term: Alkylating Agents - ID: D000045504 - Term: Molecular Mechanisms of Pharmacological Action - ID: D000000900 - Term: Anti-Bacterial Agents - ID: D000000890 - Term: Anti-Infective Agents - ID: D000000994 - Term: Antitrichomonal Agents - ID: D000000981 - Term: Antiprotozoal Agents - ID: D000000977 - Term: Antiparasitic Agents ### 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: M16768 - Name: Tinidazole - Relevance: HIGH - As Found: Cediranib - ID: M344731 - Name: Chlorhexidine gluconate - Relevance: LOW - As Found: Unknown - ID: M9918 - Name: Hydrogen Peroxide - Relevance: LOW - As Found: Unknown - ID: M3820 - Name: Alkylating Agents - Relevance: LOW - As Found: Unknown - ID: M4222 - Name: Anti-Bacterial Agents - Relevance: LOW - As Found: Unknown - ID: M4214 - Name: Anti-Infective Agents - Relevance: LOW - As Found: Unknown - ID: M4298 - Name: Antiprotozoal Agents - Relevance: LOW - As Found: Unknown - ID: M4294 - Name: Antiparasitic Agents - Relevance: LOW - As Found: Unknown ### Intervention Browse Module - Meshes - ID: D000014011 - Term: Tinidazole ### Misc Info Module - Version Holder: 2024-05-31